Consumer Health Digest #19-49

Your Weekly Update of News and Reviews
December 15, 2019


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.


Injunction issued against US Stem Cell clinics. In June, a federal judge issued an order prohibiting US Stem Cell Clinic LLC of Weston, Florida and US Stem Cell Inc. of Sunrise, Florida and their chief scientific officer Kristin Cornella, Ph.D. from manufacturing or distributing any and all unapproved stromal vascular fraction products, which are adipose (fat) tissue-derived stem cell products, unless they become legally compliant. Previously, the Court granted the government's motion for summary judgment after concluding that the defendants adulterated and misbranded their cellular products made from patients' adipose tissue. [Statement on stem cell clinic permanent injunction and FDA's ongoing efforts to protect patients from risks of unapproved products. FDA statement, June 25, 2019] In 2017, the FDA raised concerns in a warning letter that US Stem Cell was marketing unapproved drugs and deviating from current good manufacturing practices. The letter noted that the products were being administered intravenously or into the spinal canal to treat Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, pulmonary fibrosis, and other serious diseases.


Cellular therapy sales pitches questioned. An investigative report about the Tampa-based Lung Health Institute (LHI, formerly Lung Institute), which operates clinics in Florida, Arizona, Texas, Tennessee, and Pennsylvania, has been accused of predatory practices.

In 2015, pulmonologists at Johns Hopkins urged the FDA to take action against LHI to prevent the further advertising of its unproven treatment. Former patients have filed a lawsuit accusing LHI of deceptive marketing practices. LHI has denied the allegations in court filings, saying that patients sign a consent form indicating no guarantees. The patients are seeking class-action status.

Chi's founder Jimmy St. Louis served several years as chief operating officer of the nationwide chain Laser Spine Institute, which aggressively promoted a minimally invasive alternative to neck and back surgery with the claim of a 98% patient satisfaction rate. Laser Spine was the subject of dozens of malpractice lawsuits. The company abruptly shuttered its business after banks froze its assets amid multiple lawsuits. [Wan ,, McKinley L. Clinic pitches unproven treatments to desperate patients, with tips on raising the cash. Washington Post. Dec 1, 2019]


Basic Reset and Biogenyx products recalled. The FDA has announced a recall of 25 drug, dietary supplement and medical device products distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction that required the two companies and their owner, Fred R. Kaufman III, to recall and stop distributing products until they comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the decree. The recalled products include drugs such as Earth Wash and Ionyte; dietary supplements Melli-Tonin and Body Mass Reset; device Energy FX. The companies had claimed that their products were effective against inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain. The FDA conducted inspections at Basic Reset and Biogenyx between 2012 and 2017 and issued a warning letter in 2016. Despite assurances that the violations noted in the letter would be corrected, follow-up inspections revealed that the violations persisted. [FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations. FDA news release. Dec 10, 2019]


Recommendations offered for global regulation of medicines. The National Academies of Sciences, Engineering, and Medicine has called for strengthening collaboration among the medicine regulatory authorities of different nations to ensure the quality, safety, and efficacy of medicines. The report is a response to challenges posed by globalization of drug development and supply chains. It notes that an estimated 40% of medicines and 80% of active pharmaceutical ingredients used by Americans are made overseas. [National Academies of Sciences, Engineering, and Medicine. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: National Academies Press, 2019. https://doi.org/10.17226/25594]


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