Stem Cell Agency Chairman Says IOM Report ‘Quite Complimentary’

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Jonathan Thomas
CIRM Photo

Jonathan Thomas, the Los Angeles bond
financier who is chairman of the $3 billion California stem cell agency, has
weighed in at more length on the sweeping recommendations from the
Institute of Medicine for changes at the agency.

He wrote a piece for the agency's blog
that said the 124-page report was “quite complimentary.” Thomas' article carried forward the theme of the stem cell agency's press
release yesterday that said the IOM “praises the agency as a 'bold
social innovation.'”
Thomas did acknowledge that the report
“highlighted some areas and made some recommendations about where
and how we might improve our performance.” 
Thomas concluded by saying the agency
takes the report seriously and will, over the next few months,
consider how best to respond.
Nearly needless to say, other observers
of the agency differ with Thomas' characterization of the report as
“quite complimentary.(See here and here.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/HmbrFtBzcs4/stem-cell-agency-chairman-says-iom.html

‘The Knoepfler Award:’ Recognizing Risk and Those Who Make a Difference

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A UC Davis stem cell researcher-blogger has announced a “stem cell person of the year” award
complete with a $1,000 cash prize that he is putting up himself.

Paul Knoepfler, who may be the only
stem cell scientist in the U.S. actively blogging on the subject,
said he has decided to put his money where his mouth is. 
Since announcing the contest in a Nov.13 blog item, Knoepfler has already received eight nominations,
including one for a scientist. Three days after the item aappeared, UC Davis
featured Knoepfler in a press release that included a video of
Knoepfler explaining the effort.
Paul Knoepfler
UC Davis photo

He said he wanted to go beyond “old
fashioned awards” given by “stodgy committees.” Knoepfler said he
is seeking to recognize that stem cell research is “transcending the
lab.”

The goal of the award, Knoepfler said,
is “to advance the stem cell field and give credit to those who
make a real difference.”
Knoepfler wrote,

“The criteria are that the person
made a truly outstanding difference in the stem cell field for 2012.
The winner could be a scientist, a patient advocate, someone in
industry, a student, a physician…really anyone who has made the
field better. For non-scientist nominees I’m particularly
interested in those who took personal risks or gave of themselves to
help others. For scientists I am looking for outstanding scientific
achievement and in particular out-of-the-box thinking. Folks in any
country are eligible.”

Deadline for nominations is Dec. 17.
Self-nominations are permissible. Knoepfler plans to pick five
finalists and interview them by phone. He also plans an online vote
that he said  “may” influence his decision.
Complete details are available on Knoepfler's blog. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/D_njqx1jc1U/the-knoepfler-award-recognizing-risk.html

Texas Flap Looms Over California Stem Cell Agency’s Grant Appeals

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In nine days, the California stem cell
agency plans to take another crack at finding ways to curb its
free-wheeling appeal process involving scientists whose applications
for millions have been rejected by reviewers.

It is a matter of considerable interest
to researchers who need the cash to keep their labs running and remain in good standing with their host institutions.
The stem cell agency's governing board this fall created a task force to deal with the appeals issue after a
record-breaking number of researchers made public appeals featuring
emotional patient advocates. Even the former chairman of the agency,
Robert Klein, made a two-time pitch for one applicant. Board members
later complained publicly about “arm-twisting,” lobbying and“emotionally charged presentations.”
The agenda for the Nov. 30 task force
meeting in Oakland -- with teleconferencing sites in San Francisco,
Irvine, Palo Alto, Seattle and Rochester, N.Y. -- contains few clues
on what the panel is hoping to specifically accomplish in next week's
90-minute session.
But interested researchers can check
the transcript from the Oct. 24 meeting, during which CIRM President
Alan Trounson described the problem as “very critical.” He said,

“I think this is a very serious
matter that could really bite us very hard in a similar way to what's
happened in Texas. Unless we come up with some kind of process that
really addresses the science, it's a very large concern.”

Trounson's Texas reference was to the
mass resignations of reviewers at that state's $3 billion cancer
research effort. Questions have been raised about integrity of its grant review process and the program's political and biotech industry
relationships. James Drew of the Dallas Morning News produced a bit of an overview this week. In another piece, Eric Berger of the
Houston Chronicle provided quotes from emails from the infighting on
a controversial $18 million grant.
Changes in California's grant appeal process may well
be also discussed at the agency's board meeting Dec. 12 in Los Angeles.
The board hopes to wrap up its action by late January.
Here is a link to an item with more specifics on material presented to the task force in October. Here is a link to an August 2012 list of articles and documents related to the CIRM appeals process.
Interested parties can address comments
to the agency at info@cirm.ca.gov.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/5vUXCLMoJz8/texas-flaps-looms-over-california-stem.html

Knoepfler Award Update: More than a Baker’s Dozen Nominated

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As of this week, 14 persons have been
recommended for the Knoepfler “Stem Cell Person of the Year”
Award.

The total was reported by Paul
Knoepfler, the UC Davis stem cell scientist and blogger, who is
putting up $1,000 for the winner of the honor.
Knoepfler announced his award plans earlier this month, declaring that he wanted to recognize scientists or others who “truly made a difference” in the stem
field. Risk-taking is one important criteria.
Knoepfler said,

“It’s something that I’m hoping I
can do every year. It would also be a reward for risk taking,
creativity and be breaking with tradition and be something new in
that regard.” 

The award has drawn some modest
attention outside of Knoepfler's blog. A few days after he introduced
the award on his blog, UC Davis decided to put out a press release and video on it. The California Stem Cell Report followed with an item. Then CIRM blogged it as well.
So far we have not detected any stories
about the award in the mainstream media, but things could change.
Deadline for entries is Dec. 17.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/cLYLc5HQUSY/knoepfler-award-update-more-than-bakers.html

BioTime Makes Bid for Geron’s Stem Cell Assets

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Biotime, Inc., and two men who were
leading players in history of Geron Corp. today made a surprise,
public bid for the stem cell assets of their former firm.

