Legislature(2017 - 2018)CAPITOL 106
04/19/2018 03:00 PM House HEALTH & SOCIAL SERVICES
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| SB198 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
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= bill was previously heard/scheduled
| + | TELECONFERENCED | ||
| += | SB 198 | TELECONFERENCED | |
ALASKA STATE LEGISLATURE
HOUSE HEALTH AND SOCIAL SERVICES STANDING COMMITTEE
April 19, 2018
3:04 p.m.
MEMBERS PRESENT
Representative Ivy Spohnholz, Chair
Representative Tiffany Zulkosky, Vice Chair
Representative Sam Kito
Representative Geran Tarr
Representative David Eastman
Representative Jennifer Johnston
Representative Colleen Sullivan-Leonard
MEMBERS ABSENT
Representative Matt Claman (alternate)
Representative Dan Saddler (alternate)
COMMITTEE CALENDAR
SENATE BILL NO. 198
"An Act relating to a study of the effectiveness and cost of
providing long-acting reversible contraception to women with
substance abuse disorders."
- HEARD & HELD
PREVIOUS COMMITTEE ACTION
BILL: SB 198
SHORT TITLE: UAA LONG-ACTING CONTRACEPTION STUDY
SPONSOR(s): SENATOR(s) KELLY
02/19/18 (S) READ THE FIRST TIME - REFERRALS
02/19/18 (S) FIN
03/26/18 (S) FIN AT 9:00 AM SENATE FINANCE 532
03/26/18 (S) Heard & Held
03/26/18 (S) MINUTE(FIN)
04/03/18 (S) FIN AT 1:30 PM SENATE FINANCE 532
04/03/18 (S) Moved SB 198 Out of Committee
04/03/18 (S) MINUTE(FIN)
04/04/18 (S) FIN RPT 4DP 1NR
04/04/18 (S) DP: MACKINNON, BISHOP, VON IMHOF,
STEVENS
04/04/18 (S) NR: HOFFMAN
04/09/18 (S) TRANSMITTED TO (H)
04/09/18 (S) VERSION: SB 198
04/11/18 (H) READ THE FIRST TIME - REFERRALS
04/11/18 (H) HSS, FIN
04/17/18 (H) HSS AT 3:00 PM CAPITOL 106
04/17/18 (H) Heard & Held
04/17/18 (H) MINUTE(HSS)
04/19/18 (H) HSS AT 3:00 PM CAPITOL 106
WITNESS REGISTER
HEATHER CARPENTER, Staff
Senator Pete Kelly
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Presented SB 198 on behalf of the bill
sponsor, Senator Kelly.
WILLIAM TRAWICK, Advanced Nurse Practitioner
Anchorage, Alaska
POSITION STATEMENT: Testified regarding the NEST/NAS program.
MARILYN PIERCE-BULGER, Owner
FASDx Services, LLC
Anchorage, Alaska
POSITION STATEMENT: Testified during discussion of SB 198.
ROBERT BOECKMANN, PhD
Chair, Institutional Review Board (IRB)
University of Alaska Anchorage
Anchorage, Alaska
POSITION STATEMENT: Testified during discussion on SB 198.
JEANNE GERHARDT-CYRUS
Governor's Council on Disabilities and Special Education
Kiana, Alaska
POSITION STATEMENT: Testified during discussion of SB 198.
ELLEN HODGES, MD
Bethel, Alaska
POSITION STATEMENT: Testified during discussion on SB 198.
GENEVIEVE MINA
Anchorage, Alaska
POSITION STATEMENT: Testified during discussion of SB 198.
BESSE ODOM
Anchorage, Alaska
POSITION STATEMENT: Testified during discussion of SB 198.
ACTION NARRATIVE
3:04:43 PM
CHAIR IVY SPOHNHOLZ called the House Health and Social Services
Standing Committee meeting to order at 3:04 p.m.
Representatives Spohnholz, Tarr, Sullivan-Leonard, Johnston,
Eastman, Zulkosky, and Kito were present at the call to order.
SB 198-UAA LONG-ACTING CONTRACEPTION STUDY
3:05:17 PM
CHAIR SPOHNHOLZ announced that the only order of business would
be SENATE BILL NO. 198, "An Act relating to a study of the
effectiveness and cost of providing long-acting reversible
contraception to women with substance abuse disorders."
3:05:42 PM
HEATHER CARPENTER, Staff, Senator Pete Kelly, Alaska State
Legislature, shared some background on how Senator Kelly "got to
this point of introducing" the proposed bill. She stated that
the proposed bill was part of an ongoing effort to eradicate
fetal alcohol spectrum disorder (FASD). She paraphrased from a
white paper submitted by the Governor's Council on Disabilities
and Special Education [Included in members' packets], which read
as follows:
Fetal alcohol spectrum disorders (FASDs) are a range
of developmental disabilities caused by consuming
alcohol during pregnancy. The most well-known type of
FASD is fetal alcohol syndrome (FAS). Alaska has the
highest reported prevalence of FAS in the United
States. A newly published study found that FASDs may
be as common as autism, affecting up to 1 in 20
children.
