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

By Dr. Matthew Watson

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

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Pomeroy on Doing the Right Thing and Foster Care

By Dr. Matthew Watson

Claire Pomeroy
CIRM photo
On Claire Pomeroy's last day as a
member of the governing board of the $3 billion California stem cell
agency, she also published an essay on the Huffington Post in which
she discussed fleeing from an abusive home at age 14.
Pomeroy, former vice chancellor and
dean of the medical school at UC Davis and now president of the Lasker Foundation in New York,  wrote last month,

“For some children, the uncertainty
of life on the street is better than certainty of violence at home.
It was for me. At age 14, I escaped from an abusive home with no
money, nowhere to go and only the clothes I was wearing. I remember
staring into the night, standing somewhere between fear and freedom.
I became one of the millions of homeless teens, yet I was lucky
because foster care ultimately saved me.”

“However, after an emergency
placement and three foster homes, the challenges were not over. At 17
I aged out of the foster care system early when my foster parents
moved out of state. On my own again, I had to find a job, a place to
live and finish high school. Then I climbed the next mountain to
graduate from college and medical school.”

Pomeroy said she only recently began
publicly talking about her foster care experience. She said she is
doing so because “many  people lack an understanding of
the harsh statistics and their impact on the country's future. The
nation faces a crisis that demands a call to action to start truly
caring about foster youth before it is too late.”
She said that she was “lucky” in the
foster care system but said that many children, particularly minorities among others such as the disabled, were not as fortunate and “were failed by the system and society.” Pomeroy called them
“throwaway children” who were “robbed of their ideals, gave up
hope and struggled to find a reason to live.”
Less than half of the foster children
who “age out” of the system graduate from high school, she wrote. Only 3
percent to 11 percent earn a bachelor's degree. More than
400,000 children were in foster care in 2011 and have a one in 11 chance
of being homeless.
Pomeroy called for expansion and
improvement of foster care across the country. “It is time to stop
forcing children to be the heroes of their own survival,” she
wrote. “Now is the time to do the right the right thing.”
------
On a personal note, we have four
grandchildren, one of whom was adopted out of foster care as a
toddler. The other was adopted at birth. Some of the siblings of
those two African-American children remain in foster care today.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zancriHTUC4/pomeroy-on-doing-right-thing-and-foster.html

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Vatican Funding for California Stem Cell Agency?

By Dr. Matthew Watson

So what's with the Vatican sending cash
to the California stem cell agency? One would imagine that is an
improbable event since the agency is involved in human embryonic stem
cell research, which is an anathema to the Roman Catholic church.
However, CIRM President Alan Trounson
earlier this week disclosed the payment in an interview with Patt
Morrison
of the Los Angeles Times. He said,

“Last
year I was invited to the Vatican to
present a paper, but when I sent in a summary of what I was going to
say, they decided not to have it. They sent a check to the treasurer
of California and the treasurer rang us up and said, "What the
heck is this check from the Vatican for?" It was for the
inconvenience!”

We wanted to know a little more about
this so we queried the agency about the matter. Kevin McCormack, a
CIRM spokesman, said,

“The money was actually a wire
transfer from the Vatican to us for $453.23 and it went to CIRM's
account. It was to reimburse us for money spent on plane tickets,
etc., for Dr. Trounson to attend the Vatican conference on stem
cells.”   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/bOQKBXJGmJ8/vatican-funding-for-california-stem.html

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Bluebird bio of Massachusetts Still Waiting for California Stem Cell Money

By Dr. Matthew Watson

Seven months after the California stem
cell agency awarded $9.4 million to bluebird bio of Cambridge, Mass.,
the company has yet to receive any of the cash from the Golden State.
Kevin McCormack, a spokesman for the $3
billion agency, this week said negotiations are still underway with
the bluebird, which is planning to go public,  but did not elaborate. Post-award negotiations are
common at the agency, but generally take much less time.
The cash from CIRM is scheduled to
assist in clinical trials for a stem cell-gene therapy to correct a genetic disease in young patients with B-thalassemia, a
rare blood disorder that can cause widespread organ damage
and premature death.
Earlier this month, bluebird bio, which
prefers the lower case lettering for its name, announced that it
intends to take the company public in an $86 million offering. In
March, it announced a collaboration with Celgene that provided for an upfront payment of $75 million and promised up to $225 million per
product in potential option fees and clinical and regulatory
milestones. The CIRM grant is conditioned on a matching commitment
from bluebird.
Cash from the stem cell agency can only
be spent on operations within California. According to the CIRM summary of the review of the bluebird application, which was scored
at 73, the company said,

“We will have at least two clinical
sites in California, and more likely up to 4 sites, 2) our viral
vector manufacturing will occur in California, 3) our cell processing
will occur in California, 4) we will hire several consultants and
full-time employees within California to support the program.
Overall, several million dollars will be spent employing the services
of people, academic institutions, and other companies within the
state of California.”

