ACT and Geron Talk About Clinical Trials

CNNMoney.com has a piece today on two California companies that report they are edging closer to clinical trials on treatments using human embryonic stem cells.

Aaron Smith wrote the article about Geron and Advanced Cell Technology. It also mentioned Novocell.

In the case of the first two companies, Smith said tests could begin as early as next year. However, schedules have slipped in the past.

Smith wrote:

"'What we're seeing now in the stem cell field is like a chess match,' said Stephen Brozak, analyst for WBB Securities. 'The early moves will ultimately dictate who succeeds in the stem cell space.'"

Geron's product involves spinal cord injuries and ACT's vision loss. Novocell is looking at diabetes.

Stem Cell Freeze Flap: Ethics, UC San Francisco, Stanford Involved

"Modern day frankenstein story," "undeniably creepy," "trying to improve the quality of life." Some of the comments on a story in the San Francisco Chronicle involving a firm that offers "to create 'personalized' stem cells from the spare embryos of fertility clinic clients."

The article Monday by Bernadette Tansey said the idea is to freeze the stem cells for possible later use – "insurance for the future" – in the event that medical breakthroughs could make use of them.

The company is StemLifeLine Inc. of San Carlos, which is located south of San Francisco. It charges as much as $7,000 to create and freeze the stem cells with storage costs of $350 currently. Additional fees of up to $2,000 could be charged.

Tansey said the firm's proposal has set off a "flash fire of protest" from both supporters and foes of stem cell research.

Forty-seven comments were filed by the public on the story(they can be read at the end of the Chronicle story). The wide range offers some insight into the magnitude of the public education challenges that stem cell research still faces. Particularly since the Chronicle audience presumably consists largely of stem cell supporters.

The story also reported that the firm's business has triggered something of a tussle involving folks from UC San Francisco and Stanford.

The head of StemLifeLine is Ana Krtolica(see photo), a former researcher at UC San Francisco. On the firm's advisory board is Susan Fisher, who heads the UC San Francisco stem cell program. Olga Genbacev, a member of the firm's board, is a scientist in Fisher's lab. Tansey also reported that "the company's staff and boards include present and former research collaborators of Fisher's."

One of the folks from Stanford arrayed against the firm's proposal was David Magnus, director of that university's Center for Biomedical Ethics. He told Tansey,

"These companies are essentially taking advantage of people's ignorance and fears to make a buck,"

Also commenting negatively from Stanford were Rene Reijo Pera, director of Stanford's stem cell program and formerly of UC San Francisco, and Chris Scott, director of the Stanford program on Stem Cells in Society.

In addition to the comments on the Chronicle site, Monya Baker in Nature's stem cell blog, The Niche, said that it is "troubling" that the company has failed to make any of its customers available for interviews and refuses to provide a copy of the contract that customers sign.

San Diego Wildfires and the Biotech Business

San Diego is one of the global centers for stem cell research. This week it was also the scene of disastrous wildfires that destroyed 2,000 homes and left $1 billion damage.

The fires meant personal tragedies for some, closures of businesses and loss of some research. The fires also served notice once again to businesses and researchers of the impact that natural disasters can suddenly have and the importance of emergency planning, especially in Southern California which is also in an earthquake zone.

Stem cell research and businesses are just one component of a large life science industry in the San Diego -- one that encompasses 500 firms and 36,000 employees.

In an effort to provide a partial view of the fire's impact, The California Stem Cell Report queried a handful of folks in the stem cell business in fire area.

In the case of Richard Murphy, interim president of the California stem cell agency, he was in San Francisco working as the fire advanced towards his home in Rancho Santa Fe. Murphy said the home was being rented while he worked in Northern California, and reported on Thursday that the house was safe.

Researcher Jeanne Loring of the Burnham Institute in La Jolla was in Maine at a stem cell meeting. She said via email that her house in Del Mar had been on the mandatory evacuation list but that it was safe. "I took a break from following the fires on the Internet to give a seminar to a class of a human ESC training course here in Bar Harbor."

She said that at one point both Burnham and neighboring Scripps were closed, but power remained on and the cell banks were okay. Salk and UC San Diego were also partially or completely closed at times.

