[Senate Hearing 110-]
[From the U.S. Government Publishing Office]



 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                        TUESDAY, APRIL 17, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 2:05 p.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin, Durbin, Reed, and Specter.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

               Centers for Disease Control and Prevention

STATEMENT OF DR. JULIE GERBERDING, DIRECTOR

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Good afternoon, the Subcommittee on Labor, 
Health, Human Services, Education, and Related Agencies of the 
Appropriations Committee will come to order.
    The subcommittee has invited a number of distinguished 
witnesses to appear before this hearing and this subcommittee, 
to tell us more about a very important issue, autism.
    The Centers for Disease Control and Prevention estimates 
that 1 of every 157 children born this year will be diagnosed 
with autism. Millions of families across the country are facing 
the very real difficulties in coping with this disease.
    It's tough on parents who would do anything to help their 
children at home, while at the same time, fighting to find the 
supportive services that their children so badly need. We hear 
the heartbreaking stories, day after day, about families just 
trying to get the best treatments for the children, and 
wondering why it's their family that faces this ordeal.
    I know we have heard from several families and groups, and 
I want to thank them for sharing their stories.
    This hearing will address a number of questions. First, is 
the prevalence of autism on the rise, both in the United States 
and other countries? If so, why is that? Is there really an 
increase in children of autism, or is the disease being better 
diagnosed? I keep hearing both sides of that debate.
    Second, of course, what causes autism? Is it environmental, 
is it genetic? Is it a combination of both? Imagine my 
surprise, when I read the last issue of Discover magazine. It 
had a big story in there about understanding autism, and the 
subtitle is, The Answer May Lie in the Gut, Not in the Head, 
saying that there may be a direct link between physical 
illness--physical illness--and the onset of autism. So, again, 
I'll be asking questions about that article. [Discover 
magazine, April 2007, ``Autism: Its Not Just in the Head,'' by 
Jill Neimark.]
    Third, what therapies work best for children with autism? 
Are parents able to find the services they need for their kids, 
and at what cost?
    As Dr. Favell will point out, and also Marguerite Colston 
in her testimony, that in looking for a cure and putting more 
research dollars out there, and trying to find how we have a 
cure, or a good intervention, we can't forget the families need 
help now. Now--not 10 years from now, they need help right 
now--in finding the best possible support for their children.
    So, we have two panels of witnesses today. The first panel 
will be, of course, Dr. Julie Gerberding, the Director of the 
Centers for Disease Control and Prevention, who will talk about 
the incidents, and prevalence, of autism. Dr. Thomas Insel, the 
Director of the National Institute of Mental Health, will bring 
us up to date on some of the science.

                           PREPARED STATEMENT

    Our second panel will include Dr. Judy Favell, who has done 
great work with young children with autism; Marguerite Colston, 
a parent of a child with autism who can speak to the issue from 
the perspective of a parent; Mr. Bob Wright, the Co-Founder of 
Autism Speaks; and, Bradley Whitford, actor; as well as, former 
Deputy Chief of Staff to President Jed Bartlett (on TV, of 
course) and foremost an advocate for children with autism.
    [The statement follows:]
                Prepared Statement of Senator Tom Harkin
    Good Afternoon. The subcommittee has invited a number of 
distinguished witnesses, this afternoon, to bring us up to date on a 
very important topic: the status of autism, and of autism research, in 
the United States. The Centers for Disease Control and Prevention 
estimates that one of every 157 children born in the United States this 
year will be diagnosed with autism. Millions of families are grappling 
with the profound difficulties of understanding and coping with this 
disease. My heart goes out, in particular, to parents who go to heroic 
lengths to assist their autistic children at home, and who fight the 
daily fight to secure the support services that their children so badly 
need.
    This hearing will look at several key questions:
    First, the number of diagnosed cases of autism is on rise, both in 
the U.S. and in other countries. Why is this? Are we simply doing a 
better job of diagnosing autism, or has there been a real increase in 
the incidence of this disease?
    Second, what causes autism? Are the causes environmental? Are they 
genetic? My guess is that it is a combination of the two, but I am 
eager to hear the views of our witnesses.
    Third, which therapies work best for children with autism? And are 
parents able to find the services they need for their children, and at 
what cost? As Dr. Favell points out in her testimony: while doing 
research on causes and cures is important, people need help now to 
overcome or lessen the effects of autism.
    Last, what is the outlook for finding a cure for autism? And what 
more can the federal government do to help?
    We will have two panels of witnesses today. The first panel 
includes Dr. Julie Gerberding, the Director of the Centers for Disease 
Control and Prevention, who will talk about the incidence of autism; 
and Dr. Thomas Insel, Director of the National Institute of Mental 
Health, who will bring us up-to-date on the science and research.
    Our second panel includes Dr. Judy Favell, who has done great work 
with young children with autism; Marquerite Colston, a parent of a 
child with autism, who will speak to this issue from the perspective of 
a parent; Bob Wright, the co-founder of Autism Speaks; and Bradley 
Whitford, former deputy chief of staff to President Jed Bartlett--
actually, a very accomplished actor--and an outspoken advocate for 
children with autism.

    Senator Harkin. With that, I will turn to my colleague, 
Senator Specter.

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Thank you, Senator Harkin, for convening 
this very important hearing on this very debilitating disorder. 
We have seen a significant increase in the funding by the 
National Institute of Health for autism research from $27 
million in 1998, to the current funding of $108 million. CDC 
funding for autism has grown from $281,000 in 1998, to $15.1 
million today.
    My view is that the funding through the NIH is 
insufficient. As is generally known, Senator Harkin and I have 
taken the lead on increasing the funding for the National 
Institutes of Health from $12 billion to $29 billion. During 
the course of the past decade, we have re-allocated priorities 
within this subcommittee--as we frequently say, the gavel has 
changed seamlessly between the two of us over the course of the 
past decade and a half--and in some years, have increased NIH's 
funding by as much as $3.5 billion.
    This year, with a lot of pressure, the budget resolution 
came forward with an additional $1.5 billion, and Senator 
Harkin and I added an amendment to add $2.2 billion more to the 
National Institutes for Health.
    Candidly, a budget resolution is only Confederate money, it 
doesn't really count until there is an allocation. Senator 
Harkin and I are working our way up the seniority route, and 
we're getting to be closer to the coveted status of chairman of 
the Appropriations Committee. Only Senator Cochran is ahead of 
me on the Republican side, and it's a great position to have to 
be able to deal in real dollars when those allocations are 
made.
    But, we hear parents across the country tell us about their 
children with autism, and it's an ailment, a malady, which I 
think could be, could be solved if we had sufficient research 
intensity.
    For a moment, on a purely personal note, one of the leading 
national advocates on this subject is John Shestack, who is the 
son of a very prominent lawyer, Jerome Shestack in 
Philadelphia--longstanding friend of mine--and, his mother 
Marcia Rose is a noted television personality. John and his 
wife, Portia, have established a foundation, one of the largest 
non-governmental funding resources for autism, and they have 
recently joined with Bob and Suzanne Wright for the February 
merger of their two leading autism organizations.
    So, it is very heartening to see this in the private 
sector, and Senator Harkin and I, and this committee--and I 
think, really, the whole Congress--are determined to increase 
funding so we can find an answer to autism.
    Regrettably, I'm not going to be able to stay for the 
entire hearing today, we are very deeply involved in the issue 
with the Department of Justice and the resignation of the U.S. 
Attorneys which is taking a great deal of time, and I'm going 
to have to excuse myself partway through this hearing to attend 
there, but I will stay for as long as I can.
    Thank you, Mr. Chairman.
    Senator Harkin. Thank you very much, Senator Specter. 
Again, thank you for our close working relationship over all 
these years, and for your continued commitment to bio-medical 
research and especially to this very important issue of autism.
    I had dinner Sunday night with a couple whose child is 
autistic, and all I can say is that we've got to get the 
families some help. People are looking to us for answers and 
some help. Hopefully this hearing today will point us in the 
right direction.
    So, let's get started, and I'll just make it clear that all 
of your statements will be made part of the record in their 
entirety. I'm going to ask each of our witnesses to try to sum 
it up in about 5 minutes. But if you get around 7 minutes or 
so, I might start motioning for you to quit.
    So, if you could just sum it up for us, and then I'm going 
to ask both you, Dr. Gerberding and Dr. Insel, at the end of 
your presentations, to maybe take a seat on either end, and 
we'll bring up the other witnesses. It's not my intent to 
question you at that time--but to question everyone all at 
once.
    Okay? So, we'll kick it off first with Dr. Julie 
Gerberding, the Director of the Centers for Disease Control and 
Prevention. Dr. Gerberding, welcome back.

              SUMMARY STATEMENT OF DR. JULIE L. GERBERDING

    Dr. Gerberding. Thank you, it's good to be back. We really 
appreciate the committee's interest in this topic. Is my 
microphone on, can you hear me okay?
    Senator Harkin. Yes.
    Dr. Gerberding. We are very grateful for all of the support 
that the committee has given us, and particularly for our 
ability to expand our autism activities significantly.
    Senator Harkin, I also know that you walk your talk on this 
issue, having had a chance to be with you at the summer 
Olympics--the Special Olympics last summer--and knowing your 
commitment to developmental disabilities, and disabilities of 
all nature. So we really appreciate your championing this 
issue.
    I'd like to share with you the CDC perspective on autism 
and the work that we're doing. It's important to appreciate 
that we recognize that we're talking about a spectrum of 
diseases here, not a single disease. We're talking about 
autism, per se, about pervasive developmental disorders, and 
some other conditions that have characteristics in common with 
autism--Asperger's disorder and some other conditions--and 
these are diseases that are not diagnosed by a test. They're 
diseases that are diagnosed by observing behaviors, and 
watching behaviors change and develop over time. So, there's a 
lot of difficulty in making a distinction between who has what, 
and where one of these conditions leaves off and the other one 
begins.
    We know that autism has a tremendous impact on children who 
are affected as well as their families and the people who care 
for them. The diseases are characterized primarily by 
difficulties in forming relationships, and engaging in the kind 
of social interactions and communications that enrich life, and 
allow people to effectively communicate with one another.
    Many of these children also have differences in the way 
they respond to stimuli in the environment; the way they learn, 
the way they play, and the way they experience their life 
overall.
    The bottom line is, there is no cure for autism now, and 
these effects can last a lifetime. We also know that the sooner 
we make the diagnosis of autism spectrum disorders, the more 
likely children are to benefit from interventions, and so it's 
imperative that we not wait until the full-blown syndrome has 
evolved, but that we have early detection and characterization.
    Under the Combating Autism Act, CDC has three main 
responsibilities. One is, to answer your first question, what 
is the prevalence of autism in our communities, and is it 
changing over time, and who is at risk, why and when?
    Our second priority is research. We are engaged in several 
kinds of epidemiologic research that will help us look at a 
variety of the hypotheses about causality, and try to make some 
determinations about which are the most promising associations, 
and what can we learn about cause that could help us lead to 
intervention, or even treatment.
    Last, and importantly, is our responsibility for awareness. 
We need to be able to inform parents and caregivers, as well as 
teachers and clinicians about the full spectrum of these 
conditions so that earlier diagnosis is possible. We also need 
to improve community awareness so that children can live more 
comfortably in their communities, and overall public awareness 
so that we have the kind of support we need to solve these 
problems.
    Just recently, CDC published information about the rate of 
autism in communities around our country. I'm going to focus on 
the communities that were reporting data in 2002, we also have 
a report from 2000, and there will be an upcoming report on 
information from 2004. But the information from 2002, probably 
is the largest sample, and so I'm going to focus on that--this 
represents about 10 percent of 8-year-old children in our 
country, so it's not everyone, it's not every community, but 
it's a significant proportion.
    What was found in this study is that about 1 in 150 
children have autism. Boys, in general, were more likely than 
girls, and at least some of the sites showed that white 
children were more likely to have autism than non-white 
children. So, this is a healthy--a helpful--perspective, but we 
can't yet say anything about trends over time, until these 
studies go on for a longer period of time.
    We also have initiated a set of studies in a group of sites 
called CADRE, Centers for Autism and Development Disabilities 
Research and Epidemiology. And this is a study that will allow 
us to look at causes. We're going to compare children who have 
these disorders, with children who have other disabilities, and 
children who are normal, and look for the frequency of a 
variety of factors, including infections, as you mentioned in 
the Discover magazine, their parents' health status, their 
family health status, their genes and so on and so forth. We 
will be able to tease out of that leading hypothesis about why 
are children with autism different from children who have other 
conditions, or who don't have a developmental disability. This 
is a project we're starting this spring, and we will probably 
have information from the study over the next couple of years.
    The last point I wanted to make very quickly, was the 
importance of awareness. We know that at least half of children 
with autism have obvious symptoms and signs before they're age 
three, but most children with autism are not diagnosed until 
they are 4 or 5 years old, so there's a gap between when it 
should be completely clear what is going on, and the gap when 
they come to attention.
    So, we initiated this ``Learn the Signs, Act Early'' 
campaign to target parents, health professionals and caregivers 
in pre-school and daycare to be able to recognize the child who 
is at risk, or who may have early signs. Of course, we're doing 
this with a number of our partners.
    This has been an incredibly effective campaign already. 
Pediatricians now indicate that they have the tools to be able 
to diagnose autism at least two-thirds of the time, parents 
understand that this disease can be detected through 
developmental screening, and an increasing proportion of 
doctors recognize that you can diagnose autism as early as 18 
months, and that you need to initiate the screening much 
earlier than when the child enters school, which is often when 
these conditions are initially detected.

                           PREPARED STATEMENT

    So, we're going to continue this awareness campaign, we 
hope that will create a platform so that the work that we're 
doing on research, on causality and interventions will have a 
better chance to really make a difference.
    So, I--again, I thank you for your attention, and I look 
forward to being able to answer some specific questions that 
you mentioned at the beginning of this hearing.
    [The statement follows:]

             Prepared Statement of Dr. Julie L. Gerberding

    Good afternoon, Senator Harkin and distinguished members of the 
subcommittee. Thank you for the opportunity to appear before you on 
behalf of the Centers for Disease Control and Prevention (CDC), an 
agency of the Department of Health and Human Services, to discuss our 
agency's research and prevention activities addressing autism spectrum 
disorders. Thank you also for your continued support of CDC's goals in 
support of healthy people throughout all stages of their lives and 
facets of living. Good health is essential to a good life, and the 
health and well-being of a Nation's people are essential for its 
continued strength and growth.
    Today, our Nation and the world are focused on urgent threats such 
as pandemic influenza, natural disasters, and terrorism. While these 
threats require and deserve our immediate attention, we cannot lose 
sight of the pressing realities of public health issues that we face 
every day, such as autism and other developmental disabilities. Autism 
spectrum disorders include autistic disorder, pervasive developmental 
disorder--not otherwise specified (PDD-NOS, including atypical autism), 
and Asperger's syndrome.
    Autism spectrum disorders cause considerable impairments in social 
interaction and communication that show up early in a child's life--
before the family celebrates the child's third birthday--and can 
dramatically affect a child's ability to participate in activities with 
loved ones, caregivers, and peers. It is often difficult for a child 
with an autism spectrum disorder to communicate and interact with 
others, and they can retreat from group activities. An affected child 
may also have unusual ways of learning, paying attention, or reacting 
to different sensations, and can show unusual behaviors and interests. 
There's no cure at this time, and the effects of these disorders can 
last a lifetime. The profound lifelong impact of autism spectrum 
disorders, tremendous costs to the affected individuals and their 
families, the lack of known causes or cures, and concerns about the 
increased rates of diagnosis all make autism spectrum disorders one of 
our urgent realities, and a top concern for many families, health 
professionals, educators, and local and national organizations.
    CDC's efforts on autism spectrum disorders are led largely by our 
National Center on Birth Defects and Developmental Disabilities 
(NCBDDD), which was created following the Children's Health Act of 
2000. The Center takes a life-span approach by working to identify and 
prevent birth defects and developmental disabilities--including autism 
spectrum disorders--and by promoting the health of children and adults 
with disabling or potentially disabling conditions. The Center's top 
priorities are improving health and wellness for people with 
disabilities, preventing birth defects, and addressing autism and 
related conditions.
    As reauthorized by the Combating Autism Act of 2006 (Public Law 
109-416), NCBDDD's work in autism spectrum disorders focuses on three 
broad areas--understanding rates and trends, advancing public health 
research in the search for causes or a possible cure, and improving 
early detection and diagnosis so that affected children can begin 
receiving intervention as soon as possible. Early intervention that 
provides structure, direction, and organization can often help a child 
with an autism spectrum disorder. Today, I will provide an update on 
the prevalence of autism spectrum disorders, discuss the launch of 
CDC's epidemiologic study of potential causes and correlates, and share 
with you some of our successes in promoting early identification of 
autism spectrum disorders and other developmental disabilities.

           CDC'S WORK IN AUTISM SPECTRUM DISORDERS PREVALENCE

    Parents, policy makers, and the public want to better understand 
how many people are affected by autism spectrum disorders--and whether 
the higher rates are due to better identification or a true increase in 
the occurrence. In order to address these questions about rates and 
trends, we have focused our efforts on developing prevalence estimates 
of autism spectrum disorders in multiple communities over time. 
``Prevalence'' is the number of existing disease cases in a defined 
group of people during a specific time period, and it should be 
differentiated from ``incidence,'' which is the number of new cases for 
a given period of time.
    Previous efforts to understand the prevalence of these conditions 
have varied widely in their methods and findings--making it difficult 
to accurately answer critical questions about trends. For example, 
studies published before 1985 indicated that the prevalence of autism 
and related conditions was 0.4--0.5 per 1,000 children. However, later 
studies using updated diagnostic criteria and differing methods from 
multiple countries have identified rates ranging from 2.0 to 12.0 per 
1,000 children with ``best estimate'' rates ranging from 2.0 to 6.0 per 
1,000 children. Two previous CDC studies specific to U.S. communities 
from the mid-1990s found rates of 3.4 and 6.7 per 1,000 children 3-10 
years of age and have identified the urgent need for population-based 
autism spectrum disorder prevalence monitoring in the United States.
    CDC has been monitoring the prevalence of developmental 
disabilities since the 1980s and autism spectrum disorders specifically 
since 1996. Since 1999, CDC and its partners in 14 States have been 
building the Autism and Developmental Disabilities Monitoring (ADDM) 
Network to better understand the size and characteristics of the 
population of children with autism spectrum disorders, and to provide 
consistent and reliable estimates over time. This network, the only one 
of its kind, provides multiple-site, multiple-source, population-based 
prevalence data on the number of children with an autism spectrum 
disorder. CDC began with six sites (Arizona, Georgia, Maryland, New 
Jersey, South Carolina, and West Virginia) in 2000 and in 2002 expanded 
to include eight additional sites (Alabama, Arkansas, Colorado, 
Missouri, North Carolina, Pennsylvania, Utah, and Wisconsin). Today, we 
are continuing our surveillance efforts in 10 of these sites. While 
this method does not provide a nationally representative sample, the 
network represents the largest effort to monitor prevalence to date, 
capturing up to 10 percent of the U.S. population of 8-year-old 
children. The network aims to provide accurate information and a strong 
basis for bringing autism and developmental disabilities surveillance 
to scale, similar to our national efforts in monitoring other urgent 
realities.

                      RECENT PREVALENCE ESTIMATES

    Together with our partners in the ADDM network, CDC is beginning to 
answer one of the critical concerns that I discussed earlier--are rates 
of autism spectrum disorders truly increasing? In February of this 
year, the CDC released the largest summary of prevalence data from 
multiple U.S. communities ever reported. The results showed an average 
of 6.7 children out of 1,000 with an autism spectrum disorder in the 
six communities assessed in 2000, and an average of 6.6 children out of 
1,000 with an autism spectrum disorder in the 14 communities included 
in the 2002 study. The average finding of 6.6 and 6.7 per 1,000 eight-
year-olds translates to approximately 1 in 150 children in these 
communities. This estimate is consistent with the upper end of 
prevalence estimates from previously published studies, with some of 
the communities having an estimate higher than those previously 
reported in U.S. studies. Reported rates ranged from about 1 in 100 to 
1 in 300 children in the 2002 study year.
    Six of the participating sites (Arizona, Georgia, Maryland, New 
Jersey, South Carolina, and West Virginia) reported data in both 2000 
and 2002. Autism spectrum disorder prevalence was similar across the 2 
years in four of the six sites. New Jersey's prevalence estimates are 
higher than all other sites in both years, but did not increase 
significantly between 2000 and 2002. In West Virginia, the prevalence 
estimate is significantly higher in 2002 than in 2000; the prevalence 
in Georgia appears to have increased, but not significantly. While the 
stability of autism spectrum disorders in four of the six sites is 
fairly consistent, the increase in two sites is a concern.
    As anticipated, the findings from both study years confirmed a 
higher prevalence for boys than girls; this finding is consistent with 
past studies. Also, the data show some differences in rates among 
children by race or ethnicity. Similar to past reports, prevalence 
rates in most sites were similar for white and black children; however, 
five of the 14 sites found a higher prevalence among white children 
compared to estimates for black children.
    In addition to measuring prevalence and demographic differences, 
the studies looked at when parents and others first noted signs of 
developmental concerns in their children. We know that autism and 
related conditions can be diagnosed as early as 18 months. However, 
these studies showed that up to 88 percent of children with an autism 
spectrum disorder had documented developmental concerns before the age 
of three, but half of these were diagnosed between 4\1/2\ and 5\1/2\ 
years. It is of critical importance to diagnose the child as early as 
possible, as early intervention services hold the most promise to 
improve the quality of life for these children and their families.
    The 2000 and 2002 data points do not constitute a trend, but they 
do provide important baseline information on the prevalence of autism 
spectrum disorders in multiple areas of the United States. As I 
mentioned earlier, we are continuing to work with our network partners 
on prevalence estimates for 10 of these same sites for 2004 and 2006. 
Since the system has now been established, I expect information for 
these new data points will come more quickly, hopefully by the end of 
2008.
    I want to stress that CDC and many of our public and private 
partners see these numbers as an important step in understanding autism 
spectrum disorders, but more importantly, we recognize that ``1 in 150 
children'' represents the lives of the hundreds of thousands of 
children and parents touched by autism and related conditions. Because 
of this, we are committed to the search for answers. We are also 
working to ensure that parents, health care and child care 
professionals, and everyone who cares for children, are able to 
recognize the early signs of autism spectrum disorders. In the absence 
of a cure, early identification and action hold the most promise for 
affected children and families.

                         EPIDEMIOLOGIC RESEARCH

    We all want to know the causes of autism and related conditions. In 
addition to building a public health surveillance network for 
developmental disabilities, CDC has also been researching potential 
causes. Following the passage of the Children's Health Act of 2000, CDC 
has been working closely with partners in five sites to develop the 
Centers for Autism and Developmental Disabilities Research and 
Epidemiology, or CADDRE. This multi-state collaborative study will help 
to identify factors that may put children at risk for autism spectrum 
disorders and other developmental disabilities.
    CADDRE is a collaborative effort from which we expect to build a 
large pooled data set that will be used to examine priority research 
questions. As the largest epidemiologic study of its kind, it holds the 
potential to be an important complement to the array of other work 
occurring at the National Institutes of Health and in academia. It is 
important to note that what CDC brings to autism spectrum disorder 
research is a unique perspective of studying health issues in large 
populations--not just among individuals or families who self-refer for 
intervention or study. To date, CADDRE sites have studied conditions 
that often occur with autism spectrum disorders, screening and 
management, and associations with immune system and genetic and 
environmental factors.
    Later this spring, CADDRE will begin data collection to study a 
number of factors for their potential association with autism spectrum 
disorders. Known as the Study to Explore Early Development (SEED), the 
factors include: infections or abnormal responses to infections in the 
child, mother, or father; genetic factors in the child, mother and 
father; mother's reproductive history; abnormal hormone function in the 
child, mother or father; gastrointestinal problems in the child; family 
history of medical and developmental problems; select environmental 
exposures; behaviors during pregnancy; and parents' occupations and 
other socio-demographic factors. The information will be obtained by 
conducting interviews and exams, reviewing medical records, and by 
collecting cheek swabs and blood and hair samples.
    Several steps in the development of SEED have already been 
completed. The protocol has been written, and Institutional Review 
Board approval has been obtained. In addition, site-specific advisory 
boards have been established to review the study materials and the 
study design. Focus groups with parents of children--with and without 
developmental disabilities--were conducted to obtain additional 
feedback on the study design and feasibility of the study. The 
implementation and quality control protocols for all aspects of SEED 
field work have been developed and ``train-the-trainer'' sessions for 
field implementation procedures have been completed. Data sharing 
protocols and general analysis plans have been developed, and the 
CADDRE Information System (web-based subject tracking and data 
collection application) has been established. We expect data collection 
to take 3 to 4 years, and preliminary results would be available 
shortly thereafter.
    Study participants will include approximately 3,000 children ages 
2-5 years and their parents. All study children will be drawn from the 
cohort of children born and currently residing in the study areas of 
each CADDRE site in select birth years. Three groups of children will 
be selected: children identified with autism spectrum disorders, 
children identified with other developmental problems, and a random 
sample of all children in each area born in the selected birth years 
(most of them typically developing).

                      LEARN THE SIGNS. ACT EARLY.

