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Consumer Health Digest #20-06
February 9, 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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Warning about cesium supplements issuedThe U.S. Food and Drug Administration (FDA) is warning consumers to avoid dietary supplements containing cesium salts such as cesium chloride due to significant safety risks that include heart arrhythmias, dangerously lowered blood potassium levels, fainting, seizures, and death. Cesium salts have been promoted as "alternative" cancer treatments but have never been proven safe and effective for this or for any other use.
[Public health alert concerning dietary supplements containing cesium salts
https://www.fda.gov/food/dietary-supplement-products-ingredients/public-health-alert-concerning-dietary-supplements-containing-cesium-salts. FDA. Feb 5, 2020]
In 2018, FDA summarized adverse case reports and added cesium to the category
https://www.fda.gov/drugs/compounding/safety-risks-associated-certain-bulk-drug-substances-nominated-use-compoundingof substances that present significant safety risks in compounding
https://www.quackwatch.org/01QuackeryRelatedTopics/compounding.html.
[FDA alerts health care professionals of significant safety risks associated with cesium chloride
https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-professionals-significant-safety-risks-associated-cesium-chloride. FDA Jul 23, 2018]
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Contempt action filed against dietary supplement marketersThe Federal Trade Commission (FTC) and the State of Maine are seeking a civil contempt order against Health Research Laboratories, LLC (HRL), Whole Body Supplements, LLC, and their owner Kramer Duhon, alleging that they are still promoting their products with unproven claims that violate a 2018 FTC settlement order.
[FTC, State of Maine file contempt action against dietary supplement marketers
https://www.ftc.gov/news-events/press-releases/2019/12/ftc-state-maine-file-contempt-action-against-dietary-supplement. FTC press release. Dec 18, 2019]
The 2018 order
https://www.ftc.gov/system/files/documents/cases/health_research_final_order.pdfwhich stemmed from false and unsupported claims made for supplements called BioTherapex and NeuroPlus
https://www.ftc.gov/news-events/press-releases/2017/11/supplement-sellers-settle-ftc-state-maine-false-advertising, required that defendants have at least one randomized, double-blind, placebo-controlled trial to support any claim that their products effectively cure, mitigate, or treat diseases.
The FTC's contempt motion
https://www.ftc.gov/system/files/documents/cases/health_research_motion_and_memo_for_osc.pdfalleges that the defendants made unsubstantiated claims that:
* their Ultimate Heart Formula (UHF), BG18, and Black Garlic Botanicals supplements are effective against cardiovascular disease, atherosclerosis, and hypertension.
* their Neupathic supplement is effective against diabetic neuropathy and diabetes.
* these supplements provide a "miraculous natural solution" for life-threatening diseases.
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Goop accused of violating court orderTruthInAdvertising.org (TINA.org) has completed a new investigation
https://www.truthinadvertising.org/goop-2020-database/that found Gwyneth Paltrow's company Goop has apparently violated a 2018 stipulated judgment
https://www.truthinadvertising.org/wp-content/uploads/2018/09/Goop-California-Signed-Judgment.pdfthat prohibits it from making false or misleading statements about nutritional supplements or medical devices, and making claims that its unapproved products can treat diseases. TINA.org has:
found more than a dozen examples of deceptive Goop marketing materials that make health claims for 11 different products
sent district attorneys in California a complaint letter with examples of Goop's recent deceptive claims
https://www.truthinadvertising.org/wp-content/uploads/2020/01/Goop-2020-Complaint-Letter_Redacted.pdfthat urges them to reopen their investigation and take appropriate enforcement action
In 2018, Goop was required to pay $145,000 to settle claims that it deceptively overhyped the health benefits
https://www.truthinadvertising.org/california-cracks-down-on-goop-after-tina-org-complaint/of some of the products it sells on its website (including the Yoni Egg, which TINA.org had found
https://www.truthinadvertising.org/goop-database/was marketed to prevent uterine prolapse).
[G-oops! Tina.org finds wellness company in violation of court order
https://www.truthinadvertising.org/g-oops-tina-org-finds-wellness-company-in-violation-of-court-order/. TINA.org. Jan 28, 2020]
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Wasteful U.S. health care spending quantifiedBased on a review of nearly 7½ years of recent reports on health care waste, a team of researchers has estimated that the total annual cost of wasteful spending in the US health care system ranged from $760 billion to $935 billion in 2019 dollars, which is about 25% of total health care spending.
[Shrank WH and others. Waste in the US health care system: estimate costs and potential for savings
https://jamanetwork.com/journals/jama/article-abstract/2752664. JAMA 322:1501-1509, 2019]
The main findings are discussed in a video (9:34) available online
https://edhub.ama-assn.org/jn-learning/video-player/17975385The largest domain of waste was found to be administrative complexity, accounting for an estimated $265.6 billion of wasteful spending annually, but researchers said they had no data for suggesting interventions to reduce administrative complexity costs. Researchers estimated that the other types of waste can be reduced by addressing:
(a) failure of care delivery (most notably lack of adoption of preventive care practices),
(b) failure of care coordination (from unnecessary admissions and readmissions to hospitals),
(c) overtreatment or low-value care,
(d) pricing failure (most notably for medications), and
(e) fraud and abuse in Medicare.
One of three editorials published along with the study concluded:
"
In large measure, the challenge of removing waste from US health care and reinvesting that harvest where it could do much more good is not a technical one. It is a political one. In short, removing waste from US health care will require both awakening a sleepy status quo and shifting power to wrest it from the grip of greed."[Berwick D. Elusive waste: the Fermi paradox in US health care
https://jamanetwork.com/journals/jama/article-abstract/2752662. JAMA 322(15):1458-1459, 2019]
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Trump's State of the Union prescription drug cost claim mostly falseDuring his 2020 State of the Union address President Donald Trump claimed to be "taking on the big pharmaceutical companies" and said: "I was pleased to announce last year that, for the first time in 51 years, the cost of prescription drugs actually went down." Kaiser Health News and Politifact have rated Trump's claim "mostly false."
The factcheckers noted that in 2019, the prices of 4,311 prescription drugs increased an average about 21% and 619 drugs had price dips. Moreover, so far this year, 2,519 drugs have increased in price an average of 6.9% while only 70 have had price drops. Typically, branded drugs increase their prices early in the year, and generics do so later. When generics post their price increases, the 2020 average price is likely to go up.
[On drug pricing, the president's numbers are still off
https://khn.org/news/state-of-the-union-on-drug-pricing-the-presidents-numbers-are-still-off/. Kaiser Health News. Feb 5, 2020]
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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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