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Category Archives: Stem Cells

Oncologist highlights need to crack cancer stem cells

Posted: February 21, 2013 at 4:47 pm

On Wednesday, Oncology Prof. Max Wicha, director of the University of Michigan Health Systems Comprehensive Cancer Center, gave a lecture entitled Cancer stem cells: A new frontier in cancer research, the first in the Universitys Health Science Lecture Series sponsored by the Taubman Institute, the Program in Biology and several student organizations.

The lecture series aims to inform the public of important health information from University experts in medical and life science. Wichas lecture focused on the theory that cancers are driven by cells with stem-cell properties. He is optimistic that understanding the intricacies of cancer stem cells will aid cancer treatments.

In order to eradicate cancer, we have to eradicate cancer stem cells, Wicha said.

Wicha explained that recent developments of cancer therapies have given researchers the ability to slow cancer development. However, while shrinking cancer makes patients feel better, Wicha said it is not enough to prolong the lives of patients.

The problem is, just shrinking cancer will not make patients live longer, he said.

Wicha developed the cancer stem cell hypothesis, which argues that cancers arise from cells with dysregulated self-renewal. While it was previously believed that any cell in your body could become cancerous, the reality, according to Wicha, is that only certain cells in your body are prone to become malignant.

Much of these findings were discovered in recent research that involved growing human breast cells in Petri dishes and in mice in research labs. Though the research is promising, Wicha said much more needs to be done, especially for patients with advanced stages of cancer.

The goal is to cure cancer, Wicha said. In the common cancers, weve made really good progress in treating early stages of it, but in advanced cancers we havent made nearly enough progress."

Marty Fischhoff, the managing director of the Taubman Medical Research Institute, said he is impressed by Wichas research.

(Wicha) is one of the leading figures in cancer research, Fischhoff said. When he first came out with the hypothesis about cancer stem cells it was revolutionary and a lot of people didnt believe it. Now the rest of the world has come over. Its not universally accepted but most people believe its true.

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Oncologist highlights need to crack cancer stem cells

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Scientists Explore Stem Cells to Treat Diabetic Blindness

Posted: February 21, 2013 at 4:47 pm

Millions of diabetics around the world are threatened with vision loss, a secondary effect of their disease, but researchers are exploring whether stem cells can be used to treat or prevent this diabetic complication.

Juvenile and adult-onset diabetes result when the body's ability to regulate blood sugar levels goes awry. When the condition becomes chronic, it can lead to cardiovascular disease, damage the kidneys and affect blood flow to the limbs, sometimes requiring amputations.

The disease also affects the eyes, according to Alan Stitt of Queens University in Belfast, Ireland. Chronically high blood sugar levels can cause a condition called diabetic retinopathy, in which the tiny blood vessels that nourish the retina, the light sensitive tissue at the back of the eye, become blocked or leak.

They then can actually no longer carry the oxygen and the nutrients that the retina requires," Stitt says. "And the retina becomes increasingly dysfunctional as a result of these blood vessels not functioning properly.

If left untreated, diabetic retinopathy can lead to partial or total blindness.

Stitt, who directs the Queen's University Center for Vision and Vascular Science, is participating in a European-led study calledRepair of Diabetic Damage by Stromal Cell Administration (REDDSTAR).

Researchers from the U.S., Northern Ireland, Germany, the Netherlands, Denmark and Portugal are also taking part.Each team is trying to prevent and minimize damage to a particular organ as a result of diabetes.

The scientists are using adult stem cells isolated from bone marrow, the spongy tissue inside bones.Stem cells are master cells that can be coaxed to morph into any type of tissue cell in the body.

In Stitts laboratory, the stem cells are being injected directly into the eyes of mice bred to have diabetic retinopathy. So far, he says, the results are encouraging, showing signs that the progression toward blindness can be halted as the tiny retinal blood vessels are repaired and regenerated by the stem cells:

They are very clever cells, because what we know from the evidence weve got is that they seem to have this ability to go to where the tissue needs them to go," Stitt says. "So they recognize where theres not enough blood vessels and they can actually then participate in the blood vessel regrowth.

