# Presentation: 000557

## Director’s Report to the

**Director’s Report to the**
**National Advisory Council**
**on Drug Abuse**

**     ****May 20, 2004**

## Slide 2

## Slide 3

## Update on 

**Update on **
**NIH  ROADMAP Activities**

## What Has NIDA Done to Ensure Participation

***of Substance Abuse Researchers***
*** ******on the NIH Roadmap?***

## Report of the 

**Report of the **
**National Institutes of Health**
**Blue Ribbon Panel on Conflict of Interest Policies**
**A Working Group of the Advisory Committee to the Director**
**National Institutes of Health**

## Slide 7

## NIDA  BUDGET

**(Thousands)**

**Increase Over**** Prior Year**

**AIDS**

**TOTAL**

**NonAIDS**

## NIDA Program Reviews 

**NIDA Program Reviews **

## NIDA’s Response to 

***Reports and Recommendations of ***

**  ****Blue Ribbon Task Force on **
**    ****Health Services Research**
**  ****Clinical Trials Network (CTN)**
**    ****Workgroup **
**  ****Workgroup on HIV/AIDS **

##        Health Services Research 

**           ****Task Force Members **
**           ****Co-Chairs:  **
**            ****Thomas McLellan, PhD,**
**	**** ****Constance Weisner, DrPH, MSW**
**     ****Andrea Barthwell, MD****	****           Richard Frank, PhD**
**     ****Caryn Blitz, PhD****	****	****           Warren Hewitt, MS**
**     ****Rick Catalano, PhD****	****           James Inciardi, PhD**
**     ****Mady Chalk, PhD****	****           Marguerita Lightfoot, PhD**
**     ****Linda Chinnia, MEd****	****           Isaac Montoya, PhD**
**     ****Lorraine Collins, PhD****	****           Claire Sterk, PhD**
**     ****Wilson Compton, MD, MPE     Janet Wood, MBA, MEd**
**     ****Michael Dennis, PhD****	**

## NIDA’s Initial Goals Based on the 

**#*****2     *****Increase research**** on organizational, management, and economic issues to enhance policy, programs and practices**
***#3     *****Lead and collaborate in ****the development of standards**** for evidence-based practice**
** **
***#4     *****Evaluate ****causal associations**** **

**NIDA’s Initial Goals Based on the **
**Blue Ribbon Report**

##  Rec #1:  Defining Health Services Research

**A multidisciplinary field that examines how:**

** ****Rec #1:  Defining Health Services Research**

***Ultimately, the goals of health services research are to***
***identify the most effective ways to organize, manage, ***
***finance, and deliver high quality care****** ***

**access to and utilization of healthcare,**
**quality and cost of healthcare, and**
**our health and well-being.**

** ****social factors,**
** ****financing systems,**
** ****organizational     structures and processes,**
** ****health technologies and**
** ****personal beliefs and  behaviors**

**affect**

##  Rec #2: Enhance Practices Through Research on Organization, Management, and Economic Issues

***Early Responses:***
**Collaborating with CSAP on their Strategic Prevention  Framework to study changes in the organization of prevention systems nationwide.**
**Encouraging applications under existing PAs:**
**Economic Evaluation of Drug Abuse Treatment and Prevention Services for HIV/AIDS (PA-02-164)**
**Economics of Drug Abuse Treatment and Prevention Services (PA-01-013)**
**Services Research in the National Drug Abuse Clinical Trials Network (PA-03-011)**

##  Rec #3: Lead and collaborate in the development of standards for evidence-based practice

***Early Responses:***
**Leadership in DHHS (SAMHSA and NIH), Department of Justice, and Department of Education Workgroup to Standardize Measures of Program Effectiveness**
**State Agency RFA to encourage Research on Diffusion of Evidence-Based Practices *****(and similar future initiative for community based treatment and prevention agencies)***
**Collaboration of CTN and SAMHSA’s ATTCs to **_***BLEND***_** research and practice in order to implement research-based interventions more widely**

##  Rec #4:  Evaluate Causal Associations

***Early Responses:***
**Encouraging experimental designs where feasible:**
**In studies conducted in collaboration with CSAP**
**In criminal justice studies, such as the Criminal Justice-Drug Abuse Treatment Studies (CJ-DATS)**
**In Department of Education demonstration studies, such as the new drug testing programs**
**Scientific meeting ****on new methods to test causal inferences ****(in conjunction with the  NIDA, NIMH, NIAAA, SAMHSA, AHRQ, and HRSA Conference) **

