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Thousands Die While FDA has Mud on Its Face
June 11, 2007
The Avandia scandal took a new turn last week as the New York Times broke the story that Rosemary Johann-Liang, deputy director of the FDA’s Division of Drug Risk Evaluation, was reprimanded last year by FDA top brass for approving a black box warning to let doctors and patients know that Avandia causes an increased risk for heart failure. It is apparently the policy of dysfunctional FDA management to punish safety staff when they do something that may cost Big Pharma dearly so as to protect human health.
Now that the Commissioner of the FDA has been hauled before Congress and grilled on FDA ineptitude in informing doctors on Avandia risk, the FDA has changed its tune and is now placing the very same black box warning on the drug.
It was renowned cardiologist Steven Nissen’s article in the New England Journal of Medicine, showing a 43% increased risk for heart attacks from Avandia, that focused the spotlight on Avandia, GlaxoSmithKline, and FDA management. It is not that the FDA is a bumbling organization unable to protect consumers, after all the FDA had all the same information as Dr. Nissen. It is very clear these FDA management actions are INTENTIONAL and have caused death to unsuspecting Americans.
Now that the Commissioner of the FDA has been hauled before Congress and grilled on FDA ineptitude in informing doctors on Avandia risk, the FDA has changed its tune and is now placing the very same black box warning on the drug.
It was renowned cardiologist Steven Nissen’s article in the New England Journal of Medicine, showing a 43% increased risk for heart attacks from Avandia, that focused the spotlight on Avandia, GlaxoSmithKline, and FDA management. It is not that the FDA is a bumbling organization unable to protect consumers, after all the FDA had all the same information as Dr. Nissen. It is very clear these FDA management actions are INTENTIONAL and have caused death to unsuspecting Americans.