California Stem Cell Agency on Lacks: Informed Consent Cannot Remove All Questions
By Dr. Matthew Watson
 |
| (Photo and caption from the stem cell agency blog item this morning.) |
agency today weighed in on the Henrietta Lacks-NIH arrangement
restricting the use of her cell lines in research.
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.”
“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:
Stem Cell Therapy
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August 11th, 2013
Californians Top List of Stem Cell Honorees
By Dr. Matthew Watson
Diego this December.
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.
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.
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.
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
By Dr. Matthew Watson
again today in a piece in the New York Times that should
resonate among stem cell researchers and within the stem cell
industry.
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.
cells, trafficking in them and informed consent, all of which surface in one form or another in the state legislation.
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.”
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.
“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.”
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.
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.
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?
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.
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.”
“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.”
“It is absolutely true that
scientists have had a blind spot when it came to the human element of
the HeLa cells.”
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?”
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.”
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.
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.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/oncdCzO4V18/the-henrietta-lacks-story-and-eggs.html
Stem Cell Therapy
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August 11th, 2013
Skloots, Collins and More on Henrietta Lacks’ Cell Line Deal
By Dr. Matthew Watson
arrangement involving Henrietta Lacks' cell line emerged today in a
wide range of publications, including a Nature journal piece that
said it was not a precedent.
Collins, head of the NIH, and Kathy Hudson, deputy director for
science, outreach and policy at the NIH.
“It is important to note, however,
that we are responding to an extraordinary situation here, not
setting a precedent for research with previously stored,
de-identified specimens. The approach we have developed through
working with the Lacks family is unique because HeLa cells were taken
and used without consent, and gave rise to the most widely used human
cell line in the world, and because the family members are known by
name to millions of people.”
lines came about after a flap erupted about their recent use without
the knowledge of her descendants. (The California Stem Cell Report carried a commentary on it yesterday.) Rebecca Skloots, author of the
best-seller, “The Immortal Life of Henrietta Lacks,” wrote about
the controversy in a March 23 op-ed piece in the New York Times. She
said,
“Imagine if someone secretly sent
samples of your DNA to one of many companies that promise to tell you
what your genes say about you. That report would list the good news
(you’ll probably live to be 100) and the not-so-good news (you’ll
most likely develop Alzheimer’s, bipolar disorder and maybe
alcoholism). Now imagine they posted your genetic information online,
with your name on it. Some people may not mind. But I assure you,
many do: genetic information can be stigmatizing, and while it’s
illegal for employers or health insurance providers to discriminate
based on that information, this is not true for life insurance,
disability coverage or long-term care.
“'That is private family
information,” said Jeri Lacks-Whye, Lacks’s granddaughter. “It
shouldn’t have been published without our consent.'”
“This has wrapped in it science,
scientific history, ethical concerns, the bringing together of people
of very different cultures, a family with all the complications that
families have.”
morning, Ron Winslow described the arrangement with the NIH like
this.
“Under the pact, two descendants of
Ms. Lacks will serve on a six-member panel with scientists to review
proposals from researchers seeking to sequence the DNA of cell lines
derived from her tumor or to use DNA profiles of such cells in their
research. That gives family members a highly unusual voice in who
gets access to personal health information.
Terms call for controlled access to the
genomic data and credit to the Lacks family in papers and scientific
presentations based on the research done with the DNA data.”
Skloots, who was involved in the Lacks-NIH negotiations, said the
Lacks family asked for her participation.
“The only reason I was involved in
this is because scientists did this without the family’s consent
and then it got all of this press coverage, and no one asked the
question, 'Did the family give consent?' So I sort of waded back
in.”
“That OpEd that I
wrote was the first time I’d ever publicly expressed an opinion,
which was, 'Really?!? Are we going to continue to not ask the Lacks
family questions?' I was kind of shocked in a sense that nobody
thought to raise that issue.”
