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.
California's plan to create an ambitious, $150 million public/private partnership to commercialize state-funded stem cell research edged forward this week as the deadline for applications closed on Monday afternoon.
Little is known about the nature of the applications -- not even the number received. The state's stem cell agency yesterday declined to reveal the figure, declaring that the proposals needed to be examined to determine eligibility.
Traditionally the $3 billion agency does not disclose the names of applicants for its funding or details of their applications, although there have been exceptions. Their proposals are reviewed behind closed doors by scientific grant reviewers whose names are not disclosed. Nor are the reviewers' statements of economic interest publicly revealed.
A CIRM document calls for the proposal to be evaluated by reviewers during the first quarter of next year with final board action also coming during that period. The recommendations of reviewers are almost never overturned by the board.
The public/private partnership could well be one of the landmark legacies of the stem cell agency, formally known as the California Institute for Regenerative Medicine(CIRM). The project would be unique in California history and nationally.
The eligibility requirements include the following:
A California location for the work
Documentation of an "upfront financial commitment" of $75 million(no in-kind services)
Readiness to begin work as required by CIRM
Incorporation by the date of the application
The recipient must begin work on the project within 45 days of the award, which translates to before the middle of next year.
Directors of the $3 billion California stem cell agency are scheduled to meet next Tuesday with many teleconference locations throughout the state, providing members of the public an ample opportunity to speak to the agency's governing board on any issue of concern.
The session is scheduled for only one hour and is expected to involve routine approval of changes in the agency's loan policy. So interested parties who want to be heard should not be laggard in being present. State law allows the public to speak on any issue at a meeting, not just items on the agenda.
Teleconference locations are in San Francisco, San Diego, Davis, Pasadena, South San Francisco, Beverly Hills, Elk Grove, Fresno and two each in La Jolla, Los Angeles and San Francisco. The meeting will be home-based at the agency's headquarters in Oakland.
The California stem cell agency is set to embark on a risky and unique attempt to create a $150 million stem cell company. On Friday, the proposal will receive its lengthiest public examination. The public will have a chance to participate in the discussion at eight teleconference locations.
The main location is at the agency's headquarters in Oakland. Other locations are in South San Francisco, Napa, Irvine, San Diego, Los Angeles, La Jolla plus another location in Oakland.
Also available is a listen-only, toll-free audiocast. Full directions for the audiocast and specific addresses for the teleconference locations can be found on the agenda.
For more on the $150 million proposal, see here, here and here.
People around the world will have a chance to follow every minute this week of the meeting of the governing board of the $3 billion stem cell agency, which is expected to give away $44 million to chase therapies for everything from cancer to Canavan disease.
The session in Millbrae near San Francisco International Airport will be available on the Internet and by phone, including display of the charts and presentations being used during the day-long session. The phone link is audio only and is available toll-free. Full directions for listening are available on the agenda.
For those who want to comment live on Wednesday, they will have to be on the scene or at one of three remote locations, all of which are located in La Jolla. Specific addresses again are available on the agenda.
In addition to the research awards, the board is scheduled to be briefed on the agency's ambitious clinical trial effort, which could be interesting. However, the agency has not posted any background material on the briefing as of this writing. Here is a link to what the agency has on its Web site concerning the clinical effort.
Also on the agenda is a closed-door evaluation of the agency's president, Randy Mills, who was hired in April 2014.
But amply open in many ways One of the more admirable aspects of the California stem cell agency’s plan for spending its last $900 million is its attention to careful measurement of the agency’s own performance. The “success metrics” are tucked away at the end of the agency’s new, 47-page strategic plan. They lay out the criteria for determining how well each team at the agency is doing. The metrics range from the number of conflict of interest appeals to the number of clinical trials completed at Alpha clinics. Based on decades of experience with state agencies, the California Stem Cell Report can attest that such attention to performance is rare among state departments.
