Klein, Moral Mandates and Stem Cells

Just a few days ago, the California Stem Cell Report carried an item about the state's stem cell agency and its supporters' mantra that the agency has a mandate from voters albeit one that is seven years old.

We mentioned that Robert Klein, the former chairman of the agency and head of the 2004 ballot campaign that launched CIRM, is one of those fond of citing voter mandates with great regularity.

Indeed, Klein found shelter again this week under a voter mandate, but this time it was a moral one.

Klein popped up in a San Jose Mercury story about the status of the stem cell agency. Writer Steve Johnson said that Klein declared that he quit as chairman last June in part because he wants to raise money for a campaign for another multibillion bond measure for CIRM. Johnson quoted Klein as saying,

"It would be a huge failing in meeting our moral mandate" to let CIRM die. "We can't afford to break the momentum."

As we noted on Dec. 6, mandates come and go, as another multibillion California bond program, high speed rail, has discovered.

San Jose Mercury News: California Stem Cell Agency Eyeing More Bonds but Has No Treatments

In an overview of the $3 billion California stem cell agency, the San Jose Mercury News says that CIRM "still has no treatments on the market and is at a critical juncture that could determine how much longer it stays in operation. "

The story is the second significant piece about CIRM this week in a major California newspaper, which has not received much coverage in the mainstream media in the state in the last year or so. The Los Angeles Times earlier this week carried a column that raised questions about the "Geron fiasco" involving CIRM and the conduct of the agency's business.

The San Jose article yesterday by Steve Johnson said that voters "may not be as enthusiastic" about providing several billion dollars more to finance the agency as they were when they created it seven years ago.

The newspaper, located in the heart of California's Silicon Valley, quoted John Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., as saying,

"I think it's crazy. The state's economy is in a far different position now. We're not even able to provide adequate funding for education."

Johnson also reported that former CIRM Chairman Robert Klein, who led the 2004 Prop. 71 campaign, is raising or intends to raise funds for another bond issue, perhaps in 2014. The agency will run out of cash in about 2017, according to its projections.

The article noted that CIRM has awarded only $83.4 million to 15 businesses, which are the key to pushing research into the clinic,  out of the $1.3 billion it has handed out. Johnson wrote,

"Many businesses have been deterred from even trying to make stem-cell treatments because of how long it might take.

"'It's a challenge,' said Rodney Young, chief financial officer at Newark-based StemCells, which hopes early next year to obtain a $20 million institute grant to determine if a type of adult stem cell can slow the loss of cognitive function in Alzheimer's patients. 'It's an expensive, uncertain and long process.'"

Johnson additionally noted that CIRM has received criticism for the high salaries it pays its top executives and for conflicts of interests.

Directors of the California Stem Cell Conclude Meeting

Directors of the California stem cell agency have just ended their meeting in Los Angeles. Our coverage of the session today is now concluded. Here is a link to the CIRM news release on the meeting.

$30 Million 'Disease-in-Dish" Plan Wins Go-ahead from California Stem Cell Agency

Directors of the California stem cell agency today approved a $30 million program that could generate "disease-in-a-dish models" that "have the potential to make drug discovery faster, more efficient and more personalized to individual patients."

The "human pluripotent stem cell (hPSC) initiative" is aimed at generating high quality stem cell-based tools for use by the researchers and drug developers.

The proposal includes four elements, one of which is a $300,000 collaboration with the NIH to develop cell lines from patients with Huntington’s Disease, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis. The plan includes a $4 million disease line award round, a $16 million core hiPSC derivation round and a $10 million stem cell bank round. The RFAs would go out in May of next year with funding expected early in 2013.

The initial staff memo on the initiative did not mention human embryonic stem cells, but a spokeswoman for the agency said they were not excluded from the effort.

California Stem Cell Agency Approves $27 Million To Hasten Stem Cell Therapies

Efforts to speed development of stem cell therapies received a $27 million boost today from directors of the $3 billion California stem cell agency.