Source:Stem Cell Therapy
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August 11th, 2013
Memorial Services Friday for Duane Roth, Co-vice chairman of the California Stem Cell Agency
By Dr. Matthew Watson
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.
suffered in an accident last month while bicycling in the mountains
east of San Diego. He was 63.
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.
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."
"Duane was captivated by the possibilities that innovation provides in improving the world in which we live."
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.
articles on Roth: San Diego U-T (see here and here), La Jolla Patch,
La Jolla Light.
Source:Stem Cell Therapy
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August 11th, 2013
CIRM’s Roth Dies Following Bike Accident
By Dr. Matthew Watson
California stem cell agency, died yesterday from brain injuries
suffered in a bicycle accident two weeks ago.
 |
| Duane Roth, Connect photo |
organization aimed at fostering technology entrepreneurship,
succumbed yesterday afternoon at the UC San Diego Medical Center, the
San Diego U-T reported. He was 63.
while biking in the mountains east of San Diego July 21. Roth hit an
outcropping and his helmet was broken in the accident.
29-person governing board of the $3 billion California stem cell
agency and was a strong advocate for industry. He chaired the
agency's loan task force, was vice chair of the Intellectual Property
and Industry Engagement Subcommittee and a member of the executive
committee.
agency, released the following statement this morning.
“On behalf of all the CIRM family, we
mourn the loss of our colleague and dear friend Duane Roth.
Throughout his tenure with us, he was one of the true stewards of the
mission, offering countless insights on the role of industry in the
world of regenerative medicine and how best and efficiently to drive
therapies through to patients. He was unfailingly a voice of
reason and optimism and always sought to find ways to make things
happen, refusing to take 'no' for an answer. Though one of 29
Board members, his extensive participation as co-Vice Chair of the
Board, co-chair of Intellectual Property and Industry Engagement
Subcommittee and a member of our Executive Committee gave Duane a
singularly important and resonant voice in our organization.
His passing will be deeply felt by all of us as well as by the many
patients and other CIRM stakeholders whom he touched over the years.
We send our deepest sympathies to Renee, Duane's brothers and the
rest of the Roth family.”
funds for cancer, and reporter Bradley Fikes wrote in the San Diego
U-T,
“Contributions in Roth’s name can
be made to Pedal
the Cause, a fund-raiser for cancer research that Roth supported.
More than $10,000 has been raised since Roth's accident."
Source:Pay-for-Eggs Legislation: A Comment on Risk
By Dr. Matthew Watson
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.
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:Pay-for-Eggs Legislation Now Before California Gov. Jerry Brown
By Dr. Matthew Watson
officially on Gov. Jerry Brown's desk, awaiting his signature or
veto.
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.
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.
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.
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.)
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.'"
committed to signing the bill.
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?”
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.”
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:Stem Cell Therapy
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August 4th, 2013
Comment re Pay-for-Eggs Item and Forbes Article
By Dr. Matthew Watson
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.
today.
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:Stem Cell Therapy
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August 4th, 2013
Skimpy Coverage of Alpha Clinic Concept Approval
By Dr. Matthew Watson
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.
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.
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.”
voters in 2004 and funded with $3 billion in borrowed money. It will
run out of funds for new grants in 2017.
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.”
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.”
Alpha clinic plan was GenNews.
Source:Stem Cell Therapy
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August 4th, 2013
California Stem Cell Agency Looking for New Home in Two Years
By Dr. Matthew Watson
 |
| The California stem cell agency is located south of Market Street in San Francisco, close to the San Francisco Giants ballpark(upper right). Since the agency has been there, the area has grown from seedy to gentrified. |
San Francisco involving the $3 billion California stem cell agency.
science efforts but everything to do with where it is located and its
overhead expenses. The agency will be forced out of its free office
space – 20,000 square feet – in two years. The free space was
provided under an $18 million recruitment package and is worth at
least $1 million a year, according to the agency's auditors.
office-space market is sizzling hot. Google, Yahoo, Microsoft and
other technology firms are scrambling for space in
Baghdad-by-the-Bay, as the city is sometimes known. According to a story this morning by James Temple in the San Francisco Chronicle,
the firms are looking for a total of about 800,000 square feet and
are prepared to pay well for it.
