The FDA has said it will make a final decision about the drug by Aug. 18.
Thursday’s vote stunned many observers, for the committee had previously rejected flibanserin’s approval — twice. And the scientific evidence regarding this drug has not changed significantly since those earlier votes.
So what did change?
This time around, the company mounted a highly effective lobbying campaign. It funded an activist group, Even the Score, to push the idea that not approving flibanserin represented gender inequity. After all, don’t men have Viagra?
That clever framing of the argument may have made it difficult for members of the FDA panel to vote against the drug’s approval.
Yet, as Alan Cassels, a drug policy researcher and co-author of “Selling Sickness,” points out on HealthNewsReview.org, “this activity is classic faux-advocacy,” and the people who engage in it are “Astroturf advocates.”
“Astroturf looks and feels like real grass,” he writes, “but as we know, it’s plastic, has no real grassroots, and really represents no community other than the one created by the big industry (be it tobacco, oil or in this case, the drug industry) that pays their bills. I can assure you, having seen this dozens of times over the last two decades, if there was no drug company funder, there would be no Even the Score campaign.”
As Dr. Adriane Fugh-Berman, director of Georgetown University’s PharmedOut project, which educates healthcare professionals about pharmaceutical marketing practices, told the committee: “To approve this drug will set the worst kind of precedent — that companies that spend enough money can force the F.D.A. to approve useless or dangerous drugs.”
Not much more effective than placebo
The risk-benefit profile of flibanserin, which is a drug that acts on the brain and must be taken continuously, is highly questionable, as David Kroll, a pharmacologist and journalist, explains in an article published online Sunday in Forbes:
Once-daily flibanserin for 24 weeks increased the number of satisfying sexual experiences by about one per month over placebo, but the placebo group had positive effects as well.
Writer Rose Wednesday quipped on Twitter, “[W]ould it be medically irresponsible to offer people the placebo? Half as effective with zero side effects!”
But it’s a serious issue, clinically and statistically.
Isolating the effect of the drug itself in female sexual dysfunction syndromes is quite difficult, according to Andrea Bradford, PhD, a sexual and reproductive health psychologist at M.D. Anderson Cancer Hospital. In her 2013 paper in the Journal of Sexual Medicine, Bradford wrote that responders often exceed 40% of placebo-randomized subjects because of interpersonal interactions with study staff who have expertise and interest in their problems, instructions to attempt sexual behavior at a certain frequency, expectations by their partners, and more attention to factors affecting one’s sexual health and satisfaction.
On one hand, it may seem more impressive that flibanserin can even provide a benefit on top of placebo. But the question of whether this statistical difference is “clinically meaningful” is a matter of debate among physicians and personal preference among women who’ve already taken the drug.
And, of course, the idea that low sexual desire in women in otherwise healthy women is a medical condition waiting for a drug cure is highly controversial.
A sudden drop in blood pressure
Flibanserin is also associated with some significant health risks. Writes Kroll:
The drug carries some typical risks of many medicines that work on the brain, such as dizziness. The drug’s sponsor, Sprout Pharmaceuticals, dealt with that by designing studies with a single nighttime dose of the drug and demonstrating that next-day driving skills were not compromised.
But the most worrisome side effect is syncope (SINK-uh-pee), loss of consciousness and posture due to a sudden or substantial drop in blood pressure. Syncope appears to be enhanced when the drug is combined with alcohol, especially in people who don’t normally drink. …
Let me give you the numbers so you can see how difficult the safety assessment can be. Looking only at drinkers in the Phase 3 efficacy trials, 7 of 898 subjects taking flibanserin (0.8 percent) reported syncope or pre-syncope sensations while 4 of 1,212 in the placebo groups had the same experiences (0.3 percent). So, let’s say that the signal over placebo was 0.5 percent and the drug is given to a million women who are moderate drinkers. That’s 5,000 potential syncope cases.
“People go to intensive care units with blood pressures like that,” one expert told Krolls. “What are you going to do when you take a 45-year-old or 50-year-old with heart disease when you take their [systolic] blood pressure from 120 down to 70? … It’s not exaggerating that you could kill somebody with that kind of hemodynamic response to the drug.”
Incredibly, as Kroll reports, when Sprout Pharmaceuticals was told by the FDA to investigate flibanserin’s interactions with alcohol, the company put together a study involving only 25 volunteers — all men.
All these concerns led the FDA advisory committee to recommend that flibanserin be approved only if certain steps are taken to protect women, including label warnings about the drug’s side effects and about its potentially dangerous interactions with alcohol and other drugs (including birth control pills).
Such labels, however, tend to get ignored.
“Marketing won over science today,” Fugh-Berman told Vox reporter Julia Belluz after the FDA advisory committee voted on Thursday.
We’ll have to see if marketing wins again in August.
You can read Kroll’s article on the Forbes website.