Loring continued,

"Some experiments were lost just because the researchers were evacuated. Some people who were evacuated were staying at the labs. I offered my office couch, but I don't know if anyone took me up on it....One unexpected benefit was that the NIH gave grant applicants a grace period. We have a few more days to work on one stem cell grant from the Burnham that was due on Tuesday!"

Floyd Bloom, a member of the CIRM Oversight Committee and executive director for science communications at Scripps, said, "I've been hunkering down, trying to keep my mind off the tragedies by working."

Jay Blankenbeckler, a biotech manager at Invitrogen in Carlsbad in northern San Diego County, awoke early one morning in his Rancho Bernardo home to find high winds and approaching blazes. Time magazine quoted him as saying that mature palm trees in his yard were bent over.

He said,

"They were doing this swirling thing. My palm trees, 35 to 45 feet of palm tree, almost looked like a swizzle stick in a drink, moving around in a big circle."

He and his family evacuated, and at last report his home was still okay.

Bioworld Today reported that at one point half of the staff of BIOCOM, the Southern California industry association, was evacuated from their homes. The online publication reported that many biotech businesses had to close during the fire.

Invitrogen at one point sent most workers home from its main production facility. But it said shipments won't be affected, according to an article by Mike Nagle on us-pharmatechnologist.com. It has another distribution site in Maryland.

Nagle also reported that some biotech businesses at one point were in risk of losing buildings. He said,

"This poses several problems, not least of which is how to care for any animals kept at the facility and where to take them should they need to be evacuated. A further problem is what to with the, often very expensive, compounds used at each facility, many of which require special storage conditions, or are still being used in active experiments or haven't yet been fully analyzed.

"Notwithstanding the fact that much of these materials may intrinsically be commercially sensitive, this is where nearby but not at risk life sciences companies come into the equation, which obviously have the facilities to look after both research animals and chemicals.

"Of course, this is ignoring the more simple fact that a fire at a facility that contains vast amounts of chemicals could be an environmental disaster. However, the companies in the area will, of course, have made contingency plans for emergencies such as this - especially since this is not the first time California has been devastated by wildfires: four years ago, wildfires swept through Southern California, killing over 20 people."

Nagle said that the daily production of the life sciences companies in San Diego runs about $23 million a day.

Here is a link to a regularly updated map by the San Diego Union-Tribune of the fire zones in San Diego.

Fresh Comments

A "Mr. Gunn" has raised a question about our handling of the Australian stem cell investigation stories. We have a response for him. It all can be found under "comments" on the "malicious attack" item below.

Secrecy: A Recipe for Scandal

Seventeen California universities and research institutions have applied to the California stem cell agency for $227 million to build major new labs throughout the state.

It is single biggest round of grants in CIRM's short life.

As usual, CIRM refuses to release the names of the applicants, making it difficult for the public to comment, support or express reservations on the grants during the most critical stage of reviews. However, it is fair to say that any institution with a significant stem cell research presence will have applied along with those who are seeking to build that capacity. It is also fair to say that public disclosure of names of grant applicants, prior to formal review, would have avoided the flap earlier this year about a $2.6 million grant to CHA RMI in Los Angeles.

In the case of the lab grants, applicants are certain to include nearly all the University of California campuses, Stanford, USC and the San Diego stem cell consortium, which includes Salk, Scripps and Burnham in addition to UC San Diego.

So if you readers have any reservations about the ability of those institutions to make good use of a $20 million or so lab grant, you can email or write CIRM, whose web site -- www.cirm.ca.gov -- carries all the contact information.

Earlier this week, the California Stem Cell Report and the Foundation for Taxpayer and Consumer Rights appealed to the agency to reconsider its secrecy policies in connection with the use of $227 million in taxpayer funds. No, was CIRM's response.

The secrecy policies, however, fly in the face of the spirit if not the letter of the California Constitution, which states that the people of the state have a "broadly construed" right to access to information involving the public's business. The amendment to the constitution was approved by 83 percent of voters in 2004. That was the same year voters approved creation of the stem cell agency by only 59 percent.

CIRM is an agency controlled by a 29-person board that is riddled with conflicts of interest. Ultimately it is in the agency's own best interests to operate with more openness. Handing out hundreds of millions of dollars behind closed doors with no public disclosure of the conflicts involving reviewers is a recipe for scandal.

