Many clinicians at centers that offer stem cell interventions without solid evidence for their effectiveness are not physicians, or are physicians practicing beyond the scope of their formal training, according to a research letter published today in the Journal of the American Medical Association.Ā
Zubin Master, PhD, of the Mayo Clinic in Rochester, Minnesota, and colleagues identified 608 clinicians at 166 stem cell companies through online research in California, Florida, and Texas, where the companies are largely concentrated, and compiled information on their training.
“About half of the companies did not have any physicians with the appropriate qualifications (based on residency and/or fellowship training) to offer a stem cell treatment for specific conditions they claimed to treat,” Master wrote in an email to Medscape Medical News.
The researchers used state medical board licensing databases and specialty board certifications from the American Board of Medical Specialties to verify physicians‘ qualifications. They also compared physicians‘ residency or fellowship training to the conditions for which the stem cell companies advertised treatments.Ā Ā
Of the 166 companies, 157 (94.5%) had a physician on staff, but the researchers found that only 81 (48.8%) employed a physician with formal training that matched the conditions the company advertised its stem cell interventions to treat. Of the nine companies without a physician on staff, five were staffed by podiatrists, two by naturopaths, one by dentists, and one by practitioners with unclear qualifications.Ā
“Some of the people working at these businesses shouldn’t be doing what they’re doing,” said study author Leigh Turner, PhD, an associate professor at the University of Minnesota’s Center for Bioethics; School of Public Health; and College of Pharmacy in Minneapolis. Of the 608 clinicians identified, 401 (66%) were physicians. The most common nonphysician clinicians were physician assistants, nurses, and complementary and alternative medicine practitioners.Ā
Even for physicians with qualifications that match advertised treatments, the findings “say something ugly and alarming,” Turner told Medscape Medical News: “A good deal of this activity involves licensed medical practitioners who you think would know better.”Ā
“It’s more evidence that companies that are willing to sell unproven products to desperate patients and are just willing to ignore all kinds of best practices in terms of the medicine that they perform,” said Sean Morrison, PhD, director of the Children’s Medical Center Research Institute at the University of Texas Southwestern Medical Center in Dallas, past president of the International Society for Stem Cell Research, and chair of the society’s Public Policy Committee.Ā
Morrison, who was not involved in the current research, pointed out that the companies are ignoring US Food and Drug Administration (FDA) regulations about not selling products without first proving they are safe and effective. Some have departed from good manufacturing processes, resulting in patient infections.
“It’s not so surprising that many of these companies would be staffed by people that don’t have expertise in what they’re doing,” he said. “Particularly when people are making claims that are implausible for what these unproven therapies can do, I do think state medical boards should be paying attention to this, because people are being harmed.”
The study authors acknowledged limitations to their research, including that the analysis only included clinics that had entered the marketplace before 2016 in three states. The scope-of-training findings rely on the judgment of the two researchers who coded residency and fellowship training and did not take into account any additional training the physicians may have had. The researchers also defined scope of training at the company level, looking for at least one physician with appropriate training for the conditions with advertised treatments, rather than assessing whether each physician at a company had appropriate training.
The researchers did separate analyses for companies that advertised stem cell interventions only for orthopedic conditions and found that 68 orthopedic-focused practices, or 77%, employed one or more physicians with appropriate specialty training. Of the companies marketing other indications, only 13 (19%) had corresponding training. The orthopedic area is growing “explosively,” said Morrison, because although the FDA is cracking down on clinics marketing stem cell products without proven safety and efficacy, it has signaled that orthopedic procedures are a lower priority.Ā
“Many of these clinics have no idea what a stem cell is, and there is no guarantee that patients even receive stem cells,” Jeanne Loring, PhD, professor emeritus in Scripps Research‘s Department of Molecular Medicine and chief scientific officer of Aspen Neuroscience in La Jolla, California, wrote to Medscape Medical News in an email.
“The clinics have been invited to apply for FDA approval, but few have done so; the clinics are lucrative businesses, collecting thousands of dollars from desperate, vulnerable people,” Loring said.
The Federation of State Medical Boards (FSMB), which funded the study, reported last year that 8 of 51 boards had taken disciplinary action against physicians related to regenerative medicine or stem cell therapy, and 17 had investigated complaints.
In a statement provided to Medscape Medical News, FSMB President and CEO Humayun Chaudhry, DO, said that physicians should only provide treatments to patients with sufficient evidence supporting the treatment for the patient’s condition, and physicians should support claims about the treatment’s benefits with documented evidence from sources, including peer-reviewed research.Ā
“Patients may be at greater risk in circumstances where a physician is not appropriately trained to provide treatments that fall within a newly chosen area of practice,” Chaudhry said. “Physicians must therefore ensure that they are able to demonstrate competence in their selected area of practice and that they only provide treatments to patients for which they have received adequate and appropriate training.”
Study authors Joseph Fojtik and Zubin Master reported that they were part of the FSMB Workgroup to Study Regenerative and Stem Cell Therapy Practices. Master also reported that he received nonfinancial support and grants from the FSMB during the conduct of the study, including to support the research. No relevant financial relationships were reported.
JAMA.Ā Published online June 25, 2019. Research Letter
Follow Ellie Kincaid on Twitter atĀ @ellie_kincaid