When the FDA approves a new drug, it seldom causes such as stir as Sprout Pharmaceutical’s Addyi (flibanserin) did. The agency even wheeled out its big guns in the form of Janet Woodcock, director of CDER to make the announcement.
But given that the drug, whose mechanism of action is not understood, has been rejected twice before by the FDA, has limited evidence of efficacy and comes with serious health risks attached, you could be forgiven for asking what has changed.
The first question that needs to be asked is whether generalised hypoactive sexual desire disorder (HSDD) is a condition at all, or is it something that has been medicalised because a ‘treatment’ has been developed. In the best Viagra tradition, Addyi was intended originally as an antidepressant, but failed in clinical trials. However, some patients reported an increased sexual drive, so the development focus was switched to using it to treat low libido, but even then there was little evidence of effectiveness.
Unlike Viagra, this is not a case of popping a pill to rise to the occasion. Addyi has to be taken daily and carries the risk of severe hypotension and syncope in patients who drink alcohol during treatment.
Once the possibility of a ‘female Viagra’ had surfaced, the power of social media kicked in, supported by political correctness that demanded equality for women in the sexual dysfunction arena. A campaign called ‘Even the Score’ set about mobilising support on Twitter and Facebook to ‘level the playing field when it comes to the treatment of women’s sexual dysfunction.’
Add to that the suggestion of sexism on the part of the FDA for approving numerous drugs for sexual dysfunction in men but not one for women, and the pressure to increase the number of drug approvals year-on-year, and it is perhaps not that surprising that the FDA may have been swayed by a very vocal minority.
Popularity should not be part of the regulator’s remit. Addyi advocates may be claiming victory, but the loser is the FDA’s reputation for integrity and making patient safety paramount.
