[*quote*]
Consumer Health Digest #23-109
Matrch 5, 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###
Dental appliance promoters sued by patientsA months-long Kaiser Health News/CBS News investigation has revealed at least 20 patients who were fitted by dentists with the fixed Anterior Growth Guidance Appliance (AGGA) have filed lawsuits in the past three years against the AGGA’s inventor, Dr. Steve Galella
https://www.facialbeautyinstitute.org/Instructors/SteveGalella#:~:text=Steve%20Galella%20%2D%20Facial%20Beauty%20Institute, the Facial Beauty Institute
https://www.facialbeautyinstitute.org/ led by Galella, and the Las Vegas Institute
https://www.lviglobal.com/, which previously held AGGA classes for dentists and promoted the device on Facebook
https://www.facebook.com/groups/tmjtmdosa[Kelman B, Werner A. This dental device was sold to fix patients’ jaws. Lawsuits claim it wrecked their teeth
https://khn.org/news/article/dental-device-lawsuits-displaced-teeth-agga-steve-galella/. Kaiser Health News, March 1, 2023]
The AGGA, which resembles a retainer, uses springs to apply pressure to the front teeth and upper palate. It costs about $7,000 and is typically worn for several months. Dentists across the U.S. promote it on their websites, often claiming it can “grow,” “remodel,” or “expand” an adult’s jaw without surgery. At times, they have also stated it has the potential to make patients more attractive and treat common ailments like sleep apnea and disorders of the temporomandibular joint (TMJ).
At least 10,000 dental patients have been fitted with the device. The plaintiffs in the lawsuits allege AGGA left them with flared teeth, damaged gums, exposed roots, and/or erosion of the bone that holds teeth in place. The defendants have denied liability in all the lawsuits.
[KFF’s Kaiser Health News and CBS News team up to investigate a dental device that allegedly has left a trail of mangled mouths and devastated patients
https://connect.kff.org/kffs-kaiser-health-news-and-cbs-news-team-up-to-investigate-an-unregulated-dental-device. Kaiser Family Foundation and CBS News news release, March 2023]
The AGGA does not appear in the device database of the U.S. Food and Drug Administration (FDA). Its manufacturer said in a court document it has no record of communicating with the FDA about the device before beginning to make or sell it. It claimed the device is exempt from premarket review under an exemption for dental labs.
[Watch: Dental device at center of lawsuits was used on patients without FDA review
https://khn.org/news/article/watch-dental-device-at-center-of-lawsuits-was-used-on-patients-without-fda-review/. Kaiser Health News, March 2, 2023]
###
Walgreens won’t sell abortion pills in 20 statesThe Walgreens pharmacy chain, the second largest such chain in the U.S., announced
https://ag.ks.gov/docs/default-source/documents/dg-mifepristone-letter-to-ks-ag.pdf?sfvrsn=bc6bd1a_2it will not dispense the abortion pill mifepristone in 20 states after their Republican attorneys general warned
https://apnews.com/article/abortion-missouri-state-government-west-virginia-united-states-us-food-and-drug-administration-a1b1a387788bb5aaa39c9ce4128d77abboth Walgreens and CVS they would face legal consequences for doing so.
[McDade A. Calls to boycott Walgreens grow as pharmacy confirms it will not sell abortion pills in 20 states, including some where it remains legal
https://www.businessinsider.com/walgreens-boycott-pharmacy-wont-sell-abortion-pills-20-states-2023-3. Insider, March 3, 2023]
The FDA approved mifepristone in 2000 to end pregnancy up to the tenth week when used together with misoprostol. For over 20 years, the FDA had limited dispensing of the mifepristone to a subset of specialty offices and clinics because of safety concerns. Last year, following a scientific review, the agency eliminated the requirement to pick up mifepristone in-person
https://apnews.com/article/coronavirus-pandemic-abortion-health-medication-a6634601a37fb048aecdd9f030e0863a. At the beginning of 2023, the FDA updated a rule to allow brick-and-mortar drugstores with proper certification to dispense the drug
https://www.politico.com/news/2023/01/03/fda-access-abortion-pills-00076214 [Murphy T. The implications of Walgreens’ decision on abortion pills
https://apnews.com/article/abortion-pill-walgreens-mifepristone-fd2663ace286c3c48b9c66a74c652ef4. AP News, March 3, 2023]
###
Three doTERRA distributors prohibited from making unfounded health claimsThe Federal Trade Commission (FTC) has settled lawsuits against three current and former high-level distributors—so-called “Wellness Advocates”—of the Utah-based multilevel marketing company doTERRA International, LLC.