Michael West
West photo
Tom Okarma
AP file photo
The men are Michael West and Thomas
Okarma. West founded Geron in 1990 and was its first CEO. West is
now CEO of Biotime. Okarma was CEO of Geron from 1999 to 2011.
Okarma joined Biotime on Sept. 28 to lead its acquistion efforts.
Both Geron, based in Menlo Park, Ca., and Biotime, based in Alameda,
Ca., are publicly traded.
West and Okarma sent an open letter this morning to Geron shareholders and issued a press release making
a pitch for the Geron's stem cell assets. Geron jettisoned its hESC
program nearly a year ago and closed its clinical trial program for
spinal injuries. The move shocked the California stem cell agency,
which just a few months earlier had signed an agreement to loan the
firm $25 million to help fund the clinical trial. The portion of the
loan that was distributed was repaid with interest.
At the time, Geron said it would try to
sell off the hESC program, but no buyers have surfaced publicly.
Personnel in the program have been laid off or found employment
elsewhere.
The West-Okarma letter to shareholders
said that under the deal,

“Geron would transfer its stem cell
assets to BAC(a new subsidiary of Biotime headed by Okarma), in
exchange for which you along with the other Geron shareholders would
receive shares of BAC common stock representing approximately 21.4%
of the outstanding BAC capital stock. BioTime would contribute to BAC
the following assets in exchange for the balance of outstanding BAC
capital stock:

  • “$40 million in BioTime common
    shares;
  • “Warrants to purchase BioTime
    common shares (“BioTime Warrants”);
  • “Rights to certain stem cell
    assets of BioTime, and shares of two BioTime subsidiaries engaged in
    the development of therapeutic products from stem cells.”
The letter asked Geron shareholders to
write the firm's board of directors to urge them to approve the
offer.
Geron had no immediate response to the
proposal. Asked for comment, Kevin McCormack, spokesman for the
California stem cell agency, said the deal “had nothing to do with
us.” However, in the past, CIRM has indicated that it could find a
way to transfer the loan to an entity that would continue spinal
injury clinical trial. CIRM President Alan Trounson was also involved
at one point in trying to assist in a deal.
Geron's shares rose 12 cents to $1.54
today while Biotime's shares lost four cents to $3.95.
Here are links to the two news stories
that have appeared so far on the proposed deal: Associated Press, Marketwatch.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/v1bas6eGZF0/biotime-makes-bid-for-gerons-stem-cell.html

BioTime Will Have to Compete for California Cash for Geron’s Dormant Clinical Trial

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The California stem cell agency said
today it does not plan to reactivate the $25 million loan to assist
in Geron's spinal injury clinical trial despite an impending deal that would turn the effort over to BioTime, Inc.

Kevin McCormack, senior director for
public communications for the agency, said BioTime will have to
compete in an upcoming award round if it wants to win California
dollars.
Responding to a question from the
California Stem Cell Report, McCormack said,

“That (earlier) loan was specific to
Geron and when the trial was ended the loan ended too. Of course if
Biotime and Geron do complete their deal then Biotime would be free
to apply to us for a new disease team grant.”

McCormack later added that BioTime
could also compete in other appropriate rounds, including the
strategic partnership round just posted by CIRM. It provides for four
awards of up to $15 million. Funding could come as early as October
of next year. The strategic partnership round is a business-friendly
effort that is aimed at attracting “industry engagement and
investment.” The deadline for letters of intent is Dec. 18.
The stem cell agency made its $25
million loan to Geron in 2011 just a few months before the Menlo Park
firm abandoned its human embryonic stem cell trial for financial
reasons. (The full text of the loan agreement can be found here.) The company has repaid the loan with interest.
The company has tried to sell the
assets associated with the clinical trial since last November. The only public
interest that has surfaced has come from BioTime, Inc., of Alameda,
Ca. Michael West, founder of Geron, is the CEO of BioTime. Tom
Okarma, CEO of Geron from 1999 to 2011, is CEO of the BioTime
subsidiary that would assume the clinical trial.
News from clinical trial is expected to
be published soon, according to a story in the San Francisco Business
Times by Ron Leuty. He quoted CIRM President Alan Trounson as saying
that “some findings” from the trial would be published next month
in a medical journal.
Geron's stock traded at $1.24 at the
time of this writing today, up from $1.21 yesterday. BioTime's stock
stood at $2.99, up from $2.97.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/DS-6n2DoRy0/biotime-will-have-to-compete-for.html

UCD’s Knoepfler’s ‘Somewhat Provocative Paper’ on iPS

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UC Davis researcher Paul Knoepfler is
the rare stem cell scientist who blogs about his work as well as
writing about issues in the field.

Over the weekend, he posted an item on
what he described as a “somewhat provocative paper” published by his lab in
“Stem Cells and Development.”  He said the paper argued
that iPS cells “are very similar in some ways to cancer cells.”
Most of his item deals with the
technical details and background of the research. But at the end of
this item, Knoepfler wrote,

“So what does this mean in the big
picture? 

“I believe that iPS cells and cancer
cells are, while not the same, close enough to be called siblings. As
such, the clinical use of iPS cells should wait for a lot more study.
Even if scientists do not use iPS cells themselves for transplants,
but instead use differentiated derivatives of iPS cells, the risk of
patients getting malignant cancers cannot be ignored. 

“At the same time, the studies
suggest possible ways to make iPS cells safer and support the notion
of reprogramming cancer cells as an innovative new cancer therapy. 

“Stay tuned in the next few days for
part 2 where I will discuss what this paper went through in terms of
review, etc. to get published. It wasn’t a popular story for some
folks.”

The UC Davis press release on the
research, which was financed by the California stem cell agency and the NIH,  was picked up by several online sites, including Redorbit,
Medicalexpress and geekosystem.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/eNPFE1TC2TI/ucds-knoepflers-somewhat-provocative.html

Yamanaka: ‘Rejected, Slow and Clumsy’

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This week's announcement of the Nobel
Prize for Shinya Yamanaka brought along some interesting
tidbits, including who was “snubbed” as well as recollections
from the recipient.