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Scientists Explore Stem Cells to Treat Diabetic Blindness

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Texas biotech rounds up $2 million for platform to grow stem cells faster

Posted: February 21, 2013 at 4:47 pm

A University of Texas spinoff company has pulled in $2 million to test a new technique for culturing non-embryonic stem cells.

According to a regulatory filing, StemBioSys raised at least $2 million of a $3.5 million equity offering. A company representative was not available to elaborate, but CEO Dr. Steven Davis told the San Antonio Business Journal last year when the company began raising the round that it would fund research projects to validate the quality of the stem cells generated by the companys technology.

StemBioSys is developing XC-marrow ECM, a propriety three-dimensional culture for growing mesenchymal stem cells from bone marrow, adipose tissue and umbilical cord blood. These immature cells have multiple potential uses in research and therapeutics because they can self-renew and mature into a variety of cell types. Stem cell therapies are being studied as a repair mechanism for tissues all over the body, from the heart to the brain to the knees.

The company says its three-dimensional extracellular matrix can grow cells quicker than conventional media while retaining stem cell properties and may help overcome key obstacles in creating stem cell therapies.

The technology was developed by Dr. Xiao-Dong Chen, an associate professor of medicine at the University of Texas Health Science Center and the companys chief scientific officer, and licensed from UT.

Although its only available for research purposes now, this kind of technology could have therapeutic applications down the line. If this research transfers successfully to clinical application in humans, we could establish personal stem cell banks, Chen said back in 2011, when he and colleagues had a study published in the Journal of the Federation of American Societies for Experimental Biology. We would collect a small number of older stem cells from patients, put those into our young microenvironment to rescue them increasing their number and quality then deliver them back into the patient.

The company has struck a deal with GenCure, an affiliate of the nonprofit South Texas Blood & Tissue Center, to receive mononuclear cells from clinical grade umbilical-cord blood that it uses for R&D purposes.

It was founded in 2010 in San Antonio, Texas and has received previous funding from the Texas Technology Development Centers McDermott Pre-Seed Fund.

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Texas biotech rounds up $2 million for platform to grow stem cells faster

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Market Research Report — Therapeutic Applications of Induced Pluripotent Stem Cells Represent the Future of Medicine

Posted: February 21, 2013 at 4:47 pm

ROCKVILLE, MD--(Marketwire - Feb 21, 2013) - MarketResearch.com has announced the addition of the market research report "Complete 2012-13 Induced Pluripotent Stem Cell Industry Report" to their product offering.

iPSCs are adult stem cells that have been transformed into embryotic-like stem cells through the manipulation of gene expression and similar methods. Despite some initial concerns, induced pluripotent stem cells (iPSC) are now sold by more than half (53.4%) of U.S. research product companies and 38.7% of research product companies worldwide.

"It is clear that iPSC products are in high demand within the scientific community. Currently, it is difficult for stem cell research product suppliers, like BD BioSciences, Life Technologies, and others, to know what products iPSC scientists will demand in 2013 and beyond. The needs of scientists are constantly changing, so this market intelligence report reveals profitable opportunities for providers of iPSC research products to pursue," says BioInformant.

For the past five decades, stem cell research has provided insights to the inner workings of the body and cell regeneration. "Therapeutic applications of iPSCs represent the future of medicine," says BioInformant. The scientific community believes that one day stem cell research will assist in finding viable treatments for crippling diseases such as Parkinson's, Alzheimer's, spinal cord injuries and more.

For more information, visit http://www.marketresearch.com/land/product.asp?productid=7242167&progid=85189

Follow us on Facebook http://www.facebook.com/marketresearchdotcom Follow us on Twitter http://www.twitter.com/marketresearch_

About BioInformant WorldWide, LLC

BioInformant Worldwide, LLCis a global leader in stem cell industry data.As a specialty research company, BioInformant uses technology to track and identify profitable opportunities in stem cell product markets and provides this data to clients that prioritize industry dominance.

About MarketResearch.com

MarketResearch.com is the leading provider of global market intelligence products and services. With research reports from more than 720 top consulting and advisory firms, MarketResearch.com offers instant online access to the world's most extensive database of expert insights on global industries, companies, products, and trends. Moreover, MarketResearch.com's Research Specialists have in-depth knowledge of the publishers and the various types of reports in their respective industries and are ready to provide research assistance. For more information, call Cindy Frei at 240.747.3014 or visit http://www.marketresearch.com.

