The other special provisions tucked in the bill to reward other big Republican contributors are almost as disgusting. I must admit that the amendment protecting the Eli Lily Co. from future lawsuits is a fine example of really fast service for a contributor. It was just a few weeks ago that The New York Times ran the first serious look at Thimerosal, the vaccine preservative that may be related to autism, and -- wham, bam -- no problem for the Lily company. (And don't give me that bull about how it's just an arbitration panel, parents can still sue, yaddda, yadda, yadda. The purpose of that stinking amendment could not possibly be clearer. The Lily Co. bought itself a very nice piece of legislation indeed.)"
http://www.workingforchange.com/article.cfm?itemid=14125
Enough pork to gag a maggot
Molly Ivins - Creators Syndicate
11.26.02 - AUSTIN, Texas -- OK, Republicans, justify this. I want to hear your explanations for why the Republican leadership went against the will of 318 members to grant an unconscionable gift to corporations that set up offshore tax shelters to avoid paying their U.S. taxes. Come on, Rush, I really want to hear this one -- and do, please, include the word "patriotism." According to Citizens for Tax Justice, the offshore tax-shelter dodge costs this country as much as $50 billion annually. An amendment to the Homeland Security bill would not have shut down the loophole -- though Lord knows that needs to be done -– but it would have prevented rewarding these financial traitors with government contracts. The House leadership -- that would be your speaker, Dennis Hastert, and your majority leader, Dick Armey -- going against the will of both the House and the Senate, took out the "Wellstone Amendment," sponsored by the late populist senator. It would have prevented runaway companies, those that set up mailboxes in Bermuda in order to avoid paying their taxes, from getting government contracts related to homeland security. They replaced the Wellstone Amendment with a toothless provision that affects no company. The polite term for these corporate tax-dodgers is "corporate inversion" or "corporate expatriates," but they are tax cheats, pure and simple. They don't move anywhere, they just get a shell address so they won't have to pay their share of the taxes. And guess who gets stuck paying their share instead? And now we're going to reward these tax cheats with government contracts.
Here's Rep. Richard Neal of Massachusetts on how it works: "Let's take Tyco, formerly of New Hampshire, now of Bermuda, for example. Tyco avoids paying $400 million a year in U.S. taxes by setting up a shell headquarters offshore, but it was awarded $182 million in lucrative defense and homeland security-related contracts in 2001 alone. If Tyco had just paid its tax bill, Congress could easily have paid for 400 explosive detection systems (EDS), which are badly needed to protect U.S. travelers at airports around the nation.
"Or let's examine corporate expatriate Ingersoll-Rand, formerly of New Jersey, and now also in Bermuda. Ingersoll-Rand earned as much last year in U.S. defense and homeland security federal contracts as it avoids in U.S. taxes annually merely by renting a mailbox in Bermuda and calling it ‘home'. If Ingersoll-Rand paid its U.S. tax bill, Congress could easily afford to fund the Cyberspace Warning Intelligence Network, estimated to cost $30 million, or it could also buy 400,000 gas masks for American citizens."
If this is what Republicans want to stand for, fine with me. Their leadership has thwarted all efforts to have a debate and vote on a separate bill, the Corporate Patriot Enforcement Act, a bipartisan bill to deny benefits to corporations that flee to tax havens. In Texas, the home of the blunt, we call legislators who sell out the people in order to kiss the butts of their campaign contributors "whores."
And why would Republicans do such a despicable thing? Well, let's look at the lobbyists hired to fight the offshore provision: former Republican presidential candidate Robert Dole (paid by Tyco), former House Ways and Means Chairman Bill Archer, Bush family confidant Charlie Black, former
House Appropriations Committee Chair Robert Livingston, former Sen. Dennis DeConcini (one of the Keating Five) and Reagan White house Chief of Staff Kenneth Duberstein.
Here's the good news: If the people ever put up enough money, we could get exactly the same team to argue for our side. That's what I mean by "whores".
The D's, plus Sen. John McCain, tried to get this and other obnoxious special-interest provisions taken out of the bill. So the R's promised to "tone down" the offensive amendments with corrective legislation -- sometime next year. But the incoming House Majority Leader Tom DeLay has already announced that he agreed only to "consider" such changes, not actually make them. Don't put any money on this prospect.
The Homeland Security bill was 35 pages long when President Bush, who had long opposed it, did a 180 in the summer and pretended he invented it. He decided to support it instead of ignoring the proposal by Democrats (one of those "down the memory hole" moments for the D.C. press corps, which keeps announcing the bill's passage is "a major victory" for the Bush administration). By then, the "Homeland Security" bill had become a 435-page behemoth, so larded with pork and special-interest legislation that Sen. Robert Byrd (no stranger to pork) kept dropping the triple-phone-book sized bill on his desk, repeatedly calling it "this mon-stros-ity."
It's one thing to pass this kind of special interest legislation. It's another to call it "patriotism." That could gag a maggot.
© 2002 Creators Syndicate
Leaves'Average guy' image worked
By Carrie Hedges, USA TODAY
http://www.usatoday.com/news/politicselections/vote2004/2004-11-03-daniels-p
rofile_x.htm (scroll to the bottom)
Millionaire businessman Mitch Daniels, who was White House budget director under President Bush, won the Indiana governorship after touring the state in a recreational vehicle and promising to do "everything possible to make sure that the next job is created in Indiana and not somewhere else." Republican candidate for governor of Indiana Mitch Daniels talks to supporters during a victory rally in Indianapolis.
Darron Cummings, AP
Daniels, 55, who had never before run for office, showed strong campaign skills as he shook hands and promised to protect jobs. His "average guy" image seemed to work with fellow Hoosiers, and his well-known RV doubled as campaign headquarters. His campaign motto was "My Main Mitch," Bush's term for him.
Daniels was nicknamed "The Blade" by Bush because of his cost-slashing reputation as director of the Office of Management and Budget. His campaign focused on Indiana's economic troubles. His "time for a change" theme seemed to resonate with voters after 16 years of Democratic governors. He ran a tight race with incumbent Democrat Joe Kernan, a former lieutenant governor who took the office in 2003 after Gov. Frank O'Bannon died of a stroke.
As governor, Daniels will have to deal with an $830 million budget deficit. He has said he would work to stem the tide of fleeing businesses and to keep university graduates from leaving Indiana in search of better opportunities. Daniels was chief of staff to Sen. Richard Lugar, R-Ind., and adviser to President Reagan in the mid-1980s. He returned to Indiana to become a top executive at pharmaceutical giant Eli Lilly. An elder at his local Presbyterian church in Indianapolis, Daniels founded the Oaks Academy, a Christian inner-city school. He is married and has four grown daughters.
http://www.newsday.com/news/nationworld/nation/ny-usthim243016566nov24,0,470
7215.story
A Loss For Parents Of Autistic Kids Suits vs. drug makers blocked
By Thomas Frank
WASHINGTON BUREAU
November 24, 2002
Washington - Kathy Kilpatrick knows her 6-year-old daughter, Mary Kate, will never experience a normal life, because autism makes her almost unable to express feelings and needs. The privation has long saddened Kilpatrick. But last week the Jericho woman grew irate when Republicans in Congress denied her one more thing - the chance to hold someone immediately accountable.
Republicans put a last-minute provision in the homeland-security bill that blocks efforts by Kilpatrick and thousands of parents of autistic children to sue manufacturers of a children's-vaccine additive that may cause autism. The provision diverts a potential tidal wave of claims - none of them proven - that experts say could rival lawsuits filed over asbestos. Republicans say lawsuits might ruin companies whose capacity to produce vaccines is essential to fight the heightened threat of a biochemical terrorist attack.
But experts and critics call the provision a back-door gift to politically influential drug companies, particularly Eli Lilly and Co., whose chairman, Sidney Taurel, is on the White House Advisory Council on Homeland Security. The provision would extend the liability protection now given for vaccines to vaccine additives.
One additive faces serious medical questions and legal claims:thimerosal, invented by Lilly and used until recently in many common children's vaccines. An estimated 150 individual autism lawsuits and thousands more under preparation target Lilly.
But now families like the Kilpatricks must file claims with a federal compensation fund that pays medical costs and up to $250,000 more for pain and suffering, but makes no finding of fault. Plaintiffs can reject settlement offers and sue in court, but face tougher legal standards for
winning punitive damages.
It's the corporate protection - not the cash limit - that enrages Kilpatrick.
"They need to be held accountable. The thought that my daughter could be living a normal life - she could be on a soccer team, she could be going to birthday parties, she could fall in love some day - none of those things are going to happen. Ever," she said.
Experts were stunned at how the liability provision was rammed through Congress with little deliberation, circumventing the usual committee process. Lawrence Gostin, director of the Center for Law and the Public's Health a t Georgetown and Johns Hopkins universities, agreed the liability protection should help assure vaccine supplies. But, he added, "We could have also done it by just giving a trillion dollars to the vaccine industry." "Liability is there for important and complex reasons," Gostin said, citing negligence prevention and victim compensation.
The real problem with the U.S. vaccine supply is not that lawsuits threaten manufacturers, Gostin said, but that there is no national strategy to ensure that important vaccines are produced. "If the sole concern was the national interest, there would have been a full and open debate about the best way to ensure stable investment and procurement of vaccines," Gostin said. But that wasn't done when Republicans took the one-page liability provision out of a stalled bill on vaccines and added it to the 484-page homeland-security bill charging toward approval.
"It's one small item plucked out in the most crude possible way," Gostin said.
Democrats called it payback to the pharmaceutical industry, which has given Republicans $14 million since January 2001, and $5.2 million to Democrats, according to the nonpartisan Center for Responsive Politics. They also questioned the influence of Mitch Daniels, Eli Lilly's former director of North American operations who is director of the White House Office of Management and Budget.
Management and budget office spokesman Trent Duffy dismissed the charge, noting Daniels had divested himself of all Lilly holdings. And Republicans said Democrats were beholden to lawyers, who opposed the provision and have given Democrats $45 million since January 2001 versus
$17.5 million to Republicans.
Still, Republican leaders have backed off their late additions to the homeland security bill. "Some provisions went beyond what we needed to do," Senate Minority Leader Trent Lott (R-Miss.) conceded. "The speaker agreed to work on these issues," said an aide to House Speaker Dennis Hastert (R-Ill.). "I don't know that there was really any specific agreement made." That comment seems to undermine moderate Republican senators, who said party leaders promised to modify the
liability protection so it doesn't nullify pending lawsuits.
The liability protection was added as many people have blamed thimerosal for the tripling of autism cases in the last decade. The Food and Drug Administration advanced speculation in 1999 when it said infants who get recommended immunizations receive excessive mercury. It asked vaccine makers to stop using mercury-based thimerosal, which was used to prevent contamination when doctors jabbed a needle into the same vial to vaccinate child after child.
Last year, the Institute of Medicine said evidence was inadequate to find or deny a link between thimerosal and autism, a developmental disability that usually appears within the first three years of life, but "the hypothesis is biologically plausible."
The possible connection opened new avenues for lawsuits over thimerosal. Since 1988, vaccine manufacturers had been protected from liability when Congress started the federal compensation fund to compensate people claiming vaccine-related injuries. But the fund, financed with a vaccine-sales tax, proved slow and difficult. A 1999 government audit found that claims typically took more than two years, and that the government was fighting them with unexpected vigor: 68 percent of the 5,566 resolved claims have been rejected to date, leaving the fund with a $1.8 billion balance.
Thimerosal seemed to provide a way to sue its manufacturers and vaccine makers who used it directly because as an additive, it was not protected by the fund. Mike Hugo, a Boston lawyer working on 1,000 thimerosal cases, said vaccine manufacturers knew of risks in the 1970s but "continued to use thimerosal, even though scientists were telling them other things may be safer."
Industry officials denied the charge.
Republicans also noted that the liability protections were recommended by the American Academy of Pediatrics and the compensation fund's advisory commission to help stabilize the vaccine industry.
Other advocates had sought to make the fund more friendly to victims and had competing legislation. "But," said Rep. Henry Waxman (D-Calif.), whohelped create the vaccine fund, "the administration and the Republican leadership have chosen to ignore those and move only on some industry protections."
Copyright © 2002, Newsday, Inc.
http://www.workingforchange.com/article.cfm?itemid=14125
Enough pork to gag a maggot
Molly Ivins - Creators Syndicate
11.26.02 - AUSTIN, Texas -- OK, Republicans, justify this. I want to hear your explanations for why the Republican leadership went against the will of 318 members to grant an unconscionable gift to corporations that set up offshore tax shelters to avoid paying their U.S. taxes. Come on, Rush, I really want to hear this one -- and do, please, include the word "patriotism." According to Citizens for Tax Justice, the offshore tax-shelter dodge costs this country as much as $50 billion annually. An amendment to the Homeland Security bill would not have shut down the loophole -- though Lord knows that needs to be done -– but it would have prevented rewarding these financial traitors with government contracts. The House leadership -- that would be your speaker, Dennis Hastert, and your majority leader, Dick Armey -- going against the will of both the House and the Senate, took out the "Wellstone Amendment," sponsored by the late populist senator. It would have prevented runaway companies, those that set up mailboxes in Bermuda in order to avoid paying their taxes, from getting government contracts related to homeland security. They replaced the Wellstone Amendment with a toothless provision that affects no company. The polite term for these corporate tax-dodgers is "corporate inversion" or "corporate expatriates," but they are tax cheats, pure and simple. They don't move anywhere, they just get a shell address so they won't have to pay their share of the taxes. And guess who gets stuck paying their share instead? And now we're going to reward these tax cheats with government contracts.
Here's Rep. Richard Neal of Massachusetts on how it works: "Let's take Tyco, formerly of New Hampshire, now of Bermuda, for example. Tyco avoids paying $400 million a year in U.S. taxes by setting up a shell headquarters offshore, but it was awarded $182 million in lucrative defense and homeland security-related contracts in 2001 alone. If Tyco had just paid its tax bill, Congress could easily have paid for 400 explosive detection systems (EDS), which are badly needed to protect U.S. travelers at airports around the nation.
"Or let's examine corporate expatriate Ingersoll-Rand, formerly of New Jersey, and now also in Bermuda. Ingersoll-Rand earned as much last year in U.S. defense and homeland security federal contracts as it avoids in U.S. taxes annually merely by renting a mailbox in Bermuda and calling it ‘home'. If Ingersoll-Rand paid its U.S. tax bill, Congress could easily afford to fund the Cyberspace Warning Intelligence Network, estimated to cost $30 million, or it could also buy 400,000 gas masks for American citizens."
If this is what Republicans want to stand for, fine with me. Their leadership has thwarted all efforts to have a debate and vote on a separate bill, the Corporate Patriot Enforcement Act, a bipartisan bill to deny benefits to corporations that flee to tax havens. In Texas, the home of the blunt, we call legislators who sell out the people in order to kiss the butts of their campaign contributors "whores."
And why would Republicans do such a despicable thing? Well, let's look at the lobbyists hired to fight the offshore provision: former Republican presidential candidate Robert Dole (paid by Tyco), former House Ways and Means Chairman Bill Archer, Bush family confidant Charlie Black, former
House Appropriations Committee Chair Robert Livingston, former Sen. Dennis DeConcini (one of the Keating Five) and Reagan White house Chief of Staff Kenneth Duberstein.
Here's the good news: If the people ever put up enough money, we could get exactly the same team to argue for our side. That's what I mean by "whores".
The D's, plus Sen. John McCain, tried to get this and other obnoxious special-interest provisions taken out of the bill. So the R's promised to "tone down" the offensive amendments with corrective legislation -- sometime next year. But the incoming House Majority Leader Tom DeLay has already announced that he agreed only to "consider" such changes, not actually make them. Don't put any money on this prospect.
The Homeland Security bill was 35 pages long when President Bush, who had long opposed it, did a 180 in the summer and pretended he invented it. He decided to support it instead of ignoring the proposal by Democrats (one of those "down the memory hole" moments for the D.C. press corps, which keeps announcing the bill's passage is "a major victory" for the Bush administration). By then, the "Homeland Security" bill had become a 435-page behemoth, so larded with pork and special-interest legislation that Sen. Robert Byrd (no stranger to pork) kept dropping the triple-phone-book sized bill on his desk, repeatedly calling it "this mon-stros-ity."
It's one thing to pass this kind of special interest legislation. It's another to call it "patriotism." That could gag a maggot.
© 2002 Creators Syndicate
Leaves'Average guy' image worked
By Carrie Hedges, USA TODAY
http://www.usatoday.com/news/politicselections/vote2004/2004-11-03-daniels-p
rofile_x.htm (scroll to the bottom)
Millionaire businessman Mitch Daniels, who was White House budget director under President Bush, won the Indiana governorship after touring the state in a recreational vehicle and promising to do "everything possible to make sure that the next job is created in Indiana and not somewhere else." Republican candidate for governor of Indiana Mitch Daniels talks to supporters during a victory rally in Indianapolis.
Darron Cummings, AP
Daniels, 55, who had never before run for office, showed strong campaign skills as he shook hands and promised to protect jobs. His "average guy" image seemed to work with fellow Hoosiers, and his well-known RV doubled as campaign headquarters. His campaign motto was "My Main Mitch," Bush's term for him.
Daniels was nicknamed "The Blade" by Bush because of his cost-slashing reputation as director of the Office of Management and Budget. His campaign focused on Indiana's economic troubles. His "time for a change" theme seemed to resonate with voters after 16 years of Democratic governors. He ran a tight race with incumbent Democrat Joe Kernan, a former lieutenant governor who took the office in 2003 after Gov. Frank O'Bannon died of a stroke.
As governor, Daniels will have to deal with an $830 million budget deficit. He has said he would work to stem the tide of fleeing businesses and to keep university graduates from leaving Indiana in search of better opportunities. Daniels was chief of staff to Sen. Richard Lugar, R-Ind., and adviser to President Reagan in the mid-1980s. He returned to Indiana to become a top executive at pharmaceutical giant Eli Lilly. An elder at his local Presbyterian church in Indianapolis, Daniels founded the Oaks Academy, a Christian inner-city school. He is married and has four grown daughters.
http://www.newsday.com/news/nationworld/nation/ny-usthim243016566nov24,0,470
7215.story
A Loss For Parents Of Autistic Kids Suits vs. drug makers blocked
By Thomas Frank
WASHINGTON BUREAU
November 24, 2002
Washington - Kathy Kilpatrick knows her 6-year-old daughter, Mary Kate, will never experience a normal life, because autism makes her almost unable to express feelings and needs. The privation has long saddened Kilpatrick. But last week the Jericho woman grew irate when Republicans in Congress denied her one more thing - the chance to hold someone immediately accountable.
Republicans put a last-minute provision in the homeland-security bill that blocks efforts by Kilpatrick and thousands of parents of autistic children to sue manufacturers of a children's-vaccine additive that may cause autism. The provision diverts a potential tidal wave of claims - none of them proven - that experts say could rival lawsuits filed over asbestos. Republicans say lawsuits might ruin companies whose capacity to produce vaccines is essential to fight the heightened threat of a biochemical terrorist attack.
But experts and critics call the provision a back-door gift to politically influential drug companies, particularly Eli Lilly and Co., whose chairman, Sidney Taurel, is on the White House Advisory Council on Homeland Security. The provision would extend the liability protection now given for vaccines to vaccine additives.
One additive faces serious medical questions and legal claims:thimerosal, invented by Lilly and used until recently in many common children's vaccines. An estimated 150 individual autism lawsuits and thousands more under preparation target Lilly.
But now families like the Kilpatricks must file claims with a federal compensation fund that pays medical costs and up to $250,000 more for pain and suffering, but makes no finding of fault. Plaintiffs can reject settlement offers and sue in court, but face tougher legal standards for
winning punitive damages.
It's the corporate protection - not the cash limit - that enrages Kilpatrick.
"They need to be held accountable. The thought that my daughter could be living a normal life - she could be on a soccer team, she could be going to birthday parties, she could fall in love some day - none of those things are going to happen. Ever," she said.
Experts were stunned at how the liability provision was rammed through Congress with little deliberation, circumventing the usual committee process. Lawrence Gostin, director of the Center for Law and the Public's Health a t Georgetown and Johns Hopkins universities, agreed the liability protection should help assure vaccine supplies. But, he added, "We could have also done it by just giving a trillion dollars to the vaccine industry." "Liability is there for important and complex reasons," Gostin said, citing negligence prevention and victim compensation.
The real problem with the U.S. vaccine supply is not that lawsuits threaten manufacturers, Gostin said, but that there is no national strategy to ensure that important vaccines are produced. "If the sole concern was the national interest, there would have been a full and open debate about the best way to ensure stable investment and procurement of vaccines," Gostin said. But that wasn't done when Republicans took the one-page liability provision out of a stalled bill on vaccines and added it to the 484-page homeland-security bill charging toward approval.
"It's one small item plucked out in the most crude possible way," Gostin said.
Democrats called it payback to the pharmaceutical industry, which has given Republicans $14 million since January 2001, and $5.2 million to Democrats, according to the nonpartisan Center for Responsive Politics. They also questioned the influence of Mitch Daniels, Eli Lilly's former director of North American operations who is director of the White House Office of Management and Budget.
Management and budget office spokesman Trent Duffy dismissed the charge, noting Daniels had divested himself of all Lilly holdings. And Republicans said Democrats were beholden to lawyers, who opposed the provision and have given Democrats $45 million since January 2001 versus
$17.5 million to Republicans.
Still, Republican leaders have backed off their late additions to the homeland security bill. "Some provisions went beyond what we needed to do," Senate Minority Leader Trent Lott (R-Miss.) conceded. "The speaker agreed to work on these issues," said an aide to House Speaker Dennis Hastert (R-Ill.). "I don't know that there was really any specific agreement made." That comment seems to undermine moderate Republican senators, who said party leaders promised to modify the
liability protection so it doesn't nullify pending lawsuits.
The liability protection was added as many people have blamed thimerosal for the tripling of autism cases in the last decade. The Food and Drug Administration advanced speculation in 1999 when it said infants who get recommended immunizations receive excessive mercury. It asked vaccine makers to stop using mercury-based thimerosal, which was used to prevent contamination when doctors jabbed a needle into the same vial to vaccinate child after child.
Last year, the Institute of Medicine said evidence was inadequate to find or deny a link between thimerosal and autism, a developmental disability that usually appears within the first three years of life, but "the hypothesis is biologically plausible."
The possible connection opened new avenues for lawsuits over thimerosal. Since 1988, vaccine manufacturers had been protected from liability when Congress started the federal compensation fund to compensate people claiming vaccine-related injuries. But the fund, financed with a vaccine-sales tax, proved slow and difficult. A 1999 government audit found that claims typically took more than two years, and that the government was fighting them with unexpected vigor: 68 percent of the 5,566 resolved claims have been rejected to date, leaving the fund with a $1.8 billion balance.
Thimerosal seemed to provide a way to sue its manufacturers and vaccine makers who used it directly because as an additive, it was not protected by the fund. Mike Hugo, a Boston lawyer working on 1,000 thimerosal cases, said vaccine manufacturers knew of risks in the 1970s but "continued to use thimerosal, even though scientists were telling them other things may be safer."
Industry officials denied the charge.
Republicans also noted that the liability protections were recommended by the American Academy of Pediatrics and the compensation fund's advisory commission to help stabilize the vaccine industry.
Other advocates had sought to make the fund more friendly to victims and had competing legislation. "But," said Rep. Henry Waxman (D-Calif.), whohelped create the vaccine fund, "the administration and the Republican leadership have chosen to ignore those and move only on some industry protections."
Copyright © 2002, Newsday, Inc.
PROTECTION MONEY
The Health Sciences Institute e-Alert
December 2, 2002
Dear Reader,
The new Homeland Security Act is designed to protect Americans from terrorist attacks. But you may be comforted to find out that an additional provision was added to the act so that American corporations will also be protected from the parents of autistic children.
Before the age of two, most infants in America receive 18 vaccinations, and on average about 12 of them contain a preservative that's loaded with mercury. The evidence that mercury poisoning from those vaccines sometimes causes autism in otherwise healthy kids is so overwhelming that it's got plenty of people very scared. And no one is more scared than the executives at Eli Lilly, the drug giant that makes thimerosal, the mercury-based vaccine preservative.
The higher-ups at Lilly are addressing this situation aggressively. Are they making sure that not one child will ever again be injected with a vaccine containing mercury? No. But they are going to enormous trouble and expense to protect their company from lawsuits filed against them by parents whose children now suffer severe neurological damage. And this protection comes courtesy of the U.S. Senate, through the Homeland Security Act, signed into law just a few days ago.
Two articles about this controversy appeared in the New York Times last week. The first made me angry - then the second just made me angrier. Because this transparent "gift" to a well-connected drug company gets more and more unseemly with each new revelation.
-------------------------------------------------------------
A ticking bomb
-------------------------------------------------------------
More than 75 years ago, Eli Lilly & Company developed thimerosal, the vaccine preservative that contains approximately 50% mercury. In recent decades, scientists have shown that mercury is a dangerous neurotoxin. No surprise then that the high levels of mercury detected in many young children in America have been directly linked to permanent neurological damage, including autism. And the one thing all of these children have in common is that they received multiple vaccinations, beginning in the first months of their lives.
Lilly denies this connection, of course. But it obviously scares the heck out of them. Even the FDA has admitted the connection, although this admission is couched in the softest possible language, stating that "concerns" have been raised, and claiming that the agency is working with vaccine manufacturers to "reduce or eliminate thimerosal from vaccines." And even though it sounds as light as air, we know the FDA doesn't make this sort of statement lightly. Especially when a major drug company has so much at stake.
-------------------------------------------------------------
Defusing the bomb
-------------------------------------------------------------
But when you run an international pharmaceutical company, you don't just let the chips fall where they may. Not at all - you get out there and flex some influential muscle.
During the recent political season, Lilly donated $1.6 million dollars to various candidates - more than any other pharmaceutical company. So it hardly seems like a mysterious coincidence that less than two weeks after the mid-term elections someone in the senate sneaked this vaccine provision into the homeland security bill. And "sneaked" is no exaggeration - the provision was introduced at the 11th hour, as were six other provisions that had nothing whatsoever to do with homeland security. But while tucking "pork" into bills that are about to pass is business-as-usual for congress, the unusual thing about this particular pork chop is that no one is taking credit for it.
As The New York Times reported last Friday, nobody seems to know, or will admit to knowing, who placed the provision in the bill, or even who wrote it. It's almost as if someone is ashamed to be associated with this addition that will simply brush aside both class-action and individual thimerosal lawsuits aimed at Eli Lilly. A spokesman for Lilly said that the company knew absolutely nothing about the sweetheart provision.
Right.
I suppose that includes Sidney Taural, the chairman, president and C.E.O. of Eli Lilly, who has a seat on President Bush's Homeland Security Advisory Council.
Right.
-------------------------------------------------------------
"Working" it out
-------------------------------------------------------------
Well none of this has a very good smell, does it? Even the current senate minority leader Trent Lott recognizes the fishy odor. So to force through the passage of the Homeland Security bill, Senator Lott promised that three of the last-minute provisions (including the vaccine protection) would be reviewed when congress reconvenes next year. He said, "We need to work on those three provisions."
Note that he didn't say that the provisions would be removed, reworded, or changed. He only said, "we need to work" on them. And that's a perfect example of some beautifully vague political-speak for you. Meanwhile, the provision currently stands as law, sufficiently complicating all of those existing lawsuits. It will be very interesting to see just how diligently Senator Lott's "work" proceeds on behalf of a handful of citizens against a deep-pockets pharmaceutical giant like Lilly. Don't get me wrong. I am not a proponent of litigation. But this is not a hot cup of coffee at McDonald's we're talking about. And even if it were, the way it was swept off the table is shameful.
-------------------------------------------------------------
Take care of the kids
-------------------------------------------------------------
Last year, under pressure from the Centers for Disease Control, the Public Health Service, and the American Academy of Pediatrics, pharmaceutical companies agreed to stop manufacturing vaccines that contain thimerosal. But while this mercury-based preservative is no longer in production, stores of vaccines that contain it are still being used. This is a very important detail that all parents of young children should know about because they can tell their pediatricians to use only thimerosal-free vaccines on their children.
Whether or not you're a parent of young children, I hope you'll share this critical information with friends and loved ones whose children are young enough to receive vaccinations. Likewise, if you have a child or know of a child who is showing signs of autism, you can get further information and assistance from the Coalition for SAFE MINDs (Sensible Action For Ending Mercury-Induced Neurological Disorders) - a non-profit organization founded by parents to raise awareness about the exposure to mercury from medical products (safeminds.org).
Personally, I am going to take a few minutes to write to Senators Mikulski and Sarbanes and let them know that I don't consider autistic children terrorists from whom we require protection. You know, for when they "work" on those last-minute provisions.
REVIEW & OUTLOOK
The Truth About Thimerosal
Democrats and trial lawyers play politics with vaccine liability.
Was it nefarious Dick Armey? Dastardly Senator and Dr. Bill Frist? Or maybe a phantom pediatrician, hired by Eli Lilly to haunt the halls of Congress? From the press coverage, you'd think there's no greater question than who put the now-famous thimerosal rider into the Homeland Security Bill. Washington has been so busy playing political "Where's Waldo?" that no one has actually bothered to explain the merits. We're happy to fill this void with the facts, especially because they show that protecting thimerosal from runaway legal liability is the right thing to do as a matter of public health. Far from ducking behind Capitol pillars, Republicans should be trumpeting their support.
The story of thimerosal begins in the 1930s, when it was introduced into vaccines to prevent infections from fungi and bacteria. The preservative, an organic mercury compound, was so safe and uncontroversial that nobody even noticed it for 60 years. Then in 1997, as part of the FDA Modernization Act, Congress required the agency to do an inventory of mercury in all of its licensed drugs and vaccines. By 1999, researchers realized that kids were getting more shots these days, and that the thimerosal combined from all the vaccinations could, theoretically, slightly exceed an EPA mercury guideline. The findings were manna to the small but vocal anti- vaccination lobby that has spent years falsely claiming vaccines cause everything from multiple sclerosis to cancer. They soon claimed that thimerosal caused autism.
In retrospect, the researchers we've talked to agree it was the EPA standard that was the problem. The agency had based its number on a study of pregnant women whose ingestion of significant and sustained amounts of methyl mercury had led to children who later scored slightly lower on neurological and cognitive tests (nothing near autism). The EPA estimated the lowest possible amount a mother could have ingested to be associated with a disorder and then, to be ridiculously safe, divided that by 10. The agency's standard is below that of even the hyper-cautious Food and Drug Administration.
There's little evidence vaccines exceed even that extremely low level. Just last week a University of Rochester study published in Lancet looked at 61 infants--40 receiving vaccines containing thimerosal, and 21 receiving thimerosal-free vaccines. Most children had blood mercury levels of 1 or 2 nanograms per milliliter; the highest level, found in one child, was 4.11 nanograms per milliliter.
By comparison, the EPA standard is 5.9 nanograms per milliliter. The study also found that children excrete ethyl mercury more quickly than expected, so that it doesn't build up from one vaccination to the next. "A mom who eats a tuna fish sandwich probably passes along more mercury during breast-feeding than a kid gets in a vaccination," says Michael Pichichero, the study's lead investigator.
Most important, no scientific study has ever found a link between vaccines and autism, despite years of detailed research into the safety of vaccines. Even the World Health Organization continues to endorse the use of the preservative. Sadly, the real losers of this wild goose chase are parents of autistic children, who've seen anti-vaccinators use their cause to divert time and resources away from legitimate research into the disorder. U.S. public health agencies knew most of this in 1999. But they worried that anti-vaccine groups would use the FDA information to scare parents away from immunizations. So they hastily recommended that manufacturers immediately remove the preservative--a huge mistake.
"We took it out precipitously, which made it look like thimerosal is harmful--when there is no evidence it is. I think we hurt the public trust," said Paul Offit, who sits on the Advisory Committee on Immunization Practices and is chief of infectious diseases at the Children's Hospital of Philadelphia.
The recommendation brought unwarranted fear, vaccine shortages, and . .. .. tort lawyers. Usually, parents of the rare child injured by a vaccine must go through the Vaccine Injury Compensation Program before they can sue in regular courts. Set up by Congress in 1986 after lawsuits all but bankrupted vaccine makers, VICP ensures that victims get compensated quickly for genuine wrongs.
But the tort lawyers hate that VICP cuts out their giant fees, and they saw an opening in thimerosal. They've exploited every loophole to keep frivolous thimerosal cases out of VICP, and have instead filed hundreds of lawsuits against vaccine makers and Eli Lilly (which stopped making thimerosal 10 years ago). The four vaccine makers left are today stuck devoting their funds not to research into new, life-saving vaccines, but to paying legal bills.
These, readers, are the facts behind the thimerosal rider that is supposed to be so scandalous. All the legislation does is require that parents first go through VICP, as with any vaccine claim. They can sue later in other courts, if they choose (and assuming a statute of limitations problem is fixed). The vaccine court is much better positioned than other courts to decide on the merits of thimerosal cases. And it has the added social benefit of protecting vaccine research and production at a time when we need both to defend against bioterror.
None of this makes trial lawyers rich, though, and so they asked Senate Democrats, led by Joe Lieberman, to strip the rider away. They lost, but they did such a good media job that new Majority Leader Trent Lott has promised modifications to protect nervous Republicans who clearly haven't bothered to understand the issue.
We suggest they talk to Dr. Frist, who could supply a nerve transplant. If Republicans can't explain to parents that thimerosal is about supplying safe vaccines to their children, they don't deserve the majority.
Copyright © 2000 Dow Jones & Company, Inc. All Rights Reserved.
WashPost Recap: New Vaccine Clause Angers Parents of Autistic Amendment Buried in Homeland Security Law Restricts Right to Sue Makers of Drug Preservative
[By Susan Warner, special to the Washington Post.]
http://www.washingtonpost.com/wp-dyn/articles/A27949-2002Dec8.html
Thomas Brinker loves to sing and play with string. He watches ABC News anchor Peter Jennings on television every night and shouts: "Tickle Peter Jennings." He's 8 now, but his attention span is short and his temper flares easily. Thomas has autism, a condition his parents believe was caused by a simple childhood immunization. "We're waiting for his first normal moment," said his mother, Donna Brinker of Glen Mills, Pa. It was Donna Brinker's temper that flared when she learned that Congress had quietly restricted her right to sue Eli Lilly and Co. and other manufacturers of Thimerosal, the mercury-based vaccine preservative she believes caused her son's condition. The change came in two paragraphs tacked onto the massive Homeland Security Act just days before Congress approved the legislation in November.
The Brinkers are among 800 families in more than a dozen states that have filed similar cases seeking compensation for the costs of their children's autism. Under the new law, signed by President Bush Nov. 25, the parents are required to file claims with a special administrative court under the National Vaccine Injury Compensation Program before they can take their cases to civil court. The changes could sharply reduce parents' chances of prevailing in civil courts, where damage awards normally could be much higher than those in the "vaccine court." The federal program covers claims for medical and education expenses, but damages for pain, suffering and death are limited to $250,000. Lawyers for the plaintiffs say their awards would likely be higher if they could first take their cases to state courts, where civil juries are known to award millions of dollars in medical injury cases. Meanwhile, the Department of Justice has filed a request to restrict the use of information gathered in vaccine court proceedings in subsequent civil court cases, another potential obstacle for the plaintiffs.
"I felt betrayed," Brinker said of the new legislation. "I believe in protecting our homeland, but it petrifies me to think that our nation would protect any industry at the expense of our children." Penny Starr-Ashton, of Drexel Hill, Pa., whose autistic 6-year-old daughter, Maddie, is another plaintiff in a class-action lawsuit filed in Pennsylvania in July, said it is particularly painful to have the provision wrapped in the flag. "Who doesn't want a safer country?" she asked. "But who's going to protect me? Who's going to protect my child?" The National Institute of Child Health and Human Development estimates that between 1 in 500 and 1 in 1,000 children is diagnosed with autism in the United States each year. Initial studies in the 1960s found four to five cases of autism in every 10,000 people, although the institute cautions that some of the increase could be due to changes in reporting and diagnosing the disease.
A study by the University of California at Davis found that a third of California parents of autistic children diagnosed in the mid-1990s blame vaccines for their children's illnesses. Congress created the National Vaccine Injury Compensation Program in 1986 to address growing concerns about vaccine safety. Claims are filed with the Department of Health and Human Services through the U.S. Court of Federal Claims. The program has paid out 1,775 claims totaling $1.4 billion and is funded by a 75-cent surcharge on every child vaccination.
