Oceanside Firm Disappointed by NIH hESC Proposal

A California stem cell company has filed a strong critique of the NIH's proposed rules for human embryonic stem cell research.

International Stem Cell Corp. of Oceanside Tuesday said it was “surprised and disappointed” by the draft guidelines.

The company said the government is proposing to fund research that involves the destruction of human embryos while barring funding for research that uses cells from unfertilized eggs (parthenogenetic stem cells). International Stem Cell uses unfertilized eggs.

The firm said in a news release that use of such cells has been approved by CIRM and three independent embryonic stem cell research oversight committees in the United States.

International Stem Cell also said the proposed NIH rules will limit opportunities for U.S. researchers, potentially lead to lost jobs and researcher flight to other countries and create a de-facto monopoly for two organizations that control most of the patents for current embryonic stem cells.

Latest CIRM Comments on NIH hESC Rules

Here is a link to the most recent version of CIRM's comments on the proposed NIH rules on human embryonic stem cell research. Comments to the NIH must be filed by May 26.

CIRM Seeks Changes in NIH hESC Plans

The CIRM board of directors today approved recommendations for changes in proposed NIH rules for research involving human embryonic stem cells.

The action came on a 20-0 vote in a session during which directors were told that 7,000 responses to the rules had been received by the NIH. CIRM Chairman Robert Klein said the responses were running 7 to 1 against.

CIRM supports the NIH plans with some changes. The opposition appears to oppose them outright for religious reasons.

Board members were encouraged to individually call on their constituencies to file comments on behalf of hESC research with the NIH. Philip Pizzo, dean of the Stanford School of Medicine, said he had already done so in his weekly newsletter and emailed a copy of his comments to board staff for wider distribution.

Klein said the agency could not legally ask all its grant recipients in a “mass mailing” to support hESC research, but he said individual board members were free to do whatever they wished.

Geoff Lomax, senior officer for the CIRM Standards Working Group, developed the recommendations following a public hearing and contacts with researchers. He said the suggestions were aimed at avoiding the loss of material that is needed scientifically and already in use.

The document presented to the board will be refined by attorneys and staff before it is sent to the NIH by May 26.

Public CIRM Hearing Next Week on NIH hESC Rules

If you are interested in the proposed NIH regulations for hESC research and California's reaction to them, put a May 7 meeting of the California stem cell agency on your calendar.

Not long after the CIRM directors Legislative Subcommittee Monday approved creation of a task force on the subject, a meeting with teleconference locations in San Francisco, Elk Grove, Los Angeles, Healdsburg and Duarte was scheduled for next week. Specific addresses can be found on the agenda.

Comments on the proposed rules must be submitted by May 24 to the NIH. You can read more on what CIRM has done so far here, but keep in mind that this is very much a work in progress.

CIRM Panel to Debate NIH Rules This Morning

The San Francisco Chronicle this morning carried a stout defense of the NIH's proposed rules for human embryonic stem cell research just hours before the California stem cell agency is scheduled to debate the proposal.

The proposed regulations, opposed by some scientists in California, were endorsed Jesse Reynolds of the Center for Genetics and Society of Oakland, Ca., in an op-ed piece in the Chronicle.

Reynolds said the proposals were thoughtful and the "right thing to do."

He said that that barring federal funds for cloning-based stem cell research would help to prevent creation of a technical foundation for reproductive cloning, which "continues to tempt rogue scientists."

The CIRM directors Legislative Subcommittee is scheduled to take up the NIH proposal at 7:30 a.m. PDT today. The agency has only posted a cryptic agenda item on the subject and has not offered to the public any analysis of the regulations or a rationale for why CIRM should take a position on the federal plan.

We will have coverage of the meeting later today.

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 Pharmatech.com. 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 info@cirm.ca.gov.

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.

Snippets from Obama Stem Cell Media Coverage

Here are some tidbits from the vast coverage of President Obama's stem cell ceremony on Monday.

Nicholas Wade of the New York Times wrote:

“Members of Congress and advocates for fighting diseases have long spoken of human embryonic stem cell research as if it were a sure avenue to quick cures for intractable afflictions. Scientists have not publicly objected to such high-flown hopes, which have helped fuel new sources of grant money like the $3 billion initiative in California for stem cell research.

“In private, however, many researchers have projected much more modest goals for embryonic stem cells. Their chief interest is to derive embryonic stem cell lines from patients with specific diseases, and by tracking the cells in the test tube to develop basic knowledge about how the disease develops.

“...(M)any scientists believe that putting stem-cell-derived tissues into patients lies a long way off. Embryonic stem cells have their drawbacks. They cause tumors, and the adult cells derived from them may be rejected by the patient’s immune system. Furthermore, whatever disease process caused the patients’ tissue cells to die is likely to kill introduced cells as well. All these problems may be solvable, but so far none have been solved.”

