From The Montreal Gazette 8-28-2015
SEDUCED BY THE HYPE
Montreal GazetteAugust 28, 2015Christopher Labos is a Montreal doctor who writes about medicine and health issues. Christopher.labos@mail.mcgill.ca twitter.com/drlabos
Casanova used oysters and chocolate to put his female companions in the mood. They don’t actually do anything, though. I eat them all the time and have yet to become the ladies’ man I always thought I would be.
So the promise of something that may act as an aphrodisiac would be a financial blockbuster for its manufacturer.
Enter flibanserin (soon to be rebranded as Addyi), which was just approved by the U.S. Food and Drug Administration and seems likely to be approved by Health Canada soon enough. It is the first medication indicated to treat hypoactive sexual desire disorder (HSDD) in women.
Only problem is, many experts contend that HSDD doesn’t actually exist, that the drug is ineffective, has terrible side effects and was approved only because of a successful lobbying campaign. It’s kind of a funny story. Flibanserin was first developed as an anti-depressant and proved to be a flop. But in reviewing the data from trials, investigators found that patients reported improvements in their sex lives. Thus, it was repackaged and became a medication to enhance sexual desire. Studies were done and the data submitted to the FDA.
But the FDA unanimously rejected the drug application in 2010. Undaunted, the manufacturer refiled in 2013. It was again rejected. It appealed and was denied.
The FDA had two fundamental problems with the drug.
First, the FDA didn’t think it worked. To measure what effect the medication had on sexual desire, researchers asked study participants to keep a daily diary. When the results were analyzed, there was no difference between flibanserin and a placebo. The only real difference was in the number of “satisfactory sexual events.” This increased by an average of 0.5 events per month. Obviously, the FDA did not consider one extra orgasm every two months to be a meaningful improvement.
To work around this problem, the manufacturer changed its methodology and asked study participants to use the Female Sexual Function Index, a questionnaire that asks subjects to recall their experiences over the previous four weeks, instead of the daily diary. It is harder to accurately remember things that happened weeks ago, and therefore a daily diary is almost always preferred. On the six-point scale, flibanserin showed a 0.3 point improvement in sexual desire. What this means in real life is hard to say.
The second major problem that the FDA had was that any small potential benefit was outweighed by the side effects. Flibanserin causes a sudden drop in blood pressure and loss of consciousness in some patients. That’s bad. What’s worse is that the symptoms are more pronounced if you mix it with alcohol. Given that alcohol precedes most sexual encounters — at least according to HBO — that particular interaction is somewhat worrisome. It also interacts with a large number of medications including birth control pills. Think about that for a second: a sex pill that interacts with alcohol and contraceptives. And yet, here we are.
Given the significant problems of two FDA rejections, the manufacturer decided to change tactics and launched a media campaign called Even the Score. The message was simple. The FDA is sexist because it approved drugs like Viagra, but not flibanserin. They also rebranded flibanserin as “Pink Viagra” or “Viagra for women.”
The message on their website states that 26 drugs have been approved for male sexual dysfunction and, now, only one for women. This is untrue. First, they have counted several different forms of testosterone (gels, patches, pills, etc.) as different drugs, which is silly. Also worth noting that testosterone has enough side effects (it increases the risk of a heart attack) that no one should be prescribing it simply to treat low libido.
Furthermore, Viagra and flibanserin are completely different medications that do completely different things. They have nothing do with another. Drugs like Viagra and Cialis don’t actually increase sexual desire. They are phosphodiesterase inhibitors, drugs that dilate arteries and improve blood flow. In this case, they improve blood flow to the penis to initiate and sustain an erection. They don’t make you want to have sex. Also, while drugs like Viagra are taken as needed, flibanserin must be taken every day long term. Comparing them is a good marketing strategy, but bad science.
Fundamentally, the difference between men and women is that with men, sexual dysfunction is a problem of ability. Age, smoking, diabetes and high blood pressure all contribute to narrowing of blood vessels, which make erections more difficult. It is a biological problem and these medications provide a biological solution. With women, sexual dysfunction is more complex and is rarely due to a single issue as it is in men. It is a complex interplay of emotional, psychological, social and environmental issues. The old joke that a woman’s sex organ is her brain has some merit.
Sometimes, medical issues can affect a woman’s sexual desire, but flibanserin was specifically studied in pre-menopausal women with no medical problems. It is also contraindicated in women taking a very very long list of medications. As part of its media campaign, many testimonials from women suffering from hypoactive sexual desire disorder were trotted out to sway the FDA. The irony, of course, is that flibanserin would not be indicated for many of them.
The final fly in the ointment is that hypoactive sexual desire disorder doesn’t actually exist. It was removed from the most recent DSM-V, the disease manual that defines medical psychiatric disorders. Many experts consider sexual desire disorders a relic from the 1950s when “frigidity” and “nymphomania” were medical diagnoses. The growing consensus is that there is no such thing as too little or too much sex.
Even so, the Even the Score campaign was successful. It got the support of 11 congressmen in the United States, mobilized feminist groups and put sufficient pressure on the FDA to provide a conditional approval for flibanserin. It is worth noting though that a few feminist lobby groups saw through the ploy and campaigned against the drug’s approval. Nevertheless, third time’s the charm for drug approval, and this will almost certainly open the door to an aggressive media campaign designed to convince women they have a disease.
And so we have a drug that doesn’t really work, with serious side effects, to treat a condition that doesn’t really exist, that was approved not because of science, but because of a media campaign.
I’d like to think Casanova would not approve.
