Contact Information

Theodore Lowe, Ap #867-859
Sit Rd, Azusa New York

We Are Available 24/ 7. Call Now.
The $5.5 Billion Stem Cell Proposition: A
“Christmas Tree” Measure Loaded With More Than
Cash

Editor’s note: The following item was written by the
producer of the California Stem Cell Report and appeared
last week on the Capitol Weekly online news
service. 

By David Jensen


Proposition 14
, the fall ballot measure to save California’s
stem cell agency from financial extinction, contains much, much
more than the $5.5 billion that it is seeking from the
state’s voters.

Added to the agency’s charter would be research involving
mental health, “therapy delivery,†personalized medicine and
“aging as a pathology.“ That is not to mention a greater
emphasis on supporting “vital research opportunities†that are
not stem cell-related.

The measure would enlarge the board from 29 to 35 members. Even
at 29, the board has been much criticized for its large size, which
creates more possibilities for conflicts of interest, a
long-standing issue for the agency.

Proposition 14 would ban royalties generated by state-backed
stem cell inventions from being used for such things as prisons and
schools, isolating the funds from tinkering by lawmakers.

It creates a building program for treatment centers that could
total about $82.5 million. They would be located in areas not now
well-served. And the measure locks up $1.5 billion for “diseases
and conditions of the brain and central nervous system,†such as
autism and schizophrenia. 

Approved by voters in 2004, the agency is already a prodigiously
ambitious effort, seeking stem cell cures and treatment for
afflictions that backers say burden half the families in
California. However, the original $3 billion that voters provided
is dribbling to an end. Unless voters provide $5.5 billion more,
the agency — known officially as the California Institute for
Regenerative Medicine (CIRM)
 â€” will begin shutting its doors
this winter. 

While Proposition 14 is the cure for what financially ails the
agency, the measure also sends CIRM into arenas that some would
argue muddle its focus and distract from its original goals.

(Click here to
see the Legislative Analyst’s description of the measure, which
is going to nearly 21 million California voters )

Details of the changes in CIRM’s mission are tucked away in
the complex and murky, 10,000-word initiative sponsored by Robert Klein, a Palo
Alto real estate developer 
and attorney. He oversaw the writing
of the initiative as well as the
2004 stem cell measure
 that created the agency. Klein was the
first chairman of the agency and is now leading the current
campaign.

The new playing field for CIRM encompasses particularly critical
areas of costs to patients and profits for companies. Stem cell
therapies are expected to be enormously expensive — $1 million or
more in many cases. That’s a figure that makes health insurance
companies balk and Medicare blanch.

Proposition 14  would launch a hefty effort to make stem cell
therapies more affordable and accessible. The cash behind that
drive could run as high as $155 million. And that’s not
necessarily going for patients.

The intent is to create and build support for financial models
for health insurance companies. CIRM would also be charged with
helping to implement them. Such models would justify the cost of
the theoretically one-time cures by demonstrating that they would
actually save money — ending the need to treat patients in what
currently seems to be an endless and expensive cycle.

Proposition 14 speaks of covering patients and,
importantly,  their caregivers for medical expenses, lodging, meals
and travel. That would help provide access to clinical trials that
are located in prohibitively expensive urban areas, which poses
financial barriers for persons who live some distance away. The
added coverage would additionally help researchers and companies
recruit enough trial participants, which can be a problem in some
disease areas.

Proposition 14 creates a 17-member, CIRM affordability committee
to drive all this. It would work with industry and the federal
government to win their support.  The committee would be backed
with as many as 15 CIRM staffers. The ballot allows as much as $55
million for their compensation over 10 or so years. 

But if 15 is not enough, more employees could be hired beyond
the nominal cap on CIRM employees of 70 if they are compensated
through the use of private cash.

The extraordinary cost of stem cell treatments involves
something called “reimbursement,†a biomedical industry
euphemism for how companies cover the high costs of the research
and still make a profit. If money is not to be made, businesses are
not likely to be motivated to turn CIRM research into cures.

The measure additionally allows the new affordability panel to
hire consultants, capping that expense at about $105 million.

