Thursday, December 02, 2004

Intrinsa

The New York Times discusses Intrinsa, a testosterone delivering patch: http://www.nytimes.com/2004/12/02/health/02patch.html.

Procter and Gamble is trying to get FDA approval for Intrinsa. Intrinsa is mildly effective at increasing female sexual desire:

"In clinical trials, women who used Intrinsa had an increase in the number of 'satisfying episodes' of sex to five a month, from three. But women who received the placebo also had an increase - to four a month, from three. The definition of satisfying sex was left to the women, who kept log books during the clinical trials."
"Procter & Gamble is initially seeking F.D.A. approval for Intrinsa as a treatment for women who have had their ovaries removed. It said that 17 to 30 percent of the 10 million women who have undergone such surgery have 'hypoactive sexual desire disorder,' meaning low sex drive that they find distressing."

If the FDA approves Intrinsa, doctors can prescribe it off-label for other populations and disorders. The market for Intrinsa could be as big as the market for Viagra:

"The shares of Procter & Gamble gained $1.18 yesterday, to close at $54.66"

Unfortunately, like any medication, Intrinsa does have side effects
(from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15065634):

"Possible risks include hirsutism, acne, liver dysfunction, lowering of the voice, adverse lipid changes, virilization of a female fetus, and, as androgens are aromatized to estrogens, potentially the risks of estrogen therapy."
So Intrinsa can give women mildly increased sex drive at the expense of increased body hair, increased facial hair, high cholesterol, and possible birth defects in female offspring. If Intrinsa is approved by the FDA, lawyers will have a field day. After it has been out for several months, we will see ads in newspapers trying to get women who took it to sue Procter and Gamble. Due to the cholesterol-raising effects, this medication probably will slightly increase the risk of heart attacks in women who take it.

62 comments:

Menagerie said...

Lawyers will "have a field day" only if Intrinsa hurts the women who use it. Other suits will be dismissed as frivolous. Sure, anyone can file a suit, but to survive summary judgment, there has to be more than just a bald allegation.

-Shelley
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Michael Rack, MD said...

Heart attacks are very common. Many women who take Intrinsa will have heart attacks, and in most cases the heart attacks will not be due to Intrinsa. It will be similar to Vioxx. Most people who had heart attacks while taking Vioxx had them for another reason. Yet Merck (the manufacturer of Vioxx) is expected to lose billions in class-action lawsuits.
Procter and Gamble need to adequately warn patients of the possible dangers of Intrinsa if they want to avoid massive liability.

bronwyn said...

The idea of a *mildly* effective treatment to increase libido makes little sense to me. Looking at their numbers, I wouldn't think wearing the damn patch all the time would be worth the $$$. And think of all the publicity/undeserved hype this has gotten already. Oi.

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