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A new study links the Type II Diabetes drug Avandia with a 43% increase in the risk of a heart attack, but the manufacturer of Avandia, Glaxo Smith Klein, continue to deny such claim and claim that such statements are “false and misleading”. However, it appears that Avandia, much like Vioxx, was placed on the market without proper warnings for risk of harm to the patient, even though the studies performed indicated that there was an increased risk of harm, particularly related to cardiovascular disease.

Glaxo Smith Klein spent large amounts of money promoting Avandia, direct to consumers. This is an effort to get patients to ask for Avandia when they visit their physicians. However, what is not disclosed, is that there is an increased risk of heart attacks for those patients. It is also true that these drugs are prescribed, in general, to patient poplulations that are more vulnerable and already have an increased risk of heart attacks.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, conducted an analysis, evaluating the results of 42 previous studies of Avandia. His study was published in the New England Journal of Medicine on May 21, 2007, and the study concluded that Avandia increases a patient’s risk of heart attack by 43% and the risk of death from cardiovascular causes by 64%. FDA Commissioner Andrew Van Eschembac testified before a Senate hearing and announced the agency’s request that Glaxo Smith Klein include a “black box” warning to the label of Avandia. However, that warning request is somewhat misplaced because it is set to address an increased risk of heart failure, not heart attacks. Not surprisingly, at that same hearing, Glaxo Smith Klein and the FDA, both defended their action with respect to the drug Avandia.

Dr. John Buse, a diabetes expert, also testified. He stated that when he mentioned a concern about an increased risk of heart attacks from Avandia in 1999, that the drug manufacturer utilized intimidation tactics and characterized him as a liar. The tactics are typical of the bullying tactics used by large drug companies.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

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