Jon Bardin of the Los Angeles Times
wrote the “snubbed” piece and quoted Christopher Scott of
Stanford and Paul Knoepfler of UC Davis about the selection issues.
Bardin's piece mentioned Jamie Thomson and Ian Wilmut as scientists
who also could have been considered for the award but were not named.
Ultimately, Bardin wrote that the award committee was looking for a
“singular, paradigm shifting discovery,” which he concluded was
not the case with Thomson or Wilmut.
How Yamanaka arrived at his research
was another topic in the news coverage, much of it dry as dust.
However, Lisa Krieger of the San Jose Mercury News began her story
with Yamanaka's travails some 20 years ago. At the time, no one was returning his phone
calls as he looked for work, and he was rejected by
50 apparently not-so-farsighted American labs.
But that job search in 1993 came only after Yamanaka
decided he was less than successful as an orthopedic surgeon,
according to an account in JapanRealTime. “Slow and clumsy” was
how Yamanaka described himself.
And so he moved on to research. But
again he reported stumbling. In this case, he found a way to reduce
“bad cholesterol” but with a tiny complication – liver cancer.
That in turn sent him on a journey to learn how cells proliferate and
develop, which led him to the work that won the Nobel Prize.
Yamanaka said his original interest in
orthopedic medicine was stimulated by his father along with the treatments
for injuries young Yamanaka received while playing rugby and learning judo. The JapanRealTime account continued,

“'My father probably still thinks in
heaven that I’m a doctor,' he said in the interview(with Asahi
Shimbun last April). 'IPS cells are still at a research phase and
have not treated a single patient. I hope to link it to actual
treatment soon so I will be not embarrassed when I meet my father
someday.'”

And then there was, of course, the much-repeated story from the researcher who shared the Nobel with Yamanaka, John Gurdon. He has preserved to this day a
report from a high school biology teacher that said the 15-year-old
Gurdon's desire to become a scientist was “quite ridiculous.”
The teacher, who is unnamed, wrote,

“If he can’t learn simple
biological facts he would have no chance of doing the work of a
specialist, and it would be a sheer waste of time, both on his part
and of those who would have to teach him.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7J31SRIukpg/yamanaka-rejected-slow-and-clumsy.html

Los Angeles Times: StemCells, Inc., Award ‘Redolent of Cronyism’

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The Los Angeles Times this
morning carried a column about the “charmed relationship” between
StemCells, Inc., its “powerful friends” and the $3 billion
California stem cell agency.

The article was written by
Pulitzer prize winner and author Michael Hiltzik, who has been
critical of the agency in the past. The piece was the first in the major
mainstream media about a $20 million award to StemCells, Inc., that was approved in September by the agency's board. The bottom line of the
article? The award was “redolent of cronyism.”
Hiltzik noted that
StemCells, Inc., now ranks as the leading corporate recipient of cash
from the agency with $40 million approved during the last few months.
But he focused primarily
on September's $20 million award, which was approved despite being
rejected twice by grant reviewers – “a particularly
impressive” performance, according to Hiltzik. It was the first
time that the board has approved an award that was rejected twice by
reviewers.
Hiltzik wrote,

“What was the company's
secret? StemCells says it's addressing 'a serious unmet medical need'
in Alzheimer's research. But it doesn't hurt that the company also
had powerful friends going to bat for it, including two guys who were
instrumental in getting CIRM off the ground in the first place.”

The two are Robert Klein,
who led the ballot campaign that created the agency and became its
first chairman, and Irv Weissman of Stanford, who co-founded
StemCells, Inc., and sits on its board. Weissman, an internationally
known stem cell researcher, also was an important supporter of the
campaign, raising millions of dollars and appearing in TV ads. Klein,
who left the agency last year, appeared twice before the CIRM board
this summer to lobby his former colleagues on behalf of Weissman's
company. It was Klein's first appearance before the board on behalf
of a specific application.
The Times piece continued,

“But private enterprise
is new territory for CIRM, which has steered almost all its grants
thus far to nonprofit institutions. Those efforts haven't been
trouble-free: With some 90% of the agency's grants having gone to
institutions with representatives on its board, the agency has long
been vulnerable to charges of conflicts of interest. The last thing
it needed was to show a similar flaw in its dealings with private
companies too.”

Hiltzik wrote,

“(Weissman) has also
been a leading beneficiary of CIRM funding, listed as the principal
researcher on three grants worth a total of $24.5 million. The agency
also contributed $43.6 million toward the construction of his
institute's glittering $200-million research building on the Stanford
campus.”

CIRM board approval of the
$20 million for StemCells, Inc., came on 7-5 vote that also required
the firm to prove that it had a promised $20 million in matching
funds prior to distribution of state cash.
Hiltzik continued,

“The problem is that
StemCells doesn't have $20 million in spare funds. Its quarterly
report for the period ended June 30 listed about $10.4
million in liquid assets, and shows it's burning about $5 million per
quarter. Its prospects of raising significant cash from investors
are, shall we say, conjectural.

“As it happens, within
days of the board's vote, the
firm downplayed any pledge 'to raise a specific amount of
money in a particular period of time.' The idea that CIRM 'is
requiring us to raise $20 million in matching funds' is a
'misimpression,' it said. Indeed, it suggested that it might count
its existing spending on salaries and other 'infrastructure and
overhead' as part of the match. StemCells declined my request that it
expand on its statement. 

“CIRM spokesman Kevin
McCormack says the agency is currently scrutinizing StemCells'
finances 'to see what it is they have and whether it meets the
requirements and expectations of the board.' The goal is to set
'terms and conditions that provide maximum protection for taxpayer
dollars.' He says, 'If we can't agree on a plan, the award will
not be funded.'"

Hiltzik wrote,

“The agency shouldn't be
deciding on the spot what does or doesn't qualify as matching funds.
It should have clear guidelines in advance.

“Nor should the board
overturn the judgment of its scientific review panels without
clear-cut reasons....The record suggests that the handling of the
StemCells appeal was at best haphazard and at worst redolent of
cronyism.” 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6qvBfSLP3RE/los-angeles-times-stemcells-inc-award.html

Text of Comments on Awards to Stem Cell Directors’ Institutions

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Here is the full text of comments made
by the California stem cell agency, Joe Mathews, co-author of
“California Crack-Up” and Bob Stern, former president of the
Center for Governmental Studies and co-author of the California
Political Reform Act, in connection with the Sept. 23, 2012, article
in The Sacramento Bee headlined “Stem Cell Cash Mostly Aids Directors' Interests.” The comments were abbreviated for
publication in The Bee because of newspaper space constraints.

Comments by Alan Trounson, president of
CIRM:

“To make sure we do the best job of
managing taxpayer's money it's natural that we turn to people who
know most about stem cells and stem cell research. In fact, as the
state's own Little Hoover Commission reported in its analysis of
CIRM: “The fact that CIRM funding has gone largely to prestigious
California universities and research institutes is hardly surprising
and should be expected, given the goals of Proposition 71 and the
considerable expertise resident in these research centers.” But in
recruiting the best minds, we also adopt best practices to ensure
that there is no conflict of interest. Every board member has to
recuse themselves from voting on, or even being part of a discussion
on anything to do with their own institution, or to an institution or
company that they have any connections to. All this is done in
meetings that are open to the public. CIRM’s conflict of interest
rules have been subject to multiple reviews – by the Bureau of
State Audits, the Little Hoover Commission and the Controller – and
there is no evidence that any of CIRM’s funding decisions have been
driven by conflicts of interest. Indeed, CIRM rigorously enforces its
conflict of interest rules at each stage of the funding process to
ensure that all decisions are made on the merits of the proposal for
funding and not as a result of any conflicts of interest. 