MS. CARPENTER added that the life-long effects of FAS and FASD
could be physical, mental, learning, or behavioral health
disabilities. She explained that pre-natal alcohol exposure was
dose related, how much alcohol was in the blood stream and when
and for how long during the pregnancy. She stated that
dependent on when the exposure happened during pregnancy, there
were different impacts on the individual. She further
paraphrased from the white paper, which read:
Neonatal abstinence syndrome (NAS) is caused by taking
opioids during pregnancy; after birth, babies with NAS
may go through drug withdrawal. Over 69% of mothers
who had a baby that was diagnosed with NAS had
previously given birth to other children.
Infants exposed to opioids and alcohol during
pregnancy have an increased risk for pre-term birth,
life-long disabilities, and neurodevelopmental delays,
with significant emotional, social, and economic costs
for individuals, families, and the state.
FASDs and NAS are preventable when women have access
to the resources, support, information, and care or
treatment they need for their children or themselves.
3:08:30 PM
MS. CARPENTER reported that Senator Kelly had first introduced
legislation addressing FASD in 2014, Senate Concurrent
Resolution 13. She highlighted certain whereas clauses included
in the resolution:
Whereas, fetal alcohol spectrum disorder permanently
alters a child's cognitive abilities;
Whereas, fetal alcohol spectrum disorder has been
identified as a pervasive and chronic driver of
numerous social challenges throughout the state;
Whereas, the occurrence of fetal alcohol spectrum
disorder is preventable;
Whereas, Alaska has the highest documented prevalence
of fetal alcohol spectrum disorders in the United
States;
Whereas, in 2012, the legislature passed legislation
making the existence of fetal alcohol spectrum
disorder a mitigating factor for criminal sentencing;
Whereas, misconceptions continue to exist regarding
the causal factors and lifelong effects of fetal
alcohol spectrum disorder;
3:09:48 PM
MS. CARPENTER added that a further resolve from this
resolution was that the Alaska State Legislature supported
programs which would minimize the risk of fetal alcohol
exposure. She reported that there had been several efforts
to affect the rate of FASD in Alaska, which finally
intersected with the four-part FASD prevention model
offered by Dr. Nancy Poole, which included: universal
messaging strategies promoting FASD prevention; increasing
access to pregnancy tests; increasing access to long acting
reversible contraception (LARC); and increasing access to
substance abuse treatment and support services. She
recapped that the proposed bill would allow the University
of Alaska Center for Alcohol and Addiction Studies to
"evaluate the feasibility and effectiveness of providing
long acting reversible contraception to women involved in
services such as Alaska Regional's neo-natal abstinence
evaluation support treatment (NEST) program." She stated
that the population of women served by this program
represented one of the highest risk groups in Alaska for
unintended pregnancy and pre-natal drug and alcohol
exposure. She said that the study would be done in
collaboration with hospitals and health care providers in
Alaska who treat women with substance abuse disorders. She
pointed out that the incidence of children born with neo-
natal abstinence syndrome (NAS) in Alaska had increased by
more than 500 percent from 2004 - 2015, due in part to the
current opioid crisis. Alaska had more than 120 children
diagnosed with FASD each year, although, she opined, the
true rate could be significantly higher according to recent
national prevalence studies. She said that 2,660 children
had been diagnosed with FASD in Alaska since 2001. She
reported that almost 50 percent of infants with NAS treated
at the Alaska Regional Hospital NEST program were
immediately placed into the care of the Office of
Children's Services (OCS), which, she reminded the
committee, was the state law for any infant with drug
exposure.
3:13:07 PM
MS. CARPENTER, in response to Representative Johnston, said that
this included both FASD and FAS.
REPRESENTATIVE JOHNSTON shared that an issue for both was a lack
of diagnosis in children. She asked if these numbers were for
children that had "come through some system where there is some
diagnosis."
MS. CARPENTER admitted that this was a part of the challenge, as
it was necessary to prove there was some pre-natal alcohol
exposure, in order to get diagnosis, adding that diagnosis was a
long and lengthy process. She directed attention to letters of
support [Included in members' packets] from Karen Perdue and
Niesje Steinkruger. She shared some of her personal experiences
working with young people who suffered from FASD.
3:17:20 PM
REPRESENTATIVE SULLIVAN-LEONARD asked about case studies from
the Institute of Circumpolar Health with regard to FAS and its
prevention and whether this had already been studied.
MS. CARPENTER replied that this study regarding access and the
barriers had not specifically been studied. She shared that
there was a lot of interest from other states for the results of
this study.
REPRESENTATIVE SULLIVAN-LEONARD asked what information had been
pulled from these other FAS studies. She asked if it was the
desire of the sponsor to work solely through the Alaska Regional
Hospital for information from its patients or would there be
research for information from rural areas.
MS. CARPENTER replied that the proposed bill was very careful
not to name one specific hospital in the legislation. She
acknowledged that Alaska Regional Hospital was the first
hospital ready to partner because they already had the ongoing
NEST program and an ongoing relationship with the university.
She expressed hope that other hospitals in Alaska would also be
interested in participation.
REPRESENTATIVE SULLIVAN-LEONARD asked about the results of the
studies from the pregnancy tests from the various bars.
MS. CARPENTER offered to provide those results to the committee
members.
