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Bill Takes Aim at CIRM Governance, Stem Cell Research Payback

California Sen. Sheila Kuehl introduced a bill Friday to study the
structure of the California Institute for Regenerative Medicine — the
agency created to distribute $3 billion in state bond funds for
embryonic stem cell research — and to require therapies from the
research to help the state’s neediest residents.

Kuehl, D-Santa Monica, and Sen. George Runner, R-Lancaster, authored the legislation, S.B. 1565.

Kuehl said Prop. 71, the voter-approved measure in November 2004
that called for the state to sell stem cell bonds, does not ensure that
uninsured Californians and programs that serve low-income residents
have access to or get the best prices for therapies that emerge from
CIRM-funded research.

The Kuehl-Runner bill requires that publicly funded programs
get the best prices for stem cell therapies and drugs by requiring CIRM
grant winners and licensees to sell them to those programs at a price
that does not exceed one of the benchmark prices in Cal-Rx, the state’s
prescription drug discount program.

The bill also calls for the state’s Little Hoover Commission to
study the existing governance structure of San Francisco-based CIRM and
report to the Legislature by July 1, 2009.

CIRM is overseen by the 29-person Independent Citizens
Oversight Committee, chaired by Robert Klein, who spearheaded the
ballot initiative. It is made up of executives from research
institutes, California universities and medical schools, leaders of
for-profit businesses and patient advocates. But that group has come
under fire for potential conflicts of interest and accountability
issues.

"The bill will… help ensure the public’s trust by identifying
ways to increase public accountability and reduce conflicts of
interest," Kuehl said in a prepared statement.

CIRM leaders were not immediately available to comment about the Kuehl-Runner bill.

One of CIRM’s watchdogs, John Simpson, stem cell project
director for the Santa Monica-based Foundation for Taxpayer and
Consumer Rights, welcomed Kuehl’s legislation.

"The stem cell agency’s oversight board was designed with
built-in conflicts of interest and it’s too big to be effective,"
Simpson said in a prepared statement.

"An outside analysis by unbiased observers can only be good,"
he added. "A hard-nosed look by the Little Hoover Commission is just
what’s needed."

Kuehl and CIRM have been at odds over the past year. She and 12
other state legislators in early December called on the agency to
tighten its intellectual property and revenue-sharing requirements
regarding for-profit grant winners. Earlier last year, she drafted
legislation requiring CIRM to provide the state with 25 percent of
associated net licensing revenues from therapies funded by the agency
and for companies to pay 2 percent to 5 percent royalties on revenues
from CIRM-funded projects.

The $3 billion in state bonds to support CIRM represent the
largest single pot of money in the world dedicated to embryonic stem
cell research. It is significant because President George W. Bush
placed restrictions on using embryonic stem cells to research
conditions such as Alzheimer’s, Parkinson’s Disease, diabetes and
spinal cord injuries.

Proponents of stem cell research say scientists could unlock
the door to cures in a matter of years. Opponents say the research
destroys embryos and point to advances in adult stem cell research as
well as so-called induced pluripotent stem cells that could manipulate
adult cells to become embryonic-like cells.

Embryonic stem cells are important to researchers because they
can grow into any number of cell types; adult stem cells are believed
to be limited to the task for which they were initially assigned.

Although Prop. 71 was approved in November 2004, CIRM has been
hamstrung by legal challenges from taxpayer advocates and religious
groups opposed to stem cell research on the moral grounds because
research includes destruction of human embryos.

CIRM last year started to dispense hundreds of millions in
grants. Its biggest awards — more than $250 million for large research
facilities — are expected to be made in the spring. Klein has said
that the grants, which require a 20 percent match from applicants such
as Stanford University, the University of California, Berkeley, the
University of California, San Francisco, and the Buck Institute for Age
Research in Novato — could lead to $500 million in capital projects
related to stem cell research.

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