http://www.theepochtimes.com/n2/index2.php?option=com_content&task=view&id=30104&pop=1&page=0&Itemid=1
FDA: Conflict of Interest in Vaccine Approval Confirmed
By Michael Mooney
Created: Feb 20, 2010 Last Updated: Feb 20, 2010
A Food and Drug Administration building. (Compliments of the FDA) WEST HOLLYWOOD, Calif.—If you've read my two articles in WeHoNews.com questioning the safety and effectiveness of the swine flu vaccine, you know how I feel about it.
I'd rather take high dose vitamin D to strengthen my immune system so I don't have to worry about getting the flu than get vaccinated with a potentially toxic vaccine. The vaccine was rushed into circulation even after the World Health Organization balked at the lack of confirmed safety data, saying, “With such a large amount of an experimental vaccine that contains mercury being distributed, keeping track of people that experience adverse effects will be difficult.”
What's important to note is that the FDA is once more not doing its job of protecting the public to the standards of modern science. The FDA has seriously compromised its own approval process with dangerous medications. Think Vioxx.
Not only did it dumb down on what possible problems the swine flu vaccine could cause, but it went further by advocated for vaccine manufacturers and promoting the sales of the swine flu vaccine while ignoring safety concerns about solidly documented problems that other countries do not ignore.
For FDA to sell vaccines goes further than the official definition of its role as protecting the public from danger.
A new analysis from Harvard University says that the H1N1 swine flu pandemic has been oversold, agreeing with British and French media that said last month that the H1N1 pandemic has been “hyped” by medical researchers to further their own cause, boost research grants, and line the pockets of drug companies.
Could there be a conflict of interest going on with administrative people at the FDA, the people who decide what drugs are allowed to be put into general distribution for our supposedly safe use?
The answer is yes!
Consider that on Dec. 22, 2009, Julie Louise Gerberding, M.D., M.P.H., announced that she was leaving her job as the director of the Centers for Disease Control (CDC), where she had an active role in promoting vaccine sales. She has been named the president of Merck Vaccines for a salary likely to be 10 times what she made at the CDC.
For years, under the direction of Dr. Gerberding, the CDC has maintained an unbelievable position that Merck’s vaccines are so safe that we don't need to consider any possibility of side effects. She then actively promoted and sold Merck’s vaccines. This goes far beyond her job description at the CDC. So whom was she working for, anyway? Now we know.
We can ask the question, really, how can we indict her? What has she already done for her new employer while she was the deciding factor at the CDC?
When a 14-year-old girl named Jessica died following a cervical cancer vaccine injection made by Merck, Dr. Gerberding's CDC removed the onus from Merck by stating that the girl’s death was caused by her use of birth control pills. Poppycock!
Although I doubt it’ll ever happen, there's a solution to all this, of course: Pass a law that bans employees of the CDC, FDA, FTC, EPA, or USDA from ever working for the companies they regulate.
The administrators of government agencies that protect the people should not be allowed to go to work at the same companies they regulated and may regulate again. One study showed that 52 percent of FDA administrators go to and from drug company jobs in a true revolving-door, bedroom partnership.
Underline this relationship by looking on YOUTUBE for “Genetic Foods/Monsanto Revealed 3/3” and see how lawyer Michael Taylor quit his $300,000-a-year job working for Monsanto, where he wrote the paperwork to seek FDA approval for Bovine Growth Hormone (BGH), and then two years later went to work for $75,000 a year at FDA, where he approved his own BGH paperwork as senior advisor to the commissioner of the FDA.
In cases in which this role exchange has been reversed, people go to jobs that pay many times what they earned working for the U.S. government as public servants. They've been bought and sold.
When there is any risk of conflict of interest, which we have seen over and over again in recent years in the FDA, FTC, and CDC, it's more logical to bet that corruption will occur, as that it won't. History shows that this is the case the majority of the time when money this big is in play.
Indeed, the lack of regulation of this kind of conflict of interest has allowed our government agencies to effectively become marketing arms for the pharmaceutical industry. Can this be changed?
I wish I had a better answer, but the answer is more than likely, it'll just remain the status quo.
Michael Mooney writes on health issues, focusing on research and access. WeHo News.
Source: www.theoneclickgroup.co.uk
http://www.newstarget.com/021746.html
This is what the FDA thinks is important[Reuters and the NY Times provides the bulk of the information for the following report.]
www.reutershealth.com/archive/2002/10/17/eline/links/20021017elin033.html
The US Food and Drug Administration said on Thursday it had ordered the seizure of hundreds of bottles of a dietary supplement that the agency said falsely claimed to treat autism. US marshals raided Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories, and took away bottles of Kirkman's HypoAllergenic Taurine Capsules, the agency said. "FDA seized these products because they violate the Federal Food, Drug and Cosmetic Act," the agency said in a statement. "In accordance with the Act, all dietary supplement products' labeling must be truthful and not misleading and may not make any claims that the product will cure, mitigate, treat, or prevent disease." The FDA did admit in their statement that "to date no illnesses have been reported in association with consumption of this product." The FDA actions are apparently not in response to consumer complaints.
FDA will continue to identify and take appropriate enforcement actions against fraudulently marketed dietary supplement products that make unsubstantiated medical claims in their labeling. "Consequently, the claims that the capsules treat autism caused the firm's product to be a misbranded food and an unapproved new drug." Apparently, the offending assertion comes from a description of Taurine in Kirkman's catalogue that includes the following: "Dr. Jeff Bradstreet, a physician in Palm Bay, Florida who treats autistic patients reports good success in treating autism with Taurine."
The FDA said it tracked down the company from its Internet site. In a reprint of an article that appeared in this newsletter just last Tuesday, "Stung by Courts, F.D.A. Rethinks Its Rules", the NY Times reported on the FDA's controversial practices like the raid on Kirkman's: "After losing a series of court decisions that found it in violation of the First Amendment's guarantee of freedom of speech, the Food and Drug Administration has begun a wide-ranging review of regulations that control what the makers of drugs, supplements, food and cosmetics can say about their products.
"At issue is the delicate balance between a company's right to communicate with its customers and the food and drug agency's mandate to protect the public. "But the court decisions, which included a stinging rebuke from the Supreme Court in April, have prompted the agency to ask whether it may, at times, have gone too far in its insistence that it decides when scientific truth has been established and what companies can say. At issue are regulations governing everything from what a drug company can print on a T-shirt to what a sales representative can say in the privacy of a doctor's office.
"No one is advocating that false or inaccurate claims be permitted. But agency officials are asking questions like whether they can continue to prevent food companies from making health claims for their products and whether they can continue to insist that drug advertising include a full accounting of side effects and conditions that may make the drug inadvisable.
[The full NY Times article can be read at:}
http://www.nytimes.com/2002/10/15/health/policy/15FDA.html?pagewanted=1
[Kirkman Laboratories can be found at:] http://www.kirkmanlabs.com
[Contact the FDA at:] FDA Deputy Commissioner Lester M. Crawford email:
deputy.commissioner@fda.gov
or 5600 Fisher Lane, Rockville, MD 20857, Phone: 301-827-2410, Fax:
301-443-3100
Letter to the FDA
My children are do to get a flu shot and I read the package insert and it says 25 micrograms of mercury. You are recommending two shots. Isn't this way to much for a child?
Curious,
Wendy
Thank you for your inquiry. The Advisory Committee on Immunization Practices (ACIP) makes the recommendation. This is published in the MMWR journal and the most recent is at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5125a4.htm
Primary Changes and Updates in the RecommendationsThe 2002 recommendations include five principal changes or updates, as follows:
- The optimal time to receive influenza vaccine is during October and November. However, because of vaccine distribution delays during the past 2 years, ACIP recommends that vaccination efforts in October focus on persons at greatest risk for influenza-related complications and health-care workers and that vaccination of other groups begin in November.
- Vaccination efforts for all groups should continue into December and later, for as long as vaccine is available.
- Because young, otherwise healthy children are at increased risk for influenza-related hospitalization, influenza vaccination of healthy children aged 6--23 months is encouraged when feasible. Vaccination of children aged >6 months who have certain medical conditions continues to be strongly recommended.
- The 2002--2003 trivalent vaccine virus strains are A/Moscow/10/99 (H3N2)-like, A/New Caledonia/20/99 (H1N1)-like, and B/Hong Kong/330/2001-like strains.
- A limited amount of influenza vaccine with reduced thimerosal content will be available for the 2002--2003 influenza season.
The CDC site has the following about flu vaccine manufacturers and children:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5103a1.htm#VacUseChild
Children under 3 get half doses of vaccine so they would get 12.5 micrograms per dose one month apart if using standard flu shots (not the reduced thimerosal version).
See footnote 6 for Table 3. http://www.fda.gov/cber/vaccine/thimerosal.htm#tox
See the following table for currently licensed thimerosal reduced and standard flu vaccines http://www.fda.gov/cber/vaccine/thimerosal.htm#t2
There is an approved Aventis Pasteur Fluzone vaccine in pediatric dosage form with reduced thimerosal. The following is from their label at the following site:
http://www.vaccineshoppe.com/US_PDF/Fluzone_2002_2003_4675_4681.pdf
Fluzone is supplied in two unit dose
preservative-free presentations distinguished by a pink syringe plunger rod: a 0.25 mL prefilled syringe (for pediatric use) and a 0.5 mL prefilled syringe; both are formulated without preservatives but contain a trace amount of thimerosal [(contains 49.6% mercury), (≤ 0.5 µg Hg/0.25 mL dose) (≤ 1.0 µg Hg/0.5 mL dose)] from the manufacturing process. Fluzone is also supplied in two other presentations: a 0.5 mL prefilled syringe and 5 mL vial of vaccine, of which both contain the preservative thimerosal [(mercury containing compound), 25 µg mercury/0.5 mL dose]. Fluzone, after shaking syringe/vial well, is essentially clear and slightly opalescent in color.
Sincerely,
Thank you for writing me back. So my child would only receive 25 micrograms of mercury. When I asked Dr XXXXX at the CDC how much was considered safe he said 5 micrograms if you weigh 110 pounds. My children weigh 33 and 37 pds. So that means this vaccine would not be safe for my children at all or anyone's children for that matter. I don't understand why the FDA and the CDC would recommend this vaccine when clearly it is not in the patients best interest. What is going to happen to the children damaged by this? Not everyone's system can handle heavy metals without brain damage. I saw you snatched a vitamin off the shelf because of the way it was advertised, but a neurotoxin is promoted as a life saver? I don't understand. What is the logic here? Can you explain this without websites? Just in plain english?
Hoping for an explanation,
Wendy
Dear Wendy:
Thank you for your inquiry. The current vaccines manufactured as they have been for many years have a level of thimerosal so that in two doses, 25 ugs of mercury would be received but you must also factor in that the dose would not occur all at once but at least a month apart. The risk from a dose of an chemical should not be based on just the absolute quantity of chemical but must take into account the time over which the exposure occurs.
I tried to point out with multiple references that there are NEW versions of flu vaccine with significantly reduced thimerosal. This is the first year that this is available and they may be difficult to find. Please note that in the reduced mercury form of vaccine, the dose would only be half a microgram in each childhood dose so that over a month period your children could have only 1 ug total.
FDA and CDC recommend flu vaccine for the very young and the old primarily because over 20,000 people die of flu each year in the U.S. and over 100,000 people are hospitalized.
So you see this is a potentially deadly disease for the young and the old. The magnitude of the risk of death or hospitalization from influenza far exceeds any of the risks you are concerned about from the preservative. That describes the logic and I hope it was plain language. If you desire, you may call me at 800-835-4709 or my direct line 301-827-3847 (toll call). I will try other ways to explain the risk-benefit logic.
Clearly, mercury was removed or greatly reduced from all childhood vaccines, because it very plausible that it has the potential to do harm. FDA works with manufacturers to make sure that the manufacturing of the product is adjusted and studies are done to show that a vaccine will remain stable and will continue to work with reduced or no mercury based preservatives.
Sincerely,
J
800-835-4709
301-827-2000
Thanks for getting back to me and I am glad to see you are willing to explain the risk/benefit logic. I called my local health dept and they told me I would not be able to get the flu shot without mercury since there will not be many doses made and those doses with the 1 ug of mercury will be for babies. I’m not sure what you mean by “the account of the time over which exposure occurs.” 12.5 ugs would still be way over the limit and it is not spaced over time. It is an injection. The whole 12.5 micrograms at once. Can you give me the name of the company that makes the 1 ugs of mercury shot so that it is easier to find? I have called several pediatricians and most don’t even know there is thimerosal in their vaccines! It is so hard to get them to read the package insert to me. Most here in Gainesville have the Fluzone variety.
Also I tried to find out how many kids are affected by the flu and I can’t find the stats you referenced. Could you please send me a website on that? I still am having a hard time with the fact this has any mercury in it at all. It seems to me this should have been yanked off the shelf as fast as that vitamin was if not faster.
Thanks,
Wendy
Dear Wendy:
I referred to the 25 ugs being delivered over time - not 12.5 ugs - you are right an injection is all at once. However, it is not clear how fast the injection is really mobilized and metabolized. If it were to be injected into the blood it would be rapid, probably less rapidly into the muscle as flu vaccine is given. There will be limited availability of the Fluzone. Health departments may not have even ordered it.
The prescribing information or package inserts are most often in Adobe portable document format or .pdf files. You'll need Adobe Acrobat Reader installed on your computer to be able to open the files and read them. It is free on the internet if you don't have it. Once you have opened the document - you may need to increase the magnification of the file to be able to read the tiny print on screen.
