On May 22, 2007, Dr. Steve Nissen spoke out about his study of Avandia, a drug used to treat Type 2 diabetes. The study revealed that patients who take Avandia are at a 43 percent higher risk of heart attack and a 64 percent greater risk of cardiovascular death.

In response, the Food and Drug Administration (FDA) issued a safety alert about the drug’s potential risks but did not issue a recall because other studies of Avandia did not necessarily confirm the risks.

Dr. Nissen said regulators assumed that if the drug lowered blood sugar then it would help to control diabetes and lead to health outcomes benefits, like reducing complications of diabetes or heart disease. But the drug is a paradox, he said.

“Lowering blood sugar is not necessarily related to these health outcomes benefits,” he said. “What we found was a fairly striking increase in the risk of heart attack or heart-related death in people who took Avandia.”

Dr. Nissen said there was an excess of cardiovascular events in the trials that led to Avandia’s approval in 1999. While it was not statistically significant, he said, it was a signal that the drug needed to see a large clinical outcomes trial.

“But here we are, eight years later and we don’t have it,” Dr. Nissen said. “They’re telling us now maybe 2009. That’s 10 years after the drug was approved.”

There were weakness in the study, he added. The study was a meta analysis, which looked at data obtained from publicly available sources instead of raw data, but it was the only data available in the absence of a single large trial.

“[W]hen you see this kind of signal in a population as vulnerable as diabetics, you’ve got to sit up and take notice,” said Dr. Nissen. “And when it’s for a drug that has no established health benefits, well, it’s now up to the individual practitioners to weigh those risks very carefully.”

Dr. Nissen said that patients should never stop taking a drug based on what they hear in a news report, but stressed the importance of discussing any drugs with their physicians.

“[W]e hope that physicians who prescribe diabetic medications will read our study, will understand the strengths and limitations of our study, and will make their own minds up about whether to prescribe the drug or not,” he said.

Source: Ron Winslow, “Avandia critic Nissen speaks,” Wall Street Journal Online Health Blog, May 22, 2007; “Did FDA know of Avandia dangers in 2002?” CBS News, May 22, 2007.