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Rosiglitazone: A Thunderstorm from Scarce and Fragile Data

Cynthia D. Mulrow, MD, MSc, Deputy Editor; John Cornell, PhD, Associate Editor; and A. Russell Localio, PhD, Associate Editor
[+] Article and Author Information

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Customer Service, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.


Ann Intern Med. 2007;147(8):585-587. doi:10.7326/0003-4819-147-8-200710160-00013
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The U.S. Food and Drug Administration (FDA) has approved many pharmacotherapies for treating diabetes on the basis of the drugs' ability to improve glycemic control. Although preventing adverse macrovascular outcomes, such as myocardial infarction, is a desirable goal for treatment of type 2 diabetes, there is no definitive evidence that any FDA-approved pharmacotherapy achieves such aims (1). Worse, recent meta-analyses suggest that rosiglitazone, a widely prescribed oral hypoglycemic agent, might increase the risk for ischemic heart disease by a small amount. We examine the fragile data underpinning that story and the challenges of summarizing trials with scarce events.

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rosiglitazone

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Insurance Institute of Medication Information
Posted on October 18, 2007
Marcus M. Reidenberg
Weill Cornell Medical College
Conflict of Interest: None Declared

To The Editor:

The editorial, "Rosiglitazone: A thunderstorm from scarce and fragile data", asks for large studies "designed and funded by parties representing the public interest". Third party payers for medical care have both a moral responsibility to their patients and the most to gain financially from having toxic medicines identified and head-to-head comparisons of alternative therapies carried out. The health insurers should follow the example of the automobile insurers who formed the Insurance Institute for Highway Safety. These insurers pay 0.019% of premiums to fund this Institute to do research and promote highway safety (1). If private health insurers paid 0.019% of premiums, an Insurance Institute of Medication Information would have a budget of $104 million annually. If public payers also participated, the funding would more than double to do the kind of studies proposed in the editorial.

(1) Reidenberg MM. Improving how we evaluate the toxicity of approved drugs. Clin Pharmacol Ther 2007; 80: 1-6

Conflict of Interest:

None declared

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