Brinker said parents of children with signs of mercury poisoning can spend up to $20,000 a year out of pocket. Thomas is undergoing chelation therapy to draw metals out of his body and is on a strict diet. His parents take him to a specialist in Louisiana for treatment, and his mother travels to Mexico to get drugs that are not approved in the United States.
Beyond today's expenses, Brinker worries about supporting Thomas in the long term. "The mercury preservative has deprived Thomas of having a normal life," she said. "That our nation would protect such a killer is beyond comprehension."
Aside from potentially lower awards, Thomas Brinker and Maddie Ashton will have another problem in vaccine court, said their lawyer, Tobi Millrood. Like many children, they were diagnosed with autism more than three years after their vaccinations, beyond the time permitted to file under the program's rules.
Some states, including Oregon, Florida, Louisiana, Illinois and California, had ruled that they had jurisdiction over Thimerosal cases, said John Kim, a Houston lawyer who argued against the government's request to close vaccine court records. "Now I guess this new provision in the Homeland Security Act trumps that," Kim said.
Meanwhile, all Thimerosal cases have been put on hold at vaccine court while the court grapples with the scientific debate over the possible causes of autism. The Office of the Special Master, which oversees procedural issues at vaccine court, expects 3,000 to 5,000 filings.
Parents outraged about the last-minute change point to Eli Lilly, the Indianapolis drug maker, as its biggest beneficiary. Lilly invented Thimerosal and manufactured it until the 1980s. The preservative is 50 percent mercury by weight, and had been used in vaccines since the 1930s. Lilly is a defendant in 200 Thimerosal-related lawsuits. "It's turned into being about money," Brinker said. "Parents with kids with autism don't have the money to give to congressmen. It turns out whoever has the most money wins."
The provision in the Homeland Security bill was originally written by Sen. Bill Frist (R-Tenn.), a physician, as part of broader legislation aimed at helping drug companies produce vaccines after post-Sept. 11, 2001, concerns about smallpox and anthrax. The number of U.S. vaccine manufacturers has dropped to four, with companies complaining of low profit margins, manufacturing problems and fear of liability for injury.
Edward G. Sagebiel, a spokesman for Lilly, said his company had no role in pushing the last-minute legislative changes. "We express sympathy for the parents and the children who have suffered adverse reactions," he said. "However, the lawsuits that have been filed against Lilly and other manufacturers are not supported by science."
The House Government Reform Committee has scheduled a hearing on vaccine safety for Tuesday.
In 1999, the Food and Drug Administration conducted a review of Thimerosal and found no evidence of harm beyond limited cases of hypersensitivity to the vaccine. But the same year, the Academy of Pediatrics and the U.S. Public Health Service recommended that Thimerosal be removed from vaccines, partly out of fear that parents would stop immunizing their children and create a bigger public health problem.
In October 2001, the Institute of Medicine, a branch of the National Academy of Sciences, said there was no evidence that Thimerosal caused autism, but it did say the theory was "biologically plausible." Most recently, on Nov. 30, the British medical journal the Lancet published a study showing that infants who received vaccines containing Thimerosal had levels of mercury in their blood that are within federal limits.
Starr-Ashton remains unconvinced. "I don't believe anything that is 50 percent mercury by weight is safe," she said. She noted reports of health damage caused by mercury in fish, thermometers and dental fillings. "I'm not that dumb."
The debate over science has become a furor over the democratic process in the tight-knit community of parents of children with autism that is linked by the Internet and community support groups. "Nobody is owning up to it," Brinker said. "It is so underhanded. I just can't believe our government would do this. We're not going to back down on this issue. We will not be silent."
Starr-Ashton said she is not against vaccines, especially because she taught in a school for the deaf for many years: "I saw first-hand the damage done by rubella." But now she does not know who to trust. "Here I was, a dutiful parent taking my child to do what the government and the Academy of Pediatrics said I should do to protect my child against disease," Starr-Ashton said. "Something went terribly wrong. I need answers."
© 2002 The Washington Post Company
MIKE ARGENTO
Saturday, November 23, 2002
http://ydr.com/story/mike/3940/
Thank God our leaders in Congress were wide awake and working day and night, fingers to the bone, to protect us from the scourge of terrorism by trying to prevent parents of autistic children from suing a drug manufacturer that may have caused their children's autism.
Thank God our leaders in Congress were able to see the threat to our security and safety posed by parents of autistic children.Thank God our leaders in Congress tried to act decisively to keep us safe from parents of autistic children.
Whew.
That was a close one.
We can now feel safe from the threat of parents of autistic children because as we all know - without getting into stereotyping here - parents of autistic children are the real threats to our well being and safety as a nation, and a world, for that matter. Of course, not all parents of autistic children are working to destroy our way of life, and life on this planet in general. No, some parents of autistic children are fine, upstanding Americans, patriotic Americans who are just as concerned as anybody about the threat to our national security posed by other parents of autistic children.
What?
You didn't know of the terrible, terrible threat parents of autistic children pose to our national security?
That's why you're sitting there in your pajamas reading this and not striding through the halls of power in your pajamas right now.
Our members of Congress, in their deep and infinite wisdom, clearly saw the threat of the parents of autistic children and acted accordingly. They made sure that, when they voted to approve the creation of the new Department of Homeland Security, they'd take care of those parents of autistic children.
What they did is slip an amendment into the bill to create the department that would, essentially, forbid parents of autistic children from suing pharmaceutical companies. OK, it was a little more specific than that. According to The Washington Post, the amendment forbids parents from suing the manufacturer of a vaccine that contained a mercury-based preservative that some believe may cause autism.
OK, it was a little more specific than that. The amendment, backed by President Dubya, expanded liability protection for vaccines to ingredients of vaccines, language specifically targeted at helping Eli Lilly and Co.,which is being sued by parents of autistic children for its manufacture and sale of a preservative called Thimerosal.
That's how it works. The law doesn't say, "And the U.S. government gives Eli Lilly a break." But since no other drug companies are being sued for their use of vaccine ingredients, it's apparent that it is intended to help Eli Lilly. You're probably thinking, what does that have to do with protecting the nation from insane people who believe their path to heaven is paved with blood and fire?
That just shows what you know.
It's vitally important to national security that parents of autistic children not be allowed to sue a huge pharmaceutical company because . . .because . . . well, just because.
Republican lawmakers made some lame excuse that pharmaceutical companies that make vaccines that could be used in the event of biological attacks shouldn't have to worry about being saddled by lengthy and costly lawsuits just because they manufactured a product that may have caused life-changing health problems for some children.
Not all Republicans think that way. Our own U.S. Rep. Todd Platts, R-York County, voted for the bill but only because his only other choice was to vote against the whole Homeland Security bill. He said he didn't like that the bill granted immunity to pharmaceutical companies or that it permitted the government to contract with companies that moved their headquarters to Bermuda to avoid paying taxes or that it specified locating the Homeland Security Research Center at Texas A&M. He said he believes Congress will go back in January and take that stuff out.
At least that's the promise the leadership has given.
But given their record for honesty, can you believe them?
Let's look at the Texas A&M thing. The bill never mentioned Texas A&M. It just listed 15 criteria for the research center that, put together, meant Texas A&M was the only place in the nation suitable for such an august endeavor. It's not clear whether one requirement was for the school to be nicknamed "Aggies." With Eli Lilly, the congressional and presidential intent seemed to be that Eli Lilly would be so tied up with litigation that it couldn't possibly have the time and energy to make vaccines to protect against attacks that haven't occurred and may never occur.
Poor Eli Lilly.
Good thing it got this break so we can all feel safer.
And it's also a good thing that, between 1997 and 2000, Eli Lilly made $18.4 million in campaign contributions, mostly to Republicans. By giving that money to our lawmakers, Lilly was able to ensure our safety and security by getting Congress to exempt it from lawsuits from parents of autistic children.
You know, they said everything had changed after Sept. 11, 2001. Well, at least one thing hasn't changed.
We still have the best government money can buy. Mike Argento, whose column appears Mondays and Thursdays in the Living section and Saturdays on the editorial page, can be reached atmike@ydr.com.
HURT IN THE NAME OF SECURITY
By Marita Lowman 12/13/2002
When Tara McHale gave birth to her first child, Samantha, she recorded every wonderful moment of her baby's life. The first smile, the first word, the first step, the first hug, the jutting of each tooth, the nuance of each new gesture. In every way, Samantha was developmentally on target. At 15 months, she walked and talked and joyfully played.
Then, during a regular medical checkup, the pediatrician injected four childhood vaccines into Samantha's bloodstream. Samantha, of Clarks Summit, has never been the same. The next morning, her cognitive skills were dulled. Her physical abilities spun backward.
When she was 4, she could not be toilet trained. She no longer made eye contact. Her speech shrunk to one- or two-word sentences. She flapped her hands in bizarre gestures.All the while, her mother pursued pediatricians, neurologists, audiologists and other professionals to find out what was wrong. In 1997, a developmental pediatrician confirmed the diagnosis. Autism is a neurological condition that forever alters a child's life.
"It was a crushing blow," Mrs. McHale said.
It is a blow most members of Congress know nothing about. So when the federal legislators approved the Homeland Security Act last month, they glossed over a last-minute provision tucked secretly into the bill. It granted Eli Lilly and other pharmaceutical companies retroactive protection from lawsuits such as those that say Lilly's vaccines caused or contributed to autism.
Childhood vaccines have been suspect for many years, but the claims gained more credence when research found dangerously high levels of mercury and the preservative thimerosal in the vaccines. One thousand lawsuits were pending against the vaccine makers, but the last-minute addition to the Homeland Security Bill canceled all of them.
Mrs. McHale, Rita Cheskiewicz, of Dallas, and Frank Scholz, of Mehoopany --all parents of autistic children -- met Thursday with U.S. Rep. Don Sherwood, R-Tunkhannock, to seek his support in overturning the provision.
They are hurt by the government's seemingly cavalier attitude toward children with autism. They are frustrated by what appear to be cozy relationships between pharmaceutical manufacturers and the White House. Mrs. Cheskiewicz, a former administrator at Hahnemann Hospital in Philadelphia, gave up her job when her son A.J. was diagnosed with autism. He was normal in every way until age 18 months, when he received three vaccines at once. He stopped speaking and stopped responding to his name. "As a mother, it is heartbreaking, and it did not have to happen," Mrs. Cheskiewicz said.
Mr. Scholz, whose son, Joey, was diagnosed as autistic several years ago, drives two hours a day to take his son to an educational program geared to children with autism. The children will need lifelong care. The parents want more government resources put into autism research. They want more recognition of autism's devastating effects.
Mr. Sherwood, visibly moved by the families' plight, said he will try through the Health and Human Services Committee to direct funding for autism through national health institutions. He also will recommend overturning the Homeland Security provision, but the prospect of success is not good."There will be some support, and I'll give it a shot when we go back into session in January, but to turn the provision around now will be a major proposition," he said.
Samantha McHale is 10 now, and despite intensive care, she is wrapped in the limitations of autism. She needs help dressing, bathing, toileting. She doesn't understand gender or relationships, time or numbers. She does not recognize family names, and when she's in pain, she cannot explain why or where she hurts. She does not go to ballet classes or listen to music with friends or take part in other activities most 10-year-old girls enjoy.
The Health Sciences Institute e-Alert
December 2, 2002
Dear Reader,
The new Homeland Security Act is designed to protect Americans from terrorist attacks. But you may be comforted to find out that an additional provision was added to the act so that American corporations will also be protected from the parents of autistic children.
Before the age of two, most infants in America receive 18 vaccinations, and on average about 12 of them contain a preservative that's loaded with mercury. The evidence that mercury poisoning from those vaccines sometimes causes autism in otherwise healthy kids is so overwhelming that it's got plenty of people very scared. And no one is more scared than the executives at Eli Lilly, the drug giant that makes thimerosal, the mercury-based vaccine preservative.
The higher-ups at Lilly are addressing this situation aggressively. Are they making sure that not one child will ever again be injected with a vaccine containing mercury? No. But they are going to enormous trouble and expense to protect their company from lawsuits filed against them by parents whose children now suffer severe neurological damage. And this protection comes courtesy of the U.S. Senate, through the Homeland Security Act, signed into law just a few days ago.
Two articles about this controversy appeared in the New York Times last week. The first made me angry - then the second just made me angrier. Because this transparent "gift" to a well-connected drug company gets more and more unseemly with each new revelation.
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A ticking bomb
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More than 75 years ago, Eli Lilly & Company developed thimerosal, the vaccine preservative that contains approximately 50% mercury. In recent decades, scientists have shown that mercury is a dangerous neurotoxin. No surprise then that the high levels of mercury detected in many young children in America have been directly linked to permanent neurological damage, including autism. And the one thing all of these children have in common is that they received multiple vaccinations, beginning in the first months of their lives.
Lilly denies this connection, of course. But it obviously scares the heck out of them. Even the FDA has admitted the connection, although this admission is couched in the softest possible language, stating that "concerns" have been raised, and claiming that the agency is working with vaccine manufacturers to "reduce or eliminate thimerosal from vaccines." And even though it sounds as light as air, we know the FDA doesn't make this sort of statement lightly. Especially when a major drug company has so much at stake.
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Defusing the bomb
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But when you run an international pharmaceutical company, you don't just let the chips fall where they may. Not at all - you get out there and flex some influential muscle.
During the recent political season, Lilly donated $1.6 million dollars to various candidates - more than any other pharmaceutical company. So it hardly seems like a mysterious coincidence that less than two weeks after the mid-term elections someone in the senate sneaked this vaccine provision into the homeland security bill. And "sneaked" is no exaggeration - the provision was introduced at the 11th hour, as were six other provisions that had nothing whatsoever to do with homeland security. But while tucking "pork" into bills that are about to pass is business-as-usual for congress, the unusual thing about this particular pork chop is that no one is taking credit for it.
As The New York Times reported last Friday, nobody seems to know, or will admit to knowing, who placed the provision in the bill, or even who wrote it. It's almost as if someone is ashamed to be associated with this addition that will simply brush aside both class-action and individual thimerosal lawsuits aimed at Eli Lilly. A spokesman for Lilly said that the company knew absolutely nothing about the sweetheart provision.
Right.
I suppose that includes Sidney Taural, the chairman, president and C.E.O. of Eli Lilly, who has a seat on President Bush's Homeland Security Advisory Council.
Right.
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"Working" it out
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Well none of this has a very good smell, does it? Even the current senate minority leader Trent Lott recognizes the fishy odor. So to force through the passage of the Homeland Security bill, Senator Lott promised that three of the last-minute provisions (including the vaccine protection) would be reviewed when congress reconvenes next year. He said, "We need to work on those three provisions."
Note that he didn't say that the provisions would be removed, reworded, or changed. He only said, "we need to work" on them. And that's a perfect example of some beautifully vague political-speak for you. Meanwhile, the provision currently stands as law, sufficiently complicating all of those existing lawsuits. It will be very interesting to see just how diligently Senator Lott's "work" proceeds on behalf of a handful of citizens against a deep-pockets pharmaceutical giant like Lilly. Don't get me wrong. I am not a proponent of litigation. But this is not a hot cup of coffee at McDonald's we're talking about. And even if it were, the way it was swept off the table is shameful.
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Take care of the kids
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Last year, under pressure from the Centers for Disease Control, the Public Health Service, and the American Academy of Pediatrics, pharmaceutical companies agreed to stop manufacturing vaccines that contain thimerosal. But while this mercury-based preservative is no longer in production, stores of vaccines that contain it are still being used. This is a very important detail that all parents of young children should know about because they can tell their pediatricians to use only thimerosal-free vaccines on their children.
Whether or not you're a parent of young children, I hope you'll share this critical information with friends and loved ones whose children are young enough to receive vaccinations. Likewise, if you have a child or know of a child who is showing signs of autism, you can get further information and assistance from the Coalition for SAFE MINDs (Sensible Action For Ending Mercury-Induced Neurological Disorders) - a non-profit organization founded by parents to raise awareness about the exposure to mercury from medical products (safeminds.org).
Personally, I am going to take a few minutes to write to Senators Mikulski and Sarbanes and let them know that I don't consider autistic children terrorists from whom we require protection. You know, for when they "work" on those last-minute provisions.
REVIEW & OUTLOOK
The Truth About Thimerosal
Democrats and trial lawyers play politics with vaccine liability.
Was it nefarious Dick Armey? Dastardly Senator and Dr. Bill Frist? Or maybe a phantom pediatrician, hired by Eli Lilly to haunt the halls of Congress? From the press coverage, you'd think there's no greater question than who put the now-famous thimerosal rider into the Homeland Security Bill. Washington has been so busy playing political "Where's Waldo?" that no one has actually bothered to explain the merits. We're happy to fill this void with the facts, especially because they show that protecting thimerosal from runaway legal liability is the right thing to do as a matter of public health. Far from ducking behind Capitol pillars, Republicans should be trumpeting their support.
The story of thimerosal begins in the 1930s, when it was introduced into vaccines to prevent infections from fungi and bacteria. The preservative, an organic mercury compound, was so safe and uncontroversial that nobody even noticed it for 60 years. Then in 1997, as part of the FDA Modernization Act, Congress required the agency to do an inventory of mercury in all of its licensed drugs and vaccines. By 1999, researchers realized that kids were getting more shots these days, and that the thimerosal combined from all the vaccinations could, theoretically, slightly exceed an EPA mercury guideline. The findings were manna to the small but vocal anti- vaccination lobby that has spent years falsely claiming vaccines cause everything from multiple sclerosis to cancer. They soon claimed that thimerosal caused autism.
In retrospect, the researchers we've talked to agree it was the EPA standard that was the problem. The agency had based its number on a study of pregnant women whose ingestion of significant and sustained amounts of methyl mercury had led to children who later scored slightly lower on neurological and cognitive tests (nothing near autism). The EPA estimated the lowest possible amount a mother could have ingested to be associated with a disorder and then, to be ridiculously safe, divided that by 10. The agency's standard is below that of even the hyper-cautious Food and Drug Administration.
There's little evidence vaccines exceed even that extremely low level. Just last week a University of Rochester study published in Lancet looked at 61 infants--40 receiving vaccines containing thimerosal, and 21 receiving thimerosal-free vaccines. Most children had blood mercury levels of 1 or 2 nanograms per milliliter; the highest level, found in one child, was 4.11 nanograms per milliliter.
By comparison, the EPA standard is 5.9 nanograms per milliliter. The study also found that children excrete ethyl mercury more quickly than expected, so that it doesn't build up from one vaccination to the next. "A mom who eats a tuna fish sandwich probably passes along more mercury during breast-feeding than a kid gets in a vaccination," says Michael Pichichero, the study's lead investigator.
Most important, no scientific study has ever found a link between vaccines and autism, despite years of detailed research into the safety of vaccines. Even the World Health Organization continues to endorse the use of the preservative. Sadly, the real losers of this wild goose chase are parents of autistic children, who've seen anti-vaccinators use their cause to divert time and resources away from legitimate research into the disorder. U.S. public health agencies knew most of this in 1999. But they worried that anti-vaccine groups would use the FDA information to scare parents away from immunizations. So they hastily recommended that manufacturers immediately remove the preservative--a huge mistake.
"We took it out precipitously, which made it look like thimerosal is harmful--when there is no evidence it is. I think we hurt the public trust," said Paul Offit, who sits on the Advisory Committee on Immunization Practices and is chief of infectious diseases at the Children's Hospital of Philadelphia.
The recommendation brought unwarranted fear, vaccine shortages, and . .. .. tort lawyers. Usually, parents of the rare child injured by a vaccine must go through the Vaccine Injury Compensation Program before they can sue in regular courts. Set up by Congress in 1986 after lawsuits all but bankrupted vaccine makers, VICP ensures that victims get compensated quickly for genuine wrongs.
But the tort lawyers hate that VICP cuts out their giant fees, and they saw an opening in thimerosal. They've exploited every loophole to keep frivolous thimerosal cases out of VICP, and have instead filed hundreds of lawsuits against vaccine makers and Eli Lilly (which stopped making thimerosal 10 years ago). The four vaccine makers left are today stuck devoting their funds not to research into new, life-saving vaccines, but to paying legal bills.
These, readers, are the facts behind the thimerosal rider that is supposed to be so scandalous. All the legislation does is require that parents first go through VICP, as with any vaccine claim. They can sue later in other courts, if they choose (and assuming a statute of limitations problem is fixed). The vaccine court is much better positioned than other courts to decide on the merits of thimerosal cases. And it has the added social benefit of protecting vaccine research and production at a time when we need both to defend against bioterror.
None of this makes trial lawyers rich, though, and so they asked Senate Democrats, led by Joe Lieberman, to strip the rider away. They lost, but they did such a good media job that new Majority Leader Trent Lott has promised modifications to protect nervous Republicans who clearly haven't bothered to understand the issue.
We suggest they talk to Dr. Frist, who could supply a nerve transplant. If Republicans can't explain to parents that thimerosal is about supplying safe vaccines to their children, they don't deserve the majority.
Copyright © 2000 Dow Jones & Company, Inc. All Rights Reserved.
WashPost Recap: New Vaccine Clause Angers Parents of Autistic Amendment Buried in Homeland Security Law Restricts Right to Sue Makers of Drug Preservative
[By Susan Warner, special to the Washington Post.]
http://www.washingtonpost.com/wp-dyn/articles/A27949-2002Dec8.html
Thomas Brinker loves to sing and play with string. He watches ABC News anchor Peter Jennings on television every night and shouts: "Tickle Peter Jennings." He's 8 now, but his attention span is short and his temper flares easily. Thomas has autism, a condition his parents believe was caused by a simple childhood immunization. "We're waiting for his first normal moment," said his mother, Donna Brinker of Glen Mills, Pa. It was Donna Brinker's temper that flared when she learned that Congress had quietly restricted her right to sue Eli Lilly and Co. and other manufacturers of Thimerosal, the mercury-based vaccine preservative she believes caused her son's condition. The change came in two paragraphs tacked onto the massive Homeland Security Act just days before Congress approved the legislation in November.
The Brinkers are among 800 families in more than a dozen states that have filed similar cases seeking compensation for the costs of their children's autism. Under the new law, signed by President Bush Nov. 25, the parents are required to file claims with a special administrative court under the National Vaccine Injury Compensation Program before they can take their cases to civil court. The changes could sharply reduce parents' chances of prevailing in civil courts, where damage awards normally could be much higher than those in the "vaccine court." The federal program covers claims for medical and education expenses, but damages for pain, suffering and death are limited to $250,000. Lawyers for the plaintiffs say their awards would likely be higher if they could first take their cases to state courts, where civil juries are known to award millions of dollars in medical injury cases. Meanwhile, the Department of Justice has filed a request to restrict the use of information gathered in vaccine court proceedings in subsequent civil court cases, another potential obstacle for the plaintiffs.
"I felt betrayed," Brinker said of the new legislation. "I believe in protecting our homeland, but it petrifies me to think that our nation would protect any industry at the expense of our children." Penny Starr-Ashton, of Drexel Hill, Pa., whose autistic 6-year-old daughter, Maddie, is another plaintiff in a class-action lawsuit filed in Pennsylvania in July, said it is particularly painful to have the provision wrapped in the flag. "Who doesn't want a safer country?" she asked. "But who's going to protect me? Who's going to protect my child?" The National Institute of Child Health and Human Development estimates that between 1 in 500 and 1 in 1,000 children is diagnosed with autism in the United States each year. Initial studies in the 1960s found four to five cases of autism in every 10,000 people, although the institute cautions that some of the increase could be due to changes in reporting and diagnosing the disease.
A study by the University of California at Davis found that a third of California parents of autistic children diagnosed in the mid-1990s blame vaccines for their children's illnesses. Congress created the National Vaccine Injury Compensation Program in 1986 to address growing concerns about vaccine safety. Claims are filed with the Department of Health and Human Services through the U.S. Court of Federal Claims. The program has paid out 1,775 claims totaling $1.4 billion and is funded by a 75-cent surcharge on every child vaccination.
Brinker said parents of children with signs of mercury poisoning can spend up to $20,000 a year out of pocket. Thomas is undergoing chelation therapy to draw metals out of his body and is on a strict diet. His parents take him to a specialist in Louisiana for treatment, and his mother travels to Mexico to get drugs that are not approved in the United States.
Beyond today's expenses, Brinker worries about supporting Thomas in the long term. "The mercury preservative has deprived Thomas of having a normal life," she said. "That our nation would protect such a killer is beyond comprehension."
Aside from potentially lower awards, Thomas Brinker and Maddie Ashton will have another problem in vaccine court, said their lawyer, Tobi Millrood. Like many children, they were diagnosed with autism more than three years after their vaccinations, beyond the time permitted to file under the program's rules.
Some states, including Oregon, Florida, Louisiana, Illinois and California, had ruled that they had jurisdiction over Thimerosal cases, said John Kim, a Houston lawyer who argued against the government's request to close vaccine court records. "Now I guess this new provision in the Homeland Security Act trumps that," Kim said.
Meanwhile, all Thimerosal cases have been put on hold at vaccine court while the court grapples with the scientific debate over the possible causes of autism. The Office of the Special Master, which oversees procedural issues at vaccine court, expects 3,000 to 5,000 filings.
Parents outraged about the last-minute change point to Eli Lilly, the Indianapolis drug maker, as its biggest beneficiary. Lilly invented Thimerosal and manufactured it until the 1980s. The preservative is 50 percent mercury by weight, and had been used in vaccines since the 1930s. Lilly is a defendant in 200 Thimerosal-related lawsuits. "It's turned into being about money," Brinker said. "Parents with kids with autism don't have the money to give to congressmen. It turns out whoever has the most money wins."
The provision in the Homeland Security bill was originally written by Sen. Bill Frist (R-Tenn.), a physician, as part of broader legislation aimed at helping drug companies produce vaccines after post-Sept. 11, 2001, concerns about smallpox and anthrax. The number of U.S. vaccine manufacturers has dropped to four, with companies complaining of low profit margins, manufacturing problems and fear of liability for injury.
Edward G. Sagebiel, a spokesman for Lilly, said his company had no role in pushing the last-minute legislative changes. "We express sympathy for the parents and the children who have suffered adverse reactions," he said. "However, the lawsuits that have been filed against Lilly and other manufacturers are not supported by science."
The House Government Reform Committee has scheduled a hearing on vaccine safety for Tuesday.
In 1999, the Food and Drug Administration conducted a review of Thimerosal and found no evidence of harm beyond limited cases of hypersensitivity to the vaccine. But the same year, the Academy of Pediatrics and the U.S. Public Health Service recommended that Thimerosal be removed from vaccines, partly out of fear that parents would stop immunizing their children and create a bigger public health problem.
In October 2001, the Institute of Medicine, a branch of the National Academy of Sciences, said there was no evidence that Thimerosal caused autism, but it did say the theory was "biologically plausible." Most recently, on Nov. 30, the British medical journal the Lancet published a study showing that infants who received vaccines containing Thimerosal had levels of mercury in their blood that are within federal limits.
Starr-Ashton remains unconvinced. "I don't believe anything that is 50 percent mercury by weight is safe," she said. She noted reports of health damage caused by mercury in fish, thermometers and dental fillings. "I'm not that dumb."
The debate over science has become a furor over the democratic process in the tight-knit community of parents of children with autism that is linked by the Internet and community support groups. "Nobody is owning up to it," Brinker said. "It is so underhanded. I just can't believe our government would do this. We're not going to back down on this issue. We will not be silent."
Starr-Ashton said she is not against vaccines, especially because she taught in a school for the deaf for many years: "I saw first-hand the damage done by rubella." But now she does not know who to trust. "Here I was, a dutiful parent taking my child to do what the government and the Academy of Pediatrics said I should do to protect my child against disease," Starr-Ashton said. "Something went terribly wrong. I need answers."
© 2002 The Washington Post Company
MIKE ARGENTO
Saturday, November 23, 2002
http://ydr.com/story/mike/3940/
Thank God our leaders in Congress were wide awake and working day and night, fingers to the bone, to protect us from the scourge of terrorism by trying to prevent parents of autistic children from suing a drug manufacturer that may have caused their children's autism.
Thank God our leaders in Congress were able to see the threat to our security and safety posed by parents of autistic children.Thank God our leaders in Congress tried to act decisively to keep us safe from parents of autistic children.
Whew.
That was a close one.
We can now feel safe from the threat of parents of autistic children because as we all know - without getting into stereotyping here - parents of autistic children are the real threats to our well being and safety as a nation, and a world, for that matter. Of course, not all parents of autistic children are working to destroy our way of life, and life on this planet in general. No, some parents of autistic children are fine, upstanding Americans, patriotic Americans who are just as concerned as anybody about the threat to our national security posed by other parents of autistic children.
What?
You didn't know of the terrible, terrible threat parents of autistic children pose to our national security?
That's why you're sitting there in your pajamas reading this and not striding through the halls of power in your pajamas right now.
Our members of Congress, in their deep and infinite wisdom, clearly saw the threat of the parents of autistic children and acted accordingly. They made sure that, when they voted to approve the creation of the new Department of Homeland Security, they'd take care of those parents of autistic children.
What they did is slip an amendment into the bill to create the department that would, essentially, forbid parents of autistic children from suing pharmaceutical companies. OK, it was a little more specific than that. According to The Washington Post, the amendment forbids parents from suing the manufacturer of a vaccine that contained a mercury-based preservative that some believe may cause autism.
OK, it was a little more specific than that. The amendment, backed by President Dubya, expanded liability protection for vaccines to ingredients of vaccines, language specifically targeted at helping Eli Lilly and Co.,which is being sued by parents of autistic children for its manufacture and sale of a preservative called Thimerosal.
That's how it works. The law doesn't say, "And the U.S. government gives Eli Lilly a break." But since no other drug companies are being sued for their use of vaccine ingredients, it's apparent that it is intended to help Eli Lilly. You're probably thinking, what does that have to do with protecting the nation from insane people who believe their path to heaven is paved with blood and fire?
That just shows what you know.
It's vitally important to national security that parents of autistic children not be allowed to sue a huge pharmaceutical company because . . .because . . . well, just because.
Republican lawmakers made some lame excuse that pharmaceutical companies that make vaccines that could be used in the event of biological attacks shouldn't have to worry about being saddled by lengthy and costly lawsuits just because they manufactured a product that may have caused life-changing health problems for some children.
Not all Republicans think that way. Our own U.S. Rep. Todd Platts, R-York County, voted for the bill but only because his only other choice was to vote against the whole Homeland Security bill. He said he didn't like that the bill granted immunity to pharmaceutical companies or that it permitted the government to contract with companies that moved their headquarters to Bermuda to avoid paying taxes or that it specified locating the Homeland Security Research Center at Texas A&M. He said he believes Congress will go back in January and take that stuff out.
At least that's the promise the leadership has given.
But given their record for honesty, can you believe them?
Let's look at the Texas A&M thing. The bill never mentioned Texas A&M. It just listed 15 criteria for the research center that, put together, meant Texas A&M was the only place in the nation suitable for such an august endeavor. It's not clear whether one requirement was for the school to be nicknamed "Aggies." With Eli Lilly, the congressional and presidential intent seemed to be that Eli Lilly would be so tied up with litigation that it couldn't possibly have the time and energy to make vaccines to protect against attacks that haven't occurred and may never occur.
Poor Eli Lilly.
Good thing it got this break so we can all feel safer.
And it's also a good thing that, between 1997 and 2000, Eli Lilly made $18.4 million in campaign contributions, mostly to Republicans. By giving that money to our lawmakers, Lilly was able to ensure our safety and security by getting Congress to exempt it from lawsuits from parents of autistic children.
You know, they said everything had changed after Sept. 11, 2001. Well, at least one thing hasn't changed.
We still have the best government money can buy. Mike Argento, whose column appears Mondays and Thursdays in the Living section and Saturdays on the editorial page, can be reached atmike@ydr.com.
HURT IN THE NAME OF SECURITY
By Marita Lowman 12/13/2002
When Tara McHale gave birth to her first child, Samantha, she recorded every wonderful moment of her baby's life. The first smile, the first word, the first step, the first hug, the jutting of each tooth, the nuance of each new gesture. In every way, Samantha was developmentally on target. At 15 months, she walked and talked and joyfully played.
Then, during a regular medical checkup, the pediatrician injected four childhood vaccines into Samantha's bloodstream. Samantha, of Clarks Summit, has never been the same. The next morning, her cognitive skills were dulled. Her physical abilities spun backward.
When she was 4, she could not be toilet trained. She no longer made eye contact. Her speech shrunk to one- or two-word sentences. She flapped her hands in bizarre gestures.All the while, her mother pursued pediatricians, neurologists, audiologists and other professionals to find out what was wrong. In 1997, a developmental pediatrician confirmed the diagnosis. Autism is a neurological condition that forever alters a child's life.
"It was a crushing blow," Mrs. McHale said.
It is a blow most members of Congress know nothing about. So when the federal legislators approved the Homeland Security Act last month, they glossed over a last-minute provision tucked secretly into the bill. It granted Eli Lilly and other pharmaceutical companies retroactive protection from lawsuits such as those that say Lilly's vaccines caused or contributed to autism.
Childhood vaccines have been suspect for many years, but the claims gained more credence when research found dangerously high levels of mercury and the preservative thimerosal in the vaccines. One thousand lawsuits were pending against the vaccine makers, but the last-minute addition to the Homeland Security Bill canceled all of them.
Mrs. McHale, Rita Cheskiewicz, of Dallas, and Frank Scholz, of Mehoopany --all parents of autistic children -- met Thursday with U.S. Rep. Don Sherwood, R-Tunkhannock, to seek his support in overturning the provision.
They are hurt by the government's seemingly cavalier attitude toward children with autism. They are frustrated by what appear to be cozy relationships between pharmaceutical manufacturers and the White House. Mrs. Cheskiewicz, a former administrator at Hahnemann Hospital in Philadelphia, gave up her job when her son A.J. was diagnosed with autism. He was normal in every way until age 18 months, when he received three vaccines at once. He stopped speaking and stopped responding to his name. "As a mother, it is heartbreaking, and it did not have to happen," Mrs. Cheskiewicz said.
Mr. Scholz, whose son, Joey, was diagnosed as autistic several years ago, drives two hours a day to take his son to an educational program geared to children with autism. The children will need lifelong care. The parents want more government resources put into autism research. They want more recognition of autism's devastating effects.
Mr. Sherwood, visibly moved by the families' plight, said he will try through the Health and Human Services Committee to direct funding for autism through national health institutions. He also will recommend overturning the Homeland Security provision, but the prospect of success is not good."There will be some support, and I'll give it a shot when we go back into session in January, but to turn the provision around now will be a major proposition," he said.
Samantha McHale is 10 now, and despite intensive care, she is wrapped in the limitations of autism. She needs help dressing, bathing, toileting. She doesn't understand gender or relationships, time or numbers. She does not recognize family names, and when she's in pain, she cannot explain why or where she hurts. She does not go to ballet classes or listen to music with friends or take part in other activities most 10-year-old girls enjoy.
Increase in Autism Troubling: Houston Chronicle Front Page Some parents link illness to vaccines, but doctors unsure
[By Todd Ackerman and Mary Ann Fergus. Copyright 2002 Houston
Chronicle.]
http://www.chron.com/cs/CDA/story.hts/health/1654344
Beaumont residents Mark and Darla Williford can tell you exactly when their infant daughter stopped making eye contact, learning new words and smiling for the camera. It was shortly after her first birthday, on the day in November 1995 that Laura received four vaccines. That night, she had a fever and was agitated, common side-effects of vaccination. But the next six months were anything but typical: the girl acted strangely, flipping lights on and off, for example, and she would scream and laugh for no reason. "It looked like she was going insane," said her dad. In March 1999, Laura was diagnosed with autism, a devastating neurological disorder marked by jerky, repetitive movements, a lack of language skills and social withdrawal. A month after the diagnosis, Mark Williford found a report about a possible link between autism and childhood vaccines that contained a mercury-based preservative. His daughter's vaccines contained the preservative, called thimerosal; her symptoms matched those of mercury poisoning.
