Sunday, December 05, 2004

Not Your Testosterone Patch

The U.S. Food and Drug Administration (FDA) advisory panel has voted unanimously against approving Intrinsa, a drug that could enhance the sex drive of women (as many as 43% of American women are said to suffer from sexual dysfunctioning). The reason for this refusal is lack of information about the drug's long-term safety. Though FDA will make the final decision about whether Intrinsa will be made available on the market, they hardly ever go against such advisory panel recommendations.

The explanations the committee gives for not recommending Intrinsa for women's sexual malfunctions are odd to say the least:

Members of the committee said that the possible risks of the drug - a patch containing the hormone testosterone developed by - outweighed what some saw as only a modest benefit in increasing desire and the frequency of sex.
"I am not devaluing the importance of this symptom and its treatment," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a panel member. "But I also don't want to expose several million American women to the risk of heart attack and stroke, with their devastating consequences, in order to have one more sexual experience per month."

What is most interesting about Dr. Nissen's statement is that there is no evidence that the drug would cause increased risks of heart attack or stroke. What the committee is worried about is the lack of research into such possibilities:

Indeed, Intrinsa appears to have been rebuffed not by any known safety problems - the agency's staff review said the short-term effects of the drug "appear relatively benign" - but rather by its backers' inability to rule out possible long-term effects like breast cancer and heart problems.

This is indeed a new path that the FDA has chosen: in the past many drugs have been passed without any such rigorous testing. More about this a little later.

Another interesting aspect about Dr. Nissen's statement is his decision that an extra sexual experience per month is not sufficient justification for introducing a drug about which little is known. This may be true, but given that the women in the study from which this data is extracted only had three satisfying sexual experiences a month to begin with we are talking about a 25% increase here. Somehow I can't help feeling that Dr. Nissen is here making decisions on behalf of women, and that annoys me.

The whole tone of this annoys me. I don't necessarily think that the testosterone patch is a good idea, either, but I don't like the way this advisory panel has discussed the issue and women's sexuality and health in general. It is not for them to decide how many extra orgasms are adequate benefits from taking some medication with potential harmful side-effects. It is for the women who consider taking it. Did the advisory panel on approving Viagra make similar judgments? I doubt it.

By the way, Viagra can be quite dangerous, yet it's widely available in the marketplace. Here are some of the warnings that are attached to it:

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including sildenafil citrate, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
Sildenafil citrate has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), (see ). While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil citrate, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.
There is no controlled clinical data on the safety or efficacy of sildenafil citrate in the following groups; if prescribed, this should be done with caution.
Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
Patients with resting hypertension (BP <90/50) or hypertension (BP >170/110).
Patients with cardiac failure or coronary artery disease causing unstable angina.
Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Prolonged erection greater than 4 hours and priapism(painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If is not treated immediately, penile tissue damage and permanent loss of potency could result.

The same source notes that Viagra's safety has never been tested on men who suffer from many other chronic conditions, and it warns that drug interaction effects exist and can be significant. Yet many men take Viagra like candy.

So while it may be that the FDA has changed its drug approval policies towards a more stringent direction, it may also be the case that women's sexual concerns are not seen as equally important to those of men's. Maybe the advisory committee thinks that a woman can always just lie back and think about the Patriot Act?
I don't know.