They approved two initiatives that grew out of recommendations from a blue-ribbon panel that CIRM organized last year to review its operations.

One element in the plan is a $12 million "bridging fund" that would apply only to current CIRM-funded projects in three areas: disease team grants, some early translational projects and clinical development projects. The bridging fund would provide up to $3 million for up to one year for each recipient.

As originally proposed by CIRM staff, CIRM President Alan Trounson would have been authorized to approve each project. However, the board altered that process to require board approval with "peer review input."

Director Shlomo Melmed, a senior vice president at Cedars-Sinai in Los Angeles, argued that leaving the decision to Trounson and staff could place Trounson in an "untenable" position and lead to second-guessing. Melmed and others also said that process could open the agency to public criticism.

Trounson and other staff members said that biotech firms often need speedier action than can be provided by a more extended process. Director Jonathan Shestack, a Hollywood producer, agreed, but he was the lone vote to oppose removing the authority from Trounson.

No biotech companies spoke out at the meeting concerning the proposal (see here for an earlier version of the plan).

The second part of the response to the review panel's finding is a $15 million "external innovation initiative" to support collaborative efforts of CIRM grantees to work with teams that CIRM said are "making extraordinary progress outside California."

The $15 million program would provide awards as often as two times a year. The maximum amount on each award was not specified. The program was approved on a unanimous voice vote.

Ellen Feigal, CIRM's vice president of research and development, said in a memo to directors that examples of potential projects included collaborative efforts with the NIH and work with the Harvard Stem Cell Institute and its disease-focused programs. CIRM is planning to spend $300,000 over two years in work with the NIH.

Some of the latest CIRM initiatives are open to biotech businesses. Others are open only to non-profit or academic researchers.

Internet Audiocast of CIRM Directors Meeting Resumes

The Internet audiocast of today's meeting of directors of the $3 billion California stem cell agency in Los Angeles is once again available. Currently, the board is engaged in a disease spotlight involving heart failure. The business meeting is scheduled to resume in about 30 minutes.

CIRM Board Audiocast Down

The California stem cell agency said the audiocast today of its directors meeting in Los Angeles is down but that the service provider is working to restore service.

As of this writing, the broadcast has been interrupted for nearly one hour. We will resume coverage if the audiocast is restored.

A footnote on the vagaries of the Internet: Here in Panama the government provides free WiFi to many areas. However, it also limits what can be seen or read. For example, YouTube is banned, also Internet broadcasts of college football games by CBS. If you look up odds on football games, those sites are barred as well. Certain information from cellular phone companies that compete with the firm that is financially backed by the government also cannot be accessed. And this morning, the government's WiFi network blocked the audiocast of the CIRM board meeting.  We picked it up after we found a private WiFi network about an hour after the meeting started.

California Stem Cell Agency Approves $5.6 Million to Lure Harvard Researcher to Golden State

Directors of the California stem cell agency today approved a $5.6 million grant to bring a star researcher to California -- a Harvard scientist currently collaborating with a director of the stem cell agency.

The recipient is Zhigang He, who is negotiating with UC Berkeley, which also has a representative on the CIRM board, one who did not vote on the grant or speak during the discussion.

Responding to a query from the California Stem Cell Report, the researcher later said, "I am still talking to Berkeley about the details of my move."

Zhigang He
Harvard Photo

CIRM governing board Oswald Steward, director of the Reeve-Irvine Research Center, Anatomy & Neurobiology at the UC Irvine School of Medicine , was also disqualified from voting or participating in the discussion. He left the room, saying that he has been "directly collaborating with this person."

The name of the Harvard researcher was not mentioned prior to the vote on the grant, although a member of the public, patient advocate Don Reed, told directors he knew the applicant and recommended him highly.

The grant is part of a $44 million recruitment effort by CIRM. It has awarded about $11 million to bring two researchers to California institutions, both of which have representatives on the CIRM board.

