BILL ANALYSIS �
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|Hearing Date:April 29, 2013 |Bill No:SB |
| |117 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 117Author:Hueso
As Amended:April 8, 2013 Fiscal:Yes
SUBJECT: Integrative cancer treatment.
SUMMARY: Provides that a physician and surgeon shall not be subject
to discipline for unprofessional conduct solely on the basis of
providing treatment or advice for cancer given in compliance with
provisions in the California Health and Safety Code relating to
"integrative cancer treatment." Authorizes 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.
NOTE : Double-referral to Health Committee first. This measure was
heard in that Committee on April 24, and passed with a 7-2 vote.
Existing law:
1)Licenses and regulates physicians and surgeons under the Medical
Practice Act (Act) by the Medical Board of California (MBC) within
the Department of Consumer Affairs (DCA) and states that the
protection of the public is the highest priority of the MBC in
exercising its functions. (Business and Professions Code (BPC) �
2000 et. seq.).
2)Licenses and regulates osteopathic physicians and surgeons under the
Osteopathic Act by the Osteopathic Medical Board of California
(OMBC) within the DCA and states that the protection of the public
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is the highest priority of the OMBC in exercising its functions.
(Business and Professions Code. (BPC � 2450 et. seq.)
3)Requires the MBC and the OMBC to take action against any licensee who
is charged with unprofessional conduct. Specifies that
unprofessional conduct includes gross negligence, repeated negligent
acts, as defined, and incompetence. (BPC � 2234)
4)Indicates that a physician and surgeon shall not be subject to
discipline solely on the basis that the treatment or advice rendered
to a patient is alternative or complementary medicine, including the
treatment of Lyme Disease, if the treatment or advice meets all of
the following requirements: (BPC � 2234.1)
a) It is provided after informed consent and a good-faith prior
examination of the patient, and medical indication exists for the
treatment or advice, or it is provided for health or well-being.
b) It is provided after the physician and surgeon has given the
patient information concerning conventional treatment and
describing the education, experience, and credentials of the
physician and surgeon related to the alternative or complementary
medicine that he or she practices.
c) In the case of alternative or complementary medicine, it does
not cause a delay in, or discourage traditional diagnosis of, a
condition of the patient.
d) It does not cause death or serious bodily injury to the
patient.
5)Defines "alternative or complementary medicine" as those health care
methods of diagnosis, treatment, or healing that are not generally
used but that provide a reasonable potential for therapeutic gain in
a patient's medical condition that is not outweighed by the risk of
the health care method. (BPC � 2234.1 (b))
6)Makes it unprofessional conduct for a physician to fail to furnish a
breast cancer patient with a written summary made available by the
MBC regarding medically viable and efficacious alternative methods
of treatment for breast cancer. (BPC � 2257)
7)Establishes within Department of Public Health (DPH) the Cancer
Advisory Council composed of nine physicians and surgeons licensed
in California, three persons who are not licensed physicians and
surgeons, and two persons representing nonprofit cancer research
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institutes recognized by the National Cancer Institute, and the
director of DPH, who is an ex officio member. Specifies that
members of the Council are appointed by the Governor. (Health and
Safety Code (HSC) � 109255)
8)Requires DPH to do the following: (HSC � 109270)
a) Secure the investigation and testing of the content, method of
preparation, efficacy, or use of drugs, medicines, compounds, or
devices proposed to be used, or used by any individual, person,
firm association or other entity in the state for the diagnosis,
treatment, or cure of cancer, prescribe reasonable regulations
with respect to the investigation and testing, and make findings
of fact and recommendations upon completion of any such
investigation and testing.
b) Adopt regulations 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.
c) Hold hearings relating to compliance with the requirements for
treatment of cancer, as specified.
9)Defines cancer as all malignant neoplasms regardless of the tissue of
origin, including malignant lymphoma, Hodgkins disease, and
leukemia. (HSC � 109285)
10)Provides that on written request by DPH, any individual, person,
firm, association, or entity engaged or representing as engaged, in
the diagnosis, treatment, alleviation, or cure of cancer shall:
(HSC � 109295)
a) Furnish the DPH with the sample for testing of any drug,
medicine, compound, or device used or prescribed in the
diagnosis, treatment, alleviation, or cure of cancer.
b) Specify the formula of any drug or compound and name all
ingredients by their common or usual names.
c) Furnish any further information requested by DPH about the
composition and method of preparation of and use of any drug,
compound, or device.
