What does the wide stem cell and regenerative medicine community think of California’s new stem cell law requiring that clinics selling non-FDA approved stem cell offerings make specific disclosures to prospective customers and that the state medical board keep track of how this all unfolds?
You probably already know that I am supportive of the California law. With more than 100 clinics in California as of last year marketing non-FDA approved “treatments” and this number apparently increasing, something needs to be done to protect patients. You can see the 2016 map of just the S. California clinics at right from Leigh Turner and my Cell Stem Cell paper last year.
Notably, Texas also has a stem cell law, but one that is not ideal overall and tends toward promoting stem cell businesses relatively more than protecting patients. Due to the efforts of some stem cell advocates in that state, the Texas is not nearly as bad as it started out.
Below I’ve listed some of the reactions I’ve seen ranging from stem cell scientists to policy makers to clinics themselves.
From stem cell scientist Jeanne Loring:
“This is a really good start to educating people that the FDA is working to approve safe effective stem cell therapies, and warning people that the unapproved clinics only care about money, not people’s health.”
From the Sacramento Business Journal, stem cell scientist and former President of ISSCR Sean Morrison supports the new stem cell law, but emphasizes as well that more needs to be done:
“The new law is “one small step in the right direction (to ensure) consumers are informed,” he added, but it will be important for the FDA and state agencies to remain vigilant against unscrupulous stem cell clinics. Morrison suggests that one reason the number of clinics increased in the first place is because the FDA was too lax in its oversight.”
I agree that more needs to be done, but sometimes progress is in steps.
And from the same article, the operator of the Nervana stem cell clinic here in the Sacramento area (see my past posts on it here) also says he supports it:
“Locally, Dr. Tushar Goradia, president of Nervana Stem Cell Center in Fair Oaks, said he supported the law. “I am in favor of it and anything that improves patient awareness and informs consent,” he said.”
I’d be curious if Dr. Goradia believes the law applies to Nervana or not, which seems to predominantly sell non-FDA approved amniotic stem cell therapies.
Some amniotic stem cell clinics have argued that they are exempt from FDA oversight, but an important issue is whether such firms are using living cells (and if so, are these really “stem cells”?), as they most often seem to be marketing, or just dead extracts of amniotic membranes. In either case, could the products still be considered drugs because of non-homologous use (e.g. injection into a knee joint, as joints have no homology to amniotic membrane).
A bit of other coverage out there so far including from David Jensen and RAPS.
Comments on Tuesdays’ blog post here on the new law range from skeptical it will have much impact to criticism of the FDA.
I saw a number of reactions on Twitter. From Tim Caulfield and Blake Murdoch:
Nice! Indeed redundant, but the providers of these unproven therapies don't seem to respond unless we target them directly. Great news!
— Blake Murdoch (@BlakeMMurdoch) October 3, 2017
From Leigh Turner:
New CA law requires health care providers to disclose when advertised stem cell interventions are not FDA approved https://t.co/vajn0k2khc
— Leigh Turner (@LeighGTurner) October 3, 2017
From Geoff Lomax:
A win for patients considering #stemcell treatments; CA lead the way on Right-to-Know about unproven treatments: https://t.co/KFqME0H2O1
— Geoff Lomax (@Geoff_Lomax) October 3, 2017
What do you think of the law?
Perhaps the state should work on redirecting the remaining CIRM funds to something tangible, like roads?
http://www.ocregister.com/2017/10/07/take-a-scalpel-to-345-million-in-californias-stem-cell-research-waste/
As someone dealing with chronic illness, my concern is that any governmental regulation might slow down the rate of innovation. It’s important to remember that there are desperate people out there who are willing to take on the risk of bleeding edge treatments, so long as there is hope of a cure.
Yes, ours is a demographic that can be taken advantage of; but rob us of our hope, and we are left with nothing. There needs to be an officially sanctioned option for folks who want high risk/high reward treatments.
Thanks for that important perspective. Hang in there, Nigel!
The FDA is too busy regulating bakeries! It’s comforting to know they are so vigilant at keeping us all safe.
https://www.washingtonpost.com/lifestyle/food/the-latest-fda-bakery-had-violations-besides-love-label/2017/10/04/ccf733a8-a963-11e7-9a98-07140d2eed02_story.html?utm_term=.b74c5106a638
Just put another sign next to it that says, “Our treatments fall under the practice of medicine in California. They are not FDA-regulated drugs.” and back to square one. Either the FDA publishes and enforces federal regulations or they don’t. This law will have no effect at all other than the minor inconvenience of posting a sign after being caught without one the first time.
If you sell a product with a purported benefit, shouldn’t you be legally and ethically obligated to demonstrate your product can deliver the promised benefit? In God we Trust, everyone else needs evidence.