[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE FEDERAL RESPONSE TO AUTISM
SPECTRUM DISORDERS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON GOVERNMENT OPERATIONS
OF THE
COMMITTEE ON OVERSIGHT
AND GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
MAY 20, 2014
__________
Serial No. 113-155
__________
Printed for the use of the Committee on Oversight and Government Reform
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COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM
DARRELL E. ISSA, California, Chairman
JOHN L. MICA, Florida ELIJAH E. CUMMINGS, Maryland,
MICHAEL R. TURNER, Ohio Ranking Minority Member
JOHN J. DUNCAN, JR., Tennessee CAROLYN B. MALONEY, New York
PATRICK T. McHENRY, North Carolina ELEANOR HOLMES NORTON, District of
JIM JORDAN, Ohio Columbia
JASON CHAFFETZ, Utah JOHN F. TIERNEY, Massachusetts
TIM WALBERG, Michigan WM. LACY CLAY, Missouri
JAMES LANKFORD, Oklahoma STEPHEN F. LYNCH, Massachusetts
JUSTIN AMASH, Michigan JIM COOPER, Tennessee
PAUL A. GOSAR, Arizona GERALD E. CONNOLLY, Virginia
PATRICK MEEHAN, Pennsylvania JACKIE SPEIER, California
SCOTT DesJARLAIS, Tennessee MATTHEW A. CARTWRIGHT,
TREY GOWDY, South Carolina Pennsylvania
BLAKE FARENTHOLD, Texas TAMMY DUCKWORTH, Illinois
DOC HASTINGS, Washington ROBIN L. KELLY, Illinois
CYNTHIA M. LUMMIS, Wyoming DANNY K. DAVIS, Illinois
ROB WOODALL, Georgia PETER WELCH, Vermont
THOMAS MASSIE, Kentucky TONY CARDENAS, California
DOUG COLLINS, Georgia STEVEN A. HORSFORD, Nevada
MARK MEADOWS, North Carolina MICHELLE LUJAN GRISHAM, New Mexico
KERRY L. BENTIVOLIO, Michigan Vacancy
RON DeSANTIS, Florida
Lawrence J. Brady, Staff Director
John D. Cuaderes, Deputy Staff Director
Stephen Castor, General Counsel
Linda A. Good, Chief Clerk
David Rapallo, Minority Staff Director
Subcommittee on Government Operations
JOHN L. MICA, Florida, Chairman
TIM WALBERG, Michigan GERALD E. CONNOLLY, Virginia
MICHAEL R. TURNER, Ohio Ranking Minority Member
JUSTIN AMASH, Michigan JIM COOPER, Tennessee
THOMAS MASSIE, Kentucky MARK POCAN, Wisconsin
MARK MEADOWS, North Carolina
C O N T E N T S
----------
Page
Hearing held on May 20, 2014..................................... 1
WITNESSES
Mr. Thomas R. Insel, M.D., Director, National Institute of Mental
Health, Chair, Interagency Autism Coordinating Committee
Oral Statement............................................... 7
Written Statement............................................ 10
Mr. Michael K. Yudin, Acting Assistant Secretary, Office of
Special Education and Rehabilitative Services (OSERS), U.S.
Department of Education
Oral Statement............................................... 24
Written Statement............................................ 27
Ms. Marcia Crosse, Ph.D., Director, Health Care, U.S. Government
Accountability Office
Oral Statement............................................... 34
Written Statement............................................ 36
APPENDIX
Statement of Rep. Gerald E. Connolly............................. 00
Federal Autism Activies.......................................... 76
Statement of Donald J. Mueller, Executive Director............... 79
Statement for the record by Safeminds, submitted by Mr. Mica..... 82
Responses for the record by Michael Yudin........................ 88
Responses for the record by Dr. Thomas Insel..................... 92
Responses for the record by Dr. Marcia Crosse.................... 106
Statement by Autism Speaks....................................... 109
EXAMINING THE FEDERAL RESPONSE TO AUTISM SPECTRUM DISORDERS
----------
Tuesday, May 20, 2014
House of Representatives,
Subcommittee on Government Operations,
Committee on Oversight and Government Reform,
Washington, D.C.
The subcommittee met, pursuant to call, at 9:07 a.m., in
Room 2247, Rayburn House Office Building, Hon. John Mica
[chairman of the subcommittee] presiding.
Present: Representatives Mica, Turner, Amash, Woodall and
Connolly.
Also present: Representative Posey.
Staff Present: Will L. Boyington, Deputy Press Secretary;
Molly Boyl, Deputy General Counsel and Parliamentarian; Adam P.
Fromm, Director of Member Services and Committee Operations;
Linda Good, Chief Clerk; Mark D. Marin, Deputy Staff Director
for Oversight; Emily Martin, Counsel; Sarah Vance, Assistant
Clerk; Jeff Wease, Chief Information Officer; Jaron Bourke,
Minority Director of Administration; Courtney Cochran, Minority
Press Secretary; Katie Teleky, Minority Staff Assistant;
Cecelia Thoms, Minority Counsel; and Michael Wilkins, Minority
Staff Assistant.
Mr. Mica. Good morning. I would like to call to order the
Subcommittee on Government Operations. Welcome everyone this
morning, a beautiful day in Washington.
Welcome to my colleague, our ranking member, Mr. Connolly,
and we will have the introduction of Mr. Posey, and acceptance
of him into the committee's proceedings today.
Mr. Connolly. Mr. Chairman, just before you begin your
statement, if you wouldn't mind, I would ask unanimous consent
that our colleague from Florida, Mr. Posey, be allowed to
participate in today's hearing.
Mr. Mica. Without objection, so ordered.
Mr. Connolly. I thank the chair.
Mr. Mica. Thank you.
Well, again, I would like to welcome everyone. The order of
business will be opening statements by Members, and we have I
see three witnesses this morning. We go to our panel of
witnesses after we have heard from the Members. We will hear
from our three witnesses.
And welcome to them this morning.
And then we will go into questions.
So that will be the order of business, and the title of
today's hearing is Examining the Federal Response to autism
spectrum disorders. And this is a hearing that the chairman,
Mr. Issa had also committed to conduct, and we are pleased to
cooperate in conducting today's important hearing.
First of all, I always have an opening statement about the
purpose of the committee, and we do have important work. We are
the chief investigative and oversight panel in the House of
Representatives and probably in the Congress, and it is an
important responsibility. When you are home, like we were last
week, there are people working hard, making a living trying to
feed their families, keep up with all of the responsibilities
that they have as citizens, and they send us here to make
certain that government is efficient, effective, and it works
for them.
Today is a particularly important hearing because it deals
with the affliction that many families have had to experience,
unfortunately, with their children, autism, and it has impacted
dramatically their lives, and we will hear in just a few
minutes some of the questions that are being raised right now
about Federal response and Federal programs. So it is important
that we, in fact, review what is going on with these programs,
especially the Federal aspects and their impact, again, on the
issue of autism, a problem that so many families and children
face.
So, again, thank you for coming, and as I said, the hearing
is going to try to focus on the government's response and also
to the rise in the diagnosis of autism spectrum disorders, or
ASD. We will hear from some distinguished witnesses who
hopefully can shed light on, again, the Federal perspective
that we are centering and focusing our attention on today.
In March, the Center for Disease Control and Prevention,
CDC, they issued a report that estimates that now 1 in 68
children in the United States has been identified with ASD.
This estimate is roughly 30 percent higher than CDC's estimate
from 2 years ago, which showed ASD in 1 in 88 children. ASD
causes, of course, some very significant financial burdens for
diagnosed individuals and their families. Individuals with
autism on average spend $4,110 to $6,220 more on medical
expenditures every year than individuals without ASD. In 2011,
the additional cost of having a child with ASD was estimated to
be $17,000--more than $17,000 a year. In the United States,
spending on autism costs $126 billion every year, including
associated costs for health care, education, intervention
services, as well as wages lost by parents who sometimes have
to quit their jobs to care for their children.
The Federal Government also spends money on autism, and
that is one of the things we are going to review today. In
fiscal year 2012, Congress appropriated--not a huge sum but
significant money--$230 million for autism-specific research
and services. This includes $161 million for research for the
National Institutes of Health; $21 million for CDC surveillance
and research efforts; and some $48 million for Health Resources
and Services Administration within HHS; and another $5 million
for autism research within the Department of Defense's
congressionally directed medical research program.
Of course, the Federal Government has an important
responsibility, and that is to ensure that these funds are
spent both effectively and also efficiently. In 2006, Congress
established the Interagency Autism Coordinating Committee,
IACC. That agency and committee coordinates all efforts within
the Department of Health and Human Services and other Federal
agencies regarding autism-related research. And it was formed,
as I understand it, to make certain that efforts are
coordinated and that we have the most effective possible
programs.
The IACC's mission is to provide advice on Federal
activities related to ASD, also to facilitate the exchange of
information and coordination of ASD activities and increase
public understanding of ASD research and services.
However, and I think that, Gerry--Mr. Connolly--you may
recall when we had the Government Accountability Office in
recently, and they went over a list of some of the major
issues, and problems with various agencies. In their GAO report
to us in November, they stated there was a potential
duplication in 84 percent of the autism research projects
funded by Federal agencies and that better coordination was
needed from the IACC, which was actually set up for that
purpose. That is a pretty astounding figure, and we want to
review that, and that is one of the reasons for the hearing
today.
So the IACC and other agencies have disputed some of GAO's
findings, noting that research projects with similar titles may
have substantially different hypotheses, and the growth of
scientific knowledge depends on multiple studies that
investigate similar research questions at the same time. As I
said, we are going to examine, again, some of the points of
view on this report. The recently introduced Combating Autism
Reauthorization Act of 2014 would change the law to provide
coordination between agencies, first by appointing a point
person at HHS to coordinate research efforts within HHS;
secondly, to require agencies to implement IACC's strategic
plan; and then, thirdly, adding, preventing duplication to
IACC's list of statutory responsibilities.
So, today, we are going to look at ways to ensure that the
potential duplication of research efforts does not become
actual duplication. We are going to look at all of the
associated testimony that will be provided today and see if we
can make some sense out of this and make certain that we are
heading in the right manner, again, efficient and effective use
of taxpayer dollars in this important area. We will also take
the opportunity to explore how the Federal Government responds
to the evolving needs of individuals with ASD within the health
care and public school systems.
So we have got a number of areas we want to cover today,
and we will hear from now from the ranking member, Mr.
Connolly.
Please to yield to him.
Mr. Connolly. Thank you so much, Mr. Chairman.
And thanks for holding today's hearing to examine the
Federal Government's response to autism spectrum disorders,
ASD, with a particular focus on strengthening the Interagency
Autism Coordinating Committee efforts to coordinate and monitor
Federal ASD research initiatives and treatment activities.
I know I have been involved for the last 20 years in my
community in Northern Virginia with parents of autistic kids
and with various support groups. I know that one of the things
that plagued autism families dealing with this challenge was
the fact that some insurers, in fact, treated the autism as a
preexisting condition. And the good news is the Affordable Care
Act made that illegal, lifting that burden from parents who
were already dealing with many other challenges.
