UCLA Snags $3.6 Million from California Stem Cell Agency

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UCLA scored today with at least two grants, totaling $3.6 million, from the California stem cell agency. 

Seeking the cash were Donald Kohn,  application 6823, and Gerald Lipshutz, application 6831. Both of the  grants are for $1.8 million each. 


Their applications were initially in the agency's tier two category, which means that CIRM's reviewers did not approve them outright for funding.  CIRM staff, however, did under a new procedure, and the agency's governing ratified the recommendation. 

Lipshutz also appeared before the board along with several patient advocates who made emotional appeals for funding. Lipshutz's research deals with urea cycle disorders, which occur in one out of 8,200 births. Current treatment is arduous and can involve liver transplants.  

Kohn's research deals with sickle cell disease, which afflicts primarily African-Americans. His efforts are aimed at correcting the sickle gene defect in the blood stem cells before transplanting them back into the patient.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/2AMVhKsdgfc/ucla-snags-36-million-from-california.html

Skin in California’s Stem Cell Game

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The California stem cell agency’s road map to its
financial future makes a big, $200 million assumption.

The amount would be the agency’s skin in the game for a new,
public-private partnership to continue with the agency’s work after 2017, when
its cash basically runs out.

The $200 million figure is contained in the
assumptions for development of the proposed partnership, which is now in the very early stages of being crafted by a Marin County consultant, James Gollub.
He was told that whatever he comes up with can assume a onetime, $50 million to
$200 million public contribution.

The sixty-four-dollar question – to use a term from
the 1940s -- is how to raise that sort of cash. Consider two unappetizing possibilities.
The 29 members of the agency’s governing board could go to Sacramento and ask
lawmakers and the governor to give them the money, a prospect that most of them
would not relish. Such a move would open the door to tinkering or more with the
agency’s structure and operations.  Or
the board could seek more bond financing via a statewide election, requiring an
electoral campaign that would cost many millions to mount. In both cases, there
is no guarantee that funds would be forthcoming. Money is still tight in
California government, and voters may not fancy spending more on stem cell
research, especially if the agency has not delivered on the promises of the
2004 ballot campaign that created the $3 billion program.

A third possibility, however, exists, but it also could
be difficult considering pressures to spend all that the agency has. The
board of the California Institute for Regenerative Medicine (CIRM), as the agency
is formally known, has about $600 million in uncommitted cash. It could take
$200 million off the table and reserve it as seed money for whatever future
plans would involve. Or the board could simply roll back commitments it has
made for lower priority grant rounds – ones that have not yet been initiated.
Some are in concept stages, and others have not yet been posted as RFAs.

Scrimping on existing efforts is not going to suit
the condition of all board members. The question of priorities on spending came
up last month in connection with the agency’s generous, $69 million researcher
recruitment effort that benefits many institutions represented on the agency’s
board. Jeff Sheehy, who is a patient advocate member of the board but also a
communications manager at UC San Francisco, and others bridled at adding more money to the
recruitment program. Sheehy cited scarcity of funds and said it was a “distraction”
from more important efforts. His view, however, did not prevail.
Today the board is scheduled to act on a grant round that is budgeted for $70 million. However, grant reviewers have approved grants
totaling only $37 million. Board members, if they wish, could indicate that the
surplus $33 million be designated as a down payment on the future of the agency
– an organization in which they take great pride.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/H4C5-MLOao4/skin-in-californias-stem-cell-game.html

Stem Cell Agency Pays Tribute to the Late Duane Roth

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The governing board of the California stem cell agency today paid tribute to the late Duane Roth, co- vice chairman of the agency, who died recently as the result of a bicycle accident.

With members of Roth's family present, CIRM Chairman J.T. Thomas characterized Roth, 63, as a "voice of reason" on the 29-member board. The video included testimonials from both staff and board members.

He was described as a "kind person" who could find "common ground" on difficult issues. Roth was deeply involved in San Diego affairs that went well beyond the stem cell agency. More than 1,000 persons attended memorial services for Roth earlier this month in San Diego.

CIRM President Alan Trounson said following the video that he will "miss (Roth) terribly" and expressed  "hope that his memory will lighten and brighten the day for all of us."

