June 8, 2009
NIH Study Questions Benefits of Stents and Diabetes Drugs Avandia and Actos
Article in the Wall Street Journal -- Diabetes Study Questions Expensive Treatments: NIH Finds Patients With Heart Disease Fare Equally Well Without Stents and Drugs Such as Avandia, Actos, by Keith J. Winstein. Here's an excerpt:
The study, sponsored by the National Institutes of Health and several drugmakers, is the latest to humble fancy new treatments by finding them no better than older medicines at preventing the deadly consequences of major diseases. The results add to a debate about alleged overuse of stents, made by companies including Abbott Laboratories, Boston Scientific Corp. and Johnson & Johnson, and controversial diabetes drugs from GlaxoSmithKline PLC and Takeda Pharmaceutical Co.
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The overuse of drug-eluting stents, which were marketed as effectively and aggressively as Vioxx, is a scandal which has long merited exposure. FDA approval was followed by a marketing campaign that succeeded in widespread adoption, with most use being off label.
Citing the coronary stent experience I argued in my 2007 article Punctuated Equilibrium for the recognition of a common law tort duty of active surveillance of the actual use of medical products, including comparison to other products and therapies. This duty of product stewardship should be recognized during the entire life cycle of the drug or device:
"[P]roducts liability law should address not only `indicated' but also foreseeable uses. In a world where physicians are free to conduct uncontrolled experiments by employing "off-label" uses, manufacturers should assess their products for all expected and foreseeable uses, even ones contraindicated. Off-label use (for purposes and in manners not indicated in the approved labeling) is permissible and often widespread, as the coronary stent experience shows. It is neither paternalism nor puritanism to say that systematic development of knowledge of the actual uses to which a product is put, and the consequences of such uses, is the obligation of the medical product maker. " http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1025489
Posted by: George Conk | Jun 9, 2009 5:36:17 PM
Thanks for commenting. Indeed, most of these points are not new. Unfortunately they seem to be forgotten by a lot of people in healthcare.
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