10/03/2017 | Press release | Distributed by Public on 10/03/2017 17:24
SACRAMENTO - California Governor Jerry Brown signed into law Senate Bill 512, authored by Senator Ed Hernandez, O.D., (D-West Covina), which requires health care providers to disclose to patients when they are performing stem cell treatments not approved by the U.S. Food and Drug Administration.
SB 512 requires any health care provider who is administering non-FDA approved stem cell treatments to post a notice in their office and provide a handout to each patient stating that the procedure has not been approved by the FDA.
'I authored SB 512 to establish protections for consumers seeking early-stage, unproven experimental therapies,' said Senator Hernandez. 'There are currently over 100 medical offices in California providing non-FDA approved stem cell treatments. Patients spend thousands of dollars on these treatments, but are totally unaware of potential risks and dangerous side effects. Thank you to Governor Brown for understanding the need for this law.'
According to a 2016 study published in the journal Cell Stem Cell, patients suffering with chronic diseases, such as arthritis, Alzheimer's, or Parkinson's, or serious trauma, such as spinal cord injuries, are seeking alternatives to conventional medications through unproven stem cell treatments. Adverse events due to non-FDA approved injections of stem cells have included increased pain, tumor formation, and blindness.
'By signing this bill, the Governor has taken an important step to help patients in California know they are taking a risk when they purchase unproven stem cell treatments that have not been approved by the FDA,' said Hans Clevers, President of the International Society for Stem Cell Research, which supported SB 512. 'Many clinics have been selling unproven cell therapies, which often have little basis in science or medicine. At least by requiring that clinics acknowledge when treatments have not been proven to be safe or effective, Californians will be able to make more informed decisions about their healthcare.'
'SB 512 addresses an important aspect of the California Institute for Regenerative Medicine's (CIRM) mission,' said Art Torres, Vice Chair of CIRM's Governing Board. 'We aim to accelerate the delivery of stem cell treatments to patients, emphasizing on safe and effective methods. Disclosure of unproven stem cell treatments will increase awareness of potential risks for patients and may encourage them to seek out FDA-approved clinical trials that are conducting carefully designed and monitored studies.'