Yahoo would cost about $48 per square foot for a 10-year lease. If
CIRM paid at that rate, it would have nearly $1 million in additional
costs annually. However, leasing rates are expected to rise substantially in the next year or so. Also involved in a move would
be the cost of parking, which could run about $360,000 a year.
examining its options for new offices, including some sort of special
deal with the City of San Francisco.
chairman of the state Democratic Party and co-vice chairman of CIRM,
briefed agency directors on the matter at its meeting in May. He
said,
“I met with the mayor of San
Francisco(Ed Lee), who's a dear friend, and he encouraged us to be
aware that he's very committed to helping us find some space in San
Francisco. Whether it means tax credits or incentives to a potential
landlord, we still have to work that out. Obviously we still have to
work out what the space will be. But the fact that the mayor has
indicated very explicitly that he wants to keep us in San Francisco,
I think it will bode well for us down the road.“The current owner of the property
(Stockbridge Capital Partners) has not been happy that for ten years
they've had to supply free rent to us. And what they didn't
anticipate was having to provide for over $755,000 in operating
costs, which they thought some donors would take are of. Those donors
-- some of whom passed away and others who chose to give money to
other institutions, UC San Francisco, in particular, to the stem cell
lab, which was very much appreciated, I know, by UCSF – but at
the end of the day, there's no room for negotiations with this
current owner.”
Torres whether future rent would also be free. Torres, who is also
president of San Francisco's Public Utilities Commission, replied,
“I would not work on that assumption.
I would work on the assumption somewhere between a dollar and more,
again, dependent upon what kind of tax incentives the City of San
Francisco would provide. We're very fortunate that my son(Joaquin
Torres) is the deputy mayor for economic development, so we also have
him working on this as well.”
“I'll ask more questions offline.”
Source:Stem Cell Therapy
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August 4th, 2013
California Stem Cell Official Duane Roth in Improving Condition
By Dr. Matthew Watson
California stem cell agency, is improving after he was hospitalized
for treatment of a serious brain injury sustained in a bicycle accident Sunday in
the mountains east of San Diego.
Roth's brother, Ted, said yesterday,
“Were certainly moving in the
right direction. We're now looking at the recovery phase.”
has passed through the most critical period following surgery at the
UC San Diego hospital.
Diego technology organization, Connect, is in serious condition in a
medically induced coma.
stem cell agency yesterday took special note of Roth at its meeting and sent its best wishes to him and his family.
Source:Stem Cell Therapy
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July 28th, 2013
Another $23 Million to Recruit Star Stem Cell Scientists to California
By Dr. Matthew Watson
stem cell research stars to the Golden State was expanded today by
another $23 million.
approved the funds on a 14-4-1 vote. CIRM directors Jeff Sheehy and
Francisco Prieto were among those opposing the move. Prieto declared,
“We are coming up against finite resources. We have better ways to spend
our money."
Sheehy said that CIRM is contributing to inflation in stem cell science with its lucrative recruitment grants.
institutions that have not already benefited from one of the earlier
grants in the program. Up to four awards are expected to be made.
said,
“A number of California institutions
have not yet been able to secure a confirmed Research Leadership
award but would benefit greatly from the recruitment of emerging or
established leaders in stem cell biology. Participation in the CIRM
program could bring additional, exceptional researchers to
California, strengthen and synergize with other efforts to build up
local sustained research communities in stem cell biology and
medicine and provide ongoing leadership at the cutting edge of
California regenerative medicine.”
involved with the winning researchers have representatives on the
governing board of the stem cell agency. They are not allowed, however, to vote
on grants to their institutions or researchers -- only on proposals such as today's $23 expansion.
final approval scheduled for next May. The program is not open to
businesses.
