02/06/2014 03:00 PM House HEALTH & SOCIAL SERVICES
| Audio | Topic |
|---|---|
| Start | |
| HB90 | |
| Adjourn |
+ teleconferenced
= bill was previously heard/scheduled
| *+ | HB 90 | TELECONFERENCED | |
ALASKA STATE LEGISLATURE
HOUSE HEALTH AND SOCIAL SERVICES STANDING COMMITTEE
February 6, 2014
3:10 p.m.
MEMBERS PRESENT
Representative Pete Higgins, Chair
Representative Wes Keller, Vice Chair
Representative Lance Pruitt
Representative Lora Reinbold
Representative Paul Seaton
Representative Geran Tarr
MEMBERS ABSENT
Representative Benjamin Nageak
COMMITTEE CALENDAR
HOUSE BILL NO. 90
"An Act establishing a temporary program in the Department of
Health and Social Services for testing newborns for baseline
vitamin D levels."
- HEARD & HELD
PREVIOUS COMMITTEE ACTION
BILL: HB 90
SHORT TITLE: TESTING NEWBORNS FOR VITAMIN D
SPONSOR(s): REPRESENTATIVE(s) SEATON
01/30/13 (H) READ THE FIRST TIME - REFERRALS
01/30/13 (H) HSS, FIN
02/21/13 (H) HSS AT 3:00 PM CAPITOL 106
02/21/13 (H) Heard & Held
02/21/13 (H) MINUTE(HSS)
02/06/14 (H) HSS AT 3:00 PM CAPITOL 106
WITNESS REGISTER
CAROL WAGNER, M.D.
Department of Pediatrics
Darby Children's Research Institute
Medical University of South Carolina
Charleston, South Carolina
POSITION STATEMENT: Testified and answered questions during
discussion of HB 90.
STEPHANIE WRIGHTSMAN-BIRCH, Chief
Women, Children & Family Health
Division of Public Health
Department of Health and Social Services
Anchorage, Alaska
POSITION STATEMENT: Testified and answered questions during
discussion of HB 90.
ABEL BULT-ITO, Ph.D.
Department of Biology & Wildlife
University of Alaska Fairbanks
Fairbanks, Alaska
POSITION STATEMENT: Testified in support of HB 90.
WARD HURLBURT, M.D., Chief Medical Officer/Director
Division of Public Health
Central Office
Department of Health and Social Services
Anchorage, Alaska
POSITION STATEMENT: Testified and answered questions during
discussion of HB 90.
ACTION NARRATIVE
3:10:26 PM
CHAIR PETE HIGGINS called the House Health and Social Services
Standing Committee meeting to order at 3:10 p.m.
Representatives Higgins, Keller, Seaton, and Reinbold were
present at the call to order. Representatives Pruitt and Tarr
arrived as the meeting was in progress.
[Before the committee was the proposed committee substitute (CS)
for HB 90, labeled 28-LS0376\U, Mischel, 2/14/13, which the
committee had adopted as the working draft on 2/21/13]
HB 90-TESTING NEWBORNS FOR VITAMIN D
3:11:23 PM
CHAIR HIGGINS announced that the only order of business would be
HOUSE BILL NO. 90, "An Act establishing a temporary program in
the Department of Health and Social Services for testing
newborns for baseline vitamin D levels."
3:11:43 PM
REPRESENTATIVE KELLER moved to adopt the proposed committee
substitute (CS) for HB 90, labeled 28-LS0376\O, Mischel, 2/4/14,
as the working draft.
CHAIR HIGGINS objected for discussion.
3:12:12 PM
REPRESENTATIVE SEATON, as the bill sponsor, explained that HB 90
had been introduced last year and its purpose was to obtain for
one year, a sampling of Vitamin D levels at birth from all the
children born in the State of Alaska. He offered background
which referenced a variety of studies on the effects of Vitamin
D levels in Australia, Spain, and Philadelphia, Pennsylvania.
[Included in members' packets] He pointed out that, in Alaska,
the shortage of sunshine as well as the wearing of long sleeves
for protection from mosquitoes, restricted good Vitamin D
levels. He declared that the goal of the proposed bill was, for
one year, to sample two drops of cord blood from newborn
children, in order to monitor population levels of Vitamin D.
REPRESENTATIVE SEATON, in response to Chair Higgins, stated that
cord blood from the placenta would be taken at birth, so there
would not be any need for a blood draw.
CHAIR HIGGINS asked if this was as accurate as a toe prick on
the infant.
