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Consumer Health Digest #19-42
October 20, 2019

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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Marketers barred from making misleading Aloe vera claims

Boca Raton, Florida-based NatureCity, LLC and its owners/officers Carl Pradelli and Beth Pradelli, have settled
https://www.ftc.gov/system/files/documents/cases/naturecity_-_stipulated_order.pdf
a complaint by the Federal Trade Commission (FTC)
https://www.ftc.gov/system/files/documents/cases/naturecity_-_complaint.pdf

that charged them with violating the FTC Act in connection with their misleading marketing of two Aloe vera-based supplements primarily through direct mail.

[Aloe vera supplement seller barred from making misleading health claims
https://www.ftc.gov/news-events/press-releases/2019/10/aloe-vera-supplement-seller-barred-making-misleading-health
. FTC news release, Oct 16, 2019]

The defendants allegedly promoted TrueAloe and AloeCran as treatments for conditions that affect seniors, including chronic pain, ulcerative colitis, diabetes, and acid reflux. The defendants are:

* barred from making false and unsubstantiated health claims

* required to pay $537,500, which the FTC may use to provide refunds to defrauded consumers

* required to disclose any material connection they have with compensated reviewers

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Hormone therapy clinics investigated

A 6-month CBS News investigation has exposed serious concerns due to the proliferation of clinics across the U.S. that misleadingly promote thyroid and testosterone treatments as a way for people with normal hormone levels to look and feel younger. The report includes a brief video and a 22-minute video "Fountain of Youth: Hidden Danger."

[Lapook J and others. Hormone therapy clinics could be putting patients in danger
https://www.cbsnews.com/news/hormone-therapy-clinics-could-be-putting-patients-danger-2019-10-15/
. CBS News, Oct 15, 2019] The key findings include:

Dr. Neal Rouzier offers seminars at which he has trained thousands of clinicians in these hormone treatments.
In a 2016 deposition, Rouzier said he gave testosterone to patients even if their levels are normal.
Although Rouzier dismissed concern that testosterone therapy may increase the risk of heart attack or stroke, he was unable while under oath to point to any evidence that his approach to testosterone therapy is safe.
Only a few states have both medical and nursing boards that keep track of incidents involving hormone therapy.
Kevin Morgan, a nurse practitioner at the now-defunct Optimum Medical Weight Control and Family Wellness in Nederland, Texas voluntarily surrendered

http://www.casewatch.net/board/nurse/morgan/order_2019.pdf
https://app.bon.texas.gov/verify/results.php

his Advanced Practice Registered Nurse and Registered Nurse license when challenged about offering hormone therapy.

A patient who was unnecessarily treated at 25 Again 
https://25again.com/
with thyroid hormone for menopausal symptoms wound up hospitalized with a heart rate four times normal.

In 2018 the Kentucky medical license of 25 Again's then medical director Elizabeth Veeneman Bates, M.D. was indefinitely restricted
http://www.state.ky.us/agencies/kbml/finalorders/36808.pdf
from practicing medicine in the context of hormone replacement and/or optimization therapy.

[Wolfson A. Kentucky stops '25 Again' doctor from prescribing hormone therapy
https://www.courier-journal.com/story/news/2018/06/21/kentucky-suspends-hormone-therapy-doctor-license-25-again/721086002/
. Louisville Courier Journal, June 21, 2018]

Soon after the restriction on Bates, eleven nurse practitioners at a 25 Again clinic resigned at least in part because they feared they might lose their nursing licenses.

[Wolfson A. Why are nurses fleeing a controversial hormone treatment clinic?
https://www.courier-journal.com/story/news/2018/08/23/25-again-clinic-staff-resigns-nurse-practitioners/1018735002/
 Louisville Courier Journal, Aug 23, 2018]

25 Again, which has facilities in Ohio, Kentucky, and Indiana, has been repeatedly sued over harms caused by the hormone therapies it has administered.

[Wolfson A. Hormone clinic 25 Again accused of giving woman banned diet drug
https://www.courier-journal.com/story/news/local/2019/03/04/hormone-clinic-25-again-faces-another-lawsuit-banned-diet-drug/3031906002/
. Louisville Courier Journal, March 4, 2019]

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CBO and CMS predict cost savings in Pelosi's drug pricing plan

Two government agencies have predicted that H.R. 3, introduced in September by House Speaker Nancy Pelosi (D-CA), would result in lower drug prices but have other complex effects. The Congressional Budget Office (CBO) estimates that Title 1 of the bill would save Medicare $345 billion between 2023 and 2029 and reduce drug manufacturers' revenues by $500 billion to $1 trillion, which would lead to 15 fewer new drugs coming to market over the next 10 years.

[Effects of drug price negotiation stemming From Title 1 of H.R. 3, the Lower Drug Costs Now Act of 2019, on spending and revenues related to Part D of Medicare
https://www.cbo.gov/publication/55722
Congressional Budget Office, Oct 11, 2019]

The Office of the Actuary of the Centers for Medicare & Medicaid Services (CMS) has concluded that there would be savings overall for the Federal Government, Medicare beneficiaries, and the private health insurance beneficiaries, but Medicaid costs would increase.
[Financial impact of Titles I and II of H.R 3, Lower Drug Costs Now Act of 2019
https://www.scribd.com/document/429847530/HR3-TitleI-II-Memo
. CMS Office of the Actuary, Oct 11, 2019]

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Doubts about platelet-rich plasma injections summarized

Pharmacist Scott Gavura has provided a skeptical overview of platelet-rich plasma injections as a treatment for sport injuries.

[Gavura S. Platelet-rick plasma (PRP) injections: lots of hype, no convincing evidence
ttps://sciencebasedmedicine.org/platelet-rich-plasma-prp-injections-lots-of-hype-no-convincing-evidence/
. Science-Based Medicine, Oct 17, 2019]

He concluded:

"Despite the enthusiasm and aggressive marketing, there are few well-controlled and rigorous clinical trials of platelet-rich plasma. These highest quality trials are consistently negative. It could be that the variety of manufacturing practices and administration techniques are confounding clinical trials, and that there is something actually worth still pursuing. No research has yet shown that to be the case. But it's far more likely that what we see with PRP are simply placebo effects— the non-specific positive expectations initiated by health practitioners who are charging you a large sum of money for an injection (of cells!), backed by their personal assurances, patient testimonials, and glossy advertising. Until there is convincing evidence to demonstrate otherwise, there is little reason to accept the risk of PRP, regardless of your injury."

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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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