United States Congressional Briefing on Caring for Military Children with Autism – Video

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02-02-2012 14:53 On January 31, 2012, military families got their say before Congress about the injustice of losing autism benefits for their children when they retire, even when due to being wounded in action. More than 100 members of the military and their supporters jammed into a Capitol Hill briefing today to talk about the special difficulties military families face caring for children with autism. The briefing was hosted by Sen. Kirsten Gillibrand of New York and Congressman John Larson of Connecticut

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United States Congressional Briefing on Caring for Military Children with Autism - Video

euronews learning world – Coping with autism – Video

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27-01-2012 19:44 http://www.euronews.net Living with autism can be difficult, and helping children live with it can be overwhelming for parents. Education can play a key role. In this edition of Learning World we explore projects in China and Canada, and talk to Théo Peters, a neuro-linguist from Belgium. *Deserving recognition, China* In China, millions of children have Autism Spectrum Disorders, but because the condition is not widely recognised in the country, many of them do not get any help. However there is work going on to raise parental awareness about their children's behaviour.

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euronews learning world - Coping with autism - Video

Modified Definition of Autism Too Consequential to Rush Into Print: View

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Editorials

Illustration by Bloomberg View

By the Editors Mon Feb 06 00:00:00 GMT 2012

When is a person just a little different, and when is his peculiarity a symptom of a disabling disorder?

An expert panel has taken a new crack at that question, proposing a redefinition of autism and related conditions for the manual used by U.S. mental health professionals. The plan has aroused fears that it may strip many people of a diagnosis and thus the insurance and government benefits that can go with it.

So far, it’s not certain whether this would be the result. But until the consequences are known, it’s premature for the American Psychiatric Association to change the autism diagnosis in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders.

The stakes are high. About 1 percent of American children are affected by autism and related disorders, according to the Centers for Disease Control. This represents a dramatic increase, which has been attributed to changes made to the diagnostic manual in 1994. That version, the DSM-IV, carved out a separate diagnosis for Asperger’s disorder, typified by social awkwardness and an all-absorbing interest in specific topics.

For the DSM-5 (the manual will use Arabic numerals from now on), the APA’s autism working group has proposed combining classic autism, Asperger’s and two related conditions into autism spectrum disorder and has tightened the requirements for arriving at the new diagnosis. For example, to diagnose an Asperger’s case under the proposed changes, a clinician would have to identify impairment in five of seven categories rather than only three in eight, as under DSM-IV.

The autism working group is confident that its language would not disqualify those who are truly autistic. It cites still-unpublished research indicating that the DSM-IV criteria, if literally applied, lead to diagnoses that two clinicians cannot agree are warranted.

Panelists cite additional analysis showing that those whose diagnoses are confirmed by two clinicians also meet the criteria of the proposed DSM-5 rules.

Unfortunately, the APA doesn’t plan to publish this research until the DSM-5 rules are final. That’s backward. Far too many people are potentially affected by the planned changes for the working group to say, in essence, “Trust us on the evidence.”

Psychiatrists know there is a relatively simple way to clear all this up. In addition to releasing the research, the APA could order a modest new study that uses a stronger means of determining who is truly autistic than clinician judgment, a method so weak the APA gives it no validity. The study would screen children with autism characteristics using both DSM-IV and the proposed DSM-5 criteria. To check the validity of the diagnoses, researchers could rely on family history, a strong validator because the disorder runs in families.

If a portion of children lose the diagnosis in the switch to DSM-5, it should be relatively easy to tell how many of them were falsely diagnosed under DSM-IV. They would be the ones without a family history of autism. If significant numbers had such a history, however, it would suggest that the proposed new standards would deprive children who genuinely have autism disorder of the care they need. Then the APA would have an opportunity to change the rules before they did any harm.

It’s conceivable that such a study could be done in time for a full airing of the issues so that the APA could still make its Dec. 31 deadline for the DSM-5. If not, the organization should resist pushing through, without sufficient evidence, a change that would mean the end of insurance, education and social support for children who need it. Although this might save some tax dollars in the short term, it would cost society more in the long run, because without support these children would be less likely to succeed as independently functioning adults.

The reason the APA dropped the Roman numerals this time around was to allow for interim revisions of its manual. The matter of autism disorder could be a perfect subject for DSM 5.1.

Read more opinion online from Bloomberg View.

To contact the Bloomberg View editorial board: view@bloomberg.net.

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Modified Definition of Autism Too Consequential to Rush Into Print: View

Redefining Autism: Will New DSM-5 Criteria for ASD Exclude Some People?

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News | Mind & Brain

Experts call for small and easy changes to the Diagnostic and Statistical Manual, the "bible" of psychiatry, so that everyone with autism spectrum disorder qualifies for a diagnosis

By Ferris Jabr  | January 30, 2012 |

DIAGNOSING THE DSM: The DSM-5 should sharpen the definition of autism, if the American Psychiatric Association makes a few tweaks in time Image: UrsaHoogle, iStockphoto

People have been arguing about autism for a long time—about what causes it, how to treat it and whether it qualifies as a mental disorder. The controversial idea that childhood vaccines trigger autism also persists, despite the fact that study after study has failed to find any evidence of such a link. Now, psychiatrists and members of the autistic community are embroiled in a more legitimate kerfuffle that centers on the definition of autism and how clinicians diagnose the disorder. The debate is not pointless semantics. In many cases, the type and number of symptoms clinicians look for when diagnosing autism determines how easy or difficult it is for autistic people to access medical, social and educational services.

