our Weekly Update of News and Reviews
October 25, 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.
CSICOP founder dies. Paul Kurtz, Ph.D., the prominent secular humanist philosopher who founded the Committee for Skeptical inquiry (CSI)—originally called the Committee for the Scientific Investigation of Claims of the Paranormal (CSICOP)—has died at the age of 86. He also launched Prometheus Books, Skeptical Inquirer magazine, and a worldwide network of groups that will perpetuate his values and beliefs. CSICOP and the magazine originally focused on debunking supernatural claims—such as those associated with astrology, ghosts, and communicating with the dead—but they gradually expanded to include the full gamut of health-related nonsense. The Center for Inquiry and Prometheus Books have posted detailed histories of Kurtz’s accomplishments.
Prominent stem cell researcher disciplined. Gabriel P Lasala, M.D. has signed a consent order under which he has agreed to (a) serve five years of probation, (b) pay a $5,000 fine, (c) divest any interest he has in stem cell laboratories and related facilities, (d) neither promote nor profit from any stem cell treatment that is not FDA-approved, (e) attend an approved seminar in professionalism and medical ethics, and (f) permanently refrain from lecturing about stem cell treatments or representing that he is a researcher or expert in the field of stem cell treatments. Lasala, who practices interventional cardiology in Covington, Louisiana, is president and a partner of TCA Therapy LLC, medical director of TCM Therapeutics, a partner in TCA Research, Inc, and a director of the Stem Cell Foundation (a small private foundation).
TCA Cellular Therapy, LLC, a privately-held biotherapeutics company, has been conducting FDA-approved studies of stem-cell use against heart disease, peripheral vascular disease, peripheral arterial disease, limb ischemia, amyotrophic lateral sclerosis (Lou Gehrig’s disease), and spinal cord injuries. In a 2010 publication, Lasala indicated that TCA was looking for more investors and predicted that Louisiana’s Northshorewould become “The Stem Cell Center,” where people from all over the world would come to receive therapy. [Northshore poised to become healthcare tourist Mecca. Northshore Conifer, February 2010]
The Louisiana State Board of Medical Examiners acted after it learned that Lasala was administering experimental therapies to patients outside of the trials and/or who did not meet the trial parameters. In 2011, the FDA warned him and TCA about multiple research violations that included (a) failing to test specimens from donors for communicable disease and (b) treating patients outside of the trial protocols. Subsequent investigation by the Louisiana Board confirmed the FDA charges and concluded that Lasala’s Web site was making improper therapeutic claims.
QuantiaMD publishes chiropractic critique. QuantiaMD, a popular medical discussion site, has published a ten-minute talk and slide show by Dr. Stephen Barrett about chiropractors and back pain. The program makes two key points:
- In properly selected cases, manipulation may relieve low-back pain of musculoskeletal origin. However, there is little evidence that it is effective for other musculoskeletal conditions, and no evidence that it works for non-musculoskeletal conditions.
- The situation faced by consumers is actually much worse than published studies might seem to indicate. In the most important studies, patients are appropriately screened for contraindications—often by medical teams—and the treatment is limited by the experimental protocol. However, in the real world, the odds of getting appropriate treatment are much lower because of widespread problems that are described in the presentation.
The presentation is open to the public.
Another chelationist disciplined. Paveen A. Malik, M.D. has been disciplined by the licensing boards of three states. Various documents indicate that between 2001 and 2006, she inappropriately billed Medicare and private insurers for intravenous infusions associated with chelation therapy by using codes for other procedures because she knew the services she actually performed would not be covered. In 2010, in order to avoid criminal prosecution, she signed a consent judgment with the U.S. Attorney’s Office under which she agreed to repay approximately $890,000 in installments of $400 per month to the U.S. Government and $174,000 to Blue Cross Blue Shield at the rate of $100 per month, and will be barred from billing any federal agency for medical services 20 years. Subsequently:
- The Michigan Board of Medicine reprimanded her for unprofessional conduct, assessed a $2,500 fine, and placed her on probation for three years.
- The Iowa Board of Medicine assessed a $10,000 civil penalty and suspended her medical license indefinitely.
- The Florida Board of Health issued a reprimand, imposed a $3,000 fine, and restricted her from (a) administering vitamin B-12 injections for weight loss, and (b) administering chelation therapy unless patients are documented to have heavy metal toxicity.
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