3:21:47 PM
REPRESENTATIVE ZULKOSKY referenced a program by the [Centers for
Disease Control and Prevention] CDC for choices to prevent
alcohol exposed pregnancies which used motivational interviewing
to increase a woman's motivation and commitment to change. This
included two to four counseling sessions, as well as a
contraceptive counseling session. She added that this was
implemented in various settings including community health
centers and family planning clinics. She pointed out that there
were also facilitator guides, client workbooks, and counselor
manuals all developed by the CDC. She asked if the development
of the proposed study had gleaned any best practices from the
CDC.
MS. CARPENTER replied that the University [of Alaska] had built
on information from that choices study.
REPRESENTATIVE ZULKOSKY reported that the CDC research was being
implemented in Baltimore, Denver, New York City, and Los
Angeles. She pointed to the proposed fiscal note, and asked why
the proposed legislation was not duplicative, hence an
unnecessary expense, with this already implemented information
and resources.
MS. CARPENTER referenced the personnel costs in the fiscal note,
and stated that it was not covering the entire person's salary
as that person would continue to work on other projects.
3:24:40 PM
REPRESENTATIVE ZULKOSKY expressed her understanding that,
although it did not cover the full staff expense, there was only
$200,000 of the $500,000 appropriation left for statistically
relevant analysis, whether that be health care, planning, or
outreach.
MS. CARPENTER explained that, as this budget was offered in
conjunction with the university, she did not have the answers to
those questions. She opined that the university would implement
other research.
3:25:47 PM
CHAIR SPOHNHOLZ suggested that a follow up response from the
university would be useful.
3:26:32 PM
REPRESENTATIVE KITO asked about the fiscal note, which
identified personal services for more than half the grant and
noted that nothing had been allocated for travel. He opined
that the vast majority of the money would go to university
employees instead of care for the subject of the study. He
expressed his concern for adequate medical support, as nothing
was mentioned in the fiscal note for medical oversight. He
added that the fiscal note description was quite vague. He
asked whether there was enough money in the study to "do it
right" because if only so much of the money is going to the
actual study, a lot of the money is going to personnel. He
mentioned that Phase 2 of the program was to implement referral
protocols and assemble data collection and network
collaboration, and that Phase 3 was to implement data analysis
and reporting, data analysis strategy development outcomes, and
reporting strategy recommendations. He emphasized that there
was nothing mentioned for medical support to the individuals
receiving the intervention or for any follow up to those
individuals to ensure medical support throughout the time
impacted by this intervention. He asked for assurance that the
participants would receive adequate medical care.
MS. CARPENTER replied that she would contact the University and
request that the fiscal note provide more detail. She explained
that part of the money would go for a case manager to ensure
that the participants had follow up care and that part of the
money would pay for the actual contraception to those
participants who did not have medical insurance.
3:29:34 PM
REPRESENTATIVE EASTMAN asked for the total amount of funding
from all the various sources for this project.
MS. CARPENTER replied that the total funding from the fiscal
note would be drawn from the general fund, and that currently
there were not any matching funds.
3:30:03 PM
CHAIR SPOHNHOLZ offered her belief that there had also been a
federal funding request.
3:30:12 PM
REPRESENTATIVE EASTMAN asked about the impact to the project if
there was not any additional funding.
MS. CARPENTER reported that the entire University budget for the
three-year project was $500,000. She opined that the University
would continue to work to get other funding, although they could
move forward given this amount.
REPRESENTATIVE EASTMAN asked how the federal funds would be
used.
MS. CARPENTER said that she did not know without seeing the
application.
3:31:30 PM
CHAIR SPOHNHOLZ opened invited testimony on SB 198.
3:32:02 PM
WILLIAM TRAWICK, Advanced Nurse Practitioner, said that he was
the author of the NEST program at Alaska Regional Hospital. In
response to Chair Spohnholz, he explained that the NEST program
was designed to care for substance exposed infants, both the
immediate medical care and the detoxification and controlled
medical withdrawal. He said that it also involved the care of
the families of the infants, with an effort to maintain them or
enroll them in substance recovery programs. He reported that
this was a diverse population of Alaska residents, and that this
population was, on average, 99 percent state Medicaid enrollees.
He reported that this diverse population included street level
substance users, those in medication assisted drug therapy, and
persons who suffered from chronic pain syndromes which required
opiate treatment. He said this was a diverse population of both
licit and illicit substance using persons.
MR. TRAWICK, in response to Representative Zulkosky, said that
the population was very diverse, and it was difficult to draw
any specifics from this population. He added that, generally,
the patients were Medicaid recipients, were using illicit
medications as well as legal drug medication assisted therapy.
He stated that frequently there were mothers enrolled in
methadone programs, and, after delivery, as the baby would
become part of their program, the family would also become part
of the program. He explained that a defining characteristic of
the NEST program was that it was a family centered, family
intensive program.
3:36:17 PM
REPRESENTATIVE ZULKOSKY asked if there were cases which had been
referred statewide in the program, and if so, from where had
those referrals originated.
MR. TRAWICK replied that the majority of the patients were from
the Anchorage area, although there were also referrals from
outside areas. He pointed out that it was expensive and
difficult to medically air transport a baby from an outside
community to Anchorage. He reported that infants who did
require air transport to Anchorage became patients at Providence
Alaska Medical Center even though there were not the services of
the NEST program.
