Tuesday, July 05, 2016

Influential Scientific Journal Rips Effort to Loosen Stem Cell Research Rules

The prestigious journal Nature today editorialized against easing federal regulation of stem cell treatments, a major blow to the campaign by the California stem cell agency to speed such therapies to the marketplace.

The headline on the piece said,
"FDA should stand firm on stem cell treatments."
The unsigned editorial declared that those who contend that the Food and Drug Administration (FDA) is holding back "effective therapies" are peddling a false narrative. Nature declared,
"The claim that regulation is too harsh wrongly implies that the FDA is holding back therapies that work. Critics point to decades of preclinical and clinical work with stem cells and the pipelines of stem-cell treatments. With circular logic, they argue that, because the treatments have not been approved, there is something wrong with the approval system."
The $3 billion California stem cell agency has been lobbying for months for changes in FDA regulation. Randy Mills, president of the California Institute for Regenerative Medicine(CIRM) as the agency is formally known, said back in December that "patients are dying" because the FDA is  being "so careful about safety."

Mills has said the fast-track process in Japan is worth considering. However, Nature said,
 "It is not a fit and proper model to export, chiefly because it grants 'conditional approval' to treatments with minimal safety data and little attention to efficacy."
Nature was also critical of the Regrow Act, a legislative effort to overturn the FDA's current processes. CIRM has not taken a position on that bill.

Nature concluded,
"The FDA should strive to keep this debate on the proper topic — how to create a more efficient system that still scientifically evaluates whether treatments are safe and efficacious. To fall short would be a setback for science, and for patients."
The journal's editorial did not mention CIRM or Mills by name. It did cite the recent article by UC Davis stem cell researcher Paul Knoepfler and Leigh Turner, an associate professor of bioethics at the University of Minnesota, documenting the existence of 570 dubious stem cell clinics in the United States. Sphere: Related Content

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