Consumer Health Digest #20-43
Your Weekly Update of News and Reviews
November 1, 2020
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.
Prevagen claims challenged. A new investigative report tells the perplexing story of Prevagen's marketplace success despite persistent concerns about the lack of evidence that it is safe and effective for enhancing memory. [Eisner C. Americans took Prevagen for years—as the FDA questioned its safety. Wired, Oct 21, 2020] In 2012, the U.S. Food and Drug Administration (FDA) warned Wisconsin-based Quincy Bioscience that: (a) although Prevagen was labeled as a dietary supplement, therapeutic claims made for it established it as an unapproved drug in violation of the Federal Food, Drug, and Cosmetic Act, and (b) the synthetically produced apoaquorin protein in Prevagen is not a legal dietary supplement ingredient. Nevertheless, Qunicy Bioscience has continued to aggressively advertise Prevagen as containing a protein originally found in jellyfish that can improve memory. The company also says that the product is the "best-selling branded memory supplement in chain drug stores across the United States." The new report states:
- An estimated 3 million people have purchased Prevagen.
- Sales reached $165 million by mid-2015.
- A month's supply of "extra strength" Prevagen sells for about $60 at Walgreen's, CVS, and Walmart.
- Multiple FDA inspections found significant issues with Quincy's manufacturing processes, complaint handling, and quality-control testing.
- In 2018, the FDA determined that Quincy Bioscience had addressed the violations in the 2012 warning letter and no further enforcement action has been taken.
- Commercials for Prevagen describe the product as "safe and effective."
- Over 4,000 Prevagen users have complained to the FDA that they experienced health problems such as seizures, strokes, heart arrhythmias, chest pain, and dizziness while using the product, but such complaints, though concerning, are insufficient to establish that Prevagen is unsafe.
- Quincy Bioscience has been sued multiple times over allegations of false advertising for Prevagen. The company reached a class-action settlement without admitting any wrongdoing to resolve seven of these lawsuits. People who purchased Prevagen in the U.S. before July 21, 2020 could receive a refunds of up to $70 by filing a claim by October 26, 2020.
- The Federal Trade Commission and the New York attorney general are pursuing a lawsuit alleging that Prevagen's marketers relied on "false and unsubstantiated claims" about its health benefits.
- Quincy Bioscience was able to obtain GRAS (generally recognized as safe) status for apoaquorin by making it an additive in its Neuroshake food product and having three scientists affirm the ingredient's safety.
- A 2010 U.S. Government Accountability Office report stated: "FDA's oversight process does not help ensure the safety of all new GRAS determinations."
"Immune boosting" discourse on Instagram analyzed. A recent research letter describes a content analysis of 28 Instagram posts from 26 unique accounts with 500,000 followers found in searches for "#immunebooster" on Instagram from May 4 to May 10, 2020. All of the posts unequivocally portrayed immune-boosting as beneficial even though the idea of boosting one's immunity, is misleading and scientifically inaccurate and no products has been demonstrated as effective for protecting against COVID-19. [Wagner DN. Marcon AR. Caulfield T. "Immune boosting" in the time of COVID: selling immunity on Instagram. Allergy, Asthma & Clinical Immunology, 16(76), 2020] The researchers noted:
Our analysis shows that popular posts hashtagged with #immunebooster on Instagram are devoid of sound science and full of commercial content. Biomedical jargon and authoritative signaling are commonly used to give credibility to scientifically unsound ideas around boosting one's immunity. In nearly every post commercial endeavors are highlighted implicitly and explicitly.
More statements slam misguided US pandemic responses. Recent statements objecting to the spread of COVID-19-related misinformation and/or neglect by U.S. leadership include:
- Rebuttals by the American College of Emergency Physicians (ACEP) and the American Medical Association's president Susan R. Bailey, MD to President Trump's baseless assertions that physicians overcount COVID-19 deaths. [Fritze J. Doctors groups rip Trump for touting baseless conspiracy over COVID-19 death count. USA Today, Oct. 31, 2020]
- "The assault on physicians and science must end" by Dr. Bailey
- Why Nature supports Joe Biden for US president
- Dying in a leadership vacuum by the editors of The New England Journal of Medicine
The September 27th issue of Consumer Health Digest includes links to previous statements from health and science authorities against disregard for science in the U.S. pandemic response.
Indian Medical Association slams promotion of AYUSH to prevent COVID-19. The Indian Medical Association has issued a press release asserting that recommendations by the Indian Health Ministry issued on October 6th to prevent COVID-19 and treat mild cases based on AYUSH (ayurveda, yoga & naturopathy, unani, siddha, sowa rigpa, and homeopathy) are not supported by scientific evidence. [Pulla P. 'A fraud on the nation': critics blast Indian government's promotion of traditional medicine for COVID-19. Science, Oct 15, 2020] In January, the Federation of Indian Rationalist Associations questioned the silence of medical bodies in response to the AYUSH Ministry's promotion of coronavirus quackery.
Comprehensive resource on herbal products updated. Thomas J. Wheeler, PhD, a retired associate professor, of biochemistry and molecular biology at the University of Louisville School of Medicine, has updated the Herbs section of "A Scientific Look at Alternative Medicine.. The original compendium was part of a handout for an elective course that taught medical students to carefully consider the evidence regarding claims for "alternative" products and services.
This page was posted on November 1, 2020.