(An earlier version of this item said Zhigang He "is slated to go to work" at UC Berkeley, based on comments at the CIRM board meeting.)

CIRM Directors Meeting Underway

Directors of the California stem cell agency have begun their meeting in Los Angeles and are now discussing a $5.6 million recruitment grant to a researcher who is connected to CIRM Director Oswald Steward of UC Irvine. Steward is not eligible to vote and has left the room, according to the Internet audiocast.

Los Angeles Times: 'Geron Fiasco' Poses Questions About California Stem Cell Agency

The Los Angeles Times, California's largest circulation newspaper with more than 900,000 subscribers, today said the "Geron fiasco" raises questions about the conduct of business at the California stem cell agency and whether it "does a disservice to patients and taxpayers."

The comments came in a column by Pulitzer Prize-winning journalist and author Michael Hiltzik, who wrote about Geron's abandonment of its hESC trial only five months after the firm was awarded a $25 million loan by the stem cell agency. Hiltzik said,

"So we're talking at least about months of wasted effort by CIRM and Geron's researchers, crushing disappointment for those patients and conceivably a major setback for stem cell science generally. (CIRM Chairman Jonathan) Thomas observes that Geron said it made its decision strictly on financial grounds, not because of scientific reversals. But for an R&D company financial considerations always encompass scientific judgments, and Geron plainly concluded that the prospect for profits from stem cell therapies was receding.

"The Geron fiasco underscores the old questions, and raises new ones, about what CIRM is supposed to accomplish, how it does business and whether its addiction to hype does a disservice to patients and taxpayers."

Hiltzik's column contained brief remarks from Thomas. The columnist wrote,

"'There are going to be fits and starts,' its chairman, Jonathan Thomas, told me last week. Even so, he maintained, 'we remain unwavering in our commitment to pursuing the science.'"

Hiltzik has followed CIRM since the 2004 ballot initiative campaign that created the $3 billion enterprise. The effort was headed by real estate investment banker Robert Klein, who later served as CIRM's chairman for seven years. Hiltzik wrote,

"CIRM loves to compare itself to the federal government's biomedical research agency, the National Institutes of Health, but the two bodies are very different. The responsibilities of NIH are broad enough for it to make disinterested judgments about programs and scientific approaches. CIRM, however, was designed from the start (by Klein, who oversaw the drafting of Proposition 71) to focus on a very narrow field of biomedical science — embryonic stem cell research — and to promote that research in California as a sort of economic development tool.

"These two goals have always been ethically and scientifically incompatible, and the Geron case points to why."

Hiltzik said evidence exists to show that CIRM "downplayed legitimate questions about the state of Geron's science and the design of the clinical trial" in its efforts to fulfill the excessive promises of the electoral campaign. The issues, he said, included over-promising results, questions by other researchers about the trial and whether a spinal cord injury was the best subject for the first tests of stem cell therapies on humans.

Hiltzik continued,

"None of these issues were aired publicly in the run-up to the vote, because CIRM didn't disclose in advance that Geron was the loan applicant. Nor did it disclose that its own scientific review panel had awarded the Geron trial a scientific score of only 66 out of 100; that fact, along with other details of the board's consideration of the Geron loan, was pried out of CIRM later by David Jensen, the tireless proprietor of the indispensable California Stem Cell Report.

"CIRM told Jensen that although it customarily discloses its reviewers' scientific scoring of funding proposals, it didn't in this case because it was using 'new criteria' and thus the public might not find the result 'meaningful.' Call me a cynic, but I'd bet that if the score were, say, 90 out of 100, CIRM would have shouted it from the rooftops, rather than pleading that Californians were too dumb to understand what the number meant."

Hiltzik concluded,

"Another problem illuminated by the Geron case is that CIRM remains infected by the hype virus. Only a week after Geron parachuted out of the stem cell business, Thomas issued a statement bemoaning the public impression that CIRM isn't making any progress toward therapies. He declared: 'CIRM is turning stem cells into cures.'

