BILL ANALYSIS Ó 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--- SB 117 | Page 2 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 SB 117 | Page 3 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. SB 117 | Page 4 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 SB 117 | Page 5 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, SB 117 | Page 6 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, SB 117 | Page 7 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 SB 117 | Page 8 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 SB 117 | Page 9 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. SB 117 | Page 10 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 -- END --