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Market Research Report -- Therapeutic Applications of Induced Pluripotent Stem Cells Represent the Future of Medicine

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Brading Cancer Stem Cells: Discovery of a hot new intestinal cancer stem cell marker! – Video

Posted: February 20, 2013 at 1:47 pm


Brading Cancer Stem Cells: Discovery of a hot new intestinal cancer stem cell marker!
Excited about stem cells? Want to learn how stem cells influence cancer growth? Learn how scientists are paving the way to a better understanding of the identity and behavior of cancer stem cells! For more exciting science videos, visit Youreka Science: http://www.yourekascience.com Original article: "Dclk1 distinguishes between tumor and normal stem cells in the intestine." Nakanishi et al. Nature Genetics, Jan 2013

By: YourekaScience

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Brading Cancer Stem Cells: Discovery of a hot new intestinal cancer stem cell marker! - Video

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Half-full, Half-empty Editorial on California Stem Cell Agency

Posted: February 19, 2013 at 8:18 pm

The California stem cell agency's
editorial road show paid off a bit again this week with a mildly
approving editorial in the Oakland Tribune.

The Feb.18 piece said that the presence
of Jonathan Thomas, a Los Angeles bond financier, as chairman of the
$3 billion agency has improved things, compared to the reign of Bob
Klein, who “built a protective shield” around the agency's
governing board and prevented action to deal with obvious
conflict-of-interest problems.
The newspaper also said that “to some
extent” the agency has brought “cutting edge” scientists to the
state and helped boost the stem cell field.
That was the half-full side of the
editorial. The half-empty side included the headline.

“California
must get its stem cell house in order”

The editorial continued:

“...{T)he agency must prove that it
understands how to properly handle the public's money. …. If
the stem cell agency can establish a record as a good steward of
public dollars to finance brilliant science, it can continue to play
a useful role in stimulating and guiding research to bring the
potential cures from stem cell research to fruition.

“If it cannot do that, it will be
just another expensive Tyrannosaurus rex.”

Thomas and company are knocking on
editorial doors around the state in hopes of building support for the
board's modest – some might say inadequate – response to
recommendations for sweeping changes at the agency.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tMt6gs55Yvs/half-full-half-empty-editorial-on.html

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Signaling factors may be key to stem cells’ healing abilities: Discoveries

Posted: February 19, 2013 at 11:47 am

CLEVELAND, Ohio-- We've all heard of some of the amazing potential uses of stem cells: growing new tissues and organs for transplant, treating degenerative conditions such as multiple sclerosis and heart failure or safely testing new cancer drugs.

But much of the promise of future therapies depends on overcoming some significant technical hurdles and knowledge gaps.

One of those hurdles, understanding how stem cells heal injury, is now a lot smaller thanks to some cool basic-science research recently reported from a lab at Rosalind Franklin University of Medicine and Science in Chicago.

Using adult human stem cells typically found in the bone marrow, called mesenchymal stem cells, or MSCs, the Chicago team discovered that the stem cells promote healing in diabetic ulcers by signaling existing cells in the area to turn on the natural repair process that can be inhibited in people with the disease.

The team, led by Daniel Peterson, director of the Center for Stem Cell and Regenerative Medicine at the Chicago Medical School, performed the experiment in mice. Their study was published in Stem Cells Translational Medicine.

Although MSCs have come to be regarded as a cure-all for tissue injury, researchers have only recently started to gain even the smallest clue as to how they work.

"This is a problem in the whole MSC field," Peterson said. In most studies, he said, the cells are injected into the bloodstream, and then disappear, making it difficult to understand how they work.

"What happens is that they kind of get filtered out into the lungs, and where they're getting into any tissue is a bit of a mystery," he said.

To avoid that problem, Peterson's team applied the MSCs topically to a diabetic wound on the backs of lab mice. Even then, though, they couldn't be sure that the MSCs weren't traveling through the mouse's body and having a systemic effect. So a second wound on the mouse's back, untreated with the MSCs, acted as a control. If there were any systemic healing effect, the untreated wound would get better. If the effect were local only, it wouldn't.