The controversy remains front and center because the American Psychiatric Association (APA) has almost finished redefining autism, along with all other mental disorders, in an overhaul of a hefty tome dubbed the Diagnostic and Statistical Manual of Mental Disorders (DSM)—the essential reference guide that clinicians use when evaluating their patients. The newest edition of the manual, the DSM-5, is slated for publication in May 2013. Psychiatrists and parents have voiced concerns that the new definition of autism in the DSM-5 will exclude many people from both a diagnosis and state services that depend on a diagnosis.

The devilish confusion is in the details. When the APA publishes the DSM-5, people who have already met the criteria for autism in the current DSM-IV will not suddenly lose their current diagnosis as some parents have feared, nor will they lose state services. But several studies recently published in child psychiatry journals suggest that it will be more difficult for new generations of high-functioning autistic people to receive a diagnosis because the DSM-5 criteria are too strict. Together, the studies conclude that the major changes to the definition of autism in the DSM-5 are well grounded in research and that the new criteria are more accurate than the current DSM-IV criteria. But in its efforts to make diagnosis more accurate, the APA may have raised the bar for autism a little too high, neglecting autistic people whose symptoms are not as severe as others. The studies also point out, however, that minor tweaks to the DSM-5 criteria would make a big difference, bringing autistic people with milder symptoms or sets of symptoms that differ from classic autism back into the spectrum

A new chapter
Autism is a disorder in which a child's brain does not develop typically, and neurons form connections in unusual ways. The major features of autism are impaired social interaction and communication—such as delayed language development, avoiding eye-contact and difficulty making friends—as well as restricted and repetitive behavior, such as repeatedly making the same sound or intense fascination with a particular toy.

The DSM-5 subsumes autistic disorder, Asperger's disorder, childhood disintegrative disorder, and pervasive developmental disorder not otherwise specified (PDD-NOS)—which are all distinct disorders in DSM-IV—into one category called autism spectrum disorder (ASD). The idea is that these conditions have such similar symptoms that they do not belong in separate categories, but instead fall on the same continuum.

Essentially, to qualify for a diagnosis of autistic disorder in DSM-IV, a patient must show at least six of 12 symptoms, which are divided into three groups: deficits in social interaction; deficits in communication; and repetitive and restricted behaviors and interests. In contrast, the DSM-5 divides seven symptoms of ASD into two main groups: deficits in social communication and social interaction; and restricted, repetitive behaviors and interests. (For a closer look at the changes, read the companion piece: "Autism Is Not a Math Problem". You can also compare DSM-IV and DSM-5 criteria for autism on the APA's Web site.)

The APA collapsed the social interaction and communication groups from DSM-IV into one group in the new edition because research in the last decade has shown that the symptoms in these groups almost always appear together. Research and clinical experience has also established that heightened or dulled sensitivity to sensory experiences is a core feature of autism, which is why it appears in DSM-5 but not in the preceding version. The psychiatric community has generally applauded these changes to the criteria for ASD.

What is in question is how many of the DSM-5 criteria a patient must meet to receive a diagnosis—too many and the manual excludes autistic people with fewer or milder symptoms; too few and it assigns autism to people who don't have it. Since the 1980s the prevalence of autism has dramatically increased worldwide, especially in the U.S. where the Centers for Disease Control and Prevention estimates that nine per 1,000 children have been diagnosed with ASD. Many psychiatrists agree that the increase is at least partially explained by loose criteria in DSM-IV.

"If the DSM-IV criteria are taken too literally, anybody in the world could qualify for Asperger's or PDD-NOS," says Catherine Lord, one of the members of the APA's DSM-5 Development Neurodevelopmental Disorders Work Group. "The specificity is terrible. We need to make sure the criteria are not pulling in kids who do not have these disorders."

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Redefining Autism: Will New DSM-5 Criteria for ASD Exclude Some People?

‘Butter and Eggs Money” and a Gubernatorial Veto

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Nancy
Scheper-Hughes, professor of medical anthropology at UC Berkeley and
director of Organs
Watch, is one of the opponents of the legislation that would have
permitted women to sell their eggs for research. Today she filed the
following comment on the “troubling mindset” item on the
California Stem Cell Report.

