Avandia Hearing Exposes FDA as Negligent Watchdog

Evelyn Pringle weighs in with the definitive (to date) piece on the Avandia scandal. Her entire article can be read here.

“The FDA has ignored repeated warnings about the potential cardiac risks associated with the diabetes drug Avandia, and medical experts predict Americans will likely pay a heavy price for trusting its negligent watchdog because US doctors wrote 13 million Avandia prescriptions in 2006 alone, according to IMS Health a medical information tracking firm.

On May 21, 2007, the New England Journal of Medicine published a meta-analysis of the heart attack and death rates from 42 Avandia trials completed before or after drug approval, that showed a 43% excess incidence of heart attack in Avandia patients. Dr Steven Nissen, Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic and Immediate Past-President of the American College of Cardiology, and statistician, Kathy Wolski, MPH conducted the study.

The very same day, the Chairman of the US House Energy and Commerce Committee’s Oversight Subcommittee, Representative Bart Stupak (D-Mich), stated, in essence, that the Avandia debacle was the last straw.

“The FDA is on notice,” he said in a statement, “that we have reached the end of our rope on their stonewalling of investigations into their failures to keep Americans safe from dangerous drugs and poisonous foods.”

Will anything actually change I wonder?

The FDA in America and the MHRA in the UK are supposed to be the bodies that protect you and me from unsafe medication… however, their respective track records over the past 15-20 years have not been good. The failings in the regulatory and monitoring systems would seem to mirror the increasing influence of the drug companies within the FDA, the MHRA and the governments of both countries.

2 Responses to “Avandia Hearing Exposes FDA as Negligent Watchdog”

  1. Matthew Holford Says:

    I thought the MHRA was quite forthcoming, when I spoke to it. Apart from its unwillingness to discuss its assessment procedure. And ignoring my request for information concerning the relationship between the licensing of trials and the implementation of legislation concerning withhholding of data. And the absence of an industry Rule Handbook. And refusing to clarify the position on Seroxat’s banned status. And refusing to clarify what the benefit of Seroxat is. And telling me that my requests were vexatious.

    Yes, the MHRA told me all sorts of things.

    Matt

  2. Matthew Holford Says:

    Oh, and not being able to contact one of its members (GSK) and demand of them what it meant, when it claimed that the drug was “significantly more affective than placebo,” which it isn’t unless you happen to work in GSK’s Marketing Department, as far as I can establish.

    Matt


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