The issue was again brought before the FDA this past week by a Dr. Steven Nissen-cardiologist at the Cleveland Clinic. Dr. Nissen completed his own study, based upon more than 35,000 patients and a combined 56 studies, Dr. Nissen's findings indicated troubling incidences of increased cardiac risk and death associated with the use of this drug. His findings indicated a 28-39 % increased risk of cardiac incidences in otherwise healthy patients. Younger patients were found to have excessive myocardial infarction events and older patients had increased cardiac death.
Amazingly, the FDA expert panel decided against pulling the drug from the market -even in light of the compelling study details outlined by Dr. Nissen. The final voting tally noted the following; (13) votes for pulling the drug from the market ; (17) votes for increased label warnings and possible usage restrictions; (3) voted against any changes.
I would suspect that this will not be the last time we hear about issues with this drug. Glaxo has apparently paid out a number of settlement fees to individuals and families that have been impacted by the drug effects-however, this is the most financially lucrative medication for that company so it is doubtful that they allow removal of this drug from the market without a tremendous fight. After all, drug companies are in the market to make money, not save lives....Right?
"Perhaps better we not obscure the idea that happiness and misery, kindness and greed, and good works and bad deeds are in the capacities of us all, not merely a select few"
David P. Mikkelson, snopes.com, September 8, 2003
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