If you want to read about sleaze, corruption, opportunists, and useful fools, Tom Wolfe's cynical 1987 masterpiece, "Bonfire of the Vanities" has it all.
Or you can follow the story of how flibanserin, aka "Female Viagra" made it from the scrapheap of a legitimate drug company to a very different kind of company, and ultimately to the drug store, where it never belonged in the first place. Better still, no one is buying it—something I could have told you (and did) over a year ago. How this all played out is somewhere between ironic and hilarious.
The fact that Wolfe popped into my mind during the death throes of what may be the stupidest drug ever approved is no coincidence. Wolfe's premise, that nothing gets done for the right reason, describes this scummy episode just about perfectly.
(Flibanserin was intended to restore libido and make sex more pleasurable in — mostly — postmenopausal women.)
And speaking of scum, Valeant, a drug company that exists just slightly below head lice on the food chain of life, ended up being the ultimate sucker in this unseemly affair — something that is just too funny, especially given some of the nonsense that its executives have tried to pull off.
To say that the company is ethically challenged is being quite kind. (The New York Times article that documents this compares Valeant to Enron). Its "business plan" mostly consists of buying companies that are the sole providers of a generic drug, and jacking up the price, sometimes as much as five times in one year. Bunch of parasites.
Michael Pearson, former (and current) CEO of Valeant
I tried to put my two cents in very early, which would have saved the company $999,999,999.98 had they listened:
"Is the FDA Really Sexist?" (Feb. 2014): I described how Anita Clayton's Huffington Post piece reached the inescapably wrong conclusion that the reason that there were 24 approved drugs for male sexual dysfunction vs. ZERO for women was of institutional sexism at the FDA. A few minor problems here:
- Ms. Clayton, meet Mr. Stanley Kaplan, who will help you with your math SATs, should you decide to retake them. The number of ED drugs for men is actually four, but can be inflated to 24 by counting different brand names that are used in different countries for the same drug. Nice try. Other mathematically challenged individuals came up with 26 and 41.
- The real reason for the discrepancy was that "Female Viagra" was a terrible drug —something that Boehringer-Ingelheim, the discoverer of this mess, found out when the FDA voted it down unanimously in 2010, citing significant side effects and little or no benefit.
- Loribeth Weinstein, CEO and executive director at Jewish Women International recently said, “The need for advocacy in support of a balanced flibanserin review was due to a sharp contrast and disparity around gender when it comes to the evaluation of drugs that address the issue of low sexual desire.” Uh, sorry Ms. Weinstein. You can advocate all you want for a crappy drug, and it will still be a crappy drug.
Then the fun began. In 2010, Boehringer threw in the towel, and sold flibanserin to a start-up company named Sprout Pharmaceuticals for about $0.14 (this is a guess). Sprout was the brainchild of Cindy Whitehead, who was the co-founder and CEO. Remember her name. She will end up being the only winner in this sordid story.
"Will Female Viagra Be An FDA Boner?" (May 2015): Sprout runs a few more test, and goes back to the FDA for approval only to be shot down unanimously again. But, Ms. Whitehead is nothing if not resourceful. Sprout then recruited women's rights groups, and they lobbied Congress and the FDA. This worked out just as you would expect:
- Rep. Debbie Wasserman Schultz (D-FL): "There are 24 approved medical treatments for male sexual dysfunction and not one single treatment yet approved for the most common form of female sexual dysfunction." Her math isn't so good either.
- Terry O'Neill, the president of the National Organization for Women: "We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women. ... And I fear that it’s that cultural attitude that men’s sexual health is extremely important, but women’s sexual health is not so important. That’s the cultural attitude that I want to be sure the FDA has not, maybe unconsciously, imported into its deliberative process.” (Kill me)
- The data from the clinical trials are terrible. You have to look really hard to find any benefits of flibanserin but not hard at all to find plenty of side effects.
"FDA Stiffs Go Soft On Pink Viagra" (Aug. 2015): Despite dismal preclinical results, the FDA folds up like a $3 lawn chair and approves flibanserin 18-6, which will be sold as Addyi. The drug must contain a black box warning (the strongest) on its label.
But, at least someone gets it: Dr. Adriane Fugh-Berman, an associate professor in the department of pharmacology at Georgetown University: "This company already has a history of unethical marketing. If approved, I think this drug will be widely prescribed, and we would see an epidemic of adverse effects." Kudos to Dr. Fugh-Berman. She not only knows what she is talking about, but had the guts to say it.
Valeant should have listened to her. Because it was straight downhill from here. Just because I find the following timeline amusing doesn't make me a bad person, right?
- August 15th, 9:00 AM — FDA approves flibanserin
- August 15th, 9:00:01 AM — Cindy Whitehead sells Sprout to Valeant for $1 billion. They are gonna regret this soon.
- By November 2015 (three months), a grand total of 227 prescriptions for Addyi had been written. Compare this to the 500,000 that were written for Viagra during the first month alone.
- The damn stuff (predictably) doesn't even work. A new study shows that Addyi provides women with an extra “one-half” of a satisfying sexual encounter per month. Or maybe that means one extra "half satisfying" encounter per month.
- It is useless, which may have something to do with the following:
If you are laughing, you are alone:
