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Archive for the ‘Stem Cell Therapy’ Category

Research and Markets: Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics

Tuesday, June 12th, 2012

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/pqrlwc/analysis_of_the_st) has announced the addition of Frost & Sullivan's new report "Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics" to their offering.

This Frost & Sullivan research service titled Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics focuses on prospects for the stem cell therapeutics market in Europe and provides valuable recommendations and conclusions for market participants. Market segmentation is based on regulatory framework in Europe relating to research on adult and embryonic stem cells. The main countries discussed are the United Kingdom, Germany, France, Spain, Sweden, Finland, and the remaining parts of Europe.

Market Overview

New Applications in Drug Discovery Platforms to Drive Stem Cells Market

Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research. The market will be driven by stem cell applications in drug discovery platforms and by successful academia -commercial company partnership models.

The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase, notes the analyst of this research. Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these abnormal' cells have significantly contributed to a lack of translation into clinical studies. Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Host of Challenges Need to be Confronted before Stem Cell Therapeutics can Realise its Potential

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials. Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments. The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues, adds the analyst. As a result, market prices for various products may be affected. Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies, cautions the analyst. Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics. To push through policy or regulatory reforms, the technology platform and geographical location of stem cell companies should complement the terms laid down in EMEA. The methodology for cell expansion and synchronisation must be optimised to acquire a large population of the desired cell at the right differentiation point, adds the analyst. More research is needed in human pluripotent and multi potent stem cell as it differs from mice to humans. Completion of clinical trials will be essential to ensure the safety and efficacy of the stem cell therapy.

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Research and Markets: Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics

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Bioluminescence imaging lights up stem cell therapy for hair growth

Tuesday, June 12th, 2012

Public release date: 11-Jun-2012 [ | E-mail | Share ]

Contact: Susan Martonik smartonik@snm.org 703-652-6773 Society of Nuclear Medicine

Miami Beach, Fla.Finding a way to restore hair growth after substantial hair loss is something of an obsession worldwide. Investigators at the Society of Nuclear Medicine's 2012 Annual Meeting presented how stem cell research for the development of new hair follicles can be monitored with an optical imaging technique that uses bioluminescence, the same process that allows fireflies to light up.

There is a host of treatments available for hair loss, including creams and drugs, but these have not shown to be very effective for hair growth. Hair stem cells signal the actual regeneration of hair follicles and natural hair. A molecular imaging technique called bioluminescence is used to display processes at the cellular level. Bioluminescent signal is generated in specific chemical substances called substrates. These signals are easily recognized with very sensitive optical imaging systems that can see what is happening in the smallest placesin this case in hair stem cells.

"Hair regeneration using hair stem cells is a promising therapeutic option emerging for hair loss, and molecular imaging can speed up the development of this therapy," saysByeong-Cheol Ahn, M.D., Ph.D., professor and director of the department of nuclear medicine at Kyungpook National University School of Medicine and Hospital in Daegu, South Korea. "This study is the first study of hair follicle regeneration using an in vivo molecular imaging technique."

The current research involves grafting hair stem cells in animal models to investigate if they can grow and proliferate as normal cells do. The progress of hair stem cell therapy is non-invasivelytracked with bioluminescentreporter genes in specialized substrates. There are several bioluminescent reporter genes originating fromnot only fireflies, but also beetles, glowworms and other bioluminescent organisms. The strategy of using bioluminescent reporter genesis ideal for stem cell research, because bioluminescence works only in living cells.

In this study, researchers used bioluminescence imaging usingfirefly luciferase coupled with D-luciferin to monitor the engraftment of hair follicle stem cellscalled newborn fibroblastsin mice to track their viability and development into hair folliclesover time. Bioluminescence imaging was performed five times over the course of 21 days after transplantation of the stem cells.

Results of the study showed successful bioluminescence imaging forhair regeneration with hair stem cell transplantation, and new hair follicles were apparent on the surface of skin samples under microscope. More studies will have to be conducted before clinical trials could be initiated to verify whether this therapy would work for human hair regeneration.

###

Scientific Paper 74: Jung Eun Kim, Byeong-Cheol Ahn, Ho Won Lee, Mi-hye Hwang, Sang-Woo Lee and Jaetae Lee, Nuclear Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea; Seng Hyun Shin and Young Kwan Sung, Immunology, Kyungpook National University School of Medicine, Daegu, Republic of Korea, "In vivo monitoring of survival and proliferation of hair stem cells in hair follicle regeneration animal model," SNM's 59th Annual Meeting, June 9, 2012, Miami Beach, Fla.

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Experimental Stem Cell Treatment Tested for Type 1 Diabetes

Tuesday, June 12th, 2012

In Early Study, Procedure Helps Teens Halt Insulin Injections

June 11, 2012 (Philadelphia) -- In an early study, an experimental stem cell procedure helped 15 teens with type 1 diabetes stay off of insulin injections for about 1.5 years, on average.

The study was very small, and the procedure is not ready for widespread use. "We now have a unique approach with some positive findings, but it's still early. We need to better understand the biology behind the treatment and follow patients for long-term side effects," Robert E. Ratner, MD, chief scientific and medical officer of the American Diabetes Association, tells WebMD.

This is the latest of several stem cell studies to show promising results for the treatment of type 1 diabetes, Ratner notes.

In the new study, 15 of 28 teens with type 1 diabetes who got an experimental treatment using their own stem cells went into remission and did not need insulin injections for an average of about 1.5 years.