The company has said that it is working
with Donald Kohn at UCLA and Elliot Vichinsky at Oakland's Children's
Hospital.
The bluebird web site lists a
California location for bluebird at 1001 Bayhill Dr, Suite 200, in
San Bruno, which is south of San Francisco. An Internet search
indicates that is a generic address for a number of business
including a realty firm, a roof repair business and a family law
attorney. The California Stem Cell Report has asked bluebird to
clarify the nature of the address.
In an interview last October with Ron Leuty of the
San Francisco Business Times, David Davidson, the lead scientist on
the project, said,

“We began the process (with CIRM)
early in (2012) but discussions have been going on for over a year
about potentially pursuing this.

“The interaction with CIRM has been
extraordinarily collaborative. We had contact with the coordinators
at CIRM that helped us manage the process. It took a lot of effort on
our part to put together a dossier providing support for our program.
It was really like a mini-regulatory filing — on the science, the
preclinical toxicology work that we’ve done, a detailed plan for
the trial, a detailed plan for the budgets, a detailed plan on how we
intended to spend the CIRM money in California. That was an important
part of it. They wanted a clear plan on how this investment would be
spent."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zR-Ht90u_7o/bluebird-bio-of-massachusetts-still.html

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

By Dr. Matthew Watson

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

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Monterey Newspaper Chides California Stem Cell Agency

By Dr. Matthew Watson

The California stem cell agency and its
former chairman, Robert Klein, came under sharp criticism this week
in an editorial in the Monterey County Herald newspaper.
The editorial cited articles on the
California Stem Cell Report dealing with a $21,630 gift by Klein to
the agency, his employment of the vice chairman of the agency and the
violation of the agency's conflict of interest policies by a grant reviewer.
The editorial was headlined "State Stem Cell Agency Still Up to Old Tricks." The piece said,

“Robert Klein is no longer chairman
of California's stem cell bureaucracy, but it is still doing things
his way. Which is too bad for all concerned.

“Klein is the former developer and
financier who wrote and sponsored the ballot measure that created the
California Institute for Regenerative Medicine. The ballot language
practically guaranteed he would be the chairman, and he ran the
agency the way he ran his businesses, using undisclosed side deals
and other machinations to create webs that outsiders could never
penetrate.

“Now, Klein has been replaced as
chairman, but he is still up to his old tricks.”

The editorial concluded,

“Much has been said about the agency
setting a new more straightforward direction now that Klein is gone,
but so far it seems to be following a twisting and expensive path
toward irrelevance and litigation.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SGmn7k9T1Vw/monterey-newspaper-chides-california.html

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Trounson Proposes $70 Million, Fast-Track Stem Cell Clinic Plan for California

By Dr. Matthew Watson

Alan Trounson, president of the
California stem cell agency, this summer plans to seek $70 million
for creation of what he calls Alpha Clinics, high-powered
organizations that will fast-track stem cell therapies to patients.
The proposal is scheduled to come
before CIRM board at its meeting in late July and would consume a
significant slice of the $700 million to $800 million that the $3
billion agency has left to hand out.
Trounson broached the need for the
clinics as far back as two years ago, but did not put a price tag on
the concept until an interview published online late today in the Los
Angeles Times
. The interview will be carried in the print edition of
the paper tomorrow.
In the Q&A session between Times
columnist Patt Morrison and Trounson, he said, 

"I'm intending to set up a network of
stem cell clinics in California in the next couple of years, to make
treatments available as clinical trials or as registered treatments
for patients. I'm going to ask the [CIRM] board for about $70 million
to get that set up. It will make California a go-to place for stem
cell therapies. I want to make sure it's part of our medical fabric."