“Jerry Brown's
veto of AB926
which would allow young women to be paid for multiple egg extractions
for scientific research is one for the gals.  In western Ireland
women secreted away their 'butter
and eggs'
money in anticipation of hard times. In my day every smart girl had
her 'mad money' to escape a bad situation. Secret cash for young
women is a great idea, but not when it turns on multiple cycles of
pumping powerful hormones associated (in other contexts) with ovarian
cancer into young women's bodies to produce 30 or 60 eggs a month.
That's not promoting gender equity no matter what some of our best
Democratic women leaders have to say. Selling sperm and selling eggs
are a totally different matter. One  is pleasurable and safe,
the other is a complicated and invasive procedure. We need good
science and good research and  freedom of choice and action. We
also need protection from false advertising. There are no
evidence based, long term studies of the effects of these hormone
injections on women ten or twenty years after the fact. Let's fund
those needed longitudinal and cohort studies and hope for the best.
In the meantime, women had best stick to 'butter and eggs' money. It
doesn't pay a lot, but it's less painful and a heck of a lot safer.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/gMworjXp5x0/butter-and-eggs-money-and-gubernatorial.html

California Stem Cell Agency’s $150,000 Search for Its Financial Future

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A San Francisco consultant, who is
often known as an “economic therapist,” has been selected to
devise a “strategic road map” for the financial future of the $3
billion California stem cell agency.
James Gollub: 'economic therapist'
Gollub Associates photo
James Gollub, managing director of the
firm bearing his name, is under a $150,000 contract to lay out by
this fall a detailed plan for the agency. The nine-year-old research
effort is scheduled to run out of money for new awards in 2017.
Gollub was selected after the agency
posted a request for proposals (RFP) last spring. The RFP assumed an
additional $50 million to $200 million in a onetime “public
investment.” The RFP also assumed additional private funding of a
yet-to-be-determined nature.

“A leading expert in innovation
bridge building....
“Global experience assisting
universities, institutes, government agencies and public-private
partnerships link innovation sources to innovation
seekers.
“Committed to the goal of increasing flow of needed
solutions, optimizing financial returns and sustainable economic
impacts from innovation.”

Gollub's current firm dates back to
March of this year. His Linked In profile says,

“James Gollub Associates
(JGA) LLC was launched to build on 36 years of Gollub’s
professional research and consulting experience. That experience
began with 16 years at SRI International, three years at
DRI/McGraw-Hill, five years at IDeA, nine years at ICF International
and three years with E-Cubed Ventures LLC. During that
time Gollub has worked globally to deliver
economic strategies for over 30 national, state and metropolitan
regions, develop strategies to accelerate growth of new industries
(clusters), plan public and private R&D institutes and advise on
over 15 science and technology parks.”

The need for a financial transition plan for CIRM was publicly identified as long ago as 2009 by the Little Hoover Commission in its lengthy study and has been reiterated periodically by other bodies since then. Under the terms of Prop. 71, which created the agency, CIRM has only  a 10-year authority to issue state bonds, the borrowed funds that have sustained the research effort. Legal maneuvering blocked the issuance of bonds until 2007.

The California Stem Cell Report asked
the stem cell agency on May 31 for a copy of Gollub's response to the
RFP. Yesterday we asked for a copy of the contract with Gollub. Those
documents will be published when they are received.
Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tncFJBJJM5I/california-stem-cell-agencys-150000.html

California’s Alpha Stem Cell Clinics: Open in 2014, Six to Eight Locations

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The San Francisco Business Times
yesterday said that the first Alpha Clinic sponsored by the $3
billion California stem cell agency could open as early as 2014.
The timing was disclosed by CIRM
President Alan Trounson in an article by Ron Leuty, who also reported
that that Trounson's $70 million proposal (see here and here) would involve as many as
six to eight clinics. The locations of the clinics was not disclosed
and would be subject to a competitive RFA. However, Leuty's piece
mentioned UC San Francisco and Stanford.
The article also said initial
treatments might focus on eye disease, “brain therapies” and
spinal cord injuries.
The Alpha Clinic plan is scheduled to
come before the CIRM board in late July. The proposal is aimed at
speeding stem cell treatments and creating something of a one-stop
shopping experience for patients.

Once the CIRM board approves the
concept, an RFA will be issued and interested institutions will have
to submit bids and compete for funding.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/So_NOlmLU2E/californias-alpha-stem-cell-clinics.html

Light Coverage of Cellular Dynamics IPO But One Exec Says It’s Good for Stem Cell Biz

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A handful of media outlets today
carried stories about the public stock offering announced yesterday
by Cellular Dynamics International, Inc., a Wisconsin firm that will
benefit to the tune of $16 million-plus from the California stem cell agency.
Kathleen Gallagher of the Milwaukee
Journal Sentinel described the company, founded by stem cell pioneer
Jamie Thomson, as in the business of making “fully functioning human cells in industrial quantities.”
Judy Newman of the Wisconsin State
Journal in Madison, where the company is based, quoted Beth Donley,
chief executive of Stemina
Biomarker Discovery, as saying,

“It can’t help but increase the
value of other stem cell companies.”