    Recent studies have shown that developmental disabilities such as 
autism spectrum disorders can be diagnosed as early as 18 months; 
however, we know that about half of all children are not diagnosed 
until much later. Early intervention is a child's best hope for 
learning to communicate and connect with his or her parents and friends 
and to be able to learn in a classroom with his or her peers.
    CDC, in collaboration with a number of national partners--the 
American Academy of Pediatrics (AAP), Autism Speaks (Cure Autism Now 
and the National Alliance for Autism Research, which have both recently 
merged with Autism Speaks), the Autism Society of America (ASA), First 
Signs, the Interagency Autism Coordinating Committee (IACC), and the 
Organization for Autism Research (OAR)--launched a national public 
awareness campaign in 2004 called Learn the Signs. Act Early. The 
campaign aims to educate parents, health care professionals, and child 
care providers about child development, including the early signs of 
autism spectrum disorders and other developmental disabilities, and to 
encourage developmental screening and intervention. Learn the Signs. 
Act Early. builds on familiar experiences of parents, such as 
monitoring their children's physical growth, and expands to social and 
emotional milestones such as how children speak, learn, act, and play. 
Just as taking a first step is a developmental milestone, so are 
smiling, pointing, and waving goodbye.
    We know that when developmental delays are not recognized early, 
children cannot get the help they need. By increasing the awareness of 
autism spectrum disorders and other developmental disabilities and 
their signs and symptoms, we can increase early developmental 
screening, diagnosis and intervention. This means affected children can 
receive the help they need to enhance their development and improve the 
quality of life for them and their families.
    To date, the campaign has reached more than 11 million health care 
professionals, parents, partners, campaign champions, and it is 
achieving its first goal--to encourage target audiences to ``Learn the 
Signs'' of autism spectrum disorders and other developmental 
disabilities. Outcome data show significant improvements in the 
percentage of parents who are aware of early warning signs of 
developmental delays, as well as increases in the number of 
pediatricians who agree that a child with an autism spectrum disorder 
can be diagnosed as early as the age of 18 months. Since the launch of 
the campaign, more pediatricians report that they regularly screen 
pediatric patients for developmental delays.
    In November 2006, Learn the Signs. Act Early launched the childcare 
provider segment, targeting the more than 407,000 childcare facilities 
in the United States. This new phase will provide free materials to 
help childcare providers and preschool teachers educate parents about 
child development and autism spectrum disorders.

                          FUTURE OPPORTUNITIES

    CDC recognizes that parents want answers. If a child has an autism 
spectrum disorder, his or her parents want to know what caused it, the 
most effective intervention, and how they can lower their risks if they 
plan to have other children. We share their frustration at not having 
more answers about the causes and possible cure for the debilitating 
symptoms of autism and related conditions. That is why CDC continues to 
track the rates of autism spectrum disorders, research possible causes, 
and provide accurate information about identifying developmental 
concerns and seeking help during a child's early years of development.
    CDC is positioned to bring surveillance, research, awareness and 
intervention activities to scale. Building on the encouraging success 
in these areas, CDC can continue answering important questions about 
prevalence and trends and can bring to bear population-based research 
tools in the effort to find answers about potential causes of autism 
spectrum disorders. The CDC can encourage the best known timely 
interventions for children and their families. Enhancing our programs 
would allow us to maintain surveillance in key sites and evaluate 
prevalence for different age groups, research potential causes more 
aggressively, and answer prevalence and trend questions faster. We can 
build on successes in educating the public about early intervention and 
education in our Learn the Signs campaign by continuing to develop and 
implement strategies to support parents, healthcare professionals and 
childcare providers in their efforts to Act Early when concerns are 
raised about autism spectrum disorders and other developmental 
disabilities.
    Thank you for the opportunity to appear here today to discuss this 
important public health issue. Thank you also for your continued 
interest in, and support of, our activities on autism spectrum 
disorders. Together we hope to find answers for this very complex 
disorder.
    I appreciate your longstanding support for our vision of healthy 
people throughout all stages of their lives and all facets of living. I 
will be happy to answer any questions you may have.

    Senator Harkin. Thank you, Dr. Gerberding, and I just 
mentioned, I am going to change the format since Senator 
Specter has to leave, I will go with Dr. Insel, then we will 
have some questions for the two of you before we bring the 
other people up.
    Dr. Gerberding. Thank you.
    Senator Harkin. Now, we turn to Dr. Thomas Insel, Director 
of the National Institute of Mental Health since September 
2002. Dr. Insel received his B.A. and M.D. degrees from Boston 
University. Dr. Insel, welcome back to the committee.

                     National Institutes of Health


                  National Institute of Mental Health

STATEMENT OF DR. THOMAS R. INSEL DIRECTOR
    Dr. Insel. Thank you, Senator Harkin and Senator Specter.
    It's a real pleasure to be here, and I too would like to 
express my gratitude for the support that we've gotten from 
both of you, and your leadership positions over the years.
    As you mentioned, the NIH budget has increased very 
significantly, in the case of autism, it's gone up, actually, 
almost five-fold since 1997, and that's only possible with your 
leadership and with your advocacy for bio-medical research.
    I think in view of the time and the number of the things 
that we want to cover, you already have my written testimony, I 
think I will make my comments rather brief.
    What I thought I would do is speak to what we actually 
know, that we're confident about at this point in time, and 
unfortunately, I can do that in less than 5 minutes, because 
it's a fairly short list.
    So, what you have before you are what, I think, are the 
four most important points that we can use as a baseline for 
the knowledge-base. We can talk more about some of the 
specifics and some of the actual research, as we get further 
into the hearing.
    The first point to make, and it may seem obvious, but it's 
actually a fairly complicated point, is that autism is a 
developmental brain disorder. Yes, it involves other organs of 
the body, and the gut is one that has been implicated, as you 
mentioned Senator Harkin, but it's important for us to focus on 
this as a brain disorder that evolves through development.
    The reason I stress that is, because when you think about 
developmental brain disorders, it's not simply what happened, 
or where it happened, it's when it happened that may be really 
critical. So, much of what we need to understand is when the 
train goes off the tracks in brain development to result in the 
kinds of deficits that Dr. Gerberding mentioned--the 
difficulties in social reciprocity, the difficulties in 
language, the abnormal behaviors that are really key to autism.
    It changes the way we think about this a little bit because 
it suggests also that there could be multiple causes that if 
they occur at the same point in time--and many of us think that 
that point may be prenatal--it sets up a trajectory that's 
abnormal, that leads to this very, as you mentioned, 
devastating disorder.
    Point number two, you'll hear from constituents and you'll 
read in the press--is this really genetic? Is this really 
environmental? The answer is, it's both. That, with this 
disorder, as with so many of these developmental disorders that 
we study now, we've--in the scientific world--have gotten 
beyond the point of arguing between genes and environment, it's 
like the old nature/nurture debate. The debate now is about how 
genes and the environment interact to result in this disorder.
    We do know there's an important genetic component, no 
question about that, from what we have from twin studies, but 
we also know that that doesn't explain the entire disorder. And 
it certainly wouldn't explain any potential increase in the 
prevalence--or increase, even, in the incidents--over the last 
decade.
    So, lots of interest in what the environmental factors 
might be. But, to understand those, we will need to drill down, 
and get a very good understanding of who has the genetic risk 
to be responsive to that environmental factor. So, much 
interest now, in trying to understand the complicated 
interaction of those two factors.
    Third, this is--as Dr. Gerberding mentioned--important to 
have early detection, early interventions. There are treatments 
that work--they don't work for all children. Perhaps 25 to 30 
percent of children respond beautifully to behavioral 
interventions, but they respond best with early detection and 
early intervention, particularly before age 3. As Dr. 
Gerberding mentioned, many of these children aren't even 
diagnosed until sometime thereafter.

                           PREPARED STATEMENT

    Finally, current science more and more is telling us that 
this is not one illness. This is a group of disorders--much the 
way we think about hypertension, much the way we think about 
other classes of disorders in medicine. This is one--in the way 
that we perhaps once talked about mental retardation--it's 
likely we're going to find many, many disorders within this 
overall rubric. Increasingly, at NIH, we talk about ``autisms'' 
instead of ``autism.'' That is probably an important 
perspective to remember, as we begin to think about causes, and 
also about treatments.
    Thank you, I look forward to your questions, and I look 
forward to the discussion, as well.
    [The statement follows:]

               Prepared Statement of Dr. Thomas R. Insel

    Good afternoon, Senator Harkin and members of the subcommittee, I 
am pleased to present a brief review of the research activities and 
accomplishments in autism research of the National Institutes of Health 
(NIH), an agency of the Department of Health and Human Services (HHS). 
I deeply appreciate your continued support for our mission: making 
medical discoveries to improve health and save lives. In focusing 
today's hearing on autism we will be discussing an urgent, critical 
public health challenge affecting many families.

                            WHAT IS AUTISM?

    Autism is a developmental brain disorder, with onset by 3 years of 
age. We now believe that autism includes a large number of disorders 
that share deficits in social behavior, abnormal communication, and 
repetitive behaviors. Autism in turn is part of a broader continuum of 
syndromes called pervasive developmental disorders, now more commonly 
known as autism spectrum disorders (ASDs). ASDs range in severity, with 
``classic'' autism being the most disabling, while others, such as 
Asperger's syndrome, produce milder symptoms. Among children at the 
more severe end of this spectrum, mental retardation, seizures, and 
self-injurious behaviors are common.
    Current Centers for Disease Control and Prevention (CDC) estimates 
of the prevalence of ASDs are as high as 6.7 children per 1,000.\1\ 
``Prevalence'' refers to the number of affected individuals at a given 
point in time, essentially a snapshot. While prevalence estimates have 
increased many-fold since the early 1990s, it is unclear if there also 
exists an increase in ``incidence'', which measures the number of new 
cases across time in the same population. It is unclear whether the 
rise in prevalence is due to a rise in incidence, better identification 
and awareness of the disorder, or both. A similar increase in 
prevalence has been observed in many countries outside of the United 
States, and in virtually every study, boys are three to four times as 
likely to have ASDs compared to girls.\2\
---------------------------------------------------------------------------
    \1\ Centers for Disease Control and Prevention. Prevalence of 
Autism Spectrum Disorders' Autism and Developmental Disabilities 
Monitoring Network, 14 Sites, United States, 2002. Surveillance 
Summaries, February 9. MMWR 2007;56 (No. SS-1).
    \2\ Fombonne E. Epidemiology of autistic disorder and other 
pervasive developmental disorders. J Clin Psychiatry. 2005;66 Suppl 
10:3-8.
---------------------------------------------------------------------------
                          WHAT CAUSES AUTISM?

    There is much that remains unknown about the causes of autism. 
Scientific research has demonstrated that autism is highly heritable, 
as measured by concordance rates in twins. If one identical twin has 
autism, there is a 60-91 percent chance the other will also have it. 
For fraternal twins, the concordance for autism drops significantly, to 
0-10 percent.\3\ While higher concordance in identical twins is not 
proof of a genetic cause, approximately 10 percent of autism cases with 
a family history of ASDs are associated with genetic mutations.\4\ 
Recently, a study of people with autism who did not have another family 
member also affected found approximately 10 percent associated with 
spontaneous genetic mutations.\5\ In addition, autism is frequent in 
children with several known genetic neurodevelopmental disorders, such 
as Fragile X, Rett Syndrome, or Tuberous Sclerosis Complex.
---------------------------------------------------------------------------
    \3\ Veenstra-VanderWeele, J, Christian, SL, Cook, EH (2004) Autism 
as a paradigmatic complex genetic disorder. Annu. Rev. Genomics Hum. 
Genet. 5:379-405.
    \4\ Barton M, Volkmar F, J Autism Dev Disord., 1998, 28(4):273-8.
    \5\ Sebat et al, Strong Association of De Novo Copy Number 
Mutations with Autism. Science. 2007 Mar 15; [Epub ahead of print].
---------------------------------------------------------------------------
    Identifying both the environmental and the genetic underpinnings of 
autism are critical first steps in bringing the full scientific power 
of modern neuroscience to bear on this complex set of disorders. We now 
have the genetic sequencing and neuroimaging tools that will permit a 
more thorough understanding of the neural substrates of autism. Indeed, 
what these scientific tools may tell us is that ASDs are illnesses with 
multiple causes and, much like hypertension or cancer, may be treated 
and possibly prevented through interventions on multiple fronts. 
Importantly, these new scientific approaches will enable us to develop 
new diagnostic tests and rational therapies based on the biology of the 
illness that will permit us to detect and treat ASDs in much the same 
way was as other medical conditions.

                   HOW IS RESEARCH COMBATING AUTISM?

    Combating autism is a collaborative effort, involving several NIH 
Institutes, the CDC, and public-private partnerships with advocacy 
organizations. NIH has increased funding for autism nearly five-fold 
since 1997, to support broad research efforts across genetic, 
neuroscience, environmental, and treatment studies. Already, this 
investment is bearing important results for better understanding the 
brain abnormalities in autism, improved methods for early detection, 
and refining interventions for optimizing daily functioning. NIH 
continues to fuel this research momentum, most recently with program 
announcements encouraging research on the characterization, genetics, 
pathophysiology, and treatment of autism and related neurodevelopmental 
disorders, as well as requests for applications to collect data and 
biomaterials from autistic individuals and their relatives for use in 
genomic, basic, translational neuroscience research, and clinical 
trials. Here I will note just a few of the recent developments that 
offer hope for families struggling with autism.
    The recently established NIH National Database for Autism Research 
(NDAR) for the first time provides an open-access platform to 
facilitate sharing of raw research materials, foster collaborations and 
public-private partnerships, and enhance rapid dissemination of 
research findings into clinical practice. It is envisioned as a 
dynamic, federated system, with improvements and updates being added 
routinely to meet the most critical and valuable needs of the research 
community.
    Early detection is important for improving outcomes. The National 
Institute of Child Health and Human Development (NICHD) and the 
National Institute on Deafness and Other Communication Disorders 
(NIIDCD) continue to partner with Autism Speaks to support the High 
Risk/Baby Sibling Research Consortium, an effort to improve early 
detection and diagnosis. The Consortium?s primary project is to 
identify factors that may influence recurrence rates of ASDs and 
broader developmental outcomes in infant siblings of individuals with 
ASD. Recruitment of sibling and comparison groups is on target and 
database development and data analysis have begun.
    Responding to the urgent need for an amplified autism effort, the 
National Institute of Mental Health (NIMH) created a new, integrated 
autism research program in its intramural laboratories in Bethesda. 
Several new clinical trials were launched in 2006 that provide 
opportunities for rapid progress in defining the biological and 
behavioral characteristics of different subtypes of ASDs and examining 
effects of innovative treatments for autism. Intramural researchers are 
also collaborating with M.I.N.D. (Medical Investigation of 
Neurodevelopmental Disorders) Institute and University of California at 
Davis scientists in a pilot of the first large-scale effort to provide 
a comprehensive biomedical and behavioral characterization of 1,500 
individuals with autism spectrum disorders. The goal of this Autism 
Phenome Project is to identify the many subtypes of autism, providing 
guides for personalized approaches to treatment.
    In addition to these efforts, NIH is striving to identify and 
understand environmental influences as potential causes of ASDs. The 
National Institute of Environmental Health Sciences (NIEHS), in 
partnership with the Environmental Protection Agency (EPA), supports 
research through Centers that focus on this important question. One of 
the centers, at the University of California at Davis, is conducting 
the first large population-based, epidemiologic case-control study of 
children with autism. In addition, the National Institute of 
Neurological Disorders and Stroke (NINDS) is providing support for a 
five-year prospective epidemiological study of a large Norwegian birth 
cohort of 75,000 women and their babies. The study, which we expect to 
include up to 500 children with ASDs, will examine the contribution of 
genetic and environmental factors to the development of autism and 
other neurodevelopmental disorders; these factors include infection 
history, low birth weight, dietary and environmental exposure to 
methyl-mercury, and vaccination history.
    Solving the mysteries of autism will require scientists from many 
disciplines working together on common problems. To launch a broad, 
multidisciplinary attack on autism, NIH recently created an ambitious, 
integrated program in order to maximize coordination and cohesion of 
NIH-sponsored efforts--the Autism Centers of Excellence (ACE), for 
which the first grants will soon be issued. Research projects will 
focus on identifying biological and environmental causes and preventive 
interventions for autism, as well as improved pharmacological and 
behavioral treatments. These Centers will be coordinated through NDAR 
and will represent the first integrated, national research effort for 
this disorder, with an estimated funding level of $25 million per year.

                        HOW CAN WE CURE AUTISM?

    While there is not a proven biological treatment for the core 
symptoms of autism, it is generally agreed that early identification 
and behavioral intervention is beneficial. Thirty years of study have 
shown the value of employing behavioral methods to enhance social 
skills, language acquisition, and nonverbal communication. Such gains 
may be evident in individual responses to particular behavioral 
techniques in the short term ? in as little as a matter of months.
    Yet even in studies where children have received the largest gains, 
outcomes are variable, with some making significant progress and others 
advancing quite slowly or not at all. A multi-study analysis of the 
effect of treatment indicates that behavioral treatments are most 
successful when they begin early, are intensive, and highly structured. 
Current NIH-funded research includes studies for toddlers that involve 
parents in the delivery of interventions at home, immediately after 
diagnosis, as opposed to waiting for community or other services to 
begin.
    While medications are useful for some of the accessory symptoms of 
autism, such as self-injurious behaviors, we lack medical treatments 
for many of the core symptoms, such as social deficits. As we discover 
more about the causes and the mechanisms of autism, we expect to 
develop a new generation of medications to help children and adults 
affected with ASDs. Ultimately, our goal is prevention, based on early 
detection of risk, understanding environmental factors that increase or 
decrease symptoms, and development of effective interventions before 
behavioral and cognitive deficits appear.

                               THE FUTURE

    The Combating Autism Act of 2006 (Public Law 109-416) was signed 
into law on December 19, 2006. Plans are underway to implement the 
provisions of this law, which calls for the establishment of a new 
Interagency Autism Coordinating Committee (IACC) to coordinate all 
efforts within HHS concerning autism spectrum disorders, including the 
development of a strategic plan that sets research funding priorities. 
Thus, broad collaborative partnerships involving government, private 
industry, public and educational institutions, and families of those 
with autism will continue to fuel the vital research endeavors that 
will reveal the mysteries of this disabling disorder and lead to 
prevention and effective treatments.
    Autism is a serious, disabling developmental illness that affects 
many families in this country. Research is our best hope for making a 
difference for these families. Given the complexity of the disorder, 
answers will not be as simple or as quick as we wish, but NIH is 
committed to bringing the best minds and the best tools to ensure that 
we get the correct answers that will lead to the best treatments. I 
therefore appreciate the interest of the members of this Subcommittee 
on autism research. I look forward to answering your questions.

    Senator Harkin. Thank you very much, Dr. Insel, and Dr. 
Gerberding.
    I'll yield to Senator Specter.

                           BUDGET ALLOCATIONS

    Senator Specter. Well, thank you very much, Mr. Chairman 
for accommodating my schedule.
    Dr. Insel, the funding for autism has risen, as I noted, 
from $27 million in 1998, to a projected budget in 2008 of 
$107,870,000--that's actually about a $400,000 decrease from 
last year.
    The allocation for autism is substantially less than the 
allocation for other major research activities, of the National 
Institutes of Health. It is obviously a very serious disorder, 
striking 1 children out of 150. With the New Jersey statistics, 
which are said to be more representative of the national 
average, being 1 child out of 97.
    There is total discretion left within the National 
Institutes of Health to make the allocation of the $29 billion 
which is appropriated by Congress, and that is so we do not, 
so-called ``politicize'' it--we don't make political decisions, 
but leave it up to the scientists. But, I think within the 
range of following that very important principle, it is not 
inappropriate to raise a question. When you take a look at the 
budgets for cancer--and I'm all for cancer research--or the 
budgets for heart disease, they range into, close to $5 billion 
for cancer. How are the allocations made, to have the $107 
million, roughly, which is a very, very small part of the NIH 
budget, compared with other research budgets?
    Dr. Insel. Well, as you mentioned, much of this is driven 
by the science, it's investigator-initiated for the largest 
part of what we're currently doing.
    In the area of autism, unlike many of the other areas that 
you mentioned, and many areas in medicine, in general, we do 
have an organization in place to begin to think about how best 
to deploy the funds that we have. That's this Inter-agency 
Autism Coordinating Committee, that meets twice a year, 
includes public members as well as members of several Federal--
--
    Senator Specter. How about the basic decision as to how 
much goes to the National Cancer Institute, for heart research, 
contrasted with $107 million for autism?
    Dr. Insel. So, how is the decision for the envelope, the 
overall envelope, made for autism, versus other priorities at 
NIH?
    Senator Specter. Start there.
    Dr. Insel. Right. So, I would have to again, give you the 
answer that Dr. Zerhouni has given when you've asked him a 
similar question, that it's a combination of public health 
needs and scientific priorities. This case, the public health--
--
    Senator Specter. Public health, what?
    Dr. Insel. Public health needs. There, and as you 
mentioned, the public health urgency here is obvious, to all of 
us. This is a problem which is increasing in everyone's radar 
screen, this is, without question, a much bigger issue for us 
than it was 5 years ago----
    Senator Specter. I've got to move on to some other 
questions because of limited time, but you will be here for the 
entire proceeding today, and maybe when you hear some of the 
parents, you'll have a little different view of the urgency of 
a greater allocation. That is a judgment which NIH is going to 
have to make.
    Autism is characterized--as the experts have written--by 
three distinctive behavior difficulties, with social 
interaction, display problems with verbal and non-verbal 
communications, and the exhibition of repetitive behavior, or 
narrow obsessive interests.
    It is well-known, Dr. Gerberding, and you've noted it, that 
the early detection of these behavioral disorders can produce 
improvements. What should parents do as soon as they observe 
some of these behavioral disorders? Your comments here will get 
some substantial coverage on C-Span--what advice would you give 
to parents who--well, let's start with something more concrete 
than the definition I've just given you, which is pretty high-
falluting. What should parents look for, specifically, in lay 
terms?
    Dr. Gerberding. You know, when you have a child, you're 
used to thinking about, what is its weight, what is his or her 
height, what is their head circumference--we're used to 
measuring those physical development milestones. But, there are 
behavioral milestones just like that.
    By early age, a child ought to be able to make eye contact, 
if you play peek-a-boo with a child, they should engage your 
attention, they can repeat after you----
    Senator Specter. Okay, eye contact--eye contact is not 
made. Give us another easy-to-understand symptom.
    Dr. Gerberding. If a child is unable to repeat simple 
motions, in other words, if you clap your hands, a young child 
ought to be able to repeat your pattern--we have these laid out 
by age, just like you would lay out weight by age----
    Senator Specter. Laid out where, are they on a website?
    Dr. Gerberding. They are, absolutely, on the CDC website, 
www.cdc.gov, they are posted prominently in pediatricians' 
offices around the country----
    Senator Specter. Can you give us a couple of other simple 
illustrations?
    Dr. Gerberding. I would be happy to give you a whole little 
chart, because I have here----
    Senator Specter. Why don't you repeat them, so people can 
hear you on C-Span?
    Dr. Gerberding. Okay, I'd be happy to.
    I'm quoting from Newsweek magazine, because I thought they 
did a terrific job in one of the articles here of laying them 
out.
    By 7 months, a normal child ought to be able to turn its 
head when its name is called and smile at another person. If 
your children is a year old, usually they can wave ``bye-bye'' 
and they can make sounds like ``mom'' and ``dad'' or ``ma'' and 
``da'' and they can clap when you clap.
    At 18 months, a child ought to be able to pretend, like 
pretend to talk on a telephone, or to look at objects when you 
point to them. By 2 years, a child ought to be able to make 
simple sentences with several words in a phrase, and follow 
simple instructions, and, I think most importantly, engage 
socially with other children, they'll play----
    Senator Specter. Let me interrupt you, at that point--to 
ask you what should a parent do to try to deal with the issue 
of the behavioral disorder as soon as it noted?
    Dr. Gerberding. If a child is--if a parent is concerned 
about their child's development, the pediatrician or the family 
doctor is absolutely the first place to go, and we have really 
been pushing information--about 85,000 kits have gone out to 
pediatricians around the country. So, parents go in, express 
their concern when they're bringing the child in for well-baby 
care, or for the immunization clinic visit, and the most 
important thing to the parent is, don't give up. If the doctor 
says, ``Oh, no, maybe your child is just a little slower to 
catch on,'' ask for the doctor to do a screen, and if there's 
any worry, make sure that you get a second opinion, or ask the 
child to be seen by someone with more expertise.
    Senator Specter. But, what kind of a screening?
    Dr. Gerberding. It's a developmental screening, and 
typically the doctor will ask the child to go through some of 
the same activities that I just mentioned to you, they'll 
conduct a developmental assessment.

                      NEW DIRECTIONS FOR RESEARCH

    Senator Specter. One final question, because I don't want 
to go too long, and out of sequence.
    Dr. Insel, if more funds were available, suppose we're able 
to increase NIH funding so all the boats would rise, where 
would those additional research funds be directed to the kinds 
of problems that Dr. Gerberding has described?
    Dr. Insel. Well, there are at least three very urgent 
problems that we would like to do more of, and do them faster. 
One would be very similar to what Dr. Gerberding is describing, 
looking at the tools for early detection or early diagnosis, 
early intervention--much of that's going through what we call 
our ``baby sibs'' project, looking at children at risk, and 
studying them in a very comprehensive way.
    Second area, very important, is to lay out what we call the 
``autism phenome'' project, the idea of being, the phenome is 
like phenomenology, understanding the full spectrum of this 
disorder, and all of the components, so that we can get a sense 
of, what are the sub-groups? That this is many disorders, if 
it's 10 disorders, what are they? How do we diagnose them? How 
do we treat them?
    Third area that's very important, it doesn't sound so sexy, 
perhaps, but is developing a database, which we call the 
National Database for Autism Research--we have such a database 
that brings the entire research community, as well as, 
potentially, families together. It's a federated database, 
which means it will take other databases that are out there and 
bring them in for imaging, genetics, and clinical information.
    What we'd like to do--we have this now, it went live on 
April 2, but it's still very restricted--we need to grow that, 
and we need to make this a sort of electronic meeting place for 
both families and scientists from across the country, to try to 
get the best information possible about autism.
    Senator Specter. Well, in conclusion, let me just make an 
observation or two.
    Dr. Gerberding, I think the website is fine. If people 
write to you, not having access to the website, or not 
understanding the website, is CDC in a position to respond to 
parents by providing this kind of a graphic illustration of 
symptoms and signs to look for, perhaps even a copy of what 
appears in Newsweek, under the caption, Babies and Autism?
    Dr. Gerberding. We would be happy to get information to 
parents and to their doctors, and we can do that by a variety 
of means, absolutely.
    Senator Specter. Dr. Insel, when you take a look at your 
priorities, I know you'll pay attention to all of them, and I 
know you'll listen carefully to what you hear today.
    Senator Harkin and I, and some of the others on the 
committee are magnets for a lot of comments from parents, 
because they see what the committee has done. It is accurate to 
say that I hear a disproportionate comment from parents whose 
children have the autism disorder. I hear a lot of people--and 
a lot of my friends are dying of cancer--and I know a lot of 
people with heart conditions. I've seen a fair amount of that 
in the mirror. But, on a numerical basis, I hear, just a lot 
about autism, and maybe that comes because we advertise on this 
Subcommittee with what we do for NIH, but I'd like to see it 
get a little more attention.
    Senator Harkin, thank you for your courtesy.
    Senator Harkin. Thank you, Senator Specter.
    Again, just another little change because the clock is 
ticking, and I want to hear the testimony of others. I would 
ask if you two could maybe, give us some bookends here, Dr. 
Insel on one side, Dr. Gerberding, because I have questions for 
you, I'm sure other Senators do. But I'd like to ask our second 
panel to come up, if I could, at this time.
    Marguerite Colston, Dr. Judith Favell, Mr. Bob Wright, and 
Mr. Bradley Whitford.
    Again, welcome to the committee, and as I said at the 
beginning, all of your statements will be made a part of the 
record in their entirety, and I'd appreciate it if you'd just 
sort of sum up for us, the essence of your statements, and I'll 
go in the order in which I had called people up.
    First, we'll recognize, Marguerite Colston, Communications 
Director for the Autism Society of America. More importantly, 
she's a parent of a child with autism, her 6-year old son, 
Camden. Welcome to the committee, and please proceed.

