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US Government Agency To Investigate FDA Over Rofecoxib

Oct 21, 2004 | British Medical Journal

The US Government Accountability Office, a regulatory watch-dog on federal government spending, is to investigate claims that the Food and Drug Administration attempted to silence one of its senior medical officers when he tried to warn that rofecoxib (Vioxx) caused heart attacks and strokes.

The drug was withdrawn on 30 September by its manufacturers, Merck, after a study found a fourfold increase in serious thromboembolic adverse events in patients receiving rofecoxib compared with patients receiving placebo.

David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, said that he was subjected to "veiled threats" when he sent his report to superiors at the FDA, who wanted him to water down his findings.

The Government Accountability Office has already launched a separate investigation into the FDA after another FDA expert, Andrew Mosholder, said his report warning of the risks of antidepressants for children was suppressed.

A spokesperson for the Government Accountability Office told the BMJ that it will now include Dr Graham's charges in their investigation and the agency will focus on the FDA's "handling of drug safety issues." The full scope of the investigation has not yet been determined, however, since "events continue to unfold," said the spokesperson.

Senator Chuck Grassley of Iowa said in a news release that the FDA's attempts to silence Dr Graham led to the FDA sitting "on the sidelines while life threatening issues threaten the American public."

In a letter of 15 October to the FDA, Mr Grassley asked, "Did the government agency that's supposed to regulate pharmaceuticals have an inappropriate agreement with Merck? And did a cosy relationship between the FDA and a pharmaceutical company allow a drug with known safety risks to stay on the market longer than it should have?"

Eric Topol, chief of cardiovascular medicine at the Cleveland Clinic, Ohio, said that the FDA took a passive approach: "They were the first ones to uncover the issue. They knew about this as early as November 18, 1999, when the data and safety monitoring board alerted Merck there was a serious problem. They could have ordered a large trial but they didn't. As a result, anywhere from 20 000 to 160 000 people suffered heart attacks and strokes."

The FDA responded to the BMJ with an email stating, "There was absolutely no undue pressure on Dr Graham. As a scientific agency, FDA values open discussion... the standard agency review process and procedure is a more rigorous peer review."

Mr Grassley provided evidence of what he called the "cosy relationship" between the FDA and Merck by releasing a copy of an email from 12 August from Anne Trontell, deputy director of the FDA's Office of Drug Safety, in which she criticises Dr Graham's report and wrote that the FDA should notify Merck before Dr Graham's review became public "so they can be prepared for extensive media attention that this will likely provoke."

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