R-r-regulation? Hmm. Not really.

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Yesterday, we spoke about the proliferation of stem cell therapy (sic) centers  in America.  After all, these clinics are not regulated by the Feds, which leaves the business open to every single snake oil salesman and saleswomen.  Most of these slimeballs promise to extract vital stem cells from the fat in our bodies (I don’t know about you, but I have a lot of those to donate) to create medical miracles.

Too often, these miracles turn out to be terrors.  The Federation of State Medical Boards released a report in May (7 May 2018, the report is dated April 2018), after a year of study, that outlines a framework by which state medical groups can begin controlling these gin mills.   Below are the 10 recommendations that were issued in December, before the final report was issued.  The final report (I’m using their terminology, not mine) didn’t go much further;  I’m guessing they couldn’t develop the necessary consensus to do so.

FSMB Proposed Stem Cell Regulation

And, given that the Feds have been sitting on their hands, the states (even before the FSMB report) are starting to get into the act- sort of.  Like California and Washington, which wants us to think they are protecting us, passed a law stipulating that these snake oil folks must notify us that their treatments were unapproved.  (You do remember that it is illegal to regulate the practice of medicine- unless it involves abortion.)  Moreover, these “clinics” use the patients own (fat) cells to produce the stem cells; as such the clinics can claim they rely upon approved outpatient surgical procedures (liposuction).plus by using our cells, they don’t ‘legally’ produce any new drugs.

And, given the problems that have already manifested from these stem cell “cures”, the FDA believes it now can regulate the industry.  Because the stem cells are produced to treat diseases, the cells require significant processing before their use, and the clinics employ technology and the cells in ways beyond their original purpose.

Given the fact that the Congress passed the “Right to Try” Act– and it was signed into law by the President on 30 May, 2018-, controlling these trolls is going to be a bit more complicated.   While manufacturers are generally reticent to let anyone try an unproven drug (the law just means the firms won’t go to jail selling or providing these untested therapies to “desperate” patients, those who “have no medical hope”), when it comes to these stem cell entities,  it’s strictly a money-making issue.  They’ve been trying to con patients to use their wares; this law just may mean the center can’t be prosecuted.  Nor is it  clear to me that there will be any real regulation of stem cell clinics, thereby ensuring the safety of patients.  Because there’s too much money to be made. (And, there’s no need for these charlatans to have to deal with insurance claims- because insurance won’t cover these “therapies”. And, those desperate patients will fall for any “online testimonial’ despite the lack of credible evidence.)

Maybe, we can just decide to allow stem cells to be used for research and therapy- so that bona fide treatments that work, that will be tested, and will help manifold patients, shall become available.

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5 thoughts on “R-r-regulation? Hmm. Not really.”

  1. I’m so amazed that stem cell clinics aren’t regulated by the feds! It does seem like something that should be standard. I was equally as amazed this week when I heard about the atrociuos behavior of cosmetic surgeons in the States – another field that isn’t regulated and anyone with a medical certificate and a knife can call themselves a cosmetic surgeon without actual qualifications as a plastic surgeon (because they’re not calling themselves a plastic surgeon they can get around it). Boggles my mind!!

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