Consumer Health Digest #18-31

Your Weekly Update of News and Reviews
August 5, 2018

Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H., with help from Stephen Barrett, M.D. 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.

Problems with Medicare-certified hospice care reported. Hospice services, which attempt to provide comfort and alleviate suffering, are available through Medicare to patients with critical illness who are expected to die within six months and agree to forego further curative treatment. The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has issued a report addressing poor quality care and fraudulent billing by Medicare-certified hospices along with recommendations for reform. [Vulnerabilities in the Medicare Hospice Program Affect Quality Care and Program Integrity: An OIG Portfolio. OEI-02-16-00570, July 2018] The report found:

Australian chiropractor deregistered over cancer cure ads. The New South Wales Civil and Administrative Tribunal has canceled the registration to practice of Hance Limboro a chiropractor in Sydney, Australia whose articles on the Cancer Cure Sydney Web site included "Chiropractic Treatment as a Cancer Cure" and "Cancer Prevention with Regular Chiropractic Treatment." The Tribunal also prohibited Limboro from providing any health service for two years. Last year, the Australian Health Practitioner Regulation Agency prosecuted Limboro for misleading advertising. He was convicted of 11 counts of false and misleading advertising and two counts of using testimonials to advertise a regulated health service and fined $29,500. [NSW chiropractor who claimed cancer cure convicted in landmark case. Chiropractic Board of Australia news release, Feb 15, 2017]

Warning issued about devices in vaginal 'rejuvenation' procedures. The U.S. Food and Drug Administration (FDA) has warned that safety and effectiveness have not been established for radiofrequency and laser devices used for vaginal "rejuvenation" and/or cosmetic vaginal procedures. Although the FDA has cleared or approved energy-based devices for treating a few serious conditions such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts), the agency has not cleared or approved such device for vaginal "rejuvenation," cosmetic vaginal procedures, or for treating vaginal symptoms related to menopause, urinary incontinence, or sexual function. Vaginal "rejuvenation" is sometimes used to describe non-surgical procedures intended to treat symptoms and or/conditions such as vaginal laxity, atrophy, dryness, or itching; pain during sexual intercourse or urination; and decreased sexual sensation. [FDA warns against use of energy-based devices to perform vaginal 'rejuvenation' or vaginal cosmetic procedures: FDA safety communication. July 30, 2018] Patients who have undergone vaginal "rejuvenation" and experienced a complication are encouraged to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

Essure sales to end. Following a series of actions that the FDA took to address reports of serious adverse events associated with the Essure, Bayer has notified the FDA that the permanent birth control device will no longer be sold or distributed after December 31, 2018. [Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review of Essure and keeping women informed. July 20, 2018]

TINA renews attack on GOOP advertising. Truth in Advertising (TINA) has sent a follow-up letter to the District Attorneys of Santa Clara and Santa Cruz Counties after having alerted them last year about the need investigate the marketing claims at the Goop wellness site and take appropriate regulatory action. TINA notes that one of the inadequate disclaimers at the Goop site is "For Your Enjoyment: There probably aren't going to be peer-reviewed studies about this concept, but it's fun and there's real merit in that." [Amid Goop's mixed signals, repeats call for regulatory action., July 3, 2018] 

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This page was posted on August 5, 2018.