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Archive for the ‘Stem Cells’ Category

Pay-for-Eggs Legislation: Strange Bedfellows and Existential Questions

Sunday, July 14th, 2013
 The California pay-for-eggs bill
today generated a feature article that said the legislation has
“sparked an unusual lineup of partisans on both sides and resonates
far beyond” the Golden State.
The piece by Alex Mathews on Capitol
Weekly
, a news service specializing in California government and
political coverage, said,

“(C)omplicating the issue is
California’s role as a national leader in stem cell research, the
existential question of who or what constitutes a research subject,
and finally, the fact that compensation for fertility purposes is and
has been legal for years in California.”

Mathews was writing about the measure
(AB926) by Assemblywoman Susan Bonilla, D-Concord, that removes a ban
in California on paying women for eggs for scientific research.
Currently women can be paid in California for providing eggs for IVF.
The measure would not alter a ban on compensation for eggs in
research financed by the $3 billion California stem cell agency.
However, later this month, the agency will consider modifying its position somewhat.
The bill has passed the legislature and
is on its way to Gov. Jerry Brown. The industry association
sponsoring the bill expects the governor to sign it later this month
although the governor, as a general rule, does not make public
commitments on legislation.
Mathews' article covered the background
and arguments on the bill and noted that it has received little
mainstream media attention.
Lisa Ikemoto
UC Davis photo
She also quoted Lisa Ikemoto, a law
professor and bioethicist at UC Davis, on the sensitive nature of the
issue. Ikemoto said,

“On the fertility side, it’s
politically hard to touch because it’s all around family formation.
Nobody wants to restrict family formation. On the research side, when
the issue of payment for eggs came up, it was connected with human
embryonic stem cell research, and human embryonic stem cell research
was politicized from the outset.”

Mathews also wrote about the strange
bedfellows opposing the bill. She said,

“Groups that fundamentally oppose
stem cell research such as the California Catholic Conference and
other pro-life groups are natural opponents of the bill, but they are
joined by a number of pro-choice groups who expressed concerns over
the limited research on the effects of egg donation on women’s
health.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/pskHpPceyco/pay-for-eggs-legislation-strange.html

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

Sunday, July 14th, 2013
The California stem cell agency has
enjoyed a spate of good financial and scientific news this week from
the biotech industry as the research effort pushes on with its
mission of turning stem cells into cures.
The $3 billion agency is
scheduled to make its last grants in less than three years and, given
the glacial pace of medical research, needs all the help it can get
by then to bring a stem cell therapy close to the marketplace – the
promise it made to voters when the agency was created nine years ago.
CIRM, as the agency is known, requires
not only steady scientific progress but also a rosy outlook for the
industry, which has languished in past years as major investors
shunned the field. This week, CIRM garnered good news on both fronts.
There was enough so that the agency
even touted it on the agency's research blog in an item by
Neil Littman, CIRM's business development officer. He said it all
helps to leverage CIRM investments and create a favorable investment climate. The good news included yesterday's announcement that
Viacyte, Inc., of San Diego, Ca., has come up with $10.6
million needed to match a $10.1 million, much-ballyhooed award from CIRM last fall. The Viacyte financing
includes important support from Big Pharma, in the form of Johnson &
Johnson
. CIRM has pumped a total of $39.4 million into Viacyte.
Another CIRM award winner,
Cellular Dynamics International, Inc., of Madison, Wisc., yesterday
announced its price on its upcoming stock offering to raise up to $53
million. Cellular Dynamics scored $16 million from the agency last
March.
The “comfort news” for CIRM also included Monday's announcement that Capricor, Inc., a private Beverly Hills company benefiting from $27 million from the California stem cell agency, is merging with publicly traded Niles Therapeutic, Inc., of San Mateo. The merger is aimed at providing better access to capital.
And then there was Tuesday's news that a $20 million CIRM disease team award is paying off with the beginning of a clinical trial by Calimmune of Tucson, Az. for an HIV treatment.
All on top of the news in June when bluebird bio of Masschusetts brought in $101 million on its stock offering. Bluebird is the recipient of a $9.4 million CIRM award.
The rosy news comes amid a generally
better outlook for biotech in general. John Carroll, editor of Fierce
Biotech,
 this week noted that there were only 11 biotech stock offerings last
year. He wrote,

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

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

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

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HIV Clinical Trial Hailed by California Stem Cell Agency

Sunday, July 14th, 2013
The
California stem cell agency today scored what it called an “important
milestone” with the announcement of the start of a clinical trial
involving a therapy to help protect persons infected with HIV from
the effects of the virus.
The
trial is partially funded from a $20 million award from the stem cell
agency, which is known as CIRM, to researchers
at UCLA and Calimmune, a Tucson, Az.,
company. Calimmune's share of the award was $8.2 million.
Alan
Trounson
, president of the $3 billion state agency, said in a
statement,

CIRM
funding of this Phase l/ll trial is an important milestone for us.
One of our goals is to support research that moves the most promising
science out of the lab and into clinical trials in people. To be able
to do that with a disease as devastating as HIV/AIDS highlights the
importance of our funding and the potential impact it could have on
the health of people around the world.”

The
trial was announced by Calimmune this morning. The company said,

The
first patient has begun treatment in a Phase I/II clinical trial
designed to determine whether a pioneering genetic medicine approach
can help to protect individuals infected with HIV from the effects of
the virus. The study, “
Safety
Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1
Infection
,”
utilizes a gene medicine called Cal-1, developed in the lab of Nobel
Laureate Dr. 
David
Baltimore
 and
by Calimmune.”

