Avandia, Do Benefits Outweigh Risks?
February 25, 2010
Avandia, a well-known drug used in the treatment of type-2 diabetes in the battle to control blood sugar levels, is again the subject of controversy after the release this week of a report on an investigation carried out over the last two years by the U.S. Senate Finance Committee.
Among other criticisms, the report claimed that the drug manufacturer had not kept the public informed of risks that the company knew to be associated with the drug.
The chairman of the investigation committee, Senator Max Baucus, said “Americans have a right to know there are serious risks associated with Avandia and GlaxoSmithKline, the manufacture, had a responsibility to tell them.”
The committee is also critical of the Federal Drug Agency (FDA) for allowing continued marketing of the drug in spite of warnings of the risks. Some of the FDA’s own health safety experts have raised alarms about its safety, saying it should not be on the market.
GlaxoSmithKline, the manufacturer, vigorously disagrees with the conclusions stated in the report regarding the risks and dangers to health and continues to defend the efficacy and safety of the drug as it has done on several occasions since the approval of Avandia by the FDA in 1999.
Cardiovascular deaths and severe adverse events
Safety issues about the drug were raised soon after its approval. In March of 2000, for instance, Dr. John Buse, Chief of Endocrinology at the University of North Carolina wrote to the FDA expressing concerns and warning of the risks to those using Avandia, saying there is a “worrisome trend in increased cardiovascular deaths and severe adverse events” occurring among those using the drug. Dr. Buse was also critical of the marketing of Avandia and the actions taken to understate the risks associated with the drug.
FDA Alert issued May, 2007
Warnings from other sources continued to be voiced and in 2007 much publicity was given to the FDA’s official Alert issued to healthcare professionals.
The New England Journal of Medicine, early in 2007, had published results of a meta-analysis by cardiologist Steve Nissan of the Cleveland Clinic showing a 43 percent increase in heart attacks in patients using Avandia. Although the conclusions of the study were contested by the manufacturer, the FDA issued an official Alert, noting that the analysis had shown a “significant increase in the risk of heart attack and heart related deaths in patients taking Avandia.” In their view however, other data provided contradictory evidence and it was stated that the “FDA’s review of available data is ongoing.”
The FDA Alert also said that it was providing the emerging information to the doctors so that they and their patients could make individualized decisions on its use. My own decision as a patient after discussing with my doctor was to immediately stop taking Avandia.
Now, many years later, we appear to be in the same place, criticism continues and GlaxoSmithKline rejects any claims that the drug is unsafe. Company spokeswoman Nancy Pekarek, appearing on CNN a few days ago said “We disagree with the conclusions in the report. The FDA has reviewed the data and concluded that the drug should be on the market.”
Meanwhile, there are hundreds of thousands of our fellow diabetics who still take the drug. And the complications of diabetes continue to take their toll, for whatever reason whether hastened by a drug or otherwise, there are more people dying of diabetes complications than are being killed in Afghanistan, we need help and prompt decisions,
The FDA commissioner is reviewing the report issued by the Senate Investigation Committee, while awaiting recommendations of the agency’s own group of advisors. I assume those would include the beliefs of some of the FDA’s health safety experts who say the drug should be withdrawn. The advisory committee’s report is expected in July and at the present time the opinion of the FDA is that patients should not stop taking Avandia.
In our struggle to achieve normal blood sugar levels, perhaps Avandia really is effective and beneficial, in spite of the apparent risks. Let us hope that after ten years of controversy, a final decision is near on whether Avandia is safe or not.
Link for 342 page Senate Finance Committee report.
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