The agency's measurements also include the “number of board meeting documents posted with ten-day lead time.” Which is where the March 16 meeting of the governing board of the stem cell agency comes in. On Saturday, the agency posted on its Web site the agenda for the meeting, a good 11 days ahead of the session in Millbrae, near San Francisco International Airport. The agency plans to give away millions of dollars, perhaps tens of millions. It will review the status of its ambitious and risky clinical trial program, which has seen a sharp upsurge in the last year or two. At least that is what can be deduced from the cryptic agenda items, the longest of which consists of only 26 words. Total missing, as of this writing, are any documents supplying the details essential for understanding what the agency is actually doing.
The board meetings are the single most important public events of the agency. The agency professes to want to see greater public turnout at the sessions. But without adequate notice and some sort of meaningful information, the public, stem cell firms, scientists and patient advocates cannot make plans to attend the meetings even if they might have a deep impact on their lives. On Feb. 9, Kevin McCormackwrote on the agency's blog about a CIRM meeting dealing with gene editing. He said,
“(Bioethicist) Alta Charo said this is not just a question for scientists, but something that could potentially affect everyone and so there is a real need to engage as many groups as possible in discussing it
"‘How and to what extent do you involve patient advocates, members of the disability rights community and social justice community – racial or economic or geographic. This is why we need these broader conversations, so we include all perspectives as we attempt to draw up guidelines and rules and regulations.’”
Those sentiments pretty much apply to all that the agency does. It is spending $6 billion of California taxpayers’ money, including interest, on research that is yet to produce a commercial therapy, despite the facile promises of the ballot campaign that created it in 2004. It is financing experiments in areas that are new to medicine, some of which involve serious risk and ethical considerations.
All of which might seem to be issues that would engage many persons and enterprises. But the best way to discourage involvement by those not embedded in the agency is to withhold information until it is too late to respond. If interested parties don’t know what is going on, how can they offer suggestions and criticism, some of which might be useful and help the agency succeed in its endeavors? Not to mention helping to build support for continued funding beyond 2020, when the agency expects to run out of cash. Additionally, the agency basically hides the schedule of its public meetings on its Web site. They are virtually invisible on the agency’s home page, buried at the bottom in teeny lettering under a heading of “about CIRM” -- one of 11 subjects such as “mission” and “history.” In many ways, CIRM is more than amply open and transparent. Its board meetings are audiocast on the Internet and by phone. Its committee sessions are now available live online as well, an improvement that began during the last few months. Transcripts of the sessions are also available online, albeit sometimes months after the sessions. The CIRM Web site is laden with a variety of material. The agency’s excellent blog, The Stem Cellar, produces daily reports that chronicle CIRM affairs as well as research developments elsewhere. Interested persons can sign up for email alerts on various CIRM matters. Eventually, most of background information on board meeting agendas is posted online, although sometimes only a day or two ahead of the session. Nonetheless, CIRM can and should do a better job of telling California what its governing board is up to and what the agency is thinking and doing. One key and long neglected tool is to provide more detailed information -- well in advance -- about the issues that come before the 29-member board that hands out the cash and establishes the priorities for one of the most ambitious stem cell programs in the world.
If you would like to speak directly to the governing board of the $3 billion California stem cell agency, here’s your chance on Thursday. The directors are holding a teleconference meeting at 11 a.m. PST with public locations at 12 different sites around the state. The purpose of the meeting is to approve a $3.8 million application for work on process to manufacture a cord blood treatment for such afflictions as leukemia and lymphoma. Approval is expected to be routine since the agency’s blue-ribbon reviewers, meeting behind closed doors, have already decided the application should be funded. The identity of recipient, as usual, is being withheld until after the board ratifies the decision by reviewers. Every board meeting has a point at which any person can address the board on any issue. The board sets a three-minute time limit but has been very flexible in the past. The teleconference locations are in Oakland, Redwood City, Napa, South San Francisco, Beverly Hills, Fresno, San Diego, Elk Grove, Los Gatos, San Francisco (two different locations there) and Irvine. Specific addresses can be found on the meeting agenda, You may want to double-check in advance with the agency on the addresses. Only one lists a room number. Others may need to include that detail as well.
