The front page of the New York Times reported that “Hundreds of people taking Avandia [rosiglitazone], a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports.” A Senate Finance Committee review cites internal FDA documents that highlight a dispute among regulators that “has been brewing for years but has been brought to a head by disagreement over a new clinical trial.”
The Wall Street Journal reports that the Senate committee concluded that Glaxo was aware of the risks, but minimized the issue and attempted to suppress concerned physicians. The FDA’s documents also indicate that agency scientists said the drug should be pulled from the market in 2008, but FDA chiefs rejected the recommendations. Now, agency commissioner Margaret Hamburg is expected to meet “with FDA scientists and outside experts to gain a full understanding…of all of the data and issues involved,” a spokeswoman said.
The AP reported that the Senate committee is asking the FDA “why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.” Glaxo agreed to an FDA request for “a six-year study between its drug and” the Pfizer diabetes drug Actos [pioglitazone] “to give a definitive picture of Avandia’s safety.”
If the senate report proves to be accurate, this once again smacks of a company putting profits over patient safety, leading to serious injuries and death.
If prescribed Avandia, please contcat your doctor immediately. Your doctor should not prescribe any medication without first warning you of all known risks, and only if the benefits of teh medication outweigh the risks.
About the author:
Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all lawyers in the Washington metropolitan area. The magazine also describes him as “one of Washington’s best–most honest and effective lawyers” who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims. Mr. Zambri has also been named a “Super Lawyer” by Super Lawyer magazine (March/April 2009)–a national publication that honors the top lawyers in America.
Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books – a company that is touted as “the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world’s most respected companies and law firms.” To read Mr. Zambri’s publication, entitled “Constantly Preparing To Win”, please click here.