Source:Stem Cell Therapy
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July 28th, 2013
California Stem Cell Agency Launches $70 Million Alpha Stem Cell Clinic Project
By Dr. Matthew Watson
The California stem cell agency today approved
a $70 million plan to create a network of “Alpha” stem cell
clinics that is aimed at making the Golden State one of the leading
purveyors and developers of stem cell therapies in the world.
Institute for Regenerative Medicine (CIRM)adopted the plan on a 19-1 vote. The negative vote came from Joan Samuelson, who questioned
whether the plan was premature and whether existing scientific research justified development of the clinics.
former head of a Hollywood studio, said the proposal is “one of the
most exciting proposals that we have ever had in front of us.” She
said it was the “beginning of this dream coming true.”
CIRM President Alan Trounson has been promoting for two years, the
agency will finance five stem cell clinics at established
institutions in California with grants of up to $11 million. Another
$15 million will be allotted for a stem cell information and
coordination center. Major matching contributions will be expected
from award winners over the five-year terms of the grants.
clinical trials and patients from the around the world and creating a
central bank of knowledge, know-how and regulatory expertise. It
will also guide efforts to build profits into stem cell therapies
and to develop strategies to attract investors and philanthropists.
(For more information on the plan, see here, here, here, here and
here.)
“These clinics have the potential to
revolutionize how we deliver stem cell therapies to patients. Stem
cell therapies are a completely new way of treating diseases and
disorders so we need a completely new way of delivering those in a
safe and effective manner. These clinics will help us do just that
and the clinical trials carried out in this network will fulfill the
agency’s promise of bringing new therapies to patients who need
them.”
reported that the Alpha clinics would be the first-ever “clinical
trials network focused around a broad therapeutic platform.”
comment on the plan other than the remarks by Samuelson. . However,
not everyone sees a need for it. Mahendra Rao, director of the Center
for Regenerative Medicine at the National Institutes of
Health(NIH) , says its surveys of researchers have not shown a demand
for such centers. In May, a researcher at institution that likely
would be an applicant filed a blistering, anonymous comment on the
California Stem Cell Report, describing it as a "boondoggle" and "irresponsible." The scientist said,
“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.”
“The 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.”
go out in October and approval of funding coming one year from now. Here is the link to today's CIRM press release on the plan.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/EBbBzLL9dQQ/california-stem-cell-launches-70.html
Stem Cell Therapy
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July 28th, 2013
Coming Up: Live Coverage of Today’s California Stem Cell Meeting
By Dr. Matthew Watson
provide live, wall-to-wall coverage of today's meeting of the
governing board of the $3 billion California stem cell agency.
million proposal aimed at creating a string of Alpha stem cell clinics in
California that would serve as a foundation for the state's stem cell
business. Also on tap are other proposed grant programs, including a
$23 million expansion of a researcher recruitment effort and a $35 million round aimed at removing roadblocks to turning research into
cures.
throughout the day based on the Internet audiocast of the proceedings.
on the meeting via the Internet. Instructions can be found on the agenda.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Vi8IGlL2TzY/coming-up-live-coverage-of-todays.html
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July 28th, 2013
Stem Cell Lines and Paid-for Eggs: Stem Cell Agency Delays Action on Easing Restrictions
By Dr. Matthew Watson
agency today balked at approving a plan to ease restrictions on
using stem cell lines derived from women who were paid for their
eggs.
taken up tomorrow by the governing board of the $3 billion agency,
but the board's standards working group delayed action.
McCormack, a spokesman for the agency, said in an email,
“It was felt that more discussion
was needed before moving to a vote so another meeting is going to be
scheduled.”
approved regulations that banned the use of CIRM funds for stem cells
lines derived using compensation. That rule would be modified under
today's plan, which would permit the CIRM governing board to approve
the use of such lines following a staff study evaluating scientific and ethical issues.
Their use would be allowed if the lines would “advance CIRM's
mission.”
