CHD is reporting on the FDA’s actions against a wide array of companies using unsubstantiated marketing to sell their products. As most know, the “natural” healthcare industry has been virtually unregulated, allowing almost any company to claim that they have some kind of cure or natural compound that will reverse the effects of diseases. It is gratifying to see the FDA actually continuing to crack down on these companies rather than just talk about doing something.
Read and support the Consumer Healthcare Digest at http://www.quackwatch.org/00AboutQuackwatch/chd.html
Warnings issued against illegally marketing products for Alzheimer’s disease
The U.S. Food and Drug Administration (FDA) has posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling products with unsubstantiated claims that they prevent, treat or cure Alzheimer’s disease and, in some cases, other serious health problems. [FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease. FDA News Release. Feb 11, 2019] Three other warnings were send jointly by the FDA and FTC. [FTC and FDA send warning letters to companies selling dietary supplements claiming to treat Alzheimer’s disease and remediate or cure other serious illnesses such as Parkinson’s, heart disease, and cancer FTC Press Release. Feb 11, 2019] Although most of the products were marketed as dietary supplements, the disease-related claims subjected them to regulation as misbranded and/or unapproved new drugs.
Warning letters went to: Gold Crown Natural Products, Peak Nootropics LLC (aka Advanced Nootropics), DK Vitamins, Sovereign Laboratories LLC, Blue Ridge Silver, Nutrition Coalition Inc, John Gray’s Mars Venus LLC, TEK Naturals, Earth Turns LLC, Emmbros Overseas Lifestyle PVT LTD, Pure Nootropics LLC, and Capris Associates Inc. / BR Naturals.
Advisory letters went to:Alzheimer’s Corporation (ALZcorp), Alzheimer’s Organization, Dr. Fitt Intelligent Designs LLC, Healthcare Products LLC d/b/a The Alzheimer’s Store d/b/a MindCare Store, and This Wonderful Life New Age Shop.
The joint warnings went to Gold Crown Natural Products, TEK Naturals, and Pure Nootropics, LLC.
The FDA’s total for the past five years includes more than 40 companies that promoted more that 80 products with illegal Alzheimer’s disease claims on Web sites, on social media, and in stores.
The latest issue of Consumer Health Digest reports on a researcher who has identified 30 companies in Canada engaged in direct to consumer marketing of stem cells. Here’s an exerpt from the Consumer Health Digest.
Based on a series of Web searches, a researcher has identified 30 companies in Canada engaged in direct-to-consumer marketing of stem cell treatments offered at 43 distinct clinics in six provinces, with most located in Ontario. Her findings included:
- Most of the companies advertised stem cell treatments only for orthopedic diseases and injuries, pain management, and sports-related injuries, but other companies offered treatments for cosmetic purposes, hair loss, neurological, aging, immunological diseases, muscular dystrophy, lung diseases, urological diseases, sex-related issues, and cardiac disease.
- Sixteen of the companies disclosed no risks in Web ads, while the other 14 companies typically described only the possibility of short-term problems
- Only two sites disclosed that serious risks were possible.
- None provided information about long-term follow-up care.
- Most companies advertised positive but unquantified claims, but five made explicit quantitative claims without links to supportive evidence.
- Most of the companies did not disclose what they charge for their procedures. [Turner L. Direct-to-consumer marketing of stem cell interventions by Canadian businesses. Regenerative Medicine. Epub ahead of print, Sept 26, 2018]
To sign up for the Consumer Health Digest go to this web page.
I’m posting this because of the notoriety of the man charged in this. Given the large number of alternative medicine followers here on the Olympic Peninsula I thought this would be of interest.