3:38:59 PM
REPRESENTATIVE KITO asked about the resources for the NEST
program to medically oversee the actions related to the proposed
study in regard to the mothers of the children.
MR. TRAWICK reiterated that the primary characteristic of the
NEST program was for a family focus and to develop a culture of
respect with an absence of shame. He declared that the program
goal was to treat babies suffering from withdrawal and to
maintain infants in the care of their biological family whenever
possible. He emphasized that this was an extremely difficult
environment to maintain. He explained that babies who could not
be managed effectively with common sense measures such as
holding and soothing to decrease stimulation, were moved inside
the NEST unit for medically assisted therapies, often including
minute doses of morphine, which required very high levels of
nursing care. He noted that this was often a ratio of one baby
with one nurse, a fundamental requirement for babies suffering
from opiate withdrawal. He shared that when possible the
biological family was included, under guidance, in this care for
the babies, even though this was sometimes too much for the
families.
3:42:59 PM
REPRESENTATIVE KITO asked, as the proposed study included a
medical intervention for the mothers, what resources the NEST
program had to provide medical oversight and treatment for the
mothers receiving the proposed contraception intervention to
ensure they were not adversely affected health wise.
MR. TRAWICK explained that an important aspect of the NEST
program was that every mother entering Alaska Regional Hospital
for delivery underwent a screening process, called the 4 P's
Plus, which was a widely validated tool to assess a mother's
risk of alcohol and substance use and exposure. He added that
this program was now used in hospitals throughout Alaska as it
allowed the hospital to know when a woman was at risk for these
exposures. He pointed out that the NEST program was well
positioned to determine mothers who may be candidates for the
LARC, emphasizing that the program was voluntary. He declared
that it was vital to maintain this culture of respect.
3:46:25 PM
REPRESENTATIVE KITO reiterated that, as many of these women did
not have regular health care, they had no access to a health
care provider. As the proposed legislation was recommending an
invasive medical procedure, he asked for assurance that there
would be needed medical oversight for the women receiving LARCs.
MR. TRAWICK expressed his agreement that the vast majority of
the women in the program did not have a medical provider. He
explained that part of the NEST program was to get the women
into a "conventional medical relationship." He stated that
women were not discharged from the program without follow-up
providers, even though it was a small pool of medical
professionals who showed an interest in taking care of these
mothers.
REPRESENTATIVE KITO asked if there were medical doctors in the
NEST program that provided care for the mothers.
MR. TRAWICK replied, "Not in the NEST program."
3:48:40 PM
REPRESENTATIVE EASTMAN asked if the proposed program would
meaningfully contribute to the culture of respect, or was some
"fine tuning" still necessary.
MR. TRAWICK expressed his agreement that some "fine tuning"
still be necessary as it was a very sensitive issue. He stated
that it was a "horrible thought" for any family to think the
mother was going to be sterilized. He emphasized that the NEST
program was very sensitive to this issue.
3:49:52 PM
CHAIR SPOHNHOLZ asked how parents were connected with addiction
treatment.
MR. TRAWICK explained that there was a licensed clinical social
worker who maintained some very close relationships within the
provider network.
3:50:49 PM
CHAIR SPOHNHOLZ asked if there were barriers to getting people
into treatment and if there was enough access to addiction
treatment in Alaska.
MR. TRAWICK expressed his agreement, stating that there was "no
end to the amount of barriers," although he mused that there
were some promising developments. He reported that the planning
was well underway for the development of a behavioral health
program at Alaska Regional Hospital, which would include
detoxification beds as well as substance treatment. He said
that families had so many reasons to avoid these decisions, and
that the NEST focus was to work around these obstructions and
visualized threats. He added that a new peer support program
had just been instituted which he opined could be a very
powerful tool to encourage mothers to proceed in treatment.
3:52:38 PM
CHAIR SPOHNHOLZ asked if the NEST program had been able to get
everyone who was ready into treatment.
MR. TRAWICK said that the biggest issue was almost always for
the availability of beds. He reported that very few programs in
Alaska would allow a mother to be enrolled in an in-patient
program and maintain custody of their child. He noted that the
methadone program, although perfectly adequate, was not an
inpatient program.
3:56:01 PM
CHAIR SPOHNHOLZ offered her understanding that the program was
primarily designed for families with infants born with an
addiction to opiates, whereas the proposed legislation was
focused on FASD. She asked how they would identify the
patients, and what would be done differently to operationalize
this.
MR. TRAWICK replied that the assessment program was well
validated for alcohol usage issues. He opined that the efforts
for screening, including short interventions and access to
further therapies, would be the most valuable tool, adding that
all mothers delivering at Alaska Regional Hospital were
screened. He expressed his agreement with Chair Spohnholz that
this would determine the referrals to the NEST program.
3:56:36 PM
MARILYN PIERCE-BULGER, Owner, FASDx Services, added that she was
also representing the non-profit organization, Alaska Center for
FASD. She reported that FASD was more common and prevalent than
previously thought, impacting more than 1 in 20 children,
whereas autism affected 1 in 68 children and ADHD affected 1 in
110 children. She pointed out that there was not good
prevalence data for Alaska, and that individuals who had not
been diagnosed were at increased risk for self-medication with
alcohol and substances. She reported that data indicated that
80 percent of women using substances were also using alcohol.