Trounson Hit with Malicious Attack

The incoming president for the California stem cell agency, Alan Trounson, is in the news again, this time as the target of a malicious, anonymous attack.

Here are the first three paragraphs of the story from the Australian:

"Monash University has condemned anonymous allegations that leading stem cell scientist Alan Trounson used fraudulent research to obtain federal funding as false and malicious.

"Professor Trounson and his colleagues at the Monash Immunology and Stem Cell Laboratories said the charge was without substance.

"They expressed shock that someone claiming to be a stem cell researcher would make such allegations."

Fresh Comment

A "Mr. Gunn" has posted a comment on the "No Support" item below. He supports the position of CIRM.

Pluripotent Possibilities at Interstate Conference on Stem Cell Research

A California watchdog organization is calling for national guidelines on government-funded stem cell research that would ensure openness, transparency and accountability in the multi-billion dollar state programs.

The appeal came from John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights (FTCR) in Santa Monica, Ca. The organization's recommendations came as the Wall Street Journal reported on a Congressional inquiry into transparency and conflict issues in another area of government-funded science – this one involving lung cancer research.

Simpson said in a letter to the Interstate Alliance for Stem Cell Research, which begins a meeting Wednesday(Oct. 24) in Boston, that it should commit to holding public meetings for all future sessions. Simpson was ousted from a meeting of the interstate group last May in California, although he had been invited to its first session. A representative of the National Academy of Sciences, which is backing the meetings of the interstate group, told Simpson the meeting was not open to the public despite the fact that it involved public officials and public money.

Simpson commended the group for holding a public session in Boston. He said,

"I fully expect the Interstate Alliance will have a major influence on rules and regulations in all the states that are represented. That means it is imperative that the public have access to your deliberations and the ability to offer input and comments. Given the potentially contentious nature of publicly funded stem cell research, the need for the utmost transparency is even greater than would otherwise be the case."

Simpson urged the alliance to create a working group to draft model regulations to ensure openness, transparency and accountability in the various state stem cell programs. He said,

"Such a working group should go beyond members of the state stem cell agencies and include representatives of organizations committed to public access in government operations."

Simpson's letter was directed to Warren Wollschlager, chairman of the interstate group. Simpson told the California Stem Cell Report that Wollschlager said he would bring up the openness issue at the Boston meeting.

The Wall Street Journal article highlighted some of the issues involved in openness and transparency in even relatively non-controversial research, much less the heated debate over human embryonic stem cell research.

The piece by David Armstrong said that the House Energy and Commerce Committee, which oversees medical-research issues,

"...was concerned that potential conflicts of interest 'could damage the credibility' of the decade long, $200 million National Lung Screening Trial. The results are expected to have a significant impact in standards for lung-cancer screening and who will pay for it.

"Two of the trial's principal investigators have testified as paid experts for tobacco companies facing lawsuits seeking to force them to pay for smokers' annual CT scans."

Our comment: The interstate alliance has an extraordinary opportunity to influence the ESC research activities across the country. National standards are needed. And for the foreseeable future, they are not likely to be forthcoming from our friends at the federal level. Embryonic stem cell research IS pluripotent. As it exists today with the many states involved, major opportunities exist and changes are possible in non-productive grant review processes that currently hobble creative endeavors. The growth of the state research efforts has great promise. It also has great peril -- if the state endeavors become closed-door, secret activities that enable anti-science forces to foster suspicion and fear. It would be a shame for the Interstate Alliance and the states involved in stem cell research not to take advantage of what is a once-in-a-lifetime opportunity to begin to chart new and better courses.

No Support From CIRM Group on Public Disclosure on Lab Grants

A move to reveal the identities of the major universities and research institutions seeking $227 million in California taxpayer funds for stem cell lab construction was turned aside today by a key committee of the state's stem cell agency.

The Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., and the California Stem Cell Report appealed to the Grants Working Group to make an expression of support for public disclosure of the names of institutions and for opening review of their applications to the public.

The group took no action on the requests. Only two members of the group responded. Marie Csete(see photo), a scientist from Emory University, said the most important elements of the review involve the work that is proposed at the facilities – not the labs themselves, which she described as "tools." She also noted that the reviewers are funding the work of their "competitors." California stem cell Chairman Robert Klein endorsed Csete's remarks in a brief comment.

