Merck’s MK-0557 — statistical vs. clinical relevance strikes again

Merck got their “p-value”:, but no one cares about losing three more pounds in _one year_ over placebo. And certainly no one wants to take a drug once a day for 365 days to do it. It looks like MK-0557 won’t be making it in the anti-obesity field.

Other fun issues with the drug and its trial:

* 832 out of 1661 enrolled subjects completed the trial (just over 50%)
* A prominent doctor comments

“In my view, this trial suggests not that a cocktail of drugs will be needed, but that for the most part, drugs are not the right answer at all,” said Dr. David L. Katz, an associate professor of public health and director of the Prevention Research Center at Yale University School of Medicine.

“Though rare case of obesity may warrant medication as part of a comprehensive treatment plan, the hope that drugs will save most of us the trouble of addressing weight control through lifestyle practices is misplaced,” he said.

* The target receptor of the drug was completely blocked, but does not appear to have the same biological activity as researchers once thought. Or shutting it down puts a higher load onto other systems. Obesity is a complex issue.
* Except in a relatively few instances, diet and exercise are the best ways to prevent and alleviate obesity.

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