The names and web sites where I have found the labels for two of the three manufacturers of licensed 2002-2003 flu vaccine:
1) The Aventis Pasteur web site has the traditional adult flu formulation and the pediatric (preservative free) with very much reduced thimerosal forms
at this web site:
http://www.us.aventispasteur.com/PRODUCT/Default.cfm
Fluzone® Influenza Virus Vaccine 2002-2003 Formula49281-370-155 mL / 10 dose vialFluzone® Preservative-free Pediatric Dose Influenza Virus Vaccine 2002-2003 Formula
49281-369-2510 prefilled 0.25 mL syringes 1 dose
traditional Fluzone:
http://www.vaccineshoppe.com/US_PDF/Fluzone_2002_2003_4675_4681.pdf
0.25 ml pediatric FLUZONE
http://www.vaccineshoppe.com/US_PDF/Fluzone_2002_2003_4675_4681.pdf
2) The Wyeth web site for all their products has listed FluShield:
http://www.wyeth.com/products/wpp_products/full_pharma_az.asp#
FluShield®, Influenza Virus Vaccine, Trivalent, Types A and B (Purified Subvirion)
3) I received the labels for the thimerosal reduced Evans Fluvirin and traditional Fluvirin vaccine (please note that the thimerosal reduced Fluvirin is not approved for children less than 4 years of age)
I include the Evans two labels as two attachments: package insert - syringe (thimerosal reduced) package insert - multi-dose
800-835-4709
301-827-2000
Thank you so much for all of your information you really are a nice guy to share all of this with me. Most people would not have taken the time. It really would not be a good idea to tell me straight out not to inject my children with mercury because of all the major lawsuits that would ensue if you as a group were to come out and say mercury is detrimental to health and we have been damaging children since the 30's! So I guess quietly removing it is the best policy. I have told a few people about the content of mercury in the flu shot but they don't believe it. They really trust the FDA and think you would do nothing to hurt them! I found this really great video done by the university of Calgary have your seen it?
http://commons.ucalgary.ca:16080/mercury/ you can watch the neurons dissolve when mercury is added. Thank God for the Internet huh! I have decided against giving my children the flu shot anyway with or without mercury. I saw the formaldehyde and propylene glycol and all the other ingredients. No thanks! I can't believe that has passed the rigorous tests you must have put vaccines through before they were mandated! Maybe you can show me those studies sometime. I am almost positive none have been done. I can't imagine a test done of injecting formaldehyde into children to see what happens! Just wish I would have know this before I vaccinated my children with 31 doses of God knows what. Maybe this is why my son has a seizure disorder? I'm researching that now. All the medical doctors I take him to say vaccines are not implicated. I'm really starting to wonder.
Nice talking to you,
Wendy
HEALTH & SCIENCE
http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsd1104.htm
Drugs approved by FDA not always safe for all . Whether a medication's benefits outweigh potential risks will become an even greater issue as the population ages and the number of new formularies increases.
By Susan J. Landers, AMNews staff. Nov. 4, 2002. Additional information
Washington -- Although physicians and even some patients realize that no drug is 100% safe, they don't always focus on just how much is unknown about a drug even after it is approved by the Food and Drug Administration for use by the general population.
When a drug is approved, the FDA is saying, "the risk is reasonable given the potential benefit for the population that was studied and for the condition that was studied," said Nancy Smith, PhD, director of training and communications at the agency's Center for Drug Evaluation and Research.
Dr. Smith was speaking at a conference on medication safety held Oct. 17 in Bethesda, Md.
"Once a drug is on the market, you go from a population of a couple of thousand at most, to a population of millions of people who are taking these products. And things are going to show up that never could have been predicted in clinical trials," she said. While a large clinical trial may mean that a new drug is being tested on 2,000 to 3,000 people, an adverse event may show up only after 5,000 people use the medication.
New drugs are tested on only 2,000 people.
After a drug is approved, it may be prescribed for patients who are older than participants in the trial or for patients who use additional medications. "We may be in an unknown area where we don't know if the benefits outweigh the risks," Dr. Smith said.
It's also possible that there may be more benefit and less risk carried by a new drug, but that is also an unknown, said Dr. Smith. While off-label use of a drug is certainly not discouraged, she said, physicians should be aware that such use means venturing into unknown territory.
The FDA's track record indicates that about 2% of approved products have subsequently been taken off the market during the last 10 to 15 years because of conditions that weren't foreseen at the time of approval, she noted. However, that number may increase as more drugs become available, the aging population is prescribed multiple drugs and managed care limits the amount of time physicians can spend with patients explaining possible adverse effects.
A look at labels
For all those reasons the problem of drug safety is likely to get worse, said Dr. Smith. The safety of medications, as well as that of medical devices and the nation's blood supply, has caught the interest of the Healthy People 2010 project, which adopted medical product safety as one of 50 health goals for the nation to achieve in the first decade of the new century.
The responsibility for meeting that goal is shared by government regulators, physicians and other health care professionals, product manufacturers and patients, Dr. Smith said.
For its part, the FDA has embarked on a program to improve the information in the drug labels that accompany prescription medication.
During the last decade, 2% of previously approved drugs have been taken off the market.
A study carried out last fall by the FDA and the National Assn. of Boards of Pharmacy measured information that was provided with prescriptions at about 400 randomly selected pharmacies. Directions and precautions included were rated for accuracy and effectiveness by other pharmacists and for legibility and comprehensibility by a panel of consumers.
The good news was that information was provided in nearly 90% of cases, said Dr. Smith. But it was questionable how good that information was, she said. On a scale of one to 100, the expert pharmacists rated the information at 50 or 60. "When I was in school," said Dr. Smith, "60% was a D at best and that's not very good."
Another survey is planned for 2006 and pharmaceutical companies will have between now and then to improve the label information. The conference was sponsored by the Peter Lamy Center for Drug Therapy and Aging at the University of Maryland in Baltimore and the National Council on Patient Information and Education.
Ladies & Gentlemen:
A reminder from friends on the Hill--when sending letters to the FDA regarding the Gestapo tactics recently used against Kirkman Labs, be sure to cc your US Congressman, your 2 US Senators and, most importantly, the Bush Administration since President Bush is directly responsible for the actions of the FDA. Also, Acting Commissioner Lester Crawford is on the way out and, the Senate recently unanimously confirmed Dr. Mark B. McClellan as the new head of the Food and Drug Administration. So, lets give him a welcome by flooding his desk with faxes and e-mails expressing our outrage at the FDA's actions. A warning to change the website and remove the word phrase "treat autism" would have been more appropriate than charging in without prior notification and seizing the Taurine product.
Peacefully,
Jeff Sell
Hitt * Patterson * Sell
4309 Yoakum Boulevard
2nd Floor
Houston, Texas 77006
713.654.7776
713.654.7789 (fax)
832-731-3145 (cell/v-mail)
www.HittPattersonSell.com
JZSell@HittPattersonSell.com
~~~~~~~~~~~~~~~~~~~~~~
Letter from the web
I have had many unresolved questions regarding the US Anthrax scare last year, when Sen. Tom Daschle, among others, received a letter with anthrax. Although the source has been traced to a US lab, we have never found the culprit(s). The media is now so engrossed in smallpox - it seemed odd to me that there was this shift in attention.
I would like to know if I am off base with my research, but I believe that the only lab producing anthrax vaccines is Bioport in Michigan. Turns out that Bioport was bought by a company called the Carlyle Group a few years ago. I used to work for a firm in New York that handled Carlyle legal business. It is an exceptional group of business contacts with a clear mission plan. In coming full circle, turns out the Bush family was one of the original four private investors to start the Carlyle Group. After last years anthrax scare, the Federal Government authorized funds to buy enough vaccine for the population. I'm sure the Carlyle Group made a lot of good money.
I believe that what we are seeing is a deliberate self-serving agenda. I think that interested reporters may want to really look at the Bush et. al direct financial ties to the vaccine industry. War will boost our economy. Iraq has the benefit of oil in addition to being a war target with the threat of bioterrorism. The Bush administration has been using the threat of bioterrorism to stock-pile vaccines and run vaccines on the population from companies that will directly benefit his profits and bankroll his friends.
There seems to be a core, many are members of the Carlyle group and some at the Riverstone Group who are going to make millions and billions of dollars off our "war" and "vaccine" campaign. I must note that the organization is huge now, and there are many, many brilliant, fine people also involved in this huge private investor group. However, if there is this connection to the Bush family money, I think the public is entitled to understand the details that influence of our decision-makers.
Secondly, the FDA raided and seized probiotics from Claire Laboratories last week because Claire said that probiotics help children with autism. There was no media or coverage. So it isn't the product they are after, it is the message that supplements can help with autism.
Chemicals Linked to Birth Defects Can Stay in Cosmetics
http://www.ewg.org/ Chemicals Linked to Birth Defects Can Stay in Cosmetics, Says Cosmetic Industry Safety Panel Most people are surprised to learn that the government neither conducts nor requires safety testing of chemicals that go into health and beauty products. A panel funded and advised by the cosmetic industry determined that cosmetic companies can continue to add reproductive toxins known as phthalates to cosmetics marketed to women of childbearing age.
Phthalates (pronounced THAL-LATES) are linked in animal studies to birth defects of the male reproductive system, including undescended testicles, absent testicles, and a physical defect of the penis known as hypospadias. They are used in a wide range of beauty products including shampoo, hair spray, nail polish, deodorant, and lotion.
• EWG Cosmetics Home
• Washington Post: Beauty Coverup?
• Industry Review Panel: What's wrong with the process?
• Do the deodorant, hair gel, and other products you use contain phthalates?
• EWG’s list of phthalate-free products
Polluted bodies
Ruth Rosen
Monday, February 3, 2003
©2003 San Francisco Chronicle
URL:
http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2003/02/03 /ED162110.DTL
WHEN MICHAEL LERNER volunteered to give blood and urine samples to medical researchers, he figured they'd only find a few chemicals in his body. After all, Lerner, the president and founder of Commonweal, a health and environmental research institute in Marin County, has lived in Bolinas for 20 years, eaten a healthy diet and avoided exposure to industrial chemicals.
He was wrong. Researchers found his body polluted with 101 industrial toxins and penetrated by elevated levels of arsenic and mercury. Scientists call such contamination a person's "body burden."
Lerner was one of nine people -- five of whom live and work in the Bay Areas -- who were tested for 210 chemicals commonly found in consumer products and industrial pollution. Mt. Sinai School of Medicine in New York, the Environmental Working Group of Oakland and Washington, and Commonweal collaborated on this innovative study of the body burden.
At press conferences held in San Francisco and Washington, D.C., last week, researchers revealed these shocking results: On average, each person had 50 or more chemicals linked to cancer in humans and lab animals, considered toxic to the brain and nervous system or known to interfere with the hormone and reproductive systems. (The Environmental Working Group's Web site:
http://www.ewg.org/reports/bodyburden/ features biographies and toxic profiles for each person as well as the kind of products that contain such chemicals.)
Lerner was astounded. "Being tested yourself brings the body burden home in a very personal way." For years, he has lived with a condition that causes a hand tremor. Now he suspects why. "Mercury and arsenic both cause tremor, so I've stopped eating all fish that have high mercury levels." Lerner's wife, Sharyle Patton -- co-director of the Collaborative on Health and Environment -- also participated in the study. To her surprise, the Bolinas resident had as many toxins as people who have lived in cities. In fact, she had the highest levels of dioxins and PCBs -- both highly toxic substances -- of anyone in the test group. "What we learned," says Patton, "is that we all live in the same chemical neighborhood."
Lerner, who has devoted his life to promoting the health of people and the planet, hopes that such bio-monitoring tests will become routine and affordable. "Body burden tests," he says, "are the thermometer that gives us our body's chemical fever. In a prudent world, no household would be without a chemical thermometer in the medicine cabinet."
But individual tests only provide information; they don't reduce our contamination. "The truth is," Lerner says, "we are unwilling participants in a huge chemical experiment, which would never be permitted by the FDA if these chemicals came to us as drugs. But because these chemicals enter us from industrial and agricultural sources, they are not subject to testing that would ensure our safety."
The report therefore calls for "the reform of the Toxics Substance Control Act, under which chemical companies may put new compounds on the market without any studies of their effect on people or the environment."
Andrea Martin, founder and former executive director of the San Francisco's Breast Cancer Fund, strongly supports the recommendation. Martin is a breast cancer survivor who climbed Mount Fuji in 2000 with 500 breast cancer survivors and supporters. More recently, she underwent surgery to remove a brain tumor unrelated to breast cancer.
Martin, who also gave samples to the Body Burden project, was stunned by the results. "I was completely blown away," she told me. "There were 95 toxins, 59 of which were carcinogens." Martin has never worked with or near chemicals. But she now wonders whether her formative years may have turned her into a self-described "walking toxic waste site."
When she grew up in Memphis, she and her friends loved to get splashed by the streams of insecticide sprayed by trucks that roamed the neighborhood. Later, she indulged a passion for water skiing -- in lakes clouded by chemical pollutants. "Where did I get all these PCBs and dioxins?" she asks. "I'll probably never know."
In fact, no one is sure how industrial and synthetic chemical residues -- even long-banned pesticides such as DDT -- end up in our bodies. But scientists suspect that chemicals first pollute the air, soil, food and water, then climb through the food chain and finally accumulate in our blood, fat, mother's milk, semen and urine.
I asked Martin if she regrets getting tested. "At first, I was really angry. But I believe knowledge is power. We're starting to learn that pollution isn't only in the air, soil and water; it's also in us." She also wonders whether her chemical body burden has caused her cancers. "We'll never know," she says, "because right now chemical companies don't have to prove the safety of their products and no government agency has ever studied the health risks that can be caused by chemical toxins."
That may change. Last week, the Centers for Disease Control also issued its second report card on the body burden of chemicals carried by Americans. Using data from 2,500 anonymous donors, the CDC provided further evidence that chemical residues have polluted the bodies of most of us. Although no one yet knows what amount of trace chemicals are harmful for human health, scientists and environmental health activists worry about the cumulative assault on our health.
No one wants his or her body to be another pollution site. Still, lobbyists for the chemical industry resist further regulation. "As a result," says Martin, "we're living in a toxic stew and they are, quite literally, getting away with murder."