The California Stem Cell Report is concluding its live coverage of today's California conference on human genetic modification of human embryos. The quality of the stem cell agency's audiocast is so poor that it is impossible to compile an accurate account of what the speakers have to say.
We hope to bring readers more information on the impact of the proceedings on California stem cell research when written accounts of the meeting become available.
A key committee of the governing board of the $3 billion California stem cell agency this morning approved changes in its grant rules in an effort to speed basic and translational research and attract higher quality applications.
The Science Subcommittee sent the changes to the full board on an 8-0 voice vote with no discussion and no public comment. The full board is expected to ratify the proposals at its Jan. 19 meeting.
The action came as the agency continued its new effort to provide more public access to important policy discussions and actions by the board's key committees. Today's meeting was accessible live on the Internet and by audiocast. For the past decade or so, only the meetings of the full board were available live on the Internet.
The new rules will cover hundreds of millions of dollars in awards for basic and translational research as well as educational training. Hundreds of California researchers could be affected.
The proposals were based on earlier changes in clinical award rules. They are expected to strengthen the agency's ability to terminate research when milestones are not being met and establish a researcher's past performance on agency awards as a criteria for future funding. Also to be altered are rules about use of funds not spent during the award period.
The regulations are being enacted on an interim basis and will be subject to change as they wend their way through the official state regulation process.
Highlights Move Opens Door to More Public Participation Major Policy Sessions to be Available Tuesday Meeting Involves Hundreds of Millions in Grants With no fanfare, California's $3 billion stem cell agency is making a significant step forward in openness and transparency regarding the dealings of its governing board, which operates outside of the control of the governor and legislature. Next Tuesday’s meeting of the directors’ Science Subcommittee will be available live for the first time -- for all practical purposes -- on the Internet and as an audiocast, including access to presentations that are used at the meeting. The agency intends to allow public access for other directors' subcommittee meetings as well. The move appears to be patterned after action by state Treasurer John Chiang, whose office holds many public meetings involving sometimes billions of dollars. Last summer he added an audiocast feature to treasurer’s meetings. A spokesman for the treasurer told the California Stem Cell Report last summer that Chiang wanted to enhance public access and to “increase public participation in and increase awareness of the many boards, commissions and authorities" that he chairs. The treasurer’s office said the cost was much less than $100 a session. Tuesday’s stem cell audiocast follows procedures of the full board but never applied to other meetings of the California Institute for Regenerative Medicine, as the agency is formally known. Last month, the stem cell agency attempted to provide an audiocast, which are also available for later listening, of a subcommittee meeting. However, the audiocast was not accessible for subsequent public use. The problem seemed to be a technical glitch because the agency said that it could be heard when CIRM staffers logged in. Generally subcommittee meetings of the board rarely attract attendees from the public or the scientific community. However, major policy and scientific initiatives are discussed in more detail than at full board meetings. Suggestions for changes in proposals are more likely to be accepted in a subcommittee than at full board meetings, where proposals are ratified, usually without much discussion. At next Tuesday’s meeting, for example, the Science Subcommittee is scheduled to act on new rules that will involve hundreds of millions of dollars in grants. Hundreds of California scientists engaged in basic and translational research as well as the progress of their efforts are likely to be affected. Educational training awards will also see new rules. A memo to the subcommittee from Gabriel Thompson, director of grants management, said that the proposed rules are “designed to attract more high quality applications, reduce the cycle time from application to project start, accelerate progression of funded projects and provide for more efficient administration of the projects.” One of the proposed changes appears to give the agency more power to pull the plug on research when it is not progressing satisfactorily by agency standards. The new rules would affect use of grant funds that are not spent by the end of the research. Past performance of grantees would also be established as a criteria for future funding. Interested parties can find directions for logging into the Internet and audiocast on the meeting agenda. Some set-up may be required so it is best to check in advance the instructions on the agenda. The meeting will be based at the agency’s new headquarters in Oakland and is open to the public there. Teleconference locations where the public can speak to the committee as well as listen are available in Los Angeles and La Jolla. Addresses can be found on the agenda.