STATEMENT OF MARGUERITE COLSTON, DIRECTOR OF 
            COMMUNICATIONS, AUTISM SOCIETY OF AMERICA, 
            BETHESDA, MARYLAND
    Mrs. Colston. Thank you. I'd like to thank Chairman Harkin, 
and Senator Specter and the members of the subcommittee for 
giving me the opportunity today to share my experience of 
living with a child on the autism spectrum. I also wanted to 
say thank you very much to you and Senator Specter for those 
very important questions you asked.
    It is truly an honor to be asked to speak to you today, and 
I hope I can convey some of the needs, hopes and dreams of the 
more than 1 million families in America who are affected today.
    As you mentioned, I am the Director of Communications for 
the Autism Society of America, and I am the mother of two 
children, including a 6\1/2\ years old son with autism. My son, 
pictured here, is Camden, this is Camden.
    My son has a disorder with no known cause, and no known 
cure. You have, at your disposal today, the best experts on 
researching causes and cures. But I am here today to tell you 
about the very important space between causation and cure, the 
space that Camden and I occupy, that is, how we live with 
autism.
    Because that important space is occupied today by 500,000 
children, and at least as many adults, families desperately 
need Federal leadership and funding for autism today.
    Camden is on the severely affected end of the spectrum. He 
cannot talk, has some cognitive delays, major attention 
deficits, and suffers significant social and behavioral 
challenges. As you can see, though, he's also adorable, and he 
has a much larger capacity to learn than any of us imagined.
    Like many parents, I was told that autism was not 
treatable, and that the best thing I could do for Camden was to 
prepare myself and my family for the idea that he would never 
be independent. Experts told me that information when he was 
only 2\1/2\ years old.
    Today, my little boy, who for years did not turn to his 
name or react to games, now grabs my hand after dinner, and 
takes me to the refrigerator for his nightly ice cream. When 
the school bus comes every morning, he walks on with a grin and 
he finds his seat. Camden does not make these developments 
naturally, but through intensive therapy, Individualized 
Education Plans, high medical costs, and a sizable team of 
dedicated professionals.
    In many respects, my story is typical. Camden was diagnosed 
with autism when he was 2\1/2\. However, I was lucky that 
Camden was born with other medical ailments, and very low 
muscle tone, because unlike most children with autism, Camden 
began receiving Early Intervention services from our county 
when he was just 6 weeks old. Even though we only received 4 
hours per week of Early Intervention, that program was the 
reason Camden can chew, sit up, and walk onto a school bus 
today.
    Like most families, I had to wait 12 long months to get an 
appointment with a developmental pediatrician, when my 
pediatrician expressed concerns about Camden. My wait times for 
his specialists continue to be 12 to 18 months, so we rely 
heavily on the public educational services we receive, thanks 
to the IDEA Act, and thank you for your support of that.
    As I think about it, however, I am still very concerned 
about what would happen to Camden, once the school bus stops 
coming. Camden, and most children and adults with autism, is 
going to need a lifetime of supports and services. Even if he 
is able to speak someday, he will need training to prepare him 
to enter the workforce, assistance with transportation and 
housing, access to health care, and a range of other services 
to allow him to live as independently as he is able.
    Unlike most parents, I consider myself to be a very 
privileged American. I received a great education, I have a 
good job, I own my own house, and I have a wonderful and 
supportive family, and several of them are here today. I can 
afford a small amount of respite care and private therapy. So, 
I have to wonder, if I couldn't get my son diagnosed before 
2\1/2\, and if it takes me 18 months to see a doctor, and if I 
can't afford truly comprehensive services, than what is 
happening to the average American with a child on the autism 
spectrum today?
    If I accepted that autism was not treatable, and Camden had 
no hope, what do others do? What happens after Camden turns 22, 
and the federally-mandated disability services end? What are we 
going to do about this?
    One of the things we can do for Americans living with 
autism is fund the Combating Autism Act, and encourage the 
resulting research to be treatment-guided, not just causation 
specific. Funding the CAA also means funding the Inter-Agency 
Autism Coordinating Committee, and they have a wonderful 
roadmap for services. We can also pass and then fund the Autism 
Services bill put forth by Senators Clinton and Allard last 
month, and which the House introduced today.
    As a parent, I strongly support those bills. As a staff 
member for the Autism Society, I can assure you that we, our 
chapters and our members will work tirelessly to advance 
legislation that includes research services and supports for 
individuals with autism.
    I love my son, Camden, with every bone in my body. I know 
there are a million Camden's out there whose needs are not 
being met, and whose families are in crisis. Regardless of the 
cost, we need to support coordinated Federal autism solutions 
today. Only then will we be able to optimize the potential of 
each child with autism, and provide them opportunities for 
success in their communities.

                           PREPARED STATEMENT

    Being here today and being heard by the U.S. Senate gives 
me an enormous sense of hope that I never dared to have. With 
your help and your leadership, I may start to hope for Camden, 
the same hopes I have found I have for my neuro-typical 
daughter, Theresa--that he will be provided the opportunity to 
be a happy, productive member of his community.
    I'd like to thank the committee again, for hearing me, and 
for support of this legislation.
    [The statement follows:]

             Prepared Statement of Marguerite Kirst Colston

    I would like to thank Senator Harkin and the members of this 
subcommittee for giving me the opportunity today to share my experience 
of living with a child with autism. It is truly an honor to be asked to 
speak to you today, and I hope I can convey some of the needs, hopes 
and dreams of the more than 1 million families in America today who are 
affected by autism.
    My name is Marguerite Kirst Colston. I am the Director of 
Communications with the Autism Society of America and I am the mother 
of two children, including a 6-year-old son with an autism spectrum 
disorder. My son, pictured here, is named Camden.
    As you have heard today from the panelists, my son has a disorder 
with no known cause and, as I have been told by many doctors, no cure. 
You have at your disposal the best experts on researching causes and 
cures, but I am here today to tell you about the very important space 
between causation and cure--the space Camden and I occupy--that is: how 
we live with autism. Because that important space is occupied today by 
500,000 children, and at least as many adults, families desperately 
need federal leadership and funding for autism.
    Camden is on the more severely affected end of the autism spectrum, 
by which I mean he cannot talk, has some cognitive delays, major 
attention deficits and suffers significant social and behavioral 
challenges. As you can see, he is also adorable and, as I am finding, 
has a much larger capacity to learn than any of us imagined.
    Like many parents, I was told that autism was not treatable, and 
that the best thing I could do for Camden was to prepare myself and my 
family for the idea that he would never be independent. Experts told me 
that when Camden was 2\1/2\. Today, my little boy, who for years did 
not turn to his name or react to games, now grabs my hand after dinner 
and takes me to the refrigerator for his nightly ice cream. When the 
sun sets, he runs to take a bath. When the school bus comes every 
morning, he walks on with a grin and finds his seat. Camden does not 
make these developments naturally, but through intensive therapy, 
individualized education plans, high medical costs, and a sizeable team 
of dedicated professionals helping us along.
    In many respects, my story is typical. Camden was diagnosed with an 
autism spectrum disorder when he was 2\1/2\. This diagnosis came after 
2\1/2\ years of emerging symptoms, disappearing interaction, specialist 
referrals, hundreds of doctor's visits, several hospitalizations--and 
many missed clues. I was ``lucky'' that Camden was born with other 
medical ailments and very low muscle tone, because unlike most children 
with autism, Camden began receiving Early Intervention services from 
our county when he was just 6 weeks old. Even though we only received 4 
hours per week of Early Intervention, that program was the reason 
Camden can chew, sit up, and walk onto his school bus today.
    Like many parents with children with autism, I had to wait 12 long 
months to get an appointment with a developmental pediatrician when my 
pediatrician expressed concerns about Camden. My wait times for his 
specialists continue to be 12 to 18 months in duration, so we rely 
heavily on the educational services with receive in our public school 
system thanks to IDEA Act. I want to say a heartfelt thank you to you, 
Senator Harkin, for your strong support of legislation like this.
    As I think about it, however, I am still very concerned about what 
will happen to Camden once the school bus stops coming. Camden--and 
most children and adults with autism--is going to need a lifetime of 
services and supports. Even if he is able to speak one day, he will 
need training to prepare him to enter the workforce, supports in his 
job, assistance with transportation and housing, access to health care, 
and a range of other services to allow him to live as independently as 
he is able.
    Unlike most parents, I consider myself a very privileged American. 
Like the rest of the panelists here today, I received a great 
education, have a good job, own my own house, and have a wonderful and 
supportive network of family. I can afford a small amount of respite 
care and private therapy. I stand up for my rights and have the 
confidence to ask questions of the medical and educational communities. 
But I have to wonder: if I couldn't get my son diagnosed before 2\1/2\, 
and if it takes me 18 months to get into a doctor, and I can't afford 
truly comprehensive services, then what is happening to the average 
American with a child with autism today? If I accepted, in a desperate 
moment, that autism was not treatable and Camden had no hope, what do 
others do in their sorrow? What happens after he transitions away from 
the education system? And, what are we going to do about this?
    One of the things we can do for Americans living with autism is 
fund the CAA and encourage the research done here to be treatment-
guided, not just causation-specific. Funding the CAA also means funding 
the Inter-Agency Autism Committee, which could serve parents 
tremendously by coordinating Federal autism services and research along 
a road map that will help us now. This is why the Autism Society of 
America encouraged tens of thousands of members to support CAA and why 
we also support legislation like the reauthorization of the IDEA act, 
the Lifespan Respite Act, and S-CHIP funding.
    Last month, Senators Clinton and Allard took a historic step toward 
empowering families and individuals with autism by introducing 
legislation to build and support a services infrastructure for autism 
spectrum disorders. Unfortunately, our current system for assisting 
adults with disabilities is stretched way too thin. Providers do not 
have the capacity to meet the ever increasing number of individuals 
with autism. We must do more to identify best practices for serving 
people with autism spectrum disorders. The House companion bill will be 
introduced today.
    As a parent I strongly support this legislation. As a staff member 
for the Autism Society of America, I can assure you that we will work 
tirelessly to advance this bill, and other measures that improve 
services and supports for individuals with autism. I love my son Camden 
with every bone in my body, and I know there are a million Camdens out 
there whose needs are not being met and whose families are in crisis. 
Regardless of the cost, we need to support coordinated federal autism 
solutions today. We will then be able to optimize the potential of each 
child with autism and provide them opportunities to for success in 
their communities.
    Being here today and being heard by the U.S. Senate, gives me an 
enormous sense of hope that I never dared to have. With your help and 
your leadership, I may start to hope for Camden the same hopes that I 
have for my ``neurotypical'' daughter Theresa--that he will be a happy, 
productive member of his community in his way, some day. Thank you.

    Senator Harkin. Thank you very much. That is very poignant 
and heartfelt testimony.
    Next, we turn to Dr. Judith Favell, CEO of AdvoServ, a 
multi-State network of treatment programs for children and 
adults with developmental challenges. Dr. Favell received her 
Bachelor's Degree in Psychology from Western University, and 
her Ph.D. from the University of Kansas, out my way. Dr. 
Favell, welcome to the committee, please proceed.

STATEMENT OF DR. JUDITH E. FAVELL, CHIEF EXECUTIVE 
            OFFICER, ADVOSERV, EXECUTIVE DIRECTOR, THE 
            CELESTE FOUNDATION, MOUNT DORA, FLORIDA
    Dr. Favell. Thank you, Mr. Chairman.
    I'm also executive director of the Celeste Foundation, and 
a member of the Professional Advisory Board for the Autism 
Society of America.
    During my nearly 40-years' career as a behavior analyst and 
as a psychologist, I have devoted myself to the field of 
autism, and developmental disabilities.
    Now, during this period, I've specialized in the treatment 
of behavior problems such as self-injury and aggression that 
sometimes associated with these disorders. It is on the 
delivery of such treatment services that I'm focusing my 
comments today.
    While research on the cause and course of autism continues, 
while the incidents and prevalence is tracked, while basic 
research on the underlying mechanisms of the disorder is 
conducted, we cannot lose sight, as just has been said, of the 
1.5 million children and adults today living with autism who 
need help today. Today they are seeking services that will 
allow them to gain the skills and resolve the behavioral 
challenges that will enable them to live and enjoy the fullest 
life possible.
    Fortunately, across the last years, major advancements have 
been made in the development of educational and behavioral 
strategies to teach these skills and to treat these problems. 
These methods have been tested across, literally, decades of 
scientific research, and confirm that children and adults with 
autism can indeed be helped in meaningful and substantial ways.
    They can learn to communicate, they can learn to care for 
themselves. They can achieve academic and job goals. They can 
reciprocate love with friends and family. Likewise, people 
experiencing autism can engage in behavioral problems that hurt 
themselves, or harm others. In short, effective treatment and 
teaching methods designed to help people with autism, notably 
those based on learning theory, and applied behavior analysis 
are available today, and each day are becoming more effective 
with continued research.
    So, this picture is a decidedly optimistic one. However, 
effective methods of instruction and behavioral treatment are 
clearly not enough. To impact the lives of people with autism, 
an equally important issue must be addressed, and that is, how 
to actually make these services available to people who need 
them. There exists not just a gap, but a chasm, between what we 
know, and what consumers actually receive.
    For example, we know as has been said, that to be optimally 
effective, services should begin as early in a child's life as 
possible, and be intensive, that is, encompass as many hours as 
possible. Yet, as we hear, families lose precious months--
years--waiting for services, and then too often must settle for 
a fraction of what their child needs.
    Too often, then, those very services are not available when 
and where they are actually needed--at bedtime, during meals, 
or in the midst of the meltdown during the weekend. Needs of 
people with autism do not conveniently conform to professional 
appointments or clinic hours. Support may be needed any time, 
day or night.
    Further, we know that to be effective, and to produce 
positive outcomes, services need to be provided by qualified 
caregivers, and yet, despite widespread training of families 
and service personnel, despite extensive recruitment of 
professionals to the field of autism, there remains a serious 
shortfall of qualified professionals to guide the treatment 
process.
    Thus, though we know a great deal about how to help, we 
must increase the accessibility and availability of these 
services, to ensure that people with autism actually receive 
that help.
    If we're truly to ensure that services are available early, 
in sufficient amounts, and targeted when and where needed, 
traditional solutions, for example, increasing training of 
professionals--though important--is simply not sufficient. To 
meet the challenge, new service models must be developed.
    Our own work at the Celeste Foundation provides an example 
of possible new approaches to improving services, both their 
availability, and potentially their cost-effectiveness. From 
support from the Department of Education and the States within 
which we conducted this project, we recently completed a 
demonstration project, investigating the use of tele-health 
systems to provide professional services directly into homes.
    Now, in this model, after a brief period of on-site 
training, families were linked to professionals via an 
interactive video system that enabled live, real-time teaching, 
consultation and support directly into the home when and where 
it was needed. Through this tele-health model, families 
received help teaching their child, coping with their 
challenges, from professionals who might be located hundreds, 
even thousands of miles away, ensuring rapid and responsive 
assistance, regardless of the distance involved.
    This demonstration, utilizing technology developed by the 
CNOW Organization, proved to be an extremely effective and 
reliable vehicle for aiding families and children with autism.
    Children learned and maintained a wide array of skills from 
communication, to toilet training to eating green beans. 
Parents reported relief from stress, and an improvement of 
quality of life as a function of having support available to 
them on an ongoing basis, and families and professionals alike 
affirmed the effectiveness of this method of facilitating 
services, and its ease of use.
    The following brief news feature provides a graphic picture 
of the benefits of the model involved, of using tele-health 
systems for service delivery, and it features Josh Cobbs and 
his family, who is with us today.
    Work such as this by the Celeste Foundation, demonstrating 
the efficiency and effectiveness of utilizing tele-health to 
facilitate services exemplifies the type of innovative approach 
that we must pursue, if we are truly going to meet the ever-
increasing needs of children, and adults, and their families 
with autism, bridging that chasm between knowledge and 
practice, moving services from the paper to the people.

                           PREPARED STATEMENT

    I ask all in a position of influence, certainly including 
the distinguished members of this committee, to support efforts 
to find innovative methods of service delivery for all of those 
on the spectrum, including my grandson, Alex, so that they may 
receive the very best we have to offer, and lead the brightest 
future possible.
    Thank you.
    [The statement follows:]

               Prepared Statement of Dr. Judith E. Favell

              ``SEEKING INNOVATIONS IN SERVICE DELIVERY''

    Good afternoon, Mr. Chairman and members of this distinguished 
committee. My name is Dr. Judith Favell. I am CEO of AdvoServ, 
Executive Director of the Celeste Foundation, and a member of the 
Professional Advisory Board of the Autism Society of America. I have 
devoted my nearly 40-year career as a behavior analyst and psychologist 
to the field of autism and developmental disabilities. During this 
period I have specialized in the treatment of problem behaviors such as 
self-injury and aggression which can be associated with autism. And it 
is on the delivery of such treatment that I focus my comments this 
afternoon.
    While research on the cause and course of autism continues, while 
its incidence and prevalence is tracked, while basic research on the 
underlying mechanisms of the disorder is conducted, we cannot lose site 
of the one and a half million children and adults who are now living 
with autism, and who need help now. Today they are seeking services 
that will help them gain the skills and resolve the behavioral 
challenges that will enable them to enjoy the fullest life possible.
    Fortunately, across the last years, major advancements have been 
made in developing educational and behavioral methods to teach these 
skills and treat these problems. These methods, tested through decades 
of scientific research, confirm that children and adults with autism 
can be helped in meaningful and substantial ways. They can learn to 
communicate, to care for themselves, to achieve academic and job goals, 
to reciprocate love with friends and family. Likewise, people 
experiencing autism need not engage in behavior problems that hurt 
themselves or harm other people. In short, the treatment and teaching 
methods designed to help people with autism, notably those based on 
learning theory and applied behavior analysis, are available today, and 
each day are becoming more effective as a result of ongoing research. 
This picture is an optimistic one. However, improving these methods of 
instruction and treatment is not enough. To impact the lives of people 
with autism, an equally important issue must be addressed: how to 
actually make these services available to people who need them.
    There exists not just a gap, but a chasm between what we know and 
what consumers receive. For example, we know that in order to be 
optimally effective, services should begin as early in the child's life 
as possible and be intensive, encompassing as many waking hours as 
possible. Yet families lose precious months or years waiting for 
services, and then must settle for a fraction of the help that their 
child really needs. Too often, these supports are also not available 
when and where they are needed, for example at bedtime, during meals or 
in the midst of a weekend meltdown. The needs of people with autism do 
not conveniently conform to clinic hours or professional appointments. 
Support may be needed at any time, day or night.
    Further, we know that effective services and positive outcomes for 
people with autism depend on qualified caregivers, and yet despite 
widespread training of families and service personnel and extensive 
recruitment of professionals to the field of autism, there remains a 
serious shortage of qualified professionals to guide the treatment 
process.
    Thus, though we know a great deal about how to help, we must now 
increase the accessibility and availability of these services, to 
insure people with autism actually receive that help. If we are to 
truly meet this ever expanding need, if we are to insure that services 
are available early, in sufficient amounts, and targeted when and where 
they are most needed, traditional solutions such as increased training 
of professionals are simply not enough. To meet the challenge, new 
service delivery models must be explored.
    Our own work at the Celeste Foundation serves as an example of 
possible new approaches to improving the scope and cost-effectiveness 
of delivering services to people with autism and their families. With 
support from the Department of Education we have recently completed a 
demonstration project investigating the use of telehealth systems to 
provide professional services directly into homes. In this model, after 
a brief phase of on-site training, families were linked to 
professionals by an interactive video system that enabled live 
training, consultation and support directly into the home when and 
where it was needed.
    Through this telehealth model, families received help in teaching 
their children and coping with their challenges from professionals 
located hundreds of miles away, insuring rapid and responsive 
assistance. This demonstration, utilizing technology developed by the 
Cnow organization proved to be an extremely reliable and effective 
vehicle for helping families and their children. Children learned and 
maintained skills ranging from communication to toilet training, 
parents reported relief from stress due to the availability of support, 
and families and professionals alike affirmed the effectiveness and 
ease of using the system. This very brief news feature provides a more 
graphic picture of the model and benefit of using telehealth to 
facilitate services.
    Work such as this by the Celeste Foundation, demonstrating the 
efficiency and effectiveness of utilizing telehealth technology in 
service delivery, exemplifies the type of innovative approach we must 
pursue if we are to truly meet the ever increasing needs of children 
and adults with autism, bridging the current chasm between knowledge 
and actual practice, moving services from the paper to the people. I 
ask all those in a position of influence, including members of this 
distinguished committee, to support efforts to find innovative 
solutions to service delivery, so that those living with autism now 
will receive the best we have to offer, leading to the brightest 
futures possible.

    Senator Harkin. Well, thank you very much, as I said in my 
opening statement, I hear two pleas from families with autistic 
children. One, find a cure, but help us now. So many people 
that, they just don't have the ability to have someone come 
visit them every day to tell them what to do. I'll have more 
questions about that later, but I just thought--that's really 
the first time I've seen that clip, I'd heard about it, since 
it did take place in Iowa, I'd heard about it.
    So I'll have more to ask you about that when we get into 
our formal questioning period.
    Dr. Favell. Certainly.
    Senator Harkin. Mr. Bob Wright, Chairman of the Board of 
NBC Universal, the Vice Chairman of the Board and the Executive 
Officer of the General Electric Company. Mr. Wright, along with 
his wife, Suzanne, co-founded Autism Speaks.
    Mr. Wright is a graduate of the College of the Holy Cross, 
received his law degree from the University of Virginia School 
of Law.
    Mr. Wright, again, I thank you for your leadership in this 
area, and for co-founding Autism Speaks, and again, your 
statement will be made a part of the record in its entirety, 
and please proceed as you desire.

