Beyond Blastocysts: 'Simple Stories' and Stem Cell Research Funding

The California stem cell agency this week had some useful advice for telling the stem cell story, be it in Keokuk, Ia., or La Jolla, Ca. 

It is not necessarily just a matter of petri dishes and blastocysts.  It is a matter of "simple stories that illustrate what you did and who it helped or might help."

The advice came from Kevin McCormack, senior director of communications for the California stem cell agency, in an item on the agency's blog, The Stem Cellar. 

The piece grew out of a panel at the meeting this week of the International Society for Stem Cell Research in Los Angeles. McCormack began by briefly recounting the experiences of researchers who carried their pitches into legislative and Congressional arenas.

Those are places where the money is -- the lifeblood of scientific research. 

Money, incidentally, is of particular interest at California Institute for Regenerative Medicine (CIRM), as the $3 billion agency is formally known. On Monday it will shut down applications for new awards because in a few months it expects to run out of cash for them. 

Here is a little of what McCormack had to say concerning communication and scientific research, drawing from the ISSCR panel.

"(P)resenters talked about their struggles with different issues and different audiences but similar experiences; how do you communicate clearly and effectively. The answer is actually pretty simple. You talk to people in a way they understand with language they understand. Not with dense scientific jargon. Not with reams of data. Just by telling simple stories that illustrate what you did and who it helped or might help.

"The power of ISSCR is that it can bring together a roomful of brilliant scientists from all over the world who want to learn about these things, who want to be better communicators. They know that much of the money for scientific research comes from governments or state agencies, that this is public money, and that if the public is going to continue to support this research it needs to know how that money is being spent.

"That’s a message CIRM has been promoting for years. We know that communicating with the public is not an option, it’s a responsibility. That’s why, at a time when the very notion of science sometimes seems to be under attack, and the idea of public funding for that science is certainly under threat, having meetings like this that brings researchers together and gives them access to new tools is vital. The tools they can 'get' at ISSCR are ones they might never learn in the lab, but they are tools that might just mean they get the money needed to do the work they want to."

Leader of Global Research Group: California is 'Hotbed' of Stem Cell Activity

The man slated to be president of the world's largest group of stem cell scientists this week declared that California's stem cell agency has "really accelerated" the work that has made the  state a "hotbed" in the field.

In an interview in the Los Angeles Times, Deepak Srivastava,

Deepak Srivastava
Gladstone photo

also president of the Gladstone Institutes in San Francisco, provided a primer on stem cell research. He said,

"California is a hotbed of activity in the stem cell research world. The California Institute for Regenerative Medicine(CIRM) has really accelerated so much of this. We thought this international community of leaders ought to converge at this major hub in L.A.

"Many people talk about the semiconductor being the dominant discovery in the last 50 years. Now, many think biotech will be the major driver of advancements in the coming 50 years. California promises to be an epicenter for that."

Srivastava has received $17.8 million in research funding from CIRM. Gladstone has received 32 grants totaling $56.4 million.

The occasion for Srivastava's remarks is the annual meeting this week of the International Society for Stem Cell Research in Los Angeles. Srivastava is the incoming president of the organization. The meeting has drawn about 4,000 participants but little major news coverage so far. 

The light coverage is not surprising given that much of meeting deals with quite technical issues. The Los Angeles Times piece was an attempt to demystify the field for the general reader. 

For the $3 billion state stem cell agency, the session was an opportunity to tell its story to a broader research community, including the fact that expects to run out of cash for new awards this year. CIRM is hoping that voters will re-fund it with $5.5 billion in November 2020. Next week it is closing off applications for any further awards this year.

One of ISSCR's concerns is the need for strong funding for stem cell research.

The ISSCR, California Stem Cell Financing and Silence

It comes as no surprise that the largest organization of stem cell scientists in the world is in favor of "rigorous funding" for stem cell research and warns of the perils of decreased financial support. 

That organization is International Society for Stem Cell Research (ISSCR), which is meeting in Los Angeles later this week and expects 4,000 persons to attend. 

California's stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM), has long been a supporter of the ISSCR. In 2009 it contributed $200,000 to help out with the ISSCR's annual conference. 