"I remember reading the symptoms and a cold chill went up my spine,"Williford recalled. "I said, `This is what's causing it.' " In Texas and around the world, more and more people are becoming convinced that autism can be caused by the vaccines supposed to protect them. The U.S. Food and Drug Administration and Centers for Disease Control and Prevention say there's no evidence to support the hypothesis, but thousands of parents have joined a worldwide legal campaign to hold pharmaceutical companies liable for injecting infants with a known toxin.
It might sound like ambulance-chasing lawyers and blame-happy parents except for one thing: Autism's exploding these days and no one knows why. The explosion, a tripling over the last decade, suggests an environmental component that could be explained by increased mercury exposure associated with a rapid increase in vaccinations during the 1990s. The mercury has now been removed from most vaccines, but concern over a possible link to autism has led to congressional hearings, multimillion-dollar studies, and clusters of class-action lawsuits that one of the lawyers says "could be the biggest thing to come down the litigation pipeline ever."
There also have been declining immunization rates in some countries, raising fears among public health leaders that the allegations could undermine a vaccine program considered one of the great medical breakthroughs of the past century. Some scientists acknowledge that this fear threatens to stifle open inquiry into whether the concerns are legitimate.
For the most part, however, doctors seem confident that the allegations aren't legitimate. "Vaccines have been tested every which way and no link to autism has ever come up," said Dr. Jane Siegel, a pediatrics professor at the University of Texas Southwestern Medical Center in Dallas, who has served on national advisory committees on vaccines. "They're safe." Still, scientists are at a loss to explain the dramatic increase in the incidence of autism, which was not described until the 1940s and then was attributed to cold "refrigerator" mothers. That theory has been debunked and researchers are zeroing in on genetic causes, but the disorder is still poorly understood. There is no cure, though a new intensive therapeutic program is helping some children.
Once thought to occur in 1 of every 10,000 children, autism today is estimated to afflict 1 in 500. A California study last month that found a three-fold increase from 1987 to 1998 said the hike couldn't be explained away by statistical anomalies or different definitions or growing public awareness, but the study could offer no explanation. The increase in Texas was more than twice as large as in California.
There are two ways vaccines are alleged to play a role. One is that certain vaccines -- the measles, mumps and rubella (MMR) shot has attracted the most attention -- may themselves cause autism or other problems in a small percentage of sensitive people. A study in the New England Journal of Medicine, published Thursday, found no evidence to support the MMR theory, the latest in a series of such findings involving that vaccine.
The other theory involves thimerosal, which until recently was used in many vaccines to guard against contamination when pediatricians jab the same vial repeatedly to vaccinate one child after another. The amount of mercury in each shot was slight, but advocates of this theory say a dangerous amount could accumulate because the number of required vaccinations has mushroomed since the late 1980s as researchers have figured out how to prevent more infectious diseases -- a typical child now gets 32 doses of 12 vaccines by the age of 6; a 2-month-old may get five shots during one visit to the doctor's office.
Critics wonder if all that mercury was more than those little bodies could handle, whether the result is autism or some other crippling neurological disorder. "It's outrageous to think that injecting a child with all that toxicity is an acceptable risk," said Bernard Rimland, director of the Autism Research Institute in San Diego. "It's also outrageous that despite such compelling evidence of harm, the medical community would subject children to it."
In 1999, the FDA concluded that infant children who receive the recommended series of immunizations are receiving more mercury than is considered safe by the U.S. Environmental Protection Agency and asked vaccine manufacturers to voluntarily phase out their use of thimerosal. The conclusion was later echoed by the CDC, pediatric organizations and a blue-ribbon panel of experts that reviewed all the existing studies on thimerosal and autism. The manufacturers now say they're producing thimerosal-free vaccines, and a Texas Department of Health representative said the agency is confident of this. Believers in the mercury theory, however, are skeptical about whether all the old stuff is off the shelves.
For instance, it took an intense effort by Williford to get the Beaumont Health Department to replace its supply last year. The department finally agreed in August 2001, following six months of Williford's making requests, talking to his state representatives and appearing at City Council meetings.
For his and other families, the struggle was to understand what was happening. After her son was diagnosed with mild pervasive developmental disorder at age 2 1/2, autism a couple of years later, and then "severe autism," Spring resident Gina Shaw traveled to California in 2000 for a Defeat Autism Now conference. There, she heard a speaker present new information suggesting a link between thimerosal and autism. Coming on the heels of a test that had revealed high levels of metals in her son's blood, the theory seemed persuasive.
Tears began running down Shaw's cheeks as she listened to the speaker. She grew angry that government agencies allowed the use of vaccines containing thimerosal. "I was mad as hell," she said, "because they did this to my baby. "Shaw and her husband, Darwin, can barely look at early photographs of Brett. They show a laughing child with twinkling blue eyes. But in photos taken after his second birthday, Brett is stonefaced. He could barely sit still long enough to be photographed. Now 10, Brett mumbles a few random words such as "bye" and "eat." He can follow simple instructions but doesn't understand everyday conversations between his parents and his 12-year-old sister, Brianna. He takes special-education classes and functions at a 2-year-old's level. Unable even to write his name, Brett lives largely in a world of his own, entertaining himself with simple computer games or playing alone in a closet or tent.
The Shaws estimate that they've spent $50,000 on their child's care. (The Willifords have spent $60,000.) In January, the Shaws filed a complaint with the U.S. Court of Federal Claims in Washington, D.C., under the National Vaccine Injury Compensation Program, which compensates people injured by routine vaccinations. The complaint was handled by Hitt, Patterson & Sell in Houston, one of four Texas firms leading the litigation onslaught.
Two other firms are also based in Houston -- Gallagher, Lewis, Downey & Kim and Williams & Bailey -- and one is a Dallas firm, Waters & Kraus. The firms are part of two legal coalitions that estimate they have about 4,000 clients between them. The first lawsuit in a state civil court, filed by Waters & Kraus, concerns a Plano boy who had a growing vocabulary at 20 months, then lost all his language skills, was diagnosed with autism and found to have high levels of mercury exposure. The lawsuit is in Brazoria County, where one of the defendants, Dow Chemical Co., has a drug manufacturing plant.
Attorney Jeff Sell believes in the cases as a litigator and father. His 8-year-old twins have autism. Sell cannot file a complaint through the Vaccine Court because those must be filed within three years of the onset of symptoms, and it was five years before he made a connection. But because the Vaccine Court strictly limits damages, the potential for bigger money is in civil courts anyway. "With as many as 200,000 possible cases of developmental disorders that could be tied to vaccines, this could turn out to be one of the biggest mass tort cases ever in the United States," said Michael Williams, chairman of the Mercury Vaccine Alliance, which already has filed seven class-action lawsuits around the country. "But we won't know for two or three years." Complicating the plaintiffs' case is that the children could have been exposed to mercury from other sources, such as fish or dental fillings. Even if science ultimately finds a link between mercury and autism, it might not be clear whether the culprit was the vaccines or exposure from the mother's fillings or consumption of fish while the child was in the womb. At the moment, of course, the biggest threat to the lawsuits' success is the lack of science backing them, say legal observers. Scientists acknowledge that mercury is a potent neurotoxin known to damage the brains, nervous systems and immune systems of unborn children, but beyond that little is certain.
For one thing, although autism sometimes can be detectable as early as 6 months, it more often appears to hit later, at 1 1/2 to 2 years, and after the child had appeared to be developed normally. Those skeptical of a vaccine link say it is just a coincidence that symptoms appear at the
same time the MMR vaccine is given.
For another, there have been few well-designed studies looking into the mercury allegation. The blue-ribbon panel of experts assembled to look into the matter called the idea that thimerosal poses a significant threat to the developing brain "biologically plausible" but said none of the existing studies had been designed well enough to produce evidence of a link.
Both sides in the debates have seized on the panel's report. (The evidence is much better that the MMR vaccine doesn't cause autism, said the head of the panel. The New England Journal of Medicine study published Thursday tracked 500,000 Danish children born between 1991 and 1998 and found no statistical difference in autism between those who received the MMR vaccine and those who didn't. The vaccine has never contained thimerosal.) Typical of the contentiousness surrounding the issue was a July 2000 congressional hearing convened by U.S. Rep. Dan Burton, R-Ind., whose autistic grandson seemed healthy and talkative until getting a series of vaccinations at one time. Rep. Henry Waxman, D-Calif., complained that the hearing was unfairly stacked with parents and experts alleging a connection between vaccination and autism, and the only thing committee members could agree on was the need for further study of the issue. "The fact is, there just hasn't been much done in this area," said Irva Hertz-Picciotto, a professor of maternal and child health at the University of California-Davis School of Medicine, recently awarded a federally funded center to study the issue. "We don't know much about the epidemiology of autism, let alone whether mercury could foster it." This much is known about autism: There's a genetic susceptibility -- the risk increases for younger siblings of autistic children -- that scientists think involves 10 to 20 genes. But the environment also can play a role: It was more common in babies born to mothers who took thalidomide or had rubella during pregnancy. New studies will look at the interaction between genes and environment.
The Man Behind The Vaccine Mystery
[CBS Evening News.]
http://www.cbsnews.com/stories/2002/12/12/eveningnews/main532886.shtml
It's been a mystery in Washington for weeks. Just before President Bush signed the homeland security bill into law an unknown member of Congress inserted a provision into the legislation that blocks lawsuits against the maker of a controversial vaccine preservative called "thimerosal," used in vaccines that are given to children. Drug giant Eli Lilly and Company makes thimerosal. It's the mercury in the preservative that many parents say causes autism in thousands of children – like Mary Kate Kilpatrick. Asked if she thinks her daughter is a victim of thimerosal, Mary Kate's mother, Kathy Kilpatrick, says, "I think autism is mercury poisoning."
But nobody in Congress would admit to adding the provision, reports CBS News Correspondent Jim Acosta – until now. House Majority Leader Dick Armey tells CBS News he did it to keep vaccine-makers from going out of business under the weight of mounting lawsuits. "I did it and I'm proud of it," says Armey, R-Texas. "It's a matter of national security," Armey says. "We need their vaccines if the country is attacked with germ weapons." Rep. Dan Burton, R-Ind., isn't buying it. The grandfather of an autistic child, Burton says Armey slipped the provision in at the last minute, too late for debate. "And I said, 'Who told you to put it in?'" He said, 'No, they asked me to do it at the White House.'"
Critics say the Bush family and the administration have too many ties to Eli Lilly. There's President Bush's father, who sat on the company's board in the 1970's; White House budget director Mitch Daniels, once an Eli Lilly executive; and Eli Lilly CEO Sidney Taurel, who serves on the president's homeland security advisory council. Officials at the drug giant insist they did nothing wrong. "No one, not our CEO, not myself, not anyone who works with me asked the White House to insert this legislation," said Eli Lilly spokeswoman Debra Steelman. But Kathy Kilpatrick and her husband Michael argue that the thimerosal provision is not designed to protect the nation, but rather to protect Eli Lilly.
Asked what he'd say to a congressman who came forward and admitted he was responsible for inserting the provision, Michael Kilpatrick says, "I would ask him if he knew he was protecting mercury being shot into our kids." Kathy Kilpatrick asks, "Why would anyone want to save Eli Lilly on our children's backs?"
Because Armey is retiring at the end of the year, some say the outgoing majority leader is the perfect fall guy to take the heat and shield the White House from embarrassment. It's a claim both the White house and Armey deny.
Friends,
I don't care HOW many tax dollars it takes! Pharmaceutical company Eli Lilly deserves our protection! Eli Lilly has worked hard for decades researching and creating new vaccines to protect public health. It's irrelevant that vaccines have never been shown to do anything but leave death and injury in their wake. It's not Eli Lilly's fault if science can't demonstrate what vaccines must in fact do: protect our health. In exchange for Eli Lilly's efforts to protect us, we should be willing to protect them!
And protecting Eli Lilly is JUST what the awesome "Homeland Security Bill" (recently passed by congress) does! If the president signs the bill into law, taxpayers--not hardworking Eli Lilly--will pay for vaccine-related injuries. Of course, Eli Lilly will still have to pay for damages in the lawsuits they lose out of the 45 already in progress against them. But once those suits are done with, Eli Lilly should not have to spend its research dollars on court costs. The species' health is at stake!
After all, use your noggin. Vaccines SHOULD work. It's just a matter of time until somebody comes up with a study that shows they do. PROTECT ELI LILLY WITH YOUR TAX DOLLARS! That should be the bumper sticker on every car in America. Heck . . . in the world!
And believe me, I'll be the first in line to get the smallpox vaccine. I've already got my shortsleeve shirt on. Because I want to show my neighbors what it means to be a good American. And what it means to be a good American is sacrifice.
I want to be part of the first study that shows that vaccines work. And if I get smallpox or die from the vaccine, at least I know I will have contributed to the public health and to the public good, just like our forebears did when they fought the British. If I die in the war on disease, at last I know I will have helped Eli Lilly to survive and to keep working heroically toward their one and only goal of perfect public health.
God bless Eli Lilly, and God bless America!
Jock Doubleday
Director
Natural Woman, Natural Man, Inc.
A California Nonprofit Corporation
http://www.gentlebirth.org/nwnm.org
jockdoubleday@aol.com
http://www.pressdemocrat.com/local/coursey/courseycolempireb.html
Homeland bill close to home for this family
December 9, 2002
By CHRIS COURSEY
FOR THE PRESS DEMOCRAT
Ask Lynn Hartman about the homeland security bill, and her face curls in disgust. It's not that she has anything against fighting terrorists; after all, her husband, Dave, is a pilot for United Airlines. But the new legislation hits close to home for the Hartmans in another, even more personal way. Their 21/2 -year-old son, Taylor, is autistic. Connecting autism and domestic security is a stretch, but Congress managed to do it last month. Last-minute add-ons to the homeland security bill grant Eli Lilly & Co. immunity from lawsuits related to its product thimerosal, a mercury-based preservative used in many vaccines.
The Hartmans believe it is responsible for Taylor's autism.
"He's been mercury-poisoned," Lynn Hartman says.
The Hartmans are not alone. In a speech before Congress on Nov. 22, Rep. Dan Burton, R-Ind., said he had "heard from thousands of families across the country that this same thing happened to their child." He cited a growing body of evidence that suggests a huge spike in the number of autistic children may be linked to a program of infant vaccinations that began in the early 1990s.
Like most babies since then, Taylor was vaccinated very early in life -- much earlier than you and I. He had had several doses of thimerosal before he was 6 months old. Large, active and healthy at birth, Taylor developed normally. He was walking and beginning to talk by the time he was 14 months old. But then his parents, who live in Sonoma, noticed a sudden, troubling change. "He started having temper tantrums," says Lynn. "He stopped talking. He became adverse to touch."
Autism is a tricky thing to pin down. Symptoms can range from withdrawal and difficulty speaking to violent, self-injurious behavior. It once was classified as a mental illness passed on genetically to children. The past 10 years, though, have included a large increase in the number of cases of "late-onset autism" -- symptoms of the disorder that appear in young children who previously have been "normal."
The cause is the subject of intense debate. While mercury is often pointed to as a likely culprit, it is a naturally occurring element that enters the body in a number of ways. Seafood, dental fillings and various pollutants all contain mercury. Although researchers have called it "biologically plausible," no study has definitively linked thimerosal with autism. But because of the risks posed by mercury, federal health officials in 1999 advised that infants not receive vaccines containing thimerosal until they were 6 months old. Most
vaccines no longer contain it.
But Taylor's vaccines did.
Traditional treatment for autism involves a lot of occupational therapy, special education and drugs. But the Hartmans have followed a protocol suggested by Stephanie Cave, a Louisiana pediatrician who believes high doses of mercury compromise some children's ability to leach metals from their bodies. Taylor, for instance, had extremely high levels of copper, arsenic, mercury and other metals in his tissues.
They began treating him metabolically, using diet and supplements to remove the metals from his body. The regimen, the Hartmans say, has given them their son back. Taylor's blue-gray eyes peek out from under thick, curly bangs. He points out shapes in the painting he's working on and explains them to a visitor: "wee" and "see." "He started talking again about a month and a half ago," Lynn Hartman says. She says his "development age" is about 19 months -- behind, but progressing once again. She says her anger about the homeland security bill is not because she wants to sue, but because it sweeps a problem under the rug. "A lot of these kids can get better, but they need to get help now," she says. "The drug companies need to admit they messed up."
Contact Chris Coursey at 521-5223 or ccoursey@pressdemocrat.com.
Subject: Sen. Daschle, Rep. Pelosi Vow to Repeal Homeland Security
Provision
Eli Lilly & Co.
http://www.stockhouse.com/news/news.asp?tick=LLY&newsid=1413704
Sen. Daschle, Rep. Pelosi Vow to Repeal Homeland Security Provision Shielding Drug Makers from Liability
11/21/02
Claims that Congress Can 'Fix' the Problem Are Misleading WASHINGTON, Nov 21, 2002 /PRNewswire via COMTEX/ -- Safe Minds and the Mercury Policy Project are hailing a statement by the US House and Senate leadership that they will work to repeal a corporate special-interest provision in the Homeland Security Bill. The provision wipes out all legal remedies for thousands of autistic children harmed by mercury in infant vaccines and must be eliminated, the two groups working to prevent mercury-related injuries said today.
"We strongly support Senate Majority Leader Tom Daschle and House Democratic Leader-Elect Nancy Pelosi's vow to remove egregious special interest provisions, including the thimerosal liability shield for Eli Lilly," said Michael Bender, Director of the Mercury Policy Project. As passed, the Homeland bill allows the families to re-file their claims in a special administrative court for vaccine-related injury cases where it takes years for cases to be heard and 87% of the claims filed are denied. And claims can only be made by parents if their child's first symptom of neurological damage occurred within the last three years, which effectively bars many families from going to court to hold Lilly accountable for their children's injuries, the groups said. "It is a sad state of affairs when the Congress and the White House conspire to benefit a pharmaceutical giant at the expense of injured children and families whose lives have been shattered by corporate wrongdoing," said Lyn Redwood, RN, president of Safe Minds and the parent of a child who developed multiple disabilities after receiving 125 times the government-recommended exposure to mercury. "Eli Lilly has been allowed to exploit a national threat to America to further their own agenda."
The provision to benefit Lilly -- which was added to the unrelated Homeland Security Bill at the last minute -- affects lawsuits against the drug maker for injuries caused by its product thimerosal, a mercury-based preservative that was used in infant vaccines until a few years ago. "Claims by Republican congressional leaders that they will "fix" the provision next year are empty promises because it will be too late," said Michael Bender, Director of the Mercury Policy Project. "Once President Bush signs the bill -- which will happen any day -- Eli Lilly can go to court and have all the mercury vaccine-related lawsuits against it dismissed immediately."
According to Redwood, after conversations with senate staff, the "fix" will do little if anything to right this wrong. "Our children have been silenced once by autism and now the votes of Congress have silenced them again," said Redwood. "The right thing to do would be to pass legislation as soon as possible to strike the thimerosal provisions." The lawsuits were filed by the families of children who developed autism, learning disabilities and other neurological problems after multiple mercury exposures. It takes hundreds of thousands of dollars each year to care for a severely autistic child and millions over the victim's lifetime.
satire -
Rich Procter: 'Pharma-gate! Red alert! Red alert!'
Contributed by drprocter on Friday, November 22 @ 09:55:18 EST
----------------------------------------------------------------------------
(intercepted by Rich Procter)
MEMO
From: Karl Rove
To: The Team
PHARMA-GATE! RED ALERT! RED ALERT!
PEOPLE -- We're vulnerable, and we've got to act NOW to head off a debacle. As I'm sure you're well aware, our compatriot Mr. DeLay inserted a rider into the Homeland Security bill that would shield one of our biggest campaign contributors, Eli Lilly from lawsuits by outraged, betrayed parents who used a vaccine they're producing that very well may be causing autism in their kids. In a slick move we've got to remember, Tom the Bomb actually made this RETROACTIVE, so that parents of autistic kids currently suing Eli Lilly would have their suits thrown out! That guy is slicker than deer guts on a doorknob.
The VULNERABILITY, of course, comes from the fact that it looks like we the Republicans, care more about stuffing the dirty dollars of Big Pharma into our full-to-burstin' pockets than we do about the welfare of children! It looks like we, the Republicans, the party of "responsiblity," are shielding Eli Lilly from taking responsibility for their own actions. It looks like we're rigging the justice system to screw already suffering parents as a payback for the dumptruck full of cash Big Pharma dropped on us! It makes us look like soulless plutocrats -- greedy, money-grubbing whores! Whereas the truth is...ahhhh....
Anyway, we've got to get out in front of this issue like we got out in front of the whole "privatizing Social Security" issue. I'm thinking we try another "carpet-bomb the airwaves" kinda deal, that works something like this:
First, we gin up an astroturf "concerned parents" group -- I'm thinking we call it, ahhhh, "Grateful Parents of Challenged Children For Responsible Pharmaceutical Policy." Next, we hire a bunch of dewy-eyed 30-something mother-types who give out with some copy like the following:
MOTHER-TYPE -- (halting, almost overcome with emotion) "Recently, I heard that some (pause -- can barely say the word) 'Democrats' had the nerve to criticize our President and his compatriots just because they included some beneficial extras onto the Homeland Security Bill. One of those extras will free up pharmaceutical companies from frivolous lawsuits. (steels herself -- stares down camera) "As the mother of a 'challenged child,' I know what heartbreak is. And I know these partisan, obstructionist Democrats have broken the heart of our President by daring to criticize him, even as he shoulders the responsibility of leading this country into a series of righteous wars that will vaporize our enemies and make the world safe for people l ike us -- because there'll be nothing left but people like us. (graphic on screen) I'd like you to join me in calling President Bush and thanking him for making it impossible for me and other concerned parents to stop these pharmaceutical companies from generating the record profits that could possibly lead to the economic recovery the off-shore tax haven where they're based. Please call the number on the screen. Be aware this is not a free call, and you'll be charged $2.75 a minute."
Is that beautiful, or WHAT? 'Course we gotta get Rush and G. Gordo and O'Reilly and Hannity to call the Dems a bunch of whiny, hand-wringing limp-wristed Latte liberal traitors for trying to stop the Homeland Security bill for something so trivial as a bunch of whiny, lawsuit-happy parents being led down the primrose path by money-mad ambulance chasing lawyers.
Oh, and one last thing -- we need to invent some statistics proving...ahhhh....wait a minute, it's coming....that the autism these parents suffered could just as easily have been caused by the mother visiting San Francisco and consuming too many double lattes while listening to Barbra Streisand records while pregnant. Yeah.
Debbie Greco's son was a normal 3-year-old when, after finishing a round of childhood immunizations, he became withdrawn, aggressive, and slow to speak - all symptoms of autism.
THE NEEDLE AND THE DAMAGE DONE
http://www.zwire.com/site/news.cfm?newsid=6428783&BRD=2318&PAG=461&dept_id=484045&rfi=6
BY ANTONIO C. CABRAL 12/19/2002
"I didn't know what was causing them," says Greco, a San Antonio native. "Friends have the same problem, but their children's doctor told them there was no need to question the use of vaccines. We didn't know about Thimerosal." The coziness between the pharmaceutical companies and the Bush administration has harmed families but helped drug manufacturers, including Eli Lilly, producer of Thimerosal. The drug company's cause was recently buttressed after Majority Leader and Texas Republican Dick Armey(who didn't cop to the deed until last week) stealthily tacked on a protective clause to the Department of Homeland Security bill that prohibits families from suing Eli Lilly for faulty vaccinations - including those containing Thimerosal, which could have caused autism in thousands of children.
"That clause should have gone through this committee and it didn't," said U.S. Representative Dan Burton (R-Indiana), a member of the House's Government Reform Committee. He has an autistic grandchild and is a harsh critic of Thimerosal. Thimerosal prevents bacteria from forming in vaccines; it was used widely in in the 1980s and '90s. The mercury-based chemical also boosted drug companies' profits because they could sell multiple doses in one vial without fear of contamination.
Although in 1999 the Federal Drug Administration required pharmaceutical companies to remove Thimerosal from their vaccines, it didn't recall batches already sitting in doctors' offices, public health clinics, or hospitals. As many as 30 vaccines have contained Thimerosal, including the Diptheria, Tetanus, and Pertussis combination; during the 1990s, health officials required children to receive additional Thimerosal-containing vaccines, including Hepatitis B.
The FDA knew the risks of Thimerosal years before it forced drug companies to quit using it in vaccines. In the 1980s, the FDA required companies to remove the chemical from all over-the-counter products, but not vaccines. By 1999, the FDA announced that infants who receive several thimerosal-containing vaccines might be overexposed to mercury, which prompted a ban on Thimerosal - but not a recall.
Some parents of once-healthy children, such as Debbie Greco, believe that the chemical has caused autism in their kids. Other parents don't know about the possible connection between Thimerosal and autism because there is an average of a 44-month gap between the initial vaccinations and the onset of symptoms. Autism was once a rare disorder. In 1970, about one in 2,000 children suffered from it; over the next 30 years - during the time children were being exposed to more mercury-containing vaccines - that number has increased to one in 150, according to the Centers for Disease Control.
A neurological disorder, autism causes developmental delays, abnormal language and thinking skills, and other erratic behavior. Expensive therapy and medicine - out of financial reach for most working families - can lessen the symptoms and allow autistic children to learn basic skills, but do not cure the disease. The Grecos spend about $25,000 a year in additional medical and therapy expenses for her son. "My son's illness impacts our whole family for life," Greco says. "It's not something that is going away."
The federal government initially covered up the serious risk of Thimerosal-based vaccines. But a non-profit advocacy group, SAFEMINDS (Sensible Action for Ending Mercury-Induced Neurological Disorders), filed a Freedom of Information Act to obtain a confidential Thimerosal study conducted by the CDC. That study showed that children exposed to mercury from vaccines were more than twice as likely to develop autism than kids who were unexposed.
In July 2001, the CDC released a revised version of the study that downplayed the role Thimerosal had in causing autism - stating the data was inconclusive.
Many scientists, such as Dr. Boyd Haley, chairman of the chemistry department at the University of Kentucky, believe Thimerosal is toxic for children. With smaller kidneys and livers, children can't process the mercury in their bodies as adults can. "Giving a 10-pound infant a single vaccine in a day is the equivalent of giving a 100-pound adult 40 vaccines in a day. We're talking about causing death; we're talking about causing autism."
U.S. Representative Burton has also taken the Bush administration to task for protecting drug manufacturers from litigation. He held hearings on the damage caused by vaccines containing Thimerosal and said there was "clear evidence on the relationship between the vaccines and autism." He has demanded that all vaccines containing Thimerosal be destroyed. "Every day that mercury-containing vaccines remain on the market is another day of putting 8,000 children at risk."
Dallas-based law firm Walter & Kraus is representing several parents in lawsuits against Eli Lilly and other pharmaceutical companies. Attorney Andy Waters accused Lilly of hiding the truth about Thimerosal and using its own biased study to promote it. "Lilly used an unethical study to help them sell their product."
Drug companies such as Lilly are also using their political muscle to protect their financial interests. According to the Center for Responsive Politics, in the 2001-2002 election cycle, Lilly contributed more than $6 million to various Republican committees. Lilly has other connections to the White House: George Bush the First served on its board in the 1970s; Dubya hired Mitch Daniels, director of Office and Management and Budget, from Lilly, where Daniels worked as president of the company's North American operations.
Unlike the drug companies, the parents, families, and autistic children have no one to represent their concerns on Capitol Hill. "The problem is we have no lobbyists," Greco explains. Without the political or financial power, Greco and thousands of families like hers have little recourse to hold drug companies accountable, especially when the pharmaceutical industry has so many friends in government to protect them.
CounterPunch
December 18, 2002
Hi! We're Republicorp! (formerly USA)
(this noticed received in the mail by Rich Procter)
http://www.counterpunch.org/procter1218.html
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4) FREEDOM FROM PROSECUTION! Let's say you're a major pharmaceuticals company, like, oh, say, Eli Lilly. Let's say you produce a product that might just have caused thousands, even tens of thousands of families a lifetime of pain and despair by causing autism in their children. Are you on the hook? No way, now that RepubliCorpTM is here! One of our friendly RepubliCorpTM Service Representatives will be happy to cash your seven figure corporate check, and pass a special "legislative waiver" that will give you a 100% (retroactive!) lifetime pass from having to be harassed by ambulance-chasing lawyers!
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* Your "Socialist Security" money will now be "invested" by highly skilled Wall Street brokers until every penny is gone!
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Be watching for our exciting "You Get More in 2004"TM RepubliCorpTM "Mandate Rebate." Since we're no longer just a "country," we don't really need messy, inefficient "voting," do we? Instead of voting, you'll receive $10 "insta-cash" to donate to the RepubliCorpTM Personal Representative who has done the most for you!
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RICH PROCTER can be reached at planetniner@yahoo.com
A Loss For Parents Of Autistic Kids
Suits vs. drug makers blocked
http://www.newsday.com/news/nationworld/ny-usthim243016566nov24,0,5764967.st
ory?coll=ny%2Dnationworld%2Dheadlines
By Thomas Frank
WASHINGTON BUREAU
November 24, 2002
Washington - Kathy Kilpatrick knows her 6-year-old daughter, Mary Kate, will never experience a normal life, because autism makes her almost unable to express feelings and needs. The privation has long saddened Kilpatrick. But last week the Jericho woman grew irate when Republicans in Congress denied her one more thing - the chance to hold someone immediately accountable.
Republicans put a last-minute provision in the homeland-security bill that blocks efforts by Kilpatrick and thousands of parents of autistic children to sue manufacturers of a children's-vaccine additive that may cause autism.
The provision diverts a potential tidal wave of claims - none of them proven - that experts say could rival lawsuits filed over asbestos. Republicans say lawsuits might ruin companies whose capacity to produce
vaccines is essential to fight the heightened threat of a biochemical terrorist attack.
But experts and critics call the provision a back-door gift to politically influential drug companies, particularly Eli Lilly and Co., whose chairman, Sidney Taurel, is on the White House Advisory Council on Homeland Security. The provision would extend the liability protection now given for vaccines to vaccine additives.
One additive faces serious medical questions and legal claims: thimerosal, invented by Lilly and used until recently in many common children's vaccines. An estimated 150 individual autism lawsuits and thousands more under preparation target Lilly.
But now families like the Kilpatricks must file claims with a federal compensation fund that pays medical costs and up to $250,000 more for pain and suffering, but makes no finding of fault. Plaintiffs can reject
settlement offers and sue in court, but face tougher legal standards for winning punitive damages.
It's the corporate protection - not the cash limit - that enrages Kilpatrick.
"They need to be held accountable. The thought that my daughter could be living a normal life - she could be on a soccer team, she could be going to birthday parties, she could fall in love some day - none of those things are going to happen. Ever," she said.
Experts were stunned at how the liability provision was rammed through Congress with little deliberation, circumventing the usual committee process.
Lawrence Gostin, director of the Center for Law and the Public's Health at Georgetown and Johns Hopkins universities, agreed the liability protection should help assure vaccine supplies. But, he added, "We could have also done it by just giving a trillion dollars to the vaccine industry."
"Liability is there for important and complex reasons," Gostin said, citing negligence prevention and victim compensation.
The real problem with the U.S. vaccine supply is not that lawsuits threaten manufacturers, Gostin said, but that there is no national strategy to ensure that important vaccines are produced.
"If the sole concern was the national interest, there would have been a full and open debate about the best way to ensure stable investment and procurement of vaccines," Gostin said. But that wasn't done when Republicans took the one-page liability provision out of a stalled bill on vaccines and added it to the 484-page homeland-security bill charging toward approval. "It's one small item plucked out in the most crude possible way," Gostin said.
Democrats called it payback to the pharmaceutical industry, which has given Republicans $14 million since January 2001, and $5.2 million to Democrats, according to the nonpartisan Center for Responsive Politics. They also questioned the influence of Mitch Daniels, Eli Lilly's former director of North American operations who is director of the White House Office of Management and Budget.
Management and budget office spokesman Trent Duffy dismissed the charge, noting Daniels had divested himself of all Lilly holdings. And Republicans said Democrats were beholden to lawyers, who opposed the provision and have given Democrats $45 million since January 2001 versus $17.5 million to Republicans.
Still, Republican leaders have backed off their late additions to the homeland security bill. "Some provisions went beyond what we needed to do," Senate Minority Leader Trent Lott (R-Miss.) conceded.
"The speaker agreed to work on these issues," said an aide to House Speaker Dennis Hastert (R-Ill.). "I don't know that there was really any specific agreement made." That comment seems to undermine moderate Republican senators, who said party leaders promised to modify the liability protection so it doesn't nullify pending lawsuits.
The liability protection was added as many people have blamed thimerosal for the tripling of autism cases in the last decade. The Food and Drug Administration advanced speculation in 1999 when it said infants who get recommended immunizations receive excessive mercury. It asked vaccine makers to stop using mercury-based thimerosal, which was used to prevent contamination when doctors jabbed a needle into the same vial to vaccinate child after child.
Last year, the Institute of Medicine said evidence was inadequate to find or deny a link between thimerosal and autism, a developmental disability that usually appears within the first three years of life, but "the hypothesis is biologically plausible." The possible connection opened new avenues for lawsuits over thimerosal. Since 1988, vaccine manufacturers had been protected from liability when Congress started the federal compensation fund to compensate people claiming vaccine-related injuries.
But the fund, financed with a vaccine-sales tax, proved slow and difficult. A 1999 government audit found that claims typically took more than two years, and that the government was fighting them with unexpected vigor: 68 percent of the 5,566 resolved claims have been rejected to date, leaving the fund with a $1.8 billion balance.
Thimerosal seemed to provide a way to sue its manufacturers and vaccine makers who used it directly because as an additive, it was not protected by the fund.
Mike Hugo, a Boston lawyer working on 1,000 thimerosal cases, said vaccine manufacturers knew of risks in the 1970s but "continued to use thimerosal, even though scientists were telling them other things may be safer." Industry officials denied the charge.
Republicans also noted that the liability protections were recommended by the American Academy of Pediatrics and the compensation fund's advisory commission to help stabilize the vaccine industry.
Other advocates had sought to make the fund more friendly to victims and had competing legislation. "But," said Rep. Henry Waxman (D-Calif.), who helped create the vaccine fund, "the administration and the Republican leadership have chosen to ignore those and move only on some industry protections
[By Todd Ackerman and Mary Ann Fergus. Copyright 2002 Houston
Chronicle.]
http://www.chron.com/cs/CDA/story.hts/health/1654344
Beaumont residents Mark and Darla Williford can tell you exactly when their infant daughter stopped making eye contact, learning new words and smiling for the camera. It was shortly after her first birthday, on the day in November 1995 that Laura received four vaccines. That night, she had a fever and was agitated, common side-effects of vaccination. But the next six months were anything but typical: the girl acted strangely, flipping lights on and off, for example, and she would scream and laugh for no reason. "It looked like she was going insane," said her dad. In March 1999, Laura was diagnosed with autism, a devastating neurological disorder marked by jerky, repetitive movements, a lack of language skills and social withdrawal. A month after the diagnosis, Mark Williford found a report about a possible link between autism and childhood vaccines that contained a mercury-based preservative. His daughter's vaccines contained the preservative, called thimerosal; her symptoms matched those of mercury poisoning.
"I remember reading the symptoms and a cold chill went up my spine,"Williford recalled. "I said, `This is what's causing it.' " In Texas and around the world, more and more people are becoming convinced that autism can be caused by the vaccines supposed to protect them. The U.S. Food and Drug Administration and Centers for Disease Control and Prevention say there's no evidence to support the hypothesis, but thousands of parents have joined a worldwide legal campaign to hold pharmaceutical companies liable for injecting infants with a known toxin.
It might sound like ambulance-chasing lawyers and blame-happy parents except for one thing: Autism's exploding these days and no one knows why. The explosion, a tripling over the last decade, suggests an environmental component that could be explained by increased mercury exposure associated with a rapid increase in vaccinations during the 1990s. The mercury has now been removed from most vaccines, but concern over a possible link to autism has led to congressional hearings, multimillion-dollar studies, and clusters of class-action lawsuits that one of the lawyers says "could be the biggest thing to come down the litigation pipeline ever."
There also have been declining immunization rates in some countries, raising fears among public health leaders that the allegations could undermine a vaccine program considered one of the great medical breakthroughs of the past century. Some scientists acknowledge that this fear threatens to stifle open inquiry into whether the concerns are legitimate.