©2003 San Francisco Chronicle |
The face of environmental contamination - Bay Area residents participate in test of chemicals in their bodies 02/01/2003 - San Francisco Chronicle
http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2003/02/01
/MN161308.DTL
Groups find high toxin levels in people, call for reform
01/31/2003 - Breaking News
http://www.sfgate.com/cgi-bin/article.cgi?file=/news/archive/2003/01/31/stat
e0327EST0018.DTL
Groups find high toxin levels in people, call for reform
01/30/2003 - Breaking News
http://www.sfgate.com/cgi-bin/article.cgi?file=/news/archive/2003/01/30/stat
e2011EST0162.DTL
SCIENCE JOURNAL
By SHARON BEGLEY
Can Pesticide Tests on Humans Ever Meet Standards for Ethics?
The World Health Organization lists aldicarb, a pesticide, as "extremely hazardous." It calls the pesticide dichlorvos "highly hazardous"; the U.S. Environmental Protection Agency classifies it as a "possible human carcinogen."
Yet, if you are healthy and up for an adventure, pesticide makers will pay you $500, $800, even $1,500 to imbibe one or the other, either once or daily for 18 days with your morning OJ. The controversy over the scientific value and ethics of testing pesticides on people is approaching full boil, spurred by intense pressure from the pesticide industry to loosen federal policies and by a lawsuit that manufacturers filed against the EPA to make it accept data from such experiments. At last count, 14 studies of 11 pesticides have been submitted since 1996.
The push for human testing was triggered by the 1996 Food Quality Protection Act. In exchange for allowing traces of carcinogenic pesticides to remain on food (previously illegal), the act requires the EPA to use an additional "safety factor" in setting allowed residue levels, to protect children and fetuses. Pesticide makers have that safety factor in their cross hairs, hoping to persuade the EPA that if healthy adults suffer no adverse effects after consuming a bit of pesticide, then restrictions should be relaxed.
The recent experiments dosing people with pesticides haven't exactly covered themselves in glory, ethically speaking. In one testing dichlorvos, in Scotland, many of the volunteers were cash-strapped college students. The possibility of financial coercion always is an ethical no-no. And in several places, the consent form referred to dichlorvos as a "drug" and said it was used as a medicine, misleading volunteers, as The Wall Street Journal reported in 1998.
But leave aside ethics concerns for a moment and focus on the science, for unless an experiment on humans yields valuable data it is by definition unethical. The argument in favor is simple: "There is no substitute for the knowledge gained from human volunteer studies," as Monty Eberhart of Bayer CropScience, a major pesticide maker, puts it.
True -- but only in the abstract. The current round of studies have used small numbers (10 to 50, typically) of healthy adults, raising doubts about the studies' statistical power. "If you see an effect, you can be reasonably confident in that finding even if you used only 10 or 15 people," says toxicologist Michael Gallo of the Environmental and Occupational Health Sciences Institute in Piscataway, N.J. "But to be confident that you have no effect is much more difficult. You may just happen to have studied 10 people who are not sensitive to the compound. To prove a negative you need many more people," probably hundreds.
The existing studies border on junk science for another reason: You can't volunteer for them unless you're a healthy adult. Given this "voluntarism bias," as epidemiologist Lynn Goldman of Johns Hopkins University, Baltimore, calls it, there are real doubts that a level found to produce no adverse effects in such a group also is safe for children, the ill and the elderly.
When you run a toxicology study, you don't ask, "So, what does this chemical do, anyway?" You define an endpoint, such as, "How does this chemical affect acetyl cholinesterase activity?"
"This is the basic fallacy of relying on these studies," says Dr. Goldman, a former EPA pesticide official. The critical effects are things like developmental neurotoxicity in children and fetuses, and those might reflect chemical pathways unrelated to whatever is causing toxicity in adults. Organophosphate pesticides have been found to alter gene expression in the brains of fetal rats, for instance, yet are tested for how they inhibit enzyme activity in adult red blood cells.
But let's say the endpoints are chosen properly, and the tests have enough subjects to offer statistical power. Let's say, too, that the studies adhere to ethical standards. Are they OK now? You still have an inherent ethical problem. When people volunteer to test the safety of drugs, "those Phase 1 trials are for things intended to make people better," says bioethicist Jeffrey Kahn of the University of Minnesota, Minneapolis. "If the purpose is to allow industry to get higher levels of pesticides into the environment,
then it's very questionable."
When an EPA Science Advisory Panel studied the acceptability of experimenting with pesticides on people, it concluded in 2000 that if the study is conducted with rigorous ethical controls, if there is no other way to fill data gaps and if the goal is to protect public health, then the EPA should consider it. "We felt that only under the most extraordinary circumstances should human testing be done," says toxicologist Ronald Kendall of Texas Tech University in Lubbock, who chaired the panel.
Interestingly, very few experiments would likely meet those guidelines. As Prof. Gallo, who is viewed as sympathetic to industry, asks, "For existing pesticides, where we have a great deal of human data from epidemiology and 'biomonitoring' of farmworkers exposed to pesticides, why do we need these studies?"
Hoping for scientific and political cover, the EPA has asked a panel of the National Academy of Sciences to answer that. Its report is expected late this year. • You can e-mail me at sciencejournal@wsj.com.
The Hep B was taken off the schedule for awhile I know at a local hospital where I live because of the thimerosal issue. In fact, the nurse I spoke to said it was about year. I believe in 99 the cat was out of the bag about thimerosal. But, Hep B vax by itself is dangerous. Even Dr. Mercola is requesting that if anyone is pregnant or knows of someone who is to warn them not to get the Hep B
vaccine. Go to: http://www.mercola.com/2002/jan/23/hepatitis_vaccine.htm
I spoke to the FDA and was told that thimerosal containing vaccines were never recalled--they are slowly being used up and/or sent to third world countries. All flu shots contain thimerosal and even some vaccines that are said to be thimerosal free, still have a trace amount. Dr. Bradstreet, DAN doc., at a recent conference in Pittsburgh said not to be fooled. Docs. are using up the thimerosal (~50% mercury by weight) containing vaccines.
I think the FDA recalled over the counter drugs that had thimerosal in them, but not VACCINE. My beliefs are that if they had done that it would have clearly revealed the dangers of such a preservative being injected into our babies. I think they have been and are still trying to quietly phase out the thimerosal issue.
And, I think it was in 99 that AAP told their peds. that if they used a thimerosal vaccine, they had to warn the parent(s) that the thimerosal could cause neurological damage! I read a case where a doc. didn't do this and later the child was diagnosed as autistic. The parents are suing the doc. as well as the pharma.
http://www.whale.to/vaccine/fda2.html
What the FDA is really doing:
"1.) It is providing a means whereby key individuals on its payroll are able to obtain both power and wealth through granting special favours to certain politically influential groups that are subject to its regulations. This activity is similar to the "protection racket" of organised crime: for a price, one can induce FDA administrators to provide "protection" from the FDA itself.
2). As a result of this political favouritism, the FDA has become a primary factor in that formula whereby cartel-orientated companies in the food and drug industry are able to use the police powers of government to harass or destroy their free-market competiton. Eg
3). And thirdly, the FDA occasionally does some genuine publ ic good with whatever energies it has left over after serving the vested political and commercial interest of its first two activities."------- Edward Griffin, World Without Cancer. http://www.realityzone.com/
How much longer until this is used on us?
http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01221.html
FDA Talk Paper
T03-35
May 19, 2003Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Approves First Injectable Solution for Chemical Sterilization in Dogs
The Food and Drug Administration (FDA) has approved the first product for chemical sterilization of male puppies. The drug, Neutersol Injectable Solution, provides an alternative to surgical castration, and may prove to be a valuable aid in efforts to control burgeoning dog populations. Neutersol is administered by direct injection into the testicles. Unlike the surgical procedure, Neutersol does not require the use of general anesthesia, though sedation is recommended to prevent the dog from moving during injection.
While surgical castration significantly reduces testosterone production, the use of Neutersol may not. Also, it may not eliminate unwanted male behaviors such as roaming, marking, or aggression. In addition, this product may not protect against diseases associated with male hormones in dogs, such as prostatic disease or testicular and perianal tumors.
Pet overpopulation is a serious public health problem. Uncontrolled breeding of pets affects not only the animals and shelters but forces communities to spend millions of dollars to feed, shelter, and protect lost or unwanted animals. Pet shelters with on-site veterinarians can sterilize male puppies before they leave the shelter, rather than relying on the person adopting the dog to take it to the veterinarian for surgical sterilization.
Proper injection technique and post-injection care are critical for the safe use of the product. In tests, researchers discovered that the greatest potential risk was ulcers of the scrotum at the injection site, caused by incorrect injection or movement of the needle during injection. To help educate veterinarians and dog owners about safety issues and to prevent the occurrence of serious adverse events, the approved labeling includes an instructional videotape demonstrating the proper injection technique, and a client information sheet explaining the importance of post-injection care.
Addison Biological Laboratory, Inc., Columbia, Mo., is the manufacturer of Neutersol Injectable Solution, which will be available for use only by or on the order of a licensed veterinarian.
Additional Information
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
Injectable or Implantable Dosage Form New Animal Drugs; Zinc Gluconate
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Technology Transfer, Inc. The NADA provides for use of zinc gluconate solution for chemical sterilization of dogs by intratesticular injection.
DATES: This rule is effective May 19, 2003.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail:
mberson@cvm.fda.gov. SUPPLEMENTARY INFORMATION: Technology Transfer, Inc., 33 East Broadway,
suite 190, Columbia, MO 65203, filed NADA 141-217 that provides for use of NEUTERSOL (zinc gluconate neutralized by arginine) Injectable Solution for chemical sterilization of 3- to 10-month-old male dogs by
intratesticular injection. The NADA is approved as of March 17, 2003, and the regulations are amended in 21 CFR part 522 by adding new Sec. 522.2690 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In addition, Technology Transfer, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning March 17,2003. The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
(a) Specifications. Each milliliter of solution contains 13.1 milligrams zinc as zinc gluconate neutralized to pH 7.0 with L- arginine.
(b) Sponsor. See No. 067647 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. The volume injected into each testicle is based on testicular width as determined by measuring each testicle at its widest point using a metric scale (millimeter) caliper.
(2) Indications for use. Intratesticular injection for chemical sterilization of 3- to 10-month-old male dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Is the FDA Really Protecting Us? NOPE...
Guest Editorial: IAHF Webmaster: Breaking News, What's New
Opinion by IAHF President John Hammell
November 15th, 2003
What do Pondimin, Redux,Seldane, Posicor, Duracht, Hismanal, Raxar, Rezulin, Propulsid, Lotronex, Raplon, and Baycol all have in common?
Answer: All are drugs that the FDA pulled off the market within the last few years that were fraudulently approved by this criminal Agency where corruption runs rampant.
I just watched a great documentary on the Public Broadcasting System's "Frontline" program titled "Dangerous Prescription" about how the FDA is killing Americans in unprecedented numbers in the past 5 years due to criminality within the Agency.
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/
Congressional Pharma Stooges such as Senator Dick Durbin (S.722 Dietary Supplement Safety Act) and Congressmen Davis, Waxman, and Dingle (HR 3377) have a lot of nerve claiming that dietary supplements pose a threat in our society and that we need "FDA to reign them in" when we have this heavily documented level of corruption at the FDA which is clearly serving as a
Trade Association for the pharmaceutical industry.
Call your Congressman today via 202-225-3121 and complain. Tell them to tune in this PBS documentary on the web on Sunday.
On Sunday, people world wide can view this show in its entirety on at the URL above, and I encourage all of you on the IAHF list to, and to encourage your elected officials to also- because instead of engaging in witch hunts attacking safe dietary supplements, the criminals who work for the world's FDA's need to be reigned in. Some should be imprisoned for approving
poisons such as these.
Former FDA drug reviewers who quit due to total disgust at how their reports were censored, and altered, and how they were pressured to change reports to make them more favorable for approval were interviewed regarding the fraudulent approval of such dangerous drugs as Dexfenfluoramine, Pondamin, Raxar and many others.
Here is an interactive Chart showing a dozen drugs that were fraudulently approved by the FDA, then removed from the market between 1997 and 2001. The chart names the drug, the manufacturer, when there were approved, what the drug was prescribed for, the adverse effects, and the date the drug was finally withdrawn from the market.
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/etc/dozen.html
Here is information from the PBS website about this interesting program:
SAFE AND EFFECTIVE?
How good is America's drug safety system? Since 1997, more than a dozen prescription drugs have been taken off the market due to serious side effects -- in some cases after hundreds of injuries and even deaths have occurred. Is the Food and Drug Administration, which is responsible for approving and monitoring the safety of the medications we take, up to the task? Here are excerpts from FRONTLINE's interviews with the FDA's Steven Galson and Paul Seligman, Public Citizen's Sidney Wolfe, and Raymond Woosley of the University of Arizona.
HOW INDEPENDENT IS THE FDA?
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html
Is the FDA too close to the industry it regulates? Critics argue that industry funding of the drug review and approval process gives
pharmaceutical companies, and their lobbyists, too much influence over decision-making and policy. To address these issues, in excerpts from FRONTLINE's interviews, are Public Citizen's Sidney Wolfe, the FDA's Steven Galson, the University of Arizona's Raymond Woosley, and pharmaceutical industry lobbyist John Kelly.
INTERVIEW: LEO LUTWAK, MD
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/lutwak.html
"The FDA is wholly dependent on trust -- on trusting [that] the company is providing all the truth all the time," says Leo Lutwak, a retired FDA drug reviewer specializing in obesity. Dr. Lutwak was the chief medical reviewer for weight-loss drugs and was at the center of the Fen Phen controversy. In this interview, Dr. Lutwak recalls the role he played in the review of Redux and provides insight into the sequence of events that led to the recall of this drug. (Since the time this interview was conducted, Lutwak
has been retained by plaintiff's counsel in the ongoing litigation surrounding these drugs.)
INTERVIEW: MICHAEL ELASHOFF, PhD.
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/elashoff.html
"I think it was pretty well understood," say former FDA scientist Michael Elashoff, "that if you were advocating turning a drug down -- particularly if it was from a large pharmaceutical company -- that that wouldn't be good for your career." A drug reviewer for the FDA from 1995 to 2000, Elashoff says he was marginalized within the agency after he voiced his concerns about a new flu drug called Relenza. Here, Elashoff speaks out about the culture of the FDA's drug approval process.
