With more than 3.0 million page views and more than 5,000 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency. David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.
Wednesday, October 05, 2005
Want a Stem Cell Grant? Here Are Some Clues, Sort Of
He appears to have been the only newspaper reporter filing reports on the two-day conference in San Francisco. His stories Sunday and Monday (a shared byline with Cornelia Stolze)provided some insight into the thinking at the agency and some details on how it intends to proceed, although it is still facing a court battle over its existence that will extend into 2006.
Hall wrote on Sunday that presentations Saturday "broke little new ground." On Monday, he reported that the session "marked a turning point for the state stem cell agency as officials try to shift from the frustrations of starting a controversial new enterprise into solving some of the most exciting challenges of biology." ("Turning point" may have been a bit optimistic.)
Hall said stem cell directors compared the presentations at the $215,000 conference to "reading about political candidates on the eve of an election: Even though they had heard it all before, they were still primed for a fresh summary. 'We're getting a solid scientific and clinical foundation for the institute's future work,' said Michael Goldberg, a venture capitalist who serves on the Prop. 71 governing board, known as the Independent Citizens Oversight Committee.'"
Hall's stories provided some fresh reporting on possible future direction of the agency.
"Several committee members said it's clear the program must bankroll novel collaborations to solve the big problems and avoid duplicating efforts, such as creating central facilities for banking lines of stem cells and carrying out clinical trials.
"That pointed to some obvious conflicts if research centers long used to competing with one another suddenly find themselves trying to collaborate, while also allying with profit-seeking companies on projects backed by tax-exempt bonds.
"Dr. Edward Holmes, medical school dean at UC San Diego and a member of the stem cell board, said the "industrial model" of drug development is a hard sell in academia.
"'Academics are rewarded for not doing the same thing twice,' he said.
Dr. Francisco Prieto, a diabetes specialist on the stem cell board, suggested it will be no simple matter to turn the scientific priorities into a workable program, adding that some key elements were absent from the weekend agenda. 'We've heard a lot about the what and how of stem cell research, but we've talked very little about the ethical and social implications,' he said.
Jeff Sheehy, a board member appointed to represent people with HIV/AIDS, said the talks highlighted 'a fundamental tension here between basic science and clinical science.'
"'How much do you have to know before you can actually start putting these cells into somebody?' he said, a question regulators also are beginning to tackle."
If researchers are looking for clues to what types of grants they might be able get funded in the future, Hall wrote, "Although it's hardly the final list, these appear to be some of the most important recommendations most experts endorsed:
"-- A centralized bank of human embryonic stem cell colonies and other raw materials to do the research, probably one in Northern California and another in Southern California to serve labs in each region.
"-- Fundamental research on the basic tools of stem cell research, in particular how to reliably coax the ultra-flexible stem cells into forming the many specialized cells of the body, a process known as differentiation."
"-- More efficient ways to genetically reprogram stem cells to represent particular genetic diseases, probably using a type of research cloning technology, called somatic cell nuclear transfer.
"-- Foster collaborations among many institutions, drawing in corporate partners early on to ensure that basic research is done in a way that will satisfy regulators and is directed toward projects with the best chance of paying off."
Hall reported that the agency plans to create subcommittee to come up with a strategic plan, a process that could cost hundreds of thousands of dollars, according to CIRM documents. Presumably most of that will go to a private consulting firm, given its minimal staffing and high use of outside firms.
Saturday, October 01, 2005
Otis Aims at Stem Cell Report; Governor Nixes SB18
However, we can tell you that the governor vetoed a measure to tighten oversight of the California stem cell agency. Reporter Carl Hall of the San Francisco Chronicle looks like he may be the only writer this morning to cover the veto.
The measure by Sen. Deborah Ortiz, D-Sacramento, would have added performance audit requirement and egg-donor protections to the California stem cell program.
Hall wrote, "In a veto message, the governor said he supported the main provisions of the bill but found it to be "in direct conflict" with a provision in Prop. 71 barring amendments until 2008."
"Ortiz issued a news release Friday decrying the veto, arguing that the bill
was 'carefully drafted' to avoid conflict with Prop. 71. She said that
'patient protections and appropriate public accountability must be included to
maintain the public's confidence' in the stem cell effort. Zach Hall, the institute's president, said during an interview Friday that the
institute never took a formal position on the bill. Officials already are
working through details of egg-donor protections, he said, and support the
need for routine audits.
"'We have always assumed we would be audited, and we want to be," Hall said.
