Am I missing something here?

Clifford J. Rosen, chair of the FDA advisory committee that approved continued marketing of the drug rosiglitazone (brand name Avandia) gets a chance to tell his side of the story in the new NEJM, and as the have been doing lately, the editors are kind enough to give you peons access to this item of great public interest.

Rosen writes, "The joint committee, which I chaired, consisted of 24 experts in cardiovascular disease, epidemiology, biostatistics, and endocrinology. After lengthy discussions, we concluded that the use of rosiglitazone for the treatment of type 2 diabetes was associated with a greater risk of myocardial ischemic events than placebo, metformin, or sulfonylureas." Now, as we have discussed here previously, rosiglitazone was approved because it lowers the level of glycolated hemoglobin, considered an indicator of the patient's level of blood sugar over time. This is called a "surrogate endpoint," i.e. it's not a clinical outcome in itself, but an indicator that is assumed to be associated with clinical outcomes because it corresponds to a link in the presumed etiology of disease.

But people don't take rosiglitazone to lower their glycolated hemoglobin, they take it to prevent the complications of diabetes. Which, according to the finding of Dr. Rosen's committee, it does not do. At least it doesn't prevent the most important complication, which is dying. As Dr. Rosen writes, "These data suggest that we urgently need to change the regulatory pathway for drugs for the treatment of type 2 diabetes to make clinical outcomes, not surrogates, the primary end points."

So here's my question, Dr. Rosen, one to which you do not even hint at an answer, or even acknowledge that an answer might be required: Why in the name of the Honorable Wilfred P. Bazinet did you and your committee vote to approve this drug? Since there are other drugs available which accomplish exactly the same thing, but which do not kill the people who take them by giving them heart attacks, why would any sane physician prescribe rosiglitazone and why would any non-suicidal patient take it? Therefore, why would the FDA approve it?

Now, this couldn't possibly have anything to do with it:

"Dr. Rosen reports receiving a lecture fee from GlaxoSmithKline and grant support from Eli Lilly, Merck, and Novartis."