She noted that individuals diagnosed with FASD were impacting
the health, education, social services, and criminal justice
systems, and, even more important, their own daily lives and
their life trajectories. She emphasized that this was a life
long disability which could contribute to chronic pain, immune
response conditions, anxiety, and depression. She shared a
report from CDC which indicated that the women drinking in
pregnancy in 2018 were white, working, college educated women
who believed that their low to moderate alcohol doses would not
have any impact on their children. She reported that alcohol
had more long-term impact than many of the other abused
substances. She noted that although many of the women were able
to stop the alcohol use, their pregnancies were already
impacted. She offered her belief that women using substances
wanted something different for themselves and their babies, so
that helping them explore the options with LARC and substance
abuse treatment offered them more choice and control over their
lives. She stated that the proposed bill was a strategy to help
women help themselves.
4:01:45 PM
REPRESENTATIVE ZULKOSKY asked about the reduction for the
prevalence of FASD and neo-natal exposure to illicit substances
and the need to provide greater support and wrap around services
for Alaskans seeking substance abuse treatment and comprehensive
contraceptive options for women. She expressed her concern with
the proposed bill as it would seek to treat one part of Alaska's
population of women differently than others and would stigmatize
one group of Alaska women. She noted that the implication was
that women with substance abuse disorders should be prevented
from having children. She expressed her difficulty in
reconciling how providing effective birth control to a
population of women who may be having children who were seen as
a cost challenge to the State of Alaska. She deemed this as a
fine line into dangerous territory. She expressed her
understanding for protecting children but asked how the proposed
bill would protect women who were struggling and would not
malign them.
MS. PIERCE-BULGER offered her belief that the professionals
working with these issues were "incredibly sensitive to all of
what you just mentioned." She shared that, in her years of
experience working with women living on the edge, that being
safe, having a roof overhead, and food on the table was the
priority. She noted that these women were also trying to
"achieve some level of control over their lives" and wanted to
have effective birth control, although some of the women were
not able to access it for a variety of reasons. She opined that
the proposed bill could make effective contraceptive choices
more easily available to vulnerable women in the community. She
mused that, as stigma got in the way of all conversations around
substance use and FASD, it was necessary to normalizing certain
responses in the health care system.
4:06:58 PM
CHAIR SPOHNHOLZ stated that there was not a great community
awareness for the prevalence of FASD and what was needed to
provide support. She shared a personal anecdote.
4:08:27 PM
ROBERT BOECKMANN, Ph.D., Chair, Institutional Review Board
(IRB), University of Alaska Anchorage, said that this was
sometimes called the ethics committee. He explained the role of
the IRB to ensure the respectful and ethical treatment of
research participants. He corrected earlier testimony by
Senator Kelly which stated that the legislature had the capacity
to authorize the conduct of the LARC studies at UAA Center for
Addiction Studies, declaring that to be "categorically false."
He emphasized that the authorization to conduct the studies had
to go through the IRB and that ultimately, it was his decision
to authorize the conduct of a study involving human subjects.
He acknowledged that the legislature could authorize the funding
but not the conduct of the study. He offered a brief overview
of the IRB, its membership, a review of the research protocols,
and what the IRB was empowered to do with regard to reaction to
those research protocols. He stated that research with human
subjects had a fairly long, complicated, and controversial
history. He added that concerns about research ethics were not
an integral part of research until the Nuremberg Trials, which
exposed some horrible atrocities.
4:11:48 PM
DR. BOECKMANN mentioned the Tuskegee Institute syphilis studies
from 1932 - 1972 and those injustices imposed by the U.S. Public
Health Service led to the formal adoption of rules and
regulations that now guided and ensured respect to research
participants. He reported that the conduct of the IRB was
guided by federal rules. He explained that the minimum was 5
members while UAA had 11 members, and this had to include a
member with scientific expertise, a member with non-scientific
expertise, and a member not affiliated with the university, the
community representative to bring the community values, needs,
and concerns to any discussions. He added that the IRB, under
certain circumstances, could be directed to have additional
types of representative, specifically from any group to be
tested. He pointed out that with any review of a research
protocol involving medical intervention, it was necessary to
have a medical doctor included in the discussion. He noted that
the current membership of the UAA IRB was listed on its website,
with the regular open public meetings also posted on the
website. He explained that prior to the meetings, the board
members reviewed the protocols and prepared notes and comments
for deliberation on any concerns. He emphasized that the IRB
had the power to disapprove, modify, or stop any studies that
were inconsistent with the federal guidelines. He stressed that
no human research activity was allowed to be conducted at UAA
unless it was rigorously reviewed by the IRB. He highlighted
the seven criteria that IRB used for review of a protocol:
assess risks and ensure they are minimized for little or no
danger to participants; assess that any risks are beneficial to
the study results; selection of the research participants is
equitable across a wide segment of society; informed consent
documented from each participant; adequate provision for
monitoring the data security; and, privacy of the data. He
added that if and when approval of study was granted, it was
necessary for a progress report, which for a high-risk study,
was required in 3 months, or at any point necessary to ensure
the safety and well being of the participants. He stated that
any modification by the researcher of the protocol had to be
presented to the IRB for review.
