FDA Official Admits 'Lapses' on Vioxx - FDA Didn't Heed Warnings
From: Dr. Jai Maharaj (usenet_at_mantra.com)
Date: 03/02/05
- Next message: Jim: "Re: FDA Official Admits 'Lapses' on Vioxx - FDA Didn't Heed Warnings"
- Previous message: William Wagner: "Re: stroke, homocysteine and B 12"
- Next in thread: Jim: "Re: FDA Official Admits 'Lapses' on Vioxx - FDA Didn't Heed Warnings"
- Reply: Jim: "Re: FDA Official Admits 'Lapses' on Vioxx - FDA Didn't Heed Warnings"
- Messages sorted by: [ date ] [ thread ]
Date: Wed, 02 Mar 2005 22:44:37 GMT
More material for Michael Moore's upcoming film about Big Pharma:
Forwarded message from "VERACARE" <veracare@ahrp.org>
[ Subject: FDA Official Admits 'Lapses' on Vioxx_FDA Didn't Heed Warnings
[ From: "VERACARE" <veracare@ahrp.org>
[ Date: 2 Mar 2005 15:55:46 -0600
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
www.ahrp.org
FYI
As the Senate committee on Health, Education, Labor and Pensions prepares
for the second day hearing about FDA's performance, one hopes that the
committee will follow up Tuesday's hearing with some tough questions about
FDA's failure to heed warning signals, thereby endangering lives.
The New York Times reports (below) that Dr. Sandra Kweder, deputy director
of FDA's office of new drugs at the agency, acknowledged "the agency took
too long to get information about Vioxx's heart risks into the prescribing
label that is provided to physicians. More than a year passed between an
advisory panel's conclusion that those risks should be highlighted and the
label changes," she said.
Dr. Kweder blamed difficult negotiations with Vioxx's maker, Merck, for the
delay.
Who is responsible for FDA's stealthy rescinding of the statement from
antidepressant warning labels acknowledging that: ""A causal role for
antidepressants in inducing suicidality has been established in pediatric
patients"?
This statement wa part of the warning label for antidepressants that the FDA
issued on March 22, and reaffirmed on October 15-when the FDA added a Black
Box warning. But on February 10, 2005, Dr. Steve Romano, vice-president of
Pfizer, announced--during criminal court proceedings in which the
antidepressant Zoloft figured prominently--that the FDA had rescinded the
statement.
By rescinding the agreed upon language, the FDA is helping to blur the
clarity and reduce the impact of the Black Box warning. Was this action
taken under pressure from Pfizer?
Another example involves the MS drug, Tysabri, which the manufacturer has
just withdrawn after a patient died of progressive multifocal
leukoencephalopathy, or PML, a rare central nervous system disease usually
seen in AIDS patients.
The Los Angeles Times reports (below) several scientists expressed concern
about the drug prior to its fast-track approval.
Dr. Lawrence Steinman, a Stanford University professor and an MS specialist,
said he repeatedly wrote and spoke about "the potential for serious
immune-system side effects with this type of drug." Indeed, other experts
in the field say the body's immune cells were a poor target for an MS drug.
Tysabri "blocks the ability of [immune cells] to get from the blood vessels
to the tissue to fight infection." In the opinion of Stephen Miller, a
microbiologist at Northwestern University who has collaborated with Biogen
on studies in the past, "that is not the way to go."
"It's a legitimate question to ask if the FDA paid any attention to those
concerns, and if not, why not?"
Souglas Throckmorton, acting deputy director of the FDA's Center for Drug
Evaluation and Research (CDER), when confronted with these concerns and with
FDA's failure to give Dr. Steinman an opportunity to discuss with FDA
officials his concerns, Throckmorton responded: "The trials were well
planned and well conducted, and the outcomes suggested a product with
important scientific advances."
There is a cultural divide it seems, between FDA officials at CDER and
responsible scientists for whom safety issues remain a central concern. Even
scientists in the biotechnology industry acknowledge that something clearly
went wrong in the agency's expedited process:
"The fast-track process, in the situation that exists, obviously is not
working right," said Joseph Panetta, president of Biocom, an industry group
in San Diego, where Biogen ranks among the largest biotech employers.
"Something about the process needs to be restructured."
Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
http://www.nytimes.com/2005/03/02/politics/02fda.html?ei=5070
<http://www.nytimes.com/2005/03/02/politics/02fda.html?ei=5070&en=d145397e28
e93662&ex=1110430800&adxnnl=1&adxnnlx=1109791636-CH1TYkTybBJvU5M2C4+v3w>
&en=d145397e28e93662&ex=1110430800&adxnnl=1&adxnnlx=1109791636-CH1TYkTybBJvU
5M2C4+v3w
THE NEW YORK TIMES
March 2, 2005
F.D.A. Official Admits 'Lapses' on Vioxx
By GARDINER HARRIS
<http://query.nytimes.com/search/query?ppds=bylL&v1=GARDINER%20HARRIS&fdq=19
960101&td=sysdate&sort=newest&ac=GARDINER%20HARRIS&inline=nyt-per>
ASHINGTON, March 1 - After the Food and Drug Administration insisted for
months that it did nothing wrong in its oversight of the withdrawn pain pill
Vioxx, a top agency official acknowledged "lapses" in the agency's actions
before a Senate panel on Tuesday.
The official, Dr. Sandra Kweder, deputy director of the office of new drugs
at the agency, also said the power to require label changes "would be very
helpful."
Most witnesses testifying before the panel, the Senate Committee on Health,
Education, Labor and Pensions, agreed, saying the agency should have the
authority to force label changes and make companies conduct tests if safety
issues arose after a drug was approved.
Dr. Steven Galson, the director of the new drug center, said after the
hearing that the F.D.A. had not requested new authority over labels.
Dr. Kweder said the agency took too long to get information about Vioxx's
heart risks into the prescribing label that is provided to physicians. More
than a year passed between an advisory panel's conclusion that those risks
should be highlighted and the label changes, she said.
Dr. Kweder blamed difficult negotiations with Vioxx's maker, Merck, for the
delay. "We don't have the authority to tell a company, 'This is how your
label has to look,' " she said. "We have to negotiate with the company the
specific language of how things should be worded, the placement, those kinds
of things, after talking to them."
The other lapse, Dr. Kweder said, was "the failure of that information
somehow to be in the forefront of the consciousness of the prescribing
physician."
Millions of people took Vioxx in the years after its risks to the heart
became apparent. As a result, as many as 55,000 patients may have died from
heart attacks and strokes induced by the drug, according to estimates by
drug safety officials at the F.D.A. Merck withdrew the drug from the market
in September, after a test showed that it doubled the risk of heart attack
and stroke.
Dr. Kweder's admission could cause difficulties for Merck, which is battling
more than 800 lawsuits filed by thousands of patients claiming that they
were injured by Vioxx.
Casey Stavropoulos, a Merck spokeswoman, responded, "We worked diligently
with F.D.A. to do all requested analyses and develop labeling that provided
physicians with the most accurate and appropriate information."
An F.D.A. advisory panel concluded last month that Celebrex and Bextra,
similar pills made by Pfizer, also cause heart problems. The panel concluded
that all of these drugs should have labels with strong warnings about their
heart risks.
Senator Michael B. Enzi, a Wyoming Republican who is chairman of the health
committee, said he had not decided what changes, if any, he would propose
for the agency. But he said examining problems at the F.D.A. was "not only
critical, but it's also a hot issue right now."
Senator Patty Murray, Democrat of Washington, asked Dr. Kweder during the
hearing if Merck had rejected F.D.A.'s initial proposals to warn of Vioxx's
heart risks on its label. "They rejected many of our proposals, and we
similarly rejected many of the proposals they sent to us," Dr. Kweder said.
The negotiations began in February 2001 and were not resolved until April
2002, a period that Dr. Kweder said was unusually long. "Usually it's just a
matter of a few back-and-forths and getting the language right," she said.
Dr. Kweder also said the Bush administration's proposal to add $5 million to
the agency's budget in the 2006 fiscal year for tracking the safety of drugs
once they are approved represented "a good down payment."
The F.D.A. has almost no ability to uncover dangers once drugs are approved
if risks are common problems like heart attacks, top agency officials have
said. Every witness who went before the panel on Tuesday said the agency
must do a better job of uncovering such dangers using existing computer
databases.
One witness argued that the agency did not need more power. Dr. Scott
Gottlieb, a former top official at the agency who is now at the American
Enterprise Institute, a conservative research group, said the agency
"doesn't use its existing authority very well."
Dr. Gottlieb said that the agency's initial proposals to change drug labels
often "aren't worded very well," and that they improve greatly after
suggestions from drug companies.