Jeanne Loring, a stem cell researcher at Scripps, said Roth "inspired us to do more than we thought we could do." She said he was an unusual kind of businessman who respected science.  "I wish I could thank him one more time," she said.Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Oq2mWojUfsQ/stem-cell-agency-pays-tribute-to-late.html

California Stem Cell Researchers to Receive $70 Million Next Week

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The California stem cell agency is
scheduled to give away $70 million next week as it moves forward on
its efforts to turn research into cures.
As many as 20 grants and loans are
projected to be awarded in the early translation round. The awards will range up to $3.5 million over a three year period.  The round was open to
both businesses and academic institutions. Collaborators from Germany
were involved, although funding for research in that country is not provided by the state stem cell agency.
The applications will come before
the $3 billion agency's governing board at its Aug. 28 meeting in La Jolla. After next week's awards, the agency, which is known as CIRM,  will have about $500
million left to hand out before cash for new awards runs out in 2017.
The agency is currently examining ways to continue its awards with
some sort of public-private partnership.
Also on the board's agenda is a
proposed announcement for a CIRM/industry co-funding agreement. No
further details on that program were available early today on the agenda.
Other matters to be considered include final approval of the changes
in the agency's IP regulations, appointment of new members to the
grant review group and the latest report on the outside contracts
held by the agency. Details on those matters are yet to be posted by
the agency.
A tribute to the late Duane Roth,
co-vice chairman of the agency, is also scheduled. The board will
additionally meet behind closed doors to evaluate the performance of
CIRM President Alan Trounson.
The California Stem Cell Report will
carry more information on the meeting as it becomes available.
In addition to the La Jolla location
for the meeting, other locations where the public can take part in
the meeting are in Menlo Park and Duarte. Specific addresses can be
found on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/rt53_NIUkj8/california-stem-cell-researchers-to.html

Flim-Flam Stem Cell Artists Targeted by CIRM

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The California stem cell agency has
joined with other prestigious stem cell organizations to help put a
stop to the flim-flam artists that prey on desperate people by
promising miracle cures from stem cell treatments.
The agency announced the action today on its blog, declaring that it has posted a new patient advisory document that provides a “ robust and detailed set of issues
patients should consider when making treatment decisions.”
Don Gibbons, CIRM's senior science and
education communications officer and author of the blog item, said
the document addresses one of his special concerns: Internet “ads
that come up on web searches and seem to be offering everything to
everyone.”
Some of those ads can be found on many stem cell-related web sites, including this one, that carry ads that are placed there
automatically by Google.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/MsXTjRpEcFY/flim-flam-stem-cell-artists-targeted-by.html

California Stem Cell Agency Spending: Where the Money Is Going

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Analysis of CIRM funding by Pat Olson, executive director of CIRM scientific activities July 2013
The California stem cell agency will
have committed $472 million to translational research – a key to
commercializing stem cell therapies – if it awards the full $70
million in new grants and loans slated to come before its governing
board next week.
The nearly $500 million will amount to
about 17 percent of its funding so far, according to an analysis last
month by Pat Olson, the agency's executive director of scientific activities. The
largest percentage of the agency's cash, however, will be going for
“development” – 35 percent or $970 million. Olson defined
“development” as “essentially our IND enabling, our
preclinical development programs and our clinical development
programs.”
Basic research is to receive 17 percent
or about $469 million with buildings and facilities taking up $443
million or 16 percent. Training and career development has consumed
about 15 percent or $414 million.
However, those calculations include
$577 million in funds that have been allocated but not yet awarded.
Another $491 million is “concept approved” but also not awarded.
The agency's governing board could change those allocations or
withdraw approval of concepts, although it has not yet shown signs
that it might do so.
The agency will run out of money for
new grants in 2017 and is examining the possibility of generating
more cash through some sort of public-private partnership. To develop
support for continued funding, the agency is under pressure to
generate results that will resonate with the public and potential
private funding sources. Those results are most likely to come from
a late stage translational/clinical trial effort.
Here is a link to CIRM's translational portfolio as of September 2012.

(An earlier version of this item incorrectly said that the agency would run out of money for new grants in 2013. The correct year is 2017,.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/gzZM85Gu0ME/california-stem-cell-agency-spending.html

California Gov. Jerry Brown Vetoes Pay-for-Eggs Legislation

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California Gov. Jerry Brown today
vetoed a fertility industry-backed measure that would have permitted
women to sell their eggs for the purposes of scientific research.
In his veto message, Brown said,

“Not everything in life is for sale
nor should it be.”

The bill would have repealed a ban on
compensation of women who provide their eggs for scientific purposes.
The measure would not have changed existing law that allows women to
be paid for their eggs for IVF purposes with fees that range up to
$50,000. The bill also would not have affected the ban on compensation for
eggs for research that is financed by the $3 billion California stem
cell agency.
The legislation (AB926) by
Assemblywoman Susan Bonilla, D-Concord, was sponsored by the American
Society for Reproductive Medicine and easily swept through the Democratic-dominated legislature. Bonilla said the measure would have placed women on an
equal footing with men, who are paid for their sperm contributions
for research. She also said that it would help to encourage more
research into fertility issues.
Some stem cell scientists have
complained that not enough women are willing to donate eggs without
compensation, but stem cell researchers were not publicly involved in
supporting the bill.
The fertility industry group had
confidently predicted that Brown, a Democrat like Bonilla, would sign the bill. The governor's
action could be overridden by a 2/3 vote of each house of the
Legislature. It is not clear whether Bonilla will make such an
attempt.
Here is the text of Brown's veto
message:

"Not everything in life is for sale
nor should it be.