[FTC takes action against doTERRA distributors for false COVID-19 health claims
https://www.ftc.gov/news-events/news/press-releases/2023/03/ftc-takes-action-against-doterra-distributors-false-covid-19-health-claims. FTC press release, March 3, 2023]
The complaints, filed by the Department of Justice on behalf of the FTC, allege that the defendants made the claims in a series of webinars in early 2022 and touted their medical expertise in recommending the products. The defendants are:
Eliza Johnson Bacot
https://www.ftc.gov/system/files/ftc_gov/pdf/2023-01-05-ECF-1-Complaint-%28Bacot%29.pdf, a nurse practitioner and doTERRA Diamond-level distributor, who allegedly claimed the ingredients in one product “have had some great studies behind them as far as helping with COVID, post-inflammatory response and viral replication,” and another product could help prevent or treat long COVID-19
https://www.who.int/europe/news-room/fact-sheets/item/post-covid-19-condition“because of the oils in there like tangerine and cilantro, which help the body detox and also repair.”
Lauren Busch
https://www.ftc.gov/system/files/ftc_gov/pdf/2023-01-05-ECF-1-Complaint-%28Busch%29.pdf, a former registered nurse and doTERRA Diamond-level distributor at the time of the webinars, who allegedly claimed doTERRA products are part of “protocols that have been found to be completely effective and amazing by practitioners who are actually working with patients who are struggling right now and that they have been very successful with…,” and there is “amazing research on essential oils that inhibit the SARS-CoV-2 spike protein” relating to chemical compounds that are “in several of our oils.”
Dr. Tina Wong
https://www.ftc.gov/system/files/ftc_gov/pdf/2023-01-05-ECF-No.-1-Complaint-%28Wong%29.pdf, a California pediatrician and doTERRA Blue Diamond-level distributor, who allegedly discussed specific products as part of “COVID prevention basics” and “pediatric prevention/support for COVID.” She also claimed “…there’s lots of studies that show that oregano is effective against a coronavirus, which is the family that COVID is in,” and “…lemon and geranium essential oil inhibit the mRNA transcription of the virus.”
Bacot
https://www.ftc.gov/system/files/ftc_gov/pdf/2023-01-23-ECF-5-Stipulated-Order-Entered-%28Bacot%29.pdf, Busch
https://www.ftc.gov/system/files/ftc_gov/pdf/2023-03-01-ECF-13-Stipulated-Order-for-Permanent-Injunction-Civil-Penalty-Judgment-and-Other-Relief-%28Busch%29.pdf, and Wong
https://www.ftc.gov/system/files/ftc_gov/pdf/2023-01-11-ECF-No-7-US-v-Wong-Stipulated-Order.pdf have agreed to court orders requiring each of them to:
stop making unfounded COVID-19 claims
have reliable human clinical testing to support claims about other diseases
have scientific proof for any other health claims they make
pay a $15,000 civil penalty
Consumer guide to biologics and related products released
The FDA and FTC have jointly developed a four-page educational resource for consumers
https://www.fda.gov/media/165656/downloadabout biologics (biological products), biosimilars, and interchangeable biosimilars to address common misperceptions. FDA-approved biologics, like other drugs FDA approves, are safe and effective medications for treating many illnesses. However, biologics are usually made from living sources such as proteins, living cells, and microorganisms such as bacteria or yeast. They usually are more complex than other drugs, more complicated to make and, as a result, more expensive. A biosimilar is a biologic that is highly similar to an original biologic already approved by FDA. Both products are made from the same types of sources (such as living cells or microorganisms). Biosimilars must be as safe and effective as the original biologic for their approved uses. Interchangeable biosimilars, which have additional requirements, can be substituted for the reference product without consulting the prescribing doctor, depending on state pharmacy laws.
==================
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)
[*/quote*]
