Healthcare experts and federal regulators knew that the use of Avandia created a greater risk of heart attacks by as much as 43% way back in 2007, but recommended to the FDA that it stay on the market. Why?
When it comes to drug safety, they say, you can’t make an omelet without breaking a few eggs.
One key problem with the FDA’s drug-approval process is that a much greater emphasis is placed on the effectiveness of a medication than on its safety. “Only the grossest, most commonly occurring things will show up in clinical trials designed to determine efficacy,” said Sydney Wolfe, director of health research for the advocacy group Public Citizen.
Suppose a drug saves 3 people and kills 1 person… is that a good reason to keep it on the market?
See David Lazarus at the Los Angelas Times
AstraZeneca faces its first trial over a Seroquel-diabetes link. Vietnam War veteran, Ted Baker, contended he developed diabetes after taking Seroquel to deal with lingering symptoms of post- traumatic stress disorder. However, AstraZeneca claims that they knew of the risk and that the drug’s label was adequate. Baker’s case is the first to go to trial of about 26,000 such claims over Seroquel. If you or a close family member has developed diabetes after using Seroquel,we may be able to help you be compensated for your injuries.
Read the Bloomberg article: http://www.bloomberg.com/apps/news?pid=newsarchive&sid=avtv2jf6sRy8 .
The New York Times (12/13, BU1, Singer, Wilson) reported that “more than 13,000 people…have sued Wyeth over the last seven years,” alleging “that its menopause drugs” Premarin and Prempro “caused breast cancer and other problems.” Plaintiffs also contend that “Wyeth oversold the benefits of menopausal hormones and failed to properly warn of the risks.”
According to Dr. Jerome L. Avorn, a professor of medicine at Harvard Medical School who has written about the subject in the Journal of the American Medical Association, “the cases demonstrate the importance of litigation in detailing exactly how drugmakers operate their businesses.”
The court documents also “illustrate a pattern in the history of hormone therapy. First, many doctors enthusiastically prescribe hormone therapy drugs. Then a few researchers publish studies cautioning about risks, causing sales to fall. And finally, some doctors start prescribing a new iteration of hormone drugs.
And while big pharma continues to use deceptive practices to help market their drugs, consumers in Florida are limited to legal protection by earlier tort reform. Fl 768.1256 Government Rules Defense has been interpreted by some courts to mean that a Florida resident injured by a pharmaceutical drug, does not have the same legal rights as another person injured by the same drug, in the same way, who happens to be from another state.
See Emerson
(formerly Crews) v. Novartis Pharmaceuticals Corporation, 3:06-cv-00659 (M.D. Tenn.) currently pending resolution in the sixth circuit
American Association for Justice | 777 6th Street, NW | Washington, DC 20001 provides briefings.