Times have changed, however, since those halycon days 10 years ago. It is running out of cash for new awards. This year CIRM contributed "only" $50,000 to help stage the group's annual meeting. A few days ago it cut off applications for new research awards beginning next Monday. It needs support for $200 million in private "bridge" funding to continue its program while it awaits what it hopes will be voter approval in November 2020 of re-funding the agency. 

What does the ISSCR have to say about the state of the California stem cell agency?

Anne Nicholas, director of communications for ISSCR, was asked about the situation last week by the California Stem Cell Report. She replied,

 "We don’t have anything to add to your story at this point."

More Than a Minor Headache: The Stem Cell Snake Oil Problem vs. Legitimate Research

Just two weeks ago, the headlines from Bloomberg News offered a glowing view of the prospects for stem cell therapies and the industry. The story in the online publication, which counts nearly 9 million readers monthly, said,

"Stem cell crusader sparks new hope....Regenerative medicine could be a $120 billion industry by 2030"

But only three days later, that article was overwhelmed by a wave of stories with a much different flavor. They carried reports of unproven therapies, possibilities of fraud, lack of regulation and fearful, expensive consequences for desperate patients.

That theme continued even as recently as this past weekend as The Economist carried a piece headlined,

"A dish called hope: The flourishing, unregulated industry in expensive, experimental treatments"

So which is it? Hope for legitimate cures and oodles of cash for stem cell companies? Or "hope" for treatments that do not work and have sometimes damaged both the bodies and wallets of the patients?

The situation is more than a minor public relations headache for the supporters of stem cell research, be they patients, stem cell companies or the $3 billion California stem cell agency, which is on a campaign to ease federal regulation of stem cell clinical trials.

For all practical purposes, the public generally does not make much of distinction between the legitimate research conducted by institutions such as Stanford and the so-called "miracles" reported about the late hockey great Gordie Howe and others. It all goes into the same cognitive bag. The stories about mysterious and fearsome tumors found in little-known patients attract little widespread attention.

But UC Davis scientist Paul Knoepfler and bioethicist Leigh Turner of the University of Minnesota ripped open that bag with their study last month that reported for the first time that nearly 600 dubious stem cell clinics are peddling their unproven therapies across the country.  Their report supported the view that the stem cell field is rife with snake oil merchants. For the general public, which does not delve deeply into medical research, the perspective could well be described as, "You seen one stem cell therapy, you seen 'em all."

Does this mean that these clinics should be ignored and shoved quietly off into a corner in order to avoid besmirching legitimate efforts? Of course not. It certainly appears that the FDA and other  state regulatory bodies can do a better job. But stiffer regulations are not going to come anytime soon, despite an FDA hearing on the topic in September.

However, the situation DOES mean that folks like Knoepfler and Turner should continue to speak out along with many other scientists who do not want their efforts blackened by the snake oil men. Researchers can work with their institutions' PR departments to place op-ed pieces, find speaking engagements and gin up TV and radio interviews. Blogs, like the one produced by Knoepfler, can be started. The International Society for Stem Cell Research should revive its public education efforts to help patients and the general public understand the facts about stem cell research. It should also reinvigorate its warnings about dubious therapies, which were throttled back a few years ago, reportedly after legal threats were made.

California's stem cell agency has a special concern. It is trying to "de-risk" development of therapies  by a variety of means and lure biotech and Big Pharma into the stem cell game in a bigger way. This summer the agency is offering $75 million to entice a private partner into the state's first-ever, public-private partnership to create a stem cell cure.

The private sector has shied away from the stem cell business, as the stem cell agency's CEO, Randy Mills, has remarked on multiple occasions. One of the reasons involves the public climate and perception of the field. It is hard for companies to invest hundreds of millions of dollars or billions when the stem cell field is burdened with public perception and regulatory obstacles.

Selling the stem cell story in a realistic way is not necessarily an easy task. Nuances must be respected, but excitement is also needed. Balancing it all is a challenge for the men and women in the trenches. But without a good push, development of therapies will be slower, and, as Mills has noted, people will undoubtedly die who likely would have benefited from a more timely treatment.

Stem Cells, Long Odds and the 'Invisible Hand of Hype'

The headline on the California story pretty much told it all: "Stem Cells: Where Science, Hope and Hype Meet."