STATEMENT OF ROBERT C. WRIGHT, CO-FOUNDER, AUTISM 
            SPEAKS, FAIRFIELD, CONNECTICUT
    Mr. Wright. Mr. Chairman, thank you very much for having us 
here.
    Our grandson was diagnosed in 2004, at just 2 years and 3 
months, and we were helpless. He was potty-trained, he spoke, 
he was very active, he was apparently a very normally-
developing child, and everything slipped away from him. We were 
helpless as we watched him slip away into this cruel embrace of 
a disorder. My wife, Suzanne, likes to call it kidnapping, as 
if someone had taken Christian who was meant to live, yet he 
was taken away, and we got nothing back, and there's no way to 
restore him back to his family--he's a little prisoner.
    Since that diagnosis, we embarked on a mission to learn as 
much as we could about autism. We received, Christian received 
the best therapies and treatments that were available, but we 
discovered, however, that there are scarce resources for 
parents dealing with autism, and how thin the knowledge base is 
on the whole issue.
    We had so many questions, and instead of answers, we were 
confronted with a bewildering array of theories and guesses.
    Here's what we do know about autism. The numbers that Dr. 
Gerberding talked about, 1 in 150 children in the United 
States, 1 in 94 boys, that's the ratio. A decade ago, the 
experts estimated the prevalence in 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 
society, American society, approximately $35 billion in direct 
and indirect expenses each year, according to a Harvard School 
of Public Health study. Caring for a child with autism can cost 
over $3 million over a person's lifetime, those are the 
estimates.
    Frankly, Mr. Chairman, we were shocked that a disorder this 
prevalent commands so little in terms of resources devoted to 
research and treatment when compared to other, less common, 
disorders.
    For example, leukemia affects 1 in 25,000 people, children, 
but receives $300-plus million a year of support from the NIH. 
Pediatric AIDS affects 1 in 8,000, and it's about $400 million 
a year. And autism affects 1 in 150, and the funding level is 
approximately $100 million.
    To help close this gap, we launched Autism Speaks in 
February of 2005 to help raise the funds that would quicken the 
pace of research. We worked--and together we worked with 
literally thousands of families affected by autism, to 
introduce, and pass, and have the President sign the Combating 
Autism Act.
    This is an historic act, it is considered by some to be the 
most comprehensive piece of single-disease legislation ever 
passed in the U.S. Congress. It authorizes $920 million over 5 
years for research and autism surveillance, awareness, early 
identification, and authorizes a 50 percent increase in the 
Department of Health and Human Services spending on autism.
    For fiscal year 2008, the Combating Autism Act authorizes a 
spending level of a total of $168,000, to the Health and Human 
Services Secretary for autism activities, and within that 
total, provides for three, distinct, autism-specific items. 
Sixteen and a half million dollars to the Centers for Disease 
Control and Prevention, to conduct the developmental disability 
surveillance and research program, which Dr. Gerberding 
outlined, the $37 million for Health Resources and Services 
Administration to carry out an autism education, early 
detection, intervention program; and $144 million for NIH-
funded research.
    Mr. Chairman, let me elaborate quickly on each of these. 
First, for the NIH, the funding increases are incremental, in 
total. Most important, the act directs the NIH to spend those 
dollars more wisely, according to a strategic research plan, 
devised by an Inter-Agency Autism Coordinating Committee with 
consumers and advocates comprising a third of its membership. 
The act also directs the NIH to ramp up its investment in 
research, and potential environmental causes of autism.
    With these new funds, CDC can expand its awareness and 
intervention activities, to reach more parents, health 
professionals, et cetera. Previous investment in the CDC has 
produced the largest-ever surveillance study, which established 
a baseline to measure autism prevalence trends in the United 
States.
    These studied need to continue so that we can measure the 
true changes in autism prevalence over time. They probably 
aren't enough, by a long shot, but you know, that's the best we 
have right now.
    It is also critical that funds be appropriated to the CDC 
to fund the Seed Study, which is the first epidemiological 
study to search for environmental exposure, and exposure gene 
immune interactions.
    The Combating Autism Act also creates new and innovative 
State-based programs in autism education, detection, and early 
intervention. Early intervention, as we've heard here, can lead 
to improvements in speech relating to learning.
    One of the things I would offer as a comment here, that--
this is something we do know, that a child that does early 
intervention, is diagnosed before 3 years old, and is fortunate 
enough to have active therapy such as behavioral, occupational, 
or speech therapy, has a 50 percent chance of being able to 
matriculate to a public school. If you don't do that, you have 
almost no chance.
    What we also know, is that children in the minority 
community, the average age of diagnosis is 7 years old. So, if 
you put those two together, there's almost no chance those 
children are going to be able to matriculate through a public 
school system. The two largest minorities are African-Americans 
and Hispanics, which total almost 80 million, in total. A third 
of our population is in the minority community. So, I mean, 
this whole thing, the cost involved, the issues involved, it's 
critically important.
    Mr. Chairman, the funding increases recommended by the 
Combating Autism Act are relatively modest, at only $25 million 
more than the Congressional Budget Office's baseline estimates 
for HHS's autism activities. But the impact this subcommittee 
would have by not just matching those increases, but by 
dictating how those funds would be spent, would be a start.
    By doing so, Mr. Chairman, this subcommittee would take a 
giant step toward fulfilling the promise offered to hundreds of 
thousands of children and their families when Congress passed 
the Combating Autism Act. The public health crisis posed by 
autism requires an extraordinary response. With every new child 
diagnosed with autism, we're looking at another $3 million bill 
over their lifetime--it isn't business-as-usual. I know you 
understand that, I know everybody sees this.
    But we see a response needed that is akin to what happened 
with AIDS--a crisis in the 1990's. With line-item 
appropriations for autism intervention, surveillance and 
research tied to a strategic plan. This is a leg-up, it's late-
coming to recognize the prevalence, if we don't do something 
special, the funding won't rise at a fast enough level to deal 
with that.
    I'm fully aware that the autism community is asking this 
subcommittee to do something which many claim to oppose, in 
principle, namely to appropriate by disease. In fact, Congress 
already took that extraordinary step when it passed the 
Combating Autism Act. The act--by authorizing the creation of 
autism-specific line-item appropriations--recognized that 
autism deserves, no, requires, this approach, because of the 
combination of autisms high prevalence, coupled with the 
historical neglect exemplified by the numbers you heard today 
on NIH and the inability to prioritize autism within its 
portfolio, at least at this juncture.

                           PREPARED STATEMENT

    Last year, the House and the Senate unanimously passed the 
Combating Autism Act and we urge you to make the funding part 
of the implementation of the act, as it's written, equally 
bipartisan, and universally a supported effort.
    Thank you very much, Mr. Chairman.
    [The statement follows:]

                 Prepared Statement of Robert C. Wright

    Good afternoon, Mr. Chairman. I am Bob Wright, chairman of the 
board of NBC/Universal and vice chairman of the board of the General 
Electric Company. But I appear before you today in another capacity, as 
co-founder of Autism Speaks and as a grandfather of child with autism.
    Our grandson, Christian, was diagnosed with autism in 2004. 
Helpless, we watched him slip away into the cruel embrace of this 
disorder. My wife, Suzanne, likens it to a kidnapping, as if someone 
had taken away the life Christian was meant to live. We all want 
nothing more than to have him back where he belongs, restored to his 
family.
    Since the diagnosis, our family has been on a mission to learn all 
we could about autism, and to help ensure our grandchild received the 
best therapy and treatments available. What we discovered, however, was 
just how scarce the resources are for parents dealing with autism, and 
how thin the knowledge. We had so many questions, and instead of 
answers, we confronted a bewildering array of theories and guesses.
    Here's what we do know about autism.
  --According to a recent CDC report, autism is now diagnosed in 1 in 
        150 children in the United States, and a shocking 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 society the American economy more than $35 billion in 
        direct and indirect expenses each year, according to a Harvard 
        School of Public Health study. And caring for a child with 
        autism can cost over $3 million over the person's lifetime.
    Frankly, Mr. Chairman, we were shocked that a disorder as prevalent 
as autism commands so little in terms of resources devoted to research 
and treatment, when compared to other, less common disorders.
  --For example, leukemia affects 1 in 25,000 people but receives 
        research funding of $310 million per year;
  --Pediatric AIDS affects 1 in 8,000 children; its funding, $394 
        million per year; and
  --Then there's autism, which affects 1 in 150 children and yet NIH 
        research funding is a paltry $108 million.
    To help close this gap, we launched Autism Speaks in February 2005 
to help raise the funds that will quicken the pace of research. Mr. 
Chairman, we also worked together with thousands of families affected 
by autism to introduce, pass and have the President sign the Combating 
Autism Act. This historic act is considered by some to be the most 
comprehensive piece of single-disease legislation ever passed by the 
U.S. Congress. It authorizes appropriations of $920 million over 5 
years for autism research, surveillance, awareness and early 
identification, authorizing a 50 percent increase in the Department of 
Health and Human Service's spending on autism.
    For fiscal 2008, the Combating Autism Act authorizes a total of 
$168 million to the HHS Secretary for autism activities and within that 
total provides for three distinct autism-specific line items--
  --$16.5 million for the Centers for Disease Control and Prevention to 
        conduct its Developmental Disabilities Surveillance and 
        Research program;
  --$37 million for Health Resources and Services Administration to 
        carry out an Autism Education, Early Detection, and 
        Intervention program; and
  --$114.5 million for NIH-funded autism research.
    Mr. Chairman, let me elaborate on each of these items.
    For the NIH, the funding increases are incremental. Most important, 
the Act directs NIH to spend those dollars more wisely, according to a 
Strategic Research Plan devised by an Interagency Autism Coordinating 
Committee, with consumers and advocates comprising a third of its 
membership. The act also directs NIH to ramp up its investment in 
research into potential environmental causes of autism.
    With these new funds CDC can expand its awareness and intervention 
activities, to reach new parents, health care professionals and health 
care providers. Previous investment in CDC has produced the largest-
ever surveillance study which established a baseline to measure autism 
prevalence trends in the United States. These studies need to continue 
so that we can measure the true changes in autism prevalence over time. 
It is also critical that funds be appropriated to CDC to fully fund the 
SEED study, which is the first epidemiological study to search for 
environmental exposures and exposure-gene-immune interactions.
    The Combating Autism Act also creates new and innovative state-
based programs in autism education, detection and early intervention. 
Early intervention can lead to profound improvements in speech, 
relating and learning. Right now, we consider getting a diagnosis and 
intervention for a 3-year-old child a success. But we can do better. 
Through new diagnostic instruments we can reduce the age of diagnosis 
to within the first year of life. Service provision must keep pace.
    Mr. Chairman, the funding increases recommended by the Combating 
Autism Act are relatively modest at only $25 million more than the 
Congressional Budget Office's baseline estimates for HHS's autism 
activities. But the impact this subcommittee would have by not just 
matching those increases but dictating how those funds would be spent 
would be historic. And by doing so, Mr. Chairman, this subcommittee 
would take a giant step toward fulfilling the promise offered to 
hundreds of thousands of children and their families when Congress 
passed the Combating Autism Act.
    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.
    I am fully aware that the autism community is asking this 
subcommittee to do something which many claim to oppose in principal--
namely, to appropriate by disease. In fact, Congress already took that 
extraordinary step when it passed the Combating Autism Act. That act, 
by authorizing the creation of autism-specific line-item 
appropriations, recognized that autism deserves, no, requires, this 
approach because of the combination of autism's high prevalence, 
coupled with historical neglect exemplified by the failure of the NIH 
to appropriately prioritize autism within its portfolio.
    Last year, the House and the Senate unanimously passed the 
Combating Autism Act. We urge you to make funding the implementation of 
the CAA an equally bipartisan and universally supported effort.
    Thank you, Mr. Chairman.

    Senator Harkin. Thank you very much for your statement, and 
thank you for taking your time to be here today, and for all of 
your involvement in this issue.
    Next, we'll turn to Mr. Bradley Whitford, well-known 
Broadway and TV actor, who is probably best-known for his role, 
of course, on ``West Wing''.
    Mr. Whitford studied theater and English literature at 
Wesleyan University. Dr. Favell went to that school.
    Dr. Favell. Illinois.
    Mr. Whitford. Oh no, Connecticut.
    Dr. Favell. He went to the other one.
    Senator Harkin. Different Wesleyan.
    Dr. Favell. Yes.
    Mr. Whitford. Different one.
    Senator Harkin. Oh. Where was yours?
    Mr. Whitford. Connecticut.
    Senator Harkin. Oh, okay. Then earned a Master's Degree in 
Theater from the Julliard Theater Center, and again, Mr. 
Whitford, thank you very much for being here, and for your 
testimony, and please proceed.

STATEMENT OF BRADLEY WHITFORD, VOLUNTEER SPOKESPERSON, 
            AUTISM SPEAKS
    Mr. Whitford. Well, thank you, Senator Harkin, on behalf of 
the acting President of Autism Speaks, I want to thank you for 
your support on this issue.
    Autism is not a disease that any beloved celebrity is going 
to come down with, and I know sometimes it seems as if 
celebrity has no place in discussions of priorities, but I hope 
you will forgive it, because these children have no voice, and 
it seems an appropriate use of the attention that actors get, 
to bring voice to them.
    I came to this cause when my college roommate, movie 
producer John Shestack, and his wife, Portia Iverson, had their 
son, Dov, diagnosed with autism, and founded the amazing 
advocacy group, Cure Autism Now, which is known, lovingly, as 
CAN.
    CAN recently merged with Autism Speaks, founded as you 
know, by Bob and Suzanne Wright, and I just want to take a 
moment to say, I know you're aware of the urgency here, but I 
want you to express to your colleagues the incredibly proactive 
nature of the autism community. It's the most heroic response 
to personal devastation that I have seen in John's family, to 
not only take of their family, but to reach out and help 
others. I know there is a great return on whatever investment 
is made in autism research and treatment.
    Autism Speaks is going to make sure that all Americans, and 
certainly all of our elected officials understand the urgency 
of this problem.
    As my friend, John, has said many times, it's as if 1 in 
150 American children was being kidnapped. What would this 
Congress do if that was the case? What must it do to deal with 
these sad facts as they truly are?
    I know the enormous burden of your high office means you 
must bear a certain stoicism. I also know that most Senators 
are parents, and grandparents.
    Portia has written a book about Dov called Strange Son. 
Here's how she describes the kidnapping, ``It was his mind they 
came for. They came to steal his mind. Before anyone gave it a 
name, even before I knew what it was, I knew it was in our 
house. They were very, very dark things, and there was no way 
to get rid of them. When I closed my eyes, I felt their shadows 
passing over me. I didn't like to think about where they came 
from, or where they were going. It was too frightening.
    Dov was only a baby, and something was trying to steal him 
away. I knew that that was what they did whenever I 
accidentally fell asleep. Night after night, I sat beside his 
crib. I knew he was slipping away from us, away from our world, 
and there was nothing I could do to stop it from happening, and 
there was nothing anybody could do, they told me. So, I did the 
only things I could--I guarded him. Although I knew it would do 
no good, because I could not guard his mind. Then, one day, it 
happened. He was gone.''
    It is even more than just a tragedy for these kids, many of 
whom, like Dov, we now know to be of extraordinary 
intelligence, but trapped in bodies which do not allow them to 
effectively communicate or interact with the rest of us. It's 
also a tragedy for our families and for our country.
    A mother of an autistic child recently told me, through her 
tears, that she had been forced to abandon her beloved life's 
work as a nurse, not mainly to give her more time with her 
autistic child, but rather to purposely make her family poor 
enough to qualify for the payment of some of the services her 
child so desperately needs. She said, ``The one thing I won't 
do, even though I have friends who have, is get divorced just 
to qualify for additional benefits.''
    Then there are the cases which don't make national news, 
but which echo loudly among people in the autistic community. 
About once a month, somewhere in America, the father of an 
autistic child kills the child, and himself, to end the 
despair.
    Yet, despite all of this, there is some genuinely good 
news. The unanimous passage at the end of last year of the 
Combating Autism Act by both Houses of Congress can be an 
historic turning point. The act contains, for the first time, 
specific authorizations of appropriations to combat a single 
disease, including bio-medical research, public awareness, and 
consolidation and coordination of Federal efforts to ensure the 
early diagnosis of kids with autism, so they can get--when it 
matters most--the interventions that can give them the best 
possible quality of life.

                           PREPARED STATEMENT

    Now the burden falls on you. I know you have many important 
matters before you. I also know that none is more important 
than this. In no other case do you have the opportunity and 
responsibility to fulfill the commitment made by this historic 
piece of legislation. These are our most vulnerable citizens. 
It is our obligation to make them realize their potential, and 
to make their voices heard.
    Thank you.
    [The statement follows:]

                 Prepared Statement of Bradley Whitford

    Chairman Harkin, ranking member Specter, members of the 
subcommittee--it's my great honor to be here today in the hope that my 
years of training as an actor and stomaching countless audition 
rejections have led me to some degree of celebrity which I can put to 
use, helping you garner the support you need to fully fund the 
appropriations authorized in the Combating Autism Act.
    One in 10,000 kids will have autism. That's what top scientists 
would have told you little more than a decade ago. Then, it became 
clear that number was ridiculous. And the CDC--with the support of this 
subcommittee--started to really look at the prevalence of autism. 1 in 
2,500, then 1 in 500. By the time the Children's Health Act of 2000 
became law, the estimate had become 1 in 250. A few short years ago, 
the CDC said 1 in 166.
    Now, just a couple of months ago, the best data ever collected 
produced the scariest number yet--1 in 150--1 out of 94 American boys.
    I came to this cause when my college roommate, movie producer Jon 
Shestack and his wife, Portia Iverson, had their son, Dov, diagnosed 
with autism and founded the amazing advocacy group, Cure Autism Now, 
known lovingly as ``CAN''.
    CAN recently merged with Autism Speaks, founded, as you know, by 
Bob and Suzanne Wright--on behalf of their grandson. Now this strong 
national organization is going to make sure that all Americans--and 
certainly all of our elected officials--understand the urgency of this 
problem.
    As my friend Jon Shestack has said many times--it's as if 1 in 150 
American children was being kidnapped. What would this Congress do if 
that was the case? What must it do to deal with these sad facts, as 
they truly are?
    I know the enormous burden of your high offices means you must 
bring to bear a certain stoicism. I also know that most Senators are 
parents and grandparents. Portia has written a book about Dov--Strange 
Son. Here's how she describes the kidnapping.
    ``It was his mind they came for. They came to steal his mind.
    Before anyone gave it a name. Even before I knew what it was, I 
knew it was in our house . . . They were very, very dark things. And 
there was no way to get rid of them . . . When I closed my eyes, I felt 
their shadows passing over me . . . I didn't like to think about where 
they came from or where they were going. It was too frightening. Dov 
was only a baby and something was trying to steal him away. I knew that 
was what they did whenever I accidentally fell asleep . . . Night after 
night, I sat beside his crib. I knew he was slipping away from us, away 
from our world. And there was nothing I could do to stop it from 
happening. And there was nothing anybody could do, they told me. So I 
did the only thing I could. I guarded him, although I knew it would do 
no good, because I could not guard his mind.
    And then one day, it had happened. He was gone.''
    And it is even more than just a tragedy for these kids--many of 
whom, like Dov, we now know to be of extraordinary intelligence, but 
trapped in bodies which do not allow them to effectively communicate or 
interact with the rest of us. It's also a tragedy for families, and for 
our country.
    I recently spoke to one mom who told me--through her tears--that 
she had been forced to abandon her beloved life's work as a nurse--not 
mainly to give her more time with her autistic child, but rather to 
purposely make her family poor enough to qualify for the payment of 
some of the services her child so desperately needs. She told me: ``The 
one thing I just won't do--even though I have friends who have--is get 
divorced just to qualify for additional benefits.''
    Then there are the cases, which don't make national news but which 
echo loudly among people who ``get it''--probably about once a month, 
somewhere in America--the father of an autistic child kills the child 
and himself, to end the despair.
    Yet, despite all of this, there is some genuinely good news. The 
unanimous passage, at the end of last year, of the Combating Autism 
Act, by both Houses of Congress can be a historic turning point. The 
act contains, for the first time, specific authorizations of 
appropriations to combat a single disease--including biomedical 
research, public awareness and the consolidation and coordination of 
federal efforts to ensure the early diagnosis of kids with autism (so 
they can get, when it matters most, the interventions which can give 
them the best possible quality of life).
    Now the burden falls on you, on this subcommittee, to turn 
Congress' promise on autism into reality.
    I know how many important matters come before you. I also know none 
is more important that this. And in no other case, do you have the 
opportunity and responsibility to fulfill the commitment made in a 
historic piece of legislation.
    I know you will do the right thing.
    Thank you.

                       AUTISM AND THE ENVIRONMENT

    Senator Harkin. Mr. Whitford, thank you very much. You give 
a very powerful statement.
    I thank you all very much, for taking the time to be here--
as I said earlier--but also for your day in and day out 
efforts, on behalf of our families and our kids with autism.
    I'll begin this round of questions now, and then yield to 
my friend from Illinois.
    I want to start with our first panel, Dr. Insel, and I 
don't know if you're aware of this magazine article, the 
Discover magazine article that came out--maybe you are, maybe 
not--but I wrote down what you said in your testimony, you said 
that we must focus on this as a brain disorder. At least that's 
what I wrote down. I hope I can challenge you on that, and see 
what your response is.
    This Discover magazine article had a map of Texas, and the 
top map was the autism rates per 10,000 from 1990 to 1993, up 
on top, you can't see it, but the bottom two are what's 
important. It was the autism rates per 10,000 of the last few 
years of the last decade, and then it had the pounds of 
environmental toxic release. When you overlay one over the 
other, it is frighteningly the same.
    So, is there something in the environment? Why should we 
just focus on it as a brain disorder, but maybe it's, maybe 
there's something environmental out there, that we also ought 
to focus on, which is one question, and it leads to the second 
part of it--how much of the money, of the $108 million that you 
invest in autism research, is on environmental aspects, looking 
at some of the environmental aspects of this?
    Dr. Insel. These are important questions, Senator Harkin, 
and the way that we think of this is that there is an 
environmental component, but it interacts with some genetic 
component. The reason we believe in the genetic piece of this, 
which is driving the brain pathology, is that there is such a 
high concordance in identical twins, it's difficult to explain 
that based on just an environmental factor, because in non-
identical twins, the rate goes way, way down.
    Senator Harkin. Fraternal twins.
    Dr. Insel. Right. So, there's some effect--it's not 100 
percent concordance, so there's something beyond genetics--so 
we're talking about both environment and the genes.
    What are we doing about the environment? As you know, the 
2007 budget that was approved by this committee involved an 
appropriation for the Gene Environment Initiative, GEI, that 
was a particular request from, in this case, the Secretary--not 
simply through NIH, but it was part of the Secretary's budget. 
This, you know, our Secretary Levitt came from EPA, and he came 
to Health and Human Services with a tremendous interest in 
environmental issues.
    What he was recommending here was that we bring the very 
best genetics and the very best abilities on the environmental 
side together in this new initiative, and the $40 million will 
be spent each year for 4 years. The first grants in that arena 
are just being funded in the next few months----
    Senator Harkin. Did you say $40 million?
    Dr. Insel. Per year, for the next 4 years.
    Senator Harkin. On the environmental aspects?
    Dr. Insel. Not specifically for autism, but generally, if 
we're looking at gene-environment interactions--part of what's 
hung us up here----
    Senator Harkin. Through your Institute?
    Dr. Insel. This is the National Human Genome Research 
Institute doing the genetics part, and the National Institute 
of Environmental Health Sciences, which is developing the 
technology.
    We have great precision on genetic sequencing, not such 
good precision on environmental exposure. So part of this will 
be to develop the tools, so that we'll have sensors, and other 
ways of looking at environmental exposures, often well after 
the fact.
    Senator Harkin. I still need to know, and if you don't have 
it right now, if you'd provide it for the record, about how 
much of that $108 million goes in for environmental.
    Dr. Insel. We can provide that for the record.
    [The information follows:]

                 Environmental Role of Autism Research

    Of the $108 million invested in autism research in fiscal year 
2006, $14 million was invested in environmental aspects of autism 
research by the following Institutes and Centers: NINDS, NICHD, NIEHS, 
NIMH, NCRR, and OD.

    Senator Harkin. Second, if we were to provide the increase 
that the groups have asked for, how would that money, that 
extra money be utilized in the next fiscal year? I'd like to 
have some handle on that.
    Dr. Gerberding, I was shocked when my daughter and her 
husband showed me the schedule of vaccinations for my first 
grandchild in the first 2 years of his life. I was shocked. 
Evidently this is what is required; and they have good 
pediatricians, they go to great doctors out on the west coast, 
but I guess I just never realized that. I think, when my kids 
were born we had a couple, maybe three shots, but we didn't 
have this long list. I think 12 or 15, is that correct?
    Mr. Wright. Thirty-one.
    Senator Harkin. Thirty-one, thank you, Bob. Thirty-one.
    Mr. Wright. Zero to 18 months.
    Senator Harkin. Please, go ahead, what did you say?
    Mr. Wright. Between zero and 18 months, there are 31, 
including influenza.
    Senator Harkin. Okay. That's the list I looked up. They 
were upset, they were asking me, I said, ``Well, I'm not a 
doctor, how do I know?'' So, they wanted me to ask you.
    I mean, I'm serious, they wanted me to ask. They're really 
concerned about this. About all of those vaccinations in the 
early ages. When you have a small child that's not an adult, I 
would be concerned if I had that many shots in 18 months. There 
has been, and there have been some, at least, allegations, some 
thought that perhaps, many of these, at least with the use of 
thimerosal, which was a mercury additive for preservatives, 
might have had some influence in that, although thimerosal has 
now been taken out.
    Mr. Wright. Not entirely.
    Senator Harkin. Except in the influenza, the influenza shot 
still has thimerosal, am I right?
    Mr. Wright. That's right.
    Senator Harkin. I think that's right.
    Could you address yourself to that? Just the number of 
vaccinations, the fact that we still put thimerosal in the 
influenza shot, but it's been taken out of the measles, mumps 
and rubella, I understand.
    Dr. Gerberding. It's important, first of all, to recognize 
how many children are alive today because of those shots, and 
how little vaccine-preventable disease we see in this country 
as a consequence of the enormously successful immunization 
program.
    Keep in mind that an immunization is really just a way to 
expose a child to a specific protein or antigen that causes it 
to develop an immune response, and that happens to children all 
of the time, naturally. They're exposed in their food, they're 
exposed to things they come in contact with their friends and 
with day care, so while they may receive intentional exposures 
to protect their health, they're naturally doing the same thing 
to themselves, just as part of being a child, and being exposed 
to the environment.
    The concern about the safety of vaccine is something that 
we take very seriously at CDC, and we recognize that we're 
having our own challenges in keeping up monitoring the safety 
of vaccines when so many more are out there, and we haven't 
been able to scale our safety efforts the way we would like to.
    But, we do know--and I think the scientists at the 
Institute of Medicine have provided great leadership in this, 
is that when all of the information that is available has been 
looked at by external scientists, not only has the Institute of 
Medicine said that vaccines are not associated with autism, but 
they have said that there is not an association, that there is 
no evidence for an association.
    What we say to that is, that's good, and that's what we 
expected to see, but we have still a lot of work ahead of us to 
identify what are the safety aspects of vaccines, in general, 
but also what are the causes of autism? We need to continue the 
studies that we have in progress, including the study underway 
to look at the potential association of environmental toxins 
and autism, and the SEED study that's going on, and not be 
dogmatic.
    I was really struck by Mr. Wright's statement about the 
similarity between autism and AIDS, because I lived through the 
very first phases of AIDS, and if you go back to 1981, the 
situation we were in with that urgent reality for many, many 
people in our country, is we had no idea what caused it, there 
was no cure, the people who were affected were driving the 
agenda because it was so powerfully affecting their lives and 
their health status, and the people that they loved and cared 
about. Government was slow to get on board, Government was slow 
to scale and provide the kind of scientific leadership, the 
door was open for junk science, and for all kinds of theories 
to come and go, and ultimately, it was the Congress of the 
United States that stepped in and provided the leadership and 
the investment to get that whole picture turned around.
    Domestically, back in the eighties, and more recently, 
internationally with the PEPFAR fund. We don't want to go 
through that cycle again, and I think we really recognize that 
this is an urgent threat. While we're sitting here today in 
these 2 hours, at least six children will be diagnosed with 
autism in our country, 25,000 children this year. We really do 
need to regard this as an urgent threat. So, I just wanted to 
put that perspective in the context of your question.

