BILL ANALYSIS                                                                                                                                                                                                    






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 117
          AUTHOR:        Hueso
          AMENDED:       April 8, 2013
          HEARING DATE:  April 24, 2013
          CONSULTANT:    Bain

           SUBJECT :  Integrative cancer treatment.
           
          SUMMARY  :  Permits physicians, notwithstanding the prohibition  
          against prescribing non-Food and Drug Administration approved or  
          non-California Department of Public Health (DPH) approved cancer  
          treatment, to recommend or prescribe "integrative cancer  
          treatment" for cancer patients if the treatment is recommended  
          or prescribed after informed consent, the recommended or  
          prescribed treatment meets specified evidence-based medical  
          standards, the physician prescribing the treatment complies with  
          patient reevaluation requirements after the treatment begins,  
          and the physician prescribing the treatment complies with the  
          standards of care set forth in this bill.

          Existing law:
          1.Makes, under the body of law regulating cancer treatment, the  
            sale, offering for sale, holding for sale, delivering, giving  
            away, prescribing or administering of any drug, medicine,  
            compound, or device to be used in the diagnosis, treatment,  
            alleviation, or cure of cancer unlawful and prohibited unless  
            an application has been approved under a specified provision  
            of the federal Food, Drug and Cosmetic Act, or there has been  
            an approved application that meets specified requirements  
            filed with DPH.

          2.Requires DPH, with respect to the administration of the body  
            of law regulating cancer treatment, to take specified actions,  
            including enacting reasonable regulations with respect to the  
            administration of that body of law, to investigate violations  
            of that body of law and report the violations to the  
            appropriate enforcement authority, and to adopt a regulation  
            prohibiting the prescription, administration, sale or other  
            distribution of any drug, substance, or device found to be  
            harmful or of no value in the diagnosis, prevention or  
            treatment of cancer.

          3.Requires, on written request by DPH, any individual, person,  
                                                         Continued---



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            firm, association, or other entity engaged in the diagnosis,  
            treatment, alleviation, or cure of cancer to furnish DPH with  
            a sample as DPH may deem necessary for adequate testing of any  
            drug, medicine, compound, or device used or prescribed by the  
            individual, person, firm, association, or other entity in the  
            diagnosis, treatment, alleviation, or cure of cancer.
          
          This bill:
          1.Prohibits a physician from recommending or prescribing  
            integrative cancer treatment for cancer patients unless the  
            following requirements are met, as applicable:

                  a.        The treatment is recommended or prescribed  
                    after informed consent is given, as provided in this  
                    bill;
                  b.        The treatment recommended or prescribed meets  
                    the evidence-based medical standard provided in this  
                    bill;
                  c.        The physician prescribing the treatment  
                    complies with the patient reevaluation requirements  
                    set forth in this bill after the treatment begins; and
                  d.        The physician prescribing the treatment  
                    complies with all of the standards of care set forth  
                    in this bill.

          2.Defines "integrative cancer treatment" as the use of a  
            combination of evidence-based substances or therapies for the  
            purpose of reducing the size of a cancer, slowing the  
            progression of a cancer, or improving the quality of life of a  
            patient with cancer, by a physician practicing within his or  
            her scope of practice. 

          3.Prohibits a physician from providing integrative cancer  
            treatment for cancer patients unless the treatment is  
            prescribed by a physician in compliance with 1) above.

          4.Provides that informed consent has been given if the patient  
            signs a form stating either of the following:

                  a.        The name and telephone number of the physician  
                    from whom the patient is receiving conventional cancer  
                    care and whether the patient has been informed of the  
                    type of cancer from which the patient suffers and his  
                    or her prognosis using conventional treatment options;  
                    or
                  b.        The patient has declined to be under the care  




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                    of an oncologist or other physician providing  
                    conventional cancer care.

          5.Requires the form to include all of the following information:

                  a.        The type of care the patient will be receiving  
                    or that is being recommended is not, in whole or in  
                    part, the conventional treatment for treating cancer  
                    in California.
                  b.        The conventional treatment for treating cancer  
                    in California consists of radiation, chemotherapy, and  
                    surgery;
                  c.        All or part of the treatment that the  
                    physician will be prescribing or recommending is not  
                    approved by the federal Food and Drug Administration  
                    (FDA) for the treatment of cancer;
                  d.        The care that the patient will be receiving or  
                    that is being recommended is not mutually exclusive of  
                    the patient receiving conventional cancer treatment;  
                    and
                  e.        The following written statements:

             THE STATE DEPARTMENT OF PUBLIC HEALTH AND THE PHYSICIAN  
          PRESCRIBING YOUR INTEGRATIVE CANCER CARE RECOGNIZE THE  
          IMPORTANCE OF USING CONVENTIONAL CANCER TREATMENTS, INCLUDING  
          RADIATION, CHEMOTHERAPY, AND SURGERY. IT IS HIGHLY RECOMMENDED  
          THAT YOU SEE AN ONCOLOGIST OR ANOTHER PHYSICIAN TO PROVIDE YOU  
          WITH CONVENTIONAL CANCER CARE.  ANY AND ALL MEDICAL TREATMENTS  
          INVOLVE SOME DEGREE OF RISK OF INJURY UP TO AND INCLUDING DEATH.