On behalf of the millions of Americans and their families
living with ASD, I know it is your hope and mine, Mr. Chairman,
and our expectation that our expert panel of witnesses will
engage in a productive discussion this morning aimed at
identifying shared principles around which stakeholders can
coalesce and build on to ensure Federal ASD activities are
carried out in the most efficient and effective manner
possible.
The Centers for Disease Control and Prevention estimated,
as you indicated, Mr. Chairman, that as many as 1 in 68 kids in
the United States are living with ASD. That is clearly a
serious public health challenge, as millions of individuals
battle daily with symptoms that vary greatly in severity and
scope but often involve impaired social interactions, problems
with verbal and nonverbal communication, and repetitive
behaviors. According to the CDC, it is estimated, as you
indicated, Mr. Chairman, to cost perhaps as much as $17,000
more per year to care for a child with ASD compared to a child
without it. And of course, those costs arise in the form of
medical and nonmedical expenses ranging from medicines,
therapies, and special education, to caregiver time and adult
housing.
A recent National Institutes of Health study concluded the
economic burden associated with ASD is substantial and can be
measured across multiple sectors of our society and calculated
that the total societal cost for caring for children with ASD
exceeded $9 billion as of 2011.
In passing the Combating Autism Act of 2006 and
subsequently reauthorizing that act in 2011, the Congress began
to address the rising rate of ASD and established the IACC to
coordinate all efforts within the Department of Health and
Human Services concerning ASD. Creating the IACC was an
important first step in ensuring that the Federal response
responsibly leverages taxpayer dollars to engage in a
systematic and comprehensive approach to watch over research
and treatment activities across government, academia, and the
private sector.
I am concerned, as you are, Mr. Chairman, that the Federal
Advisory Committee Congress established to coordinate ASD
activities according to the GAO, is relying on data that is
outdated, not tracked over time, inconsistent and incomplete,
and risks duplication of research efforts as you cited, Mr.
Chairman.
Of course, we also must recognize that GAO only addressed
potential duplication of Federal ASD activities. So this panel
is going to be important in terms of hearing testimony about
what actually is occurring. As GAO has consistently stated in
these reports, determining actual duplication for research
projects would require a more extensive review of voluminous
and scientific data and was beyond the scope of the study. HHS
makes a fair point in noting that duplication in and of itself,
is not necessarily a negative characteristic with respect to
effectively conducting scientific research activities.
I look forward to learning more about the IACC plans to
enhance the reliability and usability of the research and the
data. Specifically, I hope we will examine how all stakeholders
work together to improve the quality of the IACC data, to
enhance coordination and monitoring of Federal autism
activities, and how the Departments of Defense, Education, HHS,
and National Science Foundation will better coordinate ASD
research activities to ensure that we get the most bang for our
buck from finite taxpayer resources.
As the GAO will testify today, I expect, researchers have
yet to identify the root causes of autism, and there are no
known cures. Thus it is absolutely vital that we sustain our
Nation's robust commitment to funding Federal research that may
enhance our knowledge of this condition and improve treatment
options for families coping with ASD. If there is one singular
principle that we can all embrace, surely, it is that no family
or child should be forced to face living with ASD alone,
particularly when we know that early detection and intervention
can make a dramatic difference in the quality of life for an
individual living with ASD.
I look forward to hearing about how we can improve the
efficiency, effectiveness of our Federal response, and I want
to thank our witnesses for being with us today.
Thank you, again, Mr. Chairman, I yield back.
Mr. Mica. Thank you, and we don't have any other members at
this point, but members may have 7 days to submit opening
statements for the record.
We do have Mr. Posey, who, if he would like, can be
recognized at this time.
Mr. Posey. Thank you very much, Mr. Chairman, it was very
kind of you.
I would like to enter into the record, if I might be able
to at this time, from SafeMinds. It's an organization of people
who are affected by autism, and it's testimony submitted for
the record on the Committee on Oversight and Government Reform,
Subcommittee on Government Operations hearing of May 20, 2014.
Mr. Mica. Without objection, that will be made a part of
record. You may proceed.
Mr. Posey. Thank you.
Thank you, Mr. Chairman, as you know, and you have
expressed interest in before, Representative Carolyn Maloney
and I introduced H.R. 1757, the Vaccine Safety Act, which calls
for the National Institutes of Health to conduct a
comprehensive study comparing the health outcomes, including
the incidence of autism spectrum disorders between individuals
who are vaccinated and those who are unvaccinated. It was
announced previously during the April 8th, 2014, Interagency
Autism Coordinating Committee meeting that a study of
vaccinated versus unvaccinated children is being undertaken
under an existing NIH contract with The Lewin Group. While I
appreciate that a study is being undertaken, I think it is
imperative that it be a little bit more transparent and that
the stakeholders should have more participation and input into
the process.
It's important that all data sets developed as a part of
this study at each step in the process be preserved for
independent review in the future. I came across a May 15th op
ed by Sallie Bernard. Sallie is a board member of Autism Speaks
and the president of SafeMinds, but more than that, she is the
mother of a 26-year-old, Bill, who has autism, and let me quote
from her op ed: ``Now a new study of over 2 million children
born in Sweden between 1986 and 2006, which has been published
in the Journal of the American Medical Association, confirms
what SafeMinds and parents have been saying for decades.
Children are as much at risk of getting autism from
environmental factors as they are from their genetics. The
study by Sven Sandin and his colleagues follows on the heels of
another landmark study of twins by Joachim Hallmayer of
Stanford published in 2011, which showed the larger component
of autism risk arise from environmental, not heredity factors.
``Since genes and environment interact to increase autism
risk, this means that we are doing something to our children,
exposing them to something harmful either while they are still
in utero or during their first months or years of life that is
altering their biology. The scientific evidence is
overwhelming. Researchers and science policymakers can no
longer deny that there is a clear and strong environmental
component to the skyrocketing rates of autism.
``By ignoring the environmental component to autism, the
government and scientific community have made a massive
strategic error, wasting enormous amounts of money and time and
mostly fruitless genetics-only research that has not helped us
stop the new causes of autism or help people living with severe
autism.''
And this is a quote: ``We can fix this. The study by Sven
Sandin and Joachim Hallmayer can guide us to the end of the
autism epidemic. The good news is that the environmental causes
of neurological disorders are more easily fixed than genetics.
When we invest in uncovering the environmental factors that are
causing our autism spectrum disorders, we can remove those
factors from our world. We can study how those factors alter
biology and identify the treatments that can remediate those
pathways.''
``Based on this latest evidence, funders like NIH should be
charging scientists with the urgent task of discovering what
the environmental causes of autism are. Clinging to outdated
paradigms harms our community. To its credit, the NIH's
National Institute of Environmental Health Sciences just
released a Request for Proposals on environmental contributors
to autism spectrum disorders.'' To its discredit--``the NIH's
Interagency Autism Coordinating Committee, continues to
obstruct environmental initiatives contained in its own
strategic plan for autism spectrum research,'' and I left out
mentioning any names in there.
This is all pretty serious, and when I listen to what
others are telling me and what the GAO report says, that we
will discuss today, and the data from the May 7th JAMA article,
the message is clear. It appears NIH has been ignoring what
parents have known for many years: Environmental exposures in
utero or early life are changing the biology of children, and
I'm out of words and out of time so I will pick this up later.
Thank you, Mr. Chairman.
Mr. Mica. Well, I thank you for your participation, your
opening statement.
And now, without further opening statements, we will turn
to and recognize our panel.
Today, we have Dr. Thomas R. Insel. He is the director of
the National Institute of Mental Health, and the chair of the
Interagency Autism Coordinating Committee. We also have Mr.
Michael Yudin, and he is the acting assistant secretary for the
Department of Education's Office of Special Education and
Rehabilitative Services. And then, finally, we have Ms. Marcia
Crosse, and she is the health care director for the U.S.
Government Accountability Office.
As you all know, this is an investigative committee of
Congress, and subcommittee, Government Operations Subcommittee
you are testifying before. We do swear in our witnesses so if
you will please stand.
Raise your right hand. Do you solemnly swear or affirm that
the testimony you are about to give before this subcommittee of
Congress is the whole truth and nothing but the truth?
Dr. Insel. I do.
Mr. Yudin. I do.
Ms. Crosse. I do.
Mr. Mica. And the record will reflect that all three
witnesses answered in the affirmative.
Again, welcome to each of you. We have sort of an SOP,
standard operating procedure, 5 minutes for your presentation.
If you have lengthy testimony or data that you would like
entered into the record, do so through request of the chair.
And we are pleased, again, to welcome and recognize first,
Thomas Insel, and he is, as I said, the director of the
National Institute of Mental Health, and the chair of the
Interagency Autism Coordinating Committee.
Welcome, sir, and you are recognized.
WITNESS STATEMENTS
STATEMENT OF THOMAS R. INSEL, M.D.
Dr. Insel. Thank you, Chairman Mica, and Ranking Member
Connolly, it is a pleasure to be here. And I appreciate your
interest in this very important public health issue.
As you just noted, I have two hats here as head of the
NIMH, which is the largest Federal funder for autism research,
and as chair of the IACC, a job that I have had since 2002, so
through many different iterations of the Combating Autism Act.
You have my testimony. I'm not going to read that. And I
hope we can discuss much of what is in there, and I really, in
the spirit of wanting to make this more of a conversation and
hopefully create a teachable moment here, I would rather save
time for questions and answers rather than taking a lot of time
with an opening statement.
I would like to make a few comments, which probably are not
going to be as apparent in the course of our conversation
today. One is just to give you a sense of how remarkably fast
things are moving in the realm of autism science. Last week was
the 13th meeting of the International Society for Autism
Research. Really, prior to 13 years ago, there was no annual
meeting. There was no society. It was a very small research
field. Last week, there were 2,000 people from 35 countries
gathered together in Atlanta to talk about the most recent
findings, which is a 30 percent increase in the number of
abstracts just in 1 year. So we have got a field that is
vibrant. That is exciting. That people are moving into.
But they are also, of course, huge questions. You talked
already both of you about the issues around prevalence, and
that is a concern that we see broadly. You also both mentioned
costs.
And it is interesting, your figures were somewhat variant.
I think Mr. Connolly said $9 billion, and Chairman Mica, you
cited $128 billion. The truth is probably somewhere in between,
but it is a lot of money. And the question I think in front of
us is when you have a cost that great and a need this urgent,
how much do you invest in science to preempt those costs and to
mitigate that public health burden? And that's what I hope we
will have a chance to talk about a little bit today. It is not
only how we invest, and where we invest, but ultimately, how
much should be invested? What should we be spending on a
problem that has grown so much and is creating so much concern
in your districts and across the country?
For us at the NIH, the good news is that the science is
moving so quickly, and there are so many interesting new
insights. It is actually at a point now where we believe very
firmly that the kind of investments we are making will soon
begin to mitigate these staggering costs and reduce the
disability of this disorder. A lot of the science that we are
most excited about actually does not have autism in the title.
It is the science of trying to understand how the brain
develops, developing technologies that allow you to actually
visualize brain development even at the molecular level,
beginning to see how the brain connects and the role of both
genetics and experience and how that happens across both
prenatal and postnatal life.
