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: Drug and Device Law

Goosy Gander: "THINC"ing about Medical Journal Disclosure

By James M. Beck and Mark Herrmann

On the topic of conflicts of interest, our clients and those who do research for them are under constant scrutiny and encounter an ever-escalating call for disclosure of every dime of research money, speaker money, consulting money, etc. Not all conflicts though boil down to money. And the sole, and obsessive, focus on financial disclosures makes us question whether what is being sought is ?context,? as often asserted in defense of witch-hunt tactics, or whether the real goal is to drive a rift between drug companies and researchers or researchers who do industry-sponsored research and those who do not. Certainly, calls for disclosure of ?drug company money? without equivalent disclosures of other measures of academic advancement or of membership in various ?flat earth? societies leaves a strange imbalance in the "disclosure" environment. If we?re really looking for context, the good for the goose rule (which is really the sauce for the goose, but which a legal buddy called the ?goosy-gander rule? and that annoyingly stuck) should apply.


Most recently, the Archives of Internal Medicine got a black eye when it published an article, a ?critical reappraisal? of a statin trial, here, in which several authors questioned the methodology and motives of a trial that showed that statin therapy prevented major cardiac events ? a good thing ? when used in people who might not have been conventionally indicated to take statin. In other words, the study suggested that more people could benefit from statin therapy than had previously been thought. So if authors disagree with the clinical trial, its conduct or outcome, all is fair in scientific debate. But the Archives published the challenge without noting that some of its authors belong to a group that questions the wisdom of statins The International Network of Cholesterol Skeptics ? and indeed, whether high cholesterol is even something that should be treated. Clearly, these folks represent a very small minority view in the medical profession. So when the Archives prints their article without any disclosure regarding this membership, it belies the claim that the expansive financial disclosures are truly meant to contextualize journal articles rather than to demonize researchers for working with drug and device companies. [hat tip to Pharmalot for its coverage of the issue]

Full post as published by Drug and Device Law on July 02, 2010 (boomark / email).

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