11) Provides that the failure to either provide the sample, disclose
the formula, or name the ingredients as required by Item # 10, shall
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be conclusively presumed that the drug, medicine, compound or device
has no value in the diagnosis, treatment, alleviation, or cure of
cancer. (HSC � 109295)
12)Prohibits the sale, delivering, giving away, prescribing or
administering any drug, medicine, compound, or device to be used in
the diagnosis, treatment, alleviation or cure of cancer unless
certain conditions, as specified, are met. Failure to comply with
these existing prohibitions is a misdemeanor and a third or
subsequent violation a felony. (HSC �� 109300, 109335)
This bill:
1) Provides that a physician shall not be subject to discipline for
unprofessional conduct relating to gross negligence, repeated
negligent acts, or incompetence solely on the basis of providing
treatment or advice for cancer given in compliance with the
requirements of Items # 3) - 9) below.
2) Repeals existing law that makes it unprofessional conduct for a
physician to fail to furnish a breast cancer patient with a written
summary made available by the MBC regarding medically viable and
efficacious alternative methods of treatment for breast cancer.
3)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 and surgeon practicing within his or her scope of
practice.
4)Prohibits a physician from recommending, prescribing or providing
integrative cancer treatment for cancer patients unless the
following requirements are met:
a) The treatment is recommended or prescribed after informed
consent is given, as specified.
b) The treatment recommended or prescribed meets evidence-based
standard, as specified.
c) The physician prescribing the treatment complies with the
patient reevaluation requirements, as specified.
d) The physician prescribing the treatment complies with all of
the standards of care, as specified.
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5)Specifies 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.
b) That the patient has declined to be under the care of an
oncologist or other physician providing conventional cancer care.
6)Requires the informed consent 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 the standard of care for treating cancer
in California.
b) The standard of care for treating cancer in California
consists of radiation, chemotherapy, and surgery.
c) 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;
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.
7)Provides that a treatment meets the evidence-based medical standard
for integrative cancer treatment if one of the following
requirements are met:
a) The treatment is recognized by the Physician's Data Query of
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the National Cancer Institute.
b) The treatment has been published in at least three
peer-reviewed scientific medical journals.
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.
8)Provides that a physician prescribing integrative cancer treatment
complies with the patient reevaluation requirements if all of the
following conditions are satisfied:
a) The patient is informed regarding the measureable results
achieved within the timeframe established, as specified, 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.
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 change the costs associated with
the change, and the timeframe within which the change will be
reevaluated.
9)Indicates that a physician complies 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:
i) Information regarding the treatment, including its
usefulness in treating cancer.
ii) A timeframe and plan for reevaluating the treatment using
standard and conventional means in order to assess treatment
efficacy.
iii) A cost estimate for the treatment.
b) The physician ensures that relevant, generally accepted tests
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are administered to confirm the effectiveness and progress of the
treatment;
c) 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.
d) At the request of the patient, the physician makes a good
faith effort to coordinate the care of the patient with the
physician providing conventional cancer care to the patient.
e) At the request of the patient, the physician and surgeon
provides a synopsis of any treatment rendered under this bill's
provisions to the physician providing conventional cancer care to
the patient, including the subjective and objective assessments
of the patient's state of health and response to that treatment.
10)Makes the failure of a physician to comply with the standards for
integrative cancer treatment unprofessional conduct and cause for
discipline by that physician's licensing board. Exempts the
physician who fails to comply with the standards for integrative
cancer treatment from the existing misdemeanor or felony penalties.
11)Requires the DPH to perform specific tasks relating to integrative
cancer treatment, including investigating violations and reporting
violations to the appropriate enforcement authority and holding
hearings and issuing subpoenas for witnesses and documents.
12)Authorizes an individual, person, firm, association or other
entity, when requested by DPH to furnish a sample of a drug,
medicine, compound or device for testing, as an alternative to
furnishing the sample, to instead furnish DPH with the contact
information of the manufacturer of the drug, medicine, compound, or
device.
