FDA's Credibility Hits Yet Another Low as Consumer Health Lands on Back Burner
American Progress
Pfizer's Greed A National Shame
The drug maker Pfizer "reaffirmed its commitment" over the weekend to keep its prescription painkiller, Celebrex, on the market, despite a disclosure last week that the drug more than tripled the risk of heart attacks, strokes and death among those taking high doses in a national trial. That level of risk is even greater than the one found in patients taking the similar painkiller, Vioxx, in a similar trial that led Merck to withdraw Vioxx in September. The results have "raised new questions about how well federal drug regulators protect the public and worsened drug makers' already dismal image." Indeed, reports following the discovery have shown Celebrex, "fast-tracked" by the agency and never even proved it protected the stomach from gastrointestinal problems associated with aspirin and ibuprofen – its primary advantage over existing pain relievers.
MARKETING TO MIDDLE AGE: Celebrex and Vioxx were designed for senior citizens, who have the highest risk of stomach bleeding – "principally people over 65 years who have suffered from gastrointestinal problems," – but marketed aggressively to middle-aged Americans, who could have benefited just as well from traditional painkillers like aspirin. Dorothy Hamill, the 1976 Olympic figure skating gold medalist, "was the middle-aged celebrity face of Vioxx," while commercials for Celebrex targeted "baby boomers beginning to suffer from arthritis." Many medical experts "now say that Celebrex and Vioxx, selling for $2 or $3 a pill, have been too widely prescribed to patients who could safely obtain the same pain benefits from over-the-counter drugs costing pennies apiece." Under pressure from the FDA, Pfizer now says it will halt advertising to consumers, but not to doctors.
THE PASSING LANE: Celebrex, like Vioxx, was "fast-tracked" by the FDA, because it was suggested the drug would help cut the rate of gastrointestinal bleeding associated with older painkillers. That meant the FDA took only six months to approve the drug, even though scientists concluded it had not "sufficiently demonstrated" it reduced the rate of the gastrointestinal problems compared with existing painkillers. Later studies by Pfizer "were never convincing enough for the agency to remove the warning from Celebrex's labeling." In other words, Celebrex "has never been proven to the FDA's satisfaction to have the stomach-protecting benefits that originally were supposed to be the point of that category of drugs."
THE 'SPECTACULAR' FDA: Celebrex and Vioxx are not the only drugs to come under scrutiny lately. On the same day the Celebrex study broke, "in less than 12 hours," AstraZeneca reported that a trial of Iressa, a lung cancer drug approved in the United States last year, showed that the drug did not prolong lives. Eli Lilly warned doctors that Strattera, its drug to treat attention deficit disorder had caused severe liver injury in at least two patients. And doctors writing in a prominent medical journal recommended that physicians stop prescribing Pfizer's Bextra painkiller. So what was the White House's reaction to the finding that several FDA approved drugs are ineffective or dangerous? White House Chief of Staff Andrew Card said the agency was doing a "spectacular job."
SPECTACULAR NEGLIGENCE: The Washington Post reports the FDA, "which regulates almost one-quarter of the U.S. economy, has been without a permanent chief for almost two-thirds of the time that Bush has been in office." The agency also has had a "high number of temporary appointees administering its centers, offices and divisions, including the key positions running the offices that evaluate new drugs and monitor the safety record of approved medications." The White House's negligence plays right into the hands of major drug companies, which would rather "have no one there than someone who favors a proactive stance that might slow down the industry or raise hard questions about profitable drugs." Observers say the agency's lack of leadership has made it "less able to respond quickly and effectively to emerging problems."
SPECTACULAR FUNDRAISERS: Another reason Bush has not appointed an FDA head may be that some Democrats have signaled they would "strongly oppose any nominee from the pharmaceutical industry." But the pharmaceutical industry, which was the major winner in last year's prescription drug bill, includes some of the GOP's biggest supporters. And of health industry contributors, Pfizer is number one. Company executives have contributed $2.7 million to Republicans since 2000, and the drugmaker's political action committee (PAC) has pitched in more than $1.4 million. Since 2000, 79 percent of the company's contributions have gone to Republicans. Merck has made almost $1.8 million in political donations since 2000, 74 percent to Republicans.
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