Consumer Health Digest #18-41
Your Weekly Update of News and Reviews
October 14, 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.
Oversight of surgery centers in California blasted. In 2011, five private accrediting agencies were given a lead role in oversight of more than 1,000 surgery centers, each of which pays its accreditation agency about $15,000 every three years for its oversight role. According to a Kaiser Health News investigation, accreditors have given approval for surgery centers to operate despite serious substandard practices at the centers identified by state or federal authorities such as:
- a physician assistant who anesthetized patients and performed liposuction with little input from his supervising doctor
- a doctor accused of gross negligence for putting patients in deep sedation without having training to save them if they stopped breathing
- an untrained receptionist put in charge of disinfecting surgical scopes
- a pediatrician handling anesthesia for plastic surgery procedures without "requisite training in anesthesia including Propofol" and "advanced airway" training to rescue patients if their breathing shut down
- a surgeon who pleaded guilty to three of 37 felony counts against him that included mayhem and conspiracy for allegedly disfiguring a woman on whom he operated
Accreditation agencies have stood by eight California surgery centers facing "involuntary decertification" by Medicare, an action used against facilities deemed unfit to care for seniors. [Jewitt C. Despite red flags at surgery centers, overseers award gold seals. Kaiser Health News. Sept 20, 2018]
Concerns raised about probiotic supplement safety. In a recent opinion piece, dietary supplement researcher Pieter A. Cohen, M.D. raised these concerns about increasingly popular mass-marketed isolated live bacteria as dietary supplements promoted for beneficial or "probiotic" properties:
- No evidence of efficacy or even safety is required to sell a probiotic supplement in the United States.
- No large, long-term clinical trials have established that probiotic supplementation is beneficial for people who are already healthy.
- There are few restrictions on structure/function claims such as "boosts digestive health" and "supports the immune system" on probiotic supplement labels.
- Dozens of case reports, especially involving people with compromised immune function, have noted serious adverse effects such as bacteria and fungi in the bloodstream.
- Actual rates of opportunistic infections from probiotic supplements are unknown as there is no effective system in place for monitoring harms.
- Manufacturers often fail to comply with established good manufacturing practices to ensure identity, purity, strength, composition, or safety of final products.
- Studies have found commercial probiotics that contain live microorganisms not listed on their labels.
- An 8-day-old premature infant's death has been attributed to treatment with a probiotic supplement contaminated with fungi.
- The potential for probiotic supplements to increase unwanted resistance to antibiotics under some circumstances has not been adequately studied.
Cohen notes that there are special instances for which certain live microorganisms have well-defined benefits to treat specific medical conditions. He suggests that new law is needed to create a consistent regulatory framework that would provide consumers with accurately labeled, truthfully advertised, high-quality microorganisms with a long track record of safety. He notes that probiotic supplement manufacturers are required in Canada, but not in the U.S., to disclose on product labels the specific strain or strains used and the number of live microorganisms per dose. [Cohen PA. Probiotic safety—no guarantees. JAMA Internal Medicine. Sept 17, 2018]
Insect repellant advertising case settled. The Federal Trade Commission (FTC) has approved a final consent order settling deceptive advertising charges against Mikey & Momo, Inc. and its owners regarding the marketing of their perfumed sprays and candles. The FTC had charged the defendant with (a) improperly claiming that their products would repel mosquitoes that carried the viruses that cause Zika, dengue, chikungunya, and yellow fever and (b) posted five-star Amazon reviews written by an owner and her relatives. [FTC approves final consent order in Aromaflage insect repellant advertising case. FTC Press Release. Sept 27, 2018] The Environmental Protection Agency offers a tool to search for safe and effective skin-applied repellants for mosquitoes and/or ticks, information on repellant-treated clothing, and provides tips on safe use of insect repellants. The Centers for Disease Control and Prevention offers tips on preventing mosquito bites and guidance for travelers related to Zika virus transmission and prevention.
This page was posted on November 25, 2018.