[Senate Hearing 111-332]
[From the U.S. Government Publishing Office]
S. Hrg. 111-332
AUTISM RESEARCH, TREATMENTS, AND INTERVENTIONS
=======================================================================
HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARING
AUGUST 5, 2009--WASHINGTON, DC
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
__________
U.S. GOVERNMENT PRINTING OFFICE
54-469 PDF WASHINGTON : 2010
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC
area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC
20402-0001
COMMITTEE ON APPROPRIATIONS
DANIEL K. INOUYE, Hawaii, Chairman
ROBERT C. BYRD, West Virginia THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont CHRISTOPHER S. BOND, Missouri
TOM HARKIN, Iowa MITCH McCONNELL, Kentucky
BARBARA A. MIKULSKI, Maryland RICHARD C. SHELBY, Alabama
HERB KOHL, Wisconsin JUDD GREGG, New Hampshire
PATTY MURRAY, Washington ROBERT F. BENNETT, Utah
BYRON L. DORGAN, North Dakota KAY BAILEY HUTCHISON, Texas
DIANNE FEINSTEIN, California SAM BROWNBACK, Kansas
RICHARD J. DURBIN, Illinois LAMAR ALEXANDER, Tennessee
TIM JOHNSON, South Dakota SUSAN COLLINS, Maine
MARY L. LANDRIEU, Louisiana GEORGE V. VOINOVICH, Ohio
JACK REED, Rhode Island LISA MURKOWSKI, Alaska
FRANK R. LAUTENBERG, New Jersey
BEN NELSON, Nebraska
MARK PRYOR, Arkansas
JON TESTER, Montana
ARLEN SPECTER, Pennsylvania
Charles J. Houy, Staff Director
Bruce Evans, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
TOM HARKIN, Iowa, Chairman
DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi
HERB KOHL, Wisconsin JUDD GREGG, New Hampshire
PATTY MURRAY, Washington KAY BAILEY HUTCHISON, Texas
MARY L. LANDRIEU, Louisiana RICHARD C. SHELBY, Alabama
RICHARD J. DURBIN, Illinois LAMAR ALEXANDER, Tennessee
JACK REED, Rhode Island
MARK PRYOR, Arkansas
ARLEN SPECTER, Pennsylvania
Professional Staff
Ellen Murray
Erik Fatemi
Mark Laisch
Adrienne Hallett
Lisa Bernhardt
Bettilou Taylor (Minority)
Dale Cabaniss (Minority)
Sara Love Swaney (Minority)
Administrative Support
Teri Curtin
Jeff Kratz (Minority)
C O N T E N T S
----------
Page
Opening Statement of Senator Tom Harkin.......................... 1
Statement of Thomas R. Insel, Director, National Institute of
Mental Health, National Institutes of Health, Department of
Health and Human Services...................................... 2
Prepared Statement of........................................ 7
Statement of Senator Thad Cochran................................ 9
Statement of Geraldine Dawson, Chief Science Officer, Autism
Speaks, Charlotte, North Carolina.............................. 16
Prepared Statement of........................................ 17
Statement of Senator Arlen Specter............................... 22
Statement of Joshua Cobbs, Chairperson, Iowa Autism Council,
Sioux City, Iowa............................................... 23
Prepared Statement of........................................ 25
Statement of Nicole Akins Boyd, J.D., Vice Chairman, Mississippi
Autism Task Force, Oxford, Mississippi......................... 27
Prepared Statement of........................................ 29
Statement of David Miller, J.D., Board of Directors, Northern
Virginia Community College, Annandale, Virginia................ 32
Prepared Statement of........................................ 35
Statement of Dana Halvorson, BEAT-Iowa, Ankeny, Iowa............. 38
Prepared Statement of........................................ 40
AUTISM RESEARCH, TREATMENTS, AND INTERVENTIONS
----------
WEDNESDAY, AUGUST 5, 2009
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:05 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
opening statement of senator tom harkin
Senator Harkin. Good morning. The Subcommittee on Labor,
Health and Human Services, and Education will come to order.
Today's hearing is on autism, regarding research,
treatments, and interventions. The Centers for Disease Control
and Prevention (CDC) estimates that 1 out of every 150 children
born this year will be diagnosed with autism. Among boys, the
rate is even higher, 1 of every 94. We don't know what causes
this disorder. Most researchers agree there is a genetic
component, at least in some cases.
Every discovery seems to raise more questions. It now looks
as though autism has, not just one genetic cause, but many, and
we still don't know what the triggering mechanisms are. Many
experts suspect that environmental factors may also be at play,
but, again, we don't know what they are exactly, or whether
they take effect during a child's first few months or years, or
maybe during gestation.
We know a little bit more about interventions. Some
behavioral interventions seem to help, if started early. But,
we are nowhere near a cure. The number of people with autism
continues to grow; the rate of incidence is growing.
This subcommittee has taken a strong interest in autism in
recent years. We held a hearing on autism 2 years ago, in April
of 2007, and the fiscal year 2010 appropriations bill that was
approved by the full committee on July 30 includes a range of
activities related to autism, such as outreach and education,
surveillance, medical research, and the Interagency Autism
Coordinating Committee (IACC). This year's bill also includes
$14 million for a new program to help students with
intellectual disabilities make the transition to college and
complete their postsecondary education.
We have an outstanding panel of witnesses today to help us
examine autism from many different perspectives--research,
treatment, interventions--and another problem that hasn't
received enough attention to date, how to address the needs of
the growing population of adults with autism.
Let me just thank all the witnesses for coming here today.
And before we begin--Senator Cochran is on his way--I will
leave the record open for his introductory statement.
We have two panels. The first panel is--Dr. Thomas Insel is
the Director of the National Institute of Mental Health (NIMH).
Panel two is Dr. Geraldine Dawson; Mr. Joshua Cobbs, from Iowa;
Ms. Nicole Akins Boyd is from Mississippi; David Miller, from
Virginia; and Ms. Dana Halvorson, from Iowa. So, I think we can
address just about all the aspects that we wanted to cover on
autism, with these two panels.
First, we will open up with Dr. Thomas Insel, the director
of the NIMH at the National Institutes of Health (NIH)--not a
stranger to this subcommittee, been here many times. Again, Dr.
Insel, welcome.
As with you and with all of the people testifying this
morning, your statements will be made a part of the record in
their entirety. Dr. Insel, we'd just ask you to go ahead and
proceed as you so desire.
STATEMENT OF THOMAS R. INSEL, DIRECTOR, NATIONAL
INSTITUTE OF MENTAL HEALTH, NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Dr. Insel. Thank you, Mr. Chairman. And let me state that
it's a real pleasure and honor to be here with the other
panelists. I know this is a very busy time for you and your
colleagues, and we greatly appreciate your taking time here in
the middle of the summer, just before recess, to hear about the
latest research and the latest challenges with autism.
My brief statement is to get you a quick update on the
research since we last met, which was a little more than 2
years ago. And I can tell you, this has been an extraordinary
period, with lots of exciting progress. I'm going to try to
review that. The testimony, I hope, will be submitted for the
record, so rather than just reading that, or going through it,
I thought I would just take you very quickly through three
questions--What do we know at this point? What do we need? And
what are we doing?--and will try to summarize those very, very
quickly.
defining autism
To get you, sort of, on track here, let me just make sure
we're all on the same page in what we're talking about. Autism,
by definition, starts by age 3. We're talking about three
different kinds of symptoms that characterize autism: reduced
social behavior, abnormal language, and, as we've talked about
before, repetitive, restrictive behaviors that often are called
stereotypes; they have many other names.
It's clear that, though these are the definitions, that
many children with autism come in with additional complicating
features, and I've just listed a few of them here. Some 20 to
30 percent will have an associated seizure disorder that can be
part of the autism syndrome, intellectual disability of various
sorts, and gastrointestinal problems of many different kinds.
About 10 percent of children who have an autism label have odd
faces or odd appearances. We call that dysmorphic. And then,
somewhere between 10 to 20 percent have what is often called
``regression''; that is, while everybody may regress to some
degree, there are children who seem to develop quite well for
the first 18 months, and then will clearly lose language, lose
function.
autism spectrum
The result of understanding these complicated features, and
the fact that this is such a heterogeneous syndrome, is that we
increasingly talk, not about ``autism,'' but about ``autisms,''
and we really think about this as many different disorders. And
in some ways, we're prisoners of our own language, here, by
thinking about it as a single syndrome.
The term that has now been most widely accepted, and that
you'll hear about most of all this morning, is called the
``autism spectrum,'' or ``autism spectrum disorder.'' And all
that really means is that we're talking about a range within
the syndrome. At one end are those children who really have
very limited functioning, often have no language whatsoever,
may have severe intellectual disability, show no interest in
social interaction, and have lots of motor abnormalities,
including the most common and what we call ``diagnostic one''
is hand flapping, and they're the ones that often have these
dysmorphic facial features.
At the other end of the spectrum are children who are going
to grow up to be, often, highly successful. I mean, they may,
in fact, have social awkwardness, they may be called ``geeky,''
or ``nerdy,'' or something like that. They may be more
interested in numbers than in people. But, they may be
tremendously useful and tremendously successful and make huge
contributions as engineers, as computer scientists, in areas
that probably aren't going to tap so much into their social
awkwardness, but allow them to really use what they do best,
which is to be able to think about the mechanical, numerical,
and less social aspects of the world.
All of those people, whether you call them classic autism
or Asperger syndrome fit within this spectrum. And so, as you
hear the debate about what's available and what the treatments
are and what the causes are, you have to remember that we're
talking about this tremendous heterogeneity within the
spectrum.
So, let's dive into what do we actually know, and what have
we learned in the last couple of years that will be important
for us in thinking about this as we go forward?
what we know
First of all, I think there is wide recognition that this
is a developmental brain disorder. We don't know yet where in
the brain, or what in the brain, or even when in the brain,
things go off track, but the most recent research would suggest
that what we're talking about here isn't a specific lesion in a
particular area, but it may be more likely what we call a
synaptic disorder. It's a problem of brain connections. And
that may be very diffuse, and it's quite possible that the
reason you see problems in language and problems in social
interaction is that those are functions that require the
greatest number of synapses. And if you're not able to process
information as quickly as you need to, or if you process
information in a way that is too quick and isn't filtered,
you're going to see deficits. If your connections aren't
working, you're going to see deficits in just those kinds of
functions.
genetics
Probably the greatest degree of progress has been in
genetics. And that's not surprising. That's true in almost
every area of medicine. The last 3 or 4 years has really seen
what we're calling an ``explosion'' of information from
genomics. That hasn't necessarily delivered the cures that many
of us were looking for, yet, but it has helped us to understand
much more about the heterogeneity of these disorders.
Two years ago, when I spoke to you, I talked to you about
how we think genomics will be important. At that point, we
would have said that it's important because we know that a
couple percent of the children who present with autism have
recognized syndromes--Rett syndrome, Fragile X syndrome,
tuberous sclerosis--these are single-gene mutations, in which
perhaps 50 percent of the children, sometimes more, have a
diagnosis of autism, as well.
In the last 2 years, we've discovered a range of other
rare, but apparently highly significant, mutations that are in
the form of structural lesions within the genome, that also
seem to contribute. And so, where 2 years ago I might have said
2, 4, perhaps 5 percent of any population of children with
autism would have one of these syndromes, I think now we can
say that number's going to be considerably higher, perhaps more
than 10 percent. We don't have names for all of these
syndromes, but we have, in the last couple of years--and I must
say it's changing almost every 2 months--there are new reports
out about rare mutations that may explain another 1 or 2
percent of the children who have this disorder.
So, there's clearly a genetic factor at work here. It
doesn't explain all of autism. We still need to learn a lot
more about how genes and environment interact. And there will
be lots more research on that in the near future. But, that is
clearly an important area of progress.
behavioral interventions
We know that--and we spoke about this 2 years ago--that, as
you said in your opening remarks, behavioral interventions are
helpful. And they're especially helpful when they're started
early. Now, you'll hear more about this from other panelists.
I'm not going to take a lot of time, except I want to flag
this, because I think the issue here is making sure that the
best behavioral interventions are available to the people who
need them. And here, we're not just talking about children, but
also about children in transition to adulthood, and adults
themselves. These do work, but they're not always available,
and they're not always paid for, at least not paid for through
insurance. And so we do need to have a conversation later this
morning about how that's going to happen.
I also would recommend that you might want to ask Dr.
Dawson about the impact of behavioral interventions. Some of
her own work in this area is really, I think, setting a new bar
for how far these behavioral interventions will go if they're
done early.
prevalence
Finally, the issue that you brought up in your opening
remarks, and I know it's one that is of great concern to you
specifically, is this increase in prevalence. And as you
mentioned, the CDC now reports, from 2007, a rate of about 1 in
150 children being given a diagnosis of something on the autism
spectrum. I don't think that that number is at great variance
with numbers we've seen elsewhere. It's also true that that's
about a tenfold increase over the numbers coming from the CDC
from the 1992-1993 period.
So, the tenfold increase in prevalence is of great interest
to many of us. I want to just caution you that a change in
prevalence is not unique to autism. We have seen a 40-fold
increase in prevalence of pediatric bipolar disorder over this
same period. We've seen perhaps a tenfold or greater increase
in attention-deficit/hyperactivity disorder in children over
the last three or four decades.
So, this kind of a change isn't unique to autism, but it's
certainly one that deserves our attention. And we have to
remember the difference between ``prevalence''--which can be
affected by ascertainment, by change in diagnosis, or a number
of other features--and ``incidence''. We don't have, right now,
good evidence that there's a true increase in incidence--in the
rate of new cases. And that's an area that requires more
research.
what we need to know
So, if that's what we know, what do we need? Well, part of
what we need is to fill in the gaps of what we don't know. And
I'll just take you through the kinds of things we're thinking
about. Certainly, understanding more about risk. The risk
architecture of the whole spectrum is going to be critical.
Genes are important, and environmental factors, as you
mentioned, will be important, but most important will be how
they interact. That's not unique to autism, it's true for
asthma, it's true for many other areas of development.
We want to know about molecular targets, to the extent that
we can get those, because that's where new therapies are going
to come from, and they already have begun to emerge in some
aspects of this syndrome. And then we want to understand this
heterogeneity far better.
The point of all this is to be able to develop ways of
detecting this disorder much earlier. We know, in general, that
for brain disorders, behavior is one of the last features to
change. That's true for Alzheimer's, it's true for Parkinson's,
it's true for Huntington's. That is why it will be most
important to have a biomarker that will allow us to detect risk
and detect the disorder much earlier.
We want to have interventions that are more effective.
Behavioral interventions are effective for many children, but
they're expensive, they're extensive, they take a long time to
work, and we're not yet where we want to be at the end of the
day. We want to be able to offer much more than just the
behavioral interventions.
And we want to know which treatments are going to work best
for which people. You'll hear a lot, over the next year, about
personalized medicine. We're hoping that the new NIH Director
will be confirmed by the full Senate this week; and should that
be the case, I think you'll hear from him the high priority put
on personalized medicine. That's something that we'll need for
autism as much as we need it for cancer and heart disease and
diabetes.
adults with autism
I also want to just point your attention to an issue that's
not so much on the research agenda, but needs to be very much
on the social policy agenda. As you mentioned in your opening
remarks, we have a whole wave of children with autism who will
soon be adults with autism. How we make sure that they have the
access to services, that we take care of this transition to
independence and the coverage for the different kinds of care
they need, deserves urgent attention from this subcommittee and
from others who make policy.
iacc strategic plan
Finally, let us just say a little bit about what we're
doing, what we know, and what we need. What we are doing can be
summed up fairly quickly. Through the work of the IACC, we have
a new strategic plan, which was released in January of this
year. That provides a whole range of activities, both short
term and long term, that we hope to be able to invest in so
that we can get some of the answers we need.
We have an extraordinary opportunity now. When we first
released this plan in January, the comment that we heard most
often was, ``This is a great road map, but is there any gas in
the car?'' And what happened soon thereafter, with the American
Recovery and Reinvestment Act (ARRA), was the opportunity to
make some very substantial new investments to jumpstart this
strategic plan, particularly focusing on the short-term
objectives. And we hope, within the next 6 weeks, to be able to
announce publicly the large number of grants that have been
funded through the ARRA. These include not only the special
request for applications that was done through five institutes
to support new autism research, to the tune of about $60
million, but also a large number of challenge grants and grant
opportunity awards that will be made. Awards will be announced
before September 30 of this year.
national database for autism research
Finally, I will just mention that we've also tried to
jumpstart much of this progress by creating the National
Database for Autism Research, which will be essentially a
meeting ground, electronically, for scientists around the world
to be able to share data and to share the tools that are
necessary to accelerate progress in this area.
As you'll see in the IACC's strategic plan, there were
really six questions that guided the effort to steer research
and to help us think about what the most important issues were.
The IACC, which was reconstituted through the Combating Autism
Act of 2006, includes both public members and Federal members.
The six questions it developed really came out of a very rich
discussion about, What is it that families, and people
themselves on the autism spectrum, most are looking for?
We have taken each of these questions to heart. We've come
up with a summary of what we know and what we still need to
know for each of these six questions. And we have, now, short-
term and long-term objectives that are being addressed through
the ARRA and through other sources of funding at NIH.
I'll finish with this vision statement, which I thought
would be worthwhile sharing with you, from the strategic plan,
which talks about what we're trying to do here as we move
forward, and that's, ``To inspire research that will profoundly
improve the heath and well-being of every person on the
spectrum across the life span.''
And I can't emphasize enough the importance of, now,
attention to adults and soon-to-become adults with autism. This
plan will not only provide the road map for research, but also
set the standard for public-private cooperation and for
engaging the broad community, who will be so invested in trying
to make sure we expedite research progress.
ellen murray
And with that, I'll just make one final comment. I know
you've been thanked for many things that you have done, both
for autism and for NIH, and for many of the other issues that
you deal with. But, I would like to send a personal thank you
for giving us Ellen Murray, who will be joining Health and
Human Services (HHS), I understand, very soon. I understand
this was a lot to offer and a lot to give up, but for those of
us at HHS, it's a terrific gift. And we're delighted that you
saw to it to share her expertise with us.
So, thank you, sir.
Senator Harkin. Thank you very much, Dr. Insel.
[The statement follows:]
Prepared Statement of Thomas R. Insel
Mr. Chairman and members of the subcommittee: I am pleased to
address the state of autism spectrum disorder research and include a
brief review of the prevalence of the disorder, research findings, and
recent initiatives at the National Institutes of Health (NIH).
Autism spectrum disorder (ASD) is a group of complex
neurodevelopmental disorders that range in severity and that are
characterized by social impairments, communication difficulties, and
restricted, repetitive, and stereotyped patterns of behavior. The most
recent Centers for Disease Control and Prevention estimate for ASD
prevalence indicates that 1 in 150 children in the United States is
affected by the disorder--more than a tenfold increase from the early
1990s.\1\ While much of this increase appears to be due to factors such
as the use of broader definitions for ASD, better diagnostic tools, or
increased ascertainment, recent research demonstrates that none of
these factors fully explain the increase in ASD prevalence. Whatever
the cause, scientists, clinicians, and families now agree that ASD has
now become an urgent public health challenge, with enormous financial
and societal costs. Estimates of the combined direct and indirect costs
to care for all Americans with ASD during their lifetimes exceed $34
billion,\2\ with estimated costs for each person over his or her
lifetime totaling $3 million.\3\ Families often incur large debts for
medical and education services that public programs or medical
insurance do not cover. Beyond the financial costs, ASD often leads to
profound emotional hardships for persons with the disorder and their
families. As more children with ASD become adults with ASD, access to
services and lack of accommodation is a growing challenge.
---------------------------------------------------------------------------
\1\ Centers for Disease Control and Prevention. Prevalence of
Autism Spectrum Disorders: Autism and Developmental Disabilities
Monitoring Network, 14 Sites, US, 2002. MMWR 56 (SS-1), 2007.
\2\ Ganz, ML. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9.
\3\ Ibid.
---------------------------------------------------------------------------
Matching the increasing public health urgency, NIH research funding
for ASD has increased progressively over the past decade, reaching $118
million in fiscal year 2008, an increase of nearly sixfold from fiscal
year 1998. What has been the yield from this investment? I will
summarize the research findings in three areas: diagnosis, causes, and
treatment. A fundamental insight and challenge is the heterogeneity of
ASD. While we use one diagnostic category, research increasingly
demonstrates that ASD covers many disorders, with different causes and
possibly requiring different treatments.
