BILL ANALYSIS                                                                                                                                                                                                    






           ----------------------------------------------------------------- 
          |SENATE RULES COMMITTEE            |                        SB 115|
          |Office of Senate Floor Analyses   |                              |
          |(916) 651-1520    Fax: (916)      |                              |
          |327-4478                          |                              |
           ----------------------------------------------------------------- 


                                   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  








                                                                     SB 115  
                                                                    Page  2


            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  







                                                                     SB 115  
                                                                    Page  3


          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.   







                                                                     SB 115  
                                                                    Page  4


          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  







                                                                     SB 115  
                                                                    Page  5


          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









                                                                     SB 115  
                                                                    Page  6


          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.
           








                                                                     SB 115  
                                                                    Page  7



          Prepared by:Melanie Moreno / HEALTH / 
          5/31/15 12:39:13


                                   ****  END  ****