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Consumer Health Digest #24-35
September 1, 2024
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; other news items; Web site evaluations; recommended and nonrecommended books; research tips; and other information relevant to consumer protection and consumer decision-making. The Digest’s primary focus is on health, but occasionally it includes non-health scams and practical tips. Items posted to this archive may be updated when relevant information becomes available. To subscribe, click here
http://lists.quackwatch.org/mailman/listinfo/chd_lists.quackwatch.org###
Stem cell marketer pleads guilty to felony distribution of unapproved drugJohn W. Kosolcharoen, 53, the founder and chief executive officer of a California-based company that marketed stem cell-based products linked to multiple hospitalizations, has pleaded guilty to a felony violation of the Federal Food, Drug and Cosmetic Act. He was charged after his company introduced a new, unapproved drug into interstate commerce with the intent to defraud and mislead. His sentencing in the U.S. Central District of California Court is scheduled for September 23. He is currently serving a sentence for a unconnected conviction.
According to court documents:
*** Beginning in 2016, Kosolcharoen created two companies, Liveyon LLC and Genetech Inc., to manufacture and distribute injectable stem cell products made from human umbilical-cord blood.
*** Liveyon marketed the products under different brand names, including “ReGen.”
*** In pleading guilty, Kosolcharoen admitted he and others misrepresented ReGen as suitable for treating lung and heart diseases, autoimmune disorders, Alzheimer’s disease, Parkinson’s disease, and others.
*** Liveyon marketed the products throughout the United States until about April 2019 using advertising materials that contained multiple false and misleading statements about their purported safety and effectiveness.
*** As part of the plea agreement, Kosolcharoen admitted to misleading the U.S. Food and Drug Administration (FDA) about Liveyon’s activities by directing Liveyon’s purchase orders to falsely state the stem cell products were being sold “for research purposes only.”
*** In 2018, the FDA and the Centers for Disease Control and Prevention received reports
https://www.cdc.gov/mmwr/volumes/67/wr/mm6750a5.htm?s_cid=mm6750a5_wof patients in multiple states requiring hospitalization for bacterial infections after using Liveyon products.
*** Kosolcharoen admitted he and others fraudulently induced customers into purchasing stem-cell-derived Liveyon products by misleading the public about the cause and severity of adverse events suffered by Liveyon patients. He also admitted falsely reporting and concealing material facts about the outcome of an FDA inspection of Genetech.
*** According to FDA records, that inspection documented
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genetech-inc-561808-11292018evidence of significant deviations from good manufacturing and tissue practices.
The FDA has warned consumers
https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomesseeking help for serious diseases and conditions that they may be misled about unapproved stem cell products that are illegally marketed, have not been proven safe or effective, or, in some cases, may have significant safety issues.
[Founder and chief executive officer of injectable stem cell product manufacturer pleads guilty to felony distribution of unapproved drug
https://www.justice.gov/opa/pr/founder-and-chief-executive-officer-injectable-stem-cell-product-manufacturer-pleads-guilty. U.S. Department of Justice press release, Aug 27, 2024]
The podcast Bad Batch
https://www.laurabeil.com/podcasts/bad-batch by freelance journalist Laura Beil describes the slick marketing by Liveyon and Kosolcharoen.
###
Financial problems of “alternative medicine” graduates spotlightedGraduates of so-called alternative medicine schools in Portland, Oregon, are complaining they have been misled about the financial returns of their investments in training, according to a two-part Oregon Public Broadcasting report.
Part 1 focused on the Oregon College of Oriental Medicine (OCOM), a private school that offered graduate degrees in acupuncture and traditional Chinese medicine
https://quackwatch.org/related/acu/ but recently shut down due to multiple administrative problems. Part 1 revealed:
Students blamed the collapse of the college on problems including high staff turnover, low staff pay, poor curriculum design, and the fact that students were encouraged to take out hundreds of thousands of dollars in student loans while their earning potential was greatly exaggerated.
Graduates were unable to take out small-business loans because they owed so much in student loans.
In 2015 and 2016, the median federal Stafford and Grad Plus loans of OCOM graduates was $175,000, according to U.S. Department of Education data
https://collegescorecard.ed.gov/data/. However, four years later, their median earnings were just above $27,000 a year, according to U.S. Department of Education and Internal Revenue Service data.
