BILL ANALYSIS                                                                                                                                                                                                    



          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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