The Los Angeles City Attorney has charged Timothy Morrow, 83, with child abuse causing death and practicing medicine without a license. The City Attorney’s press release describes the circumstances this way:
During 2014, Morrow allegedly began to treat the 13-year-old victim for his diabetes by prescribing herbs in lieu of the insulin the victim’s pediatrician had prescribed. In August, 2014, Morrow allegedly came to the family’s Harbor Gateway home to treat the 13-year-old victim after he became sick and semi-comatose due to complications from his Type-1 diabetes. Shortly before the victim died, Morrow allegedly told the victim’s parents not to give him insulin but instead to administer the herbal oils that he was selling. The victim suffered a cardiac arrest and died the next day as a result of complications from his diabetes. The medical examiner determined the victim would have lived had he received proper medical treatment.
Morrow’s YouTube channel offers 40 videos and has 2,700 subscribers. His current “Message from Our Founder”on the Common Sense Herbal Products Web site describes him as a “Master Herbalist and Iridologist” to whom God began talking about herbs over 25 years ago. The site includes a page offering a “Social Network Marketing System” as a business opportunity along with a home business compensation plan structured like many other multilevel marketing companies. Morrow’s mission page claims: “Keep in mind: there are no side effects to herbs, no labels that read “Keep Out of Reach of Children.” These herbs, in fact, are gentle enough for children.”
According to Morrow’s attorney, Sanford Perliss, since Edgar’s death, “no one did anything to indicate that Morrow did anything wrong”—no efforts have been made to take away his business license and Edgar’s parents have not sued him. If convicted of the charges, which are misdemeanors, Morrow faces up to two years in jail and a $10,000 fine. He is scheduled for arraignment on March 27th. [Herbalist charged in death of boy with diabetes. CBS/AP, March 7, 2018]
Having been in the room with my late wife at a fake stem cell facility in Mexico, I highly suggest you take this information into consideration before considering doing this therapy in this way. Feel free to contact me for more information on what we experienced.
An investigation of 368 Web sites found through Google with search terms combining stem cell with various buzzwords and practitioner names associated with “complementary and alternative medicine” has revealed:
- 243 sites marketed stem cell therapies and 116 marketed other interventions where stem cells were mentioned in the description of the treatment or its effects. The other interventions included platelet-rich plasma injections (88), prolotherapy (19) and others (9).
- The cells used for transplantation were said to be derived from adipose (fatty) tissue (112 sites), bone marrow (100 sites), blood (28 sites), umbilical cord (26 sites), and other sources [e.g., placenta, amniotic sac, amniotic fluid, embryonic stem cells] (35 sites).
- 20 sites advertised plant cell-based treatments and products (e.g., skin creams).
- The most common advertised treatment targets were: bone, joint, and muscle pain/injury (182 sites); diseases or maladies (82 sites); cosmetic concerns (52 sites); non-cosmetic aging (44 sites); and sexual enhancement (18 sites).
- 80% of the sites were for clinics in the USA; the rest were located in 17 other countries.
- The practitioner types mentioned on the 368 sites included medical doctors (161), naturopaths (63), chiropractors (61), acupuncturists (36), midwives (33), homeopaths (27) and massage therapists (13). Some sites mentioned more than one and some sites listed none.
- Hyperbolic language was found on 32% of the sites.
- Only 31% of the sites mentioned the regulatory status of the intervention, and only 33% noted that the therapy was unproven.
- Only 19% of the sites stated there was limited evidence of efficacy of the intervention and 13% said there was evidence of inefficacy.
- Only 25% of the sites mentioned general risks of the interventions.
The investigators concluded:
Many clinics seem to be engaging in scienceploitation, which can seriously obfuscate public discourse, mislead the public and make it difficult to discern real science from marketing claims that merely reference scientific sounding terminology. The marketing of unproven stem cell therapies has the potential to harm patients and to harm the reputation of stem cell science. It is incumbent on regulators and policymakers to take a proactive approach to managing the risks associated with the growing private market for stem cell-related interventions, and addressing misleading marketing practices is an important part of this strategy.
