DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

Fiscal Year 2006 Budget Request

Witness appearing before the

House Subcommittee on Labor-HHS-Education Appropriations

Nora D. Volkow, M.D., Director

National Institute on Drug Abuse

March 9, 2005

William Beldon, Deputy Assistant Secretary, Budget

Mr. Chairman and Members of the Committee:

I am pleased to present the Fiscal Year (FY) 2006 President's budget
request for the National Institute on Drug Abuse (NIDA). The FY 2006
budget includes \$1,010,130,000 an increase of \$3,711,000 over the FY
2005 enacted level of \$1,006,419,000 comparable for transfers proposed
in the President's request.

# MEETING PUBLIC HEALTH NEEDS AND 

# TAKING ADVANTAGE OF SCIENTIFIC OPPORTUNITIES

In this age of unprecedented scientific opportunity, NIDA is poised to
strike the delicate balance between taking advantage of new
opportunities, supporting strong science, and meeting existing and
emerging public health needs. Since I became Director in May 2003, we
have called upon internal and external experts and our National Advisory
Council to systematically evaluate about 80% of our portfolio. This
important exercise has allowed us to strategically set our research
priorities. Today, I would like to highlight some significant new
outcomes from our portfolio and discuss NIDA's plans to optimize the
impact that science will have on the health of the public.

# ADOLESCENT BRAIN DEVELOPMENT AND DRUG PREVENTION

As the world's largest supporter of research on the health aspects of
drug abuse and addiction, NIDA has made tremendous progress in
understanding addiction as a chronic, relapsing disease, which affects
both brain and behavior. We also now know that addiction is a
developmental disorder that begins in adolescence, and sometimes as
early as childhood. Recent advances have provided us with more insight
into why teens engage in risk-taking and thrill-seeking behaviors. These
behaviors are likely due to the fact that the part of the brain
responsible for judgment, decision-making, and control of emotional
responses, the prefrontal cortex, is the last area of the brain to
mature. Understanding the impact that drugs can have on normal brain
development, risk perception, and vulnerability to future drug use, will
allow us to maximize prevention and early intervention strategies with
youth. We will also rely on basic research with animals to directly
examine the effects that early exposure to drugs can have on brain
development and behavior. Nicotine, for example, when given to young
animals can increase the effects of the drug in adulthood. NIDA will
continue to use science to increase our ability to dissuade teens from
abusing drugs by focusing on cognitive processes (learning, judgment,
and decision-making) and emotional processes (social reinforcers,
motivation, and stress responses). From both experience and from
research, we know that prevention and early intervention are critical to
healthy development. For these reasons, NIDA is pleased to be a
participant in the NIH MRI Study of Normal Brain Development, which will
help discern more about normal brain development and the effects that
drugs can have on it.

# ENVIRONMENTAL FACTORS: THE ROLE OF EARLY EXPERIENCE

Research shows that both genetic and environmental factors impact how an
individual develops. Good parenting skills, for example, can have a
significant impact on a child's mental and physical health, since
behaviors are often molded by early experiences. We know this from
animal studies as well, where researchers have shown that early maternal
behaviors can affect neurobiological development and shape the way an
animal responds to stress throughout its life. We also know that
ineffective parenting can increase a child's risk for a range of
maladaptive behaviors. NIDA-supported researchers found that many of the
risk-taking behaviors of adult women who contract HIV were associated
with childhood sexual abuse, suggesting that early learned behaviors,
negative or positive, could impact later disease outcomes. Early
exposure to stress or trauma is also known to be a risk factor for both
substance abuse and mental health disorders. For this reason, it is
critical that we devote resources to develop interventions that are
geared towards children and adolescents who may be at high risk for
co-morbidity. Educating pediatricians and primary care physicians about
this issue and working toward the development of a more integrated
health care system to address the reality of co-occurring diseases are
important first steps.