Thomson is a professor both at the
University of Wisconsin in Madison and at UC Santa Barbara, and we
queried Dennis Clegg, co-director of the Center for Stem Cell
Biology and Engineering at UC Santa Barbara, about the school's
ties to Cellular Dynamics, which hopes to take in $57 million in its public offering.
He replied in an email that Santa
Barbara has a collaboration with Cellular Dynamics and the University
of Wisconsin to develop a vision-restoring, stem-cell-based therapy
for people with advanced retinal diseases. That $900,000 effort is financed by the Foundation Fighting Blindness.
The California stem cell agency grant
to Cellular Dynamics is for work at the stem cell bank being created
at the Buck Institute in Novato, north of San Francisco.
The Milwaukee Business Journal and
Genomeweb also carried stories on the IPO.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iGlLbdQVr0Y/light-coverage-of-cellular-dynamics-ipo.html

“Comfort News” for California’s Stem Cell Research Effort

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The California stem cell agency has
enjoyed a spate of good financial and scientific news this week from
the biotech industry as the research effort pushes on with its
mission of turning stem cells into cures.
The $3 billion agency is
scheduled to make its last grants in less than three years and, given
the glacial pace of medical research, needs all the help it can get
by then to bring a stem cell therapy close to the marketplace – the
promise it made to voters when the agency was created nine years ago.
CIRM, as the agency is known, requires
not only steady scientific progress but also a rosy outlook for the
industry, which has languished in past years as major investors
shunned the field. This week, CIRM garnered good news on both fronts.
There was enough so that the agency
even touted it on the agency's research blog in an item by
Neil Littman, CIRM's business development officer. He said it all
helps to leverage CIRM investments and create a favorable investment climate. The good news included yesterday's announcement that
Viacyte, Inc., of San Diego, Ca., has come up with $10.6
million needed to match a $10.1 million, much-ballyhooed award from CIRM last fall. The Viacyte financing
includes important support from Big Pharma, in the form of Johnson &
Johnson. CIRM has pumped a total of $39.4 million into Viacyte.
Another CIRM award winner,
Cellular Dynamics International, Inc., of Madison, Wisc., yesterday
announced its price on its upcoming stock offering to raise up to $53
million. Cellular Dynamics scored $16 million from the agency last
March.
The “comfort news” for CIRM also included Monday's announcement that Capricor, Inc., a private Beverly Hills company benefiting from $27 million from the California stem cell agency, is merging with publicly traded Niles Therapeutic, Inc., of San Mateo. The merger is aimed at providing better access to capital.
And then there was Tuesday's news that a $20 million CIRM disease team award is paying off with the beginning of a clinical trial by Calimmune of Tucson, Az. for an HIV treatment.
All on top of the news in June when bluebird bio of Masschusetts brought in $101 million on its stock offering. Bluebird is the recipient of a $9.4 million CIRM award.
The rosy news comes amid a generally
better outlook for biotech in general. John Carroll, editor of Fierce
Biotech, this week noted that there were only 11 biotech stock offerings last
year. He wrote,

“In the last 6 months, though, the
industry has seen a tremendous rebound, with almost twice that number
of IPOs in half the time. And there's no sign that the great leap
into the public market is waning, with 10 more IPOs in the queue.”

Carroll's comments were echoed in a
piece by Peter Winter on Bioworld headlined “Bubbleology and Biotech's Bull Run.”
All of this plays into what some might
call the “everybody's-doing-it dance" or the “lemming
syndrome,” depending on your point of view. The reality is that
big investors and venture capitalists are timid souls and need the
comfort of companionship-in-risk as they fork over tens or hundreds
of millions of dollars on something that may not pay off for a decade
or more. No one wants to be the out-front pioneer who winds up with
financial arrows in his or her back. Being in a crowd provides an
illusion of safety.
Of course, there is always the caveat
about how markets and investors are fickle. A piece of bad news can
translate quickly into major reversals as Apple has learned over the
last year. Nonetheless, the folks at the stem cell agency have to  be feeling good today.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/g8tqW1ynaMw/comfort-news-for-californias-stem-cell.html

The Klein Donation: Text of Stem Cell Agency’s Key Responses

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Here is the text of the key comments
from the California stem cell agency in response to questions from
the California Stem Cell Report (CSCR) concerning the $21,630
contribution by Robert Klein. Here is a link to the full story on the matter.

CSCR to CIRM:

“Is CIRM concerned about the
appearance created by the donation from Bob Klein to enable scientific
staff to attend the ISSCR meeting in Yokohoma, coming one
month after the GWG (the review group) rejected StemCells Inc's Alzheimer's application
and one month before the July Board meeting that led to the approval
of the award?”(Editor's note: It was actually two months before the board meeting.)

CIRM's response:

“No, the two items are entirely
separate with no connection. Item 1  involved Bob Klein making a
donation to allow science officers to attend a critically important
scientific meeting on stem cell research.  The science officers
 had originally planned on attending but then were told they
could not because of cuts in our out-of-state travel budget – Bob
Klein’s donation, without using state funds, enabled the science
officers to attend.  Item 2 is an ICOC decision to fund a
research project that they felt had promise and was important for the
people of California.”

CSCR to CIRM:
"Please explain why the agency
could not finance the trip itself ."
CIRM's response:
"During the financial year 2011/12  the
Governor's Office issued an Executive Order requiring state agencies,
under the Governor's direct authority, to reduce out-of-state travel.
 Although CIRM was not required to participate, we nevertheless
imposed restrictions on out-of-state travel to meet the intent/spirit
of the Governor's request.  Accordingly, we made a decision to
reduce the number of our science staff who would be attending the
 conference.  Bob Klein's donation made it possible
for those staff to go." 

