Consumer Health Digest #20-07
Your Weekly Update of News and Reviews
February 16, 2020
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.
Dangers of dietary supplements spotlighted. C. Michael White, a professor of pharmacy at the University of Connecticut, has summarized how consumers are endangered by the U.S. dietary supplement marketplace. The problems include (a) microbial contamination, (b) heavy metal contamination, (c) prescription drug adulteration, (d) herb substitutions, (e) added ingredients to herbal products, and (f) inaccurate labeling of ingredient dosages. He blames the Dietary Supplement Health and Education Act (DSHEA) of 1994, which allows supplement and herbal products to be marketed without providing proof of their quality to the Food and Drug Administration. [White CM. Dietary supplements pose real dangers to patients. Annals of Pharmacotherapy. Jan 24, 2020] Calling the situation a "Wild West scenario," White concludes:
The DSHEA Act was written to limit the FDA's oversight of dietary products, and it has done just that. Health professional and consumer advocacy organizations need to come together and with one voice sound the alarm and unequivocally call on Congress to take action to prevent the inadvertent poisoning of our populace. We should not wait until another "thalidomide moment" occurs before we act. An easy amendment would require independent third-party laboratory verification of a sample of every new product before being sold in the United States, with periodic spot checking of products on the shelves. Manufacturers would have to pay for this testing and would not be able to manipulate or suppress the results.
DSHEA also enables sellers to make misleading claims about the usefulness of their products. [Barrett S. How the Dietary Supplement Health and Education Act weakened the FDA. Quackwatch, Feb 16, 2020]
ReJuvenation sellers ordered to stop making baseless health claims. The sellers of ReJuvenation, a pill made of amino acids and herbal extracts, have settled Federal Trade Commission (FTC) charges that they deceptively claimed that their product:
- is a virtual cure-all for age-related ailments, including cell damage, heart attack damage, brain damage, blindness, and deafness
- can repair the damage from or reverse a number of ailments, including Alzheimer's disease, Parkinson's disease, and Crohn's disease
- can reverse the aging process and repair age-related damage to the body by increasing human growth hormone (HGH) and the number of stem cells in the body
- reduces the appearance of wrinkles and can significantly improve memory and cognitive functioning
The FTC's complaint indicates that (a) between March 2014 and February 2016, Maria Gutierrez Veloso advertised and sold ReJuvenation nationwide using direct mail, postcards, emails, and multiple websites, and (b) Arizona-based Quantum Wellness and its CEO Fred Suzanne took over the operation in early 2016 and similarly marketed the product. The orders settling the FTC's complaint prohibit the defendants from: (a) making such claims unless they are true and supported by scientific evidence, and (b) misrepresenting that any covered product is "clinically or scientifically" proven to treat or cure a range of ailments related to the aging process. The order against Quantum Wellness and Suzanne imposes a judgment of $993,416 against Suzanne, which will be partially suspended upon payment of $60,000. The order against Veloso imposes a $2.4 million judgment, which will be partially suspended upon payment of $600,000.
Small fraction of deaths in hospitals found to be preventable. Based on a systematic review that yielded eight studies of deaths of hospitalized patients, researchers from Yale University School of Medicine and VA Connecticut Healthcare System found that only 3.1% were judged to have been preventable. Two of the studies offered data on preventable deaths for patients with at least 3 months of life expectancy and reported that between 0.5% and 1.0% of those deaths were preventable. Considering the number of annual deaths of hospitalized patients in the USA, the researchers estimated that approximately 22,165 preventable hospital deaths annually and up to 7,150 preventable deaths among patients with greater than 3 months life expectancy. These numbers are much smaller than previous, much criticized, estimates of deaths due to medical error reported by the Institute of Medicine and in other studies. [Rodwin BA and others. Rate of preventable mortality in hospitalized patients: a systematic review and meta-analysis. J Gen Intern Med. Jan 21, 2020] According to the Yale study, most of the hospital errors involved poor monitoring or management of medical conditions; diagnostic errors; and errors related to surgery and procedures. [Hathaway B. Estimates of preventable hospital deaths are too high, new study shows. Yale-news. Jan 28, 2020] Dr. David Gorski has provided an analysis of the Yale study, previous high estimates of deaths due to medical error, and how promoters of "alternative medicine" have exploited previous estimates to undermine the public confidence in medicine. [Gorski D. Are medical errors really the third most common cause of death in the U.S.? (2020 edition). Science-Based Medicine. Feb 3, 2020]
Health outcomes of different birth settings compared. A new report from the National Academies of Sciences, Engineering, and Medicine has found that giving birth in the United States can be made safer with appropriate and continuous risk assessment during pregnancy and investment in the maternity care workforce. [No hospital, birth center, or home birth is risk-free—but better access to care, quality of care, and care system integration can improve safety for women and infants during birth, says report. The National Academies of Sciences, Engineering, and Medicine News. Feb 6, 2020] Key findings included:
- Low-risk births in birth centers are slightly more risky than hospital births.
- Home and birth center births have lower rates of interventions than hospital births, such as cesarean birth or induction of labor, and therefore lower rates of intervention-related injuries and complications, such as infection or postpartum hemorrhage.
- The experiences of women of color, especially black and Native American women, such as intergenerational trauma, marginalization, intolerance, and economic disadvantage, create risk factors for pregnancy and childbirth.
- International studies suggest that home and birth center births may be as safe as hospital births for low-risk women and infants if (a) they are part of an integrated and regulated system, (b) multiple provider options are covered by insurance, (c) providers are well qualified and have the knowledge and training to manage complications, (d) transfer to a different birth setting is seamless, and (e) risk assessment occurs throughout pregnancy.
[National Academies of Sciences, Engineering, and Medicine. Birth Settings in America: Outcomes, Quality, Access, and Choice. Washington, DC: The National Academies Press, 2020]
This page was posted on February 16, 2020.