Female Viagra Stinks a Little More Every Day

The comedian Jerry Seinfeld has a very funny bit about what happens when couples who break up, try to get back together again. Paraphrasing: "Do you ever take milk out of the refrigerator, sniff it and it's starting to smell sour? So you put it back and think 'Hmm. Maybe this will smell better tomorrow?' "

It never does, and there's a parallel in the aroma that has engulfed flibanserin, colloquially called "Female Viagra." As I've written here, and here, the whole thing has smelled wrong from the beginning but now it is a day worse.

Why?

Valeant snaps up 'Female Viagra' maker Sprout for $1 billion

Here is a brief history that shows why this whole thing stinks:

• Prior to 2010, Boehringer-Ingleheim was trying to develop a drug called flibanserin as an antidepressant
• It didn't work, but showed some signs of increasing libido in older women
• Boehringer-Ingleheim changed direction, and tried to develop it as a therapy for hyposexual disorder in women
• In 2010, the FDA voted it down unanimously, citing marginal efficacy coupled with side effects including low blood pressure, fainting, nausea, and fatigue
• Boehringer-Ingleheim gave up and sold flibanserin to Sprout Pharmaceuticals, a startup that was formed from what used to be Slate Pharmaceuticals a company that had been chastised down by the FDA for improper advertising and generally sleazy tactics
• Sprout tried for three years to address the FDA's concerns, only to be shot down, again, unanimously

All part of the risks and rewards of drug research, right? Here's where it gets strange. Sprout CEO Cindy Whitehead began to claim that the FDA rejections were due to sexism at the agency, rather than deficiencies in the drug.

She convened a newly-formed womens' right group called Even The Score (ETS) to lobby Congress and the FDA to approve the drug for women under the umbrella of reducing this sexism. ETS even lied about the "imbalance" between the number of drugs to treat male sexual dysfunction vs. the number for women. They claimed "24-0," which was misleading, because they double counted the same drugs using different names. (Different drugs have different names in different countries.)

The real number of drugs to treat men was four, but it was still irrelevant because male and female sexual dysfunction have nothing in common except the name.

Regardless of the previous criticism of flibanserin, the lobbying worked. The same advisory panel that voted down the drug twice suddenly voted 18-6 to approve it in June, and yesterday the FDA accepted the advice of the panel and actually approved the drug.

On Thursday, it was announced that Valeant purchased Sprout for $1 billion. A company being sued for insider trading has now acquired a company with a product that doesn't work. Why aren't those who are outraged by the high prices of lifesaving drugs for hepatitis C just as outraged after learning that a product that will help almost no one is going to be positioned as a solution to a complex problem -- not to mention one that everyone will demand get coverage by health insurance?

This is not a case of a small company scoring a big win with a bold new product. This is the case of Cindy Whitehead being "Ron Popeil with a bra."

If the bra fits...