By Jeanne Loring
Paul did a good job of giving an overview of the FDA meeting today. Being in the room, I have a few observations that complement Paul’s. I’ve never been to a meeting like this- there were 42 scheduled 5 minute presentations, and this is just the first of 2 days.
The question asked by the FDA is “what should we regulate?” and the answer from the majority of speakers was “don’t regulate the things that we’re doing!”
A panel of FDA representatives sat at a long table at the front of the auditorium; interestingly, 7 of the 8 were women. The 4 draft guidelines were concerning homologous use, minimal manipulation, same day surgical procedure, and adipose tissue. Not surprisingly, the goal of most of the speakers from clinics was to argue that the procedures they use are same day surgeries that use minimally manipulated cells that after transplantation serve the same function as the tissues they were derived from (homologous use). They do NOT want to be regulated by the FDA.
Some of the talks were entertaining; most were quibbles about the language of the guidances. Many were alarmed by the use of the word “main” instead of “basic” to describe the structural function of adipose tissue (from liposuction). I’m serious.
The clinics, in general, wanted the FDA to define the fat as having non-structural as well as structural functions. This would allow them to isolate cells from fat and inject them into the bloodstream, a popular treatment at many clinics, without FDA oversight.
There were amusing incidents, such as when Randy Mills used a metaphor to describe the FDA regulating rapidly developing stem cell therapies; it was, he said, as if the Wright brothers had just gotten their plane off the ground, and returned to find an FAA official who explained that he was going to regulate their planes. I also liked Arnold Caplan’s “apology” for naming the stromal cells he extracted from bone marrow 40 years ago “mesenchymal stem cells”. They aren’t stem cells, he said, but rather cells that secrete factors that may be useful for healing in some cases.
At the periphery there were the victims of reckless stem cell clinics. A man wore a sign that said he was blinded by a stem cell procedure. A woman I met while standing in line for the bathroom told me that her husband and 6 others had been blinded at a Florida clinic. In his case, she said, he did not sign the paperwork that would prevent him from suing the clinic, so they’ve found a lawyer.
Tomorrow there will be a lot of individuals recounting their experiences at unregulated clinics. From the applause whenever a speaker said they should not be regulated, I expect that most will be glowing. But I hope, for balance, that a few will report negative experiences. I haven’t decided what to say when my time comes tomorrow afternoon.
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