Healthy Skepticism Library item: 17280

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Publication type: Electronic Source

Morrison T
The FDA Fires a Warning Shot at Disease-Mongering Drug Companies -- Maybe
BNet 2010 Feb 24
http://industry.bnet.com/pharma/10006868/was-fda-rejection-of-xenoports-restless-legs-drug-a-warning-re-fake-diseases/

Full text:

Last week’s FDA rejection of XenoPort (XNPT)’s drug Horizant for restless legs syndrome got folks wondering if the agency had just sent a not-so-subtle warning to drug makers pushing new products for questionable diseases. It’s probably not true, but let’s hear them out for a moment anyway.

RLS has taken some flak in the court of public opinion and even in medical journals like PLoS Medicine as something created by drug companies to boost sales. Similar disease-mongering claims have been tied to erectile dysfunction, female sexual dysfunction, hot flashes, ADHD and pseudobulbar affect (inappropriate laughing or crying).

Now, I’m not saying that RLS isn’t a real disease. Not being able to sleep because your legs feel like they’re on fire or covered in creepy-crawlies sounds real enough to me. But the question of just how “real” RLS is came up again last week with the FDA rejection.

Horizant is a derivative of gabapentin, a drug that’s long been on the market for seizures and certain types of pain. Gabapentin has been associated with pancreatic tumors in rats, and Horizant turned up similar rat data. The FDA apparently concluded that while epilepsy and pain are serious enough to justify that risk, RLS is not.

According to Credit Suisse analyst Michael Aberman:

In our view, the implied message is that FDA does not view RLS as a serious disease.

Meanwhile Leerink Swann analyst Steve Yoo questioned:

Does FDA not like RLS or the drug?

My guess is that the FDA has nothing against RLS and isn’t trying to send a message that minimizes the importance of any disease. The agency previously approved two drugs for RLS, and when it comes to disease mongering, the agency is well aware that these conditions are very real and very serious for some patients. The fact that they are sometimes shamelessly overpromoted is a separate issue from the approvals that are needed to give doctors and patients treatment options.

The FDA might, however, be sending the message that they don’t like Horizant, which would be bad news for XenoPort’s future hopes in other indications.

Or maybe they’re saying they don’t like the risk-benefit ratio of any gabapentin-ish drugs for RLS or other less serious conditions, which could be bad news for Depomed (DEPO)’s gabapentin product for hot flashes.

Or maybe the FDA figured that with existing RLS drugs available, there’s just not that much unmet need for a drug that isn’t necessarily better. And that sounds like bad news for anyone who’s not a fan of comparative effectiveness.