Baltimore
served on the CIRM board from 2004 until June 6, 2007. He 
resigned
from the board 
about
18 months before the application process began for the grant round
that ultimately funded Calimmune, a company he helped to found. He is currently chairman of the Calimmune board. 
Asked
for comment, Jeff Sheehy, a member of the CIRM governing
board and communications director for AIDS research at UC San
Francisco
, said,

"This
trial will hopefully offer several important insights into the safety
and feasibility of genetically modifying blood forming stem cells in
an HIV patient as a potential therapy.  We are very early in
this research, and with this Phase I trial's goal of establishing
safety and the risks involved, I applaud the courage and altruism
demonstrated by the patients who are willing to participate in this
study."

The Calimmune
press release
 said
the principal investigators on the clinical trial are 
Ron
Mitsayasu
 of
UCLA and 
Jacob
P. Lalezari
 of Quest
Clinical Research
 of
San Francisco. Quest is currently soliciting patients for the
clinical trial as well as UCLA. (Persons interested in participating
in the trial can find email contacts 
at
this website
.
Twelve are needed.)
The
principal investigators on the CIRM award are Irvin Chen of
UCLA and Geoff Symonds of Calimmune.  

Here are links to the CIRM press release on the subject and the agency's blog item.

(An earlier version of this story did not include the fact that Calimmune's share of the CIRM award was $8.2 million or the links to the agency press release and blog.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Zot_z3D2WnI/hiv-clinical-trial-hailed-by-california.html

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Eggs and Cash: Stem Cell Agency Considering Easing Restrictions on Stem Cell Lines Derived Using Payments

Sunday, July 14th, 2013
The California stem cell agency is
moving to remove an absolute ban on use of stem cell lines derived
from eggs from women who have been paid to provide them.
The action comes as state legislation
is headed for Gov. Jerry Brown's desk that would permit payments for
eggs to be used in research that is not funded by the agency. The measure (AB926) would not alter the separate ban on egg payments
involving research funded by the $3 billion stem cell agency.
Under a proposal that will come before the agency's standards group July 24, CIRM's governing board could
approve the use of stem cell lines derived as a result of payment to
women. Board action would be based on whether stem cell lines would
“advance CIRM's mission” and would follow a staff evaluation
involving scientific and ethical issues.
Over recent years, stem cell
researchers around the country have reported that they are not able
to obtain sufficient eggs without payment. And earlier this year,
paid egg providers were used in research in Oregon that cloned human stem cells, a feat that researchers have struggled with for years.
A CIRM staff report said that the
Oregon research has “generated scientific interest among CIRM
grantees and the desire to utilize derived SCNT lines. CIRM’s
current policy prohibits the use of the (Oregon) SCNT lines because
oocyte donors were financially compensated. CIRM requests the Medical
and Ethical Standards Working Group (SWG) revaluate this prohibition
with regard to CIRM grantees ability to utilize the resulting lines
in light of recent scientific and policy developments.”
Last month, the California Stem Cell
Report
queried the agency concerning earlier, sketchy information onthe CIRM blog about a possible change in its compensation rules. We
asked whether the agency was considering “sidestepping” the ban
on compensation. Kevin McCormack, a CIRM spokesman, said, “No, not
at all.” He said it would be premature to elaborate until a firm
proposal was ready.
The staff proposal to be considered on
July 24 said,

“Proposition 71’s 'prohibition on
compensation' compels the ICOC(the agency's governing board) to adopt
standards 'prohibiting compensation to research donors.' This
requirement has been consistently interpreted to prohibit the use of
CIRM funds to financially compensate oocyte (or other cell or tissue)
donors. In 2006, this interpretation was extended to exclude from
use, in CIRM-funded research, any stem cell line where research
donors were financially compensated, even if the derivation was done
without the use of CIRM funds. Proposition 71, however, does not
compel the ICOC (the agency's governing board) to prohibit the use of
stem cell lines where financial compensation is provided to the
oocyte donors, provided that CIRM funds are not used to compensate
the donors or derive the lines.”

The July 24 meeting will be held in San
Francisco. No remote teleconference locations have been announced.  If approved, the changes would likely be considered July 25 by the full agency board.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/BF3kpSRnKXQ/eggs-and-cash-stem-cell-agency.html

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California Legislation Removing Ban on Payments for Eggs for Research Heads to Governor

Sunday, July 14th, 2013
Legislation to allow women in
California to be paid for their eggs for scientific research is on
its way to Gov. Jerry Brown following final legislative approval last
week.
Sponsors of the bill, a national
fertility industry organization, expect the governor later this month
to sign the measure, which would go into effect next year.
The measure, AB 926 by Assemblywoman
Susan Bonilla, D-Concord, would repeal a ban on payments to women who
provide eggs for scientific research. However, the measure would not
affect the ban on payments to egg providers in research funded by the
$3 billion California stem cell agency. That ban is covered by a
separate legal provision. Stem cell researchers around the country have complained that they they cannot get eggs without payment.
Women in California can be paid for
providing eggs for reproductive purposes. According to a legislative analysis, payments can run as high as $50,000 for women with special
characteristics but average around $9,000 for each session, which can
generate more than one egg.
The sponsor of the legislation is the
American Society for Reproductive Medicine of Alabama, whose members
represent a wide swath of the $5 billion-a-year fertility business.
The measure would open new business avenues for the industry.
Bonilla argues that the measure allows women to be treated on the same footing as men who provide sperm for
research and would encourage more research into reproductive health issues.
Opponents argue that the safety of the
egg production procedures has not been well-established including
their long-term impact. They also argue that allowing payment would
lead to exploitation of poor and minority women.
The bill received its final
legislative approval on July 1 when the Senate passed it on a 24-9
vote.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/2FyX5YnnQHA/california-legislation-removing-ban-on.html

