Consumer Health Digest #18-35

Your Weekly Update of News and Reviews
September 2, 2018

Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H., with help from Stephen Barrett, M.D. 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. Its primary focus is on health, but occasionally it includes non-health scams and practical tips.

Chelationist sued for Medicare fraud. Federal prosecutors have filed a False Claims Act complaint in the U.S. District Court in Atlanta against Charles C. Adams, M.D.; Charles C. Adams, M.D., P.C. d/b/a Full Circle Medical Center and Personal Integrative Medicine PLLC in Ringgold, Georgia. [The United States files False Claims Act complaint against Charles C. Adams, M.D., and affiliated entities. USAO press release. Aug. 31, 2018] The complaint alleges that Adams and/or his companies:

Edetate calcium disodium has a black box warning that it is "capable of producing toxic effects that can be fatal." The complaint stated that "provoked urine tests are unreliable, potentially dangerous, and should not be utilized in diagnosing heavy metal poisoning." At least ten state licensing boards, including Georgia's, have taken regulatory action against doctors who have used provoked testing as a prelude to chelation. No disciplinary action has been taken against Adams, but his physician profile at Georgia's Composite State Board of Medical Examiners indicates that he settled a medical malpractice case in 2008 for $450,000 and another in 2010 for $237,500. His profile lists his specialty as internal medicine, but he is not board-certified. Adams is the president of the International College of Integrative Medicine, a nonprofit group that features "affordable introduction and advanced training in heavy metal toxicology and chelation therapy." He became certified in Integrative and Holistic Medicine in 2011 by the Board of Integrative and Holistic Medicine, but neither this board nor such a specialty are recognized by the American Board of Medical Specialties, which is the standard-setting agency for the scientific medical community.

Complaints filed to stop use of unproven stem cell treatments. At the request of the U.S. Food and Drug Administration, the U.S. Department of Justice has filed civil complaints charging two companies with manufacturing and marketing stem cell products without FDA approval and proof of safety and efficacy. [Department of Justice files complaints against Florida and California companies to stop use of experimental stem cell drugs on patients. DOJ press release 18-606. May 9, 2018] One complaint was filed against US Stem Cell Clinic LLC, of Sunrise, Florida, US Stem Cell, Inc., and company officers Kristin Comella and Theodore Gradel. The other complaint was filed against California Stem Cell Treatment Center Inc., of Rancho Mirage and Beverly Hills, California, Cell Surgical Network Corporation, and company owners Elliot Lander, M.D. and Mark Berman, M.D.  The complaints allege:

Herbalife sued by distributors. Eight former Herbalife distributors have filed a class action complaint against Los Angeles-based Herbalife in the U.S. Southern District Court in Florida. The complaint states:

An Associated Press report states that the case might eventually involve more than 100,000 plaintiffs. [Anderson C. Herbalife distributors claim events were a sham. Boston Globe. Aug. 21, 2018] In pretrial motions, Herbalife's attorneys argued that the plaintiffs had signed contracts mandating arbitration of any disputes rather than trial in court. [Pickett A. Herbalife seeks to arbitrate potential $1 billion class action. Courthouse News Service. Aug. 21, 2018]

Sexual enhancement marketing halted. The U.S. District Court in New Jersey entered an order of permanent injunction against three marketers who claimed without relevant clinical evidence of safety and effectiveness that their unapproved and misbranded drug products could treat or prevent serious conditions, including erectile dysfunction, impotence, and prostatitis (swelling and inflammation of the prostate gland):

The defendants are required to stop distributing the products unless they comply with the Federal Food, Drug, and Cosmetic Act. The products, which were sold to consumers using more than 100 websites, were misbranded because they did not include adequate directions for use and their labels omitted material information. Some of the products were found to contain undisclosed sildenafil, the active pharmaceutical ingredient in the prescription drug Viagra, which can pose serious health risks to patients with underlying medical issues, such as heart disease and high blood pressure. [District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs. FDA News Release. Aug. 30, 2018]

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This page was posted on September 3, 2018.