Our comment. One of the stronger arguments for public disclosure and review is the fact that the scientific reviewers are dealing with the livelihoods of their professional competitors. While the reviewers are all from out-of-state, the stem cell world is truly global. It is also small and intensely competitive. We should also note that the reviewers are not eligible for funding from California. That contrasts with the NIH, whose grant reviewers are eligible for funding from that agency. At the California stem cell agency, scientific reviewers receive only a small stipend and expenses for the time they spend away from their own work. They basically do it for free with perhaps the major benefit coming from a chance to see interesting proposals from California scientists and meet with their peers at CIRM expense.

Below are the statements read to the grants group this morning.

Text of Statement by CSCR on Open Review of Lab Grants

Here is the statement by the California Stem Cell Report at the Oct. 23, 2007, meeting of the Grants Working Group of the California stem cell agency.

By way of introduction, my name is David Jensen and I publish the California Stem Cell Report on the Internet. I have followed the affairs of the California stem cell agency since December 2005 and have published nearly 1,400 items involving CIRM.

First, I want to express my appreciation for the work you are doing here today and tomorrow, especially to those of you from out-of-state. Spending two days in a hotel reviewing complex grant proposals – taking time away from your own work and families – is not a minor matter. Thank you.

My main point today involves the openness and transparency of the proceedings of the California Institute for Regenerative Medicine, an agency unlike any state department in California history. As a result of the enactment of Proposition 71, CIRM operates outside of much of the normal state government oversight and is virtually independent of the governor and legislature. At the same time, it is overseen by a board that includes employees of institutions that stand to benefit financially from the CIRM actions. In the case of the upcoming round of $222 million for lab construction, 17 of the 27 current members of the Oversight Committee could see their connected institutions benefit from a facilities grants.

Currently, review of applications from individual researchers is conducted behind closed doors. CIRM has decided to keep the discussions private in order to encourage maximum candor and frankness about the work of individuals, which would be discouraged if the reviews were conducted in a public.

However, applications for the major lab grants – which you will be reviewing in the not-too-distant future – are much different than those from the men and women who direct stem cell research labs. The applications for lab construction funds will come from huge institutions such as the University of California and other major educational and research enterprises. Their names and applications should be part of the public record. And your review of those applications for $222 million in public funds should be conducted in public.

It is hard to see a justification for a closed-door review of a lab grant application, for example, from UC Berkeley. In fact, the review of the lab grants will become public – but only after your group performs the most critical segment of the review. And that is where the public's interest is the greatest. One can argue that individual researchers and their applications should be discussed behind closed doors to avoid embarrassment and to encourage frankness. But that hardly applies in the case of an institution such as Berkeley, which regularly comes under the harshest form of public criticism with nary a flesh wound inflicted. Equating the sensitivities of UC Berkeley or other likely institutional applicants for lab grants to the sensitivities of an individual researcher would seem to defy common sense.

The California stem cell agency has a special public trust. One of its missions is to encourage public support and understanding of human embryonic stem cell research. And it should not hand the foes of good science additional weapons that can be used to attack such research. Conducting grant reviews unnecessarily behind closed doors only feeds suspicion and the worst sort of speculation. Openness and transparency inspire public confidence and make it clear to all that no mischief is afoot.

I urge you to consider making an informal expression of sentiment to CIRM and the Oversight Committee in favor of publicly identifying applicants, publicly releasing their applications and conducting the scientific review of the lab proposals in public. If there are segments of the applications that must be examined in private, that can easily be done in an executive session, just as the Oversight Committee does when it considers applications after your work is done.

Opening the doors on the lab grant review would reflect well on the agency and be an important step in fulfilling CIRM's promise of adherence to the highest standards of openness and transparency. Thank you.

Text of FTCR Statement on Open Review of Lab Grants

Here is the statement by the Foundation for Taxpayer and Consumer Rights presented at the Oct. 23, 2007, meeting of the Grants Working Group of the California stem cell agency.

First, I’d like to apologize for not being able to be present today and thank David Jensen of The California Stem Cell Report for reading this on my behalf. Second, I’d like to thank all of you for serving on the Grants Working Group. We truly appreciate your efforts.

