Consumer Health Digest #14-04

Your Weekly Update of News and Reviews
February 2, 2014

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.

New antiquackery organization launched. Mark Crislip, M.D., and four other anti-quackery activists have announced the formation of the nonprofit Society for Science-Based Medicine (SFSBM). The group's mission includes:

The group's Web site, which is a work in progress, will feature a wiki based on articles from Quackwatch and its satellite sites that will be perpetually maintained and updated by expert editorial teams. The site will also offer fact sheets, links to book reviews, a blog about the group's activities, and many other educational features. The cost of joining the group is $85 for basic membership or $25 for student membership. Volunteers are being solicited to help format wiki articles and for other projects.

Generic manufacturer further restricted. The FDA has notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients from its facility in Toansa, India, for FDA-regulated drug products. This facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in 2012 that restricts distribution from Ranbaxy's three other Indian facilities. In 2013, in the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA Inc., a subsidiary of the Indian company, pleaded guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of its Indian facilities. The company also agreed to pay a criminal fine of $130 million, forfeit an additional $20 million, and settle civil claims under the False Claims Act and related s tate laws for $350 million. In the agreements, the company admitted falsifying quality-control test reports on several of its drugs. Pharmwatch has posted details of the case and links to the court documents. The Fortune CNN Blog has published a gripping insider's account of Ranbaxy's wrongdoing. [Eban K. Dirty medicine: The epic inside story of long-term criminal fraud at Ranbaxy, the Indian drug company that makes generic Lipitor for millions of Americans. Fortune CNN Blog, May 15, 2013] The FDA Web site contains a summary of its actions against Ranbaxy.

Naturopath who uses unapproved cancer vaccine suspended. The Washington Board of Naturopathy and the Washington State Department of Health have suspended the license of John A. Catanzaro. N.D., a naturopath who operates the Health and Wellness Institute Cancer Research Group in Mountlake, Washington. The action was based on charges that Catanzaro had failed to (a) disclose the experimental nature of a cancer treatment to his patients, who thought the vaccine he gave them was effective and that his research was approved, (b) follow appropriate protocols for patient safety and informed consent, (c) keep adequate patient records, (d) perform adequate patient examinations, or (e) obtain the required Investigational New Drug approval from the FDA. Catanzaro was given 20 days to request a hearing to contest the charges. The clinic said that it was developing "individualized autologous peptide and whole cell based vaccine" made from the patient's own body tissue, blood, and serum. In 2007, to settle allegations that he had prescribed drugs that were not listed in his state's approved list, Catanzaro agreed to be reprimanded, pay a $1,500 fine, and serve one year's probation.

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    This page was posted on February 2, 2014.