When new drugs are approved by the FDA they are compared to placebo: i.e. do they do any good? and does the good they appear to do outweigh the toxic side effects? These approvals are all based on quite small samples, and short time frames. Phase IV follows approval. I call it mass marketing: the poorly controlled mass human experiment stage. That may be too kind. Most of the time there is no systematic study of the actual conditions of use, as I discuss in my 2007 article Punctuated Equilibrium, in which I call for recognition of a duty of product stewardship.
For new drugs - and for old drugs that have been little monitored - that means recognizing their experimental nature - even after FDA has approved it as "safe and effective". Their experimental nature should lead courts to recognize a corresponding duty of product stewardship - a duty of ongoing active study and product development; a duty of the manufacturer to conduct systematic active post-approval surveillance of the actual use of the product.
The need for such surveillance is highlighted by our experience with drugs like the diabetes drug Avandia - now virtually banned because it increases the risk of heart attack - the principal killer of diabetics. FDA now permits its use only if every other drug has failed. The drug's deleterious effects became known not through company study, nor through FDA surveillance, but rather because a prominent cardiologist Steven Nissen in 2007 raised the hue and cry in the pages of the New England Journal of Medicine.
Similar was the Vioxx experience - an anti-arthritic drug competitive with Aleve that caused heart attacks and lasted only 5 years before it was withdrawn. The lessons of that experience and the additional powers given the FDA in 2007 are explored here by Margaraet Gilhooley, a former Associate General Counsel at the FDA.
Since 2007 the FDA has had the power to require post-approval studies - but it still has been employed only rarely. The problem of drug safety is particularly acute when drugs - like Avandia - have been mass marketed and the problems which they cause or exacerbate are the very conditions they are meant to treat, or those from which their intended target is particularly likely to suffer - even without the drug.
As the article by Gina Kolata in today's New York Times points out drugs which are used long-term for chronic conditions present particularly difficult problems because the mass use of the drug makes active surveillance an expensive proposition. And only recently approved drugs are even subject to the review power that the FDA gained in 2007.
Since 2007 the FDA has had the power to require post-approval studies - but it still has been employed only rarely. The problem of drug safety is particularly acute when drugs - like Avandia - have been mass marketed and the problems which they cause or exacerbate are the very conditions they are meant to treat, or those from which their intended target is particularly likely to suffer - even without the drug.
As the article by Gina Kolata in today's New York Times points out drugs which are used long-term for chronic conditions present particularly difficult problems because the mass use of the drug makes active surveillance an expensive proposition. And only recently approved drugs are even subject to the review power that the FDA gained in 2007.
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