The affordability effort involves important public policy,
industry and research issues that concern patient groups and
industry. However, the affordability panel would be permitted to
operate behind closed doors as it considers the problems and weighs
the solutions.

Votes by the committee, however, would have to be taken in
public.

Members of the panel would not be required to disclose publicly
their economic or professional interests. The committee would be
exempt from the state public records act except for material
specifically submitted to the CIRM board.

Proposition 14 locks up $1.5 billion for “diseases and
conditions of the brain and central nervous system, such as
Alzheimer’s disease, Parkinson’s disease, stroke, dementia,
epilepsy, depression, brain cancer, schizophrenia (and)
autism.† The $1.5 billion would not be available for research
into the No. 1 killer in the United States, heart disease, or other
excluded conditions. 

Beyond the affordability program, Proposition 14 gives CIRM new
authority to finance research in several additional fields. The
authorization is scattered throughout the
initiative document. 
Mental health research first appears on
page nine. Depression appears on page 26. Therapy delivery, which
is not defined in the measure, crops up in 10 locations.
Personalized medicine and “aging as a pathology†surface on
page 34.

On a much smaller scale, but important to researchers, the
proposition includes up to $27.5 million for a shared labs program
that was scrubbed a few years back when CIRM turned more towards
clinical trials. And the initiative opens the door to even more
programs that are not specifically mentioned. It gives a high
priority to supporting pluripotent stem cell research that is
unlikely to receive federal funding or where funding is “not
timely or sufficient.â€

Perhaps the biggest, but not entirely new opportunity for CIRM
to expand beyond stem cell research involves “vital research
opportunities.† CIRM calls them VROs. And they are a loophole
that allows CIRM to finance almost any kind of research if there
are enough votes on the board to do so.

In both the original and current initiative, a  VRO is defined
as “scientific and medical research and technologies†that
provide “a substantially superior research opportunity, vital to
advance medical science.â€

Proposition 14 makes it easier for the CIRM board to declare a
VRO. Currently, it takes a two-thirds vote of a quorum of the group
that reviews applications. Under this year’s ballot measure, CIRM
does not need to meet those criteria. The governing board could
invoke a VRO on its own. In some cases, it could require only 12
votes or less of the 35-member board, depending on the quorum and
the number of board members present.

Proposition 14 specifically added the fields of  â€œgenetics,
personalized medicine, and aging as a patholoqy†to VROs. In the
2004 initiative, the phrase “vital research
opportunities† appeared only seven times. In this year’s
initiative, it appears 17 times as the possibility of its use has
expanded. Significantly, experience involving vital research
opportunities is now listed as part of the qualifications for the
chair, two board members and 15 members of the group that reviews
grant applications.

CIRM has invoked the original VRO clause only twice. A
third attempt was rejected last May after directors expressed
concern about mission creep.
 However, Klein’s new emphasis on
it points to the likelihood of increased use, especially if he once
again becomes chairman of CIRM.

Under existing law, CIRM’s royalties go into the state’s
general fund, the source of state expenditures for prisons, schools
and health services. Under Proposition 14, the royalties would
still go into the general fund, but they would be locked up for use
in dealing with affordability. In 2004, the stem cell campaign
financed studies that envisioned royalties
of as much as $1.1 billion.
 To date, they have totaled only
$462,433. However, it can take years for a scientific discovery to
work its way into an actual product. And a particular discovery may
well amount to only a tiny contribution to a product, which would
reduce the likelihood of major royalties.

In another major move, Proposition 14 would benefit some of the
less-than-urban areas of the state in a new “geographic
diversity†program. Rural or semi-rural areas suffer from a lack
of physicians as well as the high tech facilities needed to make
stem cell treatments available for participation in clinical
trials. The measure earmarks as much as $82.5 million for new
“community centers of excellence.†They would “support
clinical trials and…serve as the foundation for the delivery of
future treatments,†the proposition states, giving priority to
“geographic distribution.â€

One of them could well be in Fresno where the University of
California, San Francisco (UCSF), has established an outpost. One
of the new members on the CIRM board would be from the UCSF
operation in Fresno, making it the only institution that has two
representatives on the board. Another new member of the board would
be from UC Riverside, whose medical school is only seven years old.
UC Riverside also serves a community that incorporates large rural
and semi-rural areas.