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California Legislation, Human Egg Sales and Profits

Sunday, July 7th, 2013

California legislation to allow women
to be paid for their eggs for scientific research is sailing toward
final passage literally swaddled in motherhood and apple pie
arguments. Missing from the debate is a key reason behind
the bill – building profits for what some call the “baby
business.”

The legislation is touted as providing
equal treatment for women, permitting them to be paid for supplying
eggs for stem cell and other research, much as men are paid for
sperm. It also would put women who sell their eggs for research on an
equal economic footing with women who sell their eggs for fertility
treatments, which is currently permitted under state law. Payments to
those women range from an average of $9,000 to as much as $50,000,
according to a legislative analysis of the bill.

 Assemblywoman Susan Bonillla,
D-Concord, author of the bill(AB926), says,

“It is time to let women, just as any
other research subject, make an informed decision as to
participation, and justly compensate them for doing so.”

She also says that the ban on payments
has had serious impact on fertility research. In a legislative bill analysis, she says,

“It has led to a de facto prohibition
on women’s reproductive research in California, adversely
impacting the same women that the ban intended to protect. With few
oocytes donated, fertility research and fertility preservation
research has been at a standstill. This greatly affects women
suffering from fertility issues and women facing cancer who would
like to preserve their oocytes.”

Bonilla is carrying the measure on
behalf of an industry group, the American Society for Reproductive Medicine of Alabama. The fertility or baby business, which is largely
unregulated, brings in about $5 billion annually in the United
States from something like 500 clinics. It has grown rapidly over the
last couple of decades, but is likely heading for a soft spot.
Little public information is available
on the Internet discussing the industry's economic challenges.
However, demographic studies show that the size of the key market
for fertility services is stagnating. A 2012 report by the federal
government projects that the number of women in the 35 to 44 age
group, prime consumers of fertility services, is likely to grow only
0.5 percent from 2010 to 2020. And since that forecast was made, the
Census Bureau has downgraded its projections for total population
growth.
Bonilla's legislation effectively adds
a new, potential revenue stream for the industry. Fertility clinics
would be able to buy the eggs and then resell them to researchers,
adding premiums for eggs from women with special characteristics. The bill would also add a tool for bringing down the cost of fertility
treatments, which can run as much as $12,000 to $17,000 a round or
more and require several rounds, according to the NIH. Clinics could discount those prices for some women, bringing in
new customers, if they agree to authorize the use of excess eggs for
scientific research.
None of this appears necessarily
pernicious. What is pernicious is the absence of discussion of the
economics of the legislation. Without a full understanding of all
that is at stake, including economic issues and motivations,
legislators, the governor and the public are hard-pressed to make
good decisions about a significant change in California law.
Opponents of the legislation have
raised serious questions about the treatment of women by fertility
clinics, noting that the bill would turn egg providers into “vendors”
– not patients of the clinics. The Center for Genetics and Society
in Berkeley has captured the arguments in opposition including
testimony before a Senate committee hearing early in June.
Jennifer Schneider, a physician who
lost a 31-year-old daughter to cancer seven years after the younger
woman sold her eggs three times, told lawmakers,

“Unlike infertile women who are
considered patients, egg donors are treated as vendors( (her italics).
When they walk out of the IVF clinic, no one keeps track of them. 
My daughter’s death was not reported. The long-term risks of egg
donation are unknown."

Sindy Wei, a former egg provider and
now a physician with a Ph.D. in biology, testified that she wound up
in an intensive care unit after 60 eggs were extracted from her in
2001. She said,

“I fear that cases like mine are
buried deep by fertility centers concerned about their image. An
industry thriving on profits and reputation has little incentive to
report adverse events, or protect the health and medical rights of
donors.”

Where is the $3 billion California stem
cell agency on all this? The agency has not taken a position on the
bill nor have any major research organizations. The measure does not
change the law affecting agency-funded research, which bans the use of
compensation for eggs in its research. Enactment of the law, however, would
create a two-tier stem cell research standard in California, one for
scientists not constrained by the payment ban and another for those
who could use the full range of research tools. Some stem cell
researchers may well think that they have become disadvantaged as a
result.

(Editor's note: An earlier version of this article said the IVF business generated $4 billion in revenues annually. More recent estimates place it at $5 billion.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/0ke5iLQwGdA/california-legislation-human-egg-sales.html

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Challenge to WARF hESC Patents Cites Recent U.S. Supreme Court Decision

Sunday, July 7th, 2013
Patents on human embryonic stem cells
are being challenged in a new legal filing that cites the recent U.S.
Supreme Court
decision that barred the patenting of human genes.
The stem cell case involves the
Wisconsin Alumni Research Foundation (WARF), which holds the patents on the
much-heralded work performed by Jamie Thomson  at the University of Wisconsin. The lawsuit was filed
by the Public Patent Foundation of New York City on behalf of
Consumer Watchdog, a nonprofit group in Santa Monica, Ca. Jeanne
Loring
, director of the Center for Regenerative Medicine at the
Scripps Research Institute, is also involved along with Alan
Trounson
, president of the California stem cell agency. The agency
itself is not a party.
This week's filing follows the
so-called Myriad decision last month by the nation's highest court which said,

“Myriad did not create anything. To
be sure, it found an important and useful gene, but separating that
gene from its surrounding genetic material is not an act of
invention.”

