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.
I think botttom line very straight forward has FDA approved any stemcell treatment thanks donng
@admin – Perhaps you can offer your readers a bit of balance and post Richard Jaffe, ESQ version of what’s been happening at the FDA meeting?
http://rickjaffeesq.com/2016/09/13/fda-draft-stem-cell-guidance-documents-exposed-improper-rulemaking-bad-science-heartless-public-policy/
…as a blog post, not just as a link buried in the comment section.
You are obviously not happy with the contributions on this blog Bill – why don´t you start your own?
I didn’t say that I was unhappy with this contribution. It’s just as valid as any other. However, I was just trying to point out that Dr. Loring is obviously biased, to wit, her rather sarcastic and inaccurate statement regarding the use of the word “main” vs. “basic”. No one at that meeting argued that “main” should be replaced by “basic”. The point was whether cells and tissue have only one “main function” or can have several “basic functions”, which is not a trivial matter under the circumstances.
Anyway, I just thought it might be informative for you to present another, basically opposing argument to give your readers a better flavor for how experts in different fields interpreted the proceedings. That is how “bridges are built” is it not? How can you build bridges if you won’t give a real voice to those with opposing viewpoints?
Of course it’s your blog and you can choose what gets published on it. For my part, I don’t think I’m going to run out and start my own blog over this, but thanks for the idea.
Since we are on the subject of blog posts and have already determined that I am not going to start my own blog, I think it would be interesting for someone to look up the meeting’s speakers on the Internet and post which affiliations turn up.
I did so today (a little) and found some interesting information like doctors railing against using amniotic membrane for wound care just happened to associated with competing wound care companies. Who da thunk it!
I am sure there are examples to the contrary as well.
…and Richard Jaffe already has his own blog. I am just passing along what he wrote in it.
@admin – My apologies. I just noticed that you did not make the comment suggesting that I start my own blog. It seemed out of character and I should have double-checked who posted it. Nevertheless, I stand by my comments and I do appreciate the fact that you publish them.
Bill: I think the issue wasn’t “main” or “basic”..it was the “s” on functions.
I think we are splitting hairs here. The point is whether cells or tissue should be allowed to have one function or many functions. I thought your statement, “I’m serious”, in reference to this issue was disingenuous at best and needed clarification for those who did not watch the proceedings.
The issue was “main function” vs “basic function or functions”. The former allows for a single “main” use and no others. The latter is much less restrictive and accounts for the fact that cells or tissue can have more than one possible use.