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; www.davidkatzmd.com
Follow David Katz, M.D. on Twitter: www.twitter.com/DrDavidKatz
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www.angrytrainerfitness.com/2011/02/the-death-of-the-diet-pill/
i have been trying to spread the good word on water, but it seems so many people just dont think the solution can be so easy. if you drink water, you will lose weight, because your body will begin to balance. of course you need to exercise and get in shape, but once you lose the access weight, and combine that with 2 liters of water a day, and your life will drastically change.
Here are some health links about water and dehydration
http://tenmillionslaves.blogspot.com/2009/08/seems-so-obvious.html
http://www.diagnose-me.com/cond/C5223.html
The question isn't whether we should exercise more and eat better, but what remedies are available to obese individuals today. At the current time the only effective treatment for obesity is surgery which carries a one in 200 death rate, significantly higher than the mortality rate for any obesity drug past or present -- and that includes "phen/fen".
Weight loss doctors do prescribe a wide range of drug cocktails "off label" to assist patients with losing weight, but such services aren't covered by insurance and they are too expensive for most patients to afford. If an "all in one" drug is developed that keeps the physician from having to concoct his own drug cocktail, more primary physicians might treat patients for weight loss (at a more affordable rate). Without an avenue for primary physician treatment of obesity, the patient is left with the choice of surgery which is often covered by insurance, expensive specialist treatment which rarely is covered, or trying to do it on their own which is rarely effective.
http://www.diagnose-me.com/cond/C5223.html
http://tenmillionslaves.blogspot.com/2009/08/seems-so-obvious.html
I would go back on it in a minute. I was very disappointed the FDA didn't approve it. It's not a magic pill, just an edge. But for many of us that's all we need.
It is right that by eating nutritionally healthy foods and exercising we are more healthy. But it doesn't always translate to weight loss in some people. I know lots of "fat" people who exercise and eat nutritionally and they can't lose weight. I know lots of skinny people who eat poorly, even exist on sugar and white flour and don't exercise. We are all individuals. One formula does not fit all.
Drugs are irrelevant.
I haven't drunk juice or sugared drinks of any kinds in more than 20 years. I am overweight.
You are wrong. Not everyone is the same. I would prefer a relatively low side effect pill than bariatric surgery which is what is making many surgeons rich these days. If a pill gives you an edge to control your cravings, with the caveat that you also adhere to a nutritional diet and exercise program and counseling along with it, I think that's a better way to go. It's no different than getting cholesterol control medication.
If you feel like it, please visit my blog. You might find we see the world in similar ways. I think you have a wonderful attitude!
http://winningtheobesitybattle.wordpress.com/2010/
The first post is at the bottom of the page and you work your way up from there. It's just how I approached dealing with my own (a year ago) morbid obesity.
I think the company is still trying. I hope they are because I want to go back on it. They tested it on relatively healthy individuals. Testing it on Type 2 obese diabetics might help.
There are other alternatives that work for many people. Morbidly obese people CAN take off the weight and keep the pounds off without drugs or surgery. No one should feel that a 'miracle drug' is there only hope. I say this as a former morbidly obese woman who was told I could never lose so much weight and keep it off without drugs and/or surgery. The medical professionals were wrong about me. They can be wrong about you!
Jane
Keepingthepoundsoff.com
2.It Is not about Contrave.It is about whether there will be any obesity drug. The FDA rejected 3 drugs and forced off Meridia off the market. At the same time, FDA kept on the market Avandia. The real story is about Vivus Inc.’s drug, Qnexa. Qnexa has excellent weight loss but was spiked on an assumption that one ingredient, topirmate, may cause birth defects. Qnexa uses a fraction of full dose topirmate, already approved by the FDA. There is some evidence that topirmate at full strength may cause birth defects but none for low dose topirmate. Yet, FDA spiked the safe,low-dose.. Why are the birth defects acceptable to prevent a migraine headache but not accessible to lower body weight?
3. A “Big Pharma" conspiracy? Turn in your cholesterol medications, high blood pressure medications, diabetes medications,etc..
4 We have to stop the formulation that it is lifestyle OR drugs and embrace both strategies. . Neither model alone will affect this epidemic.
Morgan Downey, www.downeyobesityreport.com
is there no evidence because trials at low dose have been performed and shown the medication to be safe at that dosage, or is it because trials at low dose have not been carried out? Importantly, Qnexa is a combination of two drugs - showing a safe low dosage of toprimate itself is not the same as showing safety when co-administered with the other drug (the other drug being phentermine, which was one half of the now banned phen-fen combination)
absence of evidence is not evidence of absence, and it appears that Vivus has yet to provide FDA with data demonstrating an acceptable safety profile for a number of risks, including but not limited to the birth defects you mention
http://www.msnbc.msn.com/id/39905030/ns/health-diet_and_nutrition/
1) rarely is there an alternative to a drug that COULD improve the health of the individual in question, and those around him or her, and in fact help the individual more powerfully and sustainably by helping other family members besides. That absolutely is true with regard to the family-based application of feet and forks to the challenge of weight control
2) drugs for weight control simply don't work very well. The drugs to which you might compare them- drugs for blood pressure, lipid lowering, diabetes, etc.- work far better. My view of this is that the conversion of surplus calories into an energy reserve (ie, body fat) is fundamental, NORMAL physiology, and thus powerfully insulated by many layers of metabolic redundancy. I think we will have a very hard time ever finding a drug that can reverse engineer all of this- and may rue the day if ever we do!
I fully acknowledge that the root causes of hyperendemic obesity are societal- in fact, almost everything about modern living. That is the terrain on which solutions must be planted. There is a small space there for effective drugs, but it is, indeed, small in my view.
All best,
David
If you eat the right foods, you don't have to worry about counting calories. Our bodies have evolved over the past couple million years to regulate food intake on their own. The problem is, we've only had such high sugar, high carb foods in abundance for the last 50 or so years.
Look to what the cavemen ate.
I think these extreme examples may not help the argument, though. Telling people to eat like cavemen isn't going to curb the obesity epidemic anymore than telling people to practice abstinence is going to curb the HIV epidemic. We've had brains that have evolved too, and hunger is far more about the brain than it is about the body.