[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

                               __________


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                      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.]

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