The U.S. Supreme Court next week will begin hearing the case of Wyeth v. Levine, which centers on the question of whether FDA approval of a drug warning label pre-empts product safety suits brought in state courts, the Wall Street Journal reports (Mundy/Wang, Wall Street Journal, 10/27). The case involves Diana Levine, who lost her [...]
By DAN RODEN, M.D. • October 10, 2008 Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine. The Food and Drug Administration recently announced a public Web site listing potential drug side effects it [...]
FINALLY! In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time from the clinical trials and the FDA [...]
Reporting any adverse events (unexpected side effects) to FDA after using a medical product, or other problems with any products that the agency regulates. Printer-friendly PDF (366 KB) On this page: Tips for Reporting Quick-Reference Chart for Reporting Problems to FDA Types of Problems FDA Doesn’t Handle Consumers play an important public health role by [...]
How to Use the Consumer Complaint System and MedWatch On this page: Consumer Complaint Reporting Reporting Problems Can Spur Action MedWatch Reporting How to Report to MedWatch Problems to Report to MedWatch Reporting Emergencies FDA Consumer Complaint Coordinators (regions and telephone numbers) If you have a complaint about a product regulated by the Food and [...]
The Food and Drug Administration should rethink its rejection of the Declaration of Helsinki. Later this year, the US Food and Drug Administration (FDA) will adopt new standards for human clinical trials conducted without its advance sign-off in foreign countries. The rules will govern whether data from such trials can be used in applications to [...]
The use of beta blocker drugs before surgery to cut the risk of heart problems may be counter-productive, a study suggests. Researchers found patients given the drugs were a third more likely to die within a month of surgery than those given a dummy pill. Those on the blood pressure-lowering drugs also had double [...]
Inconvenient Woman readers know that I’m not an FDA fan. In my opinion, the troubled agency’s close ties and financial dependence on Big Pharma has been weakened its ability to perform its primary function — protecting the public. The FDA’s documented failure to impartially judge the veracity of drug trial results and enforce safety oversight [...]
The Secret History of the War on Cancer By Devra Davis, PhD, MPH Review by Leslie Botha, Holy Hormones Honey! In a recent interview on CSPAN Davis stated, “For much of its history, the cancer war has been fighting the wrong battles, with the wrong weapons, against the wrong enemies.” The Secret History of the [...]
Big Pharma Giants Schering and Merck Take Heavy Criticism Over Vytorin Failure This week Merck executives are very grateful for the revenue predictions for their blockbuster HPV vaccine, GARDASIL. Profits are predicted to climb from $300 million to $4 billion over the next year. After the Vytorin debacle —they’re going to need the cash. So [...]
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