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Results of a clinical study announced in New Orleans recently appeared to exonerate Avandia from long-held suspicions that the drug causes adverse cardiovascular events in patients undergoing treatment for diabetes 2. Many doctors and other critics, however, say that the study is flawed and remain unconvinced of the findings. Financial analysts believe the results will likely give GlaxoSmithKline’s one-time blockbuster drug a sales boost.
GlaxoSmithKline’s Avandia is once again making the headlines after it was revealed that the peer reviewer looking at the now-notorious meta-analysis on the diabetes drug’s safety profile leaked a confidential copy of the article to the firm before it was published in the New England Journal of Medicine
The consequences of deadly Avandia side-effects are now being seen in the general population, a new study has found. Previously, evidence that Avandia placed patients at an increased risk of heart attacks had only been seen in clinical trials. But now, Canadian researchers have found that patients taking the controversial diabetes drug who are not enrolled in clinical trials are showing increased evidence of heart attacks and other cardiac problems.
The Avandia debacle has prompted a safety official from the Food & Drug Administration (FDA) to call for changes in the way diabetes medications are approved for use in the United States. The FDA official, who reviewed the original approval application for Avandia, told the Journal of Diabetes Care that the safety and effectiveness of experimental diabetes medications should be tested against existing drugs before they are approved. If such a testing protocol were to be adopted by the FDA, it would mark a significant departure from the way most medications are granted approval in the United States.
The government’s own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.
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