Hundreds of companies in the United States are advertising dozens of unapproved stem cell therapies for direct-to-consumer (DTC) sale, according to a new study. A lax regulatory environment has permitted a "cowboy culture" to flourish, the authors argue in an article published online June 30 and in the August 4 issue of Cell Stem Cell.
The analysis raises questions about the adequacy of oversight provided by the US Food and Drug Administration and other federal and state agencies tasked with promoting patient safety and accurate advertising, write Leigh Turner, PhD, and Paul Knoepfler, PhD. "Such practices also prompt ethical concerns about the safety and efficacy of marketed interventions, accuracy in advertising, the quality of informed consent, and the exposure of vulnerable individuals to unjustifiable risks."
In a news release about the study, the authors say their curiosity was piqued when Dr Knoepfler started receiving enquiries about US-based stem cell businesses in a blog he maintains called The Niche . These enterprises were operating with minimal state or federal monitoring and had never been examined comprehensively.
This lack of knowledge resulted in "misunderstandings that need to be corrected," the authors write in their article.
For example, current discussions of stem cell therapies usually concern "stem cell tourism" to centers outside the United States and rarely acknowledge the US businesses engaged in DTC advertising.
Addressing what they describe as an "urgent need for better information," the authors determined how many companies actually were engaged in such marketing in the United States and then examined their marketing claims.
To conduct their study, Dr Turner, from the Center for Bioethics, School of Public Health, and College of Pharmacy, University of Minnesota, Minneapolis, and Dr Knoepfler, from the Department of Cell Biology and Human Anatomy, University of California, Davis, used Internet key word searches, text mining, and content analyses of company websites. After using phrases such as "stem cell therapy" and "stem cell treatment" to identify the companies, they visited each company's website to learn more about their claims and the stem cell products they used.
The search uncovered 351 businesses marketing stem cell treatments at 570 clinics. Although they were located throughout the country, the highest concentrations of clinics were found in California, Florida, Texas, Colorado, Arizona, and New York. "Hotspot" cities included Beverly Hills, California; New York City; San Antonio, Texas; Los Angeles, California; Austin, Texas; and Scottsdale and Phoenix, Arizona.
Most of the companies advertised autologous cell-based therapy, followed by allogeneic stem cells from amniotic material (offered by 17% of the companies), placental tissue (3.4%), and umbilical cords (0.6%). Of the businesses marketing autologous stem cells, most (61%) advertised cells derived from adipose tissue, followed by bone marrow (48%) and peripheral blood (4%). Some companies marketed a combination of therapies, usually a mixture of autologous cells from adipose tissue and bone marrow. The source of the stem cells was unidentified in approximately 3% of the businesses studied.
Many clinics marketed "placental" or "amniotic" stem cells, the authors write, although "the precise source of these products is not clear in all cases, particularly for allogeneic products such as amniotic stem cells."
Orthopedic conditions were the most common indication, with 300 businesses offering treatments. Other targeted conditions covered a wide range of medical problems, including, but not limited to, pain, sports injuries, neurological disorders, immunological disorders, cardiac disease, and respiratory or pulmonary ailments. Cosmetic enhancements also were common.
Some companies promoted treatments for conditions such as autism, cerebral palsy, and muscular dystrophy, which affect mostly children, whereas others advertised therapies for conditions such as Alzheimer's disease, which affects mostly elderly people. This raises legal and ethical alarms because in these cases, the targets of the advertising were not adults with decision-making capacity but, rather, their caregivers, the authors write.
The findings provide "clear grounds for concern" that some of these companies may not be complying with federal regulations covering stem cell therapies, with related questions about the information provided to prospective patients, Dr Turner and Dr Knoepfler warn.
Of particular concern is the proliferation of claims related to amyotrophic lateral sclerosis, Alzheimer disease, Parkinson disease, "and many other conditions for which there is no established scientific consensus that proven safe and efficacious stem cell treatments now exist."
Many of these clinics essentially may be conducting "unapproved human experimentation" without giving patients true informed consent, Dr Turner said in the news release.
There is also the risk that a patient treated at one of these clinics may not qualify for clinical trials that do comply with federal regulations, which could be a loss for stem cell research.
Unregulated businesses may diminish the reputation of the entire field, Dr Knoepfler said in the news release. If these clinics continue to proliferate and patients experience negative outcomes or receive conflicting information, "this could really negatively impact the public perception of this research."
By: Norra MacReady (Medscape).
Photo: Health Innovations.
Review: Emerging Market Formulations &
Research Unit, FLAGSHIP RECORDS.
For The #FacebookTeam