"Well, no it isn't, not yet. Geron's now-halted project was the most advanced human clinical trial in CIRM's portfolio; yet it was at an extremely early stage, involved all of five human subjects and might still have been years away from showing that a cure was even possible. CIRM needs to take a good look at whether it pushed too hard for the Geron loan and overplayed the significance of the trial; otherwise its path toward building credibility with the public will only get longer."

The California Stem Cell Report has asked CIRM Chairman Thomas if he would like to respond in more detail to the Los Angeles Times column, with a commitment to carry his remarks verbatim.

Correction

The CIRM CFO item on Dec. 6, 2011, incorrectly stated that he began work on Nov. 11. The correct date is Nov. 28.

Live Coverage and Public Participation Locations for CIRM Board Meeting Tomorrow

A second teleconference location has been added to where the public can participate in tomorrow's meeting of the directors of the California stem cell agency, which will be covered live via the Internet by the California Stem Cell Report.

The actual meeting will be in Los Angeles at Cedars-Sinai, but interested parties can weigh in from sites at Stanford and UC San Francisco. The meeting will also be audiocast on the Internet.

Here are specific addresses from the agenda for the teleconference locations.
Stanford School of Medicine
Li Ka Shing Center for Learning and Knowledge/291
Campus DriveLK3CO2 3rd Floor/MC5216/
Stanford CA 94305-5101

UCSF School of Medicine
513 Parnassus Avenue, Room S224
San Francisco, CA 94143

Here are instructions for the audiocast:
To access the live event or archive, use this URL:
https://im.csgsystems.com/cgi-bin/confCast
Enter Conference ID# 224434 then click Go.

California Stem Cell PR and Spongy Voter Mandates

Some connected to the California stem cell agency, notably its founding father Robert Klein, are fond of declaring that the $3 billion enterprise has an immutable mandate from voters to pursue its endeavors.

Well, mandates come and go.

That lesson was learned once again this morning with the results of a Field Poll that showed that another big ticket effort, the California high speed rail project which was approved by 53 percent of voters, has lost not only its luster but its support. According to the poll, 64 percent of voters would now like another chance to vote on it. And 59 percent would reject it.

The reasons for the change of heart? Severe economic conditions in California, increased mainstream media coverage of high speed rail's deficiencies and bungling by its management.

While a San Francisco Chronicle columnist last summer called CIRM "the high speed rail of medicine," the stem cell agency has not suffered from the same sort of heavy and critical media attention. CIRM is all but invisible to the public. But agency is now is embarking on an ambitious PR effort to raise its profile and to move forward to win voter approval of another multibillion bond measure. Otherwise it will run out of funds in 2017.

CIRM must tread carefully with its new communications campaign. It has a legitimate responsibility to better inform Californians, and its PR could be more robust(which is a sort of the word of the day at CIRM).

But downsides do exist. With a possible ballot measure coming up, some ungenerous folks might construe aggressive CIRM PR as electioneering at taxpayer expense, including its subsidies of patient advocate activities, such as attendance at conventions. Even without a looming election campaign, the high speed rail project's $12.5 million PR effort attracted negative attention in at least two major newspapers just this week(see here and here).

Klein, who led the campaign that created CIRM and served as its chairman for seven years, is now gone, but his footprints remain. The agency, however, cannot assume that voter support seven years ago, in a much, much different world, translates to support today.

Researcher Alert: CIRM Making Changes in Grant Administration

The California stem cell agency is readying a long list of changes that will affect all of its 453 grant recipients and all future awards.

Many of the changes are minor. Some have been requested by grantees. Others are aimed at dealing with issues posed by larger grants. Some reflect the agency's move to more streamlined reporting.

