Mary Chris Jaklevic has freelanced for HealthNewsReview.org since 2016 and recently joined the staff as a full-time health care journalist. She tweets as @mcjaklevic.
A newly published animated map shows how an unregulated industry of stem cell clinics developed in less than a decade, growing from zero businesses in 2008 to nearly 600 in 2016.
The map was created by UC Davis stem cell researcher Paul Knoepfler, PhD, and University of Minnesota bioethicist Leigh Turner, PhD, who first documented the proliferation of stem cell businesses in June 2016.
You can hear them describe how questionable clinics lure sometimes-desperate patients to unproven treatments in a HealthNewsReview.org podcast, “The Wild West of Stem Cells.”
A search of internet archives turned up no evidence of stem cell clinics in 2008, Knoepfler recently wrote on his blog, which describes their ensuing “wildfire spread.”
The first clinics opened in California, Florida, Texas, and Colorado, and “in subsequent years their abundance exploded across the country,” which led to what he calls a “seriously problematic situation.”
While direct-to-consumer stem cell ventures multiplied, the FDA issued fewer than one warning letter per year, with none issued until 2011, the researchers reported in their latest paper.
They speculate the FDA either lacked adequate staff and funds to take effective action or was “slow to grasp” the scope of the problem.
Whatever the reason, they wrote: “We fear that more businesses, physicians and entrepreneurs have entered the marketplace than would have occurred under stricter regulatory oversight because they recognize that few companies marketing stem cell interventions are ever inspected by FDA officials, issued warning letters or otherwise subjected to enforcement actions.”
“Imagine if the Obama (administration) FDA had taken some substantial action in 6-7 years ago on the non-compliant clinics? I doubt that we’d have the scope of problem that we have today,” Knoepfler wrote in his blog.
They said the market appears to have expanded, with perhaps more than 700 clinics now operating.
The researchers also took aim at the Federal Trade Commission for failing to act against false or misleading ads by stem cell clinics and cited a “similar lack of attention by state medical boards” in disciplining physicians who profit from stem cell treatments.
An FTC spokesman confirmed the agency hasn’t taken action but said it had no comment. However, a spokesman for the Federation of State Medical Boards called the statement inaccurate.
Federation spokesman Joe Knickrehm said in an email: “State medical boards rely on a number of information sources including the public, patients, and peers to conduct investigations of physician misconduct. In many cases, such as these examples in California and Florida, the medical boards investigated such complaints and ultimately acted to permanently revoke the licenses of the physicians involved,”
Knickrehm said the federation formed a work group in 2016 to evaluate the “prevalence, promotional practices, and incidences of patient harm related to regenerative medicine and adult stem cell therapies” and plans to release its findings in May along with guidance for regulators and state medical boards.
Extinguishing the current blaze of unregulated clinics could amount to “a huge task that the (FDA) has indicated they may not have the bandwidth to tackle in total,” Knoepfler wrote.
But he added, “Even acting on say the top 20 firms that the agency views as the highest risk could have a positive domino effect.”
So far that has yet to be seen. There has been an uptick in enforcement under FDA Commissioner Scott Gottlieb, MD, who took over in May 2017.
In the latest action, the FDA said American CryoStem was “putting patients at risk” by manufacturing a stem cell product derived from patients’ fat tissue that was potentially contaminated with microorganisms or may have had “other serious quality defects.”
The FDA said physicians had been directed by the company to administer the product by various routes including inhalation and injection or infusion into the central nervous system.
There was also “little basis on which to predict how the product will perform in a patient,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release. “In addition, this product may also cause harm to patients who may put their trust in an unproven therapy and make the decision to delay or discontinue medical treatments proven to be safe and effective.”
Turner said he doesn’t think these actions amount to a “crackdown,” as some media organizations reported last August. “The new FDA commissioner is adept at issuing press releases and providing assurances about more robust regulatory oversight,” he said via email. “Whether such representations will translate into meaningful action by the FDA is not yet clear.”
Knoepfler agreed: “I hope more is coming, but we’ll see.”
Click here to see a compilation of our recent stem cell coverage.