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Posts Tagged ‘testimony’

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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A few weeks ago, the Food and Drug Administration announced a new internal task force that would examine how the agency can become more transparent. The group would seek suggestions from employees, stakeholders and the public in an effort to reach the best conclusions about how the FDA could become more accessible. (For an overview of what the FDA does and does not regulate, see this Time article.)

Sure enough, the FDA has lived up to its promise. Today, Public Citizen’s own Dr. Peter Lurie, deputy director of our Health Research Group, is representing American consumers with testimony before the task force. While current FDA procedures favor secrecy so that drug companies can keep competitors in the dark about products being developed, Dr. Lurie will make three recommendations before the task force that will allow the FDA to become more open to the public.

First, Dr. Lurie will recommend that pre-approval documents should be made available to the public. This will prevent scientists from researching products similar to those that, unbeknownst to them, prior research has deemed unsafe, squandering time and money going down roads already proved to be dead ends. In addition, making this information public can save clinical trial participants from being put at needless risk by enrolling them in research likely to prove fruitless. (more…)

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