A Long Term Investment?

After researchers found a beneficial side effect while testing the blood pressure medicine Sildenafil — better known as Viagra — the pharmaceuticals have discovered the vast market for sexual-enhacement medications. They tend to play on the insecurities men and women have had for millenia about performance. Now Johnson & Johnson want to tackle the Great White Whale of male insecurity, but the Food and Drug Administration questions the need to medicate men into having more staying power:

In the hunt for a new sex pill for men, Johnson & Johnson has staying power.
The health-products giant hasn’t given up on what it hopes will become the first drug approved for premature ejaculation, even though the U.S. Food and Drug Administration rejected it in 2005. Regulators questioned whether helping men last longer during sex was a clear medical benefit, and may have had concerns about side effects of the drug, dapoxetine.
Other companies — including New York-based Pfizer Inc., the maker of Viagra — have scrapped experimental drugs for the condition since the FDA’s thumbs down for Johnson & Johnson’s.
Now, Johnson & Johnson will test its luck with dapoxetine outside the U.S. The New Brunswick, N.J., company plans to file for regulatory approval of dapoxetine in some European countries later this year, and also plans to submit it for approval in Canada. Johnson & Johnson hasn’t ruled out a second try for FDA approval to sell the drug to American men.

The FDA rejected the drug earlier, not because of any significant issues or side effects, but because they rejected the notion that premature ejaculation qualifies as a disease. Some men may differ, but the FDA took the position that the issue does not require medication at all. They may have been reacting to the backlash against Viagra and Cialis, which created some controversy over the investment of pharmaceuticals into what was seen as less-than-serious issues when other more serious but less marketable conditions escape their attention. Erectile dysfunction at least qualifies as an obstacle to procreation, while this doesn’t qualify at all.
It’s a losing battle, at least on two fronts. First, J&J will take the drug to Europe. It’s been proven effective, although the trials use an amusing method: the women use stopwatches during coitus. European administrators will not likely block its production, simply based on the economics. Many people don’t realize that Viagra primarily got produced in Ireland, where Pfizer’s investment helped contribute to the Celtic Tiger. Europe won’t mind another boost in economic fortunes, especially if the US hands them the manufacturing market.
Second, if it does get manufactured in Europe, it will be sold in the US whether the FDA likes it or not. The global market in pharmaceuticals will ensure that American men can access the drug, and spammers will facilitate those transactions. It will take less time than the announced performance improvement between the European launch of the drug and the first American purchase. The only effect the FDA’s rejection will have on the drug will be to increase the price.
I’m not necessarily opposed to the FDA, as some conservatives and libertarians are. It does good work in forcing pharmaceuticals to do the proper testing before selling potentially dangerous chemicals to sick people. Some, like Vioxx, still make it through, but we would have hundreds of Vioxx stories if the FDA closed up shop. In this case, though, they are making essentially a consumer choice rather than a safety choice, and they should reconsider their decision.
Addendum: I’ve always wanted to remark on this, but never had a post in which I could do so — but isn’t it more than a little ironic that so many web sites try to sell Viagra in the form of soft tabs?