Although women of all ages use more prescription drugs than men, they're not very good at taking them as directed, according to a new study that's a more depressing read than Valley of the Dolls. (At least Neely O'Hara was diligent about taking her speed.) And it's not because they're lazy or forgetful — it's because women are prescribed drugs with guidelines and dosing based on male subjects, even when suffering from diseases that more women experience than men.
It's pretty ridiculous that most clinical trial leaders effectively ignore the fact that women absorb and metabolize drugs completely differently than men, especially since, according to this study, women use an average of five prescription drugs compared to less than four for men — and that's not even counting their slutty prescription contraceptives. In 100% of the study's clinical trials, women failed to take prescriptions as directed, and were often not prescribed correct dosages to begin with. The study focused on cardiovascular disease — the number one killer of women in the U.S. — and diabetes, since more than half of diabetics are women. If more women than men are dying from these diseases, how come their antidotes are still tailored to men's bodies?
To be fair, the FDA is aware of the issue, and just released a draft guidance in December 2011 that recommends sex-specific analyses and calls for a larger amount of women in clinical studies. But the Society For Women's Health Research, a leading non-profit which co-sponsored the recent study, wrote a letter to the FDA last week asking them to expand the scope of their guidance from "evaluating" sex differences to actually requiring tests based on sex, race, and ethnicity before any drug is approved. "In order for the FDA to uphold its gold standard of 'safe and effective' sex differences must be accounted for in all levels of review," they wrote, and included some more depressing examples of medicines that aren't tailored to women. For example, men use 67% of cardiovascular devices, even though more women die from cardiovascular diseases — likely because the way a woman's heart works is very different from that of a man. 61% of those with arthritis are women, who specifically suffer from estrogen-based knee osteoarthritis — unsurprisingly, that specific issue is lacking in research. Women are four times more likely than men to experience bone fractures, but less women get joint replacements. SWHR also noted in the letter that out of the 10 drugs pulled from the market between 1997 and 2001, 8 had more severe effects on female patients.
Along with asking the FDA to require sex-based pre-approval tests, SWHR is very reasonably calling for proportional gender representation in clinical trials and sex-specific drug labeling regarding dosage. The labels probably wouldn't say "Warning: doctors don't really care if your bodies function completely differently than those of men, so just take a few of these pills and maybe your blood-sugar levels will stabilize." But unless the FDA changes its standards soon, they might as well!
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