It could have added that it is also a meeting place for Big Pharma, Big Academia and Big Politics.

All of those yeasty ingredients are embodied in the $3 billion California stem cell agency, which is plugging away at developing a therapy promised to voters 11 years ago during a $36 million ballot campaign..

The headline appeared on the KQED Web site, a public television and radio outlet in San Francisco. The city, coincidentally, is where the world's largest aggregation of stem cell researchers, the International Society for Stem Cell Research (ISSCR), is meeting today. The conference is also just across the San Francisco Bay from Oakland, where the stem cell agency is headquartered.

Danielle Venton wrote the article for KQED. She covered a bit of the history of the California Institute for Regenerative Medicine or CIRM, as the agency is formally known. She noted that the agency is now participating in 16 clinical trials, although it has yet to chalk up production of a commercial therapy.

Venton wrote,

"(T)he frustration many voters feel about CIRM may have more to do with the problematic way researchers, institutional communicators and the media talk about scientific progress in general, and stem cells in particular, than it does with the agency’s performance.

Timothy Caulfield

"'There has always been this high-stakes, extreme rhetoric around stem cells,' says Timothy Caulfield, who teaches science and health policy at the University of Alberta. Caulfield says because stem cell research was so embattled, many spoke of its promise in hyperbolic terms.

"'People had to make bold statements about the future of stem cells in order to counteract those that wanted to have strict laws to stop it. So you have to say, ‘This is going to save lives. This is going to cure a variety of diseases.’ Right from the beginning, the late ’90s, you have that language appearing in the popular press.”  

Venton reported that the international scientists' group, the ISSCR, is "trying to tone things down" with new guidelines about how to talk about stem cell research and its impact. She said the effort "may be facing long odds." She quoted Caulfield as saying,

“It’s really the invisible hand of hype. In most cases these pressures are largely unconscious — whether you’re talking about the media, the researchers, the institutions or the funding agencies.”

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

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

CIRM said in a news release,

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

CIRM President Alan Trounson was quoted as saying,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CIRM Provides Justification for $200,000 for ISSCR Meeting

Much to its credit, the California stem cell agency Tuesday posted a dandy backgrounder on its recommendation that CIRM directors next week approve $200,000 to assist the International Society for Stem Cell Research with its convention in San Francisco in 2010.

The document is a far cry from the original request in December that sought $400,000 but did not provide any justification or explanation. This week's document is a good example of the type of information that CIRM can provide that assists in meaningful public participation in the agency's activities.

While one may or may not agree with the recommendation to co-sponsor the convention, CIRM does a fine job in pointing out the benefits to the agency, the state and science in general. The document lists eight benefits from the contribution, including no-cost attendance by CIRM staff and interaction of CIRM grantees and trainees with the world's top stem cell scientists. CIRM said,

"All of these benefits will be continuous reminders to the attendees, including the leading stem cell scientists in the world, that California drives the field and is an attractive, vibrant location for academic researchers and biotech companies. As new funding opportunities become available for stem cell research elsewhere, California cannot rest on its laurels, if it is to attract and retain the best scientists and companies. We think that conference co-sponsorship is a valuable means to enhance those efforts."

CIRM said that about 500 California scientists are expected to attend the 2010 meeting. (About 2,800 persons attended the ISSCR convention in 2008.)

CIRM said,

"If the meeting were to be held outside California, the increased travel costs alone for 500 attendees could easily exceed $250,000, much of which would have to be paid with CIRM grant funds."

We wonder about that assertion, largely because we were not aware that CIRM grants provided for travel and participation in the annual conventions of the ISSCR. This year's meeting is in Barcelona. One would think that financing international jaunts is not necessarily an appropriate use of taxpayer funds unless it can be very explicitly tied to the purpose of the grant.

Total cost of the San Francisco meeting is an estimated $1.5 million. CIRM is also helping out in arranging for the no-cost use of Moscone Center for the meeting and the rotunda at city hall for a reception. The value of those contributions by the City of San Francisco is placed at $125,000.

CIRM's proposed $200,000 contribution would go for travel expenses for organizers and speakers ($50,000) and conference services, publicity and publications ($150,000).