INTERVIEW: STEVEN GALSON, MD
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/galson.html
"We think we can run a high-quality independent program, regardless of the source of the resources," says the FDA's Steven Galson, acting director of the Center for Drug Evaluation and Research, "as long as, of course, the resources aren't linked to performance goals that are going to interfere with our independence." In this interview, Galson discusses the FDA's drug safety system and explains how the Prescription Drug User Fee Act helps the FDA.
INTERVIEW: PAUL SELIGMAN, MD, MPH
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/seligman.html
"The fundamental point," says Seligman, director of the FDA's Office of Drug Safety, "is that no drug -- even having gone through this long period of development, testing, and review -- is 100 percent safe." Seligman explains how his office handles adverse-event reports from pharmaceutical companies and through the MedWatch system, and discusses various areas in which the agency's drug safety program could be improved. International Advocates for Health Freedom POB 10632 Blacksburg VA 24062 USA
John Hammell
http://www.iahf.com; http://iadsa-exposed.tripod.com
800-333-2553 N.America
540-961-0476 World
This "Millions of Health Freedom Fighters - Newsletter" is about the battle between "Health and Medicine" on Planet Earth. Tim Bolen is an op/ed writer with extensive knowledge of the activities of a subversive organization calling itself the "quackbusters," and that organization's attempts to suppress, and discredit, any, and all health modalities that compete with the allopathic (MD) paradigm for consumer health dollars. The focus of the newsletter is on the ongoing activities, battles, politics, and the victories won by members of the "Health Freedom Movement" against the "quackbusters" It details "who the quackbusters are, what they are, where they are operating, when they appear, and how they operate - and how easy it is to beat them..."
For background information on the "Battle between Health and Medicine" go to: http://www.savedrclark.net/by_whom2.htm. A copy of THIS newsletter, and older ones, are viewable at the website http://www.quackpotwatch.org/default.htm.
For EVEN MORE interesting and related articles go to http://www.bolenreport.com.
Contact FDA by Mail or TelephoneIf you have comments or questions you can also contact us by mail:
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
or by telephone:
1-888-INFO-FDA (1-888-463-6332) -- main FDA Phone Number (for general inquiries)Electronic Employee DirectoryFDA Public Affairs Specialists
FDA's McClellan, `Loved by Industry,' Seeks Fast Drug Reviews
http://quote.bloomberg.com/apps/news?pid=10000103&sid=ag8zIR._AD9A&refer=us
FDA's McClellan, `Loved by Industry,' Seeks Fast Drug Reviews
Nov. 11 (Bloomberg) -- U.S. Food and Drug Administration Commissioner Mark B. McClellan has won friends among companies regulated by the FDA in his first year on the job. McClellan, 40, whose agency oversees industries with about $1 trillion in annual sales of everything from lipsticks to artificial limbs, is speeding up reviews of new medicines. He has made it easier for food companies to promote their products' health benefits. He has spoken out against price controls by Germany and other countries. And he has battled moves by politicians to buy cheaper drugs in Canada for sale in the U.S.
``He is looking at his mission in a broader way than most of his predecessors,'' Eli Lilly & Co. Chief Executive Sidney Taurel said in an interview. ``He is looking at how we accelerate innovation in America.'' McClellan is so focused on making the FDA work for business that his tenure may mark a turning point at the agency as it seeks to make regulation less burdensome on companies, say analysts such as Ken Kaitin, head of the Tufts Center for the Study of Drug Development, a research group associated with Tufts University.
``He is without question the best thing that ever could have happened to the pharmaceutical and biopharmaceutical industries,'' Kaitin said. McClellan is a medical doctor and an economist, and his knowledge of both medicine and business will be a model for future FDA commissioners, Kaitin said.
Single Study
That prospect alarms critics such as Sidney Wolfe, head of a health-research group at Public Citizen, a consumer-advocacy organization. ``I cannot remember an FDA commissioner who was so loved by industry,'' said Wolfe, who has been tracking the FDA for more than 30 years. ``If he were doing his job, industry would be saying, `This guy is really tough on us.'''
McClellan, a former economic adviser to President George W. Bush and older brother of Bush's chief spokesman, Scott McClellan, has started more than half a dozen initiatives that please food and drug companies since being sworn in last Nov. 14 to head the agency and its more than 9,000 employees. On Dec. 18, 2002, little more than a month after taking office, he announced a plan to allow food companies to make claims about their products based on a single study. The decision was hailed by the Grocery Manufacturers of America, which represents companies such as General
Mills Inc. and had lobbied for the change for a decade.
`Why Not Approve It?'
For the agency's drug reviews, he has sought to eliminate what he sees as flaws that can delay approvals for years. He directed his staff to work with drugmakers to reduce the number of applications that are sent back for further drug development. In May, the FDA approved an AstraZeneca Plc drug for lung cancer, Iressa, although the medicine failed to show a significant benefit for patients in two large studies. The drug had showed some benefit to patients in earlier tests, such as in containing tumor growth, the FDA said at the time.
``McClellan has said that if a drug has medical efficacy and practitioners want to have it and it is safe, why not approve it?'' said John Farrall, an analyst with National City Wealth Management, which manages about $30 billion and owns shares of drugmakers such as Pfizer Inc. ``That's a major change.''
McClellan, who earned an economics doctorate from the Massachusetts Institute of Technology, and medical and master's degrees from Harvard by the age of 30, said he has also taken actions that displeased industry. These included proposing tougher monitoring of complications caused by medicines, he said.
`No Matter What I Do'
``No matter what I do, I am going to get criticized,'' he said in an interview. ``That's actually freeing a bit, because we can really focus on what we think is the right thing to do from the standpoint of public health.'' McClellan, whose mother is a former mayor of Austin, Texas, and is now state comptroller, cites a saying of his grandfather, Page Keeton, a former dean of the University of Texas law school: ``If you haven't made anybody mad, you haven't done anything.''
One of those he has riled up is Gil Gutknecht, a Republican congressman from Minnesota who's sponsoring a bill to legalize imports of Canadian drugs. Gutknecht said McClellan is using his post to protect drugmakers' profits. ``McClellan and his senior leadership have tried to undermine a legislative initiative the American people desperately want and need,'' Gutknecht said in a September statement.
Suing the FDA
Public Citizen and the Center for Science in the Public Interest have sued the FDA over the plan to revise rules on food- health claims, saying it puts consumers at risk. Public Citizen also says McClellan failed to protect people from products linked to heart attacks and deaths, such as the ephedra weight-loss aid made by Metabolife International Inc. and Abbott Laboratories' Meridia diet pill. Still, McClellan takes the time to listen to his critics. Before being sworn in as commissioner, he spent hours with Public Citizen's Wolfe, discussing the state of the agency.
Wolfe said he told McClellan, ```You have a tough act to follow,''' referring to David Kessler, who was appointed by President George H.W. Bush to head the FDA in 1990. By the time Kessler resigned in 1997, he had banned silicone breast implants and had tried unsuccessfully to regulate tobacco. The FDA commissioner's post was vacant from the time that Jane Henney, an appointee of President Bill Clinton, left the job in January 2001 until McClellan took over.
McClellan hasn't been shy about urging individuals to take a stronger hand in looking after their own health, advice he tries to follow himself by going for a run or taking his 5-year-old twin daughters out to play. Making Voice Heard
His office has issued more than 120 press releases this year -- three times as many as Henney did in 2000, her last full year in office. He has appeared at scores of medical meetings, some investor conferences and at least one radio call-in show. In September, McClellan used his first international speech, in Mexico, to call on other countries to pay higher prices for medicines. Countries such as Canada and Japan set their prices so low that the U.S. and poorer nations such as Poland end up footing most of the bill for pharmaceutical research, he said.
The FDA has also stepped up enforcement actions against companies that supply U.S. consumers with Canadian medicines, sending warning letters to firms such as CanaRx Services Inc., then issuing press releases about these actions. Drugmakers have struggled in recent years to bring new medicines to market to make up for sales lost to generic competition for some of the industry's biggest products. The Standard & Poor's 500 Pharmaceutical Index has fallen about 3.4 percent this year, while the S&P 500 Index rose 19 percent.
Merck & Co., the second-biggest U.S. drugmaker after Pfizer, last month said it plans to cut about 4,400 jobs after its third- quarter net income fell. Merck shares have fallen about 19 percent this year. McClellan, whose days often begin with a 7:30 a.m. meeting and continue late into the night at home exchanging e-mails on his Blackberry device, was the first doctor to serve on a U.S. president's Council of Economic Advisers, from July 2001 to October 2002. He's also the first economist to run the FDA.
He has described his mission as bridging the gap between policy makers and the doctors affected by those policies.
``There is no other place in the world where you can be as much on the cutting edge of a broad range of difficult issues in science and in medicine,'' McClellan said in the interview.
`Boy Genius'
McClellan had earned tenure at Stanford University in the economics and medicine departments before he joined the White House as an adviser to Bush. He spent four days a week doing research on health-care costs and one day seeing patients.
``Dr. McClellan has gotten a lot of press about being a boy genius, and when you meet with him, he does seem really smart and also quite personable,'' said Cynthia Pearson, executive director of National Women's Health Network. ``He's a down-to-earth guy, willing to make jokes at his own expense.'' McClellan once deflected a question about the FDA's July decision to approve a human growth hormone for use treating shortness without a medical cause. He said the agency wouldn't be weighing in on the moral implications of using the medicine, with a ``commissioner who is 5 foot 7.''
Pearson met with McClellan to discuss concerns that he would limit access to the RU-486 abortion pill and emergency contraceptives. McClellan told Pearson he wants the FDA to make its decision based on science, not politics, she said,
Reassuring
``He was reassuring,'' Pearson said. ``But, of course, when we got down to specifics about the abortion pill or emergency contraception pills or some of the other issues that are important to the religious right, he then got non-committal like any good politically appointed person would.'' McClellan had sought a career in medicine, intending to also pursue a doctorate in science. He found that research done in the laboratory wasn't for him.
``The experience I had was a little bit too far removed from people,'' he said in the interview. ``I enjoy having much more personal interactions that are more closely related to having an impact on the public health.'' There's speculation that he would be in line for a promotion if Health and Human Services Secretary Tommy Thompson resigns, said Mike Astrue, the chief executive officer of Transkaryotic Therapies Inc., a biotechnology company. Astrue, a one-time candidate for FDA commissioner, once was general counsel for the department. McClellan declined to comment on that. ``My biggest concern is that he may be promoted to be secretary of HHS after Tommy Thompson leaves,'' Astrue said. ``I'd like to see him stay as FDA commissioner for the next five years.''
Roche Warns Against Use of Tamiflu Drug in Infants (Update1)
Jan. 2 (Bloomberg) -- Roche Holding AG warned doctors that its Tamiflu influenza drug should not be used in children less than 1 year old because young rats given high doses of the medicine in studies died. Seven-day-old rats received about 250 times the recommended dose of Tamiflu for children, a Roche letter said. Tamiflu isn't approved for children younger than 1, said Terence Hurley, a spokesman for Basel, Switzerland-based Roche.
The drugmaker is concerned that people may try to treat infants with the medicine because of the severity of the current flu season in the U.S., which already has killed more than 40 children and teenagers, Roche said in the letter.
``Given the possible desire to treat very young children with Tamiflu during this active influenza season, we wish at this time to emphasize the importance of using Tamiflu only for labeled indications and only in patients 1 year and older,'' the letter said.
High doses of Tamiflu were found in study rats' brains, the letter said. Like infants, the young rats had not fully developed a key defense mechanism in the body, a filter known as the blood- brain barrier. This filter slows down how fast medicines move from the blood into the brain and blocks infections carried in the blood.
Roche shares declined 5 centimes to 124.75 Swiss francs as of the close of trading in Zurich on Tuesday, the most recent trading day. The FDA released Roche's December letter to doctors to the public today to publicize the drug's risk.
To see the FDA letter:
http://www.fda.gov/medwatch/SAFETY/2003/tamiflu_deardoc.pdf
http://www.pharmabiz.com/article/detnews.asp?articleid=20075§ionid=&z=y
PHARMABIZ.com
VaxGen receives Fast Track designation for its anthrax vaccine candidate
Friday, January 23, 2004 12:00 IST
California
VaxGen, Inc., a biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted a Fast Track designation to the company's anthrax vaccine candidate, rPA102. The Fast Track designation means that FDA will take such actions that are appropriate to expedite the development and review of a license application for rPA102, when and if it is submitted to the FDA.
Under the FDA Modernization Act of 1997, the FDA's Fast Track Program is designed to expedite the development and review of a new drug that is intended for the treatment or prevention of a serious or life-threatening condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition.
"The Fast-Track designation is designed to provide us with frequent and ongoing communication with the FDA, allows for the possibility of filing portions of the license application ahead of others, and gives priority review status to the license application for our anthrax vaccine candidate," said Carmen Betancourt, VaxGen's senior vice president of Regulatory and Quality Affairs.
VaxGen is developing rPA102 under two contracts valued at more than $100 million from a division of the National Institutes of Health. The latest contract, valued at $80.3 million and awarded on September 30, 2003, is intended to fund animal safety studies, Phase II clinical trials, the scale up and validation of the vaccine manufacturing process and production of 3 million doses of finished product. The latest contract has been funded in whole with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, under Contract No.
N01-AI-30053.
Banned! Why the FDA slammed
the door on nature's best cholesterol buster...
While many Americans are popping risky and expensive statin drugs for cholesterol control, the FDA is blocking the sale of red yeast rice - a safe, natural source of powerful lovastatin...
Why? Because the pharmaceutical companies and the FDA have convinced our medical establishment that costly drugs are the answer to all our health worries - despite their dubious track record and often -deadly side effects...
