Fwd. F.D.A. Failing in Drug Safety, Official Asserts

[Guest guest]

Z

Fri, 19 Nov 2004 07:30:42 -0800

Subject:F.D.A. Failing in Drug Safety, Official Asserts

 

 

 

[Znote: Send a copy of this, along with a thankyou note, to Newt

Gingrich, who back in 1995 said that the FDA was " killing millions of

people " by taking to long to run safety tests on drugs, and proposed

that the problem could be streamlined by having the drug companies run

their own tests. Congress passed it as part of an omnibus bill that

Clinton had to sign]

 

<http://www.nytimes.com/2004/11/19/business/19fda.html?hp & ex=1100926800 & en=a96b5\

a1c2a7455a1 & ei=5094 & partner=homepage>

 

By GARDINER HARRIS

 

Published: November 19, 2004

 

 

 

WASHINGTON, Nov. 18 - Federal drug regulators are " virtually incapable of

protecting America " from unsafe drugs, a federal drug safety reviewer

told a Congressional panel on Thursday, and he named five drugs now on

the market whose safety needs " to be seriously looked at. "

 

In testimony before the Senate Finance Committee, Dr. David Graham, the

reviewer in the Food and Drug Administration's Office of Drug Safety,

used fiery language to denounce his agency as feckless and far too

likely to surrender to demands of drug makers.

 

" We are faced with what may be the single greatest drug safety

catastrophe in the history of this country or the history of the world, "

Dr. Graham concluded.

 

Dr. Steven Galson, the director of the F.D.A.'s Center for Drug

Evaluation and Research and one of the agency's top civil servants,

later said that Dr. Graham's new numbers " constitute junk science " and

were " irresponsible. "

 

Dr. Graham, with more than 20 years of service at the Food and Drug

Administration, cited the anti-cholesterol drug Crestor, the pain pill

Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne

drug Accutane. Makers of each drug defended the medicines as safe.

 

Dr. Sandra Kweder, deputy director of the F.D.A.'s office of new drugs,

told the panel that Dr. Graham was not describing " the F.D.A. that I

know " and that she did not see the five drugs he cited as " more

concerning than any others. "

 

The clash was a rare public airing of tensions that have simmered in the

agency for decades. It is a fight between those who focus on the

potential of drugs to cure the sick and dying and those who see many

medicines as high-priced commercial products with potentially risky side

effects, between those who view pharmaceutical makers as beneficial

partners and those who see the drug makers as antagonists needing to be

curbed.

 

" My personal view is that our system works very well, " Dr. Kweder said.

 

The exchange came during a hearing called by Senator Charles E.

Grassley, a Republican of Iowa and the chairman of the Finance Committee.

 

Using his broad authority over much of the government's budget, Senator

Grassley and his staff have been investigating the F.D.A. for months

after several controversies swept the agency this year.

 

The hearing focused on the last of these controversies: Merck's decision

in September to withdraw Vioxx, a pain pill that became a $2.5 billion

seller and one of the most widely advertised drugs in the world.

 

Merck withdrew Vioxx when a study it sponsored found that after 18

months of use the drug doubled the risk of heart attack or stroke.

 

Critics of the F.D.A. have said that studies from as early as 1999 and

2000 showed that Vioxx was a risk to the heart, and many asked why the

F.D.A. had not forced the drug's withdrawal earlier.

 

The critics' case has been bolstered by many e-mail messages from Merck

and by company documents disclosed in lawsuits by users of Vioxx. In

many of the documents, Merck executives and scientists discussed the

possible link between Vioxx and heart damage years before the company

publicly admitted that the drug could cause harm.

 

Merck executives have said the documents are being taken out of context.

 

Raymond V. Gilmartin, Merck's chief executive, testified Thursday that

his company followed a " rigorous scientific process " as it examined the

risks and benefits of Vioxx.

 

But Dr. Graham and other witnesses severely criticized Merck, saying the

company should have acted years earlier to confirm the risks of Vioxx.

Dr. Graham raised his estimates of those in the United States who had

suffered heart attacks or stroke as result of taking Vioxx to a range of

88,000 to 139,000, up from 28,000. As many as 40 percent of these

people, or about 55,000, died as a result, he said.

 

Dr. Gurkirpal Singh, an adjunct clinical professor at Stanford

University, said at the hearing that Merck scientists had tried to

intimidate him after he publicly raised questions about the effects of

Vioxx.

 

Dr. Singh, a rheumatologist and science officer of the Institute of

Clinical Outcomes Research and Education in Woodside, Calif., said: " I

was warned that if I continued in this fashion there would be serious

consequences for me. I was told that Dr. Louis Sherwood, a Merck senior

vice president and a former chief of medicine at a medical school, had

extensive contacts within academia and could make life very difficult

for me at Stanford and outside. "

 

Dr. Graham said that in his years at the F.D.A., he had recommended that

12 drugs be withdrawn. Only two are still being sold, he said.

 

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