CIRM said the $200,000 should be taken from privately donated funds, which now total $3.4 million. That would be a good PR move, helping to ease any criticism of the expenditures. Nonetheless, the money is still public money. It became that when it was donated.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., publicly criticized the earlier CIRM moves to assist with the meeting. We have not heard from him yet on the latest proposal.

CIRM staff provided the breakdown and detailed justification for its recommendation as the result of requests by CIRM directors in December.

The recommendation for funding is expected to be voted on at next Tuesday's and Wednesday's meeting of the board of directors in Los Angeles.

CIRM/ISSCR Convention Proposal Reduced to $250,000

CIRM directors balked last year at coughing up $400,000 for the 2010 convention of the International Society for Stem Cell Research, but now the figure has been trimmed to $250,000.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., reported the new figure on his organization's blog. He said that CIRM has agreed to help the group raise the additional $150,000 for the San Francisco meeting.

But Simpson wrote,

"That's a mistake.  CIRM should focus with laser-like precision  on where its getting the money to fund existing grant commitments. This sort fund raising effort -- just like hiring a proposed lobbyist in Washington for roughly $200K --  is an unfortunate and unnecessary distraction."

ISSCR , $400,000 and CIRM

Remember the request that the California stem cell agency pony up $400,000 to support next year's annual meeting of the International Society for Stem Cell Research in San Francisco?

It ran into some rocky sledding at the CIRM directors' meeting last month. Some of us had expected it to come back at the board meeting later this week.

But no. John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., today wrote about last month's robust discussion of the request and has put together an explanation for the delay on his organization's blog. He quoted CIRM spokesman Don Gibbons as saying,

"We are examining other possible alternatives for the ISSCR meeting and will bring the issue back at a later date."

We were also wondering about the matter and last week separately queried scientist Irv Weissman of Stanford, incoming president of the society. He replied,

"I have no idea what is or is not on the ICOC (CIRM directors) agenda. I sure hope CIRM will assist the ISSCR convention, but I am not really knowledgeable what they can or cannot fund. I trust them to do the right thing. Irv Weissman, speaking for himself."

CIRM Begins Application Triage Experiment

The California stem cell agency is moving forward on its plan to perform closed-door, staff-connected triage on grant proposals before they move into the peer review process.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., reported on the action by CIRM directors on Tuesday. But he suggests an alternative that could serve CIRM's desire to reduce the number of applications on some grant rounds. Just open up the grant application process so that the public would know who is applying and hear the pros and cons on the applications.

Writing on his organization's blog, he said,

"It's our $3 billion that's being handed out. If you want our money, you ought to be willing to ask for it in public. Nothing builds more trust in a review process than having it completely transparent."

Simpson reported that Tuesday's special, teleconference board meeting failed to muster a quorum despite an attempt to set up multiple out-of-state locations for the convenience of traveling board members. Only 15 checked in. Nineteen are needed for a quorum. The full board has 29 members.

Failure to attain a quorum meant no action on the request by the International Society of Stem Cell Research for $400,000 to help finance its $1.5 million convention in San Francisco in 2010. It was the second time the board has failed to act on the request.

Here is a link to CIRM's four-page explanation of the triage proposal. The process will be applied in the $60 million basic biology round. The RFA should be posted before the end of this year with the "pre-applications" due towards the end of January.

Stem Cell Science Group Seeks $400,000 From CIRM

Consumer Watchdog calls it "unbelievable" and "a flagrant squandering of public money." The group says it serves no purpose other "than to inflate the already healthy egos of CIRM's globe-trotting executives "

The language comes from John M. Simpson, stem cell project director for the Santa Monica, Ca., group. Writing on the group's blog, he refers to a pitch by the prestigious International Society for Stem Cell Research for $400,000 from CIRM to pay for 28 percent of the cost of the society's 2010 convention in San Francisco.

Tomorrow afternoon, the grant request will be considered by the CIRM board of directors at a special teleconference meeting. Multiple locations are available throughout the state and even outside of the state where the public can comment.

The request first came before the board earlier this month with no written explanation or detailed justification of benefits to the state of California. Directors told CIRM staff to provide more details if funding was to be seriously considered.

