USA Today: Avandia safety debate shows flaws in FDA drug monitoring. USA Today (7/9) editorializes, “Since 2005, evidence has mounted that the blockbuster diabetes drug Avandia [rosiglitazone maleate] might increase the risk of cardiovascular complications — including heart attacks, one of the major causes of death among diabetics.” Yet, “the drug is still on the market, and scientists still are battling over its safety.” This “prolonged battle leaves nervous patients in the lurch — and renews questions about whether America’s medication safety watchdog, the Food and Drug Administration, is effectively monitoring drugs after they’ve been approved for sale. As with Vioxx [rofecoxib], the popular painkiller pulled off the market in 2004, the FDA has lagged several steps behind independent researchers.”
Florida Lawyers
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
In an op-ed in the Boston Globe (1/24) Paula J. Caplan, a clinical and research psychologist at Harvard University, wrote that an “overlooked” primary cause of “America’s obesity epidemic” is the increased use of psychiatric medicines, as many of them “cause weight gain — often of the rapid and massive sort.” Caplan suggests that this link is not well known possibly due to the power of the pharmaceutical industry or clinicians not knowing other treatments.
Caplan argues against listing obesity as a mental illness, as it can be caused by “physical problems that are often undiagnosed.” Caplan also says that doctors should “explore other non-drug ways to treat emotional problems.” What happens when the drug you are taking causes serious side-effects? Are there legal remedies for dangerous drugs?
The AP (1/22, Perrone) reports that the FDA “on Thursday added new warnings to weight loss pill Meridia [silbutramine] about the increased risk of heart attack and stroke in patients with a history of heart problems.” The new label “states only that the drug should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.”
European regulators call for sibutramine ban. The Wall Street Journal (1/22, Favole) reports that the European Medicines Agency on Thursday said the sale of sibutramine should be suspended because of the risks of stroke and heart attack. The European Commission will now review the agency’s advice. The Journal also notes that both the FDA and EMA announcements come following a study of 10,000 patients that showed 11.4 percent of those who took sibutramine had a cardiovascular event, compared with 10 percent of patients who received a placebo.
The
New York Times (1/7, B3, Pollack) reports, “The Food and Drug Administration said Wednesday that it would review the safety of…widely used anemia drugs sold by Amgen and Johnson & Johnson after another clinical trial suggested that high doses of one of the drugs,” Aranesp (darbepoetin alfa), “might cause strokes.”
Agency officials published an article in The New England Journal of Medicine that said “the results of the new trial, as well as of previous trials, ‘raise major concerns’ about the use of the drugs to treat the anemia caused by chronic kidney disease.” In a commentary published in The Journal of the American Society of Nephrology, Dr. Ajay K. Singh, of Brigham & Women’s Hospital and Harvard Medical School, said “that avoiding the use of the drugs in kidney patients not undergoing dialysis ‘is now the soundest approach given’” in the recent study.
Bloomberg News (1/7, Waters) reports that the agency “will convene an advisory committee to re-evaluate the use of” Amgen’s Aranesp and Epogen and J&J’s Procrit following studies that showed “high amounts boost the risk of heart attacks, blood clots, and stroke.” Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, noted that the trials were intended “to show that using” the drugs “to raise hemoglobin concentration…improves clinical outcomes,” but “all results have suggested the opposite.”
Agency officials said lower doses of the drugs and monitoring blood hemoglobin more frequently may improve clinical outcomes, Dow Jones Newswire (1/7, Dooren) reports. According to a spokeswoman for the FDA, the advisory panel will address target levels for blood hemoglobin. Aranesp and Procrit are also currently approved for anemia in certain cancer patients who undergo chemotherapy. Reuters (1/7) also covered the story.
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.
The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients.
“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA.
“Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”