According to a graduate-success handout
https://www.ocom.edu/images/pdf/Professional-Development_onesheet_030717.pdf published by OCOM in 2021, the estimated median gross income for its graduates, based on an alumni survey, was $57,000.
The Academy of Oriental Medicine at Austin
https://www.aoma.edu/wp-content/uploads/2024/03/FAQ-re-AOMA-Closure-as-of-3-18-24.pdf, Texas and the American College of Traditional Chinese Medicine
https://www.potreroview.net/actcm-struggles-to-do-right-by-remaining-students/ in San Francisco have shut down during the past year.
[Camhi T. With deep debt and low-paying jobs, Portland alternative medicine graduates say their degrees will never pay off
https://www.opb.org/article/2024/08/29/portland-oregon-college-of-oriental-medicine-debt-alternative-degree-acupuncture/. Oregon Public Broadcasting, Aug 29, 2024]
Part 2 revealed similar problems facing students at the Portland-based National University of Natural Medicine (NUNM), the oldest accredited university of naturopathic medicine
https://quackwatch.org/naturopathy/in North America and one of the few institutions in which OCOM students can enroll to complete their degree program. NUNM has, by far, the highest student-loan-debt-to-earnings ratio among institutions of higher education in the United States.
Ranked number two in debt-to-earnings ratio is Bastyr University, an institution offering programs in “Alternative and Complementary Medicine and Medical Systems” in California and Washington state.
OCOM was ranked third.
Of the 50 institutions with the highest debt-to-earnings ratio, 13 relate to “alternative and complementary medicine” education.
[Camhi T. Oregon alternative medicine students face a long road to loan forgiveness
https://www.opb.org/article/2024/08/30/oregon-alternative-medicine-loan-forgiveness/. Oregon Public Broadcasting, Aug 30, 2024]
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Use of potentially liver-toxic herbal products found to be commonResearchers at the University of Michigan’s Division of Gastroenterology and Hepatology analyzed nationally representative data of the general U.S. population from 9,685 National Health and Nutrition Examination Survey (NHANES) adult enrollees between January 2017 and March 2020. They found that in the 30 days before being surveyed:
*** 57.6% of enrollees used at least one herbal dietary supplement (HDS) product
*** 7.5% used at least one of these six potentially liver-toxic HDSs: turmeric or curcumin, green tea, Garcinia cambogia, black cohosh, red yeast rice, or ashwagandha
*** of the 731 adult enrollees who used at least one of the six potentially liver-toxic HDSs, 236 used turmeric or curcumin, 92 used green tea, 28 used ashwagandha, 20 used Garcinia cambogia, 20 used red yeast rice, and 19 used black cohosh
*** the vast majority of at-risk HDS use was not recommended by users’ health care providers
*** the most common reasons for use were to improve or maintain health, to prevent health problems, or to boost immunity; all the potentially liver-toxic HDSs were also used for specific health purposes;
*** the most commonly used liver-toxic HDSs were used as often as drugs used to lower blood lipids, non-steroidal anti-inflammatory drugs, and antidepressants
The researchers concluded:
*** In light of the lack of regulatory oversight on the manufacturing and testing of botanical products, it is recommended that clinicians obtain a full medication and HDS use history when evaluating patients with unexplained symptoms or liver-test abnormalities. Considering widespread and growing popularity of botanical products, we urge government authorities to consider increasing the regulatory oversight on how botanicals are produced, marketed, tested, and monitored in the general population.
[Likhitsup A and others. Estimated exposure to 6 potentially hepatotoxic botanicals in US adults
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821951. JAMA Network Open 7(8):e2425822, Aug 5, 2024]
Dr. Stephen Barrett believes
(a) the vast majority of herbal products sold as dietary supplements have no legitimate medical use,
(b) legislators have little or no interest in cleaning up the herbal marketplace, and
(c) the most prudent consumer action is avoidance.
==============
Stephen Barrett, M.D. m,
Consumer Advocate
7 Birchtree Circle
Chapel Hill, NC 27517
Telephone: (919) 533-6009
http://www.quackwatch.org (health fraud and quackery)
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Topic: Stem cell marketer pleads guilty to felony distribution of unapproved drug (Read 63 times)