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Calm Urged for Avandia Patients

No Urgent Need to Stop Avandia, Some Experts Say; More Study Needed

Calls for Calm in Wake of Avandia Alarm continued...

"When people read these stories about heart attack risk, they often stop taking their diabetes drugs," he says. "The resulting deterioration of their care can be very detrimental. Everyone says, 'Consult your doctor before stopping any prescribed medication,' but we really must stress this point more strongly."

An editorial released on Wednesday by the editors of the British medical journal The Lancet takes the unusual step of criticizing the NEJM for the "urgency" in the tone of the Nissen paper and an accompanying editorial.

"To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of [Avandia] is needed," the Lancet editors write. "Alarmist headlines and confident declarations help nobody."

Drexler notes that an ongoing study, the RECORD clinical trial, is studying whether Avandia truly causes heart problems. But the study will not be finished until the end of 2008 or 2009, depending on how many patients develop heart disease.

Another study, the ACCORD trial, which is studying outcomes in 10,000 patients with type 2 diabetes, should also reveal the true risks and benefits of Avandia. That trial, too, is years from completion.

GlaxoSmithKline, the company that makes Avandia, says these trials are being monitored by independent safety boards. Patients should be reassured by the fact that these safety boards have seen no reason to stop the studies, says GSK Chief Medical Officer Ronald Krall, MD.

"The data safety monitoring boards have done an interim analysis very recently and have reassured us there is nothing in that analysis that should affect the conduct of the study or be of concern," Krall tells WebMD. "They have looked at the specific issues raised by Dr. Nissen. Because cardiovascular events are the RECORD study endpoints, they have looked at them in great detail."

Calls for Independent Look at Avandia Risk

Drexler says these safety boards should go one step farther and do a separate and specific analysis to ensure that no signal of heart risk has been missed for any group of patients.

"We are interested not just in whether the drug helps some patients, but in whether the drug is riskier for some patients," he says. "If the Nissen paper is valid, you should be able to see these differences by now."

Drexler believes that patient faith in Avandia can only be restored if GSK hands over all the data it has to an outside panel of experts for independent review.

"GSK should ask some organization, preferably the Endocrine Society, to put together a group of scientists chosen by the organization, and open up their files without restriction and let that group study it," he says. "Unless they do that, I think they are going to have a very hard time selling this drug."

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