Learn how one courageous M.D. has spent his entire career proving that nobody does it better than Mother Nature.
http://www.agora-inc.com/reports/NAH/W6NHE603/
(if you can't open here use the HTML links listed below)
I found this about why they stopped using it for lactation suppression:
http://multinationalmonitor.org/hyper/issues/1994/09/mm0994_12.html
SHORTLY AFTER PUBLIC CITIZEN filed an August 1994 lawsuit against the Food and Drug Administration (FDA) to force the federal agency to ban Sandoz Pharmaceuticals CorporationÆs widely-used drug Parlodel (bromocriptine mesylate), the company advised the FDA that it was withdrawing the indication of the drug for post-partum lactation suppression from the U.S. market. Timothy Rothwell, president and chief executive officer of Sandoz, says the decision was intended to end unwarranted criticism over the indication. "Parlodel is widely used to treat ParkinsonÆs Disease and endocrine disorders," Rothwell says. "It would be unfortunate if the medical benefits that this product provides in those areas are overshadowed by attacks on ParlodelÆs use in the post-partum indication that have no scientific foundation."
Public Citizen argued that a ban was needed because of "an ever-increasing number of serious injuries such as strokes and heart attacks including many deaths in otherwise healthy young women associated with the use of Parlodel." Public Citizen said that from ParlodelÆs approval as a lactation suppressing drug in 1980 to June 1994, there have been 531 adverse reaction reports in women aged 15 through 45 who have used the drug, including 32 deaths.
"Although Sandoz, the manufacturer of Parlodel, must bear primary responsibility for this tragedy," wrote Public Citizen Heath Research Group Director Dr. Sidney Wolfe, "the FDA has clearly been complicit in allowing these deaths and injuries to continue."
But Rothwell said that the safety of Parlodel as a lactation suppression product has been demonstrated by independent studies and a review of data from millions of patients. "The post-partum lactation indication has never generated significant revenues for Sandoz, but we felt that women who needed this product should, in consultation with their doctors, have the choice available," Rothwell said.
Each year at least 300,000 women take Parlodel for treatment of post-partum breast engorgement, at a return to Sandoz of approximately $12.5 million a year.
http://www.reuters.com/newsArticle.jhtml?&storyID=5658907
REUTERS
July 13, 2004
FDA: Glaxo Vaccine Information Wrong
WASHINGTON (Reuters) - Product materials for several GlaxoSmithKline Plc hepatitis vaccines contain false information about flu vaccines that could lead to public health problems, U.S. regulators said in a letter released on Tuesday. Hepatitis vaccines Havrix, Twinrix and Engerix-B all included the company's version of general U.S. government vaccine guidelines but listed false flu vaccine recommendations, the U.S. Food and Drug Administration wrote.
Glaxo's chart creates "a serious public health concern because it could lead to incorrect administration" of the live attenuated influenza vaccine to pregnant women with medical problems and very young children -- for whom the drug has not been shown to be safe, the letter said.
The U.S. Centers for Disease Control and Prevention recommends flu vaccines for healthy people aged 5 to 49. The GlaxoSmithKline chart recommended the vaccine for children 6 months to 5 years old and for adults up to age 50, according to the FDA. The wrong information was a particular concern because it "was distributed during the height of the flu season," the agency also said.
Glaxo spokeswoman Amanda Foley said the British drugmaker thought the information "was in compliance with FDA policies. Any omissions and statements the FDA objected to were not intentional." The materials were distributed in late 2003 until early this year but have been discontinued, Foley said, adding that corrected information would be sent out.
Foley also said the company was reviewing all of its vaccine promotional materials to make sure they were FDA compliant. The letter, which was dated July 6, was posted on Tuesday on the FDA Web
site at www.fda.gov. Materials for the hepatitis vaccines also failed to list critical safety warnings, including adverse reactions and medical conditions that should prevent some patients from getting the vaccine, the FDA said. The agency sends dozens of similar warning letters each year. While most are resolved without regulatory action, the FDA can impose injunctions, fines and other penalties.
Related stories:
http://www.guardian.co.uk/business/story/0,3604,1260923,00.html
THE GUARDIAN, UK
http://www.forbes.com/business/feeds/ap/2004/07/13/ap1453780.html
FORBES
Associated Press
http://www.forbes.com/business/businesstech/feeds/ap/2004/09/02/ap1529292.ht
ml
FORBES
09.02.2004, 05:50 PM
Aventis Pasteur Gets FDA Warning
The Food and Drug Administration warned vaccine producer Aventis Pasteur SA earlier this month it could face regulatory action, including license suspension, if prompt corrections were not made to quality control problems found at one of its French manufacturing plants. Released by the FDA Tuesday, the letter said the company - now a unit of drug giant Sanofi-Aventis - had not sufficiently addressed quality control issues found by FDA inspectors at its Lyon, France, manufacturing plant. The inspections occurred before the Sanofi-Synthelabo and Aventis merger earlier this summer.
The FDA said the company had failed to follow up on contaminated lots of vaccines and failed to keep potentially contaminated equipment separate from manufacturing equipment, and said quality control personnel did not investigate defects, or their sources, found in certain batches of vaccine.
Products covered by the letter included thymoglobulin, used to prevent the rejection of kidney transplants; a vaccine for Haemophilus influenza type b bacteria, which can cause meningitis, pneumonia or septic arthritis; and a rabies vaccine. While the deficiencies were discovered during March and April inspections, the FDA said in its warning letter that company responses to the agency in April and May "did not identify steps to be taken to implement and assure adequate effective corrective and preventive actions within appropriate and responsive timeframes."
Additionally, the letter called upon the company to provide detailed explanations of how it would revise quality control procedures at the plant. The agency requested the company respond in writing within 15 working days of receiving the Aug. 16 letter.
Sanofi-Aventis spokesman Len Lavenda said the company was preparing a written response to the FDA in time for the deadline and that all of the issues raised by the letter have been resolved or are in the process of being resolved. "I think it's important to note that the FDA did not require a recall of any products," Lavenda said, adding that none of the lots affected by the deficiencies were ever released to markets in the United States or any other country. American depositary receipts of Sanofi-Aventis closed down 13 cents, or 0.4 percent, to $35.35 on the New York Stock Exchange.
FDA WARNING LETTER TO AVENTIS PASTEUR:
http://www.fda.gov/foi/warning_letters/g4921d.htm
http://www.fda.gov/foi/warning_letters/g4921d.pdf /PDF Version/ Department of Health and Human Services Public Health Service Food and Drug Administration
Rockville MD 20857
AUG 16 2004
CBER-04-015
WARNING LETTER
FEDEX
David Watson
Executive Vice President
Aventis Pasteur SA
2 Avenue Pont Pasteur
F-69 007 Lyon Cedex 07
France
Dear Mr. Watson:
The Food and Drug Administration (FDA) conducted inspections of Aventis Pasteur SA located at 1541 Avenue Marcel Merieux, F679280 Marcy L'etoile, Lyon, France, between March 9 to Match 18, 2004, and April 26 to April 30, 2004. During the inspections, FDA investigators documented deviations from current good manufacturing practice, including the applicable standards and requirements of Subchapter C Parts 210 and 211, and Subchapter F Parts 600-680 of Title 21, Code of Federal Regulation, (21CFR). Failure to comply with current good manufacturing practice renders products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The deviations noted on the Form FDA 483, Inspectional Observations, issued at the conclusion of the inspections, include, but are not limited to the following.
1. Failure of the quality control unit to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. [21 CFR 211.22 and 211.192] For example
a) The review by the quality control unit of [redacted] batches of Rabies vaccine manufactured between July 2002 and July 2003 did not identify the error that occurred where you failed to segregate batch processing equipment in that the [redacted] filter integrity tester was being transported back and forth from the live virus area to the inactivated virus area. You acknowledged in communications with FDA that this was a "breach of GMP."
b) Numerous lots of Thymoglobulin did not meet specifications for capping defects during filling and capping operations for which you are the contract manufacturer. Nevertheless, the quality control unit did not thoroughly investigate these defects.
c) The quality control unit did not ensure that the particulates in lots of Haemophilius b Conjugate Vaccine were thoroughly investigated. The investigation was limited to the laboratory and did not include input from other departments, including manufacturing, to determine whether particulates were coming from another source.
d) Review of batch production records for lots X0480-2 and W1386-2 was not adequate because the quality control unit did not identify label accountability errors and the errors. These errors were not investigated.
e) The quality control unit does not ensure that environmental monitoring excursions are thoroughly investigated. For example, the investigations for class [redacted] area environmental monitoring excursions did not include the identification of the organisms for nonconformance investigations
2003-05499 and 2003-003090.
f) The quality control unit does not ensure that WFI excursions for some areas are thoroughly investigated. Examples include the microbial excursion of too numerous to count organisms on port [redacted] in [redacted] in April 2002, and the action level excursions for total organic carbon (TOC) in [redacted] in September 2003 and February 2004.
g) Numerous lots of Haemophilus b Conjugate Vaccine and Rabies vaccine that failed [redacted] testing after [redacted] were released after the inspection of [redacted] additional vials of each lot. The investigation did not provide a rationale for release on the basis of inspection of the additional [redacted] vials. Some examples include Heamophilius b conjugate lots X0803, X0452, X0410, X0409 and Rabies Vaccine lots X0254 and X0115.
2. Failure to establish an adequate quality control unit having the responsibility and authority to approve or reject in-process materials and drug products, and the authority to assure no errors have occurred or, if errors have occurred, that they have been fully investigated [21 CFR 211.22(a)]. The quality control unit did not have oversight into Water for Injection (WFI) microbial excursions at various ports at [redacted]
3. Failure to keep equipment and supplies used in work on or otherwise exposed to any pathogenic or potentially pathogenic agent separated from equipment and supplies used in the manufacture of products to the extent necessary to prevent cross-contamination [21CFR 600.11(e)(5)], in that equipment was moved from the virally active area into the virally inactive area, providing an opportunity for cross-contamination.
We acknowledge receipt of your written responses dated April 19, 2004, and May 27, 2004, which address the inspectional observations on the Forms FDA 483 issued at the close of the inspection. Corrective actions addressed in these responses may be referenced in your response to this letter, as appropriate; however, we believe that your response did not provide sufficient detail to allow us to fully assess the adequacy of the corrective actions. Our evaluation of your responses follows, and is numbered to correspond to the items listed on the Forms FDA 483:
Items # 1-20
Regarding the implementation of corrective actions, your response dated April 19, 2004, states that there are gaps in that remain in the full implementation of your corrective actions and that you need to [redacted]. As evidenced by the list of inspectional observations issued on March 18, 2004, and April 30, 2004, we agree with your statements. Please be advised that prompt corrective action to all deviations is expected. Your response did not identify steps to be taken to implement and assure adequate effective corrective and preventive actions within appropriate and responsive timeframes.
Item #1
Your response dated April 19, 2004, states that a [redacted] group was created in [redacted] and that the deficiencies identified during the March 2004 inspection were largely before the complete implementation of the [redacted]. This is not acceptable. Please be advised that systems should be
in place, even during the time of implementation, to assure adequate and effective corrective and preventive actions. Please provide a detailed description of your [redacted] group and the procedures in place to ensure adequate steps are taken for the evaluation of product impact,deviation investigations, and adequate and effective correction and preventive actions.
Your response dated May 27, 2004, states that the site quality systems are being reviewed so that the processes and methods used for the review and investigation of non-conformances are more clearly defined and subjected to a fully systematic approach. Please provide a detailed explanation of the revisions, the steps taken to assure adequate and effective corrective and preventive actions, and the timeframes for implementation Neither this letter nor the list of inspectional observations (Form FDA 483) is meant to be an all-inclusive list of deficiencies that may exist at your facility. It is your responsibility as management to assure that your establishment is in compliance with all requirements of the federal regulations. Federal agencies are advised of the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of contracts.
Please notify us in writing within 15 working days of receipt of this letter, of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. lf corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Failure to correct these deviations promptly may result in regulatory action without further notice. Such actions include license suspension and/or revocation. Your reply should be sent to James S. Cohen, J.D., Acting Director, Office of Compliance and Biologics Quality, U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 N, Rockville, Maryland 20852-1448. If you have any questions regarding this letter, please contact Ms. Mary Malarkey, Director, Division of Case Management, at (301) 827-6201.
Sincerely,
/s/
James Cohen for
David K. Elder
Director
Office of Enforcement
cc:
Dated C. Williams
Chairman and CEO
Aventis Pasteur
1 Discovery Drive
Swiftwater, PA 18370
Jean Le Quenven
Vice President Industrial Operations
Aventis Pasteur SA
Campus Merieux
1541, avenue Marcel Merieux
F-69280 Marcy l'Etoile
Lyon, France
http://apnews.myway.com/article/20041008/D85IURJ00.html
FDA Accused of Silencing Vioxx Warnings
Oct 7, 9:30 PM (ET)
By DIEDTRA HENDERSON
WASHINGTON (AP) - The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. (MRK) yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday.
Dr. David J. Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators he faced stiff resistance within the regulatory agency to his findings. "Dr. Graham described an environment where he was 'ostracized,"subjected to veiled threats' and 'intimidation,'" Sen. Chuck Grassley, R-Iowa, said in a statement after Finance Committee investigators interviewed the researcher Thursday. Graham told The Associated Press that Grassley's characterization was accurate. Raising safety concerns within the agency is "extremely difficult," the 20-year employee said, declining further comment.
In a prepared statement, the FDA said it "values open discussion and frank exchange about scientific and medical issues" and subjects its scientists to "more rigorous" scrutiny than typical scientific peer reviews.
The Government Accountability Office, an investigative arm of Congress, already has been asked to look into whether the FDA muzzled another staffer who linked antidepressants to raising the odds of children suffering suicidal tendencies. When Merck voluntarily pulled Vioxx from the market on Sept. 30, the GAO was asked to roll the FDA's handling of that controversy into its inquiry. That report is not expected for months. Grassley's committee is one of three in Congress also scrutinizing the FDA's actions.
A "picture is emerging of an agency that can't see the forest for the trees," Grassley said. "Merck knew it had trouble on its hands and took action. At the same time, instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert and calling his work 'scientific rumor.'"
Graham was lead author on a research project that studied the records of 1.39 million Kaiser Permanente patients, including 40,405 treated with Pfizer's Celebrex and 26,748 treated with Vioxx. The study found that high doses of Vioxx, known as rofecoxib, tripled risks of heart attacks and sudden cardiac death.
