Consumer Watchdog Seeks Alteration of NIH Plan

Citing the “perverse effect” of proposed NIH stem cell research rules, the Consumer Watchdog group today called for changes in the guidelines along the lines recommended by the California stem cell agency and the Interstate Alliance on Stem Cell Research.

John M. Simpson, stem cell project director of the Santa Monica, Ca., group, said that the NIH plan would bar funding of research that had received financial support from the Bush Administration.

In a press release from his organization, Simpson said,

"Most of us were heartened when President Obama lifted Bush Administration restrictions on funding stem cell research, but the perverse effect of these proposed NIH rules is that the limited research scientists were able to conduct under Bush will now be ineligible for federal funding,

"Certainly this is not what President Obama intended and the regulations must be modified."

Simpson also noted that comments can be sent to the NIH online at the following Web site: http://nihoerextra.nih.gov/stem_cells/add.htm

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.

CIRM Backs Biotech Industry Legislation, Aiming for Greater Federal Influence

The California stem cell agency today performed something of a semi-reversal and endorsed industry-supported federal legislation that would set rules for creation of generic biotech drugs.

CIRM’s board of directors last month supported a move to develop a statement of principles on the legislation, declining to ratify a recommendation by its Legislative Subcommittee that it support the industry bill.

However, this morning the board decided to back the industry measure rather than acting on the statement of principles developed by its staff over the last two weeks. The vote was 16-2 with two abstentions.

The consensus was that the industry needed to be encouraged financially to develop therapies, generally following the arguments made at the board meeting April 28-29.

Board member Joan Samuelson of Healdsburg, Ca., a patient advocate representative on the board, today said,

“The overriding concern is getting therapies to patients.”

Board member Oswald Steward, chair and director, Reeve, Irvine Research Center, University of California, Irvine, said, however, the board “should not act like a political action committee.” He said it “should be respected as much as the National Academy of Sciences.”

Jeff Sheehy, another board member and director for communications, UCSF AIDS Research Institute, supported Steward’s position, declaring he had “a lot of problems supporting a particular bill.” He said it would take the board “fairly deeply into the legislative process.”

Several board members, including Chairman Robert Klein, argued that CIRM could not become a player on the legislation without taking a specific stand. A statement of principles was meaningless at this point, they said.

The bill backed by CIRM is HR 1548 by Rep. Anna Eshoo, D-Palo Alto, which is favored by the Biotechnology Industry Organization. The board took no position on a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles, which BIO opposes. The Generic Pharmaceutical Association opposes the Eshoo bill.

Some board members were concerned about irritating Waxman, including Gerald Levey, dean of the UCLA School of Medicine. He said he did not “want to see CIRM caught in a political battle because we have enough of those.”

CIRM Vice Chairman Art Torres, a former state legislator who worked with Waxman, indicated that relations with Waxman would not be a problem as long the board did not directly oppose the Waxman bill.

Torres also indicated that the competing proposals may be wrapped into President Obama’s health initiative, which Waxman would carry.

A subtext of today’s session concerned the extent of CIRM’s role as a lobbyist at the federal level. The statement of principles on the legislation made a strong case for federal activities by CIRM as did Klein. CIRM recently hired a powerful Washington lobbyist, the Podesta Group, on a $240,000, 10-month contract, but the board has never had a full-blown discussion about how far it wants to go in lobbying at the federal level. The state of California has its own lobbyist, who works out of the governor’s office, but few, if any, state agencies engage in major federal lobbying efforts.

To be a significant player on the federal scene requires a hefty effort. Spending on lobbyists (nearly 11,000 in all) totaled $3.3 billion last year, and that figure does not reflect all expenditures made in attempts to influence federal legislation and regulations.

We invite comment on this subject or others. You can comment by clicking on the word "comment" below. Anonymous comments are permitted.

More Info on CIRM Board Webcast

You will need the following conference ID number to log into the Internet audiocast for this morning's meeting of the board of the California stem cell agency: 100945.
The url is http://65.197.1.15/att/confcast

CIRM Debate on Federal Issues Available at Many Locations Throughout California

Federal biotech legislation and proposed NIH rules on hESC research are the topics early Tuesday morning at a meeting of the board of the California stem cell agency that will be accessible at teleconference locations throughout California and on the Internet.

