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Healthy Skepticism Library item: 18917

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Hopkins Tanne J
GSK lawyer is indicted on charges of obstructing FDA proceeding
BMJ 2010 Nov 17; 341:
http://www.bmj.com/content/341/bmj.c6570.extract


Abstract:

The US Department of Justice has charged Lauren Stevens, a retired GlaxoSmithKline (GSK) lawyer, in relation to alleged off-label marketing of a drug. She faces one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration.

Although drug companies have in the past been charged with off-label marketing of drugs, and several have paid large fines, it is thought that this is the first time an individual has been charged. GSK has not been charged and is not identified in the indictment.

The charges relate to the alleged off-label marketing of the antidepressant bupropion (marketed by GSK as Wellbutrin) for weight loss, and each carries a possible …

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963