Consumer Health Digest #20-24
Your Weekly Update of News and Reviews
June 21, 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.
COVID-19 conspiracy beliefs associated with social media use. Researchers have reported the findings of three online surveys about COVID-19 protective behaviors, use of social media as a source of information about COVID-19, and COVID-19 conspiracy beliefs. The conspiracy beliefs included claims that the COVID-19 public health crisis was caused by a manufactured virus and that the risks involved have been greatly exaggerated. The survey participants were UK residents aged 18 or older who had expressed an interest in surveys about COVID-19. [Allington D. Health-protective behaviour, social media usage and conspiracy belief during the COVID-19 public health emergency. Psychological Medicine. June 9, 2020] The findings included:
- The most commonly held conspiracy belief was in a laboratory origin for the coronavirus.
- Holding one or more conspiracy beliefs was associated with preference for social media over legacy media as a general source of information and with use of social media for knowledge about COVID-19.
- YouTube had the strongest association with conspiracy beliefs, followed by Facebook.
- Holding one or more conspiracy beliefs was very strongly associated with not following all health-protective behaviors.
- Holding the belief that 'Coronavirus was probably made in a laboratory' was associated with frequently checking social media for news about COVID-19.
The researchers concluded:
In the UK, broadcast media are subject to official regulation, and many print media platforms are subject to voluntary regulation, but social media are largely unregulated. One wonders how long this state of affairs can be allowed to persist while social media platforms continue to provide a worldwide distribution mechanism for medical misinformation.
Reporting of "regenerative medicine" harms encouraged. Two officials with the U.S. Food and Drug Administration (FDA) have emphasized the importance of reporting harms experienced by patients receiving unproven, unapproved regenerative medicine products promoted for a wide range of conditions including aging, arthritis, autism, and complications of COVID-19. [Marks PW. Hahn S. Identifying the risks of unproven regenerative medicine therapies. JAMA, June 17, 2020] Regenerative medicine products include (a) those derived individual's own bone marrow or fat, (b) donated tissues such as placenta or cord blood, and (c) products secreted or derived from unrelated donor cells. The officials advise prospective patients to ask promoters if their therapy is FDA-approved or has active Investigational New Drug (IND) application on file with the FDA. The rules for such investigations include:
- The IND application must identify the specific product.
- Written informed consent must be provided.
- No charge is normally requested from the patient for the product or participation in the trial.
- When there is some evidence of clinical benefit, sponsors may recover the actual cost of the product.
- Reporting of potential adverse events is encouraged and clear mechanisms are provided on how to do so.
- A summary of results is reported back to those enrolled in the clinical trial.
Inadequacies of FDA's supplement warning system identified. A new report reveals serious inadequacies of CAERS, the adverse event reporting database of the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition, in protecting users of dietary supplements. [Felton R. FDA's Supplement Warning System Has Deadly Limitations. Consumer Reports. May 27, 2020] The inadequacies include:
- While manufacturers are required to submit adverse event reports, reporting by consumers and doctors is voluntary.
- Only an estimated 2% of adverse reports are ever reported to the system, making it difficult for FDA to build a case that a supplement is unsafe and should be removed from the market.
- Reports often lack crucial information about the people who reported problems, including their age, contact information, and relevant medical history.
- The FDA isn't required to alert the public when it investigates a potential problem with a supplement, as it must do with drug products.
Federal regulations don't require supplement manufacturers to prove that their products are safe and effective before going to market, as is required for drug products. The Dietary Supplement and Health Education Act of 1994 greatly weakened the FDA's regulatory authority of dietary supplements and has been a boon to the dietary supplement industry.
"Holistic" doctor accused of unprofessional conduct. In March 2020, the Medical Board of California accused Karima Hirani., M.D. of gross negligence; repeated negligent acts; and excessive prescribing or treatment in her management of a nine-year-old girl with a chief complaint of intermittent stomach pain. The accusation states that Hirani:
- recommended and/or prescribed a gluten-free, dairy-free, sugar-free diet, and several nutritional supplements
- ordered approximately 30 laboratory test panels, many of which were redundant or lacked medical justification
- diagnosed the child with active Lyme disease, active varicella (chickenpox), and mycoplasma (walking pneumonia) infections, diagnoses that were not properly supported by the laboratory results
- ordered a homeopathic product for the alleged Lyme disease without disclosing that no peer-reviewed studies supported its use
Hirani operates the Hirani Medical Wellness Center in Culver City, California where she practices what she calls "holistic and preventative medicine." [Barrett S. Karima Hirani, M.D. accused of unprofessional conduct. Casewatch. June 11, 2020]
CFI will appeal dismissal of Walmart homeopathy fraud lawsuit. The D.C. Superior Court has dismissed the Center for Inquiry's lawsuit against Walmart, which accuses the world's largest retailer of committing wide-scale consumer fraud and endangering the health of its customers by marketing homeopathic drugs. The suit charged that Walmart misrepresents homeopathy's safety and efficacy by hawking homeopathic products alongside real, evidence-based medicines on its shelves and in its online store, with no distinction made between them, under signs indicating them as treatments for particular ailments. The judge ruled that CFI lacked standing as a consumer protection organization and had failed to specify which of Walmart's actions could harm consumers. Calling the judge's ruling "inexplicable," CFI has announced that it will appeal. [Walmart homeopathy fraud lawsuit: Center for Inquiry to appeal judge's inexplicable dismissal. Center for Inquiry news release. June 15, 2020] CFI has a similar suit pending against CVS, the country's biggest pharmacy chain.
This page was posted on June 21, 2020.