FDA’s Drug Safety System Fails to Protect Public

Published Jun 8, 2004

In September 2004, the pharmaceutical company, Merck, voluntarily withdrew its pain medication Vioxx from the market after evidence emerged that patients were at increased risk of heart attack while taking the drug. Critics have charged that the FDA failure to protect the American public in this instance is symptomatic of a larger problem at the agency. In testimony before the Senate Finance Committee, a reviewer in the Food and Drug Administration's (FDA) Office of Safety Research charged that the agency's system for evaluating drug safety is broken and fails to protect public safety. In his November 2004 testimony the reviewer, Dr. David Graham, charged that the FDA's procedures and culture made it impossible to adequately investigate drugs, and that crucial post-approval safety monitoring is especially compromised.¹ 

Dr. Graham testified that the FDA's failure to recall the arthritis drug Vioxx earlier resulted in as many as 55,000 premature deaths from heart attacks and stroke labeling it the equivalent of allowing "two to four jumbo jetliners" to crash every week for five years.² Graham also charged that FDA reviewers had failed to address serious concerns about the side effects of several drugs other than Vioxx.

When the FDA approves a drug, Graham testified, "it is also saying the drug is 'safe and effective.' When a serious safety issue arises post-marketing, [FDA officials'] immediate reaction is almost always one of denial, rejection and heat." There is an "inherent conflict of interest," said Graham, in putting the same individuals in charge of approving and recalling drugs.³

Dr. Graham told the Senate committee that his research showed that Vioxx users were 3.7 times more likely to suffer heart attack or sudden death than users of a competing arthritis and pain medication, but the FDA would not take action against the drug, instead suggesting that Graham "soften his conclusions" so that they would be consistent with those of the agency's Office of New Drugs.4

A series of studies published in the Journal of the American Medical Association (JAMA) provided further evidence that the FDA's system for regulating drug safety is flawed. JAMA editors pointed out that the system leaves drug makers largely responsible for evaluating the dangers of their own drugs, and relies on doctors' volunteer reporting of problems rather than any thorough evaluation after a drug is on the market.  The editors agreed that it was unreasonable to have the same agency both approve drugs and "also be committed to actively seek evidence to prove itself wrong."5 

Also in November 2004, Dr. Curt D. Furberg of Wake Forest University, was asked to step off an FDA advisory committee investigating COX-2 inhibitors (the class of arthritis medicine which includes Vioxx) after he spoke publicly about a study he had conducted that questioned the safety of Pfizer's entry in the category, Bextra. The FDA described the removal as standard for any scientist with such an intellectual stake in the outcome, but Dr. Furberg was quoted in the New York Times as saying "Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information."6

FDA officials responded fiercely to Dr. Graham's accusation that the drug review system was broken. Dr. Steven Galson, who was acting director of the FDA's Center for Drug Evaluation and Research, described Dr. Graham’s research as "junk science." Dr. Sandra Kweder, deputy director of the FDA's office of new drugs, said "my personal view is that our system works very well."7 These public statements were follwed by secretive attempts by senior FDA officials to discredit Dr. Graham, in anonymous calls to Tom Devine of the Government Accountability Project, the organization which was protecting Dr. Graham as a whistleblower. USA Today reported that Galson had also tried to discredit Dr. Graham's research by contacting editors at the medical journal The Lancet, where Graham's research was being reviewed for possible publication.8

1. Dr. David Graham, Testimony to the Senate Finance Committee, 18 November 2004, accessed 3 October 2006.

2. Ibid.

3. Ibid.

4. “Critics Diagnose Systematic Maladies of FDA,” OMB Watch, 30 November 2004, accessed 2 October 2006.

5. Fontanarosa, P.B., R. Drummond and C.D. DeAngelis. 2004. Postmarketing Surveillance—Lack of Vigilance, Lack of Trust. Journal of the American Medical Association 292: 2647, (subscription required).

6. Gina Kolata, “Scientist Who Cited Drug’s Risk is Barred from FDA Panel,” New York Times November 13, 2004, accessed 20 November 2006.

7. Gardiner Harris, “FDA Failing in Drug Safety, Official Asserts,” New York Times, 19 November 2004, accessed 2 October 2006.

8. Rita Rubin, “Scientist Says FDA Called Journal To Block Vioxx Article,” USA Today, 28 November 2004, accessed 20 November 2006.