BILL ANALYSIS �
AB 714
Page 1
Date of Hearing: April 16, 2012
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 714 (Wieckowski) - As Amended: April 2, 2012
SUBJECT : Roman Reed Spinal Cord Injury Research Fund.
SUMMARY : Appropriates $2 million from the General Fund to the
spinal cord injury (SCI) research fund authorized by the Roman
Reed Spinal Cord Injury Research Act of 1999 (Roman Reed Act).
EXISTING LAW : Establishes the Roman Reed Act and authorizes the
University of California (UC) to establish a SCI research fund
independent of the State Treasury, to accept public and private
funds for the purpose of injury research programs and grants.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, California is
home to approximately 650,000 people living with paralysis,
and this number is increasing steadily. The author states
that nationally, someone suffers a traumatic SCI every 41
minutes, adding anywhere from 12,000 to 20,000 new SCI
patients annually. According to a report prepared for AB
1657, a similar bill from 2012, a recent study commissioned by
the Christopher and Dana Reeve Foundation and the Centers for
Disease Control reveals that approximately 5,600,000 Americans
are afflicted by some form of paralysis, and 1,275,000
individuals are living with a catastrophic SCI. The report
states this is five times higher than earlier estimates of the
prevalence of SCI in the United States. The author maintains
that the disability, loss of earning power, and loss of
personal freedom resulting from SCI is devastating for the
injured individual, and creates a huge financial burden for
the State. The author asserts that associated health care
costs and lost income potential associated with spinal
injuries cost the State of California upwards of $1 billion
per year. The author claims that promising research-driven
therapies currently underway could greatly improve the quality
of life and functionality of individuals with spinal cord
injuries and offset a significant portion of these state
AB 714
Page 2
costs. The author indicates that the funds have resulted in
remarkable research projects and at least 175 peer-reviewed
publications and that discoveries financed by the fund are in
the pipeline toward clinical translation.
The author indicates that State funding for the Roman Reed
Fund has been eliminated, jeopardizing the research that this
program undertakes in spinal cord injuries and paralysis. The
author states that by investing new funds in this research,
California can ensure the continued success of this impressive
program and remain a world leader in neural sciences. This
bill, the author maintains, will provide the critical funding
needed to make this program viable. In conclusion, the author
points out that in vetoing AB 1657 (Wieckowski) in 2012 the
Governor indicated that this type of valuable research should
be supported through general fund activities and this bill
addresses that veto message.
2)BACKGROUND . AB 750 (Dutra), Chapter 777, Statutes of 2000,
established the Roman Reed Act to support scientific research
related to spinal cord injuries. The original five-year
program was renewed for an additional five years through AB
1794 (Dutra), Chapter 414, Statutes of 2004. Over its 10-year
history, the fund provided approximately $1.5 million per year
for SCI research in the State of California. The Roman Reed
Act funds were allocated to UC, and administered by the
Reeve-Irvine Research Center (RIRC) at UC Irvine. According
to the author, between 2000 and 2009, over 300 scientists,
technical staff, and students have participated in 129 Roman
Reed Research projects and that the $15.1 million in state
contributions to the Roman Reed Fund leveraged $84 million in
non-state funds, such as from NIH. According to the Los
Angeles Times, in an article on March 21, 2013, deep federal
budget cuts, known as sequestration, could lead to diminished
funding for medical and scientific research. According to the
article, UC Irvine receives $100 million from the NIH. The
money is used to fund stem cell, diabetes, and Alzheimer's
studies, including the campus' Institute for Memory Impairment
and Neurological disorder. It is looking at a reduction of
5%-7%.
The Roman Reed Program has three components: a) research grants
to promote innovative, high-impact research projects focusing
on SCI or nerve cell regeneration. Principal Investigators
must be from institutions within the State of California; b)
AB 714
Page 3
the Roman Reed Core Laboratory which provides a means for
investigators who are new to the field of SCI research to
launch novel research projects and obtain training in SCI
research techniques. The main purpose of the Core Laboratory
is to support experiments by scientists with novel ideas, but
who are not yet directly engaged in SCI research in their own
labs; and, c) an annual meeting fostering collaboration and
communication throughout California, both for scientists and
the lay public.
According to Dr. Oswald Steward, the Roman Reed Project
Director, there have been no grants funded by the Roman Reed
Spinal Cord Injury Research Act since 2010 (in other words, no
funding from the Legislature). UC provided funding to
continue the grants program in a modified form for one
additional year and it continues to be called the "Roman Reed
Program" for continuity. These funds were distributed in
2012. A panel of experts from the spinal cord injury field
was assembled to provide outside peer review of Roman Reed
Grant applications. Submitted grants were evaluated for
scientific merit and the top 10 were funded. A total of
$749,311 in grants was awarded.
The AB 1657 Report provides descriptions of the major areas of
research award projects between 2000 and 20120. Examples are
as follows:
a) Preventing Secondary Damage . According to the Report,
initial traumatic or mechanical insult to the spinal tissue
in only the beginning. Within hours to days of injury, a
cascade of immunological and other events takes place that
can cause the enlargement of the injury site. Seeking to
prevent this secondary damage and protect the nervous
system from additional damage immediately after SCI is a
key area of research.
b) Promoting Axon (nerve fibers) Regeneration . Many Roman
Reed projects sought to better understand the road blocks
to spinal cord repair by identifying the genes that are
expressed and those that go silent in the spinal sensory
neurons, by examining a cell death cycle where damage to
motor neuron results in a wave of cell death or by
determining the structure of a major inhibitory molecule,
Nogo.
