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Posts Tagged ‘Margaret Hamburg’

We’ve written about the dangers of the diabetes drug Avandia and have told Congress about an unethical international clinical trial, requested by the FDA, being performed by Avandia’s manufacturer, GlaxoSmithKline.

Now Public Citizen and Canadian researcher/physician David Juurlink go straight to the source, sending a letter to FDA Commissioner Margaret Hamburg asking her to halt the study, which pits Avandia against its competitor, Actos.

From the Reuters story:

“A wealth of data now suggests” that Avandia carries greater risks than Actos, the researchers said. Patients are also not adequately informed about the safety differences between the two medicines when deciding whether to participate in the trial, they added.

But FDA officials, who have said they are already taking a closer look at Avandia, are not likely to act so quickly.

And the Los Angeles Times:

In act, both drugs [Avandia and Actos] have been tagged with safety issues: In addition to raising rates of cardiovascular events, the class of Type 2 diabetes drugs known as thiazolidinediones (or TZDs) have been linked in studies to higher rates of edema, macular edema, bony fractures, anemia and acute liver injury. Older diabetes medicine such as metformin and sulfonylurea are widely believed to be safer alternatives.

But to no avail — the FDA likely won’t examine the study until July, FiercePharma reports.

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Public Citizen has been concerned about the heart dangers caused by the diebetes drug Avandia for a decade. But to add insult to injury, the makers of the drug are also now involved in an international unethical study involving it. If that weren’t bad enough, this study was ordered by the FDA. What?! Something isn’t right here.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, testified on the Hill yesterday in a House appropriations subcommittee hearing on Avandia. He presented new data since we last urged the FDA in 2008 to remove Avandia from the market.

GlaxoSmithKline, Avandia’s manufacturer, pressed forward with the FDA-requested study, drawing a pool of 16,000 subjects from 14 countries. It pits the diabetes drug against its competitor, Actos, even though some FDA officials have called the trial “exploitive of patients.”

“Thousands of high-risk patients with diabetes are being needlessly exposed to a drug with an unfavorable safety profile and no clinical advantage,” Wolfe told the lawmakers.

But FDA Commissioner Margaret Hamburg defended the study, as reported by the AP and picked up by Bloomberg BusinessWeek. Hopefully it won’t take until the end of the study in 2015 for someone to step in and protect these patients, who are suffering from type 2 diabetes without knowing that their so-called treatment could be causing them further harm.

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