By way of introduction, I’m John M. Simpson director of the Foundation for Taxpayer and Consumer Rights Stem Cell Oversight and Accountability Project. Funded by the Nathan Cummings Foundation since December 2005, the project seeks to ensure that the taxpayers funding California’s landmark $6 billion stem cell research program have affordable access to any of the discoveries they have funded. As part of the project we have challenged the validity of the stem cell patents held by WARF.

In a few minutes you will enter closed session to review the scientific merit of applications for New Faculty Awards. While I don’t agree, I understand the argument that the applicants’ names and the deliberations should be confidential to protect individual researchers from possible embarrassment.

I don’t intend to reargue that issue now. Rather, I’d like to ask you to look ahead a bit. Soon you will be weighing the scientific merit of requests from various California universities and research institutions for their share of $225 million in grants to build laboratories. As it now stands those institutions are not being identified and the reviews will be done in secret.

Ironically, the applications will be publicly reviewed later in the process by the Facilities Working Group when it weighs the proposals on their technical merits of design, construction and such.

To this outside observer that means it's OK to embarrass an institution because it can't design and build a decent building, but it's not all right to embarrass its scientists.

Sadly the public will inevitably view this as a remarkable self-serving, in-bred club that is doing scientific reviews. That's the real embarrassment. If scientists’ egos are so fragile they can't stand public scrutiny, they ought not to have a shot at public money. Nor should the institutions that employ such tender souls.

I ask you to please strike a blow for transparency that publicly funded stem cell research requires. Take the opportunity to show the public how the scientific review process works. Please take a vote amongst yourselves that urges the facilities applicants be identified and the scientific review be public.

Thank you.

More on Floyd Bloom

We have run across some additional details on Floyd Bloom, the latest appointee to the CIRM Oversight Committee, that are of some interest. He fills the position once held by David Baltimore, a Nobel Laureate and former president of Caltech. Bloom, in addition to being professor emeritus at Scripps, is executive director for science communications at that institution. Our earlier item on Bloom also mentioned Neurome, a firm he co-founded. Bloom told us that firm went out of business in September 2006.

Hitching Up Down Under

Alan Trounson, the incoming president of the California stem cell agency, says it will be a "very low key affair" with a few friends and a small reception.

You might call it a stem cell wedding. But not exactly one contemplated six months ago.

Trounson (see photo) and his partner for the last 19 years, Karin, will be getting married. As we all know, Trounson has taken a job in the United States. But Karin – not to mention their children -- will not be able to come along with him unless they perform the nuptials. So say US immigration authorities, despite Karin's Swedish and Australian citizenship and dual passports.

The couple have two boys: Karl, 16, and Alex, 6. Trounson has two other children, Kylie, a 30-year-old lawyer, playwright and actress, and Justin, 27, who has international interests in the tourist industry.

Trounson said Karin has a Ph.D. in women's health and would like to continue her career in California.

He told the California Stem Cell Report:

"We are very comfortable and supportive partners and have no problem in getting married."

He added,

"Karin thinks the event is worth celebrating but our commitment to each other is larger than this ceremony. The kids are joining in on the fun."

We figure the wedding feast will include roasted koala and aquavit. And the music? Well, probably didgeridoos and accordions.

Our congratulations to them both. Actually, congratulations to all four or is it six?

Rose Petals vs. Stem Cells

The case of the embryo vs. the California stem cell agency has been kicking around a couple of years or more – one of the reasons we did not pay much attention to it when it surfaced again recently.

But Kristen Philipkoski of Wired.com demonstrated the bizarre nature of the suit in an item last week.

Among other things, during a hearing in Pasadena, Ca., Philipkoski wrote that the attorney for the embryo "proceeded to scatter rose petals on the courtroom floor, saying they represented the California Institute of Regenerative Medicine destroying life." Philipkoski said that the judge "rolled her eyes."

CIRM Praised on California Political Blog

The New West Notes blog has taken a brief look at the life and times of the California stem cell agency – a largely laudatory review accompanied by a 9-minute video of California Attorney General Jerry Brown.

Bill Bradley, author of the blog and a longtime observer of California politics, uses the stem cell program as an example of how things can actually be accomplished in state government, as opposed the impasses on health care and water policy, among other issues.

