The big news of the week was the big FDA stem cell in court by Judge Jesus Bernal here in California, who ruled in favor of a chain of stem cell clinics called Cell Surgical Network. The FDA had been seeking an injunction against the clinics.
I believe the ruling was founded in part on at least three major scientific mistakes by the court. That makes the result all the more frustrating.
Here’s Michael Hiltzik’s column on the ruling. In blow to public health, judge tosses FDA lawsuit targeting a clinic offering unproven stem cell treatments, LA Times.
Sue Sutter at Pink Sheet also covered the verdict.
You can see a chart above of how FDA stem cell oversight decisions are supposed to be made. Judge Bernal threw a monkey wrench into that at least for a time.
Before I go on to our weekly recommended reads, please check out The Niche educational piece, What are stem cells? which I have extensively updated now in 2022.
It just seems to me that the FDA was reactive rather than proactive to work already having taken place clinically regarding the autologous use of one’s own cellular material. I cannot adequately address the tragedies that took place involving the blinding of patients who received adipose derived SVF into their eyes. My experiences as a patient of regenerative medicine is limited to bone and joint issues only since 2014. I wish Judge Bernal would have taken issue with FDA concepts like “more than minimal manipulation” and “homologous use”. Neither of these terminologies seem at all scientific to me. In fact they seem rather arbitrary and subjective.
It seems (to me) that FDA was drafting their guidance documents effectively restricting the autololgous use of stem cell material even after clinical literature was already reporting success in terms of safety and efficacy for at least bone and joint issues. This is what I mean when I say that FDA was being reactive to reported clinical success. Essentially it seems to me like FDA was making up the rules as they went along with preconceived notions of exercising power rather than upholding the health concerns of the public. What comes to mind here is the manner in which FDA changed their CFR’s that originally allowed the agency regulatory authority over only the allogeneic use of cellular material, (From one person into another) This original Code of Federal Regulation actually makes sense to me from a public health perspective. The original CFR 21-1271 did not include FDA regulatory authority over the autologous use of a person’s own cellular material. Then in April of 2006, FDA made a one word, unilateral change to CFR 21-1271 switching out the word “Another” and putting in its’ place the word “A”. Doing so, FDA effectively granted themselves greater regulatory authority over BOTH the allogeneic AND the autologous use of the publics own cellular material. Doing so conflicted with the the Administrative Procedures Act which dates all the way back to the 1940’s. My understanding is that FDA authority is supposed to come from Congress; not from the FDA itself.
https://www.youtube.com/watch?v=XSgFWw-p_XU
Why Judge Bernal and the legal authorities who preceded him in the U.S. Stem Cell and the Regenexx case did not call attention to this FDA linguistric “sleight of hand” is a mystery to me. Still I am grateful that Judge Bernal ruled in the manner that he did. Michael Hiltzik’s piece from the L.A. Times seems about as objective (to me) as “More Than Minimal Manipulation” itself. His reporting to me seems an outstanding representation of opinion journalism.
The AMD trial is incredibly exciting and hopeful. The IPS route seems to be the way that therapies are going to have to go in order to get these treatments into doctors’ offices. (Again– and this probably won’t be the last time I’ll say this– the influence of politics and religion is responsible for these treatments not already being available for patients right now. I’ve seen this at boots-on-the-ground level.) If this is what has to happen, then the fact that these trials are actually beginning in the US is a real light at the end of the tunnel. This is the only way to really stop stem cell clinics: genuine, approved treatments. Until they are finally available, we’re stuck with places like Cell Surgical Network. The bottom line is that like it or not, there is no hope of getting rid of these clinics until people can get real cures.
Dear Admin:
From my own experiences with legal actions concerning stem cell medicine, in the courts, scientific information always sits second to the legal factors, if it is considered at all. The FDA did a poor job crafting the stem cell treatment regulations, which are full of scientific inconsistencies and vague characterizations (which I have elaborated as concerns in many past articles and public postings that I will not reiterate here). Ambiguity and vague wording is the stuff that lawyers live for in their cases.
What the FDA needs to do is to craft documenting and reporting requirements for private clinics to operate, with the reported data being required to meet specific and enforceable regulations that are designed to protect patients from both physical harm and financial exploitation. It’s the failings of the FDA that got us into the present mess. The clinics are not going away until patients are no longer looking for help that they are not finding elsewhere. Instead of taking the blunt approach of trying to shut them down altogether, the FDA needs to develop a more strategic approach of regulating the quality of their clinical practice.
Bone marrow transplant didn’t start with clinical trials. It started with good clinical practice guided by increasingly better science. The FDA should consider codifying this history for managing the current problems in private stem cell clinics.
James @ Asymmetrex®