Addyi: Big Pharma Botches a Viagra for Women

I hardly know where to begin. This is all too bizarre for me. If you’re a regular scanner of cash register magazines, you’ll be reading about Addyi, released by Big Pharma and approved for something called female hypoactive sexual desire disorder (HSDD), which is essentially no or low sex drive.

This story is about a Big Pharma match made in heaven. On one side, the psychiatrist editors of the DSM (Diagnostic and Statistical Manual of Mental Disorders) who put names to conditions they deem to be illness (including shyness, social anxiety, childhood bipolar disorder, and hypoactive sexual desire disorder) are playing right into the hands of Big Pharma. And Big Pharma itself is ready with a new, overpriced, minimally useful, and potentially dangerous pill to swallow.

Having made gazillions with Viagra and its cousins Levitra and Cialis (now $40 a pill), Big Pharma desperately wanted a little pink pill, a Viagra for women. But Viagra deals with the mechanics of flaccidity (lacking firmness). Viagra works a man’s plumbing to increase circulation to his penis and…bingo!

Take a Viagra, wait an hour or so, and a guy can manage sex with himself or with his wife, husband, girlfriend, boyfriend, or Venetian blinds. Generally speaking, sexual desire in women is a bit more complicated than sending blood to an appendage to make it rigid (to be fair, men’s sexual desire is also more complex than that). Lack of desire in either gender usually has psychological roots.

But Big Pharma had a drug, flibanserin, which, having failed in its original iteration as an antidepressant, was just sitting there, unused, ripe for some clever company to find a new way to market it.

Hmmm, how about sex?

Sex always sells, and theoretically flibanserin might have had some positive effects. Many women who have taken a serotonin-increasing SSRI drug like Prozac, Lexapro, or Zoloft know that these meds can dampen desire. Sometimes, though not always, this loss of libido can be prevented by taking an antidepressant that raises both serotonin and dopamine.

But what about lowering serotonin and raising dopamine at the same time, the very mechanism of flibanserin? Hey, it might work to boost sex drive. To be the first to leap into the female HSDD breach! Big Pharma could smell the meat a-cookin’.

Just one problem: it didn’t work. Not only did flibanserin not have much impact on sex drive, it made users sleepy, dizzy, and when taken with alcohol caused significant drops in blood pressure with occasional fainting.

In round one, the FDA voted unanimously (11-0) against flibanserin for premenopausal female hypoactive sexual desire disorder. Not losing hope, the drug was acquired by Sprout Pharmaceuticals, which submitted new studies showing minimal benefit and, again, serious side effects. Strangely, the alcohol interaction issues were studied not in women, but in male Addyi-takers, who also got dizzy and fainted.

Round two: the FDA again votes against the drug

Now Sprout was fuming. They’d made a huge investment in a useless and potentially dangerous drug and wanted some return on their investment. So Sprout launched a women’s advocacy group called Even The Score and initiated an intense promotional campaign directed at journalists, women’s groups, Congress, and the FDA.

Even The Score managed to convince the National Organization of Women (NOW) to write letters to the amusingly named director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, MD, accusing the agency of sexism, having blessed men with Viagra but leaving women out in the cold.

Fortunately, not all organizations drank Big Pharma’s Even The Score Kool-Aid. The National Women’s Health Network said in a letter to the FDA “The problem with flibanserin is not gender bias at the FDA, but the drug itself.” At least someone was paying attention.

Round three: the FDA approves flibanserin

This time the FDA Advisory Committee, filled with appointed bureaucrats and industry members, voted approval (18-6) for Addyi as long as physician prescribers received special training to educate patients about Addyi’s  risks. The physician members of the FDA committee remained adamantly opposed to its approval, writing “We do not believe that it is reasonable for the approximately 90% of treated patients who will not respond to the product to be exposed to the numerous serious risks posed by flibanserin therapy.” Thousands of women had been manipulated by Big Pharma into demanding that a useless and potentially dangerous drug become available to them.

Once Addyi was approved, Sprout sold flibanserin to Canada’s Valeant Pharmaceuticals for $1 billion in cash. Valeant is a big player on Big Pharma’s evil team, specializing in buying US companies and making an art form of price-gouging Americans (but not Canadians).

Addyi is available by prescription

It’ll cost you about $800 a month and you need to take it every day. In order for me to prescribe it, I need to pass a four-question self-test called the Addyi Risk Evaluation and Mitigation Strategy (REMS) Prescriber Training Program (quoting the website) “to ensure the benefits of Addyi outweigh the risk of hypotension (low blood pressure and fainting to due an interaction with alcohol).” My guess is they’re trying to protect themselves from the class-action lawsuit that’s sure to be filed in a few years, long after they’ve pocketed billions in profits.

As you might imagine, any physician who doesn’t need to move his or her lips when reading can pass the Addyi test.

Does Addyi do anything? For the highly complex issue of low sex drive in women, clinical trials measured something called “satisfying sexual experiences” (SSEs) as recorded in diary form by women who were either taking the drug or taking a placebo (a dummy pill). There are all sorts of warnings about potential drug interactions, the most significant being that if you want to take Addyi you can’t drink alcohol in any form or amount, period.

At that romantic candlelit dinner, he can sip a flute of champagne while you drain your Big Gulp. The most common adverse reactions linked to Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.

Good times!

What you’ll gain for this sacrifice is minimal. The placebo-taking group reported 5 SSEs per month and the Addyi group 5.5 SSEs per month. I swear I am not making this up. For the risk of side effects you gain just one-half a Satisfying Sexual Experience (I cannot help you with what that means, exactly).

The physician FDA members called these results “meaningless,” “zero,” and “statistically insignificant.” The non-physician members gave a thumbs-up.

If you’re inclined to accuse me of insensitivity toward sufferers of hypoactive sexual desire disorder, understand this. Men experience HSDD, too, and more frequently than you might think. For both sexes, low libido is very, very complicated and can stem from relationship problems, including good old-fashioned boredom. There can be all sorts of chronic medical problems (underactive thyroid, adrenal fatigue, vitamin deficiencies, low testosterone in both sexes), longstanding psychological issues (gender identification issues, history of abuse or rape), or side effects from numerous prescription meds.

Big Pharma wants you to believe it’s fixable with a pill they’ll sell you for $25 a day. Take it with a glass of Cabernet and you might find yourself in an emergency room getting a CT scan to rule out concussion.

This bizarre story was brought to you courtesy of Big Pharma and the FDA.

Be well,
David Edelberg, MD