"This bill would legalize the payment of
money in exchange for a woman submitting to invasive procedures to
stimulate, extract and harvest her eggs for scientific research.

"The questions raised here are not
simple; they touch matters that are both personal and philosophical.

"In medical procedures of this kind,
genuinely informed consent is difficult because the long-term risks
are not adequately known. Putting thousands of dollars on the table
only compounds the problem.

"Six years ago the Legislature, by
near unanimity, enacted the prohibition that this bill now seeks to
reverse. After careful review of the materials which both supporters
and opponents submitted, I do not find sufficient reason to change
course.

"I am returning this bill without my
signature."

You can read more about the bill and
its history here, here, here and here.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1eDn2Is8V8E/california-gov-jerry-brown-vetoes-pay.html

Bonilla: Veto of Pay-for-Eggs Bill Shows Troubling Mindset

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A Democratic state legislator today
assailed Democratic Gov. Jerry Brown's “mindset” as “particularly
troubling” in his veto of legislation that would have allowed women
to sell their eggs for scientific research.
The statement came from Assemblywoman
Susan Bonilla, D-Concord, in response to Brown's action on her
fertility-industry sponsored bill, AB926, which would have removed a
ban on compensation for women who provide eggs for research.
Susan Bonilla
Photo from California Legislature
Brown cited health risks and other issues and said in his veto message,

“Not everything in life is for sale
nor should it be.”

Alex Matthews, writing on Capitol
Weekly, quoted Bonilla as saying,

“It (the governor's veto) shows a
glaring inconsistency...The veto statement was very overreaching in
the fact that it was making very broad statements about what women
should be able to do, and while it's not legislation it certainly
goes to a mindset that the governor has that I find particularly
troubling.”

Bonilla continued,

“Market-driven compensation of donors
by donor agencies and prospective parents continues unchecked.”

In a statement on her website, Bonilla
said the governor's veto “is a regressive action that denies
thousands of women the prospect of medical fertility breakthroughs.”
She said,

“Many women...will be denied hope and
the possibility of giving birth to a child because research on their
behalf has been halted in California.”

Bonilla has argued that women involved
in egg-related research, such as that involving stem cells, should
be compensated, just as men are for their sperm. Women who provide
eggs for fertility purposes can be legally compensated up to any
amount. The current market runs about $10,000 or so per egg cycle but can be much
higher.
Bonilla's measure would not have
affected a ban on compensation involving research funded by the $3
billion California stem cell agency. It would have taken a 70 percent
vote of each house to alter that restriction, compared to a simple
majority for Bonilla's bill. The super, super-majority requirement
was written into state law by Proposition 71, the measure that
created the stem cell agency.
Bonilla did not indicate whether she
would attempt to override the governor's veto, which would require a
2/3 vote of each house.
One of the opponents of the bill, the
Center for Genetics and Society in Berkeley, called the veto a
“welcome development.”
Diane Tober, associate executive
director of the center, said,

“It would be unconscionable to
expand the commercial market in women’s eggs without obtaining
significantly more information about the risks of retrieving them.” 

Here are links to other stories today
on the veto of the bill: Los Angeles Times, Sacramento Bee, an
additional story from late yesterday on Capitol Weekly, TheAssociated Press and National Review.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/j0Fm9p1Ac64/bonilla-veto-of-pay-for-eggs-bill-shows.html

A $6 Billion Question: Progress of the California Stem Cell Agency

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The headlines march like legions across the
Internet and throughout the world.
But then there is this extraordinarily
rare headline that sounds a harshly different note:
All these headlines go to address, in
one form or another, a request/question posed last month by an
anonymous reader of the California Stem Cell Report. The comment came
on an item about the California stem cell agency's $70 million plan
to establish a network of “Alpha” stem cell clinics in
California.
The reader said,

“It would be nice to have an overall
update on how much as been spent on California's stem cell research
project and what progress has been made.”

On the surface, the answer is easy. The
agency has given away $1.8 billion. The agency says it has made
tremendous progress and expects to make even more with the about $600
million it has left. The prestigious Institute of Medicine has said the
agency has “achieved many notable results.”
However, no thorough, rigorous
evaluation has been made of the details of the agency's scientific
contributions, specific grant awards or its impact on the field of
regenerative medicine. No one has attempted to genuinely assess
whether the work of the agency is or will be worth the roughly $6
billion(including interest) that California taxpayers will have paid
for the agency's ambitious efforts.
Then there is the question of “progress
towards what?” Is the progress to be measured against the promises
of the 2004 ballot campaign that resulted in creation of the stem
cell agency or more modest goals that eschew the hype of the
campaign?
The stem cell agency is burdened in a way that most science is not. The 2004 campaign
created a sort of contract with voters. They were led to
believe nine years ago that the cures for diseases that the campaign said afflict nearly
one-half of all California families were, in fact, right around the corner. Few,
if any California stem cell researchers were publicly warning that a
hard and long, long slog remained before therapies reached patients.
Last week, however, Simon Roach of the
British newspapers, The Guardian and Observer, shed some light on the
early, rosy promises of stem cell science compared to the world as it exists
today.
He wrote that in 1998,

“(B)iomedical engineer Professor
Michael Sefton declared that within 10 years, scientists would have
grown an entire heart, fit for transplant. 'We're shooting big,' he
said. 'Our vision is that we'll be able to pop out a damaged heart
and replace it as easily as you would replace a carburetor in a car.'

