Back in February of this year, the FDA rejected Orexigen Therapeutics’ application to approve the weight-loss drug Contrave.

Contrave is mix of two medications, naltrexone and bupropion, both already on the market.  Bupropion is the active ingredient of the antidepressant Wellbutrin and the anti-smoking aid Zyban.  Naltrexone is used to treat heroin and alcohol addiction.

Although the FDA’s advisory panel voted a tepid 13-7 in favor of approval, the FDA rejected the application because many people who took the drug had elevated blood pressure levels or pulse rates.

The FDA notified Orexigen Therapeutics that in order for Contrave to be approved, the manufacturer would have to conduct a full three to five-year trial clinical trial of the drug to test for possible cardiovascular problems.

Now it appears that the FDA has backed off that position and is willing to accept a lesser trial, one that the manufacturer is calling “reasonable and feasible.”

What happened?  Well we simply don’t know, but the most likely answer is that the members of Congress who get massive campaign donations from the pharmaceutical industry put pressure on the FDA to back off.  No surprises here.  Money talks.  And there’s potentially a lot of money here.  Market analysts predict that Contrave could be worth $1.2 billion by 2018.

So does Contrave work?  Not very well actually.  In tests reported by the manufacturer it doesn’t seem to work at all for half the people taking it.  For the other half it produces about a 5% weight loss over a period of a year.  For a person weighing 150 pounds, that’s a weight loss of 7½ pounds.  That comes to a whopping weight-loss of 2.31 ounces per week.

So here’s the deal.  You buy this drug for $100-$200 a month (you can bet it won’t be cheap).  And then, because of normal weight fluctuations, you have to take it for at least six months before you can even figure out whether you’re one of the 50% for whom it works.

So how in the world is this marginal little pill that either doesn’t work or only works a little going to produce $1.2 billion in sales?  That’s easy.

Marketing

Marketing

Marketing

The manufacturer will flood us with a massive advertising blitz for its new “breakthrough,” “FDA approved,” answer to all your weight-loss problems.  Only down in the fine print somewhere will you be able to find that Contrave only works for half the population, that you can only expect to lose a few ounces per week if it works at all, and that it may well raise your blood pressure or pulse rate.

You’ll be urged to “ask your physician if Contrave is for you?”  In other words, nag your physician until he or she finally gives in and writes you a prescription.  And enough people will do it and enough physicians will give in and write those prescriptions that we will, as a society, end up handing over $1 billion for nothing of any real value.