Amy Lewis, CIRM's grant management officer, has prepared an introductory memo along with the proposed changes for discussion at Thursday's board meeting in Los Angeles. She said the proposal is in its early stages and will not require a vote this week.But it would behoove those affected to carefully check the grant administration policy to see how it might alter their lives.

Former iPierian Exec Joins California Stem Cell Agency as CFO

A former executive at a California stem cell firm has been named as the first chief financial officer of the seven-year-old, $3 billion California stem cell agency, it was announced today.

Matthew Plunkett, CIRM CFO
CIRM Photo

Matthew Plunkett, former vice president and chief financial officer of iPierian Inc., has been at work at CIRM since late last month. The agency said in a news release today that Plunkett is overseeing "budgeting, forecasting, financial compliance and reporting, and implementation of the industry loan award program."

Plunkett will also "play a key role in securing opportunities to leverage CIRM funds with additional outside capital," said CIRM Chairman Jonathan Thomas.

Plunkett worked for iPierian from 2009 until last April. While he was at the firm, it received $7 million in grants from CIRM. The South San Francisco business has a unique connection to CIRM. Major investors in iPierian, including John Doerr of Kleiner Perkins Caulfield Byers of Menlo Park, pumped nearly $6 million into the 2004 ballot campaign that created CIRM. That amounted to 25 percent of the total contributed to the campaign, which was headed by Robert Klein, who later became the first chairman of the stem cell agency.

CIRM has said no connection exists between the contributions and subsequent awards to iPierian.

The agency has needed a chief financial officer for some time. It has sometimes struggled with routine budget matters, although that problem seems to have been largely solved even before Plunkett was hired. Plunkett will report to both the agency's chairman, Jonathan Thomas, and CIRM President Alan Trounson, in a continuation of the troublesome dual executive arrangement at the stem cell agency.

Prior to joining iPierian, Plunkett worked for Oppenheimer/CIBC World Markets from 2000 to 2009. In his last position there, he was managing director/head of West Coast biotechnology. He holds Ph.D. in organic chemistry from UC Berkeley.

Plunkett, who is earning $260,004 annually, began work on Nov. 28. Today's press release on his hiring came after the California Stem Cell Report inquired on Saturday about progress in filling the position.

Here is a link to a brief article in the San Francisco Business Times about the Plunkett announcement.
(An earlier version of this item incorrectly said Plunkett started work on Nov. 11 based on his resume which said "11/11.")

The Back Story on Baylis and the Ethics of Geron's hESC Trial

Last week Canadian bioethicist Francoise Baylis raised ethical questions about Geron's abandonment of its hESC clinical trial in an article that, it turned out, has a bit of a history.

When we notified her that we had written about her piece and its implications for the California stem cell agency, Baylis replied with a thank you and said,

"As an aside, you might be interested to know that I sought to publish a version of this commentary as a letter to the editor in a peer reviewed stem cell science journal and received the following response: I and two experts 'found the overall tone and presentation of the letter inappropriately strong and confrontational. As a result, it does not seem appropriate for us to offer to consider it further.'

"In my view, this was an unfortunate editorial decision as I believe the stem cell science community needs to engage with this issue. Moreover, I know of responsible stem cell researchers who share my point of view. Beside which, I disagree with the characterization of the piece as confrontational ...

"Another posting of mine on The Mark News makes the same point, but in a more journalistic style."

In that piece, Baylis also wrote about Geron's position that the results with four clinical trial participants would "be a fair reflection of what would have happened if we had completed the study(with 10).” She said,

"I want to suggest, however, that this is an ethically problematic response to a situation that could have been anticipated, and thus avoided. Failure to name the problem in this way leaves future participants in safety studies of novel hESC interventions at risk of abandonment whenever a private biotech company decides to end a trial mid-stream for business reasons."