Just in the last year, we have seen just--well, what I
would call breakthrough technologies like CLARITY that give you
the first transparent brain with the ability to look at three-
dimensional neuroanatomy. We have got the imaging techniques
that are giving us the most complete architecture of the
developing brain. So this is really an extraordinary time. It
is also extraordinary for the power of genomics, which is
revolutionizing every area of medicine. Last--about 3 months
ago, the American College of Medical Genetics and Genomics
summarized where we are for autism. They concluded that,
``Using current knowledge and technology, a thorough clinical
genetics evaluation of patients with ASD is estimated to result
in an identified etiology in 30 to 40 percent of individuals.''
That's up from about 5 percent only 5 years ago. So there is
incredible progress.
The good news is that both neuroscience and genomics
together are actually helping us to begin to pinpoint where the
environment must be taking its toll. And all of the evidence
right now points to mid-gestation, second trimester. What the
culprit is or the culprits, we still don't know. But it is
because of those kinds of technologies and those kinds of
approaches, just as any other area of medicine, we are getting
those insights.
Just two other points to make before I finish. One is that
there are some things unique to the autism field that I think
really are helpful here. One is NDAR, National Database for
Autism Research. It is a massive effort. We don't really have
this in almost any other area except in parts of the cancer
field. NDAR collects the data from over 70,000 subjects.
Virtually every subject who is enrolled in an NIH-funded
research project, those data are standardized through a data
dictionary and shared through the database so that they can be
interrogated much more broadly by a wide community. Only in the
last couple of months, we have seen the first fruits of that
with people analyzing all of the imaging data from many of the
different sources and coming up with some new insights. It is
very exciting.
The last thing is the IACC, which is what we are here to
talk about, and I will just leave my comments for later, but I
think in spite of your concerns around whether this committee
has done everything that it set out to do, there are some
remarkable achievements, as was pointed out by your colleagues
just 2 or 3 years ago, in another hearing in which this was
used as a model of what could happen in other disease areas
where we want to be able to coordinate research better. We have
done that in the IACC. We have created some remarkable
strategic efforts to show where the science should go, what we
can do, and we have monitored that with great detail. So if you
can find a better example, I would love to see it in the whole
realm of biomedical research. But as far as I know and I have
been involved with many, many different areas in my tenure at
NIH, there is nothing quite like this. So I am delighted to
answer your questions, talk more about each of these issues,
but I did want to give you a sense of the excitement that we
see from the scientific perspective.
Mr. Mica. Thank you, Dr. Insel.
[The statement of Dr. Insel follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Mica. We will get back to questions, but we are going
to recognize next Mr. Michael Yudin, and he is the acting
assistant secretary for the Department of Education's Office of
Special Education and Rehabilitative Services.
Welcome sir, and you are recognized.
STATEMENT OF MICHAEL K. YUDIN
Mr. Yudin. Great. Thank you, good morning Chairman Mica,
Ranking Member Connolly, Mr. Posey, members of the
subcommittee. I appreciate the opportunity to speak with you
today about the role of the Department of Education in
providing supports and services to individuals with autism
spectrum disorder.
The Department supports a wide range of activities in
improving our knowledge of ASD, methods of instruction,
vocational rehabilitation services, and the skills and
qualifications of educators and service providers to ensure
that individuals with autism, as well as all individuals with
disabilities, enjoy equal opportunity, full community
participation, independent living, and economic self-
sufficiency.
The Department's primary role in supporting services to
individuals with autism is through our funding administration
and monitoring of the Individuals With Disabilities Education
Act, or IDEA. When Congress reauthorized IDEA in 2004, it
explicitly included autism in the definition of a child with a
disability. My goal is to give you some more information about
the kinds of autism supports and services that we are providing
students and their families, to teachers, and the broader
community under the provisions of IDEA.
So, as you know, IDEA serves a very broad range of
disabilities and severity in order to ensure that their needs
are met and that children are indeed successful. All children
with disabilities receiving services under IDEA have an
Individualized Education Program, or an IEP, which is developed
by a team of stakeholders which must include the student's
parents.
More than 30 years of research shows us that students with
disabilities do better when they are held to high expectations
and have access to the general curriculum. Today, a majority of
students with disabilities spend most of their time in regular
education settings. Therefore, we must ensure that both general
education, general educators and special educators have the
proper training and tools to provide evidence-based instruction
so that students with disabilities have the opportunity to
succeed in the general curriculum. IEPs must identify the
necessary supports, accommodations, and related services for
particular students with disabilities to succeed in the general
curriculum, including speech, psychological or counseling
services, occupational behavioral therapy, or the school health
services that are particularly important to students with
autism.
For older students, IEPs will also include transition
services to ensure they are prepared for life after high
school. It is particularly important to have students
themselves participate in this transition planning, and to
learn the self-advocacy skills that are necessary for students
once they leave high school to fully participate, meaningfully
participate in their communities, enjoy competitive and gainful
integrated employment.
For our youngest children, part C of IDEA, provides support
for screening and early intervention services for children from
birth through age 2 who have or may have disabilities or
delays.
Mr. Connolly, you noted earlier that early screening is
absolutely critical to early identification, and access to
services and supports which can enhance children's learning and
development, minimize developmental delays, and result in more
positive outcomes in school and in life.
The Department also supports children with autism through
the training of teachers, and related service personnel,
providing support for technology development, assisting
schools, districts, and States to identify, adapt, and sustain
effective school-wide positive behavior interventions and
supports, and helping parents and families access the necessary
information and the tools to support their children's
education.
The Department also plays a role in supporting adults with
significant disabilities, including ASD, through the Vocational
Rehabilitation Program. Through this program, State VR
agencies, vocational rehabilitation agencies, provide a wide
range of services designed to help persons with disabilities
prepare for and engage in competitive integrated employment.
Importantly, 35 percent of VR consumers of VOC rehab consumers
are youth with disabilities. So, accordingly, the VR program
works with schools to provide youth with critical transition
services to ensure that they have the education and the skills
to be successful in postsecondary education and employment. We
know that individuals with ASD who participate in VR programs
can be successful and enjoy higher rates of employment.
As I wrap up my testimony, I want to briefly mention our
research efforts around autism. It is important to note that
our research entities do not conduct biomedical or medical
research. First, the Institute of Educational Sciences supports
research on the development, implementation, and evaluation of
interventions that are intended to improve education outcomes
for students with ASD. We know that there are communication and
social deficits associated with ASD, but we also know that kids
do better in these areas when they have access to nondisabled
peer models. Projects include interventions that target social
and communication skill impairments that are core functions--
that are core features of ASD; transition support for children
entering preschool and for adolescents leaving high school;
assistance for families and teachers working with children with
ASD; and the development and testing of technology applications
to support learning of students with autism.
And second, the National Institute on Disability and Rehab
Research, otherwise known as NIDRR, supports research and
related activities that generate new knowledge and promote its
effective use to improve the outcomes of people with
disabilities in the areas of community living, employment, and
health, and functioning. Thank you so much for the opportunity
to testify today. I'm happy to take any questions that you
have.
Mr. Mica. Thank you, and we will get to them shortly.
[The statement of Mr. Yudin follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Mica. We will now recognize Marcia Crosse, and she is
the health care director for the U.S. Government Accountability
Office.
Welcome and you are recognized.
STATEMENT OF MARCIA CROSSE, PH.D.
Ms. Crosse. Thank you, Chairman Michael--Mica, Ranking
Member Connolly, Mr. Posey, and members of the subcommittee.
I'm pleased to be here today as you examine the Federal
Government's response to autism spectrum disorders. My remarks
today are based on GAO's November 2013 report on Federal autism
activities and reflect information we included in our April
2014 report on overlap and duplication in Federal programs. And
I request that my full written statement be entered into the
record.
Mr. Mica. Without objection, so ordered.
Ms. Crosse. Thank you. From fiscal year 2008 through 2012,
12 Federal agencies awarded at least $1.4 billion to support
autism research and other autism-related activities. Funding
multiple studies in the same research area can be appropriate
and necessary, for example, for purposes of replicating or
corroborating prior research results. And multiple agencies can
provide a variety of expertise. However, the involvement of
multiple agencies can also make it challenging to identify gaps
and efficiently allocate resources across the Federal
Government.
The Combating Autism Act directed the Interagency Autism
Coordinating Committee, or IACC, to coordinate HHS autism
activities and monitor all Federal autism activities. The
Combating Autism Act also required the IACC to develop and
annually update a strategic plan for autism research. This plan
is organized into 7 research areas that encompass a total of 78
specific objectives.
We identified over 1,200 autism research projects funded by
Federal agencies in the 5-year period we examined. We found
that 84 percent of these projects had the potential to be
duplicative because they focused on the same objectives in
IACC's strategic plan as other projects. That is, each of the
agencies funded research in areas that were also funded by
other agencies. For example, for one of the 78 research
objectives, there were five agencies funding 20 separate autism
research projects. Having multiple projects related to one
objective does not necessarily mean that there is duplication.
However, given that all of the projects on an objective share a
common purpose, this raises the possibility that one or more
projects were duplicative.
The IACC performs a valuable role in monitoring Federal
autism activities and coordinating the activities sponsored by
HHS. However, we believe that the IACC and Federal agencies may
have missed opportunities to coordinate and reduce the risk of
duplicating efforts and resources. We found that the IACC was
hindered by limitations in the data it had collected. The data
were outdated, inconsistent, incomplete, and not tracked over
time. Our analysis across multiple years found that some
objectives had more autism research projects funded than were
suggested in the strategic plan, whereas other objectives were
not funded by any agency, raising the potential for
unrecognized gaps.
In our November report, we recommended that HHS improve
IACC data to enhance coordination and monitoring. HHS disagreed
and stated its efforts were already adequate. However, we note
that the updated strategic plan that IACC released last month
includes multiyear data on research projects and funding which
we believe will assist the committee.
Lastly, we found that, apart from Federal agencies'
participation in the IACC, there were limited instances of
agency coordination and monitoring. Some agencies lacked formal
policies or procedures for checking research funded by other
agencies or for identifying if agencies were funding similar
projects led by different investigators. We recommended in our
November report that the agencies improve their coordination.
The agencies supported improved coordination, but most disputed
that duplication occurs. We agree that more information on the
specific projects funded within each objective would need to be
assessed in order to determine actual duplication. However,
neither the agencies nor the IACC has undertaken such a review.
In summary, we continue to believe the recommendations we
have made are warranted and actions are needed. As established
in GAO's recent duplication work, it is important for agencies
that fund research on topics of common interest, such as
autism, to monitor each other's activities to minimize the
potential for the inefficient use of Federal resources.
Mr. Chairman, this completes my prepared remarks. I would
be happy to respond to any questions you or members of the
subcommittee may have.
[The statement of Ms. Crosse follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Mica. Well, we will start right in.
I guess Mr.--Dr. Insel, Ms. Crosse gave a pretty critical
review of efforts to eliminate duplication. She said there had
been some steps taken, but in fact, that data was incomplete,
out of date. There have been some improvements. Do you want to
take a minute and respond generally to her comments?
