Consumer Health Digest #19-18

Your Weekly Update of News and Reviews
May 5, 2019

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.

Insys executives convicted of racketeering conspiracy in promoting potent opioid. Insys Therapeutics, Inc. founder and former Executive Chairman John N. Kapoor and four company executives (Richard M. Simon, Sunrise Lee, Joseph A. Rowan, and Michael J. Gurry) have been convicted by a federal jury of RICO conspiracy in connection with:

Insys used "speaker programs" purportedly intended to increase brand awareness of Subsys through peer-to-peer educational lunches and dinners as a vehicle to pay bribes and kickbacks to targeted practitioners in exchange for increased Subsys prescriptions and increased dosages. Two other high-level Insys executives, Michael Babich and Alec Burlakoff, pleaded guilty before and testified during the trial. [Founder and four executives of Insys Therapeutics convicted of racketeering conspiracy. District of Massachusetts U.S. Attorney's Office news release. May 2, 2019]

New boxed warning issued for specific insomnia medications. The U.S. Food and Drug administration is requiring a new boxed warning—the agency's most prominent warning—for insomnia "Z-drugs" eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) about the risk of complex sleep behaviors such as: sleepwalking, sleep driving, and engaging in other activities while not fully awake, such as unsafely using a stove. Reports have implicated such drug-induced behaviors in rare but serious injuries. [FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines. FDA press release. April 30, 2019] The FDA has offered tips for patients who receive Z-drug prescriptions and advises users to contact the prescriber if they do things while not fully awake or don't recall what they did after taking the medicine. [FDA adds boxed warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines. FDA drug safety communication. Apr 30, 2019]

Newspaper coverage of medical crowdfunding scrutinized. Researchers have analyzed 336 articles about illness-related medical crowdfunding published in major U.S. and Canadian newspapers over a two-year period beginning in October 2015. The study found that approximately 44% of the articles were positive about a specific campaign, 48% were neutral about a specific campaign, 5% were negative about a specific campaign, and 4% did not specify a campaign. Nearly half of the campaigns were for people with cancer, and more than a third were for people with a rare disease. Only 9% of articles mentioned ethical concerns about crowdfunding. Of the 70 articles that indicated the treatment sought may be inefficacious, unproven, experimental, or unapproved, 56 still noted where contributions could be made and 36 hyperlinked directly to the campaign. The researchers warned:

The lack of cautionary coverage of medical crowdfunding contrasts sharply with its coverage in the academic literature, which includes more discussion of various ethical concerns and inequities. This consistently positive media portrayal may impact the public perception of the risks and benefits of crowdfunding and, for better or worse, further legitimize it as a source of funding for medical care. [Murdoch B. and others. Media portrayal of illness-related medical crowdfunding: A content analysis of newspaper articles in the United States and Canada. PLOS One. 14(4) e0215805, 2019]

"Amniotic stem cell therapy" companies settle FTC complaint. A settlement order has been issued that imposes a $3.31 million judgment to provide refunds to consumers who paid for "amniotic stem cell therapy" advertised by Dr. Bryn Jarald Henderson, D.O. and the companies he owns and operates, Regenerative Medical Group and Telehealth Medical Group. According to an October 2018 complaint by the Federal Trade Commission (FTC), the defendants deceptively advertised that their "amniotic stem cell therapy" could treat serious diseases, including Parkinson's disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart disease. The defendants have been ordered to stop making these and other health claims in the future, unless true and supported by competent and reliable scientific evidence. [FTC returns almost $515,000 to consumers who bought deceptively marketed "amniotic stem cell therapy" between 2014 and 2017. FTC Press Release. April 30, 2019]

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This page was posted on May 5, 2019