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Journal Ignored Own Rule: More Scrutiny As Docs Wrote Reviews For Drugs Made By Employers

Feb 18, 2005 | www.bostonherald.com

The prestigious New England Journal of Medicine violated its own conflict-of-interest policy when it allowed two doctors with financial ties to Merck & Co. to tout COX-2 inhibitors such as Merck's Vioxx while downplaying their heart risks in an August 2001 paper, the Herald has learned.

The medical journal disclosed in a note accompanying the paper that Dr. Garret A. FitzGerald and Dr. Carlo Patrono had gotten grants from Merck and worked as company consultants.

But at the time, the journal had a strict policy prohibiting doctors with financial links to drug makers from writing reviews of the companies' new medicines.

In fact, some 18 months before the Vioxx review, the New England journal had been forced to issue an embarrassing public apology after discovering it had published 19 reviews of new drugs by authors with financial ties to the companies that made them.

In the February 2000 apology to its readers, the publication said steps had been taken to ``ensure against any recurrence.''

The journal's editor-in-chief, Dr. Jeffrey Drazen who was appointed in May 2000 acknowledged the Vioxx reviewers' conflict through a spokeswoman, but said the Vioxx review was already in the pipeline at the time of the apology.

However, the review was based partly on a Merck-funded Vioxx study that was not completed until March 2000, a month after the letter of apology.

Under Drazen's aegis, the journal relaxed its conflict policy in June 2002, prohibiting only doctors with ``significant'' financial ties from writing drug reviews.

Former editor-in-chief Dr. Arnold Relman, who wrote the original policy, blasted the publication's lax conflict standards yesterday.

``It's very bad business,'' Relman said. ``It's wrong. It shouldn't be done. No matter how small the gift, they influence the behavior of people. The pharmaceutical companies wouldn't give them if they didn't expect them to pay off.''

Merck's Vioxx study had shown a higher incidence of heart attacks, strokes and clotting among patients given the arthritis painkiller.

But FitzGerald and Patrono, in their journal review, downplayed that risk, saying it ``may reflect the play of chance.''

FitzGerald, who did not answer a phone call, has since toughened his criticism of COX-2 painkillers, testifying against them at a U.S. Food and Drug Administration hearing earlier this week.

Drazen himself was cited by the FDA in 1999 for making ``false or misleading'' statements about an asthma drug made by a company that had hired him to consult.

Marlboro-based Sepracor Inc. had paid Drazen to evaluate studies of the drug, then used his glowing reviews to promote it.

That incident came to light in the spring of 2000, just as Drazen was taking the journal's reins.

``I'm wiser for it,'' Drazen was quoted as saying at the time. ``And I think I'll be a better editor for it.''


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