Dr. Insel. Well, you know, I think the general comment for
me, it is a little ironic because one of the last hearings I
was at on the Senate side, I sat with Senator Shelby and he
wondered why we weren't doing more to replicate the science
that NIH supports. There is a real concern because of recent
reports that not enough replication has been done, particularly
on the basic science that is funded by the Federal Government.
And so the NIH generally, under Dr. Collins, has taken on an
increasing rigor, increasing replication campaign. And so our
goal very much is to increase, not decrease duplication. We
want to make sure that more people are working on the same
problems, that we are bringing all of that data together, and
that we can ensure that any findings, such as the recent
finding about the disorganization in the cortex that was found
in children who had died with autism, so it was a postmortem
study, badly needs to be replicated. We just need to have
someone else trying to do almost precisely the same study with
other material to find out whether that, in fact, can be
replicated.
In a world in which, to my mind, this is all hands on deck,
we need to have 10 times as many people working here across
several agencies, I think being concerned about duplication,
being concerned--thinking of that as the problem is just
chasing the wrong rabbit down the wrong hole. That is not the
issue right now. I can't imagine, actually, a less relevant
problem to the issues that we are all facing. We know so little
about this disorder. The key now is, how do you get the fuel
into this engine with all of these excited scientists,
fantastic technologies we have to get this done, and to get
some answers? And if Congress comes forward and says, You know,
you are doing too many experiments, or too many people are
working on this. We don't know if it is being done in the right
way. We don't know if everybody is maybe doing the same
experiment in two different places as if that's a problem, when
we are telling you is, in science, that a precisely what we
need. We need more people working on the same problems and, to
the extent possible, using exactly the same techniques to see
if we get the same answers.
Mr. Mica. Well, again, GAO is highly critical. They said we
have had 1,200 of these projects in 5 years. It doesn't appear
that your agency has sorted out--well, also, the Interagency
Autism Coordinating Council has not, and one of the reasons it
was formed was to avoid duplication of effort, try to make
certain that the dollars are spent. If it is similar research,
and it's--that in fact, it is justified, but the last criticism
you had that you still have not undertaken, duplicative review
process, which would sort out any of the repetitive studies
that you are saying are so important. How do you respond to
that last comment that was made?
Dr. Insel. So it's a great question, and I think it's
really thinking about keeping in mind what a coordinating
committee does for us, and you could see our strategic plan
where we have gone through this extensive monitoring, as GAO
has noted. This is about strategy. It is about high-level
planning and figuring out where the priorities should be.
Questions about whether funding could be duplicated, how that
funding gets distributed, these are tactical questions, and we
have an entire staff, not on the IACC. There is a whole program
staff. I have 65 in my own institute. That is their job. So for
every grant that comes in, they go deeply into, has this been
funded before? Is this person being funded by someone else to
do the same work? Is there a possibility here that this is
redundant and doesn't need to be taken on? So it is a question
that gets answered, but not through the IACC. That's not part
of the charge, nor is it in the coordinating committee that
would even have access to the kind of data that you would need,
which is pre-award data, so the IACC has a good view of what
has been funded.
The question you are bringing up, and what I think GAO is
concerned about, is a tactical question about, how do you
ensure before you fund the next grant, what we would call pre-
award state, that something doesn't, in fact, get awarded that
isn't necessary. So we have an entire process for that. HHS
responded in their response back to GAO that the reason we
don't need to get the IACC to do this is we already have a
large staff doing this.
One other question that just in terms of the response, as
was pointed out, out of the 78 objectives, there were 4 that
actually never got funded by any agency; 74 did and were met to
a greater or lesser extent. And it may interest you to know
that one of those four was actually a recommendation from the
IACC that the agencies develop a way to ensure replication
research, that we actually find a mechanism to ensure that the
agencies are supporting identical research across agencies to
get replication or, as you might call it, duplication. That was
never funded because we couldn't figure out a way to get
anybody to actually support that. But it, again, runs exactly
counter to what you are seeing as the problem, we are seeing as
an essential need. I can't put it in any starker terms than
that.
Mr. Mica. Well, you also alluded to the kinds of
investments being made, and then you cited two specific areas
where you saw that there were either--well, first of all, you
said how vital brain research is. Obviously, it is important,
and then a couple of breakthroughs in genomics--is that the
proper pronunciation? And then neuroscience, would be the two
areas I think you identified as some--getting some promising
results. Is that correct? The most promising?
Dr. Insel. That's correct.
Mr. Mica. Okay, and you spend about $161 million for
research. There's other aspects of this, some NIH, $21 million
for CDC surveillance and research efforts, that's a little
different. Then we get to the HHS folks. They do research on
occasion, and other things.
Dr. Insel. Department of Ed.
Mr. Mica. Pardon?
Dr. Insel. Department of Education.
Mr. Mica. Department of Education, I'm sorry. But again, to
the pure science, and the two most promising areas of the $161
million, how much is going into those two areas?
Dr. Insel. Well, I would have to actually take a moment to
look up specifically what those numbers would be for autism.
Mr. Mica. Half, 20 percent, 10 percent.
Dr. Insel. Probably around half would be going into that
additional funding for interventions, development for
biomarkers, for a whole range of other clinical kinds of
studies that NIH supports.
Mr. Mica. Well, my dad used to say, it is not how much you
spend; it is how you spend it. And again, we are not in the
position of evaluating science or the research that is
conducted. We are getting a critical report and fairly pointed
from GAO. Did you want to respond to anything, Ms. Crosse?
Ms. Crosse. I would like to respond, thank you. We have
certainly no objection to duplication that is undertaken
knowingly and intentionally in order to replicate or validate
research results.
That is not what we were seeing. We were seeing, not just
within an agency, but across agencies because there were always
at least four different agencies funding research in each one
of these areas, that there was not the kind of coordination
that we think is essential to ensure that in this very
important area funds are not being wasted on efforts that have
already been undertaken by other agencies, and perhaps in a
more rigorous manner.
For example, the National Science Foundation, when we first
went to them, denied that they were funding any autism
research. They are not a member of the IACC, and their
information had not been included in previous strategic reports
from the IACC. However, it was very simple for us to identify
over 30 projects focused on autism that NSF was funding. They
were not engaged in coordination with NIH, with the Department
of Education, with HRSA.
Mr. Mica. I don't mean to interrupt, but did they have
authority as the coordinating--under their coordinating charter
to look at and also determine whether there is duplication?
Ms. Crosse. They certainly have authority to obtain
information. The IACC is charged with coordinating all autism
activities across the Federal Government to gather information
on all activities.
Mr. Mica. They didn't look at NSF?
Ms. Crosse. Not in the earlier years we examined. In the
subsequent years, at the time that we were undertaking our
work, the IACC was beginning to contact them and in their more
recent report has included information on the National Science
Foundation.
Mr. Mica. So that is improving. But it gets back to your
last point, which was that they were not conducting duplicative
review overall within--and that should be one of the primary
purposes of the IACC, right?
Ms. Crosse. Well, we believe that since they have been
charged with coordinating and obtaining information on all
activities, that that should include all of the agencies that
are conducting research. And you know, that was a primary
example, but I think that, you know, to indicate that there is
no room for improvement, I think it is not valid. We certainly
found room for improvement. We are not-- we are not making the
charge that they are not doing anything.
Mr. Mica. I don't want to put words in your mouth, but you
said that some of this has turned around since you undertook
your review, and since we have had a report in November and
then to Congress in April.
Ms. Crosse. We see some improvement. However----
Mr. Mica. It is still----
Ms. Crosse. We still believe there is room for improvement.
Mr. Mica. Do you want to respond, Doctor?
Dr. Insel. I would love to find somebody who does it
better. I would just like to see the example. I think it is
really helpful to put all of this in some context. And the
reason why I keep harping on the--this being the wrong rabbit
going down the wrong hole, is that when you compare autism to
AIDS, it is really quite extraordinary. So as you said,
Chairman Mica, that $160 million is being spent in 2012. It is
a little bit more than that. But that is basically the autism
figures, and you also, both of you cited the enormous public
health cost and economic cost. AIDS affects about a million
people in the United States. Do you want to guess what the
AIDS' budget is for research at the NIH? It is $3 billion. We
are talking about $160 million for a disorder that affects at
least as many children as are affected by--as are affected with
AIDS in the entire country.
Mr. Mica. Well, the question here is--I don't mean to
interrupt--you have got 12 agencies now identified with $1.4
billion over 4 years. Is that the correct amount?
Ms. Crosse. Yes, Chairman Mica, that's the amount.
Mr. Mica. We are trying to make certain that--again, you
have a pretty critical report, not, again, maybe most recently,
within the last 12 months or so, but----
Dr. Insel. Let me contest that a little and push back. You
know, I think the report says there is a potential for
duplication in 84 percent of the research, and they looked at
over 1,000 examples. I actually, couldn't find a single example
where there was true duplication. It is a little bit like if I
said, on your subcommittee, there is a potential for
corruption. That's a sort of, you know, presumptive, pejorative
comment, without actually any evidence to the fact that here is
an example where something was wasteful.
Mr. Mica. Well, and let me go to Ms. Crosse, and then we
will get to Mr. Connolly afterwards.
Mr. Connolly. By the way, I'm sure Dr. Insel just meant
with the exception of those present.
Dr. Insel. Absolutely, absolutely. Those present are not
considered either in a pejorative or a presumptive way to be
guilty as charged. But this is the problem with the terminology
of saying ``potential,'' because it suggests that there is a
problem when people looked and actually haven't found it.
Mr. Mica. But I think she is saying a potential and
identified specifically the NSF, and then you wanted to
respond.
Ms. Crosse. Well, we did find some instances, but we were
not, let's be clear, we were not looking for actual
duplication. We did not undertake the kind of detailed review
of the scientific hypotheses, of populations being studied, and
the methods being used for each and every one of over 1,200
studies. That was not our charge, and that is not what we
undertook. We were looking to see, as has all of GAO's recent
work on overlap and duplication and fragmentation in Federal
Government programs, to see whether or not multiple agencies
are undertaking similar work on similar populations. And we
found that to be the case.
We did have brought to our attention, a small number of
actual duplications that was--studies that were occurring, but
that's because individuals in those agencies volunteered those
to us. Our--so to say that we looked and didn't find it is--
didn't find it is inaccurate. We were not undertaking the kind
of review that we believe the agencies should be responsible
for doing when they are putting out Federal dollars.
Mr. Mica. Well, I have gone over my time. The whole purpose
of this hearing, again, is to look at the critical report and
see what we think is going on, and then try to make certain
that there are corrections in the programs.
Let me yield right now to Mr. Connolly.
Mr. Connolly. Thank you, Mr. Chairman.
And this is going to be a spirited conversation. That is
great.
Ms. Crosse, let me begin with you. Is your expertise
scientific research?
Ms. Crosse. I am not trained as a scientist. I'm a social
scientist.
Mr. Connolly. So you are familiar with the scientific
method?
Ms. Crosse. I am.
Mr. Connolly. Have you looked at Federal research dollars
in comparable audits on breast cancer?
