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Controversial Avandia Study Has Few Takers

May 20, 2010 | Parker Waichman LLP

A much maligned Avandia trial is having problems recruiting participants, according to The Wall Street Journal. The study, called TIDE, has already faced criticism from some medical ethicists, and as we have reported previously, there is speculation that the U.S. Food & Drug Administration (FDA) could halt it because of safety concerns.

Avandia, made by GlaxoSmithKline, has been the subject of several studies linking it to an increased risk of heart problems. The TIDE trial is comparing Avandia with another diabetes drug called Actos. Actos has not raised as many safety concerns as Avandia, and some scientists inside and outside the FDA have said it is unethical to compare a drug with known cardiac risks with a seemingly safer alternative.

In March, FDA Commissioner Margaret Hamburg wrote to Senator Charles Grassley (R-Iowa), one of the signatories of the senate Finance Committee report, telling him that the agency is reassessing the Avandia versus Actos trial “based on expert input and our own analysis.” The study is also expected to be discussed at an advisory panel meeting on Avandia this summer.

According to The Wall Street Journal, two research sites have dropped out of TIDE because of enrollment issues. An official with one of them – Wake Forest University Baptist Medical Center in North Carolina – told the Journal that it is “not succeeding in recruiting anybody.”

In April, GlaxoSmithKline, which is paying for TIDE, opened up a dozen research sites overseas, some in developing countries including Pakistan, India, Mexico, Latvia and Colombia. That move has some critics of the company uneasy.

Dr. Sidney Wolf of the consumer advocacy Public Citizen told the Journal he was concerned patients at some of these overseas sites might not be aware of the safety questions surrounding Avandia. Dr. Wolf’s group is on record calling for the end of the TIDE trial.

Avandia has been the subject of safety concerns for several years. In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Earlier this year, the Senate Finance Committee released a report detailing its 2-year Avandia investigation. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks.

Since the release of the Senate report, calls have increased for the FDA to pull Avandia off the market.

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