Our take? The California Stem Cell Report agrees that the decision by the unnamed journal was unfortunate, to put it mildly. Baylis' comments were neither inappropriate nor confrontational, but they did raise questions that could well make some persons uncomfortable. Nonetheless, the questions were the sort that the general public and patient advocates raise in one form or another in their dealings with the enterprises that develop therapies and drugs. Either the questions are addressed now or later -- when they may well have to be dealt with under much more difficult circumstances when things go awry.

Conflict of Interest: Harvard Researcher Resigns from IOM Inquiry into California Stem Cell Agency

One of the members of the Institute of Medicine panel conducting a 17-month investigation into the $3 billion California stem cell agency has resigned because of a conflict of interest involving a San Diego stem cell firm.

David Scadden, co-director of the Harvard Stem Cell Institute, withdrew last week after conferring with IOM officials concerning his connection to Fate Therapeutics, which lists him as a scientific founder.

In an email to the California Stem Cell Report, Scadden said,

"I have a relationship with a start-up company in CA and, after discussion, with the IOM, we concluded that it would constitute a conflict of interest. I would have enjoyed helping out, but didn't want to compromise the perception of objectivity of the report."

Fate Therapeutics does not hold an award from the California stem cell agency. It is not known whether the company has applied for CIRM funding. The agency does not release the names of applicants that are not approved.

We have queried the IOM about whether Scadden will be replaced on the now 13-member panel.

Strategy at CIRM: New Sources of Cash, More Funding Transparency, Better PR?

The California stem cell agency is huddling with industry, scientists and public as it wades through a revision of its strategic plan to determine how to spend its remaining $1.4 billion before the cash runs out.

CIRM officials have held at least 10 meetings with a variety of groups, including three public sessions. The next public hearing is Thursday in Los Angeles at the CIRM board meeting.

The revision comes as the agency wrestles with the increasing need to generate results that will resonate with California voters. CIRM's original $3 billion, which consists of cash borrowed by the state, will run out in roughly 2017. The agency is considering mounting a ballot campaign for another multibillion dollar bond measure. The agency is also under examination by the prestiguous Institute of Medicine and is likely to hear recommendations for changes from that report next fall.

Ellen Feigal, senior vice president for research and development, summarized stakeholder comments so far on CIRM's plans in a 13-page documment prepared for the meeting at Cedars-Sinai. She identified several key themes from stakeholders, including the need to find "alternate funding resources," presumably non-public financing. Feigal also cited a need to make the grant funding process more transparent, apparently reflecting complaints from industry. But she noted that stakeholders have said the agency has made "great initial progress" in its first seven years.

Here are four of the five themes Feigal identified. The fifth dealt mentioned CIRM's progress.

• "CIRM needs to become more aggressive in finding alternate funding resources and to implement greater creativity in identifying the types of organizations that may be able to contribute to the sustainability of CIRM's work"
• "Robust public affairs tactics are necessary, and CIRM needs to better communicate the organizational initiatives, as well as educate the public more broadly."
• "Greater transparency in the funding process is needed, and there is a great need for the process to be less bureaucratic and easier to navigate."
• "CIRM needs to provide greater opportunities for networking and breed collaborative projects that unite academic and industry as well as researchers across geographic reasons."

Feigal also mentioned a number of recommendations from industry, which has been less than happy with its meager share of CIRM funding. The suggestions included creation of "communications bridges" and better communication of the funding process. Also recommended was a "split review process – (academic vs. industry)" and a faster approval process that takes into account the high "burn rate" of cash at biotech companies. Another industry suggestion was creation of an "in-house champion" to help businesses navigate the CIRM funding process.

Feigal will come back to the board in January with a draft revision. It is scheduled to be approved March 21. The final plan will be shipped off to the IOM panel studying CIRM. It is scheduled to conclude its work next fall.

Interested parties can email their comments on the plan to CIRM (info@cirm.ca.gov) or speak at CIRM board meetings. The specific address for Thursday's meeting can be found on the agenda. A teleconference location is also available at UC San Francisco, where members of public can take part.

