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Vioxx Woes May Reveal FDA's Flaws

At long last, a controversial study linking a popular painkiller with thousands of heart disease cases has been published. Its lead author says his employer—the Federal Drug Administration—is unable to protect consumers

By Jennifer Barrett Ozols

Newsweek - Jan. 28, 2005 - The controversy over the drug Vioxx not only left millions of consumers confused about how to safely treat pain, but it may have exposed serious flaws in the federal government's ability to ensure drug safety. That's the contention of outside critics and some insiders, such as David Graham, a 20-year veteran of the Food and Drug Administration.

Merck voluntarily recalled its arthritis drug last September after studies indicated the popular painkiller increased the risk of having a heart attack or stroke. But in a study published this week in the online version of The Lancet, Graham contends that the popular painkiller may have caused as many as 140,000 cases of "serious coronary heart disease"—many of them fatal—during the period it was on the market. Graham and his colleagues analyzed data from 1.4 million people in California who had either used Vioxx or another non-steroidal anti-inflammatory drug (NSAID) like Celebrex or ibuprofen. They found that those patients taking Vioxx had a 34 percent higher chance of developing serious coronary heart disease compared to people who took other NSAIDs; the disease is fatal in about 44 percent of patients.

The study's findings were initially scheduled to be published in The Lancet last fall. But Graham, who serves as associate director for science and medicine in the agency's Office of Drug Safety, says he was pressured by superiors to withdraw the study because it might reflect badly on the agency. An FDA spokesperson says Graham submitted his study to The Lancet before complying with the FDA's internal peer-review procedures, leading Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research, to inform the journal that Graham's paper had not completed the standard peer review process, and therefore did not represent the conclusions of agency.

The spokesperson said the agency later decided to support the publication, despite the misgivings of other FDA scientists, since doing so "will contribute to the agency's ongoing discussions about the safety of the entire class of [NSAIDs].”

NEWSWEEK's Jennifer Barrett Ozols spoke this week with Graham about his research and his views on FDA reform. Excerpts:

NEWSWEEK: Why wasn't your Vioxx study published in The Lancet last fall as scheduled?
David Graham: It was supposed to be published online on Nov. 17, the day I was scheduled to testify at the Senate Finance Committee hearing. And I was forced to withdraw it on the 16th.

By whom?
A supervisor, who threatened me with "severe consequences" if I allowed it to be published. I interpreted that to mean I would be fired.

So why allow it to be published this week?
I came back to work on Jan. 3 after the holidays, and the manuscript had been cleared by the FDA, without comment or explanation. It was sitting on my chair.

What changed?
I don't know. It's not like we changed what we did [in the study]. Somewhere within the FDA, I guess they reconsidered it and finally cleared it. All that meant was that I had their permission to submit it for publication.

Why do you think the FDA didn't want the study to be published last fall?
What I believe they were trying to prevent from reaching the public was our estimates of the number of people who suffered heart attacks or died because of Vioxx use. Though I presented that information in my Senate testimony anyway ... I believe there were multiple levels of FDA management who wanted to keep the information of the magnitude of harm caused by Vioxx from the public and wanted to damage my credibility as a scientist.

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