The "cocktail treatment" combines stem cell therapy with drugs that suppress the body's immune system. In type 1 diabetes, the immune system attacks and destroys insulin-producing cells within the pancreas.

The experimental treatment is called autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT). It aims to kill the destructive immune system cells and replace them with immature stem cells not programmed to destroy insulin-producing cells.

First, patients are given drugs to stimulate production of blood stem cells. The blood stem cells are then removed from the body and frozen. Then, patients are hospitalized and given drugs to kill the destructive immune system cells. The harvested blood stem cells are then put back into the patient.

Eight teens who took part in the study have remained insulin-free for two years, on average. One patient has gone without insulin injections for 3.5 years.

"All our patients considered the [treatment] to be worthwhile and beneficial, though some patients experienced side effects," study head Weiqiong Gu, MD, of Ruijin Hospital in Shanghai, tells WebMD.

Read this article:
Experimental Stem Cell Treatment Tested for Type 1 Diabetes

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Business-friendly Changes Proposed for Revenue Sharing by Stem Cell Agency

Sunday, June 10th, 2012


The $3 billion California stem cell
agency, which hopes to generate income for the state through the sale
of stem cell therapies, is moving to make its profit-sharing rules
more friendly to business.

The proposed changes will come up Monday morning before the Intellectual Property and Industry Subcommittee of the
CIRM governing board.
No stem cell research funded by CIRM
has yet been commercialized. Its intellectual property regulations,
which determine payback criteria, were developed shortly after CIRM
was created in 2004. Ed Penhoet, one of the founders of
Chiron and now a venture capitalist, chaired the panel that worked
out the rules. He has since left the CIRM board.
A CIRM staff memo described the payment
rules in the case of a "blockbuster" therapy as "uneven"
and "lumpy." The memo said they "could be a
disincentive for the engagement of industry." Other rules were described as creating
"administrative challenges and uncertainty." The proposed changes, the memo said,
would address those issues and ensure a "comparable economic
return to California."
Here are links to the specific changes
-- see here and here.
Public sites where interested parties
can take part in the discussion are located in San Francisco, La
Jolla, Los Angeles and Irvine. Specific addresses can be found on themeeting agenda.
The proposed changes must go before the
full governing board and then into the state's administrative law
process before taking full effect.  

Source:
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Business Success Rate at Stem Cell Agency: Zero in Latest Round After 14 Fail

Sunday, June 10th, 2012


California biotech companies chalked up
a zero in the latest funding round by the state's $3 billion stem
cell agency, although 14 tried to run a gauntlet that industry has
complained about for years.

All $69 million in last month's
translational research round went to 21 academic and nonprofit insitutions. No business received an award. One firm, Eclipse
Therapeutics
of San Diego, appealed to the agency's governing board but was not successful despite having a higher scientific score
than at least two winners.
The miniscule amount of funding for
commercial enterprises – less than 4 percent of $1.4 billion handed
out so far – has been a matter of concern for some time for both
industry and some members of the CIRM governing board. Most
recently, industry executives complained at an April hearing of the
Institute of Medicine panel looking into CIRM's operations.
Even a 2010 review commissioned by CIRM said the agency needed to do
better by business.
The question of funding goes beyond a
simple matter of fairness or "good science," as CIRM
describes its funding goal. Without efforts by industry to turn
research into cures, CIRM will not be able to fulfill promises to
voters in 2004 when they approved creation of the stem cell agency.
CIRM last month approved a set of five-year goals that push more
aggressively for development of commercial products, but the goals
lacked such things as a financing round devoted solely to business
applicants.
In last month's translational round,
applicants went through a three-step process, which is conducted
primarily behind closed doors. First came what CIRM calls
pre-applications. Those were reviewed by CIRM staff with the help of
outside advisors if necessary. Applicants who cleared that hurdle were allowed to apply for the full, peer-reviewed round. During that
process, the CIRM Grants Working Group reviews applications,
makes decisions and sends them to the full CIRM board for
ratification and possible changes. The board almost never has
rejected a grant approved by reviewers. But the board has ultimate
authority and sometimes funds applications that reviewers have
rejected. The applicants' names are withheld from the board and the
public during the process, although some of the board discussion and
the final vote is conducted in public. CIRM does not release the
names of rejected applicants unless they appeal.
In the translational round, a total of 42
pre-applications out of 167 were approved by staff, according to
CIRM. Thirty-eight came from nonprofits and academics out of the 153
such institutions that applied. Four out of 14 business
pre-applications advanced to full applications but none made the
final cut. All of the winning applications were linked to
institutions that have representatives on the CIRM governing board.
Those representatives are not allowed to vote on or take part in
discussion involving applications to their institutions.
The primary decision tool used by the
grant review group is a scientific score. In last month's round,
scores of approved grants ranged from 88 to 53. However, eight grants
that were ranked above 53 were rejected by the board. One of those
higher-ranking applications came from San Diego's Eclipse
Therapeutics, which scored 58. The low-ranking grants were approved
for what CIRM describes as "programmatic" reasons.
More than three weeks ago, the
California Stem Cell Report asked CIRM for figures on the
numbers of applications in the translational round, including those
for business. CIRM said the figures had not been compiled and would
not be available until after the awards were made on May 24. The
numbers were finally supplied yesterday.
Our take: The number of applicants, and
their breakdown, is basic information that should be part of board's
decision-making process. The statistics should be routinely available
well in advance of the board's meeting. Indeed, the agency in its
earlier days used to routinely publish the figures. It may be now
that generating them is more time-consuming than necessary. The
recent performance evaluation of the agency said CIRM needs to make
major improvements in how it handles critical information needed for
its top management and board.
Whatever the reason, given CIRM's poor
track record with business, the agency's directors should diligently
track industry's success rate on applications. If proposals ranked as
low as 53 are approved while higher ranking applications from
business are bypassed, it warrants more than cursory examination.