Luring Stem Cell Researchers to California: A $5.6 Million Bid

The $3 billion California stem cell agency has played a role in bringing two star researchers to the Golden State through its $44 million recruitment program and is about ready to bring in a third.

Next Thursday in Los Angeles, CIRM's governing board is expected to approve a $5.6 million grant to an unidentified scientist to lure him or her to an unidentified California institution.

The funds will go for the researcher's efforts to develop "a regeneration-based functional restoration treatment for spinal cord injury," according to a summary of reviewer comments on the CIRM web site. The grant was scored at 86 by scientific reviewers.

The summary quoted the researcher as saying,

"We recently made breakthrough discoveries in identifying key biological mechanisms stimulating the re-growth of injured axons in the adult nervous system, which led to unprecedented extents of axon regeneration in various CNS injury models. While our success was compelling, we found that many regenerated axons were stalled at the lesion sites by the injury-induced glial scars. Furthermore, it is unclear whether the regenerated axons can form functional synaptic connections when they grow into the denervated spinal cord. This proposed research program is aimed at solving these obstacles by using human stem cell technologies."

The summary said,

"The PI was described by reviewers as a superb scientist and emerging leader with outstanding accomplishments and exceptional promise. The candidate has already made key contributions to the understanding of mechanism underlying axonal regeneration that have significantly advanced the field of neuroregeneration. He/she has been extremely productive, publishing a number of seminal papers in the highest profile journals including Science, Nature, Neuron and Nature Neuroscience."

The stem cell agency's recruitment efforts have helped to bring Peter Coffey ($4.9 million from CIRM)from the UK to UC Santa Barbara and Robert Wechsler-Reya ($6 million)- to Sanford Burnham in La Jolla from Duke University.

California Stem Cell Agency and Geron: Ethical Issues with Sale of hESC Trial

A Canadian bioethicist is raising ethical questions about Geron's hESC trial that have implications for the attempt by the California stem cell agency to salvage the once-vaunted effort.

Writing yesterday on the Hastings Center Bioethics Forum, Francoise Baylis of Dalhousie University said,

"It is one thing to close a trial to further enrollment for scientific reasons, such as a problem with trial design, or for ethical reasons, such as an unanticipated serious risk of harm to participants. It is quite another matter to close a trial for business reasons, such as to improve profit margins."

Geron last month said it was ending the trial because of financial reasons and to pursue development of its cancer treatments. CIRM awarded Geron a $25 million loan just last May and was surprised by the Geron move. The $3 billion state research program is now attempting to find a buyer/partner for Geron's hESC business.

Baylis noted that Stephen Kelsey, chief medical officer of the Menlo Park, Ca., firm, has been quoted as saying that the results of Geron trial – now with five patients instead of the projected 10 – "will be a fair reflection of what would have happened if we had completed the study."

Baylis wrote,

"This statement is deeply problematic, however."

Baylis, a professor and the Canada Research Chair in the departments of philosophy and of obstetrics and gynecology at Dalhousie, continued,

"No clinical trial should involve too few or too many participants. It is important that the trial not be underpowered and thus unable to generate scientific knowledge. It is equally important than no more research participants than necessary be exposed to potential research risks. If only five participants were needed to generate the scientific knowledge, then why would Geron and the F.D.A. have agreed to expose additional persons to the potential harms of trial participation?

"On the other hand, if Kelsey’s statement is false, and the findings from five research participants will be underpowered, then they may have been exposed to the potential harms of trial participation without the potential for benefit in the form of scientific knowledge."

She concluded,

"In either case, the scenario forces us to consider what measures should be taken with respect to future trials funded in the private sector so that participants are not left stranded. Perhaps regulators and institutional review boards should critically examine whether a company has both the financial (and other) resources and the will to complete a trial under review before granting regulatory or ethics approval.  If there are doubts about this, then either the trial should not be approved, or there should be stringent disclosure requirements so that prospective research participants are aware of the possibility that research may stop mid-trial for financial reasons."