Consumer Health Digest #12-07
Your Weekly Update of News and Reviews
February 16, 2012
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
Too many clinical trials going unreported. Two recent analyses have found that most clinical trials registered at ClinicalTrials.gov did not have their results posted within a year after they were published and many were never posted. [Kuehn BM. Few studies reporting results ay US Government clinical trials site. JAMA 307:651-653, 2012] The Food and Drug Amendments Act of 2007 requires study sponsors or investigators to register any clinical trials that have a study site in the United States or will be conducted under an investigational new drug application from the FDA. This law also requires most investigators to post summaries of their results on within a year of study completion. Yet:
- One analysis found that 39% of trials were registered late and only 12% of completed studies had been reported and posted on time. [Law MR and others. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. Health Affairs 30:2338-2345, 2011]
- The other analysis found that only 22% had been reported and posted on time. [Prayle AP and others. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 344:d7373, 2012]
Timely and complete reporting are important for judging the effectiveness of treatments, and If reporting is not complete, the apparent tendency to report positive results more than negative ones ("publication bias") will make some treatments seem more effective than they actually are.
Compounding pharmacy charged with misbranding. Gary D. Osborn and his corporation, ApothèCure Inc., have been charged with two misdemeanor criminal violations of the Federal Food, Drug and Cosmetic Act in connection with their shipment of two lots of colchicine solution that led to the deaths of three people in the Pacific Northwest. [U.S. files criminal charges against Dallas company in connection with misbranded drug shipment that led to three deaths. USDOJ news release, Feb 13, 2012] In 2007, ApothèCure shipped 72 vials of compounded colchicine to a now-defunct medical center in Portland, Oregon. Shortly afterward, three patients who received doses from this shipment died after receiving infusions. Colchicine is FDA-approved to prevent and treat gout attacks (sudden, severe joint pain caused by abnormally high levels of uric acid in the blood) in adults. However, the FDA subsequently determined that some of the vials contained 640% of the colchicine level declared on the label. The criminal information charges that ApothèCure committed two prohibited acts by shipping misbranded drugs in interstate commerce and that Osborn, as the person responsible the firm's operations, is strictly liable for the firm's failure to follow federal law. In addition to this case, attorneys general have pursued civil actions in Texas and Oregon against Osborn and ApothèCure.
California medical board issues disciplinary guide. The Medical Board of California has issued a 32-page Manual of Model Disciplinary Orders and Disciplinary Guidelines. The guidelines set forth the discipline the Board believes is appropriate for the identified violations. In addition to protecting the public, the guidelines are intended to promote uniformity, fairness, and deterrence and, when appropriate rehabilitation of licensees.
"Anti-aging" doctor facing more charges. The Medical Board of California has charged Edmund Chein of violating the probation to which he agreed in 2005. The accusation states:
- In 2010, following an incident in which he displayed a handgun and slashed the tires of someone's car, Chein was convicted of vandalism and placed on summary probation for three years. He was also ordered to serve thirty days in jail, pay fines and fees totaling $180, and complete three months of anger management.
- Chein violated the terms of his medical license probation by getting into trouble and by failing to report the conviction to the board.
Chein operates the Palm Springs Life Extension Institute in Palm Springs, California. In the 2005 case, he settled charges of unprofessional conduct by agreeing to (a) pay $10,000 to the State of California for costs, (b) take courses in ethics, prescribing practices, and recordkeeping, (c) refrain from making unsubstantiated advertising claims, and (d) either have his practice monitored or participate in an intensive professional enhancement program.
This page was posted on February 18, 2012