Interactivity will not be available for the Internet audiocast, but will be possible at multiple locations, including San Francisco (4), Los Angeles(2), Sacramento, La Jolla(3), Pleasanton, Berkeley, Elk Grove, Healdsburg, Hillsborouugh, Irvine(2), Stanford and Beverly Hills. Specific addresses where the public can attend can be found on the agenda.

CIRM said that the meeting can be heard on the Internet by using this URL:
http://65.197.1.15/att/confcast

No background material has been posted yet for the meeting, but you can read more about the issues here.

Podesta, CIRM and the Biotech Industry

The federal lobbyist for the California stem cell agency is doing quite well financially so far this year, but the CIRM account represents only a tiny fraction of its business.

During the first quarter of this year, the Podesta Group raked in $5.2 million, up 50 percent from a year ago, according to a story by Kevin Bogardus of The Hill Web site. The Washington, D.C., lobbyist won a $240,000, 10-month contract from CIRM earlier this year. In addition to California's publicly funded stem cell research effort, Podesta counts some major players in the pharmaceutical industry among its clients.

Federal lobbying is a big business. Total spending in 2008 hit $3.27 billion (yes, Billion) in 2008, up from $2.84 billion the previous year, according to Opensecrets.org. But the number of federal lobbyists is down to 10,785 from 15,287 last year.

Podesta accounted for only $16 million of the 2008 total. Most of its clients paid the firm less than $500,000 last year. They include Amgen, $240,000; Amylin, $180,00; Cubist Pharamceuticals, $150,000; Millenium Pharmaceuticals, $200,000; Novartis, $210,00; Reed Elsevier, $690,000; Roche, $240,000; Sereno, $350,000; Sunshine in Government Initiative, $200,000, and the University of Texas Anderson Medical Center, $300,000.

One of the issues currently being lobbied hard in Washington involves the financial future of the biotech industry. Competing legislation is before Congress that would set the rules for creation of generic biotech drugs -- biosimiliars.

It is also an issue on which CIRM is scheduled to take a position on May 12, although the CIRM board has backed away from a stand on specific bills.

J.K. Wall of the Indianapolis Business Journal on March 23 wrote about the lobbying efforts of Eli Lilly on biosimiliars.

Wall wrote:

"Indeed, generic biotech drugs represent a big threat to the large pharmaceutical companies, which increasingly have turned to biotech drugs for growth as their most successful chemical-pill-form medicines cruise toward the end of their patent lives."

Wall continued,

"Trouble is, biotech has become a synonym for exorbitant. For example, Herceptin, a biotech breast cancer treatment introduced 11 years ago by Genentech Inc, costs $40,000 for one year of treatment.

"'Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines,' said Kathleen Jaeger, CEO of the Generic Pharmaceutical Association, in a statement. 'Timely access to affordable biogenerics will save lives and save consumers and state and federal governments billions of dollars.'"

At its board meeting last month, some CIRM directors exhibited considerable discomfort at entering the fray with specific endorsements of competing legislation. Some questioned not only the appropriateness of CIRM taking a position, but whether it could have any significant impact on the legislative process. Mission creep was one complaint.

But the need to "protect" the biotech industry carried the day, and CIRM is scheduled to approve a statement of principles on generic biotech drugs on May 12.

No doubt exists that this is an important issue, affecting the industry and the development of drugs that could potentially ease much misery and suffering.

But one wonders whether California voters, in approving Prop. 71, envisioned hundreds of thousands of taxpayer dollars being spent for lobbying on behalf of any industry.

One also wonders about CIRM's relationship with Podesta and its array of drug industry clients. Which is the dog and which is the tail? Do CIRM's interests become subsumed in the pharmaceutical mix? And how can California taxpayers know for sure? Perhaps they can ask one of Podesta's other clients: The Sunshine in Government Initiative.

CIRM Takes on Federal Chores

The California stem cell agency will be dealing with federal stem cell and biotech matters over the next couple of weeks, including the proposed NIH rules on hESC research.

The agency has created a task force that will meet publicly this Thursday to hear comments on the rules. The panel is preparing a report that will be submitted to the full CIRM board on May 12 with the intent of getting the comments to the NIH later this month.

