BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 115|
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THIRD READING
Bill No: SB 115
Author: Fuller (R), et al.
Amended: 4/20/15
Vote: 27
SENATE HEALTH COMMITTEE: 9-0, 4/29/15
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/28/15
AYES: Lara, Bates, Beall, Hill, Leyva, Mendoza, Nielsen
SUBJECT: Valley fever
SOURCE: Author
DIGEST: This bill appropriates $1 million from the General
Fund to the Department of Public Health for the 2015-16 fiscal
year, for purposes of valley fever vaccine research, as
specified.
ANALYSIS:
Existing law:
1)Requires funds appropriated to the Department of Public Health
(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.
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 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 and
other federal agencies with experience in supporting vaccine
research when reviewing the research of those receiving funds.
4)Requires the contractor 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.
This bill appropriates $1 million from the General Fund to DPH
for the 2015-16 fiscal year, for purposes of valley fever
vaccine research. This bill requires $100,000 to be allocated
to DPH in the 2015-16 fiscal year for purposes of costs
associated with the administration of existing law above.
Background
According to the Centers for Disease Control and Prevention
(CDC), valley fever is caused by Coccidioides, a fungus that
lives in soil in the southwestern United States 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
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people who get valley fever, the infection can spread from the
lungs to the rest of 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 United States, 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.
Endemic areas. Most cases of valley fever in the United States
occur in people who live in or have traveled to the southwestern
United States, especially Arizona and California. However,
according to the CDC, the full extent of the current endemic
areas is unknown and is a subject for further study.
Incidence. 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. 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 heighten 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, and 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 per
100,000 population per year), are Kern, Kings, Fresno, Merced,
Madera, Tulare, and San Luis Obispo.
Vaccine. Valley fever research has been going on since the
1930s and 40s, with not much progress towards a vaccine.
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According to a report published in October 2012 by the Reporting
on Health Collaborative (an initiative of The California
Endowment Health Journalism Fellowships at the University of
Southern California's Annenberg School for Communication and
Journalism), 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. In
1997, a Bakersfield-based committee worked with California State
University, Bakersfield to select five U.S. scientists to
develop a new vaccine with funding from the California
HealthCare Foundation (CHCF) and the State of California. The
project was launched with a $1.5 million grant from CHCF,
$700,000 in state general funds, 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. However, funding dried up and the research
stalled.
According to an article published in The Atlantic in August
2014, a valley fever epidemic hit Kern County in 2001 and
remains ongoing. 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 National Institutes of
Health and the CDC announced plans to start a clinical trial in
Bakersfield. 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
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board and manufacture a vaccine. According to an August 2014
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.
Comments
Author's statement. 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 Coccidioides fungi, which live and breed
within the soil. When the dust containing the Coccidioides
spores is breathed in 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 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. Although there is currently not a known
cure for valley fever, researchers are closer 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.
Prior Legislation
AB 1955 (Ashburn, 2002), SB 1027 (Ashburn, 2003) and SB 492
(Ashburn, 2005) were substantially similar to this bill. AB
1955, SB 1027 and SB 492 were held on the Assembly
Appropriations Committee suspense file.
FISCAL EFFECT: Appropriation: Yes Fiscal
Com.:YesLocal: No
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According to the Senate Appropriations Committee, $1 million
appropriation from the General Fund.
SUPPORT: (Verified5/28/15)
California Prison Moratorium Project
Center on Race, Poverty and the Environment
Central California Environmental Justice Network
Coalition for Clean Air
Comite 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
Tri-Valley CARES
Valley Fever Solutions
OPPOSITION: (Verified5/28/15)
None received
ARGUMENTS IN SUPPORT: Valley Fever Solutions writes that
drug development is frightfully expensive, and vaccine
development is even worse. 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 drugs is going to work.
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.
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Prepared by:Melanie Moreno / HEALTH /
5/31/15 12:39:13
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