                       AUTISM IN OTHER COUNTRIES

    Senator Harkin. Well, Dr. Gerberding, obviously, CDC during 
your epidemiological studies also, I'm wondering, are they also 
looking at some of these environmental factors?
    Second, has CDC looked at autism rates in other countries? 
Has any research been done to see if countries in Europe and 
Asia have different autism prevalence rates? If so, can this 
tell us about possible environmental factors that can, or may 
contribute to autism?
    Dr. Gerberding. The SEED study that I mentioned that's 
going on in six sites initiated this summer is designed to look 
for a variety of potential associations and causes of autism, 
including exposure to mercury in the environment, in Rhogam, 
which is sometimes used to treat mothers with Rh factor 
incompatibilities, and a variety of other sources. So, it's 
looking at genes, it's looking at environment, it's looking at 
the social-behavioral context of the family.
    Also looking at occupational exposures in parents that 
could potentially create a hazard of exposure in the home for 
children. So, a comprehensive look, as a first study.
    You might know about the NIH study that will be starting in 
Europe in the cohort of Norwegian children--children in The 
Netherlands, excuse me----
    Dr. Insel. It's Norway.
    Dr. Gerberding. Norway--to follow a cohort of children 
longitudinally to look for prospective evidence of causality, 
and then there are studies, for example, in the United Kingdom. 
that have been tracking children over time, and looking at 
changes in rates.
    Finally, a very important study that we don't have data 
from, going on in Italy, where just by coincidence, some 
children were enrolled in a study of a whooping cough vaccine, 
some of the vaccine was made with thimerosal as a preservative, 
and some of it was made without thimerosal as a preservative, 
so the study was designed to compare the efficacy of the two 
vaccines, we will indirectly be able to determine whether 
there's any difference in autism among the children who did or 
did not receive the vaccine that contained the preservative.
    So, we have more information coming, but I think we're 
beginning to work in the international context of a community 
of investigators all looking for the same kinds of information. 
This is a global health issue, not just an American health 
issue.
    Senator Harkin. Well that's, that is comforting to know, 
that you--CDC is looking at other countries, you are 
coordinating with other countries to find out about the 
prevalence rates, and you're also looking at the Norway study, 
I know.
    Are you also coordinating with Dr. Insel, and his Institute 
on this?
    Dr. Gerberding. The Norwegian study is an NIH study.
    Dr. Insel. But this is an area where there's a lot of 
coordination between all of these Federal agencies, we're 
actually organized around this. This is, very much, an 
integrated effort.
    The Norwegian study, if I can just take a moment, because I 
think it's going to help us over the next couple of years. It 
makes no presumption about the cause, it says, ``We don't know 
enough, to even have a hypothesis,'' but it takes 100,000 
children, following them, their moms, from the second trimester 
to birth cohort, waits 5 years to see, 400 or so children with 
autism, and then it goes back, because samples are collected 
all the way from the very first prenatal visit. So, we have 
biological samples, we have a tremendous amount of clinical 
information. It goes back to ask, what is it, then, that might 
have been an exposure for the children who ultimately had 
autism, versus those who didn't?
    Senator Harkin. I'm going to yield to my colleague for some 
questions now, I have a couple more for Dr. Gerberding and Dr. 
Insel.
    But really, in my next round of questions, I want to focus 
on you, Dr. Favell, and I want to talk about this intervention 
program which holds so much promise, and again, involve you and 
Ms. Colston in that, and also Mr. Wright, in terms of your 
experiences with your grandson, with Dov, and see how we start 
getting to families early on, and providing that kind of help 
and support, if we don't really have an infrastructure for it, 
and we don't--what's the most cost-effective way of doing it? I 
am intrigued by this idea of a tele-health distance-type thing 
where you could support someone in a family 24 hours a day, so 
I want to focus on that in my next round.
    But, with that I would yield to my colleague from Illinois, 
Senator Durbin.

                         ALLOCATION FOR AUTISM

    Senator Durbin. Thank you, Mr. Chairman, and thank you to 
all of the witnesses. This is the first hearing I've attended 
on this issue. It isn't for lack of interest. There are many 
things pulling at us, in the position I have in the Senate, and 
the work that we have to do in so many other places, but I 
wanted to make a point of being here today. Not because we have 
any situation in my immediate family, that relates to autism 
spectrum disorder, but because of the number of friends that 
have been touched by this, and what appears to be the alarming 
increase in the diagnosis of autism across America.
    My wife and I, fortunately, raised three children, and have 
a grandchild without a problem in that regard, but we 
frequently speak of this, the incidence of this, and why it 
appears to grow as it has, I know there's a serious question as 
to whether this is an indication of incidents or just 
identification now, better identification, but I think that 
begs the question. I think, the fact is, this is a significant 
challenge.
    I thank all of you for testifying, Dr. Gerberding, again we 
really appreciate your public service, Dr. Insel, I'll have a 
question for you in a moment, thank you for what you do at NIH, 
and for all of you on the panel, starting with Ms. Colston and 
Dr. Favell.
    Mr. Wright, you raised a question which comes to the office 
of a Congressman and Senator more frequently than you can 
imagine. People visit us from my State of Illinois or other 
places, and say to you, ``Senator, can you possibly explain why 
they're spending ``x'' amount of dollars at the NIH on this 
issue?'' There are people who represent children with juvenile 
diabetes, there are people with parents who have Alzheimer's, 
there are victims of Parkinson's--you name it. They all come 
with the same basic question--how can they possibly rationalize 
this amount of money for this issue of such gravity, why isn't 
more money being spent when it comes to research--and you 
raised that question. You compare the amount of money being 
spent on autism to other significant diseases and disorders, 
and I'd like to ask Dr. Insel the question.
    Because, as I see the numbers here, in the past 10 years 
there's been a dramatic increase at NIH in terms of research 
funding for autism spectrum disorders. In 1998, in the range of 
$27 million, by the year 2008, about $108 million, and I'd like 
to ask you, if you could, give me some indication of whether or 
not this amount is adequate to the task. Do you believe that 
you are able to fund the promising research proposals that come 
before NIH in the field of autism with this amount of money, 
$108 million each year?
    Dr. Insel. Overall, what we call our success rate, that is 
the possibility that anyone in any area will get funded when 
they come to NIH is roughly 20 percent. There's a 1 in 5 chance 
that you're going to get funded.
    Senator Harkin. That's a peer-reviewed.
    Dr. Insel. Peer-reviewed grant, that's right. But, 
virtually all of our, other than contracts, virtually 
everything that we fund is through peer review. That's a system 
that provides the quality control that we need.
    Is autism--how does that stack up against other areas? 
Well, obviously, we're doing better there, because it's growing 
faster. Overall, the budget's grown, a little more than double 
since 1997, this area has grown almost by five-fold, but 
remember, we were starting at a very, very low baseline. So, we 
still have a ways to go in this area.
    I'm not proud to tell you that I can give you the full sum 
of our knowledge in less than 4 minutes, when we talk about 
autism. This is an area where we have many more questions than 
answers. We have a long way to go to fill in those answers. The 
good news is we have some of the tools now, that were not 
available 5 years ago. So, we should be able to make progress 
faster, going forward, than we have in this past period.
    Senator Durbin. So, does your response suggest that 4 out 
of 5 of these peer-reviewed clinical trials that you think are 
worthy of investment each year, have to be denied?
    Dr. Insel. Well, this isn't to say that all of the other 
four would be worthy of investment. We would like to be able to 
fund, always, more than we can do, that's the reality, it's the 
same reality we all experience with our pocketbooks, we can't 
go as far as we'd like.
    However, in the area of autism, we've made that a priority, 
and we've tried to reach as far as we can.
    The problem isn't only that we may not have enough funding 
to do everything we'd like to do, but here also, we haven't 
until recently, had the capacity, we haven't had the population 
of outstanding scientists out there really pushing this agenda. 
That's taken time to build. I think it's there now, and I think 
part of it has been through the help that we've gotten from 
this subcommittee, that's really helped us to grow overall, and 
it's also helped us to stay focused on areas of public health 
need, but there has to be the people out there asking the right 
questions for us to spend the money on.
    Senator Durbin. In order for those people to commit their 
lives and careers to that research, they have to feel that 
funding for research is somewhat reliable, and predictable in 
the years to come, is that not true?
    Dr. Insel. That is absolutely the case, and that is, of 
course, right now a particularly sensitive question. Because 
there are many people who are asking whether they can have a 
career in science, because they find that funding at this 20 
percent success rate is a high-risk game.
    Senator Durbin. I think we made some dramatic progress, and 
I want to thank my colleague from Iowa and Senator Specter from 
Pennsylvania for all their leadership in that regard, but I'm 
afraid that we have reached a part where we're flat-lining 
stagnant here, in terms of the growth in medical research at 
NIH, and I hope we can change that. We are spending a lot of 
money in other places in the world, but I think most families 
would agree that this is a high priority for us to spend.
    Mr. Whitford, you talk about, and I thank you, and Mr. 
Wright for being here, in your public capacities to engage in 
this issue--but you talk about the frustration of your friends, 
that you know, who find it difficult to qualify for help in 
Government programs without making some radical personal 
decisions about their finances and their marital status and 
things of that nature.
    I think that is the part that Ms. Colston was raising 
earlier, too, is how do we sustain the families that are doing 
their level best to help their child, suffering from autism? I 
really believe that that is something that we overlook. 
Research is the first place to turn, but beyond that, it's 
support for these families with children in this circumstance.
    One of the things that I've thought about is to view the 
role of caregivers in America as a special group that receive 
special consideration. Whether we're talking about daycare 
centers or personal attendants for the disabled, there is at 
least one State that gives all caregivers automatic health 
insurance, provided by the State. It's the State of Rhode 
Island, provides Medicaid for caregivers. It strikes me that in 
many instances, families with children with autism would be 
able better to afford the services of caregivers if they could 
offer health insurance as part of the bargain, and we can help 
them do that.
    So, I'm hoping we can find some innovative ways to expand 
the spectrum of services for children who are going to need 
much more, but I thank you for raising that.
    Mr. Whitford. I don't think it's possible to overstate the 
impact that I--actually my, I, subsequent to my involvement 
with CAN, my godson was diagnosed, and it was a different 
situation, they live in a one-bedroom apartment, they do not 
have the funds that they need, and it is absolutely devastating 
to a family, it is--depending on where you are in the spectrum, 
you know, these kids, it's 24 hours. There is a tremendous 
amount of anxiety wondering, where on the spectrum the kid will 
end up. There is, it's an absolutely full-time job, the career 
goes out the window, the marriage goes out the window, and 
you're juggling therapies in a desperate race to see if your 
kid can live an independent life. So, it sounds like a great 
idea.
    Senator Durbin. I hope we can interest some people in it.
    Ms. Colston, I'll ask you the last question I have, and 
turn it back to the chairman on this, but your son, Camden is 
in public schools now?
    Mrs. Colston. He is, he's in Montgomery County, Maryland.
    Senator Durbin. How is that working out?
    Mrs. Colston. It's great. I live--I'm lucky, again, I live 
in Montgomery County, Maryland which is the top 10 counties in 
the Nation in the way they handle disabilities, and the IDEA 
Act. It's great--he gets picked up at my door on the school 
bus, he goes to school, he gets 10 hours a week of intensive 
therapy, he is mainstreamed, or included if you will--not 
mainstreamed, he's included with his typical peers for a third 
of the day, and in a contained classroom for two-thirds of the 
day. I've seen just remarkable improvement in his socialization 
and cognition. So, I'm very grateful for that.
    Senator Durbin. Very fortunate to be in Montgomery County, 
Maryland.
    Mrs. Colston. That's right, I'd say to people, ``I love 
D.C., I'd love to move there, but I can't.''
    Senator Durbin. That just tells the story.
    Mrs. Colston. Yeah, right.

                           PREPARED STATEMENT

    Senator Durbin. A few miles away from you live----
    Mrs. Colston. I can't move there.
    Senator Durbin [continuing]. The schools cannot provide the 
basic care that these children need. I think, I want to salute 
again my chairman, it sounds like I'm doing my best to get on 
his good side, but he had been a national leader on IDEA from 
the start----
    Mrs. Colston. He has been, thank you.
    Senator Durbin. We're lucky to have him.
    Thanks, Mr. Chairman.
    [The statement follows:]

            Prepared Statement of Senator Richard J. Durbin

    As a United States Senator, I hear from thousands of people in my 
State of Illinois. But no stories are as powerful as those of a parent 
who is worried about their child. Whether the worry is because of the 
fear of having to pay for their child's upcoming educational debt, the 
angst of having their child abroad in a war that seems to have no end, 
or the uneasiness of having a child with autism and not knowing what 
the future holds for him or her.
    As we have heard today, autism is a severe neurological disorder 
that affects language, cognition, emotional development, and the 
ability to relate and interact with others. Current estimates suggest 
that over 1 million Americans suffer from some form of autism, 
including more than 24,000 children in my State of Illinois. For 
unknown reasons, the number of children diagnosed with autism has 
skyrocketed in recent years, from one in 10,000 children born 10 years 
ago to approximately 1 in 150 children born today--making autism the 
fastest-growing developmental disability in our Nation.
    Last year, I heard from a woman named Ellen whose story represents 
so well the similar sense of constant worry that I hear from so many 
others. Ellen wrote to let me know that her son's autism was a constant 
source of worry for her. She is a mother that loves her son. At the 
same time, she worries that her son's siblings carry a genetic tendency 
and that their own hopes for marriage and children are tainted with 
concerns about how these genetic tendencies will manifest themselves in 
the lives of their own children. She worries that her other son one day 
will have to bear the strain of raising a child who is affected by 
autism. Ellen writes, ``As much as we love our son, we would give 
anything to have him be `typical'. He will always require supervision 
and assistance. He is the great passion of my life and also a very 
great burden.''
    My State of Illinois has seen a dramatic increase in the number of 
autism cases in the past 10 years. The number of children in Illinois 
receiving special education with autism as a primary diagnosis has 
grown from 1,960 to 9,455--more than a 450 percent increase. As more 
and more families become aware of the disorder and the impact on their 
lives, it is imperative that we all--federal, state, and local levels--
make the most of our ability to promote research, advocacy, and policy 
for autism-related disorders.
    The State of Illinois is very involved. Our communities are 
strongly committed. In 2003, the Illinois General Assembly passed a law 
to develop an innovative model of service delivery called the Autism 
Program to help these children and their families. Through a 
partnership with the CDC, this program offers evidence-based diagnoses, 
treatments, trainings, resources and referrals. Last year, the program 
provided more than 4,700 clinical contacts and trained more than 9,400 
parents and providers. This year, there is hope to expand the 
initiative.
    Late last year, the President signed into law the Combating Autism 
Act. The new law says we have authority to provide dramatic increases 
in federal funding for autism, specifically for medical research, 
screening tools, therapy interventions and education about the 
disorder. But the new law says something else, too.
    Coupled with State based efforts like those in Illinois, the new 
law reflects the dawning awareness in Congress and throughout this 
country that far too many people are affected by autism spectrum 
disorder. It is my hope that this new law proves to be a significant 
step toward a better understanding of how to prevent autism, of 
effective treatments for people living with autism, and maybe even, one 
day, a cure.
    The efforts conducted at the State and now at the Federal level 
will bring much needed action to address the growing prevalence of this 
disorder. More importantly, however, these efforts can bring hope to 
the thousands of families impacted by autism. We may have a long way to 
go but I look forward to today's discussion and learning what the CDC 
is doing and will do to help these families and keep such hope alive.

    Senator Harkin. Thank you very much, Senator Durbin. Thanks 
for your strong support.
    Senator Harkin. As I said, I wanted to get back to 
questions, I wanted to talk about interventions now, and how we 
handle, how to handle those now.
    Now, Ms. Colston, tell me again, how old was Camden when he 
was first diagnosed?
    Mrs. Colston. He was 2\1/2\ when he was diagnosed with 
autism.
    Senator Harkin. Two and a half, and you said that he'd made 
progress through intensive therapy, Individualized Education 
Plans, a sizable team of dedicated professionals. I mean, did 
that start right at 2\1/2\ when he was diagnosed?
    Mrs. Colston. My experience was slightly different, as I 
mentioned. In addition to having autism, he's got medical 
ailments that he was born with, so when he was born, he was 
small for his age, he had horrible acid reflux--you've read the 
Discover article, so you're going to see a lot of parallels 
there.
    Senator Harkin. You read this too, then?
    Mrs. Colston. In full disclosure, I not only read it, but I 
helped place it with Dr. Herbert, so----
    Senator Harkin. Bob Wright says he individually kept the 
magazine afloat for a month by buying up all the magazines.
    Mrs. Colston. Thank you so much, Bob Wright.
    Senator Harkin. Sending them out.
    Mr. Wright. Largest single purchaser.
    Mrs. Colston. It's a great thing. So, he was undiagnosed, 
but we had horrible acid reflux, we were hospitalized, we had 
these allergies, and they thought he had something called 
Noonan Syndrome, the diagnosis changed--all that being said, in 
the NICU these problems presented, and so therefore, the 
Georgetown University Hospital made me sign up for Early 
Intervention. I didn't even know what it was. So he, because he 
had low muscle tone and these other medical problems, at 6 
weeks of age, the team came to my house. I know for a fact that 
he is where he is because they came to my house, and gave only 
4 hours of therapy, but that, I mean, with them, he turned his 
neck, he sat up, he--they were the ones that actually--the 
therapists there are amazing, because they encouraged me to 
really look at the autism before the doctor saw it.
    Senator Harkin. Yeah, I guess what I'm wondering, and I--as 
I said I had dinner Sunday night, no secret, I had dinner with 
the former Lieutenant Governor of the State of Iowa, Sally 
Peterson, who's been very much involved in this issue. Their 
son, Ron is now, I think 20, 21, doing very well.
    Mrs. Colston. Oh, good.
    Senator Harkin. But, again, they had early intervention, 
they could afford it, they had all of the accoutrements, 
everything that they needed. They asked the question--what 
happens to families that don't have the monetary resources that 
we do? How did you happen to--I don't mean to pry, but how is 
this--this costs money----
    Mrs. Colston. Oh, oh yeah. I mean, my out-of-pocket 
annually--and I have good insurance, keep in mind.
    Senator Harkin. Yes.
    Mrs. Colston. Is between $9,000 and $15,000 a year. That's 
not easy. At Autism Society of America, we have a 1-800-3AUTISM 
number, and it's a great resource, but we learned so much from 
that. Because the calls we get are about desperation 
financially.
    Senator Harkin. Sure.
    Mrs. Colston. People--so, I'm lucky to be able to swing 
that, in good years and bad, but these people mortgage their 
homes--especially when their children become adults--that's 
where the rubber hits the road, financially.
    Senator Harkin. Now, this is where I'm going to focus on 
Dr. Favell. I am so intrigued by what you're doing. As many 
families tell me, or people I've talked to with autistic 
children, you know, when they go to the doctor's office, or 
when they see a behaviorist or a psychologist, maybe the child 
is not exhibiting anything at that time.
    Dr. Favell. Right.
    Senator Harkin. When they need help is at home when things, 
go all to heck, all right? There's no one there. That's why I'm 
intrigued by what you're doing.
    How, tell me, enlighten me a little bit more about how, how 
many families could a trained psychologist, behaviorist, 
someone who is trained and knows how to deal with children with 
autism, how many could they handle on some kind of a system 
like this? I mean, on a 24-hour a day basis, I'm trying to 
figure, could one handle three families? Or two, or five? I 
just don't know.
    Dr. Favell. Mr. Chairman, it's an excellent question, and 
the answer is just evolving, but for example, we did as part of 
our work with the Celeste Foundation, one demonstration that 
calculated that, if a professional, like a behavior specialist, 
was to provide in-home services, they might be able to visit 
two families a day, given travel distances, given missed 
appointments, given inclement weather, all of the vagaries of 
the logistics of supplying services, perhaps they could see two 
to three families a day. Of course, again, in more rural areas, 
that number decreases.
    On the other hand, if you have a behavior specialist, or a 
behavior analyst, who is working with this interactive video 
kind of capacity, you could see potentially 20 families a day. 
Now, this kind of remote, this tele-health, does not replace 
face-to-face intervention and support, but it can augment it, 
and expand, exponentially, the number of families that can be 
touched a day.
    Senator Harkin. As I understand it, in the beginning you do 
have face-to-face involvement with the families, is that 
correct?
    Dr. Favell. Yes, in the model that we tested in our 
demonstration project, they spent--the families such as Josh 
Cobbs' family--spend a week on-site, developing priorities and 
learning basic strategies of intervention and teaching. Then 
they went home with their interactive video system, and then 
that began the process of the interactive consultation, support 
and training.
    It started with about 10 to 14 hours a week of interactive 
video support--it's a couple of hours a day. We think, 
actually, and the families tell us, it might be able to be 
somewhat less, it all is individualized, depending on the needs 
of the child. Then, it was after three weeks reduced to about 5 
to 7 hours a week, and then 3 to 6 hours a week.
    Senator Harkin. I see.
    Dr. Favell. So, there's yet to be worked out the formula 
for exactly the parameters for what is needed, and it will 
always be individualized, just as the IEP and the IHP requires, 
but the intuitive reasoning behind having one professional who 
now is able to touch lives through this remote medium is quite 
clear.
    Senator Harkin. What more do we need to do to test this 
out?
    Dr. Favell. Well, I think we need to bring it, as we say, 
to scale. We need to test fully the economics of it, we need to 
test it across broader bands, including some other 
disabilities, and may I say, also, this kind of innovation 
should not be restricted to children alone. We can't forget the 
many, many thousands of people who are adolescents and adults 
who are adolescents and adults who are also living with autism. 
So, we have further to test there. But, I think probably the 
single most important element in bringing this to scale, as I 
say, is to develop the policies behind reimbursement 
strategies. If I, as a psychologist and a behavior analyst, can 
be reimbursed for providing services face-to-face in a home, 
than I should presumably, also be allowed to be reimbursed for 
providing comparable services, now, over remote interactive 
video. Yet, easily half of the States do not allow for that 
kind of reimbursement through Medicaid.
    So, and then those States that do allow it, there's wide 
discrepancy in what they reimburse. Yes, sir.
    Senator Harkin. Let me ask you, Mrs. Colston. If you had 
had something like this available to you, would that have 
helped you?
    Mrs. Colston. Yes, it would have helped me a lot. Not only 
because, most parents of children with autism work full time, 
and are probably hourly wage workers, and so getting off to run 
home for the times you can do an early intervention is tough.
    But also, because then the therapist could see, as Dr. 
Favell says, the bad time of night.
    Senator Harkin. Yes.
    Mrs. Colston. Where, when the behaviors of autism, it just 
gets harder to be a kid with autism.
    Senator Harkin. I'm, I have a note here, I'm holding in my 
hand that says Josh Cobbs is here, the father of Noah Cobbs who 
is in that news clip, is that right?
    Mr. Cobbs. Yeah.
    Senator Harkin. Oh, well Josh, welcome to the committee, I 
should have pulled up a chair for you and asked you a question. 
Yeah, come up here, come up here, sit down.
    I didn't even know you were here. Now, the recorder is 
going to want to know your name.
STATEMENT OF JOSH COBBS
    Mr. Cobbs. It's Josh, last name is Cobbs, C-O-B-B-S. I am 
not prepared, but I'll do my best.
    Senator Harkin. I wasn't prepared to have you here, either.
    But, I just want to know--now. We saw that little clip, 
obviously, you know, TV wants to get in the gane, with all due 
respect to Mr. Wright, television tries to get it in a very 
short clip, tell me what this has meant for you and your wife 
and your son, on this, again, the availability of it, that you 
can do this during the day, right? On weekends, too, I don't 
know, can you, weekends?
    Mr. Cobbs. Sure, we actually had services, initially, 7 
days a week, two calls, one in the morning, one in the evening, 
and we structured them around when we were struggling, such as 
sitting at the dinner table, or breakfast table, which was very 
helpful.
    The doctors got to see Noah in his true element, so he 
wasn't acting up because there was a worker in the class, or in 
his, in our home, and he wasn't putting on, on-stage, if you 
will, so he was in his natural surroundings, which was very 
helpful for us, because that's where the behavior was 
happening. So, that was very important.
    One thing I'd like to clarify, it's not just important for 
our immediate family, but also our, his grandparents, and aunts 
and uncles who are affected by autism as well, they were able 
to come in and help and once Tina and I were trained adequately 
through the Celeste Foundation and our immediate family, we 
then had the tools to go out and help others, so----
    Senator Harkin. Now, I'm told, I'll just throw this 
question out. I'm told that many times, what might be the 
normal reaction of a parent to a behavioral problem of a child, 
that if that child is autistic, it may in fact, exacerbate the 
problem, and make it worse, and so you have to have other 
approaches.
    Mr. Cobbs. Absolutely.
    Senator Harkin. I'm not a behavioral scientist, or anything 
like that, I've just been told that. So the answer is yes.
    Mrs. Colston. We like to say that children with autism 
don't have osmosis, as many of us do. So, a lot of speech 
therapies and other therapies are talk, and so when you talk at 
a child, or even soothe them with your voice, you're changing 
the environment, and that may make them, there's a term called 
sensory violation--it may sort of freak them out a little bit.
    For example, I was trying to comfort Camden, and I would 
stroke him--well that, that just makes him feel completely out 
of his element. So, there are things that a mother does 
naturally, that sometimes we have to alter, because children 
with autism like deep pressure, and that grounds them. Or 
vestibular inputs.
    Senator Harkin. So, something like a tele-health thing 
could be instructive in that, where you could actually talk to 
someone and say, don't do this, or do this?
    Mrs. Colston. Right.
    Mr. Cobbs. Absolutely.
    Senator Harkin. Has that happened to you?
    Mr. Cobbs. Excuse me, absolutely. I do want to point out, 
the actual day that the TV station was there was Noah's worst 
day. Everything that could wrong, went wrong. He went outside, 
he was crying, he was kicking, it was--I was thinking to 
myself, ``We are failing right now, as parents,'' with TV 
reporters there, and a few other people, and through the 
project from Celeste, they actually, right there, coached us 
through the moment, and it, it took about 40 minutes, to get 
Noah reeled back in, to get him back into the house, and to get 
him calmed down, but, wow, what a great feeling. That was a 
true test for us, is we can make that happen with the right 
help and coaching.
    Senator Harkin. Bob Wright, your grandson, how old is he 
now?
    Mr. Wright. He'll be 6 in August.
    Senator Harkin. Six. He was diagnosed early on?
    Mr. Wright. He was diagnosed at 2 years and 3 months.
    Senator Harkin. Now, his parents think about what we were 
just talking about, this is a new thing, here, about having 
that kind of tele-health, where someone could come into your 
home, so to speak, at any time of the day or night, would that 
have been of help to them?
    Mr. Wright. It's hard to say, I can't imagine it wouldn't 
have been helpful. My grandson has auto-immune problems, and he 
had gastro-intestinal issues which were not diagnosed at the 
time. So, they weren't diagnosed until 2 years later, almost 2 
years. Which meant that he was suffering during that period of 
time, and we--nobody understood why. So, it was a very 
difficult situation with him. I think you made the comment, 
you're--in some respects a parent is better off, in some 
respects, if the autistic child has treatable, or at least has 
traditional medical problems. Because then you get access to 
doctors and hospitals and insurance. At least for some of it.
    If you have no medical problems whatsoever, you don't get 
access to hospitals, doctors or insurance, really.
    Senator Harkin. Yes.
    Mr. Wright. So, if you, if you're awfully serious, on the 
other hand, and it's not diagnosed, you really are in a pickle. 
That's what my daughter found.
    However, having said all of that, the kind of--anything 
that would allow a third party to be of help at the time, at 
the worst time of the day is going to be of benefit to an 
autistic family. There's no question about it--whether it's on 
the phone or whether it's in person, or--that is so important. 
Because the mothers just--I mean, you know, I worry as much 
about my daughter as I worry about my grandson. I worry about 
my daughter being on the edge all of the time.
    Senator Harkin. Yes.
    Mr. Wright. Because he has these serious problems, and he 
can't just--he can go from looking and acting very normal to 
get 104 degree temperature in like, it seems like, 3 hours 
later. You have to rush him right to the hospital. Of course, 
they look at him like, you know, ``How could this happen?'' 
They don't have a clue what he's, what's happening.
    Turns out he has severe colitis, bordering on Crohn's 
disease, that's an adult, that's an adult condition, not a 
children's condition. You also find, though, in the case of a 
lot of these children, when they have medical problems, the 
medical protocols don't exist for children for some of these 
conditions. The medical protocols generally require the 
cooperation of the patient for diagnosis of certain kinds of 
things, like gastro. Where you can't talk to a child who can't 
talk. A child who won't express and react to--you point to your 
stomach, you don't point to his, he looks at you like, you 
know, you're from another land. So you, they don't, they can't 
be diagnosed in many cases, either, which makes it 
extraordinarily frustrating.
    So, I would say that--I wrote down the Celeste Foundation, 
I thought that was an excellent concept, I'm not aware of it, 
and I think anything--I think one of the issues is how do 
organizations like that get funding? Do they, they have a 
foundation that gets them started, how do they get enough 
funding, so that they can begin to develop data, you know, that 
won't be sharply criticized by the first skeptical person that 
comes along.
    Senator Harkin. Yes.
    Mr. Wright. So that it can get, you know, it can get enough 
attention, it is very difficult to get insurance, it's very 
difficult to get State or Federal funds to support this, 
because the burden, the burden of proof is so substantial. So, 
that's a real challenge--how do you take this experiment and 
build it up and, you know, at some point, you run out of money 
to do that, and I think that's part of what Autism Speaks--
we're trying to figure out how we can help groups like that 
when they get to a point, to get to the next stage.
    Senator Harkin. Because that's again, what I'm looking at, 
you said it was costing you $9,000 to $15,000 year, out of 
pocket.
    Mrs. Colston. Yes, that's above and beyond--I mean, 
Camden's non-verbal, so of course, I've had 6.5 years of speech 
therapy--and it's always declined. So, that adds up, and 
medical issues and that. So, that's above and beyond co-pays.
    Senator Harkin. So, we do know. I'm going to make a 
statement, I don't know if it's scientifically sound or not, 
but everyone I've ever talked to says that it is factual that, 
the earlier you get to a kid with autism, and you provide 
interventions and analysis, intervention, support, training, 
the proper kind of activities--that it can lead, later on, to 
them being more self-sufficient, more independent.
    My friend Sally Peterson, and Jim Autry whose son Ron is 
now 21, lives by himself, has a job, takes the bus back and 
forth to work. They say, if it hadn't been for those early 
interventions it never would have happened. Because they know 
other people that didn't have that. Their kids, after 4 or 5 or 
6, they just level out, and that's the end of it.
    Mr. Wright. Mr. Chairman, my grandson's costs are well over 
$100,000 a year, out of pocket.
    Senator Harkin. Wow.
    Mr. Wright. Now, I can afford to help on that.
    Senator Harkin. Yes.
    Mr. Wright. But how many people could do that? That's why 
we're here.
    Senator Harkin. Well, this is what I'm trying to see, I'm 
trying to think of two things, here. How do we do more and 
better research, and I've got a couple of more questions I've 
got to ask you, too, and I know Dr. Gerberding has to leave. 
But then, how do we also do the most cost-effective, best 
methodologies to get the families that have kids now, so that 
we have that early intervention? I'm thinking that so many 
people out there can't get it, they may be isolated, they don't 
have the financial resources that some of us do, and if they 
don't have an attendant illness, they may not have anything.
    So, if we can use something like a tele-health, a thing 
like that, where one trained person can interact with a number 
of families, and where families can get help when things go all 
to heck in the family, it seems to me that that just begs, begs 
for more expansion, to see how it would work, and to see if we 
can adapt this, adopt it, adapt it, adapt it to the, to a 
larger segment of our population. It seems to cry out for that 
kind of support.
    Mrs. Colston. It seems to me, as a parent, that there's a 
natural fit. If you could take this technology, or your 
funding, and put it towards early intervention, which I think 
is IDEA Part C?
    Senator Harkin. Yes.
    Mrs. Colston. You know, there are so many great models in 
place in this country, that are cost-effective, and that's one 
of them. And I wonder if you could marry those two through Part 
C, and see how it worked, or pilot it. Because I know that the 
early intervention therapists who helped me, they had a 
tremendously huge caseload. I think they got caught up in 
overall education funding as well.
    Senator Harkin. Yes.
    Mrs. Colston. So.