The research team's original conclusion said that high doses of Vioxx should not be prescribed or used. Graham, scheduled to present those findings in late August during an epidemiology conference in France, said he ran into resistance when the FDA reviewed his abstract.
"I think the recommendation about high dose rofecoxib is unnecessary and particularly problematic since FDA funded this study and David's travel to France to present it," Anne E. Trontell, deputy director of the FDA's Office of Drug Safety, wrote in an Aug. 12 e-mail. The internal e-mail exchange was released by Grassley. In the e-mail, Trontell suggested that Graham defer his presentation in favor of a journal article so dissenting scientists - including within the FDA - could comment. She also said Merck should be alerted before the findings became public "so they can be prepared for extensive media attention that this will likely provoke."
Others within the agency suggested Graham's conclusion was too strongly worded, given the FDA had not added such warnings to Vioxx labels. "I've gone about as far as I can without compromising my deeply held conclusions about this safety question," Graham replied in an Aug. 13 e-mail. The FDA said such discussions are typical before scientific findings are published. The conclusion Graham presented in France was revised: "This and other studies cast serious doubt on the safety" of Vioxx doses higher than 25 mg. per day. The FDA said that Graham decided to revise his abstract conclusion. "He did so voluntarily," the agency said.
In testimony before a congressional panel in mid-September, Andrew Mosholder, an FDA epidemiologist, said his bosses asked him to soften recommendations about antidepressants.Mosholder's analysis pointed to increased suicidal thoughts and behaviors among children taking antidepressants well before federal advisers pushed for strident warnings on the drugs. He suggested preferential use of Prozac, the only drug approved to treat depressed children and - according to his review - the one with the lowest risk.
His supervisors within the FDA told him to suggest that children use such medications "with caution," Mosholder told the Congressional panel. Dr. Paul Seligman, acting director of the FDA's Office of Drug Safety, said the agency did not pressure Mosholder to change his conclusion.
Who does FDA serve and protect?
Sunday, November 21, 2004
BY ED SILVERMAN AND DAVID SCHWAB
Star-Ledger Staff
To hear David Graham tell it during a Senate committee hearing three days ago, the United States is virtually defenseless against unsafe medicines, which he largely blames on his own employer of the past 20 years: the Food and Drug Administration. By blaming the FDA, the scientist also thrust a simmering debate about how effectively the federal agency protects consumers and who it really serves squarely into the American conscious.
His explosive remarks -- he compared heart attacks allegedly caused by the Vioxx painkiller to "aircraft dropping from the sky" -- also now place the FDA under unprecedented pressure to overhaul how it regulates an industry that sells more than $200 billion worth of prescription drugs every year. One idea already gaining steam in Congress is to create an independent panel to oversee the agency's safety activities.
"We have a broken system," said Raymond Woosley, a respected FDA consultant who was a leader in the successful fight to get the agency to ban the dietary supplement ephedra. "At the end of the day, we need someone independent of the process who is involved in safety decisions."
The implications of a potential regulatory shakeup are tremendous for consumers, doctors and pharmaceutical companies that employ tens of thousands of workers in New Jersey.
The FDA is responsible for a delicate, high-stakes balancing act, approving drugs that provide needed relief to millions of Americans but don't cause them harm. At the same time, the agency must weigh the demands of powerful drug makers who want fast approvals so their medicines can start generating cash.
"Overall, we should remember that this agency is a gold standard, a benchmark, for the rest of the world," Fred Hassan, chief executive of Kenilworth-based Schering-Plough, said Friday. "We should respect this and be very careful not to take hasty or politicized actions."
By its own estimates, the FDA regulates more than $1 trillion worth of products, everything from pills for aches and pains, to pet food and microwave ovens used to heat lunches.
The agency operates out of a huge, plain office building in Rockville, Md., a bustling suburb of Washington D.C., but many of its 9,000 scientists, inspectors and other workers are spread across the country.
The FDA chairman is appointed by the president, though the job has received little attention under President Bush, who was in office for more than a year before filling it. The man he picked, Mark McClellan, left last February -- with plaudits from the industry -- to head the agency that oversees Medicare and Medicaid. Deputy Commissioner Lester Crawford replaced him and has kept the interim tag the past nine months.
Getting drugs like Vioxx, which was sold by Whitehouse Station-based Merck, approved is a lengthy and costly process.
Developing a single medicine costs nearly $900 million and takes an average of 10 years to go from concept to the consumer.Of every 5,000 compounds identified, only five make it to human testing, and only one winds up getting approved.
ADDRESSING THE CRITICS
Stung by the recent criticism, including over a critical shortage of flu vaccine, FDA officials argue they already are taking steps in the right direction.
Officials say the FDA plans to sponsor an independent study of how it monitors the safety of medicines on the market, fill a key safety post that has been vacant a year and create a program so outside experts can review complaints from agency whistle-blowers, such as Graham.
"The FDA takes all allegations of safety risks seriously," said Steven Galson, acting director of the agency's Center for Drug Evaluation and Research, on Friday.
Over the past decade, though, critics say efforts to walk the tightrope between consumers and drug makers are tilting too far towardthe industry.
They point to the costly withdrawal of such drugs as the fen-phen diet pills in 1997 and the Rezulin diabetes treatment three years later over safety concerns. More recently, critics blasted the agency for not doing enough to warn parents that antidepressants could cause suicidal thoughts among teenagers.
THE VIOXX CASE
Then came Vioxx, the blockbuster medicine that hit the market in 1999 with the promise to relieve arthritis and other pain without upsetting patients' stomachs.
Since its inception, though, respected physicians and researchers suggested the arthritis medicine caused heart attacks and strokes in some people. Internal Merck documents show the company was grappling with understanding links to heart problems before 1998. Eventually, the FDA did require the company to put a warning on Vioxx's label. But it was Merck -- and not the FDA -- that yanked the drug from the market Sept. 30 after a study showed a greater heart risk for patients on the medicine for at least 18 months.
"There has been real slippage. I don't think they merit the (gold standard) designation today," said Merrill Goozner of the Center for Science in the Public Interest, a consumer advocacy group. "They are not to be the friend of the pharmaceutical industry. They are to regulate the pharmaceutical industry."
CHANGED LANDSCAPE
The shift began, critics say, with legislative and regulatory changes.
A 1997 rule change, for example, quickly led to a surge in consumer ads that have drawn fire for allowing companies to promote drugs consumers may not need. Merck spent about $500 million over a five-year period to advertise Vioxx on television and in magazines. The highest annual spending occurred in 2000, when safety issues were first widely publicized.
Another important development occurred when drug companies were permitted to pay the FDA fees to cover expenses for product reviews. In 2000, those fees totaled $141 million and rose to $252 million this year, according to the FDA Web site.
To some, this created a climate in which the FDA became beholden to drug makers. Critics say some FDA officials see the companies as clients.
In his congressional testimony last week, Graham, referred to tensions within the agency's units that review medicines and analyze side effects and safety risks. "The FDA has been giving too much weight to the industry and not enough weight to its own safety staff," said Thomas Moore, a drug-policy analyst at George Washington University. Alan Goldhammer, associate vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, the industry's trade group, denied drug makers get special treatment from the FDA.
"We provide them user fees and they provide performance," he said. "But their performance does not guarantee approvals, it only requires them to meet certain timelines." These fees are supposed to pay for adding 106 new FDA staffers -- a doubling in size -- over the next four years to monitor drug safety. He also noted that, over the past 20 years, the percentage of drugs withdrawn from the market has remained at less than 3 percent.
"We think the FDA is doing a good job," he said.
But a Governmental Accountability Office report found 51 percent of prescription drugs have safety issues leading to withdrawals or changes in the labeling information, said Brian Strom, a biostatistician and epidemiology professor at the University of Pennsylvania. He suggested a ban on direct-to-consumer advertising for the first three years a drug is available to limit demand. He also advocated mandating follow-up safety studies three years after a drug is approved. "The fact that a drug is withdrawn is a success. The failures are the ones we don't know about," he said. "Almost all drugs have major side effects at the time they're approved and we need to follow that in the marketplace." Susan Todd contributed to this report.
FDA Whistle Blower Dr. David Graham Shocks Viewers In Interview With CNN's Lou Dobbs
Dec 2, 2004
Source: CNN Interview
Interview with Dr. David Graham
conducted by Lou Dobbs, CNN
December 2, 2004-12-02
DOBBS: My next guest tonight sparked a wave of controversy surrounding the Food and Drug Administration and the deadly drug as it turns out, Vioxx. In his testimony before the Senate, Dr. David Graham said we are virtually defenseless, because the FDA simply cannot protect us from dangerous drugs.
Joining me now from Washington, D.C., is Dr. David Graham. And the attorney for Dr. David Graham, Tom Devine. He's also legal director of the Government Accountability Project. And I think it would be incumbent upon me, and I will ask you, Tom Devine, to correct me on this, Dr. David Graham, in addition to providing a tremendous public service through his act of conscience and courage, in exposing not only Vioxx but other drugs as well, is in a very difficult position as a government employee, as a whistle-blower. And you are here to provide, if you will, counsel to the doctor. Is that a fair statement of the situation?
TOM DEVINE, GRAHAM'S ATTORNEY: Yes. My job is to help him commit the truth and get away with it.
DOBBS: Well put. And I will try to facilitate that as best I can as well, and in any small way that I can.
First, Dr. David Graham, I want to say to you, the country, it seems to me, clearly owes you a great debt. It's remarkable that a man who is one of the drug safety scientists, an employee of the FDA, has to speak out against his own agency in order to assure the public safety and well-being, that you've done that, and I certainly want to express my congratulations and thanks to you.
DR. DAVID GRAHAM, FDA WHISTLE-BLOWER: Thank you.
DOBBS: That being the case, where does this leave you right now with this agency?
GRAHAM: I think my position is tenuous. I continue to do the work that I love, and I'm very effective at, but it's in an environment of hostility, environment of threats, an environment of intimidation, an environment where I think that if management had its way, had its chance, I'd be gone in a nanosecond, or transferred to some place where I wouldn't be effective.
DOBBS: The very idea -- because most of us look upon the FDA in this country as serving us, the consumers, the patients, those who require prescription drugs. We look upon the FDA -- we look upon ourselves as being their primary constituent.
That is clearly not the -- the reality, if they would lash out at you after providing truth and a public service, is it?
GRAHAM: I'd have to agree with you. I think it's important -- well, two things are important. First, that people understand I'm speaking for myself and not on behalf of the FDA. But I think that's obvious. The second is, is that most of the scientists who work at FDA are very conscientious, very dedicated, and are trying to do the right thing by the American people.
I think where the problem is is with the management of FDA and the culture that that management has created, that basically, at least in the Center for Drugs where I work, the industry is the client, first and foremost. And that the public, if they're a client at all, if they're a customer at all, it's kind of a distant second.
DOBBS: That being the case, you say this current management, is it simply the management brought in at the FDA under the Bush administration? I want to be clear about this. Or is it an institutional and longer term problem at the FDA?
GRAHAM: This is institutional, and it's long term, and it's taken a generation, probably, to develop. But the culture now is well established, and it feeds on itself.
DOBBS: Dr. Alastair Wood was here last night on this broadcast, as we are examining this issue. And he gave you great credit, Dr. Graham, saying that somewhere approaching 150,000 people have died of heart attacks as a result of Vioxx.
You have also raised, before the Senate committee, a list of other drugs about which you're very concerned. You talked with praise of your colleagues and the other scientists at the FDA.
Why, then, if that is the case, would not men and women of conscience and commitment to public service, besides yourself, step forward and say, we have great reservations about these drugs? We cannot speak with authority and certainty that they are safe for the general public?
GRAHAM: I think you have to look back at the culture that we have at FDA. And I think one way to view it, at least in my experience, is management by terror. And what that involves, then, is that people become terrorized, they become threatened, they are afraid. They're afraid for their careers, they're afraid for their livelihood. They're afraid for their scientific credibility.
In my own example, FDA management did everything they could to destroy my credibility as a scientist, to destroy my personal livelihood, and to destroy my family life. And they did this to defend an indefensible position, which was that Vioxx was not safe, Vioxx probably should never have been approved, and Vioxx certainly should have been taken off the market long before it was. And that was FDA's responsibility and FDA's failing.
DOBBS: With that failing, and having the courage to step forward as a whistle-blower, Dr. Graham, you have also been assisted by Senator Charles Grassley. Give us a sense of how important his support, his relationship with you, how important that's been to you and your ability to speak straightforwardly.
GRAHAM: It's been absolutely indispensable. And I owe the senator a debt of gratitude that I'll never be able to repay. And when I met him, I told him that, and he just smiled and said "thank you." He's a very humble man. But he's very committed to what he does. And his staff are equally committed. And they know who they are, and they know how much they have helped me and the American people. And I'm very thankful for that.
DOBBS: How hopeful are you that we can get this very important agency, the FDA, straightened out, focused in such a way that its first constituency is the American people and not the drug industry in this country?
GRAHAM: In order for that to happen, external pressure, external imposition of change will be needed. FDA is incapable of reforming itself. FDA is incapable of changing its culture. The culture is part of the problem.
If you just sort of look at Vioxx right now, look at these spokespeople who have been the representatives of the agency. At the hearing, Dr. Sandra Kweder, in reference -- when I had testified that there were between 88,000 and 139,000 excess heart attacks because of Vioxx, her response was, during her testimony, "these aren't real deaths." And similarly, Dr. Woodcock has said that it's only a model, as if -- a statistical model, as if what the estimates we've come up with are somehow or another not real.
I think we have an agency in denial. It's denying that it failed the American people. It's denying that it's made a mistake. I think, in a sense, what it is saying is, is that if it had it to do over again, it would do everything exactly the way it did it before. And so, when I testified before the Senate Finance Committee that FDA is not able to protect the American people against another Vioxx, I think I was speaking quite accurately.
