11/29/2004

The Feckless FDA

The Feckless FDA

Yesterday, additional evidence emerged that, in the Bush administration, the Food and Drug Administration is more concerned about its relationship with the drug industry than the safety of the American people. Dr. David Graham, who has worked at the FDA for more than 20 years, told the Senate Finance Committee that the agency had become "feckless and far too likely to surrender to demands of drug makers." The hearing's primary focus was the recent withdrawal of the pain reliever Vioxx, produced by Merck. Graham estimated that – based on Merck's own studies – 139,000 Americans suffered from a heart attack or stroke as a result of taking the drug. Of that group, "30 percent to 40 percent probably died. For the survivors, their lives were changed forever," according to Graham. He called the Vioxx scandal "the single greatest drug safety catastrophe in the history of this country or the history of the world." (For more details on the Vioxx scandal, see last week's Progress Report.)

TOP ADMINISTRATION OFFICIALS ATTACK THE MESSENGER: Not surprisingly, the Bush administration attacked Dr. Graham for speaking honestly. Before his testimony yesterday, FDA Commissioner Lester Crawford called Dr. Graham "a maverick who did not follow Agency protocols." But Graham's supervisor at the FDA said the paper that formed the basis of his testimony was "an excellent study and analysis of a complex topic." Sen. Charles Grassley (R-IA) said Crawford's comments were "intended [to] intimidate a witness on the eve of a hearing." Grassley recommended Crawford spend time "on the problem rather than going after congressional witnesses who helped identify the problem in the first place."

MERCK CEO'S DISHONEST DEFENSE: Raymond V. Gilmartin, the CEO of Merck, also appeared before the Finance Committee. Gilmartin adamantly defended the company's conduct. He claimed that "Merck has promptly disclosed the results of Merck-sponsored studies of Vioxx to the FDA, physicians, the scientific community and the media." Gilmartin cited the fact that, after a study it conducted in March 2000, the company "immediately issued a press release providing its conclusions." But that press release didn't include the conclusions of Merck doctors who believed the data indicated that an increased risk of cardiovascular events among those taking the drug was "clearly there." The following month, Merck issued another release titled, "Merck confirms favorable cardiovascular safety profile of Vioxx" and claiming the data shows "NO DIFFERENCE in the incidence of cardiovascular events." Merck didn't release the data to the FDA until June 2000.

MERCK'S SHAMEFUL ADVERTISING BLITZ: Long after it was aware of the dangers associated with the drug, Merck continued one of the largest direct-to-consumer advertising campaigns ever, spending $160 million dollars. Millions more was spent marketing Vioxx to doctors. Last year, Vioxx sales totaled $2.5 billion.

VIOXX IS A SYMPTOM OF A LARGER PROBLEM: According to Graham, "it is important...the American people understand that what happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people." Graham named five major medications already on the market – "the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane" – whose safety needs to be "seriously looked at."

BEXTRA – THE NEXT VIOXX?: Bextra, produced by Pfizer, is a painkiller similar to Vioxx that is still on the market. Studies have shown that Bextra "increase the risks of heart attacking patients undergoing cardiac surgery [and] in rare cases...can also cause a fatal skin reaction." Moreover, it "has never proved to be any more effective at reducing pain or protecting the stomach than older medicines like ibuprofen that are a fraction of the price and pose none of these suggested or proven risks."

THE PRICE OF SAFETY: How can the pharmaceutical companies get away with it? Over the past four years the industry has contributed over $68 million to federal candidates – including almost $1.5 million to President Bush. Pfizer, the manufacturer of Bextra – a drug still on the market but singled out by Graham as potentially unsafe – contributed over $120,000 to President Bush.

Progress Report, 11/19/04 - American Progress Action Fund

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