Source:
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‘Ugly’ Stem Cell Headlines and a Stem Cell Essay Contest

Sunday, June 10th, 2012


California stem cell researcher Paul Knoepfler has been busy recently pumping out a plethora of items on his blog, including his own stem cell essay contest and a summary of "ugly" stem cell headlines.
He also rails, albeit briefly, against the Los Angeles Times "hate fest" against the California stem cell agency and offers some advice on developments involving prostate cancer, an affliction that he suffered from a few years ago.
Knoepfler, a UC Davis scientist, puts some cash on the line in his essay contest, with a prize of a $50 iTunes card plus publication of the winning piece. He is looking for a "convincing, non-fiction essay on stem cells thinking entirely outside the box." No more than 500 words. He has two categories, one for persons under 18 and one for persons over that age. June 30 is the deadline for submissions.
Knoepfler also wrote about Twitter and how it can be used by scientists in a useful item called "The scientist's top 10 guide to Twitter." We recommend it.

Source:
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Two California Stem Cell Agency Directors Plump for Proposition 29

Sunday, June 10th, 2012


Two directors of the $3 billion
California stem cell agency have popped up in the battle over the
anti-tobacco initiative on tomorrow's ballot in the Golden State.

They are Sherry Lansing and
Kristiina Vuori, who were the subjects of a column by Michael
Hiltzik
of the Los Angeles Times dealing with Proposition
29
, the "Son of CIRM" measure that would raise
$800 million for research by increasing the price of cigarettes by $1
a pack. In addition to serving on the CIRM board, Lansing heads her
own anti-cancer foundation and is chair of the board of the UC
regents. Vuori is head of the Sanford-Burnham Institute in La
Jolla.
Proposition 29 is patterned after the
measure that created the stem cell agency. The organization established by Proposition 29 would also be governed by a board that is run by
representatives of organizations almost certain to receive the bulk
of the funding, as is the case with CIRM.
In an op-ed piece on Friday, Lansing and
Vuori said the Times and Hiltzik had fallen for "a smokescreen"
put up by tobacco companies which are spending something in the
neighborhood of $40 million to defeat the initiative. Lansing and
Vuori said the measure is needed to stop smoking by young people as
well as providing cash for research for tobacco-related diseases.
Young people are more sensitive to price increases of cigarettes than
adults, according to research.
Lansing and Vuori referred to a column
in which Hiltzik opposed the measure because it would divert money
from more immediate state needs, including health and welfare
programs for children, education and the poor. (See here for thecolumn and here, here and here for related items.)
In his most recent column, Hiltzik
said,

"The...problem with Proposition 29
is its pigeonholing of the money for cancer research rather than for
immediate needs here in California that are absolutely dire. It’s
all well and good to say that cancer research benefits everyone, but
the real question is whether it should be the absolute top priority
for a state that can’t afford to keep its children fed or offer
them medical care in the here and now. 

"Lansing and Vuori say the fact
that Prop. 29 'fails to provide funding for schools, roads or
affordable housing' is irrelevant, because it was 'was never intended
to solve these problems.'

"In the context of the state’s
needs, this is a rather callous approach to take. Let’s spell out
why, so Lansing and Vuori won’t be so inclined to dismiss these
necessities of life so casually."

Hiltzik cited a list of state
government cuts that have meant the loss of health coverage for
400,000 California children, eliminated welfare benefits for 578,000
poor California families and would mean an end to state college
student aid for 72,000 young people from less affluent families.
Hiltzik continued,

"That’s just the beginning of
what might be cut because the state needs money—and won’t be able
to lay its hands on the hundreds of millions of dollars that Lansing,
Vuori, and their research colleagues are angling for. They don’t
want voters to be reminded that there are competing demands for the
tobacco money, and they do so by failing to mention that they exist,
and also by presenting the spending on cancer research as the voters’
only choice. 

"It’s the only choice because
the promoters of Proposition 29 designed it that way. Advocates of
programs like this love to pass them in via voter initiatives because
they leave no room to measure them against alternative needs."

 A final note: The New York Times
carried a piece yesterday on Proposition 29 that drew 481 comments.
The article said, 

"Organizers argued that the tax would have
less chance of passing if voters thought it would go into the state
coffers, and said that their only goal here was cutting down on
smoking."

 Also yesterday, Willie Brown, the former mayor
of San Francisco and a keen observer of California politics,
predicted voter approval of the measure along with an increase in
cigarette smuggling from adjacent states and the sale of discount
smokes at the 58 Indian casino sites in the state. 

Source:
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Stem Cell Miracles and Campaign Promises : Thomas-Trounson vs. Hiltzik of the Times

Sunday, June 10th, 2012


The Proposition 71 campaign of 2004,
which has filled the coffers of more than 500 researchers and
institutions with $1.4 billion, was the subject today of a discussion
about miracles.

