Not that I think it will help or change things, but…it’s about time our congresscritters started looking into the FDA and how it’s become nothing more than a strong-arm of bigPharma. So in the NYTimes today I found this little tidbit:
Diabetes Drug Still Has Heart Risks, Doctors Warn
By STEPHANIE SAUL and GARDINER HARRIS
Published: June 6, 2007A medical study intended to demonstrate the heart safety of a well-known diabetes treatment seems, instead, to have added to the controversy over the drug.
Its manufacturer, GlaxoSmithKline, says preliminary results of the clinical trial provide reassurance that the drug, Avandia, an oral medication for Type 2 diabetes that has been used by an estimated seven million people worldwide, does not raise the risk of a heart attack or death from cardiovascular disease.
Influential doctors said that the data published online yesterday in a major medical journal did nothing to ease their concerns about the heart risks. The doctors raised their concerns in three editorials accompanying the Avandia study in The New England Journal of Medicine.
Questions about the safety of Avandia and how regulators have dealt with its risks are to be the subject of a Congressional hearing today. The data could intensify criticism, expected at the hearing, that the Food and Drug Administration should have warned about the potential heart risks years ago.
A supervisor in the drug safety office at the agency said in an interview yesterday that she was rebuked last year after calling for a stronger warning label on Avandia and a competing drug, Actos.
The supervisor, Dr. Rosemary Johann-Liang, said that in March 2006 she approved a recommendation from a safety reviewer at the agency that the drugs be required to carry the strongest warning, a so-called black box warning, because they posed a risk of unusual swelling that could lead to heart failure.
But after officials at the agency who dealt more closely with Glaxo complained, Dr. Johann-Liang said she was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia and Actos.
“This was a very careful review that came to an inescapable conclusion,” Dr. Johann-Liang said in the interview. “They decided to act like the review never happened and punish me for approving it.”
Read the whole story at
http://www.nytimes.com/2007/06/06/health/06fda.html?_r=1&th=&adxnnl=1&oref=slogin&emc=th&adxnnlx=1181134860-BHv1wITY10vDpptff/AJHg
I’ll be interested in the outcome of this one since it’s actually looking at what the FDA is doing. I doubt (due to my jaded nature) that much will happen, but every little inkling of truth holds some hope that we can eventually loosen the strangle hold that pharmaceutical companies have on the FDA, and how they exploit illness for profit.
