testosterone and relapse?

postop said...
The story of HRT is that it (estrogen alone or estrogen + progesterone) was heavily promoted as safe and beneficial for decades and decades based on many, many more studies than exist for testosterone supplementation in men. Millions and millions of women were given it, including my mother, and wife and probably yours, too. The majority of the postmetopausal women in the US and many other countries got HRT for many decades, based on inadequate science. Only when the effort was made to perform a definitive trial was it proven that it was bad for them. Should we repeat this experiment in men?

I expect that final question was intended to be rhetorical but I find it an interesting one and am inclined to say yes. I am not sure that medical science or public health is that well served by our current binary, on or off, yes or no, categorization of drugs. It makes the approval of a new drug, device or treatment tremendously expensive, slowing the rate at which new technology becomes available and bottling up many potentially useful drugs for which the revenue expected from the anticipated target market does not justify the fabulous expense of jumping through all the hoops needed to prove the drug is safe to the satisfaction of the FDA. On the other side of the equation it also tends to suppress critical evaluation of drugs that have been approved; there is a general tendency to assume that drugs that have been approved are safer and more effective than they might, in fact, be, leading to overuse or inappropriate use.

In place of the current binary approval process I would like to see drugs and devices marked with the level of evidence that is available for their safety and effectiveness. These levels would be periodically reviewed and updated as new research was done. If would be up to the doctor, the patient (and, of course, the insurance company, if any) to decide what level of evidence -- what level of uncertainty and risk -- they are willing to accept. As long as it is clear that -- on a prescription-by-prescription basis -- the doctor made clear the level of evidence associated with a given drug or device and obtained the patient's agreement then the doctor and the drug company should be given some level of protection against lawsuits.

I admit that this would lead to a degree of anarchy -- medicine red in tooth and claw -- but it would be an enlightened anarchy. Drugs would come faster and be cheaper. People would pay a lot more attention to the drugs they took. There would be fads that wouldn't work out. There would be occasional gruesome accidents but they would be quickly self-correcting and balanced by lives saved, lengthened and improved by faster availability of innovative new treatments. On balance, I think we would all be better off.

So, yes, there are still open questions about T supplements in general, and particularly in the area of men who have / have had prostate cancer. But I think men and their doctors should be allowed to review the research and make their own decisions.

I don't see the value in front-loading the trial process beyond a rather minimal amount of basic safety and effectiveness validation. If the first women to receive HRT had been enthusiasts and early-adopters who knew (as a condition of getting it) that it was a new, and somewhat unproven, class of drugs then, perhaps, the health problems would have been noticed before quite so many women were subject to them, and those women who were put at risk would have known those risks. The initial phases of the marketing for a newly-released drug would be a self-financing continuation of those cursory clinical trials.

I don't see any need to ban advertising but it should be forbidden to misrepresent the level of evidence for any safety or effectiveness research cited. That is, it's OK to advertise but there are limits (based on fraud) to what you can say.

Post Edited (PeterDisAbelard) : 3/1/2013 1:18:55 PM (GMT-7)