Specifically did the campaign promise
miracles?
The story begins with a column May 27
by Michael Hiltzik of the Los Angeles Times about the
"Son of CIRM" initiative, Proposition 29, on the June ballot. It
seeks to fund more medical research with $800 million handed out by
an organization patterned after the stem cell agency.
In the column, Hiltzik did not speak
well of the agency and said the 2004 campaign promised miracles.
In a letter today in the Times, J.T,
Thomas
, chairman of CIRM, and Alan Trounson, president of
CIRM, said the campaign did not promise "miraculous cures."
Hiltzik filed a riposte this afternoon
on his blog, quoting from TV campaign ads featuring Christopher
Reeve
and Michael J. Fox. Hiltzik also wrote,

"Joan Samuelson, a leading
Parkinson's patient advocate, is shown in another ad asserting,
'There are more Americans than I think we can count who are sick
now, or are going to be sick in the future, whose lives will be saved
by Prop. 71.' Shortly after the measure passed, Samuelson was
appointed to the stem cell program's board. 

"Do these ads amount to promising
'miracles'? Given that the essence of scientific research is that no
one can predict the outcome, to assert as fact that 'lives will
be saved by Prop. 71' is plainly to promise something downright
extraordinary, if not outright miraculous. 

"Yes, this is the language of
advertising, not research, but for Trounson and Thomas to pretend
that the ad campaign somehow promised merely 'good science' and not
specific outcomes, as their letter suggested, is (at least)
miraculously disingenuous."

Source:
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California Stem Cell Agency Fires Back at LA Times Columnist

Sunday, June 10th, 2012


The top two leaders of the California
stem cell agency today took strong issue with a column in the Los
Angeles Times
that spoke less than favorably about the history and
efforts of the state research enterprise.

Pulitzer Prize-winning writer Michael
Hiltzik
mentioned California's $3 billion stem cell effort in a piece
May 27 about Proposition 29 on the June ballot. The "Son of CIRM" initiative,
tailored after the ballot measure that created the stem cell agency
in 2004, would provide $800 million annually for research into
tobacco-related illnesses. The money would be derived from a $1
dollar-a-pack tax on cigarettes.
Among other things, Hiltzik said,

"Proposition 71(the stem cell
initiative), you may recall, was sold to a gullible public via
candy-coated images of Christopher Reeve walking again
and Michael J. Fox cured of Parkinson's. The
implication was that these miracles would happen if voters approved a
$3-billion bond issue for stem cell research."

The reponse from J.T. Thomas, chairman
of the CIRM board and a Los Angeles bond financier, and CIRM
President Alan Trounson came in the form of a letter to the editor.
The letter was only four paragraphs long and may have been cut prior
to publication, which is common practice for letters to the editor.
We have asked CIRM about whether there is more to the letter. (Following publication of this item, CIRM spokesman Kevin McCormack said the complete text was published by the Times, which has a 150-word limit on letters. The CIRM letter was 148.)
Here is the full text as published.

"In his article opposing
Proposition 29, Michael Hiltzik makes a number of misleading
statements about Proposition 71, the voter-approved measure funding
stem-cell research. 

"No ads for Proposition 71
promised miraculous cures. They promised good science, and that is
what is being funded, with more than 62 promising therapies for 40
different diseases on their way to clinical trials. 

"The stem-cell agency has
conflict-of-interest rules as strict as any government agency. We
undergo state-mandated audits to ensure we follow all rules and
regulations, and the most recent one, completed just this month,
praised the agency for its performance. 

"As for being 'an unwieldy
bureaucrac just 6% of the money we get goes to pay for staff; 94%
goes to fund research here in California, creating new jobs,
generating income for the state and, most important, helping find
treatments for deadly diseases."  

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

Sunday, June 10th, 2012


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.

Source:
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California Stem Cell Hoopdedoo Over Rick Perry: Strange Bedfellows and Education of Politicians

Sunday, June 10th, 2012


A onetime aspirant to become the leader
of the free world was in California recently touring the lab of a
stem cell researcher in La Jolla.
The visit was somewhat unusual. The
visitor was Rick Perry, the governor of Texas who campaigned
unsuccessfully for the Republican nomination for president and who is
a strong opponent of hESC research. The lab is run by Scripps' Jeanne
Loring,
who engages in hESC research among other things.
The event – if you can call it that –
also led to a video on YouTube of Perry at the lab, three blog
items by UC Davis stem cell researcher Paul Knoepfler and
responses from Loring and Michael Thorsnes,  who put up
the video and who has what he modestly describes as
"significant political experience" in the Democratic party.
Thorsnes, a retired San Diego lawyer and now a photographer, raised about $5.4 million for John Kerry's and Al Gore's
presidential efforts as well as other Democrats.
Issues raised in all the hoopdedoo include
consorting with the enemy, openness, exploitation of scientists for
political gain, public education and education of political leaders,
promotion of patient causes, rushing to judgment and even strange
bedfellows.
As far as we can tell, Perry's visit
received no attention in mainstream media, but Thorsnes, a key figure
in arranging the visit, put up a video of it on the Internet.
Knoepfler, who is the rare stem cell scientist with a blog, saw the
video and on May 21 raised what he now calls "a big stink"
in a blog posting. Subsequently Knoepfler toned down the language in
that item because of what he says was its "overly extreme
verbiage."
For several years now, Knoepfler has
been writing a fine blog that deals mostly with stem cell science but
also public policy, biotech business and more. Unfortunately,
however, his original item is no longer available, but our
recollection is that Knoepler's item was strong, indicating that
Loring should not have allowed the visit because it would bolster the
political fortunes of an enemy of science or at least hESC science.
Knoepfler cited what he called the campaign-style video as evidence
of exploitation. 
On May 24, after a related May 22 item dealing with Rick Perry, Knoepfler said he rewrote the original item to temper his comments as a result of learning more
about what led up to the visit.   That included more information from Thorsnes, who is chair of the executive advisory board of the
Parkinson’s Disease Association of San Diego. 
Loring was quoted in original item as
saying, 

"I think that scientists have an obligation to educate the
public. I welcome visits from both stem cell proponents and
opponents, so I have a chance to clarify any misconceptions about
what it is that we really do. We have to figure out how to deal with
our opponents as well as our friends. I have a policy of welcoming
opponents so I can teach them. It works. Education wins minds."