13)Makes technical and conforming changes.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. This bill is sponsored by California Citizens for Health
Freedom (Sponsor) to provide cancer patients with more options for
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care that best suit their needs. According to the Author,
integrative medicine does not replace conventional therapy, rather
it is meant to complement it. The Author states that the bill
clarifies the ability of a physician and surgeon to administer or
provide integrative cancer treatment in California. In addition,
the bill 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,
according to the Author.
The Author states the need for the bill as follows:
While current law's limitation was put in place to help protect
vulnerable cancer patients from being fraudulently sold unproven
and ineffective cancer medications, it has also restricted the
ability of physicians to offer natural, non-toxic therapies or
treatment modalities. Integrative cancer treatment is a
multidisciplinary approach that focuses on more than just killing
the cancer cells. Integrative cancer treatment includes three
components: 1) curing the cancer, 2) increasing the patient's
quantity of life; and,
3) improving the patient's quality of life. SB 117 removes
statutory barriers for physicians and consumers to administer and
receive integrative treatment.
The Author further states: California is the only state to
statutorily restrict cancer therapy exclusively to conventional
drugs, surgery, and radiation. Past reports and legislative
analyses suggest 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. And 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.
2.Background. California's Health and Safety Code (�� 109250-109395)
currently provides a criminal penalty for the diagnosis, treatment,
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alleviation, or cure of cancer using methods other than conventional
drugs, surgery, or radiation. The Health and Safety Code makes this
a prohibition unless the treatment or use for cancer has been
reviewed by a Cancer Advisory Council and approved by the Department
of Health Services (DHS). The problem is that there is no Advisory
Council, and DHS has apparently never reviewed or approved another
treatment for cancer patients. As a result, the current law only
allows for current conventional treatments because no other
treatments have been reviewed or approved. Furthermore, any use of
an unapproved treatment is punishable as a misdemeanor or felony
(HSC � 109335).
3.Related Legislation. AB 1278 (Hueso, 2013) is essentially the same
as this bill, and has been referred to Assembly Health Committee.
SB 583 (Figueroa, 2006) by the same sponsors would have exempted
physicians who provide treatment or advice to cancer patients
regarding alternative or complementary medicine from being
disciplined solely because that treatment or advice is alternative
or complementary medicine if certain conditions are met. This bill
failed passage in Assembly Health Committee.
AB 2393 (Haynes, 2004) sought to amend the Health and Safety Code to
exempt from criminal penalty a physician and surgeon who gives
advice or treatment to a patient that involves innovative, evolving,
natural, or drugless methods instead of conventional allopathic
treatments for cancer. That bill failed passage in the Assembly
Health Committee.
SB 1691 (Vasconcellos, Chapter 742, Statutes of 2004) enacted Business
and Professions Code � 2234.1 to provide that a licensed physician
is not subject to discipline for unprofessional conduct solely on
the basis that the physician's treatment or advice is "alternative
or complementary medicine" if specified conditions are met.
SB 577 (Burton, Chapter 820, Statutes of 2002) enacted the provision of
the Medical Practice Act that now permits unlicensed persons to
offer alternative medical treatments and not be subject to
discipline for practicing medicine, so long as the practitioner does
not do specified forms of treatment (e.g. surgery, x-rays),
discloses that he or she is not a licensed physician, and makes
specified disclosures to the patient regarding the alternative
nature of the proposed treatment and their qualifications to provide
that treatment.
SB 2100 (Vasconcellos, Chapter 660, Statutes of 2000) required the MBC
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and the OMBC to establish specified policies related to the practice
of alternative medicine, and requested the University of California
to review specified issues related to alternative medicine.