In other media reports in previous
years, Trounson has said the Alpha Clinics would speed delivery of
stem cell-based therapies and reduce costs of clinical trials by
building on the success of specialist cancer, transplant and in-vitro
fertilization clinics.
Leigh Dayton wrote about Trounson's
plan in The Australian last July 14. Dayton said,

“Initially the clinics would use the
capacities and infrastructure in the most advanced university medical
clinics to deliver bone-marrow stem cell therapies. As research
evolves, so will the treatments and services offered.”

Trounson also discussed the Alpha
Clinics during an appearance at USC in 2011. A university publication wrote,

"These clinics will initially serve
to get patients into clinical trials or to offer sound advice to
individuals who might otherwise go overseas to receive harmful stem
cell therapies from disreputable clinics.

"'I’m willing to invest money to
get these [clinics] up,' Trounson said. 'I think if nothing happens
beyond 2017 and we don’t get any refunding, we can leave a
footprint of stem cell clinics in California that will go on
forever.'"

Trounson was not at last week's CIRM
board meeting, but Ellen Feigal, senior vice president for research
and development, said a white paper is being prepared on Alpha
Clinics. She said a concept proposal would be brought to the board
July 25 at a meeting in the San Francisco Bay Area. Once the board
approves the concept, the staff will then prepare and post the RFA.

Interested parties can address
suggestions or questions to Feigal at info@cirm.ca.gov.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/lND8J7NKqzc/trounson-proposes-70-million-fast-track.html

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$70 Million Alpha Stem Cell Clinic Proposal Draws Reader Comment

By Dr. Matthew Watson

In addition to the comments filed online in connection with the $70 million proposal to create Alpha Clinics in California for stem cell treatments,  two other readers commented privately in emails. 
One came from a close observer of the
stem cell agency who said, “If done right -- and I'm sure you and I
agree that is a big 'if' – it could be an outstanding legacy.”
The other comment came from a
physician-researcher at a major California institution and was longer
and more critical. Here is the text.

“Another boondoggle for some medical
schools but made to order for private operators like for profit
cancer, dialysis, and laser eye specialty clinics that do one
procedure.  I can see each of the medical schools gifted with
one as they each were gifted with about 25 million dollars for stem
cell institute buildings; and CIRM and (Irv) Weissman's companies
like Stem Cells, Inc., getting a piece of the action as well.  Of
course the deans and chancellors on the CIRM steering committee will
vote for it. How can they not? It's money in their pockets.

“This has the fit and feel of, say,
old Latin American Laetrile clinics or offshore clinics offering
suspect surgeries or injections for cancers, Parkinson's disease, and
the like.  It makes no difference that they are set up in
California.  CIRM will pay for an unneeded infrastructure that
will be empty space and staff sitting on their hands 99% of the
time.  Or worse yet, CIRM will pay but the space will be used
for other things, other clinic procedures paid for by insurance.  

“Now (CIRM President Alan) Trounson and
CIRM want to get into the medical tourism business making California
a 'go-to place' for stem cell treatments.  They want to start
with bone marrow injections and transplants, procedures that cancer
centers do regularly.  All CIRM needs is a drug or treatment. 
It's not like there are tons of drugs out there and the only barrier
is the lack of clinical space and capacity.  The start up time
for any one drug is very long.

“NIH at various times has tried to
organize clinical trials groups with infrastructure, like quick
reaction forces, ready to gear up for a new trial at the drop of a
hat. They mainly did nothing but suck money, kept staff employed,
because there are generally few drugs ready for early human trials
and each treatment that is brought along requires a unique contract,
ethics reviews, and different facilities, equipment and staff than
planned for.  The latest incarnation are CTSAs or CTSIs,
clinical and translational science centers funded by the federal NIH
that most if not all California medical schools already have.

“The CIRM clinics are going to be
generic stem cell clinics advancing California tourism.  Come to
California, we will inject stem cells for any illness, in any part of
your body, never mind that cancer is different from heart disease is
different from bone disease is different from brain disease, no
matter.  Next step is for CIRM to form a travel agency with
discounted air and Ritz Carlton packages for patients and extended
family non-stop from China.  There is likely considerable
revenue to be generated here and Trounson, Weissman, and (Robert)
Klein
(former CIRM chairman) should find a way to benefit. It sounds
so wonderful!!  The public will love it.  Now all they need
are some treatments.  Love the name: Alpha Clinics, they
wouldn't want to start with Beta test clinics when they can go big
from the get-go.  What an irresponsible waste.”    