CSCR asked several questions re the
failure to report the Klein donation to the board as required by
agency rules.
CIRM's response:

“Under the Gift Policy, the President
had the authority to accept Mr. Klein’s generous offer as a 'Direct
payment or reimbursement by third parties for the costs of general
operation or grant management administrative activities.' (Gift
Policy, Sec. III(A)(2).)  Because CIRM receives gifts only
infrequently, CIRM staff determined that it would be more efficient
to report gifts to the Board on a semi-annual basis.  Mr.
Klein’s donation was the first gift CIRM had received in some
years.  Due to the lack of additional donations, a transition in
CIRM’s finance office, and an oversight, CIRM staff has not yet
presented a report including Mr. Klein’s gift.  Staff plans to
report Mr. Klein’s gift as part of the finance report at the May
Board meeting.  Because the President had the authority to
accept the gift pursuant to section III(A)(2) of the Gift Policy, it
did not require a commitment letter.  (See Gift Policy, Sec.
III(C)(1) ['A Commitment Letter is not required for gifts described
under III.A.2., 3. and 4.'].)  However, consistent with the
policy, Dr. Trounson sent Mr. Klein a letter of appreciation, a copy
of which we have already provided you.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/dQImAqKe0Ys/the-klein-donation-text-of-stem-cell.html

A Patent War on iPS: One Researcher’s View

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As the California stem cell agency
pushes ever more aggressively to turn research into cures, the second
largest share of its awards, in terms of numbers of grants, has gone
to efforts involving induced pluripotent cells, also known as
reprogrammed adult cells.

But questions do exist whether those
efforts can surmount barriers that have to do with patents and
ownership of the intellectual property.
UC Davis stem researcher and blogger
Paul Knoepfler discussed some of the problems in a post yesterday. He wrote,

“All the talk and the slew of
publications about potentially using iPS cells to develop therapies
to help patients is exciting in theory, but unfortunately the reality
is that it is not entirely clear if most researchers are, from a
legal standpoint, even allowed to develop and commercialize iPS
cell-based therapies at all.

“The patent landscape for iPS cells
is complicated to put it mildly. A
Google patent search for “induced pluripotent stem cells”
produced almost 200,000 results.

“A search for “cellular
reprogramming produced more than 1,000
results.
I’m not sure all of these results are
really separate patents, but still….that’s a big complicated
mess.…..

“It is no exaggeration to say
there are likely dozens of institutions around the world wanting to
commercialize iPS cell-based products.

“Will they all have to pay expensive
licensing fees or end up in court?
…or will the patent holders
voluntarily and freely allow others to commercialize iPS cell-based
medical treatments?

“I don’t think so.

“This could get really messy.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZX0PoUag-pE/a-patent-war-on-ips-one-researchers-view.html

The Klein Donation: Text of Robert Klein’s Comments on Special Treatment by CIRM

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Here is the text of comments from
Robert Klein, former chairman of the California stem cell agency,
concerning his $21,630 donation to the agency and subsequent actions
by the agency. Klein's comments May 1 came in response to questions
from the California Stem Cell Report(CSCR) on April 30. The text of
the inquiry from CSCR precedes Klein's response. Here is a link to the story on the matter.

CSCR to Klein:

"I have sent the following to CIRM
asking for their response and am offering the same opportunity to
you. Here is what I sent the agency:
'The documents that I have received so
far show that after Klein gave CIRM $21,000 the agency instructed six
of its science officers to give him special access to their
activities and apparently did not object to additional instructions
from another member of the public, Melissa King, to provide Klein and
her with written summaries about their activities at the ISSCR
convention and “details” about their work at CIRM. Email
addresses of the six were also provided to Klein, who may have
additionally received their cell phone numbers although that is not
entirely clear. The CIRM documents show that the six were told to
engage in one-on-one sessions with Klein, which actually included a
third person, a wealthy Canadian mining company executive. One
document indicates that the science officers should assist in
fundraising for CIRM by identifying areas of “special importance”
to Klein and 'other donors.'
"'Additionally, Alan Trounson, at
Klein's request, invited the mining executive to a closed door
session involving the agency's international partners, a session at
which presumably valuable, little known scientific information would
be discussed and future directions charted. Trounson specifically
told the executive that it was Klein who asked that executive be
invited to the session, adding to Klein's clout in any business or
other dealings that Klein might have with the executive.'

My questions to CIRM deal with the
special treatment that was provided in connection with your donation.
I would ask you if you think that state agencies should provide this
sort of extraordinary treatment for individuals who donate to the
agency. At the very least, doesn't this raise questions about the
integrity of the agency and doubts in the public mind about whether
it can be fair and even-handed in its activities?