Diagnosis.--Early diagnosis is critical because earlier
interventions are associated with the best outcomes. Research has found
that by age 2 children with ASD show unusual patterns of eye contact
compared with typically developing children. Recent studies of children
at high risk for ASD indicate the potential for even earlier detection.
Simple tests of joint attention or responding to spoken name suggest
that diagnosis at 12-14 months of age may be possible for many
children. Ongoing research using neuroimaging and serum samples is
looking for a biomarker that might permit diagnosis even earlier.
Causes.--Scientists are looking for genetic and environmental
causes across the autism spectrum. In the past 2 years, genetic
research has proven especially informative, as more than 50 variations
in the genome, alone or in combination, have been linked to ASD.
Importantly, several new, rare mutations have been discovered. Along
with known genetic disorders that cause ASD, such as Fragile X and Rett
Syndrome, these new mutations may collectively account for 10 to 15
percent of ASD cases. These rare mutations and the many common
variations which confer risk for ASD have one striking thing in
common--nearly all of the genes implicated are critical for brain
development. In fact, most are closely linked in the developing
synapse--the connection between neurons--suggesting that ASD can now be
approached as a synaptic disorder and that new treatments can be
developed for specific synaptic targets.
Just as with other complex medical disorders, ASD research
increasingly focuses on the interaction of environmental factors with
genetic vulnerability. For ASD, the research evidence has pointed to
prenatal environmental factors as most salient. While there is
increasing research into environmental factors that might contribute,
thus far no one factor appears to explain the large number of, or
apparent increase in, cases of ASD.
Treatment.--In addition to breakthroughs in the diagnosis and
causes of ASD, recent research has shed light on the treatment of ASD.
NIH-supported randomized, controlled trials of behavioral treatment
approaches have shown positive effects, and early behavioral
interventions have been found to improve functional capabilities and
reduce the severity of challenging symptoms.\4\ Additionally, NIH has
supported double-blind, randomized, controlled trials of
pharmacological treatments. For example, the atypical antipsychotic
medication risperidone was shown to be better than placebo for reducing
aggression, self-harming behavior, and other serious behavioral
problems, without impairing the cognitive skills of children with
ASD.\5\ Conversely, a multisite, controlled trial to evaluate the
efficacy of the antidepressant citalopram to treat the occurrence of
stereotyped, repetitive behaviors in children with ASD found that this
medication worked no better than placebo.\6\ Double-blind, placebo-
controlled trials are essential for assessing treatments for ASD.
Positive effects are frequently observed with new experimental
interventions for ASD, but equivalent effects are often seen with
placebo. Only by including rigorous controls can we attribute clinical
improvement to the experimental intervention.
---------------------------------------------------------------------------
\4\ Rogers, SJ, & Vismara LA, J Clin Child Adol Psychol. 2008;
37(1): 8-38.
\5\ Aman MG, Hollway JA, McDougle CJ, Scahill L, et al. J Child and
Adolesc Psychopharmacol. 2008 Jun; 18(3): 227-236.
\6\ King BH, Hollander E, Sikich L, McCracken JT, et al. Arch Gen
Psychiatry. 2009;66(6):583-590.
---------------------------------------------------------------------------
NIH will play a major role in the administration's new initiative
to significantly increase services and research into the causes of and
treatments for ASD. Prior to this initiative, NIH will be using funding
from the American Recovery and Reinvestment Act of 2009 (ARRA) as an
opportunity to fuel further research on ASD, including its underlying
biology, methods for earlier and more effective diagnosis, and
improvements in treatment. The new Interagency Autism Coordinating
Committee (IACC) Strategic Plan for Autism Spectrum Disorder Research,
released in January 2009, provides the scientific goals and benchmarks
for this endeavor. The Combating Autism Act of 2006 (CAA) requires the
IACC to develop and annually update this Plan. The IACC is currently in
the process of monitoring the implementation of the Plan and gathering
information to update the document in January 2010. With the arrival of
ARRA funds, we will be jumpstarting many of the short-term objectives
in the Plan, utilizing economic recovery to support science that
facilitates the best possible outcomes for individuals with ASD and
their families.
NIH recently issued a series of ARRA funding opportunity
announcements (FOAs) to address ASD, entitled ``Research to Address the
Heterogeneity in Autism Spectrum Disorders.'' This collaborative effort
among several NIH Institutes and Centers is the largest single funding
opportunity for ASD research in NIH's history. The FOAs encouraged
applications for 2-year projects that address ASD measurement,
identification of biomarkers and biological signatures, immune and
central nervous systems interactions, genetics/genomics, environmental
risk factors, and ASD intervention and treatment. Participating NIH
Institutes intend to contribute over $60 million of ARRA funds to
support many of the grant applications received in response to this
initiative. Additionally, NIH will be supporting ASD research with ARRA
funding through the Challenge Grants in Health and Science Research
Program (RFA-OD-09-003) and the Grand Opportunity grants (RFA-OD-09-
004). Targets for these grants included improving access to services by
individuals with ASD and their families and expanding NIH's National
Database for Autism Research (NDAR) in order to accelerate the
availability of new data for the ASD research community. NIH has
recently completed the scientific peer review of ARRA applications. The
advisory councils for each NIH Institute and Center are currently in
the process of evaluating the reviewed applications in order to guide
final funding decisions, which are expected shortly.
Finally, NIH will continue to build its investment in ASD research
via its base budget, which supports a broad range of individual grants
for research and training related to ASD, a new intramural program for
ASD research, and the Autism Centers of Excellence (ACE) program. The
ACE program focuses on identifying the causes of ASD and developing new
and improved treatments. An example of the kinds of innovative research
emerging from the ACE program is the Early Autism Risk Longitudinal
Investigation (EARLI). Coordinated by researchers at the Drexel
University ACE network, EARLI will explore the impacts and interplay of
environmental factors and genetic predisposition in the cause of ASD.
About 1,200 mothers of children with ASD will be followed as soon as
they become pregnant again and throughout the early life of the new
baby. Through extensive data collection on a number of possible ASD
environmental risk factors and biomarkers, the study holds great
promise in advancing understanding of the causes and progression of
ASD.
In summary, ASD is a developmental disorder that affects too many
families; research represents our best hope for making a difference for
them. We at NIH are determined to continue to use the best available
tools, to fund excellent and innovative science, and to encourage input
from--and dialogue with--parents, teachers and individuals with ASD.
Only in this way, and only with your continued support, will we be able
to continue to fuel the vital research that we believe will reveal the
mysteries of ASD and lead to prevention and effective treatments.
I appreciate the interest of the members of this subcommittee on
ASD research and look forward to answering your questions.
STATEMENT OF SENATOR THAD COCHRAN
Senator Cochran. Mr. Chairman, I'm pleased to join you at
this hearing, to thank our witnesses who've come to share with
us their experience and thoughts about what we can do to more
effectively deal with the challenge of autism. We've had
hearings before, but it is important for us to continue our
efforts to stay up-to-date and join forces with the victims and
their families to help make sure we triumph and don't let the
victims and their families down. We want to support the cause.
Thank you for being here to lead it off.
Dr. Insel. Thank you.
Senator Harkin. Well, thank you again, very much, Dr.
Insel, for your leadership.
On the Interagency Coordinating Committee, I was just
looking at the list of the people on the committee. As you
know, our interest, obviously, is in research and finding
causes, which hopefully will lead to prevention and cures. But,
also we're interested in early intervention programs and how
you get to these kids early. Do you feel you have enough
expertise on this panel? Are you looking at that aspect, what
are the most effective early intervention programs that we can
find and work on?
IACC EXPERTISE
Dr. Insel. So, on the IACC specifically, do we have the
expertise?
Senator Harkin. Yes.
Dr. Insel. Well, we bring in the expertise. One of the
things we do each year is to update the strategic plan. And we
do that by bringing in the experts from all the areas of
concern.
We've heard about both ends of this spectrum. The early
detection and early intervention--we like to use the term
``preemption,'' when we can--as one of the places that needs a
big push. And the other end of the spectrum are adults who need
a lot more in the way of interventions.
Senator Harkin. So, your group, this interagency group, is
actively out there looking at different interventions and
trying to find out which ones work best and--are you also
promoting different types of--in other words, are you
instigating different types of early interventions, to track
them, to see which ones work the best?
DEVELOPING THE RESEARCH AGENDA
Dr. Insel. Right. So, let me just go through the process
very quickly. The first thing we did was to do a research
portfolio analysis. And I think this was unprecedented. We--on
the question of interventions or any of the other aspects of
the strategic plan's six questions--we sought input from not
only NIH and CDC and the Department of Education, but also from
all the Federal players that invest in this area, including the
Department of Defense, and also all the private groups, which
are very substantial players for autism and are putting in very
significant amounts of research dollars. For the first time,
everybody has shared their information about every grant they
fund, including how much they're putting into it. And we were
able to use that to map onto these six questions and say what's
missing.
One of the places where it looked like we were underfunded,
or underinvested, across the six questions, is in this area of
interventions. How do we then fill that in? Well, the first
thing we do is bring in the experts to tell us not only what
the needs are, but also what are the opportunities. What could
we do? What's really hot right now, in terms of techniques or
things that are going on in other areas in medicine?
The meeting this year will be on September 30 and October
1. We did a previous one, which was in January 2008. We used 4
days to hear from a broad panel of experts.
I might add that it's not only your typical academic
grantee that we're hearing from, but we're bringing in family
members who may have had a very interesting experience that
they think we should hear about, and we're bringing in
clinicians, as well, who may be trying things that we don't
know very much about yet. So, we're trying to throw as broad a
net as possible, to make sure we're getting all of the best
ideas onto the table before we decide what we want to recommend
for NIH and CDC and DOD and others to be looking at for
funding.
Senator Harkin. What do we know works for treating autism--
we talked about this applied behavior therapy, seems to be
successful. But, how early an age can you start that? And--yes,
do we know what age you should start that at?
Dr. Insel. Well, I'm going to duck that question, because
the world's expert on that is sitting right behind me, and
you're going to talk to her in a few minutes----
Senator Harkin. Oh, behind----
Dr. Insel [continuing]. Dr. Dawson----
Senator Harkin. All right.
Dr. Insel [continuing]. Who--and I don't want to put her on
the spot, but she has just completed, really, what is the
landmark study on just that question, going as early as
possible. I'd love to steal her thunder, but because she's a
friend and I don't want to alienate her, but it would be better
for you to hear from her, directly, about her own data.
Senator Harkin. We'll do that.
VACCINE
Dr. Insel, I hear a lot about this issue of vaccines and
autism. Can you summarize the state of the science regarding
that issue?
Dr. Insel. Well, I can tell you what we know,
scientifically, and that is that this is--I think there's no
question, from the community, that there are environmental
factors at work and that some aspect of the environment is
going to be interacting with genetics to make children, and
maybe even unborn children, vulnerable, because it may be that
these are prenatal environmental factors.
The only factor that has been explored in great detail
would be vaccines. And part of that has to do with the
increasing number of vaccines, which has--as we talked about at
the previous panel--gone up over that last 30 years or so. In
fact, I've made a slide so you can see what that looks like.
There have been this really striking increase from 1900, as you
can see, to about 2009. So, there are more vaccines that are
now in the recommended schedule. There are more injections, and
perhaps even more injections per visit, at least that are
possible currently.
It's also important for you to realize that, while the
number of vaccines has increased, the quality of vaccines has
really changed in the same time. And so, if you look at the
number of antigens that go into these vaccines, although it
doesn't show it here, actually the amount of protein that
actually goes into any of these--into the full group of
vaccines that children are receiving--is less than it was when
you were getting a single shot in 1900.
So, the vaccines today are far more refined, far more
targeted. They look very different than they would have, even
when your children would have been vaccinated, in the 1970s and
before. So, it's not quite comparing apples and apples, when
you look at this change over time.
The one--the research that's been focused on vaccines as a
potential association with autism has been largely
epidemiological research. And up until this point in time, I
believe there have been a total of about 16 studies involving
hundreds--literally hundreds of thousands of children, and
there is no evidence, at this point, of any association between
vaccines--the number of vaccines, the kind of vaccines--any of
the things we're showing here--and the increase or the
particular vulnerability to autism.
Senator Harkin. Well, I guess what I don't understand is
how you can have a study involving hundreds of thousands of
children and all with the same number of vaccines, because
they're all getting the same number, before the age of 2? If
you go back to your first chart, Dr. Insel--I have a little bit
of different information. I have an excerpt from the Centers
for Disease Control and Prevention that shows that, in 1983,
the maximum number of vaccine doses administered before age 2
was eight. In 2009, it is a minimum of 21 and a maximum of 29;
and from everything I can ascertain, it's closer to 29. So,
we've gone from 8 in 1983 to 29 this year, before the age of 2.
Most pediatricians do that. So, how would you ever find a group
of kids that don't get those?
VACCINE FORMULATION
Dr. Insel. I want to again remind you, it's not comparing
the same thing--the 8 are not the same as 29. You look at the
number of antigens that are present in 1980--or 1983--versus
what's present in the vaccines that a child would receive in
2000 or 2008, and there's this striking, striking decrease.
These are not the same formulations, they're not the same kinds
of vaccines. What we're talking about today, while the numbers
have gone up, is a profound reduction in the amount of protein,
in the number of antigens that are given.
Senator Harkin. Dr. Insel, some of these vaccines weren't
around at that time, in 1980. I mean, we've got a number of
them here, like pneumococcal conjugate, we've got influenza,
varicella--some of these weren't even around--hepatitis A--they
weren't around in 1980.
Dr. Insel. Right. And the vaccines that were around in 1980
have been changed, in many cases; they're far more refined----
Senator Harkin. The vaccines that were there then that
we're using now are----
Dr. Insel. Yes. They are not actually the same vaccines, in
many cases. So----
Senator Harkin. They're the same.
Dr. Insel. They're not the same. They may have the same
names, but they--the formulation has been greatly refined. And
that's how you get these kinds of changes.
Senator Harkin. Yes, I get confused when we get into this
area, because I just wanted to focus on the number of vaccines,
and the fact that they're all given together, a lot of times,
before the age of 2. I'm not talking about the number of
antigens in them, or anything like that, just that the total
number has gone up. And I don't know of any studies--and you
may know of some that I don't know about--but, any studies that
would compare a cohort of children from 0 to age 2 that didn't
get these shots, and the incident of autism; and those that did
receive 29 vaccines and then were diagnosed with autism. I
don't know of any study out there that's done this.
FEASIBILITY OF STUDY
Dr. Insel. Well, we've had a discussion within the IACC
about just this issue. That is could we mount a study of the
vaccinated versus unvaccinated children? We don't have, in
fact, the vaccine expertise on the IACC. And so, we have
decided to consult the National Vaccine Advisory Committee,
which is another Federal advisory committee that reports to the
Secretary, to get their expertise. Because they do have
expertise.
And we met, about 1 month ago, to have this conversation
with them. Before meeting with them, we sent them the question,
asking if there had been such a study, just the kind that you
described. And if not, why not? And could we do such a study?
And their first response back to us was, first of all, it
hasn't been done. They didn't think that it was feasible to do
it. But, most of all, they didn't think it was ethical. They
had real concerns about the ethics of randomizing a group of
children to not receive vaccines, because they were
particularly concerned about the risk involved in not
vaccinating a large number of children--and you would need a
very large number of children for such a study.
Senator Harkin. That's right. So, we really can't tell
that. Now, I do know of people who are not letting their
children get those numbers of vaccines. And some of these are
highly educated, professional people, and they have decided
that they are going to stretch them out over a longer time--
they are not going to give it to their children before the age
of 2; maybe by the age of 5 or 6. I know a lot of that is
happening out there.
Now, a lot of pediatricians will not treat a child if, in
fact, they are not receiving these immunizations. They will
tell the parents, ``Well, if you don't agree to the vaccination
schedule, I cannot--you cannot be a patient of mine.'' But, I
do know a lot of people that basically are not having their
kids vaccinated. I don't know the ramifications of that, I
don't advise that, or anything like that, but I just know that
this is happening.
Dr. Insel. So, we can imagine there's----
Senator Harkin. The problem is, we don't know. We don't
know if 29 vaccinations--immunizations--by the age of 2 do have
an effect. We don't know that.
Dr. Insel. Let me share with you the conversation we've had
on the IACC, because, as you can imagine, this is a topic that
has come up. It's a highly charged topic. The----
Senator Harkin. Sure.
FAMILIES AND VACCINATIONS
Dr. Insel [continuing]. Community is highly polarized on
just this point.
Senator Harkin. Sure.
Dr. Insel. And we hear not only from those people who are
convinced that vaccines are the problem, and from those who are
convinced it's not. I must say, these are both ends of the
spectrum, here--but, we also hear from lots of families who've
had a child with autism, and they're wondering what they should
do about their next child. And that's often the question that
is on the table, because they just don't know whom to believe,
and they don't know what to listen to.
Senator Harkin. That's right.
Dr. Insel. The group of people who feel that there really
is an issue here, who are really concerned that there's a
relationship between vaccines and autism, point to the numbers
that you point to, the large increase, and they say that, yes,
there have been 16 studies, and all 16 studies demonstrate no
relationship. However, those are all epidemiological studies,
and you can't rule out the possibility that there's a very
small signal there that might have been missed.
On the other side of the coin, the other end of the
spectrum, we're hearing from other people--and not just
scientists, but even family members on the IACC--who are
saying, ``Enough already. If there's an environmental factor at
play here, then we've spent a lot of money and a lot of time
doing these 16 studies, and nothing has shown up on this
question, maybe we don't need to turn that rock over a 17th
time. Let's move on, and let's look at something that is more
likely to shed light on what could be an important factor in
increasing the prevalence, or increasing the risk, for
autism.''
So, that's what we're hearing. And we're trying to balance
both of those points of view, and also trying to make sure that
there's information available for people who are most concerned
about what they should do with their next child.
Senator Harkin. Well, that is true. And that is why I say--
we have got to do both--the research on the causes and the
triggers, but also interventions. We need to look at early
interventions, and how we might help people that are having a
tough time dealing with children of their own, right now. We
have got to focus on those early intervention programs, and
we'll get to that in the next panel.
Senator Cochran. Mr. Chairman, thank you. I want to join
you in welcoming Dr. Insel to the hearing, and also to recall
that we've had hearings efforts in the past to try to develop a
body of information that will help us identify better ways of
dealing with autism. What are the causes? What are the possible
changes in environment or nutrition or healthcare generally,
that we can turn to for help in--helping to deal with the
sorrow and the challenges and the difficulties that autism
brings to our society.
I can recall back in Mississippi, joining with families to
help raise money--have benefits, events, go on television,
invite people to attend and contribute and the like. And some
of the experiences that I had then, observing the children who
were victims of autism and talking with families, getting to
know more about it, really made a big impact on me, and how
challenging this situation really is. And so, my heart goes out
to those families who are dealing with it.
HOPE FOR THE FUTURE
And I just want to be here today to support the effort to
identify how Government can be more helpful. What are the other
possible causes for autism? What are the things that we can do?
And to continue to work, and not give up. A lot of people have
invested a lot of time and effort, research, dollars, personal
energies, to cope with this situation.
And I'm curious to know from you, Is there hope? Have we
discovered things? Have we learned things, over the last
several years that we've embarked on this joint effort, that
give us any hope that we're making progress?
Dr. Insel. Absolutely. There is always hope. But, there's--
even more than that, right now, there's very rapid progress.
And I think this next period of time is even going to be
more extraordinary, because we're ramping up the investments
very rapidly. In 2008, our budget for autism research at NIH
went up 25 percent over 2007. In 2009, it will go up much, much
more than that, because we are seeing this ARRA effort, and we
have put money specifically into an autism request for
applications though the ARRA. It's, I think, the only disease-
specific such request in the ARRA from NIH for this year. We've
got lots of other things going for the $10.4 billion, but this
is the one that does have a disease name on it. And--because we
realized that there's an urgent need, and, equally important,
there's a tremendous opportunity right now for progress. We
have the tools we need, that we can really start to move
quickly. And so, we want to do that over the next 2 years.
Senator Cochran. Well, thank you very much for your efforts
and being involved as the director of the NIMH. We appreciate
your being here with us this morning and helping us fully
understand the challenges we have ahead.
Dr. Insel. Well----
Senator Cochran. Thank you.
