Cause is Ignored and the Symptom is Scrutinized


Within the established mainstream medical system which includes hospitals, doctors, patients, researchers, and universities, you have the controversy of which regulatory body should have jurisdiction, FDA or Medical State Boards? We already know that decision was not open for discussion, thanks to the FDA. Now you have the FDA, solely structured to regulate mass produced pharmaceutical drugs enforced towards a few drug manufacturers and not prepared for unique medical procedures performed on an individual basis. An agency ill prepared to enforce a medical establishment with tens of thousands of doctors, clinics, patients, and illnesses. In conclusion, the FDA’s SC regulations would be like squeezing a square peg into many round holes.

We currently have an ongoing proliferation of stromal vascular fraction (SVF) treatments which are autologous stem cells derived from adipose tissues performed by liposuction that can be performed and administered at a doctor’s office. Doctors can attend weekend training sessions, then perform these procedures afterwards. Now you have potentially insufficient trained doctors performing liposuction at their offices, a potential recipe for disaster. The pro-FDA advocates are saying, “I told you so - this is why we need FDA regulations.” While the Medical State Boards stand on the sidelines scratching their heads saying, “Well, this is stem cell related, so I guess this is the FDA’s jurisdiction.” There you have it; SVF treatments being pushed into unchartered territory in which regulatory agencies scratch their heads not clear who has jurisdiction. That’s the symptom; SVF treatments caught in no-mans’ land. The cause would obviously be the FDA overreaching into what should be a medical procedure, and not having State Boards on the sidelines with their arms crossed. Hence, the unfortunate circumstances of a regulatory body with decades of experience to oversee and regulate medical procedures sitting on the sidelines. I predict that would not last long, until the day comes when researchers, media, and the FDA pressures the State Boards to come down on all doctors performing SCTs.

The consequences of SVF treatments being thrown into a jurisdiction battle opens up a tremendous opportunity for FDA advocates. When news media gets their hands on botched up treatments, you will have researchers crying out, “We told you so!” Meanwhile the wool will be pulled over the general public’s eyes by emphasizing the symptom as harmful. Meanwhile, the cause which has always been the FDA overreach gets ignored.

I wonder how autologous SCTs would be handled today if it was solely regulated and categorized as a medical procedure. I think autologous SCTs would be treated like any other safe mainstream medical procedure. They would probably be performed at hospitals and reputable clinics with all the proper protocols enforced by Medical State Boards. In addition, you probably would have medical insurances covering select autologous SCTs. There you have the other current symptom - hospitals seeing these treatments as alternative medicine. I leave the worse symptom for last which are the thousands of suffering and terminally ill patients caught in this bureaucratic mess.
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Pioneer Founding member
LLL6521 - You have really nailed it. Bureaucratic mess is right. The sad thing is that it didn't have to be this way.