'Exactly how it happens is not a major issue for us. It can be by whatever
mechanism the Legislature feels is appropriate.'"
Wednesday, September 28, 2005
Stem Cell Science: Glue Your Ears to the Internet
The agency said the sessions will be webcast live on www.thesciencenetwork.org and at www.cirm.ca.gov. The full agenda for the conference can be found here.
This is the first webcast of an event involving CIRM, a move that is long overdue. Meetings of the working groups are generally available at remote locations that are set up for the benefit of Oversight Committee members. The public is welcome also. However, none of the Oversight Committee meetings have a similar arrangement and none have been broadcast.
Both the University of California and Zoomedia have the capability of doing webcasts, which are quite common on the Internet. Zoomedia is rebuilding the agency's website as part of San Francisco's bid to secure the headquarters of CIRM. It would behoove Zoomedia to also webcast CIRM meetings as well.
Tuesday, September 27, 2005
CIRM Stalls Again on Mystery Costs
We received an email from CIRM, which claims the information is "preliminary" and thus is not public. The claim is part of the hoary bureaucratic stall technique discussed in our earlier item. The appropriate translation of the message from CIRM is, "Sue us. Our $500-an-hour attorney will take on any comers. We may not prevail, but the litigation will take months, if not years, so go for it."
Here is what CIRM said: "We have determined that the record you have requested is a preliminary draft, which will not be retained by CIRM in the ordinary course of business and is exempt from disclosure under Government Code section 6254(a).
"The budgeted amount for the Scientific Conference is $215,000. This figure is available on the CIRM website at http://www.cirm.ca.gov/meetings/pdf/2005/08/31/083105_item_3c.pdf.
"The figures for individual budget items have not yet been finalized, however we anticipate that our actual costs will fall below the budgeted $215,000 figure. We will be happy to provide you with the breakdown of the conference costs when those numbers are final."
Hundreds – if not thousands – of state government bureaucrats have argued over the years that much of what they do is "preliminary" and thus not fit for the public. CIRM, however, has published online scores of documents, equally as preliminary as the proposed spending plan for its science conference. Indeed, CIRM published preliminary versions of its own annual budget plans. Other government agencies do the same. The governor of California publishes incredibly detailed preliminary versions of his budget each year as does the President of the United States.
We should note that if the preliminary information is not retained, not even the CIRM staff will know whether the figures come in under budget – unless it subscribes to the oral tradition of bookkeeping.
The significance of CIRM's response has little to do with the conference itself. It has a great deal to do with whether it is a responsible public agency that takes its charge seriously and honestly. Based on this sad reaction to a request for routine information, it appears that empty rhetoric is likely to be the order of the day for the California stem cell agency.
Mystery Spending at CIRM's Scientific Conference
The two-day event is budgeted at a total of $215,000 and is designed to help identify scientific priorities for the first phase of stem cell research by the agency. Internationally known researchers are flying in for the session in Baghdad-by-the-Bay.
Presumably CIRM is picking up their expenses, but the agency has refused to release the spending plan for the conference until some indefinite date in the future. On the surface, the conference seems to be a worthwhile endeavor. In business terms, it is good marketing move. It will help focus international attention on CIRM and help generate credibility for the agency as it hits up potential purchasers of the bond anticipation notes that it needs.
But $215,000 is a large sum for an agency that has been vocal about its need to conserve its financial resources given the court challenges it faces.
How is that money being spent? No one outside the agency knows. Is there something dubious going on? Probably not, but the agency's refusal to share – in a timely fashion --public information about its activities does raise questions.
CIRM says it will disclose the conference budget when it is "final," whatever that means. The conference begins in two days. One would think CIRM would have "finalized" its conference spending plans by now.
One version of the agenda shows 25 outside speakers (excluding CIRM officials), amounting to a per capita expense of nearly $9,000. We have been told only that there are no honoraria, but little else.
CIRM's response to the information follows a time-honored and dubious tradition in some bureaucracies that stall when they receive requests for information. Often, the techniques are used because the information contains something embarrassing. Stalling allows time to cover up the worst disclosures, impart a favorable spin or simply out wait the inquiring party. Other times, the stall amounts to a mindless reflex by an organism that simply wants to repel any intruder.
Often the stall works. Information – like fish – does not improve with age. Time passes, and the information becomes less relevant.
It is difficult to understand why the agency is refusing to release the information. It is certainly not in CIRM's best interest to raise unnecessary questions about how it conducts the public business.
