While many in the press have reported that an FDA panel’s vote not to ban GlaxoSmithKline’s (GSK) Type 2 diabetes drug Avandia is a victory for the company, the reality is that the saga, which stretches back more than a decade, is a sad tale of “our collective medical incompetence,” according to a recent article from The Guardian. (See Despite Concerns, FDA Panel Votes to Keep Avandia on the Market).
Early concerns voiced by Dr. John Buse about the drug’s safety were “silenced” and was pressured to sign various legal documents, an event a Senate committee later described as ‘intimidation.’
However, Buse wasn’t the only one raising concerns. A part of the World Health Organization contacted GSK in 2003, noting that it was seeing an unusually high number of reports claiming a connection between the drug and heart issues. Two internal meta-analyses in 2005 and 2006 showed the heart risk to both the FDA and GSK. However, the study was not made public until 2008 and neither the regulator or the company made any public comments until that point about the studies.
Then, in 2007, the FDA voted to keep Avandia on the market, despite a study suggesting the drug increases the risk of a heart attack by 43%. It is not unusual for the regulator to keep dangerous drugs on the market because the benefits may outweigh the potential side effects. While the regulator voted to keep the rug on the market, the American Diabetes Association and the European Association for the Study of Diabetes voted against the drug.
Last month a meta-analysis of 56 trials was published that found the drug came with an increased risk of heart attack. It included data of more than 35,000 patients. GSK data from seven studies since 2007 showed no excess risk. However, that pales in comparison the 56 studies that collectively do find there is an increased risk. There are other trials that draw conclusions beneficial to GSK, according to the article, but the methodology or timeline is flawed.
One of the biggest failures of the medical community is its failure to collect uniform data on the drug’s safety and whether it shows heart-related risks in the 11 years it has been on the market. Instead, the data is sliced and diced in different ways to produce different results. Rather than having meaningful data, the medical community has a “hotchpotch” of problematic data and “unforgivable secrecy.”
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