July 12, 2007

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?


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Comments (10)

Posted by Cybrludite [TypeKey Profile Page] | July 12, 2007 6:51 AM

Yeah, that whole stopwatch thing has to be a bit of a mood-killer...

Posted by MarkW | July 12, 2007 7:28 AM

The FDA should be no more than an advisory label, much as UL is.

If people want to buy drugs that haven't been approved by the regulatory behemeth, that's their concern, not the govts.

On net, FDA regulations have killed many more people than they have saved.

Posted by TomB | July 12, 2007 7:48 AM

I also see a little bit of an ageism in the position of FDA: Viagra tends to target older market, people (men) of more power and means. The new medication on the other hand would be for younger, somehow irrelevant crowd, older decision makers have little sympathy for...

Posted by AndyN | July 12, 2007 8:18 AM

Apologies in advance if I missed it, but I don't remember you ever commenting on Vioxx before, and it's unfortunate that you've chosen to do so now as an example of what the FDA should be preventing.

There are good reasons why so many Vioxx "victims" are losing their court cases, and so many of the winners are being overturned on appeal. The problem isn't with Vioxx, the problem is with consumers using a product that isn't suited for them, doctors prescribing a medication that isn't in their patients' best interest, and a judicial system where any negative outcome can mean a big payday.

I personally know smart, informed, educated people who refused to turn in their remaining supply of Vioxx when it was recalled and begged Merck employees to find a way to make more available because it's simply the only thing that works for their arthritis pain. When allowed to make an informed choice between living with debilitating pain and risking the limited potential for adverse effects based on their medical profile, they would choose not to live in pain.

Posted by docjim505 | July 12, 2007 8:46 AM

Maybe they should market the drug as "baseballotine"...

Posted by Ric James | July 12, 2007 11:44 AM

I'd love to hear that conversation before a couple takes it for a test drive:

"OK, honey, ok. You can use the stopwatch, but I'm absolutely drawing the line at the starter's pistol!"

Posted by burt | July 12, 2007 6:00 PM

Vioxx is a legitimate medication; there are people who don't function without it because of excruciating pain. It was known that it had dangerous side affects and was so labeled when it was licensed. I have never contemplated taking it, I don't personally know anyone who has, I don't own an interest in the drug, and I am not a medical practitioner. As a citizen I knew it was dangerous when it was new and that I wouldn't take it unless needed for a specific problem and that only then if prescribed by a COMPETENT physician. I think exactly the same way about dangerous immune suppression drugs.

Posted by davod | July 12, 2007 6:18 PM

I do not understand why the FDA does not want to approve this drug.

So what if they do not think premeture ejeculation is a disease.

The issue should be whether the drug works and whether sufficient testing has been done to ensure the drug is safe.

Posted by AREITZ | July 12, 2007 7:18 PM

If aspirin was scrutinized by the FDA today, it would never hit the market due to the potenetial side effects/complications from taking it.

Posted by sigh | July 13, 2007 10:27 AM

There's already a fairly harmless drug for that problem. It's called cannabis.