REPRESENTATIVE SEATON explained that, as infant blood was
circulating through the placenta, this would be as accurate.
REPRESENTATIVE REINBOLD asked why blood was taken at birth, and
not during pregnancy. She asked if this was going to be a
mandate, which she declared "is something we don't do." She
questioned what was the ultimate goal.
REPRESENTATIVE SEATON, in response, established that the
proposed bill was an attempt to understand the extent of Vitamin
D deficiency in Alaska. Pointing to the study in Australia, he
reported that the lowest 25 percent of that Vitamin D population
was similar to the bottom 50 percent of the United States
population. He pointed out that a high population of children
entered school with severe to moderate language impairment in
Alaska, which he surmised could be cured with higher levels of
Vitamin D.
3:18:24 PM
REPRESENTATIVE SEATON explained that the original proposed HB 90
had requested that the Department of Health and Social Services
(DHSS) administer the program, however, the fiscal note had
indicated a cost of $5.5 million for two years. The current
proposed committee substitute, Version O, was for a program
within DHSS to be administered by a non-profit organization
affiliated with a university. As there had also been a request
for an analysis of all the data, the charge would now be $60 per
test. There was an average of 10,000 babies born in Alaska each
year, so the current fiscal note was for $600,000. Addressing
the concern of Representative Reinbold for the health benefits,
as well as the concern for a broad enough opt out clause, he
directed attention to a program called "Protect Our Children
Now." [Included in members' packets] This program was
administered by a public health non-profit group, "Grassroots
Health," which worked with the Medical University of South
Carolina. He reported that this program was being used in
Omaha, as well as South Carolina, and that it was a voluntary
program which took blood tests in the first 12-16 weeks of
pregnancy to establish a baseline, and could then make
adjustments with Vitamin D supplements. Each 10 weeks of
pregnancy, another blood test was administered. He declared
that this program would bring science into the project to help
determine the health of newborn children and women in Alaska
communities. He directed attention to page 21, which listed the
total cost to be $450,000, including $90,000 for on-site support
in the villages and hospitals to ensure that the program worked
and $50,000 in supplements. [Included in members' packets] He
noted that this funding would accommodate 500 participants, and
would require coordination with local groups. He offered his
understanding that, in South Carolina, there was coordination
with Blue Cross-Blue Shield; as each pre-term birth cost about
$50,000, there was a potential for huge cost savings. He
declared that three different research projects [Included in
members' packets] had shown Vitamin D supplementation during
pregnancy would lower the pre-term birth rate and adverse
outcomes. He discussed his search for program partners in
Alaska, noting his discussions with Providence Hospital and the
Alaska Native Health Board. He declared that this program would
not just be for research, but would also be an achievement in
public health. He pointed out that the program would supply
baseline information for women when pregnant and what Vitamin D
supplementation was necessary to attain the recognized levels
for improved health.
3:26:06 PM
REPRESENTATIVE SEATON asked the committee for an opt in, not an
opt out, in order to gather data from a large sample. He
mentioned Fairbanks Memorial Hospital as another program
possibility. He declared that these partnerships could lower
the number of children entering school with severe to moderate
language impairments, a "huge mental health advance for the
State of Alaska."
REPRESENTATIVE REINBOLD asked if the timing for the proposed
bill was appropriate, as budgets were tight.
REPRESENTATIVE SEATON replied that there would not be any cost
to the patient, with a total program cost of $450,000. This
would include the supplemental Vitamin D, as well as all four
blood tests: the test at 12-16 weeks when entering the program,
the test at 22-26 weeks, the test at 32-36 weeks, and the test
at birth. He reiterated that they were searching for partners
to help fund the program, as it required on-site participation.
REPRESENTATIVE REINBOLD offered her belief that this sounded
like a public relations campaign for Vitamin D and its many
benefits. She directed attention to Version O, Section 1, and
asked which research group would be contracted, who would have
access to the information, and what would be the cost of the
contract with the university.
REPRESENTATIVE SEATON replied that "Grass Roots Health," a non-
profit organization connected with the Medical University of
South Carolina, would be the research group. He directed
attention to the aforementioned problems for an opt out clause
that only supplied data without any improvement to health. He
reported that Version O included participation with the "Protect
Our Children Now" program, which allowed for 500 women to opt
in, at a cost of $450,000. In further response to the concerns
of Representative Reinbold, he declared that there would be a
need to generate partners in Alaska, and that the program result
would be improved medical outcomes for women and babies. He
recognized the need to offer another committee substitute which
would address these concerns. He declared that the total cost
of $450,000 could be substantially less, dependent on the
participants.
