This weekly column offers opinions on the latest pharmaceutical industry news.
After years of controversy, a pill to help women with low libido will finally become available in a few weeks. But there’s a catch: The prescription drug, Addyi, shouldn’t be taken with alcohol. And because the pill must be taken each day on an ongoing basis, this means no more drinking for those who take it — ever.
There’s a sobering reason for this. But whether anyone will follow the instructions is another matter.
If nothing else, the uncertainty will probably extend the ruckus surrounding the medicine, which already inspired a contentious lobbying campaign that accused the FDA of being biased against treatments to help women overcome a loss of sexual desire.
Here’s the problem: A small study of 25 people found a few experienced a severe drop in blood pressure when mixing the drug and a few drinks in a short amount of time. All but two of those in the study, by the way, were men, which isn’t the best way to gauge an effect in women. The FDA is concerned women might have an even more pronounced reaction.
To get the word out, the agency has slapped a warning on the Addyi product label and insisted that the manufacturer, Sprout Pharmaceuticals, devise a so-called risk management program. Such programs are designed to restrict availability and lower the chance that a patient develops a serious side effect. Some might say fainting isn’t all that serious. Then again, you can crack your head open when you faint.
So the program requires doctors to become certified before prescribing the drug, which means they must review material about side effects and convey these to their patients. And only a select number of pharmacies will be allowed to stock the drug. Women, meanwhile, will have to sign a form stating they are aware of the risks before receiving a prescription, which might also be a way to limit legal liability.
But will women, who should expect only a very modest benefit from the drug, really refrain from drinking?
After all, women will have to take an Addyi every day because the drug works by manipulating the central nervous system. By comparison, erectile dysfunction drugs such as Viagra and Cialis work by increasing blood flow to the penis and so can be taken “on demand.” Given that many people drink to lower their inhibitions, how practical is it to expect that some women will never drink while taking the drug?
“We see people all the time who we tell not to drink because they’re on certain medications. But the longer you’re on a med, the more likely you are to eventually think it’s OK to drink,” said Jen Gunter, an obstetrician and gynecologist in San Francisco. “When women first start taking a drug under such circumstances, they’re more careful. But later some start to wonder whether just one drink can hurt.”
Sprout’s chief executive, Cindy Whitehead, said she is confident that the risk program will work. “We’re going to use it as an opportunity” to educate physicians and women about the possibilities for combating a loss of sexual desire, she said.
And she noted that Sprout, which sold itself to Valeant Pharmaceuticals for $1 billion two days after Addyi was approved, is committed to conducting three post-marketing studies in women that the FDA required to better gauge the effects of mixing Addyi with alcohol. The first must be done by end of 2016 and the others by the end of 2018.
As for the FDA, a spokeswoman reiterated the risk program is essential but acknowledged that avoiding alcohol will really be up to patients. Meanwhile, Addyi becomes widely available next month. And though Sprout has voluntarily agreed to refrain from running consumer ads for the next 18 months, recent media coverage of the drug has already generated tremendous buzz. In fact, even before the FDA approved the drug late last month, a recent survey found that 80 percent of 554 women would be willing to take Addyi. The survey, however, did not collect detailed information about the respondents.
Moreover, a spokeswoman for Treato, a social media research firm that conducted the survey, said women were not asked questions about their willingness to avoid alcohol or whether they had concerns about the risk of drinking while taking the drug.
“There’s really nothing they can do to prevent women from drinking,” said Ira Loss, a senior health care analyst at Washington Analysis, a consulting firm. “If women are determined to take that medication and drink, they’re going to do it. Maybe the one thing that will serve as a reminder not to drink is taking the pill each day. But for some, a drink may still be tempting.”
Twice before, the FDA rejected Addyi because of such risks, as well as limited effectiveness. But at the time, the drug was owned by another company that was not part of the campaign accusing the FDA of bias. Michael McCaughan of Prevision Policy, a health care consulting firm, points to another factor. “At this moment in history,” he said, “the FDA is working to find a way to say yes” to drug approvals.
Perhaps the concerns about drinking will become moot. After all, if enough women find that Addyi isn’t particularly effective, the buzz will wear off and prescriptions won’t be refilled.
And alcohol sales might rise instead.