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Consumer Health Digest #19-14
April 6, 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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WHO blasted for legitimizing non-evidence-based Chinese medicineThe editors of Scientific American have harshly criticized the World Health Organization for including in the 11th edition of the International Statistical Classification of Diseases and Related Health Problems (ICD) disorders described in ancient Chinese medicine
https://www.who.int/health-topics/international-classification-of-diseases (ICD-11).
[Editors. The World Health Organization gives the nod to Traditional Chinese Medicine. Bad Idea
https://www.scientificamerican.com/article/the-world-health-organization-gives-the-nod-to-traditional-chinese-medicine-bad-idea/. Scientific American. April 2019]
Their key points include:
* Including traditional Chinese medicine in the ICD is an egregious lapse in evidence-based thinking and practice. Data supporting the effectiveness of most traditional remedies are scant, at best.
* In China, traditional medicines are unregulated, and they frequently make people sick rather than curing them.
* Analyses of Chinese remedies have revealed hidden ingredients including banned Western drugs, toxic chemicals, and DNA from endangered species.
* The proliferation of traditional medicines contributes to destruction of ecosystems and increases the illegal trade of wildlife.
Until they undergo rigorous testing for purity, efficacy, dosage and safety, the WHO should remove traditional medicines from its list. These remedies should be given the same scrutiny as other treatments before being included in standard care practices.
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Cannabidiol promoters warnedThe Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) have jointly sent warning letters to
Nutra Pure LLC
https://www.ftc.gov/system/files/attachments/press-releases/ftc-joins-fda-sending-warning-letters-companies-advertising-selling-products-containing-cannabidiol/nutra_pure_llc_warning_letter.pdf, PotNetwork Holdings, Inc.
https://www.ftc.gov/system/files/attachments/press-releases/ftc-joins-fda-sending-warning-letters-companies-advertising-selling-products-containing-cannabidiol/potnetwork_holdings_inc_warning_letter.pdf, and Advanced Spine and Pain, LLC (d/b/a Relievus)
https://www.ftc.gov/system/files/attachments/press-releases/ftc-joins-fda-sending-warning-letters-companies-advertising-selling-products-containing-cannabidiol/advancedspine_relievus_wl.pdf because they believe the companies are illegally marketing products containing cannabidiol (CBD) to treat a variety of serious diseases and conditions.
[FTC joins FDA in sending warning letters to companies advertising and selling products containing cannabidiol (CBD) claiming to treat Alzheimer's, cancer, and other diseases
https://www.ftc.gov/news-events/press-releases/2019/04/ftc-joins-fda-sending-warning-letters-companies-advertising. FTC Press Release. April 2, 2019]
CBD is a chemical compound found in marijuana and hemp that does not produce a high. In 2018, the FDA approved a cannabidiol preparation (brand name Epidiolex) to treat two rare, severe forms of epilepsy
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm. But since 2015, the FDA has ordered many companies to stop making unapproved claims
https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm The market for unapproved CBD products is nevertheless burgeoning, as consumer protection is lacking. The FDA and others
https://jamanetwork.com/journals/jama/fullarticle/2661569?mod=article_inlinehave found that some CBD products have not contained dosages claimed by marketers. Dangerous chemicals have been found
https://www.consumerreports.org/marijuana/dangerous-chemicals-found-in-popular-cbd-products-diamond-cbd-5f-adb/in popular CBD vaping liquids. Although there is great interest in potential medical uses for CBD, the evidence for its safety and effectiveness falls far short of the marketing hype for available products
https://www.consumerreports.org/marijuana/what-is-cbd-what-to-know-about-this-cannabis-product/###
Homeopathy companies warned for manufacturing quality violationsThe FDA has warned four homeopathic
http://www.homeowatch.org/ drug companies about various quality and misbranding violations of current good manufacturing practice:
Tec Laboratories Inc
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm634492.htm of Albany, Oregon for releasing products marketed for use with children, without conducting testing to ensure they were free from objectionable levels of microbial contamination. The company also did not adequately investigate test results that found high microorganism levels in its water system.
