End Avandia Study, Group Urges

We recently wrote that a large <"http://www.yourlawyer.com/topics/overview/avandia">Avandia study—known as TIDE—could be terminated by the U.S. Food and Drug Administration (FDA) over ethical concerns. That decision could impact the controversial diabetes drug’s standing in the market.

Reuters pointed out that, in 2007, the FDA asked Glaxo, maker of Avandia (generically known as rosiglitazone), to conduct a trial comparing the long-term effects of Avandia against those of Takeda Pharmaceutical Co. Ltd.’s Actos when prevailing data pointed to an increased risk of heart attack and chest pain in Avandia.

Since that time, increasing data have linked Avandia to increased cardiac risks, according to Public Citizen, a science-focused consumer advocacy interest group, said Reuters. Public Citizen said it wants the study to end, noting that continuing to involve patients in a trial that seeks 16,000 global participants by 2015 is placing diabetics at unnecessary risk, reported Reuters.

TIDE, said Public Citizen’s Health Research Group Director Sidney Wolfe and Canadian researcher David Juurlink in a letter to FDA Commissioner Margaret Hamburg, is “exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator,” quoted Reuters. “A wealth of data now suggests” Avandia carries increased risks over Actos, the two added.

Wolfe and Juurlink also mentioned that patients apparently do not receive sufficient information regarding safety differences between the two drugs when they are making decisions to enter or not be involved in the trial, said Reuters. 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.

According to Reuters, officials at the FDA confirm that they are looking at the drug; however, the agency is not moving as quickly as consumer advocates would like. “The TIDE trial will be discussed at a joint advisory committee in July,” FDA spokeswoman Karen Riley said in an emailed statement, quoted Reuters. “Based on expert input and our own analysis, FDA will reassess the rationale for the TIDE trial, review the trial’s enrollment and respond accordingly,” Riley said. The FDA has not yet reached a conclusion. Meanwhile, diabetes continue to be enrolled in TIDE and continue to be prescribed Avandia.

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 two-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. The FDA is conducting another safety review of Avandia, the results of which will be discussed at a public meeting in July.

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