          6.Defines a treatment as meeting the evidence-based medical  
            standard for integrative cancer treatment if one of the  
            following requirements is met:

                  a.        The treatment is recognized by the Physician's  
                    Data Query of the National Cancer Institute;
                  b.        The treatment has been published in at least  
                    three peer-reviewed scientific medical journals; or
                  c.        The treatment has been reported in at least  
                    three peer-reviewed articles published in  
                    complementary and alternative medicine journals to  
                    have the potential of reducing the size of a cancer,  
                    slowing the progression of a cancer, or improving the  
                    quality of life of a patient with cancer.





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          7.Defines a physician prescribing integrative cancer treatment  
            as complying with the patient reevaluation requirements if all  
            of the following conditions are satisfied:

                  a.        The patient is informed regarding the  
                    measurable results achieved within the timeframe and  
                    plan for reevaluating the treatment and at regular and  
                    appropriate intervals during the treatment plan;
                  b.        The physician reevaluates treatment when  
                    progress stalls or reverses, in the opinion of the  
                    physician or the patient, or as evidenced by objective  
                    evaluations; and 
                  c.        The patient is informed about and agrees to  
                    any proposed change or changes in treatment,  
                    including, but not limited to, the risks and benefits  
                    of the proposed change or changes, the costs  
                    associated with the proposed change or changes, and  
                    the timeframe within which the proposed change or  
                    changes will be reevaluated.

          8.Provides that a physician is complying with all of the  
            standards of care in prescribing integrative cancer treatment  
            if all of the following requirements are met:

                  a.        The physician provides the patient with all of  
                    the following when prescribing the treatment:
                  b.        Information regarding the treatment  
                    prescribed, including its usefulness in treating  
                    cancer;
                  c.        A timeframe and plan for re-evaluating the  
                    treatment using standard and conventional means in  
                    order to assess treatment efficacy;
                  d.        A cost estimate for the prescribed treatment; 
                  e.        The physician ensures that relevant, generally  
                    accepted tests are administered to confirm the  
                    effectiveness and progress of the treatment;
                  f.        The physician, prior to prescribing or  
                    changing the treatment, makes a good faith effort to  
                    obtain from the patient all relevant charts, records,  
                    and laboratory results relating to the patient's  
                    conventional cancer care;
                  g.        The physician makes a good faith effort to  
                    coordinate the care of the patient with the physician  
                    providing conventional cancer care to the patient, at  
                    the request of the patient; and
                  h.        The physician provides a synopsis of any  




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                    treatment rendered under the integrative cancer care  
                    provisions established by this bill to the physician  
                    providing conventional cancer care to the patient,  
                    including subjective and objective assessments of the  
                    patient's state of health and response to that  
                    treatment, at the request of the patient.

          9.Makes the failure of a physician to comply with integrative  
            cancer care provisions of this bill unprofessional conduct and  
            cause for discipline by his or her licensing board. Exempts  
            that physician from the criminal and financial penalties in  
            specified provisions of existing law

          10.Prohibits a physician from being subject to discipline under  
            specified provisions of law solely on the basis that the  
            treatment or advice is alternative or complementary medicine  
            if the treatment or advice is for cancer and is given in  
            compliance with this bill.

          11.Repeals a provision of existing law making it unprofessional  
            conduct for the failure to furnish a breast cancer patient  
            with a written summary made available by the Medical Board of  
            California regarding medically viable and efficacious  
            alternative methods of treatment for breast cancer.

          12.Requires DPH to investigate violations of this bill, to hold  
            hearings regarding compliance with this bill, and to require  
            the DPH director to investigate possible violations of this  
            bill and report those violations to the appropriate  
            enforcement authority.

          13.Permits an individual, person, firm, association, or other  
            entity to furnish to DPH the contact information of the  
            manufacturer of the drug, medicine, compound, or device being  
            prescribed or used for cancer treatment, upon request of DPH,  
            instead of being required to furnish a sample of the drug,  
            medicine, compound, or device being used or prescribed, under  
            existing law.