Even when applied topically, the MSCs disappeared quickly, Peterson said. But the mice healed only in the area where the MSCs were applied, not in the other wound. And levels of several types of molecules that are key to signaling and triggering the healing response -- called Wnt3a, VEGF and PDGFR-alpha -- rose in the treated area, suggesting that the MSCs "recruited" the mouse's own stem cells in the vicinity to do the repair work.

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Signaling factors may be key to stem cells' healing abilities: Discoveries

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Time For Public Disclosure of Financial Interests of Stem Cell Agency Reviewers

Posted: February 17, 2013 at 9:47 pm

Should the scientists who evaluate
and score the applications for $3 billion in taxpayer funds be
required to publicly disclose their financial interests?

No, says the California stem cell
agency, despite concerns by the state auditor and the state's Fair
Political Practices Commission (FPPC) that date back at least six
years. The agency says that its governing board makes the decisions
on the applications – not the grant reviewers – and that the
members of the board fully disclose their economic interests.
However, last month the agency produced
a document that sheds new light on the issue. The document confirms
that the board rubber-stamps virtually all the reviewers' decisions,
going along with their actions 98 percent of the time. The board
exercised independent judgment on 28 out of 1,355 applications.
Why is this important? Here is what the state auditor said in 2007,

“(T)he FPPC believes that, under
state regulations, working group members (including grant reviewers)
may act as decision makers if they make substantive recommendations
that are, over an extended period, regularly approved without
significant amendment or modification by the committee. Thus, as
decision makers, working group members would need to be subject to
the conflict-of-interest code. This would mean that working groups
would be subject not only to the (public) financial disclosure requirements of
the Political Reform Act but also to the prohibition against a member
participating in a government decision in which that member has a
disqualifying financial interest and may be subject to the penalties
that may be imposed on individuals who violate that act.”

The auditor recommended that the stem
cell agency seek an attorney general's opinion on the matter, a
recommendation the agency agency summarily dismissed seven months later..
Then interim CIRM
President Richard Murphy, a former member of the agency's board and
former president of the Salk Institute, replied to the auditor:

"We have given careful
consideration to your recommendation and have decided it is not
appropriate to implement at this time. In almost three years of
operation and approval of four rounds of grants, the recommendations
of the CIRM working groups have never been routinely and/or regularly
adopted by the ICOC. Until the time that such a pattern is detected,
the question you suggest we raise with the attorney general is
entirely hypothetical, and is therefore not appropriate for
submission. We will, however, continue to monitor approvals for such
a pattern and will reconsider our decision if one emerges."

In the four rounds mentioned in
Murphy's response, 100 percent of reviewer decisions were
rubber-stamped by the board. In the other two rounds, the percentage
was 95 and 96 percent.
Currently, scientific grant reviewers at the stem cell agency, all of whom are from out-of-state, disclose financial and professional conflicts
of interest in private to selected CIRM officials. (See policy here.)
From time to time, grant reviewers are excused from evaluating
specific applications.
The CIRM governing board has resisted
requiring public disclosure of the interests of reviewers. The subject
has come up several times, but board members have been concerned
about losing reviewers who would not be pleased about disclosing
their financial interests.  Nonetheless, disclosure of interests among researchers is becoming routine in scientific research articles. Many universities, including
Stanford, also require public disclosure of financial interests of
their researchers. Stanford says,

“No matter what the circumstances --
if an independent observer might reasonably question whether the
individual's professional actions or decisions are determined by
considerations of personal financial gain, the relationship should be
disclosed to the public during presentations, in publications,
teaching or other public venues.”

The latest version of CIRM's conflict
of interest rules are under review by the FPPC. They do not include
any changes in public disclosure for grant reviewers. In view of the
new information that confirms that reviewers are making 98 percent of
the decisions on who gets the taxpayers' dollars, it would seem that it is long past due for public disclosure of both financial and professional
interests of reviewers. Indeed, given the nature of scientific
research and the tiny size of the stem cell community, disclosure of
professional interests may be more important than financial
disclosures.

