Bremelanotide in the desire trials
I prize worthwhile change above a triumphant verdict. The published record offers several measures and an argument about how much they amount to.
RECONNECT
The RECONNECT report describes two identical randomized Phase 3 trials enrolling 1267 premenopausal women with HSDD. Over 24 weeks, bremelanotide produced statistically significant improvements compared with placebo on the coprimary desire and desire-related distress measures.
In the integrated results, the difference on the Female Sexual Function Index desire measure was +0.35, and the difference on the distress measure, FSDS-DAO item 13, was -0.33; both had P<.001. These are differences on the named measures. They do not represent percentages of women helped.
I favour giving distress its own measure alongside desire. Relief from an upsetting problem seems worth attending to in its own right. The result still leaves the harder judgement of how large a change feels worthwhile.
The enjoyable-encounter objection
A critical analysis by Mintzes, Tiefer and Cosgrove reports that bremelanotide produced no additional enjoyable sexual experiences on average in the clinical trials. The authors question the clinical benefit and the regulatory precedent behind approval.
That criticism tests my enthusiasm. The trial report's positive desire and distress findings remain findings on those measures; the criticism asks whether the account of benefit survives another way of describing sexual experience. Both deserve space in an honest account.
The baseline review complicates an encounter count from another direction: women with documented HSDD were already sexually active in the trials it examined. Between them, these papers make the count useful to examine and difficult to treat as a complete answer.
Limited efficacy deserves plain language
A pharmacotherapy review characterises bremelanotide's efficacy as limited and discusses potential adverse effects and transparency concerns in reporting. I take limited benefit to be a reason for precision, not embarrassment.
My objection would be to making a modest drug result carry a larger social argument. Women can deserve more attention to sexual health without that fact enlarging the drug's effect. Equally, a disappointing average does not make a person's distress trivial. The argument for being heard and the argument for a particular medicine each need their own support.
The tolerability record is the next necessary entry. An improvement becomes harder to value when the account of it leaves out how treatment felt.