Friday, April 05, 2019

Crackdown on Stem Cell Snake Oil: California's Approach vs. New York's

An attempt in the California legislature to take limited and preliminary action to regulate "snake oil" stem cell clinics stands in sharp contrast to this week's legal action by New York state's attorney general.

California's Assembly Health Committee has scheduled an April 23 hearing on the bill (AB617) by Assemblyman Kevin Mullin, D-San Mateo. Supported by the $3 billion state stem cell agency, it would require the state Department of Health to look into the dubious clinics next year and make recommendations to the legislature.

The legislative hearing comes as New York state attorney general Letitia James announced a lawsuit yesterday against a New York business that has performed what she said are unproven and rogue procedures on patients. 

The enterprise is called Park Avenue Stem Cell. A New York Times article by Reed Abelson said, 
"According to (New York) state regulators, Park Avenue Stem Cell also had ties to a California business, Cell Surgical Network, with roughly 100 affiliates around the country, that was sued by the F.D.A. (the Food and Drug Administration) last year. The federal agency is seeking a permanent injunction against Cell Surgical Network...."
California is taking a slower and more limited path than New York.  Mullin's legislation would do little to halt activity by the clinics this year. California's attorney general, Xavier Beccera, has not spoken out publicly on the issue. The state medical board has created a task force to look into the problem but it is unclear whether it has made any headway.

California has the largest number of the clinics, more than 100, according to a 2016 study and its authors. The New York Times said the businesses "offer people treatments that cost thousands of dollars, which patients typically pay out of pocket because health insurers refuse to cover the therapies. Some products have proved dangerous to patients, blinding some and causing severe infections in at least a dozen people."

UC Davis stem cell researcher Paul Knoepfler and Leigh Turner of the University of Minnesota were the first in the nation in 2016 to document the full scope of what the chairman of the state stem cell agency, Jonathan Thomas, has dubbed a "snake oil" industry. 

Regarding the New York lawsuit, Knoepfler was quoted by the Washington Post as saying, 
"The unmistakable message is that the firms' time to come into compliance is rapidly running out."
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