“In addition all funding applications
are reviewed by an independent panel of scientists on our Grants
Working Groups, all of whom are out-of-state and meet strict conflict
of interest requirements, and it is their recommendations that help
guide the ICOC (CIRM governing board) on what to fund.”

Joe Mathews' comments:

“California ballot initiatives are a
terrible way to make public policy. And they are even worse as a
method for making scientific policy. 

“It's not merely that
this initiative was drafted in such a way as to benefit the
enterprises of its directors. It's that, under this initiative's own
provisions and the California constitution, it's so hard to change
Proposition 71 and fix what ails CIRM. Effectively, these provisions are
baked in, and nothing short of another vote of people can really make
the change. (Yes, there are provisions, as you know, that permit the
legislature by super-majority to do things, but supermajorities are
effectively out of reach in California). 

“Sadly, initiatives
like Proposition 71 are not uncommon. Many measures are drafted to benefit
the people who would support the measure, or oversee the program
established. This has been very common with bonds. Essentially, to
win the support of various groups whose money and backing is
important to passage of a bond, a sponsor of an initiative bond will
set up rules and include money specifically intended for each group.
This is a form of pay-to-play. Agree to back the initiative and
you're in. And it happens because there's no rule against it and
because passing initiatives in California require difficult,
expensive campaigns. 

“And this sort of thing will continue
to happen. There is no serious push to do anything about this.
Indeed, good government groups and reformers in California have
opposed changes to the initiative process -- because they want to use
the process for their own schemes.”

Bob Stern's comments:

“It would have been better had
institutions receiving grants not to have had their representatives
on the board awarding grants. On the other hand, we want to have the
most knowledgeable people on the board overseeing this very important
program. The question: Were these people the only qualified ones to
sit on the board?”

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

$1.5 Billion in Stem Cell Awards Goes to Directors’ Institutions

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The Sacramento Bee today published an article that reported that $1.5 billion, more than 90 percent of the amount dispensed by the California stem cell agency, has gone to institutions linked to past and present directors of the agency.

The piece was carried on the front page of the newspaper's Sunday Forum section and was written by David Jensen, publisher-editor of the California Stem Cell Report.

The text of the Forum article is below. The Bee also carried a chart listing the top 10 recipient institution. The full text of the comments from Alan Trounson, president of the California stem cell agency,  and two other persons quoted in the article can be found here.

Stem cell cash mostly aids directors' interests

Special to The Bee

By David Jensen

With its latest round of awards earlier this month, California's stem cell agency has now handed out $1.5 billion to enterprises linked to its directors.

The figure amounts to 92 percent of the $1.7 billion awarded by the agency. The grants and loans range from $261 million to Stanford University, whose medical school dean, Philip Pizzo, sits on the agency's governing board, to $170,500 to Children's Hospital in Oakland, whose president, Bert Lubin, also is a member of the board.

The University of California, Davis, has received $128 million. Claire Pomeroy, chief executive officer of UC Davis Health System, is another one of the 29 board members. In all, 27 institutions with past or present representatives on the agency board have received funding.

None of this is illegal. And none of it is likely to change. The situation was created by Proposition 71, the 2004 ballot measure that established the state's $3 billion stem cell agency, formally known as the California Institute for Regenerative Medicine, or CIRM. The initiative was crafted so that virtually all of the institutions that stood to benefit from the state's largesse had seats at the table where the money is handed out.

The built-in conflicts of interest at CIRM have perturbed some experts in California government, but concerns have also reached into the scientific community. The prestigious journal Nature, in 2008, editorialized against what it called cronyism at CIRM. It said the agency "must fight the tendency of the academic institutions on the board to hoard dollars."

Some California scientists, wary of offending those who control the lifeblood of their research, privately grumble about an "old boys network."

Joe Mathews, co-author of "California Crackup," a study of major issues in state government, said last week: "California ballot initiatives are a terrible way to make public policy. And they are even worse as a method for making scientific policy."

The stem cell agency has a different view. Alan Trounson, president of the San Francisco-based enterprise, said: "There is no evidence that any of CIRM's funding decisions have been driven by conflicts of interest. Indeed, CIRM rigorously enforces its conflict of interest rules at each stage of the funding process to ensure that all decisions are made on the merits of the proposal for funding and not as a result of any conflicts of interest."

Mathews, California editor of Zocalo Public Square, and others point to the creation of the California stem cell agency as an example of abuse of the initiative process by special interests. The 10,000 words in Proposition 71 were written in private by Bay Area real estate investment banker Robert Klein and a handful of associates, who quietly determined the composition of the board. Klein later served six years as the first chairman of the stem cell agency, leaving in June 2011.

Klein later argued publicly that placing medical school deans and university and research institution executives on the board provided the expertise needed to make the decisions about how to spend the research money. However, the makeup of the board also served to win the support of institutions that envisioned the prospect of fresh cash – in this case money that the state borrows via bonds.

Mathews described the state's initiative process this way: "Essentially, to win the support of various groups whose money and backing is important to passage of a bond, a sponsor of an initiative bond will set up rules and include money specifically intended for each group. This is a form of pay-to-play. Agree to back the initiative, and you're in."

Bob Stern, who co-wrote the California Political Reform Act, said, "It would have been better had institutions receiving grants not to have had their representatives on the board awarding grants."

Trounson said the board follows "best practices" when it comes to grants and legal conflicts of interest. The agency has worked out an unusual procedure to prevent its directors from violating conflict of interest laws as they vote on applications that seek as much as $20 million each. Before each public session, agency attorneys determine which board members cannot vote on a proposal because of legal conflicts of interest. Applications to be approved are considered as a group. Each board member then votes on the entire group by saying, "Yes, on all those except with which I have a conflict."

No final tally is announced. The public can ferret out the overall vote a month or two later in the minutes of the meeting on the CIRM website (http://www.cirm.ca.gov). But the minutes do not list individual votes or conflicts of interest.