"The public trust in what we do is
just essential, and we cannot afford to take any chances with the
integrity of the research process."

Here is the CIRM document concerning
reviewers' decisions and governing board action. The table has not
been posted on the CIRM website, but it was prepared for last month's
meeting dealing with the Institute of Medicine's recommendations for
sweeping changes at the agency, especially related to conflicts of
interest.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/oma-MLcANoY/time-for-public-disclosure-of-financial.html

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San Jose Newspaper Lauds CIRM Chairman Thomas

Posted: February 17, 2013 at 3:05 am

The California stem cell agency got some good
news this week. The San Jose Mercury News ran an editorial yesterday
that was headlined,

“State stem cell agency is
taking Institutes of Medicine advice”
The 306-word editorial said CIRM
Chairman Jonathan Thomas is a refreshing change from Robert Klein,
the first chairman of the $3 billion enterprise. The brief editorial
said Thomas recognizes that the eight-year-old agency "has to mature." It said Thomas was trying to improve transparency and accountability.
The last paragraph declared,
 “If the stem cell agency can establish a record
as a good steward of public dollars to finance brilliant
science, it can continue to play a useful role in
stimulating and guiding research to bring the potential
cures from stem cell research to fruition.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZgT5-BiCODk/san-jose-newspaper-lauds-cirm-chairman.html

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No Improper Influence: CIRM Defends ‘No Actual Conflicts’ Claim

Posted: February 17, 2013 at 3:05 am

Earlier
this month the California Stem Cell Report  published an item that said:

“In
the wake of recent considerable criticism concerning conflicts of
interest at the $3 billion California stem cell agency, its leaders
have taken to saying 'no actual conflicts' have been found at the
agency.

“That
assertion is simply not true.”

We
asked the stem cell agency if it would like to respond and said that
its response would be carried verbatim. The agency's comments are below. Our
take on the response follows the CIRM comments, which were authored
by Kevin McCormack, the agency's senior director for public
communications and patient advocate outreach.