4.Arguments in Support. This bill is sponsored by California Citizens
for Health Freedom (CHF) to provide more options for care that
better suits the needs of cancer patients. CHF suggests that
integrative medicine is intended to complement rather than replace
conventional cancer therapy. CHF states that the bill clarifies a
physician's ability to administer or provide integrative cancer
treatment in California, while requiring that the treatment must
meet an evidence-based medical standard. CHF points out that the
bill would encourage communication with a patient's oncologist, as
well as treatment with conventional therapies. CHF argues that it
empowers physicians and patients to choose the treatment they want
for cancer so long as there is a scientific basis for this decision,
that it broadens options for treatment of cancer, encourages
oncologists and integrative cancer physicians to work together to
develop superior strategies, increases the awareness of natural
approaches, protects the public by making sure patients are well
informed during the course of their treatment, and requires
physicians to follow the practices mandated in the Business and
Professions Code.
5.Arguments in Opposition. Writing in opposition to the bill,
Association of Northern California Oncologists (ANCO) and Medical
Oncology Association of Southern California, Inc. (MOASC) argue that
the 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
states the bill would dilute 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; however, none
of the complementary treatments have been proven to actually treat
cancer by themselves and are only used in conjunction with
FDA-approved treatments.
6.Integrative Cancer Treatment. It appears that a basic difference
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between proponents of this measure and opponents of this measure is
the way in which the term "integrative cancer treatment" is used.
Opponents contend that oncologists who treat cancer with
conventional means often use "integrative cancer treatment" to refer
to other treatments which may be used along with chemotherapy or
radiation treatments to help a patient to feel better and improve
the quality of the patient's life, but is not intended to be the
primary treatment for the cancer itself. Proponents, however appear
to use the term "integrative cancer treatment" to refer to
treatments other than conventional cancer treatments which seek to
treat the cancer itself.
7.Senate Health Committee Amendments. This bill was heard on April 24
in Senate Health Committee. At that time, the Author agreed to make
the amendments to the bill shown below. Since the bill was also
referred to this Committee, because of the short turnaround time for
the bill to meet the legislative deadlines and still be heard in
both Committees, the amendments will be processed in this Committee.
Amendments in bold, italics and underline
Page 3, lines 34-39, and Page 4, lines 1-17:
SEC. 3. Section 109270 of the Health and Safety Code is
amended to read:
109270. The department shall:
(a) Prescribe reasonable regulations with respect to the
administration of this article and Article 2 (commencing with
Section 109300).
(b) Investigate violations of this article and , Article 2
(commencing with Section 109300), and Article 2.5 (commencing
with Section 109400), and report the violations to the
appropriate enforcement authority.
(c) Secure the investigation and testing of the content, method
of preparation, efficacy, or use of drugs, medicines, compounds,
or devices proposed to be used, or used, by any individual,
person, firm, association, or other entity in the state for the
diagnosis, treatment, or cure of cancer, prescribe reasonable
regulations with respect to the investigation and testing, and
make findings of fact and recommendations upon completion of any
such investigation and testing.
(d) 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 , except as
authorized under Article 2.5 (commencing with Section 109400) .
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Page 9, lines 3-15:
109403. For purposes of paragraph (2) of subdivision (a) of
Section 109401, a treatment meets 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 and has been reported to reduce
the size of a cancer, slow the progression of a cancer, or
improve the quality of life of a patient with cancer.
. (b) The treatment has been published in at least three
peer-reviewed scientific medical journals
(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.
(b) The treatment has been reported, in peer-reviewed
literature, peer-reviewed biomedical compendia, and other
peer-reviewed medical literature that meet the criteria for
indexing of the National Institutes of Health's National Library
of Medicine, to reduce the size of a cancer, slow the progression
of a cancer, or improve the quality of life of a patient with
cancer.
SUPPORT AND OPPOSITION:
Support:
California Citizens for Health Freedom (Sponsor)
Bobbiey's Foundation
California Naturopathic Doctors Association
Cancer Control Society
Citizens for Health, Inc.
Fisher Chiropractic
Health Action
Health Medicine Forum
International Association of Cancer Victors and Friends, Inc.
Life Support
Meltzer Wellness Institute
Quantum Functional Medicine
Raphael Medicine & Therapies
The Holistic Health Center
Thousand Oaks Republican Women Federation
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Thriving Health and Wellness
Tumesh for Optimal Health
24 physicians and individuals
Opposition:
Association of Northern California Oncologists
Medical Oncology Association of Southern California, Inc
Consultant:G. V. Ayers