Domination of the board by academics and nonprofit institutions has led to bitter complaints from business. Less than 7 percent of all awards have gone to for-profit enterprises. Currently, however, the agency is embracing industry more warmly in an effort to commercialize stem cell research, which raises another set of coziness problems. They surfaced in July and again this month.

Klein, who led the stem cell ballot campaign before becoming chairman of the agency, appeared before his old board to lobby on behalf of a $20 million request from StemCells Inc. of Newark. The California firm was founded by the eminent Stanford stem cell scientist Irv Weissman. He sits on StemCells Inc.'s board, and he and his wife hold 273,821 shares of stock in the firm. Weissman was also an important backer of Proposition 71, working the "billionaire circuit" and raising more than $1 million for the campaign, according to an article in San Francisco magazine.

CIRM's reviewers had rejected StemCells Inc.'s application. After Klein made his pitch in July, the board sent the application back for re-review, an unusual procedure.

When the application returned to the board early this month, reviewers again rejected it. Klein again importuned his former colleagues, and – following a closed door session – the board approved the award, 7-5.

Eleven members were disqualified from voting because of legal conflicts of interest. It was the first time in the board's eight-year history that it approved an application twice rejected by reviewers.

Mathews said no likelihood exists of changing the board structure at CIRM. He said it is "baked in" by Proposition 71. That's because Klein and company wrote into the initiative a requirement for a super, super-majority vote – 70 percent – of each house of the Legislature to make any modifications.

Another initiative could be mounted, but that possibility is also exceedingly remote. 

Source:
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Text of Klein’s Response to Questions Concerning His Advocacy on Rejected Grant Applications

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Here is the text of Robert Klein's response today to the California Stem Cell Report concerning his appearance before the governing board of the California stem cell agency July 26, 2012. Klein, former chairman of the agency, real estate investment banker and attorney, promoted two applications seeking $20 million each from the agency. Both applications had been rejected by the agency's reviewers. Here is a link to an item on the subject.

"Dear David,
"You have posed two
questions related to my continuing role as a Patient Advocate in
contributing information to the Board of the California Institute for
Regenerative Medicine, in an effort to optimize decisions on medical
and scientific grants and loans for research that could mitigate
and/or cure chronic diseases or injuries. 

"Q: Do you have any sort
of financial ties to StemCells Inc. or any of the individuals or
firms that would benefit from approval of those awards by the ICOC(the CIRM governing board)?
"A: I have no financial
interest in StemCells Inc. or any of the individuals or firms that
would benefit from approval of those awards by the ICOC. In fact, I
have no financial interest in any biomedical research company.

"Q: Do you think it is
appropriate for the former chairman of the ICOC to lobby that body on
behalf of awards to specific companies or individuals?
"A: First, it is
fundamental that the terms be defined to properly respond to your
question. A “Patient Advocate” is a member of a patient family or
a medical/scientific care /support group who advocates for medical
and scientific advances that might potentially mitigate and/or cure a
patient’s chronic disease or injury. A “Patient Advocate” is
not paid for his/her advocacy, unless they are staff members of a
non-profit institution dedicated to a specific disease or group of
diseases or injuries. 

"Second, a “lobbyist”
is a paid representative of a company or a for-profit institution(s)
with a financial interest in the outcome of a governmental decision. 

"I am serving as a
Patient Advocate in my presentations to the Board of the California
Institute for Regenerative Medicine. As the former Chairman of the
Board, I have a particular responsibility to contribute my background
knowledge and experience for the Board to consider, along with all
new information, in reaching their best decision. I hope other former
Board members, who possess a wealth of scientific, medical, and
institutional knowledge that can benefit the Board, would consider
the value they can contribute to future decisions. As Board terms
expire, it will be important not to lose that institutional knowledge
and medical/scientific expertise that has been built up over the last
seven plus years of the Agency’s existence. 

"In an outline format,
I would suggest the following areas where the knowledge of former
Board members can be especially valuable in optimizing the input for
Board decisions in the future. 

"A number of Board
members have participated in up to 20 or more Peer Review meetings,
some of which cover multiple days. Current grant or loan requests
represent the result of scientific and medical advancement that has
been intensely vetted in prior peer reviews; the information gained
in those peer reviews should not be lost, when a subsequent grant or
loan request – built on the earlier research outcomes – is
considered. Each peer review session has the benefit of different
specialists and scientists and/or biotech representatives with
unique backgrounds and areas of expertise. The value of the prior
contributions may be pivotal, in considering a later application,
developed from the earlier medical or research advances funded
through CIRM’s grants or loans. The current peer review,
scientific staff presentation, and Board expertise, is not the limit
of the Board’s information, in reaching the best current decision.
To the extent the Board can draw from prior peer reviews (unique
insights), prior scientific staff presentations, and prior Board
expertise, additional information that can enhance a potential
decision, the Board has the opportunity to optimize its decision
making process. This is particularly valuable, when there is a high
standard deviation – a substantial split – in the scoring
positions from the current peer review. 

"Beyond peer review
participation, Board members have intensely engaged in another 35
plus Working Group sessions on Facilities and Standards, in addition
to more than 70 Board meetings and over 125 Subcommittee meetings,
as of August 2012. Retiring Board members possess a treasury of
information on policy development, process, federal and state laws
and regulations, and the regulations of the agency, as well as in
depth information on research facilities and capabilities throughout
California, the nation, and the world. It takes a substantial length
of time for a new Board member to gain a comprehensive knowledge in
all of these areas and each Board member will develop unique
insights, which it would be a tragedy to lose. As Chairman, I
frequently reached back to consult with former Board members on
areas of their special expertise and I would hope that all current
and future Board members utilize the significant asset in developed
knowledge of the prior Board members. To the extent prior members
can be available for public meetings, this would be a substantial
benefit to the agency to broadly inform the Board, the scientific
staff, and the public. 

"The Board has a
unique contribution to make on programmatic resource allocations and
risk management of the research and clinical investments in each
disease area. The opportunities in some disease areas for major
advancement are numerous, whereas there are major diseases and/or
critical research areas where the potential, high-value advancement
options are relatively limited. For Board members who have
participated in over 20 peer reviews and 70 Board meetings, the
programmatic perspective on the opportunities in each disease area
has been highly developed. Concurrently, those Board members or
former Board members have substantial knowledge that is of critical
value in reaching programmatic decisions on the number of
opportunities for advancement in any specific disease area and the
relative risk that needs to be taken to accomplish meaningful
breakthroughs in advancing the research and clinical opportunities
in a disease and/or injury area. 