“Fifteen years on, however, we've had
some liver cells, eye cells, even a lab-grown
burger, but no whole human organs. We could be forgiven for
asking: where's our heart? It does seem strange that a field stoking
so much excitement could be so far off the mark. Speaking last week
about the vision that he and his colleagues outlined in 1998, Sefton
said they had been 'hopelessly naïve.' As time plodded on and an
understanding of the biological complexity increased, the task seemed
bigger and bigger. Even now, a cacophony of headlines later, we are
not much further ahead.

“Chris Mason is a professor of
regenerative medicine at University College London and believes that
concentrating on organ regeneration is missing a trick. 'These organs
are immensely complex,' he said. 'They've got nerves, blood vessels,
in the case of the liver, a bile system – there are huge degrees of
complexity. These things take a long time to grow in humans, let
alone in the lab without all the natural cues that occur in the
growing embryo.'"

The final paragraph in Roach's article
said,

“There's a tension in medical
research between the glory of the big discovery and the
assiduous commitment to real application. 'We're hoping the scope and
possibilities of this project will catch the public's imagination,'
Sefton concluded in 1998. It did, but perhaps the public's
imagination isn't always what science should be vying for.”

Little doubt exists that the California
stem cell agency has made a significant contribution to stem cell
science, although the size of that contribution – beyond dollars –
remains to be measured. For now, the key for the agency and the
public is to focus on activities that will generate the greatest value over the
next few years and advance the science that has already been financed
by the agency.
As the $700,000 Institute of Medicine
report said,

“The challenge of moving its research
programs closer to the clinic and California’s large biotechnology
sector is certainly on CIRM’s agenda, but substantial achievements
in this arena remain to be made.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/O78NzUdZE88/a-6-billion-question-progress-of.html

Duane Roth: Ecumenical Innovator for San Diego and Biotech

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The Xconomy news service today carried
a sterling look at the contributions that Duane Roth, co-vice
chairman of the California stem cell agency, made before his untimely
death as the result of a bicycle accident.
Reporter Bruce Bigelow pulled together
a host of comments concerning Roth's involvement in the San Diego
community, ranging from biotech to action sports companies. The
headline on the piece read, “The Connector Who Wired up a Regional
Innovation Economy.”
At the time of his death at the age of
63, Roth was CEO of Connect, a nonprofit organization that supported
technology and innovation and one that he was credited with reviving.
Bigelow also wrote,

“Once California voters approved a
2004 ballot proposition that authorized the issuance of $3 billion in
grants for stem cell R&D, (Mary) Walshok (associate vice
chancellor for public programs at UC San Diego) said Roth also played
a key role in bringing together UCSD, Scripps, Salk, and
Sanford-Burnham to create the Sanford Consortium for Regenerative
Medicine. In fact, Walshok doubts whether anyone but Duane Roth could
have brought the four major research centers together.”

Another speaker at the memorial
services Friday attended by about 1,000 persons was Bill Walton, the
former UCLA and NBA great, who grew up in San Diego.
Bigelow wrote,

“Walton, the NBA Hall of Famer who
has led San Diego Sports Innovators as a division of Connect since
2010, said Roth became a business mentor to him. In his comments
Friday afternoon, Walton said Roth inspired him to be a better
person, and he counted Roth among the people who had the biggest
influence on his life—a list that included his own father, UCLA
coach John Wooden, sportscaster Chick Hearn, author David Halberstam,
and Jerry Garcia of the Grateful Dead.”

Bigelow described Roth as an ecumenical
and pragmatic advocate for innovation who could work with persons who
did not always agree with him on all issues. He was a conservative
and active Republican, but his co-vice chair at at the stem cell
agency, Art Torres, former chairman of the state Democratic Party, on
more than one occasion has lauded Roth's ability to work together.
Bigelow wrote about similar remarks
Friday by Don Rosenberg, an executive vice president and general
counsel at Qualcomm.

