In an exclusive interview on CNBC, GlaxoSmithKline’s CEO J.P. Garnier defended the company's diabetes drug Avandia, saying recent safety questions are based on statistical analysis, not medical evidence.
“The question raised on Avandia was done on a statistical analysis – not a well-controlled clinical trial," Garnier told CNBC’s Mike Huckman. "All the clinical trials treating thousands of patients for years have shown no (danger) signal.”
Last month, a Cleveland Clinic analysis linked Avandia to a 43% higher chance of having a heart attack. The Food and Drug Administration and Glaxo said other data provided conflicting evidence.
On Tuesday, Glaxo released early findings from an ongoing company-funded study that was unable to show a link to heart attacks.
“Yesterday, the interim results for record showed that the group of people receiving Avandia had an incidence of cardiovascular death which was 17% lower than well-known medicines that could have been used instead of Avandia,” Garnier said. “This is very reassuring for patients and physicians.”
Garnier said clinical trials haven’t reproduced the results found by the preliminary analysis.
'Watch the Science'
“Watch the science – not the politics,” Garnier said. “If you watch the science, if you talk to your physician…you will be fine.Meanwhile, U.S. health officials and Glaxo are likely to face tough questioning from lawmakers Wednesday over their handling of data suggesting a heart risk with the widely used diabetes pill Avandia.
Glaxo has said it gave regulators information in August 2006 that estimated a 30% higher heart-attack risk with Avandia. Some critics question why neither the FDA nor Glaxo alerted patients sooner.
"The American people deserve to know why eight years after FDA approved Avandia, it's still unclear whether the drug is harmful or helpful," Rep. Henry Waxman, a California Democrat and chairman of the House Oversight and Government Reform Committee, said in a statement.
Millions of patients take Avandia, known generically as rosiglitazone, and sales topped $3 billion last year. But analysts this week said prescriptions have fallen 16% since the Cleveland Clinic report as doctors switch patients to Takeda Pharmaceutical Co. Ltd.'s rival drug Actos.
Waxman's panel is set to question Slaoui, FDA Commissioner Andrew von Eschenbach; cardiologist Steve Nissen, who wrote the Cleveland Clinic analysis, and others.
Criticism of FDA
Concerns over Avandia have sparked an outcry from members of Congress who have blasted the FDA in recent years as being slow to respond to problems with other medicines, including Merck & Co Inc.'s withdrawn arthritis drug Vioxx.
The controversy comes as Congress considers legislation meant to bolster the FDA's oversight of drug side effects. Some critics are seeking to use the Avandia case to push for tougher safeguards.
Waxman said the House hearing would focus on whether the FDA is properly safeguarding the public and whether changes in the agency's authority, resources or leadership might be needed.
The FDA is finishing its own Avandia analysis to better assess the heart risk but has not said when it will be completed.
FDA officials have defended their actions, saying they had to weigh warning the public against concerns that diabetic patients could stop taking their medication altogether.
"I believe we did it right with regard to Avandia," von Eschenbach told reporters last week.
The agency has scheduled a July 30 public meeting to discuss the drug's risks.