Thursday, September 19, 2019

California Regulators and Dubious 'Stem Cell' Clinics: Possible New Rules Sometime Next Year

The California state Medical Board is expected to come up with new regulations to deal with rogue "stem cell" clinics sometime next year, the San Francisco Chronicle reported yesterday. 

The rules could require more patient education about the treatments and risks as well as providing more information to physicians about federally permissible treatments. The chairman of the state's $3 billion stem cell agency has described the unproven treatments as "snake oil."

The Chronicle story by Erin Allday emerged from a hearing yesterday by a small panel of the Medical Board. Any proposal for more regulation would have to go to the full board and run through the lengthy state administrative process before taking effect.

UC Davis stem cell scientist Paul Knoepfler, who also testified at the hearing, wrote about the session on his blog. He said that physician and patient education could be "helpful." He added,

"(B)ut I wonder whether the board will actually take more direct action on the few physicians who are arguably running the riskiest clinics here in our state. Such a step would do the most to rein in the problem."
Knoepfler, who has long studied the dubious clinics, described yesterday's hearing as a "positive development." He added, 
"I just don’t know how much concrete action will come out of it and when."
Chronicle reporter Allday wrote,
"The state has come under increasing pressure by stem cell experts to tamp down on the booming consumer industry in recent years, but almost no action has been taken. Wednesday’s meeting in Sacramento, attended by a few dozen scientists, patient advocates and stem cell providers, was largely informational, and medical board representatives repeatedly noted that they have limited authority over the industry.
"But they also acknowledged concerns that 'some providers are deceiving patients and placing them at risk,' said Dr. Randy Hawkins, co-chair of the stem cell task force organized by the California Medical Board."
Also testifying was the president of the state stem cell agency, Maria Millan. Here is a link to an item earlier this week on Millan's presentation.  

Here are links to a presentation by Mehrdad Abedi of UC Davis, a specialist in bone marrow transplantation,  on biologics regulation of stem cells and to a presentation by Charity Dean, assistant director of the State Department of Public Health.
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