Dr. Insel [continuing]. Thank you for your interest and
support.
Senator Harkin. Well, thank you very much, Dr. Insel.
We would like to call our second panel. I didn't talk to
you earlier about this, but if you have the time to stay, I
would appreciate that. If you have to get back to the
Institute, I understand, but if you can stay for a second
panel, I would appreciate that.
Dr. Insel. I'd be happy to stay, and I, most of all, want
to hear the copanelists----
Senator Harkin. Good.
Dr. Insel [continuing]. Because I think all of us need to
hear some of the personal experiences----
Senator Harkin. Good. You--why don't you just stay up here,
or----
Dr. Insel. Will do.
Senator Harkin [continuing]. Stay where you are. You don't
have to move, just stay----
Senator Harkin. Let's call our----
Dr. Insel. You got me.
Senator Harkin. Let's call our second panel: Dr. Geraldine
Dawson--let's just start from left to right, as I call the
name--Dr. Geraldine Dawson, Mr. Joshua Cobbs, Ms. Nicole Akins
Boyd, David Miller, and Dana Halvorson.
Thank you all for being here. Some of you have come a great
distance. And again, your statements will be made a part of the
record in their entirety. And if you could kind of summarize--5
minutes or so--I'd appreciate it very much.
We'll just start from left to right, here. Dr. Geraldine
Dawson, the chief science officer for Autism Speaks. Prior to
that position, she was a professor of psychology and psychiatry
at the University of Washington, the founding director of the
University's Autism Center. Dr. Dawson received her Ph.D. from
the University of Washington.
Dr. Dawson, thank you very much. And please proceed. And if
you would, just summarize it in 5 to 7 minutes, that would be
appreciated.
STATEMENT OF GERALDINE DAWSON, CHIEF SCIENCE OFFICER,
AUTISM SPEAKS, CHARLOTTE, NORTH CAROLINA
Dr. Dawson. Good morning, Mr. Chairman. I want to thank you
for inviting me. I'm very honored to appear before this
subcommittee. And I want to thank the subcommittee members, and
you, Mr. Chairman, for your leadership in providing full
funding for the Combating Autism Act, and also for your most
recent fiscal year 2010 appropriations bill.
Now, this year more children will be diagnosed with autism,
as you may know, than with AIDS, diabetes, and cancer combined.
Autism research, however, is still significantly underfunded,
despite greater public and congressional awareness. For
example, leukemia affects 1 in 25,000 people, but receives
research funding of $310 million annually. Pediatric AIDS
affects 1 in 8,000 children. Its funding is $255 million a
year. Autism, as you know, affects 1 in 150 individuals, and
yet NIH funding for fiscal 2009 is estimated to be $122
million.
Now, as you've heard, most scientists agree that autism is
caused by a combination of both genetic risk factors and
environmental factors. Now, we've discovered some of the
autism-risk genes, but we still know very little about the role
of the environment and how it interacts with these genes.
We have come to understand that autism is not one disease,
but many different diseases that has many different causes, and
each cause will likely only explain a minority of cases. So,
piece by piece, we must discover each of these causes so that
effective treatments and prevention will be possible.
To identify the causes, it'll be necessary to invest in
large-scale, population-based studies that broadly examine
genetic factors and environmental triggers, such as the NIH
National Children's Study. It'll also be important to invest in
large-scale databases and bio repositories, such as the
National Database for Autism Research, the Autism Genetic
Resource Exchange, and the Autism Tissue Program.
Now, recent studies suggest that autism may be,
fundamentally, a problem of the synapse, as you've heard from
Dr. Insel, the connection between brain cells. Some of the very
best neuroscientists in the world are working hard at
understanding how genetic mutations can change the way in which
neurons communicate, and they're developing therapeutic
strategies that might restore the function of the synapse. Now,
while this work is offering real hope, the pace of discovery is
simply too slow, in large part because of lack of adequate
funding.
And we can now screen for autism at 18 months of age, and
Autism Speaks is funding several clinical trials that are
evaluating interventions for at-risk infants who are as young
as 12 months of age. The hope is that by detecting autism
early, we'll be able to reduce its severity or even prevent the
syndrome from developing. However, the impact of this work will
not be felt unless pediatricians are using the available
screening methods and parents have access to trained
professionals who can deliver these interventions.
That's why it's critical that we continue to study
dissemination methods, invest in training professionals and
caretakers, and support federally mandated insurance coverage
for behavioral interventions, which we know are cost effective
in the long run.
Now, while behavioral interventions are effective for some
individuals, most individuals with autism suffer without relief
from the autism itself and a wide range of medical conditions,
such as sleep disorders, gastrointestinal problems, and
epilepsy. Very few clinical trials have been conducted that
address these medical conditions, and virtually no cost-
effectiveness studies have been conducted to determine which
treatments are most effective. Thus, parents are left to sort
through confusing and often inaccurate information about the
various treatment options and claims, and clinicians are often
at a loss in helping parents to make evidence-based treatment
decisions. This gap in autism research must be addressed.
Very little research has been conducted today that
addresses the issues that adults with autism face, despite the
fact that adult care accounts for the bulk of the $35 billion
that is spent annually on caring for individuals with autism in
the United States. Unlike other health conditions, we have
limited information about autism health care utilization,
barriers to access, healthcare disparities in the United
States, or cost-effectiveness models.
Mr. Chairman, over the past 2 years you and your
subcommittee have been responding to the challenge of autism
with resources, and this is beginning a meaningful fight
against this very challenging disorder. But, more is needed to
better understand the disorder, to diagnose it, and to better
treat those individuals who have it.
PREPARED STATEMENT
I want to end by thanking you for your time, for your
commitment, and for your leadership, and I'm very happy to
entertain any questions that you may have.
[The statement follows:]
Prepared Statement of Geraldine Dawson
Good morning, Mr. Chairman. I am Dr. Geraldine Dawson, Chief
Science Officer of Autism Speaks. I also serve as a Research Professor
of Psychiatry at the University of North Carolina at Chapel Hill.
I am honored to appear before the Senate Appropriations Committee
Subcommittee on Labor, Health and Human Services, and Education, and
related agencies at its second hearing on autism and the status of
autism research, treatments, and services. I want to thank this
subcommittee and you, Mr. Chairman, for your leadership in providing
full funding of the Combating Autism Act (CAA) over the last 3 years,
and more specifically, for your most recent fiscal year 2010
appropriations bill.
Autism Speaks was founded in February 2005 by Bob and Suzanne
Wright, grandparents of a child with autism. Since then, Autism Speaks
has grown into the Nation's largest autism science and advocacy
organization, dedicated to funding research into the causes,
prevention, treatments and cures for autism; increasing awareness of
autism spectrum disorders; and advocating for the needs of individuals
with autism and their families. We are proud of what we've been able to
accomplish and look forward to continued success in the years ahead.
Here are a few facts about autism:
--According to the Centers for Disease Control and Prevention (CDC),
autism is diagnosed in 1 in 150 children in the United States,
and 1 in 94 boys.
--A decade ago, experts estimated the prevalence of autism to be 1 in
2,500.
--This year more children will be diagnosed with autism than with
AIDS, diabetes, and cancer combined.
--Autism costs the American economy more than $35 billion in direct
and indirect expenses each year, according to a Harvard School
of Public Health study. Caring for a child with autism is
estimated to cost over $3 million over that person's lifetime.
When Bob and Suzanne Wright founded Autism Speaks just 4 years ago,
they were shocked that a disorder as prevalent as autism commanded so
little in terms of resources devoted to research and treatment--when
compared to other, less common disorders. That disparity continues,
despite greater public and Congressional awareness, and despite the
efforts of you and this subcommittee to direct additional resources
into autism research.
--For example, leukemia affects in 1 in 25,000 people, but receives
research funding of $310 million a year.
--Pediatric AIDS affects 1 in 8,000 children; its funding, $255
million a year.
--Compare these figures with those for autism, which affects 1 in 150
children and yet the National Institutes of Health (NIH)
funding for fiscal 2009 is estimated to be $122 million.
To close the gap, Autism Speaks raises its own funds to support
autism research. We hold walks and special events, and cultivate major
giving opportunities for individuals as well as corporations and
foundations all to help accelerate the pace of autism research. We are
proud to be putting our hard-earned dollars to work to move forward in
finding a cure for autism.
Through our grants (scientist-initiated requests for funding) and
initiatives (targeted projects designed by Autism Speaks), we support
research designed to answer questions poised in each of five targeted
areas: What causes it? (etiology); What is it? (biology); How do you
know if someone has it? (diagnosis); How do we make it better?
(treatment); and How do we effectively disseminate best practices to
the community? (dissemination). Since its founding in 2005, Autism
Speaks has committed more than $130 million toward autism research.
But we realize, Mr. Chairman, that our nonprofit, no matter how
successful we may be in raising funds, cannot match the resources that
the Federal Government could marshal in the campaign to find treatments
and cures for autism. For that reason, we also worked together with
thousands of families affected by autism to introduce, pass and have
former President George W. Bush sign into law the Combating Autism Act
in December 2006. This historic act, considered by some to be the most
comprehensive piece of single-disease legislation ever passed by
Congress, authorizes appropriations of $920 million over the 5-year
period, from fiscal year 2007 to fiscal year 2011, for autism research,
surveillance, awareness and early identification.
Combating Autism Act
Mr. Chairman, let me elaborate on each of the three sections of the
CAA.
For the NIH, the funding increases are incremental, from $100
million in fiscal 2007 to an authorized level of $158 million for
fiscal 2011. Most important, the act directs NIH to spend those dollars
strategically, according to a Strategic Research Plan devised by the
Interagency Autism Coordinating Committee (IACC) with consumers and
advocates comprising a third of its membership. The act also directs
NIH to increase its investment in research into potential environmental
causes of autism.
For the CDC, whose autism portfolio would increase from $15 million
to $21 million over the 5-year span, its increased funds are targeted
for expansion of its awareness and intervention activities to reach new
parents, healthcare professionals, and healthcare providers.
The Health Resources and Services Administration (HRSA) autism
activities, which would increase from $32 million in fiscal year 2007
to $52 million by fiscal year 2011, are designated for creation of new
and innovative State-based programs in autism education, detection and
early intervention and for best practices research on autism
interventions, an area in which Autism Speaks is at the forefront
through a cooperative agreement between our Autism Treatment Network
and HRSA.
Our investment in the Autism Treatment Network, a collaborative
network of 15 hospitals providing care for children with autism, is now
being leveraged by the Federal Government through this HRSA funding and
through a developing collaboration with Dr. Susan Swedo's National
Institutes of Mental Health (NIMH) Intramural Research program on
autism. The establishment of research networks by private funders, like
Autism Speaks, has created the infrastructure that can now benefit both
HRSA and the NIH, providing significant time and cost savings. The
collaboration with the NIMH Intramural Research Program is an excellent
example of a productive public-private partnership.
Autism Speaks also recently contributed $5 million to expand and
link two NIH-funded large-scale, multi-site studies investigating
genetic and environmental risk factors for autism in 2,000 infant
siblings of children with Autism Spectrum Disorders (ASDs). These are
only a couple of examples of the many ways that Autism Speaks is
collaborating with the NIH to facilitate research on the causes and
treatment of autism.
President Obama and Autism
Congress' commitment to autism has now been matched by the
President. Last year, Mr. Obama committed to increasing ASD funding for
research, treatment, screenings, public awareness, and support services
to $1 billion annually by the end of his first term in office. He also
pledged to end insurance discrimination against people with autism. (Of
course, Autism Speaks is now working to bring this promise to fruition
through the healthcare reform process.)
President Obama fulfilled his campaign promises in the fiscal year
2010 budget he submitted to Congress in February of this year. That
budget includes $211 million in Department of Health and Human Services
(HHS) funding for research into the causes of and treatments for ASD,
screenings, public awareness, and support services.
Appropriation's Leadership
The authorizations and Presidential budgets will mean little if not
matched by real dollars appropriated by your subcommittee, Mr.
Chairman. And you have done a heroic job of identifying and targeting
the resources to match the authorization targets set by the Combating
Autism Act for HHS's autism activities.
In your fiscal year 2008 and 2009 bills, the Senate Appropriations
Committee matched or beat the CAA authorized levels for CDC and HRSA.
And in each of those years, you also provided the resources to NIH to
create and fund the operational costs of the IACC, and to adhere to the
research funding targets set by the Combating Autism Act. As of just
last week, the Senate Appropriations Committee fiscal year 2010 bill
provides $71 million for CDC and HRSA's autism activities, the same
levels proposed by the President.
On behalf of Autism Speaks, I also want to thank you for ensuring
that $2 million of the increase proposed for HRSA's autism activities
will be targeted for expansion of research on evidence-based practices
for interventions for individuals with autism and other developmental
disabilities, for development of guidelines for those interventions,
and for information dissemination, as directed by the CAA. As I
mentioned earlier, this program, in particular, is already being
leveraged to the benefit of other Federal research.
State of Autism Research
Causes of Autism.--Most scientists agree that autism is caused by a
combination of genetic susceptibilities which interact with
environmental risk factors. We have learned that autism is a complex
genetic disorder involving many genes. In recent years, studies have
shown that several rare mutations confer significant risk for autism.
While we have discovered some of the risk genes for autism, we still
know little about the potential environmental risk factors. We also
have come to understand that there are many different causes of autism,
and that any one cause will likely only explain a minority of cases.
Piece by piece, we must discover each of these causes so that effective
treatments and prevention will be possible.
To identify the genetic and environmental risk factors for autism,
it will be necessary to conduct large scale population-based studies
that broadly examine both genetic susceptibilities and environmental
exposures. The NIH National Children's Study, a prospective
longitudinal study of 100,000 children in the United States,
potentially provides such an opportunity and should be fully utilized
to increase our understanding of autism. Autism Speaks is currently
advising the staff of the National Children's Study on ways the study
could be leveraged to better understand how genetic and environmental
risk factors may increase risk for autism. Autism Speaks also is
funding expansion of two NIH-supported Autism Center of Excellence
Network studies to include the capture of a number of environmental
exposures and the analysis of how they interact with genetic
vulnerability. In addition to funding large scale studies of risk
factors, continued investment in large-scale databases and
biorepositories, such as the National Database for Autism Research, the
Autism Genetic Resource Exchange, and the Autism Tissue Program, will
be crucial for understanding the causes of this complex disorder. By
identifying the causes, we will be able to identify individuals at risk
for the disorder as early as possible and develop methods for treating
and preventing autism.
Biological Mechanisms.--We are also gaining an understanding of the
underlying biological mechanisms in autism. Evidence is converging that
autism may be fundamentally a problem of the synapse, the connection
between brain cells (neurons). Neuroscientists are mapping the
biochemical pathways that appear to be disrupted in autism and that are
interfering with how neurons in the brain communicate with each other.
Some of the very best neuroscientists in the world are working hard at
understanding how genetic mutations can change the way in which neurons
communicate and developing therapeutic strategies that might restore
synaptic function. While this work is offering real hope, the pace of
discovery is simply too slow in large part because of a lack of
adequate funding for such research. Barriers to translational science
that can bring basic findings from the bench to the bedside are
significant. The gulf between a basic discovery and the development of
a new treatment is so overwhelming that it has been called ``a valley
of death'' by some scientists. Scientists are ill-equipped to develop
the technologies that are required for translational research, and
funding of such research is often a lower priority relative to
discovery-focused research at the NIH. Thus, translational research
must be supported through multi-disciplinary collaboration and targeted
funding to support technological and scientific advances that will help
pave the way to treatment, prevention, and cure. This is why Autism
Speaks strongly supports Senator Specter' s ``Cures Acceleration
Network'' (CAN Act) and hopes that the policies addressed in that bill
will be incorporated into the final healthcare reform legislation.
It will be crucial for the Federal Government to provide the
necessary resources needed to move scientific discovery from the lab to
the clinic. Autism Speaks is poised to help in this process not only
with scientific grants, but also with our support for the large
scientific databases, such as the Autism Genetic Resource Exchange, and
collaborative networks that are capable of conducting clinical research
and disseminating evidence-based methods, such as the Autism Treatment
Network and the Clinical Trials Network.
Early detection and early behavioral intervention. Two areas in
which we have made significant progress in the past several years are
early diagnosis and early intervention. Screening methods for autism
now exist for children as young as 18 months of age, and the American
Academy of Pediatrics now recommends that all babies be screened for
early signs of autism at 18 and 24 months of age. Autism Speaks and the
NIH are funding several studies focused on detecting autism in even
younger infants. Building on these important findings, researchers have
developed a variety of protocols to intervene at early ages, and Autism
Speaks is funding several clinical trials that are evaluating the
efficacy of these intervention methods for infants as young as 12
months of age. The hope is that, by detecting autism early in life
before the full syndrome has become manifest, we will be able to reduce
its severity or even prevent the syndrome from developing. However, the
impact of this work will not be felt unless pediatricians are using the
available screening methods and parents have access to trained
professionals who can deliver these interventions. That is why it is
critical that we continue to study dissemination methods, invest in
training professionals and caretakers, and support federally mandated
insurance coverage for behavioral interventions which are very cost
effective in the long run.
Treatment Across the Lifespan.--While behavioral interventions are
effective for some individuals, there is significant individual
variability in response to such interventions. Biological research is
offering hope that medical interventions that address core symptoms of
autism will someday be available. Today, however, many individuals with
autism suffer without relief both from the autism itself and also from
a range of medical conditions that are associated with autism, such as
sleep disorders, gastrointestinal problems, epilepsy, anxiety, and
depression. Very few clinical trials have been conducted that address
these co-morbid medical conditions. Practice standards that can guide
physicians on how to detect, assess, and treat these conditions do not
exist. Virtually no comparative effectiveness studies have been
conducted to evaluate which treatment methods are more effective for
treating core autism or its associated conditions. Thus, parents are
left to sort through confusing and often inaccurate information about
various treatment claims and options. Without the benefit of
comparative effectiveness research, clinicians are often at a loss in
helping parents make evidenced-based treatment decisions. This is a gap
in autism research that must be addressed.
It is imperative that enhanced effort be directed toward developing
effective treatments across the entire lifespan. Very little research
has been conducted to address the issues that adults with autism face,
despite the fact that adult care accounts for the bulk of the $35
billion that is spent annually on caring for individuals with autism in
the United States. Unlike other health conditions, we have very limited
information about autism healthcare utilization, barriers to access,
health care disparities in the United States, or cost-effectiveness
models.
A major barrier to appropriate treatment for individuals with
autism is lack of access to well-trained providers. Research must
identify the most effective, scalable, and feasible models for
community-based delivery of services. This will require identifying
factors that impede or promote the adoption of optimal practices.
Training and capacity-building are needed to increase the number of
well-trained professionals, including physicians and allied health
professionals, such as nurses, psychologists, and educators, as well as
physical, occupational, and intervention therapists.
In summary, it is clear that the insights we have gained have
resulted directly from investments in scientific research on autism.
However, without further and increased investment in science, our
progress will be very slow. The IACC Strategic Plan for Autism Research
has benefited greatly from input from the autism community, including
private funding agencies. The IACC conducted a portfolio analysis of
public and private autism research to enable future iterations of the
Strategic Plan to build on existing research. We have seen how
important this coordination and collaboration has been, and we must, as
a community, continue to insist on it. The Strategic Plan was completed
in January 2009, so it remains to be seen how closely it will be
followed by the NIH with respect to research support. But I am hopeful
that the collaboration between public and private funders of autism
research will result in significant and innovative research that
advances our understanding of the causes, prevention methods,
treatments, and a cure for autism.
Next Steps
Mr. Chairman, the challenge of autism and its impact on our
children, our families, and our Nation are daunting, and the plans of
Autism Speaks are equal to the task.
In the short term, we are focused on ensuring that Congress matches
in its appropriations bills the authorized levels for HHS's autism
research, surveillance, education and treatment set by the Combating
Autism Act over the next 2 fiscal years. We are also planning for the
reauthorization of the Combating Autism Act which is set to expire on
September 30, 2011.
We have also been working on the next phase of the autism agenda--
the provision of enhanced treatment, support, services, and research
for individuals with ASD. That effort, which began with preliminary
discussions with then-Senator Barack Obama, has produced the Autism
Treatment Acceleration Act of 2009 (ATAA), introduced in the Senate by
Senator Richard Durbin (S. 819) and in the House by Congressman Mike
Doyle (H.R. 2413). The ATAA includes a number of key authorizations,
including Autism Care Centers and an Adult Services Demonstration, a
population-based autism spectrum disorders registry, a National Network
for ASD Research and Services, and most important, a requirement that
health insurers cover diagnostic assessment and treatments for autism,
including Applied Behavioral Analysis therapy. Of course, we are making
every effort to see to it that this insurance component of the ATAA
becomes law as a component of healthcare reform.