This week's stem cell suit said,

"WARF did not create or alter the
properties inherent in stem cells any more than Myriad created or
altered the genetic information encoded in the DNA it claimed.” 

The legal filing came in an appeal of
an earlier decision by the U.S. Patent Office. The Public Patent
Foundation, which was a successful party in the Myriad case, did the earlier legal work on the challenge to the WARF patents as well as this
week's appeal.
The appeal, prepared by Dan Ravicher,
said the WARF patents have "put a severe burden on taxpayer-funded
research in California.”
Trounson released a statement saying,

“We don't want to do anything that
gets in the way of finding treatments for some of the biggest killers
today, so we feel that all patients with all kinds of diseases
deserve to have access to these kinds of cells.”

Loring was quoted in a Consumer Watchdog press release as saying,

"Human embryonic stem cells hold
great promise for advancing human health, and no one has the ethical
right to own them.”

John M. Simpson of Consumer Watchdog
said,

 “The best course if WARF truly
cares about scientific advancement would be to
simply abandon these over-reaching patent claims.”

A story by Bradley Fikes in the San
Diego U-T
cited intellectual property attorney Lisa Haile of DLA
Piper
as saying,

“A successful use of the Myriad case
as a precedent for throwing out the foundation’s patent would open
the door to similar challenges in just about any biotech product
using material derived from life.”

WARF made no immediate comment.

Other stories on the WARF challenge
appeared in the Milwaukee JournalGenomeweb and the LaCross Tribune. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/LuLuZLLjyDo/challenge-to-warf-hesc-patents-cites.html

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Bluebird and Banking: Media Pluses for California Stem Cell Agency

Sunday, June 30th, 2013
The California stem cell agency scored
a couple of favorable publicity points last week as the result of a
successful stock offering by an award recipient and another piece
about creation of a stem cell bank in Northern California.
The IPO by bluebird bio (the company's
preferred spelling) of Massachusetts was a big winner for the
company, raising millions of dollars more than anticipated.
The Boston Globe wrote,

“Shares of the Cambridge life
sciences company bluebird bio Inc. soared almost 60 percent on their
first day of trading (last) Wednesday, an impressive debut for a
business that endured years of stagnation and another encouraging
sign for the biotechnology industry.

“The local gene therapy company
raised $101 million in an initial public offering priced at $17 per
share, higher than the $14 to $16 estimated by investment bankers.
Bluebird shares closed at $26.91 per share on Wednesday.”

The stock continues to trade around $25
a share at the time of this writing, which is good news generally for
the biotech industry.
The company received a $9.4 million
award last fall from the $3 billion stem cell agency. The company has yet to receive any actual cash from the agency as both parties work
out final details of an agreement, a spokesman for the agency said
last week.
The stem cell agency touted the
successful IPO in a blog item by  that said,

“Bluebird Bio, one of the oldest
companies in the struggling gene therapy field, is having an
outstanding first day in the stock market today, and largely by
marrying its gene therapy technology with stem cell science. The
company’s financial milestone brings hope and excitement to both
fields.”

However, the news stories about the IPO
failed to mention the stem cell agency's involvement, which would
have been nice for the agency but was to be expected given the way
news is covered.
The story about the stem cell bank
appeared on Xconomy, an Internet news service dealing with
technology. Written by Bernadette Tansey, a former San Francisco
Chronicle
reporter, the piece dealt with the both business and science of stem cell banking. She wrote,

“One of the main goals of
California’s $3 billion stem cell research agency is to draw
companies into the state so they can vie for a share of the funding.

"With a recently funded $32 million
initiative, the California
Institute for Regenerative Medicine
(CIRM) has attracted two of
the biggest US players in stem cell banking to Novato, CA, to form
one of the largest biobanks of induced pluripotent stem cells (iPS
cells) in the world.”

The stem cell bank effort has become a
minor staple in recent news coverage of CIRM, surfacing in a number
of articles since the awards were approved. One of the reasons for that is that the project has a relatively straight-forward story line compared to many research efforts and the concept of "banking" is familiar to editors, writers and readers. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6WeU6kIIs6E/bluebird-and-banking-media-pluses-for.html

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Cost of a Stem Cell Therapy? An Estimated $512,000

Sunday, June 30th, 2013
The likely costs of potential stem cell therapies
and cures receive almost no attention in the media as well as
publicly from scientists and the biotech firms.
Usually any public discussion is
obliquely framed in the context of “reimbursement,” as if
industry is owed something instead of making a business decision
about what will make a profit. Euphemisms and jargon cloak unpleasant realities such as astronomical patient costs. But what reimbursement really involves are, in fact, pricing decisions and profit margins along with
lobbying campaigns for inclusion of
therapies in normal coverage of health insurance and Medicare
And today a singular figure – $512,000
for one stem cell treatment – appeared in the Wall Street
Journal
. The story by Kosaku Narioka and Phred Dvorak dealt
with what would be the first-ever human study of a treatment that
uses reprogrammed adult stem cells.
They reported that the study received
preliminary approval on Wednesday from a key panel of the Japan
Health Ministry.
The treatment involves a form of age-related macular
degeneration, which has also been targeted by the California stem
cell agency with different approaches.
Buried deep in the Wall Street Journal
article, with little other discussion, was this sentence:

“One eventual obstacle, even if tests
go well, could be cost: (Masayuki) Yamato (of Tokyo Women's Medical
University
) says initial estimates for the treatment run around ¥50
million ($512,000) per person."