"Stanford University, Memorial Sloan
Kettering Cancer Center, and other prestigious medical research
institutions have flagrantly violated a federal law
requiring public reporting of study results, depriving patients and
doctors of complete data to gauge the safety and benefits of treatments,
a STAT investigation has found.
"The violations have left gaping holes in a federal database used by
millions of patients, their relatives, and medical professionals, often
to compare the effectiveness and side effects of treatments for deadly
diseases such as advanced breast cancer
"The worst offenders included four of the top 10 recipients of federal
medical research funding from the National Institutes of Health:
Stanford, the University of Pennsylvania, the University of Pittsburgh,
and the University of California, San Diego. All disclosed research
results late or not at all at least 95 percent of the time since
reporting became mandatory in 2008."
Francis Collins, head of the NIH, said he finds the failure to report "very troubling."
Call it California’s $900-million road map to a stem cell cure. That’s what up for final action next week by the governing board of the state’s $3 billion stem cell agency, officially known as the California Institute for Regenerative Medicine (CIRM).
The plan includes a $105 million lure to entice Big Pharma and other possible investors to join the Golden State’s regenerative medicine bandwagon and create an “industrial stem cell therapeutic powerhouse.” Randy Mills, president of the California stem cell agency, and his team are calling for “attacks” on barriers to clinical development of therapies. That includes the FDA which Mills and company say “appears to be literally lobbying against the very therapeutic modality they are responsible for promoting.” (See here and here.) The key part of the $105 million stem surge would bring together next year the state of California and private investors in a joint enterprise. Under the plan, the private investors would have the pick of the best research from CIRM that has not already attracted partners. The agency would pony up $75 million with another $75 million coming from investors.
(Here are links to the CIRM description of the three components of the $105 million effort: here, here and here.) The agenda for the Dec. 17 meeting in Los Angeles includes other matters, such as action on a clinical research applications for millions of dollars. The review summaries of those applications are not yet available online, but most of the additional supporting material for the meeting has been posted. That is a healthy change from some recent past meetings where backup information has been missing until much too late. (The morning of Wednesday Dec. 9, the agency posted a note on the agenda saying the applications were no longer under consideration. Often that means that the proposals have been withdrawn because of negative recommendations from reviewers.) Also on tap is a major change in the scoring of applications in non-clinical programs. Here is how the change is described by a CIRM memo:
“For non-Clinical Program applications, therefore, we propose to revert to our former scoring system (1 to 100) with two tiers: (Tier 1) average score of 85 or above, recommended for funding, if funds are available, and (Tier 2) average score of 84 or below, not recommended for funding. In addition, for those programs for which only one application is expected to be funded, we propose to specify that the application that receives the highest average scientific score shall be deemed to be the GWG’s recommendation for funding.”
These changes would be in effect for the three rounds involved in the $105 million surge. The board is also being asked to raise the cap on payments to patient advocate members of the board from $15,000 to $30,000 annually. The move would be retroactive to the beginning of this year.
A CIRM memo said that demands on patient advocate directors have increased dramatically both in terms of the numbers of meetings and their role. The memo said that prior to Mills’ arrival at CIRM patient advocates were involved in only three or four review sessions a year. In 2015, those sessions have already risen to close to a dozen. While next week’s meeting will be based in Los Angeles, remote, telephonic locations where the public can participate will be located at Stanford and UC San Diego. Specific addresses can be found on the agenda.
If you would like to speak directly to the overseers of
California’s $3 billion stem cell research effort, today would be a good day.
The agency will have the most ever sites available for
public access in its nearly 11-year history to a meeting of its governing board. Twenty-two teleconference locations around
California are scheduled to be accessible, ranging from Davis to Fresno to La
Jolla as well as major population centers such as Los Angeles and the San
Francisco Bay Area.
The meeting begins at noon. The public is entitled to speak
to the board on any subject, including its proposals for spending its last
$800 million to $900 million. (Seehere,here,hereandhere.)