The Continuing Challenge
At the Senate Labor-HHS Subcommittee's first hearing on autism in
April 2007, Autism Speaks co-founder Bob Wright issued a challenge to
Congress and our Nation, when he stated:
``The public health crisis posed by autism requires an
extraordinary response. With every new child diagnosed with autism
costing an estimated $3 million over his or her lifetime, we cannot
afford to rely on standard, `business as usual' practices. The autism
crisis demands a focused, coordinated, and accountable response by our
public health agencies, similar to the federal response to the AIDS
crisis in the 1990s, with line-item appropriations for autism
intervention, surveillance and research tied to a strategic plan.''
Mr. Chairman, over the past 2 years, you and your subcommittee have
met this challenge and responded to autism not with promises, but with
resources to begin a meaningful fight against this public health
crisis.
But more is needed to better understand the disorder, to better
diagnose it, to better treat those children who have it, and ultimately
to find cures for this spectrum of disorders. We do not need only to
ramp up the NIH's investment in autism research, we also need to ensure
that every dollar spent on this disorder is targeted and maximally
impactful.
Thank you, Mr. Chairman, for your time, for your commitment, and
for your leadership.
Senator Harkin. Thank you very much, Dr. Dawson.
And before we go on with the rest of the panel I want to
recognize my good friend and colleague, from Pennsylvania, with
whom I've shared the gavel here over the last almost 20 years.
Senator Specter is a member of the Judiciary Committee; they
are over on the floor now with the Sotomayor nomination, so he
may have to go to the floor. And, I would yield to Senator
Specter.
STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Well, thank you, Mr. Chairman, for
yielding. We're taking up the confirmation hearing of Judge
Sotomayor for Supreme Court, and I'm due on the floor shortly,
but I wanted to thank you, Mr. Chairman and Ranking Member
Cochran, for scheduling this hearing on this very important
subject, and thank the witnesses for coming in.
Autism is a heartbreaking ailment, and of the many issues
we have to face, among the toughest, talking to parents who
have children who suffer from autism, and there's a real
question of doing more.
Senator Harkin and Senator Cochran and I have worked hard
on funding for the NIH, and for a decade we were able to raise
funding from $12 to $30 billion, at a time when Senator Harkin
and I have transferred the gavel, Senator Cochran was chairman
of the full Appropriations Committee; and regrettably, that's
not enough. I note that funding for autism was slightly under
$52 million in 2000, up to $122 billion--million now, and
estimated to $141 million, and CDC's spending has increased
from a little over $1 million to a little over $22 million. We
have been successful in getting into the stimulus package $10
billion, as you doubtless know, and it is my projection that
some of that will be going to autism.
These funding levels were set by NIH in order to avoid what
we call ``politicization.'' Our job is to get the money, but
not to distribute it. And I think there ought to be a bigger
share for autism, and we're pushing to make that happen.
And on comprehensive healthcare reform, which we're working
on now, we're trying to get $10 billion added, as a base of
30--start with 40--which would give us a better opportunity to
do more on this very, very important ailment.
So, I wanted to express those views today. And staff will
be here to follow the testimony. We'll have a chance to review
it.
I appreciate your coming in. And you have our assurances
that we'll do everything we can on this very important malady.
Thank you, Mr. Chairman.
Senator Harkin. Thank you very much, Senator Specter. And I
understand you have to be on the floor for the nomination.
And now we'll go to Mr. Cobbs.
Mr. Cobbs, if I remember right you're from Iowa, up near
Sioux City.
Mr. Cobbs. Yes, sir, I grew up in the Sioux City area, of
course.
Senator Harkin. And you're the chairman of the Iowa Autism
Council, the father of a 9-year-old boy with autism, Noah. I
understand your wife, Tina, is with you here.
Mr. Cobbs. She's in the audience.
Senator Harkin. Okay. And two other children--Ethan, 16,
and Sidney, 8. And you were here at our last hearing. Weren't
you here a couple of years ago?
Mr. Cobbs. I was, sir, I was in the audience in the last
hearing.
Senator Harkin. And you've been involved in the telehealth
project with a young boy, with Noah, right?
Mr. Cobbs. Yes. Yes. Correct, sir.
Senator Harkin. Well, I'm interested in, what's happened in
the last couple of years. So, welcome to the subcommittee.
Please proceed.
STATEMENT OF JOSHUA COBBS, CHAIRPERSON, IOWA AUTISM
COUNCIL, SIOUX CITY, IOWA
Mr. Cobbs. Thank you for having me.
Good morning, Mr. Chairman and members of this
distinguished subcommittee. My name is Joshua Cobbs. I am the
chairperson of the Iowa Autism Council, a parent advisor to
Cnow, and, most importantly, a parent of a child with autism.
I've spent over 7 years trying to better the lives of
individuals and families affected by autism, through insurance
and education reforms. When I was last in front of this
distinguished committee, I spoke of the successful and cost-
efficient services my son received using telehealth technology.
These services were provided in my home, in Iowa, from
professionals in Florida, through the Celeste Foundation's
federally sponsored National Research Project. We are one of 15
families that participated in this demonstration across the
nation.
In this model, after a brief phase of onsite, face-to-face
training, which is crucial to build a therapeutic relationship,
we were linked to professionals by an interactive video system
that enabled live training, consultation, and support directly
into our home, when and where we needed it. Through this
telehealth model, we receive professional support in teaching
our son language, life skills, and, overall, improving his
quality of life.
One of the main components of participating in this study
was the reduction in our family stress through empowering us as
front-line teachers and therapists. Additionally, through
training and education in this project, we had a better
understanding of our child's condition and those things we
could do--could bring to bear to improve his life.
Not only did it improve my son's quality of life, but it
had an impact on my life--on my family, as well. Also, as a
family we showed a dramatic reduction in stress, anxiety, and
became more focused as a family unit.
I'll never forget the call my--I will never forget the call
from my wife, saying, ``You'll never guess what our son did. He
went potty on the big-boy potty.'' This moment was a monumental
moment for the entire family. While many consider toilet
training a milestone, it becomes a super-milestone when your
child is 5 years old with autism and has the additional burden
of societal rejection. Through our telehealth connections and
access to certified professionals, we were given the right
teaching skills and able to achieve what previously was
unobtainable.
Our experience was chronicled in a two-part series filmed
by the CBS affiliate in Sioux City, Iowa, and aired during
Recognition of Autism Awareness Month. We have copies of the
footage that we would like to share with the subcommittee, and
it can also be viewed at www.CelesteFoundation.org.
I cannot stress enough that the needs of a--of persons with
autism do not conveniently conform to clinic hours or
professional appointments. We were able to access these
professionals' health when we needed it, and it made all the
difference. Also, just having the support in my home allowed
natural interaction for my son, and allowed the professionals
to see the behaviors as they really occur.
As chairperson of the Iowa Autism Council, I have the
opportunity to speak with many family members and stakeholders
within the autism community to learn their needs. From my
perspective and my experience, these families are desperately
in need of services.
Today, as parents search online for appropriate telehealth
services for their children, they are confronted with an array
of unvalidated technologies and various individuals claiming
expertise in treatment. Unfortunately, there are no safeguards
for--in place to protect vulnerable parents and children.
For example, from anywhere in the world, anyone with a
personal computer, a Web cam, and Internet access can offer
video services termed as ``advice.'' Under these circumstances,
any individual or group can claim qualifications in helping
parents and children with autism. Not only are families
experiencing the emotional burden of treating a child with a
disability, but they also have the financial burden of paying
for this treatment, with no assurance as to the quality of care
provided. When individuals or organizations that are collecting
fees for services can distance themselves into the cloud that
is the Internet, what can families expect for recourse to
failed expectations?
The reality of standard-setting is evidence--is evident,
because, without standards there can be no reimbursements.
While the method and systems are cost effective, without a
proper reimbursement model they still remain unobtainable for
most parents, who, similar to the rest of the nation, are
struggling financially to find care for their children.
There are millions of dollars being placed into rural
telehealth networks. However, there are few, if any,
methodologies for reimbursement for autism telehealth
treatments. Additionally, the current wave of statewide health
insurance requirements, aimed to provide reimbursements for
individuals with autism, do not have well-defined standards for
telehealth reimbursements. In absence of consistent
reimbursement policy and standards, families and children are
not granted access to proven and effective care.
I know this subcommittee, through report language, has
recognized the need to assess, quote, ``best practices and
professional criteria standards, and to make recommendations to
the committee concerning national standards for telehealth
reimbursement, which advances and encourages this technology,''
end quote. I commend the committee's foresight in doing so, and
simply urge that this momentum continues.
In closing, you may be wondering how my son is doing today.
He's now 9 years old, and my family is still utilizing
telehealth technology. We are currently addressing such
behaviors as food selectivity, expressive language, academic
skills, just to name a few. It is important to note that, as my
son grows, his treatment program continues to grow and address
his ever-evolving needs. We continue to use telehealth
treatment because it's been an effective delivery system for
our family. In fact, it has been so effective that now my 8-
year-old daughter has become a mini-therapist, using teaching
strategies that we learned in the telehealth program with my
son.
PREPARED STATEMENT
At this point in my son's life, he continues in the role of
student and teacher to us all. Indeed, his future is bright.
I'd like to thank you for your time and the opportunity to
share our story, and the stories of thousands of families, here
today.
Thank you.
[The statement follows:]
Prepared Statement of Joshua Cobbs
Good morning, Mr. Chairman and members of this distinguished
subcommittee. My name is Joshua Cobbs. I am the Chairperson of the Iowa
Autism Council, a Parent Board member of the Iowa Association for
Behavior Analysis, the Autism Speaks Chapter Advocacy Chair for Iowa,
the Co-Chair of Marketing and Fundraising for the Siouxland Autism
Support Group, a Chapter of the Autism Society of America, a Parent
Advisor to Cnow and most importantly, the parent of a child with
autism. I have spent over 7 years trying to better the lives of
individuals and families affected by autism by working on education and
insurance reforms.
When I was last in front of this distinguished subcommittee I spoke
of the successful and cost-efficient services my son and family
received using telehealth technology. These services were provided in
my home in Iowa from qualified professionals in Florida through the
Celeste Foundation's federally funded national research project. We
were 1 of 15 families that participated in this demonstration across
the Nation. In this model, after a brief phase of on-site, face-to-face
training (which is crucial to build a therapeutic relationship), we
were linked to professionals by an interactive video system that
enabled live training, consultation and support directly into our home
when and where it was needed. Through this telehealth model, we
received professional support in teaching our son language, life
skills, and overall improving his quality of life. One of the main
components of participating in this study was the reduction in our
family stress through empowering us as frontline teachers and
therapists. Additionally, through training and education in this
project we had a better understanding of our child's condition and
those things we could bring to bare to improve his life. Not only did
it improve my son's quality of life, but it had an impact on my family
as well. Also, as a family we showed a dramatic reduction in stress,
anxiety and became more focused as a family unit.
I will never forget the call from my wife saying, ``You'll never
guess what our son did, he went potty on the big boy potty!'' This was
a monumental moment for the entire family. While many consider toilet
training a milestone, it becomes a super-milestone when you're child is
5 years old with autism and has the additional burden of societal
rejection. Through our telehealth connections and access to certified
professionals, we were given the right teaching skills and able to
achieve what previously was unobtainable. Our experience was chronicled
in a two part series filmed by the CBS affiliate in Sioux City, Iowa,
and aired during recognition of Autism Awareness Month. We have copies
of this footage that we would like to share with the subcommittee and
it can also be viewed at www.celestefoundation.org.
I can not stress enough that the needs of persons with autism do
not conveniently conform to clinic hours or professional appointments.
We were able to access these professional's help when we needed it and
it made all the difference. Also, just having the support in my home
allowed natural interaction for my son and allowed the professionals to
see the behaviors as they really occur.
As chairperson of the Iowa Autism Council, I have the opportunity
to speak with many family members and stakeholders within the autism
community to learn their needs. From my perspective and my experience,
these families are desperately in need of services. Today, as parents
search online for appropriate telehealth services for their children,
they are confronted with an array of unvalidated technologies and
various individuals claiming expertise in treatment. Unfortunately,
there are no safeguards in place to protect vulnerable parents and
children. For example, from anywhere in the world anyone with a
personal computer, a webcam and Internet access can offer video
services termed as ``advice''. Under these circumstances, any
individual or group can claim qualifications in helping parents and
children with autism. Not only are families experiencing the emotional
burden of treating a child with a disability, but they also have the
financial burden of paying for this treatment with no assurance as to
the quality of care provided. When individuals or organizations that
are collecting fees for services can distance themselves into the
``cloud'' that is the Internet, what can families expect for recourse
to failed expectations?
The reality of standard setting is evident because without
standards there can be no reimbursements. While the method and systems
are cost effective, without a proper reimbursement model they still
remain unobtainable for most parents who, similar to the rest of the
Nation, are struggling financially to find care for their children.
There are millions of dollars being placed into rural telehealth
networks. However, there are few, if any, methodologies for
reimbursement for autism telehealth treatments. Additionally, the
current wave of state-wide health insurance requirements aimed to
provide reimbursements for individuals with autism do not have well-
defined standards for telehealth reimbursements. In the absence of
consistent reimbursement policies and standards, families and children
are not granted access to proven and effective care.
I know this subcommittee, through report language, has recognized
the need to assess ``best practices and professional criteria standards
and to make recommendations to the Committee concerning national
standards for telehealth reimbursement which advances and encourages
this technology.'' I commend the Committee's foresight in doing so and
simply urge that this momentum continues.
In closing, you may be wondering how my son is doing today. He is
now 9 years old and my family is still utilizing telehealth technology.
We are currently addressing such behaviors as: food selectivity,
expressive language, academic skills, etc. It is important to note that
as he grows, my son's treatment program continues to address his ever
evolving needs. We continue to use telehealth treatment because it has
been an effective delivery system for our family. In fact, it has been
so effective that now my 8-year-old daughter has become a mini-
therapist using teaching strategies learned in the telehealth program
with my son. At this point in my son's life he continues in the role of
student and teacher to us all. His future is bright. Thank you.
Senator Harkin. Thank you very much, Mr. Cobbs. We'll have
some questions for you later.
And now, we turn to Ms. Nicole Akins Boyd, vice chairman of
the Mississippi Autism Task Force, an attorney, mother of two
children. Her second child--``Spite?''
Ms. Boyd. ``Spate.'' [Speight]
Senator Harkin. Sorry for mispronouncing that--her son
Speight developed regressive autism at around 22 months of age.
She was recently appointed to Mississippi's Department of
Education, Special Education Advisory Committee. Ms. Boyd
attended Mississippi State and received her Juris Doctor degree
from Ole Miss.
Welcome to the subcommittee. Please proceed.
STATEMENT OF NICOLE AKINS BOYD, J.D., VICE CHAIRMAN,
MISSISSIPPI AUTISM TASK FORCE, OXFORD,
MISSISSIPPI
Ms. Boyd. I want to thank this subcommittee, on behalf of
the many Mississippians and families with autism I represent,
and Senator Cochran's leadership as he's held meetings with
many of us throughout the State of Mississippi.
In late fall of 2005, our family was living in San Antonio,
Texas, while my husband completed his surgical fellowship. My
youngest child, Speight, at the age of 22 months, developed
regressive autism. Almost overnight, he digressed, from using
words and sentences in two languages, with fine gross motor
coordination well above his developmental peers, to someone who
lost almost all of those skill sets. It was as though a tornado
had hit our lives, and there was no end in the foreseeable
future.
At age 25 months, my son began a rigorous program filled
with behavioral, speech, and occupational therapy that has
continued after our move back to Mississippi. Currently, we can
see progress, and we're cautiously optimistic about the future.
He's quite verbal, and his gross and fine motor skills have
greatly improved. His medical condition is always tenuous, as
he's believed to suffer from a mitochondrial disorder which is
proposed to be a contributing factor to his autism. Simple
viruses will turn this very high-functioning child--on the
spectrum--to a low functioning child within just a matter of
hours.
Today, he will attend his kindergarten open house at
Bramlett Elementary, in Oxford, Mississippi. He'll attend a
regular education class, and he'll have some classroom and
resource assistance. As the class of 2022 starts kindergarten,
schools across this country are going to look very different.
Twenty years ago, in this country, Speight would have probably
been the only child in his kindergarten class with autism, or
even his whole school district. However, his kindergarten class
of roughly around 200 students will have 6 children diagnosed
with the autism spectrum. All are very high functioning. If you
do the math, that's roughly 1 in 34.
Now, in Mississippi, according to the surveys we did on the
task force, we know that children typically don't get diagnosed
until much later than 5, so that number is probably going to be
higher. This is a very high number compared to what we see as
national statistics, but, unfortunately, I think you will see
this number replicated in kindergartens throughout this country
in various places. We know that the rate of autism goes up 10
to 17 percent per year, so it--this next decade, can you
imagine what autism is going to look like?
The medical establishment, as it often is, gives itself a
pat on the back for saying they're doing a better job
diagnosing this, but we know there's got to be contributing
factors that are the root of this autism increase. It does--
better diagnosis doesn't completely explain the explosion that
we're seeing here in America.
What--oftentimes--we see adversarial relationships develop
between pediatricians and family members who believe that their
autism was caused by vaccines. We see, also, relationships--
adversarial--when parents don't accept the advice of physicians
that there could be multiple causes of the autism. And thus, we
reach an impasse, and help for the child, as you pointed out,
Mr. Harkin, is very hard to come by.
The Autism Society of America currently estimates that the
lifetime cost of caring for a child with autism is from $3.5 to
$5 million. Taking those numbers, we're looking at facing
almost a $90 billion annual cost in autism. The question that
we have to ask this subcommittee, and this whole Senate body,
is, Can we afford not to put the money into research and
treatment if these are the numbers that we're looking at?
The Combating Autism bill brought great hope to parents,
and we appreciate your work in passing that. However, we've got
to move quicker. We've got to see the Interagency Coordinating
Committee look at all aspects and possible causes to autism.
We've also got to see that subcommittee quickly make some
identifiers and look at populations of these children to find
out, What are the general pictures that we see of these
children's parents, their family members? What are some health
indicators that we see? And it's got to be done quicker than we
usually operate at Government bureaucracy levels.
The other thing, too, I would be remiss in representing the
parents that I feel like I represent, even across this country,
if I did not go back to your question, Senator Harkin. We have
to look at the causal--causation with vaccines. Dr. Bernadine
Healy, who I'm sure has testified before this subcommittee
many, many times and really doesn't have any financial
interest, pecuniary or otherwise, has noted that there is a
dearth of research in truly looking at the vaccine-autism
connection. There are some very good studies that are yet to be
done. And I know this subcommittee, and this Senate, doesn't
like to tell the NIH how to spend those research dollars, but
on behalf of the parents across America, I ask that you
particularly look at this, particularly when you're confirming
a new NIH director.
I want to give you some optimism that--as we talk about
autism. In this classroom--in the children--Bramlett Elementary
group of six, five of those children have been blessed to be
able to receive intensive behavioral therapy. Their families
have--one of the situations, they've taken two jobs to be able
to afford this intensive behavioral therapy. That's not often
the case in Mississippi. And that's a rarity. With
Mississippians, the average annual income is less than $35,000
a year, and yet this private intensive behavioral therapy runs
most of us around over $50,000 a year. So, it is impossible for
many of the constituents back home to afford the therapy that
they know will make their child better.
So, on behalf of those Mississippians, I beg you to look at
ways that we can afford intensive behavioral therapy for all
children. These children, that I mentioned, that have received
this intensive behavioral therapy, even at the age of 5, they
already are requiring less classroom supports than they would
have. It is--you can see the financial bright spots, down the
road, of investing in early intensive behavioral therapy.
PREPARED STATEMENT
So, the question I guess I will leave you with is, If we
know that we are looking at a $90 billion annual healthcare
cost, and we're looking--and I put the information that--I've
turned in to you--and we're looking at initial investments of
around $32,000 a year, and we know that, over that child's
life, we can see healthcare returns roughly at about $2.5
million of healthcare savings for those children who get this,
the question is, Senators, ``Can we afford not to make that
investment?''