The other comments can be found at the end of the original item or in the column to the right of this item, headed "recent comments."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/nKbicxl9mzA/70-million-alpha-stem-cell-clinic.html

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Sacramento Bee: Ongoing Conflict Problems No Help for Future Funding of Stem Cell Agency

By Dr. Matthew Watson

The Sacramento Bee says conflict of
interest problems continue to trouble the California stem cell agency
despite its assertions that it has “turned a page” on the issues.
In an editorial Saturday, The Bee said
that CIRM Chairman Jonathan Thomas “has vowed to be aggressive in
avoiding conflicts in dispersing millions of public dollars for stem
cell research. Yet serious conflicts continue to be
revealed involving CIRM.”
The Bee cited articles on the
California Stem Cell Report earlier this month about a $21,630 gift
by its former chairman, Robert Klein, and the employment by Klein of
Vice Chairman Art Torres. The Bee said the situation “throws
into question a $20 million grant awarded last year to StemCells
Inc.
, a company that wants to transplant neural stem
cells to treat Alzheimer's
disease.” (See herehere and here)
The Bee also cited the case of Lee
Hood
, an internationally renown scientist who violated the agency's conflict of interest policy. Hood failed to disclose to CIRM a
conflict involving an application that he was reviewing on behalf of
the agency. The Bee said the agency's failure to detect the conflict
was “serious oversight."
Eight readers commented on the
editorial and agency, generally unfavorably about CIRM.
But reader “bchild” said,

“It took a couple years for them to start funding projects and it may take years to see results. Wall
Street got 1.5 trillion and the promise of 10x that if they get
into trouble again, the scientists (and their business buds) just
want a couple billion...In the end who do you trust more with
public money? At least there is the appearance of public benefit
here..."

The Bee concluded,

“None of this helps CIRM's reputation
in being fair and impartial in spending $3 billion in public funds.
It surely won't help the institute's standing with the Legislature
and the public, should it need help staying in operation when its
funding is exhausted in a few years.”

The editorial was also carried by at least one other paper in the McClatchy chain.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/BZeSccFCbBU/sacramento-bee-ongoing-conflict.html

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Multimillion Dollar Carrots for Stem Cell Research in California

By Dr. Matthew Watson

Directors of the California stem cell
agency approved an $80 million business-friendly plan that will
dangle multimillion dollar carrots before biotech firms in an effort
to push therapies into the marketplace.

The upfront payment effort will allow
CIRM to take part in early stage clinical trials at no risk and could
generate a list of achievements that will be useful in creating
support for fresh funding after CIRM's money runs out in 2017.
The proposal is the first-ever from
CIRM that involves no upfront payments. Instead, recipients will have
to meet agreed-upon criteria to receive either grants or loans.
A CIRM staff document said,

“The major development milestone and
success criteria will be mutually agreed upon between CIRM and the
applicant at the beginning of the project(s) and at a minimum will
require completion of a clinical trial that shows some level of
biological activity/clinical efficacy and safety. The advantage to
CIRM of this...is that CIRM funds will only be applied to projects
that are successful.”

The proposal was wrapped into what the
agency calls its strategic partnership plan, which also has a more
conventional aspect, providing loans and grants in advance.
As part of the program, the CIRM board
also today approved a $6.4 million award to Sangamo BioSciences of
Richmond, Ca., to help develop a therapy for
beta-thalassemia. The firm will have to match the amount of the
award.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/uJidDBHhPdI/multimillion-dollar-carrots-for-stem.html

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California Stem Cell Agency: 5 Percent Budget Increase for Coming Fiscal Year

By Dr. Matthew Watson

Directors of the California stem cell
agency today approved a $17.4 million operating budget for the fiscal
year beginning July 1, an increase of 5.1 percent over spending for
the current year.

As usual, the agency tries to portray
its budget as a decrease in spending. Directors were told that it
represented a 3 percent decline from the current year. However, the
comparison is not made to actual spending for this year. Instead, the
staff compares the 2013-14 budget to budget figures proposed last
May, which are now no more than time-worn ephemera.
Most of the budget goes for salaries
and benefits ($12.2 million ) with outside contracting running next
($2 million). (See here for details.) The budget projects 59 employees for next year
compared to 57 currently. CIRM staff said the number of employees is expected to remain about
the same until 2017 or so when its workload is projected to diminish.
The agency is expected to run out of
money for new grants in 2017, but it is working on a plan to develop
a combination of private and public funding to continue its work.
The spending plan reflects the cost of
overseeing about $1.8 billion in nearly 600 grants and loans plus
developing new research proposals that are likely to be funded in the
next few years. The operational budget is capped by law at 6 percent
of the amount of funds the agency distributes over its lifetime.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GJSQ_B3ck_8/california-stem-cell-agency-5-percent.html

