Thursday, November 18, 2004

FDA Is Flexing Less Muscle
Washington Post story - "In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health. From 2001 to 2004, three important drugs were taken off the market, compared with 10 that were recalled from 1996 to 2001. ... In the same period, the number of warning letters sent by the FDA's drug marketing office challenging misleading or dishonest drug advertising also plummeted. From 1996 to 2001, the agency issued about 480 cease-and-desist letters. Over the past four years, the total has been about 130. The decrease in FDA enforcement has come despite a steadily rising number of reports of potentially harmful side effects from approved drugs. From 1996 to 2004, the annual number of these 'adverse events' almost doubled." [Viewing Washington Post stories requires registration, which is free.] See also the detailed overview of reactions to recent criticisms of the FDA at the Kaiser Daily Health Policy Report.  
  

Capsules May Be Effective In Treating Bipolar Disorder, Study Finds
PR Newswire story reprinted at Yahoo - "University of North Carolina at Chapel Hill researchers have announced study results finding that a formulation of three-beaded extended-release carbamazepine capsules (ERC-CBZ) was effective, safe and tolerable in the treatment of bipolar I disorder and showed no clinically significant weight gain or changes in blood glucose between treatment groups. The pooled data presented by UNC researchers ... at the 17th annual U.S. Psychiatric and Mental Health Congress in San Diego are results from two of the first trials to use an extended-release form of carbamazepine capsules manufactured by Shire Pharmaceuticals."