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Consumer Health Digest #19-20
May 19, 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.
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Amniotic "stem cell" treatments scrutinizedAn investigation by ProPublica with help from The New Yorker has concluded that unscientific methods, deceptive marketing, price gouging, and disregard for patients' well-being are rampant across the amniotic stem cell therapy industry.
[Chen C. The birth tissue profiteers
https://www.propublica.org/article/amniotic-stem-cell-treatment-transplant-therapy. ProPublica. May 7, 2019]
The investigation found:
* Because amniotic stem cell treatments don't undergo the clinical trials required for FDA approval, there's little data or research on them. Their efficacy is highly questionable and, in one case where bacteria contaminated the supply, the lack of accountability in the industry has led to serious infections for a dozen patients.
* The providers include disgraced doctors who were recast as salespeople, manufacturers that cloaked themselves in pseudoscience and had few scientists on staff, and clinics that offer to treat conditions like multiple sclerosis or kidney disease without specialized training.
* The treatments typically cost thousands of dollars.
* From 2010 to 2017, the FDA sent warning letters to only seven of the hundreds of companies that made or marketed stem cell treatments.
The ProPublica article focuses mainly on the activities of David Greene, whose company, R3 Stem Cell distributes amniotic stem cells to about 30 clinics nationwide. Greene also conducts seminars at which he promotes "amniotic stem cell" injections
https://sciencebasedmedicine.org/ftc-settles-deceptive-advertising-claims-against-amniotic-stem-cell-clinics/ as effective against a wide variety of ailments.
Although Greene is presented at the seminars as "a retired orthopedic surgeon," he stopped practicing because his Arizona medical license was revoked
https://gls.azmd.gov/GLSuiteWeb/Repository/0/0/3/5/db523e6e-b394-4357-884f-2675805864c4.pdfin 2009 due to botched surgeries that resulted in several deaths. The article also reported why several experts believe that the treatments offered at such clinics would be ineffective.
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FDA blasted for failing to crack down on bogus stem cell treatmentsAnother investigative report has criticized the FDA for permitting hundreds of clinics to offer unproven stem cell treatments.
[Grady D. Abelson R. Stem cell treatments flourish with little evidence that they work
https://www.nytimes.com/2019/05/13/health/stem-cells-fda.html. The New York Times. May 13, 2019]
The reporters noted:
* There is almost no regulatory oversight of orthopedic procedures using bone-marrow extracts or platelets, which are regarded as low risk. While the Food and Drug Administration insists that it does have the authority
https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies to regulate stem cell treatments, it adopted an industry-friendly approach in 2017 by giving companies a three-year grace period in which to describe their products or treatments so the agency can determine whether they meet the criteria of drugs that would require agency approval. So far, few companies have submitted any information.
* In the meantime, rogue clinics offering other kinds of procedures have flourished, accused of blinding people by injecting cells into their eyes, mixing stem cells with smallpox vaccine to treat cancer or causing severe infections by administering contaminated blood from umbilical cords into patients' joints or spines. In some of the worst cases, patients had already been harmed before the agency took any action, and the patients took legal steps themselves, suing the clinics that injured them. . . .
* Some stem cell businesses have carefully navigated F.D.A. rules to stay just inside the lines. The agency regulates cell and tissue products, but treatments that use a patient's own cells do not require the agency's approval if the cells are "minimally manipulated," meaning that they have not been cultured or multiplied in a lab, and no drugs or other substances have been added.
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Class action lawsuit against Prevagen marketer proceedingThe U.S. District Court for the Northern District of California has ruled that a class action lawsuit can proceed to trial against Quincy Bioscience, which markets Prevagen, a dietary supplement advertised on television as providing brain health and memory benefits. The lawsuit concerns the labeling and advertising of Prevagen products. The Court certified two classes under California consumer fraud laws:
Under California's Unfair Competition Law, one class consists of all California consumers who, within the time period of January 21, 2012 to May 7, 2019, purchased Prevagen Regular Strength, Prevagen Extra Strength, or Prevagen Mixed Berry Chewable.
Under California's Consumers Legal Remedies Act, the other class consists of all California consumers who, within the time period of January 21, 2011 to May 7, 2019 purchased the aforementioned products.
Additional information is available at the Racies v. Quincy Bioscience, LLC site
https://www.prevagenproductsclassaction.com/.
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Quackwatch praised in credit card articleCardrates.com
http://cardrates.com/has reported on the role of Quackwatch in helping to protect consumers from fraud. The article was especially concerned about using Care Credit to finance long-term treatment plans offered by chiropractors.
[West A. Quackwatch: A 23-year record of vigilance against questionable healthcare claims and their financial implications
https://www.cardrates.com/news/quackwatch-protects-against-questionable-healthcare-claims-and-their-financial-implications/. Cardrates.com, May 13, 2019]
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Stephen Barrett, M.D.
Consumer Advocate
287 Fearrington Post
Pittsboro, NC 27312
Telephone: (919) 533-6009
http://www.quackwatch.org (health fraud and quackery)
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