Map of life expectancy at birth from Global Education Project.

Friday, December 15, 2006

Will we finally learn?

No doubt you have read all about the sudden, sharp drop in diagnoses of breast cancer right after the news came out the Hormone Replacement Therapy was dangerous, and millions of women stopped taking it. The cause and effect case looks quite convincing.*

What the news reports don't give us is the history. Hormone Replacement Therapy (HRT) was approved, and widely prescribed, essentially on the basis of speculation. Women's risk of heart disease goes up after menopause to become more similar to that of men, so it seemed plausible that this might have to do with an estrogen deficiency. There was also a lot of baseless hype about how HRT would keep women youthful and libidinous. None of the Above was the correct answer. In fact it increases the risk of heart disease as well as breast cancer, and it doesn't make or keep you young. All it does is kill you. (It is still prescribed in relatively brief courses to control symptoms of menopause, mostly because the FDA had to give the drug companies some way of saving face and continuing to make money. Even that seems difficult to justify from my point of view, although I have to admit menopause has not been a big problem for me.)

The bottom line is that despite this debacle, and the Vioxx debacle, and so on and so forth, we still have not reformed the drug approval process and we still start to prescribe drugs widely without adequate evidence of safety and effectiveness. Drug companies get to test chemicals against placebo, rather than the best existing therapy, or rig trials by testing them against inadequate or otherwise sub-optimal competing therapies; they get drugs approved on the basis of short-term follow up, insufficient to detect adverse effects of long term use, or delayed effects; they get drugs approved on the basis of so-called "surrogate end points," meaning there is no direct evidence of effectiveness, but only a plausible argument for why they might be effective (viz. HRT, a perfect example of this); there is completely inadequate post-marketing surveillance to detect adverse effects that the clinical trials didn't even look for, or which emerge only in large populations and over longer periods of time; despite some progress in this area, they still get to cherry pick the most favorable trials and suppress studies that tend not to support their products; the researchers who conduct most trials have powerful conflicts of interest, as do members of the FDA panels that evaluate them; and the drug companies aggressively market compounds so that they are often prescribed far more widely than the evidence would support.

In spite of repeated disasters, very little changes. Will the new congress finally force meaningful reform? Stay tuned, but don't hold your breath.

*The drop in diagnoses happened so quickly that it appears to reflect, not a reduction in the actual genesis of new cancers, but rather drastically slowed development of estrogen responsive cancers. In other words, some women actually had minute clusters of cancerous cells when they stopped HRT, which may now develop very slowly, so what we are seeing is at least in part a delay in breast cancer diagnoses, rathe than permanent avoidance of breast cancer. That remains to be seen.

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