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Your Sex Drive, the FDA, and Big Pharma

Strange trio, right? But keep this health tip in mind a few months from now when you’re watching a sexually charged TV commercial for a (yet unnamed) prescription libido enhancer as your wonder “Didn’t I read about this somewhere?”

Let’s start with the FDA. By now, everyone pretty much knows the powerful Food and Drug Administration is in the pocket of Big Pharma. The FDA regularly approves new drugs that have no business being released to consumers, based on the flimsiest of evidence that they are safe and effective (Fen-phen, Avandia, and many others). Like Toyota, the FDA drags its feet before it will withdraw a drug that’s clearly harming people. The appetite suppressant Meridia, for example, is still available today in the US, even though it’s banned throughout Europe for causing strokes and heart attacks.

With each passing decade, the FDA accepts an increasing number of clinical studies containing mediocre results, allowing Big Pharma to release its blockbusters. Even though most people seem to know that many doctors involved in these studies have fudged data to “prove” a drug’s effectiveness, the FDA regularly gives thumbs-up to drugs other countries have banned.

As they run out of new drugs to release, the latest strategy by Big Pharma has been to “create” new diseases in order to get FDA approval for drugs to “fix” those diseases. Although this sounds like something out of Huxley’s Brave New World, I assure you it occurs more often than you’d like to know. Financially, it can mean billions. With FDA approval and thus the go-ahead for reimbursement from health insurance companies, there’s virtually no limit to the price Big Pharma can demand.

Examples:
• Restless legs syndrome (RLS) was always considered a relatively rare sleep disorder until Big Pharma’s advertising blitz for Requip. The company flooded physician offices with “educational material” about RLS that lowered the diagnostic criteria, allowing it to be diagnosed in just about anyone who awakened with rumpled bedsheets.
• Being shy could get you diagnosed with social anxiety disorder and as the FDA gave its approval to Zoloft, it rarely mentioned that by taking it you’d have a good chance of becoming an overweight shy person in the process.
• Feel drowsy during the day? You might have “daytime sleepiness disorder” and be prescribed Nuvigil at a cost of $400 per month.

Sometimes Big Pharma is stuck with a chemical they hoped would do one thing but when tested turned out to be a dud. At this point they often analyze the drug’s side effects to see if there might be a glimmer of hope, a side effect that might possibly salvage their multimillion dollar investment. The attention deficit disorder (ADD) drug Strattera is one of these. Originally thought to be an antidepressant, it was inferior to those already available. But people reported they seemed to concentrate better when using it and Big Pharma saw salvation. They reframed all the clinical studies toward ADD, discovered that Strattera fared better than placebo (though no better than the standard ADD drugs Ritalin and Adderall) and lo! a new chemical to push down the gullets of unsuspecting children (who regularly complained of tummy aches, but that’s another issue).

Which brings me to your sex drive.
Big Pharma German giant Boehringer Ingelheim Pharmaceuticals, Inc, had a chemical called flibanserin for which they were planning clinical trials as an antidepressant. Although it wasn’t very effective as an antidepressant, patients reported “increased sexual thoughts.” Hmm. Viagra had made billions. A Viagra for women could be a grand-slam.

While a company could sell flibanserin as a libido-enhancer, in order to get some serious money pouring in, they’d need to link a drug to a “disease.” Why? Because renaming something as a disease gives you access to the big bucks of health insurers.

So the company went to the Diagnostic and Statistical Manual of Mental Disorders (DSM), the thick manual psychiatrists use to diagnose any of the hundreds of mental illnesses we allegedly endure. (To say the listings are controversial is an understatement.)

Someone at the drug company likely said, “Here’s something called hypoactive sexual desire disorder” (HSDD). It’s just like it sounds: you don’t have a lot of interest in sex. Maybe it’s by choice or maybe it’s because you can’t find a trusted partner. Whatever the case, once there’s a “disease,” the Big Pharma company can petition the FDA to start clinical studies using their new chemical to treat it.

But in order to make a financial killing, Boehringer needed to prove that HSDD was a health risk that, left untreated, might have dangerous physical or psychological consequences. So they funded a huge study with the goal of proving that women who had low sexual desire suffered more “psychological distress.” Just reading this, smoke should be pouring from your ears. Boehringer’s researchers were paid millions to “prove” this was true, and the FDA nodded its approval.

The Boehringer Study, fetchingly named DESIRE (Desire and its Effects on female Sexuality Including Relationships) was presented this past weekend by a Boehringer-funded physician, Anita Clayton, at the International Society for the Study of Women’s Sexual Health. Not surprisingly, Boehringer is the sole corporate sponsor of this event.

According to the European-conducted study, 7,542 women (out of more than 65,000 questioned) reported having low sexual desire with distress and 5,098 of them were queried about it. These women allegedly reported guilt and confusion about their lack of desire, sufficiently so that the relationship with their partner was strained.

Essentially, Boehringer has funded a project in Marketing 101, to determine whether a market existed for its product. Since roughly 10% of their surveyed population reported diminished desire with distress, the answer was yes. Part two of this project was to get FDA clearance. Does the “diminished desire with stress” these women experience qualify as “disease?” Again, using the controversial DSM guidelines, the answer would be yes.

To the possible question “Are there better ways to treat this alleged condition, such as counseling or natural products?” the answer (to Boehringer, who’s paying for all this) is simply not relevant.

Their business is selling drugs. And they do quite well at it. Boehringer Ingelheim posted net sales of $17 billion in 2008.

A germane postscript: when it was pointed out that a great many women dropped out of the flibanserin clinical trials because of side effects (dizziness, daytime sleepiness, fatigue, dry mouth, insomnia) the lead researcher reassured everyone that this happens all the time with drugs that act on the brain.

Are you reassured by all this? I’m not.

Be well,

David Edelberg, MD

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