[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:
Primary Changes and Updates in the Recommendations
The 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:
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).
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:
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
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
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.
Contact FDA by Mail or Telephone
If 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)
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
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."
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.
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.
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.
"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.)
"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.
"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.
"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.
FDA's McClellan, `Loved by Industry,' Seeks Fast Drug Reviews
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
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:
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?type=businessNews&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
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 y
