BILL ANALYSIS Ó
SB 115
Page 1
Date of Hearing: June 23, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
SB
115 (Fuller) - As Amended April 20, 2015
SENATE VOTE: 39-0
SUBJECT: Valley fever.
SUMMARY: Appropriates $1 million from the General Fund (GF) to
the California Department of Public Health (DPH) for the 2015-16
fiscal year (FY), for purposes of valley fever vaccine research.
Requires $100,000 to be allocated to DPH in the 2015-16 FY for
purposes of costs associated with the administration of existing
law above.
EXISTING LAW:
1)Requires funds appropriated to DPH for the purpose of valley
fever (coccidioidomycosis) vaccine research to be used to
continue and expand the current research effort being
conducted by the Valley Fever Vaccine Project (VFVP).
2)Permits DPH to contract on a sole source basis with a
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nonprofit organization that has provided funding for vaccine
research on valley fever. Requires the contract to require
the organization to distribute research grants to support
research efforts that are likely to advance the effort to
develop a vaccine.
3)Requires the contractor in 2) above to establish an advisory
group consisting of persons with relevant expertise in the
fields of mycology and vaccine development and a
representative from DPH. Requires the advisory group to
approve grants for those whose research is likely to advance
the effort to develop a safe and effective vaccine and to seek
advice from the appropriate agencies in the National
Institutes of Health (NIH) and other federal agencies with
experience in supporting vaccine research when reviewing the
research of those receiving funds.
4)Requires the contractor in 2) above to provide DPH with
periodic status reports on the progress of the researchers
receiving funds. Requires DPH to review progress reports from
the contractor describing the research progress and plans for
future funding.
5)Requires the contract to require that funding is provided on
the condition that, if a valley fever vaccine is developed and
successfully marketed, the state be reimbursed for the cost of
grants made in proportion to the state's contribution to the
research and development effort.
FISCAL EFFECT: According to the Senate Appropriations
Committee, $1 million from the GF for the 2015-16 FY.
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COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, California has
seen an increase of valley fever case counts from 719 to 5,697
over the last 13-year period. Valley fever is caused by air
or soil disturbance of the Coccidioides fungus, which lives
and breeds in the soil. When the dust containing the
Coccidioides spores is inhaled, the fungus attacks the
respiratory system, causing infection that can lead to
symptoms that resemble a cold, influenza, or pneumonia.
Within California, cases of valley fever have been reported
from most counties.
Over 75% of cases have been reported in portions of the
Sacramento Valley, all of the San Joaquin Valley, desert
regions, and portions of Southern California. Valley fever
can be costly and debilitating, with nearly 75% of patients
missing work or school because of their illness, and more than
40% requiring hospitalization. There is also an influx of
cases among prison inmates and employees. Anyone can get
valley fever, even young and healthy people. The author
states that although there is currently no cure for valley
fever, researchers are close to developing a vaccine that will
help combat this devastating disease. Experts say the lack of
funding and serious attention to valley fever has stalled
efforts to combat the disease.
2)BACKGROUND. According to the Centers for Disease Control and
Prevention (CDC), Coccidioides lives in soil in the
southwestern U.S. and parts of Mexico, Central America, and
South America. Inhaling the airborne fungal spores can cause
infection, but is not spread from person to person. Most
people who are exposed to the fungus do not get sick, but some
people develop flu-like symptoms that may last for weeks to
months. In a very small proportion of people who get valley
fever, the infection can spread from the lungs to the rest of
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the body and cause more severe conditions, such as meningitis
or even death.
A March 2013 CDC report notes that more than 20,000 cases of
valley fever are reported each year in the U.S., but many more
cases likely go undiagnosed. Some researchers estimate that
each year the fungus infects more than 150,000 people, many of
whom are sick without knowing the cause or have cases so mild
they are not detected. It is difficult to avoid exposure to
the fungus that causes valley fever, and there is no vaccine
to prevent the infection.
3)INCIDENCE IN CALIFORNIA. In California, providers and labs
are required to report valley fever to DPH. According to an
article in the Spring 2013 Medical Board of California
Newsletter written by DPH Infectious Diseases Branch staff,
there has been a substantial increase in the numbers of
reported cases and hospitalizations of valley fever. From 2000
to 2011, the annual number of reported cases increased greater
than six-fold, from 816 to 5,366 cases per year. These
increases represent a substantial and growing burden to
California residents, providers, and the government, but the
reason for the increase is unclear. Researchers believe that
contributing factors may include changes in climate and
rainfall patterns, soil-disturbing construction activities, an
increase in susceptible persons moving to disease-endemic
areas, and heightened awareness and diagnosis.