The increase in the size of the board to 35 flies in the face of
recommendations by the prestigious Institute of Medicine (IOM).
Among other things, it said in 2012 that the current 29 board
members are more than sufficient for the agency. CIRM
paid $700,000 for the IOM study, which it hoped would help generate
voter support for more funding.

If Proposition 14 passes, the measure creates a relatively quick
way to begin to overhaul the board. Under the measure, a number of
current members of the board could lose their seats if they have
served at least half of their terms.

It is not clear whether the CIRM governing board understood the
removal provisions when they endorsed
Proposition 14 June 26 on a 21-1 vote. 
The discussion lasted
only 30 minutes. â€œIt’s
a no-brainer,â€
 said George Blumenthal, chancellor of the UC
Santa Cruz campus and a member of the CIRM board..

Proposition 14 is something of a “Christmas Tree†measure
— a term used to describe legislation that has something for
everyone. Many ballot initiatives are like that. They must run the
gauntlet of a ballot campaign, luring millions of voters into
voting for them. Backers of initiatives need to satisfy potential
donors and potential beneficiaries, all the while not alienating
anybody enough to generate well-funded, powerful opposition.   

The 2004 measure fulfilled those needs nicely. Nearly every
institution that stood to benefit from CIRM funding gained a seat
at the table where the decisions were made — for better or
worse. 

Proposition 14 carries on in that tradition and expands it. Plus
the initiative attempts to deal with the tough challenges of costs
and profits in what many expect to be a revolution in medicine.
Voters will begin casting their ballots in early October. Backers
of the initiative have only five weeks to catch the early birds in
that particular flock.
—
Editor’s Note: David Jensen is a retired newsman who has followed
the affairs of the $3 billion California stem cell agency since
2005 via his blog, the California
Stem Cell Report
. He has
published more than 5,000 items on California stem cell matters.
His upcoming book, â€œCalifornia’s
Great Stem Cell Experiment: Inside a $3 billion Search for
Cures
,†is
available for pre-order on Amazon. 

Editor’s note: The following item was written by the
producer of the California Stem Cell Report and appeared
last week on the Capitol Weekly online news
service. 

By David Jensen


Proposition 14
, the fall ballot measure to save California’s
stem cell agency from financial extinction, contains much, much
more than the $5.5 billion that it is seeking from the
state’s voters.

Added to the agency’s charter would be research involving
mental health, “therapy delivery,†personalized medicine and
“aging as a pathology.“ That is not to mention a greater
emphasis on supporting “vital research opportunities†that are
not stem cell-related.

The measure would enlarge the board from 29 to 35 members. Even
at 29, the board has been much criticized for its large size, which
creates more possibilities for conflicts of interest, a
long-standing issue for the agency.

Proposition 14 would ban royalties generated by state-backed
stem cell inventions from being used for such things as prisons and
schools, isolating the funds from tinkering by lawmakers.

It creates a building program for treatment centers that could
total about $82.5 million. They would be located in areas not now
well-served. And the measure locks up $1.5 billion for “diseases
and conditions of the brain and central nervous system,†such as
autism and schizophrenia. 

Approved by voters in 2004, the agency is already a prodigiously
ambitious effort, seeking stem cell cures and treatment for
afflictions that backers say burden half the families in
California. However, the original $3 billion that voters provided
is dribbling to an end. Unless voters provide $5.5 billion more,
the agency — known officially as the California Institute for
Regenerative Medicine (CIRM)
 â€” will begin shutting its doors
this winter. 

While Proposition 14 is the cure for what financially ails the
agency, the measure also sends CIRM into arenas that some would
argue muddle its focus and distract from its original goals.

(Click here to
see the Legislative Analyst’s description of the measure, which
is going to nearly 21 million California voters )

Details of the changes in CIRM’s mission are tucked away in
the complex and murky, 10,000-word initiative sponsored by Robert Klein, a Palo
Alto real estate developer 
and attorney. He oversaw the writing
of the initiative as well as the
2004 stem cell measure
 that created the agency. Klein was the
first chairman of the agency and is now leading the current
campaign.