The stem cell agency's actions in this case fall woefully short of the promises by stem cell chairman Robert Klein to meet the highest standards of openness and transparency.
Sunday, September 25, 2005
Too Much Inside-The-Box Thinking From CIRM
Just how uncommon it actually is was highlighted recently by The Economist magazine in a piece that makes clear the opportunities and challenges faced by the California stem cell agency.
The Economist article (Sept. 22 edition) cites a report by Michael Steiner and Nils Behnke, consultants with Bain & Company that forecasts only a $100 million market for stem cell therapies by 2010, rising to $2 billion by 2015. That contrasts with some reports that predict a $10 billion market by 2010.
The Economist says Bain's predictions are convincing.
"According to Bain's estimates, there are now roughly 140 stem-cell-related products in development, for various forms of cancer, liver disease and other conditions. But more than four-fifths of these projects are in early-stage development, where many a gleam in a scientist's eye dies, and still far from the clinical studies where promising new treatments can also still falter. In addition to these scientific hurdles, the field is fraught with ethical debate over some of its most promising areas, such as the use of stem cells from embryos and therapeutic cloning," the magazine wrote.
Steiner estimated that slightly more than "$1 billion was spent on stem-cell work last year, a mere 1% of global spending on health-care R&D. More than four-fifths of that investment came from governments. Venture capital, the traditional engine of biotechnology, is remarkably scarce in stem cells. Only $50 million was pumped into the field last year, as private investors look for safer bets in more developed products with larger markets, where regulation and patent protection is more clearly defined," the magazine said.
Given the $1 billion figure, that would make CIRM's probable $300 million a year pretty hefty. It would be a figure large enough to have a significant impact on stem cell research and its practices, including the possibility of changing them So far CIRM has been in a get-along, go-along mode, too timid to challenge the sacrosanct, closed-door, we-know-best attitude of the scientific community and its business allies. Yes, it is difficult and risky to make changes in the comfortable practices of old. But, as stem cell chairman Robert Klein likes to point out, 59 percent of California voters said emphatically that they are fed up with inside-the-box thinking when they approved Prop. 71.
Friday, September 23, 2005
Where's The Money?
Reporter Malcolm Maclachlan quoted Deal in a piece in Capitol Weekly headlined "Stem Cell's Shell Game. It was the first interview that we have seen with Deal, whose report has come under criticism, particularly in light of the California Council on Science and Technology's admonition that California should not expect big returns from the California stem cell agency any time soon.
One might suspect some of the critics of a bit of dissembling. Most of them are not so naïve as to expect that studies generated on behalf of political campaigns are paragons of balance and objectivity. It is, and was, hardly realistic to expect campaign supporters to put out a report on Prop. 71 that was less than approving.
The report in question was produced by Laurence Baker, an associate professor of the Stanford University School of Medicine, and Deal, managing partner of the Analysis Group.
Maclachan wrote, "The figures, Deal said, were based on payouts that some research universities have received for IP (intellectual property) rights. They were calculated on the assumption that, over time, Prop. 71 would pay for both basic research and later-term studies leading to commercially available therapies. 'The idea of the report was to give examples of what could be possible if therapies were successful and the state could secure intellectual property rights,' Deal said. 'People quote things out of context all the time, but we tried to make it clear what it was.' "
The Baker/Deal study is likely to be a subject of continuing interest because of the intellectual property issues involving the the stem cell agency. State Sen. Deborah Ortiz, chair of the Senate Health Committee, has already said she expects more benefits than what the CCST study says is reasonable. The stem cell agency itself scheduled and the cancelled one meeting this month on IP matters. And still out there is Ortiz' proposed constitutional amendment which could make a statewide ballot in nine short months. Her previous legislative efforts at openness within the agency forced it to tighten its rules. The constitutional change could serve as a hammer to convince CIRM to attempt to provide more benefits to the California from taxpayer-financed stem cell research.
Wednesday, September 21, 2005
Bustamante Names New Stem Cell Overseer
Lt. Gov. Cruz Bustamante made the appointment, filling a vacancy left by the resignation of Phyllis Preciado, who took a job in Oregon.
Here is the full text of Bustamante's press release, which was not available on the Internet at the time of this writing.
"Lt. Governor Cruz Bustamante today announced the appointment of Marcelina "Marcy" Andaya Feit to the Independent Citizens Oversight Committee overseeing California’s stem-cell research initiative, which was created when voters approved Proposition 71 in 2004.