The California Stem Cell Report
queried Loring about any additional comments she had on the subject.
She replied,

"Governor Rick Perry left my lab
understanding far more about induced pluripotent stem cells than he
did when he arrived. If we don't engage those who don't share our
views, who will tell them the truth? How will they know that we are
ethical and working to improving human health? 

"The visit was arranged by Michael
Thorsnes, a well-known Democratic fundraiser. He is a very
impressive person who knows politicians of every stripe, and he
arranged the meeting with Perry so that I could explain our project
to make iPSCs from people with Parkinson's disease, and our work
using iPSC derivatives in multiple sclerosis. Perry is promoting
'adult' stem cell therapy in Texas, and I wanted to be sure that he
understood the difference between 'adult' stem cells and pluripotent
stem cells. He does. Educating those in positions of power is one
of our responsibilities, and I take it very seriously."

Our take: Perry is first and foremost a
politician with large ambitions. It is more than legitimate to think
about how such a visit might be used or misused. Nonetheless,
foregoing the opportunity to educate political leaders, who control
research spending in this country, means isolation of the scientific
community and less understanding on the part of lawmakers. As far as
Perry's possible political gain is concerned, it is conceivable that
the visit could backfire on Perry should a political opponent
characterize the Loring lab tour as some sort of endorsement by him
of hESC research.
Everybody's particular interests were
at work in this episode: Thorsnes' desire for support for his cause,
Perry's political schmoozing and his own special interest in stem
cells – pro adult and con hESC, and Loring's desire to promote
scientific research in general and to educate a major political
figure.
As for the video, Knoepfler now says he
would allow a lab visit by Perry but no video. But in this digital
age, that condition could kill a likely visit. If researchers want to
talk to politicians – and they should -- risks are always involved,
but that is the price of relying on public funding and building
public enthusiasm for continued support.
One final note: Earlier in this item,
we said it was unfortunate that the original Knoepfler post is not
available. Without being able to read the original, it is difficult
to completely understand the subsequent string of events. On the
California Stem Cell Report, when corrections or other changes are
made, we always retain something to show what the original item said
and note where changes are made and why. It keeps the record straight
and provides a necessary paper trail. All in all, however, from
Perry's visit to today, it has been a robust and healthy exchange for
the stem cell community and beyond.

Source:
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CIRM Board Member Prieto Endorses Proposition 29

Sunday, June 10th, 2012


One of the members of the governing
board of the California stem cell agency, Francisco Prieto, has
commented on the item yesterday dealing with California's Proposition 29, which
would create a CIRM-like agency to fund research into tobacco-related
illness.
Prieto, who is a Sacramento physician
and president of the Sacramento Sierra Chapter of the American
Diabetes Association
, said in an email,

"I'm with George Skelton(Los
Angeles Times
columnist). Whatever you think about ballot box
budgeting, you could take every penny raised by this and bury it in
the ground - it would still: Reduce smoking (mostly by preventing
some kids, the most price-sensitive group of smokers from starting) .
Save lives. Hurt the lying tobacco companies. All very good things."

CIRM has not taken a position on the measure.

Source:
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Business-friendly Changes Proposed for Revenue Sharing by Stem Cell Agency

Sunday, June 10th, 2012


The $3 billion California stem cell
agency, which hopes to generate income for the state through the sale
of stem cell therapies, is moving to make its profit-sharing rules
more friendly to business.

The proposed changes will come up Monday morning before the Intellectual Property and Industry Subcommittee of the
CIRM governing board.
No stem cell research funded by CIRM
has yet been commercialized. Its intellectual property regulations,
which determine payback criteria, were developed shortly after CIRM
was created in 2004. Ed Penhoet, one of the founders of
Chiron and now a venture capitalist, chaired the panel that worked
out the rules. He has since left the CIRM board.
A CIRM staff memo described the payment
rules in the case of a "blockbuster" therapy as "uneven"
and "lumpy." The memo said they "could be a
disincentive for the engagement of industry." Other rules were described as creating
"administrative challenges and uncertainty." The proposed changes, the memo said,
would address those issues and ensure a "comparable economic
return to California."
Here are links to the specific changes
-- see here and here.
Public sites where interested parties
can take part in the discussion are located in San Francisco, La
Jolla, Los Angeles and Irvine. Specific addresses can be found on themeeting agenda.
The proposed changes must go before the
full governing board and then into the state's administrative law
process before taking full effect.  

Source:
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‘Ugly’ Stem Cell Headlines and a Stem Cell Essay Contest

Sunday, June 10th, 2012


California stem cell researcher Paul Knoepfler has been busy recently pumping out a plethora of items on his blog, including his own stem cell essay contest and a summary of "ugly" stem cell headlines.
He also rails, albeit briefly, against the Los Angeles Times "hate fest" against the California stem cell agency and offers some advice on developments involving prostate cancer, an affliction that he suffered from a few years ago.
Knoepfler, a UC Davis scientist, puts some cash on the line in his essay contest, with a prize of a $50 iTunes card plus publication of the winning piece. He is looking for a "convincing, non-fiction essay on stem cells thinking entirely outside the box." No more than 500 words. He has two categories, one for persons under 18 and one for persons over that age. June 30 is the deadline for submissions.
Knoepfler also wrote about Twitter and how it can be used by scientists in a useful item called "The scientist's top 10 guide to Twitter." We recommend it.

