Weight Loss Drug Contrave Banned By FDA, Good News or Bad?

02/03/2011 08:43 am ET | Updated May 25, 2011

The FDA has formally denied approval for the weight loss drug, Contrave. Is this good, or bad for efforts to turn the tide of epidemic obesity?

The New York Times reporting includes comments from friends and colleagues of mine, some of whom think this is bad. Dr. Robert Kushner, for example, whom I respect, very reasonably points out that the two drugs combined in Contrave -- bupropion and naltrexone -- are already in widespread use. Concerns about heart-health risks of Contrave, therefore, seem somewhat overblown -- since the drugs conferring such risk are approved for other uses.

I sympathize with this perspective, and agree with colleagues that (a) obesity can pose grave health risks; (b) drugs for severe obesity are needed; and (c) all drugs carry some risk, but may be defensible nonetheless in light of risk/benefit trade-offs.

But in spite of all that, I think the FDA decision on Contrave was a good one. I have one lesser reason for my position, and one greater.

The lesser reason is that the evidence demonstrating net benefit from Contrave really isn't there. The drug facilitates moderate weight loss in the short term, as long as people keep taking it. We don't yet know if that benefit persists over time, or if the body acclimates and finds a way around the drug effects. We don't know that the drug can prevent diabetes, or confer a true health benefit. We also know the drug confers no benefit on anyone other than the person taking it -- so unlike a lifestyle intervention, leaves family members behind.

My greater reason for siding with the FDA, however, has to do with fish out of water, or polar bears in the Sahara. Imagine trying to fix either of these problems with a drug.

I have long worried that Big Pharma might manage to convince us all that investments in the effort to stop and reverse obesity trends mostly meant investments in wonder drugs. The fundamental reality, though, is that the proximal cause, and proximal cure, for weight gain is all about feet and forks.

The root cause, though, is everything about modern living that favors injudicious use of forks, and inadequate use of feet. It's all about the environment, in other words. We need eating well and being active to lie along the path of least resistance that runs though everyone's day. For now, they lie along the road very much less traveled.

Fish out of water are in trouble because fish don't belong out of water. No drug could fix this, unless it turned a fish into something other than a fish -- and that would be one heckuva drug! Polar bears in the Sahara would be in trouble, because all of their formidable adaptations to the cold would cook their goose in the heat. Tough to imagine a drug that could fix this either.

Human beings are adapted to a world in which calories are relatively scarce and hard to get, and physical activity is unavoidable. We have devised a modern world in which physical activity is scarce and hard to get, and calories are unavoidable. We are fish out of water. We are polar bears in the Sahara.

But with one advantage: we are, ostensibly, smarter than the average bear. We can understand this problem, and address it at its origins. We can work to reconcile the modern world with our native traits and tendencies so that health and weight control lie along the path of lesser resistance, rather than the road all-too-little traveled. The role for pharmacotherapy in this effort is very small; the role for feet and forks, and the policies, programs, and practices that foster their good use -- far greater.

And that's my greater reason for siding with the FDA about Contrave. It's not just that this drug may be the wrong answer; it's that it's an answer to the wrong question.

Dr. David L. Katz;