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$36 Million Recruitment: Names of Researchers Being Lured to California

By Dr. Matthew Watson

Here are the names of the researchers being recruited to California by the California stem cell agency with $36 million in awards. The sixth asked not to be revealed since he/she has yet to tell the current institution and are in
negotiations with their new institution

·      Hiromitsu
Nakauchi
of the University of Tokyo, who would be moving to Stanford
University
·      Barry
R. Stripp
of Duke moving to Cedars-Sinai Medical Center
·      Richard
Gregory
of Harvard and Children’s Hospital, Boston moving to UC
Santa Cruz
·      Eric
Ahrens
of Carnegie Mellon moving to UC San Diego

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Kbc3TScH6ds/36-million-recruitment-names-of.html

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Stem Cell Agency Approves $36 million to Recruit Six Scientists to California

By Dr. Matthew Watson

The California stem cell agency today
awarded $36 million to six scientists to lure them to the Golden
State, in what was the agency's largest-ever recruiting round.

The awards more than doubled the amount
of CIRM has spent on recruitment. Until today, the agency had awarded
only $23.2 million for four awards.
Today's awards ranged from $7.5 million
to $4.8 million. The agency did not immediately identify the recipients. However, testimony at the meeting indicated that two of the institutions involved were UC San Francisco and the Gladstone Institute (the $7.5 million award) and UC Santa Cruz (a $5.4 million award). (The agency later released the list, which can be found here. Here is a link to the CIRM press release.)

The differences in the size of the awards had to do with the overhead charges that are levied by the institutions at which the scientists would work, CIRM staff said. The "direct costs" of the research for each grant was $4.5 million.

Six applications were considered in the
latest round, including one that was scored at 75 that was rejected by grant reviewers. However, CIRM staff recommended that application, which involved UC San Francisco and Gladstone, be funded. (See here and here.)
Previous winners of the recruitment awards were Robert Wechsler-Reya, Sanford-Burnham; Dennis Steindler,
The Parkinson's Institute; Andrew McMahon, USC
, and Peter Coffey, UC
Santa Barbara.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4jJo64qAjcY/stem-cell-agency-approves-36-million-to.html

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California Stem Cell Agency to Court Patient Groups This Summer

By Dr. Matthew Watson

Jonathan Thomas, chairman of the California stem cell agency, said this morning that he and a team from the agency will begin a round of meetings this summer with patient advocate groups throughout the state.

He said the effort is aimed at keeping the groups up to speed on developments at CIRM. While Thomas did not mention it to the agency's governing board, it is also critical that the agency have strong support from patient advocate groups as it tries to develop new sources of funding, either public or private.

The agency will run out of cash for new grants in 2017 and hopes to have a plan for the future before the board later this year. Its initial assumptions include as much as $200 million in onetime public funding with more cash coming from the private sector.

Currently the agency is funded by state bonds at a cost of about $6 billion, including interest. It spends roughly $300 million a year on grants and loans for research.Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/lra474LHezU/california-stem-cell-agency-to-court.html

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Nature Reports on Lee Hood Conflict Case

By Dr. Matthew Watson

The journal Nature and genomeweb.com
today picked up the story from the California Stem Cell Report about
the conflict of interest case at the California stem cell agency involving renown scientist Lee Hood of
Seattle, Wash.

Science news aggregators on the
Internet also relayed various versions of the story. The facts were
first reported on this blog yesterday. The matter involved a $24
million application for a genome project involving Irv Weissman of
Stanford. Hood was one of the reviewers in the round. Hood and
Weissman are longtime friends and own property together in Montana.
They have also have a number of professional relationships.
In piece by Ewen Callaway, Nature
additionally referred to ongoing conflict of interest issues at the agency,
including the findings of an Institute of Medicine study. Harold Shapiro, head of the study, said the agency directors make "proposals to themselves, essentially, regarding what should be funded. They cannot exert independent oversight." 
The genomeweb item was also brief and
did not mention the IOM study.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xBpF71FS1Ys/nature-reports-on-lee-hood-conflict-case.html

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Grant Reviewer Conflict in $40 Million Round at California Stem Cell Agency

By Dr. Matthew Watson

Internationally renown scientist Lee
Hood
, winner of a National Medal of Science, violated the conflict of
interest policies of the California stem cell agency earlier this
year when he was involved in reviewing applications in a $40 million round to create genomics centers in California.