The subject of costs for potential stem
cell treatments has rattled around in the background for years
without much deep public discussion. One reason is that high costs of
treatments are controversial and can trigger emotional debate.
Another reason is that it is very early in the therapy development
process and estimates are not likely to be entirely reliable.
A few years ago, however, the California stem
cell agency commissioned a study involving costs of stem cell therapies. The UC Berkeley report said,

“The cost impact of the therapy is
likely to be high, because of a therapy’s high cost per patient,
and the potentially large number of individuals who might benefit
from the therapy. This expense would put additional stress on
the Medicare and Medicaid budgets, cause private
insurance health premiums to increase, and create an incentive for
private plans to avoid covering individuals eligible for a therapy.”

The findings did not seem to be exactly
welcomed. The agency sat on the 2009 study for seven months until it
was uncovered by the California Stem Cell Report in April 2010. Then
the agency was careful to say that the study did not reflect the view
of CIRM management or board leadership.
Their wariness of being out in front on the issue could be well-advised. The pharmaceutical industry received some unpleasant attention this spring when more than 100 influential cancer specialists from more than 15 countries publicly denounced the cost of cancer drugs that exceed more than $100,000 a year.
Nonetheless pricing is critical
to both patient accessibility and therapy development. If companies
cannot make a profit on a possible therapy, it is virtually certain
not to appear in the marketplace.
While the subject remains in the
background, it does not mean there is a lack of interest. The copy of
the Berkeley stem cell cost study that was posted online by the California
Stem Cell Report has been read 11,701 times since it was made
available in April 2010 on scribd.com.
A copy of the study can be found below.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/IObtHBtAe_E/cost-of-stem-cell-therapy-estimated.html

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International team submits IND application

Sunday, June 23rd, 2013

On 18 June 2013, there was an announcement at the Princess Margaret Cancer Centre, Toronto. There was also a post on the California stem cell agency blog entitled: Clinical trial to thwart cancer stem cells may begin soon. An excerpt from the post:

The Prince Margaret Center announced the FDA filing, called an Investigational New Drug application (IND), at an event in Toronto recognizing the private donors. A press release about the announcement was picked up at this biotech news site.

The Principal Investigators present for the announcement were Dr. Tak Mak of the Princess Margaret Cancer Centre and Dr. Dennis Slamon of the University of California, Los Angeles (UCLA). What they have done is summarized in another excerpt from the blog post:

By working first to understand the various proteins that drive cells to divide, particularly in cancer, they were able to pinpoint an enzyme, that if blocked, could be the key to keeping cancer in check. They then discovered that this enzyme, called PLK4, can be derailed by a new drug they developed. In the lab, it has been shown to inhibit the growth of breast, ovarian, colorectal, lung, pancreatic and prostate cancer, as well as melanoma.

Information about the human PLK4 protein is available here.

Some background: In June 2008, it was announced that a partnership had been formed between Canada’s Cancer Stem Cell Consortium (CSCC) and the California Institute for Regenerative Medicine (CIRM) for international collaboration to advance cancer stem cell research. An excerpt from the CSCC's announcement:

It is proposed that one of the first initiatives to be launched by the CSCC will be a collaboration between Canadian and Californian scientists through CIRM's upcoming Disease Team Research Awards Competition, which will support multi-disciplinary teams of scientists in pursuit of therapies for specific diseases.The goal is to fund teams that will develop therapy or diagnostics for a particular disease or serious injury.Successful proposals will likely include a description of a path to an Investigational New Drug filing at the end of the four-to-five year grant.

Note the intent to file an IND by the end of the term of the grant.

The results of the Disease Team Research Awards Competition were announced on October 28, 2009. The award to Drs. Slamon and Mak is Grant number DR1-01477. See: Therapeutic Opportunities to Target Tumor Initiating Cells in Solid Tumors. As was stated in a page about Cancer Stem Cells on the website of the Canadian Institutes for Health Research (CIHR), this award was to one of two multi-disciplinary research teams co-led by Canadian and Californian scientists. The other team is co-led by Dr. John Dick of the University Health Network and Dr. Dennis Carson of the University of California, San Diego. My blog post (October 29, 2009) about the awards is entitled: Disease Team awards announced. The post ends with this Disclosure:

I'm a member of the Board of the CSCC, but also a staff member (emeritus) at the University Health Network. So, I was in conflict of interest, and was absent during all of the discussions, by the CSCC Board, about which Canadian applications should be considered for the Disease Team awards.