Red Mountain Inc
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm634194.htmof Oakland Park, Florida for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.
B. Jain Pharmaceuticals Pvt. Ltd
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm634630.htmof Rajasthan, India for insects in the facility and in ingredients used to make its products.
King Bio Inc
ttps://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm634078.htm
of Asheville, North Carolina for inordinately high microbiological contamination of homeopathic drug products and recurring microbial contamination associated with the water system used to manufacture drugs.
The FDA previously warned consumers and pet owners not to use homeopathic drug products made by King Bio Inc
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm618691.htmdue to high levels of microbial contamination identified at the manufacturing site. In August 2018, King Bio issued a voluntary nationwide recall
https://www.fda.gov/Safety/Recalls/ucm618585.htm of all water-based products for human and animal use due to possible microbial contamination.
The FDA notes: "Products labeled as homeopathic have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality." Considering the implausible rationales and lack of evidence supporting the therapeutic effectiveness of homeopathic medicine
https://www.quackwatch.org/01QuackeryRelatedTopics/homeo.html, it is puzzling that the FDA permits such products to be marketed at all in the United States.
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High prices of diabetes medications in U.S. scrutinizedAccording to a new report by the U.S. House of Representatives Committee on Oversight and Reform for the 27th Congressional District of California:
The prices of diabetes medications—and insulin in particular—are far higher in the United States than they are overseas, in part because certain federal programs lack the authority to negotiate directly with drug manufacturers.
The 50 most popular brand-name diabetes medications used by approximately 17,000 Medicare beneficiaries in the district are available at significantly lower prices in other countries. For example, the cost of these drugs to the Medicare program in the district are 4.3 times the cost in Australia, 3.3 times the cost in the United Kingdom, and 2.4 times the cost in Canada.
The uninsured diabetes patients in the district who purchase Novolog Flexpen—a popular brand of insulin—pay 23 times more than they would in Australia, 16 times more than they would in the United Kingdom, and 14 times more than they would in Canada.
[Prices of diabetes drugs for seniors and uninsured in the United States and abroad
https://chu.house.gov/sites/chu.house.gov/files/documents/Diabetes_Drug_Report_CA-27.pdf. Staff Report of U.S. House of Representatives Committee on Oversight and Reform, March 2019]
Another recent analysis attributes ongoing inflation of brand-name insulin costs in the U.S. in part to middlemen who buy drugs on behalf of insurers and hospitals and negotiate discounts off the list price.
[Rosenthal E. Analysis: Why Americans shouldn't feel grateful for $137 insulin
https://khn.org/news/analysis-why-should-americans-be-grateful-for-137-insulin-germans-get-it-for-55/. Kaiser Health News. Mar 27, 2019]
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No antibody responses found for homeopathic vaccinesA well-controlled study in a sample of 150 university students found:
Homeopathic "nosodes" promoted for prevention of diphtheria, pertussis, tetanus, mumps, and measles did not evoke antibody responses.
Their antibody responses were similar to placebo.
Standard vaccines for the same diseases provided a robust antibody response in most of those vaccinated.
[Loeb M. et al. A randomized, blinded, placebo-controlled trial comparing antibody responses to homeopathic and conventional vaccines in university students
https://www.sciencedirect.com/science/article/pii/S0264410X18312325?via%3Dihub. Vaccine. 36(48):7423-7429, 2018]
Nosodes are homeopathic products made from pathological organs or tissues; causative agents such as bacteria, fungi, ova, parasites, virus particles and yeast; disease products; or excretions. Some homeopaths falsely claim that nosodes are effective as vaccines. Health Canada was recently criticized for continuing to license homeopathic nosodes and merely warning the public that they are not a substitute for vaccines.
[Ireland N. Stronger action urged against homeopathic products touted as alternatives to vaccines
https://www.cbc.ca/news/health/health-canada-homeopathy-vaccine-hesitancy-1.5058393. CBC News. Mar 18, 2019]
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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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