Lee Hood
Institute of Systems Biology photo
The agency quietly disclosed the
February violation in letters dated April 2 to the leadership of the
California Legislature. The letter (full text below)
said that Hood “agreed that there was a conflict of interest that
he had overlooked.”
The conflict of interest involved a $24
million application that included participation by another eminent
scientist, Irv Weissman of Stanford University, and funding for facilities at
Stanford.
Hood owns property jointly with
Weissman in Montana. In 2008, San Francisco Magazine, in a well-reported piece on the ballot measure that created the stem cell
agency, described the property as a ranch and Hood as Weissman's
“good buddy.” Hood has co-authored research papers with
Weissman. Both are on the scientific advisory board of Cellerant
Therapeutics, Inc.
, of San Carlos, Ca., a firm co-founded by
Weissman. Hood's nonprofit firm, Institute for Systems Biology in
Seattle, lists Stanford as a partner in the genetics of aging in humans. At Stanford, Weissman is director of the Institute
for Stem Cell Biology and Regenerative Medicine
, whose research
involves aging. Weissman also serves on the Hood's institute's scientific advisory board.
Hood has not responded to an inquiry
yesterday by the California Stem Cell Report for his perspective on
the conflict of interest matter.
The conflict was not discovered by the
agency during the review. It was raised by another reviewer at the
end of the review, which, for the first time in CIRM history, failed
to conclude with a decision supporting any of the proposals.
Reviewers' comments have been sent back to applicants with another
review scheduled for November. The agency said Hood will not take
part in that session.
CIRM spokesman Kevin McCormack said
today that Hood's conflict was “clearly a case of a new reviewer
making an innocent error.” McCormack said it was not a violation of
the state's conflict of interest law. The agency's conflict policies
go beyond economic issues and deal with personal and professional
conflicts. 
The agency's letter to the state legislative leadership said,

“Dr. Hood had not previously
participated in a meeting of the GWG(grant review group), and as a
result, he was not familiar with CIRM’s conflict of interest
policy, particularly the policy’s inclusion of 'personal' conflicts of interest.  Thus, when he completed the conflict of
interest form for the Genomics Awards review, he inadvertently
neglected to indicate that he had a personal relationship with an
investigator who was involved in one component of a joint application
submitted by two institutions. Dr. Hood and the investigator are
close personal friends and their families own vacation property
together. Because of his personal relationship with the
investigator, Dr. Hood had a conflict of interest with respect to the
joint application under CIRM’s conflict of interest policies.”

The agency's letter said that Weissman would have received $11,000 over five years under the terms of the application, but that it also involved  "creation of a data center at one institution and three research projects that would be undertaken at (Weissman's) institution (Stanford). 
The California Stem Cell Report asked the agency about the involvement of CIRM President Alan Trounson, who has
been a guest at the Montana ranch, and whether he recruited Hood as a
reviewer. Last year, Trounson excused himself from participating in
public discussion of another application involving Weissman.
McCormack said,

“Alan helps recruit many reviewers,
including in this case Dr. Hood, but he is not involved in assigning
reviewers to individual applications.”

The conflict of interest involving Hood
was easily detectable in routine searches on the Internet, including
a Google search on the search term “lee hood irv weissman.” The first
two entries in that search yesterday turned up serious red flags.
Asked whether the agency performed “any
sort of serious examination” of the confidential statements of
interests filed by reviewers prior to review sessions, McCormack said,

“Yes, we do a serious examination of
statements of interest from all our reviewers. However, this conflict
was not identified by the reviewer either in the financial disclosure
statement or identified in the conflict of interest list. Normally we
do not check Google for all possible combinations of 15 GWG reviewers
times about 200 individuals listed in these applications. That would
be about 3000 independent Google searches to identify a possible
conflict.”