3:33:15 PM
CHAIR HIGGINS clarified that there was no intent to pass the
proposed CS out of committee today.
REPRESENTATIVE KELLER, asking for more information to the use of
the baseline information, suggested that it was unusual to have
specific legislation for a specific study.
REPRESENTATIVE SEATON, in response, opined that the data would
determine better pregnancy outcomes, as adequate Vitamin D could
reduce or eliminate many of the adverse outcomes in pregnancy.
He suggested that this would result in huge savings in Alaska,
as well as a great statistical base for the effect of adequate
Vitamin D during pregnancy. He expressed his hope that some
women would continue to work with the program to allow further
study of their children and the effect on Alaskans. He pointed
out that this two year project to collect information, save
money, and protect the health of new born children would be of
"tremendous value to us." He remarked that the only available
Vitamin D data was for the entire US and Canada, even though
Alaska was the northernmost state. It was important for
Alaskans to see outcomes of the studies done in Alaska, and this
project would put applicable science toward promoting the health
of women.
3:38:04 PM
CHAIR HIGGINS opened public testimony.
DR. CAROL WAGNER, Department of Pediatrics, Darby Children's
Research Institute, Medical University of South Carolina, said
that Representative Seaton had captured the results of the
various studies, and she reported that sunny South Carolina also
had profound Vitamin D deficiency. She established that it was
necessary to go outside and uncover in order to absorb the
necessary Vitamin D. She pointed out that Vitamin D came not
only from diet, but from exposure to sunshine, as 90 percent of
Vitamin D came through synthesis in the skin. She reported that
the average American diet supplied about 200 IU of Vitamin D,
whereas summer sunshine in a bathing suit would generate 10,000
IU of Vitamin D. She declared that a pre-natal vitamin supplied
about 400 IU. She said that there were wide spread deficiencies
throughout the United States, and there was even greater risk in
the higher latitudes, which included Alaska. She reported that
Vitamin D was actually a preprohormone, a precursor to an active
hormone called 1,25-di-hydroxyvitamin D which acted in every
organ system in the body and every cell had a receptor for it.
She shared that studies were just beginning to show the impact
of Vitamin D on white blood cell function and long latency
diseases.
3:42:46 PM
CHAIR HIGGINS asked if South Carolina had a program similar to
the program proposed by Representative Seaton, and if there was
any data that this saved money for the state from any Medicare
or Medicaid issues.
3:43:24 PM
DR. WAGNER replied that there was not any data directly related
to cost. She directed attention to an article from the American
Journal of Obstetrics and Gynecology [Included in members'
packets] which presented the health effects from raising the
Vitamin D level during pregnancy. She pointed out that this
reduced the risk for pre-term labor, pre-term birth, infection,
and hypertensive disorders of pregnancy. She noted that, as the
cost for a pre-term birth in a neo-natal intensive care unit was
$60,000, prevention of one pre-term birth was an equivalent cost
savings. She replied that the program was still gathering
information for the savings of tax dollars, and she offered to
share the information once it was available.
3:45:20 PM
REPRESENTATIVE SEATON asked about the status and locations for
the Protect Your Children Now programs.
DR. WAGNER replied that the same program was in Charleston, and
had been funded by the W. K. Kellogg Foundation in 2012. She
reported that the first pregnancy trials were begun in 2004,
with the community based project beginning in 2006. She relayed
that another community based project would begin in Columbia,
South Carolina during the upcoming year.
3:46:37 PM
REPRESENTATIVE KELLER asked for clarification that the only item
addressed by the program was collection of Vitamin D data on
newborn infants, and if any other applicable factors, including
patient history, were considered.
DR. WAGNER, in response to Representative Keller, explained that
the program measured maternal Vitamin D levels monthly,
beginning after 10 weeks of gestation. The program also
collected urine, analyzed the placenta, and looked at immune
function indicators. She noted that the primary outcome of the
project was to measure maternal Vitamin D throughout pregnancy,
and to then follow the neuro-development of the children.
3:49:00 PM
REPRESENTATIVE SEATON clarified that Version O had just looked
to acquire the status of cord blood; whereas, the current
project under discussion was to offer information for health
benefits and allow women to adjust the Vitamin D level during
pregnancy. He proposed to submit another committee substitute
based on the "Protect Our Children Now" program, and to move
forward for partnerships in Alaska to improve the maternal
status of Vitamin D, on a voluntary basis, and follow the health
outcomes, similar to the aforementioned Kellogg program. He
noted that this would allow women to individually adjust their
Vitamin D status with supplements.