“'Duane and I were as different as
two people can be,' Rosenberg said during his eulogy at the Church of
the Immaculata. 'Duane was born in Iowa, baptized in the Mennonite
church, a Republican. And me, raised in Brooklyn, Jewish, a Democrat.
We quickly learned we had more in common. We were kindred spirits. We
liked the same things: Bikes, biking, cars, and people.'”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/g7BsEVSkzS0/duane-roth-ecumenical-innovator-for-san.html

Californians Top List of Stem Cell Honorees

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Californians dominated the list of those to be honored at the World Stem Cell Summit coming up in San
Diego this December.
They include fellow blogger Paul
Knoepfler, a stem cell scientist at UC Davis, and Roman Reed, the San Francisco Bay Area stem cell activist and son of another stem cell advocate, Don Reed. Both are among the 2013 Stem Cell Action Award honorees for this
year.
Others include Denny Sanford, a
philanthropist whose name now adorns the Sanford-Burnham Institute in
La Jolla, and Malin Burnham, who is also linked to the institute.
Also being honored is Mary Ann Liebert, whose firm publishes
peer-reviewed journals in science and biomedical research.
Malin is a San Diego businessman who
joined with an anonymous donor in 1996 to contribute $10 million to
the La Jolla Cancer Foundation. It was renamed to reflect that
contribution. In 2010, Sanford pledged $50 million to the
organization, and it was renamed again.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1ThJSyU8BBU/californians-top-list-of-stem-cell.html

The Henrietta Lacks Story and Eggs, Money and Motherhood

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The legacy of Henrietta Lacks popped up
again today in a piece in the New York Times that should
resonate among stem cell researchers and within the stem cell
industry.
It even has a current hook involving
California legislation to permit women to sell their eggs for the
purposes of scientific research – a bill that is now on the desk of
Gov. Jerry Brown.
The issues in the Lacks saga involve ownership of human
cells, trafficking in them and informed consent, all of which surface in one form or another in the state legislation.
But first a refresher on Henrietta
Lacks. She was an African-American woman who died in 1951 of cervical
cancer at the age of 31. Shortly before her death, physicians removed
some of her tumor cells, and, as recounted in today's NYTimes article
by Carl Zimmer,

“They later discovered that the cells
could thrive in a lab, a feat no human cells had achieved before.

"Soon the cells — nicknamed HeLa cells
— were being shipped from Baltimore around the world. In the 62
years since — twice as long as Ms. Lacks’s own brief life — her
cells have been the subject of more than 74,000 studies, many of
which have yielded profound insights into cell biology, vaccines, in
vitro fertilization and cancer.”

But Lacks never consented to her cells'
being studied, a situation not uncommon at the time, nor did her
family know about the situation until 1973. The complete story was
chronicled in 2010 in a best-selling book, “The Immortal Life of
Henrietta Lacks," by Rebecca Skloot.
Zimmer noted in today's article,

“For 62 years, (Lacks') family has
been left out of the decision-making about that research. Now, over
the past four months, the National
Institutes of Health has come to an agreement with the Lacks
family to grant them control over how Henrietta Lacks’s genome is
used.”

The particulars involving her genome
are in Zimmer's story. But the article implicitly raises anew
questions that make many scientists uncomfortable. Often they contend
that the situation involving Lacks could not occur today because of
higher ethical standards. Standards ARE higher today. But problems
continue to arise in the scientific community, including the sale a few years ago of willed body parts at UCLA for $1.5 million to private medical companies.
Development of products based on human
stem cells promises even greater rewards, with billion-dollar
blockbuster therapies not out of the range of possibilities. Profit
and the desire to record a stunning research triumph are powerful
motivators. They can lead to short cuts and dubious practices, such
as seen in the Korean stem cell scandals of 2006.
So we come to whether women who donate
their eggs for stem cell research can give truly informed consent
when they surrender all rights to whatever products may result from
parts of their bodies, as is common on such consent agreements. Or
for that matter, what about the men who give up adult cells for
reprogramming to a pluripotent state? Can they really understand the
likelihood of a billion dollar product being generated with the help
of their contribution? On the other hand, can the donors also truly
understand that they are probably more likely to be struck by
lightning than have their body parts result in a medical blockbuster?
These considerations may seem
insignificant to some in science. But to grasp their full
implications, one only has to read a few of the nearly 200 reader
comments today on Zimmer's article today. Here is a sample.
From Frank Spencer-Molloy in
Connecticut:

“(T)the Lacks family was robbed.
Scores of companies profited to the tune of tens of millions of
dollars from products they made derived from Henrietta Lacks'
cancerous cells. Maybe this will provide some impetus to a wider
consideration of the rights patients are entitled to when their
tissues are cloned and disseminated to other researchers and
ultimately put to use in profit-making ventures.”

From Robbie in New York City:

“At the very least, this family needs
to be financially compensated for the anguish of their discovery and
for the time and energy they've put into pursuing their rights. In my
opinion, they also deserve a portion of any commercial gain that's
been made using the HeLa cells. It is only through having to give
away money that the powerful learn manners.”

From Julia Himmel in New York City:

“It is absolutely true that
scientists have had a blind spot when it came to the human element of
the HeLa cells.”

