Download governor`s veto

AB 1060
Page 1
GOVERNOR'S VETO
AB 1060 (Bonilla)
As Enrolled September 14, 2015
2/3 vote
ASSEMBLY:
(May 7, 2015)
SENATE:
39-0
(September 3, 2015)
(vote not relevant)
COMMITTEE VOTE:
(HEALTH)
ASSEMBLY:
72-6
17-1
(September 9, 2015)
RECOMMENDATION:
concur
(September 10, 2015)
Original Committee Reference: B. & P.
SUMMARY: Requires the California Health and Human Services Agency to establish a
nonprofit Cancer Clinical Trials Foundation to solicit and receive funds from business, industry,
foundations, and other private and public sources for the purpose of administering the Cancer
Clinical Trials Grant Program to increase patient access to, and diverse participation in, cancer
clinical trials.
The Senate amendments delete the previous Assembly-approved provisions of this bill and
replace contents with this bill.
FISCAL EFFECT: According to the Senate Appropriations Committee, one-time costs of
$650,000 to establish the nonprofit foundation, develop grant guidelines, provide initial
administrative support to the foundation, and begin the initial fundraising effort before sufficient
donations have been received to support the foundation (General Fund). Unknown annual costs
to award grants and provide administrative support to the new foundation (private funds). The
amount of grant funding that the foundation will be able to award will depend on future
donations from the public as will the level of administrative support needed to award the grants
and manage the foundation.
COMMENTS: The author states that this bill would increase participation of underrepresented
communities in United States (U.S.) Food and Drug Administration approved clinical trials by
creating a privately funded state grant program to help patients pay for the ancillary cost
associated with participation in these trials. Studies show that there is a disproportionately low
number of patients from minority communities in clinical trials of new drugs and cancer
therapies. There are many costs associated with participating in a clinical trial including
transportation costs, hotel costs, and companion traveling expenses. Clinical trials do not pay
these ancillary costs. The costs fall onto the clinical trial participant who may be unable to pay
and therefore, unable to enroll in the trial. The author contends that this bill creates an
opportunity for the state to leverage public-private partnerships to improve the health and
wellbeing of its residents with limited state investment.
According to the Intercultural Cancer Center, only about 3% to 5% of the 10.1 million adults
with cancer in the U.S. participate in cancer clinical trials. Clinical trials are a critical step in the
discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic
minorities, older adults, rural residents, and individuals of low socioeconomic status are
AB 1060
Page 2
underrepresented among participants in cancer-related trials. Without adequate representation of
these populations in clinical trials, researchers cannot learn about potential difference among
groups and cannot ensure the generalization of results. In addition, participation in clinical trials
increases access to state-of-the-art cancer care, a critical survival factor in many minority and
underrepresent populations that suffer disproportionately from cancer.
1) Disparities. A Cancer Clinical Trial Fact Sheet made possible by an unrestricted educational
grant from Genentech, provided by the author, indicates that only about 3% to 5% of the 10.1
million adults with cancer in the U.S. participate in cancer trials. This compares to 60%
participation rate for children with cancer. The National Cancer Institute is the largest
sponsor of cancer clinical trials at 3,000 sites. Over 30,000 patients are enrolled in cancer
clinical trials annually. A review of Food and Drug Administration approved drugs from
1995 to 1999 revealed that African Americans, Asian/Pacific Islanders, Hispanics/Latinos
and Native Americans collectively represented less than 10% of participants in trials that
were testing cancer drugs. In 2004, the Selenium and Vitamin E Cancer Prevention Trial
(SELECT) prostate cancer prevention trial completed recruiting over 35,000 men of whom
21% were minorities.
2) Barriers to Trial Participation. There are many different factors that have been attributed,
in part, to the very low participation rate of all eligible patients in clinical trials, and the
disproportionately low participation rate of minority populations. They include, among
many other things:
a) Lack of awareness: A national survey of cancer patients found that 85% of respondents
were unaware that participating in a clinical trial was a treatment option for them.
b) Language/Linguistic differences: Many U.S. clinical trials require English proficiency
for potential participants, automatically excluding those who do not speak the language.
Language factors also pose a serious barrier to provider-patient communication.
c) Practical obstacles: Transportation to and from a trial, particularly if it is located in a
distant location, can be a barrier for many patients.
d) Public misconception: Among patients that are aware of clinical trials, a large percentage
choose not to enroll, often due to a fear of getting a placebo in place of actual treatment,
belief that standard treatment is better than what they would be offered in a clinical trial
and fear of being a "guinea pig." In fact, placebos are rarely used in cancer treatment
trials, and never in lieu of standard treatment.
e) Physician lack of awareness: Primary care physicians do not have sufficient information
on available clinical trials, fail to refer patients to trials, and often leave the discussion of
clinical research to the patient’s oncologist. Yet, many oncologists outside of the
academic setting may also not be aware of trials or otherwise choose not to participate in
or refer their eligible patients to clinical trials.
The University of Southern California writes in support that this bill will help improve patient
access, especially for women and underrepresented minorities, to clinical trials by establishing a
privately-funded state grant program. The current lack of diversity in clinical trial participants is
alarming and negatively impact the ability of researchers to evaluate the effect of new treatments
on different populations.
AB 1060
Page 3
There is no known opposition to this bill.
GOVERNOR'S VETO MESSAGE:
This bill would direct the California Health and Human Services Agency to create a non-profit
foundation to solicit donations to fund participation in cancer clinical trials."
"Numerous private organizations already perform this fundraising function. While I support
eliminating barriers to take part in clinical trials, I am hesitant to place this new burden on the
Health and Human Services Agency which is managing a huge expansion of our health care
system.
Analysis Prepared by: Dharia McGrew / HEALTH / (916) 319-2097
FN:0002461