Reasons To Be Skeptical Of "Female Viagra" Drug, Big Pharma's Spanish Fly

So yesterday results of a study of a drug called Flibanserin (its generic name) were rolled out at a conference in France. Flibanserin was designed as an anti-depressant, but failed its trials except in one key sense: female patients were reluctant to return the study drug at trial's end because they'd had a low libido pre-trial and experienced heightened libido while on the drug, which is made by a Germany pharma company called Boehringer Ingelheim. Since the company has run several phase 2 and phase 3 trials of the drug to treated so-called hypoactive sexual desire disorder or HSDD.

Anyhow one study of the drug got a ton of press attention yesterday. It involved 1,378 women in stable relationship who were diagnosed with HSDD. The drug was trialed against placebo over 24 weeks and study subjects reported more "satisfying sexual events"--a careful term if there ever was one--on the drug than on placebo.

Before I get to the skepticism of my headline, let me address the two or three of you who might wonder why I'm writing about a purported treatment for HSDD on a mental health website. First, sex and relationships are obviously entwined with mood and, in many respects, overall mental health. Second, I'm endlessly fascinated by how anti-depressants have been repurposed over the years and this story is a big repurposing.

Now for some skepticism:

1. The press coverage I've seen of Flibanserin so far mixes its metaphors when it dubs the drug a female Viagra. Viagra and its ilk are drugs to treat erectile dysfunction--meaning an inability to get it up or keep it up, to be blunt--whereas HSDD involves a lack of female sexual desire. While I recognize that the two phenomena are loosely-related, it's little more than cheap tricks for the press to headline Flibanserin a Viagra type of drug. In effect, Flibanserin is an aphrodisiac, Big Pharma's Spanish Fly, if you will. It's not approved by the FDA.

2. If the response rate is as high as claimed--60 percent to 75 percent--then that means the placebo response in this study was very high. In one press account of the study, the effect size is put at 22 percent. That means that the placebo response rate would be 38 percent to 53 percent. Very high.

3. It's an anti-depressant playing with serotonin receptors and that likely means that there were patients in the study who could have had some level of side effects associated with taking the drug. None of the press accounts I've seen so far get into that question. But you know there's bound to be reports of suicidality and withdrawal problems and the like once this drug gets to a large population, if it ever does.

4. With such a high placebo response, you know something else has to be going on to explain these women's lack of libido.

"Problems with sexual desire are 'a big deal,' for women, according to Dr. Marie Savard, a medical consultant to ABC News.

"'We know the role of sex is so important to relationships,' she said. 'But for women it's unrealistic to think a pill is going to fix the impact of so many issues that women face.'

"Savard said women have many reasons for a lack of libido, including stress, caregiving roles and lack of self-esteem, and added it's difficult to label women with a simple diagnosis like HSSD. But she said since the brain is a woman's 'biggest sex organ,' it might make sense that they would benefit from a drug like flibanserin."

5. Said one of the study researchers:

"'Viagra increases blood flow. This doesn't do that. It affects the brain. (Flibanserin) affects the neurotransmitters in the brain that affects sex,' Guay said."

Points 4 and 5 come from the same article and in the same article you have two doctors in fundamental disagreement about what causes lack of desire.

6. Reportedly 20 percent of adult women in America experience HSDD. With roughly 115 million adult American women that would work out to about 23 million American women with HSDD, a potentially gigantic market for drug treatments as far as Big Pharma is concerned. By comparison, about 10 million to about 12 million American women take anti-depressants to treat depression. With a potential market so large, any drug that gets approved to treat HSDD--the causes of which remain unclear--will be marketed very aggressively, perhaps as aggressively as ED treatments. My point is that any claims for these drugs should be greeted with extreme skepticism because when Big Pharma is chasing a big market drug companies--and doctors --will make outlandish claims.

7. The results of four different studies of Flibanserin were presented at the same conference that resulted in the press coverage of but one of the studies. I don't know what the results of the other three were, but it's likely that the press was being spoonfed the results of one study. It'll be interesting to see the results of the other studies, once they become public.

8. I sure hope the FDA takes a long, hard look at the results of the main study because the placebo response is so high that it makes me a bit suspicious. Was there something odd with the study design? Why were so many people getting such a response to placebo? Is it really a good idea for the US for millions of Americans to take Flibanserin when it's clear that HSDD drug trials had such a high placebo response? The FDA isn't the most skeptical organization on Earth, but on occasion it does surprise me. I hope this is one of those times.

9. If Flibanserin is approved by the FDA, I simple cannot wait to see the television commercials that will roll out for this drug and what imagery the ad agencies will use to capture women's imaginations. One of the classic Viagra commercials, for example, features a bunch of country pickers cranking out "Viva Viagra" before blazing down the road on loud motorcycles and in fast cars. What would the women's version of that be? Who would be the feminine equivalent of NASCAR god Mark Martin tearing 'round Talledega in the Viagra car a few years ago? Would there be female sports stars endorsing the drug a la Rafael Palmeiro? The mind boggles.