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,
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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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