[Murdoch B and others. Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites’ marketing of stem cell therapies. BMJ Open 8(2), March 2, 2018]
Worth noting if you or someone you love is chasing ‘alternative’ cures for cancer.
In response to a complaint for permanent injunction and other equitable relief by the Federal Trade Commission (FTC), Derek E. Vest, individually and as owner of CellMark Biopharma, LLC, has signed a stipulated order for permanent injunction that prohibits the company from making any representation for any dietary supplement, food, or drug of treating, curing, mitigating, or preventing any disease; symptom of cancer; and side effect, condition, or ailment resulting from cancer treatment. The FTC’s complaint alleged deceptive advertising of two CellMark products: (1) CellAssure, which was marketed as having “anti-cancer and anti-tumor properties” and as a medical breakthrough solution for cancer-related malnutrition; and (2) Cognify, which the company promoted for patients receiving chemotherapy as “the world’s first product designed specifically to alleviate…chemo fog.” [Marketers barred from making deceptive claims about products’ ability to mitigate side effects of cancer treatment: CellMark and its CEO lacked scientific evidence to back up their products’ claims. FTC news release, Jan 11, 2018]
My late wife went through something like this test during her search for a cancer cure. It was the most absurd thing I saw during our journey through medical fraud. In case anyone is wondering, this notion of kinesiology being able to determine internal organ health was debunked decades ago. Applied kinesiology is a method of testing that is virtually unregulated and has a large amount of ‘practioners’ who claim it can cure almost anything. To be clear, the basis of kinesiology is applicable to many fields such as sports medicine, etc. It’s about human movement. It’s has many legitimate sports medicine clinics that use it. The fraudsters are out there creating ‘machines’ and testing based on it to prey on the chronically ill. If you run into someone ‘practicing’ to try and heal cancer, or other internal diseases, run the other way.
Quackwatch has posted a report on the bi-digital O-ring test (BDORT), a variant of applied kinesiology that is claimed to provide information about internal organs by testing finger strength. To perform the test, the patient positions the thumb and another finger of one hand together to form a circle (“O-ring”) while his other hand holds a sample tissue of an internal organ. The practitioner then places his fingers into the circle and tries to pull the patient’s fingers apart. Proponents claim that whether or not the circle can be forced open reflects the health status of the patient’s organ that corresponds to the tissue sample. BDORT was developed in the early 1980s and patented in 1993 by Yoshiaki Omura, M.D., Sc.D., a physician/acupuncturist who worked in New York City during most of his professional career. BDORT is closely related to Quantum Reflex Analysis, which is also discussed in the report. [Barrett S. Some notes on the bi-digital O-ring test and Quantum Reflex Analysis. Quackwatch, Sept 10, 2017] The idea that muscle-testing can determine the status of the body’s organs or provide a basis for treating health problems is preposterous. Despite this, thousands of practitioners use such tests.
This in from Quackwatch. As someone who’s late wife was the victim of a stem cell scam, I am thrilled to hear this news. This is a very real scam, both here and in the Mexican border to southwest of Yuma, which unfortunately won’t be within the reach of the FDA.
FDA Commissioner Scott Gottlieb, M.D., has announced that the FDA “ ill be stepping up enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit.” [FDA warns US Stem Cell Clinic of significant deviations. FDA news release, Aug 28, 2017] The agency also posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida and its Chief Scientific Officer, Kristin Comella, for marketing unapproved stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products. A recent FDA inspection found that the clinic was processing stem cells derived from body fat and administering the product both intravenously or directly into the spinal cord of patients to treat Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease, heart disease, and pulmonary fibrosis. In a parallel action, at the FDA’s request, U.S. Marshals seized five vials of live vaccinia virus vaccine that had been used or were awaiting use to create an unapproved stem cell product for cancer patients. The FDA’s announcement noted that this vaccine is reserved only for people at high risk for smallpox (such as some members of the military) and has considerable potential for harm. [FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients. FDA news release, Aug 28, 2017]