"Ms. Feit is the President and CEO of ValleyCare Health System, a non-profit healthcare system with hospitals in Livermore and Pleasanton. Valley Care Systems also operates a skilled-nursing facility, a geriatric-psychology program, and a health and wellness center.
"'Ms. Feit has spent her entire 32-year career in Central Valley health-care programs,' Bustamante said. 'She is a registered nurse who began her career as a surgical nurses’ aide and advanced through the ranks to become one of the few minority women to become a chief executive officer of a California health-care system.
"'She is a native of Stockton and the daughter of a farmer. She spent her youth in the Stockton area and was graduated from Manteca High School. She worked her way through nursing school and earned a Master of Science Degree in Nursing Administration.
"'She has a life-long commitment to improving health care for Central Valley residents, particularly those in rural areas. Her tenacity and her tireless efforts to overcome many obstacles in her career have provided her with the tools and the strength to greatly benefit the work of the Independent Citizens Oversight Committee.
"'Ms. Feit has made a formal commitment to seek policy guidance from medical providers and activist groups in Central Valley communities. Californians are very fortunate to have a person with her medical knowledge and management skills on the Independent Citizens Oversight Committee.'
"The Lieutenant Governor has five appointees on the committee. Ms. Feit fills the position for an appointee from a 'Type II Diabetes advocacy group.'
"Ms. Feit helped spearhead the Livermore Center of Excellence in Diabetes, which provides inpatient and outpatient care for individuals with Type I, Type II or gestational diabetes. The program also provides diabetes counseling, group support, nutritional advice and education services to the community. The American Diabetes Association has certified and recognized the Center of Excellence in Diabetes for its high quality of self-management education."
Reviewers Unaware of Funding Shortfall?
In an article on the grant program, writer Alison McCook said, "Stuart Orkin, Dana-Farber Cancer Institute researcher and cochair of the committee that reviewed the grant applications, told The Scientist that committee members did not consider where the money was coming from when awarding grants, and some likely didn't even know about the ongoing legal battles."
The reviewing scientists ranked the proposals on scientific merit as part of the process of making recommendations for funding to the stem cell Oversight Committee.
McCook also interviewed Dennis Clegg, chair of the department of molecular, cellular and developmental biology at the University of California, Santa Barbara, a grant recipient. He was quoted as saying, "We can't write checks yet."
That appears to be contrary to the expectations of California stem cell leaders, who had expressed hope earlier that grant recipients would proceed with the programs and seek reimbursement later. One suspects the response to that expectation would vary, depending on how flush a particular recipient is.
Stem Cell Discussions on Saturday
On tap is Sen. Deborah Ortiz, D-Sacramento, the chair of the state Senate Health Committee and the most influential legislator on stem cell issues. Ortiz has been critical of the performance of the California stem cell agency. Recently she has focused more on the possibility of generating revenue and benefits for the state from any stem cell research funded by the agency.
Also on the conference panel sponsored by the California Science Center are Lawrence S.B. Goldstein, professor of cellular and molecular medicine at the University of California, San Diego, School of Medicine, and a leader in stem cell research; Ted Peters, pastor and professor at Pacific Lutheran Theological Seminary, Berkeley, Ca., and ethicist on the stem cell citizen’s oversight committee. and Irving Weissman, immunologist, professor, and director of the Stem Cell Institute at Stanford University, School of Medicine.
For more information, check the California Science Center site.
Monday, September 19, 2005
CIRM System: Convoluted and Opaque?
"It is hard to imagine a system that is more convoluted and opaque," The Bee editorialized on Sunday.
"You can't say the oversight board wasn't warned. Months ago, institute reformers told the oversight board that its closed-door policies would be self-defeating. 'You will be confined to considering what the working groups put on your plate, with little or no sense of how it got there, or what is missing or why,' wrote Terry Francke, counsel for the good-government group, Californians Aware.
"The institute overseers now have two choices:
"1) Become a true decision-making board and insist on all information about grant applications it is judging.
"2) Become more like the National Institutes of Health, and delegate the job of awarding grants to an outside panel of scientists. Such scientists, as decision makers, would need to disclose their potential conflicts.
"Without changes, the current experiment seems doomed for failure."
Wednesday, September 14, 2005
More Favorable PR Stems From Training Grants
None that we saw mentioned that zero dollars were delivered with the awards, except for the press releases from the University of California, Santa Barbara, and Stanford University.
Nonetheless, the decisions on the grants and the follow-up press releases create an appearance of activity and momentum, which is exactly what CIRM officials sought.
