Monday, October 03, 2016

'Hands Off My Cells' -- Reaction to Proposals to Change FDA Stem Cell Research Rules

A California scientist has plunged into the jungle of 4,000-plus comments dealing with the federal government's proposal to change regulation of stem cell research and has discovered an intense sense of ownership on the part of many. 

Paul Knoepfler of UC Davis yesterday wrote on his blog,
"In fact more than 700 use the exact same phrase 'My cells are MY cells' and it looks like hundreds more comments have the exact same or similar language is used in more extensive forms. 'My cells are my property.'  'My cells are mine.'" 
In all, Knoepfler said that the Food and Drug Administration(FDA) had received 4,251 comments by the time the comment period closed. The comments showed a clearly organized effort by one segment of the public. He said the general sense of many was:
"Keep your hands off my cells!"
Knoepfler wrote,
"It would seem the point is that these particular commenters believe that cells taken from their bodies should not be regulated as drugs under any circumstances.
"Everyone is of course entitled to their own opinion, but cells can be drugs if they are changed or used in ways that are not homologous because these factors make them have higher risk to patients. To ask for cells to never be regulated as drugs is asking for chaos and many harms to patients, but people may not realize that."
California's $3 billion stem cell agency is among those seeking changes in the FDA guidelines. The FDA has not set a public timetable for action on new rules, which Knoepfler and others have said are needed to deal with "an out-of-control, direct-to-consumer stem cell clinic industry."

Knoepfler surveyed the industry earlier this year and reported nearly 600 unregulated clinics operating nationwide. It was the first time that the size of the industry has been documented.++ Sphere: Related Content

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