You can find CIRM's preliminary work on the subject here and our report here. Comments for CIRM can also be submitted via email at info@cirm.ca.gov.

Also on tap for the May 12 board meeting is consideration of a statement of principles dealing with federal legislation on production of biosimiliars, which would be copies of biotech drugs following expiration of their patents.

Teleconference locations are available for the May 12 meeting in San Francisco, Los Angeles(2), Sacramento, La Jolla(2), Pleasanton, Berkeley, Elk Grove, Healdsburg, and Irvine(2). Specific addresses can be found on the agenda.

Five teleconference locations exist for Thursday's meeting: San Francisco Elk Grove, Los Angeles, Healdsburg and Duarte. You find the addresses on the agenda.

Advisory

The California Stem Cell Report will be publishing intermittently over the next couple of weeks. We are back from Mexico for a visit to the Old Country (California) for visits with family and friends, who sometimes get in the way of daily publication of items on stem cell matters. And, no, we did not bring swine flu back with us from Mexico although a herd of wild swine chased us down the street as we ran to catch our plane out of Mazatlan.

Skimpy Coverage of CIRM Board Meeting

News coverage of the meeting of the board of the California stem cell agency was quite light today, focusing entirely on the approval of $68 million in grants.

Here are links to the stories and the few news releases put out by recipients. More publicity handouts are likely to surface over the next few days.

News

Terri Somers, San Diego Union Tribune

San Francisco Business Times

News releases

BioTime

Stanford

UC Irvine

CIRM Approves $68 Million in Grants; Wrestles with Executive Evaluation

LOS ANGELES -- The California stem cell agency today approved $68 million in grants for early translational research and left open the possibility that more might be awarded in June.

CIRM said in a news release,

"The 15 early translational grants approved by the board will go to 13 not-for-profit and two for-profit organizations. These grants are intended to either lead to a drug candidate for an unmet medical need or address a bottleneck in the development of new therapies."

CIRM President Alan Trounson was quoted as saying,

“With these early translational grants CIRM has taken the first step in funding translational research that will be critical for the development of future therapies.”

CIRM has talked about the importance of making grants to business. In this round, Novocell of San Diego, received $5.4 million and BioTime of Alameda, Ca., received $4.7 million. You can see a complete list of the approved applicants here.

Twelve additional grants had been recommended for funding by reviewers – if funds were available. But the board decided to put off a decision on those until June in hopes that CIRM will have an improved financial situation.

The board took no action on four letters from applicants seeking to reverse negative decisions by reviewers, but it rejected all applications ranked in the bottom tier. You can find the text of the petitions via the meeting agenda.

The board additionally approved $200,000 to co-sponsor the annual convention of the International Society for Stem Cell Research in San Francisco during the summer of 2010. John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., supported the move although he was critical when the subject was first broached last December with a $400,000 price tag. Simpson praised as thorough the CIRM staff justification for the expenditure.

In other business, CIRM directors approved an evaluation process for the CIRM chair, vice chairs and president – the first such in the four-year history of the organization. The plan stirred debate concerning the composition and chairmanship of a new Evaluation Subcommittee of directors.

Some directors objected to permitting the Evaluation Subcommittee, which includes three of the four persons to be evaluated, decide who chairs the panel. Board member Jeff Sheehy, director for communications at the AIDS Research Institute at UC San Francisco, moved to designate the chair and vice chair of the Governance Subcommittee to fill the same positions on the Evaluation Subcommittee. Sherry Lansing, a UC regent and former movie studio CEO, and Claire Pomeroy, dean of the UC Davis School of Medicine, are chair and vice chair of the governance panel. They were key to working out the evaluation process.

Sheehy said it was not appropriate for the people being evaluated to have a voice in picking the chair of the Evaluation Subcommittee.

Klein, who will sit on the Evaluation Subcommittee, opposed Sheehy's motion although he indicated he was willing to permit the full board to select the heads of the evaluation panel. Sheehy's motion failed on a vote of 5-15 with four self-recusals and two abstentions.

