Wednesday, October 04, 2017

California Moves to Protect Patients Seeking Unregulated Stem Cell Treatments

Beginning next year, California will have a new law that imposes the first-ever disclosure requirements on currently unregulated stem cell clinics that offer therapies that have not been approved by the Food and Drug Administration.

UC Davis stem cell scientist Paul Knoepfler, who for years has raised concerns about such clinics, wrote an item yesterday about the new law for his blog. It was headlined:
"Groundbreaking new California stem cell law gives consumer protections on clinics"
Ed Hernandez, Daily News photo
The measure is the first of its kind in California and probably the entire nation.  Authored by state Sen. Ed Hernandez, D-West Covina, it will require clinics to specifically notify its customers that he or she is about to undergo a treatment not approved by the FDA. The notification also must include advice encouraging customers to consult their primary care physician prior to undergoing a stem cell therapy.

A legislative analysis of the bill, SB512, cited a statement from the Center for Public Interest Law that said, 
"It is critical to patient safety that these individuals are not misled into believing they are partaking in an FDA-approved clinical trial and assuming serious health and financial risks in the process. The disclosure notices required by this bill are an important step in ensuring that patients have the information they need before making such monumental decisions about their treatment."
Paul Knoepfler, UC Davis photo
Knoepfler co-authored a research paper in 2015 that documented  the presence of nearly 600  unregulated clinics nationwide with California leading the way. He wrote on his blog, 
"Taken together, the provisions of this law will help consumers learn more about the stem cell clinic industry, make better decisions about their health and that of their loved ones, and delineate the difference between stem cell clinics versus compliant researchers conducting stem cell clinical trials with FDA approval.
"In the big picture, this new California law plus a more active FDA on the stem cell front together give me more hope that the wild west of stem cell clinics can be reined in sooner rather than later! Perhaps other states will follow suit with new laws and state medical boards will get more involved in overseeing stem cell therapies. With more 570 stem cell clinics in the US and more than 100 here in California alone, more efforts like these are needed on the consumer protection and educational outreach front."
Knoepfler deserves great credit for his efforts regarding unregulated clinics. It is fair to say that without his work, California would not have seen this law at this time. He was the first to document the size of the industry with the 2015 article, co-authored by Leigh Turner of the University of Minnesota.  Their work makes it abundantly clear that scientists can make a real difference on public policy issues if they are persistent and effective. One of Knoepfler's key tools was blogging, a practice that some scientists think is less than dignified. Nonetheless, his blogging helped to elevate the issue and served as a source for the news media as they looked into the matter. 

Like most new state laws, the law takes effect Jan. 1, 2018.
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