by Diana Zuckerman, National Center for Health Research
& Judy Norsigian, Our Bodies Ourselves
It’s been almost impossible to ignore the media fascination with “pink Viagra” and the public debate about whether the drug flibanserin — soon to go sale as Addyi — should have been approved last month by the Food and Drug Administration.
The debate was strongest among feminists, who were divided between those who agreed with the FDA scientists who deemed the drug not effective and possibly unsafe, and those who joined the Even the Score campaign, accusing the FDA of sexism for rejecting the drug twice before. The campaign was organized and funded by Sprout Pharmaceuticals, maker of flibanserin.
It wasn’t always comfortable speaking against FDA approval — and against the claims of our friends at NOW, National Council of Women’s Organizations, National Consumer League, and elsewhere. But we scrutinized the evidence and found it very weak, as did the National Women’s Health Network and Jacobs Institute of Women’s Health, among others.
Here are the facts.
The FDA has approved numerous drugs for men’s erectile dysfunction and for women’s vaginal dryness. Both are physiological problems that greatly reduce sexual enjoyment. What the FDA has never approved — before Addyi, that is — is a drug that increases men’s or women’s libido.
Very few men complain about lack of libido, but 10 percent of pre-menopausal women do. That’s a lot of women, and drug companies have been trying to find a solution, knowing it would be a lucrative one. (One physician in particular, Dr. Irwin Goldstein, whose ties to pharmaceutical companies were recently chronicled by Mother Jones, has been eager to help.)
So one part of the debate centered around women’s lack of libido, a complicated issue. When women define it as a problem, are the origins physiological, psychological, sociological, or some combination of all three? And were pharmaceutical companies turning a temporary problem related to specific circumstances into a medical problem (what many experts call “disease mongering”)?
As we all know, there are many possible reasons for lack of libido. The quality of a relationship — and the quality of a sexual relationship — are key factors. We also know that some women who experience reduced spontaneous desire for their partners have no trouble experiencing desire once they become aroused by physical contact or another form of intimacy. For them, the desire is simply responsive, rather than spontaneous.
Addyi is indicated for the treatment of premenopausal women with low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
- A co-existing medical or psychiatric condition
- Problems within the relationship
- The effects of a medication or other drug substance
Exhaustion from childrearing, household tasks and work are also important factors. Some of us find that the emotion and energy we put into childrearing, not just the number of hours, tends to deplete sexual passion.
During the FDA debate, a key unanswerable question was whether low desire is a physiological problem that sometimes has nothing to do with women’s relationships or life circumstances. However, some doctors suggested that regardless of the cause, medication could help.
Let’s look at the data on Addyi to see what it tells us. Studies yielded two important results. First, the drug had a positive impact on women’s sexually satisfying experiences — but so did the placebo, the sugar pill with no active ingredient. In fact, based on daily diaries that the women were required to keep online, the drug added nothing or very little to the very robust “placebo effect.”
So Sprout Pharmaceuticals did something that many of us questioned. It convinced the FDA that it made more sense to ask about sexually satisfying experiences once a month, instead of daily, to measure the impact of the drug. Once that change was made, the pill was slightly better than the placebo: Users registered somewhere between 0.5 and 1.0 more sexually satisfying experiences per month.
But in addition to questioning how accurately anyone can remember the previous month’s sexual moods, medically that benefit is minimal, at best. So what about the risk?
Unlike drugs that men take to increase blood flow to the penis when they cannot have or maintain erections, Addyi is more similar to an antidepressant in that it acts upon chemicals in the brain and needs to be taken every day for as long as you want it to work. Women are warned not to drink alcohol — at all — or use numerous other prescription medications because the interaction is potentially dangerous.
Exactly how dangerous is unclear, because the drug maker tested what happens when you mix Addyi and alcohol on 23 men and two women. That’s right: two women.
“Once again we are through the looking glass,” said Dr. Carolyn M. Mazure, director of Women’s Health Research at Yale. “Prescribing medical treatments for women without fully exploring the possible differences between how that treatment might react in women as opposed to men.”
Based on safety data submitted to the FDA, we know that four of 23 subjects who took Addyi with the equivalent of two glasses of wine, consumed quickly, had events of severe hypotension or syncope — a temporary loss of consciousness caused by a drop in blood pressure. Let’s hope women taking Addyi don’t pass out while driving or walking across the street.
The FDA is trying to protect women from danger by making Addyi available by prescription only through certified health care professionals (doctors who have been trained via a 15-minute online course) and certified pharmacies. And, the filled prescription will come with a black box warning — the FDA’s strongest warning language — about the risk of fainting or dangerous drops in blood pressure in patients who drink alcohol or use certain other drugs.
The FDA is also requiring the company to conduct three post-marketing studies to better understand the serious risks from interactions between the drug and alcohol for women. But if the company didn’t do such a study to get approval, what is the chance of doing it anytime soon?
Sprout, the pharmaceutical company that claims to care deeply about women’s health, was sold for $1 billion just one day after the FDA approved Addyi. We wish that the feminists who worked so hard to make that happen would receive a generous bonus to use on a wide-range of feminist issues, but we’re not optimistic.
The bottom line: We want the FDA to base approval decisions on scientific evidence. After the FDA twice rejected flibanserin, the drug maker developed a slick marketing campaign that underscored the importance of women’s choices and paid nonprofit organizations and health experts to actively oppose the FDA decision — something that most would not have had the time and resources to do otherwise.
While many of those supporters clearly believe in Addyi, some lack the scientific expertise needed to make sound judgments about the drug’s safety or effectiveness.
We believe that the FDA caved in to a marketing campaign in a way that sets a disturbing precedent. Women deserve safe and effective medical treatment, but there is every reason to believe that Addyi is not safe or effective for many of the women who will be taking it.