Friday, February 4, 2011

Friday's Food For Thought - Real Helpful Diet Advice, Federal Government People

The 2010 dietary guidelines were released earlier this week (um, aren't we in 2011 - but do we really expect government officials to keep on a schedule?). According to the U.S. Department of Agriculture and the Department of Health and Human Services, we are supposed to eat less, eat better, and enjoy our food.

Well that's just brilliant. It took them 6 years (including a 1 year delay) to come up with that gem?

Coincidentally, despite the public health concern over the rise in obesity, a trend that shows no signs of abating, it was in the same week as the release of the updated guidelines that a third US biotech company had their regulatory application for a new obesity drug rejected. For those of you in the drug industry, I know the FDA response to Orexigen's NDA was a complete response letter, but with the request for a new clinical trial to study the cardiovascular risk for their drug Contrave is in essence a rejection at this time. The biotech company Orexigen finds itself in the same place as Arena Pharmaceuticals and Vivus, who both had their weight-loss drugs rejected when reviewed by the FDA in the fall of 2010.

I've done research in the obesity field for a few years, and I'm convinced that there are biochemical changes, both neurologic and metabolic, that drive weight gain and sabotage attempts at weight loss. In other words, it's all fine and dandy for a government agency to tell us to eat less, but it may not be as simple a matter as exerting self-control. Re-training or behavioral modification over the long-term will be key in maintaining weight loss, but a little boost in the beginning to kickstart the process could probably help a lot of people.

So what I'm really trying to say is that I think there is a need for weight-loss drugs used in a responsible way, and I'm annoyed but not surprised that the three obesity drugs got rejected by the agency that is in place to protect the public from evil pharmaceutical companies. The FDA is worried over the safety of weight-loss drugs that will undoubtedly be used by millions of people, and I'm sure they have valid reasons for not approving the drugs yet - for example, there's a higher rate of cancers in rats who take the drug would probably be a reason to worry. But until the FDA has the right data to convince them that weight-loss drugs are worthwhile approving for general consumption, it looks like we'll have to make do with the dietary guidelines - eat less, eat better, and enjoy our food.


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