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Article challenges FDA, which says drug 'approvable'

WASHINGTON - A new diabetes drug on track to win approval from the Food and Drug Administration more than doubles the risk of death, heart attack and stroke, a finding that renews concerns about the government's safety screening for new medications.

Researchers at the Cleveland Clinic analyzed data provided to the FDA by the drug's manufacturers and found that the drug, Pargluva, also increased the risk of congestive heart failure and mini strokes.

The study was published online Thursday by the Journal of the American Medical Association just days after the FDA had issued a letter notifying Bristol-Myers Squibb Co. and Merck & Co. that their drug was "approvable" once some follow-up safety information was provided. An FDA advisory committee, in an 8-1 vote, recommended approving Pargluva for Type 2 diabetes last month.

The medical journal said it moved up publication because of its "timeliness and potential importance for public health."

Dr. Steven Nissen, lead author of the study, said the failure of the FDA panel to recognize the drug's health risks shows a continuing weakness in the government's drug-approval process.

"I think the FDA advisory committee was asleep at the switch," Nissen said. "The question is, did they not get it, or did they get it and were not willing to stand their ground?"

In an editorial accompanying the study, Dr. James M. Brophy of McGill University said the drug makers skewed the data.

He said they excluded many patients with existing heart troubles and included other patients who took dosages well below the levels they planned to market.

David Rosen, a spokesman for Bristol-Myers Squibb, said experts at the company still were examining the new journal reports and weren't ready to comment on their specific conclusions.

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