Print

[Krik]

[*quote*]
Consumer Health Digest #19-49
December 15, 2019

Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H
http://www.calstatela.edu/faculty/william-m-london
., with help from Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.html
. 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
https://www.casewatch.net/fda/court/us_stem_cell/order_2019.pdf
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
https://www.fda.gov/news-events/press-announcements/statement-stem-cell-clinic-permanent-injunction-and-fdas-ongoing-efforts-protect-patients-risks
. FDA statement, June 25, 2019]

In 2017, the FDA raised concerns in a warning letter
http://www.casewatch.net/fdawarning/prod/2017/us_stem_cell.shtml
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.

Since 2013, LHI has conducted a multimillion-dollar campaign to lure patients with targeted online ads, hyped claims, and high-pressure seminars promoting stem cell treatments, which it now calls "cellular therapy" and "platelet-rich plasma platelet-concentrate."
Former patient coordinators who had the job of converting leads generated by responses to ads into sales claim they were given a minimum quota of ten sales each month, a claim disputed by the company's chief operating officer.
Coordinators were taught to point to testimonials by patients in response to patients asking if the treatments would work for them.
Coordinators were taught to use marketing scripts to respond to patients' concerns about LHI offering treatments unapproved by FDA and not covered by insurance.
Former employees responsible for fielding patients' calls said they were given monthly sales quotas.
Former company doctors and nurses worked as "closers," using their medical credentials to persuade wavering patients to put money down.
Patients who attended LHI seminars said they were offered discounts if they put down a deposit on the spot.
Staffers told a patient that more than 80% of their patients found relief through their stem cell treatments and that treating him would cost $5,500, thanks to a summer sale. Staffers suggested that funds could be obtained through GoFundMe. A year and a half after receiving LHI treatments, the patient's health deteriorated and he struggled to pay off a $3,000 credit card bill for the procedure.
Other patients said they were encouraged to take out bank loans or borrow money from family members to pay for treatments. A November 2017 LHI blog post describes ways patients have gotten funds to pay for treatment including loans/gifts from relatives, bake sales, garage/yard sales, walkathons, potlucks, raffle, and obtaining a fixed-term loan with monthly payments.
Some former patients withdrew money from their retirement account, took up church offerings, or borrowed against their homes.
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
https://www.classaction.org/news/two-patients-sue-lung-institute-over-sham-stem-cell-treatments
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
https://www.bloomberg.com/news/articles/2011-05-12/patients-sue-back-surgery-company-laser-spine
lawsuits. The company abruptly
https://www.abcactionnews.com/news/region-hillsborough/laser-spine-institute-operations-shut-down-more-than-500-employees-lose-jobs
shuttered its business after banks froze its assets amid multiple lawsuits.
https://www.tampabay.com/health/whats-left-of-laser-spine-institute-a-consultant-tries-to-pick-up-the-pieces-20190320/
[Wan ,, McKinley L. Clinic pitches unproven treatments to desperate patients, with tips on raising the cash
https://www.washingtonpost.com/national/health-science/clinic-pitches-unproven-treatments-to-desperate-patients-with-tips-on-raising-the-cash/2019/12/01/fe94cfcc-d3c6-11e8-8c22-fa2ef74bd6d6_story.html
. 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
https://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decree-against-tennessee-drug-dietary-supplement-and-device
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
https://www.fda.gov/drugs/drug-recalls/recalled-basic-reset-and-biogenyx-products-including-drugs-dietary-supplements-and-devices
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
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biogenyx-basic-reset-07012016
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
https://www.fda.gov/news-events/press-announcements/fda-underscores-consumers-should-not-use-drugs-dietary-supplements-and-devices-recalled-basic-reset
. 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
https://www.nap.edu/catalog/25594/regulating-medicines-in-a-globalized-world-the-need-for-increased
. Washington, DC: National Academies Press, 2019. https://doi.org/10.17226/25594]

=================================

Stephen Barrett, M.D.
Consumer Advocate
287 Fearrington Post
Pittsboro, NC 27312

Telephone: (919) 533-6009

http://www.quackwatch.org (health fraud and quackery)
[*/quote*]