William Schultz, another former top official at the F.D.A., said the agency
should be given the power to limit or ban drug advertising for a period
after a drug's initial approval and limit prescriptions of some medicines to
certain specialists.
http://www.latimes.com/business/la-fi-biogen2mar02,0,5738399.story?coll=la-h
ome-headlines
THE LOS ANGELES TIMES
March 2, 2005
Warning Didn't Slow Approval of MS Drug
* A specialist in the disease repeatedly questioned Tysabri's safety before
a patient's death.
By Ricardo Alonso-Zaldivar and Denise Gellene, Times Staff Writers
WASHINGTON - A multiple sclerosis drug pulled off the market after a patient
died was approved by the Food and Drug Administration even though a
prominent neurobiologist and a top medical journal had questioned the drug's
safety.
When the FDA gave the drug, Tysabri, so-called fast-track approval in
November, "there was already somebody out there saying 'Whoops,' " Arthur
Levin, director of the New York-based Center for Medical Consumers, said
Tuesday.
"It's a legitimate question to ask if the FDA paid any attention to those
concerns, and if not, why not?"
Dr. Lawrence Steinman, a Stanford University professor and an MS specialist,
said he repeatedly wrote and spoke about the potential for serious
immune-system side effects with this type of drug. The MS patient who died
while taking Tysabri suffered from progressive multifocal
leukoencephalopathy, or PML, a rare central nervous system disease usually
seen in AIDS patients.
"I was really worried this would cause opportunistic infections," Steinman
said. "I was largely on the sidelines, issuing jeremiads and negative
predictions that this would lead to troubles."
Steinman - whose career as a developer of drugs for multiple sclerosis makes
him a potential competitor to Tysabri's manufacturers - began raising his
concerns long before the New England Journal of Medicine published an
editorial in early 2003.
At that point, Tysabri was in what is known as a Phase II trial in which a
relatively small number of people taking the drug were studied for six
months. The Journal said that "firm conclusions about safety . must await
the results of much larger" studies.
Those larger, Phase III studies haven't yet been completed. Nonetheless, the
drug was approved under an accelerated program for breakthrough medicines
that the FDA sees as offering extraordinary benefits to patients.
"This was a product that absolutely fit the criteria for accelerated
approval," said Dr. Douglas Throckmorton, acting deputy director of the
FDA's Center for Drug Evaluation and Research. "The trials were well planned
and well conducted, and the outcomes suggested a product with important
scientific advances."
Throckmorton said he didn't know whether agency scientists saw an article
Steinman wrote last summer in the journal Science, in which he warned that
"there is at least a theoretical concern that recipients of the therapy
would become generally compromised in their ability to fight infection."
But Throckmorton said he was confident that FDA scientists knew about, and
considered, such a theoretical risk. He stressed that in almost 3,000
patients involved in clinical trials before Tysabri was approved, there were
no cases of PML or life-threatening immune system reactions.
"It's clear that other drugs used for MS have effects on the immune system,
and I'm sure the office thought about those same issues when they looked at
this new entity," he said. "I am certain the division looked at that."
A spokeswoman for Biogen Idec Inc., which developed the drug with Elan
Corp., said Steinman never met with the company to share his concerns. "Our
focus now is on patients," said Amy Brockelman. "Our concern is for their
safety and that is what is guiding our actions."
Some in the biotechnology industry said something clearly went wrong in the
agency's expedited process, which has been criticized in the past for
rushing drugs to the market before they have been thoroughly scrutinized.
"The fast-track process, in the situation that exists, obviously is not
working right," said Joseph Panetta, president of Biocom, an industry group
in San Diego, where Biogen ranks among the largest biotech employers. "It
needs to be looked at .. Something about the process needs to be
restructured."
MS affects some 400,000 Americans and leaves about half of its victims
permanently disabled. The cause of the disease is unknown, but scientists
believe it is rooted in a malfunction of the immune system, which prompts
immune system cells to attack the brain and spinal cord.
The FDA approved Tysabri based on results from the first year of two Phase
III clinical trials, each of which was designed to last for two years. The
first-year results of those trials showed that the drug reduced the
frequency of MS attacks by as much as 66%.
The drug is believed to work by binding to certain immune system cells,
preventing them from traveling to the brain where they can cause damage. The
fast-track clearance was hailed as a breakthrough for MS patients, who had
not seen a new drug in a decade. Usually the agency requires the completion
of clinical trials before granting approval.
On Feb. 17, Biogen announced that it had completed one of the two-year
clinical trials and that the results confirmed the positive one-year
outcome. But the next day the makers of the drug reported to the FDA that
one patient taking Tysabri as part of the studies had developed PML and that
there was a second suspected case.
