There may be a new drug on the market later this year called Flibanserin. You’ve probably heard of it. It’s being billed as the “female Viagra.” You’ve heard of the innocuously named “little purple pill” for acid reflux, Nexium? Well, Flibanserin will be the “little pink pill” for sexual indifference.
The US Food and Drug Administration’s (FDA) Drug Safety Oversight Board recently voted 18-6 to approve Flibanserin, a new drug developed by Sprout Pharmaceuticals, Inc. of Raleigh, NC aimed at treating low libido for women. Although the FDA has on two previous occasions opted to reject Flibanserin because it had concerns about the drug’s safety and whether it even worked, the agency is now apparently expected to act favorably on the advisory panel’s recommendation by August 18, 2015. And why shouldn’t it. After all, an 18-6 vote is pretty convincing.
All those doctors voting in the affirmative wouldn’t do so unless they were absolutely certain, or at least nearly certain, that the drug would be both safe and efficacious. After all, the first ethic in medicine is “do no harm.” Yes, six of the members on the panel voted to reject Flibanserin outright. But then there were the 18, so you just have to trust the weight of the vast majority and assume the drug is safe for women.
Those 18 members agreed that the FDA should approve Flibanserin so long as the drug carries with it a strict warning about the potential side-effects… like all those other prescription drugs and vaccines that list everything from the possibility of a mild headache, skin rash and upset stomach to internal bleeding, encephalitic shock and death.
Obviously, all of the 18 must think that the benefits of the drug so outweigh the potential side-effects that it is well worth the risk to women.
Take the case of Walid Gellad, MD, MPH of the University of Pittsburgh. Dr. Gellad, whose research at UPitt’s Health Policy Institute focuses on “the quality, safety, and efficiency of prescribing,” said about Flibanserin:
I have serious, serious, serious safety concerns. The benefits are modest, maybe less than modest. But I think that puts it in good company with other approved drugs.
Let that sink in for a moment. I have serious… serious… serious safety concerns. Count them. That’s three seriouses. This is coming from a guy who is supposedly a specialist on the safety aspect of prescribing drugs. So he should know what he’s talking about, and so he should be taken seriously. But if so, then you have to wonder how he could, in good conscience, vote to recommend that the FDA allow the drug to be put on the market and sold to possibly tens of millions of women.
Then comes the kicker from Dr. Gellad. The benefits are modest… maybe less than modest? That’s an awfully strange cost-benefit analysis Dr. Gellad. You’re giving a thumbs up to a drug that the FDA has already rejected twice and about which you have extremely serious safety concerns and may be less than modestly beneficial?
You have to wonder about these kind of seemingly callous and senseless cost-benefit analyses by members of advisory committees for government institutions like the FDA and the Centers for Disease Control Control (CDC) charged with looking out for the health and welfare of the U.S. population. Are they the exception, or the rule? (Although you can certainly speculate based on Dr. Gellad’s last comment, “But I think that puts it in good company with other approved drugs.”) … And do they occur only with regard to reviews of prescription drugs, or also with reviews of proposed new vaccines?
Finally, what drives such thinking? Incompetence maybe, or something more tangible like conflicts of interest?
Keep in mind that, while Flibanserin is designed to increase the female libido, the drug doesn’t work the same way as Viagra does for men. Instead of simply increasing the flow of blood to the genitals, Flibanserin actually has the effect of altering the brain chemistry. According to the CEO of Sprout Pharmaceuticals, Cindy Whitehead, the drug increases the excitatory chemical neurotransmitters dopamine and norepinephrine that stimulate sex drive and decreases the inhibitory chemical neurotransmitter serotonin that can dampen it.
Again, read carefully. Flibanserin would alter the brain chemistry. That should scare the bejeesus out of every woman who is even remotely considering popping this little pink pill. That sounds a lot more serious than a four-hour erection.