Ms. Crosse. I have not.
Mr. Connolly. AIDS?
Ms. Crosse. No.
Mr. Connolly. Prostate cancer?
Ms. Crosse. No. We have not been requested to do such work.
Mr. Connolly. I am not asking that question, Ms. Crosse. I
am asking about your experience.
Ms. Crosse. No, we have not.
Mr. Connolly. So you don't have any basis other than this,
apparently, for this whole idea of duplication?
Ms. Crosse. I have a basis for how GAO examines duplication
across Federal programs. I do not have similar----
Mr. Connolly. Ma'am, you don't have--ma'am, you do not have
any basis, based on what you just said to me and your
experience, and this audit, to claim that you come here with
expertise on duplication of research allowing you to opine
whether this particular set of research, in fact, stands out
because there's 84 percent of 1,200 projects at risk of
duplication. That is a pretty explosive charge, whether you
want to admit it or not, that plays right into the narrative in
this body that taxpayer dollars are just constantly being
wasted.
And when you say that, GAO, you risk legitimate scientific
research that can affect people's lives. And that is a very
heavy burden when you come here and assert what you assert
based on virtually nothing.
It is okay to say there is room for improvement. There is a
risk of inefficiency. That is true. And we want to explore
that. But to go much beyond that is what Dr. Insel is objecting
to. And I think he has a point, based on the expertise you
don't bring to this table.
Ms. Crosse. Sir----
Mr. Connolly. Yes.
Ms. Crosse. -- I believe that what we did say is there is
room for improvement. There is the potential for duplication.
Mr. Connolly. I am very well aware of what you said. I
heard your testimony, and it was repeated by Dr. Insel, and it
was repeated by the chairman. And what you are doing is playing
into the hands of those up here, whether you intend to or not,
who actually want to cut back on Federal resources because all
Federal spending is bad. The Federal Government can't do
anything well. And so what you are putting at risk with that
kind of statement is legitimate research.
Now, maybe there's duplication. Let's examine that. Is
duplication, per se, bad? I thought I heard you say in your
testimony not necessarily.
Ms. Crosse. I said that if it's undertaken intentionally,
with the purpose----
Mr. Connolly. Oh, it has to be intentional?
Ms. Crosse. Well, I think if duplication is occurring
without knowledge that it's occurring, and without an
examination of whether or not the results that are achieved are
similar or different, then you haven't advanced the science. It
is just happening. And it is not--it is not being recognized. I
think that is a different situation. And that's one that I
would be concerned about.
Mr. Connolly. Well, okay. I seem to recall that some very
key scientific research sometimes happens even accidentally,
through mistakes. I seem to recall a mold that produced
antibiotics. I think if GAO were around at that time, you would
have criticized them for having a messy lab. And you would have
been right. But scientific research isn't always a pure,
pristine, clean, nonduplicative process. And there may be lots
of different reasons for giving similar research grants to see
what they come up with, because your lab may be different than
his lab. Your approach may be different. You may have a
slightly different angle that actually leads to dramatically
different results. That's how science sometimes works. And
sometimes it is a dead end. And when you look back at it
retroactively, you go, What a waste of money. But they didn't
know at the beginning, and the effort was an honest one to
begin with. Now, there may be some research that is, you know,
frankly, not particularly legitimate, and who knows why they
got the grant and so forth. But in terms of the scientific
endeavor, given the mission we have here, you know, I think Dr.
Insel's point is let a thousand flowers bloom. In this case,
let 1,200 flowers bloom. The risk of inefficiency has to be
outweighed with the potential for discovery, for dramatic
breakthroughs, not only in detection, but in treatment. And so
it's a risk weighing kind of thing, the scientific method. And
it doesn't always lend itself neatly to green eyeshade audits,
Ms. Crosse.
Ms. Crosse. Mr. Connolly, we did not make recommendations
for any cuts in Federal funding. We made recommendations for
improvement and a more thoughtful and knowledgeable approach to
managing the research enterprise across a range of agencies
that are working in the same area.
Mr. Connolly. Ms. Crosse, I accept that.
And I hope Dr. Insel accepts that as a helpful, broad
generalization of good management. But you went beyond that.
There is something almost insidious in suggesting that 84
percent of 1,200 research projects over a 5-year period are at
risk of duplication. That goes far beyond recommending good
management principles. That insinuates that there is something
there though we haven't cited it. And that's Dr. Insel's point.
And all right, you didn't look at it. But that is sort of an
indictment hanging out there by implication. And I accuse you,
I accuse the GAO of being irresponsible when you do that. That
is not helpful to scientific endeavor, and it actually damages
a very important research component of the Federal Government
that's very small compared to other diseases. Because one of
the problems we have, Dr. Insel made the point, you know,
frankly sometimes up here, why do research dollars go to
particular conditions or illnesses? Frankly, lobbying. It's not
based on the prioritization of who suffers from it or, you
know, how pervasive it is, or even a careful cost-benefit
analysis. It's often based on public pressure. And that's how
democracy works. But in this case, we are talking about a very
small amount of Federal research dollars. And it seems to me
the real issue here is actually getting more resources to this
scientific endeavor, not fewer.
But I repeat, I think it is irresponsible of GAO to make
that kind of statement. The first statement is fine. The second
one is insidious. And I don't think you have the
qualifications, quite frankly, to make that kind of statement.
Ms. Crosse. Mr. Connolly, I respectfully disagree. I
believe our statement was pointing out the portion of the
research where there is room for examination.
Mr. Connolly. No, ma'am, you said 84 percent of 1,200
research projects are at risk of duplication.
Ms. Crosse. Have the potential.
Mr. Connolly. Based on what?
Ms. Crosse. Because they are----
Mr. Connolly. You didn't look at them. You didn't come up
with a conclusion that we looked at this, this, this, this,
compared it, and it's quite clear there is rampant duplication
and inefficiency, and you didn't need to do it that way. You
didn't come to that conclusion.
Ms. Crosse. Because 84 percent of the projects are
overlapping across agencies, that was the basis for our
conclusion.
Mr. Connolly. Does that mean they are not coordinating?
Ms. Crosse. We found room for improvement in coordination.
Mr. Connolly. Well, okay. There is always room for
improvement, even at GAO, Ms. Crosse.
Ms. Crosse. Yes, sir.
Mr. Connolly. But the only example I thought I heard you
say here today was NSF, because it's outside the penumbra of
the IACC, and it was doing its own thing.
Ms. Crosse. That's not the only instance where we believe
improvements in coordination could occur. We think that that
was a clear--the clearest example.
Mr. Connolly. Okay. Give us another one.
Ms. Crosse. We thought--for example, we found frequent
meetings between HRSA and CDC to discuss their research
proposal and excellent coordination. However, AHRQ did not take
HRSA's advice that the work they were funding was duplicative
with work HRSA had already funded. That was an example.
Mr. Connolly. Did you conclude, based on your examination,
that taxpayer dollars were wasted?
Ms. Crosse. We did not.
Mr. Connolly. Thank you.
Dr. Insel, you want to talk a little bit about the
scientific method? And are you concerned at the implied
duplication and overlap that might mean that dollars--that
there is an opportunity cost, that dollars could have been
better focused or targeted but weren't? I guess that's what we
are supposed to conclude from this broad generalization from
the GAO.
Dr. Insel. Well, I am going to rise to defend Ms. Crosse a
little bit, because after all, her organization----
Mr. Connolly. This isn't personal, Ms. Crosse, but it's
about----
Ms. Crosse. I understand.
Mr. Connolly. Listen, I have been working on and off up
here since 1979. And GAO is a wonderful organization, does
great work. But there are times when GAO can't see the forest
for the trees because they bring a green eyeshade approach to
something, forgetting the mission, and not bringing in
expertise--they can't to every endeavor--but they need to be a
little more humble about that sometimes in their methodology.
And in this particular case, I am bothered, I am really
bothered by this report, because I think it can do real damage
in the current climate up here. It plays right into the hands
of the wrong narrative: So we are wasting dollars; we don't
need to be investing more. Not that that's GAO's intention. But
even GAO can try now and then to avoid being politically tone
deaf in a context, especially when something as important as
autistic research is at stake. That's my point.
Dr. Insel, sorry.
Dr. Insel. I am not sure I have anything to add, Mr.
Connolly.
Mr. Connolly. I was asking you the previous question, and
you decided to defend Ms. Crosse, and I was telling you you
didn't need to. But maybe we can return to the subject at hand,
which is, are you worried, though--I mean does she make a
point, does the GAO make a point that there is duplication that
worries you, overlap that worries you, lack of coordination
that worries you because it's diverting really precious
resources that could have been better targeted? Are there
examples in your mind as the head of the IACC?
Dr. Insel. I have a long list of worries, but none of them
are on it, none of the things you just mentioned.
Mr. Connolly. Why not?
Dr. Insel. Because there are so many more pressing problems
that we are facing. Again, I go back to the fact that we know
so little about this disorder. We know the prevalence is
increasing, as both of you have said. And really, this issue is
to me a complete side bar. This is not a place to focus.
Mr. Connolly. Okay. But put yourself in the position, for a
minute, of a lay person who sincerely may be concerned and
share your concern about let's try to get to the heart of this,
and better understand it, and to be able to develop more
effective interventions and, ultimately, hopefully, prevention
even. And I hear a report that 84 percent of your 1,200
projects over 5 years are at risk or potential duplication.
That doesn't concern the head of the IACC, that some of those
projects may in fact be duplicative? Because that's the
implication.
Dr. Insel. As I said at the outset, I am looking for
duplication. That is what I think is actually essential to the
scientific process.
But that is not to say that there aren't ways we can do
things better. The IACC is not perfect. We are always looking
for input from outside groups. I would say that this particular
investigation, because that's what it was over a period of I
believe 2 or 3 years, at some point began to actually interfere
with the very thing we were trying to do. My own staff, I at
one point asked them how much time is this taking? And this ran
into hundreds of hours, 20 or more meetings. I mean, it is just
an extraordinary burden for people looking for something that,
ultimately, frankly, they never found. And what you have is a
report that ends up saying there is a potential for
duplication.
Mr. Connolly. And I will add, but I mean, is it not true
that, sadly, a lot of scientific research, especially in the
medical field, ends up at dead ends with the best of
intentions?
Dr. Insel. That's the way science works. If you knew the
answer, you wouldn't have to do the experiment.
Mr. Connolly. Thank you.
Thank you, Mr. Chairman.
Mr. Mica. Well, just to state for the record Mr. Connolly
consumed 13 minutes. And I consumed about 10 and a half. I just
want to add a couple of things here, and I will count it
against time. Then we will go to Mr. Woodall.
Mr. Woodall, we are doubling the time for members on the
panel.
And then we will get to Mr. Posey next. Let me just say a
couple of things clarifying. First, I asked the question if
this was just--if this was a report--I am not that familiar
with all of the history of this issue. But the study was
actually mandated by a public law, 111-139. It wasn't a request
of Members. Is that correct?
Ms. Crosse. The report that we issued in April, where we
included information on our November report, was mandated by
law. But our original report issued in November was requested.