Source:
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Business Success Rate at Stem Cell Agency: Zero in Latest Round After 14 Fail

Sunday, June 10th, 2012


California biotech companies chalked up
a zero in the latest funding round by the state's $3 billion stem
cell agency, although 14 tried to run a gauntlet that industry has
complained about for years.

All $69 million in last month's
translational research round went to 21 academic and nonprofit insitutions. No business received an award. One firm, Eclipse
Therapeutics
of San Diego, appealed to the agency's governing board but was not successful despite having a higher scientific score
than at least two winners.
The miniscule amount of funding for
commercial enterprises – less than 4 percent of $1.4 billion handed
out so far – has been a matter of concern for some time for both
industry and some members of the CIRM governing board. Most
recently, industry executives complained at an April hearing of the
Institute of Medicine panel looking into CIRM's operations.
Even a 2010 review commissioned by CIRM said the agency needed to do
better by business.
The question of funding goes beyond a
simple matter of fairness or "good science," as CIRM
describes its funding goal. Without efforts by industry to turn
research into cures, CIRM will not be able to fulfill promises to
voters in 2004 when they approved creation of the stem cell agency.
CIRM last month approved a set of five-year goals that push more
aggressively for development of commercial products, but the goals
lacked such things as a financing round devoted solely to business
applicants.
In last month's translational round,
applicants went through a three-step process, which is conducted
primarily behind closed doors. First came what CIRM calls
pre-applications. Those were reviewed by CIRM staff with the help of
outside advisors if necessary. Applicants who cleared that hurdle were allowed to apply for the full, peer-reviewed round. During that
process, the CIRM Grants Working Group reviews applications,
makes decisions and sends them to the full CIRM board for
ratification and possible changes. The board almost never has
rejected a grant approved by reviewers. But the board has ultimate
authority and sometimes funds applications that reviewers have
rejected. The applicants' names are withheld from the board and the
public during the process, although some of the board discussion and
the final vote is conducted in public. CIRM does not release the
names of rejected applicants unless they appeal.
In the translational round, a total of 42
pre-applications out of 167 were approved by staff, according to
CIRM. Thirty-eight came from nonprofits and academics out of the 153
such institutions that applied. Four out of 14 business
pre-applications advanced to full applications but none made the
final cut. All of the winning applications were linked to
institutions that have representatives on the CIRM governing board.
Those representatives are not allowed to vote on or take part in
discussion involving applications to their institutions.
The primary decision tool used by the
grant review group is a scientific score. In last month's round,
scores of approved grants ranged from 88 to 53. However, eight grants
that were ranked above 53 were rejected by the board. One of those
higher-ranking applications came from San Diego's Eclipse
Therapeutics, which scored 58. The low-ranking grants were approved
for what CIRM describes as "programmatic" reasons.
More than three weeks ago, the
California Stem Cell Report asked CIRM for figures on the
numbers of applications in the translational round, including those
for business. CIRM said the figures had not been compiled and would
not be available until after the awards were made on May 24. The
numbers were finally supplied yesterday.
Our take: The number of applicants, and
their breakdown, is basic information that should be part of board's
decision-making process. The statistics should be routinely available
well in advance of the board's meeting. Indeed, the agency in its
earlier days used to routinely publish the figures. It may be now
that generating them is more time-consuming than necessary. The
recent performance evaluation of the agency said CIRM needs to make
major improvements in how it handles critical information needed for
its top management and board.
Whatever the reason, given CIRM's poor
track record with business, the agency's directors should diligently
track industry's success rate on applications. If proposals ranked as
low as 53 are approved while higher ranking applications from
business are bypassed, it warrants more than cursory examination.

Source:
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Two California Stem Cell Agency Directors Plump for Proposition 29

Sunday, June 10th, 2012


Two directors of the $3 billion
California stem cell agency have popped up in the battle over the
anti-tobacco initiative on tomorrow's ballot in the Golden State.

They are Sherry Lansing and
Kristiina Vuori, who were the subjects of a column by Michael
Hiltzik
of the Los Angeles Times dealing with Proposition
29
, the "Son of CIRM" measure that would raise
$800 million for research by increasing the price of cigarettes by $1
a pack. In addition to serving on the CIRM board, Lansing heads her
own anti-cancer foundation and is chair of the board of the UC
regents. Vuori is head of the Sanford-Burnham Institute in La
Jolla.
Proposition 29 is patterned after the
measure that created the stem cell agency. The organization established by Proposition 29 would also be governed by a board that is run by
representatives of organizations almost certain to receive the bulk
of the funding, as is the case with CIRM.
In an op-ed piece on Friday, Lansing and
Vuori said the Times and Hiltzik had fallen for "a smokescreen"
put up by tobacco companies which are spending something in the
neighborhood of $40 million to defeat the initiative. Lansing and
Vuori said the measure is needed to stop smoking by young people as
well as providing cash for research for tobacco-related diseases.
Young people are more sensitive to price increases of cigarettes than
adults, according to research.
Lansing and Vuori referred to a column
in which Hiltzik opposed the measure because it would divert money
from more immediate state needs, including health and welfare
programs for children, education and the poor. (See here for thecolumn and here, here and here for related items.)
In his most recent column, Hiltzik
said,

"The...problem with Proposition 29
is its pigeonholing of the money for cancer research rather than for
immediate needs here in California that are absolutely dire. It’s
all well and good to say that cancer research benefits everyone, but
the real question is whether it should be the absolute top priority
for a state that can’t afford to keep its children fed or offer
them medical care in the here and now. 