Stanford received $3.7 million. Its press release quoted Michael Longaker, professor of medicine and chair of the advisory committee for Stanford’s Program in Regenerative Medicine, as saying, “It is particularly gratifying to be able to link the incredible depth and breadth of talent at Stanford. We want stem cell biology and regenerative medicine to be a catalyst for collaborations between faculty and trainees in all the schools. This exciting educational environment should help propel Stanford to a leadership role in regenerative medicine.”
USC, which received $3.2 million, noted that its application was described as "very thoughtful" by reviewers.
"This grant award bodes well for the program we are trying to develop here at the Keck School of Medicine - the USC Institute for Stem Cell and Regenerative Medicine - and speaks highly of the research being conducted here and at Childrens Hospital Los Angeles," said Brian E. Henderson, M.D., dean of the Keck School of Medicine and a member of the Oversight Committee that awarded the grants.
Childrens Hospital Los Angeles announced that it is "the only pediatric institution in California awarded a stand-alone CIRM training grant." It was approved for $2.4 million.
"The biomedical environment and strength of stem cell research at Childrens Hospital Los Angeles and the Keck School of Medicine combine to provide a rich milieu for training the next generation of physicians and scientists who will use stem cells as the basis for research and therapy," said Donald B. Kohn, director of the Gene, Immune and Stem Cell Therapy Program at Childrens Hospital Los Angeles. Childrens is affiliated with USC.
The University of California, San Francisco, combined the announcement that it had received a $3.6 million grant with a press release on creation of the Institute for Stem Cell and Tissue Biology.
It said its training program "will be led by Renee Reijo Pera, PhD, co-director of the UCSF Program in Developmental and Stem Cell Biology’s Human Embryonic Stem Cell Center and associate professor in the Department of Obstetrics, Gynecology and Reproductive Sciences, and Kevin Shannon, MD, professor in the Department of Pediatrics, who studies genes that normally regulate the growth of immature blood-forming cells that are mutated in leukemias."
The Gladstone Institutes at UC San Francisco received a $2.4 million grant. "Gladstone Institutes President Robert W. Mahley, MD, PhD, a professor of medicine and pathology at the University of California, San Francisco (UCSF), will serve as the director of the CIRM Scholars Training Program. Gladstone Institute of Cardiovascular Disease Associate Investigator Bruce Conklin, MD, a UCSF associate professor of medicine and cellular and molecular pharmacology, will serve as associate director," a press release said.
UCSB noted that funding of its $1.3 million grants awaits the sale of bond anticipation notes, since litigation has effectively halted the sale of other California state bonds.
The press release went on to say, "Martin Moskovits, UCSB's dean of the Division of Mathematical, Life and Physical Sciences, called the grant 'a strong statement that we are significant international players in the kind of biomedical research from which important new therapies for human disease will be developed." He explained further that, 'We have already established important partnerships with companies and medical schools with whom we intend to pursue a vigorous research program.'"
Freezing Out the Conflict
However, the California stem cell agency went to excruciating lengths to avoid the appearance of a conflict of interest, barring committee members from discussing or voting when their institution's application was considered.
Oversight Committee members were given only bowdlerized summaries of the grant applications, which were solely identified by an alphanumeric code, along with funding recommendations from an agency working group. The summaries were identical to the material available on the Internet. Names of the institutions and individuals were blacked out.
Privately ahead of the meeting, individual committee members were notified that they could not participate in discussion when an application with a particular code came up. None of the committee members knew when another was barred from discussion, according to CIRM officials.
And when the actual vote was taken, the name of the committee member whose institution was seeking funds was not called during the roll call.
Monday, September 12, 2005
Serrano Sewell Demures on Stem Cell Report Item
Here is what he had to say:
"As an ICOC member, I do enjoy this blog. However, on occasion you get things wrong. Recently the report stated:
"'David Serrano Sewell, a patient advocate committee member from the Amyotrophic Lateral Sclerosis Association, abruptly cut off attorney Charles Halpern of Berkeley, Ca., when he raised questions about the criteria for the training grants. Sewell heatedly declared that CIRM had been 'transparent in every respect.'
"First, I represent both the MS and ALS community. At our recent 9/9/05 meeting, Mr. Halpern did raise a series of issues regarding the ICOC training grants. ICOC staff forwarded his letter via email and a hard copy was provided for all the ICOC members at the meeting. At the meeting, Mr. Halpern's opportunity to speak well exceeded his three minutes. Charlie was getting close to seven minutes, and that's when I reminded (stem cell chairman) Bob (Klein) that members of the public are given three minutes to speak. So, yes I did 'cut off' Charlie, not because of the subject matter, but because the ICOC had other issues to address."
