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
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
"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
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
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
"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."