The agency's legislative letter said
that it plans to “amend its regulations to add greater clarity in
an effort to prevent future conflicts from arising and to augment its
efforts to educate reviewers, particularly new reviewers.”
Our take?
This is the latest in a series of
questionable activities involving the stem cell agency, which is
trying to come up with a plan to sustain itself after its state
funding runs out in 2017(see here, here and here). The agency is
giving more-than-serious consideration to an effort to raise funds
from the private sector, which can lead to new and more difficult
ethical considerations than a state-funded agency would normally face.
What these questionable activities
demonstrate is that the $3 billion agency needs to give much more
thought, to put it mildly, to its policies ranging from conflicts of
interest to incompatible employee/director activities to the conduct
of top management in providing special treatment for donors.
It also is clear that the statements of
interests of reviewers are not examined closely for their accuracy by
CIRM staff and attorneys. McCormack's remarks clearly indicate that
the agency does not think it has time to be sure that no conflicts
exist among its plethora of reviewers. That is precisely the reason
reviewers' statements of interests – economic, professional and
personal – should be made public rather than kept under wraps
by CIRM. Then, interested parties, presumably mainly applicants, can
check a panel of reviewers, if they wish, for conflicts in a
particular round. Obviously, the agency can and should withhold the
names of reviewers examining a specific application – the release
of the names on the panel in a given review session is sufficient.
Tomorrow the CIRM governing board's
evaluation subcommittee meets privately to discuss Alan Trounson's
performance. It appears to be the second part of an evaluation
process that began last October. Trounson's involvement with Weissman
and Hood -- and his actions in connection with a $21,630 gift from a member of the public, albeit a not-so-ordinary member of the public
-- should also be on the evaluation subcommittee agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/mIVQtkph_JQ/grant-reviewer-conflict-in-40-million.html

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Text of CIRM Comments on Lee Hood Questions

By Dr. Matthew Watson

Here is the full text of the statement
today by Kevin McCormack, senior director for public communications
at the California stem cell agency, in connection with the conflict
of interest issue involving Lee Hood, president of Institute for
Systems Biology
of Seattle, Wash. See here for a story on the matter.

McCormack's comments came in response
to the following questions from the California Stem Cell Report.

“Did (CIRM President Alan) Trounson
recruit Hood to serve on the grants working group?

“Does CIRM perform any sort of
serious examination of the statements of interests of its scientific
reviewers prior to specific review sessions. The conflict involving
Weissman and Hood was easily detected by a Google search. The first
two entries on the search term "lee hood irv weissman"
raise serious red flags. Additionally, I imagine it is more than
common knowledge among many in the scientific community that
these two scientists are longtime friends.”

Here is McCormack's reply,

“Alan helps recruit many reviewers,
including in this case Dr. Hood, but he is not involved in assigning
reviewers to individual applications. Furthermore he expects all
reviewers to declare whatever conflicts they have.  

“Yes, we do a serious examination of
statements of interest from all our reviewers. However, this conflict
was not identified by the reviewer either in the financial disclosure
statement or identified in the conflict of interest list. Normally we
do not check Google for all possible combinations of 15 GWG reviewers
times about 200 individuals listed in these applications. That would
be about 3000 independent Google searches to identify a possible
conflict. While this relationship may be known to some it certainly
was not known to the CIRM staff who checked the conflicts. If it had
been they would have raised it before the meeting.

“It's also important to point out
that Dr. Hood was a new member of this review panel and was not
familiar with our conflict of interest rules. This was clearly a case
of a new reviewer making an innocent error.

“Finally, CIRM’s rules are stricter
than state law, and this would not have been a conflict under
California conflict of interest law.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1ndmVIt2OlQ/text-of-cirm-comments-on-lee-hood.html

To Read More: Text of CIRM Comments on Lee Hood Questions
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Replicating Oregon Cloning in California: Views on the Legality

By Dr. Matthew Watson

Oregon's stem cell cloning achievement
has triggered some discussion about whether it could be replicated
legally in California, which bans paying for eggs as was done in
Oregon.

Stanford researcher Irv Weissman said
it is “not true” that Oregon's stem cell research would be
illegal in California. Leftovers from IVF clinics could be used, he said.
But in response Oregon researcher
Shoukhrat Mitalipov said that “SCNT (the process he used) did not
work with discarded human eggs.”
He added,

 “SCNT worked with eggs from
healthy young volunteers (paid of course). IVF patients (whether paid
or not) have reproductive health problems and may not provide
acceptable quality eggs for SCNT.” 

