To: Hippieslayer who wrote (22959 ) 7/9/1998 2:47:00 AM From: DMB 1 Recommendation Respond to of 32384
Fugazi, Nice to see all the work you've done and there may be some merit in a few of your examples. I don't feel entirely comfortable being an apologist for the FDA; however, let me respond with the following points. Re: <<Beta-blockers effective in preventing heart attacks and coronary deaths might have saved 10000 to 20000 lives a year had they been approved sooner>> Beta blockers have been widely available in this country since I was in medical school over 20 years ago. Re: <<as many as 15,000 people died unnecessarily during the FDA's review of the drug misoprostrol which alleviates gastric ulcers.>> Highly speculative in my opinion. Misoprostil (Cytotec) is a useful drug, but to imagine that 15,000 people have died from gastric ulcers simply from the want of this drug is far fetched. I'd have to see the reasoning behind this one. Re: <<22000 heart patients might have lived but for the FDA's delay in approving streptokinase, which dissolves blood clots.>> Streptokinase has been approved and available for decades...long before anyone ever conceived of the idea of using it in the setting of an acute myocardial infarction. Re: <<the FDA forbade manufactures from advertising this benefit on the grounds that aspirin was not labeled as heart medicine.>> Maybe I am naive but I just don't see medical progress being dependent on how a drug is marketed. As a practicing physician, I find that important new information is readily available from many, many sources. I would just as soon get rid of pharmaceutical advertising altogether. Even with the policing that goes on, advertising is often extremely misleading and is not the optimal way to inform medical practitioners on new advances in treatment. Again, I don't think the FDA is always without fault but you have not mentioned that the FDA has regularly made important new drugs available prior to approval through the compassionate use program. I don't want to beat this one to death. I am sure this discussion could go on forever and I don't have the free time to respond to too many comments. I hope my remarks are useful, and I hope I am not sounding too argumentative. I just wanted to present another side of the story. DMB