While anyone in an endemic area is at risk, those working in
occupations involving dirt and dust exposure may be at
increased risk of infection. Several groups of people are at
higher risk for developing the severe forms of valley fever,
including African Americans, Asians, women in their 3rd
trimester of pregnancy, people with weak immune systems,
including those with an organ transplant or who have HIV/AIDS.
In California, highly endemic counties (more than 20 cases
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per 100,000 population per year), are Kern, Kings, Fresno,
Merced, Madera, Tulare, and San Luis Obispo.
According to an article published in The Atlantic in August
2014, a valley fever epidemic hit the southern San Joaquin
Valley in 2001 and is continuing. It led to the deaths of
more than three dozen inmates since 2006 at two nearby state
prisons, Avenal and Pleasant Valley. Because the prisons house
high concentrations of black and Filipino inmates, valley
fever infection rates are higher than the state average: 1,000
times higher at Pleasant Valley, where more than 1,000 inmates
have contracted valley fever over the past five years, and 189
times higher at Avenal. Following a federal mandate to
transfer more than 2,500 at-risk inmates out of Kern County in
2013, the NIH and the CDC announced plans to start a clinical
trial in Bakersfield.
4)ORPHAN DISEASES. An orphan disease is defined as a condition
that affects fewer than 200,000 people nationwide. Some
diseases have patient populations of fewer than a hundred.
Collectively, however, they affect as many as 25 million
Americans, according to NIH. Historically, pharmaceutical
companies and research institutions have not focused on
research for orphan product development due to inability to
recoup research and development costs with a large enough
market. The Orphan Drug Act of 1983 created financial
incentives for drug and biologics manufacturers, including tax
credits for costs of clinical research, government grant
funding, assistance for clinical research, and a seven-year
period of exclusive marketing given to the first sponsor of an
orphan-designated product who obtains market approval from the
Food and Drug Administration (FDA) for the same indication.
At the same time, federal programs at the FDA and the NIH
began encouraging product development, as well as clinical
research for products targeting rare diseases.
5)EFFORTS TO DEVELOP A VACCINE. Valley fever research has been
going on since the 1930s and 40s, with not much progress
towards a vaccine. According to a 2012 published report by
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the Reporting On Health collaborative, when a valley fever
vaccine was evaluated in the late 1970s and early 1980s, and
proved to be effective in mice and monkeys, hundreds of people
signed up for the human clinical (Phase III) trials. However,
patients complained of very sore arms and swelling at the
injection site even at low doses. The shot was so painful
people dropped out of the trial and ultimately the vaccine did
not show conclusive protection.
6)Valley Fever Vaccine Project. The Valley Fever Vaccine
Project (VFVP) is an inter-institutional cooperative which
seeks to discover a vaccine for valley fever. The California
State University, Bakersfield Foundation is the primary
contractor and has overseen the distribution of grants to
researchers at the University of California (UC) San
Francisco, UC Davis, UC San Diego Veterans Medical Center, the
University of Arizona, and the Medical College of Ohio.
Through a combination of funds from the State of California,
the California HealthCare Foundation (CHCF), and other donors,
the VFVP funded research projects for developing and
conducting trials on potential valley fever vaccines. The
project was launched with a $1.5 million grant from CHCF,
$700,000 in state GF, and a contribution of more than $100,000
from rotary clubs.
With further contributions over the next decade from CHCF, the
federal government, the state, the County of Kern, and
nonprofit groups, total funding reached about $16 million. In
2009, the Budget Act included an ongoing appropriation of $1
million to continue research activities earmarked toward the
development of a vaccine.
