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FDA Panel Appears Skeptical Over Key Avandia Data
Date:7/13/2010

dia for physicians fighting diabetes," said Dr. Ellen Strahlman, Glaxo's chief medical officer, in a statement released at the time. "We believe that the results showed that Avandia is safe."

On Friday, the company, in a prepared statement, said, "The RECORD study was conducted according to good clinical practices and the data are reliable. . . RECORD demonstrated that Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death compared to metformin and sulfonylureas."

According to the Times, Marciniak was on hand at Tuesday's hearings and reiterated his doubts about RECORD. He pointed to the case of one participant in the trial whose heart attack was excised from his medical record by the doctor in charge of those materials.

"I think this type of handling of events is completely unacceptable, Marciniak told those at the hearing.

But the researcher in charge of RECORD defended the trial's integrity. Dr. Philip Home, professor of diabetes medicine at Newcastle University, to panel members that contrary to the allegations in an editorial published in last week's New England Journal of Medicine, the trial's independent safety committee "was not compromised by GSK in 2007."

Also on Tuesday, groups including the American Diabetes Association, the American Association of Clinical Endocrinologists and The Endocrine Society issued a joint statement advising patients who are using Avandia to hold steady for now.

"Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider," the experts said. "Stopping diabetes medications can result in higher levels of blood glucose that may cause serious short-term health problems and could increase the risk of diabetes-related complications in the long term."

They added that "until further clarification is provided by the FDA, the decision whether or not to use a
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