4:22:30 PM
REPRESENTATIVE KITO asked how many requests for research
involving medical intervention did the IRB review annually.
DR. BOECKMANN replied that they did not see a medically invasive
intervention similar to the LARC studies very often, perhaps one
or two per year.
REPRESENTATIVE KITO expressed his concern for follow up care and
asked about individuals who may leave the study but then have a
medical problem post-study. He asked if the IRB would recommend
that the intervention be terminated before completion of the
study or recommend a protocol for follow up care to every
individual who had received the intervention and could have
support for removal post-study. He asked for assurance that the
individuals would have support while in the study, as well as
post-study.
DR. BOECKMANN said that the IRB would require a specific
procedure or plan of follow up care and funding for those
individuals having the LARC intervention.
4:27:06 PM
DR. BOECKMANN, in response to Representative Tarr, said that
informed consent from each individual in the study would be
documented.
REPRESENTATIVE TARR expressed her concern that the actual
process would include coercion to participate, as the individual
would be in a very vulnerable state during post-delivery and
withdrawal. She asked how the plan could be "whole person
centered" and suggested that the individual could need an
advocate.
4:31:26 PM
DR. BOECKMANN segued into the informed consent requirement and
process. He stated that the IRB reviewed specific procedures
and plans, and expressed his understanding that currently this
plan did not yet exist. He stated that the federal government
required an informed consent process and he listed the seven
requirements for informed consent: the study has been
adequately described; a description of an foreseeable risks or
discomforts that may be encountered; describe the benefits the
subject may receive directly or the benefits extended through
study to society; a statement that participation was voluntary
and that refusal to participate or discontinue participation at
any time would involve no penalty or loss of benefit to which
the participant was otherwise entitled; disclosure of any
alternative procedures or courses of treatment that may be
available; describe the extent to which any confidentiality of
record or identifying information would be maintained, and if
there were any possibility for a breach of confidentiality; an
explanation for more than minimal risks from the research, and
any medical treatment available if injury occurs; and,
information for who to contact if there are concerns or
questions about the research participation. He stated that
there are some special requirements for vulnerable populations,
including children and adults with diminished capacity,
regarding consent.
4:38:15 PM
REPRESENTATIVE TARR reported that, as her constituency had
varying levels of trust for those in positions of authority,
there was a concern that individuals would feel they did not
have the ability to make their own choice. She stated her need
to feel there were enough safeguards in place. She pointed out
that reproductive health care and the use of birth control was
not always viewed as positive.
DR. BOECKMANN declared that the issue of coercion was very
important to the IRB. He offered an example of proposals for
research participants from prisons. He pointed out that the
issues of choice, coercion, and the power differential between
the researcher and the participant was closely examined by the
IRB as it differed by population group.
4:42:20 PM
REPRESENTATIVE KITO expressed his concern that mothers would
have an expectation that participation in the study with the
LARC, or other contraceptive, might have an impact for whether
they would get their child back from OCS custody.
DR. BOECKMANN said that the IRB was very sensitive to the
context of the research, recognizing that different groups of
people had different needs, concerns, and perceptions. He
acknowledged that a woman may believe that she would gain an
advantage, possibly getting her baby back, if she participated.
He suggested that this would be a conversation by the IRB, which
could require language in the consent form that would indicate
that hospital treatment for the baby would not differ as a
function of participation in the study.
REPRESENTATIVE KITO said that there were nuances in the proposed
bill that could be very complicating.
4:45:22 PM
REPRESENTATIVE TARR shared a letter to the House Health and
Social Services Standing Committee that indicated that the IRB
could make mistakes, even though unintentional. She listed some
of the concerns for follow up care and removal of the LARC which
would be addressed by proposed amendments. She asked about the
IRB representation from the people participating in the study.
DR. BOECKMANN acknowledged that IRBs had made mistakes in the
past, even as he did his best to ensure that there would not be
any mistakes. He directed attention to a letter [Included in
members' packets] from Serene Rose O'Hara-Jolley, pointing out
that this letter was not clear as to which IRB or which protocol
she was referencing, and that he did not recall working with her
at the UAA IRB. He relayed that the UAA IRB processed about 600
protocols each year. He spoke about the requirement for
representation on the IRB, and, although there was not a
requirement for a certain ethnic representation, there was an
attempt to have ethnic diversity and a balance of men and women.
4:51:54 PM
REPRESENTATIVE TARR offered her belief that it was very
important to have women, and women of color, as part of this
representation to introduce some of their experience. She asked
whether there were invitations for feedback or participation, or
would the advisory council developing the protocols be diverse.
DR. BOECKMANN said that part of the evaluation was looking at
the extent to which the protocol was inclusive and respectful
for the community assessed. He pointed out that the actual IRB
membership included: a Hispanic woman with advanced health
professional credentials, including two master's degrees focused
on women and community health, and a Doctorate. He reported
that he had been working with this IRB for more than a decade
and that "they take the community's concern very seriously."
CHAIR SPOHNHOLZ announced that SB 198 would be held over.
4:54:47 PM
JEANNE GERHARDT-CYRUS, Governor's Council, shared that she was a
parent of multiple children with pre-natal exposure [to alcohol]
and that she was Chair of the prevention work group on FASD.