7)State Funding for VFVP. State funding for the VFVP began with
a budget augmentation request by then-Assemblymember Ashburn
for $700,000 in FY 1997-98. GF monies allocated to the VFVP
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by fiscal year are as follows:
--------------------
|Fiscal |Amount |
|Year | |
| | |
| | |
|---------+----------|
| 1997-98 |$0.7 |
| |million |
| | |
| | |
|---------+----------|
| 1998-99 |$1.7 |
| |million |
| | |
| | |
|---------+----------|
| 1999-00 |$1.7 |
| |million |
| | |
| | |
|---------+----------|
| 2000-01 |$1.7 |
| |million |
| | |
| | |
|---------+----------|
| 2001-02 |$1.2 |
| |million |
| | |
| | |
|---------+----------|
| 2002-03 |$0.7 |
| |million |
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| | |
| | |
|---------+----------|
| 2006-07 |$1 |
| |million |
| | |
| | |
|---------+----------|
| 2009-10 |$1 |
| |million |
| | |
| | |
--------------------
In 2009, the Budget Act included an ongoing appropriation of
$1 million to continue research activities earmarked toward
the development of a vaccine. Funding was subsequently
discontinued in 2010. Since that time, funding dried up and
the research stalled.
In June of 2014, the FDA also announced plans to include cocci
on its Generating Antibiotic Incentives Now program, a federal
system intended to encourage the development of new
antibacterial or antifungal drugs to treat what the government
deems serious or life-threatening infections.
Adding cocci to the list extends the period that valley fever
antibiotics or vaccines can be sold without any generic-brand
competition on the market by five years, which is expected to
act as an incentive for a pharmaceutical company to jump on
board and manufacture a vaccine. According to an August 2014
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announcement from UC Merced, the university's Health Sciences
Research Institute received approval and funding to conduct
patient studies at Children's Hospital Central California in
Madera. Researchers will study the blood of 30 pediatric
patients with valley fever to understand the immune system's
response to the disease, with a long-term goal of developing a
vaccine.
8)SUPPORT. Valley Fever Solutions, a small biotech company
working to develop a new antifungal treatment for valley
fever, writes that drug development is frightfully expensive,
and vaccine development is even more expensive. Valley fever
is considered an orphan disease, which means it is devilishly
hard to find investors until drug development is significantly
advanced, to the point scientists can demonstrate the drug is
going to work. Valley Fever Solutions states that government
support for combating this rare disease is important and
precious and is often the make or break component without
which motivated researchers simply have to turn away and work
on other projects that have better support.
9)PREVIOUS LEGISLATION. SB 1044 (Fuller) of 2014 would have
appropriated $1 million from the GF for FY 2014 15, for
purposes of extending the VFVP. SB 1044 was referred to
Banking and Finance but never acted upon.
10)POLICY COMMENTS.
a) Vaccine development is a multi-year, multi-million
dollar effort. News reports state that CHCF stopped
supporting the vaccine project because the foundation is
not set up to thoroughly evaluate such scientific research.
Significant state, federal, and private money was
previously invested in this project; yet there is no way of
knowing how much more would be needed to bring this
important vaccine to market. Without commitments from
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outside groups for matching funds or a long-term funding
commitment from the state, it is unclear how much of a
meaningful impact on the effort the one-time appropriation
contained in this bill would accomplish.
b) DPH notes that state funding for the vaccine ended about
six years ago and DPH does not currently have expertise or
experience with Valley Fever vaccine development. The
project was not under the jurisdiction of DPH other than as
a function of pass through of funds. This project was
conducted by California State University, Bakersfield
Foundation with whom CDPH does not have a current
relationship. Committee staff has been unable to confirm
whether the VFVP public-private cooperative is still in
operation. The committee may wish to ask the author about
the status of the VFVP cooperative and their capability and
timing for using the funds appropriated in this bill.
REGISTERED SUPPORT / OPPOSITION:
Support
American Federation of State, County, and Municipal Employees,
AFL-CIO
California Life Science Association
California Prison Moratorium Project
Center on Race, Poverty & the Environment
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Central California Environmental Justice Network
Coalition for Clean Air
Comité Si Se Puede
Committee for a Better Arvin
Committee for a Better Shafter
Global Community Monitor
Greenfield Walking Group
Leadership Council for Justice and Accountability
Padres Socios de Lamont
Physicians for Social Responsibility - Los Angeles
Residentes Organizados al Servicio de un Ambiente Sano (ROSAS)
Tri-Valley CARES
Valley Fever Solutions
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Opposition
None of file.
Analysis Prepared by:Dharia McGrew / HEALTH / (916)
319-2097