Brown (photo above) is seen on a YouTube taken at what appears to be a campaign appearance last year at Advanced Cell Technology in Alameda. The video, although lengthy, has been edited to focus on Brown's stem cell remarks. In the video, he promises to be a "champion" of stem cell research in California and nationally. "I will do whatever I can to alleviate suffering," he says.

One of the interesting aspects of Bradley's item are the numerous comments on it from readers.

One, NickM, said,

"The embryonic stem cell research bond was one of the biggest special interest giveaways in history.

"Companies that stood to make hundreds of millions or billions APIECE by having the taxpayers fund their R&D (and their investors)donated millions to convince the taxpayers that this research wouldn't happen without billions in taxpayer support. It worked.

"So now the biotech conglomerates and VC firms have a huge subsidy, and we're all supposed to feel good about it.

"It's the Donald Trump model: convince someone else to pay your costs while you reap the benefits."

New CIRM Director No Intellectual Shrinking Violet

Consider the following from Floyd Bloom, the latest appointee to the board of directors of the largest single source in the world of funding for human embryonic stem cell research.

"A growing problem of major proportions has been staring us in the face for many decades. Until solved, this long-neglected problem presents a gigantic obstacle to the application of the discoveries flowing from biomedical research into deliverable standards of medical practice that could benefit all of society, both in the United States and globally. This problem is the imminent collapse of the American health system. Unless steps are taken soon to undertake a comprehensive restoration of our system, the profound advances in biomedical research so rapidly accruing today may never be effectively transformed into meaningful advances in health care for society.

"Today's term for such evolutions of discovery into application has been dubbed 'translational research'. The appealing notion that research advances travel from bench to bedside is laudable, but conceptually flawed."

Bloom made the statement in 2003 when he was was president of the American Association for the Advancement of Science. While some on the Oversight Committee of the California stem cell agency may share his sentiments, few have expressed them so publicly and eloquently. Indeed, Bloom's views seem, in many ways, a departure from the standard operating procedure at CIRM, which is somewhat wary of flying in the face of established scientific and medical culture.

Bloom (see photo) was appointed this month by state Treasurer Bill Lockyer to fill a vacancy on the 29-member CIRM Oversight Committee. Lockyer said that Bloom has "dedicated his life to biological science research and is responsible for numerous breakthroughs in neuroscience understanding."

Bloom retired in 2005 as chairman of the Scripps Research Department of Neuropharmacology in La Jolla, Ca. At the time, he said he planned to devote more time to Neurome, Inc., a La Jolla biotechnology firm involved research into human neurodegenerative diseases. Bloom co-founded the firm in 2000.

At one stage in his youth, according to an article on Molecular Interventions, Bloom was encouraged to go into journalism because of his penchant for telling stories. In 2002, he became editor-in-chief of Science, the AAAS journal. He spoke with Molecular Interventions about his views on running a magazine:

"The best thing is to have controversy in an intellectual manner because people read it. They like to see the Christians fight the lions, right? And so if you can engage in an intellectual discussion, then you attract readers and at the same time people get informed from the debate because they'll learn parts of alternative arguments."

Bloom, who also served both as president and chairman of the AAAS, carried his views beyond the pages of scientific media. A few years ago, he told the New York Times:

"I'd like for us to consider health care to be regarded as something like a public utility. To me, if we agree that universal coverage is something to be desired, is that really much different than the fact that we've all agreed that everyone in the country is entitled to have electricity, water, telephone connections, if they can pay for it. We have all kinds of ways to help people get those basic provisions of life.

"And health benefits could be viewed in exactly that same utilitarian way. It could be a corporate network like water power and electricity, with regulatory agencies that set the rates for profit."

Position Change: CIRM Now Permitting Public Comment at $85 Million Hearing

The California stem cell agency today reversed itself and decided to permit public comments prior to two days of closed hearings next week on requests for $85 million in grants to California researchers.

The change in position came quietly today as the agency posted a new agenda for the hearings on the CIRM web site that did not mention that it had been revised. The new posting specifically stated that public comment would be allowed. It also removed this sentence from the agenda::

"An open session will not be held for the meeting of October 23-24, 2007 as business will be limited to review of grant applications."