"Lansing and Vuori say the fact
that Prop. 29 'fails to provide funding for schools, roads or
affordable housing' is irrelevant, because it was 'was never intended
to solve these problems.'

"In the context of the state’s
needs, this is a rather callous approach to take. Let’s spell out
why, so Lansing and Vuori won’t be so inclined to dismiss these
necessities of life so casually."

Hiltzik cited a list of state
government cuts that have meant the loss of health coverage for
400,000 California children, eliminated welfare benefits for 578,000
poor California families and would mean an end to state college
student aid for 72,000 young people from less affluent families.
Hiltzik continued,

"That’s just the beginning of
what might be cut because the state needs money—and won’t be able
to lay its hands on the hundreds of millions of dollars that Lansing,
Vuori, and their research colleagues are angling for. They don’t
want voters to be reminded that there are competing demands for the
tobacco money, and they do so by failing to mention that they exist,
and also by presenting the spending on cancer research as the voters’
only choice. 

"It’s the only choice because
the promoters of Proposition 29 designed it that way. Advocates of
programs like this love to pass them in via voter initiatives because
they leave no room to measure them against alternative needs."

 A final note: The New York Times
carried a piece yesterday on Proposition 29 that drew 481 comments.
The article said, 

"Organizers argued that the tax would have
less chance of passing if voters thought it would go into the state
coffers, and said that their only goal here was cutting down on
smoking."

 Also yesterday, Willie Brown, the former mayor
of San Francisco and a keen observer of California politics,
predicted voter approval of the measure along with an increase in
cigarette smuggling from adjacent states and the sale of discount
smokes at the 58 Indian casino sites in the state. 

Source:
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Stem Cell Miracles and Campaign Promises : Thomas-Trounson vs. Hiltzik of the Times

Sunday, June 10th, 2012


The Proposition 71 campaign of 2004,
which has filled the coffers of more than 500 researchers and
institutions with $1.4 billion, was the subject today of a discussion
about miracles.

Specifically did the campaign promise
miracles?
The story begins with a column May 27
by Michael Hiltzik of the Los Angeles Times about the
"Son of CIRM" initiative, Proposition 29, on the June ballot. It
seeks to fund more medical research with $800 million handed out by
an organization patterned after the stem cell agency.
In the column, Hiltzik did not speak
well of the agency and said the 2004 campaign promised miracles.
In a letter today in the Times, J.T,
Thomas
, chairman of CIRM, and Alan Trounson, president of
CIRM, said the campaign did not promise "miraculous cures."
Hiltzik filed a riposte this afternoon
on his blog, quoting from TV campaign ads featuring Christopher
Reeve
and Michael J. Fox. Hiltzik also wrote,

"Joan Samuelson, a leading
Parkinson's patient advocate, is shown in another ad asserting,
'There are more Americans than I think we can count who are sick
now, or are going to be sick in the future, whose lives will be saved
by Prop. 71.' Shortly after the measure passed, Samuelson was
appointed to the stem cell program's board. 

"Do these ads amount to promising
'miracles'? Given that the essence of scientific research is that no
one can predict the outcome, to assert as fact that 'lives will
be saved by Prop. 71' is plainly to promise something downright
extraordinary, if not outright miraculous. 

"Yes, this is the language of
advertising, not research, but for Trounson and Thomas to pretend
that the ad campaign somehow promised merely 'good science' and not
specific outcomes, as their letter suggested, is (at least)
miraculously disingenuous."

Source:
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California Stem Cell Agency Fires Back at LA Times Columnist

Sunday, June 10th, 2012


The top two leaders of the California
stem cell agency today took strong issue with a column in the Los
Angeles Times
that spoke less than favorably about the history and
efforts of the state research enterprise.

Pulitzer Prize-winning writer Michael
Hiltzik
mentioned California's $3 billion stem cell effort in a piece
May 27 about Proposition 29 on the June ballot. The "Son of CIRM" initiative,
tailored after the ballot measure that created the stem cell agency
in 2004, would provide $800 million annually for research into
tobacco-related illnesses. The money would be derived from a $1
dollar-a-pack tax on cigarettes.
Among other things, Hiltzik said,

"Proposition 71(the stem cell
initiative), you may recall, was sold to a gullible public via
candy-coated images of Christopher Reeve walking again
and Michael J. Fox cured of Parkinson's. The
implication was that these miracles would happen if voters approved a
$3-billion bond issue for stem cell research."

The reponse from J.T. Thomas, chairman
of the CIRM board and a Los Angeles bond financier, and CIRM
President Alan Trounson came in the form of a letter to the editor.
The letter was only four paragraphs long and may have been cut prior
to publication, which is common practice for letters to the editor.
We have asked CIRM about whether there is more to the letter. (Following publication of this item, CIRM spokesman Kevin McCormack said the complete text was published by the Times, which has a 150-word limit on letters. The CIRM letter was 148.)
Here is the full text as published.

"In his article opposing
Proposition 29, Michael Hiltzik makes a number of misleading
statements about Proposition 71, the voter-approved measure funding
stem-cell research. 