## DRUG USE RATES: THE GOOD, THE BAD, AND THE NEED TO DO MORE

**TO COMBAT EMERGING PROBLEMS SUCH AS METHAMPHETAMINE**

When NIDA released its 2004 Monitoring the Future data in late December
we were encouraged by much of the news about declines in drug use (See
**Figure 1**). Eighth, tenth, and twelfth grade students showed a
continuing downward trend in drug use, with almost a 7 % decline from
2003 to 2004 and about a 17% decline over the last three years. However,
a few troublesome problems revealed themselves. We found that there is a
"silent epidemic" lurking, one that strikes young children. It is the
use of inhalants. For the second year in a row, we are seeing eighth
graders abusing inhalants at disturbing rates, with nearly one in five
reporting that they had tried inhalants. In response, NIDA launched a
new website in January,
[www.inhalants.drugabuse.gov](http://www.inhalants.drugabuse.gov/), and
formed partnerships with other stakeholders including the Community
Anti-Drug Coalitions of America and the National Inhalant Prevention
Coalition to create awareness among parents, teachers, students, and
community leaders about the potential dangers that common household
products used as inhalants can bring in their wake.

The MTF and other monitoring mechanisms have also alerted us to some
disturbing news about the abuse of prescription drugs. When used as
prescribed, these medications are very effective, but non-medical use of
medications like opioids, central nervous system depressants, and
stimulants can lead to abuse and addiction. About 5% of 12^th^ graders
reported using Oxycontin for non-medical purposes, and about 9.3 % of
12^th^ graders, or nearly one in 10, reported similar use of Vicodin in
the past year, making Vicodin one of the most commonly abused drugs in
this population. Similarly about 10% of 12^th^ graders reported
non-medical use of amphetamines in the past year, a class of stimulant
drugs often prescribed to treat Attention Deficit Hyperactivity Disorder
(ADHD). NIDA has reinvigorated its research and dissemination efforts on
prescription drug abuse, especially in the treatment area. We will
launch later this year two large-scale clinical studies in our Clinical
Trials Network. One will focus on treatments for prescription opiate
abuse and the other on treatments for substance abusers who also suffer
from ADHD.

NIDA also continues to monitor methamphetamine use in the country.
Though we are seeing significant decreases in methamphetamine use among
eighth graders, the use among 10^th^ and 12^th^ graders appear to have
stabilized according to MTF. Moreover, NIDA's Community Epidemiology
Work Group (CEWG), which monitors drug abuse problems in sentinel areas
across the Nation, is alerting us to increases in 11 of the 21 CEWG
areas, including rural areas. Methamphetamine also appears to be growing
in popularity among men who have sex with men, and is often associated
with risky sexual behaviors, which can increase the risk for
transmission of HIV, hepatitis C, and other STDs. Indeed, the recent
case of an HIV-infected methamphetamine abuser with a particularly
virulent strain of HIV has raised concern over the potential deleterious
effects of mehtamphetamine on the immune system and medication response.
To curtail the spread of methamphetamine and its related consequences,
NIDA maintains a comprehensive program that includes basic,
epidemiological, prevention and treatment research.

NIDA focuses much effort on finding treatments for methamphetamine abuse
and addiction. Currently cognitive behavioral interventions remain the
most effective way to treat methamphetamine abuse, though we are making
progress in developing medications through the five sites that comprise
our Methamphetamine Clinical Trials Group (MCTG). Additionally, NIDA is
very concerned about the effects of methamphetamine on the development
of children exposed to the drug prenatally. NIDA recently launched the
first large-scale study of the developmental consequences of
methamphetamine exposure, which includes seven hospitals in Iowa,
Oklahoma, California and Hawaii. At a more basic level, we are learning
more about the long and short-term effects of this addictive stimulant,
including how it affects brain structure and function. As you can see in
the brain images depicted in **Figure 2**, after about a year of
abstinence from methamphetamine, there appears to be recovery in some
parts of the brain. Brain activity or metabolism in the thalamus, an
important area for coordinating the response of the brain to external
stimuli, returned to near normal levels. The images in **Figure 3** also
illustrate that some of the destructive effects of methamphetamine may
be reversible, as seen by the recovery of dopamine transporters after
prolonged abstinence. More research needs to be supported to understand
the impact these changes have on brain function and to determine why
other parts of the brain do not recover.

