A risky new Florida stem cell law is likely to come into effect in a matter of weeks as the state senate and house both unanimously passed versions of their respective stem cell bills. I imagine that Florida Governor Ron DeSantis will sign it.
It will be effective July 1, opening the door to unproven cell injections throughout the state.
What would the new Florida stem cell law mean?
The new Florida stem cell law explicitly will permit a variety of non-FDA-approved cell therapies. In this way, it would increase the risks of consumer harm. There’s no reason to legalize non-scientifically or medically proven cell injections. Some physicians in Florida like Mari Mitrani are celebrating, but in my view Florida lawmakers are doing no favors to their citizens with this. From a past Cell Culture Dish item on Dr. Mitrani:
“Dr. Maria-Ines “Mari” Mitrani has been Chief Science Officer and Co-Founder of Organicell Regenerative Medicine, Inc. since 2015. Previously Dr. Mitrani co-founded the American Cellular & Anti-Aging Center in Quito – Ecuador, one of the first Autologous Stem Cell centers in South America and was instrumental in opening additional stem cell clinics in Guatemala, Trinidad & Tobago and Jamaica.”
Organicell is now Zeo Scientifix and is publicly traded. I’m not sure if Dr. Matrani is still at the firm. As a side note, the Chief Medical Officer is George Shapiro, who was also a leader at Fountain Life, a health and longevity firm that I’ve reviewed here on The Niche. Small world.
Getting back to the Florida bill, it talks about ethics. That seems to relate just to not including fetal or embryonic material in its scope. In my view, it is unethical to sell unproven cell injections, but the Florida bill does not appear to take that kind of view into consideration.
A final or near-final version of the bill appears viewable on this most recent amendment page.
There’s a lot not to like about it as it seems more pro-industry than prioritizing what’s best for consumers. Who is behind this law anyway? Certain unproven stem cell clinics and suppliers?
Felonies for certain things
There’s this specific clause:
“A physician who willfully performs, or actively participates in, the following commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 171 775.084, and is subject to disciplinary action under this chapter and s. 456.072: (a) Treatment or research using human cells or tissues derived from a fetus or an embryo after an abortion; or (b) The sale, manufacture, or distribution of computer products created using human cells, tissues, or cellular or tissue-based products.”
These days, I guess it’s no shocker that Florida would make it a felony for a physician to conduct procedures involving fetal or embryonic tissue related to abortion, but that’s still extreme. Is that just related to unproven fetal or embryonic cells? What if the FDA approves fetal or embryonic stem cell-based therapies? They still couldn’t be used in Florida without the threat of a felony charge? The language in the bill/law seems vague.
Okay, what about the computers part? What the heck?
Researchers have talked about making computers from human cells or tissues like organoids, which is a cool idea, but that doesn’t seem to be what this bill is referring to here. Maybe that clause was mistakenly included? Or they really mean to threaten felonies for that kind of biological computer research?
Exclusions
Which non-FDA-approved cells are covered by the upcoming state law? It emphasizes perinatal products, but others are included.
An earlier version of the bills excluded unproven adipose cells, but that seems to have been removed.
Oddly, the bill/law still apparently will exclude unproven bone marrow-based injections.
Some other vague language weirdly might also exclude unproven exosomes, which is another surprise. I would have thought clinics in Florida would want to have the state’s OK to infuse exosomes.
Perspectives: loopholes, synching with other states challenging the FDA
Unfortunately, while the law will require cells to first get a nod from industry groups like AABB, there seems to be a loophole there. Someone or a group deemed an expert could provide approval instead. The bill says that approval could come from “an entity with expertise in stem cell therapy as determined by the department.” Could unproven clinic groups including in Florida be defined as experts? I wouldn’t be shocked.
As a reminder, stem cell clinics and related groups in Florida have a long track record of harming patients including blinding them. Overall, this soon-to-be law is just going to make things much worse.
As I’ve written before, the Florida stem cell bill is also part of a wider state trend to weaken or go around the FDA.
After a flurry of warning letters on biologics last year, to my knowledge the FDA has issued none in the last 3-4 months. That could be just a normal pause or reflect transition time needed with the new administration. However, it could also be just the start of a long, risky period of FDA softness under RFK Jr., Makary, and Prasad on certain cell and tissue biologics oversight that will just be accentuated by these misguided state laws.
The computer language is likely about the CL1 brain cell computer that hit the news in March:
https://www.tomshardware.com/tech-industry/worlds-first-body-in-a-box-biological-computer-uses-human-brain-cells-with-silicon-based-computing
If that’s the device on the lawmakers’ minds, why make it a felony?
Thank you for your thoughtful comments.
The Florida law is an excellent and necessary step in the right direction. Other states should follow Florida’s lead. Amendments and further clarifications can always be made later as things play out. That’s how lawmaking works.
As far as “ethics” are concerned, I for one find it supremely unethical to deny disabled/sick/suffering people a viable/safe/potentially life-changing medical alternative to costly/ineffective/dangerous/potentially deadly pills and surgeries. That’s both unethical and inhumane.
Thus, while your concern for patient safety is clear, your interpretation of ethics seems a bit narrow and incomplete. The exposition of “ethics” must never be some patriarchal, top-down, elite-driven, ivory tower enterprise that ignores the voice of the people affected. That’s both unethical and dictatorial.
Indeed, the needs of the people must be accorded superordinate and preponderant consideration. By listening to the collective voice of its residents – at the same time articulating necessary medical and legal safeguards – Florida has, in fact, acted with the utmost ethics by legalizing SCT.
When I got my SCT in Nanjing, China in 2010 there were people there were on their second or third trip. I heard first-hand from them how SCT had improved their lives. Now, with Florida’s new law, Americans won’t have to travel as far as I did. There are no such things as small miracles.
It’s time to end the suffering.
Thanks again.
Rahman
As I’ve said before, increased access to unproven cells doesn’t help patients. Then throw in that the patients have to pay large sums of money and it is generally not ethical in my view. If the FDA properly monitors expanded access programs (compassionate use) for terminally ill patients or those suffering from life-threatening illnesses, that can give options but I still don’t think the patients should have to pay.