Drugs

Addyi: Not the Women's Sex Pill You've Been Waiting For

How did a drug with a shady past and "marginal" benefits get FDA approval?

Photo Credit: Shutterstock.com/Goodluz

There’s a new sex pill in town, the very first for women. Too bad for sufferers of “low desire” that the story of Addyi (flibanserin) is looking so shady. Questions persist about the quality of the drug and also the process behind its FDA approval in August. 

Clearly women deserve some sort of help by now from the laboratories that concocted Viagra 17 years ago and then product-after-product for men. And there are profits to be made on women’s sexual difficulties: Addyi’s maker was snatched up for $1 billion immediately after the drug’s approval.

But the pharmaceutical industry might be the wrong direction for women to look in the first place. Addyi revives a debate about whether drugs can ever genuinely be of service to women in this way—as opposed to talk therapy, a well-placed divorce or looking into whether some other medicine you’re taking (a sleep aid, for instance) might be killing the mood on its own.

Part of the problem with Addyi, according to some of its opponents, is that it works a little too much like men’s little blue pill. “Women are more complicated, it’s not just increasing blood flow,” Georgetown University doctor and pharma-policy wonk Adriane Fugh-Berman told Slate last year. 

One of the pink pill’s other big troubles is the allegation that many of the prominent experts who advocated for its FDA approval were on the drug company’s payroll. 

Some of these advocates put together a non-profit organization last year called Even the Score to help push the approval through. The FDA had already rejected flibanserin twice; perhaps a more (seemingly) grassroots approach was called for.

“It’s time to level the playing field when it comes to the treatment of women’s sexual dysfunction,” the group’s website argued then and argues still, alongside logos from the Center for Health and Gender Equity, Women’s Health Foundation, American College of Nurse-Midwives, Black Women’s Health Imperative, Sexual Medicine Society and many more.

In the run-up to the FDA’s decision, Even the Score contributed an authoritative voice to the discussion, along with compelling numbers such as that there are 26 sex drugs on the market for men, compared to zero for women—until Addyi. The group was able to get several members of Congress to write letters to the FDA and to summon a good deal of public awareness.

Whatever Even the Score’s genuine sympathies for women with sexual dysfunctions, however, its members’ reliability as advocates was widely taken to task the moment it was reported that some had been paid. (Interview requests to Even the Score and some of its members went unanswered.)

Meanwhile, the National Women’s Health Network, Our Bodies Ourselves and other women’s health organizations said they felt the group’s anti-sexism approach was an inappropriate distraction from questions about whether research on the drug had been rigorous enough.

The Addyi campaign hit pay dirt. Yet the question remains: Did the strategy corrupt the approval process? 

“The high-road answer is that the FDA is trying to treat women equally to men and be responsive to their sexual needs,” says Dr. Prudence Hall, a California gynecologist. “The more correct answer, however, is that the company created this political campaign using and manipulating women to push the approval through.”

Last June, at a hearing before an FDA advisory panel, Sprout Pharmaceuticals—Addyi’s developers—presented results from clinical trials spanning 24 weeks, and said 46-60% of trial subjects had benefited from taking the drug.

Not so fast, said some members of the committee: What about the placebo effect? They adjusted the numbers down to 10% in order to accommodate the natural inclination of subjects who want a little too badly for flibanserin to work. 

The panel was concerned not just about whether it worked but also about side effects (fainting, nausea, dizziness, sleepiness and low-blood pressure) and about Sprout’s very strong warnings against combining the pill with alcohol or prescribing it to menopausal women. 

What these limitations mean in the real world is that the number of women able to take Addyi is rather small. Whatever your judgments about couples sharing a bottle of wine to enhance intimacy or “loosen up,” good luck getting them to stop. And there’s no question that low-sexual desire is a bigger problem for older women than younger ones. 