## 

## TRANSLATING RESEARCH TO IMPROVE HEALTH OF THE NATION

NIDA has made much progress in developing effective treatments for
addiction, both behavioral and pharmacological. In addition to bringing
new medications like buprenorphine and buprenorphine/naloxone to
physicians treating opiate dependence, NIDA's medications program is
bringing us one step closer to having new treatments for cocaine
addiction. It has identified several promising compounds in animal
studies and has shown initial efficacy in clinical studies of several
marketed medications (such as disulfiram for alcoholism, modafinal used
to treat narcolepsy; and topiramate for seizures). Progress is also
being made to develop vaccines for cocaine and nicotine addiction, as
well as new treatments for marijuana abuse and addiction.

Testing treatments in real life settings is a top priority for NIDA. Six
different treatment protocols have been completed in our national
clinical trials infrastructure, including a medication detoxification
protocol that has shown to be acceptable to both patients and providers,
and is being adopted in traditional "medication or drug-free" clinics.
We are also proud of the fact that through our collaborations with the
Substance Abuse and Mental Health Services Administration (SAMHSA) we
were able to develop two research dissemination products that treatment
providers and managers can use to improve the quality of treatment in
their communities. Three other products derived from CTN research
findings are currently being developed by the NIDA and SAMHSA "blending
teams." NIDA is also working with SAMHSA to stimulate and support
innovative research to determine the components necessary for adopting,
adapting, delivering, and maintaining effective evidence-based programs,
and practices.

# 

# REDUCING HIV/AIDS RATES

NIDA-supported researchers continue to look for cost effective ways to
prevent and treat diseases. Just last month, two independent papers
published in the [New England Journal of Medicine]{.underline}
reinforced the value of screening interventions for HIV and provided
food for thought for changing the current recommendations on screening
in populations with lower HIV prevalence rates. Using modeling
paradigms, the researchers showed that if you screen for HIV in health
care settings, detect it, and start active antiretroviral therapy
(HAART) early you can increase life expectancy and reduce transmission
rates, comparable to what is seen with screening for breast cancer and
high blood pressure (see **Figure 4**). For example, a person who is
screened at 30 years of age, would increase life expectancy by almost
two years. Moreover the researchers also estimated that by expanding
screening to a larger segment of the population HIV transmission rates
can be decreased by about 20%. Screening can improve the quality of life
of individuals and appears to be cost-effective for society.

NIDA is also pursuing ways to reduce the burden of HIV and other medical
consequences often associated with drug abuse among all populations, but
is particularly interested in reducing HIV rates among African
Americans. The HIV/AIDS epidemic has taken a disproportionate toll on
racial and ethnic minority populations. The CDC reports that during
2000--2003, HIV/AIDS rates for African American males were 7 times those
for white males, and African American females were 19 times the rates
for white females and exceeded the rates for males of all
races/ethnicities other than African Americans. NIDA has launched an
initiative that is specifically focusing on reducing HIV rates among
African Americans, including conducting more studies in geographic areas
where rates are highest and developing interventions that are ethnically
appropriate. Identifying other avenues for intervention, such as
correctional facilities to prevent HIV in this population is also
another priority for NIDA. African American males are nearly 8 times
more likely to be incarcerated than white males, and much of this is for
drug-related crimes. Supporting research on the intersection of drug use
and criminal justice consequences in the African American population
will help us develop improved prevention and treatment services.

# 

# ACCELERATING NEUROSCIENCE RESEARCH THROUGH NIH 

# NEUROSCIENCE BLUE PRINT AND ROAD MAP ACTIVITIES

Recognizing that neuroscience research is the foundation for all of our
drug abuse prevention and treatment efforts, NIDA will look for
innovative and cost-effective ways to support this critical research.
For example, NIDA is an active participant in the new NIH Neuroscience
Blueprint activities. The Blueprint provides a forum for the 15 NIH
Institutes and Centers that support research on the nervous system to
pool resources and expertise. In addition to taking the lead in
inventorying all the neuroscience tools funded by NIH and government
agencies this year, in FY 2006 NIDA will take the lead in developing
crosscutting training mechanisms for important areas such as
neuroimaging and computational biology. NIDA researchers are also
benefiting from their participation in NIH Roadmap activities,
especially the Molecular Libraries and Imaging efforts.

