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But Yale University cardiologist Dr. Harlan Krumholz questioned how doctors could get patients to give truly informed consent to participate in a study "where the best-case scenario is that they are not harmed by the drug."
"I just wonder if patients in this trial really understand that the entire point is to determine if those randomized to the arm with Avandia are at higher risk," said Krumholz, who is also a professor at Yale.
Public Citizen's Dr. Sidney Wolfe said the FDA's move is an "important half-step," but said it would not help patients who are already enrolled in TIDE.
"It doesn't really speak to the health risks of the people staying in the trial," said Wolfe, who has petitioned the FDA to withdraw Avandia. "My guess is most, if not all the people in that study would drop out if they were given information about how much more dangerous Avandia is compared with Actos."
The American Diabetes Association said in a statement that the FDA's announcement only pertains to the TIDE trial and urged doctors "not to over-generalize this announcement to the use of Avandia in clinical care."
The FDA first approved Avandia in 1999 and it quickly became the top-selling diabetes pill in the world. However, U.S. sales have plummeted from $2.2 billion in 2006 to $520 million last year as safety concerns swirled around the drug.
The drug works by increasing the body's sensitivity to insulin, a key protein needed for digestion that diabetics don't adequately produce.
The FDA added a black box warning to the drug in 2007. New studies on the drug's safety combined with pressure from safety advocates has prompted the agency to take another look at the drug.
In coming months the FDA is expected to make a decision on whether to keep the drug on the market.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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