Klein's response:

"In April or May of 2012 I committed
to contribute a charitable donation to CIRM to cover the travel costs
for 5-7 additional science officers to attend the International Stem
Cell Conference in Japan.  It is important to CIRM that their
science officers understand the cutting edge research being developed
around the world so that CIRM does not fund redundant research; but,
to the contrary, the science officers understand how to create
networks between California scientists and scientists in other
foreign countries who are doing complementary research that can
potentially accelerate the advancements of therapies for patients. I
do not hold any financial interest in biotech companies. I have
historically been involved in encouraging international collaboration
to advance medical therapies; for patients, every day of delay in the
development of a therapy is a delay they cannot afford. To
conceptually document the value of additional scientists traveling to
these meetings, it was discussed that there should be conceptual,
bullet point summaries about the value for CIRM obtained through the
scientists discussions at the international conference.  The
idea was to create bullet points of information about a few of the
most meaningful scientific concepts and contacts the science officers
benefitted from each day of attendance at the conference. I did not
participate in the selection of the science officers who attended and
I did not play any part in determining what activities they
participated in. There were two fundamental goals to the very short
one-on-one sessions that were arranged at "down time" that
would not conflict with their other activities. The first goal was to
conceptually understand if each of the science officers believed that
the benefit to the agency was sufficient to justify the cost of their
attending, when considering the learning and contacts they had gained
which might accelerate research and therapies for patients. The
second goal was to assist universities and non-profits, principally
in Canada - a research partner of CIRM - in advancing their
contributions from an existing donor or donors.

"The Canadian mining executive had an
important history in contributing to the International Stem Cell
Society and to Canadian non-profit research institutions. This
individual has an expert background in mining and a passionate
personal commitment to medical research; but, he does not engage in
technical discussions of research. On a conceptual basis it was
important for him to understand the spectrum of medical advances
towards therapies. His additional contributions to Canadian
non-profits could assist Canada in collaborating with California on
more international research, with California only funding the
research done in California and the donor helping to fund the
research done in Canada. No specific grant applications were
discussed. Finally, the discussion with the international partners
focuses on the funding process and funding collaboration it does not
discuss any individual grants. The value of international
collaboration and the benefits of collaborating with new
international partners is discussed. Scientific theories and
individual grants are not discussed and new scientific information is
not presented. I attended this session of international partners to
support international collaboration; again, I do not hold any
financial interest in any biotech organizations. Additionally, I do
not have any business or financial relationship with the Canadian
mining executive. The Canadian executive, based upon family and
friends who have had chronic disease, is a significant donor to
non-profit research institutions in Canada. All of my activities, the
donation and the encouragement to develop information to validate the
future benefits of science officers traveling to international stem
cell conferences were focused on benefitting California patients with
chronic illness or injury and the agency formed through Proposition
71."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SBGFem2qPWo/the-klein-donation-text-of-robert.html

The Klein Donation: Text of Robert Klein’s Response re StemCells, Inc.

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Here is the text of the initial
response from Robert Klein, chairman of the California stem
cell agency until July 2011, to questions from the California Stem Cell Report (CSCR)
concerning his $21,630 donation to the agency. The questions posed by
CSCR on precede the response by Klein. Here is a link to a story on
the matter.


CSCR to Klein:

“Why did you give the agency the
money?
“Did you place on conditions on its
use?
“Did anyone connected with the agency
indicate in advance  that your donation would be desired? If so
who? Who did you deal with primarily on the donation -- Trounson,
Thomas or...?
“The donation came one month after
grant reviewers rejected StemCells Inc.'s Alzheimer's application. Do
you think it was appropriate to make the donation and then ask the
board twice to override its reviewers?
“Do you think the donation and
subsequent action on StemCells, Inc.'s Alzheimer's application will
negatively color the perception of future efforts by CIRM at private
fundraising?”

Klein's response:
“In April or May of 2012 I committed
approximately $20,000 as a contribution to CIRM to cover the travel
expenses of staff to the International Stem Cell Society
meeting in Japan. My commitment to ensure scientific staff can
participate in international meetings dates back many years. In 2011
I wrote the following explanation of its importance in obtaining the
knowledge to accelerate the drive of scientific research to reach
patients with chronic disease.
            Leverage
Leading Edge Science
           