Weissman said,

 "Not true. They did
it with nearly 40 percent efficiency, which does not require paying
for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal
to pay donors for their eggs in California. The question is whether
the research could be done properly without using paid donors. In recent
years, researchers at Harvard and elsewhere have said they needed paid donors for stem cell research to properly perform their research
and could not find them without providing compensation.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/IimgOYxndkg/replicating-oregon-cloning-in.html

To Read More: Replicating Oregon Cloning in California: Views on the Legality
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Oregon-style Stem Cell Cloning Research Illegal in California: No Pay for Eggs in Golden State

By Dr. Matthew Watson

The good news out of Oregon is that
some diligent scientists in the Beaver State have accomplished a
major advance in stem cell research --- the cloning of human stem
cells.

That bad news is that their research
would have been illegal in California, and probably will be banned
for decades, if not longer – thanks to Proposition 71 of 2004.
The proposition was the ballot
initiative that created the $3 billion California stem cell agency,
which is hailed internationally as being one of the world leaders in
financing stem cell science. Unfortunately, the 10,000-word
initiative also contains language that was aimed at winning voter
approval of the measure -- not promoting good science.
The team writing the initiative, led by
Robert Klein, the former and first chairman of the stem cell agency,
put in a provision that made it illegal to pay women for their eggs.
The Oregon researchers paid women $3,000 to $7,000 each for their eggs, reflecting the current market rate based on prices paid in
connection with IVF. In some cases for IVF, the compensation is
dramatically higher. (See here and here.) Stem cell researchers in
recent years in the United States have found that they cannot secure
an adequate number of donors without matching IVF donor compensation.
While compensation for eggs is a matter
of some controversy, strong cases have been made that women
should make their own decisions about selling their eggs – not the what some call the nanny state. Of course, that should occur under well-regulated
situations. But Proposition 71 backers wanted to remove any possible
campaign objections by opponents of stem cell research, and so they
inserted the ban along with management minutia and other dubious
material.
Can't that be changed, one might ask?
Not without a herculean effort. That means another ballot measure or
a super, super majority vote in the California legislature plus the
signature of the governor. Imagine a measure on the ballot to
allow women to sell their eggs. The uproar would be heard
internationally. In 2004, when Proposition 71 was approved, it would
have been better to leave the compensation issue unaddressed. Then it
could have been dealt with through regulation or normal legislation,
both of which are far more flexible than ballot measures that alter
the state Constitution and state law.
Our quick and limited survey of the
news coverage indicated that many of the mainstream media stories
omitted the price of the eggs, which may suggest that the issue of
compensation is becoming moot.
In related news about the Oregon
accomplishment, UC Davis stem cell researcher Paul Knoepfler has
posted a good look at the some of the misinformation that is
surfacing on the Internet about the research, including its
implications.
He said,

“Keep in mind that on day one of the
iPS cell era in the stem cell field we had a huge number of
misconceptions because we simply had so much to learn. Same is true
here.”

Jessica Cussins over at the
Berkeley-based Biopolitical Times also has a solid roundup of the
coverage of the Oregon research and the analysis of its significance.
Here are links to two blog items from
the California stem cell agency on the Oregon research, including one
dealing with “cloning hysteria” and a more general look.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A4AXZfPs3dc/oregon-style-stem-cell-cloning-research.html

To Read More: Oregon-style Stem Cell Cloning Research Illegal in California: No Pay for Eggs in Golden State
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Weissman Says Oregon-style Stem Cell Research Could be Done in California

By Dr. Matthew Watson

Stanford researcher Irv Weissman says it
is “not true” that Oregon's stem cell research could not be done
legally in California.

Weissman said, 

"Not true. They did
it with nearly 40 percent efficiency, which does not require paying
for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal
to pay donors for their eggs in California. The question is whether
the research could be done without using paid donors. In recent
years, researchers at Harvard and elsewhere have said they needed paid donors to properly perform their research
and could not find them without providing compensation.
We have queried Shoukhrat Mitalipov in
Oregon concerning his views on Weissman's comments. We welcome other
comments as well. Comments can be filed directly by clicking on the word "comment" at the end of this item or you can email them to djensen@californiastemcellreport.com
We should also note the comment from
researcher Paul Knoepfler of UC Davis who notes that SCNT cloning is
permissible in California, which is what was done in Oregon. The
state does ban reproductive cloning, however.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/vlJ5XeK4AOU/weissman-says-oregon-style-stem-cell.html

To Read More: Weissman Says Oregon-style Stem Cell Research Could be Done in California
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