FDA immunity in Michigan
The recent disclosures regarding Avandia, a commonly prescribed Type II diabetes drug, confirm yet again the absurdity of the Michigan law granting complete immunity to drug manufacturers if their drug was approved by the FDA. When the New England Journal of Medicine reported that Avandia may increase the risk of heart attack by as much as 43 percent, researchers then documented that a leading diabetes physician in North Carolina had warned the FDA of a "worrisome trend in cardiovascular deaths" seven years ago. Five years ago a safety monitoring group within the FDA expressed similar concern. These concerns were not examined by the FDA at the time of approval of the drug in 1999, and nothing was done by the agency when it learned of legitimate concerns after approval.
In 2005 when the manufacturer reported a study of its own that showed a 31 percent increase in cardiovascular risk, the FDA refused to act, in part in reliance on the manufacturer's claim that it had additional contradictory studies. These studies are only being discussed publicly today because the manufacturer agreed, as part of a settlement with the State of New York arising out of Paxil deaths among teens, to make the results of its clinical studies public. When the manufacturer posted its research on Avandia, physicians from the Cleveland Clinic subjected them to analysis and documented the extraordinary risk involved.
It is a travesty that a wealthy industrial like the United States' pharmaceutical industry is not obligated to make public its safety data. Some six million Type II diabetics take Avandia, for example. It is even more repulsive that this data is not closely monitored by the FDA, which, unfortunately, is more-or-less controlled by manufacturer's representatives. It is outright despicable that the right of Michigan citizens to seek redress for unsafe or negligently marketed medications has been delegated to a governmental agency that appears to be under-funded, under-motivated and under-regulated.