FDA Squelches Findings of Own Scientist.... Again.
by Guest Blogger, 10/8/2004
Though studies dating as far back as 2000 pointed to increased risk of cardiovascular disease and stroke for users of Vioxx, FDA has stood quietly on the sidelines while more than 27,000 users of the drug experienced serious side effects. In fact, a top FDA scientist in the Office of Drug Safety alleged yesterday that higher-ups at FDA attempted to suppress his conclusions about the dangers of Vioxx. According to the Washington Post, [Sen. Charles] Grassley said in a news release that David Graham, associate science director of the Office of Drug Safety, told him that agency officials "ostracized" him and subjected him to "veiled threats" as he tried to have his study cleared for publication. When a top FDA official suggested "watering down" the report, Graham responded in an e-mail: "I've gone about as far as I can without compromising my deeply-held conclusions about this safety question." Said familiar? Two new articles in the New England Journal of Medicine indicate that other drugs in the same class as Vioxx might also pose a risk. Will FDA continue to play the patient observer or will it exercise it authority to protect our public health? According to the Washington Post, Both commentaries in the journal took the FDA to task for not being sufficiently aggressive in making sure that Vioxx and other COX-2 inhibitors are safe. Topol, in particular, was highly critical of the agency for allowing Merck to aggressively advertise Vioxx despite concerns going back to 2000 about the increased risk of cardiovascular disease. The papers had been scheduled for publication on Oct. 21 but were released early by the journal yesterday. "The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health," Topol wrote. FitzGerald wrote: "Only the FDA can provide unbiased and informed guidance; it has a role to play beyond watchful waiting. In the absence of such guidance, what should physicians and patients do?" FDA's inaction also speaks to the increased need for registered clinical trials. If we can't rely on objective health experts at FDA to protect us, then it becomes even more critical that experts in the medical community have access to clinical trial data.