##      Clinical Trials Network 

**     ****Work Group Members**
**Chair:  David Rosenbloom, Ph.D**
**Richard R. Boozin, Ph.D.**
**Kathleen Burlew, Ph.D.**
**Nancy Hamilton, M.P.A., CAP, CCJAP**
**Steven C. Hayes, Ph.D**
**Yasmin Hurd, Ph.D.**
**Ron Jackson, M.S.W.**
**Herbert D. Kleber, M.D.**
**Thomas R. Kosten, M.D.**
**Curtis Wright, M.D., M.P.H.**

## NIDA’s Response to Recommendations: Main Issues

**Mission  **
**Organization**
**Operations  **
**Dissemination**
**Collaborations**

## NIDA’s Response to Recommendations: Main Issues

**Mission:  **
** ****use as research platform:  genetics, HIV/HCV **
** ****use as training platform: training supplements**
** ****use for priority studies (e.g bup/hepatotoxicity)**
**Organization: **
** ****Director and deputy director, **
** ****consolidation of coordinating centers (data  monitoring and management); competitive selection **
** ****size of CTN, RFA for competitive renewals and new  nodes will be released in summer 2004**

## Operations: 
 GCP:  MUST 
 Review of protocols (protocol review board (PRB) and Data Safety Monitoring Board (DSMB))
Dissemination:  collaborations with DESPR         and OSPC
Collaborations with NIAAA and NIMH

** ****GCP:  MUST **
** ****Review of protocols (protocol review board (PRB) and Data Safety Monitoring Board (DSMB))**
**Dissemination:  collaborations with DESPR         and OSPC**
**Collaborations with NIAAA and NIMH**

**NIDA’s Response to Recommendations: Main Issues (cont)**

## National Advisory Council on Drug AbuseWorkgroup on HIV/AIDSReport on Findings and Recommendations

**National Advisory Council on Drug Abuse****Workgroup on HIV/AIDS****Report on Findings and Recommendations**

| Council Members
David Vlahov, Ph.D.
Claire E. Sterk, Ph.D.
Jose Szapocznik, Ph.D

Consultants to Council
Judith Auerbach, Ph.D.
Carl Dieffenbach, Ph.D.
Paul Volberding, M.D.
Taha Taha, MBBS, Ph.D.
Walter Ling, M.D.
 | 
NIDA Staff Members
Jack Blaine, M.D.
Wilson Compton, M.D.
Henry (Skip) Francis, M.D.
Barry Hoffer, M.D., Ph.D.
David Shurtleff, Ph.D.
Frank Vocci, Ph.D.
Bill Grace, Ph.D.

Other NIH Institute Staff Members
Kendall Bryant, Ph.D.
Jonathan Kagan, Ph.D.
Ellen Stover, Ph.D. 
 |
| --- | --- |

**WORKGROUP MEMBERS**

## HIV/AIDS Workgroup Recommendations: Main Issues

**Organization**
**Portfolio should reflect HIV epidemic**
**Priority setting**
**Collaborations with other divisions**

**Notes:**
I’m not sure if this is a good idea– but you could give the major results right up front.
This would be a good place to note that the recommendations related to scientific areas, for the most part, are a matter of recommending more or less emphasis and that NIDA does a pretty good job of covering the areas.

## HIV/AIDS Workgroup Recommendations: Organization

**Current organization promotes conflict in mission and should consider bringing AIDS into OD office**
**Separate coordination of HIV and AIDS activities and medical consequences portfolio**

**(1) *****NIDA reorganization****** in progress –dissolved CAMCODA and brought AIDS coordination to OD***
***(2) ******Steven Gust, Ph.D.****** named Acting Director, AIDS Research ***
***(3) ******National search****** for a permanent Director in progress – announcement closes June 11, 2004. ***

**Notes:**
I’m not sure if this is a good idea– but you could give the major results right up front.
This would be a good place to note that the recommendations related to scientific areas, for the most part, are a matter of recommending more or less emphasis and that NIDA does a pretty good job of covering the areas.

