Consumer Health Digest #18-17
Your Weekly Update of News and Reviews
April 29, 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.
Former holistic nutritionist "confesses." After spending the better part of a decade as a holistic nutritionist with only ten months of training in a certificate program, Denby Royal has dedicated herself "to defusing the influence and clout of the wellness world one snarky article at a time." After she began denouncing her former beliefs, she was accused of being a "shill for Big Pharma" and received other nasty comments, to which she replied:
What greatly outweighed all of this nonsense were the many comments I received from fellow holistic nutritionists, many of whom have experienced the same sense of contempt toward their limited education or have witnessed the lack of respect and understanding for real science that runs rampant in the industry. Above all else, it was the overwhelming support that I found from friends and strangers in the wellness community, who I greatly feared I would alienate, which was a far more purgative experience than any quacky cleanse on the market. [Royal D. I used to be a holistic nutritionist. Science-Based Medicine, April 27, 2018]
QLaser marketers sentenced. In January, Robert "Larry" Lytle, who organized and led a scheme to deceptively promote and sell the QLaser system as effective for treating more than two dozen health problems, pleaded guilty to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead, and one count of criminal contempt. As part of his plea agreement:
- Lytle admitted that beginning in 2005 he entered into an agreement with others to sell medical devices with false and misleading labeling in order to defraud consumers and that he continued to do so in violation of a federal court order.
- Lytle acknowledged that he obtained at least $16,669,015 over the course of the scheme.
- Lytle made an initial restitution payment of $637,000 and turned over several thousand dollars' worth of gold and silver coins to be applied to restitution.
He received one of the longest prison sentences ever imposed on a device marketer who has made outrageous health claims: 12 years in prison, followed by 2 years of supervised release. Also pleading guilty for their roles in the scheme were Ronald D. Weir, Jr. and Irina Kossovskaia. Weir was sentenced to 24 months in prison, followed by 3 years of supervised release. Kossovskaia was sentenced to 15 months in prison, followed by 2 years of supervised release. [Barrett S. Quack device marketers get prison sentences. Device Watch, April 26, 2018]
Sale and distribution of Essure restricted. The FDA has ordered Bayer to ensure that prospective users of its Essure System for Permanent Birth Control are given sufficient risk information to make an informed decision. The Essure device consists of flexible coils made of a nickel-titanium alloy that are implanted through the cervix into the fallopian tubes to cause scarring over a 3-month period and provide a barrier that keeps sperm from reaching eggs. In 2016, the agency ordered Bayer to conduct a post-market study and add a boxed warning and a patient decision checklist to the labeling, but some women have had the device implanted without receiving information about its risks. The FDA believes that Essure remains an appropriate contraceptive option, but says some women may be at risk for serious complications such as persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, allergy, and hypersensitivity reactions. [FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information. FDA News Release, Apr. 9, 2018] Dr. Jen Gunter, who was trained to implant Essure devices, has described the product testing as inadequate. She noted that Essure doesn't cost much less than a tubal ligation and is far more expensive than IUDs. [Gunter J. Is Essure safe or are we not so sure? Dr. Jen Gunter Blog, Sept. 24, 2015]
Funeral homes failing to disclose pricing information. Out of 134 funeral homes visited by Federal Trade Commission investigators working undercover in 11 states, 29 (22%) failed to disclose prices as required by the FTC's Funeral Rule. The rule requires funeral homes to provide (a) an itemized general price list at the start of in-person discussions of funeral arrangements, (b) a casket price list before consumers view any caskets, and (c) an outer burial container price list before consumers view grave liners or vaults. Since 1996, the FTC has inspected nearly 3,200 funeral homes and found 559 homes with violations that required referral to a remedial program. [FTC undercover inspections of funeral homes in 11 states test prompt compliance with Funeral Rule disclosure requirements. FTC press release, Apr. 18, 2018]
Registration opens for upcoming skeptic conferences. Event schedules and speaker lineups have been announced for the Northeast Conference on Science and Skepticism's 2018 conference (NECSS) at the Fashion Institute of Technology in New York City from July 12-15 and the Committee for Skeptical Inquiry's 2018 conference (CSICON) at the Westgate Resort & Casino in Las Vegas from October 18-21. Several scheduled speakers have written about consumer health issues. At NECSS, they include Clay Jones, David Gorski, Michael Marshall, Steve Novella, James Randi, and Grant Ritchey. At CSICON, they include Timothy Caulfield, Yvette d'Entremont, Jen Gunter, William M. London, Paul Offit, James Randi, and Kavin Senapathy.
This page was posted on April 30, 2018