The pay-for-eggs legislation (AB926)
now before Gov. Brown requires informed consent from those who
provide eggs. Opponents of the measure, however, argue that truly
informed consent from some women could be actually impossible because
of economic pressures felt by the women. Writing in The Sacramento Bee last month, Diane Tober and Nancy Scheper-Hughes said,

“Allowing a market in eggs for
research would reach beyond the current pool to target women who may
be motivated by dire need. How many low-income women might consider
selling their eggs, multiple times, to feed their children or pay the
rent?”

Even the fertility industry group
sponsoring the legislation acknowledges that informed consent can be
problematic. A 2012 news release from the American Society for
Reproductive Medicine said, 

“Prospective egg donors must
assimilate a great deal of information in the informed consent
process, yet it remains difficult to determine the extent of their
actual understanding of egg donation and its potential risks.”

The story of the treatment of Henrietta
Lacks and her descendants is a poor commentary on science and
medicine. Yet it resonates with the public, which is keenly sensitive
to scientific and medical abuses, even in situations that did not
appear to be abuses at the time.

Stem cell research already is burdened by its own
particular moral and religious baggage. With
commercialization of new, pluripotent stem cell therapies coming ever
closer, the last thing the field needs is contemporary version of the
Lacks affair. It would behoove researchers and the stem cell industry
to walk with more than normal care as they manipulate products that
are tied inextricably to visions of both motherhood and money.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/oncdCzO4V18/the-henrietta-lacks-story-and-eggs.html

California Stem Cell Agency on Lacks: Informed Consent Cannot Remove All Questions

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(Photo and caption from the stem cell agency blog item this morning.)
The $3 billion California stem cell
agency today weighed in on the Henrietta Lacks-NIH arrangement
restricting the use of her cell lines in research.
Writing on the agency's blog, Geoff
Lomax, the agency's senior officer for its standards group, noted
that the DNA sequence of her cell line was published without the
knowledge of her descendants. Lomax said,

“The family was understandably upset
by the lack of consultation and in response the research team removed
the genome data from public access.”

Lomax continued,

“CIRM has benefited from these
efforts. We are currently supporting an initiative to collect tissue
samples from thousands of people with a range of incurable diseases
and create reprogrammed iPS cells from those tissues (here's
more about that initiative). These cells will be a resource for
scientists worldwide working to understand and treat diseases. Part
of this initiative includes a consent process to make sure people who
donate fully understand how their cells will be used. (This process
is formally called informed consent.) 

“The informed
consent process includes a form that identifies the purposes of the
research and describes the way cells will be used. We are also
developing education materials that will help potential donors
quickly and easily understand the basic aspects of research that will
be conducted with those cells. The end result of this collaboration
with our grantees will be a process that is truly informative to
donors.

“The informed consent process can’t entirely
eliminate all future questions on the part of the donor, but it does
ensure that donors have a chance to understand how their cells will
be used and what information will be made public—something
Henrietta Lacks and her family never had.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8PQGYcYpszg/california-stem-cell-agency-on-lacks.html

Pay-for-Eggs Legislation: A Comment on Risk

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The author of the Forbes piece cited in
the eggs legislation item today has responded to a comment filed
by two persons opposed to the measure that would remove the ban in
California on paying women for their eggs for scientific research.
Here is the text filed by Jon Entine,
executive director of the Genetic Literacy Project.

“Diane and Nancy, I'm shocked that
you are either unaware or do not acknowledge that there are studies
of oocyte retrieval surgeries that show very persuasively that the
potential harm from this procedure is manageable. While you refer to 'stories' of women being harmed--that's called anecdotal
evidence and is the antithesis of science--you ignore the established
research in this area, which makes it clear that you are reacting
hysterically rather than responding to empirical evidence. I would
suggest that you read the National Academies Press workshop report:
Assessing the Medical Risks of Human Oocyte Donation for Stem Cell
Research (http://www.nap.edu/catalog.php?record_id=11832).
It cites numerous studies, including a German study that examined the
outcome of approximately 380,000 oocyte retrieval surgeries during
2000-2004. For the procedures for which there was information, the
rate of complications was very low: only 0.002 percent—2 in every
100,000—had complications that required surgery to correct.

“Studies have also examined the
potential risks of retrieval for a woman's future fertility.
“According to one large study, the
rate of infection after oocyte retrieval was about 1 in every 200 IVF
cycles, and surgery is needed to treat pelvic abscesses in less than
1 in 1,000 IVF cycles. 

“About five hundred egg donations
take place in Canada each year, according to the Canadian Fertility
and Andrology Society.The CFAS told me that, between 2001 and 2010,
only two donors in Canada, out of a total of 4,177 donations,
suffered from “severe” OHSS, which usually involves
hospitalization. Fourteen others had “moderate” OHSS. These
numbers are collected in a database called the Canadian Assisted
Reproductive Technologies Registry.

