Journal Editors Dispute Merck Claim

posted on:
February 9, 2006

author:
Staff

The New England Journal of Medicine demanded changes before publishing results of the study that led Merck and Co. to pull the painkiller Vioxx from the market, and one of its top editors disputes the way the drugmaker is using it as a pillar of its legal defense in liability suits.

According to a court deposition of Executive Editor Gregory Curfman, the respected medical journal initially didn’t accept the draft of the manuscript because it advanced the idea that Vioxx use was safe for up to 18 months. Curfman said he contested that claim while the article was being edited early last year and continued to discredit it at his November deposition.

Discussions between editors and authors over articles for scientific journals are commonplace, but this disagreement goes to the heart of Merck’s defense: The company contends that a doubling of risks for heart attacks and strokes didn’t show up until after 18 months among users of the pain medication, and that once those findings became known, the drug was immediately pulled from the market in September 2004.

The article published five months later in the Journal did include the 18-month figure, but it twice was preceded by a scientific term that Curfman insisted be inserted to signal that it was a hypothesis—not a proven fact.

Curfman was deposed only weeks before the Journal published an unusual editorial in December. It chastised Merck for a separate article published in November 2000 about an earlier Vioxx study that Journal editors said concealed details about three heart attacks suffered by patients. Merck has said those heart attacks happened after the study’s cut-off date for side effects, but Journal editors said such data is routinely added until a study’s publication.

Portions of Curfman’s video deposition may be shown to jurors Friday at a federal trial under way in New Orleans. Evelyn Irvin Plunkett, whose husband Richard “Dickie” Irvin died of a heart attack after using Vioxx for only one month, is seeking damages from Merck and the issue of how long it took for the painkiller to cause problems looms as a pivotal issue.

The deposition was provided to The Associated Press on the condition that the source not be revealed.

A spokeswoman for the Journal said Thursday the publication’s editing process is confidential and declined to comment on the deposition’s contents.

An outside Merck lawyer, James Fitzpatrick, said an order from the judge in the New Orleans case prevents him from commenting specifically on Curfman’s statements. But he did note that the article’s authors worked with Journal editors to address their concerns. And he added that the U.S. Food and Drug Administration has said publicly that Vioxx doesn’t cause problems with short-term use.

Howard Erichson, a professor at Seton Hall Law School, said Curfman’s deposition could prove valuable for plaintiffs’ lawyers’ because it could be easier for jurors to understand than the scientific jargon used in the published article. But plaintiff lawyers still will have to prove that Vioxx caused health issues no matter how long they the drug was used, he said.

Curfman said in the Nov. 21 deposition that the 18-month cutoff “is not credible” because as the article itself pointed out, other adverse medical events such as cardiac failure and fluid build-up in the lungs showed up after as little as five months of Vioxx use.

He also said the 18-month figure cited by Merck when it abruptly ended the study and halted the sale of Vioxx “was only a hypothesis.” For it to be proven, Merck would have to replicate the data, he said.

The deposition shows that the Journal editors had to ask authors for charts with details about other cardiac problems such as congestive heart failure and hypertension because it was not initially provided. But Fitzpatrick said those problems have nothing to do with clotting events like heart attacks and strokes.

An outside reviewer examining the Approve study for the Journal said that the manuscript “aggressively promotes the safety of up to 18 months of use of rofecoxib (Vioxx). That goes beyond the data of the study.”

It is common practice for the Journal to use outside experts to review articles and their identities are not revealed. According to the deposition, some of the reviewers were very critical of the initial manuscript.

Curfman told the lawyers he and other journal editors were “very skeptical” of the 18-month figure and tried to get a study author to “back away from this contention” in the article.

According to the deposition, Curfman said one sentence which originally said “the increased relative risk was observed beginning after approximately 18 months of treatment” was revised to include a clause at the beginning which reads “In the post-hoc analysis.”

Curfman said he wanted the clause inserted to convey the idea that the 18-month cut-off was a hypothesis. But Merck does not refer to the 18-month cut-off as a hypothesis and the published version of the article said that the relative risk of thrombotic events became apparent after 18 months of treatment.

The concern voiced by the Journal editors underscores claims by others in the medical community such as prominent cardiologist Dr. Eric J. Topol and pharmaco-epidemiologist Wayne Ray, who say Vioxx can trigger heart problems in much less than 18 months.

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