It was requested by Senators Coburn, Ron Johnson, Mike Lee, and
Robert Menendez.
Mr. Mica. Okay.
Ms. Crosse. And it was at their initiative that we
undertook this.
Mr. Mica. I just wanted to get the genesis of the study
that was--that you were requested to do. That's the first
thing. Secondly, I don't want anyone to think that this hearing
was organized or its purpose is to cut funding for autism. If
there was wasteful money or something uncovered and that was an
issue--I think what we wanted to do, again, I was startled by
the April--no, April of this year, yes, and the 2013 report. So
when an agency makes a statement like that, that does get her
attention. So that's part of the purpose of the hearing. And if
we aren't spending money where we are getting the most results,
and there was an agency set up in 2006 to try to better
coordinate those efforts, then we may have issues. And that's
why we are doing this hearing. We want every dollar to be as
effective as possible. My side of the aisle, too, Mr. Connolly,
we have put--Mr. Gingrich, when we took over, we doubled,
almost doubled some of the money for research. And I am one of
the individuals who feels that you can't--if it is properly
applied and you are doing the research, then look at the
billions you could save, the agony, the heartache for these
families and these individuals that are affected. So I just
want the record to clearly reflect this isn't any attempt to
cut funds, or to, again, do away with research that is needed.
So, with that, let me----
Mr. Connolly. And Mr. Chairman?
Mr. Mica. Yeah.
Mr. Connolly. Can I just point out for the record that my
friend has now matched, if not exceeded, my time.
Mr. Mica. That is exactly what I intended to do. You are
not going to get an extra minute out of me.
Mr. Connolly. You have always been fair. Thank you.
Mr. Mica. I always try to be fair. I learned from my first
year in Congress from a Democrat Member who treated me with
fairness and equality, that I would repeat it even if it
required me to buy Preparation H.
Mr. Connolly. And it is also important to note that the
chairman's brother was a wonderful Democratic Member this of
this body from Florida.
Mr. Mica. We all have our issues.
Mr. Woodall, you are recognized.
Mr. Woodall. Thank you, Mr. Chairman.
I appreciate the time. And I appreciate you pointing out
that this is not a hearing about reducing autism funding; this
is a hearing about making sure that every penny counts. I don't
know who represents an area that is not full of moms and dads
who want answers and want to make sure that every penny is
being spent effectively.
And candidly, to Mr. Connolly's point, Dr. Crosse, when you
have explosive things that come out in a report, I would argue
that that GAO report has done more to focus the discussion on
autism research and whether or not there are enough dollars
there or not as anything. I have not seen the negative
undercurrent. I have seen the very positive persuasion. But
more importantly, whether doing your work and reaching your
conclusions helps the autism research cause or hurts the autism
research cause, GAO is not tasked with sorting that out.
GAO is tasked with sorting out the answer to the question
that in this case four Senators asked and a law mandated. And I
hope that the takeaway will never be that if there is a
political point that you can make that you should make it, or
if there is an end that you can justify, you should justify it.
We rely on GAO to share the good and the bad and the ugly. And
I am grateful to you all for the work that you do.
To that end, thinking about those hundreds of hours that
you all invested, Dr. Insel, I kind of think of that as the
price of admission. I always hate to see dollars wasted on
compliance. That is something that we fight on a regular basis
in my part of the world. But when you are talking about $1.4
billion over a series of years, folks do want some
accountability. And folks at home don't understand why DOD is
working on part of this issue, and DOE is working on part of
this issue, and NIH is working on part of this issue.
Understanding that accountability is a part of what we all do,
using this as the model, Dr. Crosse has been criticized for
making an observation but not recommending solutions. You made
an observation about the time involved. Is there a solution to
that?
Dr. Insel. It is essential that people, when they have a
question, look at the evidence. I wouldn't contest that for a
moment.
But what I would contest is the importance of looking at
all the evidence. Parts of the report are simply inaccurate or
incomplete. There has been an enormous work on looking at the
accountability within the autism research funding stream. So we
have this recent report, which is really an accountability
report of our strategic plan that looks at every single
objective, finds out how much was spent over every year, where
the money has gone, how does that map onto what was planned. So
none of that, by the way--all of that was available last year.
It has only recently been published, but GAO saw that. This was
presented at the public meetings that the IACC held. Somehow
that failed to make it into the report.
Mr. Woodall. Well, my experience is, and yours may be
similar, the report Congress does on its own success generally
turned out pretty good. Turns out we think pretty highly of the
work that we do. The work that outside groups do on our success
sometimes don't come back quite as optimistic. I look at that
report, it looks like it was prepared in-house. Is there a
similar document that you would hold out as the be all, end all
of outside examination of the IACC's work?
Dr. Insel. That's a great point. And it is important to
realize that the IACC isn't inside, it isn't outside; this is
made up of a whole range of stakeholders. By the way, they
virtually never agree on anything, either with respect to
autism or with respect to anything else. So this is their best
attempt to take an honest accounting and evaluation of how the
funding agencies had done. Half of this group, nearly half, are
actually non-Federal members. Most of them family members, some
people with autism itself. They are hardly cheerleaders for
either the IACC or for the Federal agencies.
Mr. Woodall. Mr. Chairman, I don't want my time to expire
without asking unanimous consent to enter the statement of Don
Mueller in the record.
Mr. Mica. Without objection. And you still have 5 minutes
remaining.
Mr. Woodall. Thank you, Mr. Chairman.
Don is the executive director of the Marcus Autism
Institute, which is down in my part of the world. And I brag
about the work that they do all the time. In fact, our school
system that I represent, largest school system in the
southeastern United States, has slots prepaid down there
because of the work that they do and the importance of being
able to find those limited resources available when we need
them. Because there are not enough--there are not enough
opportunities for folks to seek that help. But as I was reading
your testimony, Doctor, I couldn't help but notice a reference
to some eye-tracking technology that sounded a whole lot like
some of the things that I brag about coming out of the Marcus
Institute. Am I right about that, or am I just a proud public
servant bragging about the scientists and folks in his
district?
Dr. Insel. You have every right to brag. That is a
spectacular group doing fantastic work and actually is probably
the group that will open up this opportunity to diagnose autism
before the first year. That is a game changer.
Mr. Woodall. When we think about the dollars that go into
it, and I appreciate what GAO did to help folks to get their
minds around the many different baskets that dollars can go
into, candidly the dollars that we spend on palliative care
aren't all that inspiring to me. The dollars we spend on game-
changing science, there is not a man or woman in my district
who wouldn't say, Rob, I will write the check, to tell me that
what we are doing is making a difference. Tell me that it's
going to be a game changer, and I will write the check tomorrow
to do more. I think so often when I have conversations with lay
people about autism, it is a conversation about treatment of
symptoms, not a conversation about changing a life. And if we
can use this opportunity and others to publicize it, celebrate
it, get folks excited about it, again, there is just no limit
to the power of the American people to invest in ideas that
will change the future. To Mr. Connolly's point, yes, folks are
worried about government waste. And the potential duplication
is something that folks have on their mind. But we would not
have the opportunity to talk about the ideas that we celebrate,
we wouldn't have an opportunity to talk about the successes, at
least not in this forum, but for the laws mandating a report,
the Senate's requested report.
And I am grateful that we have had that time. Let me ask
you, Dr. Crosse, director of health care, you have heard Mr.
Connolly's criticisms of what I would call the standard GAO
process, right? This is what we fund you to do. Hearing those
concerns, knowing that, generally, as we look around this room,
this is a group of folks who all agree on the goal and who all
want to get to that goal as soon as possible, is there a tool
that the GAO does not have in its quiver? Is there an arrow
that is not in the quiver that you would have liked to have had
to do something different in this report? Or did you do this
report right the first time given the mandate, and you would do
it the exactly the same way again?
Ms. Crosse. I believe that we did exactly what we were
requested to undertake, and that aligned with the mandate we
have been given and the approach that is being used to look at
fragmentation, overlap, and duplication that can occur across
the Federal Government. If it has come across as tone deaf,
that certainly is not our intention. We try to be very clear,
and we try to be very precise in what we say and in what we
don't say. And again, we did not call for reductions in
funding. We did not say that dollars being spent on autism
research were wasteful.
Mr. Connolly. Would my friend yield?
Mr. Woodall. Be happy to yield.
Mr. Connolly. I thank my friend. I just note for the record
that GAO, we rely on GAO a lot, so sometimes GAO, they are
fallible, too. They don't speak ex cathedra. I recall a
situation where GAO reported that there were 56 Federal
financial literacy programs. And that went viral. They were
wrong. There were not. They had to go back, and they admitted
that, well, actually, maybe there were 12 or 13, but the damage
was done. That's the concern I have. I thank my friend.
Mr. Woodall. Always looking for those areas of agreement.
And certainly, this research is one of those. I think Mr.
Connolly is absolutely right when he talks about the power of--
that lobbying has in making these decisions. I will tell you,
Dr. Insel, when constituents come and ask for an earmark or a
plus-up in this area of NIH or that, I always tell them that we
have tried to hire the absolute finest folks that the world has
to offer. And if you believe that a lawyer trained out of the
University of Georgia has more to offer scientific research
than the best minds on the planet, I am happy to start making
those decisions. But our goal is to find the very best folks,
put them in positions of responsibility, then take every penny
that we can find to dedicate in that direction, and allow those
folks who see where those areas of opportunity are to dedicate
those dollars appropriately. I am grateful to the coordinating
work that you do. I know you can be doing many, many other
things with your time. But none that would have a greater
impact on the men and women that I serve back home in Georgia.
And I am grateful to you for it.
Dr. Insel. Thank you, sir.
Mr. Woodall. Mr. Chairman, I yield back.
Mr. Mica. Thank the gentleman. Mr. Massie, did you have any
questions at this time?
Mr. Amash. Amash.
Mr. Mica. Mr. Amash. I don't know why I did that.
Mr. Amash. No, I yield back to you, Mr. Chairman.
Mr. Mica. Thank you. There is a distinct difference between
the two members. And I apologize.
Then we will go to Mr. Posey, who had unanimous consent to
participate.
Mr. Posey. Thank you, Mr. Chairman.
And Dr. Insel, let me say that I think you are a good man,
you are well qualified for the job, and you have good
intentions. And I hope that this discussion about the direction
it is going is not something that you are taking personally.
You know. Some folks, and I am one of them, believe that the
government and the scientific community has made a strategic
error by mostly focusing on genetics-only research. I am just
finishing up my opening statement here, basically. It seems NIH
is clinging to outdated paradigms, and IACC leadership for some
reason or reasons has obstructed progress in researching the
environmental initiatives that are actually listed in the
IACC's own strategic plan. Those have been underfunded, while
genetics have been funding at around threefold the
recommendation. I am interested in knowing what, if any,
changes Congress and the parents can expect to see from the
IACC.
Dr. Insel. Well, thank you, Mr. Posey. If I can, just to
put this in context, because often there is some confusion
about what we mean when we use the term genetics or genomics.