## HIV/AIDS Workgroup Recommendations: HIV epidemics

**Need more focus on unique dimensions of drug use as they relate to HIV/AIDS**
**Need to be guided by HIV epidemiology; advances in HIV treatment & prevention**

**0**

**10**

**20**

**30**

**40**

**50**

**60**

**70**

**1986**

**1988**

**1990**

**1992**

**1994**

**1996**

**Year of Diagnosis**

**Percent of Cases**

**Proportion of Estimated* Adult/Adolescent AIDS Cases **

**by Exposure Category and Year of Diagnosis, **

**1985 - 2000, United States**

**1998**

**2000**

**MSM & IDU     **

**Men who have sex with men (MSM)**

**Injection drug use (IDU)     **

**Heterosexual contact**

***Source: Centers for Disease Control and Prevention (CDC)***

**The Consequences of Drug Abuse ****and Addiction Disproportionately ****Affect Minority Populations**

**Notes:**
I’m not sure if this is a good idea– but you could give the major results right up front.
This would be a good place to note that the recommendations related to scientific areas, for the most part, are a matter of recommending more or less emphasis and that NIDA does a pretty good job of covering the areas.

## HIV/AIDS Workgroup : Priorities and Collaborations

**NIDA’s planning process and priority setting process need improvement**
**Limited collaborations with other divisions**
***   ******(1)  increase expertise of HIV/AIDS in divisions and CTN***
****(2) create a working group for evaluation or priorities and for inclusion of HIV/HCV in relevant RFA and PA ***
****(3) Create a document to define what should be labeled as AIDS related research***
**** Waiting for new director to implement***

**Notes:**
I’m not sure if this is a good idea– but you could give the major results right up front.
This would be a good place to note that the recommendations related to scientific areas, for the most part, are a matter of recommending more or less emphasis and that NIDA does a pretty good job of covering the areas.

## NIDA Reorganization

**  ****Respond to the Report of the National Advisory Council**
**    ****on Drug Abuse Workgroup on HIV/AIDS to ****better integrate**
**    ****HIV/AIDS**** with drug abuse and addiction studies **

**  ****Realignment of other programs**** in keeping with NIDA**
**    ****priorities, particularly on adolescents and prevention**
**	****Create a new Division****...**
**	****   ****to better integrate clinical neurobiology with **
**             ****human development and behavioral therapies **
**	****   ****to take advantage of advances in imaging to better**
**	****   ****understand the neurobiological underpinnings**
**	****   ****of drug abuse and addiction**

**NIDA Reorganization**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**EEO**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**Population-Based**
**Health Interventions**
** ****Unit**
** **

**Medical **
**Consequences Unit**

**Developmental Unit**

**Clinical Etiology Branch**
**Behavioral Therapies **
**  ****Development Branch**

**Medical Consequences Branch**

**Increased emphasis on:**
**Proteomics/Genetics**
**Pain Management/ Sensitivity of HIV patients to Addictive Analgesics**

## Other NIDA Program Reviews in Progress 

**  ****Medications Development Program**

***Other NIDA Program Reviews in Progress ***

**Workgroup Members:**
**Chair: Peter Kalivas, Ph.D.**
**	****Bankole Johnson, M.D., Ph.D.**
** ****	****Herb Kleber, M.D.**
**	****George F. Koob, Ph.D.**
**	****Mary Jeanne Kreek, M.D.**
**	****Bertha Madras, Ph.D.**
**	****Eric Nestler, M.D., Ph.D.**
**	****Scott Reines, M.D., Ph.D.**
**	****Raymond White, Ph.D.**

**Status: First Meeting **
**Held May 18-19, 2004**

***Purpose:  To comprehensively review NIDA’s current medications development research portfolio and to provide recommendations for ***
***current and future research objectives****** ***

## Other NIDA Program Reviews in Progress 

**  ****Minority Health Disparities**

***Other NIDA Program Reviews in Progress ***

**Status: Additional **
**Workgroup Members**
**Being Recruited**

***Purpose:  To comprehensively review NIDA’s current minority health research portfolio and to provide recommendations for current and future research objectives ***

**Workgroup Members:**
**Chair: Jose Szapocznik, Ph.D. **
**	****Rodolfo Arredondo, Jr. Ed.D.**
**	****Allyn Howlett, Ph.D. **
**	****James S. Jackson, Ph.D.**
**	****Patricia Molina, M.D., Ph.D. **
**	****Beny Primm, M.D.**
**	****Beverly Watts Davis, B.S.**

