If you start by asking the wrong question, you’re pretty sure to wind up with the wrong answer.
Consider, for example, the case of flibanserin, a drug whose manufacturer purports that it works on the central nervous system (suppressing serotonin and releasing dopamine and norepinephrine) to increase libido in women. The data are so-so: women using the drug in a 24-month study reported 4.5 “sexually satisfying events” per month, compared to 3.7 for those given a placebo and 2.7 for those given no pill at all. [This sentence edited to remove gibberish.]
Naturally, the drug has side-effects, including dizziness, nausea, and fatigue. (If there are long-term effects, we’ll learn about them after the drug is approved.)
Now, is the risk of those side-effects, plus the cost of the drug, compensated for by a 25% gain sexual gratification? That isn’t really a medical question, is it?
In any case, it’s not the one the FDA is called on to answer. Instead, the FDA must decide whether there exists a disorder called “female sexual dysfunction,” and whether flibanserin is a safe and effective treatment for that disorder.
Of course the critics are all over the drug company for inventing a new disease so that people will think they’re sick. Fair enough. But note that the company couldn’t have said “We think some women want to pay for having more libido, and here’s a drug that does that.” They had to study specifically women with unusually low libido.
With respect to male sex-enhancers, the market has spoken: Viagra and its competitors, though approved for “erectile dysfunction,” are used mostly by men who want to improve their performance. (Those drugs act on blood flow rather than directly on desire.) Is there anything wrong with that?
Maybe health insurers ought not to have to cover drugs to enhance normal performance as opposed to those prescribed to treat deficiencies, but the current standard doesn’t make any sense. A drug that could raise an I.Q. of 75 to 85 would obviously be approvable as a treatment for cognitive impairment, but one that raised an I.Q. of 130 to 140 could never make it. That, I submit, is insane.
Yes, there are going to be all sorts of problems about competitive economic pressure to use cognitive enhancers which may turn out to have nasty side-effects. But we ought to debate those questions on their merits, not with scholastic arguments about how many symptoms can dance on the head of a diagnosis.
If you think you may have erectile dysfunction, see a professional.
If that doesn't work, see a doctor.
Could you check the writing of this bit — seems so garbled as to be nonsensical, at least to me. I really have no idea what the data are here.
"The data are so-so: women using the drug in a 24-month study reported 4.5 “sexually satisfying events” per month, compared to for women given no pill and 3.7 for those given a placebo 2.7 before the study and 4.5 a month on average. The reported events, which did not have to include orgasm, compared with 3.7 a month by women taking a placebo."
Yes. Demedicalizing biotechnology is a long-term thing, but enhancement inevitably will shake off its awkward, artificial relation to medicine. Needless to say, this has pretty profound — not to say unnerving — cultural implications.
Roy Moynihan had an article about this subject in the BMJ a few years ago. Free full text at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11249… .
A PubMed search for flibanserin shows only 26 articles, of which 19 are animal studies, and only 7 are about humans; of these, none is a clinical trial. They are mostly on the activity of the drug on cell membranes and ion channels, not on clinical anything. At the time that Viagra was released in early 1998, there was a similar situation, where the trials that were the basis for approval were mostly unpublished. This makes it difficult to find out what is really going on when a new drug is released. Clinical trial data released only to the FDA for the approval process does no one else much good.
Ray (not Roy, my typo) Moynihan (in the 29 May BMJ) reports that the German manufacturer Boehringer Ingelheim released abstracts of unpublished clinical trials, and that the trials in Europe failed to show any statistically significant benefits compared to placebo on “satisfying sexual events” of any kind (with or without orgasm). The North American trials showed a small but statistically significant effect. The Times article says that there were 1323 premenopausal women in the key studies; this may be a big enough sample size to give statistical significance to a pretty small clinical effect.
I'm not too upset with what the FDA did. Lawyers and judges do it all the time: deliberately asking the wrong question in order to get the right answer. (To private-sector lawyers, the right answer is their clients' interest, but let us be more forbearant for judges and government lawyers.)
Mark is asking for the law to always catch up with social reality. Na ga ha pen. Creative misreading, and deliberately asking wrong questions, is how the law handles the transitional steps. Law is, after all, a conservative enterprise. (By "conservative", read "Edmund Burke", not "wingnut.") Ultimately, the formal law will catch up.
The FDA may be reluctant to approve this drug because of fairly fresh memories of what happened with estrogen, not only the excesses of “feminine forever” nonsense in the 1960s but more recently with “hormone replacement therapy” in the 1980s and 1990s. It took a large randomized trial to show that HRT did more harm than good, and increased, rather than decreased, the number of cardiovascular events in the target population. The advisory panel appears to be using good judgment in declining to recommend approval of a drug with such scant data.
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Mark is asking for the law to always catch up with social reality. Na ga ha pen. Creative misreading, and deliberately asking wrong questions, is how the law handles the transitional steps. Law is, after all, a conservative enterprise. (By “conservative”, read “Edmund Burke”, not “wingnut.”) Ultimately, the formal law will catch up.
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Is this actually true? Law in the Anglo world operates this way, under these constraints, but is this the case with all law in all countries? (This is only marginally related to Mark's post, but is a subject of great interest to me.) I do not understand why, for all we hear of how the economies, or politics, or education, or health systemsof other countries are different, we do not hear the same regarding law. To take an obvious example — once DNA testing allowed for the retroactive evaluation (with some degree of certainty) of the guilt of the previously imprisoned, we had a magnificent chance to see if Japanese justice, or French justice, or Brazilian justice, lead to more or fewer wrongful convictions. And yet I have never heard of such a study, or even close to it.
Likewise, for this particular example, is it always the case that the law has to be deliberately obtuse to get things done? Are there no systems with some sort of feedback, for example, whereby lawyers and regulators can more directly interact with legislators to generate clarifications and rewrites, rather than the Rube Goldberg machinations we are aware of in the US system?