“Travel by CIRM staff members and leadership permits CIRM to stay
in contact with, and understand, the leading edge advances of
scientists all over the world, and to leverage those advances by
creating a platform for collaborations between these leading
scientists and their peers in California. Currently, CIRM has
collaboration agreements with 15 foreign governments pursuant to
which these governments have pledged $134,380,000 in commitments to
fund the work of their scientists on join teams with California
scientists to develop therapy candidates and to advance therapies to
human trials. Although a significant amount of this commitment is
currently pending scientific peer review and not all of it will be
awarded as part of a successful application, every dollar in
funding by a foreign government magnifies the scientific impact of
California’s taxpayer dollars. If just $40 million is awarded each
year over ten years, it would provide California with $400 million of
scientific leverage.
  •     It
    is critical to understand that there are unpublished scientific
    discoveries in progress in each of these nations. Often, publication
    may trail a scientific discovery by nine months or more.
  •     The
    travel requested by CIRM provides a critical link for the timely
    transmission of valuable new information. California cannot afford to
    lose the opportunity to harness discoveries in other countries to
    advance the development of therapies in California and to capture the
    opportunity to advance therapies for patients instead of using
    California taxpayer dollars to duplicate discoveries already mastered
    in other countries.
  •      While
    CIRM’s scientific staff works with scientists in other countries to
    capture the scientific knowledge for the benefit of California’s
    therapy development teams, the Chairman’s Office works with
    international finance ministers, the premiers of international
    states, and foreign funding agencies to ensure funding allocations
    for these bilateral funding agreements. These discussions often
    involve face-to-face negotiations in foreign nations and states, in
    addition to meetings at international conferences, all of which are
    supported by extensive staff work in California.
  •      CIRM
    issued its first co-funding awards early in 2009. Over the last two
    years, these agreements have yielded $57 million in international
    funds actually approved through peer review. This $57 million
    represents participation by only the first five countries and one
    international state with which CIRM established a collaboration. Now,
    CIRM has agreements with nine countries and two international states
    and an additional three countries will be added in the near future.
  •     Even
    if CIRM were only to obtain $30 million per year in international
    matching funds, the ratio of return on CIRM’s $206,920 travel
    expenditures would be approximately 145 to 1.
  •    Proposition 71 specifically anticipated
    and directs CIRM to develop leverage and global leadership to capture
    the benefit for patients.
Keeping on the Cutting Edge of Stem
Cell Science
"CIRM’s over 20 MDs and/or PhDs
science officers on the grant review staff at CIRM reach out
nationally and internationally through conferences that may include
10-20 meetings per day and workshops of 8-12 hours per day to grasp
the leading edge of this pre-publication, dynamic
revolution in medical knowledge. In order to ensure that the
every research dollar is optimally deployed to advance therapies to
save lives or rescue the quality of life for patients, it is critical
that CIRM staff remain on the cutting edge of new discoveries.
International conferences and workshops provide a critical
opportunity for massive and decisive transfers of information, which
ensures that California is funding the right research.
“I principally corresponded with Dr.
Trounson on the issue covering the travel expenses for the staff for the reasons stated above. I had no input into the selection
of scientific staff. In May and even in June when the conference
occurred I had no idea that there would be any disagreement on the
Alzheimer’s application of Stem Cells Inc. in August. At the Board
meeting I asked that there be consideration for the fact that three
other peer reviews had found the work leading up to this application
to be outstanding and they had ranked it highly. In addition, the
current peer review had not been briefed on the fact that they
downgraded the applicant for following the directions on material
points by the prior peer reviews. Finally, the standard deviation on
the 2012 peer review was extremely high and the re-review by the
three member committee resulted in a split decision. It is
particularly appropriate with a huge standard deviation,
demonstrating both strong support and opposition within the peer
review group, for the Board to make its own independent decision. 
Please recall that the staff recommended against approval so that
they clearly were not influenced by my commitment to a contribution
to the Agency, months before, for the benefit of scientific staff to
be able to attend an international science conference. Additionally,
Dr. Trounson, I believe, recused himself from the review of the Stem
Cells Inc. application, for unrelated reasons, so he was not
involved. I personally had served on the three prior peer reviews,
including one in the prior year that recommended this application for
a Disease Team approval. I know how strongly the scientists on those
three prior peer reviews supported funding this scientific research,
with the 2011 review specifically recommending this Disease Team for
approval. I believe it was extremely important for me to provide a
voice to those three scientific panels who disagreed with a portion
of the scientists on the 2012 scientific panel. Supporting the
scientific movement to human trials for Alzheimer’s has to be
eventually approved by the FDA; but, this loan will move the science
and the potential for clinical trials forward significantly and
hopefully obtain FDA approval. I believe all three of the Board’s
overrides of the peer review recommendations on the Disease Team
round in 2008 are leading directly to human trials in the United
States and/or United Kingdom. 92% of the all of the funds awarded by
CIRM have followed the recommendations of the peer review committee;
but, in those significant cases where the Board has made an
independent decision, there has been an extremely high success rate
particularly when there has been a high level of disagreement within
the Peer Review Board that was overridden and prior peer reviews
recommended and/or approved the scientific approach and concepts of
the applicant.”

(Editor's note:  The applications in this round were reviewed once in April 2012 by CIRM's full grant review group. StemCells, Inc.'s application was subject to a reevaluation after Klein's appeal in July 2012 and rejected again, but it was not a full review.  Klein may be referring also an earlier round that provided grants for planning to apply for the full $20 million.) 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/57qJcfMUql0/the-klein-donation-text-of-robert_5.html

Stem Cell Agency’s Duane Roth Eulogized at Memorial Services

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An estimated 1,000 persons attended
services last week for Duane Roth, co-vice chairman of the California
stem cell agency, who died at the age of 63 following a bicycle
accident.
The San Diego U-T reported,

“A Who’s
Who of San Diego’s technology, business and civic community
gathered Friday to bid farewell to Duane Roth.
The biotech entrepreneur, community leader and director of Connect
died last weekend of injuries sustained in a cycling accident.

