|In 2016, the scope of clinics selling unproven stem cell |
treatments was first documented. This 2016 map shows their
spread. Since then the number is estimated to have grown
from about 600 to more than 1,000.
The state Medical Board, which regulates physicians, last week told the California Stem Cell Report that its response to the clinics will be limited to "guidelines," which have not yet been drafted. The guidelines, if eventually approved, would not have the power of legal regulations. (See the board's full statement at the end of this item.)
More than 1,000 clinics are estimated to be operating in the United States with the highest percentage of them in California. Injuries involving fecal contamination and deaths have been reported. At least 20,000 persons are estimated to have been treated.
Nearly two years ago, the Medical Board first took up the issue and created a two-person "task force" to look into possible regulation. State legislation aimed at establishing regulations died quietly last year.
The Medical Board's update on its activities came as officials of the state's stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), called for stepped-up action against what some describe as "snake oil" peddlers.
The agency's appeal came in an article this month in the scientific journal Stem Cells Translational Medicine. Authored by Geoffrey Lomax, CIRM's senior officer for therapeutics, strategic infrastructure and public policy; Art Torres, vice chairman of the agency's board, and Maria Millan, president of the agency, the article cited reports of injuries and deaths caused by treatments "often administered by clinicians practicing outside their medical training."
The trio called for "regulated, reliable and reputable" standards for stem cell treatment in California as well as nationally. The Food and Drug Administration (FDA), however, has been attempting for a number of years to deal with the problem with mixed success. In a warning to consumers, it said,
"(D)on’t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures—and confirm what’s really being offered before you consider any treatment."Currently persons seeking the unproven treatments have no legal assurance that they are actually receiving stem cells.
Not all states are as passive as California in regulation of the clinics and employees. Last month, the Minneapolis Star Tribune reported that the Minnesota State Medical Practice Board disciplined a physician for making claims that haven't been proven in medical research.
Last April, the state of New York sued one clinic, declaring that the rogue clinics "shamelessly add to the suffering of these consumers by charging them thousands of dollars for treatments that they know are ineffective.”
The clinics operated generally unnoticed until Paul Knoepfler, a UC Davis stem cell researcher, and Leigh Turner, a bioethicist at the University of Minnesota, published an article in 2016 a scientific journal that laid out the size of the business.
The two have also noted the too-good-to-be-true pitches of the clinics. The officials of the California stem cell agency cited the case of a single product that was purported to treat "Parkinson's disease, multiple sclerosis, cerebral palsy, macular degeneration, osteoarthritis, strokes, heart attacks, and chronic kidney disease."
Writing earlier this month on his blog, The Niche, Knoepfler said that federal efforts have had some impact on the clinics. But he said,
"The bottom line though is that it’s not clear if all these state and federal actions are going to make a meaningful dent in the massive marketing of unproven stem cells in the U.S. Some kind of more assertive action seems necessary by regulators in the most extreme cases where, for example, the product in question is clearly a drug and has harmed patients."California stem cell officials said,
"(I)t is vital to (support) the continued development of promising regenerative medicine products while protecting patients from the risks posed by unproven interventions."Here is the full text of the statement that the California's Medical Board made to the California Stem Cell Report:
"The Board is continuing to work toward the goal of providing recommendations on stem cell and regenerative therapies and developing some guidelines that California physicians and patients can follow. Board staff is working on compiling the information discussed at the interested parties meeting into a document to be reviewed by the Task Force. The Task Force will then work with staff on developing a guidance document for physicians regarding stem cell and regenerative treatment that will include a sample informed consent document and educational materials for the public to present to the Board for review and final approval. The Board does not have a timeline to share at this time."