One Small Step Toward Regulating Dubious Stem Cell Clinics

California has enacted a law that begins to provide a framework for regulating the dozens of state stem cell clinics currently peddling treatments whose safety and effectiveness are dubious at best. The law, which sailed through Sacramento unopposed, goes into effect on January 1, 2018, and requires clinics to notify patients in writing if the treatments they offer have not been approved by the US Food and Drug Administration. It’s a start, but it’s only one small step in the right direction.

The notice must be “posted conspicuously in the entrance of the health care practitioner’s office” and also provided to the patient. In both cases, the paper must be at least 8.5 x 11 inches and the type size must be “no less than 40-point.” Failure to do so leads to a fine of up to $1,000 per violation. The Medical Board of California is charged with publishing, in its annual report, the number of complaints received and any disciplinary or administrative actions taken.

Paul Knoepfler, the UC Davis stem cell scientist who has become the California go-to expert on dubious stem-cell clinics, testified in favor of the bill, which he calls “groundbreaking.” He summarized reactions around the state in a blog post; they are mostly favorable though some are skeptical about how much difference it will make. David Jensen of the California Stem Cell Report blog applauds Knoepfler and considers it “fair to say that without his work, California would not have seen this law at this time.” The vice-chair of the California Institute for Regenerative Medicine’s governing board welcomed the law, and it was officially supported by the International Society for Stem Cell Research.

One problem, of course, is that reputable operations shouldn’t need this reminder, and disreputable ones are likely to ignore it. Or they might pay the fine and carry on, or move to Nevada or Mexico or even further afield. And yet no legislator voted against the bill on the grounds that it was too weak. That’s a little disappointing.

According to research conducted by Knoepfler and University of Minnesota Center for Bioethics’ Leigh Turner, there are over 100 stem cell clinics in California (some 570 in the US) selling unapproved stem cell products or interventions. There has been a flood of hype about stem cells for 15 years now directed at desperate patients who are vulnerable to promises of cures. There have been repeated journalistic exposés of stem cell quacks seeking to reach into the wallets of sick and credulous people.

And this is the best we can do? Well, it’s a start.

Previously on Biopolitical Times:

• Blinded by Bad Science and Bad Oversight
• Selling Stem Cells Honestly
• 60 Minutes Exposes Stem Cell Scams — Again
• Stem Cells Update: Clinical Trials, Possible Funds, Long-Range Visions and Short-Term Scams

Image courtesy of CGS.