She expressed her agreement for the safeguarding of people's
rights. She declared support to empower women to plan
pregnancies when they were ready and to enable them to give
birth to healthy children by virtue of having access to LARC.
She pointed out that, although unplanned pregnancies did not
mean unwanted pregnancies, it could include unprepared for
establishing a healthy environment for the baby. She
acknowledged the high rate of women with opioid use disorder who
had unplanned pregnancies. She shared her personal experience
of children with FASD, all of which was 100 percent preventable.
She declared that she was not looking to prevent these children
from being born, but just wanted to increase the odds that they
would be born healthy by ensuring that women had the access to
choose LARC. She encouraged the proposed study.
REPRESENTATIVE TARR reiterated that it is necessary for women to
be empowered and to have choices.
5:02:51 PM
ELLEN HODGES, M.D., advised that she is a physician in rural
Alaska that primarily serves Alaska Native residents, and she is
testifying on her own behalf. She expressed concern regarding
SB 198, the testimony regarding the children affected by drugs
and alcohol, and the women who will be affected by this
legislation. Dr. Hodges advised that within her practice, she
takes care of many women and children and she offers
reproductive health. This legislation could return the state to
the "shameful days" when forced sterilization and contraceptive
coercion was a common occurrence for vulnerable populations,
including the Alaska Native and American Indian population. In
the 1990s, Norplant was used, which is a long-acting reversible
contraceptive (LARC) implant and has since been removed from the
market, wherein it was required of some women to obtain its
benefits in order to avoid incarceration. Clearly, she said, no
one wants children born who have been exposed to drugs and
alcohol in utero, but medical professionals already have
available the randomized controlled trials that established best
practices in order to reduce alcohol use in women who engage in
risky drinking behavior. The Center for Disease Control (CDC)
CHOICES program [prevent alcohol-exposed pregnancies] details
such best practices and, she advised, there are many other such
evidence based programs that have been validated across the
nation in many populations. Furthermore, she advised, the
American Academy of Pediatrics already established the best
treatment for utero abstinence syndrome, and further advised
that there are many disciplinary teams across the state able to
diagnose and treat fetal alcohol substance disorder (FASD), and
follow up with the families. This money, she pointed out, could
be better spent on programs such as the CDC CHOICES program that
has already been researched and validated, or spend the money on
drugs and alcohol treatment programs that are so desperately
needed in the rural areas in Alaska, and in her community.
5:05:11 PM
DR. HODGES further expressed concern about this sort of design
and the follow up of the women with long-acting reversible
contraceptives implants because this type of contraception
cannot be removed by the woman herself, the removal requires an
appointment with a health care provider. These implants can
remain in place for up to ten years, and she asked: "How will
they be followed; who pays for the removal; what if they leave
the State of Alaska; who handles complications - for example, an
exploratory laparotomy for a woman with a migrated intrauterine
device (IUD)." She referred to the evidence that comprehensive
wrap around care with motivational interviewing and
comprehensive contraceptive counseling reduces risky drinking
behavior, and stressed that this legislation does not describe
the design in enough detail. The testimonies heard today from
the (NEST) program and the IRB from UAA do not alleviate her
considerable concerns that these women will either explicitly or
implicitly be coerced into using long-acting reversible
contraception. Thereby, returning the state to the days of
forced sterilization when it was allowed and encouraged, she
expressed. Studies have proven that access to birth control
counseling and motivational interviewing reduces risky drinking
behavior among women who do, and do not, have children. She
said that she simply does not believe this study is necessary,
and it puts the state at risk of going down in history of using
those shameful programs that allow this type of coercion. That
history is a dark stain put upon the medical area where she
practices, she remarked.
5:07:07 PM
GENEVIEVE MINA advised that she is a UAA student representing
herself, and offered support for the legislation. As a woman
with a long-acting reversible contraceptives (LARC), she knows
that her IUD is over 99 percent effective and it is far cheaper
and convenient than other forms of birth control. She noted
that she comes from a privileged background that included
comprehensive sexual education at her high school, and knowing
under which providers she is covered under her health insurance.
Currently, the conventional method of birth control works for
her, but it is not working for women with substance abuse issues
who statistically have higher rates of unplanned pregnancies.
It is her belief, she said, that addressing women's health
regarding substance abuse disorders is far more complex and
nuanced than simply offering more access to contraceptive care.
It is necessary to rethink what access means, and she explained
that access is about surpassing financial, institutional, and
social barriers. She pointed to the financial barriers and
noted that simply because the service can be accessed free of
charge does not necessarily mean a woman has the incentive to
obtain that service. For example, there are probably
legislators who did not obtain the flu shot even though the cost
was covered by insurance. As to the institutional barriers,
many women may want the service but cannot locate a provider
with LARC available at their facility. The conventional method
of care in the healthcare system may not work and be accessible
for these women. Finally, she stated, as to social barriers,
many women have misconceptions about LARC because they have not
received proper sexual education, or if they are a user of
opioids, they often have a huge distress and fear of the
healthcare system and avoid providers all together.