Sunday, September 11, 2005
Greenlining Enters Fray with Emphasis on Minorities
"The health and well being of our families is on the line," the organization said in an e-mail to the California Stem Cell Report. "It is time for California’s minority communities to take ownership of their billion dollar investment by asking questions, demanding answers, speaking up, and being heard."
Greenlining, a self-described "multi-ethnic public policy think tank bridging together a coalition of more than 40 non-profits throughout the state," popped up last spring during a legislative hearing involving the stem cell agency but has been silent since.
In the wake of the grant announcement on Friday, Joe Tayag, health policy associate at Greenlining, said, . "We feel that it’s time for communities of color to participate in this dialogue and we’ll be starting our public advocacy campaign soon."
Tayag also offered the following commentary, which he titled "The Color of Stem Cells: Why the benefits of stem cell research might not be for people like me."
Here are his remarks in full since they are not available elsewhere on the Internet:
"After losing half of one of my lungs to tuberculosis while volunteering in the Andes last year, I assumed that life would just never be the same again. By this I meant that the flight of stairs to my apartment would always seem twice as long and that I would have to give up things I enjoyed like taking long runs on Sunday mornings.
"However, the promise of therapeutic treatments derived from stem cell research gives individuals like me a hope for normalcy. Yet, as an immigrant from a low-income family, I can’t stop from cringing at the thought that the low-income and marginalized communities of the state still have no explicit guarantee of access to the promised 'cures' of Prop. 71—much less to adequate health care in general.
"Last Friday, the Independent Citizen’s Oversight Committee (ICOC) allocated a little over $39 million to prestigious research institutions like UCLA, UC Berkeley, Stanford, USC, and Cal Tech among others. Yet, it’s unclear from perusing through many of their grant proposals just how much focus these research institutions will give to communities of color and their health needs.
"The initiative passed last November with overwhelming minority support. Despite this, there has been no mention of issues crucial to communities of color especially with regard to the California Institute of Regenerative Medicine’s research and staffing diversity. After all without minorities represented at CIRM’s decision making bodies, who will listen to the needs of the African American communities who are more susceptible to heart disease? Or to the Latino communities who suffer from diabetes? Or to the Asian Pacific Islanders who are more prone to sickle cell anemia?
"Without a more diverse governing board, these questions will be left to dwindle in uncertainty as California drafts the first ever model of state-sponsored stem cell research arrangements that will be referred to by the rest of the nation. New Jersey and North Carolina are already following suit and unless California sets a proper example of diverse representation, we’re bound to see the ignorance of minorities’ needs ripple throughout the rest of the country.
"To prevent this, minority communities should be represented proportionate to their numbers in California in each of the following areas of Prop. 71’s implementation:
-- The institute’s governing board (also known as the Independent Citizen’s Oversight Committee). As it stands, only 3 members of the ICOC are minorities.
-- The recipients of the $39 million in grants going toward the training of lab technicians, medical students and social scientists.
-- The groups of people on whom the medical products are tested to ensure compatibility amongst all communities.
"Due to scarce resources, we currently have a kind of disease hierarchy with regard to research priorities. Diseases that disproportionately affect communities of color (such as diabetes, heart disease, HIV/AIDS and sickle cell anemia) should be considered and represented in any discussion of the allocation of grants and research goals—but who will uphold the needs of the underserved when communities of color are not being allowed at the decision-making table?
"The reverse is also true: just as the minority public deserves to be represented, the state-sponsored agency needs to report the proper information to the minority public. CIRM is notorious for releasing important information as late as hours before its public hearings and thus, does not allow enough time for people to digest their materials—much less understand them.
"The last September meeting of the Independent Citizen’s Oversight Committee is evidence of this. Although the ICOC meeting agenda contained some background material on several matters such as the proposed budget and guidelines for embryonic stem cell research, the items were not 'translated' to the public in terms that regular citizens could understand.
"Though the 'translation' from scientific jargon to understandable speech seems like a difficult task, the request does not seem even close to colossal considering that CIRM currently has an almost $30,000 a month public relations contract with the Edelman PR firm. With $30,000 a month going to public relations, why is it that communities of color still hide at the sound of the words, 'stem cell research?' I would argue that it is due to the lack of outreach and education in our communities that many people of color believe that the issue does not concern them."
