In celebrating last week’s federal approval of Addyi, the first-ever drug to treat female sexual dysfunction, Sprout Pharmaceutical CEO Cindy Whitehead said “science won, and so too did women.”
But did they?
In one of the more worrisome developments spotted by critics, the study to determine the degree of danger in mixing Addyi and alcohol enrolled 23 men and only two women. That’s a study population of 92 percent men for a drug intended only for 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.”
According to the National Institute on Alcohol Abuse and Alcoholism, women absorb more alcohol in their blood when drinking the same amount as men, leaving them more inebriated and vulnerable to adverse consequences such as accident-induced trauma and liver and brain damage.
Dr. Mazure expressed concern but not disbelief over the nature of Addyi’s alcohol interaction study, noting how it comes two years after the FDA cut the dosage of the sleep-aid Ambien in half because of how that drug is metabolized differently in men and women, leaving women with more of the drug in their systems and more susceptible to accidents the following day.
“There is no valid reason to ignore the well-established biological and behavioral differences between men and women when conducting biomedical research,” Mazure said. “Yet it continues to happen.”
A spokeswoman for Sprout provided a written statement saying that the alcohol interaction study was designed with FDA guidance and required participants to drink the equivalent of a half a bottle of wine within 10 minutes on a nearly empty stomach before taking Addyi.
“More men than women agreed to enroll in this kind of study,” the statement said.
The statement said 60 percent of about 2,700 women taking Addyi in the pre-approval studies – which allowed consumption of alcohol – characterized themselves as social drinkers. The statement said that Sprout plans to conduct additional studies on the effects of alcohol in women after the drug goes on sale in October.
“And yet the company did not work harder to ensure adequate female participation in a study exploring more extreme interactions with this medicine and alcohol,” Mazure said.
Medical experts have long criticized the drug’s effectiveness and safety. The U.S. Food and Drug Administration accepted the drug, known as flibanserin and marketed as Addyi, after two previous failed attempts.
Whitehead said the agency was swayed by new clinical and safety trials, not a well-funded marketing campaign advocating for a potential blockbuster drug to increase female libido while painting the effort as a bid for equality in a world saturated by male erectile dysfunction drugs like Viagra.
“It was a lot more science that has come forward, that’s allowed us to truly characterize what the benefit and the risk for patients (are),” Whitehead said on an Aug. 19 segment of “CBS This Morning.”
But what are those benefits?
In its FDA application, Sprout admits not knowing the exact mechanism by which the drug might work. Many experts believe that a woman’s libido reacts to social, emotional, biological and psychological conditions rather than representing a regular baseline of sexual arousal. In contrast, drugs like Viagra treat male erectile dysfunction on an as-needed basis, not by increasing the desire for sex but by relaxing blood vessels to allow the penis to become erect. Addyi works more like an antidepressant, targeting chemicals in the brain to supposedly change a woman’s overall mood toward sex.
Studies of women showed a large placebo effect, with those women who responded to Addyi reporting a comparative increase of between .5 and .7 “sexually satisfying events” over the course of a month.
Even more concerning for critics, the drug has been shown to severely lower blood pressure in patients when drinking alcohol, possibly leading to fainting. For a drug taken every day, that could present a serious obstacle and a potential pitfall.
“No drug comes without side effects,” Whitehead said on CBS. “What we do in drug development is we really study it to understand what would be the benefits to patients, what would be the risks and provided the FDA stamps that, as approvable, we turn that over and let patients make those decisions with their health care providers.”
The company’s statement noted that patients are advised to avoid alcohol when using several FDA-approved medications, including antidepressants.
“Women are capable of weighing the risks and benefits of these medications and making an appropriate treatment decision in consultation with their doctors,” the statement said. “And they should be afforded the same trust with Addyi.”
According to materials Sprout supplied to win FDA approval, patients should consider taking Addyi only if they experience low sexual desire that causes distress; if their low libido is not due to another medical or psychiatric condition (including pregnancy or recent childbirth), problems within the relationship, or the effects of medication or drugs; if they are premenopausal; if they understand that the drug does not enhance sexual performance; if they agree to never drink alcohol; if they agree to only take the drug at bedtime; and if they agree to lie down right away if they feel lightheaded or dizzy.
Dr. Mary Jane Minkin, Clinical Professor of Obstetrics, Gynecology, and Reproductive Sciences, said the drug is not for everyone, particularly those who have physical discomfort with sex, problems with their relationship, and environmental stress caused by sources such as work or family.
“So there are a lot of problems that can be out there,” Minkin said. “And unfortunately in this country many of us are looking for a pill to take care of all problems. And most of these other kinds of problems won’t be taken care of by a simple pill.”
However, she did say she would consider prescribing the drug as long as her patients understand the side effects and are not taking it to improve a relationship suffering from complications such as poor communication or external stress.
Source: Yale University