3:51:57 PM
STEPHANIE WRIGHTSMAN-BIRCH, Chief, Women, Children & Family
Health, Division of Public Health, Department of Health and
Social Services, said that she was available for questions.
REPRESENTATIVE KELLER asked about the promising trends projected
by the Vitamin D data. He asked if she would undertake a study
like this based on the current evidence, on her own, without
statute.
3:52:39 PM
MS. WRIGHTSMAN-BIRCH replied that her division had reviewed this
data, but she did not concur with the results of these studies.
She declared that a focus on public health, when health issues
and disparities were reviewed, required peer reviewed scientific
literature indicating a modification in standard of practice.
She relayed that the difficulty, as the bill focused on
newborns, was that both the American College of Obstetricians
and Gynecologists and the American Academy of Pediatrics had
withdrawn recommendations for Vitamin D levels and
supplementation. She reported that her division was not
research based, and required published guidelines and standards.
She stated that DHSS was not structured to engage in a similar
study. She pointed out the controversy in the literature for
the type of blood testing, as rigorous research trials required
quality methodology and certified laboratories. She expressed
concern for fitting all of this into a limited budget. She
declared a need to be considerate and thoughtful for an opt out
process in any research study. She asked about a process for
the collection and mailing of samples to a research laboratory
for those deliveries outside of hospitals, about 6 percent of
total births.
3:56:02 PM
REPRESENTATIVE KELLER asked that she monitor the legislation to
help shape the bill for its use by DHSS. He expressed concern
for any "scientific study directed by one sentence in a law we
write, with our limited understanding."
REPRESENTATIVE SEATON, in response to Representative Keller,
stated that this was not a research project, but "predominantly
putting science into practice on the health with an opt in
project for Alaskan women." He pointed out that "Grass Roots
Health" had an institutional review board. He allowed that
there could be a question if there was partnership with the
Alaska Native Health Board or the Alaska Native Tribal Health
Consortium. He reiterated that this was a voluntary opt in
program, not a research or a clinical trial project, and was
designed to promote health and healthy outcomes for women in
Alaska.
REPRESENTATIVE REINBOLD asked for Ms. Birch to forward her
concerns to the committee. Expressing her surprise that the
American College of Obstetricians and Gynecologists had not
supported Vitamin D supplements, she asked for a reason.
MS. WRIGHTSMAN-BIRCH replied that the American College of
Obstetricians and Gynecologists had not established acceptable
blood Vitamin D levels for pregnant women. She reported that
many national organizations which provide recommendations for
practices had not firmly stated support of a specific level of
Vitamin D during pregnancy.
REPRESENTATIVE REINBOLD asked for clarification for any
recommendation to Vitamin D supplements.
MS. WRIGHTSMAN-BIRCH said that she would research this and
report back.
4:00:33 PM
REPRESENTATIVE SEATON expressed his agreement, as "some of this
does get confusing because some of the people that are being
quoted, the Institute of Medicine, their job is to recommend to
manufacturers what they should put in food," and stated that
they did not offer clinical practice guidelines. He reported
that the Endocrine Society recommended best clinical practices,
with a recommendation for 30 nanograms per milliliter as the
minimum level of Vitamin D. He pointed out that the Cystic
Fibrosis Foundation also offered clinical practice guidelines
and also recommended 30 nanograms per milliliter as the minimum
level of Vitamin D. He pointed out that the American College of
Obstetricians and Gynecologists did not recommend Vitamin D
supplements unless you lived in the northern latitudes, or had
dark skin, or were vegetarian. He directed attention to the
"unless" as it described Alaska and Northern Europe. He
suggested that the full recommendations should be viewed when
reviewing best clinical practices.