[The statement follows:]
Prepared Statement of Nicole Akins Boyd
In the late fall of 2005 our family was living in San Antonio,
Texas, while my husband completed his surgical fellowship. My youngest
child, Speight at around the age of 22 months developed regressive
autism. Almost overnight he digressed from using words and sentences in
two languages with fine and gross motor coordination well ahead of
developmental milestones to a child who lost nearly all language with
impaired neuromuscular control. It was as if a tornado had hit our
lives with no end in the foreseeable future to the destruction.
At age 25 months Speight began a rigorous program filled with
behavioral, speech, and occupational therapy that has continued after
our move to Mississippi. Currently, we can see progress and are
cautiously optimistic about the future. He is quite verbal and his
gross and fine motor skills have greatly improved. His medical
condition is always tenuous as he is believed to suffer from a
mitochrondrial disorder which is proposed to be a contributing factor
for his autism. Simple viruses will turn a high functioning child on
the spectrum to a low functioning child within a matter of hours.
Today, he will attend his kindergarten open house at Bramlett
Elementary in Oxford, Mississippi.
Speight will attend a regular education class and will have some
classroom and resource assistance. As the class of 2022 starts
kindergarten, schools across this country will look very different.
Twenty years ago in this country Speight would have probably been the
only child in his kindergarten class or even his school with Autism
Spectrum Disorder (ASD). However, his kindergarten class of around 200
students will have 6 children diagnosed with ASD. If you are trying to
do the math that is roughly 1 in 34. In Mississippi, a small survey
conducted by the State task force indicated that many Mississippi
children are often not diagnosed before age 5 and therefore it is
probable this number may go even higher. Although this number of 1 in
34 may be somewhat of an anomaly, it is unfortunately less of an
anomaly than we would all like to believe in the kindergarten classes
around this country.
The February 2007 Centers for Disease Control and Prevention Autism
Prevalence Report was of no surprise to Americans or those of us in
Mississippi living with the effects of ASD. The report, which looked at
a sample of 8 year olds in 2000 and 2002, concluded that the prevalence
of autism had risen to 1 in every 150 American children, and almost 1
in 94 boys. Based on the statistics from the U.S. Department of
Education and other governmental agencies, autism is growing at a rate
of 10 to 17 percent per year. At this rate in the next decade the
prevalence of autism could reach 4 million Americans. Indeed, the class
of 2022 will look very different.
Despite the fact the incidence of autism has risen almost 6,000
percent since the 1980s, we have yet to clearly define why there has
been such a dramatic increase. The medical establishment, as is often
the case, gives credit to itself by stating that better diagnoses is
the root cause of the increase. However, this does not completely
explain the explosion of autism in America. Currently, there is no
``mainstream'' medical treatment for autism. Yet, there are more camps
and theories that have lined up in this debate than mosquitoes in
Mississippi. And yes, all are lined up in the name of science and of
``helping my child.''
Everywhere a parent turns there are those telling them the
``reason'' their child has autism as if they had been whispered a
reason by God on high. Parents who believe that vaccines harmed their
children have been marginalized by their pediatricians when their have
been clear clinical vaccine reactions that propel children into
autistic behavior. Physicians who try to suggest a multiple set of
reasons for autism are ignored and rebuffed by their patient's
families. An adversarial relationship is thus created, leading to an
impasse in determining why my child developed autism and what the
underlining medical conditions that prevent his full recovery.
Moreover, we also do not know how we keep your children and
grandchildren from suffering the same fate.
As parents we appreciate that Congress has devoted attention to
autism, starting with the Children's Health Act of 2000, now almost a
decade ago. But, after so many words and so many years, it's absolutely
clear that autism is still woefully under funded by the National
Institutes of Health compared to the prevalence and the costs to our
society of the condition. The Autism Society of America currently
estimates that the lifetime cost of caring for a child with autism
ranges from $3.5 million to $5 million, and that the United States is
facing almost $90 billion annually in costs for autism.
For parents, the passage of the Combating Autism Act (CAA) brought
great hope that research would begin promptly in identifying children
at greater risk for developing the disorder and whether there were sub-
populations more predisposed to have ASD children. Yet, to date
research has failed to make those clear identifications. Parents and
autism professionals are voicing their frustration with the speed or
lack thereof with The Interagency Autism Coordinating Steering
Committee that is responsible for disbursing the millions of dollars in
CAA funds. For parents, this subcommittee looks like the height of
Washington bureaucracy.
The parents of ASD children were thrilled this last year when
autism became a major issue for both parties in the Presidential
campaign. And this year when President Obama became the first President
ever to specifically call for a significant increase in autism research
in his budget, this subcommittee did not ratify that policy. I
understand Congress's reluctance to mandate NIH dollars for specific
research. However, you will understand that parent's confidence is
lacking in an entity where their biggest highlight on their ``Health
Publications about Autism and Related Disorders'' web page is about
dental and oral care of the special needs population. Parents want more
than how to brush and care for our kid's teeth.
On behalf of parents, I am asking this subcommittee in the future
to be very explicit to the NIH in how research dollars are spent for
autism. We want the questions answered that identify children more
likely to develop autism by looking at the current parents of ASD
children. Also, we want the true research questions answered on
vaccines and autism that have been pointed out by Dr. Bernadine Healy,
the former director of the NIH.
For the population of children already with ASD we know certain
behavioral therapies can greatly diminish a child's autism. Let's look
back at my son's kindergarten class and these ``Bramlett 6.'' For the
``Bramlett 6'' there are signs of optimism. Five of the six children
with ASD have been fortunate enough to receive private behavioral
therapy. Studies have shown that as many as 47 percent of the ASD
children that undergo early intensive behavioral therapies achieve
higher education placement and increased intellectual levels in
programs that use the science of Applied Behavior Analysis (ABA). The
2001 U.S. Surgeon General's Report on Mental Health states, ``Among the
many methods available for treatment and education of people with
autism, ABA has become widely accepted as an effective treatment.
Thirty years of research demonstrated the efficacy of applied
behavioral methods in reducing inappropriate behavior and in increasing
communication, learning, and appropriate social behavior.'' A
significant portion of children who receive ABA are placed into
mainstream/regular educational settings. These results have been shown
to last well beyond the end of treatment. In addition, when implemented
intensively and early in life (beginning prior to the age of 5 years),
ABA may produce large gains in development, reduce in the need for
special services and forego costly intensive special education in the
future.
Although these ``Bramlett 6'' are still not finished with this
therapy, you can already see positive signs from the intensive
behavioral intervention. One child went from hiding under a table in a
complete meltdown due to overstimulation at another child's birthday
party to being the center of attention at her own birthday party just 6
months after intensive therapy was initiated. For the ``Bramlett 6''
needed classroom supports are already decreasing from their pre-
kindergarten years. It is easy even at this very early age to
understand why the investment in intensive therapy is critical.
A February 2009 report from Autism Speaks on Arguments in Support
of Private Insurance Coverage of Autism Related Services notes:
``A 1998 study by John W. Jacobson and others titled, Cost-Benefit
Estimates for Early Intensive Behavioral Intervention for Young
Children with Autism--General Model and Single State Case, examined the
cost/benefit relationship of early intensive behavioral intervention
treatment at varying levels of treatment success. The study used
estimates of costs for early intensive behavioral interventions (EIBI)
from childhood (age three) through adulthood (age 55) based on prices
in the Commonwealth of Pennsylvania and compared these costs with the
expected amount of income the child would earn later in life to arrive
at an estimated cost savings. With a success rate of 47 percent for
early intensive behavioral intervention therapy (as determined by
Lovaas), Jacobson's study found that cost savings per child served are
estimated to be from $2,439,710 to $2,816,535 to age 55.
The study also accounts for the initial investment in early
intervention by concluding that, with an initial annual cost of
$32,820, the total cost-benefit savings of EIBI services per child with
autism or PDD for ages 3-55 years averages from $1,686,061 to
$2,816,535 with inflation.''
Additionally the report found:
``According to a 2005 Government Accounting Office (GAO) report,
`the average per pupil expenditure for educating a child with autism
was more than $18,000 in the 1999-2000 school year. This amount was
almost three times the average per pupil expenditure of educating a
child who does not receive any special education services.' ''
Investments into this intensive therapy will, in the long run pay
benefits, both economic and social, to the greater population. However
in Mississippi this intensive therapy is not an option for all
concerned parents. These ``Bramlett 6'' are a rare story in
Mississippi. The Mississippi autism task force noted:
``At present, funding for comprehensive treatment must be provided
privately in most instances by families as there is limited
governmental or insurance support. The average cost for a privately-
contracted comprehensive treatment plan is well over $50,000.00 a year.
When the average Mississippi family only makes $34,343.00 annually
according to the 2006 U.S. Census Bureau, the amount of financial
stress is overwhelming for parents trying to provide private therapy
for their child with ASD.''
One autism mother (who had private health insurance) noted to
Mississippi's task force: ``The part of this disease that makes me the
saddest is the fact that I know the therapy my child needs to become
better and I do not have the money to give my child the therapy.'' For
the parents of these ``Bramlett 6'', paying for this therapy has been
financially stressful. For one child's parents, they both took second
jobs. Sadly, both parents had private healthcare insurance which would
not pay for the needed therapy. For the other parents of the ``Bramlett
6'', cushioned bank accounts, big vacation trips, and college savings
accounts are nonexistent.
The question we have to ask ourselves as a Nation is not whether we
can afford to provide these therapies but whether we can afford not to.
It is imperative that we look at both the private and public sectors
for this support as the costs of autism is borne by everyone. On behalf
of the parents, I implore you to end the insurance discrimination for
our children, fund intensive intervention through early intervention
programs, and look at mandating coverage for those on Medicaid systems.
Additionally, I would give a cautionary word of warning when looking at
a national single payer healthcare system. For parents who are
utilizing Medicaid services, the services can be described at best as
``limited.'' For example, in Mississippi, speech therapy services for
special needs children were essentially eliminated as of July 1, of
this year. Furthermore, provider numbers willing to see these children
is limited due to low reimbursement rates.
Additionally, I ask you as Senators to support legislation such as
S. 493 that would create tax-exempt savings accounts to care for
individuals with disabilities and other measures that would ease the
burden of our families.
When the Mississippi Autism Task Force held public hearings
financial issues were not the only stressors. The lack of medical care,
insurance coverage, inadequate educational supports, finding additional
therapy services and time away from job and home to obtain the needed
services for their family member with ASD were listed as major
stressors for families.
ASD not only affects individuals with the diagnosis, but the entire
family. Raising any family can be difficult, but it becomes even more
complex when a family member is diagnosed with ASD. After the
diagnosis, families are filled with questions, confusion, anger, grief,
and despair. Physical stressors, compounded by psychological stressors
further complicate the issues for parents. Because of the unusual
behaviors and a lack of social skills that are common in those with
ASD, families face isolation from friends, family and their community.
Nationally, divorce rates of parents with ASD children are about 80
percent.
Another, sometimes unnoticed, turmoil created by autism is the
affect on the siblings. An excessive amount of parents' time has to be
focused on the child with ASD. Siblings commonly experience diminished
attention and support from parents while parents devote substantial
energy and resources getting a diagnosis and treatment for the child
with ASD. Often, siblings find themselves socially isolated from
friends, family, and community because the brother or sister's
behaviors are so erratic. Typical assistance offered by family and
friends are less available as a result of the difficultly in managing
behaviors.
For the above reasons, depression is often high among our parents.
This year in our region of Mississippi we lost two parents from the
stress and depression produced due to the difficulties from parenting
an ASD child.
However, we see our families improve as their children's prognosis
improves. Senators with the growth of the disorder and its impact on
families we must move quickly to provide the necessary treatment and
intervention for these ASD children and their families.
Senator Harkin. Very profound statement. Thank you very
much, Mrs. Boyd. Thank you.
And now we'll turn to David Miller, a resident of Fairfax
County, Virginia; he serves on the board of directors at
Northern Virginia Community College, where he cofounded the
Community College Consortium on Autism and Intellectual
Disabilities. He received his B.A. degree at Boston University,
a masters in public administration at Northeastern, and his law
degree at George Mason University. He's retired from the Armed
Forces. He's the father of two 7-year-old autistic boys. Who
are identical twins?
Mr. Miller. Yes, they are.
Senator Harkin Mr. Mueller, welcome to the subcommittee.
Mr. Miller. Thank you.
STATEMENT OF DAVID MILLER, J.D., BOARD OF DIRECTORS,
NORTHERN VIRGINIA COMMUNITY COLLEGE,
ANNANDALE, VIRGINIA
Mr. Miller. Thank you very much, sir. Chairman Harkin and
Senator Cochran, again, thank you very much for holding this
hearing.
As the Chairman indicated, I am a board member of Northern
Virginia Community College, where I represent Fairfax County.
We are the second-largest community college in the Nation.
As you indicated, again, Mr. Chairman, I'm the cofounder of
the Community College Consortium on Autism and Intellectual
Disabilities, which is comprised of 41 community college
presidents from those States that have the highest incidence of
autism in the country.
I'm pleased to say, Mr. Chairman, that Mr. Nick Starcevich,
from Kirkwood Community College, based in Iowa, is a very
active member of our consortium, as is Dr. Clyde Muse,
president of Hinds Community College, which I understand--he
tells me repeatedly, is the largest community college in
Mississippi. Both of these respected leaders could not be here
today because of previously scheduled board meetings. But, we
do have some community college presidents here, that I would
like to introduce the subcommittee to.
The first one is Willie Duncan, who I believe is behind me.
President Duncan is the chairman of Taft College and is the
chairman of our Consortium on Autism and Intellectual
Disabilities. The second president we have accompanying me
today is Dr. Wayne Burton--Wayne?--who's the president of North
Shore Community College, based up in Massachusetts. We have
Steve Rose, who I think is here today, who is the chairman of
Passaic County Community College.
Also with me today is Dr.--is Mr. Jeff Ross, the director
of Taft College's Transition to Independent Living program,
which, in my opinion, is one of the foremost postsecondary
programs in the country for students with autism and
intellectual disability. In fact, if you look at my testimony,
on page 2 or 3, I really--the summary of the measurable results
that Taft has achieved these last 13 years with respect to
students with intellectual disability and developmental
disability is astounding. In fact, we, at the community college
level, aspire to have programs as effective as the Taft
program.
This hearing today has particular poignancy to me because,
as you indicated, Mr. Chairman, I'm the father of two 7-year-
old autistic boys who are identical twins, Joseph Harris Miller
and William Louis Miller. Their sister, Sallie Kathryn Miller,
is the youngest of these triplets--she's here today--and
thankfully she's a healthy, happy, 7-year-old princess.
Sallie, I know you're back there somewhere.
Mr. Miller. My comments are purely those of a parent who is
concerned about the long-term ability of my children, and
children in similar circumstances, to live independently and to
develop a career track that will enable them to support
themselves financially while at the same time meeting and
overcoming challenges that, frankly, I have never faced and
probably you have never faced in our entire lives.
I am not an educator, like President Duncan or President
Rose, or President Burton; I'm not a therapist in the field, as
is Jeff Ross; nor am I as well versed in the nuances of autism
and as well read as my wife is--who really, on a daily basis,
meets the challenges, not only during the day, but in evening,
as was pointed out before, in terms of the nocturnal tendencies
of autistic children. She's a wonderful woman, and a very
accomplished woman. She, frankly, should be seated in this
witness chair. So, if you do another hearing, she needs to be
invited.
You know, people talk about takeaways--and I'll go through
the testimony in a second. I think that, when this hearing is
over and when you go on to further activities, the two
takeaways I would like you to have from my testimony are these:
Number one, my kids are here. They're here to stay. I think
what you're doing with respect to research is excellent. We
need to have funds invested in screening and diagnosis and all
that good stuff. I think it's tremendous. We need to do that.
But, having said that, my kids are here. And all the panelists
that have autistic kids are here. So, what are we going to do
with these kids?
And I think the second thing that I find more and more, as
I talk to more and more autism advocates and more and more
proponents is, What's the game plan here? What's the end
result? What are we looking toward? What are we working for?
It's true that most of these kids are below the age of 17 at
this stage, but more and more of these kids right now are
entering middle school, they're entering high school. At some
point they're going to be adults. What are we going to do with
these kids? And I think that's a critical question that we all
have to consider, and I think we need to keep that objective in
mind.
We, at the community college level, are seeing our first
beginnings of autistic kids on our campus. The HELP Committee
chairman, by the way, Chairman Kennedy, obviously gets it.
We've had a number of discussions, our Community College
Consortium and he, and he's called this a ``tsunami.'' He's
said to us that we've not invested in the infrastructure to
deal with this coming tsunami, as he described it.
Section 767, Higher Ed bill, based on his authorship and
that of Senator Enzi, authorized the Secretary of Education to
award 5-year grants in support of model demonstration programs
that, quote, ``promote the successful transition of students
with intellectual disabilities into higher education.'' There's
no specific amount authorized, and I have a letter--I'm sure
you've seen it, Chairman Harkin; I know you've seen it, Senator
Cochran--from Senator Kennedy, where he requests $35 million
for fiscal year 2010 to fund this--to fund these types of
programs.
The reason for this funding request is that, as stated in
the chairman's correspondence, that vast majority of autistic
and intellectually disabled students are currently at community
colleges, and will attend community colleges, because we have
what are called ``open admissions policies.'' They graduate
from secondary school or they reach age 21, and they come on
our campuses, They are here. And, frankly, we have no programs,
effective programs, to--with the exception of Taft--to deal
with these children. What they do is, they come on our
campuses, they enroll in normal academic courses, they're soon
put on academic probation, and they're soon academically
dismissed, and that's it. They have no further contacts, with
respect to job training programs, albeit perhaps sheltered
workshops. They have no further--or additional educational
opportunities. That is it. So, what happens to these kids after
that?
And again, that's what Senator Kennedy is really focused
on. Schools like Kirkwood will tell you, and schools like Hinds
Community College will tell you, these are expensive programs.
They run roughly $30,000 a school. And President Starcevich
tells me, as does President Muse, that they are limited by law
to approximately $2,000 to $3,000, as far as tuition. They
don't have access to any further funding. That's it. And with
the reduction in State operating funds right now, they just do
not have the financial resources to develop programs to assist
these students.
I think one thing--and I realize I'm way over my time--I
think one thing that--you have to look at these funds. They're
essentially investment--they're essentially economic
development funds. They're essentially local stimulus funds.
These funds will be focused, by community colleges, in life-
skills training and in vocational training.
PREPARED STATEMENT
So, again, Mr. Chairman and Senator Cochran, we appreciate
the fact that you've seen fit to put approximately $15 million
toward this program, and we hope that, in conference, that, at
the end of this conference, you will walk away at least with
that minimum amount of money.
Again, thank you very much.
[The statement follows:]
Prepared Statement of David H. Miller
Chairman Harkin and Ranking Member Cochran: Thank you for this
hearing and for the opportunity to present my thoughts regarding
autism, research, treatment, and intervention'.
I have the privilege of being here today, as a board member of
Northern Virginia Community College (NVCC) which is the second largest
community college in the United States. I have represented Fairfax
County for the last 4 years on the NVCC board and have recently been
reappointed to another 4-year term by Chairman Bulova and the Fairfax
County Board of Supervisors.
I am also the co-founder of the ``Community College Consortium on
Autism and Intellectual Disabilities'' which is comprised of 41
Community College Presidents from States that have the highest
incidence of autism.
Dr. Mick Starcevich, the president of Iowa-based Kirkwood Community
College is a member of our Community College Consortium as is Dr. Clyde
Muse, president of the largest community college in Mississippi--Hinds
Community College. Both of these highly respected leaders could not be
here today because of previously scheduled board meetings.
Although I am the only ``non-President'' of our Consortium I have
had the honor of working with 41 of the foremost educators in our
Nation some of whom are here with me today.
I would like to take a moment to introduce to the subcommittee Mr.
William Duncan, president of Taft College. President Duncan is also the
chairman of ``The Community College Consortium on Autism and
Intellectual Disabilities''; Dr. Wayne Burton, president of North Shore
Community College (member of our Executive Committee), and Dr. Steven
Rose, president of Passaic County Community College.
Also with me today, is Mr. Jeff Ross, the Director of Taft
College's Transition to Independent Living (TIL) program which in my
opinion is one of the foremost postsecondary programs in the country
for students with autism and intellectual disabilities.
