A further study of the data on the drug by cardiologists at the Cleveland Clinic Foundation showed that diabetic patients taking muraglitazar faced an increased risk of deaths, heart attacks and strokes, compared to patients on similar drugs already on the market.
"We moved very quickly to get this analysis in print with the hope that we could prevent a public health catastrophe," said Dr. Steven Nissen, lead author of the study and cardiologist at the Cleveland Clinic. The study showed that 35 of 2,374 people treated with muraglitazar either died or had a stroke during the 24 to104- week trial periods.
Bristol-Myers Squibb Co and Merck Co. are the manufacturers of the new drug.
JAMA rushed the study into publication online within 17 days after receiving it. JAMA's editor-in-chief Dr. Catherine DeAngelis said the journal does not do something like this very often.
"We had to essentially pull out all stops," DeAngelis said. "We had to get it online because the soonest we could put it in print was Nov. 23."
DeAngelis said JAMA only takes this type of action when there is a serious public health implication.
"We were hoping to stimulate the FDA to think twice about approving the medication," DeAngelis said.
DeAngelis and Nissen are hopeful that the FDA will wait for more clinical research before making a decision on the drug.
"I think we have really preempted approval," Nissen said.
FDA spokeswoman Laura Alvey said the application for the drug is still pending and that no further comments would be made at this time.
She added that an advisory's committee's recommendation for final approval was not binding.
The findings of the study "raises some new safety concerns," said Dr. Dan Fintel, a cardiologist at Northwestern University Hospital.
In general, diabetic patients are at high risk of cardiovascular disease, particularly heart attacks and stroked, Fintel said.
More than 630,000 adults in Illinois had diabetes in 2002, according to the Illinois Department of Public Health.
This is cache, read story here