BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 115
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|AUTHOR: |Fuller |
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|VERSION: |April 20, 2015 |
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|HEARING DATE: |April 29, 2015 | | |
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|CONSULTANT: |Melanie Moreno |
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SUBJECT : Valley fever.
SUMMARY : 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.
Existing law:
1.Requires funds appropriated to the State 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
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.
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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. 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.
FISCAL
EFFECT : This bill has not been analyzed by a fiscal committee.
COMMENTS :
1.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 percent 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 percent of patients missing work or school because
of their illness, and more than 40 percent 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.
2.Background. According to the Centers for Disease Control and
Prevention (CDC), valley fever is caused by Coccidioides, a
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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 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.
3.Endemic areas. Most cases of valley fever in the US occur in
people who live in or have traveled to the southwestern United
States, especially Arizona and California. The map below,
"Areas where valley fever is endemic," was generated from
studies in the 1950s, and shows the areas where the fungus
that causes valley fever is thought to be endemic, or native
and common in the environment. According to the CDC, the full
extent of the current endemic areas is unknown and is a
subject for further study.
4.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
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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.
5.Vaccine. Valley fever research has been going on since the
1930s and 40s, with not much progress towards a vaccine.
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
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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 Centers for Disease Control and
Prevention 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
(GAIN) 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 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.
6.Prior legislation. AB 1955 (Ashburn) of 2002, SB 1027
(Ashburn) of 2003 and SB 492 (Ashburn) of 2005 were
substantially similar to this bill. AB 1955, SB 1027 and SB
492 were held on the Assembly Appropriations Committee
suspense file.
7.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.
8.Policy comment. Previous efforts to develop a vaccine were
multi-year, multi-million dollar efforts. It is unclear how
the one-time appropriation contained in this bill will make a
meaningful impact on efforts toward developing a vaccine. The
author may wish to work through the budget process and/or
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develop a matching fund program to draw down additional
federal or private monies so that the effort has sufficient
funding towards its goal.
SUPPORT AND OPPOSITION :
Support: Valley Fever Solutions
One individual
Oppose: None received.
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