In a currently in-press (and online) article entitled Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry in the journal Cell Stem Cell, authors Leigh Turner and Paul Knoepfler “found 351 U.S. businesses engaged in direct-to-consumer marketing of stem cell interventions offered at 570 clinics.” In a careful examination of marketing claims used by these 351 businesses, they found that “U.S. businesses promoting stem cell interventions claim to treat a wide range of diseases and injuries, as well as advertising stem cells for cosmetic applications, “anti-aging,” and other purposes.” In addition to “relatively specialized marketplace niches” such as cosmetic surgery clinics and orthopedic and sports medicine clinics advertising stem cell treatments, “other clinics take a much broader approach and list stem cell interventions for 30 or more diseases and injuries. Such businesses commonly market treatments for neurological disorders and other degenerative conditions, spinal cord injuries, immunological conditions, cardiac diseases, pulmonary disorders, ophthalmological diseases and injuries, and urological diseases as well as cosmetic indications.” The authors wrote that “Many of these marketing claims raise significant ethical issues given the lack of peer-reviewed evidence that advertised stem cell interventions are safe and efficacious for the treatment of particular diseases. Such promotional claims also generate regulatory concerns due to apparent noncompliance with federal regulations.”
They found many instances of stem cell marketing claims directed not at potential patients themselves, but at patients’ caregivers or parents. These included specific marketing claims for stem cell treatments for Parkinson’s disease, Alzheimer’s disease, amyotrophic lateral sclerosis, autism, cerebral palsy, and muscular dystrophy. They found that marketing claims are being asserted for these and “many other conditions for which there is no established scientific consensus that proven safe and efficacious stem cell treatments now exist.” The authors’ concerns are that “This kind of advertising reveals another tangled knot of ethical and legal concerns, as the apparent target audience for such marketed interventions is not adults with decision-making capacity but rather the parents or guardians” of potential patients.
The authors’ in-depth examination of the online information provided by each of the companies they identified led them to conclude that “. . . there are clear grounds for concern that some of the companies we found are not compliant with federal regulations. There are related ethical concerns about information provided to prospective clients and the veracity of marketing claims, the safety and efficacy of advertised procedures, and the risk of physical, emotional, and financial harm to already ill or injured and vulnerable individuals.”
The International Society for Stem Cell Research offers a free downloadable .pdf Patient Handbook on Stem Cell Therapies that is available in English, Dutch, French, German, Italian, Portuguese, Spanish, Turkish, Persian and Japanese.
The REGROW Act, sponsored by Senator Mark Kirk (IL) (U.S. Senate HELP Committee markup (“Amendment 1; document BOM 16344″)), was noted by the authors as “an example of the current push . . . for lowering safety and efficacy standards for adult stem cell-based interventions.” The National Organization for Rare Disorders (as well as the Cystic Fibrosis Foundation, the Friedreich’s Ataxia Research Alliance, the Friends of Cancer Research, Global Genes, the Michael J. Fox Foundation for Parkinson’s Research, the Myotonic Dystrophy Foundation, the National MS Society, the National Patient Advocate Foundation and the Prevent Cancer Foundation) expressed opposition to this proposed legislation (as it is currently drafted) in a letter to Senator Kirk dated May 24, 2016. They wrote, in part, “We are concerned that the REGROW Act as currently drafted could compromise patient safety by providing “conditional approval” to products that simply show “preliminary clinical evidence of safety” as part of Phase I and Phase II trials. We are troubled that these provisions establish a new approval standard that is potentially lower than existing standards. By allowing products to be marketed as approved therapies, this implies to patients a high level of approval which is not warranted given the current requirements in the bill. We believe this proposed legislation may result in grave consequences for patients.”
Interested readers are encouraged to read the authors’ report of their extensive study of this public health issue. The authors highlight many additional aspects not mentioned here.