                           TREATMENT RESEARCH

    Senator Harkin. I wanted to ask you a question, and I'm 
glad my panels are still here for Dr. Gerberding, Dr. Insel. In 
this party, in Discover magazine, there's some interesting, 
interesting language about different approaches to treating 
kids, people with autism. There's some indication that using 
chelation therapy, chelation therapy, which I'm not all that 
familiar with, I just kind of halfway know what it is, after 
reading this, I looked it up some more, but that it quotes at 
least one or two families in here whose, I think they had more 
than one child that was autistic that went through this, and 
they just, improved immensely. I'm wondering, have you looked 
at that? Is there something there?
    This, the doctor they quote in this is a Dr. Asco, she's a 
microbiologist, she has a Doctorate in Microbiology and other 
things. Now, I'm intrigued by this. Is this part of looking at, 
you know, of treating people with autism?
    Dr. Insel. One of the ways that, at NIH, we've tried to 
increase our effort in this whole area is to develop an 
intramural program, the first such program for focusing on 
autism. It started about a year ago, there are five protocols 
that have been rolled out there, and this is to have a kind of 
rapid response team that can pick up an idea and run with it 
quickly, where we don't have to go through a very long process 
of peer-review.
    They have, as one of their protocols, they do have a 
chelation protocol, that was approved by our Science Committee 
in September. It's actually been held by the Institutional 
Review Board, whose members have some additional questions, 
they're going to address it again on May 1. So there have been 
no subjects actually entered into the protocol. But the hope is 
that will be approved and we can use this intramural program as 
the first place to do a controlled trial, a real, randomized 
controlled trial to find out whether there's, a, value in this 
approach, and b, what the risk is.
    Senator Harkin. Is NCCAM involved in that?
    Dr. Insel. I'm sorry.
    Senator Harkin. NCCAM?
    Dr. Insel. NCCAM is not involved. This is one that NIMH is 
taking the lead on.
    Senator Harkin. But, you say on May first, you're going 
to----
    Dr. Insel. May first the IRB, the Institutional Review 
Board, will be reviewing this particular protocol, and we are 
hopeful that once it's approved, we can begin to run with it. 
But I must say, they have has some considerable reservations, 
the Review Board itself, about the safety of chelation, they've 
brought in some outside experts who have made them even more 
concerned about the potential risks involved, based on some 
very recent animal research.
    Senator Harkin. Dana Halburtson, from Iowa, told me that 
chelation therapy made a big difference with her 8-year old 
daughter, Robin. So, again, this is something I don't 
understand completely, but if things are happening out there, 
that people are having success with, I would think that NIH 
would want to look at it.
    Dr. Insel. That's exactly why we have this intramural group 
put together for just that purpose, and it's not only on this, 
but on a number of other ideas that have come up, we're trying 
to move quickly to be able to test them out, but we want to 
bring the best science to those questions, and we want to make 
sure that we're doing it in a way that's safe as well as 
informative.
    Senator Harkin. I know, Dr. Gerberding, you have to go, and 
I'm respectful of your time, but again, I just, I want to be 
reassured that you're coordinating with NIH in your, in your 
epidemiological studies, that you are coordinating with them, 
and that you're looking at, in your studies, the different 
aspects of these vaccinations that we talked about, I mean, 
look--I agree that, you know, the vaccinations obviously have 
saved a lot of lives. But, one has to begin to wonder, are 
there some other side effects that are happening out there that 
we don't know about? Maybe they need to be modified, or 
something, I don't know.
    But, I'm just, I want to be reassured that CDC is 
coordinating with NIH, in looking at the possible causes, and 
maybe environmental factors that might, that might spur on the 
genetic predisposition to have autism.
    Dr. Gerberding. First of all, we are collaborating across 
the Department, in particular with NIH in two lanes that are 
relevant to your question. The first has to do with the autism 
agenda, and we have the inter-agency approach to doing that.
    Separate from that, we have collaborative work going on, on 
vaccine safety, that includes NIH, CDC, FDA and the National 
Vaccine Program Office, and those are two separate but related 
issues, and we are fully engaged. I love to spend NIH's money. 
So, I have a very strong incentive to collaborate with NIH on 
the development and research agendas and so forth. I'm 
concerned, Senator, because I've been long aware of the worries 
about the safety of vaccine with respect to autism, but we 
really need to get past that, and I think one of the downsides 
of focusing on that association is that it's closed us off to 
really looking, broader, at some of the more biologically 
tenable hypotheses.
    So, I want to reassure your daughter that she's doing the 
right thing for your grandchildren, but we also know that no 
vaccine is ever going to be 100 percent safe, and we have a 
responsibility to investigate safety, not just from this lane, 
but from the whole spectrum.
    Senator Harkin. I don't want to continue on this, we can 
discuss this at further hearings that we'll have, Dr. 
Gerberding. My point is not that these vaccines aren't safe. 
That's not my point. My point is, that you add them all up, and 
do we really know that 31 of those, given in the first 18 
months--within that short span of time--each one of them may be 
individually fine, but do we know what the outcomes, what the 
impact is, say, on someone who may be genetically predisposed, 
to have autism. Then you hit them with 31 of these vaccines, 
all combated in a short period of time. What may be--how could 
that, perhaps, trigger that genetic predisposition? I don't 
know that you can answer that question.
    Dr. Gerberding. Well, I can tell you that it's not related 
to thimerosal. Because the childhood vaccines that your child, 
your children are getting do not contain thimerosal as a 
preservative, so----
    Senator Harkin. Except that one.
    Dr. Gerberding. If they, some of the flu shot vaccines 
still contain thimerosal, they're trying to take it out, but it 
hasn't happened----
    Senator Harkin. Yes.
    Dr. Gerberding [continuing]. Across the board, yet.
    Senator Harkin. Yes.
    Dr. Gerberding. But, it's a very small amount of 
thimerosal, and you know, we've been talking about, is the 
prevalence of autism increasing in our country? It's continuing 
to either stay the same, or increase, even though we have 
removed the thimerosal as a preservative of vaccine for several 
years now, so----
    Senator Harkin. But I'm not talking about thimerosal. I'm 
just talking about the combined effects of all those vaccines 
on a small body that may be genetically predisposed anyway? 
That's what I'm talking about. I'm not talking about 
thimerosal.
    Dr. Gerberding. It's one of the hypotheses that, I think, 
needs to be evaluated in the studies that are going on. I don't 
think it's the most likely hypothesis, but it certainly should 
be included in the risk profile.
    Dr. Insel. I think the message that we'd like to convey is 
it's too early to reach premature closure on any of this--we 
simply don't know--I think all of us agree that there must be 
something beyond the genetics.
    Senator Harkin. There's got to be, because, Dr. Insel--and 
that's why I asked the question at the beginning--do we know 
what's happening in other countries? Now, there are other 
countries that have a pretty decent standard of living in which 
they do not give all of these vaccinations in the first year or 
two of life. Do we know what the incidents of autism is in 
those societies?
    Dr. Insel. We have good prevalence estimates for most of 
Western Europe and for Japan. So, we have some comparisons, and 
in fact, the United Kingdom is a good example where, in this 
case, the thimerosal came out in the early nineties----
    Senator Harkin. I'm not talking about, I'm just talking 
about all of those vaccines----
    Dr. Insel [continuing]. But in terms of the early child, 
and vaccines----
    Senator Harkin. Does every child in Great Britain get 31 
vaccinations before they're 18 months?
    Dr. Insel. Julie would have a better idea of that.
    Dr. Gerberding. No, and their rate of prevalence of autism, 
if anything, is higher than it is here.
    Senator Harkin. Well, then I'd, that's what we'd like to 
look at. Other countries, too, to see what's happening. Now, 
that would be an interesting epidemiological study. To compare 
what we're doing here to other countries, and to see if there's 
any correlation. Now, you say they have a higher incidence in 
Great Britain than we have here.
    Dr. Gerberding. When we talk about the incidence or 
prevalence of autism, there's been an issue that hasn't come up 
in this hearing, and I just want to lay a marker down, so we 
can talk about it. In order to know how many children have this 
disease, we have to have access to their health records, as 
well as their education records. As you know, we are stymied in 
getting that information. So, in order to compare across 
countries, we have to be able to get similar information from 
all of the other countries that are in play here, and that's 
really touch--that's a tough challenge to make those direct 
comparisons.
    Senator Harkin. You had, earlier, a memorandum of 
understanding with the Department of Education.
    Dr. Gerberding. That's right.
    Senator Harkin. I understand that they stopped that because 
of privacy concerns.
    Dr. Gerberding. Well, smart people have looked at the law, 
the Family Education Responsibility Privacy Act, and the 
Department of Education attorneys have interpreted that law, to 
say that our means of having access to children's educational 
records is inconsistent with FERPA, that act.
    We think, our responsibility is toward the HIPPA Act, the 
Privacy Act, and under the Privacy Act, public health 
utilization of data is allowed, so there's a stalemate here, 
and the Department of Health and the Department of Education 
are trying to work this out, but right now, it's really 
jeopardizing our ability to understand the true prevalence of 
autism in our children, and that's a big concern to me.
    Mr. Wright. We've looked at this at Autism Speaks, this is 
a very serious issue, because it, obviously so much work has 
been done at Government expense at CDC to put in the system of 
developing the data that the CDC is publishing, and this whole 
system relies upon getting information from school records. If 
you lose that, the system--which has taken several years to 
build--will collapse, and it would be a lost, you know, tons 
of--years will be lost.
    My personal conclusion is, that having looked at this, 
hard, that it probably is going to take, it is going to take 
some congressional action to clarify this. Because it, after 
all, it is going to end up being the reading of legislation and 
when you have disagreements, you're going to have different 
kinds of positions, and at some point or other, I think, that's 
going to require a congressional, a few lines, in a few bills, 
to say that this is the interpretation we intended. Because 
this all comes from congressional legislation over prior years. 
It probably is absolutely necessary.
    Senator Harkin. Well, I would welcome any suggestions you 
have that your, or your organization has on legislative 
changes, legislation that we need to do to change the language 
so that we can get that kind of information from the Department 
of Education.
    Mr. Wright. We would be happy to help you in any way we 
can.
    Senator Harkin. I would apreciate that--that could be very, 
very helpful. Or you, or anybody else. I don't know if I could 
call on Federal Government people to do that, or not, I don't 
know if I can ask you to do that.
    Well, listen, this has been a very helpful hearing. Again, 
I feel good that through NIH that we're doing more research.
    Now, we have ramped it up, but I do want to say this. I 
hear every time, I hear people tell me, ``Well, you know, the 
percentage increase has been so great here or there.'' I always 
remind people that from zero to one is infinite increase.
    Now, I've got to know where you start before you tell me 
what the percentage increase is. I want to look at the total 
dollars, and what is needed and what can be used. That's why I 
ask, Dr. Insel, if we had this increase, could it be used, what 
it would be used for, and whether or not.
    Now, I do believe that your answer to the questions of 
Senator Durbin, I think informs me that, yes, if only 20 
percent of the peer-reviewed are being funded, well, that 
indicates that, obviously, there are more out there that can be 
funded, that are peer-reviewed, obviously. So, that we can 
provide that kind of, if we provide that funding for you.
    But, I also thank the other panelists for being here. I, 
we've just got to do something about getting to these kids 
earlier. Darn it, we just always patch and fix and then later 
on it costs us a thousand times more. If we can get these kids 
earlier with the kinds of interventions that we know works. I 
mean, we've seen what's happened with families that had the 
wherewithal to do that and we've seen what's happened to their 
kids and how much better they perform. So, what's most cost 
effective? How do we reach out?
    I am anxious to see how the Celeste Foundation will expand 
this and we'd like to be helpful in any way we can. But, I 
just, my senses tell me that this could really be very helpful 
to a lot of families around the country who are somewhat 
isolated. I'm thinking of rural areas, obviously in small towns 
and communities where they just don't have the ability to get 
that kind of intervention.
    So, I'm hopeful that we can take a further look at that. I 
would, I would invite any from you, Dr. Favell, any suggestions 
that you have for how we might expand the scope of this. You 
suggested that in your testimony in response to a question.
    Mr. Whitford, I just want to say that, that you mentioned 
something about celebrity status. I wrote it down here, about 
celebrity. You know, people pay attention to people like you 
and, you know, if you're one of those celebrities that are 
dancing with the stars, or running off to the Riviera and all 
that, well, people read this, they pay attention. But, if 
you're a celebrity and you're using your status, and the fact 
that you reach a lot of people and you're using that to focus 
people's attention on good things that they can do to help our 
society, to help people live better, to help us do our job 
here--I think that's commendable. I just want to commend you 
for that, for doing that, and being out in front on this issue. 
It helps a great deal that you would use your status to do that 
and I appreciate it very much.
    Do we have anything else that any of you want to say for 
the record or, anything before I call this to a close, at all?
    Dr. Insel?
    Dr. Insel. I think all of us would like to thank you for 
your interest in this problem. This is the first such hearing 
we've had on this topic and for everyone here at the panel, 
even for somebody who's not at the panel, but right behind us. 
This is a mission, and we really appreciate your interest and 
your willingness to support it.
    Senator Harkin. Well, I appreciate all of you, and the 
organizations that you started or that you've been involved in. 
Dr. Gerberding, I thank you for your great leadership and Dr. 
Insel.
    Mr. Whitford, no Ms. Favell.
    Dr. Favell. Yes.
    Senator Harkin. Dr. Favell, and all of you.
    So, this, I think, this is the first hearing of this 
nature, but there will be more. I'm hoping that our budget, 
again to echo what Senator Specter said at the very beginning, 
I just hope that within our budget confines that we can move 
ahead more aggressively on this whole area of autism than we 
ever have before. It, it almost is like that AIDS epidemic. 
We've just got to get to it.
    Mr. Wright. Mr. Chairman, this reminds me, almost a little 
bit, of the early 1980s. There were two things going on. It was 
the AIDS issue was going on and, if you also remember at that 
point in time, there was this enormous outcry for cancer 
treatment, effective cancer treatments. People were running off 
to South America and Mexico and France. It was not like one or 
two people. It was, that they were just going down there for 
treatments, they were all considered to be too risky----
    Senator Harkin. Yes.
    Mr. Wright [continuing]. For the United States. That 
brought on a tremendous surge in, in cancer study. Some of it 
had to do with AIDS, some of it didn't. You had, Herceptin came 
out of all of that and you had the AIDS vaccine and the AIDS 
treatment. You know, it took a period of time, but it was an 
enormous upswing.
    I get, I have a sense that this is the same, we're in the 
same timeframe here with the same kinds of issues.
    You know, even though Dr. Insel is, I understand exactly 
the concerns of safety, but there are thousands of children 
that are undergoing that Kelation, one or more of those 
Kelation processes today. The parents are all told, they all 
know there are risks involved. They're saying, ``Look at the 
risks I have at home. I have to make a judgment. Look at the 
state of my child. If this has a possibility of making him 
better, much better, I'm going to have to take the chance. 
Because I just don't, I don't believe I can't.''
    So, there is, there is a, it isn't going to Mexico for 
cancer treatment, but it is going, this Kelation activity, you 
know, rightly or wrongly, is a little bit like that migration 
that took place, you know, years and years ago.

                  ADDITIONAL STATEMENTS FOR THE RECORD

    Senator Harkin. Well, I hope and trust that we'll be 
looking at that and that NIH will be examining that. I hope 
this May 1 IRB will come through and it will be moving ahead on 
that, in that area of research.
    [The statements follow:]

               Prepared Statement of Senator Thad Cochran

    Mr. Chairman, thank you for scheduling this hearing to discuss 
autism and the spectrum of disorders related to autism. Since the month 
of April has been designated by the Senate as ``National Autism 
Awareness Month,'' it is fitting that we have a discussion on this 
important issue during this time. We welcome Dr. Gerberding and Dr. 
Insel as members of the panel today. As leaders of Federal agencies 
tasked with autism surveillance, research, and treatment, your insight 
into current programs and your vision of future efforts to combat this 
disorder is important. We appreciate other distinguished panel members 
joining us today to provide their unique perspectives of the impact of 
autism disorders. We look forward to your comments and your direction 
on how this committee can be helpful in addressing your concerns as we 
move through the appropriations process.
    Autism Spectrum Disorders are developmental disorders which affect 
a child's social interaction, behavior, and basic ability to 
communicate with others. The prevalence of autism-related disorders 
continues to increase, with recent Centers for Disease Control and 
Prevention reports estimating that 1 in 150 children in our country is 
affected, referring to this increase as a national public health 
crisis. Despite the increased attention to autism in recent years, the 
cause remains unknown and a cure is not available.
    Congress has been responsive to this heightened public awareness 
and focus on autism from the medical community. The Combating Autism 
Act of 2006, which I cosponsored in the last Congress, was signed into 
law in December. This comprehensive legislation authorizes 
approximately $800 million over the next 5 years for research, early 
detection and intervention of autism. For the upcoming fiscal year, the 
President's budget contains no new funding for the Combating Autism Act 
and recommends level funding, approximately $115 million, for existing 
autism programs at the CDC and the NIH. Autism advocates have requested 
an increase in this funding to $168 million to expand autism efforts.
    I look forward to your comments on the status of the current 
programs and on how an increase in autism funding would be used.
                                 ______
                                 
                 Prepared Statement of Allison Chapman

    To Whom It May Concern: I am a parent of a child who regressed into 
Autism after his vaccinations. I have several areas I would like 
addressed at these hearings and I hope that an A-CHAMP representative 
will be there to represent my son and the hundreds of thousands of 
others with the same story. The following are a list of my questions,
  --Will there be money for double blind studies using the DAN! (defeat 
        autism now) protocal?
  --Is there an understanding that Autism is a Whole Body Illness which 
        can be treated?
  --Will there be a vaccinated vs. non-vaccinated study?
  --Will there be monies for studies on the dangers and implications of 
        thimerosal (49.6 percent ethyl mercury) like the Burbaker 
        study?
  --Will there be an extension to these genetic studies to find out if 
        it is Mercury (a known mutagen) that is causing deletions and 
        mutations in the DNA?
  --WILL THERE BE BIOLOGICAL TESTS TO FIND OUT WHAT'S GOING ON IN THESE 
        KIDS BODIES THAT MIGHT BE CAUSING THE BRAIN DIFFERENCES?
  --Will there be monies to teach Drs and pediatricians that Autism can 
        have many medical issues that need treatment and to refer them 
        to professionals who understand this like DAN!s, Toxicologists, 
        GIs, etc.
  --Will you separate vaccine safety into a separate, independent 
        organization other than the CDC which is the org that mandates 
        them (A tremendous conflict of interest)?
    I my mind there are 4 areas of Autism that need attention. 
Diagnosis, Educational intervention, whole body medical treatments that 
are already helping these children and research broken into BOTH 
environmental and genetic pieces. I've seen much in the areas of 
diagnosis, education, and genetics but by concentrating on those only 
leaves the biggest areas untouched. This is about the children and 
making them better or else the windfall of financial assistance it will 
take to support these kids who don't get treatment for the rest of 
their life, will most likely bankrupt this country. Thank you so much 
for your time. I truly do look forward to what happens in this Senate 
hearing, I am hoping you side with the children no matter what.
                                 ______
                                 
