Tuesday, September 13, 2016

The Wright Brothers, the Blind and Stem Cells: A Different Look at the FDA Hearing on More Regulation

A California stem cell researcher has filed a report that chronicles some of the details that help to provide a sharper picture of the events yesterday and today at 9000 Rockville Pike in Bethesda, Maryland.

Writing on The Niche blog, Jeanne Loring, head of the stem cell program at the Scripps Insitute, covered matters -- ranging from aircraft flight to the blind -- that came up at the Food and Drug Administration hearing into new regulation of stem cell therapies. .

Loring is at the hearing, which is underway again this morning, and will testify later today. Her item noted that the marathon yesterday included 42 presentations of five minutes each.

She wrote,
"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!'"
Loring continued,
"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 (president of the California stem cell agency)  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."
Loring predicted that today's session will include much from unregulated clinics. She said,
"From the applause (yesterday) 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 (this) afternoon."
Sphere: Related Content

No comments:

Post a Comment