Directors Robert Azziz, chairman of the department of obstetrics and gynecology at Cedars of Sinai in Los Angeles, and Carmen Puliafito, dean of the USC School of Medicine, expressed concern about the composition of the committee. Azziz said he wanted to avoid the perception of a conflict of interest. Puliafito said that the membership could give the appearance of "self-dealing."

The process was finally approved on an 18-5 vote with one self-recusal and two abstentions.

The board will make a decision on the chairs at a later date.

Here is the structure of the subcommittee as presented during today's board meeting. It will include:

• The chair and vice chairs of the Governance(Sherry Lansing), Finance (Michael Goldberg) and Legislative(CIRM Chairman Robert Klein) directors subcommittees.
• The chairs of the IP Task Force(Ed Penhoet) and the Biotech Loan Task Force (Duane Roth, who is also vice chair of the CIRM board of directors).
• The vice chairs or acting vice chair or co-chair where applicable of the Grants(Joan Samuelson or Sheehy), Standards (Lansing), Facilities (David Serrano Sewell) working groups.
• Two members appointed by the board but not yet named.
• The chair (Klein) and vice chairs (Roth and Art Torres)of the board except when they are the subject of an evaluation.

CIRM Debates Federal Legislation; $60 Million Grant Approvals Scheduled for Today

LOS ANGELES -- The board of the California stem cell agency last night backed away from endorsing industry-supported federal legislation dealing with biosimiliars, which would be copies of original biotechnological drugs following expiration of patent protection.

The board did not go along with its Legislative Subcommittee recommendation to support HR 1548 by Rep. Anna Eshoo, D-Palo Alto, which is favored by the Biotechnology Industry Organization. The subcommittee took no position on a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles, which BIO opposes.

Instead of endorsing the Eshoo measure, the board voted to seek development of a statement of principles that it would like to see in any such legislation. That statement could come up before the full board during a telephonic meeting May 12.

Robert Price, who sits on the board as an alternate for UC Berkeley Chancellor Robert Birgeneau, questioned the value of CIRM taking any position at all on the legislation.

Price, who is associate vice chancellor for research at UC Berkeley, asked,

"Do we really matter that much? I think we don't. Let's not engage in hubris here."

A number of other members of the board spoke both on behalf of the legislation and the need to protect businesses that put up the cash to develop new drugs.

Board member Ed Penhoet, former president of Chiron and a member of the National Academcy Sciences Board on Science, Technoloogy and Economic Policy, said the two pieces of legislation deal with the balance between the cost of therapies and the cost of innovation. He said it was "the most important issue in health care today."

Board member Sherry Lansing, the former head of a Hollywood film studio and a University of California regent, said,

"There will be no drugs unless we protect the people who take the risk."

As for the argument over high costs denying access to drugs, CIRM Vice Chairman Art Torres, former chairman of the California state Democratic Party, said,

"You can't have accessibility unless you have something to access."

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., characterized the push for CIRM to become a player in Congress as a "little bit of mission creep."

In other business, CIRM communications chief Don Gibbons previewed the agency's new website, which he said should be up in a few days. He said it was designed to offer more information that will be better organized and accessible.

CIRM officials also officially confirmed for board members the news on the California Stem Cell Report that the agency's financial woes are over for some time. The agency will receive $505 million from the recent state bond sale. However, cash will get tight again by the end of 2010 unless CIRM raises more funds through the sale of state bonds.

In light of the good financial news, the board indicated that it wanted to reconsider its one-year delay in a training grant program. That topic is expected to come up in June. Additionally put off was an update on CIRM grantee progress report monitoring. Earlier a CIRM official had said said grants would be pulled because of a lack of progress, but he did not say when that would be announced.

Also on the board agenda last night were applications for $60 million in grants, including four petitions to overturn negative recommendations from reviewers. However, that was put off until this morning along with a request for $200,000 to co-sponsor the annual convention of the International Society for Stem Cell Research.

Another item scheduled to be acted on today is the performance evaluation process for the Chairman Robert Klein, President Alan Trounson and Vice Chairs Torres and Duane Roth. It is the first time the CIRM board has officially promulgated publicly an evaluation procedure for the positions. But until recently the chair and vice chairs did not receive compensation. Roth has declined a salary, but Torres is receiving one.

