Showing posts with label nature. Show all posts
Showing posts with label nature. Show all posts

Monday, November 16, 2020

California's $5.5 Billion Stem Cell Boost: The Journal Nature Reports on "Split" Views, Conflicts and Priorities

The internationally respected journal Nature today took a look at the $5.5 billion refinancing of California's stem cell research program in an article that is not likely to please its supporters. The headline on the piece said:

"California's vote to revive controversial stem-cell institute sparks debate

"The California Institute for Regenerative Medicine will receive billions in state funding — but some scientists oppose the plan."

The first paragraph of the article said, "(S)cientists are split over whether the California Institute for Regenerative Medicine (CIRM) in Oakland is a worthwhile investment for the US state — or for the field of stem-cell research."

In significant ways, the article by senior reporter Nidhi Subbaraman echoed important elements of an examination of CIRM that Nature published in 2008. The journal, in fact, warned at the time of "cronyism" at the agency. (See Nature's editorial here and the article by Erika Check Hayden here.)

Today's latest article in Nature said,

"(C)ritics of CIRM are concerned about oversight at the state agency, which has faced complaints about potential conflicts of interest among its board members for years. They also point out that the field has grown and now receives federal support, making state funding hard to justify — especially amid a pandemic that has imperiled California’s economy."
Comments about priorities and the failure of the $5.5 billion measure (Proposition 14) to correct governance flaws at CIRM were also carried by Nature. Subbaraman wrote,
"'Unfortunately, Proposition 14 sets a bad example for the use of public money for the advancement of science,' says Zach Hall, a neurobiologist who led CIRM as its first president between 2005 and 2007."

Nature continued,

"'You could argue that California would do better, economically and scientifically, to have a CRISPR institute,' Hall says, arguing that the revolutionary precision gene-editing tool is better placed to benefit from such a huge infusion of cash."

 Subbaraman quoted another former top level scientist at CIRM.

"'As scientists, everybody always welcomes additional funding,' says Arlene Chiu, former director of scientific activities at CIRM. 'But as a Californian, one wonders if there are better ways to do this.'"

Nature mentioned a $700,000 study of the agency by the Institute of Medicine in 2012, which recommended a major restructuring of CIRM along with steps to deal with its conflicts of interest, which the IOM regarded as a serious problem. 

The California Stem Cell Report, which has followed the agency since 2005, has analyzed CIRM's awards and reported earlier this year that 79 percent ($2.1 billion) has gone to institutions with links to members of CIRM's governing board. Members of the board cannot vote on grants to their institutions, but they control the direction of the agency and approve plans for all award rounds.

Most of the recommendations by the IOM were not implemented by CIRM or Proposition 14. Nature interviewed one of the members, Cato Laurencin, of the IOM panel that spent months examining CIRM, which financed the study.

Subbaraman wrote,

"'It is very exciting that Prop. 14 passed and that CIRM will continue its funding,' says Cato Laurencin, a biomedical engineer at the University of Connecticut in Farmington, who is not funded by the institute. 'This field is at a bit of an inflection point in terms of our understanding of stem-cell science.'"

Subbaraman's piece included comments from Robert Klein, the real estate developer who sponsored Proposition 14 and poured millions into the campaign for it. Klein was also responsible for writing the 17,000-word measure.

The Nature article said,

"Responding to the criticisms, Klein says he crafted the proposal with the guidance of multiple groups of experts, and kept the mandate deliberately broad to allow for flexibility as the field grows. 'There's an intent here,' he says, 'to have the agency be responsive to the development of science.'"

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.

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