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Consumer Health Digest #23-14
April 2, 2023

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. To subscribe, click here
http://lists.quackwatch.org/mailman/listinfo/chd_lists.quackwatch.org


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Judge reduces coverage of preventive services under Affordable Care Act plans

A U.S. District Court judge in the Northern District of Texas issued a final judgment
https://storage.courtlistener.com/recap/gov.uscourts.txnd.330381/gov.uscourts.txnd.330381.114.0.pdf
in a case challenging the provision of the Affordable Care Act that requires most private health plans to cover a range of preventive
https://www.kff.org/womens-health-policy/fact-sheet/preventive-services-covered-by-private-health-plans/
services without any cost-sharing for those enrolled in the plans. The judge concluded
ttps://www.kff.org/womens-health-policy/issue-brief/explaining-litigation-challenging-the-acas-preventive-services-requirements-braidwood-management-inc-v-becerra/
that coverage requirements of services recommended by the U.S. Preventive Services since March 2010 were unconstitutional because members of that panel—16 volunteers, typically doctors and scientists—were not appointed by the president and approved by the Senate, which he said violated the U.S. Constitution’s appointments clause.
[Owermohle S. Texas judge strikes down major Obamacare provision protecting preventive care
https://www.statnews.com/2023/03/30/aca-birth-control-prep/
. Stat, March 30, 2023]

The judge’s decision places limits on the government’s ability to enforce those requirements nationwide. That means lung-cancer screening, medications such as statins to prevent heart disease, and medications to lower the risk of breast cancer (e.g., tamoxifen) may now be subject to copays, deductibles, or coinsurance. Full coverage would be maintained for screening mammography, colorectal-cancer screening, and cervical-cancer screening because they were recommended prior to March 2010.

The judge also ruled that the mandate to cover pre-exposure prophylaxis (PrEP) medication taken to prevent HIV infections violates the religious rights of the conservative groups that brought the case under the Religious Freedom Restoration Act. Coverage requirements that have not been overturned include: (a) vaccines recommended by the Advisory Committee on Immunization Practices (ACIP), (b) women’s health services (such as contraception) recommended by the Health Resources and Services Administration (HRSA), and (c) children and young-adult services recommended by Bright Futures.
[Levitt L, and others. Q&A: Implications of the ruling on the ACA’s preventive services requirement
https://www.kff.org/policy-watch/qa-implications-of-the-ruling-on-the-acas-preventive-services-requirement/
. Kaiser Family Foundation Policy Watch. March 31, 2023]
Both the plaintiffs and the Biden administration are expected to appeal the case as each side objects to parts of the judge’s decision.
[Appleby J, Andrews M. Judge’s decision would make some no-cost cancer screenings a thing of the past
https://khn.org/news/article/braidwood-becerra-aca-preventive-services-court-decision-reed-oconnor/
. Kaiser Health News, March 30, 2023]

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FDA evaluating safety of unapproved dental devices

The U.S. Food and Drug Administration (FDA) has issued a safety communication about concerns with the use of fixed (non-removable) palatal expanders used as dental devices on adults to remodel the jaw or treat conditions such as obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMD).
[Evaluation of safety concerns with certain dental devices used on adults
https://www.fda.gov/medical-devices/safety-communications/evaluation-safety-concerns-certain-dental-devices-used-adults-fda-safety-communication
. FDA Safety Communication, March 30, 2023]
The devices of concern include:

Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance Appliance (FAGGA)
Anterior Remodeling Appliance (ARA) and Fixed Anterior Remodeling Appliance (FARA)
Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA)
any other similar device types
The FDA announced it is evaluating safety concerns following reports of serious complications with the use of these devices such as chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss. Its recommendations include:

Be aware that the safety and effectiveness of these devices to treat conditions such as OSA and TMD, or to remodel the jaw in adults have not been established.
Consider that these devices intended for these uses have not been cleared or approved by the FDA.
Consult with a dental professional for problems or concerns with a dental device.
Report
https://www.fda.gov/medical-devices/safety-communications/evaluation-safety-concerns-certain-dental-devices-used-adults-fda-safety-communication?utm_medium=email&utm_source=govdelivery#reporting
 any problems with these devices to the FDA.
The FDA’s safety communication was likely prompted by a recent Kaiser Health News–CBS News investigation
https://khn.org/news/article/dental-device-lawsuits-displaced-teeth-agga-steve-galella/
 of the AGGA. At least 20 patients have filed lawsuits in the past three years alleging the device caused grievous harm.
[Werner A, Kelman B. FDA evaluates ‘safety concerns’ over dental devices featured in KHN-CBS investigation
https://khn.org/news/article/fda-safety-concern-evaluation-agga-dental-device-investigation/
. Kaiser Health News, March 31, 2023]

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Experts spotlight liver injury from herbal dietary supplements in the U.S

Experts on natural products and toxicology have provided an overview of the problem of liver damage due to herbal dietary supplement (HDS) use in the United States. They suggest two strategies they hope will improve consumer safety and drive bad actors from the marketplace. One is a path for pre-clinical assessment and the other is the establishment of a list of products.
[Gurley BJ, and others. Hepatoxicity due to herbal dietary supplements: Past, present, and the future
https://pubmed.ncbi.nlm.nih.gov/36183923/
. Food and Chemical Toxicology 169:113445, 2022]

Their key points include:

The Dietary Supplement Health and Education Act of 1994 provides an insufficient framework for regulating HDS products.
20% of adult Americans regularly consume HDS products.
Liver toxicity is among the most frequent serious events reported through the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition Adverse Event Reporting System.
20% of all drug-induced liver injuries in 2013, many of which required hospitalization and liver transplantation or resulted in death, were attributable to HDS, according to the Drug-Induced Liver Injury Network.
Most HDS-induced liver injuries (HILI) are attributable to unusual and heretofore untested combinations of exotic botanical extracts and/or purified phytochemicals, poorly researched new dietary ingredients, products intentionally adulterated with approved or unapproved drugs, or combinations of these.
Multi-ingredient products linked to HILI cases have included Slimquick, Hydroxycut, OxyELITE Pro, and several formulations marketed by Herbalife.
HILI cases have been linked to products marketed for bodybuilders and products containing cannabidiol.
Ingredients in HDS products, including caffeine and yohimbine extract, can interact with other ingredients, leading to liver injury.
Ingredients in HDS products that came on the market since 1994, such as green tea extract, Hoodia gordonii, Garcinia cambogia, or Scutelleria, are responsible for a significant proportion of HILI cases.
Adulterated products have contributed significantly to the HILI problem.
HDS products on the market with suspected potential for causing liver injuries include products containing: (a) Ashwagandha and Coleus forskohlii extract (CFE) used in Ayurvedic medicine, (b) kratom, (c) turmeric, and (d) Tinospora cordifolia, more commonly known as Giloy.
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Barefoot-running claims scrutinized

Exercise physiologist Nick Tiller, MRes, PhD, has examined the history, false advertising, and demonization of the sneaker industry associated with the promotion of oxymoronic “barefoot running shoes.” He notes that several systematic reviews have found no reduction on injury rates from runners transitioning from cushioned sneakers to barefoot shoes.
[Tiller N. Barefoot running: Conspiracies and controversies
https://skepticalinquirer.org/exclusive/barefoot-running-conspiracies-and-controversies/
. Skeptical Inquirer, Feb 17, 2023]

==================
Stephen Barrett, M.D.
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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