In
David Jensen’s recent blog about the stem cell agency he claims to
“debunk” claims that there have been no actual conflicts in
CIRM’s funding decisions saying “the agency has a long history of
problems involving conflicts of interest, 'actual' and otherwise.”
In fact, in the cases cited by Mr. Jensen, show 'otherwise' is the
appropriate word here because as we’ll show CIRM’s conflict
procedures worked and the funding decisions were not affected by any
improper influence.
Let’s
take it case by case, looking at each instance of a “conflict”
cited by Mr. Jensen.
John
Reed
In
2007, John Reed, a member of the stem cell agency’s Governing
Board, contacted staff in his capacity as the president of the
Burnham Institute after the Board approved a SEED grant award to a
Burnham investigator. Dr. Reed did not participate in the Board’s
decision to approve the award and played no role in that decision.
All he did was send a letter to CIRM staff after the Board meeting to
provide factual information in response to technical questions raised
by CIRM staff concerning the investigator’s eligibility for an
award. Those questions ultimately led staff to reject the grant.
Because the Board had already made the decision to award the grant,
it did not occur to Dr. Reed that the conflict rules would prevent
him from contacting staff to provide relevant information. And why
would it? The decision was made so there was nothing to influence.
After CIRM staff received Dr. Reed’s letter, they informed Dr. Reed
that he must refrain from participating in any way in CIRM's
consideration of the Burnham grant. In addition, CIRM staff did not
consider the letter in conducting their administrative review of the
Burnham grant and their determination that the investigator was not
eligible did not change. The FPPC determined that, although Dr.
Reed’s conduct raised ethical concerns, he had not violated
conflict of interest laws because he attempted to influence a
decision that had already been made. Furthermore, Dr. Reed’s
conduct did not affect a CIRM funding decision because the grant was
rejected by CIRM staff.
New
Faculty Awards
When
a candidate applies for a CIRM New Faculty Award it is standard
practice for them to include a letter of support from the institution
where they hope to be working. In December 2007, during a review of
applications for New Faculty Awards, CIRM staff discovered that ten
applications were accompanied by letters of institutional support
signed by members of the Board. This was due to a miscommunication by
staff, a poorly drafted memo to Board members leading them to think
it was OK to sign the letters of institutional support. The error was
discovered before the Board considered any of the applications. CIRM
staff determined that the letters could be perceived to create a
conflict of interest and so, to avoid even the appearance of a
conflict, CIRM staff disqualified the ten applications. As a result,
the applications were not presented to the Board for its
consideration, thereby avoiding any potential for a conflict of
interest in a funding decision.
John
Sladek
In
2011, while preparing the public summary for Basic Biology III
applications, CIRM staff discovered that Dr. John Sladek was one of
several co-authors on scientific publications with a researcher who
was listed as a consultant on a CIRM grant application. This is a
technical violation of the Grants Working Group (“GWG”) conflict
policy, which prohibits a member of the GWG from participating in the
review of an application if the member has co-authored papers with a
salaried investigator listed on a CIRM application within a three
year window. It should be noted, however, that Dr. Sladek’s
participation in the review of the application would not have
constituted a conflict of interest under state conflict of interest
laws because Dr. Sladek did not have a financial interest in the
application. In addition, the amount of funding involved –
approximately $3,000 of salary per year for three years, less than
one percent of the total award – was not material, and Dr. Sladek
did not stand to receive any financial benefit from the application.
Finally, Dr. Sladek’s participation in the review did not affect
the outcome because the application was not recommended, or approved,
for funding.
The
three instances cited by Mr. Jensen share two common features.
First, CIRM staff identified the potential for a conflict before any
funding decision was made. Second, CIRM’s funding decisions were
not affected by any improper influence.
Ted
Love
Mr.
Jensen also cites the service of Dr. Ted Love, a member of the Board
who volunteered his time to assist CIRM in offering his scientific
and medical expertise, as evidence of a conflict of interest.
Although Mr. Jensen insinuates that Dr. Love’s service constituted
a conflict of interest, he does not cite any facts, except Dr. Love’s
“deep connections to the biomedical industry.” But the fact that
Dr. Love has experience in the biotech industry does not constitute a
conflict of interest, and as a member of the Board and as a volunteer
to CIRM, Dr. Love abided by CIRM’s conflict of interest policies.
In
the past Mr. Jensen has criticized the stem cell agency for its lack
of connections and engagement with industry. In this case he
criticizes us precisely because of our connection and engagement with
someone who has industry experience.
Venture
Capital Firm
Mr.
Jensen also suggests that a conflict of interest arose from the fact
that “iPierian,Inc., whose major investors [a venture capital firm]
contributed nearly $6 million to the ballot measure that created the
stem cell agency, has received $7.1 million in awards from the
agency.” While it is true that Proposition 71 involved a
multi-million dollar campaign, the funding for the campaign came
primarily from individuals who had a family member who suffered from
a chronic disease or injury, including individuals associated with a
venture capital firm. The firm itself did not contribute to the
campaign, nor did the campaign accept contributions from
biotechnology or pharmaceutical companies. Furthermore, the venture
capital firm did not invest in a CIRM grantee; rather, it invested in
a different company which subsequently merged with yet another
company to form an entity that later applied for, and was awarded a
CIRM grant.
Stem
Cells, Inc.
Mr.
Jensen cites CIRM’s award to Stem Cells, Inc. as another source of
a conflict. In support of this claim, Mr. Jensen’s references Bob
Klein’s support of the award, as well as the fact that Irv
Weissman, PhD, appeared in an ad for Proposition 71 in 2004.
However, neither Mr. Klein’s support for the award nor Dr.
Weissman’s support for Proposition 71 constitutes a conflict of
interest. First, Mr. Klein, like any member of the public, has the
right to express his views to the Board. The state’s revolving
door laws do not apply to a former member of the Board who, like Mr.
Klein, is not compensated for making an appearance. As for Dr.
Weissman’s support for Proposition 71, nothing in state law
prohibits a member of the public from seeking CIRM funding even
though he supported the measure during the campaign. In fact, it
would be reasonable to expect that most stem cell scientists in
California (and elsewhere) supported Proposition 71. Disqualifying
individuals from receiving funding because they supported the law
would leave few, if any, eligible applicants.
Allegation
of Conflict at Board Meeting
As
further evidence of an “actual conflict”, Mr. Jensen cites
another instance in 2008 in which a representative of a for-profit
applicant publicly complained at a Board meeting that a member of the
GWG had a conflict of interest “from a business perspective.” As
provided for by CIRM’s regulations, the applicant had filed an
appeal, claiming that the reviewer had a conflict of interest because
he had a financial relationship with another company that was not an
applicant for CIRM funding. CIRM’s legal counsel reviewed the
appeal and determined that there was no conflict of interest under
CIRM’s policy.
Saira
Ramasastry and Laurence Elias
Mr.
Jensen cites two instances in which CIRM’s hired consultants in
support of his claim that CIRM has “actual conflicts of interest.”
In 2010, CIRM retained a partner at Life Sciences Advisory, LLC,
Saira Ramasastry, to assist CIRM’s External Advisory Panel, which
completed its work in December 2010. In 2012, Sangamo BioSciences,
Inc., nominated Ms. Ramasastry to serve on its Board of Directors.
Although Ms. Ramasastry continued to provide some consulting services
to CIRM through fiscal year 2011-12, none of her work for CIRM
involved Sangamo or any CIRM program in which it was involved. Ms.
Ramasastry’s services on behalf of CIRM did not create any conflict
of interest. The same is true of the second instance cited by Mr.
Jensen. In 2010, CIRM hired Dr. Laurence Elias, a former Geron
employee and an accomplished clinical development professional, to
provide CIRM with technical and regulatory input to ensure that the
clinical elements of an RFA were technically complete and accurate.
The concept for RFA had already been approved and as such Dr. Elias
was not in any position to influence the overall scope or structure,
nor did he have any role in evaluating applications. CIRM staff and
Dr. Elias complied with all conflict of interest requirements.
Neither contract led to an “actual conflict of interest”.
Diane
Winokur
Mr.
Jensen’s laundry list of “conflicts” also includes a reference
to the recent appointment of Diane Winokur to serve on CIRM’s
Board. Mr. Jensen quotes a representative of the ALS Association who
said that Ms. Winokur will be “a tremendous asset in moving the ALS
research field forward through CIRM funding." Of all the
insinuations made in his blog this is perhaps the cheapest shot,
taking aim at a woman who has dedicated her life to fighting a deadly
disease, one that claimed the lives of her two sons. Mr. Jensen knows
very well that the ALS Association does not speak for Ms. Winokur or
CIRM and while we expect that Ms. Winokur will bring her expertise as
an advocate for people suffering from ALS to the Board, she, like all
members of CIRM’s Board, represents all Californians, not just
those suffering from a particular disease. Ms. Winokur’s
appointment does not create a conflict of interest.
Press
Releases
Finally,
Mr. Jensen cites a Board debate from 2006 involving a requirement in
CIRM’s intellectual property regulations regarding press releases.
Under Health and Safety Code section 125290.30(g)(1)(C), the
discussion of standards does not create a conflict of interest, and
the Board’s debate was enriched by the participation of members who
brought their expertise and experience to bear.
Mr.
Jensen says that one of the reasons why the IOM did not report any
instances of conflict of interest in its report is that it did not
look for any conflicts of “inappropriate behavior,” But Mr.
Jensen was present in the public hearing at UC Irvine in April of
2012 when the IOM panel asked Stuart Drown, Executive Director of the
Little Hoover Commission that also looked into allegations of
conflict of interest at CIRM, if he could cite any actual instances.
Mr. Drown said he could not. Nor did Mr. Jensen offer any when it was
his turn to talk.



