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.
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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.
Disturbing news that it appears the market for dubious or outright fraudulent cures is now in friends asking friends to fund those treatments.
Two recent reports add to the literature on the use of crowdfunding platforms to support the pursuit of unproven treatments for serious health problems:
- One research team looked at the largest crowdfunding platform (GoFundMe) and three other well-trafficked sites that permit medical crowdfunding (YouCaring, CrowdRise, and Fund Razr). The search terms they used were related to (a) homeopathy or naturopathy for cancer, (b) hyperbaric oxygen therapy (HBOT) for brain injury, (c) stem cell therapy for brain injury, and (d) spinal cord injury, and (e) long-term antibiotic therapy for “chronic Lyme disease”—all of which the researchers considered poorly supported and/or potentially dangerous. The study found that from Nov 1, 2015 through December 11, 2017, 1,059 campaigns had sought a total of $27.25 million and raised nearly $6.8 million. GoFundMe hosted 98% of the campaigns, YouCaring had 2%, and the others had none that met the researchers’ inclusion criteria. [Vox F and others. Medical crowdfunding for scientifically unsupported or potentially dangerous treatments. JAMA 320:1705-1706, 2018]
- Another research team searched GoFundMe in June 2018 for campaigns that included the words “cancer” and variations on the word “homeopathy.” They found 220 unique campaigns with all but eight located in the United States and Canada. The campaigns, which mentioned 26 unproven interventions, requested nearly US $5.8 million and garnered pledges of more than $1.4 million. In addition to homeopathy, the most common methods were dietary changes such as juicing and organic foods (39% of campaigns). The other methods for which funding was sought by at least 10% of the campaigns were: (a) dietary supplements and herbal remedies, (b) vitamin C infusions, and (c) oxygen, ozone, and hyperbaric treatments. Unsubstantiated claims for the treatments sought were made in 29% of the campaigns. Among those seeking the treatments: (a) 38% wanted to try every available treatment and use it in addition to standard treatment; (b) 29% chose to forgo standard treatment because of fear of adverse effects or doubts about effectiveness, and (c) 31% could not pursue standard treatment for financial or medical reasons. At least 28% had died after their campaign began. [Snyder J, Caulfield T. Patients’ crowdfunding campaigns for alternative cancer treatments. Lancet Oncology. DOI:https://doi.org/10.1016/S1470-2045(18)30950-1, 2019]
Past issues of Consumer Health Digest have summarized the findings of studies of crowdfunding that involved cancer patients in the UK, claims that stem cell treatments were being offered through research studies, and claims that stem cell treatments had been proven effective.
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The NY Times has a fascinating article on the latest research into the Placebo Effect. The Times does a good job of outlining the history of the Effect, including the beginning of modern science’s interest in it, with none other than Benjamin Franklin in the mix. The latest research helps paint a picture that if correct, could help us understand the interconnection between faith healing, eastern medicine, therapeutic touch, and western medicine. It also holds out the possibility of even making our drugs more effective. Read on…
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]
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This is not going to help anyone. In fact, it very likely will hurt people who are dying. While the idea behind this seems to the uninformed to be an interesting idea, the possibility of dying people taking drugs that may cause greater suffering to them is very real. The Trump Administration attempt to undermine the FDA is clearly underway. The beneficiaries of this are large drug companies.
President Donald Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, which had been opposed by a coalition of more than 100 non-governmental organizations. The law permits terminally ill patients who have exhausted approved treatment options and who are unable to participate in a clinical trial of an investigational new drug to receive the drug after it has passed only the first of three phases of testing required for marketing approval. Phase 1 testing requires only 20 to 80 healthy volunteers to determine a drug’s most frequent side effects and how it is metabolized or excreted. While it can reveal unacceptable toxicity, Phase 1 does not establish effectiveness. Most drugs that move past Phase I testing do not get approved for marketing because they are found to be unsafe and/or ineffective.
The Food and Drug Administration (FDA) already has “compassionate use” programs with safeguards that enable people with serious and life-threatening diseases to receive investigational medical devices, drugs, and biologics outside of clinical trials. The agency sometimes requires dosing and safety improvements but grants 99% of requests it receives and enables treatment to begin within 30 days (or five working days after emergency requests). The new law removes FDA’s consultative role in ensuring safety and fails to ensure informed consent requirements. It also “limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.”
Senator Ron Johnson, who sponsored the legislation, said recently that its goal was to “diminish the FDA’s power over people’s lives, not increase it.” It was based on a model bill drafted by the Goldwater Institute, a libertarian think tank that opposes the FDA’s regulatory power. The Koch brothers-associated, right-wing groups Freedom Partners and Americans for Prosperity lobbied for the legislation. Similar legislation has already been enacted in 38 states. David Gorski, M.D., Ph.D. recently wrote:
Right-to-try is only a little about helping patients. It’s far more about dismantling the FDA and giving drug and device manufacturers more freedom to market drugs and devices with much less testing. [Gorski D. The very worst version of the sham known as “right-to-try” is poised to become law. Science-Based Medicine, May 21, 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]
Interesting story on Homeopathy. There is no science behind homeopathy and this review of it by a noted association, gets to the core of the issue.
The British Veterinary Association’s journal has published two articles that place homeopathy in historical and scientific perspective. Although the articles concern veterinary practices, their conclusions are equally relevant to human drugs. The first article notes that, “For many drugs the mechanism of action is proven, and for most drugs without proven mechanisms of action, scientifically plausible mechanisms exist.” [Lees P and others. Comparison of veterinary drugs and veterinary homeopathy: Part 1. Veterinary Record, Aug 12, 2017] In contrast, the second article notes that “Homeopathy . . . is top down and faith-based; governed by arbitrary laws, invented by the founder, Hahnemann, which are immutable. As such, homeopathy is not just unscientific, it is a genuinely mystical belief system.” [Lees P and others. Comparison of veterinary drugs and veterinary homeopathy: Part 2. Veterinary Record, Aug 19/26, 2017]