## Slide 30

## Response to New NIDA PAs and RFAs

**  ****Treatment Interventions **
**	**

**  ****Prevention Research (Children and Adolescents)**
**	**

**  ****Novel Approaches to ****Phenotyping Drug Abuse ****(RFA) **
**  ****Behavioral and Cognitive Processes**** in Adolescent Drug Abuse (RFA) **
**  ****Animal Models of Adolescent Drug Abuse ****(RFA) **
**  ****Prevention**** Research for the Transition to Adulthood (RFA) **
**  ****Consequences of ****Marijuana Use**** on the ****Developing Brain ****(RFA) **

**Response to New NIDA PAs and RFAs**

**  ****Medications Development for Cannabis****-Related Disorders (RFA)**

**22**
**34**
**56**
**26**
**31**

**19**

**Number of **
**Applications**

## Response to New NIDA PAs and RFAs

**  ****Training**
**	**

**  ****HIV/HCV**
**	**

**   ****Drug Abuse Aspects of ****HIV/AIDS**** and Other Infections (PA) **
**   ****HIV/AIDS**** and Other Infections Among Drug Users in the**
**     ****Criminal Justice System ****(RFA)**
**   ****HIV/AIDS**** Prevention, Treatment, and Related Health**** ****Issues for **
**     ****Highly Vulnerable Youth ****(RFA)**
**   ****Targeted Integrative Research in Drug Abuse and HIV/AIDS in **
**     ****Pregnancy ****(RFA)**

**Response to New NIDA PAs and RFAs**

**  ****Research Education**** Grants in Drug Abuse and Addiction (PA) **

**9**
**34**
**42**
**8**

**Number of **
**Applications**

## NIDA PAs and RFAs  Just Issued

**  ****Epidemiology**** of Drug Abuse (PA-04-100)**
**	**

**  ****Collaborative ****Clinical Trials**** in Drug Abuse (PAR-04-073)**

**NIDA PAs and RFAs  Just Issued**

**  ****Developmental Centers for ****Translational Research**** on the**
**    ****Clinical Neurobiology of Drug  Addiction (RFA-DA-05-003)**
**	**

## PAs and RFAs Recently Issued With

**Other NIH Components/Agencies**

**5 New PAs and**
**5 New RFAs ****(Totaling $3 Million)**

**Focus predominantly on:**
**GENETICS**
** ****CO-MORBIDITY**
**HIV/AIDS**
**SERVICES (with SAMHSA)**

## Slide 35

## Slide 36

## Recent Congressional Hearings

**In Which NIDA Played A Role**

** ****Measuring the Effectiveness of Addiction Treatment**
**     ****(House Government Reform Subcommittee on Criminal Justice, Drug Policy **
**      ****and Human Resources – Representative Mark Souder [R-IN], Chairman)**

** ****Fiscal Year 2005 NIH Budget**
**     ****(Senate Appropriations Subcommittee on Labor, HHS and Education – **
**      ****Senator Arlen Specter [R-PA], Chairman)**

** ****Marijuana and Medicine: The Need for a **
**   ****Science-Based Approach**
**     ****(House Government Reform Subcommittee on Criminal Justice, Drug Policy **
**      ****and Human Resources – Representative Mark Souder [R-IN], Chairman)**

** ****Substance Abuse and Mental Health**
**     ****(House Appropriations Subcommittee on Labor, HHS and Education–**
**      ****Representative Ralph Regula [R-OH], Chairman)**

## Document: ADDICTION AS A MEDICAL DISEASE

**Healthy Heart**

**Diseased Heart**

**Decreased Heart Metabolism in *****Heart Disease Patient***

**Document: ADDICTION AS A MEDICAL DISEASE**

***Sources:  From the laboratories of Drs. N. Volkow and H. Schelbert***

## American Psychiatric Association

**American Psychiatric Association**
**Annual Meeting**

***NIDA-Sponsored ***
***Research Track***

**Including: **
**7 Major Lectures**
**11 Symposia**
**9 Issues Workshops**

## 8th Annual PRISM Awards Event

**8****th**** Annual PRISM Awards Event**
**Hollywood Palladium – Los Angeles, CA**
**May 8, 2004 **

**PRISM Event Premiered **
**on Capitol Hill**
**May 12, 2004 **

**Aired on FX May 16, 2004**