New Diabetes Pill May Increase Risk of Heart Attacks and Strokes

Ronald Grisanti D.C., D.A.B.C.O., M.S.

According to a recent editorial, the drug company Bristol-Myers Squibb and Merck may be found guilty of giving misleading information about a new diabetes drug.

The editorial posted in the "The Journal of the American Medical Association" said Bristol-Myers Squibb and Merck submitted data to the Food and Drug Administration that "may have fostered an illusion of safety."

The authors of the article, Dr. Steven E. Nissen and Dr. Eric J. Topol stated the the proposed diabetes pill, Pargluva, seemed to significantly increase heart attack and stroke risks.

The editorial also raised concerns about a cancer risk with Pargluva and listed eight ways that the companies' methods for patient trials might have skewed results in favor of Pargluva's approval.

Bristol-Myers had hoped that Pargluva would revitalize its franchise in diabetes, a $20 billion market. Merck is also eager for new drugs after its withdrawal last year of the painkiller Vioxx and related suits.

Besides raising questions about Pargluva, the journal article appeared to challenge the F.D.A. advisory panel process. In an interview, Dr. Nissen criticized the panel that reviewed the drug last month and voted to recommend its approval.

Even though the F.D.A. staff was worried about Pargluva's cardiovascular risks, the panel included no cardiologists.

Dr. Grisanti's Comments
I become concerned when I read articles like this. Public safety should take precedence over profits. Where do you stand?

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