FDA Says Bayer Failed to Reveal Lethal Drug Risks–but Fails to Change Licensure or Label_NYT

A front page article in The New York Times (below) reports: "Bayer A.G., the
German pharmaceutical giant, failed to reveal to federal drug officials the
results of a large study suggesting that a widely used heart-surgery
medicine might increase the risks of death and stroke, the Food and Drug
Administration."

Failure to disclose study findings to the FDA is a federal crime.

So what is preventing the U.S. Department of Justice from prosecuting Bayer
for manslaughter?

Executives of Enron, WorldCom (MCI), Global Crossing, Adelphia, Tyco et al
were prosecuted and sentenced to prison.

Why are pharmaceutical giants whose repetitive crimes of concealment have
resulted in hundreds of thousands of preventable deaths-allowed to continue
to use their government license to engage in business as usual?

One primary reason-as confirmed in the scathing report by the Institute of
Medicine-safety is not a priority for the FDA which consistently shields
those whom FDA officials perceive as the agency’s paying "clients."  Whereas
taxpayers are treated with lethal drugs bearing FDA’s seal of approval,
pharmaceutical and biotech companies receive the red carpet treatment–even
when they are caught selling lehtal drugs without warning.

The Times reports that despite Bayer’s failure to reveal the results:
"Nevertheless, the agency did not change its advice about whether patients
should be given the drug. Instead, it restated previous warnings that
Trasylol’s use should be limited to patients in whom the risks of blood loss
outweighed the drug’s risks."
 
The Times also reports: "Several members of the advisory committee that met
last week said they were shocked that Bayer failed to inform them of the
study."

About as "shocked" as Claude Reins was when told there was gambling in
Casablanca!

Contact: Vera Hassner Sharav
veracare@ahrp.org
 

http://www.nytimes.com/2006/09/30/health/30fda.html
THE NEW YORK TIMES 
F.D.A. Says Bayer Failed to Reveal Drug Risk Study
By GARDINER HARRIS
September 30, 2006

WASHINGTON, Sept. 29 – Bayer A.G., the German pharmaceutical giant, failed
to reveal to federal drug officials the results of a large study suggesting
that a widely used heart-surgery medicine might increase the risks of death
and stroke, the Food and Drug Administration
http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and
_drug_administration/index.html>  announced Friday.

 Bayer scientists even appeared at a public meeting called by the
F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might
have serious risks. But they did not mention the study or its worrisome
results.

 In a highly unusual move, the food and drug agency released a public
health advisory saying it had learned of the study’s existence only on
Wednesday. Preliminary results of the study demonstrate "that use of
Trasylol may increase the chance for death, serious kidney damage,
congestive heart failure and strokes," the advisory said.

 Nevertheless, the agency did not change its advice about whether
patients should be given the drug. Instead, it restated previous warnings
that Trasylol’s use should be limited to patients in whom the risks of blood
loss outweighed the drug’s risks.

 The disclosure comes exactly two years after Merck announced it was
withdrawing its arthritis drug, Vioxx, after a study showed that it doubled
the risks of heart attacks.
http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/arthritisandrheumatism/index.html  

Since then, members of Congress and even top scientific advisers have
concluded that the F.D.A. lacks the regulatory authority and the money
needed to detect and protect against drug dangers.

 Drug companies have also been sharply criticized for failing to make
public the results of some human trials of their drugs that suggest that the
drugs are either ineffective or dangerous. Some lawmakers have proposed
legislation that would require that nearly all human drug trials must be
announced and their results disclosed publicly.

 A top F.D.A. official said the agency learned of the Trasylol study
on Wednesday only after a getting a tip from a researcher involved in it.
The official insisted on anonymity because of the sensitive nature of the
information.

 In a written statement, Bayer said "that it mistakenly did not
inform" the F.D.A. of the study and added, "This data was not shared
immediately with the agency because it was preliminary in nature."

 Staci Gouveia, a Bayer spokeswoman, said the company nonetheless
stood behind the safety of Trasylol, which has become one of Bayer’s fastest
sellers. Sales last year were $200 million and were expected to nearly
triple this year.

 Several members of the advisory committee that met last week said
they were shocked that Bayer failed to inform them of the study.

 "For them not to mention that it was under way, that it was being
analyzed or that results were available is appalling and will do significant
harm to their reputation for transparency," said Dr. John Teerlink, an
associate professor of medicine at the University of California
<http://topics.nytimes.com/top/reference/timestopics/organizations/u/univers
ity_of_california/index.html> , San Francisco, and a member of the advisory
committee.

 Steven Findlay, a health care analyst at Consumers Union
<http://topics.nytimes.com/top/reference/timestopics/organizations/c/consume
rs_union/index.html>  and another committee member, said the agency needed
to investigate whether Bayer knowingly withheld the information from the
advisory committee.

 "The safety of this drug is called into further question now," Mr.
Findlay said.

 Doctors give Trasylol to patients before surgery to reduce the risks
of blood loss. It can also reduce the need for transfusions in patients
undergoing heart bypass surgery. Trasylol, also known as aprotinin, has been
on the market for 13 years.

 But two recent studies suggested that the drug might have serious
risks. One of the articles, published in January in The New England Journal
of Medicine
<http://topics.nytimes.com/top/reference/timestopics/organizations/n/new_eng
land_journal_of_medicine/index.html > , found that the drug increases the
risks of kidney failure, heart attack and stroke. The study concluded that
halting the drug’s use would prevent 10,000 to 11,000 cases of kidney
failure a year and save more than $1 billion a year in dialysis costs, as
well as nearly $250 million spent on the drug itself.

 There are other, cheaper drugs that can be used in Trasylol’s place.

 Still, the advisory panel concluded that Trasylol’s risks were worth
taking in some patients. Dr. Teerlink said that despite the results of the
new study, that might still be true.

 Bayer’s study was performed by a contract research organization. But
Bayer did not inform the F.D.A. that the study was being done, even though
that is routine practice.

 It examined hospital records of 67,000 patients, 30,000 of whom
received Trasylol. The rest got other drugs. It concluded that the patients
given Trasylol were at greater risk.

 Such studies, however, are fraught with statistical and other
problems. Patients given Trasylol may have been sicker than those given
other drugs. Their worse outcomes would be explained not by problems with
Trasylol but by their own illness.

 Susan Bro, an F.D.A. spokeswoman, said it was evaluating the new
study and would decide soon whether the results merit changing the agency’s
advice about use of the drug.

 "It is regrettable that the F.D.A. advisory board did not have the
benefit of a frank scientific dialogue based on the totality of available
data," she said.

 Senator Charles E. Grassley
<http://topics.nytimes.com/top/reference/timestopics/people/g/charles_e_grassley/index.html  ,

 Republican of Iowa and chairman of the Senate Finance
Committee and a longtime critic of the F.D.A., said Bayer’s behavior proved
that the agency was largely toothless.

 "The remedy is mandatory reporting of all clinical trials and real
teeth for the F.D.A. to do its job in holding drug companies accountable,"
Mr. Grassley said.
                        Copyright 2006   The New York Times Company

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