“Among
attendees were Gayle and former Gov. Pete
Wilson, who had just celebrated his upcoming 80th birthday
with former colleagues and friends in Sacramento, county
Supervisor Ron Roberts, former
Assemblyman Nathan Fletcher, Chamber
head Jerry Sanders, Preuss School
benefactors Peggy and Peter
Preuss, SDG&E CEO Jessie Knight,
and many biotech and high-tech leaders. These included Irwin
Jacobs, Ted Waitt and Denny
Sanford.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8V0OyzjYBEs/stem-cell-agencys-duane-roth-eulogized.html

Meager California Biotech Representation in Governor’s China Trip

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California Gov. Jerry Brown and a flying squad of business types visited China last week, beating the drum for the Golden State in an effort to raise billions of dollars in investments.

Some 90 persons were involved in the governor's delegation, but representation was meager from California's renown biotech sector and none at all from the $3 billion California stem cell agency, which has a collaboration underway with Chinese scientists. It may have been the only state agency with a formal collaboration agreement with China prior to Brown's visit.
According to many reports, the Chinese government regards growth of its biotech industry as one of its core economic efforts. Within that sector, biomedicine ranks as the most important and fastest growing, according to an Italian Trade Commission report. Stem cell research is especially important, according to this Canadian study. Indeed, some scientists in China are eyeing a Nobel Prize in the field (See here or here.)
California would seem to be well placed to take advantage of that situation, given its substantial biotech industry and community, which is only rivaled by Massachusetts. Add to that the existence of the unique California stem cell agency, which has funded a $1.5 million study by Holger Willenbring at UC San Francisco that also involves research by Lijian Hui at the Shanghai Institutes for Biological Sciences, which is separately funded by that country to the tune of nearly $1 million.
A look at the list of those traveling to China with the governor showed two representatives who could be considered from biotech: Joe Panetta, head of BioCom, a life science industry organization in Southern California, and Michel Baudry, dean of the Graduate College of Biomedical Sciences, Western University of Health Sciences in Pomona, Ca..
We queried Baudry before he left for China about the situation. Here is the full text of his reply.

“I do not know how this set of delegates were selected. What I do know is that this is the first of several delegations of California business delegates going to China with Governor Brown, and that more trips are scheduled. The focus of this first trip is Energy and Environment, and this might be why there is no biotech delegates in this trip. I am quite sure that they will participate in the following trips.”

Meanwhile, the folks in Richmond on San Francisco Bay are waiting to hear about plans of a major but unnamed Chinese biotech company for the 53-acre, former Bayer Healthcare Campus.

(Following the posting of this item, Ron Leuty of the San Francisco Business Times gave us a heads up on the latest on the site. He reported in March that Joinn Laboratories, a Chinese contract research organization, purchased the site. Leuty said that its plans are vague about future development, but that it may lease some of the space.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/x57uSahTPNI/meager-california-biotech.html

‘Praise’ for California Stem Cell Agency from Unlikely Corner

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The California stem cell agency this
month received what some might consider a gesture of approval from a
longtime foe – LifeNews.com.

LifeNews is a site devoted to
anti-abortion efforts and information and is sharply opposed to research
involving human embryonic stem cells.
So it was with some surprise that we
read a tacit endorsement of recent CIRM activities in an April 22 piece written by Gene Tame out of Sacramento. It said the most recent
$32 million grant round from CIRM “demonstrates – again – where
the future of stem cell reserch lies.”
Tame wrote,

“CIRM has been steadily moving away
from its original mission to give preferential
treatment to funding for human embryonic stem cell research
(hESCR). Instead, after adopting a renewed
emphasis on translating research into clinical trials, CIRM
has more and more shifted the bulk of its grants towards funding
research utilizing adult stem cells and other alternatives to hESCR,
such as induced
pluripotent stem cells (iPSCs).”

Tame continued,

“(T)he lack, once again, of funding
for hESCR only serves to highlight how old and dated that approach to
finding treatments and cures increasingly seems.”

Tame is correct in his assertion that
the stem cell agency has moved a considerable distance from its
reason for being – research involving human embryonic stem cells.
In 2004, the ballot campaign to create the agency pitched voters hard
on hESC research and made no real mention of adult stem cells.
Instead, it focused on the threat from the Bush Administration with its
restrictions on hESC research, which have been lifted by the Obama
Administration. .
In 2010, a study by a Georgia Tech
academic, Aaron Levine, reported that through 2009 only 18 percent of California's dollars went for grants that were "clearly" not eligible for federal funding under the Bush restrictions. 
At the date of the study, CIRM had not
publicly disclosed statistics on its funding of hESC research.
Today, however, its web site shows that only about 240 of the 595 awards that it has handed out are going for hESC research. CIRM has not made public the dollar value of
those 240 awards, but it has given away a total of $1.8 billion. (Following publication of this item, the agency told the California Stem Report that it has funded $458 million in hESC research.) 
A footnote: Levine was a member of the
blue-ribbon Institute of Medicine panel that recommended sweeping
changes at CIRM.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hxYse4K5TpU/praise-for-california-stem-cell-agency.html