Consumer Health Digest #12-41

Your Weekly Update of News and Reviews
November 22, 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.

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Colorado Stem cell clinic clipped. A U.S. District Court judge has ordered Regenerative Sciences of Broomfield, Colorado and three of its employees (Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever) to stop performing their Regenexx stem cell procedure in the United States. The procedure, which uses stem cells cultured from the patient's bone marrow, is intended for people suffering from moderate to severe joint, muscle, tendon or bone pain due to injury or other conditions. Drs. Centeno and Schultz practice together and jointly own the Centeno-Schultz Clinic in Broomfield. They are also the majority shareholders of Regenerative Sciences, which owns the Regenex™ Procedure and licenses the clinic to use it. In 2008, the FDA warned Centeno that it regarded the cells used in the Regenexx procedure as drugs subject to FDA regulation and that Regenerative Sciences was not complying with the relevant federal laws and regulations. FDA investigators inspected the clinic in 2009 and 2010 and concluded that the laboratory did not comply with current good manufacturing practices. In August 2010, after the FDA concluded that the company had failed to make sufficient corrections, the Justice Department filed suit charging that (a) the cultured product is unapproved, (b) well-controlled studies have not been done to demonstrate its safety or effectiveness, and (c) the company has violated good manufacturing practices. Regenerative Sciences argued that the FDA lacked jurisdiction because (a) they were only practicing medicine within Colorado and (b) the Regenexx procedure is not a drug subject to federal regulation. However, the judge granted a permanent injunction under which the procedure could not be used again unless the company complied with FDA regulations. The company has appealed this ruling. Quackwatch has additional details and links to the relevant documents.

Chiropractic practice-builders hit with large damage award. A New Jersey judge ordered Daniel H. Dahan, D.C., Practice Perfect, and Robert H. Borsody, Esq. to pay Allstate Insurance Company nearly $4 million for violating New Jersey's Insurance Fraud Protection Act. The judge also ordered Dahan and Medical Neurological Diagnostics, Inc. (MNDI) to pay an additional $10,125. Dahan is president of Practice Perfect Management & Consulting Services, of Long Beach, California, which specializes in helping chiropractors set up clinics that "integrate" chiropractic, medical, and physical therapy services. Borsody, who practices law in New York City, devised the legal strategy and forms used to provide the "integration." Practice Perfect seminars taught chiropractors how to set up medical corporations that appeared to comply with state regulations as to ownership and control, but would actually be under the chiropractor's control through devices such as undated documents, penalty clauses, and one-sided agreements. The suit focused on the billings of Scott Neuner, D.C., a New Jersey chiropractor who became a Practice Perfect client. Allstate noted that soon after the clinic began operating (a) Neuner raised his charges for accident cases from $67.50 per visit to $90 per visit by billing as though services were performed by more than one provider instead of just by him and (b) for each patient tested by an MNDI technician, Neuner paid an average of $106.50 but billed Allstate between $1,400 and $2,150. Chirobase has additional details and links to the relevant documents.

Burzynski escapes state board discipline. The Texas Medical Board has dropped the charges it filed against Stanislaw Burzynski, M.D., Ph.D., in 2011. The 2011 charges concerned his alleged administration of cancer drugs for uses that were not FDA-approved. In 2012, the Texas State Office of Administrative Hearings dismissed most of the charges and denied the board's request to reverse its ruling. In November 2012, the board decided to drop the case. This was the second time Burzynski faced board action. In 1994, he was placed on 10-years' probation for violating state and federal laws by treating AIDS and cancer patients with "antineoplastons," a group of substances that he claims are effective. He subsequently worked out a unique arrangement under which he could conduct clinical trials, the validity of which have been challenged by knowledgeable observers. In 2009, the FDA notified the Burzynski Research Institute's institutional review board that its oversight of Burzynski's research was seriously deficient. In 2012, the FDA warned Burzynski that his Web site contained inappropriate promotional claims for two of the products involved in his research.

Antiquackery book published. Morton E. Tavell, M.D., Clinical Professor of Medicine at the Indiana University School of Medicine, has produced an excellent book intended to help people sort health-related facts from fictions. The book's first section discusses in great detail how facts are determined. The second section covers fallacies and misconceptions related to specific claims. The third compare scientific and religious thought. Copies of Snake Oil Is Alive and Well: The Clash between Myths and Reality are available from Amazon Books for $13.95 for the hard cover and $5.99 for the Kindle edition.

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