Avandia should be withdrawn
Unpublished study says Avandia should be withdrawn
U.S. FDA: Researcher’s email states diabetes drug has higher risk of stroke, heart attack and death than rival
WASHINGTON — An analysis by U.S. government scientists found GlaxoSmithKline’s controversial diabetes drug Avandia increased heart risks and deaths compared to a rival pill, according to an email from a Food and Drug Administration reviewer who worked on the study.
The reviewer, Dr. David Graham — known for his strong opposition to the now-withdrawn painkiller Vioxx — and other government staffers reviewed data on patients in the Medicare health insurance program who used Avandia or Takeda Pharmaceutical Co. Ltd.’s competitor Actos.
The findings, which have not been published, come just weeks ahead of a highly anticipated public meeting next month on the safety risks of Avandia.
A 2007 study first raised concerns about the drug’s cardiovascular effects.
Graham has argued that Avandia is more dangerous to the heart than Actos and should be removed from the market.
In the newest research, Graham and colleagues at the FDA and the Centers for Medicare & Medicaid Services looked at data on nearly 230,000 Medicare patients and found Avandia increased the risk of stroke by 27 per cent, heart attack by 25 per cent and death by as much as 17 per cent.
Overall, there were 48,000 excess complications with Avandia use in older patients between 1999 and June 2009, Graham said in a May 28 email to FDA Commissioner Margaret Hamburg.
But because Medicare patients are 65 and older, and more than 60 per cent of Avandia users are under age 65, “the national impact is probably 100,000 or more,” he wrote.
A copy of the email was obtained by Reuters.
An FDA official confirmed the email was authentic. Graham did not respond to requests for comment.
FDA spokeswoman Meghan Scott said agency officials reviewed Graham’s findings and told him he could submit them for publication with a disclaimer that the conclusions were not those of the agency.
The FDA has not yet completed its review of Avandia’s safety issues, she said.
Doctors give drugs of which they know little,
into bodies, of which they know less,
for diseases of which they know nothing at all.