This hearing has a particular poignancy to me because I am also the
father of two 7-year-old autistic boys who are identical twins--Joseph
Harris Miller and William Louis Miller. Their sister, Sallie Kathryn
Miller, is the youngest of the triplets and is a healthy, happy 7-year-
old ``princess''.
Let me preface my comments, by giving the subcommittee some
perspective. I am not an educator by profession like President Duncan,
President Burton, and President Rose. I am not a therapist or an expert
in the field of autism and intellectual disabilities as is Mr. Ross.
Nor I am not as well versed in the nuances of autism and in meeting the
daily (and nightly) challenges of autism as is my wife Lynn.
My comments are purely those of a parent, who is concerned about
the long-term ability of my children and children in similar
circumstances to live independently and to develop a career track that
will enable them to support themselves financially while at the same
time meeting and overcoming challenges that probably you and I never
had to face.
The chain of events that led me to this table begins like this.
Almost 3 years ago, I was asked to give a presentation to the members
of the Association of Community College Trustees on the authorization
and appropriations process. During the course of that presentation, I
referred to the then recently enacted ``Combating Autism'' legislation
as an example of the Authorizing and Appropriations Committees working
together to produce a truly remarkable piece of legislation. As you
know the ``Combating Autism Act of 2006'' (Public Law 109-416)
allocates nearly $1 billion for the National Institutes of Health (NIH)
to conduct autism, research, screening, surveillance, and intervention.
As a preface to my comments, I indicated that I had two young sons
(5 years of age at the time) who had been diagnosed with autism and
that I as a parent was very concerned about their future. After my
presentation, I was approached by the then president of Taft College,
Dr. Roe Darnell. Dr. Darnell told me about the program at Taft College,
called the TIL program, which since 1995 has developed a remarkable
record of success with autistic and intellectually disabled post
secondary students.
The Taft College Program is a 2-year residential program that
houses 28 students in our dormitories and 20 students who live
independently within the community. The curriculum consists of 38
courses which are approved by the California Community College
Chancellors Office.
The curriculum is life skills and vocational based and the students
receive a Certificate of Completion from Taft College when they
demonstrate competency in the following areas: meal planning and
preparation; housekeeping; laundry; money management; personal safety;
Internet access and safety; personal advocacy; individual rights and
responsibilities; work ethic; and work experience.
As the TIL program services students from the entire State, TIL
assists students with their transition back to local communities. The
program also tracks all of its graduates for a period of 10 years and
produces an annual ``Student Outcome'' report which demonstrates
dramatic results:
--95 percent of TIL graduates live independently;
--93 percent are competitively employed (the national average is 14
percent);
--93 percent receive no financial assistance from other agencies or
their families;
--97 percent report that they are satisfied with their adult life;
and
--30 hours of home assistance is provided on average each month (the
State average is 88 hours per month).
It is estimated that the above savings in home assistance services
alone saves the citizens of California over $110 million over 40 years
not counting the taxes TIL graduates pay as well as services that they
consume. Obviously, ``quality of life'' has no price tag.
Taft College services all of California and has a waiting list of 4
years.
When I looked for similar services in Northern Virginia I found
that there was almost no postsecondary educational or training
opportunities for children with autism who had graduated from high
school or had reached the age of 21.
Those opportunities that were available were either prohibitively
expensive or were research based.
None of these ``opportunities'' were readily adaptable to the broad
range and numbers of students we in higher education can expect to
flood our campuses in the not too distant future.
As a harbinger of things to come for our college campuses and for
our Nation, Director Ross, who follows these trends, reported the
alarming statistic that the number of autistic children enrolled in
California's fourth and fifth grades currently exceeds the entire
number of adults receiving assistance for intellectual disabilities
which numbers approximately 350,000.
The actual numbers of autistic children enrolled in California is
indeed alarming however, the trend is identical for States that are not
as large nor as diverse. In my own Commonwealth of Virginia a 10-year
study of autism prevalence from 1992-2003 pursuant to the reporting
requirements of the Disabilities Education Act (IDEA) reported a 519
percent growth rate of autism from 1992-2003 with a 17 percent annual
growth. That study is now 6 years old and the numbers of children with
autism reported in Virginia's public schools has almost tripled since
2003.
Mr. Chairman, in your State of Iowa, the prevalence study reported
a 1,727 percent cumulative growth rate of autism from 1992-1993 with a
33 percent annual growth rate of 33 percent. Senator Cochran, the same
study showed a 3,788 cumulative growth rate for autism in 1992-2003
with a 53 percent average annual growth rate. I am sure that the
incredible growth of students with autism in Virginia since 2003 is
similar in your States.
Clearly, the vast majority of autistic children are still under the
age of 18 with a significant number just now entering middle and high
school. We at America's community colleges, including NVCC, are
beginning to see the first significant influx of students with autism.
Community colleges have, for a number of years, had intellectually
disabled students on our campuses, often times with no programs to
serve them. Because most States provide for an ``open admissions''
policy, many of these students enroll in regular academic classes.
However, a great majority of these students are unable to meet the
normal academic requirements of these classes; are soon placed on
academic probation and later are dismissed for academic reasons.
Unfortunately, most of these students leave their secondary or post
secondary experience with no preparation for living independently or
with job skills. Although some States contribute to their welfare until
the age of 21, the vast majority provide for no or minimal assistance
after that age.
Thankfully, educators across the country, notably Dr. Starcevich
and Dr. Muse are working on ways to provide innovative practical
programs for these students once they leave the secondary school
environment as are their colleagues in other States such as President
Dale Chapman and Dr. Linda Chapman from Lewis and Clark Community
College; Dr. Pamela Transue, president, Tacoma Community College; Dr.
Debbie Sydow, president, Onondaga Community College; Dr. Peter Sireno,
president, Darton College; Dr. Wright Lassiter, Chancellor, Dallas
County Community College; Dr. Ray D. Pasquale, president, Community
College of Rhode Island; Dr. Raymond Yannuzzi, president, Camden County
Community College; and many others.
Your colleague, Chairman Edward Kennedy of the Senate Committee on
Health, Education, Labor and Pensions (HELP) is very much aware of
these trends and described the coming influx of autistic students at
postsecondary level as a ``tsunami''.
Thanks to the efforts of Anthony K. Shriver, founder and chairman
of Best Buddies International, Inc. and President Wayne Burton, we had
the opportunity to speak directly with the chairman and work with him
and Senator Enzi on designing a program to assist students with autism
and intellectual disabilities.
While not perfect, section 767 of H.R. 4137 (the Higher Education
Opportunity Act) authorizes the Secretary of Education to award 5-year
grants to support model demonstration programs that ``promote the
successful transition of students with intellectual disabilities into
higher education.''
Although no specific amount is authorized in Public Law 110-315,
Chairman Kennedy recently wrote a letter to you, Chairman Harkin, and
to you, Senator Cochran, requesting funding for this program in the
amount of $35 million for fiscal year 2010.
Chairman Kennedy's May 7, 2009 letter categorizes his funding
request as follows:
``It is estimated that $24 million of the $35 million will fully
fund programs at 10 community colleges, enabling each college to
provide life skills and vocational training for approximately 75
intellectually disabled students.
``$9 million will provide funding for 30 programs at 4-year
colleges, with an average funding of $300,000 per institution. Each
grant will provide academic and other instructional courses for
approximately 10 intellectually disabled students.''
The reason for this difference in funding is that, as stated in the
chairman's correspondence, the vast majority of autistic and
intellectually disabled students ``attend community colleges because of
their open admissions policies.''
In addition, community colleges are limited by law in their ability
to pay for the true cost of these programs. Based on the experience of
Taft College's successful TIL program the cost to operate this type of
program for 75 students is approximately $30,000 per student with the
average annual budget of around $1 million. A program at a typical 4-
year university for 8-10 students will cost approximately $300,000 as
the university serves far fewer autistic students and has the ability
to draw on other sources of income including raising tuition.
As community colleges like Kirkwood or Hines can only charge a
maximum of approximately $3,000, the remaining $27,000 in operational
costs can only be borne by the Federal Government. Infrastructure and
other nonoperational capital costs must be borne by the educational
institution.
It is our understanding, Mr. Chairman and Senator Cochran, that
your subcommittee has allocated approximately $15 million for this
program. We are appreciative of your efforts particularly given the
fiscal demands of your subcommittee in this time of economic hardship.
We hope that this amount at a minimum be retained in conference and
that you consider allocating this amount, consistent with Chairman
Kennedy's letter, on a 3 to 1 basis so that community colleges and
universities are able to compete for these funds separately.
In addition, we thank you for the language that we understand is in
the subcommittee's report that directs the Secretary of Education to
award grants for no less than $1 million per grant. Anything less would
preclude Kirkwood Community College, Hinds Community College, and most
other community colleges from offering life skills and vocational
training programs for their autistic students.
I thank you for the opportunity to testify and I look forward to
answering any questions.
Senator Harkin. Thank you very much, Mr. Miller.
And now we'll complete our testimony with Ms. Dana
Halvorson, cofounder of BEAT-Iowa: Biological Education for
Autism Treatments, Iowa. Usually when we are in front of all
these people, we don't say ``Beat Iowa''.
Senator Harkin. I should have looked at that before I said
it. And that little clip could be misinterpreted, you know? She
lives on a farm in Northwood, Iowa--that's way up in northwest
Iowa--with her husband and three children. Her 7-year-old
daughter, Robin, was diagnosed with autism when she was 15
months old. Ms. Halvorson has an associate degree in applied
science and veterinary technology from the University of
Minnesota, and a B.A. in French from South Dakota State
University.
Ms. Halvorson, welcome. Please proceed.
Ms. Halvorson. She was diagnosed, a little over age 3; she
regressed between 15 and 18 months.
Senator Harkin. Oh, age 3.
Ms. Halvorson. Yeah, the diagnosis was at 3 years and 3
months.
Senator Harkin. Would you punch that button on your mic,
there? There.
Ms. Halvorson. Certainly.
Senator Harkin. Thank you very much.
Ms. Halvorson. Okay.
Senator Harkin. Go ahead, Ms. Halvorson.
STATEMENT OF DANA HALVORSON, BEAT-Iowa, ANKENY, IOWA
Ms. Halvorson. Thank you, Mr. Chairman and Senator Cochran,
colleagues, for this opportunity to encourage more thought and
action on autism.
My name is Dana Halvorson. On a daily basis, I am a wife
and mother of an Iowa farm family. My days are filled, from
very early to very late, with joys, blessings, and challenges.
Of my three children, I have one daughter who has heavy-metal
toxicity. Her original diagnosis, at just over age 3, was
autism and mental retardation.
Although my daughter was given the label of ``autism,''
this term fails to describe the physiological nature of her
disorder. Shortly after her diagnosis, I discovered biomedical
origins of her condition. Over the next several years, we
confirmed multiple medical diagnoses, including intestinal
dysbiosis, multiple food allergies, growth hormone deficiency,
metabolic dysfunction, endocrine dysfunction, pituitary
dysfunction, hypothyroidism, allergic colitis, immune
dysfunction, and heavy-metal toxicity, to name a few.
We have only been able to help Robin by struggling to
travel all over the country and working with many medical
practitioners, spending thousands of dollars on tests and
clinical visits, mostly not covered by insurance.
The list of diagnoses Robin carries is long for such a
young child. Her healthy appearance belies the depth of her
medical problems. Based on her appearance, people expect her to
be able to respond to them, speak to them, and share with them.
Robin has come a long way, but still has difficulties.
I know of children who have fully recovered, with the
proper therapies for their medical conditions, and my daughter
is on that path to recovery. I only hope that everything we
have--are doing will be enough, so that someday she can live a
normal life.
Once we learned of Robin's medical issues and sought out
properly trained medical professionals for appropriate
treatment, she began to improve. The symptoms we see in Robin
and so many children like her are not psychiatric in origin,
needing only psychological therapy. Autism is a neurobiological
disorder, a set of physical disorders with behavioral
characteristics. Many families hesitate to use the word
``autism''--we call it the ``A'' word--because these underlying
medical problems exist in our children and can cause the very
symptoms that are labeled ``autism.''
I have been involved in multiple meetings with elected
officials, doctors, parents, and researchers for 8 years,
discussing the root causes and treatment issues. Because no
action has been taken, thousands more children have suffered
damage, and their families' lives have destroyed. Very soon,
the financial burden of their 24/7 care will not fall only to
their parents and families, but to taxpayers, in general, as a
large wave of some of the oldest children start aging out of
school, cannot work, and must collect disability checks.
Professionals in the field estimate that lifetime care for a
child like Robin will cost millions of dollars.
I've accepted your invitation today because I want to set
the record straight. You cannot address the ``A'' word,
``autism,'' without addressing some other ``A'' words. You
should all be very alarmed that we currently have the sickest
generation of children in 60 years, with 1 in 9 children
suffering from asthma, 1 in 6 children with some form of
neurodevelopmental delay, and at least 1 in 150 with autism,
the most severe disorder. Posing the right questions to
unbiased and unconflicted scientists is essential to obtaining
constructive answers.
Agencies charged with protecting the health of our children
suffer from serious financial conflicts of interest. These
Government agencies need to be held accountable. Senators, it
is difficult for me to sit at this table and tell you that you
have been lied to, that we have all been lied to. Mercury
levels exceeding EPA safe levels were in Robin's vaccines, and
in my RhoD immune globulin injections while pregnant and
immediately after her birth. The industry material safety data
sheet for thimerosal identifies the chemical's effects as
follows: ``The mercury component has caused nervous-system
effects in experimental animals, including mild to severe
mental retardation and motor coordination impairment.''
You don't need to take my word for these scientific facts.
Dr. George Lucier, former founding editor of Environmental
Health Perspectives, the official journal of the NIEHS, for 28
years, and former associate director of the National Toxicology
Program, considered the world's largest toxicology research and
testing program, is with me today. He has, on many occasions,
shared his view of the dangers of thimerosal, and the harm it
has caused to many children.
The number of vaccines given since I was a child has risen
from around 10 to 49, according to the National Vaccine
Information Center. Those who create vaccines often sit at the
table and vote to approve vaccines, reap the dollars from the
products being used, and then are immune from legal liability.
Where else in the world do we see this scenario of no
accountability and conflict of interest?
Who is at the table demanding truth and voting on behalf of
children? That is your job, as our elected officials, and for
some reason, very few are doing it. We need transparency,
honest communication, and, once and for all, as you suggested
earlier, Senator Harkin, a valid, unbiased study of vaccinated
versus unvaccinated populations.
Congress scrambled to hold hearings about grown men
voluntarily injecting themselves with steroids, while thousands
of children have continued to be injected with vaccines
containing a known neurotoxin, under Government mandate.
We all know that some children are injured by vaccines.
Unfortunately, their access to justice and compensation is
barred by many legal obstacles. Our compensation system for
vaccine-injured children needs reform. Although I do not have
time to describe the necessary reform, please take a look at
the unfairly restricted 3-year statute of limitations, among
other legal problems facing these families.
Heavy metals, like mercury and other toxic substances,
should not be injected into people, especially babies and young
children and other individuals susceptible to vaccine injury.
Vaccine safety certainly encompasses more than concerns only
about mercury. However, mercury is so highly toxic that it is
the 600-pound gorilla in the living room. It only takes 0.6
micrograms of mercury, in the form of thimerosal, to harm human
tissue, according to valid peer-reviewed scientific studies.
Thimerosal continues to be used in some vaccines, including
tetanus and flu shots. That is a fact. Thimerosal is damaging
at nanomolar levels. That is also a fact, and has been
documented, replicated, and ignored. It is in front of us, but
we pretend not to see.
Those in power have not listened and discerned facts, and
acted on those facts to protect the health and future of the
children of this Nation, and instead have protected industry
and Government.
My hope, on behalf of this vaccine-injured generation, is
for action. Can we really afford, with continued inaction, to
risk losing another generation?
PREPARED STATEMENT
Thank you for listening and allowing me to share my
concerns. As I return to our Iowa farm, I will reflect upon
what my daughter and my family have lost, and the many other
mothers and fathers whose hopes and dreams have been crushed
with this chronic illness. We will continue to hope for action.
Our children and our future depend on you.
[The statement follows:]
Prepared Statement of Dana Halvorson
Thank you Senator Harkin and colleagues, for this opportunity to
encourage more thought and action on autism. My name is Dana Halvorson.
On a daily basis I am a wife and mother of an Iowa farm family. My days
are filled from very early to very late with joys, blessings and
challenges. Of my three children, I have one daughter who has heavy
metal toxicity. Her original diagnosis at just over age 3 was autism
and mental retardation.
Although my daughter was given the label of ``autism'', this term
fails to describe the physiological nature of her disorder. Shortly
after her diagnosis, I discovered biomedical origins of her condition.
Over the next several years we confirmed multiple medical diagnoses
including intestinal dysbiosis, multiple food allergies, growth hormone
deficiency, metabolic dysfunction, endocrine dysfunction, pituitary
dysfunction, hypothyroidism, allergic colitis, immune dysfunction, and
heavy metal toxicity, to name a few. We have only been able to help
Robyn by struggling to travel all over the country and working with
many medical practitioners, spending thousands of dollars on tests and
clinical visits, mostly not covered by insurance. The list of diagnoses
Robyn carries is long for such a young child. Her healthy appearance
belies the depth of her medical problems. Based on her appearance,
people expect her to be able to respond to them, speak to them, and
share with them. Robyn has come a long way but still has difficulties.
I know of children who have fully recovered with the proper
therapies for their medical conditions, and my daughter is on that path
to recovery. I only hope that everything we are doing will be enough,
so that someday she can live a normal life.
Once we learned of Robyn's medical issues and sought out properly
trained medical professionals for appropriate treatment, she began to
improve. The symptoms we see in Robyn and so many children like her are
not psychiatric in origin, needing only psychological therapy. Autism
is a neurobiological disorder--a set of physical disorders with
behavioral characteristics.
Many families hesitate to use the word autism--we call it ``the A-
word,'' because these underlying medical problems exist in our children
and can cause the very symptoms that are labeled ``autism.'' I have
been involved in multiple meetings with elected officials, doctors,
parents and researchers for 8 years. discussing the root causes and
treatment issues. Because no action was taken thousands more children
have suffered damage and their families lives have been destroyed. Very
soon, the financial burden of their 24/7 care will not fall only to
their parents and families, but to taxpayers in general, as a large
wave of some of the oldest children start aging out of school, cannot
work, and must collect disability checks. Professionals in the field
estimate that lifetime care for a child like Robyn will cost millions
of dollars.
I have accepted your invitation today because I want to set the
record straight. You cannot address the A-word, ``autism,'' without
addressing some other A-words. You should all be very ``alarmed'' that
we currently have the sickest generation of children in 60 years with 1
in 9 children suffering from ``asthma," 1 in 6 children with some form
of neurodevelopmental delay, and at least 1 in 150 with autism the most
severe disorder. Posing the right questions to unbiased and
unconflicted scientists is essential to obtaining constructive answers.
Agencies charged with protecting the health of our children suffer from
serious financial conflict of interest. These Government agencies need
to be held accountable. Senators, it is difficult for me to sit at this
table and tell you that you have been lied to, that we have all been
lied to. Mercury levels exceeding EPA safe levels were in Robyn's
vaccines and my RhoD Immune Globulin injections while pregnant and
immediately after her birth. The industry material safety data sheet
for thimerosal identifies the chemical's effects as follows: ``the
mercury component has caused nervous system effects in experimental
animals, including mild to severe mental retardation and motor
coordination impairment.''
You don't need to take my word for these scientific facts. Dr.
George Lucier, former founding editor of Environmental Health
Perspectives, the official journal of the NIEHS for 28 years, and
former associate director of the National Toxicology Program
(considered the world's largest toxicology research and testing
program) is with me today. He has on many occasions shared his view of
the dangers of thimerosal and the harm it has caused to many children.
The number of vaccines given since I was a child has risen from
around 10 to 49, according to the National Vaccine Information Center.
Those who create vaccines often sit at the table and vote to approve
vaccines, reap the dollars from the products being used, and then are
immune from legal liability. Where else in the world do we see this
scenario of no accountability and conflict of interest? Who is at the
table demanding truth and voting on behalf of children? That is your
job as our elected officials, and for some reason, very few are doing
it. We need transparency, honest communication, and once and for all, a
valid unbiased study of vaccinated wersus unvaccinated populations.
