The focus of this effort is Boehringer-Ingelheim's new "female viagra" drug, Flibanserin, which is to be discussed by an FDA advisory committee on June 18. A petition asking that committee not to approve the drug is being circulated and New View will be testifying as a lay group against approval.
I apologize for not being able to follow this particular debate as closely as I would have wished in recent weeks. The major points stressed by New View are:
- Flibanserin was discovered accidentally as part of a search for new antidepressants. It is said to work by modifying several neurotransmitters. So far, drugs that alter neurotransmitter chemistry have been frequently shown to cause severe adverse effects, many of which were not evident in the initial approval trials.
- B-I is taking full advantage of the FDA rules that to be approved, a drug has to be shown to be better than placebo in a few trials, and that is all. The actual amount of improvement shown by subjects in the trials B-I is submitting to the FDA is marginal at best.
- The larger societal issue is the medicalization of female sexual desire and the idea that if a women has low sexual desire, it must be because her brain chemistry is whacked out; it cannot be because she's stressed out of her mind or her boyfriend never bathes or any of the various environmental causes of low sexual desire. According to New View, the marketing campaign that B-I has launched for its new drug pushes all these buttons.
