Monday, April 20, 2009

CIRM and the NIH: A Stand on the Proposed hESC Rules?

Directors of the California stem cell agency next week will take up the proposed NIH regulations for human embryonic stem cell research that have triggered dismay among some scientists in the state and elsewhere.

The topic is on the agenda of the CIRM directors' Legislative Subcommittee meeting one week from today and then it comes before the full board the following day or two at its Los Angeles meeting.

In the eyes of some influential scientists, the proposed regulations are too restrictive. Irv Weissman of Stanford promptly criticized them last Friday as just substituting one ideology for another. Susan Fisher, co-director of stem cell research at UC San Francisco, also was not pleased. She told Lisa Krieger of the San Jose Mercury News,
"This mostly moves the line in the sand from 2001 to 2009."
Fisher said,
"We still desperately need CIRM and private funding,"
On the East Coast, reporter Ceci Connolly of the Washington Post wrote,
"'I am really, really startled,' said Susan L. Solomon, chief executive of the private New York Stem Cell Foundation. 'This seems to be a political calculus when what we want in this country is a scientific research calculus.'"
Generally, however, the proposed NIH rules received mild or better praise in most of the stories that we have seen. Jesse Reynolds of the Center for Genetics and Society in Oakland, Ca., wrote on his organization's blog, Biopolitical Times, that the NIH "got it right."

He said the regulations are "consistent with his (Obama's) campaign promises, consistent with public opinion, and draw lines in a way that will allow promising research to go forward while preventing potential abuses."

It was clear, however, that the NIH rules are very much a product that was based on a reading of public opinion about stem cell science, a fact that was mentioned in several stories.

Reporter Gardiner Harris of the New York Times also noted a bit of presidential political history, writing,
"During the campaign last year, Mr. Obama said he supported 'therapeutic cloning of stem cells,' a policy his administration rejected Friday. A White House spokesman, Reid Cherlin, said the president 'directed N.I.H. to formulate the best method for moving forward with stem cell research, both ethically and scientifically,' in an independent process."
CIRM's decision to place the regulations before its directors raises some interesting questions.
What does CIRM have to gain by entering this particular fray? Failure to oppose them will alienate some influential researchers and perhaps their parent institutions.

Supporting the rules could be regarded as institutionally self-serving and as an attempt to justify the continued existence of CIRM, whose origins were based on former President Bush's restrictive policies. Some of have argued that CIRM is now irrelevant, given Obama's moves and the changing nature of stem cell science. However, it is hard to see how $3 billion in research funding could be considered irrelevant by anyone. The NIH is certainly not going to fund all the fondest desires of even those who qualify under its proposed rules.

Also on next week's CIRM agendas are other federal matters that could place CIRM in the middle of a pharmaceutical war. Up for consideration by CIRM directors are two Congressional bills involving biosimiliars – HR 1427 by Rep. Henry Waxman, D-Los Angeles, and HR 1548 by Rep. Anna Eshoo, D-Palo Alto.

The Biotechnology Industry Organization does not care for Waxman's bill, declaring that it "would jeopardize patient safety and undermine future medical breakthroughs," according to Patricia Van Arnum of Waxman, of course, thinks differently.

He said his bill would "allow the Food and Drug Administration to approve affordable copies of biotech drugs." He said,
"Biotech drugs, while often life-saving, are the fastest growing and most expensive components of the nation’s prescription drug bill."
BIO favors Eshoo's bill, according to Van Arnum, declaring that it balances "the need to increase access, lower costs, ensure drug safety and promote continued biomedical breakthroughs."

The Legislative Subcommittee meeting will have teleconference access available 7:30 a.m. next Monday at seven locations: two in San Francisco and others in Portola Valley, Menlo Park, Elk Grove, Healdsburg and La Jolla. You can listen in and participate from those locations. If you are unable to attend, you may submit a statement by sending it to

The full board meeting does not have interactive teleconference access, but it may be available via the Internet and a phone line audiocast.

We invite comment on this item and CIRM's role in NIH affairs. You can submit comments by clicking on the word "comments" below. Anonymous comments are permitted.

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