Items on the brief agenda include three non-controversial
matters. As usual, the California Stem Cell Report will provide live coverage of the session.
The teleconference sites are in San Francisco (3), Los
Angeles (4), San Diego (2), La Jolla (2) and one each in Davis, Sacramento,
Redwood City, Irvine, Oakland, Fresno, Berkeley, Elk Grove, South San
Francisco, Stanford and San Jose. Specific addresses can be found on the agenda.
For years the California stem cell agency has given the
public access to the meetings of its governing board via a one-way audiocast
over the Internet and by phone.
But patients, advocates, scientists and business folks have
not had the opportunity to comment and make suggestions re the doings of the
29-member board of directors through the same method. The public could only
listen unless they were on the scene.
However, that could change if the $3 billion stem cell
enterprise follows the lead of the state Treasurer John Chiang. This summer he
began opening up meetings of the many important boards in his office to live, two-way, teleconference connections with the public.
Chiang also uses the same sort of service and company as used by the stem cell agency. But he has added an inexpensive touch that genuinely
opens up the meetings to the public.
We recently stumbled across Chiang's press release on the move, which may well be unique in California state government. We queried
Drew Mendelson, a spokesman in the treasurer’s office, for more details.
Mendelson said,
“Participants on the phone are in listen only mode, but when
the meeting chair calls for public comments, callers can press a set of numbers
to indicate they want to speak. The conference call is monitored online
by (treasurer’s) staff and the call monitor must click on the caller in the
queue to allow the person to speak.”
Mendelson continued,
“Under our state contract with AT&T, we determined that
an hour long meeting with 10 callers would cost less than $15. The cost
increases significantly if you have AT&T provide conference monitoring
services. We chose to monitor the calls ourselves. What we are
using is a basic conference call service with an online component where the
monitor sees the list of callers to know how many people are on the line and
when someone indicates they want to speak.”
Mendelson said that the move was generated by Chiang's desire to enhance public access and his “desire to increase public participation in and increase awareness of
the many boards, commissions and authorities" that he chairs.
On-the-scene public participation in CIRM meetings is slim.
One of the reasons is that the sessions often require travel and overnight
stays that pose barriers for many persons, particularly patients and their
advocates. The agency would make it easier for its stakeholders and enhance its
reputation for openness and transparency by instituting this inexpensive
practice. It also fits with the goal of Randy Mills, the president of the
agency, to provide more clarity in what the agency does.
Jenifer Raub, Bill Maddox and Cassandra Peters (left to right), members of the Summit4StemCells group. San Diego UT photo
The San Diego Union Tribune this week spotlighted a
Parkinson’s patient group that is pushing the $3 billion California agency to
speed up financing on research that the group says is promising.
Earlier this month, the group was perturbed by the
cancellation of the scheduled, face-to-face meeting in San Diego tomorrow. It was changed to
a teleconference meeting that is set for only 90 minutes. However, the group is
expected to make its views known by teleconference from the Sanford Consortium in
La Jolla, where agency President Randy Mills will be based.
The face-to-face session was cancelled, the agency said, because it was
expected to be brief and because of the expense involved in bringing together
the 29 members of the governing board and some agency staff. Mills told Fikes that many of the board
members would not have been able to attend in San Diego, but the meeting would
have cost about $30,000 to stage.
The California stem cell agency has posted a letter online from
Parkinson’s patient advocates that says that an emotional outpouring at a July stem cell meeting grew out of an “overwhelming” need to protest agency delays in funding
research.
The link to the Aug. 2 letter is part of the agenda for this
Thursday’s teleconference meeting of the directors of the $3 billion research
effort. It said,
“Our group at Summit4StemCell (has) been regularly attending
the CIRM meetings for the past 18 months. Out of respect for Jeanne Loring PhD,
we have typically shown up in ‘silent solidarity’ but this meeting was
different and many of us had an opportunity to speak publicly about our
project, our progress and our desperate need for funding.