“So sure, you can find your 'stories' but they do not represent a scientific review of the available
data--you are trying to legislate based on fear. That's not science;
that's the dark ages, and it's exactly the tactics used by
anti-abortionists (and indeed by organizations like the Center for
Genetics and Society which opposes such beneficial advances as
mitochondrial replacement surgery).

“Furthermore, because women have a
set of two ovaries and two fallopian tubes, they can remain fertile
even if one set is damaged, and there is no evidence that both might
be threatened simultaneously by the side effects of retrieval
surgery. 

“Today doctors have had two decades
of experience with the use of hormone treatments to maximize the
number of eggs that can be harvested from a woman, and they have
become quite proficient in the production of oocytes. During that
time they have also worked to improve the safety of the procedure and
decrease the potential risks. Despite these improvements some risk
will remain, because hormones have a powerful effect on the body—they
could not increase egg production so dramatically if this were not
true—and anything with a powerful effect on the body has the
potential for harmful side effects as well. 

“Egg donations are done for a reason.
There are risks and benefits. For you to exaggerate the risks based
on 'stories' and ignore the evidence is unconscionable.
It's exactly what anti-abortion groups do and what opponents of
genetically modified foods do--you promote fear around manageable (or
in the case of GMOs, negligible) risk. 

“Your call for 'further studies' is the age old technique of reactionaries trying to control other
people and impose their values on other people. You know darned well,
because of your fundamental ideological opposition to this procedure,
no study results could ever meet your standard of acceptability. 

“You are trying to control other
women's bodies, claiming you have superior knowledge and
wisdom--those are pro-life talking points. Your views, and that of
the organizations that you represent, are illiberal.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ib44Z4ZI-j0/pay-for-eggs-legislation-comment-on-risk.html

Memorial Services Friday for Duane Roth, Co-vice chairman of the California Stem Cell Agency

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A memorial service for Duane Roth,
co-vice chairman of the California stem cell agency, will be held
Friday at 11 a.m. at Immaculata Church at the University of San
Diego.
Roth died Saturday from injuries
suffered in an accident last month while bicycling in the mountains
east of San Diego. He was 63.
San Diego has seen an outpouring of
tributes in the wake of Roth's death for his contributions to the
community in the life sciences, philanthropic and technology areas.
He had served on the stem cell agency board since 2006 and had been
scheduled to become of chairman of the Sanford-Burnham Institute this
fall. He was CEO of Connect, a non-profit organization aimed at
support entrepreneurship in the technology field.
Ted Roth, Duane's brother, remembered him in a piece in the San Diego U-T as the oldest of five sons growing up in Wayland, Iowa. Ted Roth wrote that their parents relied on Duane "to set an example for his brothers, and he
was the one they called upon in their later years. He was a lifelong
mentor and friend to his brothers, someone that was always there to
share in life’s experiences." 
Ted also wrote about his brother's involvement in technology and business.

 "Duane was captivated by the possibilities that innovation provides in improving the world in which we live." 

The
family has
suggested that in lieu of flowers that donations be made to the Otterson Fund at Connect, Challenged Athletes Foundation or the Copley-Price Family YMCA.
Here are links to some of the other recent
articles on Roth: San Diego U-T (see here and here), La Jolla Patch,
La Jolla Light.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Bui3CXvil70/memorial-services-friday-for-duane-roth.html

Pay-for-Eggs Legislation Now Before California Gov. Jerry Brown

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California's pay-for-eggs bill is now
officially on Gov. Jerry Brown's desk, awaiting his signature or
veto.
The measure, AB926 by Assemblywoman
Susan Bonilla, D-Concord, was sent to the governor at 4:45 p.m. PDT
yesterday. On July 1, it easily won legislative approval and
has been held in legislative processing since then. The governor has
12 days to act on the measure or it becomes law without his
signature.
The legislation would remove the state
ban on payment to women for their eggs for scientific purposes.
Currently women who provide their eggs for fertility purposes can be
compensated. Fees run as high as $50,000 in some cases, depending on
the characteristics of the woman providing the eggs, but generally
are in the $10,000 range or less. The bill does not affect the ban on
the use of funds from the California stem cell agency to compensate
egg providers.
Bonilla's bill is sponsored by the $5
billion-a-year fertility industry, which is backing it on motherhood
and sexual equity grounds. Supporters say women should receive
payment for their eggs just as men are paid for their sperm. They
also argue that more eggs are needed for research into fertility
problems. In the stem cell field, scientists have also said it is
nearly impossible to find women who will provide eggs unless they are
paid.
Opponents contend that the process of
stimulating production of eggs can be risky or dangerous. They say
that the longterm effects of the process have not been studied well.
They also argue that it will lead to exploitation of low income and
minority women to produce eggs that then can become a profitable
commodity for the largely unregulated fertility industry. (For more
informationon on the bill, see here, here and here.)
In one op-ed piece in The Sacramento
Bee, opponents cited the late philosopher Ivan Illich, who was much admired by Jerry Brown, who considered him a friend. Illich was quoted as warning "against the processes of medical
industries which 'create new needs and control their satisfaction and
turn human beings and their creativity into objects.'"
The industry group says, however, that Brown is
committed to signing the bill.
The measure surfaced in the news
yesterday in an article on the Forbes magazine website by Jon Entine.
He wrote,

“Should activist groups, working
through legislators, exercise their control over women’s
reproduction? Do we really 'own' our own bodies? Or does that tenet
only hold when nanny groups say it’s okay?”