"I hope these examples
of how former Board members can contribute to the current Board’s
information in reaching decisions on the best medical/scientific
grants and loans are helpful. As I stated earlier, it would be a
tragedy if the expertise of Board members built up over six or more
years is lost. The field is extremely complicated and the Board needs
the opportunity to consider all of the information available. The
Board can choose to accept or reject any past advice or opinions
gained from prior peer review sessions or Board meetings, but the
Board should have access to the full spectrum of information and the
treasury of scientific and medical advice the agency has received
since its inception.

"There are areas that I
have not addresses in this short response, such as the institutional
value of applicants being able to rely upon prior scientific and/or
policy direction, in their current applications. From a historical
perspective, prior Board members and/or the Chairman can have
significant information that is relevant to these evaluations,
especially if the individual Board member served on a special Task
Force , Subcommittee or peer review. These more complicated areas of
individual contribution by former Board members I can address in a
future communication; but, this specific subject – alone – could
comprise several pages and I would like to obtain critical advice and
perspective from other former Board members and the scientific
community before discussing this area in greater detail.
"Bob Klein
"Chair Emeritus
"California Institute
for Regenerative Medicine"

Source:
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CIRM Board Member Prieto Defends Klein’s Right to Appear Before Board

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A member of the governing board of the
California stem cell agency, Francisco Prieto, has commented
in an email about the “unseemly performance” item concerning the
agency's former chairman, Robert Klein. Prieto is a
Sacramento physician who serves as a patient advocate member of the
board. He has been on the board since its inception. Here are his
remarks.

“I wanted to comment on this piece
from the perspective of another patient advocate.  While I think
you know that I did not always agree with Bob Klein during his tenure
on the ICOC(the agency's governing board), I would strongly defend
his right to appear and give his opinions to the Board.  He is a
private citizen now, albeit one with considerable experience and
expertise, and I think his greatest vested interest in this case
stems (you should pardon the expression) from being the child of a
parent with Alzheimers.  As you point out, some eyebrows may be
raised, and I can imagine that some board members might be swayed in
either direction by his testimony, but  he is a passionate and
committed advocate, and he has the right to advocate before us.”

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Bob Klein, “Lobbying” and Reader Reaction

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A robust discussion has arisen
concerning Bob Klein and his appearance last month before the
governing board of the $3 billion California stem cell agency, a body
that he once chaired and an enterprise that he once oversaw.

The comments were triggered by the original "unseemly performance" item on the California Stem Cell Report and a subsequent comment by Francisco Prieto, a longtime member of the board.
The comments discussed whether Klein
was manipulated and whether he was engaged in so-called “revolving
door” activity – the practice of former government officials,
such as Klein, becoming paid representatives of enterprises that were
involved with their former agency.
The comments raise a number of
interesting questions that we will discuss on the California Stem
Cell Report during the next few days.
You can read the remarks by going to this item and scrolling down to the end of the piece.
(Editor's note: Our apologies to some
of those who commented for the delay in posting their remarks.)

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Harvard’s McMahon on His Way to USC

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Andy McMahon
Harvard photo

The governing board of the California stem cell agency this afternoon approved a $5.7 million grant to lure a Harvard researcher to the University of Southern California in Los Angeles.

The scientist is Andrew McMahon, who serves on the executive committee of the Harvard Stem Cell Institute. CIRM officials said McMahon is ready to begin his work immediately at USC.

McMahon won stellar reviews from CIRM's grant reviewers who said he was an “exceptional scientist and one of the leading young developmental biologists.” Reviewers gave his proposal a score of 90 and, in summary, said,

“Major strengths include the candidate's exceptional productivity and contributions to the fields of mammalian embryology and kidney development, the significance and potential of the research program, the PI's proven leadership capabilities, and the outstanding institutional commitment.”

Source:
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Text of Klein’s Comments Supporting Rejected Applications

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Robert Klein, who served 6 ½ years as the first chairman
of the $3 billion California stem cell agency,  testified before the agency's board for the first time on July 26, 2012. Klein, a real
estate investment banker and attorney, spoke on behalf of two applicants whose
grants had been rejected by the agency's reviewers. The appearance
has raised questions about the propriety of Klein's actions.

Here is a link to an item on his appearance. Here is the text of
his comments as reported in the transcript of the meeting.

“As the board knows, I've never addressed any grant from the
floor. It is critical here to understand that we have here
StemCells, Inc., which is the only company in North America
and, for that matter, maybe in the world, that has had two stem cell
therapies in the brain with these specific neural stem cells. They
have a huge body of experience here. 

“Secondly, one of the fundamental issues here that it (the
company's grant application) was downgraded on was the issue of the
fundamental concept, the platform concept, of injecting two focal
injections in the brain, in the hippocampus of the brain. It's
important to note that I've sat on three (CIRM)peer reviews where the
scientists really affirmed this specific approach with extremely high
scores, three different views. All right.

“So it's very important to realize we have a standard deviation
here of 12 (on the review scores). These scientists were completely
split. With some recusals on that panel, if you have 12 or 13 that
can really vote, three or four very low scores can bring it out of
the funding category all the way down. It is in the region where
this board is looking where the other three peer reviews, right,
early translation, the one before that was the planning grant review,
that the hippocampus was a good platform.

“Then they said the key weakness was you can't show migration.
Dr. Laferla (a co-PI on the application) has told me that
today the Journal of Neuroscience accepted the publication of
the data demonstrating migration. It was stated previously in the
application, but it wasn't accepted for publication. It now is.
That is the fundamental weakness that they identified in this
approach.  

“So we have a reaffirmed approach to the hippocampus by three
different peer review groups and a substantial portion of these
reviewers along with data dealing with the weak point. I'm sorry it
happened today. The data was out there, accepted for publication
today, means that it should definitely fall into this category. And,
of course, Dr. (Alan) Trounson (president of CIRM) wouldn't
have been able to review that in process because he was recused from
this grant by his own voluntary recusal. So the progress of this
data being accepted for publication is new information today. 

“If I look at the entire history of CIRM, as Leeza (Gibbons,
a CIRM director) says, building up to this point, we have reaffirmed
this approach from the very beginning with Dr. Laferla, with multiple
scientific approvals, and board approval, and we have the best
company in North America with the greatest experience with these
neural stem cells, with the best researcher we have for the potential
to address this disease, and we have brand-new data that demonstrates
and totally contradicts the key weakness on which it was downgraded.”

