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White House Defends FDA as Drug Safety Debate Looms (washingtonpost.com)

 

 

White House Defends FDA as Drug Safety Debate Looms

 

By Marc Kaufman

Washington Post Staff Writer

Monday, December 20, 2004; Page A02

 

The Bush administration and some of its critics squared off yesterday over

whether the Food and Drug Administration is doing an adequate job overseeing

drug safety, and whether the agency needs major reforms.

 

In a preview of the debate to come, White House Chief of Staff Andrew H. Card

Jr. said the agency is doing a " spectacular " job and should " continue to do the

job they do. "

 

 

But Sen. Edward M. Kennedy (Mass.), ranking Democrat on the Senate Health,

Education, Labor and Pensions Committee, shot back that the FDA's " record on

protecting us from harmful prescription drugs is a catastrophic failure. "

 

" Early action on bipartisan FDA reforms is possible in Congress, and I hope that

the White House and congressional leadership will not stand in the way, " Kennedy

said.

 

The agency has come under intense scrutiny for its handling of drug safety

questions involving the arthritis drug Vioxx, antidepressants for children and

last week the painkiller Celebrex.

 

Vioxx was taken off the market by manufacturer Merck & Co. in September, the

agency toughened guidelines on pediatric use of antidepressants in October after

public and congressional criticism, and the fate of Celebrex remains uncertain.

 

The maker of Celebrex, Pfizer Inc., reiterated yesterday that it would not take

the drug off the market after a clinical trial showed increased risk of heart

attacks and strokes among users. Acting FDA Commissioner Lester Crawford said

Friday that the agency is concerned about the finding and left open all possible

regulatory responses.

 

Card made his comments about the FDA during ABC's " This Week, " when he was asked

whether he supported last week's call by Sen. Charles E. Grassley (R-Iowa),

chairman of the Senate Finance Committee, for an investigation of the federal

drug agency similar in scale to the Sept. 11 commission.

 

Card responded that " I don't know that we need a commission " and that " I've got

great confidence in the FDA. " He said news coming out about previously

unaddressed safety risks associated with popular drugs on the market is " a

testament to the FDA in how they do their job. "

 

In the cases of Vioxx and Celebrex, the agency had little to do with the studies

that identified the additional heart attack and stroke risks. According to FDA

drug safety officer and whistle-blower David Graham, his research showing

apparent dangers in Vioxx was suppressed by the agency.

 

Speaking later on the same news show, Pfizer chief executive Hank McKinnell

defended the decision to keep selling Celebrex. " For many patients, Celebrex is

the best option or, in some cases, the last option to live a normal life with

the pain and inflammation of arthritis, " he said.

 

McKinnell said that although one large and well-controlled study had found a

significant cardiovascular risk with Celebrex, another large one in progress did

not find the risk, and nor have about 50 other clinical studies of the drug. " So

I'm not sure we really understand yet the relevance of this new data, " he said.

 

A company official said yesterday, however, that direct-to-consumer advertising

for Celebrex will be ended.

 

Graham, who also appeared on " This Week, " said he wouldn't prescribe Celebrex

" to my mother-in-law. "

 

" The FDA wasn't concerned about Vioxx, and would not have removed it from the

market if Merck hadn't, yet 100,000 patients had heart attacks because of

Vioxx, " Graham said. " The fact that the FDA now says that it's concerned about

Celebrex to me is a very serious signal. "

 

The FDA has lacked a permanent commissioner since March, and has had an acting

leader for about two-thirds of President Bush's first term. Yesterday, Kennedy

called for the quick nomination of a reform-minded commissioner while Card said

acting Commissioner Crawford " is doing a very good job. "

 

Congress has shown growing concern over the FDA's safety monitoring, and

committees in both chambers are actively involved in investigating the

withdrawal of Vioxx and the potential risks from Celebrex. On Friday, the House

Energy and Commerce Committee asked Pfizer for scores of documents on Celebrex,

including all communications with the FDA about its possible cardiovascular

risks. Grassley's Senate Finance Committee has done the same with Merck and

Vioxx.

 

Grassley has called for FDA reforms that would enlarge the agency's Office of

Drug Safety and make it more independent, but has acknowledged there is not

strong support for the idea.

 

The FDA announced early last month that it would take steps to improve safety

reviews and make the agency more open to dissenting views from drug reviewers.

It also asked the congressionally mandated Institute of Medicine to examine its

entire approach to drug safety.

 

The new concerns regarding Celebrex came from a study run by the National Cancer

Institute into possible new uses of the drug in the prevention of colorectal

cancer. On Thursday, a data-safety monitoring committee studying the trial

reported that subjects taking Celebrex were significantly more likely to suffer

heart attacks and strokes than those on a placebo.

 

Those taking a high dose had a 3.4 times greater risk of cardiac problems than

those on a placebo, and those on the lower dose had a 2.5 times greater risk.

After the trial was stopped, the Cancer Institute reported there had been six

cardiac events among those given a placebo, 15 for those on the lower dose of

Celebrex, and 20 for those taking the higher dose.

 

 

 

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