The delay came after four
organizations, including the Center for Genetics and Society in
Berkeley, argued that the plan is vague and did not adequately
address safety issues.
said that the plan does not appear to have met “numerous concerns”
raised in 2009 in a document co-authored by the CIRM staff. Those
concerns include long-term risk and ethical issues.
that the agency governing board
“...will decide whether to approve a
grantee’s request to use a stem cell line created with paid-for
eggs on the basis of whether doing so 'will advance CIRM’s
mission.' This criterion is much too vague, and doesn’t include
consideration of the health or welfare of the women who undergo egg
retrieval. Protecting the well-being of women providing eggs is not
even mentioned (though perhaps it could be considered as an element
of the fifth of five 'factors to be considered by the ICOC(the agency
board),' 'whether the donation…was consistent with `best practices’
at the time of donation').”
The standards group also heard from a
UCLA researcher who argued on behalf of the change. Kathrin Plath
said she and her colleagues wanted to use a paid-for stem cell line
from the Oregon experiment that cloned human stem cells.
the four organizations.
Source:Stem Cell Therapy
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July 28th, 2013
$70 Million Alpha Stem Cell Clinic Project Garners Mainstream Media Attention
By Dr. Matthew Watson
chain of “Alpha” stem cell clinics today received its first major
attention from the mainstream media.
circulation newspaper, appearing this morning on the home page of the
website of Los Angeles Times.
around the state and a coordination/information center under a
concept that comes before the governing board of the state's $3
billion stem cell agency at its meeting tomorrow in Burlingame, Ca. Funds could be
awarded as early as a year from now. (For more information, see here
and here.)
DeWitt, special projects officer for CIRM, as the stem cell agency is known, and Maria Millan, a CIRM
medical officer. Brown wrote,
“Clinics to conduct trials of stem
cell therapies have different needs than clinics designed to deliver
conventional therapies, DeWitt and Millan said. They need special
facilities for handling the cells safely, as well as imaging
equipment to track the cells once they're delivered into a patient’s
body. Some of this infrastructure already exists, but other
parts of it still need to be perfected. Establishing clinics to
house multiple trials might create the critical mass needed to get
the infrastructure in place, they said....
"Additionally, they said, CIRM
hopes that such collaboration would encourage stem cell companies to
share information -- speeding their own work and also helping out
policymakers and insurers who are trying to figure out how they'll
pay for stem cell therapies in the future.”
California Stem Cell Report as saying last week,
“The Alpha clinics
are aimed at creation of a sturdy foundation for the stem cell
industry in California, capitalizing on the burgeoning, international
lure of stem cell treatments.”
clinics at major, established institutions around the state. It is
possible that two could be located in the Los Angeles area at
institutions such as UCLA, USC, Cedars-Sinai or the City of Hope, all
of which have representatives on the stem cell agency's governing
board. Other likely locations are in the San Francisco Bay area and
San Diego, again at facilities such as Stanford, UC San Francisco and
UC San Diego that have representation on the agency board.
including businesses, will be subject to closed-door. peer review
prior to final action by the full governing board.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/s_-mm4nTU_0/70-million-alpha-stem-cell-clinic.html
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July 28th, 2013
UCLA Researcher Calls for Easing of Restrictions on Stem Cell Lines Derived from Eggs From Paid Providers
By Dr. Matthew Watson
support of a proposal to allow use of California stem cell agency
funds to purchase stem cell lines derived from eggs provided by women
who have been paid for the service.
experiment by Shoukhrat Mitalipov in which human stem cells were cloned. Currently agency funds cannot be used for that purpose as
a result of regulations that are the extension of a state law that
bars use of agency funds for payment for eggs.
then go before the full board tomorrow.
“In my lab, we are ... interested in
understanding what happens to the somatically silenced X chromosome
when differentiated cells are reprogrammed by SCNT. The key question
is: are these SCNT-ESCs more similar to iPSCs or
fertilization-derived ESCs with respect to the epigenetic state of
the X chromosome. Furthermore, it has been shown in mouse
reprogramming that the active X chromosome becomes deregulated during
SCNT-based reprogramming, and we would like to address this problem
in the human system as well.