"No ads for Proposition 71
promised miraculous cures. They promised good science, and that is
what is being funded, with more than 62 promising therapies for 40
different diseases on their way to clinical trials. 

"The stem-cell agency has
conflict-of-interest rules as strict as any government agency. We
undergo state-mandated audits to ensure we follow all rules and
regulations, and the most recent one, completed just this month,
praised the agency for its performance. 

"As for being 'an unwieldy
bureaucrac just 6% of the money we get goes to pay for staff; 94%
goes to fund research here in California, creating new jobs,
generating income for the state and, most important, helping find
treatments for deadly diseases."  

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

Sunday, June 10th, 2012


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.

Source:
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California Stem Cell Hoopdedoo Over Rick Perry: Strange Bedfellows and Education of Politicians

Sunday, June 10th, 2012


A onetime aspirant to become the leader
of the free world was in California recently touring the lab of a
stem cell researcher in La Jolla.
The visit was somewhat unusual. The
visitor was Rick Perry, the governor of Texas who campaigned
unsuccessfully for the Republican nomination for president and who is
a strong opponent of hESC research. The lab is run by Scripps' Jeanne
Loring,
who engages in hESC research among other things.
The event – if you can call it that –
also led to a video on YouTube of Perry at the lab, three blog
items by UC Davis stem cell researcher Paul Knoepfler and
responses from Loring and Michael Thorsnes,  who put up
the video and who has what he modestly describes as
"significant political experience" in the Democratic party.
Thorsnes, a retired San Diego lawyer and now a photographer, raised about $5.4 million for John Kerry's and Al Gore's
presidential efforts as well as other Democrats.
Issues raised in all the hoopdedoo include
consorting with the enemy, openness, exploitation of scientists for
political gain, public education and education of political leaders,
promotion of patient causes, rushing to judgment and even strange
bedfellows.
As far as we can tell, Perry's visit
received no attention in mainstream media, but Thorsnes, a key figure
in arranging the visit, put up a video of it on the Internet.
Knoepfler, who is the rare stem cell scientist with a blog, saw the
video and on May 21 raised what he now calls "a big stink"
in a blog posting. Subsequently Knoepfler toned down the language in
that item because of what he says was its "overly extreme
verbiage."
For several years now, Knoepfler has
been writing a fine blog that deals mostly with stem cell science but
also public policy, biotech business and more. Unfortunately,
however, his original item is no longer available, but our
recollection is that Knoepler's item was strong, indicating that
Loring should not have allowed the visit because it would bolster the
political fortunes of an enemy of science or at least hESC science.
Knoepfler cited what he called the campaign-style video as evidence
of exploitation. 
On May 24, after a related May 22 item dealing with Rick Perry, Knoepfler said he rewrote the original item to temper his comments as a result of learning more
about what led up to the visit.   That included more information from Thorsnes, who is chair of the executive advisory board of the
Parkinson’s Disease Association of San Diego. 
Loring was quoted in original item as
saying, 

"I think that scientists have an obligation to educate the
public. I welcome visits from both stem cell proponents and
opponents, so I have a chance to clarify any misconceptions about
what it is that we really do. We have to figure out how to deal with
our opponents as well as our friends. I have a policy of welcoming
opponents so I can teach them. It works. Education wins minds."

The California Stem Cell Report
queried Loring about any additional comments she had on the subject.
She replied,

"Governor Rick Perry left my lab
understanding far more about induced pluripotent stem cells than he
did when he arrived. If we don't engage those who don't share our
views, who will tell them the truth? How will they know that we are
ethical and working to improving human health? 

"The visit was arranged by Michael
Thorsnes, a well-known Democratic fundraiser. He is a very
impressive person who knows politicians of every stripe, and he
arranged the meeting with Perry so that I could explain our project
to make iPSCs from people with Parkinson's disease, and our work
using iPSC derivatives in multiple sclerosis. Perry is promoting
'adult' stem cell therapy in Texas, and I wanted to be sure that he
understood the difference between 'adult' stem cells and pluripotent
stem cells. He does. Educating those in positions of power is one
of our responsibilities, and I take it very seriously."

Our take: Perry is first and foremost a
politician with large ambitions. It is more than legitimate to think
about how such a visit might be used or misused. Nonetheless,
foregoing the opportunity to educate political leaders, who control
research spending in this country, means isolation of the scientific
community and less understanding on the part of lawmakers. As far as
Perry's possible political gain is concerned, it is conceivable that
the visit could backfire on Perry should a political opponent
characterize the Loring lab tour as some sort of endorsement by him
of hESC research.
Everybody's particular interests were
at work in this episode: Thorsnes' desire for support for his cause,
Perry's political schmoozing and his own special interest in stem
cells – pro adult and con hESC, and Loring's desire to promote
scientific research in general and to educate a major political
figure.
As for the video, Knoepfler now says he
would allow a lab visit by Perry but no video. But in this digital
age, that condition could kill a likely visit. If researchers want to
talk to politicians – and they should -- risks are always involved,
but that is the price of relying on public funding and building
public enthusiasm for continued support.
One final note: Earlier in this item,
we said it was unfortunate that the original Knoepfler post is not
available. Without being able to read the original, it is difficult
to completely understand the subsequent string of events. On the
California Stem Cell Report, when corrections or other changes are
made, we always retain something to show what the original item said
and note where changes are made and why. It keeps the record straight
and provides a necessary paper trail. All in all, however, from
Perry's visit to today, it has been a robust and healthy exchange for
the stem cell community and beyond.

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