Congress scrambled to hold hearings about grown men voluntarily
injecting themselves with steroids, while thousands of children have
continued to be injected with vaccines containing a known neurotoxin,
under Government mandate.
We all know that some children are injured by vaccines.
Unfortunately their access to justice and compensation is barred by
many legal obstacles. Our compensation system for vaccine-injured
children needs reform. Although I do not have time to describe the
necessary reform, please take a look at the unfairly restricted 3-year
statute of limitations among other legal problems facing these
families.
Heavy metals like mercury and other toxic substances should not be
injected into people, especially babies and young children, and other
individuals susceptible to vaccine injury. Vaccine safety certainly
encompasses more than concerns about only mercury. However, mercury is
so highly toxic, that it is the 600-pound gorilla in the living room.
It only takes 0.6 micrograms of mercury in the form of thimerosal to
harm human tissue according to valid, peer-reviewed scientific studies.
Thimerosal continues to be used in some vaccines, including tetanus and
flu shots. That is a fact. Thimerosal is damaging at nanomolar levels.
That is also a fact and it has been documented, replicated, and
ignored. It is in front of us, but we pretend not to see. Those in
power have not listened and discerned facts, and acted on those facts
to protect the health and future of the children of this Nation, and
instead have protected industry and Government.
My hope on behalf of this vaccine-injured generation is for action.
Can we really afford, with continued inaction, to risk losing another
generation?
Thank you for listening, and allowing me to share my concerns. As I
return to our Iowa farm, I will reflect upon what my daughter and
family have lost and the many other mothers and fathers whose hopes and
dreams have been crushed with this chronic illness. We will continue to
hope for action--our children, and the future of our Nation, depend on
you.
Senator Harkin. Thank you very much, Mrs. Halvorson.
Well, I think we have heard the whole gambit of everything,
we are confronted with.
And, Dr. Dawson, since you're first on the left here, I'll
just start with you. You mentioned that virtually no
comparative effectiveness studies have been done to evaluate
treatments for autism. And again, I just want to say--this is
something that we really have to focus on. I mean, we have to
do the research. But, as Mrs. Halvorson so poignantly pointed
out, we're in--and Mr. Miller also Mrs. Boyd--we're in the here
and now, and families are struggling, and we're facing this
whole generation growing up, and what's going to happen to them
as adults. So, we have to focus on what are the most effective
treatments we have now.
This subcommittee provided more than $1 billion to HHS in
the recent ARRA--Dr. Insel mentioned that earlier--for
comparative effectiveness studies--$1.1 billion, to be exact.
Now, again, we don't say exactly where to put them. But, do you
know if any of those dollars will be spent on autism? The
Institute of Medicine, included autism as one of the conditions
that should be studied. And I just wonder if you have thoughts
on that. Have you been watching, or have you had any
involvement in trying to see that some of these comparative
effectiveness studies are done on early intervention programs?
Dr. Dawson. Yes, I'm aware of the focus, by the Agency for
Healthcare Quality, on comparative effectiveness, and we have
submitted recommendations, in terms of the kinds of questions
that we feel need to be asked. I think it's so critical that
parents have a sense of, you know, whether one thing is
effective, more than another treatment.
The other, I think, aspect of comparative effectiveness
work has to do with method of service delivery. So, what we
know now is that when children receive care, they often receive
it by a set of professionals who individually work with the
child. So--and the parent themself has to act as a case
coordinator. There are other models, for how to effectively
work with a child with autism, which involve a
multidisciplinary team, which has different, kind of, financial
aspects that go to coordinating care. But, we feel that this
kind of model is much more effective. So, that's another
example of a comparative effectiveness study that needs to be
done, is to look at different models of service delivery to
find out what is ultimately more cost effective.
The other question has to do with this issue of
personalized medicine. So, what kinds of treatments work for
which kinds of individuals? We know that autism is not going to
be a one-size-fits-all kind of treatment approach, and so, we
need to understand the effectiveness of understanding
underlying biomarkers, whether we're looking at medical
conditions, such as one of the parents talked about, or genetic
conditions, metabolic conditions, and so forth, and how these
can direct treatment approaches.
So, it's very--we're at a very early stage in understanding
the question of which treatments work best for which
individuals, and until we do that, parents go onto the
Internet, they seek out answers themselves, and often are
acting on nonevidence-based decisions.
Senator Harkin. That kind of brings me to Mr. Cobbs, and
all of you here. I got interested in using telehealth sometime
ago for a variety of different things. I come from a rural
State, and we don't have a lot of the access to facilities that
people in urban areas do, so I've been interested in telehealth
in different areas. And then, finally, when I became more
interested in, and more tuned in on, the issue of autism, a few
years ago, it came clear to me that a lot of families that have
young children that are diagnosed with autism, they're at their
wit's end. They don't know what to do. And yes, there are some
residential programs, Mr. Miller, mostly for older kids, for
transitional things like you're talking about. But--and correct
me if I'm wrong, and Dr. Insel, you can jump in on this, too--
but, I think there is some pretty good evidence that the
earlier you get to these kids and provide them with supportive
services, interventions by trained people that know what
they're doing, that they really do get over a lot of these
problems. The earlier you get to them, the more effective it
is. But, how do you get to them early if they're living in
Sioux City or Northwood or Oxford, Mississippi, or someplace
like that?
So, we've put some money in this project, looking at
telehealth, and how you can get together with a group of
professionals early on, and then, with a high-speed Internet
connection, it's like you are in the doctor's office. So you
get that guidance, 24/7.
Mr. Cobbs, tell me a little bit about this. You've been in
this experimental program for 3 years?
Mr. Cobbs. Well, since last time. We have continued with
the services to continue the study so we can test the
longevity, and also to show that the program can grow with the
child throughout the lifespan.
Senator Harkin. Now, have you talked with other people?
You're the head of--chairman of the Iowa Autism Council now--
have you talked to others about this? I don't know how many
people are on this system right now. And what interest is there
in this?
Mr. Cobbs. Senator Harkin--Chairman Harkin, that's a great
question. In fact, just this morning we were talking, and it's
an ``Aha'' moment for parents. It's that light bulb that goes
on, ``Do you really mean I can get services when and where I
need them?''
For instance, if Noah's having a great behavior day, and
it's in-home, well, we can replicate that, we can start to
build off that, with a foundational of applied behavioral
analysis and other proven methodologies. Or, if he's having a
bad day, it's not because we're in an abstract physician's
office or a clinical environment; it's because he's in his own
home, and there's something that has triggered that behavior.
So, it's immediate response to track down what's causing the
behavior, and we can get immediate results, when the behavior
is happening, both good and bad.
Senator Harkin. That's the other thing that kind of got me
thinking about this a few years ago. A lot of times, kids with
autism, they don't act up or anything when they're in the
doctor's office, but then, when you get home, they do.
Mr. Cobbs. In our case, Chairman Harkin, it might be the
exact opposite. The environment of a doctor's office may have
too much stimulus in the area and so, you're going to get the
reverse effect. You're going to get--maybe we went in for an
earache, but all of a sudden we have a--you know, a behavior
taking place, and therefore, we may even have to leave that
environment without properly getting the care. So, it's a
really great adjunct piece to a complete behavior treatment
program.
And to dovetail on--Ms. Dawson said is--it's also a great
way to bring a comprehensive team together to treat the child
in the natural environment.
Senator Harkin. Are we doing any studies now to show
comparative effectiveness? Or, is this something that
hopefully, this billion dollars we put in the budget will start
taking a look at? Does anyone know that? Do you know that, Ms.
Dawson?
Ms. Dawson. Right.
Senator Harkin Have you looked at these early intervention
telehealth-type of treatments?
Dr. Dawson. Well, not with respect to the telehealth
program, per se, that I'm aware of.
Dr. Insel. We've just completed a fairly large telehealth
study for autism, specifically. The good news is, again, the
ARRA has given us this opportunity to open up the doors for
additional work, and we do have some exciting proposals on just
this topic, on telehealth for autism, specifically, that we're
hoping we'll be able to fund. I can't say more until we
actually have the notice of award. But, I think this is the
chance to see real progress in this arena.
And just, again, to stress what Mr. Cobb's statement had
already implied, is that it's not only for the child. This is
for the family. And that's where some of the big implications
will be.
Senator Harkin. Now, Ms. Halvorson, I'm assuming that
you're not on this telehealth?
Ms. Halvorson. No.
Senator Harkin. No?
Ms. Halvorson. Our approach has been--well, we really hit
all aspects. We found out about the biomedical side first, and
then found out about ABA. And we've used both, and I feel both
have been essential in Robin's progress. However, I know a lot
of other families agree with me that at least exploring if your
child does have these biomedical issues, you're going to get
better results when you're using the ABA.
Senator Harkin. I guess what I'm getting at is, How would
you feel, as a parent, if you had access, in your own home,
with your child, 24/7, so that anything that happens, in terms
of behavioral problems, that you would have access, ready
access, to trained specialists who you would be in constant
contact with?
Ms. Halvorson. My daughter responded so well to biomedical
intervention that behaviors really became not nearly as much of
an issue.
Senator Harkin. I see.
Ms. Halvorson. So it--for me--and the medical care that she
needs, I can only obtain in our doctors' offices, other than--
--
Senator Harkin. Oh.
Ms. Halvorson [continuing]. Supplements that we use.
Senator Harkin. I see.
Ms. Halvorson. But, if I'm taking her in as a matter--well,
as an example, monthly, right now, since the beginning of the
year, she's been undergoing intravenous immune globulin
therapy. That's a 6-hour infusion in our doctor's office.
Senator Harkin. Yeah.
Ms. Halvorson. And then we do some chelation, on top of
that, to remove the metals. So, that has to be done for us.
It's a drive, no matter what.
Senator Harkin. I see the difference, okay.
Well, I've taken 10 minutes of time, so I would yield to
Senator Cochran.
Senator Cochran. Well, Mr. Chairman, thank you, you're very
kind. I appreciate your calling the hearing. It brings back
memories of other hearings we've had and our efforts, as a
subcommittee, to just try to tailor programs of support,
research, that are needed, that will help make positive
contributions to solving the problems that all of you face,
personally or professionally.
So, I'm wondering, is there something that any of you have
in mind to suggest? I know Ms. Halvorson talked about financial
support and a willingness for Government, maybe, to find--
figure out ways to be more supportive, tangible benefits of
some kind, insurance programs that maybe the Government can
help support, in terms of costs of premiums or disbursements, a
sharing of responsibility. Seems to me we have a lot of organic
medical disabilities and frailties, that come with the ambit of
insurance, that this challenge is just not being helped with.
So, I wonder if you have any thoughts along those lines?
I'd start with Ms. Dawson.
Dr. Dawson. Well, I'd like to comment, first, on this
notion of early intervention, and actually tell you about the
study that Dr. Insel was referring to.
So, this is a study that--I was the principal investigator
of this study. And it's an NIMH-funded study, where children
began the intervention below 30 months of age. It's the first
randomized clinical trial that has been conducted with toddlers
who are at risk for autism. So, the children were randomized
into either standard care in the community or a--an intensive
early behavioral intervention that focused, not only on working
directly with the child with a therapist, but also taught the
family how to use intervention strategies so that intervention
occurred throughout the daily activities with the child.
The intervention went over a 2-year period, approximately
25 hours a week of structured intervention. All assessments
were done blind, without--with respect to knowledge of whether
the child had received early intervention.
At the beginning, both groups of toddlers with autism had
IQs in the mentally retarded range, and after 2 years the
children in the treatment group, their IQ had increased, the
average IQ, to the extent that they no longer were in the
mentally retarded range. They had developed language. Their
diagnoses were less severe. Many of the children went from a
diagnosis of autism to what we can ``pervasive developmental
disorder,'' which is a less-severe diagnosis.
And this, remember, is only 2 years, so the children are
only 4, and early intervention, you know, should continue for
another at least 1 or 2 years, in terms of these intensive
interventions.
So, we know these are effective. This study is in press in
the Journal of Pediatrics, and will come out soon.
What we don't have is two things that limit access. One is
financial support for families. It's absolutely essential that
we get federally mandated insurance coverage for these. It's
going to save us money. It's going to help families. And it's
going to allow individuals to take advantage of some of the
programs that we've heard about, the community colleges and so
forth.
The second piece is training for professionals and for
parents. So, many of the interventions that we're developing
now, because we're working now with infants and toddlers, are
actually teaching the parents to deliver the interventions,
because in--many of these interventions occur throughout the
day as we interact with the baby in normal settings.
So, we need programs such as telemedicine or--we're also
developing web-based training programs that we're using to
train parents and professionals, not only here in the United
States, but really around the world. We're working in India, in
Africa, and other developing countries to train processionals.
So, this combination of insurance coverage and trained
professionals is really going to be absolutely key.
Then we're going to get kids on the right trajectory, and
then we need to look, step-by-step throughout the life span, at
how we can continue to support people with autism to become the
most productive citizens they can.
Senator Cochran. Thank you very much. That's very
interesting and helpful analysis of some of the options that we
should seriously consider. I think we should, too.
Ms. Boyd, you were seeking recognition, and I wanted to
call on you next.
Ms. Boyd. The task force looked at this in Mississippi
extensively because of our financial situation of many of our
parents, and there were--publicly, early interventions
presently don't cover behavioral services. And it's already a
program that is out there, federally. It needs to now include
behavioral services, because many of these children are
starting to be identified very early.
I can anecdotally speak to the success of that. As we were
in San Antonio this summer, getting some therapy, I met a
precious child named Catalina. Her mother recognized that there
were signs and symptoms at 8 months, began behavioral therapy
after a year. The child is 4 years old now and is absolutely
amazing, Senators; you would never recognize that she was a
child on the spectrum. So, I, anecdotally, saw that working.
The other program, too, that has to be looked at is
Medicaid. The States have an option of whether or not they can
give autism-specific waiver. I would encourage you to look at
that, and not give States that option, because it is one of the
things that could definitely reach out to these families who
don't have the finances to do that.
The other thing, obviously, that Dr. Dawson mentioned, is
private insurance. There are virtually almost no policies in
our State that cover autism therapies. There's none. In fact,
not--it doesn't not only in cover behavioral therapy but,
Senator Cochran and Harkin, it only covers 20 visits of any
type of speech, OT or PT. So, usually by the first 6 weeks of
the year, you've run through your insurance coverage for your
child, because it--that is combined speech and OT. So, you can
see why many of these children are not getting the assistance
they need, because the visits are kind of costly. So, those are
the things that we looked at, as to gaps that had to be filled
within the State system and Federal system.
Senator Cochran. Mr. Chairman, I think we ought to
introduce a bill to modernize our laws on Medicaid and
reimbursement. This ought to be included.
Senator Harkin. Yes, how do people afford to do this?
Senator Cochran. Well, they can't.
Ms. Boyd. They can't.
Senator Cochran. Ms. Halvorson.
Ms. Halvorson. It's----
Mr. Miller. They can't. I mean, frankly, they can't. I
don't have the exact figures, but I know that we've been
working quite a bit to get insurance in Virginia. A number of
States have insurance coverage, they've mandated insurance
coverage within their States. But, it's a foxhole-by-foxhole
fight.
In Virginia, the average income, which, unfortunately, is
still rather modest, is about $40,0000-$50,000, and the average
cost of services is about $85,000. These families have to do
without. They have to without.
And again, it's being done on a State-by-State basis. How
you can do some sort of insurance preemption would be an ideal
way to go. What the insurance people are saying to my local
legislators is that this is not--this is an educational issue,
it's not a health issue.
And, Senator Cochran, if you see my two sons, who are
wonderful children, it is clearly a combination of an
educational health-related problem.
Ms. Boyd. The other factor that didn't get brought up, that
I would be remiss if I didn't quickly tell you, is the
financial--not--the financial stress, what it leads to with
families--I was talking to Dr. Insel earlier--is--the divorce
rates. Conservative estimates--and we see this anecdotally--all
these families do--is, at a minimum, around 80 percent. There's
some estimates--there was a speaker from California last week,
and the group that--the people that she counsels, her divorce
rates were among 90 percent. So, I mean, these are absolutely
incredible numbers.
In Mississippi, in our region, we lost two parents, this
year, who could no longer handle the stressors of having a
child in the spectrum. And one of them was a dear friend of
ours.
And so, those are--but--and you--that is not unique to
Mississippi; that is things that we foresee all around the
country, and we hear about all around the country.
Senator Cochran. Thank you.
Senator Harkin. Mr. Cobbs.
Mr. Cobbs. I would just like to go ahead and piggyback a
little bit off that statement. Again, the Government needs to
move rapidly to go ahead and advance great technology, such as
telehealth technologies, and the insurance part--portion. They
really work hand in hand. It's easy to go ahead and pass a bill
here or there, but in order to make true change we have to have
the standards, and we also have to have the reimbursement model
for applied behavioral analysis and other proven therapies, as
Ms. Dawson said. In fact, applied behavior analysis is
recommended by the Surgeon General, yet private insurance
companies typically don't reimburse that for families with
autism.
Dr. Dawson. I just wanted to say that, you know, we do
have, I think, a unique opportunity, with healthcare reform, to
address this issue. And the House bill does include a--coverage
for behavioral intervention for autism, as well as ABA. And I
think it's critical that, with this opportunity that we're
looking at, in terms of healthcare reform, that we include
this. And the payoff, in terms of the financial payoff down the
road, is going to be tremendous. It's going to help with the
``tsunami,'' and the impact on families will be, also,
tremendous.
So, it's an opportunity that we must not miss, in terms of
a Federal mandate for insurance coverage for these treatments
that we know work and are cost effective.
Senator Cochran. We're going to introduce something
together. We'll find out the details a little later, with the
aid and assistance of our able staff.
Dr. Insel. If I can also add, from the IACC perspective, we
do have a services group, made up of family members, as well as
someone from CMS who's been leading this charge, along with Lee
Grossman, who's the president of the American--of the Autism
Society of America. Together, they've been listening to
families about these issues, trying to come up with some
recommendations. And so, if we can be helpful as you pull
together some ideas, I'm sure that group would love to have an
audience and give you some ideas that they've been grappling
with, as well.
Senator Harkin. Thank you.
The other issue I want to discuss you just mentioned it is
``standards.'' Someone mentioned about how you can go on the
Internet and get all kinds of misinformation.
Mr. Cobbs, you've been on this telehealth program for 3
years now, but you're dealing with trained professionals. When
you mentioned ``standards,'' is that what you're talking about,
setting up those kinds of standards?
Mr. Cobbs. Absolutely. And I think it's important to
realize that, when we started our treatment program, it was a
comprehensive treatment program that first started with face-
to-face interaction. Unfortunately, right now families can
pretty much pop up any Internet search and type in ``telehealth
treatment'' or ``video chat treatment'' and their first
contact's video-to-video, which--I just can't see how that's
possible to form a true therapeutic bond, and to actually get
to know the child, to go ahead and treat the child. It's very
disconcerting.
And Ms. Dawson also touched on the fact that you can query
pretty much anything with autism and related disorders, and
you'll get a myriad of different treatments, kind of, scattered
amongst--whether it be somebody to repair your car, offer car
advice, or for somebody to, you know, go ahead and--``Hey I'll
paint your house''--I mean, it's just so sporadic. Parents
don't have a consistent place to ensure that they're going to
receive quality of care.
And I'm encouraged that you have folks meeting and talking
about new treatments, and--but, until we get a set of
parameters for standards, so, when parents go to get
treatment--especially over innovative technology such as
telehealth, which is reasonably new to a lot of folks--they
have the assurance that they're going to get a trained, quality
professional, and that there's actually some standards that
they can rely on. Right now, those just aren't there.
Senator Harkin. Go ahead.
Dr. Dawson. Yeah. Well, I just wanted to mention a program
that is, I think, a wonderful example of a public-private
partnership that is beginning to address this issue of
standards, and that is the Autism Treatment Network. This is
built on the cystic fibrosis model, which--as you may know,
decades ago, cystic fibrosis was in the same situation of not
getting quality care, no standards for what--how a child should
be treated.
And so, the way in which this model works is, it's 15
hospitals, that care for children with autism, that have come
together to both look at quality of care, models of care, as
well as to develop standards that can be--practice standards,
published in journals, that physicians then can use to guide
things like assessment--assessment of medical conditions,
behavioral interventions, and so forth.
So, there is a mechanism where this is beginning to be
addressed, but it's in the very early stages. It's cofunded by
Autism Speaks and by HRSA.