The change in public access followed disclosure earlier today by the California Stem Cell Report of the ban and subsequent complaints by at least one member of the CIRM Oversight Committee, David Serrano Sewell (see item below).

Comment on Ban on Public at $85 Million CIRM Meeting

David Serrano Sewell, a member of the CIRM Oversight Committee, sent the following on the "Public Barred" item below.

"Just read your item regarding the public being barred from the upcoming Grants Working Group meeting. To my recollection, those agendas have always included an opportunity for the public to address the working group. The failure to include such an item for this agenda was probably a honest mistake that must be corrected. I (and the the patient advocate working group members) support the public attendance at working group meetings. Thanks for catching this!"

Our comment: The agenda for the meeting in question contains a sentence that we cannot recall ever seeing before on a CIRM agenda:

"An open session will not be held for the meeting of October 23-24, 2007 as business will be limited to review of grant applications."

Interstate Stem Cell Issues Coming Up in Public Session Next Week

The Interstate Alliance for Stem Cell Research, which once ousted a member of the public from a meeting in California, will hold two days of open public meetings in Massachusetts next Wednesday and Thursday.

The agenda (see item below) for the group, operating under the auspices of the National Academy of Sciences, includes a host of major issues that states are grappling with across the country. They include model language for the term "acceptably derived," payment issues and health care for egg donors, certification of stem cell lines from other states and countries and the grant review process.

We applaud the decision to make the meeting public. Billions of dollars in public resources are involved along with the need to maintain confidence in embryonic stem cell research. Closed door meetings and secret processes generate suspicion and encourage the worst sort of speculation.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, was the man ousted from last May's meeting. He says,

"I'm glad to see the change of heart. Too often the scientific establishment has displayed a paternalistic 'trust-us-we-know-best' attitude that in fact undercuts public support for science. Scientists need to engage and educate, otherwise we end up with the know-nothing attitude too often exemplified by the current administration."

Agenda for Public Meeting on Interstate Stem Cell Issues

Here is the agenda for next week's public interstate stem cell meeting.

Interstate Alliance for Stem Cell Research

British Consulate
Cambridge, MA
October 24-25, 2007
Agenda


October 24

12:00 pm Lunch (at Consulate)

1 pm Welcome and Introductions
Warren Wollschlager, Chair, Office of Research and Development, State of Connecticut and Fran Sharples, National Academies’ Secretariat for IASCR

Introduction of other participants

The purpose of this meeting is to review progress on the working group assignments made at the May 23-24 Irvine, CA meeting and to identify additional issues the IASCR needs to address.

1:15 pm Governance Issues - preliminary discussion: Warren Wollschlager

1:30 pm Report of Working Group on the development of a Glossary of Stem Cell Terms: William Lensch (Tab 1)

2:15 pm Report of Working Group on an IASCR Website: Fran Sharples, Susan Stayn, Eli Zupnick (Tab 2)

3:00 pm Break

3:15 pm Report of Working Groups on Developing Model Language for “Acceptably Derived;” Payment Issues and Health Care for Donors; and Certification of Stem Cell Lines from Other States and Countries (formation of standing committee): Marianne Horn, Geoff Lomax, Melissa Lopes, Susan Stayn, Ann Willey, Eileen Naughton, and Alta Charo (by phone) (Tab 3)

5:15 pm Adjourn meeting for the day

6:00 pm Reception (on site)



October 25

8:30 am Breakfast (at Consulate)

9:00 am Report of Working Group on Grant Reviews: Marianne Horn, Warren Wollschlager (Tab 4)

9:45 pm Report of Working Group of Legal Counsels on Role of Regulations vs. Guidelines and Policy Documents: Marianne Horn (Tab 5)

10:30 am Break

10:45 am Summary discussion of Working Group next steps

12:00 pm Working Lunch: Roles of International Society for Stem Cell Research: Jonathan Auerbach and Heather Rooke (Tab 6)

1:15 pm Governance Issues
Officers
Membership in IASCR
Budget
Roles of IASCR: information resource vs. policy development
Product branding

2:00 pm Recruitment of additional states and other members: discussion

2:30 pm Break

2:45 pm Working Group breakouts

3:30 pm Other agenda items TBD

4:00 pm Adjourn