AB 714
Page 4
c) Remyelinating Axons . Some axons that survive a spinal
cord injury still lose their protective sheath of myelin,
the fatty substance that insulates and protects them.
Without myelin, the axons stop functioning. Roman Reed
grants have been awarded five times to test approaches for
remylination. One study confirmed that the transplantation
of federally approved human embryonic stem cells can
produce functional myelin in a rat model of spinal cord
injury and form part of the pre-clinical results that will
be evaluated by the Federal Drug Administration (FDA) to
determine if this strategy will eventually be used in
human.
d) Replacing Cells . One strategy for repairing the damaged
spinal cord and restoring function is to replace the lost
neurons and the glial cells that support, protect, and
nourish them. Ten grants have been awarded to researchers
who are working on cellular replacement.
e) Implanting Artificial Substrates . Some scientists
believe that therapies to repair circuits will work better
if they are combined with a device that actually spans the
gap in the injured spinal cord. Seven Roman Reed grants
are testing tiny bridges, tunnels, and scaffolding,
fabricated from natural or synthetic biomaterials that
would be placed between the two stumps of the injured
spinal cord to support and guide regenerating axons.
f) Retraining and Rewiring the Spinal Cord . Certain forms
of rehabilitation appear to do more than maintain bone
mass, muscle strength, and cardio-vascular fitness. Recent
Roman Reed research has shown that some training protocols,
including progressive weight bearing and repetitive
stepping routines may restore function by promoting axon
regeneration and the creation of new neuron-to-neuron
connections, or synapses.
g) Restoring Concomitant Function and Eliminating
Complications . The complications and loss of function that
accompany SCI not only impair quality of like but also can
be life threatening. Roman Reed awards have supported
three projects examine bladder function, four exploring
pain following SCI and on examining carbohydrate metabolism
impairments.
AB 714
Page 5
h) Using Robotics for Assessment and Training . Nine Roman
Reed awards have focused on robotic devices and recovery of
locomotor functions.
i) Creating New Models for Spinal Cord Research . Fifteen
Roman Reed Grants have been awarded to develop new SCI
animal models and ways of assessing or understanding SCI.
j) Pre-Clinical Studies . One project is screening drugs
that are already approved by the FDA or that are in late
phase of development for other applications for use in SCI
repair. This has the potential of bypassing many years of
pre-clinical testing and safety trials and save hundreds of
millions of dollars.
3)SUPPORT . Baybio, the California Healthcare Institute and
others write in support that California is a leader in
neurological and SCI research. Baybio further states in
support that if we are to maintain our prominence in this
field of research, additional funding for SCI research to
replace General Fund contributions must be found or we risk
losing the matching funds and other grants that we
successfully attracted in the recent past. According to these
supporters, many discoveries supported by the fund are in the
pipeline toward clinical translation including: a) the world's
first clinical trial for stem cells for SCI; b) a treatment
initially developed for SCI in clinical trials for
inflammatory bowel disease; and, c) new surgical techniques
developed to treat people with nerve injuries. Don Reed,
father of Roman Reed writes in support that for every dollar
invested by the state more than four additional dollars have
been leveraged in federal research grants such as the NIH.
4)OPPOSITION . The California Catholic Conference writes in
opposition that although recent amendments have shifted the
funding from traffic fines to the General Fund, this bill
continues the unfortunate policy of spending money on
speculative research. This opposition points out that at a
time in which we have cut funding for our state's safety
net-upon which our poor and vulnerable Californians rely-it is
highly inappropriate to divert money to University
researchers.
5)PREVIOUS LEGISLATION .
AB 714
Page 6
a) AB 1657 of 2012 would have added an additional penalty
assessment of $1 to every fine, penalty, or forfeiture
deposit imposed by any court on violations of specified
Vehicle Code sections or local ordinance adopted pursuant
to the Vehicle Code. AB 1657 was vetoed by Governor Brown.
In his veto message, the Governor stated that SCI research
is certainly worthwhile, but the funding method chosen is
not. Loading more and more costs on traffic tickets has
been too easy a source of new revenue. Fines should be
based on what is reasonable punishment, not on paying for
more general fund activities.
b) AB 190 (Wieckowski) of 2011, proposed an additional $3
penalty assessment for every violation of the vehicle code,
except parking violations, to provide support to the SCI
research program at UC. AB 190 was held in the Assembly
Appropriations Committee.
c) AB 1931 (Torrico), Chapter 457, Statutes of 2010,
eliminated the sunset date for the Roman Reed Act and
specified that the Roman Reed Fund be located at UC, rather
than the State Treasury.
d) AB 1794 extended the sunset date for the Roman Reed Act
to January 1, 2011, and the sunset date for the Traumatic
Brain Injury pilot project from July 1, 2007 to July 1,
2012.
e) AB 750 established the Roman Reed Act and created the
Roman Reed Fund.
REGISTERED SUPPORT / OPPOSITION :
Support
Baybio
California Healthcare Institute
Californians 4 Cures
CONNECT
Don Reed
Gwendolyn Strong Foundation
California Hepatitis C Task Force
Missouri Cures
StemCells, Inc.
AB 714
Page 7
Opposition
California Catholic Conference
Analysis Prepared by : Marjorie Swartz / HEALTH / (916)
319-2097