When I was a kid growing up in South Florida, we made the yearly pilgrimage to Disneyworld. One of the attractions back then was Mr. Toad’s Wild Ride, which is what a new stem cell bill in Florida feels like. Let’s dig in.
Florida is Stem Cell Crazy Central
It’s no coincidence that the US Stem Cell cases happened in Florida. Near as I can tell, Florida is stem cell crazy central. For example, it’s got one of the densest maps of chiro owned clinics fleecing patients with fake stem cell offerings.
Hence, it makes sense that the Florida legislature has tried to put through bills to tame the insanity. Last year Florida HB 65 tried to institute that investigational stem cell procedures could only be performed directly by physicians. That made sense and would have made it harder for chiros to hire NPs and PAs on the cheap to staff their clinics, but the bill never got through the legislative gauntlet.
Florida HB 313
This year the Flordia House introduced 313 which is really just a voluntary registration of stem cell providers. However, I could immediately tell when reading the bill that things were a little strange. Take this insane paragraph:
“For purposes of this section, the term “stem cell” means an allogenic or autologous cell that is altered or processed to become undifferentiated, losing its original structural function, so that it can become differentiated into a specialized cell type. The term does not include cells that are only rinsed, cleaned, or sized and remain differentiated.”
Let’s unpack this mess:
- A stem cell is altered or processed to become undifferentiated? Huh? This sounds like it was written by one of the crazy chiros we feature on this blog. A stem cell is undifferentiated, but altering or processing it to become undifferentiated sounds like induced pluripotency.
- Losing its structural function? The FDA regs state that if structural tissue is being processed it must retain its initial structural function to be minimally manipulated and not a drug. In Florida, it’s the opposite? Again, this looks like this was written by somebody with dyslexia who read the federal 1271 regs.
- A stem cell becomes differentiated? The definition of a stem cell is that it’s more undifferentiated than a somatic cell. Again, a stem cell definition that was written by a dyslexic.
- This stem cell definition does not include cells that only rinsed, cleaned, or sized? This seems to be a reference to the 21 CFR 1271 FDA regulations on minimal manipulation, but here’s it’s being applied backward.
So are these just errors created by a staffer who doesn’t know which end is up? Or are these definitions intentionally messed up? I would have thought the former until I saw the additions to the bill described below.
Another Bizarre HB 313 Mess
If you thought that the above language in the original bill was a mess, just read this:
“A physician who registers under this section shall agree to adhere to the current applicable good manufacturing practices for the collection, removal, processing, implantation, and transfer of stem cells, or products containing stem cells…”
Let’s unpack this disaster. Physicians must adhere to cGMP (current good manufacturing practices) standards. While this term gets thrown around a lot by physicians who process cells, most have no idea what it actually means. cGMP is a drug manufacturing standard designed to safely manufacture millions of doses of pills. It contains all sorts of things like having a full-time compliance department. Or the fact that you can’t use sterile medical gases without independently testing each lot for sterility. Or not being able to use an FDA regulated disinfectant without first coupon testing it on all surfaces where it will be used in your facility and independently verifying that it kills the bacteria, fungi, or viruses you want to kill. Meaning running a cGMP operation is about a 1 million dollar per year cost.
Again, is the insertion of cGMP in reference to medical clinics just a bone head move by some doctor who doesn’t know what that actually means? Or is there a more sinister motive here? Again, I would have thought the former until I saw the new additions to the bill.
Mr. Toad’s Wild Ride and Cellular Compounding
HB 313 flew out of the house subcommittee in a unanimous 12-0 vote on 2/3/20. Last night, I was asked to take a look at what it had morphed into in the last 24 hours. Now a whole large section has been inserted that contemplates compounding pharmacies being able to sell and distribute more than minimally manipulated stem cells? I won’t bother you with all of the crazy details of the bill as it exists right now, but suffice it to say that if passed “as is”, the bill would allow federally illegal activities to be performed in Florida. This will set up a showdown between the state of Florida and the FDA.
So who’s behind this most recent expansion of HB 313? Compounding pharmacies? The providers in Florida who are still illegally culture expanding stem cells? Your guess is as good as mine. However, I’m beginning to think that the mangling of the language in HB 313 is no accident.
My recommendation to my contact was to kill the bill and start over. While a few things that have been added might put a dent in the crazy chiro stem cell clinics, creating a whole new industry of federally illegal stem cell compounding pharmacies is a really bad idea. Also, I’m pretty sure the whole bill was written by a dyslexic with ADHD who was off their Ritalin. Or, perhaps someone who’s as stupid as a fox who knows that most people won’t notice that this bill will open a whole new section of the stem cell and exosome wild west.
The upshot? If you’re in Florida, pay attention to HB 313. Ask your state representative or senator to kill it and start over. In the meantime, this whole bill looks more like what I remember of Mr. Toad’s Wild Ride than a sane approach to curb the excesses of the Florida stem cell crazies.