For the most part, however, doctors seem confident that the allegations aren't legitimate. "Vaccines have been tested every which way and no link to autism has ever come up," said Dr. Jane Siegel, a pediatrics professor at the University of Texas Southwestern Medical Center in Dallas, who has served on national advisory committees on vaccines. "They're safe." Still, scientists are at a loss to explain the dramatic increase in the incidence of autism, which was not described until the 1940s and then was attributed to cold "refrigerator" mothers. That theory has been debunked and researchers are zeroing in on genetic causes, but the disorder is still poorly understood. There is no cure, though a new intensive therapeutic program is helping some children.
Once thought to occur in 1 of every 10,000 children, autism today is estimated to afflict 1 in 500. A California study last month that found a three-fold increase from 1987 to 1998 said the hike couldn't be explained away by statistical anomalies or different definitions or growing public awareness, but the study could offer no explanation. The increase in Texas was more than twice as large as in California.
There are two ways vaccines are alleged to play a role. One is that certain vaccines -- the measles, mumps and rubella (MMR) shot has attracted the most attention -- may themselves cause autism or other problems in a small percentage of sensitive people. A study in the New England Journal of Medicine, published Thursday, found no evidence to support the MMR theory, the latest in a series of such findings involving that vaccine.
The other theory involves thimerosal, which until recently was used in many vaccines to guard against contamination when pediatricians jab the same vial repeatedly to vaccinate one child after another. The amount of mercury in each shot was slight, but advocates of this theory say a dangerous amount could accumulate because the number of required vaccinations has mushroomed since the late 1980s as researchers have figured out how to prevent more infectious diseases -- a typical child now gets 32 doses of 12 vaccines by the age of 6; a 2-month-old may get five shots during one visit to the doctor's office.
Critics wonder if all that mercury was more than those little bodies could handle, whether the result is autism or some other crippling neurological disorder. "It's outrageous to think that injecting a child with all that toxicity is an acceptable risk," said Bernard Rimland, director of the Autism Research Institute in San Diego. "It's also outrageous that despite such compelling evidence of harm, the medical community would subject children to it."
In 1999, the FDA concluded that infant children who receive the recommended series of immunizations are receiving more mercury than is considered safe by the U.S. Environmental Protection Agency and asked vaccine manufacturers to voluntarily phase out their use of thimerosal. The conclusion was later echoed by the CDC, pediatric organizations and a blue-ribbon panel of experts that reviewed all the existing studies on thimerosal and autism. The manufacturers now say they're producing thimerosal-free vaccines, and a Texas Department of Health representative said the agency is confident of this. Believers in the mercury theory, however, are skeptical about whether all the old stuff is off the shelves.
For instance, it took an intense effort by Williford to get the Beaumont Health Department to replace its supply last year. The department finally agreed in August 2001, following six months of Williford's making requests, talking to his state representatives and appearing at City Council meetings.
For his and other families, the struggle was to understand what was happening. After her son was diagnosed with mild pervasive developmental disorder at age 2 1/2, autism a couple of years later, and then "severe autism," Spring resident Gina Shaw traveled to California in 2000 for a Defeat Autism Now conference. There, she heard a speaker present new information suggesting a link between thimerosal and autism. Coming on the heels of a test that had revealed high levels of metals in her son's blood, the theory seemed persuasive.
Tears began running down Shaw's cheeks as she listened to the speaker. She grew angry that government agencies allowed the use of vaccines containing thimerosal. "I was mad as hell," she said, "because they did this to my baby. "Shaw and her husband, Darwin, can barely look at early photographs of Brett. They show a laughing child with twinkling blue eyes. But in photos taken after his second birthday, Brett is stonefaced. He could barely sit still long enough to be photographed. Now 10, Brett mumbles a few random words such as "bye" and "eat." He can follow simple instructions but doesn't understand everyday conversations between his parents and his 12-year-old sister, Brianna. He takes special-education classes and functions at a 2-year-old's level. Unable even to write his name, Brett lives largely in a world of his own, entertaining himself with simple computer games or playing alone in a closet or tent.
The Shaws estimate that they've spent $50,000 on their child's care. (The Willifords have spent $60,000.) In January, the Shaws filed a complaint with the U.S. Court of Federal Claims in Washington, D.C., under the National Vaccine Injury Compensation Program, which compensates people injured by routine vaccinations. The complaint was handled by Hitt, Patterson & Sell in Houston, one of four Texas firms leading the litigation onslaught.
Two other firms are also based in Houston -- Gallagher, Lewis, Downey & Kim and Williams & Bailey -- and one is a Dallas firm, Waters & Kraus. The firms are part of two legal coalitions that estimate they have about 4,000 clients between them. The first lawsuit in a state civil court, filed by Waters & Kraus, concerns a Plano boy who had a growing vocabulary at 20 months, then lost all his language skills, was diagnosed with autism and found to have high levels of mercury exposure. The lawsuit is in Brazoria County, where one of the defendants, Dow Chemical Co., has a drug manufacturing plant.
Attorney Jeff Sell believes in the cases as a litigator and father. His 8-year-old twins have autism. Sell cannot file a complaint through the Vaccine Court because those must be filed within three years of the onset of symptoms, and it was five years before he made a connection. But because the Vaccine Court strictly limits damages, the potential for bigger money is in civil courts anyway. "With as many as 200,000 possible cases of developmental disorders that could be tied to vaccines, this could turn out to be one of the biggest mass tort cases ever in the United States," said Michael Williams, chairman of the Mercury Vaccine Alliance, which already has filed seven class-action lawsuits around the country. "But we won't know for two or three years." Complicating the plaintiffs' case is that the children could have been exposed to mercury from other sources, such as fish or dental fillings. Even if science ultimately finds a link between mercury and autism, it might not be clear whether the culprit was the vaccines or exposure from the mother's fillings or consumption of fish while the child was in the womb. At the moment, of course, the biggest threat to the lawsuits' success is the lack of science backing them, say legal observers. Scientists acknowledge that mercury is a potent neurotoxin known to damage the brains, nervous systems and immune systems of unborn children, but beyond that little is certain.
For one thing, although autism sometimes can be detectable as early as 6 months, it more often appears to hit later, at 1 1/2 to 2 years, and after the child had appeared to be developed normally. Those skeptical of a vaccine link say it is just a coincidence that symptoms appear at the
same time the MMR vaccine is given.
For another, there have been few well-designed studies looking into the mercury allegation. The blue-ribbon panel of experts assembled to look into the matter called the idea that thimerosal poses a significant threat to the developing brain "biologically plausible" but said none of the existing studies had been designed well enough to produce evidence of a link.
Both sides in the debates have seized on the panel's report. (The evidence is much better that the MMR vaccine doesn't cause autism, said the head of the panel. The New England Journal of Medicine study published Thursday tracked 500,000 Danish children born between 1991 and 1998 and found no statistical difference in autism between those who received the MMR vaccine and those who didn't. The vaccine has never contained thimerosal.) Typical of the contentiousness surrounding the issue was a July 2000 congressional hearing convened by U.S. Rep. Dan Burton, R-Ind., whose autistic grandson seemed healthy and talkative until getting a series of vaccinations at one time. Rep. Henry Waxman, D-Calif., complained that the hearing was unfairly stacked with parents and experts alleging a connection between vaccination and autism, and the only thing committee members could agree on was the need for further study of the issue. "The fact is, there just hasn't been much done in this area," said Irva Hertz-Picciotto, a professor of maternal and child health at the University of California-Davis School of Medicine, recently awarded a federally funded center to study the issue. "We don't know much about the epidemiology of autism, let alone whether mercury could foster it." This much is known about autism: There's a genetic susceptibility -- the risk increases for younger siblings of autistic children -- that scientists think involves 10 to 20 genes. But the environment also can play a role: It was more common in babies born to mothers who took thalidomide or had rubella during pregnancy. New studies will look at the interaction between genes and environment.
The Man Behind The Vaccine Mystery
[CBS Evening News.]
http://www.cbsnews.com/stories/2002/12/12/eveningnews/main532886.shtml
It's been a mystery in Washington for weeks. Just before President Bush signed the homeland security bill into law an unknown member of Congress inserted a provision into the legislation that blocks lawsuits against the maker of a controversial vaccine preservative called "thimerosal," used in vaccines that are given to children. Drug giant Eli Lilly and Company makes thimerosal. It's the mercury in the preservative that many parents say causes autism in thousands of children – like Mary Kate Kilpatrick. Asked if she thinks her daughter is a victim of thimerosal, Mary Kate's mother, Kathy Kilpatrick, says, "I think autism is mercury poisoning."
But nobody in Congress would admit to adding the provision, reports CBS News Correspondent Jim Acosta – until now. House Majority Leader Dick Armey tells CBS News he did it to keep vaccine-makers from going out of business under the weight of mounting lawsuits. "I did it and I'm proud of it," says Armey, R-Texas. "It's a matter of national security," Armey says. "We need their vaccines if the country is attacked with germ weapons." Rep. Dan Burton, R-Ind., isn't buying it. The grandfather of an autistic child, Burton says Armey slipped the provision in at the last minute, too late for debate. "And I said, 'Who told you to put it in?'" He said, 'No, they asked me to do it at the White House.'"
Critics say the Bush family and the administration have too many ties to Eli Lilly. There's President Bush's father, who sat on the company's board in the 1970's; White House budget director Mitch Daniels, once an Eli Lilly executive; and Eli Lilly CEO Sidney Taurel, who serves on the president's homeland security advisory council. Officials at the drug giant insist they did nothing wrong. "No one, not our CEO, not myself, not anyone who works with me asked the White House to insert this legislation," said Eli Lilly spokeswoman Debra Steelman. But Kathy Kilpatrick and her husband Michael argue that the thimerosal provision is not designed to protect the nation, but rather to protect Eli Lilly.
Asked what he'd say to a congressman who came forward and admitted he was responsible for inserting the provision, Michael Kilpatrick says, "I would ask him if he knew he was protecting mercury being shot into our kids." Kathy Kilpatrick asks, "Why would anyone want to save Eli Lilly on our children's backs?"
Because Armey is retiring at the end of the year, some say the outgoing majority leader is the perfect fall guy to take the heat and shield the White House from embarrassment. It's a claim both the White house and Armey deny.
Friends,
I don't care HOW many tax dollars it takes! Pharmaceutical company Eli Lilly deserves our protection! Eli Lilly has worked hard for decades researching and creating new vaccines to protect public health. It's irrelevant that vaccines have never been shown to do anything but leave death and injury in their wake. It's not Eli Lilly's fault if science can't demonstrate what vaccines must in fact do: protect our health. In exchange for Eli Lilly's efforts to protect us, we should be willing to protect them!
And protecting Eli Lilly is JUST what the awesome "Homeland Security Bill" (recently passed by congress) does! If the president signs the bill into law, taxpayers--not hardworking Eli Lilly--will pay for vaccine-related injuries. Of course, Eli Lilly will still have to pay for damages in the lawsuits they lose out of the 45 already in progress against them. But once those suits are done with, Eli Lilly should not have to spend its research dollars on court costs. The species' health is at stake!
After all, use your noggin. Vaccines SHOULD work. It's just a matter of time until somebody comes up with a study that shows they do. PROTECT ELI LILLY WITH YOUR TAX DOLLARS! That should be the bumper sticker on every car in America. Heck . . . in the world!
And believe me, I'll be the first in line to get the smallpox vaccine. I've already got my shortsleeve shirt on. Because I want to show my neighbors what it means to be a good American. And what it means to be a good American is sacrifice.
I want to be part of the first study that shows that vaccines work. And if I get smallpox or die from the vaccine, at least I know I will have contributed to the public health and to the public good, just like our forebears did when they fought the British. If I die in the war on disease, at last I know I will have helped Eli Lilly to survive and to keep working heroically toward their one and only goal of perfect public health.
God bless Eli Lilly, and God bless America!
Jock Doubleday
Director
Natural Woman, Natural Man, Inc.
A California Nonprofit Corporation
http://www.gentlebirth.org/nwnm.org
jockdoubleday@aol.com
http://www.pressdemocrat.com/local/coursey/courseycolempireb.html
Homeland bill close to home for this family
December 9, 2002
By CHRIS COURSEY
FOR THE PRESS DEMOCRAT
Ask Lynn Hartman about the homeland security bill, and her face curls in disgust. It's not that she has anything against fighting terrorists; after all, her husband, Dave, is a pilot for United Airlines. But the new legislation hits close to home for the Hartmans in another, even more personal way. Their 21/2 -year-old son, Taylor, is autistic. Connecting autism and domestic security is a stretch, but Congress managed to do it last month. Last-minute add-ons to the homeland security bill grant Eli Lilly & Co. immunity from lawsuits related to its product thimerosal, a mercury-based preservative used in many vaccines.
The Hartmans believe it is responsible for Taylor's autism.
"He's been mercury-poisoned," Lynn Hartman says.
The Hartmans are not alone. In a speech before Congress on Nov. 22, Rep. Dan Burton, R-Ind., said he had "heard from thousands of families across the country that this same thing happened to their child." He cited a growing body of evidence that suggests a huge spike in the number of autistic children may be linked to a program of infant vaccinations that began in the early 1990s.
Like most babies since then, Taylor was vaccinated very early in life -- much earlier than you and I. He had had several doses of thimerosal before he was 6 months old. Large, active and healthy at birth, Taylor developed normally. He was walking and beginning to talk by the time he was 14 months old. But then his parents, who live in Sonoma, noticed a sudden, troubling change. "He started having temper tantrums," says Lynn. "He stopped talking. He became adverse to touch."
Autism is a tricky thing to pin down. Symptoms can range from withdrawal and difficulty speaking to violent, self-injurious behavior. It once was classified as a mental illness passed on genetically to children. The past 10 years, though, have included a large increase in the number of cases of "late-onset autism" -- symptoms of the disorder that appear in young children who previously have been "normal."
The cause is the subject of intense debate. While mercury is often pointed to as a likely culprit, it is a naturally occurring element that enters the body in a number of ways. Seafood, dental fillings and various pollutants all contain mercury. Although researchers have called it "biologically plausible," no study has definitively linked thimerosal with autism. But because of the risks posed by mercury, federal health officials in 1999 advised that infants not receive vaccines containing thimerosal until they were 6 months old. Most
vaccines no longer contain it.
But Taylor's vaccines did.
Traditional treatment for autism involves a lot of occupational therapy, special education and drugs. But the Hartmans have followed a protocol suggested by Stephanie Cave, a Louisiana pediatrician who believes high doses of mercury compromise some children's ability to leach metals from their bodies. Taylor, for instance, had extremely high levels of copper, arsenic, mercury and other metals in his tissues.
They began treating him metabolically, using diet and supplements to remove the metals from his body. The regimen, the Hartmans say, has given them their son back. Taylor's blue-gray eyes peek out from under thick, curly bangs. He points out shapes in the painting he's working on and explains them to a visitor: "wee" and "see." "He started talking again about a month and a half ago," Lynn Hartman says. She says his "development age" is about 19 months -- behind, but progressing once again. She says her anger about the homeland security bill is not because she wants to sue, but because it sweeps a problem under the rug. "A lot of these kids can get better, but they need to get help now," she says. "The drug companies need to admit they messed up."
Contact Chris Coursey at 521-5223 or ccoursey@pressdemocrat.com.
Subject: Sen. Daschle, Rep. Pelosi Vow to Repeal Homeland Security
Provision
Eli Lilly & Co.
http://www.stockhouse.com/news/news.asp?tick=LLY&newsid=1413704
Sen. Daschle, Rep. Pelosi Vow to Repeal Homeland Security Provision Shielding Drug Makers from Liability
11/21/02
Claims that Congress Can 'Fix' the Problem Are Misleading WASHINGTON, Nov 21, 2002 /PRNewswire via COMTEX/ -- Safe Minds and the Mercury Policy Project are hailing a statement by the US House and Senate leadership that they will work to repeal a corporate special-interest provision in the Homeland Security Bill. The provision wipes out all legal remedies for thousands of autistic children harmed by mercury in infant vaccines and must be eliminated, the two groups working to prevent mercury-related injuries said today.
"We strongly support Senate Majority Leader Tom Daschle and House Democratic Leader-Elect Nancy Pelosi's vow to remove egregious special interest provisions, including the thimerosal liability shield for Eli Lilly," said Michael Bender, Director of the Mercury Policy Project. As passed, the Homeland bill allows the families to re-file their claims in a special administrative court for vaccine-related injury cases where it takes years for cases to be heard and 87% of the claims filed are denied. And claims can only be made by parents if their child's first symptom of neurological damage occurred within the last three years, which effectively bars many families from going to court to hold Lilly accountable for their children's injuries, the groups said. "It is a sad state of affairs when the Congress and the White House conspire to benefit a pharmaceutical giant at the expense of injured children and families whose lives have been shattered by corporate wrongdoing," said Lyn Redwood, RN, president of Safe Minds and the parent of a child who developed multiple disabilities after receiving 125 times the government-recommended exposure to mercury. "Eli Lilly has been allowed to exploit a national threat to America to further their own agenda."
The provision to benefit Lilly -- which was added to the unrelated Homeland Security Bill at the last minute -- affects lawsuits against the drug maker for injuries caused by its product thimerosal, a mercury-based preservative that was used in infant vaccines until a few years ago. "Claims by Republican congressional leaders that they will "fix" the provision next year are empty promises because it will be too late," said Michael Bender, Director of the Mercury Policy Project. "Once President Bush signs the bill -- which will happen any day -- Eli Lilly can go to court and have all the mercury vaccine-related lawsuits against it dismissed immediately."
According to Redwood, after conversations with senate staff, the "fix" will do little if anything to right this wrong. "Our children have been silenced once by autism and now the votes of Congress have silenced them again," said Redwood. "The right thing to do would be to pass legislation as soon as possible to strike the thimerosal provisions." The lawsuits were filed by the families of children who developed autism, learning disabilities and other neurological problems after multiple mercury exposures. It takes hundreds of thousands of dollars each year to care for a severely autistic child and millions over the victim's lifetime.
satire -
Rich Procter: 'Pharma-gate! Red alert! Red alert!'
Contributed by drprocter on Friday, November 22 @ 09:55:18 EST
----------------------------------------------------------------------------
(intercepted by Rich Procter)
MEMO
From: Karl Rove
To: The Team
PHARMA-GATE! RED ALERT! RED ALERT!
PEOPLE -- We're vulnerable, and we've got to act NOW to head off a debacle. As I'm sure you're well aware, our compatriot Mr. DeLay inserted a rider into the Homeland Security bill that would shield one of our biggest campaign contributors, Eli Lilly from lawsuits by outraged, betrayed parents who used a vaccine they're producing that very well may be causing autism in their kids. In a slick move we've got to remember, Tom the Bomb actually made this RETROACTIVE, so that parents of autistic kids currently suing Eli Lilly would have their suits thrown out! That guy is slicker than deer guts on a doorknob.
The VULNERABILITY, of course, comes from the fact that it looks like we the Republicans, care more about stuffing the dirty dollars of Big Pharma into our full-to-burstin' pockets than we do about the welfare of children! It looks like we, the Republicans, the party of "responsiblity," are shielding Eli Lilly from taking responsibility for their own actions. It looks like we're rigging the justice system to screw already suffering parents as a payback for the dumptruck full of cash Big Pharma dropped on us! It makes us look like soulless plutocrats -- greedy, money-grubbing whores! Whereas the truth is...ahhhh....
Anyway, we've got to get out in front of this issue like we got out in front of the whole "privatizing Social Security" issue. I'm thinking we try another "carpet-bomb the airwaves" kinda deal, that works something like this:
First, we gin up an astroturf "concerned parents" group -- I'm thinking we call it, ahhhh, "Grateful Parents of Challenged Children For Responsible Pharmaceutical Policy." Next, we hire a bunch of dewy-eyed 30-something mother-types who give out with some copy like the following:
MOTHER-TYPE -- (halting, almost overcome with emotion) "Recently, I heard that some (pause -- can barely say the word) 'Democrats' had the nerve to criticize our President and his compatriots just because they included some beneficial extras onto the Homeland Security Bill. One of those extras will free up pharmaceutical companies from frivolous lawsuits. (steels herself -- stares down camera) "As the mother of a 'challenged child,' I know what heartbreak is. And I know these partisan, obstructionist Democrats have broken the heart of our President by daring to criticize him, even as he shoulders the responsibility of leading this country into a series of righteous wars that will vaporize our enemies and make the world safe for people l ike us -- because there'll be nothing left but people like us. (graphic on screen) I'd like you to join me in calling President Bush and thanking him for making it impossible for me and other concerned parents to stop these pharmaceutical companies from generating the record profits that could possibly lead to the economic recovery the off-shore tax haven where they're based. Please call the number on the screen. Be aware this is not a free call, and you'll be charged $2.75 a minute."
Is that beautiful, or WHAT? 'Course we gotta get Rush and G. Gordo and O'Reilly and Hannity to call the Dems a bunch of whiny, hand-wringing limp-wristed Latte liberal traitors for trying to stop the Homeland Security bill for something so trivial as a bunch of whiny, lawsuit-happy parents being led down the primrose path by money-mad ambulance chasing lawyers.
Oh, and one last thing -- we need to invent some statistics proving...ahhhh....wait a minute, it's coming....that the autism these parents suffered could just as easily have been caused by the mother visiting San Francisco and consuming too many double lattes while listening to Barbra Streisand records while pregnant. Yeah.
Debbie Greco's son was a normal 3-year-old when, after finishing a round of childhood immunizations, he became withdrawn, aggressive, and slow to speak - all symptoms of autism.
THE NEEDLE AND THE DAMAGE DONE
http://www.zwire.com/site/news.cfm?newsid=6428783&BRD=2318&PAG=461&dept_id=484045&rfi=6
BY ANTONIO C. CABRAL 12/19/2002
"I didn't know what was causing them," says Greco, a San Antonio native. "Friends have the same problem, but their children's doctor told them there was no need to question the use of vaccines. We didn't know about Thimerosal." The coziness between the pharmaceutical companies and the Bush administration has harmed families but helped drug manufacturers, including Eli Lilly, producer of Thimerosal. The drug company's cause was recently buttressed after Majority Leader and Texas Republican Dick Armey(who didn't cop to the deed until last week) stealthily tacked on a protective clause to the Department of Homeland Security bill that prohibits families from suing Eli Lilly for faulty vaccinations - including those containing Thimerosal, which could have caused autism in thousands of children.
"That clause should have gone through this committee and it didn't," said U.S. Representative Dan Burton (R-Indiana), a member of the House's Government Reform Committee. He has an autistic grandchild and is a harsh critic of Thimerosal. Thimerosal prevents bacteria from forming in vaccines; it was used widely in in the 1980s and '90s. The mercury-based chemical also boosted drug companies' profits because they could sell multiple doses in one vial without fear of contamination.
Although in 1999 the Federal Drug Administration required pharmaceutical companies to remove Thimerosal from their vaccines, it didn't recall batches already sitting in doctors' offices, public health clinics, or hospitals. As many as 30 vaccines have contained Thimerosal, including the Diptheria, Tetanus, and Pertussis combination; during the 1990s, health officials required children to receive additional Thimerosal-containing vaccines, including Hepatitis B.
The FDA knew the risks of Thimerosal years before it forced drug companies to quit using it in vaccines. In the 1980s, the FDA required companies to remove the chemical from all over-the-counter products, but not vaccines. By 1999, the FDA announced that infants who receive several thimerosal-containing vaccines might be overexposed to mercury, which prompted a ban on Thimerosal - but not a recall.
Some parents of once-healthy children, such as Debbie Greco, believe that the chemical has caused autism in their kids. Other parents don't know about the possible connection between Thimerosal and autism because there is an average of a 44-month gap between the initial vaccinations and the onset of symptoms. Autism was once a rare disorder. In 1970, about one in 2,000 children suffered from it; over the next 30 years - during the time children were being exposed to more mercury-containing vaccines - that number has increased to one in 150, according to the Centers for Disease Control.
A neurological disorder, autism causes developmental delays, abnormal language and thinking skills, and other erratic behavior. Expensive therapy and medicine - out of financial reach for most working families - can lessen the symptoms and allow autistic children to learn basic skills, but do not cure the disease. The Grecos spend about $25,000 a year in additional medical and therapy expenses for her son. "My son's illness impacts our whole family for life," Greco says. "It's not something that is going away."
The federal government initially covered up the serious risk of Thimerosal-based vaccines. But a non-profit advocacy group, SAFEMINDS (Sensible Action for Ending Mercury-Induced Neurological Disorders), filed a Freedom of Information Act to obtain a confidential Thimerosal study conducted by the CDC. That study showed that children exposed to mercury from vaccines were more than twice as likely to develop autism than kids who were unexposed.
In July 2001, the CDC released a revised version of the study that downplayed the role Thimerosal had in causing autism - stating the data was inconclusive.
Many scientists, such as Dr. Boyd Haley, chairman of the chemistry department at the University of Kentucky, believe Thimerosal is toxic for children. With smaller kidneys and livers, children can't process the mercury in their bodies as adults can. "Giving a 10-pound infant a single vaccine in a day is the equivalent of giving a 100-pound adult 40 vaccines in a day. We're talking about causing death; we're talking about causing autism."
U.S. Representative Burton has also taken the Bush administration to task for protecting drug manufacturers from litigation. He held hearings on the damage caused by vaccines containing Thimerosal and said there was "clear evidence on the relationship between the vaccines and autism." He has demanded that all vaccines containing Thimerosal be destroyed. "Every day that mercury-containing vaccines remain on the market is another day of putting 8,000 children at risk."
Dallas-based law firm Walter & Kraus is representing several parents in lawsuits against Eli Lilly and other pharmaceutical companies. Attorney Andy Waters accused Lilly of hiding the truth about Thimerosal and using its own biased study to promote it. "Lilly used an unethical study to help them sell their product."
Drug companies such as Lilly are also using their political muscle to protect their financial interests. According to the Center for Responsive Politics, in the 2001-2002 election cycle, Lilly contributed more than $6 million to various Republican committees. Lilly has other connections to the White House: George Bush the First served on its board in the 1970s; Dubya hired Mitch Daniels, director of Office and Management and Budget, from Lilly, where Daniels worked as president of the company's North American operations.
Unlike the drug companies, the parents, families, and autistic children have no one to represent their concerns on Capitol Hill. "The problem is we have no lobbyists," Greco explains. Without the political or financial power, Greco and thousands of families like hers have little recourse to hold drug companies accountable, especially when the pharmaceutical industry has so many friends in government to protect them.
CounterPunch
December 18, 2002
Hi! We're Republicorp! (formerly USA)
(this noticed received in the mail by Rich Procter)
http://www.counterpunch.org/procter1218.html
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RICH PROCTER can be reached at planetniner@yahoo.com
A Loss For Parents Of Autistic Kids
Suits vs. drug makers blocked
http://www.newsday.com/news/nationworld/ny-usthim243016566nov24,0,5764967.st
ory?coll=ny%2Dnationworld%2Dheadlines
By Thomas Frank
WASHINGTON BUREAU
November 24, 2002
Washington - Kathy Kilpatrick knows her 6-year-old daughter, Mary Kate, will never experience a normal life, because autism makes her almost unable to express feelings and needs. The privation has long saddened Kilpatrick. But last week the Jericho woman grew irate when Republicans in Congress denied her one more thing - the chance to hold someone immediately accountable.
Republicans put a last-minute provision in the homeland-security bill that blocks efforts by Kilpatrick and thousands of parents of autistic children to sue manufacturers of a children's-vaccine additive that may cause autism.
The provision diverts a potential tidal wave of claims - none of them proven - that experts say could rival lawsuits filed over asbestos. Republicans say lawsuits might ruin companies whose capacity to produce
vaccines is essential to fight the heightened threat of a biochemical terrorist attack.
But experts and critics call the provision a back-door gift to politically influential drug companies, particularly Eli Lilly and Co., whose chairman, Sidney Taurel, is on the White House Advisory Council on Homeland Security. The provision would extend the liability protection now given for vaccines to vaccine additives.
One additive faces serious medical questions and legal claims: thimerosal, invented by Lilly and used until recently in many common children's vaccines. An estimated 150 individual autism lawsuits and thousands more under preparation target Lilly.
But now families like the Kilpatricks must file claims with a federal compensation fund that pays medical costs and up to $250,000 more for pain and suffering, but makes no finding of fault. Plaintiffs can reject
settlement offers and sue in court, but face tougher legal standards for winning punitive damages.
It's the corporate protection - not the cash limit - that enrages Kilpatrick.
"They need to be held accountable. The thought that my daughter could be living a normal life - she could be on a soccer team, she could be going to birthday parties, she could fall in love some day - none of those things are going to happen. Ever," she said.
Experts were stunned at how the liability provision was rammed through Congress with little deliberation, circumventing the usual committee process.
Lawrence Gostin, director of the Center for Law and the Public's Health at Georgetown and Johns Hopkins universities, agreed the liability protection should help assure vaccine supplies. But, he added, "We could have also done it by just giving a trillion dollars to the vaccine industry."
"Liability is there for important and complex reasons," Gostin said, citing negligence prevention and victim compensation.
The real problem with the U.S. vaccine supply is not that lawsuits threaten manufacturers, Gostin said, but that there is no national strategy to ensure that important vaccines are produced.
"If the sole concern was the national interest, there would have been a full and open debate about the best way to ensure stable investment and procurement of vaccines," Gostin said. But that wasn't done when Republicans took the one-page liability provision out of a stalled bill on vaccines and added it to the 484-page homeland-security bill charging toward approval. "It's one small item plucked out in the most crude possible way," Gostin said.
Democrats called it payback to the pharmaceutical industry, which has given Republicans $14 million since January 2001, and $5.2 million to Democrats, according to the nonpartisan Center for Responsive Politics. They also questioned the influence of Mitch Daniels, Eli Lilly's former director of North American operations who is director of the White House Office of Management and Budget.
Management and budget office spokesman Trent Duffy dismissed the charge, noting Daniels had divested himself of all Lilly holdings. And Republicans said Democrats were beholden to lawyers, who opposed the provision and have given Democrats $45 million since January 2001 versus $17.5 million to Republicans.
Still, Republican leaders have backed off their late additions to the homeland security bill. "Some provisions went beyond what we needed to do," Senate Minority Leader Trent Lott (R-Miss.) conceded.
"The speaker agreed to work on these issues," said an aide to House Speaker Dennis Hastert (R-Ill.). "I don't know that there was really any specific agreement made." That comment seems to undermine moderate Republican senators, who said party leaders promised to modify the liability protection so it doesn't nullify pending lawsuits.
The liability protection was added as many people have blamed thimerosal for the tripling of autism cases in the last decade. The Food and Drug Administration advanced speculation in 1999 when it said infants who get recommended immunizations receive excessive mercury. It asked vaccine makers to stop using mercury-based thimerosal, which was used to prevent contamination when doctors jabbed a needle into the same vial to vaccinate child after child.
Last year, the Institute of Medicine said evidence was inadequate to find or deny a link between thimerosal and autism, a developmental disability that usually appears within the first three years of life, but "the hypothesis is biologically plausible." The possible connection opened new avenues for lawsuits over thimerosal. Since 1988, vaccine manufacturers had been protected from liability when Congress started the federal compensation fund to compensate people claiming vaccine-related injuries.
But the fund, financed with a vaccine-sales tax, proved slow and difficult. A 1999 government audit found that claims typically took more than two years, and that the government was fighting them with unexpected vigor: 68 percent of the 5,566 resolved claims have been rejected to date, leaving the fund with a $1.8 billion balance.
Thimerosal seemed to provide a way to sue its manufacturers and vaccine makers who used it directly because as an additive, it was not protected by the fund.
Mike Hugo, a Boston lawyer working on 1,000 thimerosal cases, said vaccine manufacturers knew of risks in the 1970s but "continued to use thimerosal, even though scientists were telling them other things may be safer." Industry officials denied the charge.
Republicans also noted that the liability protections were recommended by the American Academy of Pediatrics and the compensation fund's advisory commission to help stabilize the vaccine industry.
Other advocates had sought to make the fund more friendly to victims and had competing legislation. "But," said Rep. Henry Waxman (D-Calif.), who helped create the vaccine fund, "the administration and the Republican leadership have chosen to ignore those and move only on some industry protections
Whose Hands Are Dirty?
By BOB HERBERT
http://www.nytimes.com/2002/11/25/opinion/25HERB.html?ex=1038891600&en=15a1ad31cbd3dfa5&ei=5062&partner=GOOGLE
Thimerosal is a preservative that contains mercury and was used for many years as an additive in some routinely administered children's vaccines.
Fears developed a few years ago that the additive might have been causing dangerously elevated levels of mercury in infants, resulting in neurological impairment and, in some cases, autism.
Studies thus far have neither shown nor ruled out a link between the vaccines and neurological damage in children. But in the summer of 1999 the American Academy of Pediatrics and the Public Health Service urged vaccine manufacturers to stop using thimerosal as quickly as possible.
Thus, thimerosal, which was developed by Eli Lilly & Company in the 1920's and was in widespread use by the 1990's, is no longer added to vaccines commonly given to children. But a serious controversy continues. Lawsuits have been filed by parents across the country who are convinced that their children suffered severe neurological damage from the mercury in the vaccines. Talking to them can be heartbreaking.
Lyn Redwood, a nurse practitioner and the wife of a physician in suburban Atlanta, spoke to me last week about her 8-year-old son, Will. "I have a little boy who was completely normal at birth — walking, talking, smiling, meeting all of his developmental landmarks," she said. "Then, shortly after he turned 1 year old, he lost his ability to speak, to make eye contact. He started regressing and ultimately was diagnosed with pervasive developmental disorder, which falls into a spectrum of autism disorders."
Ms. Redwood contends that three infant vaccines administered to her son when he was 2 months old exposed him to levels of mercury that far exceeded all safety guidelines.
At this point we must interrupt our narrative and turn our attention to the federal government's effort to fight terrorism in the United States.
Last week the Senate approved legislation to establish a Department of Homeland Security and it will soon be signed into law by the president. Buried in this massive bill, snuck into it in the dark of night by persons unknown (actually, it's fair to say by Republican persons unknown), was a provision that — incredibly — will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their children were harmed by thimerosal.
Now this has nothing to do with homeland security. Nothing. This is not a provision that will in any way protect us from the ferocious evil of Osama bin Laden and Al Qaeda. So why is it there? Perhaps it has something to do with the fact that the major drug companies have become a gigantic collective cash machine for politicians, and that the vast majority of that cash goes to Republicans.
Or maybe it's related to the fact that Mitch Daniels, the White House budget director, is a former Eli Lilly big shot. Or the very convenient fact that just last June President Bush appointed Eli Lilly's chairman, president and C.E.O., Sidney Taurel, to a coveted seat on the president's Homeland Security Advisory Council.
There's a real bad smell here. Eli Lilly will benefit greatly as both class-action and individual lawsuits are derailed. But there are no fingerprints in sight. No one will own up to a legislative deed that is both cynical and shameful.
An official spokesman for Eli Lilly, Edward Sagebiel, insists the company knew nothing about it, nothing at all.
While the vote for the Homeland Security Department was overwhelming, even some Republicans were upset by the provision to benefit Lilly and the other drug companies.
Senator John McCain of Arizona characterized the provision as "among the most inappropriate" in the homeland security legislation. He said: "This language will primarily benefit large brand-name pharmaceutical companies which produce additives to children's vaccines — with substantial benefit to one company in particular. It has no bearing whatsoever on domestic security."
The politicians with their hands out and the fat cats with plenty of green to spread around have carried the day. Nothing is too serious to exploit, not even the defense of the homeland during a time of terror.
Lyn Redwood put together an advocacy group, called Safe Minds, for parents struggling with the thimerosal issue. They're at a slight disadvantage, wielding a popgun against the nuclear-powered influence of an Eli Lilly.
Life during Wartime
Security any CEO would love
By A.C. Thompson http://www.sfbayguardian.com/37/09/x_news_war.html
The Homeland Security Act signed by President George W. Bush Nov. 25 is certain to make corporate America feel secure, cheery even, in this season of economic gloom. The law, which will establish a new, 177,000-employee Homeland Security Department, is loaded with perks for big business and peril for personal liberty.
Perhaps most significantly, the law exempts businesses from being sued under certain circumstances. Section 803, headlined "Litigation Management," will relieve companies manufacturing counterterrorism technology from liability should their products cause injury or death.
