Drug regulators in the United States this month will decide whether to approve the first ever sex drug for women with a so-called “disorder” of low desire.
Advisers to the powerful Food & Drug Administration will meet on June 18 on the outskirts of Washington DC to assess the merits of a drug called flibanserin, which has previously failed as an anti-depressant.
If the influential FDA approve the drug, it is likely Australian regulators would follow suit.
It’s being proposed as a treatment for a highly controversial condition called “hypoactive sexual desire disorder”, HSDD. With claims the condition affects up to 10% of all women, there is much excitement within the pharmaceutical industry about new billion dollar markets opening up.
Flibanserin works on neurotransmitters in the brain, including serotonin. It was originally tested as an anti-depressant, but it was not found to be effective and was never approved for that use.
The drug’s German manufacturer, Boehringer Ingelheim, has just completed clinical trials of the drug on women in Europe and North America, which have not yet been published.
However, from the limited evidence released at scientific conferences, flibanserin is already looking a little sick.
In the company-run trials in Europe the drug simply failed to beat the placebo — or dummy pill — in improving the number of “satisfying sexual events” a woman experienced.
A “satisfying sexual event” is the official measure demanded by regulators in these trials, and it can include intercourse, masturbation, or oral sex, but does not necessarily have to include an org-sm.
In the trials in North America, compared to a placebo, the drug offered women an extra 0.7 satisfying sexual events per month. That’s right, 0.7.
Side effects of flibanserin picked up in the trials include dizziness, nausea, fatigue, somnolence and insomnia, and these side effects caused around one-in-seven women to drop out of the trials early.
In the lead up to the FDA hearing this month, with help from PR companies, the drug maker has unleashed a major publicity campaign across the United States, designed to raise awareness about the little-known condition called HSDD. Drug company-paid spokespersons and celebrities have given a string of media interviews in recent weeks trying to persuade women that brain chemistry may be the source of their distressing loss of desire.
In turn that PR campaign is being attacked by a global feminist network called the New View, which has exposed the drug industry’s involvement in helping build the science of “female s-xual dysfunction”.
So far no drugs have been approved in the United States for HSDD — one of the sub-disorders of “female s-xual dysfunction” — and if flibanserin is given the green light this month, the subsequent tsunami of marketing could well rival that for Viagra.
A testosterone patch for women with HSDD was rejected by the FDA in 2004, but was later approved in Europe — though it has since been attacked by independent assessment bodies because of concerns about its long-term safety, and questions around how well it actually works.
*Ray Moynihan has a book coming out in Australia and North America in September, called S-x, Lies & Pharmaceuticals.