The new playing field for CIRM encompasses particularly critical
areas of costs to patients and profits for companies. Stem cell
therapies are expected to be enormously expensive — $1 million or
more in many cases. That’s a figure that makes health insurance
companies balk and Medicare blanch.

Proposition 14  would launch a hefty effort to make stem cell
therapies more affordable and accessible. The cash behind that
drive could run as high as $155 million. And that’s not
necessarily going for patients.

The intent is to create and build support for financial models
for health insurance companies. CIRM would also be charged with
helping to implement them. Such models would justify the cost of
the theoretically one-time cures by demonstrating that they would
actually save money — ending the need to treat patients in what
currently seems to be an endless and expensive cycle.

Proposition 14 speaks of covering patients and,
importantly,  their caregivers for medical expenses, lodging, meals
and travel. That would help provide access to clinical trials that
are located in prohibitively expensive urban areas, which poses
financial barriers for persons who live some distance away. The
added coverage would additionally help researchers and companies
recruit enough trial participants, which can be a problem in some
disease areas.

Proposition 14 creates a 17-member, CIRM affordability committee
to drive all this. It would work with industry and the federal
government to win their support.  The committee would be backed
with as many as 15 CIRM staffers. The ballot allows as much as $55
million for their compensation over 10 or so years. 

But if 15 is not enough, more employees could be hired beyond
the nominal cap on CIRM employees of 70 if they are compensated
through the use of private cash.

The extraordinary cost of stem cell treatments involves
something called “reimbursement,†a biomedical industry
euphemism for how companies cover the high costs of the research
and still make a profit. If money is not to be made, businesses are
not likely to be motivated to turn CIRM research into cures.

The measure additionally allows the new affordability panel to
hire consultants, capping that expense at about $105 million.

The affordability effort involves important public policy,
industry and research issues that concern patient groups and
industry. However, the affordability panel would be permitted to
operate behind closed doors as it considers the problems and weighs
the solutions.

Votes by the committee, however, would have to be taken in
public.

Members of the panel would not be required to disclose publicly
their economic or professional interests. The committee would be
exempt from the state public records act except for material
specifically submitted to the CIRM board.

Proposition 14 locks up $1.5 billion for “diseases and
conditions of the brain and central nervous system, such as
Alzheimer’s disease, Parkinson’s disease, stroke, dementia,
epilepsy, depression, brain cancer, schizophrenia (and)
autism.† The $1.5 billion would not be available for research
into the No. 1 killer in the United States, heart disease, or other
excluded conditions. 

Beyond the affordability program, Proposition 14 gives CIRM new
authority to finance research in several additional fields. The
authorization is scattered throughout the
initiative document. 
Mental health research first appears on
page nine. Depression appears on page 26. Therapy delivery, which
is not defined in the measure, crops up in 10 locations.
Personalized medicine and “aging as a pathology†surface on
page 34.

On a much smaller scale, but important to researchers, the
proposition includes up to $27.5 million for a shared labs program
that was scrubbed a few years back when CIRM turned more towards
clinical trials. And the initiative opens the door to even more
programs that are not specifically mentioned. It gives a high
priority to supporting pluripotent stem cell research that is
unlikely to receive federal funding or where funding is “not
timely or sufficient.â€

Perhaps the biggest, but not entirely new opportunity for CIRM
to expand beyond stem cell research involves “vital research
opportunities.† CIRM calls them VROs. And they are a loophole
that allows CIRM to finance almost any kind of research if there
are enough votes on the board to do so.

In both the original and current initiative, a  VRO is defined
as “scientific and medical research and technologies†that
provide “a substantially superior research opportunity, vital to
advance medical science.â€

Proposition 14 makes it easier for the CIRM board to declare a
VRO. Currently, it takes a two-thirds vote of a quorum of the group
that reviews applications. Under this year’s ballot measure, CIRM
does not need to meet those criteria. The governing board could
invoke a VRO on its own. In some cases, it could require only 12
votes or less of the 35-member board, depending on the quorum and
the number of board members present.