Before the bill had even reached Dubya's desk, Public Citizen, a Ralph Nader-founded government watchdog group, was hollering. "These are the special deals that industry gets out of the people they give large campaign contributions to," Public Citizen president Joan Claybrook tells us. The no-liability provisions, she adds, are a stealth move by conservatives to push tort-law reform, a concept long embraced by CEOs and loathed by trial lawyers and consumer advocates. "Big corporations hate liability," she says.
Drug companies get an even better break: for injuries or illnesses caused as side effects of vaccines, the liability exemption is retroactive. It's a legislative handout. Consider the context: vaccine companies are under fire for including high doses of mercury in their products during the 1990s, a practice that has spurred parents in at least 35 states to sue a host of major pharmaceutical companies, among them Pfizer, GlaxoSmithKline, Merck, and Eli Lilly. The now-doomed suits are a bid to force the companies to scrutinize a possible link between mercury-laden vaccines and autism.
Another possible big business boon comes in a section covering "critical infrastructure" that is, power generation and the electrical power grid, telecommunication systems, oil refining, water and sewage systems, food production, and so on. The law encourages companies in these fields to communicate with the Homeland Security Department regarding their vulnerabilities to terrorism. The information will be kept secret and
exempted from the federal Freedom of Information Act.
For corporations with a habit of spewing toxic chemicals into the air or dumping heavy metals into rivers, the new law could be a way to avoid public scrutiny and legal hassles. If a company admits to improperly storing hazardous materials or failing to maintain its facilities, that information, by decree of the Homeland Security Act, can't be used by federal or state prosecutors.
"There's very widespread concern that homeland security measures are being used to protect polluters and withhold information that doesn't need to be withheld," says Bradley Angel, executive director of Greenaction, a San Francisco-based environmental justice group that relies heavily on government documents.
At the Environmental Protection Agency, officials aren't entirely sure how the new rules will affect their operations. "It's difficult to read the tea leaves at this point," says Daniel Meer, an EPA emergency management expert. "I'm sure there are going to be all kinds of working groups and meetings."
While the law shields corporations from citizens' prying eyes, it subjects the public to increased electronic snooping by the feds. Under the rubric "Cyber Security Enhancement," federal agents will be able to monitor the e-mail of suspected hackers, without a court order. The law shreds privacy-protecting rules, allowing Internet service providers to turn over their customers' e-mails to the feds without a warrant.
"There's really no justification for this," argues Lee Tien, senior staff attorney for the Electronic Frontier Foundation, a cyber-liberties group. "I think it's likely there'll be use of this power for illegitimate reasons."
Of course, if the Defense Department gets its way, the privacy-infringing aspects of the Homeland Security Act will seem almost quaint. The Pentagon, as you've probably read, is trying to build the Death Star of surveillance, the Total Information Awareness system, a massive "data-mine" of e-mail messages, phone call records, financial documents, and other personal information.
Tien warns, "This would mean tremendous power to do surveillance. The threats to civil liberties are enormous."
Mercury Falling
Homeland Security Act inoculates drug makers against autism lawsuits.
BY CHRIS LYDGATE
243-2122
http://www.wweek.com/flatfiles/News3373.lasso
_____ When President George W. Bush signed the Homeland Security Act in the White House on Monday, he praised the bill as a "heroic action" that demonstrated "the resolve of this great nation to defend our freedom, our security and our way of life." Three thousand miles away, Portland lawyer Mike Williams rolled his eyes.
Williams represents hundreds of families who are suing pharmaceutical companies--in particular, Eli Lilly--over a mercury-based preservative used in some childhood vaccines. The families contend that the preservative
triggered neurological damage in their children, who have been diagnosed with autism.
Last week, Williams was stunned to learn that an unknown lawmaker had slipped a last-minute rider into the Homeland Security Act, shutting down the lawsuits in the name of the war on terrorism.
"I thought I had lost my naiveté about the power of big money," Williams told WW minutes after Bush signed the bill. "But even I was naive to think Congress wouldn't do this. There was no notice, no warning, no debate--it just came out of nowhere."
Sitting in his 19th-floor office, with a crystalline view of Mount Hood, Williams, 55, is not exactly your buttoned-down tort geek. Rumpled in a black waistcoat, he sports a gray-white beard and a shoulder-length shag of hair. He holds a master's in philosophy from the University of California-Berkeley, where he studied Wittgenstein and artificial intelligence.
In the mid-'70s, frustrated by intellectual hairsplitting, he quit his doctoral studies and became a truck driver, delivering propane in Montana. "I was in my Zen and the Art of Motorcycle Maintenance phase," he explains.
Williams' wanderings eventually led to Harvard Law School, where he graduated magna cum laude; in 1978 he moved to Eugene, where his very first case concerned the Dalkon shield, a controversial contraceptive. Since then, he has become one of America's top trial lawyers, litigating issues such as asbestos, breast implants, fen-phen, Propulsid and Rezulin.
His latest obsession is thimerosal (thigh-MARE-oh-sahl), a preservative used in childhood vaccines until 1999. His clients suspect thimerosal, which contains the potent neurotoxin ethylmercury, is responsible for their
children's autism, a devastating neurological disorder that distorts perception, behavior and speech.
The new legislation wipes out all thimerosal cases filed in state courts. Instead, parents are supposed to apply to the National Vaccine Injury Compensation Program, established by Congress in 1986 to handle rare cases of damage from childhood vaccines. The program grants a maximum of $250,000 to families who can prove their children suffered harm; if parents lose, they can file regular lawsuits.
Williams says the program is stacked against his clients in several ways. First, parents must file a claim within three years of their children's first symptoms. Autism is typically not diagnosed until 18 months after the first symptoms appear, and two-thirds of his clients have already missed the deadline. Under the new rules, he says, "they'll never get their day in court."
Second, the burden of proof is harder to meet under NVIC, which requires plaintiffs to show that a majority of scientists agree with them, as opposed to state courts, where they need only find some experts. Third, the limit of $250,000 is considerably lower than the typical award for autism in state court. The lifetime costs of caring for an autistic individual are estimated at $2 million.
Most importantly, the legislation means delay. It takes four to five years to reach a decision under NVIC--an eternity for parents struggling to provide for children who often require round-the-clock care.
The long delay also lengthens the odds against their lawyers, who don't see any money unless they win a case. Williams reckons he will shell out $200,000 in out-of-pocket costs plus $1 million worth of time to bring a single case to trial. Some tort lawyers go bankrupt before they ever get to stand before a jury. "The pharmaceutical companies can hire more lawyers than anyone," Williams says. "It's some of the toughest litigation around."
There is little question that autism is on the rise. Last month, researchers at University of California-Davis concluded that the nearly threefold surge in California's autism rate--which now stands at 4 to 5 per 10,000
people--could not be explained by shifting definitions, misclassification or migration.
Williams suspects the culprit is thimerosal, which was manufactured and marketed by Eli Lilly as a preservative that could be dissolved in the vaccine to stop bacteria from contaminating vials that might contain up to 100 doses in the same jar.
"It was a packaging issue," Williams says. "It was cheaper for the manufacturer to produce multidose vials than to package them as single doses." Unbeknownst to parents, their children were being injected with a few micrograms of mercury along with every dose of vaccine. Starting around 1990, several new vaccines were added to the typical childhood schedule, many of which came with thimerosal.
"So you have kids getting three or four doses of organic mercury in one day--hundreds of times the current EPA limits, which are probably about to be lowered," says Williams. Many scientists scoff at the mercury hypothesis, but the theory got a big boost in 1999, when the American Academy of Pediatrics urged vaccine makers to quit using mercury-based preservatives. Last year, the federal Institute of Medicine concluded that the link between autism and thimerosal was "biologically plausible."
Williams is convinced that such evidence would be compelling, if he ever got the chance to present it in court: "I think I could win the case if I would just get to a jury." One of the most remarkable things about the legislative legerdemain is that its author remains unknown. "It's the Republican version of immaculate conception," says Josh Kardon, chief of staff to Sen. Ron Wyden.
Congressional sources say the Republican leadership must have OKed the rider. Eli Lilly, which made $1.6 million of political contributions in the last election cycle, has strong ties to the Bush administration. Bush's
budget director, Mitch Daniels, formerly worked at Lilly; the company's CEO, Sidney Taurel, sits on the Presidential Homeland Security Council; and the president's father, George Bush, sat on Eli Lilly's board of directors.
Homeland bill helps firms block lawsuits over autism
Clovis girl is one of many who may have been affected by mercury in vaccines.
By Michael Doyle
The Fresno Bee
(Published Friday, November 29, 2002, 5:16 AM)
http://www.fresnobee.com/local/story/5406459p-6393578c.html
WASHINGTON -- Mary Wyrick knew something was wrong when her daughter Annie was just 3 months old.After Annie received her first round of vaccinations, her leg turned red. A lump grew to the size of an egg where the injections pierced her skin.
Three times when Annie was an infant she stopped breathing. She developed digestive problems, had trouble sitting up and didn't respond to the people around her.
"She responded to her doctor as if he was a piece of furniture," Wyrick said.
Annie was 3 when doctors diagnosed the young Clovis resident as autistic. Now 6 years old, Annie is still a thin 43-pound child who sometimes screams but does not talk. Wyrick and her doctor said medical evidence shows Annie's autism was caused by mercury-laden vaccines. At least 40 Californians are suing makers of the vaccines they consider responsible for their children's autism. Theirs is a tough legal case, which just got immensely more difficult. In a vivid flexing of pharmaceutical industry muscle, the homeland security bill newly signed by President Bush squelches -- or, at the least, bumps off course -- the vaccination lawsuits. This means the end of about 100 individual lawsuits, and another half dozen or so class-action suits, filed nationwide against vaccine makers.
"It makes me very angry," said Genett Reed of Manteca, whose son Adam is autistic. "It makes me sad that he has to suffer, and he does suffer." When Adam was 2 he stopped talking. He would not eat. He simply rocked and stared into space. Now his parents are in court. Wyrick, the Clovis mother, said she plans to sue the drug manufacturers she holds responsible for Annie's autism. "And what I hope comes out of it is for the medical community to become more responsible." Annie has a weak immune system which should have been considered before she was vaccinated, Wyrick said. Advised that such a lawsuit could not proceed under the bill signed by Bush, Wyrick audibly gasped. "I'm really disappointed that he would take that right away from us," Wyrick said.
One-third of California parents of autistic children diagnosed in the mid-1990s blamed vaccines, a University of California at Davis survey issued last month found. The study, completed by the university's Medical Investigation of Neurodevelopmental Disorders Institute, did not pinpoint a cause for the state's stunning rise in autism cases.
But parental questions about vaccines persist, despite official skepticism about any linkage to autism. California's 273% increase in reported autism between 1987 and 1998 is forcing lots of parents and lawmakers alike to dig into causes. "We're angry that nobody was willing to listen to us," Reed said, adding that her lawsuit was designed "primarily to let people know that this can happen to their child."
Drug companies, in turn, complain that constant litigation threatens their ability to supply the public. Slipped at the last minute into the bill establishing the Department of Homeland Security, the provision indemnifies drug companies not just against future lawsuits but also against those already filed.
"A number of lawsuits that are without merit have been filed," Ed Sagebiel, spokesman for drug manufacturer Eli Lilly, told the San Francisco Chronicle. "That's why this legislation is a good idea. It prevents groundless lawsuits." A handful of moderate Republicans joined with Democratic lawmakers in vowing an uphill fight next year to restore the vaccination lawsuit option. Republican leaders consented to consider revising the lawsuit provision next year but did not commit themselves to eliminating it.
The defendant companies can now cite the law in asking judges to dismiss the lawsuits in state and federal courts. Texas attorney Andy Waters, who represents Reed and a half dozen other Central Valley parents, said he hopes he still can maneuver to keep at least part of the lawsuits alive.
Parents, however, can still go to the U.S. Court of Federal Claims.
This is the same court already used by parents who claim their children suffered other vaccine injuries. Conceivably, parents can win hundreds of thousands of dollars to help pay for their children's treatment.
Dollar awards in the claims court come from the government and widespread industry fees rather than from individual companies. That is preferred by the pharmaceutical industry, which according to a Center for Responsive Politics analysis has contributed at least $14.5 million to federal candidates since last year.
It also is a specific advantage to drug manufacturer Eli Lilly, whose former senior vice president, Mitch Daniels, is now Bush's budget chief.
In San Joaquin Valley homes, though, these legislative and litigation details seem a bit removed from the day-to-day challenge of raising autistic children.
Genett Reed is the 30-year-old owner of a dog grooming business. Her husband, Nathan, installs alarms. Adam is their only child. He was thoroughly happy and developing well, Genett said, until he started getting shots designed to protect him from diseases like measles, mumps and rubella. "After every vaccination, he would withdraw more and more," Reed said. Until, "after his last set of shots, he just withdrew completely."
Research through the Internet and library convinced Reed that her son might have been harmed by Thimerosal. This is a preservative, containing mercury, formerly used in childhood vaccines. Tests of Adam's urine showed mercury present at nearly five times expected levels. Adam's original doctor was doubtful about linking the vaccines and autism. So are the federal Institute of Medicine scientists who have completed their own review.
"Preliminary data from a few studies have suggested that Thimerosal-containing vaccines could possibly -- very minimally -- affect some measures of normal child development," stated Dr. Marie McCormick, chair of the Institute of Medicine's study panel. "But the data are inconclusive."
McCormick added in her report that the evidence was "inadequate to either accept or reject a causal relationship between exposure to Thimerosal from vaccines" and autism.
This scientific ambiguity will complicate any case filed in claims court. The court has an established no-fault system for handling vaccine injuries, though it doesn't always work quickly. But autism, unlike shock or encephalitis, is not listed among the conditions presumed to be caused by vaccines. That means parents must still prove the vaccine actually caused the condition.
Adam, meanwhile, has been showing improvement after undergoing some controversial therapy designed to rid his body of toxins. Reed said her son is making eye contact, showing affection and once more using the words more precious than gold: mommy and daddy.
The reporters can be reached
at mdoyle@mcclatchydc.com and (202) 383-0006 or mleedy@fresnobee.com and 441-6208.
litigation
[By Terence J. Kivlan for the Staten Island Advance. Thanks to Joseph
Gamble.]
http://www.silive.com/search/index.ssf?/xml/story.ssf/html_standard.xsl?/bas
e/opinion/104117135880420.xml <- - address ends here.
Parents with children suffering from autism are outraged at a provision slipped into the Homeland Security bill to shield drug companies from litigation over a vaccine preservative alleged to cause the disorder. The two-paragraph provision was quietly inserted into the 475-page bill as it was about to pass Congress last month by House Majority Leader Dick Armey of Texas, apparently to protect the Eli Lilly company. It introduced the mercury-laden preservative -- called thimerosal -- 60 years ago and has been recently hit with hundreds of lawsuits filed by families seeking damages. The provision retroactively bars such lawsuits in state courts, thus eliminating the possibility of large judgments, and channels all complaints into a 14-year-old, taxpayer-financed compensation program in which awards are capped at $250,000.
"This is really a horrible situation," said Joseph Gamble of Annadale. "A tremendous injustice has been done to thousands of people." Gamble, the father of a 10-year-old autistic son and the executive director of the Grace Foundation, a support group representing about 300 Island families affected by autism, said Armey's last-minute maneuver had embittered many of them against the Republican Party and President Bush. "A lot of people are saying they are never going to vote Republican again," said Gamble, a plaintiff in one of the Eli Lilly lawsuits.
Ties To Eli Lilly Other Island members of the Foundation charge that Armey acted at the urging of the White House, which they say has close ties to the Eli Lilly. As evidence of the relationship, they note that Bush's father once sat on the company's board and that current White House Budget Office director Mitch Daniels is a former Eli Lilly executive. "This is absolute travesty," said Gina Giordano of Tottenville, the mother of an 8-year-old autistic boy. "I believe 100 percent that there is a cover-up going on within the White House and the Republican Party."
She charged that Armey was selected as the "fall guy" for taking responsibility for the provision because he was retiring from Congress as of Jan. 1. "As far as I am concerned, this came from the White House," said Thomas McComb or Grant City, who has a 5-year-old autistic son. "The more you look at this, the more disgusting it is." Armey has denied acting at the behest of the White House and defended the provision as necessary to protect Eli Lilly and other drug companies that produce life-saving childhood vaccines from a bankruptcy-threatening flood of litigation.
Eli Lilly officials say they sought to have the anti-liability provision attached to the Homeland Security package this summer but ceased their lobbying efforts this fall when congressional leaders informed them
they wanted a "clean bill." Although Eli Lilly had nothing to do with the last-minute inclusion of the provision, the company still "strongly" supported it, said spokesman Ed Sagebeil. "It is an important part of homeland security to make sure our nation has viable vaccine program," Sagebeil said.
He also contended that there was "no credible evidence" connecting thimerosal to autism and that, in fact, several recent studies on the issue had ruled out the link. "We have the deepest compassion for families with individuals suffering from autism but the link between thimerosal and autism does not stand up," he said.
The Island families and their lawyers disagree. "We are not saying that it 'causes' autism," said Gamble of thimerosal. "But we are saying that it is a trigger for someone who might be pre-disposed to autism." Mrs. Giordano stressed that the heavy mercury content of thimerosal automatically made it a highly dangerous substance. "We know that mercury is one of the most toxic metals in the world," she said. "How could it be
injected into children and be safe?"
Evan Feinberg, a lawyer for some of the Island families suing Eli Lilly, dismissed as "propaganda" the recent studies concluding that thimerosal was not a factor in autism. He said his side has assembled a large body of evidence showing that autism was a "form of mercury poisoning." An effort to strip the homeland security bill of the anti-liability rider has been announced by several members of Congress, including one leading Republican, House Government Reform Committee Chairman Dan Burton of Indiana, Eli Lilly's home state.
In a recent statement, Burton, who has an autistic grandson, said the provision "takes away an avenue for restitution" and "leaves families without hope." Republican Rep. Vito Fossella indicated he was in favor of revisiting the issue to reach a compromise acceptable to both the companies and the families. "I have seen first-hand the debilitating effects of autism," he said in a statement. "Not for a moment will we allow to stand a law that is not in (the families') best interest."
"We need to strike the right balance to ensure that there is an adequate number of vaccine producers ... while also guaranteeing who have been harmed access to appropriate legal remedies," said the congressman.
Aides stressed that he had been a long-time supporter of the Grace Foundation and had served as the honorary chairman of a recent fund-raising event held by the group.
HUFFINGTON: Finding The Answer To Washington's Hottest Whodunit
By Arianna Huffington, AlterNet
December 4, 2002 http://www.alternet.org/story.html?StoryID=14694
Quick, somebody call Sherlock Holmes. Or at least the Hardy Boys. Or maybe even newly-designated Homeland Security Secretary Tom Ridge. There's a Washington mystery that needs solving.
Everyone in D.C., it seems, is utterly baffled as to how an ugly little provision shielding pharmaceutical behemoth Eli Lilly from billions in lawsuits filed by the parents of autistic children made its way, in the 12th hour, into, of all things, the 475-page Homeland Security bill.
"It's a mystery to us," shrugged Eli Lilly spokesman Rob Smith.
It's a mystery to us, too, echoed spokesmen for the White House, the Department of Health and Human Services, and physician-turned-senator-turned-drug-company-shill Bill Frist, who had originally penned the Lilly-friendly provision for a different bill.
The haphazard lawmaking also proved baffling for pharmaceutical industry lobbyists, and for White House budget director Mitch Daniels, a former Lilly executive, who made a very public show of disavowing any knowledge of the amendment's mystifying genesis. Gosh, maybe the little provision just flew down from heaven. Or was immaculately conceived. Or maybe Osama bin Laden snuck over and planted the little public policy bomb himself.
The outrageous rider stuck onto the end of the Homeland Security bill provides security for Lilly from suits filed by the families of autistic children who believe that their kids' condition is linked to Thimerosal, a mercury-based preservative made by Lilly that used to be a common ingredient in childhood vaccines.
But in a town where knowledge is power, and where there is no shortage of people willing to take credit for even the most minute accomplishment, there has been a sudden outbreak of people playing dumb. Official Washington is observing a code of omerta that makes the Sopranos look like the loose-lipped gals on "The View." In other words: Nobody's seen nothin'.
Here are the clues we have to work with: Over the Veteran's Day weekend, GOP negotiators from the House and Senate hunkered down to finalize the details of the elephantine security bill. At some point – no one is willing to say when – someone – no one is willing to say who – inserted the Lilly provision – though no one is willing to say why.
It's vital that we solve the mystery – even if you believe that the custom-made legislation is justified. We need to find out because this kind of behind-closed-doors monkey business is an affront to our democracy – the very democracy this bill was theoretically designed to protect. Perhaps it should have been called "The Homeland and Lilly Protection Act."
"The ability," Rep. Dennis Kucinich, D-Ohio, told me "of a special interest group to secretly insert provisions into law for its own narrow benefit and to the detriment of the public interest raises fundamental questions about the integrity of our government."
Kucinich has vowed to lead a challenge to congressional rules that permit our representatives to do the bidding of their deep-pocket donors away from the prying eyes of the public. At the most crucial part of the bill-drafting process – when the language of the law is being finalized – Washington's corporate alchemists work their black magic to turn legislative gold into self-preserving lead.
"It's a defect in the system," explains Kucinich. "When a bill goes into a conference committee, it gets yanked out of the sunlight and into the shadows. The conference process is a closed one, so you can go into a conference committee and basically add anything or take out anything you want and no one really knows. It transforms the legislature into a secret cabal."
So this fight is about a lot more than pushing for the repeal of the Lilly provision, something Sens. Debbie Stabenow, D-Mich., and John McCain, R-Ariz., have promised to do when the 108th Congress convenes in January. It's about putting an end to the gaming of the system that is turning the legislative process into a prize-a-minute carnival for big contributors. "Inserting such favors for special interests in a bill is a directive that can only come from some very high places," Stabenow told me.
Intriguingly, Stabenow, McCain, and Kucinich may have found an unlikely ally in their battle – one with a very personal stake in the issue. It turns out that Rep. Dan Burton, R-Ind., the chairman of the Government Reform and Oversight Committee, has a grandson who first began showing symptoms of autism within days of receiving vaccinations containing Thimerosal. "He became radically different," says Burton, "banging his head against the wall, running around flapping his arms. Twenty years ago we had one in 10,000 children that they thought was autistic. Now, it's more than one out of 250."
This is clearly not a left-right issue. Any politician who has waxed lyrical about "accountability" and "transparency" – that includes you, Mr. President – owes it to the public to demand that Congress get to the bottom of just whose directive it was to insert into the homeland security bill a provision that has absolutely nothing to do with homeland security. And to find out whether the $1.6 million that Lilly contributed in the last election cycle – 79 percent of which went to Republicans – had anything to do with the inclusion of this designer provision. And, come to think of it, whether these donations had anything to do with the Bush administration asking a federal claims court to block public access to documents unearthed in over a thousand Thimerosal-related lawsuits.
For anyone remotely familiar with the ways of Washington – and Sherlock Holmes – the answer should be "elementary."
We're used to having pounds of fatty pork stirred into almost every recipe Congress dishes up. But the abuse of a bill about homeland security is especially distasteful. Washington's greedy corporate masters may finally have overreached. Their continued influence constitutes a clear and present danger to our security and if the president is serious about protecting the homeland, he should speak up.
By BOB HERBERT
http://www.nytimes.com/2002/11/25/opinion/25HERB.html?ex=1038891600&en=15a1ad31cbd3dfa5&ei=5062&partner=GOOGLE
Thimerosal is a preservative that contains mercury and was used for many years as an additive in some routinely administered children's vaccines.
Fears developed a few years ago that the additive might have been causing dangerously elevated levels of mercury in infants, resulting in neurological impairment and, in some cases, autism.
Studies thus far have neither shown nor ruled out a link between the vaccines and neurological damage in children. But in the summer of 1999 the American Academy of Pediatrics and the Public Health Service urged vaccine manufacturers to stop using thimerosal as quickly as possible.
Thus, thimerosal, which was developed by Eli Lilly & Company in the 1920's and was in widespread use by the 1990's, is no longer added to vaccines commonly given to children. But a serious controversy continues. Lawsuits have been filed by parents across the country who are convinced that their children suffered severe neurological damage from the mercury in the vaccines. Talking to them can be heartbreaking.
Lyn Redwood, a nurse practitioner and the wife of a physician in suburban Atlanta, spoke to me last week about her 8-year-old son, Will. "I have a little boy who was completely normal at birth — walking, talking, smiling, meeting all of his developmental landmarks," she said. "Then, shortly after he turned 1 year old, he lost his ability to speak, to make eye contact. He started regressing and ultimately was diagnosed with pervasive developmental disorder, which falls into a spectrum of autism disorders."
Ms. Redwood contends that three infant vaccines administered to her son when he was 2 months old exposed him to levels of mercury that far exceeded all safety guidelines.
At this point we must interrupt our narrative and turn our attention to the federal government's effort to fight terrorism in the United States.
Last week the Senate approved legislation to establish a Department of Homeland Security and it will soon be signed into law by the president. Buried in this massive bill, snuck into it in the dark of night by persons unknown (actually, it's fair to say by Republican persons unknown), was a provision that — incredibly — will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their children were harmed by thimerosal.
Now this has nothing to do with homeland security. Nothing. This is not a provision that will in any way protect us from the ferocious evil of Osama bin Laden and Al Qaeda. So why is it there? Perhaps it has something to do with the fact that the major drug companies have become a gigantic collective cash machine for politicians, and that the vast majority of that cash goes to Republicans.
Or maybe it's related to the fact that Mitch Daniels, the White House budget director, is a former Eli Lilly big shot. Or the very convenient fact that just last June President Bush appointed Eli Lilly's chairman, president and C.E.O., Sidney Taurel, to a coveted seat on the president's Homeland Security Advisory Council.
There's a real bad smell here. Eli Lilly will benefit greatly as both class-action and individual lawsuits are derailed. But there are no fingerprints in sight. No one will own up to a legislative deed that is both cynical and shameful.
An official spokesman for Eli Lilly, Edward Sagebiel, insists the company knew nothing about it, nothing at all.
While the vote for the Homeland Security Department was overwhelming, even some Republicans were upset by the provision to benefit Lilly and the other drug companies.
Senator John McCain of Arizona characterized the provision as "among the most inappropriate" in the homeland security legislation. He said: "This language will primarily benefit large brand-name pharmaceutical companies which produce additives to children's vaccines — with substantial benefit to one company in particular. It has no bearing whatsoever on domestic security."
The politicians with their hands out and the fat cats with plenty of green to spread around have carried the day. Nothing is too serious to exploit, not even the defense of the homeland during a time of terror.
Lyn Redwood put together an advocacy group, called Safe Minds, for parents struggling with the thimerosal issue. They're at a slight disadvantage, wielding a popgun against the nuclear-powered influence of an Eli Lilly.
Life during Wartime
Security any CEO would love
By A.C. Thompson http://www.sfbayguardian.com/37/09/x_news_war.html
The Homeland Security Act signed by President George W. Bush Nov. 25 is certain to make corporate America feel secure, cheery even, in this season of economic gloom. The law, which will establish a new, 177,000-employee Homeland Security Department, is loaded with perks for big business and peril for personal liberty.
Perhaps most significantly, the law exempts businesses from being sued under certain circumstances. Section 803, headlined "Litigation Management," will relieve companies manufacturing counterterrorism technology from liability should their products cause injury or death.
Before the bill had even reached Dubya's desk, Public Citizen, a Ralph Nader-founded government watchdog group, was hollering. "These are the special deals that industry gets out of the people they give large campaign contributions to," Public Citizen president Joan Claybrook tells us. The no-liability provisions, she adds, are a stealth move by conservatives to push tort-law reform, a concept long embraced by CEOs and loathed by trial lawyers and consumer advocates. "Big corporations hate liability," she says.
Drug companies get an even better break: for injuries or illnesses caused as side effects of vaccines, the liability exemption is retroactive. It's a legislative handout. Consider the context: vaccine companies are under fire for including high doses of mercury in their products during the 1990s, a practice that has spurred parents in at least 35 states to sue a host of major pharmaceutical companies, among them Pfizer, GlaxoSmithKline, Merck, and Eli Lilly. The now-doomed suits are a bid to force the companies to scrutinize a possible link between mercury-laden vaccines and autism.
Another possible big business boon comes in a section covering "critical infrastructure" that is, power generation and the electrical power grid, telecommunication systems, oil refining, water and sewage systems, food production, and so on. The law encourages companies in these fields to communicate with the Homeland Security Department regarding their vulnerabilities to terrorism. The information will be kept secret and
exempted from the federal Freedom of Information Act.
For corporations with a habit of spewing toxic chemicals into the air or dumping heavy metals into rivers, the new law could be a way to avoid public scrutiny and legal hassles. If a company admits to improperly storing hazardous materials or failing to maintain its facilities, that information, by decree of the Homeland Security Act, can't be used by federal or state prosecutors.
"There's very widespread concern that homeland security measures are being used to protect polluters and withhold information that doesn't need to be withheld," says Bradley Angel, executive director of Greenaction, a San Francisco-based environmental justice group that relies heavily on government documents.
At the Environmental Protection Agency, officials aren't entirely sure how the new rules will affect their operations. "It's difficult to read the tea leaves at this point," says Daniel Meer, an EPA emergency management expert. "I'm sure there are going to be all kinds of working groups and meetings."
While the law shields corporations from citizens' prying eyes, it subjects the public to increased electronic snooping by the feds. Under the rubric "Cyber Security Enhancement," federal agents will be able to monitor the e-mail of suspected hackers, without a court order. The law shreds privacy-protecting rules, allowing Internet service providers to turn over their customers' e-mails to the feds without a warrant.
"There's really no justification for this," argues Lee Tien, senior staff attorney for the Electronic Frontier Foundation, a cyber-liberties group. "I think it's likely there'll be use of this power for illegitimate reasons."
Of course, if the Defense Department gets its way, the privacy-infringing aspects of the Homeland Security Act will seem almost quaint. The Pentagon, as you've probably read, is trying to build the Death Star of surveillance, the Total Information Awareness system, a massive "data-mine" of e-mail messages, phone call records, financial documents, and other personal information.
Tien warns, "This would mean tremendous power to do surveillance. The threats to civil liberties are enormous."
Mercury Falling
Homeland Security Act inoculates drug makers against autism lawsuits.
BY CHRIS LYDGATE
243-2122
http://www.wweek.com/flatfiles/News3373.lasso
_____ When President George W. Bush signed the Homeland Security Act in the White House on Monday, he praised the bill as a "heroic action" that demonstrated "the resolve of this great nation to defend our freedom, our security and our way of life." Three thousand miles away, Portland lawyer Mike Williams rolled his eyes.
Williams represents hundreds of families who are suing pharmaceutical companies--in particular, Eli Lilly--over a mercury-based preservative used in some childhood vaccines. The families contend that the preservative
triggered neurological damage in their children, who have been diagnosed with autism.
Last week, Williams was stunned to learn that an unknown lawmaker had slipped a last-minute rider into the Homeland Security Act, shutting down the lawsuits in the name of the war on terrorism.
"I thought I had lost my naiveté about the power of big money," Williams told WW minutes after Bush signed the bill. "But even I was naive to think Congress wouldn't do this. There was no notice, no warning, no debate--it just came out of nowhere."
Sitting in his 19th-floor office, with a crystalline view of Mount Hood, Williams, 55, is not exactly your buttoned-down tort geek. Rumpled in a black waistcoat, he sports a gray-white beard and a shoulder-length shag of hair. He holds a master's in philosophy from the University of California-Berkeley, where he studied Wittgenstein and artificial intelligence.
In the mid-'70s, frustrated by intellectual hairsplitting, he quit his doctoral studies and became a truck driver, delivering propane in Montana. "I was in my Zen and the Art of Motorcycle Maintenance phase," he explains.
Williams' wanderings eventually led to Harvard Law School, where he graduated magna cum laude; in 1978 he moved to Eugene, where his very first case concerned the Dalkon shield, a controversial contraceptive. Since then, he has become one of America's top trial lawyers, litigating issues such as asbestos, breast implants, fen-phen, Propulsid and Rezulin.
His latest obsession is thimerosal (thigh-MARE-oh-sahl), a preservative used in childhood vaccines until 1999. His clients suspect thimerosal, which contains the potent neurotoxin ethylmercury, is responsible for their
children's autism, a devastating neurological disorder that distorts perception, behavior and speech.
The new legislation wipes out all thimerosal cases filed in state courts. Instead, parents are supposed to apply to the National Vaccine Injury Compensation Program, established by Congress in 1986 to handle rare cases of damage from childhood vaccines. The program grants a maximum of $250,000 to families who can prove their children suffered harm; if parents lose, they can file regular lawsuits.
Williams says the program is stacked against his clients in several ways. First, parents must file a claim within three years of their children's first symptoms. Autism is typically not diagnosed until 18 months after the first symptoms appear, and two-thirds of his clients have already missed the deadline. Under the new rules, he says, "they'll never get their day in court."
Second, the burden of proof is harder to meet under NVIC, which requires plaintiffs to show that a majority of scientists agree with them, as opposed to state courts, where they need only find some experts. Third, the limit of $250,000 is considerably lower than the typical award for autism in state court. The lifetime costs of caring for an autistic individual are estimated at $2 million.
Most importantly, the legislation means delay. It takes four to five years to reach a decision under NVIC--an eternity for parents struggling to provide for children who often require round-the-clock care.
The long delay also lengthens the odds against their lawyers, who don't see any money unless they win a case. Williams reckons he will shell out $200,000 in out-of-pocket costs plus $1 million worth of time to bring a single case to trial. Some tort lawyers go bankrupt before they ever get to stand before a jury. "The pharmaceutical companies can hire more lawyers than anyone," Williams says. "It's some of the toughest litigation around."
There is little question that autism is on the rise. Last month, researchers at University of California-Davis concluded that the nearly threefold surge in California's autism rate--which now stands at 4 to 5 per 10,000
people--could not be explained by shifting definitions, misclassification or migration.
Williams suspects the culprit is thimerosal, which was manufactured and marketed by Eli Lilly as a preservative that could be dissolved in the vaccine to stop bacteria from contaminating vials that might contain up to 100 doses in the same jar.
"It was a packaging issue," Williams says. "It was cheaper for the manufacturer to produce multidose vials than to package them as single doses." Unbeknownst to parents, their children were being injected with a few micrograms of mercury along with every dose of vaccine. Starting around 1990, several new vaccines were added to the typical childhood schedule, many of which came with thimerosal.
"So you have kids getting three or four doses of organic mercury in one day--hundreds of times the current EPA limits, which are probably about to be lowered," says Williams. Many scientists scoff at the mercury hypothesis, but the theory got a big boost in 1999, when the American Academy of Pediatrics urged vaccine makers to quit using mercury-based preservatives. Last year, the federal Institute of Medicine concluded that the link between autism and thimerosal was "biologically plausible."
Williams is convinced that such evidence would be compelling, if he ever got the chance to present it in court: "I think I could win the case if I would just get to a jury." One of the most remarkable things about the legislative legerdemain is that its author remains unknown. "It's the Republican version of immaculate conception," says Josh Kardon, chief of staff to Sen. Ron Wyden.
Congressional sources say the Republican leadership must have OKed the rider. Eli Lilly, which made $1.6 million of political contributions in the last election cycle, has strong ties to the Bush administration. Bush's
budget director, Mitch Daniels, formerly worked at Lilly; the company's CEO, Sidney Taurel, sits on the Presidential Homeland Security Council; and the president's father, George Bush, sat on Eli Lilly's board of directors.
Homeland bill helps firms block lawsuits over autism
Clovis girl is one of many who may have been affected by mercury in vaccines.
By Michael Doyle
The Fresno Bee
(Published Friday, November 29, 2002, 5:16 AM)
http://www.fresnobee.com/local/story/5406459p-6393578c.html
WASHINGTON -- Mary Wyrick knew something was wrong when her daughter Annie was just 3 months old.After Annie received her first round of vaccinations, her leg turned red. A lump grew to the size of an egg where the injections pierced her skin.
Three times when Annie was an infant she stopped breathing. She developed digestive problems, had trouble sitting up and didn't respond to the people around her.
"She responded to her doctor as if he was a piece of furniture," Wyrick said.