                   Prepared Statement of Anna W. Wolk

    I am the very proud mother of a young man diagnosed with PDD/NOS-
high functioning Autism at the age of 3. Adam is now 14--nearly 15--and 
as puberty has set in, so have many new behaviors. He has become 
frustrated with an inability to express his anxiety over the many 
changes occurring within his body, and as a result has become 
aggressive with us, his parents. What has become increasingly clear to 
me as we travel our journey that is autism is three things:
    (1) We all (as parents of any child) have the same destination in 
mind--we are simply traveling different routes to get there,
    (2) There are many books and tons of advice for the parents and 
families of newly diagnosed children, but nothing of substance for 
those of us who have made it to the teen years,
    (3) The State of Illinois is not servicing our children as well as 
the rest of the Nation. Why is it that, when my son turns 20 years 364 
days old, he is cut loose from the system. Is it the State of Illinois' 
opinion that, on my son's 21st birthday he is magically cured? If only 
it were true!
    It is a disgrace that we are ranked 48th out of the 50 States in 
services for our Special Needs children and their families--and we must 
include the families, as Autism affects the entire family unit.
    Luckily, my husband and I have not become one of the many couple 
who have divorced due to the pressures of raising a child with autism, 
but I can tell you the toll--both emotional as well as financial--is a 
huge burden. And the effect on the siblings is enormous as well, as 
they don't get ot have a normal childhood either. Simple things like 
birthday parties, sleep overs or even extra-curricular sports require 
enormous analyzing before undertaking them. Many times, the siblings 
just have to forego many of the usual rites of childhood because of 
their siblings needs.
    When it is time to plan for the disabled child's future, there is 
no central ``clearinghouse'' of information regarding residential 
settings, day programs, vocational training, etc. It's purely luck of 
the draw and word of mouth. Many times, it comes down to who you know.
    Well, I don't know anyone. I don't have any idea where to begin 
this new phase of my son's life, and there' s no direction from the 
school system. I feel lost to my son, and I feel lost as to how to help 
him.
    ANYTHING you can do to help centralize information for parent's and 
families would be an enormous help.
    Current statistics reveal that 1 in every 150 children is diagnosed 
with Autism--one of them is my son.
    Help create a miracle--support Autism Research and Awareness.
    Thank you for your time.
                                 ______
                                 
         Prepared Statement of the National Autism Association

    On behalf of the Board of Directors and membership of the National 
Autism Association and SafeMinds, we thank Senator Harkin and all the 
committee members for holding these hearings to ensure funding the 
Combating Autism Act. Once fully funded, this landmark legislation will 
help answer questions of vital concern to the autism community: what 
causes this disorder, now at epidemic levels, affecting 1 in 150 
children, and how can it be most effectively treated and prevented.
    Several dozen recently published peer-reviewed scientific papers 
point to environmental triggers, including vaccines and their 
components, as a cause of autism. Most recently, a study by the Autism 
Genome Consortium Project of 1,500 families with multiple affected 
children failed to identify an autism gene and failed to replicate most 
highly touted finding from recent genome scans. The negative AGPC 
findings provide strong evidence that heritability claims are 
exaggerated, if not false. Provided with massive resource support and 
under the most favorable study conditions, the AGPC found no evidence 
of heritability. These powerful findings suggest that the search for 
the actual cause of autism must focus on the environment to which the 
mother, fetus, and infant are exposed.
    In the report language accompanying the CAA, Congressman Joe Barton 
stated, ``. . . the legislation rightfully calls for renewed efforts to 
study all possible causes of autism--including vaccines and other 
environmental causes.'' Representative Barton also said, ``. . . these 
provisions will insure continuation and intensification of crucial 
research at NIEHS so that it is able to conduct all necessary research 
to determine the environmental factors in autism.''
    Senator Chris Dodd stated in the Senate colloquy, ``In our search 
for the cause of this growing developmental disability, we should close 
no doors on promising avenues of research. Through the Combating Autism 
Act, all biomedical research opportunities on ASD can be pursued, and 
they include environmental research examining potential links between 
vaccines, vaccine components and ASD.''
    With acknowledgement from our Federal Government that environmental 
factors such as mercury from vaccines may play a role in the 
development of autism, and a clear directive that this will be 
investigated by the National Institutes of Environmental Health 
Sciences (NIEHS), the National Institute of Mental Health, and other 
Institutes, we must now ensure that this area receives the necessary 
funding to establish a solid program of goal-driven research.
    Rather than merely counting the children diagnosed with autism, we 
now have government confirmation that autism is a national health 
emergency that must be addressed with all deliberate speed. The 
government can move quickly and decisively when it wants to. Recent 
examples include the coordinated responses to E. Coli outbreaks in 
spinach, SARS, and threats from bird flu and mad cow.
    Autistic children deserve and must have this same level of 
commitment and response. Imagine how quickly the government, indeed 
every institution of society, would react if 1 in 150 children were 
suddenly kidnapped. This is the stark reality faced every day by 
families with autistic children. Autism imposes massive costs to 
families and society, totaling $3.2 million in lifetime care per 
individual, according to a recent study from Harvard University.
    Epidemiology studies performed by the CDC must now test a clear 
environmental hypothesis rather than simply count affected children. 
Also, since it is scientifically impossible to have a genetic epidemic, 
the funds spent on finding an ``autism gene'' should more appropriately 
be devoted to finding the environmental triggers. NIEHS must play a 
leading role as such research is within its area of specialization, 
while NIMH and other Institutes are best equipped to fund research 
within their areas of expertise.
    Placing the major focus of government research on the environmental 
factors triggering autism and on biomedical treatments reaffirms the 
National Autism Association's long-standing position that there is hope 
for all families affected by autism. An environmentally triggered 
disorder is both treatable and preventable; therefore, there is hope--
hope both for families that already suffer with autism and hope that 
this disorder can quickly be relegated from an epidemic to the annals 
of history.
    To that end, we urge this committee to fully appropriate the 
Combating Autism Act. In the area of environmental research including 
vaccines and their components, we ask the committee to include a line 
item amount of $45 million over 5 years, as was authorized in the 
Senate-passed version of the bill. These funds should be specifically 
designated to the NIEHS so that this under-funded area of research can 
finally receive the attention it deserves. Hundreds of thousands of 
children suffering with autism spectrum disorders, that we now know is 
caused by one or more environmental factors, are depending on the 
wisdom of this committee to fully fund this critical research 
directive.
                                 ______
                                 
    Prepared Statement of Robert J. Krakow, Esq. President, A-CHAMP

    My name is Robert J. Krakow. Thank you for this opportunity to 
submit written testimony regarding the epidemic of autism and 
neurodevelopmental disorders that exists among our children. The autism 
epidemic is the most urgent public health issue facing our Nation.
    This testimony is submitted on behalf of A-CHAMP, a political 
action organization that is comprised of thousands of parents 
nationwide. We have supporters in every state and District Leaders in 
more than 200 Congressional Districts. Most of our members have 
evidence showing that their children, labeled with autism, are vaccine 
injured, heavy metal toxic, with proof that their children are mercury-
toxic. Notwithstanding this focus we advocate for all children with 
autism, irrespective of the possible causes of their disorders. We are 
a 100 percent volunteer organization that is organized on a grassroots 
and ``netroots'' basis. We are all parents or grandparents trying to 
improve the welfare of our children.
    We appreciate the opportunity to submit written testimony and to 
have an A-CHAMP representative make a statement in person before the 
committee. As you know, we learned of this hearing only two business 
days prior to the hearing. We have had many members of A-CHAMP 
contacting their Senators and the committee to impress upon you our 
right and desire as stakeholders on this issue to voice our concerns 
about the autism epidemic and about our children. As a preliminary 
matter we wish to express our concern that only one organization 
appears to have participated in the planning of this hearing and to 
have been invited to testify before the committee, other than 
representatives of the Centers for Disease Control and the National 
Institute of Mental Health. We do recognize that once you heard our 
concerns about this hearing the subcommittee was responsive to our 
concerns and offered the opportunity to submit our concerns in writing.
    It was A-CHAMP that alerted the larger autism community about this 
hearing and urged other organizations that are concerned with autism to 
attend, participate and submit testimony. This reflects a core 
principle of A-CHAMP that our government must recognize that there are 
many stakeholders that have claim to a voice on the issues affecting 
children with autism and that, notwithstanding the claims of one 
organization, it is not the case that a particular organization speaks 
for all of us. I think you have learned from our telephone calls and 
other communications over the last several days that no one but A-CHAMP 
speaks for us or our children.
    I also wish to emphasize that our organization represents many 
constituents of the honorable members of this subcommittee. I have 
conferred with residents of Iowa, the home of this committee's 
Honorable Chairman, Tom Harkin, and they have authorized me 
specifically to state that this submitted statement reflects their 
views and concerns. These individuals include among others Dana 
Halvorson, Lin Wessels, John Olsen, Ruby Olsen, Meg Oberreuter, Barb 
Romkema and many others. Similarly, in Pennslyvania, home of the 
ranking minority member of this committee, Senator Arlen Specter, Holly 
Bortfeld, and Colleen Strom, among many others have authorized us 
specifically to represent their views to the committee. This is but a 
tiny portion of the parents we represent in every State of the Union.
    The issue of which persons or what organization is the authentic 
voice of our children is one that is not easily answered, despite the 
claims that you may hear. We appreciate the responsiveness of this 
committee to our concerns in this regard.
    I am the father of a 7 year-old boy named Alexander who became sick 
in 2001 at the age of 2 years old, after receiving flu shots that were 
recommended by the Centers for Disease Control. An immunologist and 
pediatrician first diagnosed him with heavy metal toxicity, immune 
dysfunction, colitis, hypotonia, endocrine dysfunction, multiple 
additional autoimmune symptoms and a list of other physiological 
disorders too long to state here. My wife and I were told to 
immediately see a neurologist. We later brought our son to a world-
renowned neurologist who observed a child who was very ill, in great 
pain but who had nothing to offer but the label of autism.
    My son is unable to speak but is an extremely intelligent and 
loving child who is very related to his parents and sister. My daughter 
is 13 years old and is in Middle School and loves her brother dearly.
    I am an attorney. I spent the first decade of my career as a 
prosecutor in Manhattan serving for 5 years as a Bureau Chief with the 
Office of the Special Narcotics Prosecutor for the City of New York. I 
have been engaged in the private practice of law for 18 years.
    I became involved in working for individuals with developmental 
disabilities before my son became ill. I have served as chairman of the 
board of Lifespire, Inc. for 5 years. As you will read in separately 
submitted testimony, Lifespire is a large 55 year-old not-for profit 
with 1,500 employees that serves 6,000 developmentally disabled persons 
every day--in group homes, day centers, supported work, medical 
clinics, after-school programs, transition counseling and many other 
areas. Lifespire, formerly Association for Children with Retarded 
Development (``ACRMD'') has always served individuals with autism. In 
the last 5 years we have devoted a great deal of time and resources to 
developing programs for children and adults with autism. Lifespire was 
founded by parents and its Board consists today primarily of parents or 
relatives of individuals with developmental disabilities. We are a 
homegrown, local, community-based organization, even if we have grown 
large over the years. The reason we grown large is because we and 
others have advocated long and hard over the past half-century to 
improve services for the developmentally disabled. In our State of New 
York the response has been good in some areas. In other parts of the 
nation the response has been uneven. Lifespire's concern is not 
research or etiology. Our concern is client-centered individually 
tailored community-based services and supports.
    Now we need to confront a new emerging challenge--a very real 
increase in the numbers of individuals, mostly children aged 4-17 who 
are diagnosed with autism.
    At Lifespire we knew very well in 2002 that there was an 
unacceptably high number of cases of autism among children, that rates 
of autism were 1 in 150 or higher and that there existed then, in 2002, 
a looming crisis for our State. We also knew that the prevalence of 
autism was something new, because for 50 years we were in the business 
of serving individuals with disabilities. While autism was always 
present in some of the population who we serve, it was not nearly as 
prevalent among our adult population as what we were observing among 
children.
    In 2002 we knew that we needed to act immediately to address the 
crisis in services that would result as the leading edge of children 
with autism--the cohort of increased prevalence born around the year 
1990--moved forward in age. Sadly, little has been done in the last 5 
years by government to address these concerns.
    Lifespire provides services and does it well for a long time. The 
tradition of Lifespire was born in a crucible of parent activism that 
became necessary because the schools and government were not responding 
the needs of families. 50 years ago parents joined together to provide 
for their children, by pressuring government to do what was necessary. 
30 years ago ACRMD /Lifespire parents blew whistles outside 
legislators' windows to call attention to problems with our care for 
those who area least able to care for and speak for themselves--then 
they were whistleblowing about infamous Willowbrook and the 
institutional abuse of disabled children.
    As I stated, Lifespire's CEO will be submitting testimony 
separately.
    Sadly, today, things are better but children and adults with 
developmental disabilities still suffer abuse and often do not get the 
care that they need.
    It is evident from the overwhelming response to this hearing today 
that parents are once again active. Two years ago, along with some 
dedicated parents we founded a national political advocacy group called 
A-CHAMP, and I am honored to serve as its President. We have 10,000 
supporters and we are growing. Our volunteer parent-advocates 
throughout the country have already persuaded legislators in many 
States to enact provisions to make vaccines safer, thus protecting 
children, and to make insurance coverage fairer for individuals with 
autism.
    I have a message for you as legislators. Parents are mobilized. We 
do not need nor do we use professional lobbyists. We find our 
children's interests are best served by direct parent-citizen 
communication with legislators. We find that professional lobbyists who 
may be employed by some large organizations do not necessarily 
understand what our children need. Parents understand what our children 
need and we are sufficiently sophisticated, motivated and organized to 
make sure that our children's voices are heard loud and clear, so that 
our children's needs may be heard, even though many cannot speak.
    We urge you to get it right on this--get it right on the autism 
issue. The parents know what's right and they will be heard.
    I call for what we describe as ``A Culture of Advocacy for a 
Lifetime of Care.'' Around the State and the country parents are 
learning to advocate for their children. This echoes the story of 
Lifespire. My uncle and cofounder of Lifespire was a postal worker who, 
60 years ago, had a child with special needs. He was also a labor 
organizer. In those days there was nothing for children like my cousin, 
Eugene. He and a few other parents created an organization and changed 
the laws of New York State by direct parent advocacy, not through 
professional lobbying. His campaign was called ``A Children's 
Mandate.'' My uncle is gone now for some 10 years but his son has a 
home and an extended family to watch over him at Lifespire--for LIFE. 
My uncle gave him the greatest legacy--a lifetime of care by people who 
care. His mandate for his son and many other children was realized.
    Nothing will stop the advocacy of a parent who fights for his or 
her child. At A-CHAMP we have worked hard to empower parents around the 
country by instilling them with the will and desire to advocate for 
their children so that they will be taken care of with love and 
generosity. When a parent fights for his own child he or she fights for 
every child.
    I say to you as legislators that this is the problem confronting 
you--how to use limited resources to create a lifetime of care for our 
children. Parents expect a lot from our government--you--and our 
children deserve it. These hundreds of thousands of children will be 
the responsibility of our government. We need to come to grips with the 
problem and we need to do that NOW.
    We are years too late and we are playing catch-up--we are playing 
with the lives of children.
    I would like to address a few specific areas that are of great 
concern to me and many parents that address the subject of today's 
hearing.

              COMMUNITY CONTROL OF SERVICES AND RESOURCES

    We have developed detailed information on the daunting costs of 
caring for an individual with autism through his or her lifetime. We 
know that for a an autistic adult the cost of care from age 23 through 
66 will be approximately $17 million for an individual who is severely 
disabled and at least $10 million for an individual who is less 
severely disabled. These numbers are based on actual experience and are 
explained in testimony given by Mark Van Voorst, CEO of Lifespire at a 
March 8, 2007 hearing conducted by the New York legislature. I have 
attached a copy of Mr. Van Voorst's testimony. Given the Centers for 
Disease Control's recent estimate that there are exist 560,000 children 
under age 21 with autism, and probably many more given the reports of 1 
in 94 children in New Jersey having some form of autistic spectrum 
disorder the costs of caring for our children will be staggering. We 
know from hard and concrete experience that the costs will be in the 
trillions.
    We are already many years late in addressing the demands that this 
crisis will make on our resources. We will need innovative ideas in 
housing, in creating bridges to our communities for our developmentally 
disabled adults, and in providing therapeutic and loving environments 
for our children. Most importantly, we must create an environment in 
which parents will feel confident that as they grow old their children 
will be provided and cared for--``A culture of advocacy for a lifetime 
of care.''
    What does this mean? It means that when we develop a ``coordinated 
response'' to addressing the autism epidemic we must understand that we 
are dealing with individuals and not numbers. This means that we must 
direct our resources to solutions that are community-based. We see in 
legislation pending before this committee and laws already enacted that 
one approach to the autism epidemic is to create large centralized 
institutions that will address needs on a mass scale. While a massive 
response to the autism epidemic is required that response must not be 
overly centralized and it cannot favor one or a few gatekeeper 
organizations that aim to control the autism industry. We must invest 
in local and regional institutions so that we may build a community of 
care. We must involve parents in homegrown organizations because only 
then will our precious children receive the care and concern that they 
deserve. I fear that the solutions to services and support issues that 
have been promoted before Congress, including the Combating Autism Act, 
do not reflect these values. I have observed that moneyed power 
organizations driven by a corporate model have gained access to 
Congress by professional lobbyists and have begun to dominate the 
public forum on autism. For the sake of our children this trend must 
stop.
    I have spoken with many parents around the county, including those 
in Iowa and Pennsylvania, among many others. They have told me that 
what works for their children are integrated community-based programs 
that address their needs and provide supports where they live. This 
builds community and provides service. They require a combination of 
behavioral approaches applied locally in community centers or at home 
by qualified therapists, in combination with approaches that address 
the fundamental physiological disorders that have cause our children to 
become ill. I will address the issue of using effective non-
pharmaceutical biomedical interventions for our children later in this 
statement, but the important point here is to provide services and 
supports through community-based parent-driven regional and local 
organizations. Our experience is that these organizations are usually 
most effective if they are structured on a not-for-profit rather than a 
for-profit basis. Profit making ventures certainly may have a role in 
providing services but they should not be the gatekeepers or primary 
caregivers of our children.
    I would like to address another point that has arisen in the 
context of this hearing. One witness invited to this hearing will 
address a strict behavioral approach to therapy for children with 
autism that focuses on delivery of service by interactive video--a 
method dubbed ``telehealth'' that involves, in part, installing a video 
camera in one's home and engaging in therapeutic sessions by video. It 
appears that the Department of Education and the NIMH have devoted 
substantial funds to research in this area. I have studied this area 
over the last few days and consulted with many parents about it. The 
universal response to this approach to service delivery is surprise and 
rejection. Children with autism are often characterized by their 
inability to develop proper socialization. They cannot speak--they need 
social reinforcement. It is incongruous to think that therapists in 
remote locations who essentially ``phone it in'' can address these 
problems and others.
    We urge you to invest in our communities and not some technological 
fix that can lay claim to addressing children with needs when in 
reality it presents a method of providing services on the cheap. While 
I welcome learning more about telehealth I have serious concerns about 
this approach toward providing therapy for our dear children.

                                Research

    Autism is not genetic. A recent genetic research study that cost 
more than $10 million found almost no clear indication of a genetic 
association with autism. At most, the researchers found genes that 
might create susceptibility to environmental toxins, but their great 
breakthrough was finding a gene association in 1 out of 1,168 families. 
The researchers will dispute what I have said here, but quietly other 
researchers will tell you I am correct. There is no ``autism gene.'' We 
can produce well-respected researchers to support our position.
    Epidemics cannot be genetic because gene mutations occur very 
slowly. The unavoidable evidence points to an environmental factor or 
trigger that has caused the upsurge in the numbers of cases of autism. 
Yet, little government or private research money is devoted to the 
study of environmental factors.
    For reasons that are not valid, research in autism has been 
disproportionately devoted to genetic research. Notwithstanding the 
bias by private organizations and government to fund genetic research a 
great deal of peer-reviewed replicated research has shown that autism 
is a physiological disorder. The emerging research research strongly 
implicates environmental toxins and toxins from vaccines, including 
mercury, in creating impairment leading to physiological disease.
    We must have honest research that inquires into every area of 
autism etiology regardless of who may find the results of such research 
inconvenient.
    Parents supporting A-CHAMP almost universally believe that vaccines 
have injured their children, either alone or in combination with other 
external toxins to which their children have been exposed. We have also 
found that treatment focused on addressing these problems have worked 
to improve the health of many children and even recovered some children 
fully from autism. Our children's physiological disorders are not 
comorbid or unrelated to their autism. Their physiological disorders 
collectively are what autism is--and result in the observable 
behavioral symptoms that we define as autism. We need research into 
these treatments--research that has shamefully been ignored or set 
aside because it is too controversial. Backing off from controversy 
will not help our children.
    Some valiant practitioners from the Autism Research Institute, 
DAN!, Thoughtful House in Texas and others have developed effective 
treatments and undertaken vital research that is directly helping our 
children today. Why is this research ignored or actively suppressed by 
our government agencies? How can ``evidence-based'' treatments such as 
these be validated if there exists no funding for the supporting 
research? The answer, of course, is that it cannot be validated. A 
highly manipulated scenario has developed that has resulted in a self-
fulfilling prophecy: condemn treatments as ``anecdotal'' and not 
sufficiently evidence-based while simultaneously blocking funds 
necessary for research that will validate the same treatments. We 
regard this process as a cruel and unacceptable joke that has deprived 
our children of the chance for recovery. The scenario is not acceptable 
and our parents will work tirelessly to change it.
    Recently, we were pleased to learn that the NIMH had initiated a 
chelation study. Without going into detail we were concerned about the 
study protocol used for this study because we knew that the protocol 
did not reflect the methods many of us have used successfully in 
chelating our children, safely and effectively. We have also heard 
rumors that this study has been suspended. We urge the committee to 
investigate why research like the chelation study is not proceeding and 
further, make sure that practitioners who have used chelation 
successfully are consulted in constructing meaningful research 
protocols.
    There are some questions raised by some about whether there is a 
true increase in the incidence of autism among our children. We have 
observed some so-called experts in the field revise past estimates of 
prevalence of 1 in 2,000 children affected in the 1980's as being 
incorrect because current research shows a rate of 1 in 150 or higher. 
We hear claims that current methods result in better counting and that 
autism at current rates have always been with us but that individuals 
with autism were ``hiding in plain sight.'' We reject such claims as 
the product of an agenda promoted by those who need to deny the 
existence of an epidemic to protect the vaccine program or avoid 
potential liability for vaccine related injuries.
    So that we may know with certainty how many children and adults are 
affected we need epidemiological studies conducted by independent 
researchers outside the CDC or the government. We also need a study 
comparing individuals who are vaccinated versus those who are 
unvaccinated to determine which group has more disease. Legislation 
calling for such as study was introduced last session and will be 
introduced again. We support it.
    Finally, the CDC has placed barriers to access to by independent 
researchers to the Vaccine Safety Datalink (``VSD''). This database can 
help answer questions about the cause or causes of the autism epidemic. 
The Institute of Medicine has severely criticized the CDC's handling of 
the VSD. A panel of public and private experts has found that 
productive research can be conducted using the VSD to answer the 
question of whether vaccines or their components cause autism, a 
question not yet fully answered using the VSD. Yet to shield the VSD 
from outside researchers the CDC has paid a private company millions of 
dollars to house the data--data developed by the investment of millions 
of dollars of taxpayer funds. We respectfully request the Senate to 
conduct an investigation of this issue.
    An addendum is attached to this statement that contains a non-
exhaustive list of areas of research that we believe have been ignored 
and require attention.

                               TREATMENT

    There is great controversy over treatment for autism, as discussed 
earlier in a different context. While Applied Behavioral Analysis 
(``ABA'') has helped some children it is not the panacea that some 
originally thought it would be. Yet, at every turn the only treatment 
option offered by medical professionals and schools is ABA. The use in 
legislation of the words ``evidence-based'' to validate treatments will 
surely result in the only approved treatment covered by insurance to be 
ABA.
    I can tell you that my son has made tremendous progress not because 
of some strict regimen of ABA--the technique has been used to some 
extent with him--but through the use of various non-pharmaceutical 
biomedical interventions. My son's so-called ``tantrums'' were the 
result of one thing: severe gastrointestinal inflammation. He was in 
pain.
    Once this was treated my son was able to become the happy--very 
related to his family--child he was meant to be. It is a myth that 
children with autism are all in their own world and cannot relate to 
others. It is also a myth that little can be done to improve their 
condition and welfare. Much can be done; we have done it. I know other 
parents are submitting to the subcommittee information about biomedical 
intervention that can effectively treat autism--a physiological, 
neurobiological disorder. I have met many children who have completely 
recovered by children through non-pharmaceutical biomedical 
intervention. Yet, few research dollars are devoted to this area. Those 
who criticize biomedical interventions in autism decry the lack of 
``peer-reviewed'' research supporting ``evidence-based'' research. This 
criticism is a self-fulfilling prophecy made by those who block the 
very research that could support diets such as the specific 
carbohydrate diet, supplements such as methyl B12, hyperbaric oxygen 
therapy, safe methods of chelation therapy and many more.
    At the same time pharmaceutical treatments such as Prozac, Ritalin, 
Concerta, Adderall, Zyprexa, Seroquel, Geodon and others are used even 
though they are untested and unapproved for children, and have serious 
side effects. While Risperdal has been approved for treatment of 
irritability in autism it gained approval only through the expenditure 
of large sums of research dollars, and it is most definitely not a 
treatment for autism. It too has serious side effects that its 
manufacturer failed to disclose until the manufacturers were pressured 
to do so.
    While there may be place for pharmaceuticals in some cases focus on 
these non-treatments have sucked the life out of any effort to produce 
research that will satisfy those who seek peer-reviewed research. 
Notwithstanding this, the research has been produced, often privately. 
More needs to be done.