In contrast, the $3 billion that minority communities pledged to give to stem cell research clearly means that it does concern them. The legislative fate of these tiny cells is calling for communities of color to ask questions such as: will the treatments derived from the research that I am helping to fund cure my ailing loved ones? And even if they will, will the treatments be affordable to my community?
"The health and well being of our families is on the line. It is time for California’s minority communities to take ownership of their billion dollar investment by asking questions, demanding answers, speaking up, and being heard."
,
Peddling the Name of the Stem Cell Scholar Program
Klein discussed the plan with the Oversight Committee late in Friday's meeting in Sacramento. As a hypothetical example, he suggested an individual or foundation known as "Patent" who purchased $10 million in bond anticipation notes for the agency would be offered the right to have recipients of CIRM training grants identified as "Patent Scholars."
He said there is precedent for such a move, noting that universities and colleges have buildings and programs named after individuals.
No formal vote was taken on the suggestion, which had a mixed response from board members.
Gayle Wilson, wife of the former Gov. Pete Wilson, opposed the plan, saying she could not recall any other state agency that had such a program. Robert Price, a surrogate for Oversight Committee member Robert Birgeneau, chancellor of the University of California at Berkeley, said there could be "political problems" with some individuals or organizations that might be viewed askance.
Oversight Committee members Oswald Steward, chair and director of Reeve, Irvine Research Center University of California, Irvine, and Michael Goldberg, a general partner with Mohr, Davidow Ventures, said they supported the proposal but did not elaborate on their reasons.
Klein said he would exercise "care and sensitivity" in pursuing the matter.
Coverage is Right Medicine for Stem Cell Agency
"Stem Cell Grants Begin," "Medical Schools Get Stem Cell Grants," "Stem Cell Funds Awarded," "Stem Cell Agency Awards $39 million" -- those were some of the headlines.
Subordinated was the reality that the agency does not yet have the money. Even more deeply subordinated were complaints about the grant process from critics.
Which is just what stem cell chairman Robert Klein and president Zach Hall like to see. Hall told reporters the agency wanted to counter its critics and their negative message with a positive move. The two leaders also indicated they wanted to have grants ready in place to aid in their fundraising pitch to philanthropies.
What most people saw or heard across the country was The Associated Press story by Paul Elias. That is the one that turns up most often in Internet searches and also the one that would used by thousands of newspapers, radio and televisions.
He wrote, "California's $3 billion stem-cell agency began awarding its first research grants yesterday despite legal challenges that put its future in doubt. 'This is really a historic and important occasion for us,' said Zach Hall, interim president of the California Institute for Regenerative Medicine."
In California, the most thorough story appeared in The Sacramento Bee. Reporter Edie Lau wrote, “Selecting the recipients was an arduous process that took the board the better part of the day, and revealed some of the weaknesses in a system that is still being invented.”
“David Baltimore, a Nobel laureate and president of the California Institute of Technology, said the working group's recommendation to fund 60 percent of the applications was too generous,” Lau said.
“Citing the stringent standards of the National Institutes of Health, Baltimore said, 'Were we to go with 60 percent at NIH reviews, many of us scientists would be very uncomfortable with the quality.' "
Reporter Alex Raksin of the Los Angeles Times focused on grants to schools in the paper's circulation area. He did not mention until the fifth paragraph that no funds were available.
At the San Jose Mercury News, the first paragraph on reporter Steve Johnson's story said, "The board overseeing California's stem-cell research institute Friday awarded $12.5 million in training grants to 16 applicants around the state -- including five in the Bay Area -- despite not having the money yet to pay for them."
At the San Francisco Chronicle, David Perlman, the paper's science editor, wrote, "Leaders of California's $3 billion stem cell research agency announced their first multimillion-dollar grants Friday to train dozens of scientists in the field -- but where the money will come from remains uncertain."
The bulk of the material in all the stories dealt with the grants, how much, to whom and what they are for.
The coverage had some downsides, apart from the issue of funding. The story broke late on Friday on a day when other events continued to dominate the news. While it is unlikely that the grant announcement would have ever been front page news, one good way to bury a story is to run it out late for Saturday papers.
Also lost in the shuffle for the most part was the appointment of Hall as permanent president, which could have been peddled separately from the grants on another day as a good sign that the agency was moving forward. Repitition of a message is an important PR tool.
TV and radio coverage was largely missing, and is likely to continue to be missing unless the agency can generate events that play to the interests of those media.