CIRM has close ties to ISSCR. CIRM President Alan Trounson is on the board of directors of the society. CIRM Chairman Robert Klein was a member of an advisory committee to ISCCR in 2007, according to The Niche, Nature magazine's stem cell blog. Don Gibbons, CIRM's chief communications officer, is a member of the group's public education committee.

The request for the grant is signed by Irv Weissman of Stanford, whose medical school dean is on the CIRM board of directors. Weissman will be president of the group in 2009. Stanford has received $95 million in grants from CIRM. Weissman has received $2.6 million.

It is not uncommon for professional organizations to seek some sort of financial assistance from enterprises whose executives serve on the professional group's board of directors.

However, the timing on this pitch is unfortunate, to say the least, given the $40 billion California budget shortfall. Moreover, funding of the convention seems a tad lavish. For example, it includes $235,000 for marketing expenses, a figure that seems more appropriate for MacWorld than a gathering of stem cell researchers.

Even in brighter times, a $400,000 donation from the state would be dubious. Today it cannot be justified unless CIRM wants to chalk up some serious minus points with the folks in the state Capitol and with the public at large.

The public can participate in the meeting from locations in San Francisco (3), Berkeley, Elk Grove, Healdsburg, Los Angeles (3), Koloa, Hi., Beverly Hills, Irvine (2), La Jolla (2), Stanford, Cornelius, NC, Sacramento, Philadelphia and Chicago. The out-of-state locations are presumably where some CIRM directors will be tomorrow afternoon but they are still legally public as far as CIRM meetings go. The specific addresses can be found on the meeting agenda.

(Editor's note: An earlier version of this item incorrectly stated that the ISSCR grant request totalled $420,000. The erroneous information came from CIRM. The additional $20,000 appeared in the CIRM grant application from the ISSCR which we have been told automatically adds 5 percent "indirect costs" to the amount requested. However, the 5 percent does not apply in this case. )

Magnus: Do We Need More Guidelines?

"Too little, too late." That's what Stanford ethicist David Magnus has to say about the recommendations released last week concerning embryonic stem cell research.

The proposals came from the International Society for Stem Research. But Magnus asked, "Do we really need another set of guidelines."

Writing in the San Jose Mercury News, he said:

"The ISSCR group missed a real opportunity to address many new challenges that stem-cell researchers and oversight committees face -- challenges that have had little attention.

"All of the guidelines to date focus on bench research. But Menlo Park biotech company Geron has already announced that it intends to start clinical trials using differentiated embryonic stem cells for patients with acute spinal cord injury. Yet we have almost no guidance on how oversight committees should evaluate these trials or what should go into informed consent forms. Astonishingly, neither the NAS nor ISSCR has said anything about the right of subjects who may oppose stem-cell research to know that the cells placed in their bodies for research come from embryonic stem cells."

Magnus also said that the "one really novel stand" from the group concerned payment for eggs for research. He continued:

"The ISSCR group says local oversight committees should determine the appropriate policy: no payment, reimbursement of direct expenses, or substantial compensation for time and suffering. The problem with this recommendation is that it seems to fly in the face of virtually every law in place. The NAS guidelines call for a prohibition on payment of egg donors beyond direct expenses. Proposition 71 has a similar ban in place. Many other states and countries have made it unlawful to pay women more than a token amount or to pay anything beyond their direct expenses.

"Many researchers are worried that they will have a difficult time getting access to the eggs they need. But offering standards that cannot be followed by any of the major players in stem-cell research is a recipe for irrelevance."

The recommendations have been praised by John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, who said:

"We are pleased the international guidelines stress public benefit and we will continue to insist that California's regulations provide affordable access to any discoveries or cures resulting from research funded by the state program. Too often stem cell advocates have hyped the immediate benefit of stem cell research. I'm delighted to see the call for realism. The Scientific Strategic Plan for the California Institute For Regenerative Medicine already reflects that realistic approach."

Reporter Terri Somers of the San Diego Union-Tribune quoted Larry Goldstein, an ESC researcher at UC San Diego and a member of ISSCR task force, as saying.

“Realizing that stem cell research is an international community, we have to be able to share cells and our scientific methods across borders with some confidence that we have been doing our work to some agreed-upon ethical standards.”