Is the FDA Approval of the “Pink Pill” a Probable Outcome?
A failure to approve flibanserin would set a dangerous precedent. Why? Because the pharmaceutical company did everything the FDA asked it to do, and the results came out statistically significantly better than placebo—which was the desired endpoint. If the FDA were to deny approval of the drug, it would be saying, in effect, that it can change its mind in the middle of the argument.
In reality, the FDA is likely to say yes to approval, but with restrictions, as that is what its advisory committee recommended. What those restrictions will be remains to be determined, but they are likely to resemble those of other drugs in the class, such as selective serotonin reuptake inhibitors (SSRIs), including a warning to be careful using flibanserin with alcohol until the drug’s effects are clear.
These days, it seems like hormone “treatment centers” are popping up all over the place, and online “pharmacies” are constantly pushing the latest and greatest hormones for menopausal and postmenopausal women. But what about the woman who is looking for individualized evidence-based counsel and care to help guide her through the menopause transition? Why is it so hard to find a physician who specializes in menopausal medicine?
Part of the reason dates back to the Women’s Health Initiative, a first-of-its-kind, 15-year study that included a trial on the effects of combined (estrogen-progestogen) hormone replacement therapy. Before the trial’s abrupt end in 2002, menopause care was a developing area of medicine, with a growing number of continuing education classes being offered to healthcare professionals, and the use of hormone therapy among postmenopausal women on the rise. But then the combined hormone therapy arm of the study was cut short—four years ahead of schedule—and news quickly spread of its controversial results.
Results showed that women taking the estrogen-progestogen combination had a greater incidence of breast cancer, heart disease, stroke and blood clots—risks that far outweighed the benefits of hormone therapy. With this news, everything stopped. Patients were advised to discontinue treatment. Physicians were afraid to prescribe anything.
Unfortunately, the publicity surrounding the combined therapy results overshadowed the positive results of the estrogen-only therapy, which did not show an increased risk of heart disease or breast cancer. But the damage was done. The topic didn’t get much attention after that. And the impact on physician education was significant.
Ten years later, views on hormone therapy continue to evolve. For instance, recently released guidelines from the North American Menopause Society (NAMS) indicate that many women can safely take hormone therapy. (To view the latest NAMS recommendations, click here. But I suppose some physicians are still a bit gun-shy about what remains a controversial topic in the media and even the medical community—despite the rapidly growing number of women seeking menopause care.
The fact remains, however, that the alternative treatment options—the online pharmacies and “hormone houses”—are no substitute for evidence-based medical care by a certified menopause practitioner. Menopause treatment is highly individualized and requires a patient-focused approach to care.