A letter urging the FDA not to allow flibanserin onto the market—signed by almost 100 sex experts—said: “We will leave the topic of flibanserin’s safety to others, except for mentioning the truly absurd situation of approving a daily drug to boost the sex lives of women in their 30s and 40s that must not be taken with alcohol. As sexologists we can say with confidence that this advice is both preposterous and doomed.”

The June panel decided to give Addyi a “yes.” It was a qualified yes, with Addyi’s benefits described as “marginal.” But it was enough to sway the agency to officially okay the drug in August.

No one is disputing that low libido is a sexual dysfunction of sorts and that it involves suffering.  

“Loss of desire can be upsetting for women because they enjoy having sex and all the benefits that come along with it, like connection, energy, attraction, feeling attractive,” says Dr. Kelly Wise, a New York sex therapist. “It can make women feel sad, hopeless, disconnected. And in their relationships, they may feel unworthy.”

Viagra gave women hope that one day all that might be treated with a pill. The search for an easy solution has prompted all manner of quackery and dubious, potentially dangerous products online.

But Addyi’s opponents say mainstream science is moving away from the idea that low libido in women is a narrow problem that can be tackled without trying to find out what else is happening in someone’s life.  

The sexologists’ letter says there is a “paradigm shift from viewing women’s sexual desire as a straightforward matter of internal and spontaneous drive (‘lust’) to a more complex incentive motivation model of sexual response that emphasizes the interaction of desire with psychological, stimulus and relational context.”

They refer to a 2013 change in the Diagnostic and Statistical Manual of Mental Disorders (DSM), the mental health diagnosis bible for clinicians, researchers, insurance companies, policymakers and various agencies.

In essence, the DSM has combined libido problems with arousal disorders (when sexual stimuli cause no physical or emotional response) into a single diagnosis by replacing the term Hypoactive Sexual Desire Disorder (HSDD) with Female Sexual Interest/Arousal Disorder (FSIAD). 

The thinking is that for women, desire often comes in response to a stimulus, instead of before. 

Plenty of professionals dispute the DSM change. Sprout and Even the Score have continued to describe Addyi as a treatment for the old one.

AIDS activists made an ethical tradeoff in the '90s much like what some of the people behind Even the Score seem to have achieved by getting into bed with drug-makers to speed this product to market. Then again, AIDS activists sacrificed their independence on behalf of people who were dying and had no other solution in sight. And there was no genuine trust there between industry and advocates.

Another harsh accusation is that pro-Addyi groups may have been unwitting parties to a cynical (and not uncommon) pharmaceutical industry maneuver: inventing a medical condition out of whole cloth and then cashing in on its alleged treatment. 

The hope is that Even the Score’s hyperbole—“The approval of Addyi opens the door to momentous change for women, similar to that of the pill in 1960…”—has not put women off other solutions showing promise, such as talk therapy.

Dr. Wise has seen good psychotherapy results at his thriving Brooklyn practice among women coming to him with libido issues. “With one couple who I had about 10 sessions with, we discovered that in order for the woman to want to have sex, she needed to feel connected to her husband,” he said. “After several sessions we identified ways that the husband can be more available to his wife.”

In this case—do not try this at home!—the most effective solutions were walking the dog together in the mornings and building a weekday dinner date into their busy schedules. 

Of course, lots of women try talk therapy (or non-monogamy or sex toys or what have you) for their sexual disinterest problems without moving the dial a single inch. The reason the Addyi debate is so heated is because there is a big problem here and the yearning for a solution is strong. 

Dr. Hall, the California gynecologist, won’t be prescribing the pink pill to her patients when it arrives in drugstores mid-October mostly because she opposes the idea of using drugs for what, in her opinion, are often questions of hormonal imbalance. But who knows how many doctors Addyi might still win over if it can improve its record of success—whether in women’s bodies or on their minds. “I wish it would generate a greaterplacebo effect,” says Hall.  

 

Sally Chew was an editor at Time Inc.’s Health.com as well as at Vibe, Out and POZ magazines. She also authored a true crime book and was a wire-service reporter overseas. She last wrote about oxytocin as well as drugs and suicide.

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