Just put autism aside for the moment. Again, you look at
disorders that we study that are major public health problems
that we know have a very clear environmental cause, lung
cancer, asthma. Those are two pretty good examples. If you
looked into the NIH funding for those, it is heavily dominated
by genomics. Now, we know there is an environmental cause for
lung cancer, and we know the same for asthma. So what are we
doing studying genomics? The reason is because in 2014,
genomics isn't about necessarily just finding a cause, it is a
tool. It is the engine for discovery. It has given us a way to
faster, better, and cheaper figure out mechanisms of disease.
And sometimes that takes us in ways and places we had never
expected to go. But to say that we----
Mr. Posey. My time has run out here. Are mostly the studies
that they were talking about being redundant on genomics, do
they have the same goals? Do they have the same metrics? Are
they being measured by the same metrics? Are they using the
same techniques?
Dr. Insel. I am not sure that I am aware of projects that
were thought to be redundant on genomics. In the area of
genomics, everything that we do, not just in the United States,
but around the world, filters into a single site called the
database of Genotypes and Phenotypes, dbGaP. And so all of that
has to be standardized to use exactly the same techniques and
to provide the same kind of data.
Mr. Posey. Thank you. Your job is, you know, much broader
than simply autism. And in the last 4 years, you were not only
director of the National Institutes of Mental Health, but also
the acting director of the newly formed National Center for
Translational Medicine. Realizing there is only so many hours
in a week, a day, I am curious about how much of your actual
time outside of IACC meetings do you spend singularly focused
on autism?
Dr. Insel. That's a great question. My wife asks me that
quite a bit, actually, because the hours are there, but on the
percent basis, it's not at this point the majority of my time.
I have lots of other things that I am responsible for. I have
to say that part of the reason I have focused as much as I have
on autism for the National Institute of Mental Health is
because increasingly we think about this as the prototype.
Today we think about schizophrenia, bipolar disorder----
Mr. Posey. Would you say it's an hour a week, 4 hours a
week?
Dr. Insel. Oh, no, no, no. It has got to be more than that.
I would have to actually sit down and look at my calendar. But
it probably tracks pretty well with our funding commitments. It
is probably about 10 percent of our funding. And I suspect it
is about 10 percent of my time.
Mr. Posey. Okay. And if you find differently, if you would
send the committee back----
Dr. Insel. I will be happy to provide something for the
record.
Mr. Posey. One of the findings of the GAO was the potential
for duplicative research, which has been a big topic up here
today. Who at the NIH actually makes the final funding
decisions on autism research grants?
Dr. Insel. It is certainly not the IACC. It is the
institute directors at the NIH, who are responsible for their
own budgets. In this case, there are six different institutes
that have some commitment to autism. Five of them are on the
IACC.
Mr. Posey. Would you send me a list of them and their names
and----
Dr. Insel. Absolutely. We will provide that for the record.
Mr. Posey. And their budget amounts?
Dr. Insel. Yes.
Mr. Posey. Is there a coordination between NIMH, the
Child's Health Institute, and other centers and institutes on
what will and won't be funded?
Dr. Insel. Yeah. Theres a separate parallel group called
the ACC, the Autism Coordinating Committee, which is made up of
the program officers at each of those institutes, those and
others as well, deafness as well. They get together on a
regular basis, at least once a month. They hash through their
portfolios, both what they have and what's coming in, and make
decisions about what the funding should look like going
forward.
Mr. Posey. Thank you. Will you send me a list of all those
players and who they represent?
Dr. Insel. Absolutely. We will do that for the record.
Mr. Posey. I know that before the final decision there is a
review by experts of grant applications. The IACC members do
not have grant review authority the way that a typical advisory
body for centers and institutes do. It was announced on April
29th in the Federal Register that the National Institute of
Child Health and Human Development, Special Emphasis Panel,
Outcomes in Autism Spectrum Disorders, Mechanisms and Needs
Assessment would be meeting on May 6th in a closed door meeting
to review grants. I am wondering who serves on this and other
special emphasis panels that review the body of autism grant
applications at the NIH.
Dr. Insel. There are two tiers of review at the NIH. One is
the one you just described, which is the level of usually
scientific experts, but sometimes public members as well, to
look at scientific merit for the grants that come in, and to
rank them. The second tier is it then goes to a body called the
advisory council. And each institute has one of these. They go
through that entire list with people from program, look at both
scientific merit, public health needs, and also programmatic
balance, and help the institute director to make a final
decision about what should get funded.
Mr. Posey. Thank you. Would you please provide me in
writing the name and staff position so I can kind of get that
straight on a chart?
Dr. Insel. Right. We can lay that out for you. Would you
like it for the institutes that handle autism research?
Mr. Posey. Everybody that touches it.
Dr. Insel. So that would be the members of council for each
of those institutes. It is actually public record.
Mr. Posey. Both layers, yeah.
Dr. Insel. Well, so I should just clarify that the review
committees, of which there are several, in this case the one
that you reference is what is called a special emphasis panel.
Mr. Posey. Correct.
Dr. Insel. So that's put together for just this particular
review on this particular request for applications. We can
certainly provide you with those names. Those are, of course,
public. But we will get you that for all of the recent requests
for applications. We just had three for NIMH, and we will make
sure you have those names.
Mr. Posey. Thank you. It just wasn't in our package. And so
it may be available, but you know, you can put your finger on
it in 5 minutes, and it would take my staff 5 days just as a
practical matter.
Dr. Insel. It is not worth 5 days. We will get it to you.
Mr. Posey. Okay. Would you please provide that list their
bios and CVs and financial disclosure forms?
Dr. Insel. And again, all of that is public record for
government employees. And at the institute, directors and
council members, all of that is available. For members of
special emphasis panels, I would have to check to find out
whether they are vetted in the same way in terms of their
financial disclosures. I believe they are, but I would actually
have to look at that. And we will let you know that for the
record.
Mr. Posey. Okay. Thank you. Are there any parents of
individuals with autism included in the review process?
Dr. Insel. Well, at NIMH, we have had a tradition of doing
that, all the way from our--the ARRA funding, where they were a
large part of the review, to now having generally a member of--
usually a parent who sits on our council. At this point--or
sometimes it is actually a person affected by the disorder. The
most recent parent of a person with autism was Portia Iversen,
who sat on the NIMH council until about 2 years ago. This
rotates around. So the other public members, I don't know that
right now--we do have one parent of a person with autism, but
that is not something that is public. But the people are chosen
to serve partly to provide that kind of perspective. Now this
is at the high level. This is at the council level that is
making the final decisions on an advisory basis.
Mr. Posey. Yeah. Somebody from Autism Speaks, for example,
what would be their odds of being on that review panel?
Dr. Insel. So for that first level, tier one, scientific
review, there is--if they don't have a conflict with
applications coming in, we are always looking for people who
can bring scientific expertise to that discussion. At the
second level, at the higher tier, Portia Iversen was the
founder of Cure Autism Now. So that is somebody who was deeply
involved in the advocacy community. So, again, NIMH covers many
disorders. It is not just about autism. But we have tried to
make sure there is someone with an autism focus on the council
so that those grants get a very careful look.
Mr. Posey. Okay. Have there been any discussions of public
grants to balance out the private sector grants?
Dr. Insel. That's a terrific question. And it's something
we haven't talked about so far. But as the NIH funding has gone
down about 25 percent over the last decade in terms of
purchasing power, we have been fortunate that there has been an
increase in private investment. Simons Foundation, Autism
Speaks, the Autism Science Foundation, those three really
making a difference and helping to buffer what has been a very
difficult period for the NIH. The way that that gets
coordinated is through the IACC. So we would love to have
members or leadership from each of those private groups on the
IACC. They have been there until recently. Rob Ring was just
appointed from Autism Speaks. But he has not attended any of
the meetings. That will happen. Because of turnover at both
Autism Speaks and Simons Foundation, we have lost their
representation. But that is going to be repaired very quickly.
Mr. Posey. Good. I am glad to hear that.
My time has expired, Mr. Chairman. I hope we do another
round.
Mr. Mica. Well, I am not sure how much additional time we
will have.
I had a couple of questions.
Mr. Turner, did you have anything at this point? He has
just joined us.
Mr. Turner. No.
Mr. Mica. Let me just ask a couple of questions I didn't
get to before. And I was trying to look at, again, the most
promising areas. And I talked about the neuroscience, and how
do you pronounce it?
Dr. Insel. Genomics.
Mr. Mica. Genomics. I had heard you mention some research,
maybe I was wrong, about the second trimester. Could you
elaborate on that? Is that another promising area?
Dr. Insel. Well, as Congressman Posey pointed out in his
opening remarks, there is virtually no expert who would doubt
that environmental factors are important for autism. We don't
know yet exactly what those are. And that has got to be a major
focus going forward. The few that we do know about do point us
towards the second trimester as the point at which they act. So
whether it's drug exposure, sometimes prematurity, other
events, other kinds of exposures, even one that has been
purported for pollution, when you map those factors onto
development it is not post-natal, it is not early prenatal, it
is really right in that period around 12 to 24 weeks that we
are most concerned. But what is it? You know, it's probably
many things. And how do we get our hands around that? And how
do we help people to know what to avoid when they are carrying
a baby at risk? Those are the questions that we haven't yet
answered.
Mr. Mica. Well, one of the things that if you could provide
us for the record, I would just like to have in the record, and
I would ask you some of the money we are spending in the more
promising areas, maybe you could just give us a little
breakdown of estimates in the most promising areas for the
future. I think that's important to establish for the record.
And then, again, we want to direct as many additional funds to
where you have the promising research or results. So, again, if
you wouldn't mind providing that.
Then you started talking about data collection. And I guess
you are getting better at it. And what is it, NDAR?
Dr. Insel. Yes, sir.
Mr. Mica. How old is that data collection system?
Dr. Insel. NDAR was started I believe in 2005, just built
as an infrastructure. It has taken a while to grow it. We are
up to over 70,000 individuals with an ASD diagnosis, and
millions, actually over billions of records. We are just seeing
the first fruits of that as people----
Mr. Mica. And how much money are you spending on data
collection?
Dr. Insel. It costs us about $3 million to build it. It is
about a million dollars a year to----
Mr. Mica. Is that adequate? Again, your sampling is
somewhat small, 70,000, considering the population. And then
the data collection I guess has become more sophisticated. Did
you all look at that, Ms. Crosse?
Ms. Crosse. We did not look at that, no.
Mr. Mica. But I think that's also important, building an
accurate database. But if you could, again, provide to the
committee any information on where we might make improvements
if we don't have enough funds for data collection and we aren't
expanding that base of knowledge. I think those are my
questions, follow-up questions at this point. It is just
important that--you talked about the kinds of investments. And
we want to make certain that we are investing properly, that if
we don't have the coordination that we need, that we achieve
that.
Dr. Insel. Again, sir, just to make sure we are clear on
this, I would push back against the sense that we don't have
sufficient coordination. I don't think that's the problem. And
as I said at the outset, I don't know that there is any disease
area that does it better than autism. The problem is we just
don't have enough----
Mr. Mica. It's also been held up as a model, too, of what
we have done with the IACC. But again, we have some differing
of opinion, and that's what the hearing is about today, and
making certain that we are targeted and focused adequately. Mr.
Connolly.