“The outpouring on Thursday (July 23) was spontaneous and
unexpected. We at Summit feel strongly that we communicate with all board
members that our presence at any of the CIRM board meeting is not orchestrated
by Jeanne Loring, Dr. Melissa Houser (of the Scripps Clinic) or anyone from the Loring lab.
“We are a passionate group of dedicated Californians that
believe strongly in the probability of success of this research using
pluripotent stem cell technology. Dr. Loring has always counseled respect and
brevity. We believe she would prefer that we be the face of the issue and not
the strident voice.
“When confronted with the possibility that there could be no
help (or hope) for over a year, the need to speak and be heard was
overwhelming. We sincerely believe that you and the board heard us and will do
all you can to find an exception or some way to help.”
The reference to Loring, who is head of the stem cell
program at the Scripps Research Institute in La Jolla, has to do with the Summit group’s
support of her research. It also seems to be linked to an anonymous comment filed
on the California Stem Cell Report’s account of the July protest.
The writer indicated that Loring had submitted an
application earlier that was scored unfavorably by the agency, based on a
conversation that the writer had overheard at the Oakland meeting. In response,
Loring said no such conversation took place. She said an earlier application in
another round did not meet CIRM criteria and was withdrawn. The agency does not
publicly comment on such grant review processes, which are conducted in secret.
It also does not release the names of unsuccessful applicants. (See Loring's and the writer's complete comments at the end of this item.)
Summit4StemCell is also not happy with teleconference
nature of this week’s meeting. Earlier this month, they said their voice was “diminished”
because of the inability to speak to the governing board face-to-face.
The California Stem Cell Report item on the teleconference/Parkinson’s
flap is the most widely read post this month, exceeding the readership of the item
dealing with the agency’s announcement concerning its $32 million stem cell bank.
Release of the information is a step forward in openness and
transparency for the agency, which has slipped in that area recently. (See here and here.)
The $20 million award is the only application up for
approval next Thursday, just four business days away. The California Stem Cell
Report will have more on the proposal later today.
Still missing is information involving the agency’s plans to
correct deficiencies identified in a $230,000 performance audit and the agency’s
ongoing revision of its plans for spending its last $1 billion.
Next Thursday’s meeting will be a teleconference session
with 17 remote locations, including Atlanta, where the public can participate
and listen in. All are places from which board members log in for the meeting. The locations include
San Francisco (3 locations), Fresno, Davis, Los Angeles(3 locations), Napa, Stanford,
Sacramento, Davis, Fresno, Berkeley, Los Gatos, Irvine and La Jolla (2
locations). Specific addresses can be found on the agenda.
The meeting will also be audiocast on the Internet, but no
public participation is available by that means.
All but one site is in California. One board member, Lauren Miller, will be
logging in from Atlanta for what is expected to be about an hour-long meeting.
This month’s session was originally scheduled for San Diego,
where board members and staff would have been available for face-to-face
discussions with the public. But the San Francisco-based agency switched the
meeting to a teleconference session because of estimates that it would last only
an hour.
The move upset Parkinson’s patient advocates in San Diego,
who planned to attend the session in their area to speak about the need for
funding for research into a possible cure for the affliction. They already have
protested delays in funding at the July meeting of the board in Oakland.
On this month’s agenda are mostly routine matters considered
earlier by board subcommittees that are expected to be quickly approved. Also
on the agenda is consideration of presumably multi-million dollar applications
for clinical stage research proposals. The board nearly invariably
rubber-stamps the actions of its blue-ribbon panel of application reviewers. No
information is yet available on those applications.
Up for discussion is a plan to correct
unspecified deficiencies identified in a $230,000 performance audit of the agency.
The study, commissioned by the agency
and required by law, said the agency needed to improve its procedures involving
conflicts of interest and grant application reviewers. Also identified as an
area needing work is the tracking of potential royalties. No board action is expected to be necessary this
month to implement the plan.
The agency’s president, Randy Mills, is additionally
scheduled to give an update on the agency’s strategic plan, which is being
reformulated. The board has roughly $1 billion left before its cash for new applications runs out in 2020.
