Consumer Health Digest #17-12

Your Weekly Update of News and Reviews
March 19, 2017

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

Drug companies facing massive lawsuit over deceptive "low-testosterone" campaigns. Six sets of defendants are being sued for inappropriate marketing of testosterone-replacement therapy (TRT) with misleading claims. Separate cases have been consolidated into a master complaint that is proceeding in proceeding in Illinois Federal Court. The third amended master complaint summarizes the case this way:

TRTs were approved for use in the treatment of a medical condition known as hypogonadism, but widely marketed by Defendants for off-label use for a condition invented by Defendants and referred to as "Low T." . . . Defendants marketed TRTs as safe and effective for this off-label use, when in fact (a) TRTs confer little or no benefit for so-called "Low T" in the absence of"classical hypogonadism"; and (b) the drugs cause serious medical problems, including life-threatening cardiac, cerebrovascular, and thromboembolic events, for which Defendants failed to provide adequate warnings.

The fact that testosterone levels normally decline as men get older does not mean that it is beneficial to administer medication to raise them. A 2015 editorial in the Journal of the American Geriatrics Society referred to the "Low-T" campaign as "disease-mongering" and called on the FDA, the FTC, and Health Canada to ban educational and product advertising of testosterone for contrived "indications." The FDA has tightened labeling requirements and issued a public warning but has taken no enforcement action against the companies listed as defendants in the lawsuit. Truth in Advertising has published an insightful overview of the situation.

FTC finds more Funeral Rule violations. FTC undercover investigators found failures to disclose pricing information to consumers in 31 of the 133 funeral homes they visited during 2015 and 2016 in nine states. [FTC undercover inspections of funeral homes in nine states prompt compliance with Funeral Rule disclosure requirements. FTC news release, Feb 15, 2017] The FTC uses undercover inspections to check whether funeral homes provide prospective customers with an itemized general price list at the start of an in-person discussion of funeral arrangements, a casket price list before consumers view any caskets, and an outer burial container price list before they view grave liners or vaults. The Funeral Rule also prohibits funeral homes from requiring consumers to buy any item, such as a casket, as a condition of obtaining any other funeral good or service. These requirements enable consumers to compare prices and buy only the goods and services they want. Funeral homes that violate the price list disclosure requirements for the first time can enter the Funeral Rule Offender's Program (FROP), a training program run by the National Funeral Directors Association (NFDA). All the homes found in violation during the past two years have chosen to enter the FROP rather than subject themselves to the possibility of an enforcement lawsuit seeking civil penalties of up to $40,654 per violation. The FROP provides participants with a legal review of the price disclosures required by the Rule, and on-going training, testing and monitoring for compliance. Participants make a voluntary payment to the U.S. Treasury in place of a civil penalty and pay annual administrative fees to the NFDA. Since the FROP began in 1996, the FTC has inspected more than 3,000 funeral homes and found that 530 homes were violative.

The use of cremation is rising rapidly in the United States. The 2016 NFDA Cremation and Burial Report noted that the cremation rate exceeded the burial rate in 2015 and is projected to reach 71% by 2030. Direct cremation, which bypasses the expense of funeral home services, is available for less than $1,500 in most parts of the U.S. The Funeral Consumers Alliance offers trustworthy advice on funeral and body disposition planning.

Proposed "Obamacare" cuts pose huge financial risk to millions. Although President Trump and other Republican leaders have pledged to "repeal"or "repeal and replace" major provisions of the Patient Protection and Affordable Care Act, this cannot be done without harming huge numbers of American citizens. The Congressional Budget Office estimates that by 2026, the recently proposed American Health Care Act of 2017 (H.R. 277) would result in 52 million Americans being uninsured, compared with 28 million who would lack health insurance that year under the current law. Wikipedia has an excellent political analysis.

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This page was posted on March 19, 2017.