This morning's meeting can be heard via the Internet. Details for the Web access are here. Teleconference locations for listening and participating are available in Sacramento, Pleasanton and at Stanford. Specific addresses can be found here.

Controller Calls for Online Posting of Financial Holdings of CIRM Officials

California's top fiscal officer wants to see posted on the Internet the statements of economic interests and travel and other expense forms of the top officials of the state's $3 billion stem cell agency.

Controller John Chiang, who chairs the committee that oversees CIRM's financial practices, will soon call a meeting of the panel to discuss how to implement the postings.

Chiang's plan would cover the 29-member CIRM board of directors, its executive staff and the members of the financial practices panel, which is officially called the Citizens Financial Accountability and Oversight Committee (CFAOC).

Chiang's move follows the lead of Gov. Arnold Schwarzenegger, who posts his top staff's economic interest statements and expenses on the Web. On April 2, we wrote about governor's postings and recommended the practice as something to be emulated by CIRM.

Internet publication of CIRM's information came up April 14 at a meeting of the CFAOC. Ruth Holton-Hodson, deputy controller for health and consumer policy, was filling for Chiang, who was ill.

According to the transcript, she said,

"The public is naturally very concerned about transparency, especially in these times when it comes to spending public dollars and potential conflicts of interest that might arise."

She noted that Chiang will be offering online the financial information for himself and his staff.

Posting the information serves the public well. But it is also healthy for CIRM, an agency that is riddled with built-in conflicts of interest, perhaps more so than any other state department.

The CIRM board of directors is dominated by folks from the institutions that have been the chief beneficiaries of CIRM´s largess. As of last October, 18 institutions with representatives on the board (past and present) had received $552 million in CIRM grants. More has been awarded since then. This week the CIRM board is expected to approve an additional $60 million in grants, most of which is likely to go to institutions connected to board members. Board members cannot vote on grants to their institutions, but the entire board sets the rules under which the grants are made and establishes the priorities for spending the billions of dollars.

Hallye Jordan, spokeswoman for Chiang, said a date has not yet been set for the meeting of the CFAOC to discuss implementing postings by CIRM. The subject will be the only item on the agenda.

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.

California's Stem Cell Education Bill Comes Before CIRM and Senate on Wednesday

The board of directors of the California stem cell agency on Wednesday will discuss newly strengthened legislation to push stem cell research training and education into California public schools.

The bill, SB 471 by Sen. Gloria Romero, D-East Los Angeles, and Senate President Pro Tem Darrell Steinberg, D-Sacramento, will now require state schools to establish and promote as a state priority a stem cell and biotech education program. Previously the legislation said such an effort "should" occur.

The bill is now dubbed the "California Stem Cell and Biotechnology Education and Workforce Development Act of 2009." It is supported by the BIOCOM industry group and opposed by the California Catholic Conference. CIRM has not yet officially taken a position on the measure, but has been working with the measure's authors.

The measure was added Monday afternoon to the board's agenda for its meeting that begins today in Los Angeles. Remote, interactive teleconference locations for the meeting are available in Sacramento, Pleasanton and at Stanford. Specific sites can be found on the board's agenda.

The bill is now before the Senate Education Committee, where it is certain to be approved on Wednesday. The legislation is likely to move easily through the Senate because the top Senate leader, Steinberg, is one of the authors.

Here is a link to the legislative staff analysis of the measure.

Public Can Participate in CIRM Board Meetings at Stanford, Sacramento and Pleasanton

For those of you unable to be personally present at the Tuesday and Wednesday meetings of the board of the $3 billion California stem cell agency, you can hear and participate in the proceedings from remote locations in Sacramento, Pleasanton and at Stanford.

The specific locations can be found on the agenda for the meetings. The remote access is being provided for the convenience of board members whose schedules make it difficult for them to attend the meetings in Los Angeles.

The practice began a few months ago to help avoid the problem of mustering the super-quorum needed for the CIRM board to officially do its business.

Also available is an Internet audiocast of the proceedings – one-way only. No participation is permitted via the audiocast. You can find details of how to gain access to the audiocast here.

For your planning purposes, the Tuesday session usually is devoted mainly to grant reviews, although Chairman Robert Klein is likely to discuss CIRM finances. Other business may come up as well.