STANDARDS OF CARE
Senator Harkin. Dr. Insel, is your group working on
standards, that interagency group? ``Who does this? Who is
charged with the responsibility of coming up with standards
that have to be met so we don't have people out there that
don't know what they're doing, trying to treat people?''
Dr. Insel. I think you've stumbled onto a really important
issue. It's not unique to autism. We've built standards around
biomedical interventions that are essentially overseen by the
FDA. But, in the broad psychosocial intervention arena, of
which APA or behavioral interventions would be part of that,
there is not an agency, and there's not a sort of licensing
body, that oversees this in quite the same way. So, it's a gap
as we look at this.
The question is, Even in this healthcare reform discussion,
when you're talking about treatments that may not be given at a
doctor's office, or may not be one of the 15 hospitals, but
involves training families to administer care, 10, 15 hours a
week, how does that get reimbursed? How do we look at quality
measures for outcomes? And how do we set standards for the
degree of care and the level of care that's needed to be
reimbursed?
Senator Harkin. Were you asking me that question or was
that just rhetorical? I mean, have we got to answer that
question now?
Dr. Insel. Someone--I am a psychiatrist, so I----
Senator Cochran. Right. ``How do I feel, Doctor?''
Senator Harkin. That's true.
Well, again, obviously we have a whole range of interests
here--everything from the research into the causes--I mean,
obviously, Dr. Insel, there's a lot of talking about vaccines.
You covered that in your testimony. We had a couple of little
questions here about it--about the number of vaccines and how
we set up that kind of a study. Ms. Boyd had talked--or, not
Ms. Boyd, I think it was Ms. Halvorson--I forget just who was--
talked about that kind of a study--but, I just don't know how
you do it. As you said, it would be kind of immoral to just
say, ``Well, your kids are not getting immunizations, because
we want to put them in a study. But, if you wanted to determine
that, I just don't know how you would go about doing that.
Ms. Boyd. One of the reasons I wanted to bring that up, Mr.
Harkin--Senator--is that there are so many families right now--
and this greatly concerns me, because I actually am a vaccine
proponent; I believe in vaccines, I think they're one of the
greatest public health achievements that we've ever had. So,
I'm actually a huge proponent of it. What I am concerned
about--there are so many families right now that are not
vaccinating their children--and we do vaccinate our children--
but, there are so many that are not vaccinating right now,
because of what they perceive as a huge risk--and so, I am
concerned that the NIH and the CDC, by their failure to
aggressively actually look at this and get good valid
scientific studies, free of people who may have some interest,
one way or the other, into this, that we--they are doing more
harm to lower the herd immunization rates than anybody that is
yelling out there, ``Be concerned about vaccines.''
There are so many people right now that are choosing not to
vaccinate their children. I don't think that population is
going to be as difficult as scientists perceive that it is,
because within the autism community, we see that going on right
now. And that concerns many of us, who feel that vaccines are
very important, because--but, we hear families all the time
come up to us and say, ``We're not going to vaccinate our
kids.''
And that, as a--having a husband as a medical professional;
I worked as an attorney in public health--that greatly concerns
me, because many of these families that are saying they're not
going to vaccinate their kids don't have any of the possible
health characteristics that some of us who did have children
with vaccine reactions had that could have been red flags, had
they--now that we know that, could be possibly studied.
So, I think that you will--that the scientific community
can find these people to do this.
Senator Harkin. Well--Dr. Insel? And then we'll go to Ms.
Halvorson. Go ahead. Or, Ms. Halvorson----
Dr. Insel. I'll yield, and----
Senator Harkin. Okay.
Dr. Insel [continuing]. If I could----
Senator Harkin. Ms. Halvorson.
Ms. Halvorson. I was just going to mention, I don't know
how many people you're thinking would need to be included in a
study like this, but there's a physician in, I believe, the
Chicago area that has a practice of about 3,500 patients and
many of them choose not to vaccinate, and their autism rate is
next to nothing. And so, there are populations of people who
are--who have that documentation. I agree, I don't think it's
going to be that hard to find.
You know, the Amish people can argue on that. There's, you
know, maybe a--it's more of a closed situation. But, this
population with Dr. Eisenstein is very broad-based. It's not--
just people from every walk of life.
Senator Harkin. I don't know about that.
Dr. Insel.
Dr. Insel. So, let me----
VACCINE STUDIES
Senator Harkin. I'd like to know more about it.
Dr. Insel [continuing]. Just be very clear on this point,
because I'm representing what we know about the scientific
evidence so far. And that's really unequivocal. It's not that
CDC and NIH, and actually now multiple European and Japanese
studies, haven't looked at this. This problem has been looked
at over and over again, 16 large-scale studies that have plowed
into this question at many different levels and many different
populations. And whether you read those studies or whether you
listened to the Institute of Medicine, or whether you look at--
--
Senator Harkin. Excuse me, Dr. Insel, for--studies on
thimerosal or on the--just the total number----
Dr. Insel. Both.
Senator Harkin [continuing]. Of vaccines----
Dr. Insel. Looking at----
Senator Harkin [continuing]. That were----
Dr. Insel [continuing]. The connection--the possibility of
a connection between vaccination, with or without thimerosal,
with particular formulations or without, and the prevalence of
autism, whether this is a risk factor. The studies have
consistently found no evidence of a connection. We heard that
from the Institute of Medicine, that looked at this whole broad
spectrum of studies. We heard it from the Vaccine Injury Court,
which said there's not even plausibility here.
Senator Harkin. But, I thought, earlier, Dr. Insel, you
told me, when I mentioned getting a study done of the number of
vaccines--not the thimerosal issue, but the number of
vaccines--in the first 2 years of life, now, compared to what
it was 20, 30 years ago, and I said, ``Could we compare--what
would the incidence of autism among a cohort of children age 0
to 2 that received 29 vaccines in 2 years, compared to a cohort
of kids that got 5 or 6 or 7 or 8--what they did in 1980--
compared to 29?'' Do you see what I'm saying? How--I don't know
of any studies. And you just told me there are no studies that
have done that.
Dr. Insel. So, if you're asking the question, ``Has the
prevalence of autism increased over the time when the number of
vaccines has increased, is there a relationship?''----
Senator Harkin. We don't know that.
Dr. Insel. Well, we know that they're--we know they've both
gone up, right?
Senator Harkin. Both gone up.
Dr. Insel. But, a lot of things----
NUMBER OF VACCINES
Senator Harkin. But, we don't--but, what we don't know is,
Is there any causal relationship between the number of vaccines
that----
Dr. Insel. Right.
Senator Harkin [continuing]. Are given--now it's 29 over 2
years, now; we know in 1980, it was 8 or 9--what we don't know
is, Is there any causal relationship between the number of
vaccines--29 in 2 years--and higher incidence of autism? We
don't know that, do we? Because there's no studies that have--
--
Dr. Insel. So, the way to do such a study clearly would be
asking--we'd have to do a randomized, controlled design.
Senator Harkin. Sure.
Dr. Insel. You'd want to be able to look very carefully at
those who are vaccinated and those who are either unvaccinated,
or vaccinated in a different way.
And that's where I said that we get into ethical problems.
Most--because of the scientific evidence----
Senator Harkin. I know that.
Dr. Insel [continuing]. And I just can't stress this
enough--the scientific evidence is so consistent----
Senator Harkin. Ms. Halvorson says there are--she just
mentioned someone in Chicago--I have no idea who this is--who
doesn't vaccinate kids. I'm interested in that. She mentioned
thousands of them who have not been vaccinated. Are there place
like that? And you mentioned, Ms. Boyd, there are people down
in your area that aren't getting their kids vaccinated now.
Couldn't you set up a study like that?
Dr. Insel. You could--if you were to set up a study like
that, I think the question that one would ask is, not only
about, does this have an impact on autism, but what's the
impact on measles, on pertussis?
Senator Harkin. Very true.
Dr. Insel. What's the impact on rubella, on a whole----
Senator Harkin. Yes.
Dr. Insel [continuing]. Series of----
Senator Harkin. Yes.
Dr. Insel [continuing]. Preventable illnesses for which we
know----
Senator Harkin. Yes.
Dr. Insel [continuing]. The cause, for which we know the
vaccines can prevent them? Do you really want to ask parents to
put their children at risk for those illnesses for which we
could lose herd immunity so that we could investigate, for the
17th time, whether there's a potential relationship here?
Senator Harkin. Ms. Boyd, I----
Ms. Boyd. Senators, this is where--there are many people in
the medical community--and I mentioned Dr. Bernadine Healy--
that feels like this issue has not been appropriately
evaluated, particularly also looking at subpopulations of the
autism community, to look at whether there are immunological--
--
Senator Harkin. Mitochondria.
Ms. Boyd [continuing]. Mitochondrial, thank you--where
there are many issues involved with that. And she's
articulately laid those things out that are missing from the
studies right now. And I think it is imperative that we look at
those particular studies. I understand the ethical delimination
or--thing about asking about asking parents to do this. But,
Senators, we already have populations of families that are not
doing this, anyway. So, we're--and absolutely we should look at
whether or not their children developed measles. But, quite
frankly, Senator, measles and autism?
Senator Harkin. If you had a--it's a terrible--have you got
a choice?
CHILDHOOD ILLNESSES
Senator Harkin. You know, I had all those diseases when I
was a kid. We had mumps and measles and chicken pox, and I had
everything like that.
Senator Cochran. Did you have whooping cough? That's a
real----
Senator Harkin. I don't think I had it. I don't--I may
have. I don't know.
Dr. Insel. So, it is important to recognize, many of us
were exposed to those illnesses and did quite well. They're
also fatal in a proportion of children. And I grew up, as a
physician, watching children die with H flu meningitis, and
watching children die with the ramifications of measles,
because we weren't preventing all of those diseases at that
point in time. I would be loath to go back to those days, I can
tell you, to think that we've been able to finally succeed in
that sphere, and to go backwards, and invite that to come
back--it would--I just think we're better than that. We--the
science tells us that we're better than that.
Senator Harkin. Well, I would still like to see the studies
done. I know we're better off, in that regard, but I'd like to
see whether or not--I still have questions and--believe me,
I've had a lot of hearings, I've talked to a lot of
professionals about this, as to whether or not you need all of
those vaccinations in the first 2 years of life. Or should they
be stretched out longer? That's an open question. Don't know. I
don't know the answer to that question.
Ms. Halvorson.
Ms. Halvorson. I just have to point out also--vaccines
don't always work all the time. My son is a walking example of
this. The chickenpox vaccine was brand new when he was 2 years
old, and my doctor said that I should get it for him. And I
thought, okay, great. I had chickenpox as a kid. It was not a
big problem. I came through it, but I missed a couple weeks of
school. And 6 months later, after being immunized, my son
developed a full-blown case, anyway.
That was my first clue that I was not necessarily going to
choose immunizing my daughters for chickenpox--my future
children; at the time, I didn't know I was going to have two
more daughters--because I was pregnant at the time that my son
developed chickenpox, 6 months after his vaccine, and had I not
had it as a child, and had lifelong immunity, my baby could
have been at risk for birth defects, as I understand it.
So, there's more to consider than just a blanket statement
of, ``The vaccine is automatically going to protect.'' It
doesn't always work that way.
Senator Harkin. Dr. Dawson.
Dr. Dawson. I want to say that, in many ways I agree with
Dr. Insel, that we have answered some questions definitively.
It does not appear that thimerosal is--or, accounts for this
large increase that we've seen in prevalence of autism. And the
introduction of the MMR vaccine does not appear to account for
the increase in the prevalence.
I do think there are important questions that still remain
to be addressed, that have not been addressed by the large
epidemiology studies that have been conducted so far. And, in
particular, I think it's important to understand the role of
underlying genetic and medical susceptibilities, and whether
they may lead to an averse response to a single vaccine, or a
set of vaccines that are given over a short period of time.
We know that the era of personalized medicine is beginning
to infuse our practice of the infectious--treating infectious
disease. But, our understanding of underlying variation in
genetics has not been studied in the context of responses to
vaccinations. And it's--so, it's--Autism Speaks' focus, in
terms of our funding in this area, is trying to understand
those medical or genetic vulnerabilities, whether it's
mitochondrial disorder, sodium channel genes, which we know--
that can affect responses to vaccines in developing seizure
disorder, and so forth--whether these may account for, again,
some minority of cases of autism.
The other thing I would like to put out is--or, suggest
is--I agree with Tom--Dr. Insel--that a randomized study in
which we ask parents to forego getting vaccines is not ethical
and not feasible. We could, however, study the potential role
of vaccines in the context of at least two ongoing NIH studies.
One is a study, that both NIH and Autism Speaks are funding,
which is following a cohort of at-risk infants. These are
infants who have an older sibling with autism, and so, they
have a much higher chance of developing autism. And we know
that many of those parents are choosing to vaccinate their
children, and some of those children are--parents are choosing
not to vaccinate. So, it's important that we leverage those
studies to look at how vaccination rates among these at-risk--
genetically at-risk infants affects outcome.
The other study is the NIH National Children's Study. So,
this is a cohort of 100,000 children that are being followed,
prospectively, from conception through adulthood. Now, keep in
mind that 600 individuals in that cohort will develop an autism
spectrum disorder, based on our current prevalence estimates.
One of the weaknesses in the current design in--and Autism
Speaks is overseeing the advisory--expert advisory panel that
is advising the National Children's Study on how to leverage
this study to inform autism--but, one of the weaknesses in the
current design is that they're not collecting medical records,
so they're not collecting information that would inform how
parents are vaccinating their children. And again, with many
parents now choosing not to vaccinate their children, this is
another opportunity, with the collection of medical records,
that we could leverage an ongoing study to address this
important question.
And I want to say that our position at Autism Speaks is one
of very evidence-based--we're really agnostic with respect to
whether vaccines play a role or not, but we believe that, by
addressing parents' questions, that this will increase
confidence in the vaccine program and will ultimately lead
parents to be more likely to vaccinate their children, which we
think is going to be critically important for public health.
Senator Harkin. I did not know this. I've been a big
supporter of that Children's Study, and I have used my position
on this subcommittee to make sure that we continue the funding
for it, and keep it going. I think it's one of the most vital
longitudinal studies that we've ever done.
Dr. Dawson. Right.
Senator Harkin. And you're telling me that of all the money
we've put in for that, and we're going to continue to do this--
what, 20--is this a 20 year? How many years is this
longitudinal study? 20 years--that they're not keeping medical
records?
Dr. Dawson. Well, the--so, they don't have the--no, it's
true--they have questionnaire data, but they do not have the
funding to go back and actually obtain the medical records and
extract the information that we need. And this not only affects
our ability to address questions about vaccines, but it also
affects our ability to address really, critically,
scientifically based questions like, What's the effect of a
mother having a flu infection during pregnancy? The specific
medications that she received. Any kinds of prenatal and
perinatal events. These are all only being obtained through a
questionnaire, rather than medical records. And so, our advice
to the National Children's Study is, this is a key component.
And the reason for not doing it is strictly financial. They
just don't have the funds to do it.
Senator Harkin. Dr. Insel.
Dr. Insel. I just want to make sure that you don't go away
with the idea that they're not--that they don't have medical
records. They're not able to obtain the original records, with
the current budget. And they've looked at the possibility of
getting supplementary funding that would allow them to obtain
the raw records from the physician of referral. That has not
been done. So, Dr. Dawson's right about that.
CAUSES OF AUTISM
I would just--I know we're running out of time, and I just
think it should be said by someone here that there will be a
time in the future that we will have a much better
understanding of the environmental causes of autism. One
concern that many people have is that if we get stuck by
looking at one thing over and over again, that we're going to
miss the opportunity to look at what may be a much more
important cause.
Where Dr. Dawson and I agree is that the evidence now is
very clear that, whatever the story is with vaccines, it
doesn't explain very much about what we know about autism. And
we may never be able to fully eliminate a very, very rare event
that may be in play here that would connect the two. But, all
the evidence, so far, says this isn't the main story.
The question for us is, Where is the main story, and where
should we be looking? And I would hope that the focus on this
topic, particularly in this conversation today, doesn't obscure
that fact that there's probably something out there that is
truly important that we need to be focusing on very quickly,
and move into very quickly. And the hope is that the kinds of
studies that Dr. Dawson suggests, that are agnostic, that look
broadly at a lot of prenatal factors, also include some
postnatal factors--we'll begin to see a pattern emerge. But, so
far, we don't have that.
Senator Harkin. Well, we are going to explore that, the
whole idea of the medical records. I wrote that down. We have
got to--I have to find out about that.
I know we are out of time. We've got three things, I think.
Let me see if I can summarize this.
One, the research that needs to be ongoing, that we are
putting a lot of money into, to find what is causing this--that
is basic research.
Then there is the other element of interventions and
helping families right now. We know families, in the next
several years, are still going to have children with autism. It
is just going to happen. So, we have to think about what we do
on early interventions and how we structure that to provide the
most effective early interventions.
And the next thing is, we have a whole group of young
people out there with autism, and they are going to be adults
soon. What is happening to them, and how can we develop
programs for independent living, and things like that.
So, it is a big task, but it is one that we can't shirk
from trying to address in multiple ways. And that is what this
subcommittee is going to try to do.
So, I picked up some good ideas here this morning. It is
good to be refreshed on all of the information. I wish I had a
simple answer.
Do you have anything to add, Thad?
Well, thank you--does anybody else have one last thing they
want to get across, or not, before we leave?
Dr. Insel. Thank you for your interest.
Ms. Boyd. Thank you for your leadership.
Senator Harkin Well, it bedevils us, I can tell you that.
Yes, Ms. Halvorson.
Ms. Halvorson. I would just encourage you all to continue
to talk with more of our independent researchers.
I really take issue with Dr. Insel's statement, ``all of
the evidence says that this is not a connection.'' If you don't
look, you won't find. There is evidence that does say that
thimerosal is very much a concern. And I would really encourage
you all to talk more with people like Dr. Lucier, who is seated
behind me, Dr. Boyd Haley--I could name a whole bunch of
scientists that you would glean a lot of really great
information from.
Senator Harkin. I believe in open inquiry. As I said to a
group last night, I do not believe in closed minds or closed
doors or closed inquiry. I want open inquiry into this. But,
again, if something has been looked at scientifically and the
vast majority of the scientific community, after looking at
this and going through it, says there is no correlation, well,
then you have got to move on to something else at that point in
time. But, again, I am always for open inquiry.
Any other last things before we go?
Mr. Cobbs. And then we're going to have to adjourn.
Chairman Harkin and Senator Cochran, I just wanted to thank you
for, again, allowing us to tell the story of a truly innovative
technology that has helped our family. Thank you so much.
Senator Harkin. I'm still interested in telehealth, because
there are so many families out there, and they are at wit's end
on how to take care of their kids that have just been
diagnosed. They can't go to a doctor's office every day. You
are an example of what happens when you have someone--when the
child is acting up, and someone--a professional, with good
standards, can come in and say, ``Here's what you should do.
Here's how you should take care of that''----
Mr. Cobbs. Absolutely.
Senator Harkin. But, of course, the problem is, we don't
get reimbursed for that.
Mr. Cobbs. You hit the nail on the head, sir.
Senator Harkin. You don't get reimbursed.
Mr. Cobbs. Absolutely.
Senator Harkin. If you go--probably if--I don't know, if
you went to a hospital or someplace, there would probably be
some reimbursement for that, I don't know. But----
Mr. Cobbs. Somewhat. There still is, as Ms. Dawson and the
others pointed out, a complete both public and private
insurance breakdown----
Senator Harkin. Yes.
Mr. Cobbs [continuing]. For reimbursement, for autism.
Senator Harkin. Yes, hopefully we'll look at that. And with
healthcare reform, hopefully we'll look at the whole issue of
reimbursement for preventative category of services.
Well, again, thank you all very much. This--to me, has been
very informative. It's just good to be brought up to speed on
it. And we will continue our involvement in this issue--it
just, as I said, bedevils us all on getting a good handle on
it.
But, Dr. Insel, thank you for your great leadership at NIMH
and on the Interagency Task Force. Ms. Dawson, all of you
here--Ms. Halvorson--thank you very much. And believe me, we'll
continue to pursue open inquiry and if there's questions out
there, let's have some answers, and let's pursue them.
Thank you all very much.
CONCLUSION OF HEARING
The subcommittee will stand recessed.
[Whereupon, at 12:18 p.m., Wednesday, August 5, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
-