DOBBS: And certainly bravely. And we thank you for the great public service that you've performed. And Tom Devine, I hope that you're satisfied that Dr. Graham has committed the truth, as you put it, without getting in trouble. We certainly don't want him to do that. We're also reassured that he has help in avoiding that.
DEVINE: The problem is he doesn't have any viable legal rights. Congress needs to give government workers the same serious free speech laws that corporate employees have. So it's not realistic to expect that government scientists will defend the public if they can't defend themselves. Not everybody has a political angel like Charles Grassley.
DOBBS: And Tom Devine, we thank you for being with us, as we have talked about these very important issues with a brave man, angel or no, in David Graham. Thank you, Dr. Graham.
GRAHAM: Thank you very much, Lou
http://www.usatoday.com/news/health/2004-11-29-fda-graham_x.htm
USA Today
11/29/2004 10:34 PM
Quiet scientist no more
By Rita Rubin, USA TODAY
OLNEY, Md. - Scientist, father, husband and scoutmaster David Graham recently added another job to his résumé. Unlike the others, though, it's one he never sought. "FDA made me into a whistle-blower," Graham, a scientist in the Food and Drug Administration's Office of Drug Safety, said in a three-hour interview Saturday at a coffee shop near his home. "It wasn't my intention to be a whistle-blower.
"All I wanted to do was a study on Vioxx."
As a result of that study, Graham - who for the most part has worked in the relative obscurity typical of an FDA scientist - has appeared recently on Nightline, CNN and Good Morning America. His photo has run in major newspapers across the country. All this because he testified before a Senate
panel Nov. 18 that the FDA, his employer for 20 years, is incapable of protecting the public from dangerous drugs once they come on the market. "What I'm painting is a picture of an FDA that is completely insensitive to drug safety," Graham says.
On Saturday, no one seemed to recognize the wiry 50-year-old, clad in jeans,checked shirt and fleece vest, as he sipped his usual decaf mocha with skim milk and talked passionately about his new role as whistle-blower. One customer did walk over to ask him to stop talking so loudly about bowel movements, part of his discussion of Lotronex, a drug for irritable bowel syndrome. It came back on the market after it was withdrawn because of safety concerns. The study that has thrown Graham into the limelight involved analyzing a database of 1.4 million Kaiser Permanente members. Graham and his collaborators compared the rate of heart attacks and sudden cardiac deaths in patients who took Vioxx or Celebrex, its main competitor, or other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.
"We did this study because I recognized Vioxx was a potential disaster," Graham says. It had all the ingredients: a blockbuster drug used by millions that carried a significantly increased risk of heart attacks, the leading killer in industrialized countries. "I don't think that (FDA management) appreciated what we might find." Graham and his collaborators found that Vioxx users had a higher rate of heart attacks and sudden cardiac deaths than Celebrex users.
Initially, the study received little publicity. Graham presented his results Aug. 25 at a scientific meeting in France. But five weeks later, on Sept. 30, Merck pulled Vioxx off the market because its own study had found a higher rate of heart attacks and strokes in patients taking the drug than in
those on a placebo. Suddenly, Graham's work and questions about what the FDA knew about Vioxx
and when were making headlines. A whistle-blower was born. "FDA has made a systematic attempt to block me in the exercise of my free-speech rights," Graham says.
. Graham says his superiors pressured him to soften his conclusions before presenting them at the August meeting in France. In a news release the day before the Senate hearing, acting FDA commissioner Lester Crawford said Graham voluntarily revised his conclusions. "FDA encourages open and vigorous internal debate about the often difficult scientific questions it routinely faces," Crawford said. Graham paints a different picture: "When you live in a climate of fear, retaliation and intimidation, no decision that one makes is entirely voluntary."
. E-mails between Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, and Richard Horton, editor of The Lancet, a medical journal that had accepted Graham's Vioxx study, suggest that the agency tried to plant doubts about the credibility of the results. . Graham says friends at the FDA have told him that agency officials plan to force him into an administrative job. The agency, saying it could not discuss personnel matters, would neither confirm nor deny that Graham is to be transferred.
"I don't know what's at the bottom of this," Graham says. "The reaction of FDA management to my study of Vioxx is disproportionate to the study." Sen. Chuck Grassley, R-Iowa, last week called for a government investigation into whether FDA management may have tried "to discredit an outspoken safety officer who was challenging the FDA's drug-safety policies." In a letter Monday, Grassley, chair of the Senate Finance Committee that heard Graham's testimony, asked Crawford whether he was planning to fire or transfer Graham against his wishes.
Graham says he has many supporters among the agency's rank and file as well as the public. Colleagues gathered in a cafeteria to watch a broadcast of his Senate testimony. When he returned to work the next day, they greeted him with hugs, kisses and pats on the back. Graham says he has received hundreds of e-mails and telephone calls. Nearly all, he says, are variations on "thank you so much. You're in our prayers. We appreciate what you are doing. This must be so hard on your family." Graham says he has heard concerns similar to his from counterparts who monitor medical devices and biologics, such as vaccines, but they're reluctant to come forward.
"They are absolutely afraid for their jobs," Graham says. "We've got families to support." He's married to his college sweetheart, and they have six children ages 9 to 23. Graham could make a fortune as an expert witness, as other former FDA scientists have, says Wayne Ray, a preventive medicine professor at Vanderbilt University and co-author on Graham's Vioxx study. But that won't happen, Ray says. "Dave is an excellent epidemiologist. He is extremely hardworking. He's extremely honest. He's extremely conscious of data and data accuracy. And he's very devoted to public health. Given those characteristics, I think the job he wants most is the job he has now."
Dear FDA,
I served my country unselfishly for 17 years as a US Marine. I have five children, one was vaccine injured and disabled for life and is such a biological mess that he will need some type of care for his entire life. I scratch my head and wonder why we are injecting our troops with squalene in the anthrax vaccine and thimerosal (mercury) and living aborted fetal tissue in other vaccines. Stop injecting our troops with toxins, moral filth, and experimental vaccines.
This is abhorrent and does nothing other than hurt moral, not to mention those damaged for life. As a result I cannot recommend that my children serve in the US Military. When we all scratch our heads and wonder why the medical establishment has added the thimesoral containing flu vaccine to the infant / toddler schedule amongst the concerns of congress and many doctors with the safety of the current vaccine schedule we can look to history for the answer.
http://www.temple.edu/epiworks/washhands/profile.htm
I read about this doctor in Bob Barefoot's Book "Death by Diet." I then researched and found two pages on him in the encyclopedia Britannica. Check out the above link. One thing my encyclopedia states is that after he encouraged hand washing in Vienna the mortality rate fell from 18.27 to 1.27 percent for those women having babies delivered in the hospital. In March 1848 and August of 1848 the mortality rate was zero while hand washing was taking place. These doctors and their students would go from conducting autopsies on people who died from a disease directly to operating on and delivering babies. No hand washing at all.
So what was Vienna's response? They fired Semmelweis, he went to a different hospital in Pest and began saving lives there. Vienna went back to NOT washing and then mortality went back up to 10 to 15 percent. Things did not change for literally decades.
*** Reluctance to change ***
That is what continued to kill woman having babies delivered in the hospitals by the doctors. The midwife wing did not have the severity of the problem nor did those who were delivering at home. History has many answers. So, when you leave the hospital or doctors office with your autistic child. Just think of Dr. Semmelweis, and the lives he saved by standing up for common sense and cause and effect medicine. The DAN protocol has been written by the Dr. Semmelweis' of our day. They hold some measure of relief for your suffering children. Buy the protocol and read, and don't stop. Your child is where your responsibility is at.
However, one last fact to remember. Dr. Semmelwies is said to have gone insane as a result of his inability to understand why peoples "pride" and "reluctance to change" took precedence over the health of their patients. So be careful, don't expect things to change overnight. A generation will have to die off prior to common sense ever taking hold again. If it ever does.
Unless the FDA is able to stand up to the big money interests of the Pharmecutical Giants
Robert Meyer
2330 William Court NW
Cedar Rapids, Iowa 52405
r_d_meyer@netzero.net
National Vaccine Information Center Newsletter e-NEWS
" Consumers won't be aware that meat and poultry products have been treated with the spray, Zajac added. The Department of Agriculture will regulate the actual use of the product. The viruses are grown in a preparation of the very bacteria they kill, and then purified. The FDA had concerns that the virus preparation potentially could contain toxic residues associated with the bacteria. However, testing did not reveal the presence of such residues, which in small quantities likely wouldn't cause health problems anyway, the FDA said." - Associated Press, Aug. 18, 2006 Barbara Loe Fisher Comments:
In yet another stunning demonstration of callous disregard for the health of American citizens, a pathetically weak and useless Food and Drug Administration has given the green light to industry microbe hunters to spray cold cuts, poultry and other meats with a mix of viruses that are supposed to eat bacteria contaminating the meat without hurting anyone in the process. Right.
And the best part? Meat producers won't have to tell consumers which meats have been bathed in the viruses so everyone gets a dose eating a hot dog at a baseball game or frying up some ham and eggs for breakfast - whether they want it or not. And when Uncle Leo in the Bronx drops dead from a mysterious infection after eating an italian sub at a neighborhood picnic, the story will be: it wasn't the virus infected sausage that did it, it was - A COINCIDENCE. (But if enough people drop dead after eating virus infected meat, an enterprising drug company will probably develop a food vaccine and convince the CDC to mandate it).
In America, apparently the only way consumers will be able to protect themselves from FDA-sponsored contaminated meat is to become a vegan or go organic. It's an expensive alternative but a small price to pay to keep viruses, chemicals and hormones that don't belong in the food we eat out of our bodies.
FDA Says Viruses Safe for Treating Meat
Associated Press
FORBES
August 18, 2006
By ANDREW BRIDGES
A mix of bacteria-killing viruses can be safely sprayed on cold cuts, hot dogs and sausages to combat common microbes that kill hundreds of people a year, federal health officials said Friday in granting the first-ever approval of viruses as a food additive. The combination of six viruses is designed to be sprayed on ready-to-eat meat and poultry products, including sliced ham and turkey, said John Vazzana, president and chief executive officer of manufacturer Intralytix Inc.
The special viruses called bacteriophages are meant to kill strains of the Listeria monocytogenes bacterium, the Food and Drug Administration said in declaring it safe to use on ready-to-eat meats prior to their packaging.
The viruses are the first to win FDA approval for use as a food additive, said Andrew Zajac, of the regulatory agency's office of food additive safety. The bacterium the viruses target can cause a serious infection called listeriosis, primarily in pregnant women, newborns and adults with weakened immune systems. In the United States, an estimated 2,500 people become seriously ill with listeriosis each year, according to the Centers for Disease Control and Prevention. Of those, 500 die.
Luncheon meats are particularly vulnerable to Listeria since once purchased, they typically aren't cooked or reheated, which can kill harmful bacteria like Listeria, Zajac said. The preparation of bacteriophages - the name is Greek for "bacteria-eater" -attacks only strains of the Listeria bacterium and not human or plant cells, the FDA said.
"As long as it used in accordance with the regulations, we have concluded it's safe," Zajac said. People normally come into contact with phages through food, water and the environment, and they are found in our digestive tracts,the FDA said. Consumers won't be aware that meat and poultry products have been treated with the spray, Zajac added. The Department of Agriculture will regulate the actual use of the product. The viruses are grown in a preparation of the very bacteria they kill, and then purified. The FDA had concerns that the virus preparation potentially could contain toxic residues associated with the bacteria. However, testing did not reveal the presence of such residues, which in small quantities likely
wouldn't cause health problems anyway, the FDA said.
"The FDA is applying one of the toughest food- safety standards which they have to find this is safe," said Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, a consumer advocacy group. "They couldn't approve this product if they had questions about its safety."
Intralytix, based in Baltimore, first petitioned the FDA in 2002 to allow the viruses to be used as a food additive. It has since licensed the product to a multinational company, which intends to market it worldwide, said Intralytix president Vazzana. He declined to name the company but said he expected it to announce its plans within weeks or months. Intralytix also plans to seek FDA approval for another bacteriophage product to kill E. coli bacteria on beef before it is ground, Vazzana said. Scientists have long studied bacteriophages as a bacteria-fighting alternative to antibiotics.
February 26, 2007 by the Boston Globe
Taking Back the FDA
by Marcia Angell, who is now a Senior Lecturer in the Department of Social Medicine at Harvard Medical School. She stepped down as Editor-in-Chief of the New England Journal of Medicine on June 30, 2000. A graduate of BostonUniversity School of Medicine, she trained in both internal medicine and anatomic pathology and is a board-certified pathologist. She joined the editorial staff of the New England Journal of Medicine in 1979, became Executive Editor in 1988, and Editor-in-Chief in 1999.
http://www.boston.com/yourlife/health/diseases/articles/2007/02/26/taking_back_the_fda
It's time to take the Food and Drug Administration back from the drug companies. Before a prescription drug can be sold, the manufacturer must conduct clinical trials to prove to the FDA that the drug is safe and effective. Without that, doctors have no way of knowing how good or bad a drug is. Just trying it out would be not only risky, but unreliable, since individual experience can be misleading. The scrutiny that this agency exists to provide is vital to our health.
But in 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process. In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.
But while it's a small investment for drug companies, it's a lot of money for the agency, and it has drastically changed the way it operates -- creating a disproportionate emphasis on approving brand-name drugs in a hurry. Consequently, the part of the agency that reviews new drugs gets more than half its money from user fees, and it has grown rapidly. Meanwhile, the parts that monitor safety, ensure manufacturing standards, and check ads for accuracy have languished or even shrunk.
Most tellingly, the office that approves generic drugs is so small that approval time for generics is twice as long as for brand-name drugs. There is now a backlog of more than 800 generics. That delay is worth billions of dollars to the drug companies whose high prices depend on not having generic competition.
As part of the emphasis on speed, the FDA often approves brand-name drugs on the basis of less evidence than in the past. In these cases, approval may be contingent on companies conducting further safety studies after the drugs are on the market. But the companies usually don't honor that commitment. Of the roughly 1,200 such studies outstanding -- some for years -- over 70 percent haven't been started.