No background information has yet been posted on the meeting
agenda for any item to be discussed or acted on. The California Stem Cell
Report will carry items on the material as it becomes available. If interested
parties would like to submit comments to the board in advance of the meeting,
they can be addressed to mbonneville@cirm.ca.gov.
The teleconference locations where the public can
participate in the meeting and comment can be found on the agenda. The session is scheduled to be audiocast on the Internet as well. Directions will be placed on the agenda.
This is a Summit4stemcell video prepared following an emotional protest at the July meeting of the board of the California stem cell agency.
Highlights
Lack of speed, openness protested
Agency cites cost issues
Patient-CIRM relationships unique
A group of Parkinson’s patients from San Diego is less
than pleased today with a move by the $3 billion California stem cell agency that the
group says will stall efforts to secure much-needed funding for a possible cure for the disease.
The events this week follow an emotional protest at an agency board meeting in Oakland in July and highlight the often intense
relationship between patient advocates and the stem cell agency – not to
mention the pressure on the agency to move fast to find cures.
Anger and the Parkinson's symptoms of trembling and speech difficulties marked the protests. One patient advocate, Jenifer Raub of San Diego, said it was "outrageous" that an award round being discussed at the meeting would not provide funding until possibly 2017.
The patient advocate group, Summit4stemcell, had planned to
address the stem cell agency board again at a Sept. 24 meeting scheduled to be
held in San Diego. However, yesterday the group was told that the meeting would
not be held in their city. Instead the session was being turned into a
teleconference meeting and would be only about one hour long. Most in-person
board meetings last much of the day.
Responding to questions from the California Stem Cell Report,
Sherrie Gould, executive director of the Summit group and a nurse practitioner,
said in an email,
Sherrie Gould, Scripps Health photo
“We are both confused and disappointed that this PUBLIC (Gould’s
capitalization) meeting has been essentially cancelled. We were prepared
to talk with the ICOC (the agency board) and answer all questions about our patient advocacy
movement (Summit4stemcells) and our research….
“Unless we can be present in front of the CIRM board,
Summit's strong voice is diminished. Being physically present in human form is always more effective than a teleconference. Delays, which we realize are a part of any government associated agency, are devastating to people suffering from the progressive symptoms of Parkinson's disease.”
Jeanne Loring, head of the Scripps stem cell program in La
Jolla, also voiced her displeasure in an email to Kevin McCormack, senior
director of communications for the California Institute for Regenerative
Medicine(CIRM), as the agency is formally known.
She wrote,
“CIRM has rather pulled the rug out from under the patient
advocates. These meetings are supposed to be public, so how is the public going
to participate if there is no access?…. I'm disappointed and the Parkinson's
patients are exceedingly disappointed. The Parkinson's group is trying to
find out the resolution, if any, of the timing of the grant applications.”
The Summit group has raised $2 million to support Loring’s
research and to match what CIRM might award for her effort.
Asked for comment today, McCormack said in an email,
“The reason we switched from an in-person to a
teleconference board meeting is simple, the agenda for this meeting consisted
of just a few items that could probably be handled in one hour. We can’t justify
the cost of an in-person meeting in San Diego – which includes transportation
for all those going there, plus hotel rooms, meals and the cost of the ballroom
for the day - for one hour’s worth of business. As a state agency we are always
mindful of how we spend our money so we made the change.”
Under the agency’s procedures and state law, members of the
public can listen in and speak during teleconference meetings but only from the specific
location from which an individual board member is participating.
On the other hand, the in-person meetings offer
an opportunity to speak face-to-face with all board members, chat with them
informally during breaks and to converse directly with CIRM staff. The meetings
have been an important tool for many patient advocate groups to press their
cases. At times, however, their lengthy presentations have tried the patience of the agency.
The relationship between patient advocates and CIRM is notable. One of the unique features of the agency is the influence
of patient advocates, particularly on its board. Twelve sit on the 29-member panel and often
play important roles. Sometimes they are the only way the board can approve
awards because most of the other members have legal conflicts of interest and
cannot vote.
