They just won’t quit, will they?

According to this article in the New York Times, an advisory panel to the FDA just voted 11 to 8 to recommend approval of the diet drug Contrave, which is manufactured by the Japanese firm Orexigen. Contrave is a combination of two existing generic drugs, bupropion, the antidepressant marketed under the brand names Wellbutrin and Zyban, and naltrexone, which is used to treat drug and alcohol addiction.

Clinical trials showed that patients taking Contrave lost an average of 4.2% of their body weight more than those taking a placebo. Let’s see, that means that this drug will enable someone who weighs 400 pounds to lose, uh, 17 pounds. You think that’s gonna make any difference? You think his life is going to suck any less?

And no one’s even claiming that this modest weight loss will result in any clinically meaningful outcome for the people who take it, such as a reduction in the number of heart attacks or strokes. In fact, clinical trials showed that the drug caused an increase in blood pressure for some of the people who took it.

To their credit, some of the panel members raised concerns for precisely that reason, but they were overruled. It was decided that the relevant safety studies could be done after the drug was put on the market.

I’d like you to read that last sentence again. Are they serious? What the Hell is going on here? Has the admonition “First, do no harm” been replaced with “Shit happens?”

We’re already spending untold billions of dollars a year underwriting drugs which produce small decreases in blood pressure, blood sugar, or cholesterol levels – often without any data showing that this results in any kind of clinically meaningful outcome for the patient. Why should the taxpayers be forced to underwrite a drug which produces even a small increase in blood pressure, without any data showing it results in any meaningful benefits for the patient?

It’s also not clear why the FDA is approving a “new” drug which is just a combination of two existing generic drugs, or why the taxpayers should be forced to underwrite such a concoction. If doctors really feel their patients can benefit from taking these two generic drugs, why don’t they just prescribe the two generic drugs? Because then they won’t get lavish gifts from the drug companies?

The FDA has a standard that any weight-loss drug must enable patients to lose at least five percent of their body weight. They didn't explain why that standard was ignored in this case. Perhaps the panel members felt that the FDA, having already rejected three weight-loss drugs this year, had to throw the drug companies something.

The first NYT article I linked to above notes:

“Several groups that advocate for obese people, or treat them, testified in favor of approval of Contrave. But their arguments were not so much about the drug itself as about the need for more options and about the attitude of the F.D.A.

“’This panel has voted against every obesity treatment that has come before it this year,’ said Theodore K. Kyle of Pittsburgh, a former industry executive who is in several advocacy groups for the obese. ‘I ask you to take the disease seriously and take the benefits of treatment seriously.’”

I’d love to know how much of Mr. Kyle’s salary is paid for by the would-be manufacturers of weight-loss drugs, like, oh, say, Contrave. Advocacy group for the obese, indeed.

I freely admit I am no great friend of the “fat rights” crowd, but I am perfectly willing to live and let live. If you are reading this and you are obese, I respectfully suggest you think long and hard about whether the folks who want to foist all sorts of ineffective and dangerous “cures” on you are your friends.

Illustration via the National Library of Medicine

UPDATE 5 JUNE 2011: According to this article in the New York Times, Orexigen has abandoned efforts to obtain approval for the drug Contrave in the United States, citing "unprecedented" demands by regulators for safety trials. After the announcement, the price of Orexigen shares fell 33%. Orexigen vowed to continue efforts to foist the drug on other countries.

UPDATE 23 SEPTEMBER 2011: In a press release dated 20 September, Orexigen announced that the FDA has agreed to reconsider its decision not to approve Contrave if the results of a clinical trial could exclude a 40% increase in the risk of adverse cardiovascular events associated with this drug. Orexigen called the FDA decision “reasonable and feasible.” The trial is expected to begin next year and to be finished by 2014.