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Consumer Health Digest #20-40
October 11, 2020
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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Harm by "Lyme literate medical doctors” investigatedAn investigation of government documents obtained through a Freedom of Information Act request reveals that physicians at the Centers for Disease Control and Prevention (CDC) have (a) tracked dozens of reports of significant harm including several deaths that were the direct consequence of procedures ordered or administered by so-called Lyme-literate medical doctors (LLMDs), (b) become aware of malpractice allegations at a constellation of private clinics, and (c) noted that the LLMDs who've been reprimanded have tended to face few professional repercussions.
[Gellman L. Dubious alternative Lyme treatments are killing patients
https://www.bloomberg.com/news/features/2020-10-07/lyme-disease-dubious-alternative-treatments-are-killing-patients. Bloomberg Businessweek, Oct 9, 2020]
A 2017 CDC report discussed five patients who had been given a Lyme diagnosis, sometimes without evidence, by doctors who recommended unproven, long-term IV treatments via a central-line catheter, which became the site of a life-threatening infection.
[Marzec NS and others. Serious bacterial infections acquired during treatment of patients given a diagnosis of chronic Lyme disease—United States
https://www.cdc.gov/mmwr/volumes/66/wr/pdfs/mm6623a3.pdf. MMWR 66:607-609, 2017]
Most LLMDs offer a variety of dubious "alternative" treatments. Quackwatch
https://quackwatch.org/related/lyme/and LymeScience
https://lymescience.org/ provide additional background about their activities.
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FDA warning letters to COVID-19 quackery sellers analyzedA recent paper provides an analysis of Food and Drug Administration (FDA) warning letters (WLs) issued from March 2020 to July 2020 pertaining to unapproved, adulterated, and misbranded COVID-19 products.
[Bramstedt KA. Unicorn poo and blessed waters: COVID-19 quackery and FDA warning letters
https://link.springer.com/article/10.1007/s43441-020-00224-1. Therapeutic Innovation & Regulatory Science. Oct 1, 2020]
The analysis revealed:
98 such letters representing 3.1% of all warning letters in the designated time period
82 of the letters had US-based recipients
88 of the letters were about drug products
A wide range of specific herbal and non-herbal products were mentioned in the letters
49 recipients made claims for prevention and treatment, 27 made prevention claims, 19 made treatment claims, and 3 made claims for a COVID-19 antibody test
The paper concludes:
Online selling and social media platforms should have policies that ethically manage pandemic misinformation and quackery. These platforms can also be a powerful voice to proactively warn people to be cautious and reflective in their purchasing, and to verify content with robust sources such as professional societies. Beyond WLs, the consequences for manufacturers and vendors should be meaningful in order to deter fraud. Potential examples include facility inspections, product seizure, business injunction (legal cease of business activity), professional development education (i.e., regulatory and business ethics courses), and import bans and international regulatory agency notifications for non-USA products.
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Legal and historical analysis of COVID-19 quackery provided. recent essay describes the history of quackery during pandemics; COVID-19 quackery issues in different countries; and consumer protection initiatives against COVID-19 quackery in the United States, the United Kingdom, Japan, and Australia.
[Freckleton I. COVID-19: Fear, quackery, false representations and the law
https://www.sciencedirect.com/science/article/pii/S0160252720300704?via%3Dihub. International Journal of Law and Psychiatry, Sept/Oct 2020]
Highlights of the paper include:
Pandemics generate fear, anxiety, and paranoia that can lead to undesirable community phenomena, including discrimination, scapegoating, and predation on the vulnerable.
Literature, religious connotations, film, and gaming as shared cultural experiences are replete with emotive tropes relating to pandemics, plagues, and pestilences.
An outcome of the emotional resonances of pandemics can be an opportunity for the unscrupulous to take advantage by the publication of false claims of prevention, treatment, and cure.
State responses to the risk of predatory quackery need to focus on providing calm, reasoned responses to a pandemic such as COVID-19 by provision of scientifically-based, up-to-date information.
Cease-and-desist notices should initially be issued to those responsible for promotion of quackery. Robust legal action should be initiated against those who do not comply.
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NutraClick LLC settles FTC charges
Boston-based supplement marketer NutraClick LLC and its two officers have agreed to pay $1.04 million and be banned from negative option marketing
https://itlaw.wikia.org/wiki/Negative_option_marketing in order to settle Federal Trade Commission allegations that the company's deceptive sales and billing practices violated federal law and a 2016 federal court order
https://www.ftc.gov/news-events/press-releases/2016/09/ftc-action-nutraclick-must-change-billing-practices from a prior FTC case. The payment is intended to reflect all of the consumer harm as well as the total revenue made through their allegedly deceptive conduct. According to the FTC's complaint
https://www.ftc.gov/system/files/documents/cases/1_-_complaint_-_de_novo.pdf and proposed contempt order
https://www.ftc.gov/system/files/documents/cases/9-1_-_proposed_contempt_sanctions_-_contempt.pdf, NutraClick and the other defendants violated the Restore Online Shoppers' Confidence Act, the FTC's Telemarketing Sales Rule, and the previous court order, by failing to clearly and conspicuously disclose all material terms of their negative option sales offers, despite agreeing to do so in the 2016 order. In 2016, NutraClick agreed to settle
https://www.ftc.gov/news-events/press-releases/2016/09/ftc-action-nutraclick-must-change-billing-practices the FTC's complaint alleging that it did not clearly disclose that people who ordered samples of supplements and beauty products would be enrolled in a membership program and billed from $29.99 to $79.99 monthly unless they canceled within an 18-day trial period. At least 70,000 people filed complaints about the operation.
[NutraClick LLC to pay $1.04 million and agree to negative option marketing ban to settle FTC allegations that it violated 2016 court order
https://www.ftc.gov/news-events/press-releases/2020/09/nutraclick-to-pay-1-million-and-agree-to-marketing-ban?utm_source=govdelivery. FTC press release. Sept 22, 2020]
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Evidence of effectiveness of HPV vaccine reviewedSkeptical Raptor has provided a readable summary of the major evidence of the effectiveness of HPV vaccine Gardasil.
[Gardasil vaccine effectiveness – prevents HPV and reduces cancer risk
https://www.skepticalraptor.com/skepticalraptorblog.php/gardasil-vaccine-effectiveness-prevents-hpv-and-reduces-cancer-risk/. Skeptical Raptor, Oct 8, 2020]
The author notes:
I have presented in this article four published, peer-reviewed, high-quality articles that establish firm evidence supporting Gardasil vaccine effectiveness. These are not unpublished junk science
https://www.skepticalraptor.com/skepticalraptorblog.php/corvelva-promotes-fake-hpv-vaccine-research/ that does nothing but scare parents and individuals from protecting themselves from dangerous cancers. I only chose four of the best articles, but there are many others that say the same thing – the HPV vaccine prevents cancer. Again, there are so few ways
https://www.skepticalraptor.com/skepticalraptorblog.php/prevent-cancer-12-easy-steps-ok-easy/to prevent cancer, why wouldn't you take the vaccine that can actually prevent cancer?
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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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