Source:
http://cancerstemcellnews.blogspot.com/2013/06/international-team-submits-ind.html

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Pay-For-Eggs Legislation Draws More Media Attention

Sunday, June 23rd, 2013
California legislation to allow women
to be paid for their eggs for scientific research generated several news articles this week as the measure neared final legislative
approval.
The coverage included both pro and con
but did not amount to major attention from the mainstream media. And,
with one exception, the articles failed to report that the
legislation did not apply to research funded by the $3 billion
California stem cell agency, which bans compensation for egg
providers.
The proposal (AB926) is now on the
state Senate floor with a vote possibly coming as early as next
Thursday. A spokesman for the American Society for Reproductive
Medicine
in Birmingham, Ala., an industry group sponsoring the bill,
said unequivocally that the Gov. Jerry Brown is expected to sign the
measure. (See the Senate floor bill analysis here and a press release on the bill here.)
Assemblywoman Susan Bonilla
Photo Source -- Bonilla's office
The articles about the legislation by
Assemblywoman Susan Bonilla, D-Concord, have appeared in the journal
Nature, the San Francisco Chronicle and the Huffington Post over the
past few days.
Alice Crisci, a California patient
advocate writing on the Huffington Post, yesterday remarked that
women egg providers should be treated the same as men involved in
scientific experiments.

“After all, aren't we past the days
when we treat women like they are less capable than men of making
sound decisions for their own well-being? It's my body and my choice
if I want to donate a dozen of my eggs to science. Who knows -- maybe
it's my egg that will be used to find a cure for cancer.”

Debra Saunders, writing a column in the
Chronicle on Sunday, said,

“That sperm-egg parity argument is so
bogus. When men donate sperm, they risk second thoughts about
unknown, random offspring, but they do not risk serious medical side
effects. Egg donation, on the other hand, can be hazardous to your
health. The New York Times reports, "Egg donors can suffer
serious side effects from the powerful hormones needed to generate
multiple eggs." And: "The most significant risk is ovarian
hyper-stimulation syndrome, which can cause bloating, abdominal pain
and, rarely, blood clots, kidney failure and other life-threatening
ailments."

Charlotte Schubert, writing in Nature
on Tuesday, said,

“In practical terms, the bill would
bump up payments from hundreds to thousands of dollars. In Oregon —
which, like most states, does not have regulations governing egg
donation — women recently received $3,000–7,000 each for eggs
used in a study that created stem-cell
lines from cloned human embryos
.”

Prices for eggs can run substantially higher depending on the characteristics of the supplier.
Bonilla's office said the bill did not
come up for a vote during today's Senate floor session but could come
up next Thursday.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/O3i-n3NxdnA/pay-for-eggs-legislation-draws-more.html

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Merksamer Makes Only Bid For Stem Cell Agency Lobbying Contract

Sunday, June 16th, 2013
Only one of California's lobbying firms
is interested in working for the California stem cell agency – at
least interested enough to put in a bid.
However, that is likely more of a
function of the small size of the contract – $65,000 – and the
entrenched nature of CIRM's existing lobbyist – Nielsen, Merksamer,
Parrinello, Gross & Leoni LLP
– one of the state Capitol's
larger lobbying firms with $5 million in billings last year.
The firm touted its longstanding
connection to the $3 billion agency in its 21-page proposal in
response to a CIRM RFA this spring. The firm has been with CIRM since
2005.
Nielsen Merksamer's proposal also noted
a couple of other interesting aspects of the continuing arrangement.
CIRM will run out of money for new grants in 2017, and Nielsen
Merkasamer said,

“Furthermore, as a premier
legislative advocacy and (Nielsen's italics) ballot measure
law ?rm, Nielsen Merksamer can actively and effectively assist CIRM
as it contemplates returning to the voters for additional funding.”

The proposal also suggested that it can
conceal information that normally would be public record. The firm
said,

“Another unique advantage offered by
Nielsen Merksamer is that, unlike the vast majority of lobbying ?rms,
since we are a full-service law ?rm, our relationships with our
clients are subject to the attorney-client privilege.”

CIRM used such a technique in 2012 and 2008 in matters involving its budget and PR advice.
Nielsen Merksamer also said,

“(N)o one understands CIRM’s 'total
picture' better than Nielsen Merksamer. Not only has Nielsen
Merksamer been representing CIRM before the Legislature for the past
decade, but Nielsen Merksamer was also one of the principal drafters
of the aforementioned Proposition 71—which brought CIRM to life.
The depth of Nielsen Merksamer’s familiarity with, and
understanding of, CIRM’s mission and structure, the challenges it
faces, and the promise it holds simply cannot be matched by any other
legislative advocate.”

The firm said it would not need the
$65,000 offered by CIRM but would charge only $49,200 annually, about the same as
it has been paid for several years. Steve Merksamer and Gene Erbin,
who drafted portions of Proposition 71, would handle most of CIRM's
affairs. John Moffatt and Missy Johnson would also be available.
The firm's proposal outlined several
instances where it successfully killed legislation opposed by CIRM.
You can read about them in their proposal below.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/kTRN6kUuSDk/merksamer-makes-only-bid-for-stem-cell.html

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Compensation for Human Eggs Approved by Key California Senate Committee, But Not For CIRM Researchers