Saturday, September 10, 2005
Coming Up
CIRM Hands Out $39 Million (sort of), Picks Almost New President
Both steps were aimed at delivering a message that the infant agency is determined to survive and thrive despite lawsuits aimed at snuffing it in its crib. The Oversight Committee also gave short shrift to critics who complained that its grants were, in fact, illegal.
Zach Hall, who was named interim president only last March, was chosen as the new permanent president of CIRM. The action removes questions about the direction of the leadership of the organization, which had hoped to name a permanent executive three months ago. Hall is highly regarded by many in the scientific community outside of the agency.
While Hall's appointment helps to solidify the management of CIRM, the training grant program remains a question because it is unfunded. During Friday's meeting of the Oversight Committee, Hall told reporters that it was important to make decisions on the grants in order to deliver a message that CIRM is alive and well, despite its much publicized travails.
CIRM chairman Robert Klein said he hopes to deliver the funding for the stem cell training grants by the beginning of November. He indicated that grant recipients should begin their programs with the expectation they will be reimbursed later. Klein hopes to sell bond anticipation notes to provide the $12.5 million that is needed for the first year funding. His target market is philanthropic institutions and individuals. The clinker in his plan is that holders of the notes would not be repaid if CIRM's legal critics are successful.
CIRM's $3 billion plan makes it the single largest source of stem cell research funding in the world. Hall said the nearly $39 million in training grants approved Friday would create the “broadest training (stem cell) training program in the country and, I assume, the world.”
There were few surprises in the training grant program awards, which, by law, are limited to California organizations. Eight University of California campuses received funding. Other winners included the Burnham Institute, the California Institute of Technology, Childrens Hospital in Los Angeles, the Scripps Research Institute, Stanford University, the J. Gladstone Institutes and the Salk Institute for Biological Studies.
The names of the losers were not announced, although we reported earlier that all of the UC campuses had sought funding. CIRM officials said they would not disclose the names in order to avoid embarassing the losing institutions.
The grants are expected to provide funding for 180 stem cell scholars -- “intellectual capital” as described by Klein. New stem cell researchers are needed because President Bush's anti-stem cell policies have discouraged many from entering the field. “We know the pipeline is pretty dry,” said Philip Pizzo, dean of the Stanford University School of Medicine.
A few members of the Oversight Committee, which is largely composed of high-powered executives and academicians, on Friday demonstrated they are not used to being criticized openly during the public comment portion of their meetings. Oswald Steward,
chair of the Reeve, Irvine Research Center University of California, Irvine, sharply objected to the length of comments by Susan Fogel, coordinator of the Pro-Choice Alliance for Responsible Research, and then muttered under his breath at her retort.
David Serrano Sewell, a patient advocate committee member from the Amyotrophic Lateral Sclerosis Association, abruptly cut off attorney Charles Halpern of Berkeley, Ca., when he raised questions about the criteria for the training grants. Sewell heatedly declared that CIRM had been “transparent in every respect.”
Halpern is a longtime member of the Institute of Medicine of the National Academy of Sciences, he has served as dean of the City University of New York Law School and the president of the Nathan Cummings Foundation. He said said Prop. 71 required adoption by the Oversight Committee (ICOC) of criteria for training grants prior to their consideration by the working group that reviewed them. The working group had a draft version of the criteria, but the Oversight Committee did not approve the criteria until Friday, only minutes before it began to consider the grant recommendations. All but one of the group's 26 funding recommendations were approved.
Halpern said, “The (working group) cannot apply its proposed criteria to pending applications until these criteria have been reviewed, amended, and approved by the ICOC—nor can the (working group) assume that the ICOC will simply rubberstamp its proposed criteria.”
Prior to the meeting, Marcy Darnovsky, associate executive director of the Center for Genetics and Society in Oakland, Ca., said, “It is irresponsible for (CIRM) leaders to promise grants that they may be unable to deliver.”
Jesse Reynolds, director of the program on biotechnology accountability at the Center, attended the Friday meeting. He told the board that approval of the grants continues “a pattern of doing things fast at the expense of doing things right. Good policy would be guided by the availability of resources, rather than a concern with a public relations campaign.”
The full text of Halpern's letter to CIRM, which is not available elsewhere on the Internet, follows this item.
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(Note: Normally our coverage of CIRM is prepared at sea in the far reaches of the Sea of Cortez in Mexico. Today's report, however, and those that will appear over the next day or so are based on our attendance at what turned out to be a nonstop session Friday of the Oversight Committee in Sacramento.)