Consumer Health Digest #19-20

Your Weekly Update of News and Reviews
May 19, 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.

Amniotic "stem cell" treatments scrutinized. An 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. ProPublica. May 7, 2019] The investigation found:

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 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presented at the seminars as "a retired orthopedic surgeon," he stopped practicing because his Arizona medical license was revoked in 2009 due to botched surgeries that resulted in several deaths.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.

FDA blasted for failing to crack down on bogus stem cell treatments. Another 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. 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 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.

Class action lawsuit against Prevagen marketer proceeding. The 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:

Additional information is available at the Racies v. Quincy Bioscience, LLC site.

Quackwatch praised in credit card article. 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., May 13, 2019]

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This page was posted on May 19, 2019.