           FISCAL EFFECT  :  This bill has not been analyzed by a fiscal  
          committee.

           COMMENTS  :  
           1.Author's statement. California law currently restricts the use  
            of unconventional remedy in the diagnosis, treatment,  




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            alleviation, or cure of cancer. In fact, California is the  
            only state to statutorily restrict cancer therapy exclusively  
            to conventional drugs, surgery, and radiation.  Past reports  
            and legislative analysis suggests that current law was  
            established to protect the public from fraudulent, misleading,  
            and potentially harmful therapies. It is extremely important  
            to ensure vulnerable patients are not taken advantage of or  
            misled. However, the stringent and outdated nature of existing  
            statute has prevented Californians from capitalizing on new  
            and innovative cancer therapies. Options for integrative care  
            are limited to travel outside of our state borders or  
            participation in a research program. While several academic  
            institutions in the state have already invested in integrative  
            treatments for cancer, such as UCLA, UCSF, Scripps, and Bastyr  
            University, open access for consumers to integrative care is  
            essential. California would benefit by joining the several  
            other states and countries currently offering integrative  
            cancer treatment to patients.

            SB 117 provides cancer patients with more options for care  
            that best suit their needs.  Integrative medicine does not  
            replace conventional therapy, rather it is meant to complement  
            it.  This bill clarifies the ability of a physician or surgeon  
            to administer or provide integrative cancer treatment in  
            California. In addition, SB 117 specifies that integrative  
            cancer treatment must meet an evidence-based medical standard,  
            as defined in the bill, and includes language that encourages  
            communication with a patient's oncologist, as well as  
            treatment with conventional therapies.

          2.Background. California's cancer statute, as indicated in its  
            legislative findings, is intended to address individuals in  
            this state making misleading representations as possessing  
            medicines, methods, skills, techniques or devices that are  
            effective for the diagnosis, treatment or cure of cancer. The  
            findings continue that there be a means for testing and  
            investigating the value or lack thereof of alleged cancer  
            remedies, devices, drugs or compounds, and that DPH administer  
            the cancer law with regard for the importance of bona fide  
            scientific research and the clinical testing in hospitals,  
            clinics or similar institutions of new drugs or compounds. 

          According to DPH, the cancer law established the Cancer Advisory  
            Council within the "Board of Public Health" (which no longer  
            exists and is now DPH). The original cancer law allowed for  
            two approval processes for approval of any drug, medicine,  




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            compound, or device to be used in the diagnosis, treatment,  
            alleviation, or cure of cancer: 

          (1) An application approved under a specified section of the  
            federal Food, Drug and Cosmetic Act; or 
          (2) An approved application with the Board (CDPH) that meets one  
            of specified requirements. 
           
            DPH indicates the Cancer Advisory Council no longer exists as  
            the National Cancer Institute (NCI) was established in 1971  
            and was closely integrated with the FDA to become the national  
            center for pursuit of new safe and effective cancer therapy.  
            After the establishment of the NCI, new drug and device  
            applications to the Board or the Cancer Advisory Council  
            ceased, and the Cancer Advisory Council was therefore  
            disbanded. DPH states that all cancer therapies must be  
            approved under a specified provision of the federal, Food,  
            Drug and Cosmetic Act.  Pursuant to the state Sherman Food,  
            Drug, and Cosmetic Law, CDPH adopts all requirements  
            established under FDA regulation regarding new drug and new  
            device applications. DPH states all drugs or devices utilized  
            in the diagnosis, treatment, alleviation, or cure of cancer  
            are rigorously tested by the FDA to ensure safe and effective  
            use. 

          3.Double referral. This bill is double referred. Should it pass  
            out of this committee, it will be referred to the Senate  
            Committee on Business and Professions.

          4.Prior legislation. SB 583 (Figueroa) of 2005 would specify  
            that a physician who provides treatment to cancer patients is  
            not subject to certain disciplinary action for unprofessional  
            conduct on the basis that the treatment or advice rendered to  
            the patient is alternative or complementary medicine, as  
            defined, if that treatment or advice meets specified  
            requirements, including not delaying traditional diagnosis and  
            not causing death or serious bodily injury to the patient.  In  
            addition, SB 583 would have made the failure of a physician  
            engaged in the diagnosis, treatment, alleviation, or cure of  
            cancer to comply with specified the regulations unprofessional  
            conduct, unless the physician complies with the alternative or  
            complementary medicine provision of the bill. SB 583 failed  
            passage in the Assembly Health Committee.
               