There is no known effective treatment for PML, which often leads to death.
One of the patients died Thursday, four days before the drug was recalled.
Biogen previously said the patient had died Feb. 18. Company executives said
they learned of the two patients after its pre-dawn Feb. 17 announcement
about the trial, but refused to be more specific.
Researchers familiar with Tysabri said they weren't surprised to learn that
patients had become infected with the deadly virus. Emmanuelle Waubant, a
neurologist at UC San Francisco, said PML didn't show up in the one-year
data because such infections take long to develop.
"In patients with HIV, it takes several years of having their immune system
compromised to develop this virus," she said. "It is not surprising it took
two years in each [Tysabri] case," she said. "There is a reason why these
studies were designed to take two years."
Waubant said she would not have approved the drug without seeing two years'
worth of data, but she was loath to criticize the FDA because the drug also
appeared beneficial. Waubant was one of the academics who helped conduct the
clinical trial for Biogen and Elan.
"You are always more intelligent after the fact," she said. "It is hard to
blame the FDA."
Stephen Miller, a microbiologist at Northwestern University who has
collaborated with Biogen on studies in the past, said the body's immune
cells were a poor target for an MS drug. Tysabri "blocks the ability of
[immune cells] to get from the blood vessels to the tissue to fight
infection," he said. "In my opinion, that is not the way to go."
Alonso-Zaldivar reported from Washington and Gellene from Los Angeles.
FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which
has not always been specifically authorized by the copyright owner. Such
material is made available for educational purposes, to advance
understanding of human rights, democracy, scientific, moral, ethical, and
social justice issues, etc. It is believed that this constitutes a 'fair
use' of any such copyrighted material as provided for in Title 17 U.S.C.
section 107 of the US Copyright Law. This material is distributed without
profit.
End of forwarded message from "VERACARE" <veracare@ahrp.org>
Jai Maharaj
http://www.mantra.com/jai
Om Shanti
Hindu Holocaust Museum
http://www.mantra.com/holocaust
Hindu life, principles, spirituality and philosophy
http://www.hindu.org
http://www.hindunet.org
The truth about Islam and Muslims
http://www.flex.com/~jai/satyamevajayate
The terrorist mission of Jesus stated in the Christian bible:
"Think not that I am come to send peace on earth: I came not so send
peace, but a sword.
"For I am come to set a man at variance against his father, and the
daughter against her mother, and the daughter in law against her mother in
law.
"And a man's foes shall be they of his own household.
- Matthew 10:34-36.
o Not for commercial use. Solely to be fairly used for the educational
purposes of research and open discussion. The contents of this post may not
have been authored by, and do not necessarily represent the opinion of the
poster. The contents are protected by copyright law and the exemption for
fair use of copyrighted works.
o If you send private e-mail to me, it will likely not be read,
considered or answered if it does not contain your full legal name, current
e-mail and postal addresses, and live-voice telephone number.
o Posted for information and discussion. Views expressed by others are
not necessarily those of the poster who may or may not have read the article.
FAIR USE NOTICE: This article may contain copyrighted material the use of
which may or may not have been specifically authorized by the copyright
owner. This material is being made available in efforts to advance the
understanding of environmental, political, human rights, economic,
democratic, scientific, social, and cultural, etc., issues. It is believed
that this constitutes a 'fair use' of any such copyrighted material as
provided for in section 107 of the US Copyright Law. In accordance with Title
17 U.S.C. Section 107, the material on this site is distributed without
profit to those who have expressed a prior interest in receiving the included
information for research, comment, discussion and educational purposes by
subscribing to USENET newsgroups or visiting web sites. For more information
go to: http://www.law.cornell.edu/uscode/17/107.shtml
If you wish to use copyrighted material from this article for purposes of
your own that go beyond 'fair use', you must obtain permission from the
copyright owner.
- Next message: Jim: "Re: FDA Official Admits 'Lapses' on Vioxx - FDA Didn't Heed Warnings"
- Previous message: William Wagner: "Re: stroke, homocysteine and B 12"
- Next in thread: Jim: "Re: FDA Official Admits 'Lapses' on Vioxx - FDA Didn't Heed Warnings"
- Reply: Jim: "Re: FDA Official Admits 'Lapses' on Vioxx - FDA Didn't Heed Warnings"
- Messages sorted by: [ date ] [ thread ]
Relevant Pages
|
