SOURCE: CBS -- 60 Minutes [THANK YOU, Lesley Stahl !!!}
DATE: February 9, 2014
EXCERPTS: "Earlier this year, the Food and Drug Administration made an unusual and surprising announcement. It cut the recommended dose of the most popular sleep drug in the country, Ambien, in half for women. It turns out men and women metabolize Ambien, known generically as Zolpidem, very differently, leaving women with more of the drug in their bodies the next morning, and therefore at a greater risk of impaired driving. .... Take aspirin. Low-dose aspirin lowers the risk of heart attacks in healthy men; but in healthy women, turns out it doesn’t though it does protect women against stroke. And drugs are just the beginning. Sex differences have been found in pain receptors, liver enzymes, even the wiring of the brain."
Larry Cahill [a neuroscientist at the University of California Irvine]: If you're clumping men and women together in your study and there truly is a sex difference, you're not just harming the women; you're harming the men. You're muddling up the understanding of what's going on, you're muddling up the path to clear treatment, not just for the women, but for the men as well.
The problem, he says, is that the scientific establishment hasn’t caught up with its own discoveries.
Lesley Stahl: If science got Ambien so wrong, does that tell you that we really need to go back and review—
Larry Cahill: Yes.
Lesley Stahl: What? Everything?
Larry Cahill: Pretty much everything, yeah, ‘cause once you see this difference and that difference and that difference and that difference and that difference and you see, "This thing's everywhere," you go, "Wait a minute. So the assumption we're making that it really doesn't matter, sex, is not a valid assumption." It may not matter. It may matter hugely. It may flip your results on their head and you don't know. So what happens is you start to realize, "Wow. The status quo is not OK. The way we're doing business has has to change."
"Lesley Stahl: It sounds like the FDA is being more reactive than aggressive about this.
Dr. Sandra Kweder [deputy director of the FDA’s office of new drugs]: I think we're being very aggressive about bringing the most sophisticated science to new drugs and being aggressive about applying the science where we have reason to believe there is a concern to older drugs.
The FDA told us it is looking at other sleep drugs for possible sex differences, but not mounting an across the board review. As of today, Zolpidem remains the only drug on the market with different recommended doses for men and women." more