Profs at Odds Over Drug Threat

Colleagues at Medical School debate testimony in Merck Vioxx trial

Harvard Medical School (HMS) professors are questioning a colleague’s court testimony that there is no link between the short-term use of the popular painkiller Vioxx and severe heart problems.

HMS Associate Professor of Medicine J. Michael Gaziano’s testimony this week in the New Jersey Superior Court broke from the published work of two of his colleagues, Assistant Professor of Medicine Daniel H. Solomon and Professor of Medicine Jerome L. Avorn.

Avorn said that he could find no explanation for Gaziano’s ideas, as expressed in court.

“You’d have to ask him that yourself,” said Avorn. “The evidence is incontrovertible. Merck [the company that manufactures Vioxx] itself admitted that it found a doubling of heart attack and stroke in Vioxx users in a randomized trial it conducted. That’s why it took the drug off the market.”

Gaziano, a cardiologist who has never done Vioxx research, said he feels the evidence is insufficient and that more research is needed.

“I don’t believe there is a link for short-term use,” he said in an interview. “Questions have been raised about long-term use.”

But studies by Harvard and the Food and Drug Administration (FDA) do not exclusively address long-term use. Both studies have identified a strong link between heart problems and Vioxx.

Professor of Ambulatory Care and Prevention Richard Platt, who serves on the FDA’s Drug Safety and Risk Management Committee, said he believes there are risks associated with the drug in all doses.

“The evidence seems compelling that there is extra risk at high doses, and probably also at lower doses,” he said. “In the clinical trials published within the last year, this risk is evident as long as there is good follow-up.”

While the Associated Press (AP) reported that Gaziano’s testimony “contradicted” the FDA study, Gaziano maintains that his opinions were “mischaracterized” and that his views are “quite consistent” with the FDA study.

During the trial, the attorney for the prosecution, David Buchanan, attacked Gaziano’s credibility, depicting him as an “expert-for-hire witness” in the pocket of drug companies, according to the AP. Buchanan pointed out that Gaziano has also testified that the there was no proof that the weight-loss drug Ephedra was dangerous.

Gaziano said in the interview that he had to answer “very artificial questions” and that “the courtroom’s a very artificial place to have dialogue about these sorts of issues.” He said he felt it was important, however, for “good scientists to weigh in.”

Merck pulled Vioxx from the market last fall after its own 18-month-long study confirmed the FDA’s findings, which linked Vioxx with an elevated risk of heart attack, stroke, and death with long-term use. Since then, approximately 5,800 lawsuits have been filed against the company, with experts estimating legal costs of between $4 and $18 billion, according to the AP.

Avorn says that Merck attempted to suppress the results of the Harvard study, which he co-authored with Solomon. Avorn, whose book, “Dangerous Medicines: The benefits, risks and costs of prescription drugs,” was recently published by Knopf, called Merck’s alleged actions “unethical.”

“The irony was that it was a study funded by Merck,” he said. “It took forever to get the work done, and then Merck disavowed the study and said we got it wrong.”

Avorn said Merck even demanded that one of its own researchers have her name removed from the study in order to distance the company from the results.

The Harvard researchers ultimately decided to publish their study in Circulation, the journal of the American Heart Association, despite Merck’s alleged requests.

“We made a decision that we should let the science rule the day,” Solomon told The Wall Street Journal last November.

Gaziano said he had concerns about the Harvard study.

“They’re very good scientists,” he said. “But it was an observational study, and there are limitations to observational studies. It’s certainly possible that there are some inconsistencies.”

He says more data is needed to confirm a link between long-term use of Vioxx and heart attacks.