The FDA is strangely silent about this inexcusable dereliction. When questioned, it weakly protests that it doesn't have the authority to compel the research. In fact, it has enormous leverage, since it can withdraw drugs from the market. The FDA also refuses to release unfavorable research results in its possession without the sponsoring company's permission. Here again, it contends not to have the authority to do so, but providing evidence of side-effects or negative results would seem to be an integral part of its job. It's no wonder that serious safety concerns about drugs such as Vioxx, Paxil, and Zyprexa have emerged very late in the day -- years after they were in widespread use.
The agency's coziness with industry is underscored by the composition of its 18 advisory committees -- outside experts who help evaluate drugs. Incredibly, many of these advisers work as consultants for drug companies. Although they are supposed to recuse themselves if there is a direct conflict of interest, the FDA regularly grants exemptions from that requirement. Of the six members of the advisory committee that in 1999 recommended approving Vioxx -- the arthritis drug pulled from the market in 2004 because it caused heart attacks -- four had received waivers from the conflict-of-interest rule.
The FDA now behaves as though the pharmaceutical industry is its user, not the public. Fortunately, the user fee law is subject to renewal every five years, and this is one of those years. Congress should let the law die this time around and substitute its own support -- which ought to be increased. Other reforms recently proposed, such as administratively separating drug approval from safety surveillance, will not mean much as long as this law is in effect. At $300 million to $400 million a year, the equivalent of about a day in Iraq, Congress can easily afford to buy this vital agency back for thepublic, and it should.
*The material in this post is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.For more information go to: http://www4.law.cornell.edu/uscode/17/107.html http://oregon.uoregon.edu/~csundt/documents.htm If you wish to use copyrighted material from this email for purposes that go beyond 'fair use', you must obtain permission from the copyright owner.
http://www.chron.com/disp/story.mpl/nation/4600179.html
March 3, 2007, 10:19PM
FDA poised to approve cattle antibiotic despite warnings
Agency likely will approve antibiotic despite fears it could harm people
By RICK WEISS
Washington Post
The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous — for people.
The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defense against several serious human infections. No drug from that class has ever been approved in the United States for use in animals.
The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotic, as has happened with other drugs. Those super-microbes could then spread to people.
Echoing those concerns, the FDA's advisory board voted last fall to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.
Yet by all indications, the FDA will approve cefquinome this spring. That is all but required by a recently implemented "guidance document" codifying how to weigh threats to human health posed by proposed animal drugs.
The wording of "Guidance for Industry 152" was crafted within the FDA after a long struggle. Some say it makes it too difficult for the FDA to say "no" to some drugs.
"The industry says that 'Until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,' " said Edward Belongia, an epidemiologist at the Marshfield (Wis.) Clinic Research Foundation. "But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open."
The FDA knows how hard it can be to close that door. In the mid-1990s, overriding the objections of public health experts, it approved the marketing of Baytril and SaraFlox for use in poultry. Both are fluoroquinolones, drugs important for their ability to fight the bacterium that causes anthrax and the food-borne bacterium campylobacter, which causes a diarrheal disease in people.
Before long, doctors began finding fluoroquinolone-resistant strains of campylobacter in patients hospitalized with severe diarrhea. When studies showed a link to poultry, the FDA sought a ban. Abbott Laboratories pulled Saraflox, but Baytril's manufacturer, Bayer, pushed back.
Late in 2005, Bayer gave up, but not before not before fluoroquinolone resistance had spread further.
http://www.newstarget.com/z021795.html
NewsTarget.com printable article Originally published April 16 2007
Americans fed up with drug industry influence, FDA corruption, reveals remarkable Consumer Reports survey by Mike Adams
(NewsTarget) More than four out of five Americans think drug companies have too much influence over the Food and Drug Administration, and 84 percent believe that advertisements for prescription drugs with safety concerns should be outlawed, reveals a striking new survey from Consumer Reports.
The survey results, released today, are based on a telephone survey of 1,026 American adults conducted by the Consumer Reports National Research Center. They reveal the Food and Drug Administration to be alarmingly out of touch with the concerns of the American people. Some of the most interesting results include:
• 96 percent agreed the government should have the power to require warning labels on drugs with known safety problems. As Consumer Reports explains, "Right now, the Food and Drug Administration must negotiate safety warning labels with a drug maker."
• 84 percent agree that drug companies have "too much influence over the government officials who regulate them." More than two-thirds of those surveyed are concerned that drug companies actually pay the FDA to review and approve their drugs. It's a situation that turns drug companies into the "customers" of the FDA. (See related cartoon, The Puppets of Big Pharma)
• 92 percent agree that pharmaceutical companies should disclose the results of ALL clinical trials, not just the ones with positive results that they wish to publicize. (Currently, drug companies can bury negative drug trials, and the FDA has in fact been caught conspiring with drug companies to keep negative drug data secret from the public.)
• 93 percent think that the FDA should have the power to demand follow-up safety studies from drug companies. Currently, the FDA has no authority to require follow-up safety studies on drugs after they are introdued to the market. This is a serious oversight shortfall, given that many problems with drugs only appear after widespread use. (Patients are widely used as guinea pigs in any new drug launch.)
FDA Conflicts of Interest. Click to view full cartoon.• 60 percent agreed that doctors and scientists with a financial conflict of interest should not be allowed to serve on FDA advisory boards (what were the other 40 percent thinking?). Currently, doctors who earn hundreds of thousands of dollars each year in "consulting fees" from drug companies are not only allowed to vote on the recommendations for FDA approval of their drugs, there is not even any FDA requirement to disclose such conflicts of interest. (See related cartoon on FDA Conflicts of Interest)
New rules proposed by the FDA would reduce this level of corruption by allowing doctors to receive a maximum of $50,000 per year from companies impacted by their decisions. (Thereby making the FDA numerically less corrupt than it is now, but still tolerating blatant conflicts of interest. It's like setting a "bribery ceiling.")
• 91 percent said they had seen a drug advertisement on television or in print (a "victory" accomplished by the FDA legalizing such ads in 1998), and 26 percent said they asked their doctor for a brand-name medication after learning about it from an advertisement. This is the purpose of advertising, of course: To increase sales of drugs, not -- as is claimed by Big Pharma and the FDA -- to "educate" patients about medical treatments.
• 75 percent agreed that the allowing of drug advertising has resulted in the over-prescribing of pharmaceuticals. Fifty-nine percent said the government should restrict pharmaceutical advertising, and 26 percent said they "strongly agree" with such restrictions.
Direct-to-consumer advertising is the bread and butter of Big Pharma, and it is the primary reason the industry has exploded its revenues and influence since 1998. The invention and marketing of fictitious diseases via television advertising has proven instrumental to the drug industry's successful pushing of medically unjustified drugs onto consumers. (See the Disease Mongering Engine to invent your own fictitious diseases and disorders right now!)
• The survey further revealed 54 percent of consumers think that viewing drug advertisements allows them to "take charge of their health care." The survey did not, however, reveal whether these people were in fact suffering from deterimental cognitive side effects at the moment they were taking the survey. Statistically, it seems reasonable to assume that approximately half of the adults taking the survey were on drugs at the time they were answering the survey questions.
When Pharmacists Tell the Truth. Click to view full cartoon.• More than half of those surveyed said they are currently taking prescription drugs, indicating that more than half of American adults are now on drugs. Forty percent said they have experienced a negative reaction (side effect) from taking prescription medications. (See related cartoon on side effects.)
Most side effects go unreported, and there is currently no enforced legal requirement that doctors or drug companies report known side effects to the FDA. According to the Journal of the American Medical Association, prescription drugs currently kill approximately 100,000 Americans each year. None of those deaths are accurately recorded as "death by pharmaceuticals."
• As mentioned earlier, 84 percent agree that advertisements should be outlawed for drugs with safety concerns. The United States is the only advanced nation in the world that allows drug companies to advertise directly to consumers. It was legalized in 1998 by the FDA, following political pressure and influence from the drug companies who knew that being able to promote fictitious diseases and push brand-name drugs would result in windfall profits. (Some drugs are sold at markups as high as 300,000% over the cost of their ingredients.)
The makers of Vioxx and Paxil had studies that indicated safety problems for years, but did not release those results to the public. - Consumer Reports
The real threat of pharmaceuticals Interestingly, the survey did not ask consumers the following question: How many Americans do you think is acceptable for the drug companies to kill each year?
Because right now, that number is, conservatively, about 100,000 American citizens. More realistic estimates put it at double that number, or 200,000. I've often stated that pharmaceuticals kill more Americans each year than diet in the entire Vietnam War, and the number of Americans killed by acts of terrorism are dwarfed by the number killed by prescription drugs that the FDA and drug companies unquestionably knew were killing people. It's not that these deaths were truly accidental... they were fully documented but ignored anyway by an industry that is now clearly a very real threat to the health and safety of the American people.
This is no exaggeration: The number of people killed by FDA-approved pharmaceuticals since 9/11 is equivalent to dropping a nuclear bomb on a major U.S. city. International terrorists could not even hope to cause the number of casualties in the United States that have been achieved by the drug companies working in conspiracy with the FDA.
If we don't put limits on the influence and corruption of the drug companies by banning drug ads and demanding serious FDA reforms, the body count will only get worse. Consumers are finally waking up to this reality, and they're increasingly demanding "get tough" solutions that would require the FDA to protect the people instead of protecting Big Pharma profits.
As Bill Baughan, a senior policy analyst with Consumers Union (Consumer Reports), said, "Consumers expect Congress to take their concerns about drug safety seriously, and deliver legislation that will prevent future Vioxx-type disasters. Failure to act this year on the strongest possible bill, when more than 80 pecent of Americans agree that Congress should do whatever is necessary to ensure drug safety, would equate to gross legislative malpractice."
Most Americans agree with NewsTarget What's really interesting about these results is that they show most Americans agree with NewsTarget on issues like drug advertising, ending conflicts of interest at the FDA, requiring all clinical trials to be published, and other similar topics covered in this survey.
Meanwhile, very few Americans agree with the FDA or the wishes of organizations like the American Medical Association and drug companies themselves -- most of which like things just fine the way they are.
Drug companies, of course, would love to maintain the status quo and continue conducting business as usual. But thanks to grassroots consumer advocacy campaigns such as StopDrugAds (www.StopDrugAds.org), and sites like this one, the real story about the dangers of pharmaceuticals are no longer being censored and kept from the public.
The word is out: Pharmaceuticals are now the 4th leading cause of death in America. The best way to protect Americans from these dangerous, deadly products is to enact sweeping reforms that end the medical racket currently being operated by the FDA / Big Pharma tag-team.
Unfortunately, many of the very lawmakers who will vote on this pending legislation are, much like FDA advisors, "on the take" from the very same pharmaeutical companies that stand to be impacted by their vote. And no lawmakers that I know of are abstaining from the vote due to conflicts of interest. The reality is that Big Pharma has bought Congress, and whatever vote that will soon emerge is a far cry from the real reforms we'd see if our national lawmakers weren't financially beholden to the drug companies for their own reelection campaigns.
Thus, if Congress actually manages to pass a law that would eliminate drug company influence over FDA decision makers, it would be a clear case of lawmakers under the influence of drug money passing laws to eliminate the influence of drug money for others, but not for themselves.
There should be a law against that, it seems.
The FDA Vision Test. Click to view full cartoon.
True facts about the FDA The following are facts about the FDA I've documented in my new book, Natural Health Solutions and the Conspiracy to Keep You From Knowing About Them. As this book reveals, the FDA has:
Worked to keep deadly drugs on the market as long as possible before reluctantly pulling them (usually only after being sued by groups like Public Citizen). The astonishing story of Rezulin, a diabetes drug, is a good example.
Repeatedly banned and confiscated herbs and nutritional supplements that compete with prescription drugs. Ephedra, for example, was banned by the FDA based on a political agenda, not good science.
Conducted armed raids on alternative medicine clinics, confiscating computers, threatening alternative health practitioners, and scaring away patients. (See Tyranny in the USA: The true history of FDA raids on healers, vitamin shops and supplement companies)
Ordered the destruction of recipe books promoting stevia, a natural sweetener that competes with sales of aspartame (yes, the FDA actually ordered the books to be destroyed).
Been caught red-handed accepting bribes.
Voted to put deadly drugs right back on the market even after such drugs were recalled by their manufacturer.
Openly opposed the banning of junk food advertising to children during World Health Organization meetings.
Suppressed information about the harm caused by dangerous drugs in order to prevent the press and the public from learning the truth about them.
Attempted to silence its own drug safety scientists to prevent them from going public with the truth about dangerous drugs.
Censored scientific information about the benefits of natural foods like cherries by threatening cherry growers with legal action if they did not remove scientific information about cherries from their websites. (See FDA tyranny and the censorship of cherry health facts)
Pursued and shut down companies selling genuine cancer cures that provably work better than any prescription drug (such as Lane Labs' MGN-3).
Vigorously argued against making "optimal health" a goal of the Codex Alimentarius discussions, striking the phrase from the final report.
Rigged its drug safety review panels with decision makers who have substantial financial ties to drug companies, even while refusing to disclose such blatant conflicts of interest.
Planned, organized, and took part in armed "SWAT-style" raids on vitamin shops, pet food stores, and even a church.
Knowingly approved harmful food additives for widespread use in the food supply (such as aspartame, which has a rather dubious history and has been proven toxic in several studies), even when its own safety experts recommended denying approval.
Allowed the continued legal use of harmful, cancer-causing food additives in the national food supply such as sodium nitrite (which causes cancer and yet is intentionally added to nearly all processed meats).
Refused to ban a poisonous artificial fat from the food supply (hydrogenated oils) for decades, even though the World Health Organization urged member nations to outlaw the substance in 1978. Hydrogenated oils continue to harm infants, children, and adults today.
It is clearly time to reform not merely the FDA, but the entire medical industry. Drug companies are running amok, and this new Consumer Reports survey reveals that consumers are finally fed up with it.
Action Items: Support the Health Freedom Protection Act introduced by Rep. Ron Paul. Learn more at http://www.stopFDAcensorship.org
Send a letter to protect your health freedom
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