CIRM's Initial Assessment on NIH hESC Rules; Task Force to Develop More Analysis

A key group of directors of the California stem cell agency this morning moved to create a task force to study and comment on the proposed NIH rules for human embryonic stem cell research.

The Legislative Subcommittee of the CIRM board of directors voted 7-0 to proceed with the work on the NIH rules, which have drawn fire from scientists in California. The action now goes to the full board for expected approval at its meeting Tuesday and Wednesday in Los Angeles.

CIRM plans to consult with institutions, scientists, the public and others in developing an analysis and recommendations on the NIH rules by May 24. Meetings of the task force are expected to be conducted in public. The CIRM board will hold a telephonic, public meeting on the final CIRM document, according to CIRM Chairman Robert Klein.

CIRM will also work with the Interstate Alliance on Stem Cell Research in developing its proposal. The alliance previously scheduled a May 5 meeting in Washington, D.C., which could provide a venue for exploration of the issues, said Geoff Lomax, senior officer for medical and ethical standards.

Following the 7:30 a.m. meeting today, CIRM posted background material and other information on the issues on its website. They include a comparison between the NIH guidelines and CIRM regulations and an intial assessment of the impact of the NIH proposal.

Among other things, CIRM's first-cut at the rules said,

"Our conclusion from this preliminary analysis is that the consent protocol for some lines does not include all items identified by NIH in its eligibility criteria, suggesting some scientifically significant lines may not qualify. All lines evaluated were derived from balstocysts created for reproductive purposes but no longer required for family planning."

"The draft policy sets ' high bar' for consent and disclosure. There are concerns that established cell lines may not meet the proposed standard. Substantial foundational research has been performed utilizing established lines. NIH should consider a 'grandfathering' clause or other mechanism that enables continued use of established lines. NIH should give consideration to whether a particular line was derived in accordance with consensus guidelines or the legal requirements at the time of consent or derivation."

"Further, experience suggests there may be uncertainty to whether specific cell lines conform to every requirement of the draft guidelines. This uncertainty may result in qualifying lines not being utilized. There was broad consensus that a registry of compliant lines would be the most efficient method for identifying lines and ensuring promising research materials are not unnecessarily disqualified."

"For grantee institutions the promulgation of NIH guidelines raises question related to the implementation of grants where a mix of funding is involved. For example, one institution identified the case where research involves a comparative analysis of multiple hESC lines. It is conceivable that such a study could involve lines not recognized or approved by every funding source. Harmonization of rules, to the extent allowed by law, would be desirable from this grantees perspective."

CIRM said,

"As the largest funder of human embryonic stem cell research in the world, CIRM has an interest in ensuring that the NIH rules are consistent with CIRM’s medical and ethical standards, which were modeled upon guidelines adopted by the National Academies of Science, and with the best interests of science and patients."

The NIH announced its proposed new rules only 10 days ago. CIRM completed its preliminary analysis last Friday. However, the actually posting of documents relies on a state department that does not work during the weekend.

The Legislative Subcommittee also voted to support 6-0 with one abstention (Jeff Sheehy) a federal bill dealing with biosimiliars, which are copies of the original biotechnological drugs following the expiration of patent protection.

The panel backed HR 1548, by Rep. Anna Eshoo, D-Palo Alto, which is also supported by the Biotechnology Industry Organization. The industry group opposes a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles. The subcommittee did not take a position on Waxman's bill.

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 Reassures Grantees on Their Cash

Late Friday, the California stem cell agency sent the following email to CIRM grantees:

"We at CIRM headquarters want to send you some reassuring news regarding CIRM’s finances and our plans to continue a full and robust research portfolio. This week the California State Treasurer successfully sold $6.85 billion in bonds, more than twice the amount originally sought by the treasurer. This vote of confidence by the investor community is good news for CIRM, our grantees and all the patients in California and elsewhere we seek to serve.

"Robert Klein, chair of the CIRM governing board, thanked the State Department of Finance and the State Treasurer’s Office for their tremendous efforts. He indicated that the estimated $275 million in additional funds expected for the agency raises the funds available for grants and facilities to some $400 million and this will cover all commitments, existing and expected, for the next 18 months."