Annie was 3 when doctors diagnosed the young Clovis resident as autistic. Now 6 years old, Annie is still a thin 43-pound child who sometimes screams but does not talk. Wyrick and her doctor said medical evidence shows Annie's autism was caused by mercury-laden vaccines. At least 40 Californians are suing makers of the vaccines they consider responsible for their children's autism. Theirs is a tough legal case, which just got immensely more difficult. In a vivid flexing of pharmaceutical industry muscle, the homeland security bill newly signed by President Bush squelches -- or, at the least, bumps off course -- the vaccination lawsuits. This means the end of about 100 individual lawsuits, and another half dozen or so class-action suits, filed nationwide against vaccine makers.
"It makes me very angry," said Genett Reed of Manteca, whose son Adam is autistic. "It makes me sad that he has to suffer, and he does suffer." When Adam was 2 he stopped talking. He would not eat. He simply rocked and stared into space. Now his parents are in court. Wyrick, the Clovis mother, said she plans to sue the drug manufacturers she holds responsible for Annie's autism. "And what I hope comes out of it is for the medical community to become more responsible." Annie has a weak immune system which should have been considered before she was vaccinated, Wyrick said. Advised that such a lawsuit could not proceed under the bill signed by Bush, Wyrick audibly gasped. "I'm really disappointed that he would take that right away from us," Wyrick said.
One-third of California parents of autistic children diagnosed in the mid-1990s blamed vaccines, a University of California at Davis survey issued last month found. The study, completed by the university's Medical Investigation of Neurodevelopmental Disorders Institute, did not pinpoint a cause for the state's stunning rise in autism cases.
But parental questions about vaccines persist, despite official skepticism about any linkage to autism. California's 273% increase in reported autism between 1987 and 1998 is forcing lots of parents and lawmakers alike to dig into causes. "We're angry that nobody was willing to listen to us," Reed said, adding that her lawsuit was designed "primarily to let people know that this can happen to their child."
Drug companies, in turn, complain that constant litigation threatens their ability to supply the public. Slipped at the last minute into the bill establishing the Department of Homeland Security, the provision indemnifies drug companies not just against future lawsuits but also against those already filed.
"A number of lawsuits that are without merit have been filed," Ed Sagebiel, spokesman for drug manufacturer Eli Lilly, told the San Francisco Chronicle. "That's why this legislation is a good idea. It prevents groundless lawsuits." A handful of moderate Republicans joined with Democratic lawmakers in vowing an uphill fight next year to restore the vaccination lawsuit option. Republican leaders consented to consider revising the lawsuit provision next year but did not commit themselves to eliminating it.
The defendant companies can now cite the law in asking judges to dismiss the lawsuits in state and federal courts. Texas attorney Andy Waters, who represents Reed and a half dozen other Central Valley parents, said he hopes he still can maneuver to keep at least part of the lawsuits alive.
Parents, however, can still go to the U.S. Court of Federal Claims.
This is the same court already used by parents who claim their children suffered other vaccine injuries. Conceivably, parents can win hundreds of thousands of dollars to help pay for their children's treatment.
Dollar awards in the claims court come from the government and widespread industry fees rather than from individual companies. That is preferred by the pharmaceutical industry, which according to a Center for Responsive Politics analysis has contributed at least $14.5 million to federal candidates since last year.
It also is a specific advantage to drug manufacturer Eli Lilly, whose former senior vice president, Mitch Daniels, is now Bush's budget chief.
In San Joaquin Valley homes, though, these legislative and litigation details seem a bit removed from the day-to-day challenge of raising autistic children.
Genett Reed is the 30-year-old owner of a dog grooming business. Her husband, Nathan, installs alarms. Adam is their only child. He was thoroughly happy and developing well, Genett said, until he started getting shots designed to protect him from diseases like measles, mumps and rubella. "After every vaccination, he would withdraw more and more," Reed said. Until, "after his last set of shots, he just withdrew completely."
Research through the Internet and library convinced Reed that her son might have been harmed by Thimerosal. This is a preservative, containing mercury, formerly used in childhood vaccines. Tests of Adam's urine showed mercury present at nearly five times expected levels. Adam's original doctor was doubtful about linking the vaccines and autism. So are the federal Institute of Medicine scientists who have completed their own review.
"Preliminary data from a few studies have suggested that Thimerosal-containing vaccines could possibly -- very minimally -- affect some measures of normal child development," stated Dr. Marie McCormick, chair of the Institute of Medicine's study panel. "But the data are inconclusive."
McCormick added in her report that the evidence was "inadequate to either accept or reject a causal relationship between exposure to Thimerosal from vaccines" and autism.
This scientific ambiguity will complicate any case filed in claims court. The court has an established no-fault system for handling vaccine injuries, though it doesn't always work quickly. But autism, unlike shock or encephalitis, is not listed among the conditions presumed to be caused by vaccines. That means parents must still prove the vaccine actually caused the condition.
Adam, meanwhile, has been showing improvement after undergoing some controversial therapy designed to rid his body of toxins. Reed said her son is making eye contact, showing affection and once more using the words more precious than gold: mommy and daddy.
The reporters can be reached
at mdoyle@mcclatchydc.com and (202) 383-0006 or mleedy@fresnobee.com and 441-6208.
litigation
[By Terence J. Kivlan for the Staten Island Advance. Thanks to Joseph
Gamble.]
http://www.silive.com/search/index.ssf?/xml/story.ssf/html_standard.xsl?/bas
e/opinion/104117135880420.xml <- - address ends here.
Parents with children suffering from autism are outraged at a provision slipped into the Homeland Security bill to shield drug companies from litigation over a vaccine preservative alleged to cause the disorder. The two-paragraph provision was quietly inserted into the 475-page bill as it was about to pass Congress last month by House Majority Leader Dick Armey of Texas, apparently to protect the Eli Lilly company. It introduced the mercury-laden preservative -- called thimerosal -- 60 years ago and has been recently hit with hundreds of lawsuits filed by families seeking damages. The provision retroactively bars such lawsuits in state courts, thus eliminating the possibility of large judgments, and channels all complaints into a 14-year-old, taxpayer-financed compensation program in which awards are capped at $250,000.
"This is really a horrible situation," said Joseph Gamble of Annadale. "A tremendous injustice has been done to thousands of people." Gamble, the father of a 10-year-old autistic son and the executive director of the Grace Foundation, a support group representing about 300 Island families affected by autism, said Armey's last-minute maneuver had embittered many of them against the Republican Party and President Bush. "A lot of people are saying they are never going to vote Republican again," said Gamble, a plaintiff in one of the Eli Lilly lawsuits.
Ties To Eli Lilly Other Island members of the Foundation charge that Armey acted at the urging of the White House, which they say has close ties to the Eli Lilly. As evidence of the relationship, they note that Bush's father once sat on the company's board and that current White House Budget Office director Mitch Daniels is a former Eli Lilly executive. "This is absolute travesty," said Gina Giordano of Tottenville, the mother of an 8-year-old autistic boy. "I believe 100 percent that there is a cover-up going on within the White House and the Republican Party."
She charged that Armey was selected as the "fall guy" for taking responsibility for the provision because he was retiring from Congress as of Jan. 1. "As far as I am concerned, this came from the White House," said Thomas McComb or Grant City, who has a 5-year-old autistic son. "The more you look at this, the more disgusting it is." Armey has denied acting at the behest of the White House and defended the provision as necessary to protect Eli Lilly and other drug companies that produce life-saving childhood vaccines from a bankruptcy-threatening flood of litigation.
Eli Lilly officials say they sought to have the anti-liability provision attached to the Homeland Security package this summer but ceased their lobbying efforts this fall when congressional leaders informed them
they wanted a "clean bill." Although Eli Lilly had nothing to do with the last-minute inclusion of the provision, the company still "strongly" supported it, said spokesman Ed Sagebeil. "It is an important part of homeland security to make sure our nation has viable vaccine program," Sagebeil said.
He also contended that there was "no credible evidence" connecting thimerosal to autism and that, in fact, several recent studies on the issue had ruled out the link. "We have the deepest compassion for families with individuals suffering from autism but the link between thimerosal and autism does not stand up," he said.
The Island families and their lawyers disagree. "We are not saying that it 'causes' autism," said Gamble of thimerosal. "But we are saying that it is a trigger for someone who might be pre-disposed to autism." Mrs. Giordano stressed that the heavy mercury content of thimerosal automatically made it a highly dangerous substance. "We know that mercury is one of the most toxic metals in the world," she said. "How could it be
injected into children and be safe?"
Evan Feinberg, a lawyer for some of the Island families suing Eli Lilly, dismissed as "propaganda" the recent studies concluding that thimerosal was not a factor in autism. He said his side has assembled a large body of evidence showing that autism was a "form of mercury poisoning." An effort to strip the homeland security bill of the anti-liability rider has been announced by several members of Congress, including one leading Republican, House Government Reform Committee Chairman Dan Burton of Indiana, Eli Lilly's home state.
In a recent statement, Burton, who has an autistic grandson, said the provision "takes away an avenue for restitution" and "leaves families without hope." Republican Rep. Vito Fossella indicated he was in favor of revisiting the issue to reach a compromise acceptable to both the companies and the families. "I have seen first-hand the debilitating effects of autism," he said in a statement. "Not for a moment will we allow to stand a law that is not in (the families') best interest."
"We need to strike the right balance to ensure that there is an adequate number of vaccine producers ... while also guaranteeing who have been harmed access to appropriate legal remedies," said the congressman.
Aides stressed that he had been a long-time supporter of the Grace Foundation and had served as the honorary chairman of a recent fund-raising event held by the group.
HUFFINGTON: Finding The Answer To Washington's Hottest Whodunit
By Arianna Huffington, AlterNet
December 4, 2002 http://www.alternet.org/story.html?StoryID=14694
Quick, somebody call Sherlock Holmes. Or at least the Hardy Boys. Or maybe even newly-designated Homeland Security Secretary Tom Ridge. There's a Washington mystery that needs solving.
Everyone in D.C., it seems, is utterly baffled as to how an ugly little provision shielding pharmaceutical behemoth Eli Lilly from billions in lawsuits filed by the parents of autistic children made its way, in the 12th hour, into, of all things, the 475-page Homeland Security bill.
"It's a mystery to us," shrugged Eli Lilly spokesman Rob Smith.
It's a mystery to us, too, echoed spokesmen for the White House, the Department of Health and Human Services, and physician-turned-senator-turned-drug-company-shill Bill Frist, who had originally penned the Lilly-friendly provision for a different bill.
The haphazard lawmaking also proved baffling for pharmaceutical industry lobbyists, and for White House budget director Mitch Daniels, a former Lilly executive, who made a very public show of disavowing any knowledge of the amendment's mystifying genesis. Gosh, maybe the little provision just flew down from heaven. Or was immaculately conceived. Or maybe Osama bin Laden snuck over and planted the little public policy bomb himself.
The outrageous rider stuck onto the end of the Homeland Security bill provides security for Lilly from suits filed by the families of autistic children who believe that their kids' condition is linked to Thimerosal, a mercury-based preservative made by Lilly that used to be a common ingredient in childhood vaccines.
But in a town where knowledge is power, and where there is no shortage of people willing to take credit for even the most minute accomplishment, there has been a sudden outbreak of people playing dumb. Official Washington is observing a code of omerta that makes the Sopranos look like the loose-lipped gals on "The View." In other words: Nobody's seen nothin'.
Here are the clues we have to work with: Over the Veteran's Day weekend, GOP negotiators from the House and Senate hunkered down to finalize the details of the elephantine security bill. At some point – no one is willing to say when – someone – no one is willing to say who – inserted the Lilly provision – though no one is willing to say why.
It's vital that we solve the mystery – even if you believe that the custom-made legislation is justified. We need to find out because this kind of behind-closed-doors monkey business is an affront to our democracy – the very democracy this bill was theoretically designed to protect. Perhaps it should have been called "The Homeland and Lilly Protection Act."
"The ability," Rep. Dennis Kucinich, D-Ohio, told me "of a special interest group to secretly insert provisions into law for its own narrow benefit and to the detriment of the public interest raises fundamental questions about the integrity of our government."
Kucinich has vowed to lead a challenge to congressional rules that permit our representatives to do the bidding of their deep-pocket donors away from the prying eyes of the public. At the most crucial part of the bill-drafting process – when the language of the law is being finalized – Washington's corporate alchemists work their black magic to turn legislative gold into self-preserving lead.
"It's a defect in the system," explains Kucinich. "When a bill goes into a conference committee, it gets yanked out of the sunlight and into the shadows. The conference process is a closed one, so you can go into a conference committee and basically add anything or take out anything you want and no one really knows. It transforms the legislature into a secret cabal."
So this fight is about a lot more than pushing for the repeal of the Lilly provision, something Sens. Debbie Stabenow, D-Mich., and John McCain, R-Ariz., have promised to do when the 108th Congress convenes in January. It's about putting an end to the gaming of the system that is turning the legislative process into a prize-a-minute carnival for big contributors. "Inserting such favors for special interests in a bill is a directive that can only come from some very high places," Stabenow told me.
Intriguingly, Stabenow, McCain, and Kucinich may have found an unlikely ally in their battle – one with a very personal stake in the issue. It turns out that Rep. Dan Burton, R-Ind., the chairman of the Government Reform and Oversight Committee, has a grandson who first began showing symptoms of autism within days of receiving vaccinations containing Thimerosal. "He became radically different," says Burton, "banging his head against the wall, running around flapping his arms. Twenty years ago we had one in 10,000 children that they thought was autistic. Now, it's more than one out of 250."
This is clearly not a left-right issue. Any politician who has waxed lyrical about "accountability" and "transparency" – that includes you, Mr. President – owes it to the public to demand that Congress get to the bottom of just whose directive it was to insert into the homeland security bill a provision that has absolutely nothing to do with homeland security. And to find out whether the $1.6 million that Lilly contributed in the last election cycle – 79 percent of which went to Republicans – had anything to do with the inclusion of this designer provision. And, come to think of it, whether these donations had anything to do with the Bush administration asking a federal claims court to block public access to documents unearthed in over a thousand Thimerosal-related lawsuits.
For anyone remotely familiar with the ways of Washington – and Sherlock Holmes – the answer should be "elementary."
We're used to having pounds of fatty pork stirred into almost every recipe Congress dishes up. But the abuse of a bill about homeland security is especially distasteful. Washington's greedy corporate masters may finally have overreached. Their continued influence constitutes a clear and present danger to our security and if the president is serious about protecting the homeland, he should speak up.
http://www.s-t.com/daily/01-03/01-04-03/a01lo004.htm
[Kudos to Dr. Martha Herbert for telling it like it is.]
This story appeared on Page A1 of The Standard-Times on January 4, 2003.
Family blames vaccine additive for son's autism Homeland Security rules hamper lawsuit
By SAM HORNBLOWER, Standard-Times correspondent
TARA BRICKING/The Associated Press
Nicole Bernier is furious with the Homeland Security provisions that undermine her suit against the pharmacy companies. She is fighting on behalf of her son Jevyn Neves, 6, who is autistic. Ms. Bernier is part of a class-action lawsuit alleging that the mercury-based additive Thimerosal, which extends the shelf life of vaccines, caused Jevyn's autism.
Until he was about 15 months old, Jevyn Neves was hitting all his developmental milestones. Then he began to regress. His speech vanished. After perplexing doctors for more than a year, he was diagnosed with autism."He did not play with me like other kids did with their mom," said his 25-year-old mother, Nicole Bernier, a New Bedford native.
Ms. Bernier believes that her 6-year-old son's condition was caused by a series of DTP (diphtheria, tetanus and pertussis) and MMR (measles, mumps and rubella) vaccinations Jevyn received during that critical early period of his life. She and her husband, Antonio Neves, are plaintiffs in a class action lawsuit against Eli Lilly and other pharmaceutical companies who manufactured the mercury-based additive called Thimerosal, used to give these vaccines a longer shelf life.
With Republican Sen. Bill Frist succeeding Trent Lott as Senate majority leader and a recently passed Homeland Security bill inoculating vaccine manufacturers from paying hefty damages, the prospects are dimming for the class action.
"(Sen. Frist) is our public enemy number one," said Mark Blaxill of Safeminds, a parent advocacy group in the thick of the Thimerosal controversy. "It's frightening. He is in the forefront of the movement to deprive families of their due process, the prime mover behind complete immunity provisions for Eli Lilly."
Sen. Frist defended the amendment to the Homeland Security bill on the floor of the Senate last November. He said he fears that without the added legal protections, there will be a chilling effect on vaccine manufacturer's incentive to fight bioterrorism. "The threat of lawsuits mustn't be a barrier to protecting the American people," said Frist before the bill was passed.
Frist said the vaccine injury compensation program, a special vaccine court that caps the payout to families harmed by vaccines, provides adequate recompense.
The families in the class action suit are fighting a statute of limitations specification, which bars compensation three years from the onset of signs and symptoms. "You have a class of individuals who will go uncompensated," said attorney John Kim of Gallagaher, Lewis, Downey and Kim, of Houston, Texas, one of the two law firms appointed to handle the case.
Drug manufacturing giant Eli Lilly developed Thimerosal in the 1930s and sold it for 40 years. It was used as a preservative in a number of applications other than with vaccines, such as in cosmetics and eye drops. "It had been considered a medically safe project," said Dr. Ann Bajart at the Ophthalmic Consultants of Boston, "until we realized that over time, it caused inflammatory conjunctivitis, a reddening of the eyes. The preservative was causing an allergic response." Mercury-based products would be taken off the market for topical applications in 1985. Pharmaceutical companies continued to manufacture childhood vaccines with Thimerosal up until a few years ago, when a 1997 report on mercury was submitted to Congress. In 1999, the American Academy of Pediatrics demanded that childhood vaccines stop being produced with the chemical preservative. Three years later, many of these vaccines are still on the shelves.
The amount of Thimerosal in any given vaccine shot was too small to be of any significance 30 years ago when a child received only a few vaccines. Today, the federally mandated vaccine program will have a child injected with anywhere between 25 and 30 shots.
And as autism rates skyrocket, parents are raising concerns of possible links between autism and vaccinations. Republican congressman Dan Burton from Indiana has an autistic grandson.
"I am personally convinced that there is a link," he said on C-SPAN last month. "Christian received nine shots in one day. Seven of them contained mercury. And two days later he became autistic, he started running around and banging his head against the wall. Severe constipation and diarrhea. Lost his ability to speak well."
Scientists are confounded. "It appears to be a dramatic increase (in autism)," said Harvard pediatric neurologist Dr. Martha Herbert. Studies indicate a spike of anywhere between 283 and 400 percent in the past 10 to 15 years.
Dr. Herbert is on the forefront of research on autism. She believes that certain children are more vulnerable to "environmental insults," or changes to their brains and bodies. These children are more susceptible to becoming autistic through environmental agents.
But the question of a connection between Thimerosal and autism has not yet been solved definitively. "We just don't really know," she said from her lab at Massachusetts General Hospital. "There is a lot of data suggesting that it does cause problems. And there are a lot of studies that should be done that have trouble being funded."
Pam Ferro, a registered nurse at Hopewell Associates in Mattapoisett, tests and treats children for autism. "Some parents can tell you to the day. It was like a switch."
She is convinced that there is a link between Thimerosal and autism. She explained that there is no good test for mercury. Unlike lead, it does not stay in the blood stream. "But one of the tests is a hair analysis. Some of the autistic children were found to have lower levels of mercury (in their hair) than normal children."
She believes this suggests that some kids do not have the ability to expel the toxic substance from their bodies. "Some kids are able to detox mercury and others cannot," she claims.
Dr. Herbert is not surprised that the Food and Drug Administration, the Center for Disease Control and the drug companies have chosen not to recall the vaccines. "It would be an admission of guilt more than anything else."
Eli Lilly spokesman Edward Sagebiel insists that there is "no scientifically credible causal link between Thimerosal and autism." Mr. Sagebiel fears that trial lawyers attempting to cash in on the families of autistic children ultimately harm science. "We are seeing our vaccine industry reduced to absolutely nothing," he lamented. "It is important that (pharmaceutical companies) are not weighing potential liabilities as they undergo the development to find new vaccines." And while Dr. Herbert might agree with him, she believes that the reason for this is more a function of inadequate study than hard proof. A lot of the recent studies on the subject were either "poorly designed" or had "a long list of conflicts of interest." These are the symptoms of a tragic and disturbing trend that she calls "Epidemic Denial," the title of her recently published paper. "Why is it that we don't fully entertain the (autism-Thimerosal) hypothesis?" she asks. "Because it is too painful. They don't want to believe that we could make mistakes like this."
The scientists, government officials and businessmen involved are very proud of the young lives they save through the vaccine program. "These people really want vaccines to be a good thing for children," said Dr.
Herbert.
She is suggesting an endemic intellectual dishonesty in the scientific studies and public relations spheres pertaining to vaccines. "This casts a pall over all of science," she said. "It puts a bias on what you are allowed and not allowed to think about." "I want to protect the pharmaceutical companies as much as possible," Rep. Burton said last month on C-SPAN.
"We need that research. We need to fight the war on terrorism. But what do you do about these thousands and thousands of children who have been damaged for life?" Meanwhile, Nicole Bernier acknowledges how onerous the liabilities might be if companies such as Eli Lilly were held liable. "But it will cost our government a whole lot more to educate (these autistic children)," she says. "Taxpayers are paying to support corporate America."
http://www.cnn.com/2003/HEALTH/parenting/01/08/vaccine.makers.ap/index.html
Washington AP - Parents rallied at the Capitol on Wednesday against a law that protects vaccine makers, and Democrats promised to fight to repeal the measure. The vaccine provision was attached to a bill creating a new Homeland Security Department, which President Bush signed into law in November. The Republican-backed provision essentially shields vaccine makers from lawsuits concerning the use of the compound Thimerosal by requiring that claims go through a special federal program that pays limited damages for vaccine-related injuries, rather than through courts.
Thimerosal is a mercury-containing preservative once added to some childhood vaccines. Indianapolis, Indiana-based Eli Lilly, a major Republican Party contributor, was the biggest manufacturer of Thimerosal.
A spokesman for Eli Lilly, Ed Sagebiel, said the company had lobbied for the measure earlier but had no role in its placement in the homeland security bill. But Sagebiel added, "It's something we support now. We think it's good public policy."
Medical research has not established a link between autism and Thimerosal, but many parents believe the ingredient may be to blame. Scores of parents have filed lawsuits that claim that Thimerosal caused their children to develop autism or related nerve diseases. Many of those parents on Wednesday held signs that said "Homeland Security Took Our Rights" and "Vaccine Injured." They accused Congress of stripping them of their rights. "It's injustice at its worst," said Teri Small of Wilmington, Delaware, whose 4-year-old son was diagnosed with severe autism. "These are vulnerable, defenseless children who have been harmed irreparably."
Trish Desgroseilliers of Landenberg, Pennsylvania, said when she heard of the new law, "I was sad to think that our government is not protecting these children and that there are things going on behind closed doors that us as Americans are not privy to." Several Democrats have already introduced legislation to repeal the measure. Sen. Debbie Stabenow, D-Michigan, called the measure "government and politics at its worst." "Shame on the Congress and the administration for allowing it to happen," Stabenow said.
Copyright 2003 The Associated Press.
Government protects drug companies instead of children Homeland Security?
http://www.s-t.com/daily/01-03/01-10-03/a15op079.htm
I am writing in regards to the Autism article printed on Sat. Jan. 4, "Family blames vaccine additive for son's autism." For two years now our family has been trying to answer the horrific question: "Did Thimerosal ( mercury-based vaccine preservative) in vaccines play a key role in our child's autism?" After spending countless days reading literature on this topic, attending numerous conferences, having heated debates with five different pediatricians, visiting specialists of all sorts, and reading the transcripts of the Congressional Hearings on Autism, our question was finally answered by the Homeland Security Bill. Not in my wildest dreams (or nightmares) would I have guessed that the bill introduced to create a Cabinet-level Homeland Security Department to safeguard our nation against future acts of terrorism would include language that would answer our question.
So the pharmaceutical companies wanted liability protection before proceeding with their investment in producing anti-terrorism vaccines such as small pox or anthrax. So our government finds it ethical to grant them permission to produce unsafe vaccines with scary side effects, rather than ask them to pursue a safer version (a topic for a different day), why then provide the liability protection retroactively? What anti-terrorism vaccine did you receive in the past? None! The carefully chosen loose wording was intentional to limit lawsuits on drugs such as Thimerosol. I thought this bill was about restructuring our government to better safeguard our homeland, but I guess I have a lot to learn about politics.
The millions of dollars spent to lobby this last minute language only tells me one thing.that the nightmare I have been trying to figure out for two years is true.Thimerosal is indeed unsafe, so much in fact that its manufacturer, Eli Lilly, sought liability protection against the autism related class-action lawsuits. I guess Thimerosal did in fact play a key role in our child's autism! After all Thimerosal's active ingredient is ethylmercury which has not been well-studied by any governmental agency. The FDA's Center for Biologics Evaluation & Research has calculated that six month old infants receiving all scheduled vaccine doses would receive a total of 187.5 micrograms of mercury. Compare that to the 17 micrograms of mercury found in a 6 ounce can of tuna, which we have been warned not to eat. Not to mention that the 187.5 micrograms exceeds the suggested safe limits set by the EPA.
But don't worry, our governmental agencies have "recommended" that Thimerosal be removed from the vaccines. Demanding such a removal would not be feasible to the manufacturers as stated by the FDA at the recent Congressional Hearings on Autism televised 12/14/02.. Yes, a parent can request Thimerosal free vaccines from the pediatrician, but request to read the insert listing the ingredients yourself as mercury is still present today in multi-dose vaccines. Also watch for the adult boosters such as tetanus and flu, which also contain Thimerosal.
So please next time you hear that Thimerosal in vaccines do not cause autism or other developmental disabilities, think again. The FDA representative was not able to make that statement during the recent Congressional Hearings on Autism, so who can? Dr. Martha Herbert hit the nail on the head in last Saturday's article when she said that the problem is more a function of inadequate study than hard proof. The Institute of Medicine on Oct. 1, 2001 stated that "existing epidemiological evidence is inadequate to either accept or reject a causal relationship between exposure to thimerosal from vaccines and the neurodevelopmental disorders of autism, Attention Deficit Hyperactivity Disorder (ADHD) and speech or language delay." So they don't know based on the studies to date, however the public is continually fed the following verbiage."no link between vaccines and autism."
Why not recall the mercury- filled vaccines to be on the safe side. It would be an admission of guilt as stated by Dr. Herbert. Well they surely admitted their guilt through the Homeland Security Bill. Unfortunately Thimerosal is not yet fully removed from public use. It's sad to know that our government prefers to protect pharmaceutical companies rather than our children.
Gloria Bancroft
Dartmouth
Thomas P. Wyman
Lilly vaccine issue will get front-door hearing it deserves
http://www.indystar.com/print/articles/5/015415-9055-031.html
January 14, 2003
"Look, Ma, no hands!" As soon as you hear those words, you can bet what happens next is going to look ugly.
Ask Eli Lilly and Co.
Two months ago, a measure protecting Lilly from vaccine-related lawsuits turned up in a very unlikely place -- attached to the Homeland Security Act. Lilly professed surprise and said it had no hand in the matter. Lilly wasn't steering the measure, the company says. Just going along for the ride. Indeed, diligent searching turned up no identifiable Lilly fingerprints. But, predictably, this careening ride through the halls of Congress has ended in a noisy crash.
On Friday, Senate Republicans agreed to repeal the Lilly lawsuit protection measure. The House quickly pledged to follow suit. For nearly a year's lobbying, Lilly has come away with little more than a public relations black eye.The White House and Congress drew up the Homeland Security Act to guard the nation against terrorists, not trial lawyers.
But must-pass legislation like this is particularly tempting to lobbyists. Get your pet measure attached to it, and it will pass into law. Nobody will dare vote no, or cast a veto, against critical legislation just to dunk a
pesky rider.
What tempted Lilly was the prospect of shielding itself from lawsuits involving thimerosal, a vaccine preservative that contains mercury. Lilly no longer makes thimerosal. Scores of parents of autistic children blame their kids' autism on thimerosal, and are suing. Lilly says the lawsuits are groundless.
Research on the question so far is inconclusive.
Last fall, Lilly spokesman Edward Sagebiel said Monday, Lilly asked Congress to add thimerosal lawsuit protection to the Homeland Security bill. Lilly got the door slammed in its face. No way, the word came back. Congressional leaders wanted a clean bill -- one not burdened with lots of special favors.
At that point, Sagebiel says, "We stopped our lobbying efforts." But when the measure emerged from Congress, lo and behold, there was the lawsuit protection. There was no lack of suspects, including maybe some unidentified Capitol Hill ally of White House budget maestro Mitch Daniels, a former Lilly executive.
All denied involvement.
But Lilly nevertheless appeared to have benefited from someone's cynical manipulation of critical national security legislation. In a statement released Friday, Lilly said it "agrees that the process by which this legislation was enacted was not desirable, and fully understands the action taken by the Senate."The legislative sleight-of-hand that slipped the lawsuit shield into the Homeland Security Act didn't just put egg on Lilly's corporate face. It also heightened the suspicions of those parents who are suing.
And it's handed ammunition, at least in a public relations sense, to their attorneys. Lilly's not giving up, though. It plans to pursue identical legislation this spring, Sagebiel says.In that effort, the company has powerful political allies. The list includes Senate Majority Leader William Frist, a medical doctor who favors the lawsuit shield.
And that's the way to go about it. As a piece of separate legislation. Debated on its merits, in full public view.
Contact Thomas P. Wyman at 1-317-444-6424 or via e-mail at
thomas.wyman@indystar.com
Marketers' observations of doctor visits trouble psychiatric group
http://forums.delphiforums.com/medical/messages?msg=35514.1
- Some doctors are letting drug company sales representatives sit in while they treat patients - a practice called "shadowing" that is being questioned by at least one professional group.
An organization of psychiatrists says it intends to ask the American Medical Association to review the ethics of the practice. Sales reps have been known to sit in doctors' offices and examining rooms and observe routine checkups, various treatments and diagnostic tests, even child psychiatric therapy. Some doctors are paid hundreds of dollars in return. Some, if not all, of the pharmaceutical companies require the doctors to obtain the patient's consent.
The companies say these preceptorship programs, as they are formally known, are purely educational, allowing sales reps to learn more about doctors' jobs and better serve physicians who use their products. But critics see the efforts as an unethical marketing attempt that violates the privacy of the doctor-patient relationship.
It is unclear how widespread the practice is, but the players include major pharmaceutical companies like Eli Lilly and Co. Lilly spokesman Ed Sagebiel said the practice began at Lilly at least five years ago and involves doctors of many types around the country. Sagebiel said Lilly's reps are told just to observe, not participate. Lilly's policy says participating doctors must obtain patient consent.
But critics say confidentiality and consent are especially problematic when psychiatric patients and children are involved. Some question whether parents can adequately represent their children's wishes. The American Academy of Child and Adolescent Psychiatry plans to raise the issue at the AMA's annual meeting in June in Chicago. Dr. David Fassler, a Vermont psychiatrist and member of the academy's governing council, said he wants the AMA to come out against the practice unless patients have "full knowledge and informed consent."
"It seems quite inappropriate to have non-clinical personnel present during therapy sessions," Fassler said in an interview this week. "I'm also concerned that patients may not always feel free to say no when asked by their doctor if something like this would be OK." The AMA does not have policy on shadowing, but one is needed - especially if doctors are being paid, said Dr. J. Edward Hill, chairman of the AMA Board of Trustees. "I would be extremely concerned about that being unethical behavior," he said. He added: "We don't want anybody interfering with the patient-physician relationship, whether it's a pharmaceutical representative or anybody. That's such a sacred trust."
While the extravagant freebies that drug companies have lavished on doctors have come under increased scrutiny in recent years, the industry's presence in examining rooms is less well-known. But some recent cases have raised concern among doctors and prompted calls for an end to the practice.
In one of those cases, a Lilly sales rep in Maryland sat in on a psychiatric therapy session involving children.
In another case, Parke-Davis, now part of Pfizer Inc., is accused of illegally marketing the epilepsy drug Neurontin for unapproved uses through tactics that included sitting in on patient visits. The allegations were contained in a whistle-blower lawsuit filed last year in Boston. The case has prompted an investigation into Parke-Davis' marketing practices in 47 states.
David Waterbury, an assistant attorney general in Washington state who is overseeing the Parke-Davis probe, said that even if sales reps are not overtly marketing, their presence would probably make a doctor reluctant to recommend another company's drug to a patient.
"If the person's there from 'X' company, is the doctor going to have a lot of discussions about the virtues of 'Y' company's drug? I think not," Waterbury said. Lilly pays doctors $250 for one half-day session or $500 for allowing a sales rep to accompany a doctor all day, Sagebiel said. Doctors may be paid directly or their fee can be donated in the physician's name to a medical school or a charity, he said.
Sagebiel said paying doctors is appropriate because they are providing a valuable service. "It helps the reps have a hands-on observation to the challenges of a physician and helps them to be a better partner," he said. Dr. Bill Arnold, an Indianapolis psychiatrist, said he has been paid to take part in several such programs involving Lilly and others. He defended the practice as a way to give sales reps exposure to medicine the way it is practiced.
"They've heard about schizophrenia and heard about Alzheimer's; here it is - live," Arnold said. "They're going to market their products anyway, so instead of them trying to beat down my door, why not have them learn about what the market's really like?" Arnold said the money is minimal given the amount of time shadowing takes away from his practice: "It's not a lucrative thing to do at all."
A Pfizer spokesman declined to comment on the Neurontin case.
http://www.house.gov/rules/omni12.pdf
On 2/14/03 The Omnibus Appropriations Bill passed. It completely repealed the thimerosal protection rider that was in the Homeland Security Act. Here is the language that was drafted as a compromise between Snowe, Collins, Chafee and Frist:
DIVISION L- HOMELAND SECURITY ACT OF 2002 AMENDMENTS
SEC. 102.NON-PREJUCIAL REPEAL OF SECTIONS 1714 THROUGH 1717 OF THE HOMELAND
SECURITY ACT OF 2002. (a) REPEAL. - In accordance with subsection (c), sections 1714 through 1717 of the Homeland Security Act of 2002 (Public Law 107-296) are repealed.
(b) APPLICATION OF THE PUBLIC HEALTH SERVICE ACT. - The Public Health Service Act (42 U.S.C. 201 et seq) shall be applied and administered as if the sections repealed by subsection (a) had never been enacted.
(c) RULE OF CONSTRUCTION.- No inference shall be drawn from the enactment of sections 1714 through 1717 of the Homeland Security Act of 2002 (Public Law 107-295), or from this repeal, regarding the law prior to enactment of sections 1714 through 1717 of the Homeland Security Act of 2002. Further, no inference shall be drawn that subsection (a) or (b) affects any change in that prior law, or that Leroy v Secretary of Health and Human Services, Office of Special Master, No. 02-392V (October 11, 2002), was incorrectly decided.
(d) SENSE OF CONGRESS. -It is the sense of Congress that-
(1) the Nation's ability to produce and develop new and effective vaccines faces significant challenges, and important steps are needed to revitalize our immunization efforts in order to ensure an adequate supply of vaccines and to encourage the development of new vaccines;
(2) these steps include ensuring that patients who have suffered vaccine-related injuries have the opportunity to seek fair and timely redress, and that vaccine manufacturers, manufacturers of components or ingredients of vaccines, and physicians and other administrators of vaccines have adequate protections;
(3) prompt action is particularly critical given that vaccines are a front line of defense against common childhood and adult diseases, as well as against current and future biological threats; and
(4) not later than 6 months after the date of enactment of this Act, the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives should report a bill addressing the issues described in paragraphs (1) through (3).
Kathi Williams
Director and Co-founder
National Vaccine Information Center
421-E Church Street
Vienna, VA 22180
703-938-0342
www.909shot.com
AIDS activists wary of Tobias selection
- July 5, 2003 11:23am
Randall Tobias' nomination Wednesday as President Bush's global AIDS czar drew praise from congressional leaders but criticism from the world AIDS community, whose activists question the former Eli Lilly and Co. CEO's allegiances -- and his knowledge of public health.