(One of the authors of The Sacramento Bee op-ed piece criticized in the Forbes article later filed a comment concerning their position.)

The egg legislation may have implications for
regulation of stem cell research by the state Department of Public
Health(again not involving the California stem cell agency). Last
month the California Stem Cell Report asked Hank Greely, a Stanford
law professor and chair of the state department's Human Stem Cell Research Advisory Committee, about the measure. He replied,

“Well, if (when?) AB 926 is signed, I
think our committee should meet to consider what recommendations we
would make to the (the department) as a result of the bill.  Those
recommendations could lead, if the committee and the department
agree, to a revision of the state guidelines.  As a matter of
law, a statute, particularly a subsequent statute, trumps a guideline
where they are in conflict, but basically I expect we'll see what the
committee thinks and what the department decides.  I don't wish
to guess at the results of either process.”

Another question that was not discussed
publicly during the debate on the legislation deals with whether human eggs provided with compensation would be subject to state sales tax at any stage in the process. A check of the tax code, however, makes it
clear that eggs are tax free. The code states that “any human body
parts held in a bank for medical purposes, shall be exempt from
taxation for any purpose." The definition of “bank”
includes research facilities, and "medical purposes" includes research.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/sZ_beYvQCX8/pay-for-eggs-legislation-now-before.html

Comment re Pay-for-Eggs Item and Forbes Article

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One of the authors of an op-ed piece in The
Sacramento Bee has filed a comment in connection with an item today on the California Stem Cell Report. The item dealt with the California pay-for-eggs bill, which was also the subject of an op-ed piece in The Sacramento Bee as well as an article yesterday on the Forbes
magazine website that discussed the op-ed piece critically.
A quotation from the article was contained in this item earlier
today.
Here is the text of the comment from
Nancy Scheper-Hughes, a professor of anthropology at UC Berkeley and
director of Organs Watch.  Diane Tober, associate executive director of the Center for
Genetics and Society of Berkeley, was the other author.

“Dr. Diane Tober and Prof. Nancy
Scheper-Hughes  are 'pro choice'  social scientists who are
concerned about the absence of any evidence-based medicine on the
long term effects of hyper-stimulation for oocyte (egg) production in
young women research subjects. We are not concerned about abortion,
right to life, or obstructing  needed and valuable research on
stem cells. We are concerned about the safety for potential research
subjects who are being actively recruited to participate in
 invasive medical procedures without any medical research
studies on the possible risks and consequences of egg multiplication
and extraction. We are on record that we  fully support stem
cell research but not at the expense of unprotected egg donors.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/CdOjDrBctTE/comment-re-pay-for-eggs-item-and-forbes.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

'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

Skimpy Coverage of Alpha Clinic Concept Approval

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News coverage of approval of the
California stem cell agency's ambitious, $70 million Alpha clinic
plan has been quite light but does include one article in the Los
Angeles Times, the state's largest circulation newspaper.
The concept proposal was ratified last
week by the agency's board with RFAs scheduled to be posted in
October. The agency is seeking to build a basis for a robust stem
cell clinic business in California that would have an international
reach and give the state dominance in the industry.
Karen Kaplan's story in the Times last
week quoted CIRM President Alan Trounson as saying in 2010 about
agency's goals.

“If we went 10 years and had no
clinical treatments, it would be a failure. We need to demonstrate
that we are starting a whole new medical revolution.”

The stem cell agency was created by
voters in 2004 and funded with $3 billion in borrowed money. It will
run out of funds for new grants in 2017.
Outsourcing-Pharma.com caught up with
the plan this week in a story that said,

“The opportunity to run trails under
the well-funded CIRM could be a boon for CROs (contract research
organizations)....But the difficulties of handling the stem cells and
gathering enough patients to enroll in a trial may prove daunting for whatever
company tries to conduct the trials.”

The article also quoted CIRM spokesman
Kevin McCormack as saying,

 “No one has reached out to us yet
because the specific details of what we are looking for in the
clinics have not yet been decided.”

That said, considerable information is
available here, here, here, here and here.)
Also reporting on board approval of the
Alpha clinic plan was GenNews.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/g-INer3wY50/skimpy-coverage-of-alpha-clinic-concept.html