Avandia Trial: Science vs. Safety?

by Ralph Brindis June 23, 2010 04:17

The Boston Globe published an interesting article this morning on a clinical trial underway for diabetes drug Avandia. Seventeen physicians are in the process of recruiting patients for a trial that would look at the increased risk of heart attack that has been reported to be associated with the drug. According to the article:

Many specialists — including some officials within the FDA — contend that the drug is too dangerous to remain on the market and that the ongoing Avandia clinical trial is unethical, exposing patients to needless risk of cardiovascular harm.

But the drug has its defenders ... who say it has not been proven to be harmful. The clinical trial, they say, promises to provide answers about the drug, which has been on the market for more than a decade and last year was prescribed more than 2 million times in the United States.

As the Globe article notes, the controversy over Avandia “demonstrates how ... the FDA is still struggling to find the correct response when evidence emerges that big-selling drugs are unsafe.”

What do you think? Should the FDA continue with the trial?

 

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About the Authors

The ACC in Touch blog is co-authored by ACC CEO Jack Lewin, MD, current ACC President David Holmes, MD, FACC, and Board of Governors Chair Thad Waites, MD, FACC.

Jack Lewin Jack Lewin, MD, has been chief executive officer of the ACC since November 2006. Under his leadership the College has continued to build upon its standing as a national leader in advocacy, with a particular focus on reforming Medicare, Medicaid, and the financing and delivery of quality health care.

David Holmes

David Holmes, MD, FACC, became ACC president in April 2011. Dr. Holmes is the Edward W. and Betty Knight Scripps Professor in Cardiovascular Medicine at Mayo Clinic College of Medicine and an interventional cardiologist in the Division of Cardiovascular Diseases and the Department of Internal Medicine at Mayo Clinic in Rochester, Minn.

Thad Waites

Thad Waites, MD, FACC, began as Board of Governors chair in April 2011, and currently practices clinical cardiology with emphasis on interventional cardiology at Hattiesburg Clinic in Hattiesburg, Miss. He is also a board member of the Mississippi State Board of Health, and director of the cardiac cath lab at Forrest General Hospital.

Learn more about Drs. Lewin, Holmes and Waites.



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