4:02:35 PM
ABEL BULT-ITO, Ph.D., Department of Biology & Wildlife,
University of Alaska Fairbanks, reported that he had 30 years of
research experience, and, although he did not study Vitamin D,
he had performed behavioral neuro-science and pharmalogical
studies in rodents, with extensive literature review of Vitamin
D. He said that he also taught human anatomy, sharing that
Vitamin D discussion arose on the first day of class when he
asked how many people were taking Vitamin D supplements. He
suggested to his students that they take 50,000 IU of Vitamin D
every day. He focused on other health issues, and the studies
showing correlations between low levels of Vitamin D and
disease, including breast cancer, prostate cancer, colon-rectal
cancer, auto immune diseases, Multiple Sclerosis, and the
effects on the immune system. He explained that the immune
system killed pre-cancer cells. He listed Types 1 and 2
diabetes, hypertension, and heart disease, and shared that
Vitamin D receptors were in almost every cell. He stated the
importance for the educational component of the proposed study
to teach pregnant women about sufficient Vitamin D levels for
healthy babies. He shared that studies had shown that the
longer a person had sufficient Vitamin D levels, the larger the
health benefit. He declared that, as a scientist, he was
excited for the study as it was important for new mothers to
understand the benefits of good, healthy nutrition, specifically
with adequate levels of Vitamin D. He allowed that, as the cost
of health care in Alaska was rising quickly, it was necessary to
educate and assist people for "doing the right thing." He
expressed his support for the proposed bill as it educated the
parents and the children, which was so important to overall
health.
4:08:02 PM
CHAIR HIGGINS expressed his agreement with Dr. Bult-Ito.
4:08:15 PM
WARD HURLBURT, M.D., Chief Medical Officer/Director, Division of
Public Health, Central Office, Department of Health and Social
Services, said that he was available for questions.
REPRESENTATIVE REINBOLD asked his opinion of the proposed bill.
DR. HURLBURT said that discussion of the proposed bill had
shifted from a testing program by DHSS to a sampling of opt in,
with a follow up program. He expressed his agreement with
Representative Seaton that Vitamin D was an essential nutrient,
especially for bone health. He reported that there were
diametrically opposite conclusions, however, for its benefits.
He directed attention to the Institute of Medicine, which
reviewed medical issues, weighed the evidence, and offered
conclusions. He expressed his understanding that this was much
broader than simply advising industry. He explained that the
United States Preventive Services Task Force was the entity for
recommendations for vaccines and minimum daily levels of
vitamins. The National Institute of Health and the Agency for
Healthcare Research and Quality looked at data and offered
conclusions to what this data supported. He noted that there
were also private entities which made evidence based decisions.
He declared that all of these entities agreed that it cannot be
concluded that there was a reduction in cancers, multiple
sclerosis, suicidal behavior, or periodontal disease with
Vitamin D. He acknowledged that the proposed bill would add to
the body of knowledge. He declared that this was not, however,
a function of DHSS, and he suggested that it would make more
sense to present it through the University of Alaska. He
tendered his respectful disagreement with the bill sponsor for
the benefits from Vitamin D.
4:14:17 PM
REPRESENTATIVE KELLER asked that the bill sponsor keep sending
committee substitutes for proposed HB 90 to the Division of
Public Health for its feedback.
DR. HURLBURT expressed his agreement.
CHAIR HIGGINS noted that the DHSS budget was $2.6 billion and
rising. He declared that preventive medicine was the best cure
and would save money. He expressed a need to start with
something.
REPRESENTATIVE SEATON expressed his thanks, noting that he would
take into account all the attitudes, including those of the
Department of Health and Social Services. He stated that he
would continue to collect information and promote public health,
as the collected data would be used to make public health
decisions. He declared that there would be a project
partnership to help promote the health of Alaskans.
CHAIR HIGGINS announced that the proposed committee substitute
(CS) for HB 90, Version O, would be held over and public
testimony would be kept open.
4:17:47 PM
ADJOURNMENT
There being no further business before the committee, the House
Health and Social Services Standing Committee meeting was
adjourned at 4:17 p.m.
| Document Name | Date/Time | Subjects |
|---|---|---|
| HB090 Draft Proposed CE Ver LS0376O.pdf |
HHSS 2/6/2014 3:00:00 PM |
HB 90 |
| HB090 Explanation of changes.pdf |
HHSS 2/6/2014 3:00:00 PM |
HB 90 |
| HB090 Support Document-Hollis-Wagner-study-effects-2012.pdf |
HHSS 2/6/2014 3:00:00 PM |
HB 90 |
| HB090 Support Document-Hollis-Wagner-study-RCT safety-2011.pdf |
HHSS 2/6/2014 3:00:00 PM |
HB 90 |
| HB090 Support Document-Protect our Children Now-booklet 2-3-14_grassroots.pdf |
HHSS 2/6/2014 3:00:00 PM HHSS 4/8/2014 3:00:00 PM |
HB 90 |
| HB090 Support Document-study-Wagner-2013.pdf |
HHSS 2/6/2014 3:00:00 PM HHSS 4/8/2014 3:00:00 PM |
HB 90 |