          5.Support. This bill is sponsored by the Citizens for Health  




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            Freedom (CHF) to provide cancer patients with more options for  
            care that best suit their needs. CHF states integrative  
            medicine does not replace conventional therapy, but is meant  
            to complement it. CHF argues this bill clarifies the ability  
            of a physician to administer or provide integrative cancer  
            treatment in California. In addition, CHF states this bill  
            specifies that integrative cancer treatment must meet an  
            evidence-based medical standard, as defined in this bill, and  
            includes language that encourages communication with a  
            patient's oncologist, as well as treatment with conventional  
            therapies. CHF argues this bill is designed to do multiple  
            things, including empower physicians and patients to choose  
            the treatment they want for cancer so long as there is a  
            scientific basis for this decision, broaden options for cancer  
            treatment, encourage conventional oncologists and integrative  
            cancer physicians to work together to develop superior  
            strategies, increase the awareness of natural approaches,  
            protect the public by making sure patients are well informed  
            during the course of their treatment and that physicians  
            follow the good practices mandated by the Business &  
            Professional Code, make it legal for physicians to attend  
            certified state and national workshops and conferences  
            offering educational credits for physicians to learn about  
            integrative cancer treatment, make it legal for hospitals  
            treating cancer to expand their treatment programs to include  
            physicians trained in integrative cancer treatments, provide  
            an economic advantage to California by making it possible for  
            its citizens to obtain treatments that now must be obtained  
            out of state because of outmoded laws, and provide more  
            effective and economical cancer treatment. CHF concludes that  
            there has been a paradigm shift in the health field, and more  
            people know there are natural cures for cancer and they do not  
            want to limited to the current conventional treatment, and  
            this bill will put pressure on physicians to become more  
            knowledgeable in natural approaches.
          
          6.Opposition. The Association of Northern California Oncologists  
            (ANCO) and the Medical Oncology Association of Southern  
            California, Inc. (MOASC) write in opposition that this bill  
            will substantially weaken the standard of care for cancer  
            treatment contained in the Cancer Quackery Act. After the  
            diagnosis of cancer, patients are often scared and at their  
            most vulnerable. Unfortunately, it is at this time where  
            millions of dollars are made off trusting and desperate people  
            through promises of cures delivered by methods not proven safe  
            or effective. ANCO and MOASC argue this bill would dilute the  




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            original purpose of the Cancer Quackery Act, which was enacted  
            in response to the rise of scams involving profitable cures  
            and remedies such as laetrile. ANCO and MOASC argue vulnerable  
            and trusting patients deserve the highest quality of care and  
            safeguards from false hopes and fraudulent schemes. ANCO and  
            MOASC conclude that integrative oncology, which is referenced  
            in this bill, is the use of complementary treatments to  
            alleviate pain and discomfort associated with cancer and is  
            legal under current law, but none of the complementary  
            treatments have been proven to actually treat cancer by  
            themselves and are only used in conjunction with FDA-approved  
            treatments.
          
          7.Evidence-based medical standard for integrative cancer  
            treatment. This bill states that a treatment meets the  
            evidence-based medical standard for integrative cancer  
            treatment if one of three criteria is met. These criteria  
            include being published in peer-reviewed journals. However,  
            there is not requirement that these journal articles find the  
            treatment to be safe and effective. Additionally, the bill  
            does not require the peer-reviewed journals to be recognized  
            by a governmental entity, such as Medicare.  
               
          8.Recommended amendment. This bill amends the existing  
            requirement that DPH adopt a regulation prohibiting the  
            prescription, administration, sale or other distribution of  
            any drug, substance, or device found to be harmful or of no  
            value in the diagnosis, prevention, or treatment of cancer by  
            allowing such treatments under the provisions of the  
            integrative cancer treatment provisions of this bill. This  
            provision would appear to allow treatment that is harmful or  
            of no value, committee staff recommends this provision be  
            deleted.



           SUPPORT AND OPPOSITION  :
          Support:  California Citizens for Health Freedom (sponsor)
                    California Naturopathic Doctors Association
                    Bobbiey's Foundation
                    Cancer Control Society
                    Health Action
                    Health Medicine Forum
                    International Association of Cancer Victors and  
               Friends, Inc.




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                    Life Support
                    Metzler Wellness Institute
                    Raphael Medicine & Therapies
                    The Holistic Health Center
                    Thriving Health and Wellness
                    Tumesh for Optimal Health
                    Multiple Individuals

          Oppose:   Association of Northern California Oncologists
                    Medical Oncology Association of Southern California,  
                    Inc.
                    1 individual


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