“We believe that the comparison of
the epigenetic states between fertilization-derived ESCs, SCNT-ESCs
and human iPSCs is important for a better characterization of these
cells and understanding of their epigenetic nature.”
Source:Stem Cell Therapy
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July 28th, 2013
California Stem Cell Agency to Commit 20 Percent of Remaining Cash
By Dr. Matthew Watson
Thursday is expected to move forward with plans to give away $128
million, roughly 20 percent of its remaining funds.
of the $3 billion agency's hallmark efforts. The other “concept”
rounds up next week include a $35 million “tools and technology”RFA and $23 million to recruit four more star, stem cell scientists to California.
billion of its $3 billion so far with about $700 million available
for future spending. The remainder is going for the agency's
administrative expenses. Cash for new grants is expected to run out
sometime in 2017. Total cost of the agency's efforts run to about $6
billion because it operates with money borrowed by the state and must
pay interest.
developing a plan to develop new sources of funding with an eye on
some sort of public-private model. It solicited proposals in May for
help with the effort, with the goal of completing a plan by this
fall. At last report, however, the contract with the consultant had
not been let.
called, is likely to come up at next week's governing board meeting
along with a review of agency goals for the 2013-14 fiscal year.
also be heard by the agency's standards group next Wednesday.
implementing recommendations from a performance audit in May 2012.
The audit said the agency was laboring under a range of problems that
include protection of its intellectual property and management of its
nearly 500 grants plus an inadequate ability to track its own
performance. A staff Power Point presentation seems to indicate that it is making substantial progress in solving the problems identified by the audit.
Burlingame near the San Francisco Airport. Two remote locations where
the public can participate are also available in Los Angeles.
Addresses can be found on the agenda.
provide live coverage of the meeting based on the Internet audiocast
with stories filed as warranted.
Source:Stem Cell Therapy
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July 21st, 2013
Paying for Human Eggs, Ivan Illich and Jerry Brown
By Dr. Matthew Watson
stalled in a technical parliamentary process as opponents continue to
wage their campaign urging Gov. Jerry Brown to veto the proposal,
which swept easily through the legislature.
industry-sponsored measure appeared this week as an op-ed in The Sacramento Bee. The legislation would allow women to be paid for eggs for scientific research. The op-ed piece invoked the philosopher Ivan Illich, a
longtime friend of Jerry Brown and much respected by him.
Scheper-Hughes of the Center for Genetics and Society of Berkeley,
the July 16 article said,
“The late historian of science and
technology, Ivan Illich, warned against the processes of medical
industries which 'create new needs and control their satisfaction and
turn human beings and their creativity into objects.'"
“Women's research eggs (have) become
the hot new bio-product, increasing the profits of the
multibillion-dollar-per-year infertility industry at the expense of
women's health, safety and possibly, their future fertility. Is this
the 'equity' we want for ourselves, our sisters and our daughters?”
Illich, whom he first met in 1976. Brown said that Illich
“...bore witness to the destructive
power of modern institutions that 'create needs faster than they can
create satisfaction, and in the process of trying to meet the needs
they generate, they consume the earth.'”
Assemblywoman Susan Bonilla, D-Concord) would remove a ban in
California on paying women who provide their eggs for scientific
research. Currently women who provide eggs for fertility purposes can
be paid, sometimes as much as $50,000, depending on the
characteristics of the woman providing the eggs. The bill would not
alter the ban on using research funds from the California stem cell
agency to pay for eggs. However, the agency next week will consider a proposal to allow use of agency funds to purchase stem cell lines
derived from eggs through compensation. (For
more information on
the bill,
see here, here and here.)
approval on July 1. The governor has 12 days to act on the measure
once it actually reaches his desk. However, as of this morning, the
legislation remained in what is known as the “engrossing and
enrolling” process. It could be a routine delay but the process can
also be used to manage the flow of legislation to the governor. Brown
is currently on a two-week trip to Germany and Ireland and is not
expected to return until near the first of August.
Source:Stem Cell Therapy
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July 21st, 2013