Mr. Connolly. Thank you, Mr. Chairman.
I just have two follow ups. One quick question for Dr.
Insel. Ms. Crosse pointed out that NSF is not part of the IACC,
and kind of was doing its own thing. Why isn't it part of IACC,
and shouldn't it be?
Dr. Insel. It would be great if they were. They feel that
their mandate is in basic science, that autism is a clinical
problem, and this is outside of their lane. The fact is they
work on issues, like robotics, that we think could be extremely
helpful for the autism community. We--outside of the IACC, we
have a lot going on with NSF. In fact, we have joint funding
efforts with them in computational science and other areas.
Mr. Connolly. And here I do credit GAO, Ms. Crosse pointed
out initially they said, no, we are not doing any autism
research, and GAO discovered, well, actually they were doing
about 30, I think you said. So it just seems to me, Mr.
Chairman, that's something we may want to follow up on. I am
not sure it ought to be NSF's decision whether or not they are
part of the IACC.
Dr. Insel. Love to have your help on that. That would be
terrific.
Mr. Connolly. I think that is a follow up, definitely, Mr.
Chairman, if you want to work together on that.
Mr. Yudin, just one question. I have known lots of families
who have autistic kids. And you know, for 14 years, I was in
local government and helped finance and oversee the 12th
largest school district in the United States. And you talked
about the best policy is try to integrate these kids into the
general curriculum. And that's a noble goal. But practically,
most teachers have no training whatsoever in dealing with
autistic kids. And it can be very challenging. There are all
kinds of issues, depending on the spectrum.
So what are we doing to provide that kind of training so
that teachers are not afraid, not intimidated, not wanting to
avoid this integration in the general curriculum? Because if
that's the goal, the key is teachers who are trained and
familiar and embrace that goal, too.
Mr. Yudin. Thank you, sir. That's a fantastic question. We
know that research shows that kids with disabilities do in fact
do better when they have access to the general curriculum and
they are held to high expectations. You know, as you noted, as
everyone knows, autism spectrum disorder is in fact, you know,
kids have autism on the spectrum. So there is a range of
severity, a range of individual needs, interventions, services,
and supports, you know, across that spectrum. We have invested
in a number of efforts in research-based strategies, such as
positive behavior interventions and supports, PBIS is what it
is known, and it is a school-wide effort that sets a framework
for behavior. It sets clear expectations for behavior. Teachers
are trained on it. Parents are trained on it. The school
cafeteria workers are trained on it. Bus drivers are trained on
it. And if implemented with fidelity, has fantastic outcomes
that address a number of areas around behavior, around office
referral, around suspensions, around attendance, around
engagement, and ultimately around academic support. So I would
start with that framework. That is a solid research base that
is really making a difference in classrooms all across the
country. What it also then does is frees up specialists,
whether they are special ed. teachers, or counselors, or
psychologists to then really work with kids that do have more
intensive behavioral needs. We support a technical assistance
center on intensive interventions that works with States and
districts to provide those research-based tools and strategies.
Mr. Connolly. Thank you, Mr. Chairman.
Mr. Mica. Mr. Posey.
Mr. Posey. Thank you, Mr. Chairman.
And, you know, please don't mistake me for advocating that
we abandon genetic or genomic research. My question was just
why the environmental-based research was funded at much less
than the recommendation, and the genetic research was funded at
three times more than the recommendation. What would you
recommend to improve the relevance of research funded by NIH to
families?
Dr. Insel. Can I get you to unpack that question a little
bit to get some sense of----
Mr. Posey. All right. How many of the therapies currently
that are typically used by the autism community have been
evaluated by NIH research grants?
Dr. Insel. There is a robust cohort of efficacy trials
looking at a variety of interventions, both behavioral and
biomedical interventions, pharmacological, and devices. But as
you probably know, the range of what is being used in the
community is vast. And in the absence of anything that seems to
truly work in randomized control trials that has been shown to
be effective and rapid and accessible, people are reaching for
all kinds of things. So we do have effective behavioral
interventions. At this point, in 2014, remarkably, we have no
pharmacological treatment for the core symptoms of autism. And
that is extraordinary.
Mr. Posey. Yeah. Okay. Some years ago, NIH staff informed
this committee that a chelation study would be conducted to
evaluate its benefits in children who test for high levels of
heavy metals like lead, mercury, and cadmium. Do you know if
that was ever conducted?
Dr. Insel. I know that there was a proposal to do such a
study in the NIMH intramural program. And my recollection of
that, this is many years ago, was that it did not make it
through the Institution Review Board process, that the IRB felt
that it was difficult to do that study under the ethical
constraints based on the information they had.
Mr. Posey. Okay. The previous question about the research
grants. Could you also give us a list of those?
Dr. Insel. I am sorry, just to clarify the question about
research grants, a list of----
Mr. Posey. On therapies currently typically used by the
autism community. You said there were a number of them.
Dr. Insel. Yes. Absolutely. And again, all of that
information is also in this tome that has recently come out
that looks at the accountability of the strategic plan. I
should, because I didn't respond directly to your question
about the proportion of the budget that's going to genetics
versus environment, in the realm of looking at environmental
risk factors, more than half is either on the environment,
specifically on gene environment interactions, or epigenetics,
which is a mechanism by which the environment would have that
impact. So that's in excess of $30 million that go into that
area.
Mr. Posey. Okay. And this is just out of curiosity. Has
NIH, NIMH, or NIH funded studies looking at the use of vitamin
B6 in children with autism? Are you aware of that?
Dr. Insel. I would love to take a look at that for the
record and let you know. I don't know offhand of such a study.
Mr. Posey. There is a question of why there haven't been
studies of whether autism prevalence is higher in children who
received versus did not receive one of the seven vaccines
administered in the first year of life, and how you can
legitimately state that vaccines don't cause autism studies
until the actual studies are conducted. And I am not saying
you, I am saying anyone, you know. That's not a personal
statement. You know, put aside all the criticisms about how to
do the study, where do you come down on that?
Dr. Insel. Well, this may be, again, a place where GAO
might have suggested that there has been some duplication.
There has been an enormous amount of focus on this topic over a
long period of time. I have never counted the number of
studies, but I know that there is a--even today yet another
report out, a large meta analysis out of the University of
Sidney looking at 10 different projects that have looked
specifically at this question about the role of vaccines and,
again, comes up completely empty handed. There is just no
evidence there. So how much more needs to be done there, how
much do you want to continue to bang away at that question?
Personally, I think the environment is an important factor
here, but it is probably going to be prenatal, not in the first
or second year of life.
Mr. Posey. Well, are you aware of any studies that we have
done that have not been tarnished by the touch of Poul Thorsen
that conclusively have done a blind study of vaccinated versus
unvaccinated?
Dr. Insel. Well, those are two different questions. There
has been an enormous amount of epidemiological work, not just
in the United States but around the world. And part of what the
report out of Sidney describes is that effort. The question
about doing a prospective vaccinated versus unvaccinated
clinical trial came up at our previous hearing. And I think
that's going to be a tough one to get through an Institution
Review Board, to tell parents in a random way that you are not
going to be allowed to vaccinate your children.
Mr. Posey. Okay. Let's stop it right there. Because every
time we have ever talked about doing one of those studies, some
idiot in the media says I am suggesting that children
intentionally don't get vaccinated. And I don't know that
anybody ever has ever proposed that. But there are plenty of
children whose parents will not allow them to be vaccinated.
There are plenty of cultures where children are not vaccinated.
And there are other reasons children are not vaccinated. And
there are children who take large doses of vaccination, and
children whose parents decide to have them take one vaccination
at a time to avoid thimerosal. And I have not been able to
ascertain that there has actually been a legitimate study done
that wasn't tainted by the touch of the international colossal
scumbag Poul Thorsen.
Dr. Insel. Well, perhaps I can reassure you a little bit on
that score. I agree with you that there are a lot of parents
today who are choosing not to vaccinate. And that does provide
maybe the unenviable opportunity to ask, does that matter? We
are trying to do that through a very large study of 35,000
families with autism in a very large health care system where
some of the families have decided, when they have a child with
autism, not to vaccinate their next child. And the question
will be, does that--two questions, actually. A, does that make
a difference? Does that next child have a greater or lesser
possibility of developing autism if they are not vaccinated?
And the second question is, are they more likely to develop
preventable medical illnesses as a result?
I guess the other question I keep wondering for myself,
since we have already done this, we don't have the data yet,
but we will very soon, is will--if the results come out
negative again, will people accept that answer?
Mr. Posey. Absolutely. If it's a transparent, bona fide
study, I think no matter where people fall on the issue, what
side, they would be relieved at a credible, transparent
conclusion. Yes, I think everyone would be relieved, regardless
of what the results are. They just want to see a straight
arrow, bona fide examination, study, and conclusion. And I
don't think they want anybody to invent anything. I mean, I
have had--I have talked to, you know, hundreds of mothers
personally. And I am sure there's thousands and maybe millions
that I haven't talked to who have said, you know, my child,
usually a little boy, was absolutely perfectly normal until the
day after he got his vaccinations. And through a related
career, I have got a little bit of experience with mercury.
And, you know, I know that if we find mercury in our fish, we
shouldn't eat them. And I think that the spectrum causes are
very wide. I think this is one of them. I think genetic-
enhanced foods are one of them. I mean, we changed genetics of
what we eat and don't expect it to change our genetics? I mean,
there are so many things. I think pollution goes into it. I
mean, we know that it harms children who eat lead pipes. I
mean, clearly, the children who have eaten lead off the pipes,
it has harmed the children. I mean, there is a lot of reasons
for it. But one heavy reason that I hear often about is the
thimerosal in the vaccinations.
And I think it would be great if the government, who is
here to do good things for people, would take that off the
table. But not in a way that we met, and we did this and we did
that, but in a very public way, and a very transparent way. You
could I think remove that question forever with just one
decent, highly qualified, respected study.
Dr. Insel. Sir, if you will permit me, as soon as we get
the data in a form that has been accepted for publication, I
would love to sit down with you and go through them. And we can
do that one to one.
Mr. Posey. I look forward to it.
Dr. Insel. And let you see what that looks like. I am
interested to see it myself. And we will know that I think in
the next 3 months.
Mr. Posey. Thank you.
Mr. Chairman, you let me go over a little bit. Thank you
very much.
Mr. Mica. Thank you. Thank you, Mr. Posey, for attending
and participating. And I also want to thank our three witnesses
for their participation, testimony today.
Without objection, we are going to leave the record open
for an additional 7 days. And we have additional questions that
we will be submitting to some of the witnesses for responses
for the record.
There being no further business, I do want to thank
everyone again for participating. Raised a lot of important
issues that looked at some of the study results from GAO and
heard testimony from the IACC representative. And again,
sorting through this and making certain that we are doing the
best possible with taxpayer dollars is our goal. And hopefully,
we can get closer to finding both the cause and prevention and
help a lot of people who have had to struggle through the
terrible problems brought about by autism. So with that, there
being no further business before the Government Operations
Subcommittee, this hearing is adjourned. Thank you.
[Whereupon, at 11:05 a.m., the subcommittee was adjourned.]
APPENDIX
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