The drug industry’s race to create the first pink Viagra is exhibiting a unique pathology: A near-irrational desire to turn “not now honey, I’ve got a headache” into a bonafide medical problem.
First came the testing of Viagra in women to fulfill a deeply seated desire to “grow the market” and otherwise create a product for use in the other half of the population.
That failed. Spectacularly so.
Next was the transdermal testosterone patch, which was touted as a cure for a disease that has afflicted womankind since time immemorial: low sexual desire. The US Food and Drug Administration (FDA) were having none of it.
It crashed and burned.
The next round, early last summer, saw the drug flibanserin facing off at the FDA, armed with evidence suggesting a woman’s neurotransmitters needed tweaking if she were suffering from hypoactive sexual desire. Flibanserin, as a female libido enhancer, showed some moderate evidence of effectiveness, but not enough to impress the FDA. It failed approval so spectacularly one would think that searching for the pharmacologic answer to low female sexual desire would be a non-starter for decades.
But it’s not.
Apparently, having a regulator say no, only adds to the thrill of the chase.
Those who think that pharma would give up after three strikes are naively unaware of the legendary staying power of one of the most successful businesses in the history of the world. The market for female sexual dysfunction drugs could be colossal and so we can expect pharma to continue to throw incredible amounts of clinical and marketing mojo at the problem.
And they’ll need it too, because “the problem” of female sexual dsfunction is mind-bogglingly elusive and complex, quite unlike the simple plumbing problem known as erectile dysfunction. In fact, no one can adequately answer the question: What exactly is female sexual dysfunction?
Part of the problem is that consulting Dr. Google on female sexual difficulties is a parodist’s playground. Typing hypoactive sexual desire disorder (HSDD) into a search engine leads you to places like HSDD online (www.hsddonline.com) a disease awareness campaign that claims HSDD affects about 20 per cent of women in the US and provides links to products that they claim can help. Their descriptions of what seems like normal female behaviour (i.e., not wanting sex sometimes) sound medical and messy.
The Internet also serves up the opposite view in the New View Campaign, which marches under the banner: “Sex for our pleasure or their profit?” (www.fsd-alert.org). It takes on the corporate-sponsored definition of female sexual difficulties and delivers a damning indictment of the pharmacologizing of women’s sex lives. These activists want to keep pharma’s labels off their libidos and risky drugs out of women’s medicine cabinets, even as they acknowledge that sex for many women could be more satisfying.
No doubt some women will be helped, and even possibly some relationships saved, by a pharmaceutical solution to a more active libido. Whether or not you’re gung-ho for a drug for what some have called the “not tonight honey, I’ve got a headache” disease, the potential for much collateral damage along the way is always there. Will women legitimately be able to say “not tonight” when there is a drug to “cure” their reticence?
Beyond the problems of defining the disease in terms of sexual pharmacology is the need, at the end of the day, for a drug that actually “works” in the conventional sense of “works.”
Which brings us back to the embarrassing FDA hearing of flibanserin where it was summarily rejected. The clinical research found that compared to placebo, 100 mg of flibanserin increased the number of “satisfactory sexual experiences” per month, from 3.7 to 4.5. The 0.8 additional satisfying sexual episodes per month works out to less than 0.03 additional satisfying sexual experiences per day!
It’s true that some women may want more sex and better sex, but do they want the pharmaceutical industry to be tinkering with their brains or libidos for such pitiful results? Will we ever get to the point where sufficient amounts of sexual pleasure are going to flow from a prescription pad? At least compared to the competition?
Speaking of which, I don’t think it’s ethical to be testing libido-enhancing drugs against anything except already proven therapies. Anyone can show a benefit of a drug over placebo, but the real question is: How does the drug compare with the man vacuuming the house or doing the laundry without being told? If you could only create a drug that would make men fold laundry — now that would be a blockbuster.