Many see Tobias as a representative of the pharmaceutical industry, which, they say, has blocked access to affordable, generic AIDS drugs by patients in developing countries. Such countries represented 95 percent of the 42 million adults and children who were living with HIV and AIDS at the end of 2002, according to the World Health Organization.
"It demonstrates incredible lack of tact and respect for people with HIV living in the developing world who frequently cannot access life-saving medicines," said Nathan Geffen, national manager for Treatment Action Campaign in South Africa, where an estimated 5 million people have HIV or AIDS.
"He's certainly not someone who's known for being at the forefront of AIDS."
But President Bush said Tobias is the right man for the job.
"I have chosen a superb leader who knows a great deal about lifesaving medicines and who knows how to get results," Bush said at a White House news conference introducing his nominee.
If confirmed, Tobias will head an AIDS plan that will provide $15 billion during the next five years to fight the disease, primarily in 14 African and Caribbean countries. Among his duties will be to establish a network to get medications to the farthest reaches of Africa and help train health professionals so they can treat patients with HIV and AIDS, Bush said.
Tobias would carry the rank of ambassador and report to Secretary of State Colin Powell.
Tracy Elliott, executive director of Indianapolis' Damien Center, said Tobias' business acumen could be more of an asset than a public health background would be in the role.
"I think it's sort of inspired, actually,' Elliott said of Tobias' nomination. "It's a more inspired choice than the typical retired professor."
Because Tobias would work through the State Department with the status of ambassador, he would have more access to governments, some of which have made AIDS assistance difficult, Elliott said.
"And if they don't deal with that, it's just throwing money at a rat hole," Elliott said.
A spokeswoman said Tobias would have no comment on his nomination until the process is complete.
Tobias, 61, is from Remington and was chairman and chief executive officer of Lilly from 1993 to 1998. He would be one of at least a half-dozen Hoosiers to hold prominent positions with the Bush administration.
His nomination must first go to the Senate Foreign Relations Committee, chaired by Sen. Richard Lugar, R-Ind., before proceeding to the full Senate for confirmation.
Lugar was at a conference in Helsinki, Finland, and was unavailable Wednesday, but his spokesman, Nick Webber, praised the Tobias nomination.
"It's exciting for Hoosiers, particularly," he said.
Sen. Evan Bayh, D-Ind., agreed.
"Randy is an outstanding individual with a big heart," Bayh said. "He is also a skilled manager, and I'm confident he'll do a good job at addressing the significant challenge." But Amanda Lugg, community advocate with The African Services Committee in New York, said the buzz among AIDS activists in the first hours after Tobias' nomination was largely negative. "What makes us really nervous . . . is that he's the retired CEO of a pharmaceutical giant," she said. "I would see that as a conflict of interest."
She also noted Tobias' strong Republican ties. Since 1999, Tobias and his wife, Marianne, have contributed $6,000 to Lugar, $7,000 to Bush, $42,500 to state and national Republican political action committees and thousands more to other Republican candidates, according to the Center for Responsive Politics. Sharonann Lynch, an activist with the New York-based Health GAP (Global Access Project), also was critical of Tobias and what the nomination says about Bush. "Why this person? He's so far removed from the reality of people living with AIDS," she said. Lynch said she and others will push senators to ask Tobias pointed questions during the confirmation process.
Not all of the negative reaction came from AIDS activists. The Family Research Council, generally considered to be at the conservative end of the political spectrum, expressed concerns that Tobias would not follow what it called the "pro-family" spirit of Bush's AIDS bill.
"We are concerned that Mr. Tobias does not have a proven track record of supporting the effective strategies to combat AIDS," Connie Mackey, vice president of the organization, said in a written statement issued in Washington. Mackey's group fears Tobias would not emphasize abstinence-based messages or support the belief that condoms should be distributed as a last resort. But Geffen, the South African activist, said there are concerns that Tobias will set out to "promote Bush's Christian fundamentalism," with an abstinence-only message siphoning money from groups that promote condom use.
"It's got the potential to be quite detrimental," he said.
At a glance
Presidential pick: President Bush named Randall Tobias to direct a $15 billion AIDS program that will involve coordinating the administration's international AIDS/HIV activities.
Still to come: The Senate must confirm Tobias, who would carry the rank of ambassador.
Hoosiers in D.C. Hoosiers with prominent roles in Washington:
Deborah J. Daniels
Former deputy prosecutor and chief counsel under Mayor Stephen Goldsmith. Now assistant attorney general for the office of justice programs.
James R. Moseley
Tippecanoe County farmer served as assistant secretary for natural resources in the first Bush administration. Now serves as deputy secretary of agriculture.
Vicky Lynn Anderson Bailey
Indianapolis native is former president of PSI Energy and served on the Indiana Utility Regulatory Commission from 1986 to 1993. Now assistant secretary of energy for policy and international affairs.
Ellen Gayle Engleman
Indiana native has served as president and chief executive officer of Electricore, a nonprofit research and development consortium. Now administrator of the research and special programs administration in the U.S. Department of Transportation.
James T. Morris
Former Indianapolis Water Co. chief executive officer, aide to Sen. Richard Lugar and Lilly Endowment president. Now executive director of the United Nations' World Food Program.
Recent departures:
Mitch Daniels
Recently resigned as director of the Office of Management and Budget; is running for governor of Indiana.
Carol D'Amico
Indiana University graduate recently resigned after serving two years as assistant secretary for vocational and adult education.
AIDS facts and figures
Of the 42 million adults and children living with HIV and AIDS at the end of 2002, 95 percent were in developing countries.
Most in Africa: 70 percent of those with HIV and AIDS lived in sub-Saharan Africa.
Spread continues: In 2002, an estimated 5 million people were newly infected with HIV, and 3.1 million died of AIDS.
Young victims: 610,000 children under 15 died of AIDS in 2002.
Sources: World Health Organization; U.S. Centers for Disease Control and Prevention
The Associated Press and Gannett News Service contributed to this report.
Call Star reporter Diana Penner at 1-317-444-6249.
Copyright © 2003 The Indianapolis Star
THE PAYBACK PRESIDENT: After the oil companies, it's the turn of the drugs
cartel
Big business helped get George W Bush elected. His campaign chest was the largest ever garnered by any presidential candidate - and his entire presidency ever since has been about paying back his benefactors. The oil giants have enjoyed access to remote areas previously protected by environmental agencies, and they finally got their pipes into Afghanistan once that had been invaded. Companies offering infrastructure support and services have been enjoying unprecedented revenues from the rebuilding of Iraq.
Now, with just months left of his presidency, George is making sure the drug companies get their snouts in the trough (a not unusual position for them). Of course, when big business is given a presidential mandate to push for bigger profits, people can get hurt. In Iraq it was the soldiers and the innocent civilians of Iraq. So, to give a helping hand to the pharma cartel, every citizen in the USA, including toddlers, is in George's sights. The great thing about George is that he's wonderful at window dressing. The Patriot Act was a triumphal name for a nasty piece of legislation. And now we have the New Freedom initiative.
Under the initiative, every citizen of virtually every age, including preschool children, is to be screened for mental illness. Schools will be used as the screening centres for the 52 million kids and 6 million teachers who attend them. The model for the New Freedom initiative is the TMAP, which stands for the Texas Medication Algorithm Project - that's right, the state that George used to govern, a project that first saw the light of day during his time in office there.
TMAP promotes the use of the new, and more expensive, antidepressants and antipsychotic drugs, such as Zyprexa (olanzapine), which is Eli Lilly's best selling drug. It grossed $4.28bn in 2003, with 70 per cent of the revenues paid for by government agencies such as Medicare and Medicaid. Needless to say there's a link between Eli Lilly and the Bush family. George senior has been a board member, while George junior appointed Lilly's chief executive to a seat on the Homeland Security Council. Lilly made a contribution of $1.6m to the Bush campaign in 2000, and donations have already reached $700,000 for the current campaign. It's got to be the best investment they have ever made.
(Source: British Medical Journal, 2004; 328: 1458).
http://www.laleva.org/eng/2004/05/the_pharmaceutical_business_with_desease_e
li_lilly_zyprexa_and_the_bush_family.html
Big Pharma
ELI LILLY, ZYPREXA & THE BUSH FAMILY
The diseasing of our malaise
By Bruce Levine
More than one journalist has uncovered corrupt connections between the Bush Family, psychiatry, and Eli Lilly & Company, the giant pharmaceutical corporation. While previous Lillygates have been more colorful, Lilly’s soaking state Medicaid programs with Zyprexa—its blockbuster, antipsychotic drug—may pack the greatest financial wallop. Worldwide in 2003, Zyprexa grossed $4.28 billion, accounting for slightly more than one-third of Lilly’s total sales. In the United States in 2003, Zyprexa grossed $2.63 billion, 70 percent of that attributable to government agencies, mostly Medicaid. Historically, the exposure of any single Lilly machination—though sometimes disrupting it—has not weakened the Bush-psychiatry-Lilly relationship. In the last decade, some of the more widely reported Eli Lilly intrigues include:
• Influencing the Homeland Security Act to protect itself from lawsuits • Accessing confidential patient records for a Prozac sample mailing • Rigging the Wesbecker Prozac-violence trial
A sample of those who have been on the Eli Lilly payroll includes:
• Former President George Herbert Walker Bush (one-time member of the Eli Lilly board of directors)
• Former CEO of Enron, Ken Lay (one-time member of the Eli Lilly board of directors) • George W. Bush’s former director of Management and Budget, Mitch Daniels (a former Eli Lilly vice president)
• George W. Bush’s Homeland Security Advisory Council member, Sidney Taurel (current CEO of Eli Lilly)
• The National Alliance for the Mentally Ill (a recipient of Eli Lillyfunding)
In 2002, British and Japanese regulatory agencies warned that Zyprexa may be linked to diabetes, but even after the FDA issued a similar warning in 2003, Lilly’s Zyprexa train was not derailed, as Zyprexa posted a 16 percent gain over 2002. The growth of Zyprexa has become especially vital to Lilly because Prozac—Lilly’s best-known product, which once annually grossed over $2 billion—having lost its patent protection, continues its rapid decline, down to $645.1 million in 2003.
At the same time regulatory agencies were warning of Zyprexa’s possible linkage to diabetes, Lilly’s second most lucrative product line was its diabetes treatment drugs (including Actos, Humulin, and Humalog), which collectively grossed $2.51 billion in 2003. Lilly’s profits on diabetes drugs and the possible linkage between diabetes and Zyprexa is not, however, the most recent Lillygate that Gardiner Harris broke about Zyprexa in the New York Times on December 18, 2003.
Zyprexa costs approximately twice as much as similar drugs and Harris reported that state Medicaid programs—going in the red in part because of Zyprexa— are attempting to exclude it in favor of similar, less expensive drugs. Harris focused on the Kentucky Medicaid program, which had a $230 million deficit in 2002, with Zyprexa being its single largest drug expense at $36 million. When Kentucky’s Medicaid program attempted to exclude it from its list of preferred medications, the National Alliance for the Mentally Ill (NAMI) fought back. The nonprofit NAMI—ostensibly a consumer organization—bused protesters to hearings, placed full-page ads in newspapers, and sent faxes to state officials. What NAMI did not say at the time was that the buses, ads, and faxes were paid for by Eli Lilly.
Ken Silverstein, in Mother Jones in 1999, reported that NAMI took $11.7 million from drug companies over a three and a half year period from 1996 through 1999, with the largest donor being Eli Lilly, which provided $2.87 million. Eli Lilly’s funding also included loaning NAMI a Lilly executive, who worked at NAMI headquarters, but whose salary was paid for by Lilly. Though NAMI’s linkage to Lilly is a scandal to psychiatric survivors—whose journal MindFreedom published copies of Big Pharma checks to NAMI—the story didn’t have the widespread shock value that would elevate it to Lillygate status.
In 2002, Eli Lilly flexed its muscles at the highest level of the U.S. government in an audacious Lillygate. The event was the signing of the Homeland Security Act, praised by President George W. Bush as a “heroic action” that demonstrated “the resolve of this great nation to defend our freedom, our security and our way of life.” Soon after the Act was signed, New York Times columnist Bob Herbert discovered what had been slipped into the Act at the last minute and on November 25, 2002, he wrote, “Buried in this massive bill, snuck into it in the dark of night by persons unknown…was a provision that—incredibly—will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their
children were harmed by thimerosal.”
Thimerosal is a preservative that contains mercury and is used by Eli Lilly and others in vaccines. In 1999 the American Academy of Pediatrics and the Public Health Service urged vaccine makers to stop using mercury-based preservatives. In 2001 the Institute of Medicine concluded that the link between autism and thimerosal was “biologically plausible.” By 2002, thim-erosal lawsuits against Eli Lilly were progressing through the courts. The punchline of this Lillygate is that, in June 2002, President George W. Bush had appointed Eli Lilly’s CEO, Sidney Taurel, to a seat on his Homeland Security Advisory Council. Ultimately, even some Republican senators became embarrassed by this Lillygate and, by early 2003, moderate Republicans and Democrats agreed to repeal this particular provision in the Homeland Security Act.
In early 2003, “60 Minutes II” aired a segment on Lillygate and Prozac. With Prozac’s patent having run out, Eli Lilly began marketing a new drug, Prozac Weekly. Lilly sales representatives in Florida gained access to
“confidential” patient information records and, unsolicited, mailed out free samples of Prozac Weekly. How did Eli Lilly get its hands on these medical records? Regulations proposed under Clinton and later implemented under Bush contained a provision that gave health-care providers the right to sell a person’s confidential medical information to marketing firms and drug companies. Despite many protests against this proposal, President Bush told Health and Human Services Secretary Tommy Thompson to allow the new rules to go into effect.
Perhps the most cinematic of all Lillygates culminated in 1997. The story began in 1989 when Joseph Wesbecker—one month after he began taking Prozac—opened fire with his AK-47 at his former place of employment, killing 8 and wounding 12 before taking his own life. British journalist John Cornwell covered the Louisville, Kentucky trial for the London Sunday Times Magazine, ultimately writing a book about it. Cornwell’s The Power to Harm (1996) is not only about a disgruntled employee becoming violent after taking Prozac, but is also about Eli Lilly’s power to corrupt the judicial system.
Victims of Joseph Wesbecker sued Eli Lilly, claiming that Prozac had pushed Wesbecker over the edge. The trial took place in 1994, but received scant attention as the public was transfixed by the O.J. Simpson spectacle. While Eli Lilly had been settling many Prozac violence cases behind closed doors (more than 150 Prozac lawsuits had been filed by the end of 1994), it was looking for a showcase trial that it could win. Although a 1991 FDA “blue ribbon panel” investigating the association between Prozac and violence had
voted not to require Prozac to have a violence warning label, by 1994 word was getting around that five of the nine FDA panel doctors had ties to Big Pharma—two of them serving as lead investigators for Lilly-funded Prozac studies. Thus, with the FDA panel now known to be tainted, Lilly believed that Wesbecker’s history was such that Prozac would not be seen as the cause of his mayhem.
A crucial component of the victims’ attorneys’ strategy was for the jury to hear about Eli Lilly’s history of reckless disregard. Victims’ attorneys especially wanted the jury to hear about Lilly’s anti- inflamatory drug
Oraflex, introduced in 1982 but taken off the market three months later. A U.S. Justice Department investigation linked Oraflex to the deaths of more than 100 patients and concluded that Lilly had misled the FDA. Lilly was charged with 25 counts related to mislabeling side effects and pled guilty—but in 1985, the Reagan-Bush Justice Department saw fit to fine them a mere $25,000.
In the Wesbecker trial, Lilly attorneys argued that the Oraflex information would be prejudicial and Judge John Potter initially agreed that the jury shouldn’t hear it. However, when Lilly attorneys used witnesses to make a case for Eli Lilly’s superb system of collecting and analyzing side effects, Judge Potter said that Lilly had opened the door to evidence to the contrary and ruled that the Oraflex information would now be permitted. To Judge Potter’s amazement, victims’ attorneys never presented the Oraflex evidence and Eli Lilly won the case. Later, it was discovered that—in a manipulation Cornwell described as “unprecedented in any Western court”—Eli Lilly cut a secret deal with victims’ attorneys to pay them and their clients not to introduce the Oraflex evidence. However, Judge Potter smelled a rat and fought for an investigation. In 1997, Eli Lilly quietly agreed to the verdict being changed from a Lilly victory to “dismissed as settled.”
Looking back further to 1992, Alexander Cockburn, in both the Nation and the New Statesman, was one of the first to connect the dots between the Bush family and Eli Lilly. After George Herbert Walker Bush left his CIA director post in 1977 and before becoming vice president under Ronald Reagan in 1980, he was on Eli Lilly’s board of directors. As vice president, Bush failed to disclose his Lilly stock and lobbied hard on
behalf of Big Pharma—especially Eli Lilly . For example, Bush sought special tax breaks from the IRS for Lilly and other pharmaceutical corporations that were manufacturing in Puerto Rico.
Cockburn also reported on Mitch Daniels, then a vice president at Eli Lilly, who in 1991 co-chaired a fundraiser that collected $600,000 for the Bush-Quayle campaign. This is the same Mitch Daniels who in 2001 became George W. Bush’s Director of Management and Budget. In June 2003, soon after Daniels departed from that job, he ran for governor of Indiana (home to Eli Lilly headquarters). In a piece in the Washington Post called “Delusional on the Deficit,” Senator Ernest Hollings wrote, “When Daniels left two weeks ago to run for governor of Indiana, he told the Post that the government is ‘fiscally in fine shape.’ Good grief! During his 29-month tenure, he turned a so-called $5.6 trillion, 10-year budget surplus into a
$4 trillion deficit—a mere $10 trillion downswing in just two years. If this is good fiscal policy, thank heavens Daniels is gone.”
There is one Eli Lilly piece of history so bizarre that if told to many psychiatrists, one just might get diagnosed as paranoid schizophrenic and medicated with Zyrprexa. Former State Department officer John Marks in The Search for the “Manchurian Candidate”: The CIA and Mind Control, The Secret History of the Behavioral Sciences (1979)—along with the Washington Post (1985) and the New York Times (1988)—reported an amazing story about the CIA and psychiatry. A lead player was psychiatrist D. Ewen Cameron,
president of the American Psychiatric Association in 1953. Cameron was curious to discover more powerful ways to break down patient resistance. Using electroshock, LSD, and sensory deprivation, he was able to produce severe delirium. Patients often lost their sense of identity, forgetting their own names and even how to eat. The CIA, eager to learn more about Cameron’s brainwashing techniques, funded him under a project code-named MKULTRA. According to Marks, Cameron was part of a small army of the CIA’s LSD-experimenting psychiatrists. Where did the CIA get its LSD? Marks reports that the CIA had been previously supplied by the Swiss pharmaceutical corporation Sandoz, but was uncomfortable relying on a
foreign company and so, in 1953, the CIA asked Eli Lilly to make them up a batch of LSD, which Lilly subsequently donated to the CIA.
The most important story about Eli Lilly is that Lilly’s two current blockbuster psychiatric drugs—Zyprexa and Prozac—are, in scientific terms, of little value. It is also about how Lilly and the rest of Big Pharma have
corrupted psychiatry, resulting in the increasing medicalization of unhappiness. This diseasing of our malaise has diverted us from examining the social sources for our unhappiness—and implementing societal solutions.
Much of the scientific community now acknowledges that the advantage of Prozac and Prozac-like drugs over a sugar-pill placebo is slight—or as Prevention and Treatment in 2002 defined it, “clinically negligible.” When Prozac is compared to an active placebo (one with side effects), then Prozac is shown to have, in scientific terms, zero value. Moreover, many doctors and researchers now warn us about the dangers of Prozac. Psychiatrist Joseph Glenmullen’s Prozac Backlash (2000) documented “neurological disorders including disfiguring facial and whole body tics indicating potential brain damage...agitation, muscle spasms, and parkinsonism,” and he stated that debilitating withdrawal occurs in 50 percent of patients who abruptly come off Prozac and Prozac-like drugs.
Just as Prozac and other SSRI drugs are no longer seen by many scientists as an improvement in safety and effectiveness over the previous class of antidepressants, psychiatry’s highly touted Zyprexa (and other “atypical antipsychotics”) turns out to be no great advance over the older problematic anti-ps ychotics such as Haldol. Journalist Robert Whitaker, in Mad in America (2002), details how Eli Lilly’s Zyprexa research was biased against the inexpensive Haldol and how claims of improved safety of Zyprexa are difficult to justify. Whitaker reports that in drug trials used by FDA reviewers, 22 percent of Zyprexa patients had “serious” adverse effects as compared to 18 percent of the Haldol patients.
The United States and other nations that have bought psychiatry’s and Big Pharma’s explanations and treatments turn out to have worse results with those diagnosed as psychotic than those nations who are less enthusiastic about drugs and who care more about community. In 1992, the World Health Organization (WHO), in a repeat of earlier findings, found that so-called underdeveloped nations, which emphasize community support rather than medications, have better results with those diagnosed as psychotic than nations, which stress drug treatments. In nations such as the United States, where 61 percent of those diagnosed as psychotic were maintained on antipsychotic medications, only 37 percent had full remission. While in India, Nigeria, and Colombia, where only 16 percent of patients diagnosed
as psychotic were maintained on antipsychotic medications, approximately 63 percent of patients had full remission.
While scientists are not certain about the reasons for these WHO findings, two possible explanations are: (1) psychiatric drugs, even for the most disturbed among us, are not the greatest long-term solution; (2) community support, crucial to our mental health, does not lend itself to commercialization. Thus, in areas such as mental health, radically commercialized societies such as the United States are backward societies.
Though some mental health professionals insist that atypical antipsychotics such as Zyprexa are a great advance, I’ve met few Zyprexa users who agree. A few years ago, a well-read man with a professorial manner in his early 60s, diagnosed by several other doctors as paranoid schizophrenic, came to see me. He had, at various times, taken several types of antipsychotic drugs and told me, laughing loudly between each sentence, “I’m crazy on drugs and crazy off drugs. Haldol helped me sleep and Zyprexa helped me
sleep, but I hated the Haldol and when I was on Zyprexa, I couldn’t take a shit for three weeks. Now I don’t take any drugs and I can’t sleep and I am a big pain-in-the ass, but I can remember better what I read.” A few weeks later he told me, “It’s all friendly fascism. Yes, friendly fascism. Was it you who told me—or was it I who told you—that fascism is about the complete integration of industry and government under a centralized authority? Friendly fascism, right? I suppose I say ‘friendly fascism’ too much, but you’re not Ashcroft and neither am I, right? Don’t you agree that it’s all friendly fascism?” Then he flashed a giant smile and said one more time, “Friendly fascism, right, Bruce?”
Bruce E. Levine, PhD, is a psychologist and author of Commonsense Rebellion: Taking Back Your Life from Drugs, Shrinks, Corporations and a World Gone Crazy (New York-London: Continuum, 2003).
TONS more out there
http://www.msnbc.com/news/854647.asp#BODY
KATHY KILPATRICK has to watch her daughter very closely. Six-year-old Mary-Kate is autistic and needs constant supervision. “She’s different and she’s isolated,” says Kilpatrick. “She knows that she’s different.”
Mary-Kate is one of about 90,000 children in America diagnosed with this neurological disorder that impairs her mental and social development. Her parents believe her vaccinations are to blame, specifically a preservative added to them.
“I never once questioned the shots,” says Kilpatrick. “There was never any discussion of any risks involved.” At issue is a vaccine preservative called thimerosal. It contains mercury and was used in child vaccines until 1999. Although a scientific link to autism has never been proven, thousands of parents believe thimerosal is the cause and filed suit against its maker, Eli Lilly. But just days before the homeland security bill was passed this fall, an amendment was slipped in. It was part of a bill written by incoming Senate majority leader Bill Frist, and it closed off the major avenue by which people could sue a vaccine maker for illness.
“What it did to the families is it took away their last option, literally or figuratively closed the door on their last access to the courts of justice,” says Prof. Lawrence Gostin of Georgetown University School of Law.
One of the most powerful members of Congress, outgoing House majority leader Rep. Dick Armey, R-Texas, was behind the amendment and argues that if drug companies weren’t protected, they might refuse to make vaccines, a big worry amid fears of bioterrorism. “I’m proud that I put it in there and I know that it’s going to make America more secure, and that’s why it’s there,” says Armey.
But congressman Dan Burton is among those who are furious. For anybody to say they’re proud for putting that kind of an amendment in there is just beyond me,” says Rep. Burton, R-Ind. Burton’s grandson is autistic. He also chairs the committee that oversaw the bill and says he was blindsided by Dick Armey’s last-minute addition. “Now, he can take sole responsibility for it, that’s his prerogative if he wants to, but that amendment is criminal in my opinion,” says Burton.
Some critics of the amendment point out that drug companies give generously to the Republican party and that some top officials at Eli Lilly have close ties to the White House. Lilly’s chairman, Sidney Taurel, served on the White House advisory council on homeland security. Mitch Daniels, a former top Lilly executive, is now director of the White House office of management and budget. The White House denies any influence. Eli Lilly released a statement reading, “at no point did anyone at Lilly... past or present, ask for this language to be inserted in the homeland security act.”
Some members of Congress from both parties say they’re already trying to undo the effects of the recent legislation to once again give parents the right to sue in court — despite the absence of conclusive evidence to back up the families’ claims. “There’s been no scientific connection made between thimerosal and autism, not in the medical community, not in the scientific community,” says Armey. And for families like the Kilpatricks?
Every night when I go to bed,” says Kathy Kilpatrick, “I think, ‘my God,’ what’s going to happen to this poor baby when I’m gone? She’s going to outlive me by 40 years.” For now, this family and others wait to find out how the next move in vaccine politics might affect the quality of their lives.
Is someone feeling guilty at Eli Lilly?
http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=165437&print=yes
New Scholarship Program to Help Adults Living With ADHD Focus on Their Possibilities
June 8, 2005
Lilly Scholarship Program Provides Winners Help with Tuition Costs
INDIANAPOLIS, June 8, 2005 /PRNewswire-FirstCall via COMTEX/ -- Eli Lilly and Company (NYSE: LLY) today announced the launch of the Focus on Your Possibilities scholarship program, the first and only scholarship program specifically for adults living with attention-deficit/hyperactivity disorder (ADHD). A total of 20 scholarships worth up to $5,000 each will be awarded to United States citizens by an independent panel of experts for the 2005 fall semester -- allowing recipients to continue their education in traditional colleges, graduate schools, technical institutes or General Education Development (GED) courses.
For adults with ADHD, achieving academic success may mean a constant battle with symptoms of the disorder -- such as making careless mistakes, having trouble finishing tasks or having problems remembering appointments or obligations -- that have plagued them throughout their childhoods. Some may never have achieved the advanced degree they desire. These are the individuals Lilly wants to help.
"Far too many bright people with ADHD don't go to college at all or drop out before completing a degree," said Ruth Hughes, mother of a student with ADHD preparing for college and deputy chief executive officer for public policy and community services for Children and Adults with Attention-Deficit Hyperactivity Disorder (CHADD), a nonprofit organization. "Every student with ADHD deserves the opportunity to achieve the highest academic level possible for that individual. These adults have incredible talent and energy. Let's help them use them."
"The Focus on Your Possibilities scholarship program is designed to decrease the financial barriers of achieving the education level that matches the individual's talents, desires and hard work," said Deirdre Connelly, president of Lilly USA. "This scholarship is encouragement for the person with ADHD to achieve what may have seemed impossible -- a high school degree, a college degree, technical expertise or even a graduate degree."
To apply for the scholarship, adults 25 years or older must be:
* diagnosed with ADHD by a physician and currently undergoing treatment;
* enrolled or planning to enroll in an accredited college, university, vocational/technical school or GED program on a full-time basis;
* able to provide examples of significant drive and passion that will enable them to capitalize on their talents through education.
The award recipients will have a demonstrated record of overcoming challenges, and the scholarship program will reward them in their work toward academic success.
Applications for the fall semester are due July 15, 2005, and award recipients will be announced August 5, 2005. For application information, please call 1-800-LillyRx or visit www.ADHD.com .
"This scholarship gives adults with ADHD a second chance to achieve their life goals, and we are excited to play a small role in that," Connelly said.
About ADHD
ADHD affects 3 percent to 7 percent of school-aged children and manifests itself in levels of attention, concentration, activity, distractibility and impulsivity that are inappropriate to the child's age.(1) In addition, 60 percent of children with the disorder carry their symptoms into adulthood.(2) Experts estimate 4 percent of adults in the United States, more than 8 million people, have ADHD.(3,4)
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com . O-LLY
(1) American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, Washington, D.C., American Psychiatric Association, 2000.
(2) Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med Clin of North Am. 2001; 85(3): 757-777.
(3) Murphy K, Barkley, RA. J Atten disord. 1996; 1:147-161.
(4) United States Census Summary File; 2000.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
Jennifer Bunselmeyer of Eli Lilly and Company, +1-317-655-8808
http://www.prnewswire.com
Copyright © 2005 PR Newswire. All rights reserved.
News Provided by COMTEX
Washington AP - Parents rallied at the Capitol on Wednesday against a law that protects vaccine makers, and Democrats promised to fight to repeal the measure. The vaccine provision was attached to a bill creating a new Homeland Security Department, which President Bush signed into law in November. The Republican-backed provision essentially shields vaccine makers from lawsuits concerning the use of the compound Thimerosal by requiring that claims go through a special federal program that pays limited damages for vaccine-related injuries, rather than through courts.
Thimerosal is a mercury-containing preservative once added to some childhood vaccines. Indianapolis, Indiana-based Eli Lilly, a major Republican Party contributor, was the biggest manufacturer of Thimerosal.
A spokesman for Eli Lilly, Ed Sagebiel, said the company had lobbied for the measure earlier but had no role in its placement in the homeland security bill. But Sagebiel added, "It's something we support now. We think it's good public policy."
Medical research has not established a link between autism and Thimerosal, but many parents believe the ingredient may be to blame. Scores of parents have filed lawsuits that claim that Thimerosal caused their children to develop autism or related nerve diseases. Many of those parents on Wednesday held signs that said "Homeland Security Took Our Rights" and "Vaccine Injured." They accused Congress of stripping them of their rights. "It's injustice at its worst," said Teri Small of Wilmington, Delaware, whose 4-year-old son was diagnosed with severe autism. "These are vulnerable, defenseless children who have been harmed irreparably."
Trish Desgroseilliers of Landenberg, Pennsylvania, said when she heard of the new law, "I was sad to think that our government is not protecting these children and that there are things going on behind closed doors that us as Americans are not privy to." Several Democrats have already introduced legislation to repeal the measure. Sen. Debbie Stabenow, D-Michigan, called the measure "government and politics at its worst." "Shame on the Congress and the administration for allowing it to happen," Stabenow said.
Copyright 2003 The Associated Press.
Government protects drug companies instead of children Homeland Security?
http://www.s-t.com/daily/01-03/01-10-03/a15op079.htm
I am writing in regards to the Autism article printed on Sat. Jan. 4, "Family blames vaccine additive for son's autism." For two years now our family has been trying to answer the horrific question: "Did Thimerosal ( mercury-based vaccine preservative) in vaccines play a key role in our child's autism?" After spending countless days reading literature on this topic, attending numerous conferences, having heated debates with five different pediatricians, visiting specialists of all sorts, and reading the transcripts of the Congressional Hearings on Autism, our question was finally answered by the Homeland Security Bill. Not in my wildest dreams (or nightmares) would I have guessed that the bill introduced to create a Cabinet-level Homeland Security Department to safeguard our nation against future acts of terrorism would include language that would answer our question.
So the pharmaceutical companies wanted liability protection before proceeding with their investment in producing anti-terrorism vaccines such as small pox or anthrax. So our government finds it ethical to grant them permission to produce unsafe vaccines with scary side effects, rather than ask them to pursue a safer version (a topic for a different day), why then provide the liability protection retroactively? What anti-terrorism vaccine did you receive in the past? None! The carefully chosen loose wording was intentional to limit lawsuits on drugs such as Thimerosol. I thought this bill was about restructuring our government to better safeguard our homeland, but I guess I have a lot to learn about politics.
The millions of dollars spent to lobby this last minute language only tells me one thing.that the nightmare I have been trying to figure out for two years is true.Thimerosal is indeed unsafe, so much in fact that its manufacturer, Eli Lilly, sought liability protection against the autism related class-action lawsuits. I guess Thimerosal did in fact play a key role in our child's autism! After all Thimerosal's active ingredient is ethylmercury which has not been well-studied by any governmental agency. The FDA's Center for Biologics Evaluation & Research has calculated that six month old infants receiving all scheduled vaccine doses would receive a total of 187.5 micrograms of mercury. Compare that to the 17 micrograms of mercury found in a 6 ounce can of tuna, which we have been warned not to eat. Not to mention that the 187.5 micrograms exceeds the suggested safe limits set by the EPA.
But don't worry, our governmental agencies have "recommended" that Thimerosal be removed from the vaccines. Demanding such a removal would not be feasible to the manufacturers as stated by the FDA at the recent Congressional Hearings on Autism televised 12/14/02.. Yes, a parent can request Thimerosal free vaccines from the pediatrician, but request to read the insert listing the ingredients yourself as mercury is still present today in multi-dose vaccines. Also watch for the adult boosters such as tetanus and flu, which also contain Thimerosal.
So please next time you hear that Thimerosal in vaccines do not cause autism or other developmental disabilities, think again. The FDA representative was not able to make that statement during the recent Congressional Hearings on Autism, so who can? Dr. Martha Herbert hit the nail on the head in last Saturday's article when she said that the problem is more a function of inadequate study than hard proof. The Institute of Medicine on Oct. 1, 2001 stated that "existing epidemiological evidence is inadequate to either accept or reject a causal relationship between exposure to thimerosal from vaccines and the neurodevelopmental disorders of autism, Attention Deficit Hyperactivity Disorder (ADHD) and speech or language delay." So they don't know based on the studies to date, however the public is continually fed the following verbiage."no link between vaccines and autism."
Why not recall the mercury- filled vaccines to be on the safe side. It would be an admission of guilt as stated by Dr. Herbert. Well they surely admitted their guilt through the Homeland Security Bill. Unfortunately Thimerosal is not yet fully removed from public use. It's sad to know that our government prefers to protect pharmaceutical companies rather than our children.
Gloria Bancroft
Dartmouth
Thomas P. Wyman
Lilly vaccine issue will get front-door hearing it deserves
http://www.indystar.com/print/articles/5/015415-9055-031.html
January 14, 2003
"Look, Ma, no hands!" As soon as you hear those words, you can bet what happens next is going to look ugly.
Ask Eli Lilly and Co.
Two months ago, a measure protecting Lilly from vaccine-related lawsuits turned up in a very unlikely place -- attached to the Homeland Security Act. Lilly professed surprise and said it had no hand in the matter. Lilly wasn't steering the measure, the company says. Just going along for the ride. Indeed, diligent searching turned up no identifiable Lilly fingerprints. But, predictably, this careening ride through the halls of Congress has ended in a noisy crash.
On Friday, Senate Republicans agreed to repeal the Lilly lawsuit protection measure. The House quickly pledged to follow suit. For nearly a year's lobbying, Lilly has come away with little more than a public relations black eye.The White House and Congress drew up the Homeland Security Act to guard the nation against terrorists, not trial lawyers.
But must-pass legislation like this is particularly tempting to lobbyists. Get your pet measure attached to it, and it will pass into law. Nobody will dare vote no, or cast a veto, against critical legislation just to dunk a
pesky rider.
What tempted Lilly was the prospect of shielding itself from lawsuits involving thimerosal, a vaccine preservative that contains mercury. Lilly no longer makes thimerosal. Scores of parents of autistic children blame their kids' autism on thimerosal, and are suing. Lilly says the lawsuits are groundless.
Research on the question so far is inconclusive.
Last fall, Lilly spokesman Edward Sagebiel said Monday, Lilly asked Congress to add thimerosal lawsuit protection to the Homeland Security bill. Lilly got the door slammed in its face. No way, the word came back. Congressional leaders wanted a clean bill -- one not burdened with lots of special favors.
At that point, Sagebiel says, "We stopped our lobbying efforts." But when the measure emerged from Congress, lo and behold, there was the lawsuit protection. There was no lack of suspects, including maybe some unidentified Capitol Hill ally of White House budget maestro Mitch Daniels, a former Lilly executive.
All denied involvement.