5:08:56 PM
MS. MINA referred to SB 198, Section 1, subparagraphs (2), (3),
and (8), page 2, which read as follows:
(2) evaluate best practices for treating women
and children when there is a high risk of neonatal
abstinence syndrome or fetal alcohol spectrum
disorders;
(3) facilitate the creation of an effective
network of hospitals and service;
(8) provide a data-driven framework to establish
a comprehensive strategy for using long-acting
reversible contraception to reduce the occurrence of
neonatal abstinence syndrome and fetal alcohol
spectrum disorders in the state.
MS. MINA related that those subparagraphs support a research
project that aims at better strategies for women's health.
Additionally, she explained, as was heard today, the concerns
about coercion will be acknowledged under the review of the IRB
which specified room in the study for education and the
economies for the women to choose whether they want to use birth
control in the form of a LARC. She described that substance
abuse during pregnancy is a complicated and sensitive issue and
it does require a nuanced approach in order to improve public
health for the most vulnerable in our population, including
women and children. She asked that the committee pass SB 198.
5:09:57 PM
BESSE ODOM advised that she is representing herself, and
acknowledged that the intent of the legislation means well.
However, she asked that the committee not support this bill in
its current form because it does not get to the bottom of the
problems for these particular groups of women that it seeks to
help. She related that the state should put more resources into
programs to help these women in need. She said she would rather
see the money allocated to improving the already existing
programs and organizations who aid women battling a substance
abuse disorder. She described that this bill insinuates that
these women should have their rights to have children controlled
not by herself, but by those who they do not know and may not
even trust. She said that she genuinely believes that the
research showing that good educational programs and
accessibility to programs wherein women can turn their lives and
situations around are being ignored. As a woman, and
particularly an African American woman, she described this bill
as highly insulting to her because it reminds her of the
histories told to her by women such as her grandmother. Many
women, living around the time of her grandmother were uneducated
and lacked the resources they needed to make a truly informed
decision about their reproductive rights and their bodies.
Historically, groups of women were targeted and sought out
because it was believed their offspring would be less than
desirable to the population. This bill is a great reminder that
"we should be educating ourselves" regarding the history of
reproductive rights and marginalized communities. These women,
suffering from substance abuse disorder and women of color, have
always been victims of violator reproductive rights and this
bill in its current form opens the door to the rights of
vulnerable women being violated. She described that this bill
is also insulting because it insinuates that a woman battling
substance abuse disorder is not fully capable of having children
and turning her own life around with the right support.
Clearly, substance abuse disorder is a huge issue in this state
as she has three siblings who battle the disorder on a daily
basis. Ms. Odem encouraged the committee to read the history
books, and to be sympathetic to the groups of women desperately
in need of true support systems and great educational programs
that address their needs.
CHAIR SPOHNHOLZ left public testimony on SB 198 open.
[SB 198 was held over.]
5:13:19 PM
ADJOURNMENT
There being no further business before the committee, the House
Health and Social Services Standing Committee meeting was
adjourned at 5:13 p.m.
| Document Name | Date/Time | Subjects |
|---|---|---|
| SB 198 Amendment D.4.pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Amendment D.9.pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Amendment D.12.pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Amendment D.13.pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Sectional Analysis.pdf |
HHSS 4/19/2018 3:00:00 PM SFIN 3/26/2018 9:00:00 AM |
SB 198 |
| SB 198 Sponsor Statement.pdf |
HHSS 4/19/2018 3:00:00 PM SFIN 3/26/2018 9:00:00 AM |
SB 198 |
| SB 198 Supporting Documents - ACT Letter of Support.pdf |
HHSS 4/19/2018 3:00:00 PM SFIN 3/26/2018 9:00:00 AM |
SB 198 |
| SB 198 Supporting Documents - Alaska Dispatch Article May 2016.pdf |
HHSS 4/19/2018 3:00:00 PM SFIN 3/26/2018 9:00:00 AM |
SB 198 |
| SB 198 Supporting Documents - JSAT Article.pdf |
HHSS 4/19/2018 3:00:00 PM SFIN 3/26/2018 9:00:00 AM |
SB 198 |
| SB 198 Supporting Documents - NEJM Study May 2012.pdf |
HHSS 4/19/2018 3:00:00 PM SFIN 3/26/2018 9:00:00 AM |
SB 198 |
| SB 198 PPVNH_SB 198_LARC study_testimony.pdf |
HHSS 4/17/2018 3:00:00 PM HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 SisterSong LARCStatementofPrinciples.pdf |
HHSS 4/17/2018 3:00:00 PM HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Guttmacher Policy Review.pdf |
HHSS 4/17/2018 3:00:00 PM HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198_LARC study_testimony_PPVNH.pdf |
HHSS 4/19/2018 3:00:00 PM SFIN 3/26/2018 9:00:00 AM |
SB 198 |
| SB 198 Sectional Analysis.pdf |
HHSS 4/17/2018 3:00:00 PM HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Sponsor Statement.pdf |
HHSS 4/17/2018 3:00:00 PM HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Amendment D.14 (revised D.13).pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Letter of Support - Judge Steinkruger (retired).pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Letter of Support - Judge Steinkruger (retired).pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Letter of Opposition - Serene O'Hara-Jolley.pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |
| SB 198 Letter of Opposition - PPVNWH.pdf |
HHSS 4/19/2018 3:00:00 PM |
SB 198 |