Here is the text of Klein's remarks on
behalf of a second application, also rejected by CIRM reviewers.

“This is the only other disease team grant I will address. Very
specifically, this was a disease team grant that I was on the peer
review in the planning grant stage. There are some fundamental
issues here. Is the international company on which the one antibody
that's not coming from Stanford, the two for sorting are
coming from Stanford, is the other antibody coming from this
international company a commitment that you can rely on? 

“The reviewers said this was a showstopper. That's the word they
used. They made a decision this was a showstopper because they did
not believe the company because they thought that the documentation
was inadequate. You now have a letter that goes into great
proprietary depth about the depth of this company's commitments
written by the head of development and translation internationally
for the company. 

“If we cannot depend on company commitments of this type, and
you will review the letter in executive session, if you have one, I
will not understand how we'll be able to collaborate with companies
with proprietary products and processes where they're making
commitments to academic institutions of the highest standard. I
believe this company is going to perform. I was on an hour call to
confirm with eight members of that company their level of commitment,
and I am completely convinced by that point. 

“The review is completely factually wrong on this issue about
the other two antibodies for sorting this. Dr. (Irv) Weissman
has just said they have not only been developed, they have been used
in clinical trials. There's data on them. And they are, in fact,
being thawed under FDA direction to reuse in this trial. 

“So I believe there's a major factual difference. Remember with
Karen Aboody there was a major factual error that was pivotal
in elevating that, and we found tremendous performance on that grant
by Karen Aboody of City of Hope. 

“So you have a decision to make. As a risk issue, do we believe
this company? Finally, this is broader than SCID. 

“Donald Kohn has written a letter that's in the public
domain that I suggest you read. It makes it very clear that opening
the niche for repopulating the immune system without chemotherapy and
radiation is a key contribution to every form of genetically modified
stem cells for an entire range of childhood diseases and other
genetic diseases in addition to therapies like sickle cell or aids. 

“I suggest that that profound contribution that can be made to
the field is a risk that is worth taking early on because of his
contribution to so many other areas. You have 12 other letters from
North America's leading pediatric geneticists that fundamentally
provide extraordinary support for this position and this approach.”

Source:
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Finding on ‘Evil’ Stem Cells Boosts Stem Cell Agency PR

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The California stem cell agency, which
is struggling to spread the word about its good deeds, made a bit of
progress last week when it was praised – not once but three times –
on a widely followed national media outlet.
Jill Helms, Stanford photo
The PR bonus occurred on Science
Friday, the NPR program that is a favorite on PBS radio stations
around the country. It has 1.4 million listeners and 600,000 podcast downloads each week.
Jill Helms, a surgery professor at
Stanford and a specialist in regenerative medicine, was the guest
last Friday. She talked about what Science Friday host Ira
Flatow called a "paradigm-shifting" finding that
cholestrol and fat are not the likely villains in clogging arteries.
Instead the villain is a stem cell – an evil one.
While evil stem cells are not a matter that is pushed by the California stem cell agency, Helms said her
collaboration began as a result of a CIRM-sponsored meeting in Japan.
Although she and lead researcher Song Li, an associate professor of bioengineering at UC Berkeley, work nearly within shouting distance,
they had never met. She said,
Zhenyu Tang (at microscope) examines vascular stem
cells in culture along with Aijun Wang (left) and Song Li.
UC Berkeley/Zoey Huang photo

"Even though he works just across
the (San Francisco) Bay from me - I met him at a meeting in Japan
that was sponsored by the California Institute for Regenerative
Medicine, or CIRM, and they fund a lot of stem cell research in
California."

Later she said,

"I will tell you that cancer is
certainly a disease that looks very much like a stem cell gone out of
control. And so if we understand what normally regulates a stem
cell's behavior, then we gain some crucial insights into what
regulates maybe a cancer cell's behavior. It's that kind of approach
that I think that CIRM is largely funding initiatives to try to
target human diseases, the big ones, and the ones that make us all
sort of quake in our shoes, and attempt to come up with new
therapies."

And then still later, she said,

"Most basic scientists that work
in stem cells and in the area of stem cell are trying as hard as
possible to move this into translational therapies, things that can
be used in humans. And, of course, CIRM, our funding institution, is
very adamant about this being the trajectory. So, you know, I'll be
taking a stab at it about five to seven years. I think that the
ability to rapidly screen existing drugs for their ability to target
this cell population is why we think that it might have a shorter
course to getting into humans."

We should note that Helms has not
received a grant from the stem cell agency nor is she even one of the
featured players in CIRM's many videos. Song Li does have a $1.3million grant from the agency.
The three-pronged push by Helms is just
what the agency needs if it is to sell its efforts, which are almost
totally ignored by the mainstream media. However, the Science Friday
audience consists almost entirely of "true believers" in
the virtues of science and research. If CIRM is to accomplish its
PR-communications-marketing goals it also has to reach the unwashed
heathens, who are, however, unlikely converts. But most importantly,
CIRM needs to persuade fence-sitters. All of which will require a
long, hard and sometimes frustrating campaign.
One final note: The UC Berkley press release on the research said it was supported by cash from CIRM, the
NIH and the United States Army.  According to CIRM's research blog post
on Li's work, his team included two researchers who were
part of Berkeley’s CIRM-funded training program.

Source:
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Parsing Geron’s Stem Cell Foray: A Nature Journal Commentary

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Why did Geron "fail" in its
much ballyhooed pursuit of the first-ever human embryonic stem cell
therapy?

Christopher Scott, senior
research scholar at Stanford, and Brady Huggett,
business editor of the journal Nature, took a crack at
answering that question in a commentary in the June edition of
Nature.
Following the sudden abandonment last
fall by Geron of its hESC business and the first-ever clinical trial
of an hESC therapy, Scott and Huggett scrutinized the history of the
company. The financial numbers were impressive. They wrote,

"How did Geron’s R&D program
meet such a demise? After all, the company raised more than $583
million through 23 financings, including two venture rounds, and
plowed more than half a billion dollars into R&D (about half of
that into hESC work) through 2010. 

"There are problems with being at
the forefront of unknown territory. Of Geron’s development efforts,
the hESC trial was the most prominent, and fraught. Therapies based
on hESCs were new territory for the US Food and Drug
Administration (FDA), and it eyed Geron warily. The
investigational new drug application (IND), filed in 2008, was twice
put on clinical hold while more animal data were collected among
fears that nonmalignant tumors would result from stray hESCs that
escaped the purification process. Geron says it spent $45 million on
the application, and at 22,000 pages, it was reportedly the largest
the agency had ever received."