Sunday, June 16th, 2013
Legislation that would permit women in
California to be paid for their eggs for scientific research
yesterday cleared a key state Senate committee and is likely headed
for the governor's desk.
The measure by Assemblywoman Susan
Bonilla,
D-Concord, was approved on a 6-1 vote by the Senate Health
Committee
and now goes to the Senate floor. Earlier, it passed the
Assembly on a 54-20 vote.
Some stem cell researchers and other
scientists have chafed under state restrictions that bar compensation
for eggs while that the same time fertility clinics are paying an average of $9,000 a session for eggs, with some prices going as high as $50,000.
However, the legislation will not
affect researchers using grants from the $3 billion California stem
cell agency. The agency's regulations bar compensation for eggs in
the research that it funds. That means that at least a two-tiered
research system would exist in California not to mention another tier
created by federal regulations that differ from both those of the
stem cell agency and those set by the legislation.
CIRM's restrictions are required by
Proposition 71, which created the agency in 2004, and cannot be
changed without a 70 percent vote of the legislature. Bonilla's bill
requires only a majority vote.
Bonilla's legislation is sponsored by
American Society for Reproductive Medicine, the chief industry
group for the largely unregulated fertility industry.
The analysis prepared for yesterday's
committee session summarized Bonilla's arguments for the measure in
this fashion:

“This bill seeks to create equity in
the field of medical research compensation by removing the
prohibition on compensation for women participating in oocyte (egg)
donation for medical research. All other research subjects are
compensated for their time, trouble, and inconvenience involved in
participating in research. AB 926 ensures that women are treated
equally to all other research subjects - allowing them to actively
evaluate their participation in research studies. Unfortunately, the
ban on compensation has had serious unintended consequences. It has
led to a de facto prohibition on women’s reproductive research in
California, adversely impacting the same women that the ban intended
to protect. With few oocytes donated, fertility research and
fertility preservation research has been at a standstill. This
greatly affects women suffering from fertility issues and women
facing cancer who would like to preserve their oocytes.”

A number of organizations are opposed
to the bill including the Center for Genetics and Society in Berkeley
and the Catholic Church. The bill analysis summarized some of the
opposition arguments in this fashion:

“Egg harvesting exposes healthy young
women to multiple synthetic hormones in order to produce many times
the normal number of eggs per cycle. One of the potential harms is
OHSS, which has resulted in hospitalizations and at least a few
documented deaths. These groups state that many experts remain
concerned about the long-term risks of these drugs, especially
their potential impact on infertility and various cancers.
Follow-up research on egg providers, which could establish the
frequency and severity of these adverse outcomes, is widely
recognized to be grossly inadequate.”

In addition to risk and religious
objections, opponents also argue that poor and minority women are
likely to be exploited by enterprises seeking their eggs to resell at
a profit.
No major stem cell research
organizations, including the California stem cell agency, have taken
a position on the bill. The legislation has received little public
attention, although The Sacramento Bee carried an article last March.
Ruha Benjamin, author of "People's Science" and assistant professor at Boston
University
, also wrote about the measure in April on the Huffington
Post
. Benjamin said,
UC Berkeley professor Charis
Thompson
 compares egg
donation to 'other kinds of physically demanding service work,'
arguing for a 'salary negotiation between the state agency (or
relevant employer) and the donor.' This, she contends, is a 'sensible
and dignified recognition of [the donor's] work, time, and effort.'
And instead of refusing compensation to women, Thompson suggests that
we 'direct our efforts to understanding and minimizing' the risks.
“Indeed. Now more than ever, we must
redouble our efforts, because the market in eggs appears to be
expanding from private reproduction to public research, and
increasingly overseas, if the surrogacy
industry
 is any indication of how 'cheaper' women become a
reserve army of bio-labor in less regulated regions.” 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SVuriAz87l0/compensation-for-human-eggs-approved-by.html

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Cellular Dynamics: California Stem Cell Agency Recipient Plans $57 Million IPO

Sunday, June 9th, 2013
A Wisconsin firm that is the
beneficiary of more than $16 million from the California stem cell
agency today announced that it intends to go public to raise $57.3
million for its iPS cell ventures.
Jamie Thomson
UCSB photo
The firm is Cellular Dynamics
International, Inc.
, and was co-founded by internationally known stem
cell scientist Jamie Thomson of the University of Wisconsin, who is
currently the company's chief scientific officer. Thomson is also a professor
at UC Santa Barbara, where he is co-director of the Center for Stem
Cell Biology and Engineering.
In March, the California stem cell
agency awarded a $16 million grant to Cellular Dynamics to derive
three iPS cell lines from 3,000 individuals as part of the agency's
stem cell banking initiative. (Here is a link to the grant review summary.)
The company said in its SEC
filings that it also will be the prime subcontractor on a $10 million
grant that the Coriell Institute for Medical Research of Camden,
N.J., received in the agency's stem cell banking round. Cellular Dynamics said
some of the funds from the IPO will be used to complete its
California laboratory in leased space at the Buck Institute in
Novato, north of San Francisco.
Cellular Dynamics was founded in 2004
and sold its first commercial product in 2010. It reported revenues
of $6.6 million in 2012 and losses of $22.3 million. It has 115
full-time and part-time employees worldwide.
The company said,

“During 2011 and 2012, we had three
large biopharmaceutical customers that individually accounted for
greater than 10% of our total revenue in one or both years. Eli Lilly
and Company (Lilly)
accounted for 10% of total revenue in 2011 and
18% of total revenue in 2012. Hoffmann-La Roche Inc. (Roche)
accounted for 13% of total revenue in 2011 and GlaxoSmithKline plc
(GSK)
accounted for 11% of our total revenue in 2012.”

