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Nearly half of stem cell clinics lack physicians trained in advertised treatments
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Among companies who advertise unproven, direct-to-consumer stem cell therapies and employ at least one physician, only about half claimed to treat conditions that matched the scope of their physicians’ training, according to data published in JAMA.
“What we know about the backgrounds of clinicians has been largely anecdotal and no study has systematically examined the background qualifications of clinicians who offer unproven stem cell treatments,” Zubin Master, PhD, of the Mayo Clinic Biomedical Ethics Research Program, told Healio Rheumatology. “By knowing the residency and/or fellowship qualifications of physicians at each company, we were able to examine whether [at least one] physician has the appropriate training to provide stem cell treatments for the conditions that companies claim to offer.”
To analyze the characteristics and training of clinicians employed by companies who market unproven stem cell treatments, Master and colleagues started with a list of 351 U.S. companies identified in a 2016 study. According to that study, these 351 companies advertised unproven stem cell procedures at 570 clinics, mostly concentrated in California, Florida and Texas. Master and colleagues focused on the 166 companies in those three states who continued to market stem cell treatments as of January 2018.
The researchers reviewed information on clinician characteristics and training from each company’s website. In evaluating physicians, qualifications were confirmed against information in state medical board licensing databases, as well as the Federation of State Medical Board (FSMB) Physician Data Center. In the event of discrepancies, the researchers used data from the FSMB.
To determine scope of training, two researchers with medical coding expertise analyzed the conditions each company claimed to treat and used their judgement to determine whether at least one physician employed at said company possessed the appropriate background. Due to the high prevalence of stem cell companies that claim to treat orthopedic conditions, the researchers compared orthopedic companies with nonorthopedic facilities.
The researchers identified 608 clinicians working at the 166 companies included in the study, of whom 401, or 66%, were physicians. Nonphysician clinicians were most commonly physician assistants, nurses or complementary and alternative medicine practitioners. Among the companies, five were staffed completely by podiatrists, two by naturopaths, one by dentists and one by clinicians of unclear qualifications. As many as 40% were solo practices, while 19% had six or more clinicians.
Among the 401 physicians, orthopedics was the most common training background. Approximately 30.8% of identified physicians had residencies, and 10.8% had completed training fellowships, in orthopedics.
According to the researchers, among the 157 companies with at least one physician, 52% advertised stem cell treatments within the scope of their training. Among the companies focused on orthopedic conditions, 77% had at least one physician with the appropriate training. Just 19% of the included companies that marketed stem cell treatments for nonorthopedic conditions had physicians practicing within their training.
“We found that about half of the companies examined offer stem cell treatments for conditions which they do not have a physician with the appropriate residency and/or fellowship training to treat those conditions,” Master said.
“The responsible translation of stem cell and other regenerative therapies requires that such interventions be performed by individuals who have the appropriate qualifications, training and experience to help ensure the best care for patients,” he added. “While it may be difficult for patients to know whether a clinician is appropriately qualified, patients should consider the backgrounds of physicians and can look up physicians on state medical board license databases or the Federation of State Medical Boards’ Physician Data Center.” – by Jason Laday
Disclosure : Master reports being part of the FSMB workgroup to study regenerative and stem cell therapy practices and receiving nonfinancial support and grants from the group while conducting this study.
Perspective
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David A. McLain, MD, FACP, FACR
The use of stem cell therapy has great promise in the treatment of many types of illness and is already proven to work in human studies in hematology and oncology. Likewise, SCT has demonstrated positive results in bone, ligament, tendon, and joint repair in areas of veterinary medicine. I recently had a professor at a major university ask me about going to Tennessee for SCT for his knees — the price per knee around $8000. I provided him with a literature search and he ultimately decided not to go.
Studies are underway in humans but the benefit of SCT for musculoskeletal problems remains unproven; nonetheless, there are clinics marketing directly to the consumer for these procedures. The present article studies the training of providers in direct-to-consumer advertised clinics in 3 states — Florida, Texas, and California. Surprisingly, only 66% of the providers were physicians, meaning 34% were non-physicians.
The largest group were nurse practitioners and physician assistants at 15%. Podiatry accounted for 5% and 5 of the SCT companies in this study had only podiatrists as their providers. Physical therapy accounted for 3% and dentists for 1%. Of the physicians, 30% had completed orthopedic residencies and 28% had completed orthopedic fellowships. Only 0.4% had completed a rheumatology fellowship.
Other physician specialties included pain medicine, family medicine, sports medicine, physical medicine and rehabilitation and anesthesiology. The researchers noted that among the companies advertising SCT, only 52% had at least one physician who had training in conditions they advertised to treat.
The researchers note that one-third of state boards of medicine had complaints related to SCT in 2018, 16% of which took regulatory action. In October 2018, a California physician and two of his SCT companies settled charges with the Federal Trade Commission for claiming that “amniotic stem cell therapy” could treat serious diseases, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, osteoarthritis and heart attacks. The physician had earned over $3.3 million dollars for SCT over a 3-year period.
The settlement prohibited the defendants from misrepresenting that SCT was “comparable, or better than, conventional medical treatments in treating any health condition, unless such claims are true and can be supported by competent and reliable scientific evidence.”
SCT holds significant promise for treating osteoarthritis and many other diseases — for rheumatology, however, it is not yet ready for primetime.
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