## CONCLUSION

NIDA's research portfolio is comprehensive and strategically poised to
take advantage of new opportunities that present themselves. We continue
to make great strides to translate and disseminate research-based
products so they can be used in the real world, providing the Nation
with the tools necessary to reduce drug use in this country. Sustaining
the momentum of our efforts will lead to even more discoveries that will
improve health for all Americans.

Thank you, Mr. Chairman. I will be pleased to answer any questions the
Committee may have.

**Nora D. Volkow, M.D.**

**Director**

**National Institute on Drug Abuse**

**National Institutes of Health**

Nora D. Volkow, M.D. is the Director of the National Institute on Drug
Abuse (NIDA). Before assuming this position on May 1, 2003, Dr. Volkow
was Associate Director for Life Sciences at Brookhaven National
Laboratory (BNL), Director of Nuclear Medicine at BNL and Director of
the NIDA-Department of Energy Regional Neuroimaging Center at BNL. She
was also Professor at the Department of Psychiatry, State University of
New York (SUNY) at Stony Brook and Associate Dean for the Medical School
at SUNY-Stony Brook. Dr. Volkow received her M.D. in 1981 from the
National University of Mexico, in Mexico City, Mexico, and performed her
residency in psychiatry at New York University.

Her main area of interest is the investigation of the mechanisms
underlying the reinforcing, addictive, and toxic properties of drugs of
abuse in the human brain. Dr Volkow was the first to use imaging to
investigate the neurochemical changes in the human brain that occur
during drug addiction. Her studies have documented a decrease in
function of the dopamine system in addicted subjects that is associated
with a disruption in function of frontal brain regions involved in
motivation and drive. Her work has also focused on the investigation of
the neurochemical mechanisms responsible for intersubject variability in
response to drugs of abuse and its potential link to vulnerability to
drug abuse and alcoholism.

Dr. Volkow has also used imaging to investigate the effects of stimulant
drugs with respect to both their rewarding as well as therapeutic
actions. By doing a systematic comparison of the pharmacological effects
of cocaine (one of the most addictive drug of abuse) and of
methylphenidate (a drug used to treat children with attention deficit
hyperactivity disorder) in the human brain, her studies have highlighted
the relevance that drug pharmacokinetics play in enabling the
reinforcing effects of stimulant drugs to occur. These studies have also
shown that stimulant drugs, when used therapeutically, amplify DA
signals in the brain, enhancing the saliency of a stimulus and thus
improving attention and performance.

She has also used imaging to investigate the changes in the dopamine
system that occur with aging and their functional significance. Her work
has documented that the loss of dopamine brain function with age in
healthy subjects with no evidence of neurological dysfunction is
nonetheless associated with motor slowing and with changes in
performance of cognitive tasks that involve executive functions. Her
work now focuses on strategies to minimize the age-related losses in
dopamine brain activity as a means to improve quality of life in the
elderly.

Dr. Volkow has authored or coauthored more than 300 peer-reviewed
publications, three edited books, and more than 50 book chapters and
non-peer reviewed manuscripts. She is the recipient of multiple awards
for her research, and has been elected to membership in the Institute of
Medicine in the National Academy of Sciences. Dr. Volkow was named
"Innovator of the Year" in 2000 by *US News and World Report.*

**Department of Health and Human Services**

**Office of Budget**

**William R. Beldon**

Mr. Beldon is currently serving as Deputy Assistant Secretary, Budget in
the Department of Health and Human Services. He has been a Division
Director in the Budget Office for sixteen years, most recently as
Director of the Division of Discretionary Programs. Mr. Beldon started
in federal service as an auditor in the Health, Education and Welfare
Financial Management Intern program. Over the course of more than 30
years in the Budget Office, Mr. Beldon has held Program Analyst, Branch
Chief and Division Director positions. Mr. Beldon received a Bachelor's
Degree in History and Political Science from Marshall University and
attended the University of Pittsburgh where he studied Public
Administration. He resides in Fort Washington, Maryland.