Avandia's Safety Questioned

New York, NYIt's the stuff movies are made of: company executives arrange a secret meeting with a scientific expert who is trying to discredit the company. The expert secretly tapes the meeting and releases the tape to the media. Yet this is no movie script—according to the New York Times, this is exactly what happened when GlaxoSmithKline, maker of Avandia, got together with Dr. Steven E. Nissen to discuss potential side effects of the diabetes drug.

Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, published an article in the New England Journal of Medicine suggesting that use of Avandia increases the risk of heart attacks by 43 percent. Following the release of his study, GlaxoSmithKline put more strongly worded warnings on Avandia labels, although the drug remains on the market.

The New York Times reported on 2/22/10 that on May 10, 2007, shortly before Dr. Nissen's study was published, he met with four GlaxoSmithKline executives face to face. Nissen recorded the meeting, believing he might face pressure from the executives (in Ohio it is legal to record a meeting so long as one of the parties in the conversation knows about the recording). In February, 2010, Nissen shared his recording with the Times.

In the recording, executives promise to start analyzing the safety of Avandia "within days." To date, however, no such study has appeared in any medical journals. GlaxoSmithKline reportedly posted results of a study on its website, but studies published in journal must be peer reviewed and are held to a higher standard of data collection and recording than those published on a website.

According to Congressional investigators, GlaxoSmithKline had access to Nissen's article, which at that point was still unpublished. The Times report that a journal reviewer who was also employed as a GlaxoSmithKline consultant had "inappropriately" sent the drugmaker a copy of the manuscript. However, executives spoke at the meeting as though they did not know the results of that study.

GlaxoSmithKline later dismissed Nissen's study as "incomplete" and having "significant limitations," although one of the pharmaceutical maker's own researchers wrote in an e-mail that the data in Nissen's study was fine.

"F.D.A, Nissen and G.S.K. all come to comparable conclusions regarding increased risk for ischemic events, ranging from 30 percent to 43 percent!" Dr. Moncef Slaoui wrote.

Meanwhile, confidential studies by US Food and Drug Administration (FDA) officials recommend that GlaxoSmithKline pull Avandia from the market because of its link to heart attacks. The studies also say that any head-to-head trials in which some patients receive Avandia while others receive Actos, another oral diabetes treatment, would be "unethical and exploitative."

GlaxoSmithKline says the government's reports were based on inaccurate information.