Cellular Dynamics also said in its
filings,

“Our total revenue grew from $2.6
million in 2011 to $6.6 million in 2012, an increase of 154%. This
growth was driven by a 247% increase in sales of our iCell products
which grew from $1.5 million in 2011 to $5.2 million in 2012. At
December 31, 2011, our backlog of revenue expected to be recognized
in 2012 was $1.1 million. At December 31, 2012, our backlog of
revenue expected to be recognized in 2013 had grown to $4.1 million.

“For the three months ended March 31,
2013 our total revenue was $2.4 million, an increase of 109% over the
corresponding period in 2012. This growth was driven primarily by an
increase in iCell product sales, which grew from $0.6 million for the
three months ended March 31, 2012 to $1.8 million for the three
months ended March 31, 2013, an increase of 173%.”

Paul Knoepfler of UC Davis, writing on his blog, touched on some of the aspects of the IP issues involving
Cellular Dynamics and  Japanese researcher Shinya Yamanaka, who won the Nobel Prize last year for discovering how to reprogram adult stem cells into pluripotent cells (the iPS process).
 Knoepfler wrote,

"A
recent question is the issue of who has the intellectual property
(IP) rights to iPS cell technology.
People have told me in the
past that they wondered if Cellular Dynamics has unambiguous rights
to develop all of these iPS cell-based products."

Knoepfler also wrote,

 “This (the IPO) looks to
be very interesting and could transform the field as it develops.”

News coverage today of the IPO filing
was light, but is more expected to surface tomorrow. Here is a link to the only story that had surfaced as of this writing. 

No price or date has yet been set for
the offering.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/0oup8hU2FGE/cellular-dynamics-california-stem-cell.html

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

Sunday, June 9th, 2013
A handful of media outlets today
carried stories about the public stock offering announced yesterday
by Cellular Dynamics International, Inc., a Wisconsin firm that will
benefit to the tune of $16 million-plus from the California stem cell agency.
Kathleen Gallagher of the Milwaukee
Journal Sentinel
described the company, founded by stem cell pioneer
Jamie Thomson, as in the business of making “fully functioning human cells in industrial quantities.”
Judy Newman of the Wisconsin State
Journal
in Madison, where the company is based, quoted Beth Donley,
chief executive of Stemina
Biomarker Discovery
, as saying,

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

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

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

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Pomeroy on Doing the Right Thing and Foster Care

Sunday, June 9th, 2013
Claire Pomeroy
CIRM photo
On Claire Pomeroy's last day as a
member of the governing board of the $3 billion California stem cell
agency, she also published an essay on the Huffington Post in which
she discussed fleeing from an abusive home at age 14.
Pomeroy, former vice chancellor and
dean of the medical school at UC Davis and now president of the Lasker Foundation in New York,  wrote last month,

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

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

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

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

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Vatican Funding for California Stem Cell Agency?

Sunday, June 2nd, 2013
So what's with the Vatican sending cash
to the California stem cell agency? One would imagine that is an
improbable event since the agency is involved in human embryonic stem
cell research, which is an anathema to the Roman Catholic church.
However, CIRM President Alan Trounson
earlier this week disclosed the payment in an interview with Patt
Morrison
of the Los Angeles Times. He said,

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

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

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

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

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Bluebird bio of Massachusetts Still Waiting for California Stem Cell Money

Sunday, June 2nd, 2013
Seven months after the California stem
cell agency awarded $9.4 million to bluebird bio of Cambridge, Mass.,
the company has yet to receive any of the cash from the Golden State.
Kevin McCormack, a spokesman for the $3
billion agency, this week said negotiations are still underway with
the bluebird, which is planning to go public,  but did not elaborate. Post-award negotiations are
common at the agency, but generally take much less time.
The cash from CIRM is scheduled to
assist in clinical trials for a stem cell-gene therapy to correct a genetic disease in young patients with B-thalassemia, a
rare blood disorder that can cause widespread organ damage
and premature death.
Earlier this month, bluebird bio, which
prefers the lower case lettering for its name, announced that it
intends to take the company public in an $86 million offering. In
March, it announced a collaboration with Celgene that provided for an upfront payment of $75 million and promised up to $225 million per
product in potential option fees and clinical and regulatory
milestones. The CIRM grant is conditioned on a matching commitment
from bluebird.
Cash from the stem cell agency can only
be spent on operations within California. According to the CIRM summary of the review of the bluebird application, which was scored
at 73, the company said,

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

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

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

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

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

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Monterey Newspaper Chides California Stem Cell Agency

Sunday, June 2nd, 2013
The California stem cell agency and its
former chairman, Robert Klein, came under sharp criticism this week
in an editorial in the Monterey County Herald newspaper.
The editorial cited articles on the
California Stem Cell Report dealing with a $21,630 gift by Klein to
the agency, his employment of the vice chairman of the agency and the
violation of the agency's conflict of interest policies by a grant reviewer.
The editorial was headlined "State Stem Cell Agency Still Up to Old Tricks." The piece said,

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

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

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

The editorial concluded,

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

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

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$70 Million Alpha Stem Cell Clinic Proposal Draws Reader Comment

Sunday, June 2nd, 2013
In addition to the comments filed online in connection with the $70 million proposal to create Alpha Clinics in California for stem cell treatments,  two other readers commented privately in emails. 
One came from a close observer of the
stem cell agency who said, “If done right -- and I'm sure you and I
agree that is a big 'if' – it could be an outstanding legacy.”
The other comment came from a
physician-researcher at a major California institution and was longer
and more critical. Here is the text.

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

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

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

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

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

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

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

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