But Lilly nevertheless appeared to have benefited from someone's cynical manipulation of critical national security legislation. In a statement released Friday, Lilly said it "agrees that the process by which this legislation was enacted was not desirable, and fully understands the action taken by the Senate."The legislative sleight-of-hand that slipped the lawsuit shield into the Homeland Security Act didn't just put egg on Lilly's corporate face. It also heightened the suspicions of those parents who are suing.
And it's handed ammunition, at least in a public relations sense, to their attorneys. Lilly's not giving up, though. It plans to pursue identical legislation this spring, Sagebiel says.In that effort, the company has powerful political allies. The list includes Senate Majority Leader William Frist, a medical doctor who favors the lawsuit shield.
And that's the way to go about it. As a piece of separate legislation. Debated on its merits, in full public view.
Contact Thomas P. Wyman at 1-317-444-6424 or via e-mail at
thomas.wyman@indystar.com
Marketers' observations of doctor visits trouble psychiatric group
http://forums.delphiforums.com/medical/messages?msg=35514.1
- Some doctors are letting drug company sales representatives sit in while they treat patients - a practice called "shadowing" that is being questioned by at least one professional group.
An organization of psychiatrists says it intends to ask the American Medical Association to review the ethics of the practice. Sales reps have been known to sit in doctors' offices and examining rooms and observe routine checkups, various treatments and diagnostic tests, even child psychiatric therapy. Some doctors are paid hundreds of dollars in return. Some, if not all, of the pharmaceutical companies require the doctors to obtain the patient's consent.
The companies say these preceptorship programs, as they are formally known, are purely educational, allowing sales reps to learn more about doctors' jobs and better serve physicians who use their products. But critics see the efforts as an unethical marketing attempt that violates the privacy of the doctor-patient relationship.
It is unclear how widespread the practice is, but the players include major pharmaceutical companies like Eli Lilly and Co. Lilly spokesman Ed Sagebiel said the practice began at Lilly at least five years ago and involves doctors of many types around the country. Sagebiel said Lilly's reps are told just to observe, not participate. Lilly's policy says participating doctors must obtain patient consent.
But critics say confidentiality and consent are especially problematic when psychiatric patients and children are involved. Some question whether parents can adequately represent their children's wishes. The American Academy of Child and Adolescent Psychiatry plans to raise the issue at the AMA's annual meeting in June in Chicago. Dr. David Fassler, a Vermont psychiatrist and member of the academy's governing council, said he wants the AMA to come out against the practice unless patients have "full knowledge and informed consent."
"It seems quite inappropriate to have non-clinical personnel present during therapy sessions," Fassler said in an interview this week. "I'm also concerned that patients may not always feel free to say no when asked by their doctor if something like this would be OK." The AMA does not have policy on shadowing, but one is needed - especially if doctors are being paid, said Dr. J. Edward Hill, chairman of the AMA Board of Trustees. "I would be extremely concerned about that being unethical behavior," he said. He added: "We don't want anybody interfering with the patient-physician relationship, whether it's a pharmaceutical representative or anybody. That's such a sacred trust."
While the extravagant freebies that drug companies have lavished on doctors have come under increased scrutiny in recent years, the industry's presence in examining rooms is less well-known. But some recent cases have raised concern among doctors and prompted calls for an end to the practice.
In one of those cases, a Lilly sales rep in Maryland sat in on a psychiatric therapy session involving children.
In another case, Parke-Davis, now part of Pfizer Inc., is accused of illegally marketing the epilepsy drug Neurontin for unapproved uses through tactics that included sitting in on patient visits. The allegations were contained in a whistle-blower lawsuit filed last year in Boston. The case has prompted an investigation into Parke-Davis' marketing practices in 47 states.
David Waterbury, an assistant attorney general in Washington state who is overseeing the Parke-Davis probe, said that even if sales reps are not overtly marketing, their presence would probably make a doctor reluctant to recommend another company's drug to a patient.
"If the person's there from 'X' company, is the doctor going to have a lot of discussions about the virtues of 'Y' company's drug? I think not," Waterbury said. Lilly pays doctors $250 for one half-day session or $500 for allowing a sales rep to accompany a doctor all day, Sagebiel said. Doctors may be paid directly or their fee can be donated in the physician's name to a medical school or a charity, he said.
Sagebiel said paying doctors is appropriate because they are providing a valuable service. "It helps the reps have a hands-on observation to the challenges of a physician and helps them to be a better partner," he said. Dr. Bill Arnold, an Indianapolis psychiatrist, said he has been paid to take part in several such programs involving Lilly and others. He defended the practice as a way to give sales reps exposure to medicine the way it is practiced.
"They've heard about schizophrenia and heard about Alzheimer's; here it is - live," Arnold said. "They're going to market their products anyway, so instead of them trying to beat down my door, why not have them learn about what the market's really like?" Arnold said the money is minimal given the amount of time shadowing takes away from his practice: "It's not a lucrative thing to do at all."
A Pfizer spokesman declined to comment on the Neurontin case.
http://www.house.gov/rules/omni12.pdf
On 2/14/03 The Omnibus Appropriations Bill passed. It completely repealed the thimerosal protection rider that was in the Homeland Security Act. Here is the language that was drafted as a compromise between Snowe, Collins, Chafee and Frist:
DIVISION L- HOMELAND SECURITY ACT OF 2002 AMENDMENTS
SEC. 102.NON-PREJUCIAL REPEAL OF SECTIONS 1714 THROUGH 1717 OF THE HOMELAND
SECURITY ACT OF 2002. (a) REPEAL. - In accordance with subsection (c), sections 1714 through 1717 of the Homeland Security Act of 2002 (Public Law 107-296) are repealed.
(b) APPLICATION OF THE PUBLIC HEALTH SERVICE ACT. - The Public Health Service Act (42 U.S.C. 201 et seq) shall be applied and administered as if the sections repealed by subsection (a) had never been enacted.
(c) RULE OF CONSTRUCTION.- No inference shall be drawn from the enactment of sections 1714 through 1717 of the Homeland Security Act of 2002 (Public Law 107-295), or from this repeal, regarding the law prior to enactment of sections 1714 through 1717 of the Homeland Security Act of 2002. Further, no inference shall be drawn that subsection (a) or (b) affects any change in that prior law, or that Leroy v Secretary of Health and Human Services, Office of Special Master, No. 02-392V (October 11, 2002), was incorrectly decided.
(d) SENSE OF CONGRESS. -It is the sense of Congress that-
(1) the Nation's ability to produce and develop new and effective vaccines faces significant challenges, and important steps are needed to revitalize our immunization efforts in order to ensure an adequate supply of vaccines and to encourage the development of new vaccines;
(2) these steps include ensuring that patients who have suffered vaccine-related injuries have the opportunity to seek fair and timely redress, and that vaccine manufacturers, manufacturers of components or ingredients of vaccines, and physicians and other administrators of vaccines have adequate protections;
(3) prompt action is particularly critical given that vaccines are a front line of defense against common childhood and adult diseases, as well as against current and future biological threats; and
(4) not later than 6 months after the date of enactment of this Act, the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives should report a bill addressing the issues described in paragraphs (1) through (3).
Kathi Williams
Director and Co-founder
National Vaccine Information Center
421-E Church Street
Vienna, VA 22180
703-938-0342
www.909shot.com
AIDS activists wary of Tobias selection
- July 5, 2003 11:23am
Randall Tobias' nomination Wednesday as President Bush's global AIDS czar drew praise from congressional leaders but criticism from the world AIDS community, whose activists question the former Eli Lilly and Co. CEO's allegiances -- and his knowledge of public health.
Many see Tobias as a representative of the pharmaceutical industry, which, they say, has blocked access to affordable, generic AIDS drugs by patients in developing countries. Such countries represented 95 percent of the 42 million adults and children who were living with HIV and AIDS at the end of 2002, according to the World Health Organization.
"It demonstrates incredible lack of tact and respect for people with HIV living in the developing world who frequently cannot access life-saving medicines," said Nathan Geffen, national manager for Treatment Action Campaign in South Africa, where an estimated 5 million people have HIV or AIDS.
"He's certainly not someone who's known for being at the forefront of AIDS."
But President Bush said Tobias is the right man for the job.
"I have chosen a superb leader who knows a great deal about lifesaving medicines and who knows how to get results," Bush said at a White House news conference introducing his nominee.
If confirmed, Tobias will head an AIDS plan that will provide $15 billion during the next five years to fight the disease, primarily in 14 African and Caribbean countries. Among his duties will be to establish a network to get medications to the farthest reaches of Africa and help train health professionals so they can treat patients with HIV and AIDS, Bush said.
Tobias would carry the rank of ambassador and report to Secretary of State Colin Powell.
Tracy Elliott, executive director of Indianapolis' Damien Center, said Tobias' business acumen could be more of an asset than a public health background would be in the role.
"I think it's sort of inspired, actually,' Elliott said of Tobias' nomination. "It's a more inspired choice than the typical retired professor."
Because Tobias would work through the State Department with the status of ambassador, he would have more access to governments, some of which have made AIDS assistance difficult, Elliott said.
"And if they don't deal with that, it's just throwing money at a rat hole," Elliott said.
A spokeswoman said Tobias would have no comment on his nomination until the process is complete.
Tobias, 61, is from Remington and was chairman and chief executive officer of Lilly from 1993 to 1998. He would be one of at least a half-dozen Hoosiers to hold prominent positions with the Bush administration.
His nomination must first go to the Senate Foreign Relations Committee, chaired by Sen. Richard Lugar, R-Ind., before proceeding to the full Senate for confirmation.
Lugar was at a conference in Helsinki, Finland, and was unavailable Wednesday, but his spokesman, Nick Webber, praised the Tobias nomination.
"It's exciting for Hoosiers, particularly," he said.
Sen. Evan Bayh, D-Ind., agreed.
"Randy is an outstanding individual with a big heart," Bayh said. "He is also a skilled manager, and I'm confident he'll do a good job at addressing the significant challenge." But Amanda Lugg, community advocate with The African Services Committee in New York, said the buzz among AIDS activists in the first hours after Tobias' nomination was largely negative. "What makes us really nervous . . . is that he's the retired CEO of a pharmaceutical giant," she said. "I would see that as a conflict of interest."
She also noted Tobias' strong Republican ties. Since 1999, Tobias and his wife, Marianne, have contributed $6,000 to Lugar, $7,000 to Bush, $42,500 to state and national Republican political action committees and thousands more to other Republican candidates, according to the Center for Responsive Politics. Sharonann Lynch, an activist with the New York-based Health GAP (Global Access Project), also was critical of Tobias and what the nomination says about Bush. "Why this person? He's so far removed from the reality of people living with AIDS," she said. Lynch said she and others will push senators to ask Tobias pointed questions during the confirmation process.
Not all of the negative reaction came from AIDS activists. The Family Research Council, generally considered to be at the conservative end of the political spectrum, expressed concerns that Tobias would not follow what it called the "pro-family" spirit of Bush's AIDS bill.
"We are concerned that Mr. Tobias does not have a proven track record of supporting the effective strategies to combat AIDS," Connie Mackey, vice president of the organization, said in a written statement issued in Washington. Mackey's group fears Tobias would not emphasize abstinence-based messages or support the belief that condoms should be distributed as a last resort. But Geffen, the South African activist, said there are concerns that Tobias will set out to "promote Bush's Christian fundamentalism," with an abstinence-only message siphoning money from groups that promote condom use.
"It's got the potential to be quite detrimental," he said.
At a glance
Presidential pick: President Bush named Randall Tobias to direct a $15 billion AIDS program that will involve coordinating the administration's international AIDS/HIV activities.
Still to come: The Senate must confirm Tobias, who would carry the rank of ambassador.
Hoosiers in D.C. Hoosiers with prominent roles in Washington:
Deborah J. Daniels
Former deputy prosecutor and chief counsel under Mayor Stephen Goldsmith. Now assistant attorney general for the office of justice programs.
James R. Moseley
Tippecanoe County farmer served as assistant secretary for natural resources in the first Bush administration. Now serves as deputy secretary of agriculture.
Vicky Lynn Anderson Bailey
Indianapolis native is former president of PSI Energy and served on the Indiana Utility Regulatory Commission from 1986 to 1993. Now assistant secretary of energy for policy and international affairs.
Ellen Gayle Engleman
Indiana native has served as president and chief executive officer of Electricore, a nonprofit research and development consortium. Now administrator of the research and special programs administration in the U.S. Department of Transportation.
James T. Morris
Former Indianapolis Water Co. chief executive officer, aide to Sen. Richard Lugar and Lilly Endowment president. Now executive director of the United Nations' World Food Program.
Recent departures:
Mitch Daniels
Recently resigned as director of the Office of Management and Budget; is running for governor of Indiana.
Carol D'Amico
Indiana University graduate recently resigned after serving two years as assistant secretary for vocational and adult education.
AIDS facts and figures
Of the 42 million adults and children living with HIV and AIDS at the end of 2002, 95 percent were in developing countries.
Most in Africa: 70 percent of those with HIV and AIDS lived in sub-Saharan Africa.
Spread continues: In 2002, an estimated 5 million people were newly infected with HIV, and 3.1 million died of AIDS.
Young victims: 610,000 children under 15 died of AIDS in 2002.
Sources: World Health Organization; U.S. Centers for Disease Control and Prevention
The Associated Press and Gannett News Service contributed to this report.
Call Star reporter Diana Penner at 1-317-444-6249.
Copyright © 2003 The Indianapolis Star
THE PAYBACK PRESIDENT: After the oil companies, it's the turn of the drugs
cartel
Big business helped get George W Bush elected. His campaign chest was the largest ever garnered by any presidential candidate - and his entire presidency ever since has been about paying back his benefactors. The oil giants have enjoyed access to remote areas previously protected by environmental agencies, and they finally got their pipes into Afghanistan once that had been invaded. Companies offering infrastructure support and services have been enjoying unprecedented revenues from the rebuilding of Iraq.
Now, with just months left of his presidency, George is making sure the drug companies get their snouts in the trough (a not unusual position for them). Of course, when big business is given a presidential mandate to push for bigger profits, people can get hurt. In Iraq it was the soldiers and the innocent civilians of Iraq. So, to give a helping hand to the pharma cartel, every citizen in the USA, including toddlers, is in George's sights. The great thing about George is that he's wonderful at window dressing. The Patriot Act was a triumphal name for a nasty piece of legislation. And now we have the New Freedom initiative.
Under the initiative, every citizen of virtually every age, including preschool children, is to be screened for mental illness. Schools will be used as the screening centres for the 52 million kids and 6 million teachers who attend them. The model for the New Freedom initiative is the TMAP, which stands for the Texas Medication Algorithm Project - that's right, the state that George used to govern, a project that first saw the light of day during his time in office there.
TMAP promotes the use of the new, and more expensive, antidepressants and antipsychotic drugs, such as Zyprexa (olanzapine), which is Eli Lilly's best selling drug. It grossed $4.28bn in 2003, with 70 per cent of the revenues paid for by government agencies such as Medicare and Medicaid. Needless to say there's a link between Eli Lilly and the Bush family. George senior has been a board member, while George junior appointed Lilly's chief executive to a seat on the Homeland Security Council. Lilly made a contribution of $1.6m to the Bush campaign in 2000, and donations have already reached $700,000 for the current campaign. It's got to be the best investment they have ever made.
(Source: British Medical Journal, 2004; 328: 1458).
http://www.laleva.org/eng/2004/05/the_pharmaceutical_business_with_desease_e
li_lilly_zyprexa_and_the_bush_family.html
Big Pharma
ELI LILLY, ZYPREXA & THE BUSH FAMILY
The diseasing of our malaise
By Bruce Levine
More than one journalist has uncovered corrupt connections between the Bush Family, psychiatry, and Eli Lilly & Company, the giant pharmaceutical corporation. While previous Lillygates have been more colorful, Lilly’s soaking state Medicaid programs with Zyprexa—its blockbuster, antipsychotic drug—may pack the greatest financial wallop. Worldwide in 2003, Zyprexa grossed $4.28 billion, accounting for slightly more than one-third of Lilly’s total sales. In the United States in 2003, Zyprexa grossed $2.63 billion, 70 percent of that attributable to government agencies, mostly Medicaid. Historically, the exposure of any single Lilly machination—though sometimes disrupting it—has not weakened the Bush-psychiatry-Lilly relationship. In the last decade, some of the more widely reported Eli Lilly intrigues include:
• Influencing the Homeland Security Act to protect itself from lawsuits • Accessing confidential patient records for a Prozac sample mailing • Rigging the Wesbecker Prozac-violence trial
A sample of those who have been on the Eli Lilly payroll includes:
• Former President George Herbert Walker Bush (one-time member of the Eli Lilly board of directors)
• Former CEO of Enron, Ken Lay (one-time member of the Eli Lilly board of directors) • George W. Bush’s former director of Management and Budget, Mitch Daniels (a former Eli Lilly vice president)
• George W. Bush’s Homeland Security Advisory Council member, Sidney Taurel (current CEO of Eli Lilly)
• The National Alliance for the Mentally Ill (a recipient of Eli Lillyfunding)
In 2002, British and Japanese regulatory agencies warned that Zyprexa may be linked to diabetes, but even after the FDA issued a similar warning in 2003, Lilly’s Zyprexa train was not derailed, as Zyprexa posted a 16 percent gain over 2002. The growth of Zyprexa has become especially vital to Lilly because Prozac—Lilly’s best-known product, which once annually grossed over $2 billion—having lost its patent protection, continues its rapid decline, down to $645.1 million in 2003.
At the same time regulatory agencies were warning of Zyprexa’s possible linkage to diabetes, Lilly’s second most lucrative product line was its diabetes treatment drugs (including Actos, Humulin, and Humalog), which collectively grossed $2.51 billion in 2003. Lilly’s profits on diabetes drugs and the possible linkage between diabetes and Zyprexa is not, however, the most recent Lillygate that Gardiner Harris broke about Zyprexa in the New York Times on December 18, 2003.
Zyprexa costs approximately twice as much as similar drugs and Harris reported that state Medicaid programs—going in the red in part because of Zyprexa— are attempting to exclude it in favor of similar, less expensive drugs. Harris focused on the Kentucky Medicaid program, which had a $230 million deficit in 2002, with Zyprexa being its single largest drug expense at $36 million. When Kentucky’s Medicaid program attempted to exclude it from its list of preferred medications, the National Alliance for the Mentally Ill (NAMI) fought back. The nonprofit NAMI—ostensibly a consumer organization—bused protesters to hearings, placed full-page ads in newspapers, and sent faxes to state officials. What NAMI did not say at the time was that the buses, ads, and faxes were paid for by Eli Lilly.
Ken Silverstein, in Mother Jones in 1999, reported that NAMI took $11.7 million from drug companies over a three and a half year period from 1996 through 1999, with the largest donor being Eli Lilly, which provided $2.87 million. Eli Lilly’s funding also included loaning NAMI a Lilly executive, who worked at NAMI headquarters, but whose salary was paid for by Lilly. Though NAMI’s linkage to Lilly is a scandal to psychiatric survivors—whose journal MindFreedom published copies of Big Pharma checks to NAMI—the story didn’t have the widespread shock value that would elevate it to Lillygate status.
In 2002, Eli Lilly flexed its muscles at the highest level of the U.S. government in an audacious Lillygate. The event was the signing of the Homeland Security Act, praised by President George W. Bush as a “heroic action” that demonstrated “the resolve of this great nation to defend our freedom, our security and our way of life.” Soon after the Act was signed, New York Times columnist Bob Herbert discovered what had been slipped into the Act at the last minute and on November 25, 2002, he wrote, “Buried in this massive bill, snuck into it in the dark of night by persons unknown…was a provision that—incredibly—will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their
children were harmed by thimerosal.”
Thimerosal is a preservative that contains mercury and is used by Eli Lilly and others in vaccines. In 1999 the American Academy of Pediatrics and the Public Health Service urged vaccine makers to stop using mercury-based preservatives. In 2001 the Institute of Medicine concluded that the link between autism and thimerosal was “biologically plausible.” By 2002, thim-erosal lawsuits against Eli Lilly were progressing through the courts. The punchline of this Lillygate is that, in June 2002, President George W. Bush had appointed Eli Lilly’s CEO, Sidney Taurel, to a seat on his Homeland Security Advisory Council. Ultimately, even some Republican senators became embarrassed by this Lillygate and, by early 2003, moderate Republicans and Democrats agreed to repeal this particular provision in the Homeland Security Act.
In early 2003, “60 Minutes II” aired a segment on Lillygate and Prozac. With Prozac’s patent having run out, Eli Lilly began marketing a new drug, Prozac Weekly. Lilly sales representatives in Florida gained access to
“confidential” patient information records and, unsolicited, mailed out free samples of Prozac Weekly. How did Eli Lilly get its hands on these medical records? Regulations proposed under Clinton and later implemented under Bush contained a provision that gave health-care providers the right to sell a person’s confidential medical information to marketing firms and drug companies. Despite many protests against this proposal, President Bush told Health and Human Services Secretary Tommy Thompson to allow the new rules to go into effect.
Perhps the most cinematic of all Lillygates culminated in 1997. The story began in 1989 when Joseph Wesbecker—one month after he began taking Prozac—opened fire with his AK-47 at his former place of employment, killing 8 and wounding 12 before taking his own life. British journalist John Cornwell covered the Louisville, Kentucky trial for the London Sunday Times Magazine, ultimately writing a book about it. Cornwell’s The Power to Harm (1996) is not only about a disgruntled employee becoming violent after taking Prozac, but is also about Eli Lilly’s power to corrupt the judicial system.
Victims of Joseph Wesbecker sued Eli Lilly, claiming that Prozac had pushed Wesbecker over the edge. The trial took place in 1994, but received scant attention as the public was transfixed by the O.J. Simpson spectacle. While Eli Lilly had been settling many Prozac violence cases behind closed doors (more than 150 Prozac lawsuits had been filed by the end of 1994), it was looking for a showcase trial that it could win. Although a 1991 FDA “blue ribbon panel” investigating the association between Prozac and violence had
voted not to require Prozac to have a violence warning label, by 1994 word was getting around that five of the nine FDA panel doctors had ties to Big Pharma—two of them serving as lead investigators for Lilly-funded Prozac studies. Thus, with the FDA panel now known to be tainted, Lilly believed that Wesbecker’s history was such that Prozac would not be seen as the cause of his mayhem.
A crucial component of the victims’ attorneys’ strategy was for the jury to hear about Eli Lilly’s history of reckless disregard. Victims’ attorneys especially wanted the jury to hear about Lilly’s anti- inflamatory drug
Oraflex, introduced in 1982 but taken off the market three months later. A U.S. Justice Department investigation linked Oraflex to the deaths of more than 100 patients and concluded that Lilly had misled the FDA. Lilly was charged with 25 counts related to mislabeling side effects and pled guilty—but in 1985, the Reagan-Bush Justice Department saw fit to fine them a mere $25,000.
In the Wesbecker trial, Lilly attorneys argued that the Oraflex information would be prejudicial and Judge John Potter initially agreed that the jury shouldn’t hear it. However, when Lilly attorneys used witnesses to make a case for Eli Lilly’s superb system of collecting and analyzing side effects, Judge Potter said that Lilly had opened the door to evidence to the contrary and ruled that the Oraflex information would now be permitted. To Judge Potter’s amazement, victims’ attorneys never presented the Oraflex evidence and Eli Lilly won the case. Later, it was discovered that—in a manipulation Cornwell described as “unprecedented in any Western court”—Eli Lilly cut a secret deal with victims’ attorneys to pay them and their clients not to introduce the Oraflex evidence. However, Judge Potter smelled a rat and fought for an investigation. In 1997, Eli Lilly quietly agreed to the verdict being changed from a Lilly victory to “dismissed as settled.”
Looking back further to 1992, Alexander Cockburn, in both the Nation and the New Statesman, was one of the first to connect the dots between the Bush family and Eli Lilly. After George Herbert Walker Bush left his CIA director post in 1977 and before becoming vice president under Ronald Reagan in 1980, he was on Eli Lilly’s board of directors. As vice president, Bush failed to disclose his Lilly stock and lobbied hard on
behalf of Big Pharma—especially Eli Lilly . For example, Bush sought special tax breaks from the IRS for Lilly and other pharmaceutical corporations that were manufacturing in Puerto Rico.
Cockburn also reported on Mitch Daniels, then a vice president at Eli Lilly, who in 1991 co-chaired a fundraiser that collected $600,000 for the Bush-Quayle campaign. This is the same Mitch Daniels who in 2001 became George W. Bush’s Director of Management and Budget. In June 2003, soon after Daniels departed from that job, he ran for governor of Indiana (home to Eli Lilly headquarters). In a piece in the Washington Post called “Delusional on the Deficit,” Senator Ernest Hollings wrote, “When Daniels left two weeks ago to run for governor of Indiana, he told the Post that the government is ‘fiscally in fine shape.’ Good grief! During his 29-month tenure, he turned a so-called $5.6 trillion, 10-year budget surplus into a
$4 trillion deficit—a mere $10 trillion downswing in just two years. If this is good fiscal policy, thank heavens Daniels is gone.”
There is one Eli Lilly piece of history so bizarre that if told to many psychiatrists, one just might get diagnosed as paranoid schizophrenic and medicated with Zyrprexa. Former State Department officer John Marks in The Search for the “Manchurian Candidate”: The CIA and Mind Control, The Secret History of the Behavioral Sciences (1979)—along with the Washington Post (1985) and the New York Times (1988)—reported an amazing story about the CIA and psychiatry. A lead player was psychiatrist D. Ewen Cameron,
president of the American Psychiatric Association in 1953. Cameron was curious to discover more powerful ways to break down patient resistance. Using electroshock, LSD, and sensory deprivation, he was able to produce severe delirium. Patients often lost their sense of identity, forgetting their own names and even how to eat. The CIA, eager to learn more about Cameron’s brainwashing techniques, funded him under a project code-named MKULTRA. According to Marks, Cameron was part of a small army of the CIA’s LSD-experimenting psychiatrists. Where did the CIA get its LSD? Marks reports that the CIA had been previously supplied by the Swiss pharmaceutical corporation Sandoz, but was uncomfortable relying on a
foreign company and so, in 1953, the CIA asked Eli Lilly to make them up a batch of LSD, which Lilly subsequently donated to the CIA.
The most important story about Eli Lilly is that Lilly’s two current blockbuster psychiatric drugs—Zyprexa and Prozac—are, in scientific terms, of little value. It is also about how Lilly and the rest of Big Pharma have
corrupted psychiatry, resulting in the increasing medicalization of unhappiness. This diseasing of our malaise has diverted us from examining the social sources for our unhappiness—and implementing societal solutions.
Much of the scientific community now acknowledges that the advantage of Prozac and Prozac-like drugs over a sugar-pill placebo is slight—or as Prevention and Treatment in 2002 defined it, “clinically negligible.” When Prozac is compared to an active placebo (one with side effects), then Prozac is shown to have, in scientific terms, zero value. Moreover, many doctors and researchers now warn us about the dangers of Prozac. Psychiatrist Joseph Glenmullen’s Prozac Backlash (2000) documented “neurological disorders including disfiguring facial and whole body tics indicating potential brain damage...agitation, muscle spasms, and parkinsonism,” and he stated that debilitating withdrawal occurs in 50 percent of patients who abruptly come off Prozac and Prozac-like drugs.
Just as Prozac and other SSRI drugs are no longer seen by many scientists as an improvement in safety and effectiveness over the previous class of antidepressants, psychiatry’s highly touted Zyprexa (and other “atypical antipsychotics”) turns out to be no great advance over the older problematic anti-ps ychotics such as Haldol. Journalist Robert Whitaker, in Mad in America (2002), details how Eli Lilly’s Zyprexa research was biased against the inexpensive Haldol and how claims of improved safety of Zyprexa are difficult to justify. Whitaker reports that in drug trials used by FDA reviewers, 22 percent of Zyprexa patients had “serious” adverse effects as compared to 18 percent of the Haldol patients.
The United States and other nations that have bought psychiatry’s and Big Pharma’s explanations and treatments turn out to have worse results with those diagnosed as psychotic than those nations who are less enthusiastic about drugs and who care more about community. In 1992, the World Health Organization (WHO), in a repeat of earlier findings, found that so-called underdeveloped nations, which emphasize community support rather than medications, have better results with those diagnosed as psychotic than nations, which stress drug treatments. In nations such as the United States, where 61 percent of those diagnosed as psychotic were maintained on antipsychotic medications, only 37 percent had full remission. While in India, Nigeria, and Colombia, where only 16 percent of patients diagnosed
as psychotic were maintained on antipsychotic medications, approximately 63 percent of patients had full remission.
While scientists are not certain about the reasons for these WHO findings, two possible explanations are: (1) psychiatric drugs, even for the most disturbed among us, are not the greatest long-term solution; (2) community support, crucial to our mental health, does not lend itself to commercialization. Thus, in areas such as mental health, radically commercialized societies such as the United States are backward societies.
Though some mental health professionals insist that atypical antipsychotics such as Zyprexa are a great advance, I’ve met few Zyprexa users who agree. A few years ago, a well-read man with a professorial manner in his early 60s, diagnosed by several other doctors as paranoid schizophrenic, came to see me. He had, at various times, taken several types of antipsychotic drugs and told me, laughing loudly between each sentence, “I’m crazy on drugs and crazy off drugs. Haldol helped me sleep and Zyprexa helped me
sleep, but I hated the Haldol and when I was on Zyprexa, I couldn’t take a shit for three weeks. Now I don’t take any drugs and I can’t sleep and I am a big pain-in-the ass, but I can remember better what I read.” A few weeks later he told me, “It’s all friendly fascism. Yes, friendly fascism. Was it you who told me—or was it I who told you—that fascism is about the complete integration of industry and government under a centralized authority? Friendly fascism, right? I suppose I say ‘friendly fascism’ too much, but you’re not Ashcroft and neither am I, right? Don’t you agree that it’s all friendly fascism?” Then he flashed a giant smile and said one more time, “Friendly fascism, right, Bruce?”
Bruce E. Levine, PhD, is a psychologist and author of Commonsense Rebellion: Taking Back Your Life from Drugs, Shrinks, Corporations and a World Gone Crazy (New York-London: Continuum, 2003).
TONS more out there
http://www.msnbc.com/news/854647.asp#BODY
KATHY KILPATRICK has to watch her daughter very closely. Six-year-old Mary-Kate is autistic and needs constant supervision. “She’s different and she’s isolated,” says Kilpatrick. “She knows that she’s different.”
Mary-Kate is one of about 90,000 children in America diagnosed with this neurological disorder that impairs her mental and social development. Her parents believe her vaccinations are to blame, specifically a preservative added to them.
“I never once questioned the shots,” says Kilpatrick. “There was never any discussion of any risks involved.” At issue is a vaccine preservative called thimerosal. It contains mercury and was used in child vaccines until 1999. Although a scientific link to autism has never been proven, thousands of parents believe thimerosal is the cause and filed suit against its maker, Eli Lilly. But just days before the homeland security bill was passed this fall, an amendment was slipped in. It was part of a bill written by incoming Senate majority leader Bill Frist, and it closed off the major avenue by which people could sue a vaccine maker for illness.
“What it did to the families is it took away their last option, literally or figuratively closed the door on their last access to the courts of justice,” says Prof. Lawrence Gostin of Georgetown University School of Law.
One of the most powerful members of Congress, outgoing House majority leader Rep. Dick Armey, R-Texas, was behind the amendment and argues that if drug companies weren’t protected, they might refuse to make vaccines, a big worry amid fears of bioterrorism. “I’m proud that I put it in there and I know that it’s going to make America more secure, and that’s why it’s there,” says Armey.
But congressman Dan Burton is among those who are furious. For anybody to say they’re proud for putting that kind of an amendment in there is just beyond me,” says Rep. Burton, R-Ind. Burton’s grandson is autistic. He also chairs the committee that oversaw the bill and says he was blindsided by Dick Armey’s last-minute addition. “Now, he can take sole responsibility for it, that’s his prerogative if he wants to, but that amendment is criminal in my opinion,” says Burton.
Some critics of the amendment point out that drug companies give generously to the Republican party and that some top officials at Eli Lilly have close ties to the White House. Lilly’s chairman, Sidney Taurel, served on the White House advisory council on homeland security. Mitch Daniels, a former top Lilly executive, is now director of the White House office of management and budget. The White House denies any influence. Eli Lilly released a statement reading, “at no point did anyone at Lilly... past or present, ask for this language to be inserted in the homeland security act.”
Some members of Congress from both parties say they’re already trying to undo the effects of the recent legislation to once again give parents the right to sue in court — despite the absence of conclusive evidence to back up the families’ claims. “There’s been no scientific connection made between thimerosal and autism, not in the medical community, not in the scientific community,” says Armey. And for families like the Kilpatricks?
Every night when I go to bed,” says Kathy Kilpatrick, “I think, ‘my God,’ what’s going to happen to this poor baby when I’m gone? She’s going to outlive me by 40 years.” For now, this family and others wait to find out how the next move in vaccine politics might affect the quality of their lives.
Is someone feeling guilty at Eli Lilly?
http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=165437&print=yes
New Scholarship Program to Help Adults Living With ADHD Focus on Their Possibilities
June 8, 2005
Lilly Scholarship Program Provides Winners Help with Tuition Costs
INDIANAPOLIS, June 8, 2005 /PRNewswire-FirstCall via COMTEX/ -- Eli Lilly and Company (NYSE: LLY) today announced the launch of the Focus on Your Possibilities scholarship program, the first and only scholarship program specifically for adults living with attention-deficit/hyperactivity disorder (ADHD). A total of 20 scholarships worth up to $5,000 each will be awarded to United States citizens by an independent panel of experts for the 2005 fall semester -- allowing recipients to continue their education in traditional colleges, graduate schools, technical institutes or General Education Development (GED) courses.
For adults with ADHD, achieving academic success may mean a constant battle with symptoms of the disorder -- such as making careless mistakes, having trouble finishing tasks or having problems remembering appointments or obligations -- that have plagued them throughout their childhoods. Some may never have achieved the advanced degree they desire. These are the individuals Lilly wants to help.
"Far too many bright people with ADHD don't go to college at all or drop out before completing a degree," said Ruth Hughes, mother of a student with ADHD preparing for college and deputy chief executive officer for public policy and community services for Children and Adults with Attention-Deficit Hyperactivity Disorder (CHADD), a nonprofit organization. "Every student with ADHD deserves the opportunity to achieve the highest academic level possible for that individual. These adults have incredible talent and energy. Let's help them use them."
"The Focus on Your Possibilities scholarship program is designed to decrease the financial barriers of achieving the education level that matches the individual's talents, desires and hard work," said Deirdre Connelly, president of Lilly USA. "This scholarship is encouragement for the person with ADHD to achieve what may have seemed impossible -- a high school degree, a college degree, technical expertise or even a graduate degree."
To apply for the scholarship, adults 25 years or older must be:
* diagnosed with ADHD by a physician and currently undergoing treatment;
* enrolled or planning to enroll in an accredited college, university, vocational/technical school or GED program on a full-time basis;
* able to provide examples of significant drive and passion that will enable them to capitalize on their talents through education.
The award recipients will have a demonstrated record of overcoming challenges, and the scholarship program will reward them in their work toward academic success.
Applications for the fall semester are due July 15, 2005, and award recipients will be announced August 5, 2005. For application information, please call 1-800-LillyRx or visit www.ADHD.com .
"This scholarship gives adults with ADHD a second chance to achieve their life goals, and we are excited to play a small role in that," Connelly said.
About ADHD
ADHD affects 3 percent to 7 percent of school-aged children and manifests itself in levels of attention, concentration, activity, distractibility and impulsivity that are inappropriate to the child's age.(1) In addition, 60 percent of children with the disorder carry their symptoms into adulthood.(2) Experts estimate 4 percent of adults in the United States, more than 8 million people, have ADHD.(3,4)
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com . O-LLY
(1) American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, Washington, D.C., American Psychiatric Association, 2000.
(2) Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med Clin of North Am. 2001; 85(3): 757-777.
(3) Murphy K, Barkley, RA. J Atten disord. 1996; 1:147-161.
(4) United States Census Summary File; 2000.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
Jennifer Bunselmeyer of Eli Lilly and Company, +1-317-655-8808
http://www.prnewswire.com
Copyright © 2005 PR Newswire. All rights reserved.
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