Proposition 14 specifically added the fields of  â€œgenetics,
personalized medicine, and aging as a patholoqy†to VROs. In the
2004 initiative, the phrase “vital research
opportunities† appeared only seven times. In this year’s
initiative, it appears 17 times as the possibility of its use has
expanded. Significantly, experience involving vital research
opportunities is now listed as part of the qualifications for the
chair, two board members and 15 members of the group that reviews
grant applications.

CIRM has invoked the original VRO clause only twice. A
third attempt was rejected last May after directors expressed
concern about mission creep.
 However, Klein’s new emphasis on
it points to the likelihood of increased use, especially if he once
again becomes chairman of CIRM.

Under existing law, CIRM’s royalties go into the state’s
general fund, the source of state expenditures for prisons, schools
and health services. Under Proposition 14, the royalties would
still go into the general fund, but they would be locked up for use
in dealing with affordability. In 2004, the stem cell campaign
financed studies that envisioned royalties
of as much as $1.1 billion.
 To date, they have totaled only
$462,433. However, it can take years for a scientific discovery to
work its way into an actual product. And a particular discovery may
well amount to only a tiny contribution to a product, which would
reduce the likelihood of major royalties.

In another major move, Proposition 14 would benefit some of the
less-than-urban areas of the state in a new “geographic
diversity†program. Rural or semi-rural areas suffer from a lack
of physicians as well as the high tech facilities needed to make
stem cell treatments available for participation in clinical
trials. The measure earmarks as much as $82.5 million for new
“community centers of excellence.†They would “support
clinical trials and…serve as the foundation for the delivery of
future treatments,†the proposition states, giving priority to
“geographic distribution.â€

One of them could well be in Fresno where the University of
California, San Francisco (UCSF), has established an outpost. One
of the new members on the CIRM board would be from the UCSF
operation in Fresno, making it the only institution that has two
representatives on the board. Another new member of the board would
be from UC Riverside, whose medical school is only seven years old.
UC Riverside also serves a community that incorporates large rural
and semi-rural areas.

The increase in the size of the board to 35 flies in the face of
recommendations by the prestigious Institute of Medicine (IOM).
Among other things, it said in 2012 that the current 29 board
members are more than sufficient for the agency. CIRM
paid $700,000 for the IOM study, which it hoped would help generate
voter support for more funding.

If Proposition 14 passes, the measure creates a relatively quick
way to begin to overhaul the board. Under the measure, a number of
current members of the board could lose their seats if they have
served at least half of their terms.

It is not clear whether the CIRM governing board understood the
removal provisions when they endorsed
Proposition 14 June 26 on a 21-1 vote. 
The discussion lasted
only 30 minutes. â€œIt’s
a no-brainer,â€
 said George Blumenthal, chancellor of the UC
Santa Cruz campus and a member of the CIRM board..

Proposition 14 is something of a “Christmas Tree†measure
— a term used to describe legislation that has something for
everyone. Many ballot initiatives are like that. They must run the
gauntlet of a ballot campaign, luring millions of voters into
voting for them. Backers of initiatives need to satisfy potential
donors and potential beneficiaries, all the while not alienating
anybody enough to generate well-funded, powerful opposition.   

The 2004 measure fulfilled those needs nicely. Nearly every
institution that stood to benefit from CIRM funding gained a seat
at the table where the decisions were made — for better or
worse. 

Proposition 14 carries on in that tradition and expands it. Plus
the initiative attempts to deal with the tough challenges of costs
and profits in what many expect to be a revolution in medicine.
Voters will begin casting their ballots in early October. Backers
of the initiative have only five weeks to catch the early birds in
that particular flock.
—
Editor’s Note: David Jensen is a retired newsman who has followed
the affairs of the $3 billion California stem cell agency since
2005 via his blog, the California
Stem Cell Report
. He has
published more than 5,000 items on California stem cell matters.
His upcoming book, â€œCalifornia’s
Great Stem Cell Experiment: Inside a $3 billion Search for
Cures
,†is
available for pre-order on Amazon. 

Share:

administrator