David Higgins of San Diego is one of the patient advocate members of the board, which has a
David Higgins
specific slot for a Parkinson’s disease advocate. He
was interviewed in July following the protest of the many-months delay in
possible funding for Parkinson’s research. His remarks were recorded on a
Summit-produced video(see at top of this item). Higgins, who is a scientist and has Parkinson's, said,
“It’s tough, it’s really tough, to be involved in the
Parkinson’s community, especially to have Parkinson’s disease, and to watch
things go in what seems like slow motion.”
Contacted today for additional comments, Higgins said,
“In my year at CIRM I have only encountered enthusiasm and
support for patient advocacy - both from the staff as well as the board.
Patient and patient advocate participation in the process is welcomed. CIRM is
first and foremost about patients.”
Following the protests at the July meeting, CIRM President
Randy Mills told the board he would see if there is anything he could do to speed
funding. He said he would report back to the board later.
McCormack did not directly respond to a question today about
whether recent, proposed changes in the award scheduling would have an impact
on the Parkinson’s research. He said
only that the changes would provide more flexibility.
(The text of remarks by the various parties follow this item.)
Here is the text of the Sept. 9, 2015, email message to
Sherrie Gould, executive director of Summit4stemcell, from Kevin McCormack,
senior director of communications for the California stem cell agency, along
with one from Jeanne Loring, head of the stem cell program at Scripps, to
McCormack. Loring sent her email to McCormack after she received a copy
of his email to Gould.
The Gould-McCormack email comes first with the
Loring-McCormack email following.
“Dear Sherrie
“I just wanted to let you know that there has been a change
in plans for our September board meeting. As you know, it was originally
scheduled to be held in San Diego, however, that has changed and it is now
simply a telephonic meeting. The reason is that the agenda is going to be
lighter than originally anticipated and it didn’t make sense to incur the cost
of an in-person meeting for one hour’s worth of business.
“I know you were planning to have many of the
Parkinson’s group attend the meeting so I wanted to let you know so
you can alert them to the change. “Our next in-person meeting will now be in Los Angeles
on December 17th.
“Cheers,
“Kevin McCormack”
Loring’s email to McCormack:
“Hi Kevin: “Two in a row?? CIRM has rather pulled the rug out
from under the patient advocates -these meetings are supposed to be public, so
how is the public going to participate if there is no access? Does CIRM
have a plan to give access? More importantly, is CIRM doing this to avoid
having public access? “I'm disappointed and the Parkinson's patients are
exceedingly disappointed. The Parkinson's group is trying to find out the
resolution, if any, of the timing of the grant applications. Has anything
been done in that regard yet? “In addition to the advocates, my students will be
disappointed. I always bring my interns and my CIRM fellows to the
meetings so they can meet their benefactors. “Any plans for access to the public would be welcome. “Jeanne”
Here is the text of comments by Sherrie Gould, executive
director of Summit4stemcellof San Diego, made in connection with changes in the stem cell
agency board meeting Sept. 24. Gould made the remarks in response to a query
from the California Stem Cell Report.
“We are both confused and disappointed that this PUBLIC
meeting has
been essentially cancelled. We were prepared to talk with the ICOC (the stem cell agency) board and answer all questions about our patient advocacy
(Summit4stemcells) movement and our research. The Summit4stemcell
project has been faithfully attending public meetings every other
month for the last two years. We have flown in numbers to make sure
our voice is heard. We have spoken to board members, and to the media
about our plight. This San Diego meeting, now cancelled, was an
opportunity attend to discuss the funding possibilities for
Parkinson's disease and whether funding might be appropriate for our
project. Our science is sound and we have a clinical arm to this
project. We believe CIRM could take ownership of this very exciting
translational research if we were indeed funded.
“Unless we can be present in front of the CIRM board, Summit's strong
voice is diminished. Being physically present in human form is always
more effective than a teleconference. Delays, which we realize are a
part of any government associated agency, are devastating to people
suffering from the progressive symptoms of Parkinson's disease. And
although hope springs eternal, we are saddened by the repetitive
delays.”
