Consumer Health Digest #19-15
Your Weekly Update of News and Reviews
April 4, 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.
Many FDA warnings issued to stem cell marketers. The U.S. Food and Drug Administration has announced that during the past year it has sent warnings and other regulatory correspondence to 45 manufacturers and health care providers. Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA's continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk. . . April 3, 2019] Two court cases against stem cell clinics are pending. The FDA recently warned Cord for Life, Inc. of Altamonte Springs, Florida that: (a) its umbilical cord blood products intended to treat orthopedic conditions is being illegally marketed as an unapproved biologic, (b) inspection revealed evidence of significant deviations from current good manufacturing practice posing potential significant safety concerns from contamination with microorganisms or other serious product quality defects.
NYC stem cell clinic sued for fraudulent advertising. New York State Attorney General has charged Park Avenue Stem Cell, a New York City for-profit clinic, and its managing doctor, Joel B. Singer, M.D., with engaging in fraudulent and illegal advertising of its stem cell procedures. [Attorney General James announces lawsuit against New York City stem cell clinic for scamming vulnerable patients out of thousands. NYAG press release, Apr 4, 2019] The complaint alleges:
- The advertising falsely claimed that stem cells from the patients' fat tissue could treat urological diseases; erectile dysfunction; cardiac/pulmonary disease; neurological diseases such as Parkinson's disease and ALS; autoimmune diseases such as lupus; and orthopedic conditions.
- The defendants falsely represented that (a) their procedures were FDA-approved, (b) patients would participate in an established research study, and (c) several scientific and medical organizations had endorsed their procedures.
- The cost was nearly $4,000 per procedure.
Position statement issued on restorative therapies for erectile dysfunction. The Sexual Medicine Society of North America has concluded that restorative (regenerative) therapies for erectile dysfunction (a) are experimental, (b) should be conducted under research protocols in compliance with Institutional Review Board approval, (c) should not be offered without patients giving consent after being fully informed of risks and benefits, and (d) should cost patients no more than basic research costs for participating in clinical trials. Specific methods mentioned in the paper include low-intensity shock wave therapy (LISWT), intracavernous stem cell therapy (SCT), intracavernous platelet rich plasma (PRP) therapy, and amniotic fluid. [Position statement: ED restorative (regenerative) therapies (shock waves, autologous platelet rich plasma, and stem cells). Sexual Medicine Society of North America. March 2018]
Warning issued against unproven medical devices to assess concussions. The FDA is advising against the use of devices marketed to consumers for evaluating head injuries. [FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion. FDA news release. April 10, 2019] The warning notes that smartphone apps marketed to coaches or parents for use during sporting events have not been reviewed for safety and efficacy and could result in an incorrect diagnosis that leads a person with a serious head injury to resume normal activities instead of getting medical care.
Kidney failure after high-dose vitamin D reported. A 54-year-old man developed kidney failure after: (a) being advised by a naturopath to take 8 drops daily of a brand of vitamin D that contained 500 international units (IU) per drop and, (b) unknowingly obtaining another vitamin D preparation containing 1,000 IU per drop. The resultant total 8,000 to 12,000 IU daily for 2.5-years, during which he was not counseled about toxicity risks. A year after his kidney failure was diagnosed and treatment was initiated for his elevated blood levels of vitamin D and calcium, he was left with stage 3B chronic kidney disease. [Auguste BL and others. Use of vitamin D drops leading to kidney failure in a 54-year-old man. CMAJ 191:E390-E394, 2019]
A 2014 review of hundreds of studies concluded that highly convincing evidence of a clear role of vitamin D does not exist for any health outcome. [Theodoratou E. and others. Vitamin D and multiple health outcomes: umbrella review of systematic reviews and meta-analyses of observational studies and randomised trials. BMJ 348:g2035, 2014]
Last year, the U.S. Preventive Services Task Force recommended against daily supplementation of 400 IU or less of vitamin D and 1000 milligrams or less of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women. It also concluded that current evidence is insufficient to assess the balance of the benefit and harms of:
- daily supplementation with doses greater than 400 IU of vitamin D and greater than 1000 mg of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women
- vitamin D and calcium supplementation, alone or combined, for the primary prevention of fractures in men and premenopausal women
This page was posted on April 14, 2019.