The view from the California Stem Cell Report:
Generally
speaking, CIRM's response about “actual” conflicts of interests
is a reiteration of what the California Stem Cell Report carried at
the time of each incident and does not add much new to the discussion
of the issues. All of the agency's earlier responses could be found in
the links in the “debunking” piece. Additionally the agency
confuses what are clearly actual conflicts with other instances that
could involve either actual or perceived conflicts, which the IOM
noted can be as deadly as the real thing. However,
in the most egregious cases involving Reed and later the five medical
school deans, the agency would like the public to believe that these
were not serious matters because the staff detected and caught the
conflicts before the grants were made.
That
is like saying a burglar who was caught in the act before he escaped
with his booty committed no offense.
The
acts were committed by members of the CIRM board, and they were
violations of conflict of interest standards. In the case of
the five deans, that is why the agency voided 10 applications
totaling $31 million from their five institutions. If there had been
no actual conflict of interest, that would not have been necessary.
As
for blaming the staff for “miscommunications,” the applications
that the five deans signed were quite clear and offered them the
option of having another person at their institution sign the grant
proposal. Other deans on the board did not sign applications in the
same round. Those applications were then handled in the normal
fashion. One might ask how in the world could the head of a medical
school who was also serving on the CIRM board NOT recognize a
conflict of interest when asked to sign a request for cash from the
board on which he served?
Regarding
John Reed and his conflict of interest violation, both he and then
CIRM Chairman Robert Klein have acknowledged Reed's actions
were wrong. Klein, an attorney who directed the writing of the
10,000-word measure that created CIRM, advised Reed to contact CIRM
staff to lobby on behalf of a grant that was approved by the board
but was about to be denied by staff.(See here, here and here.)
CIRM's
response contends that Reed's 6 ½ page letter was nothing more than
“factual” information dealing with technical matters. That is
hardly the case. In fact, Reed explicitly “emphasized” (Reed's word) that failing to comply with his letter would damage the future
of the stem cell agency. Denial of the grant, he said, “will surely
discourage clinical researchers from participating in the CIRM
mission to advance stem cell therapies.”   
Reed's
action was inappropriate, and the California Fair Political
Practices Commission warned Reed about his actions. The journal Nature reported,