          INTERAGENCY AUTISM COORDINATING COMMITTEE (``IACC'')

    The Combating Autism Act did expand the Interagency Autism 
Coordinating Committee. But the IACC was not given sufficient authority 
to conduct oversight over the NIH research agenda. In addition, for too 
long the community participants in the IACC have been limited to the 
same individuals from the same organizations. The IACC has been 
ineffective. The key to making government responsive to the autism 
crisis is to listen to the parents. They know what their children need. 
Give parents a central role in fashioning government's response to the 
autism crisis. Broaden the participation in the IACC to voices outside 
the ones that bureaucrats may find safe. The IACC and other government/
private committees should not be window-dressing that allows government 
to make empty claims that the community participated in their decision-
making on policy. Community and stakeholder participation must be 
genuine so that members of our community can say that their voices are 
being heard. Many in our community believe that they are excluded from 
the process and that the IACC and other committees are not functioning, 
as they should in a democratic society.
    Returning to the theme that introduced by testimony I want to 
emphasize that our government must give all parents, not just those 
from one or two self-selected groups, a central role in solving the 
autism epidemic. If government fails in this area the consequence will 
be a public health, political and social problem even greater than the 
one we face today. A-CHAMP's slogan is ``We Are Everywhere, and We're 
Not Going Away.'' We are watching our government's response to the 
autism epidemic with great attention because our responsibility to our 
children's welfare and future mandates such scrutiny.
    Parents are mobilized, engaged, empowered. We are sophisticated and 
smart. We are also beleaguered and our resources are strained to the 
breaking point. We urgently need help now for our kids. We are ready 
for government to become our partners in addressing the autism crisis--
but that means true partners in our communities, not public-private 
partnerships with special interest group organizations.
    On behalf of all the supporters of A-CHAMP I thank you for 
convening this hearing today to listen to our concerns. We appreciate 
the opportunity to be heard. Given that this testimony was prepared on 
extremely short notice I will be happy to answer any questions from the 
Committee to clarify or amplify the points I have made in this 
statement.

                                Addendum

            SUGGESTIONS FOR SOME AREAS OF RESEARCH ON AUTISM

    With respect to research we recommend the inclusion of the 
following areas into a research agenda on autism and environmental 
factors:
  --Research related to treatment of autism as a ``treatable'' or 
        ``reversible'' condition. Specifically, the focus must be 
        placed on autism as a chronic impairment, resulting from 
        oxidative stress. For example, there exists evidence showing 
        that autism is characterized by the presence of ``sick'' 
        neurons rather than ``dead'' ones or even impaired development 
        processes (e.g., GABAergic neuron migration). This type of 
        research highlights the inherent reversibility of the disorder 
        and must be pursued with urgency in order to develop and 
        validate treatment of the disorder.
  --Research on large cohorts of children to determine their status 
        based on testing for urinary porphyrins, urinary toxic metals, 
        urinary amino acids, organic acid tests, immune panels, 
        cytokine testing, chemokine testing, etc.
  --Research of the use in treatment of autism of anti-inflammatory 
        medications such as Actos, Celebrex or Singulaire in quelling 
        inflammation in the gut and brain and in reducing levels or 
        pro-inflammatory cytokines and chemokines;
  --Genetic research should be focused on single nucleotide 
        polymorphisms and their relationship to metabolic and other 
        mechanisms that create vulnerability to environmental toxins 
        (including vaccines) rather than the latest genetic research 
        focusing on genetic anomalies or CNV's that have not been tied 
        to a biological mechanism affecting more than a tiny number of 
        children;
  --Research evaluating the mitochondrial status of children diagnosed 
        with autism. Mitochondrial impairment plays such a strong role 
        in MS;
  --Full investigation of the role of heavy metals, including mercury, 
        aluminum, lead and arsenic, from any source, in any form 
        (including thimerosal), specifically including vaccine 
        exposures in the etiology of autism;
  --Complete access to the Vaccine Safety Datalink data by independent 
        researchers outside the government;
  --A recognition in developing a research agenda that vaccine sourced 
        exposures may be a contributing factor in many cases of autism 
        alone or in conjunction with other environmental exposures;
  --Funding of research of the biological mechanisms that may 
        contribute to autism;
  --Full investigation of the role of viruses, bacteria and other 
        infectious agents independently or in conjunction with other 
        environmental exposures in the etiology of autism;
  --Research of environmental factors, including the MMR vaccine, as 
        they relate to gastrointestinal symptoms and histopathological 
        findings'' and treatment of these underlying bowel problems;
  --Investigation of the effect of various metals, viruses, toxins with 
        each other and other environmental agents--also known as 
        synergistic toxicity--in the etiology of autism;
  --Research of the role urinary porphyrin profile analysis can play in 
        measuring heavy metal toxicity;
  --Research of the role of mercury and other toxicants in ambient air 
        pollution, including toxicants emitted from coal burning power 
        plants, in the etiology of autism;
  --A thorough analysis of the role of thimerosal, heavy metals, and 
        other toxins play as mutagens and how this mutagenicity may 
        play a role in autism;
  --The role of the hypothalamus-pituitary-adrenal axis in the etiology 
        and trealuient of autism.
                                 ______
                                 
   Prepared Statement of Mark van Voorst, CEO/President of Lifespire

    Good morning/good afternoon. My name is Mark van Voorst. I am not a 
physician, scientist, geneticist, statistician, nor even a practicing 
clinician so my comments will not address the issue of the rise in the 
numbers of individuals diagnosed with autism, nor will I attempt to 
offer any insights regarding the cause of this phenomenon.
    However, for the past 29 years I have worked as an administrator in 
organizations that provide an array of services to individuals 
diagnosed with Mental Retardation or other forms of Developmental 
Disability. I am presently the CEO of a large not-for-profit 
organization in New York City which provides services to roughly 5,000 
individuals per day and my comments are intended to enlighten the 
Committees on the enormous challenges that every New York State 
voluntary agency will face in the coming years as we struggle to ensure 
that all children and adults who are diagnosed with an Autism Spectrum 
Disorder receive the supports and services they will need.
    In February 2007, the Center for Disease Control and Prevention 
released a new finding that concluded that the rate of autism in the 
United States is now 1 per 150 births. The National Census for 2004 
shows that there were 4,115,590 births in 2004. Using CDCs figures, 
this means that of all of the children born in 2004, roughly 27,437 
will be diagnosed with some level of autism. Current national estimates 
suggest that there are already between 560,000 and 800,000 individuals 
who are diagnosed with some level of autism.
    In 2003 the New York State Office of Mental Retardation and 
Developmental Disabilities estimated that there were 52,991 individuals 
with autism.
    In 2004 the National Census figures for New York indicated that 
there were 250,894 births. Using the newly released CDC figures, this 
means that roughly 1,673 of all new births in 2004 will at some point 
be diagnosed with autism. Current literature suggests that roughly 50 
percent (45 percent--60 percent) of these 1,673 individuals will also 
be diagnosed with an IQ of 70 or less, which means that in addition to 
being autistic, they will carry a diagnosis of Mental Retardation. It 
is safe to say that of the 1,673 children born in 2004 who will be 
diagnosed with autism, approximately 837 will require some level of 
support and assistance throughout their entire lives.
    As I am not an educator, I do not know the cost of providing 
supports and services to these individuals from birth to 21. However, I 
can give you some idea of what it will cost to provide support and 
services to these individuals once they become adults. The figures I am 
presenting are based on real, current annual costs for providing day 
and residential services at Lifespire Inc.
Individual with a high level of need
    Day Services--$44,174
    Residential Services--$154,764
    Combined Annual Costs--$198,983
Individual with a lower level of need
    Day Services--$26,686
    Residential Services--$109,489
    Combined Annual Costs--$136,175
    If we now project these figures over the lifetime of an individual 
who needs ongoing supports and services (between the ages of 23 and 66 
= 43 years) and build in an annual increase of costs of 3 percent the 
total costs rise dramatically.
Individual with a high level of need between 23-66
    Day Services--$3,933,615
    Residential Services-$13,790,753
    Cost over 43 Years--$17,724,368
Individual with a lower level of need between 23-66
    Day Services--$2,376,328
    Residential Services--$9,756,402
    Cost over 43 Years--$12,132,730
    Looking only at the 837 children born in 2004 who may well need 
lifelong supports and services, it will cost between $10,155,095,010 
(low side) and $14,835,296,016 (high side) to provide services once 
they leave the school system.
    In 2003 the Office of Mental Retardation and Developmental 
Disabilities estimates that there are 52,911 individuals with autism 
currently in New York. Until we have an actual breakdown of the ages of 
these individuals we have no way of knowing how many are currently 
being served and how many are about to enter the adult service world. 
However, I think it is fair to say that the need for increased funding 
will be staggering.

     CRISIS NUMBER TWO: WHO WILL PROVIDE THE SUPPORTS AND SERVICES?

    In January 2006 the U.S. Department of Health and Human Services 
released a report entitled ``The Supply of Direct Support 
Professionals'' (DSP). HSS estimated that, in 2003, approximately 
874,000 individuals worked full time providing care for roughly 4.3 
million Americans of all ages. Most importantly the report noted ``DSPs 
are essential to the quality of life, health and safety of more than 
one million Americans who are in need of long term services and 
supports''.
    By 2020 the demand for DSPs will grow to 1.2 million. This 
represents an increase of 37 percent. However, during this same time 
period the available pool of labor will increase by only 7 percent.
    HHS also estimates that on a national level there is a 10-11 
percent vacancy rate in all Direct Support Professional positions. The 
situation is so severe that many existing service providers are 
refusing to expand services to meet the growing demand because they 
cannot recruit and retain the work force necessary to do so. 
Additionally, the turnover rate of DSPs is estimated to be 50 percent 
nationally.
    While perhaps not as severe as the ``national problem'', Lifespire 
Inc. is experiencing both crises identified in the 2006 HHS report. At 
any given time we have between 80-100 positions that are not filled and 
our turnover rate for those individuals providing direct support to our 
consumers in 2006 was 39 percent. While I have not seen any figures for 
all of New York State, I suspect that my experience at Lifespire is 
shared by most, if not all not-for-profit organizations in the State.
    The legislature and OMRDD have done a wonderful job providing 
resources that enable organizations like Lifespire to serve New Yorkers 
with developmental disabilities. Unfortunately, the funds allocated by 
the legislature are still not enough to allow us to attract and retain 
a skilled work force. Unless we are in a position to both attract new 
staff while at the same time are given the dollars to retain our 
existing staff, the wave of individuals diagnosed with autism which 
will begin to spill over into the supports and services within the 
``adult world'' will simply overwhelm the provider system and will have 
disastrous consequences for an entire generation of children and their 
families.
    During one of his campaign speeches, Governor Spitzer stated that 
it was important that we ``take care of those who cannot take care of 
themselves'', and that ``everyone who has special needs will get the 
care they need for as long as they need it''.
    Mr. Chairman, I believe that we have a moral obligation to ensure 
that all New Yorkers who have been or will be diagnosed with autism 
have access to a service system that is both sufficient in size and 
sufficiently well trained to provide the services and supports that 
they will need. While I certainly hope that there is funding for 
ongoing research to determine a cause for autism, I also implore the 
Committees to take this message back to the full Senate and Assembly so 
that increased dollars flow to the voluntary provider community or to 
parents so that they can directly purchase the services they feel their 
children need. If we do not do something soon the provider community 
will simply not be equipped to deal with the numbers of individuals 
diagnosed with autism who will need adult services.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Harkin. There will be some additional questions 
which will be submitted for your response in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

             Questions Submited by Senator Daniel K. Inouye

                       AUSTISM SPECTRUM DISORDER

    Question. I would like to thank the Centers for Disease Control and 
Prevention (CDC) for their attention to accurate reporting of autism 
spectrum disorders by each State. The startling rise in the prevalence 
of autism spectrum disorders presents many challenges to society. The 
uniqueness of Hawaii raises even further challenges when one considers 
the remoteness and relative lack of resources available to support 
individuals affected by autism spectrum disorders. How can the Centers 
for Disease Control and Prevention (CDC) work with States such as 
Hawaii with rural areas and other unique needs to contribute to a 
better understanding of autism spectrum disorders?
    Answer. Early identification and intervention hold the most promise 
for children and families affected by autism spectrum disorders (ASD) 
and other developmental disabilities. CDC is working with partners on a 
campaign reaching parents, health professionals, and childcare 
providers with information on developmental milestones and the early 
signs of autism. The campaign--Learn the Signs. Act Early.--is helping 
to change perceptions about the importance of identifying developmental 
concerns early.
    Recent ASD surveillance data show concerns had been raised for more 
than half of the children with autism or related disorders prior to 
their third birthday, yet children were not diagnosed until well into 
their fourth or fifth years. Encouraging early intervention will help 
children reach their full potential during the critical window of early 
development.
    Since the launch of the campaign in October 2004, information about 
Learn the Signs. Act Early. has been made available to more than 11 
million health care professionals, parents, partners, campaign 
champions, and child care providers. CDC and its partners have 
distributed more than 83,000 resource kits targeting the three major 
audiences.
    CDC continues to work with campaign partners on new ways to reach 
parents, child care professionals, and health care providers with the 
most up to date information about developmental disabilities--including 
ASD. Also, CDC has been working with partners to reach underserved 
populations--including minorities and both urban and rural/remote 
populations. For example, campaign staff recently worked with the 
Autism Society of America (ASA) on a project to increase dissemination 
of campaign materials in underserved communities (including rural 
populations) through ASA chapters throughout the country.
    The campaign is also in the process of piloting multi-disciplinary 
teams of medical professionals, educators, policymakers, and parents to 
develop action plans to address obstacles in early identification and 
intervention at the State and local level. If this model proves to be 
successful, it could be replicated in additional States.

                          COMBATING AUTISM ACT

    Question. A recent study by the Centers for Disease Control and 
Prevention (CDC) found that autism spectrum disorders now affect 1 in 
150 children in the United States, up more than tenfold from a decade 
ago. The Congress responded to this growing public health crisis when 
it passed the Combating Autism Act, which authorized more than $900 
million over 5 years for the Department of Health and Human Services' 
autism activities. How does the NIH and the National Institute of 
Mental Health intend to implement the Combating Autism Act's 
recommendations with the budget recommendations that have been sent to 
us?
    Answer. The NIH has made considerable progress in implementing 
provisions of the Combating Autism Act (CAA) of 2006 (Public Law 109-
416). A noteworthy accomplishment was the creation of the Autism 
Centers of Excellence (ACE) program, which received $25.5 million in 
fiscal year 2007. The ACE program represents a consolidation of two 
existing programs, the Studies to Advance Autism Research and Treatment 
(STAART) and the Collaborative Programs of Excellence in Autism (CPEA), 
to maximize coordination and cohesion of NIH-sponsored ASD research 
efforts. The ACE program encompasses research centers and networks 
focusing on a broad range of autism-related research, including topics 
such as neuroimaging, biomarkers and susceptibility genes, 
pharmacotherapy, early intervention, and personal and environmental 
risk and protective factors.

               INTERAGENCY AUTISM COORDINATING COMMITTEE

    Question. How does the National Institute of Mental Health intend 
to implement the recommendations of the Combating Autism Act with 
respect to the Interagency Autism Coordinating Committee (IACC) 
strategic plan?
    Answer. The Combating Autism Act (CAA) of 2006 (Public Law 109-416) 
requires the Secretary of the Department of Health and Human Services 
(HHS) to establish a new Interagency Autism Coordinating Committee 
(IACC) with the following responsibilities regarding autism spectrum 
disorders (ASD):
  --Develop and annually update a summary of advances in ASD research
  --Monitor Federal activities with respect to ASD
  --Make recommendations to the Secretary regarding any appropriate 
        changes to Federal activities and public participation in 
        decisions relating to ASD
  --Develop, annually update, and submit to Congress a strategic plan 
        for the conduct of, and support for, ASD research, including 
        proposed budgetary requirements
    The IACC was chartered under the Federal Advisory Committee Act 
(FACA) with the National Institute of Mental Health designated as the 
lead for this activity. With a sense of urgency and a spirit of 
collaboration, the IACC is developing a strategic plan for ASD research 
that focuses on the unique needs of individuals with ASD and their 
families. The plan will encourage public and private partners to work 
together to rapidly advance our scientific understanding of ASD, 
improve health and well-being across the lifespan, and help individuals 
with an ASD lead fulfilling lives. In developing the strategic plan, 
the IACC assembled expert workgroups to tackle challenging tasks, 
identified recent investments and accomplishments in ASD research, 
gathered ideas for research priorities from many stakeholders, and 
convened four scientific workshops with broad stakeholder 
participation. Furthermore, the IACC has decided to amplify its efforts 
and accelerate progress by meeting four times a year (a minimum of two 
meetings per year are required by the CAA).
    The IACC strategic planning workgroup will consider the research 
initiatives proposed by the scientific workshops. The IACC strategic 
planning workgroup will review public comment and current ASD research 
funding to offer recommendations for structuring the strategic plan and 
estimating budgetary requirements for components of the plan. The IACC 
will consider the recommendations of the strategic planning workgroup 
and define the next steps in the strategic planning process, which may 
include additional opportunities for stakeholder input through Web-
based town hall meetings or other innovative approaches for outreach. 
Once approved by the IACC, a draft strategic plan will be posted on the 
IACC website for public comment. Upon completion, the IACC will submit 
the strategic plan to the Secretary of HHS.

             CARE OF INDIVIDUALS WITH ASD LIVING IN HAWAII

    Question. Realizing that the care of individuals with autism 
spectrum disorders requires an interagency approach, what suggestions 
do you have for those living in Hawaii faced with the unique challenges 
of remoteness caring for individuals with autism spectrum disorders?
    Answer. NIH does not provide direct patient services, but several 
agencies that belong to the IACC address issues concerning care for 
individuals with ASD in remote or rural locations, and these agencies 
have provided information to NIH on their efforts. For example, 
according to the Centers for Medicare & Medicaid Services (CMS), adults 
with ASD enrolled in Medicaid receive many home and community-based 
services through Hawaii's section 1915(c) waiver for children and 
adults with developmental disabilities and/or mental retardation. The 
CMS renewed the waiver in June 2006 for 5 years. The waiver provides 
numerous services to about 3,000 people throughout the islands, 
including people with ASD, who choose to live in community, rather than 
institutional, settings. The operating agency for this waiver is the 
State's Department of Health, supervised by its Department of Human 
Services, the State Medicaid Agency. These two entities are charged 
with working together to assure that eligible individuals are aware of 
and can access waiver services.
    The CMS also indicates that the State of Hawaii has included a 
``self-directed'' option in the waiver that permits individuals to 
hire, fire, supervise, and train direct support workers. This option 
greatly expands the universe of potential providers, particularly in 
rural areas, and may include family members and spouses as providers. 
In February 2008, CMS approved an extension of the State's section 1115 
demonstration, which will provide mandatory managed health care 
starting in November 2008 to aged, blind, and disabled beneficiaries in 
Hawaii. The expansion of the demonstration to include this group, which 
likely also includes individuals with ASD, will permit the State to 
streamline and better coordinate care and expand provider networks in 
remote areas.
    In addition to these efforts from CMS, successful models for 
providing interagency services within remote and rural settings may be 
found among the Systems of Care Sites (including programs in Idaho, 
Wyoming, Alaska, Hawaii, Montana, and other States) funded by Substance 
Abuse and Mental Health Services Administration (SAMHSA), another 
member of the IACC. These programs emphasize the core principles and 
practices of the Systems of Care, focusing on designing services that 
are child-centered, family-driven, community-based, and culturally 
competent. Some interagency groups have used technology to employ tele-
health, tele-psychiatry, clinical supervision, case consultations, and 
interactive videoconferencing. Training of local leaders is another 
important element. Some programs employ culturally-specific approaches 
developed with community elders that respect native traditions--e.g., 
oral traditions and storytelling, a holistic ``heart centered'' 
approach or understanding that the family is the central unit, rather 
than the individual. Cross-agency training has been used in several 
locations. Hawaii is conducting innovative work linking communities of 
practice at the local and State levels.
    Furthermore, SAMHSA's Children's Mental Health Program has a grant 
in the Kalihi-Palama area in Oahu (urban area) that is focusing on 
transition-age youth with emotional or behavioral challenges. This 
cross-agency approach uses combined funding to surround the individual 
with formal and informal services and supports. The approach is 
appropriate in rural areas where there are often shortages of trained 
professional providers.
                                 ______
                                 
              Questions Submitted by Senator Thad Cochran

               AUTISM DEVELOPMENTAL DISABILITIES PROGRAM

    Question. The CDC supports autism surveillance through a 
collaborative program, the Autism Developmental Disabilities Program 
(ADDP). It is my understanding that the program now has monitoring 
sites in 17 States. Could you comment on the CDC's plan for expanding 
this program and project a timeline when all States will benefit from 
the data collected through this program?
    Answer. The dramatic increase in the number of children diagnosed 
and receiving services for autism spectrum disorders (ASD) suggests 
that the disorder is more common than was once believed. Understanding 
the prevalence of a disorder like autism depends on collecting and 
analyzing data from multiple sources. In addition, it is important to 
use this method of data collection in multiple locations across the 
nation at different points in time. Doing so gives us the best 
understanding of ASD rates and trend in different communities in the 
United States
    In order to do this, CDC currently supports the Autism and 
Developmental Disabilities Monitoring (ADDM) Network at 11 sites 
(including CDC). Together with the ADDM partners, CDC provides critical 
data needed to answer questions about how common ASD are, whether we 
are identifying more children with ASD over time, and whether ASD 
affect certain groups more than others (i.e. boys are affected more 
often than girls). Also, it provides clues into potential causes that 
can be investigated further through research.
    The goal of the ADDM Network is to provide comparable, population-
based estimates of the prevalence rates of autism and related disorders 
in different sites over time. The program has made significant strides 
in attaining this goal. During the first phase of the project, as many 
as 16 sites (including CDC) have participated in the ADDM Network to 
determine the prevalence and characteristics of children with ASDs in 
their study areas.
    In 2006, CDC awarded funds to 10 ADDM Network sites to allow the 
network to develop ASD prevalence estimates for 2006 and 2008. The 
sites are currently working on a report from 2004 and another report to 
look at changes in ASD prevalence across 3 time periods in 4 sites.
    Establishing a national surveillance system for ASD is complex. CDC 
will continue to support in-depth, ongoing prevalence tracking in the 
current ADDM sites. Opportunities to enhance autism surveillance 
efforts in the United States include:
    1. Developing and implementing projects that continue to link 
prevalence studies with screening and early identification efforts,
    2. Supplementing national surveys, and
    3. Conducting investigations of ASD occurrence in adults. Doing so 
will enhance our understanding of the population characteristics of 
ASDs and how they have changed over time.

    CENTERS FOR AUTISM AND DEVELOPMENTAL DISABILITIES RESEARCH AND 
                              EPIDEMIOLOGY

    Question. The Children's Health Act of 2000 directed the CDC to 
create regional centers of excellence to study autism spectrum 
disorders and other developmental disabilities. The Centers for Autism 
and Developmental Disabilities Research and Epidemiology (CADDRE) 
Network was created in response to this direction. Can you comment on 
the most recent research developments resulting from implementation of 
this network?
    Answer. The search for the causes of autism spectrum disorders 
(ASD) is a top priority at CDC. CDC has engaged with partners in the 
Centers for Autism and Developmental Disabilities and Research 
Epidemiology (CADDRE) network to develop and implement public health 
research tools to identify potential causes.
    Last year, CDC and CADDRE partners launched the Study to Explore 
Early Development (SEED). Through this effort, study partners expect to 
collect information on 2,700 children with ASD and their parents that 
will help answer questions about the characteristics of affected 
individuals as well as potential ASD causes. Researchers will explore a 
number of priority hypotheses such as the role of infections, genetic, 
reproductive and hormonal factors as well as select exposures.
    As the largest epidemiologic study of its kind, SEED holds the 
potential to be an important complement to the array of other work 
occurring at the National Institutes of Health and in academia. CDC 
brings a unique public health perspective of studying health issues in 
large populations--not just among individuals or families who self-
refer for intervention or study.

           LEADING RESEARCH HYPOTHESES ON THE CAUSE OF AUTISM

    Question. In recent years, certain vaccines have been suggested as 
being linked to autism. Scientific evidence and the most recent 
Institute of Medicine report do not support this theory. What are the 
other leading hypotheses among the research community of the cause of 
autism? How much of current autism funding is being focused on research 
to determine the cause of autism-related disorders?
    Answer. Most scientists believe that there are multiple causes of 
autism spectrum disorders (ASD), resulting in various manifestations of 
the core symptoms. Twin studies provide strong evidence that ASD is 
highly heritable, but that the disorder involves the interaction of 
many genes. NIH-funded research has begun to reveal clues about how 
genetic variations affect the risk of developing ASDs. Although some 
studies have shown that mutations in individual genes are linked to 
only a small percentage of autism cases, new reports suggest that part 
of the explanation for ASDs may be due to deletions and duplications of 
genetic material. Many of these are spontaneous de novo mutations not 
present in the parents. The study indicates that different cases of 
autism could be traceable to any of 100 or more genes, alone or in 
combination.
    Environmental modifiers may also interact with genes to cause ASD 
or modify its expression, although such environmental mechanisms have 
not yet been identified. The delicate interplay between genetic 
susceptibility and immunological and environmental triggers may lead to 
differences in the healthy development of brain circuits and brain 
function. NIH is committed to meeting this complex challenge, 
determining the potential causes of ASDs.
    In fiscal year 2007, the NIH spending for autism-related research 
totaled approximately $127 million. About 22 percent of the funding 
supports grants addressing specific risk factors, including genetics, 
environmental mechanisms, and gene-by-environment interactions. An 
additional 29 percent supports grants aimed at better understanding the 
underlying neurobiology of the disorder, which is critical knowledge in 
order to identify hypotheses about additional risk factors for 
investigation. Several large initiatives to uncover the underlying 
causes of ASD involve joint initiatives and activities sponsored by the 
NIH Autism Coordinating Committee (NIH/ACC). The NIH/ACC functions to 
synchronize autism research activities funded and conducted by the 
various NIH Institutes (NIMH, NICHD, NINDS, NIDCD, and NIEHS).

                           SUBCOMMITEE RECESS

    Senator Harkin. Well, thank you all again very much. It's 
been a very informative and constructive hearing.
    The committee will stand in recess to reconvene at 9:30 
a.m., Friday, April 20, in room SD-116. At that time we will 
hear testimony from the Honorable Richard J. Hodes, M.D., 
Director, National Institute on Aging.
    [Whereupon, at 4:16 p.m., Tuesday, April 17, the 
subcommittee was recessed, to reconvene at 9:30 a.m., Friday, 
April 20.]
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