Rob Stein of the Washington Post wrote about the job facing the NIH.

“The task of deciding what kinds of studies will be supported now falls to the National Institutes of Health, which finds itself confronting far more extensive questions than its officials were contemplating. It has 120 days to do the job.

“Among other things, officials will have to decide whether to endorse studies on cells obtained from much more contentious sources, such as embryos created specifically for research or by means of cloning techniques. “

Lynn Sweet of the Chicago Sun-Times carried, on her blog, a list of guests at the Obama ceremony. They included Zach Hall, first president of CIRM, and other Californians tied to the state's stem cell agency. The list did not include CIRM Chairman Robert Klein, but other stories indicated that he attended. The current CIRM president, Alan Trounson, was invited but did not attend.

Reporter Terri Somers of the San Diego Union-Tribune reported that Klein was at the ceremony and reported that he said the door is now open for more collaboration between California scientists and those in other states.

Somers also wrote:

“At a 'Free the Stem Cells' breakfast at the home of researcher Jeanne Loring of The Scripps Research Institute, scientists gathered to watch the event and toast Obama. Some were moved to tears, Loring said, because the president's actions validated research to which they have dedicated their careers.”

CIRM Presidential Search: Battey Approached

One of the directors of the California stem cell agency has approached federal stem cell chief James Battey to see if he is once again interested in seeking the presidency of the state's $3 billion research effort.

Nature magazine reported today that Battey, chair of the NIH stem cell task force, had been approached. He was a candidate for the position in 2005 but dropped out of consideration.

In a piece by Meredith Wadman, Nature reported that Battey "has been excused from all stem cell related work" at the NIH. He remains as director of the National Institute on Deafness.

Nature, which did not say which CIRM director had approached Battey, wrote:

"The search committee hasn't discussed a shortlist 'with any real seriousness,' member Joan Samuelson, founder of the Parkinson's Action Network, told Nature on 29 January. 'We need to think about what talents and what skill set we need in the new president. And we should be clear about that before we write a job description,' she said."

The magazine continued:

"Battey is highly respected within the NIH as an able administrator who rarely makes trouble, but who will speak frankly when necessary. During the controversy over tightened conflict-of-interest rules at the agency, Battey said bluntly that if it adopted the stringent set of rules thatwas first proposed, he would resign (see Nature 435, 397; 2005). The rules were loosened before they were finalized.

"Battey's absence from his NIH stem-cell duties became publicly apparent at a 19 January Senate committee hearing on human embryonic stem-cell research. There, Story Landis, director of the National Institute of Neurological Disorders and Stroke, testified on behalf of the agency. She is now acting chair of the Stem Cell Task Force. It has also emerged that Battey will not be attending a meeting of stem-cell funding agencies being held in Singapore this week."

When Battey withdrew from consideration for the CIRM presidency in May 2005, he told the California Stem Cell Report that the position at CIRM was "exciting and important" but that his current position at NIH was also an "important opportunity."

We queried Battey to see if he has more to say currently on the subject. He did not.

CIRM Scholar Produces Mouse Brain Finding

There it was – in the 4th paragraph of the press release – a CIRM scholar produces a newsworthy finding as the result of "some of the first research funded by the California stem cell agency," according to one reporter.

Rebecca Vesely of the Contra Costa Times highlighted the CIRM connection in her story about the research at UC San Francisco that suggests "stem cells in the brain have a surprising capacity to repair damaged tissue." She said that researchers indicated that "the findings could help in the quest for treatments of brain trauma such as stroke."

Chay Kuo, a postdoctoral fellow at UCSF, led the study. The press release from UC San Francisco said:

"Kuo is one of 16 UCSF CIRM Stem Cell Scholars – up and coming young scientists funded by the California Institute for Regeneration (sic) Medicine, established by California voters in 2004 to allocate $3 billion over 10 years to support stem cell research."

Vesely noted that funding also came from the National Institutes of Health. She also wrote:

"Kuo said he received a $45,000 stipend, plus funds for medical benefits and a $10,000 allowance for research costs.

"'It allows trainees independence,' he said. 'It's given me incredible freedom to do my research.'"

Obviously the research is of considerable interest, but what adds to it is the CIRM-funding connection. One of the abiding concerns at the agency is producing results that fulfill the promise of Prop. 71. This is the first such event the agency can point to, albeit only as a modest funding effort.

Kuo's research, to be published in Cell magazine, also received news coverage internationally, but there was little mention of the CIRM connection. Other California newspapers also do not seem to have picked up on the CIRM relationship. The agency itself has not posted anything on Kuo at the time of this writing.