“California’s
Fair Political Practices Commission (FPCC) decided that Burnham
Institute President violated conflict-of-interest rules by writing a
letter to the California Institute of Regenerative Medicine appealing
a decision that an affiliate of his institute was ineligible for
funding.”

The
California Stem Cell Report's “debunking” piece went beyond "actual" conflicts to describe other instances where conflicts emerged.
Readers can go back to the original links for all the details, but
the cases of StemCells, Inc., and iPierian, Inc., are worth reviewing
again. Both cases involve fund-raising efforts that ran into
millions of dollars for the ballot measure campaign that created
CIRM. The campaign was run by Bob Klein who later became the agency's
first chairman, serving for six years and becoming something of a
hallowed figure in stem cell circles. One of the principal jobs of a
campaign manager is to raise the millions needed to run a successful
statewide election campaign in California. It is common for members
of the public to believe that major campaign contributors are
rewarded later for their contributions. Whether that was the case in
these instances, the reader must decide for himself or herself. But
the appearance is less than salubrious for an agency that claims to
have never seen an actual conflict of interest as it has handed out
$32,000 an hour, 24 hours a day, seven days a week during the last six
years.
The
facts are that about 90 percent of the $1.7 billion awarded by the
CIRM board has gone to institutions tied to present and past members
of its governing board. The agency, however, does work hard to be
sure legal conflicts do not arise during board action on grant
applications, using a voting procedure that is so convoluted that the
actual vote on nearly all applications is not even announced at board
meetings. Sometimes the procedure means that only a handful of
governing board members can participate in debate or vote. In the
case of the five medical school deans, as the board struggled to deal
with the fallout in 2007, only eight of the 29 members of the board could participate in the discussion because the rest had conflicts.
As
for CIRM's comments about “insinuations” and “cheap shots” by
the California Stem Cell Report, we naturally differ with that
characterization. The case in point involved what the chief scientist
for a patient advocate group said she expected as the result of a
recent appointment to the board. The scientist's remarks were offered
as example of the type of expectation and entitlement that can arise when governing
board members must be picked from specific constituencies, as is the
case with all 29 CIRM board members.


And as for my testimony at the IOM hearing last April, here is a link to my statement, which includes a discussion of conflicts of interest.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zwk3dz23Ewc/no-improper-influence-cirm-defends-no.html

Posted in Stem Cells, Stem Cell Therapy | Comments Off on No Improper Influence: CIRM Defends ‘No Actual Conflicts’ Claim

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