May 212011
 

If you spend $10,000 for a single injection you would expect the medicine to be very effective for the condition for which it is being used. However this is not the case with Factor VIIa (FaVIIa) which is sold under the brand name NovoSeven RT. This drug is approved by the FDA only for use in hemophilia and related inherited bleeding disorders and a few other very rare conditions. But through clever marketing and manipulated research this drug is being used to stop bleeding in patients who do not have any bleeding disorders.

Originally the drug was approved under a fast track system for use in patients with bleeding disorders. Once approved by the FDA,  doctors are free to prescribe it for other conditions which is called off-label use. This is perfectly legal. The company producing FaVIIa sponsored studies on the use of this drug in various conditions such as prostate surgery, cardio-vascular surgeries, and bleeding from multiple trauma.

An independent analysis of these studies (1) revealed that FaVIIa does not improve mortality in any of the off-label conditions for which it is being used. The individual studies, sponsored by the company, emphasize that using FaVIIa reduces the number of blood units transfused. The fact that FaVIIa does not help the patient and may be detrimental was omitted from the reports. This drug increases blood coagulation leading to thrombotic episodes. So the overall effect of the drug is negative.

Doctors are inundated with conferences, medical articles, drug reps, and other promotional tools that push the use of FaVIIa for treatment of almost any bleeding patient. Several self-serving clinical trials appear to say that the drug is very useful. No wonder doctors feel they must use this very expensive drug to give their patients every chance even though independent studies shows it does not work.

Reference

1. Veronica Yank, M.D., C. Vaughan Touhy, B.S., Aaron C. Logan, M.D. et al: Systematic Review: Benefits and Harms of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications; Ann Inter Med, 2011;154:529-540.

 

 Posted by at 5:24 pm

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