Doctors Object to Gathering of Drug Data

NYT: "Although virtually unknown to consumers, the information has long been considered the most potent weapon in pharmaceutical sales — computerized dossiers showing which physicians are prescribing what drugs. Armed with such data, a drug sales representative can pressure a doctor to write more prescriptions for a name-brand medicine or fewer orders for a competitor's drug.

But now a rebellion is under way by some doctors, who consider the data-gathering an intrusion that feeds overzealous sales practices among the nation's estimated 90,000 drug company representatives. Public officials are also weighing in. A vote on a state bill to clamp down on the practice is scheduled for today in New Hampshire, and similar bills have been introduced in other states, including Arizona and West Virginia."

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How the New England Journal of Medicine Missed Warning Signs on Vioxx

The New England Journal of Medicine waited until Vioxx had already been recalled before it reported flaws in a 2000 article praising Merck's pain drug. But the influential journal's role in the drug debacle has so far received little attention. Journalists at WSJ bring some information to light: 5/15/06: How the New England Journal of Medicine Missed Warning Signs on Vioxx

Excerpt: "Merck says the extra heart attacks, three in total, happened after a predetermined cutoff date for recording events in the trial. Merck says the article was properly done and doesn't require a correction. That puts the company at odds both with critics of the New England Journal and the journal's editors, who now are calling for a correction while defending their failure to ask for one earlier.

Dr. Drazen says journal editors are "just the middleman in picking what goes out there" and "when there are problems the onus lies with" authors to sound the alert. "If you ask me, it is none of our concern about whether [Vioxx] is a cardiovascular risk in the patients that are on trial," he says. The concern was making sure what was published was correct, he says, and "people could have set the record straight.""

Further Reading: "Expression of Concern" published by the New England Journal of Medicine Dec. 29, 2005, about the Vigor trial.

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VIoxx Warning Signs

Pharmacist Jennifer Hrachovec challenged Jeffrey Drazen, editor of the New England Journal of Medicine, about the Vigor study in a call to a Seattle radio show Aug. 14, 2001.

Hrachovec: "With this study in particular, it bothers me that there is more data from the trial than has ever been published and the New England Journal still hasn't published an editorial or any kind of update to let readers and clinicians using this drug and giving it to patients who they think will benefit from a better side-effect profile. My concern is that doctors are still using this and exposing their patients to higher risks of heart problems and they just don't even know that that's the case."

Drazen: "… We can't be in the business of policing every bit of data that we put out. We think that that's the role of people who know the field. And when they think that the field has advanced to the point where something which was true at the time it came out may no longer be true … having brought that evidence to our attention in the form of a manuscript or a letter, we can judge whether there's enough new information and put it out if we believe that the re-analysis is correct."
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[Listen to NPR]
Listen to the full exchange on the Web site of KUOW, Puget Sound Public Radio. (Hrachovec's call begins at about minute 44:30.)

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Some Faqs about NEJM

* Started in 1812, the New England Journal has 200,000 subscribers and is considered must reading for doctors who want to stay current. Its selectivity and editing practices are feared and respected. The weekly rejected 93% of the 3,586 manuscripts it received last year.

* The journal won't disclose its revenue, but its owner, the nonprofit Massachusetts Medical Society, listed $88 million in total publishing revenue for the year ending May 31, 2005.

[resource: WSJ article 5/15/06 How the New England Journal Missed Warning Signs on Vioxx]

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Peer Review has Credibility Gaps

Excerpt: Recent disclosures of fraudulent or flawed studies in medical and scientific journals have called into question as never before the merits of their peer-review system.

NYT: For Science's Gatekeepers, a Credibility Gap by LAWRENCE K. ALTMAN, M.D., published: May 2, 2006

Virtually every major scientific and medical journal has been humbled recently by publishing findings that are later discredited. The flurry of episodes has led many people to ask why authors, editors and independent expert reviewers all failed to detect the problems before publication.

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Journals have devolved into information-laundering operations for the pharmaceutical industry, say Dr. Richard Smith, the former editor of BMJ, the British medical journal, and Dr. Richard Horton, the editor of The Lancet, also based in Britain.

The journals rely on revenues from industry advertisements. But because journals also profit handsomely by selling drug companies reprints of articles reporting findings from large clinical trials involving their products, editors may "face a frighteningly stark conflict of interest" in deciding whether to publish such a study, Dr. Smith said.

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