The California stem cell agency also
bet $25 million on the company just a few months before it pulled the
plug. Geron repaid all the CIRM money that it had used up to that point.
Geron suffered from a lack of revenue
despite its vaunted stem cell patent portfolio. Scott and Huggett
reported that Geron received only $69 million from 1992 to 2010 from
collaborations, license and royalties. At the same time losses were
huge – $111 million in 2010.
The Nature article noted all of that
was occurring while other biotech companies – such as Isis
and Alnylam – found ample financial support, revenue and
success.
Scott's and Huggett's directed their
final comment to Advanced Cell Technology, now the only
company in the United States with a clinical trial involving a human
embryonic stem cell therapy.

"Your technology may be
revolutionary, your team may be dedicated and you may believe. But it
does not matter if no one else will stand at your side."

Our take: The California stem cell
agency obviously has learned something from its dealings with Geron.
The company's hESC announcement was an unpleasant surprise, to put it
mildly, coming only about three months after CIRM signed the Geron
loan agreement. Today, however, the agency has embarked on more,
equally risky ventures with other biotech enterprises. Indeed, CIRM
is forging into areas that conventional investment shuns. It is all
part of mission approved by California voters in 2004.
The dream of cures from human embryonic
stem cells or even adult stem cells is alluring. And CIRM is feeling
much justifiable pressure to engage industry more closely. All the
more reason for CIRM's executives and directors to maintain a steely
determination to terminate research programs that are spinning their
wheels and instead pursue efforts that are making significant
progress in commercializing research and attracting other investors.  

Source:
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California’s $12.4 Million Stem Cell Recruitment Lure

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Directors of the California stem cell
agency next Thursday are likely to approve spending $12.4 million to
lure a couple of stem cell stars to the Golden State.

It is part of a $44 million recruitment
program that has brought three highly regarded scientists to three
California research institutions, all of which have representatives
on the CIRM board. (See here, here and here.)
As usual, the $3 billion stem cell agency does not
identify the potential recipients in advance of the meeting or the
institutions that are recruiting them. However, if you have a modicum
of knowledge about the specific fields involved, it is likely that
you can identify them based on the information in CIRM's review summaries and some Internet searching.
One of the proposed research grants–a
$5.7 million award--would go a scientist who won raves from CIRM's
reviewers. The researcher was described as an “exceptional
scientist and one of the leading young developmental biologists.”
Reviewers gave his proposal a score of 90 and, in summary, said,

“Major strengths include the
candidate's exceptional productivity and contributions to the fields
of mammalian embryology and kidney development, the significance and
potential of the research program, the PI's proven leadership
capabilities, and the outstanding institutional commitment.”

 The other grant was larger–$6.7
million–but reviewers raised a number of questions about the
candidate although they recommended it for funding. The review summary ranked the application at 57 and said,

“In summary, this is an application
from an established leader in NSC biology to pursue research focused
on disease mechanisms in PD. Strengths of the proposal include the
quality of the PI, the focus of the project on an interesting
hypothesis, and the leadership in basic science that the candidate
would bring to the applicant institution. Weaknesses included
deficiencies in the research plan, the limited track-record of the PI
in PD research and an institutional environment lacking adequate
support for basic science investigations.“

Last January, in a rare move, CIRM
directors rejected a $6.3 million recruitment grant with a score of
76 sought by the Buck Institute, which is not represented on the
board.
The proposals are scheduled to be acted
on at a public CIRM board meeting in Burlingame, Ca.

(Editor's note: an earlier version of this item incorrectly said the total of both grants was $13.4 million.)

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The Market’s Invisible Hand and Its Impact on Stem Cell Research

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As the $3 billion California stem cell
agency intensifies its efforts this year to push cures into the
clinic, a Canadian academic is raising a host of serious questions
about the drive towards commercialization in scientific research.
Exhibit No. 1 was stem cell research,
in an article Monday in The Scientist magazine. It was written
by Timothy Caulfield, a Canada Research Chair in Health Law
and Policy, and a professor at the Faculty of Law and School of
Public Health, University of Alberta. He said,

"Commercialization has emerged as
dominant theme in both the advocacy of science and in the grant
writing process.  But is this push good for science? What damage
might the market’s invisible hand do to the scientific process?"

Caulfield noted that research has
played a role in commercial enterprises and that the goal-oriented
research has led to important developments. But he also wrote,

"There are many recent examples of
how commercialization plays out in top-down policy approaches to
science.  The UK government recently justified a £220 million
investment in stem cell research on the pledge that it will help
stimulate an economic recovery. A 2009 policy document from
Texas made the optimistic prediction that stem cell research could
produce 230,000 regional jobs and $88 billion in state economic
activity.  And President Obama’s 2011 State of the
Union address went so far as to challenge American researchers
to view this moment in time as 'our generation’s Sputnik
moment'—the opportunity to use science and innovation to drive the
economy, create new jobs, and compete with emerging economies, such
as China and India. 

"The impact of this
commercialization pressure is still unfolding, but there is a growing
body of research that highlights the potential challenges, including
the possibility that this pressure could reduce collaborative
behavior, thus undermining scientific progress, and contribute to the
premature application of technologies, as may already be
happening in the spheres of stem cells and genetic
research. For example, might the controversial new Texas stem cell
research regulations, which allow the use of experimental adult
stem cell therapies without federal approval, be, at least in part, a
result of the government’s belief in the economic potential of
the field? 

"Such pressure may also magnify
the growing tendency of research institutions and the media to hype
the potential near future benefits of research—another phenomenon
that might already be occurring in a number of domains and
could have the effect of creating a public expectation that is
impossible to satisfy. 

"Furthermore, how will this trend
conflict with the emerging emphasis on an open approach to
science? A range of national and international policy entities, such
as the Organisation for Economic Co-operation and Development,
suggest 'full and open access to scientific data should be adopted as
the international norm.' Can policy makers have it both ways? 
Can we ask researchers to strive to partner with industry and
commercialize their work and share their data and results
freely and as quickly as practical?"

In late July, the governing board of
the California stem cell agency is expected to make some hard
financial decisions about where its future spending will be targeted.
Just last week it approved a five-year plan with explicit goals for speeding stem cell research into the marketplace.

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