1. What is the most important contribution your Institute/Center has made to the health of the American people within the last five years
Knowledge from scientific research on drug abuse and addiction has prompted notable shifts in attitudes and behaviors toward drugs. Latest Monitoring the Future (MTF) survey results show a 24-percent decline among 8th, 10th, and 12th graders combined in recent abuse (i.e., during the past month) of "any illicit drug" between 2001 and 2007 (see figure). This translates into approximately 860,000 fewer young people using illicit drugs than in 2001. Moreover, use of nicotine is now lower than at any time since the MTF survey of students began in 1975. (NIDA's Monitoring the Future Survey, 2007)
We cannot underestimate the importance of this decline, since we now understand that the brain does not fully mature until early adulthood; therefore, exposure to drugs of abuse in childhood or adolescence may adversely affect brain development and cause changes that increase addiction and other psychiatric vulnerabilities. Thus, we recognize addiction as a developmental disease that can have serious and long-term health consequences.
2. Overall, the NIH budget has failed to keep pace with inflation as measured by the Biomedical Research and Development Index (BRDPI) in each of the past five years. What has been the impact of this loss of purchasing power in your fields of science, and can you give examples of specific research opportunities that are being lost because inadequate funding?
The impact of a cumulative loss of purchasing power can be felt at all levels of the research enterprise. Our institute is forced to fund fewer scientists and reduce the number of clinical trials and medication development opportunities. We are also particularly concerned about the impact of reduced funding on the robustness of the young investigators' pipeline. They tend to be the most vulnerable in this climate of uncertainty, and resulting disillusionment among their ranks is likely to cause major deficits in future scientific recruitment and productivity.
Here are some specific examples of research opportunities that are being lost or curtailed because of inadequate funding:
- Development of innovative immunotherapies for methamphetamine abuse and addiction.
- Clinical trials of immunotherapies for nicotine addiction.
- Identification and development of potential new medications to treat drug addiction. Good examples in this category are (1) the phase I clinical trials of depot naltrexone, aimed at reducing the thrice weekly frequency with which patients must now take the medication and (2) antiepileptic drugs, such as Gamma vinyl-GABA (GVG, vigabatrin), which hold promise as a treatment for cocaine and other addictions.
- Clinical trials of non-addictive medications, such as modafinil and bupropion, for cocaine and methamphetamine abuse
- Clinical studies in NIDA's Drug Abuse Treatment Clinical Trials Network (CTN), which tests the effectiveness of medications and behavioral treatments for substance abuse in real-world settings with diverse patient populations. Among those trials likely to be affected are: (1) the Prescription Opioid Addiction Treatment Study (POATS), testing buprenorphine and psychotherapy for the treatment of patients addicted to pain medications and (2) the comorbid ADHD/substance abuse treatment studies, focused on whether the use of ADHD medication improves substance abuse treatment outcomes in patients with both disorders.
3. Looking at the most promising basic and clinical research avenues that your institute/center should be addressing strategically over the next five years, if the budget remains at subinflationary levels:
- which research areas will you be capable of funding;
In spite of the budgetary constraints, we will continue to fund the following three major initiatives, toward which we have already made significant commitments:
which areas will you be forced to trim back; and
- Epigenetics. As one of the key current NIH Roadmap initiatives, epigenetics (i.e., physical changes in DNA structure that have functional implications), represents an emerging area of research that NIDA will continue to support. These changes are triggered not only by drug exposure, but also by social stressors, parenting style, and peer group influences, to name a few. Environmental influences during fetal development, including exposure to licit and illicit substances, can also affect future vulnerabilities, including the propensity for developing an addiction. Understanding the causes and effects of epigenetic changes offers a real opportunity for developing interventions to counter, prevent, or take advantage of them.
- Brain Development. We will continue to pursue knowledge about how the brain develops throughout the lifespan, but especially in utero and during the protracted transition from adolescence into young adulthood, two stages that present critical windows of vulnerability to the deleterious effects of exposure to drugs. To that end, we have bolstered support for research that will help us better understand the impact and consequences of drugs of abuse during pregnancy and on the developing adolescent brain so as to enhance our already substantial prevention efforts. Neuroimaging is an important tool in this regard; thus, we are encouraging researchers to use it as part of studies looking at how exposure to multiple substances, including methamphetamine, opiates, cocaine, and inhalants, affects the brain and behavior. These efforts will closely complement NIDA's social neuroscience initiative. A social neurobiological perspective could be used to investigate the mechanisms underlying adolescents' increased sensitivity to social influences (i.e., peer pressure) and decreased sensitivity to negative consequences of their behavior that together make them particularly vulnerable to drug abuse and other risky behaviors.
- HIV/AIDS. The nature of the HIV epidemic in this country is changing, with new infections now spreading less frequently through injection drug use than through other routes, such as high-risk heterosexual sex. In this regard, drug abuse continues to play a major role in the spread of HIV - - by altering judgment that leads to impulsive high-risk sex, or by prompting risky behaviors driven by addiction, such as sex for drugs. Understanding this link is critical for developing more integrated and effective prevention strategies, and is reflected in our HIV initiatives and research portfolio. This includes research to mitigate the health disparities that fall disproportionately on ethnic minorities, particularly African Americans, who are at heightened risk for disease transmission and accelerated disease progression. Gathering meaningful data on the various factors contributing to these disparities will be integral to efforts to resolve them through earlier diagnosis and treatment.
Effective reductions in NIDA's budget will force the Institute to trim back on its funding of truly innovative research. Included in this group are:
which areas will you be forced to forgo?
- The previously mentioned identification and development of potential new medications to treat drug addiction, which entails time-consuming and exceptionally expensive preclinical studies and clinical trials. This important arm of NIDA's research portfolio will be curtailed or delayed during times of budgetary hardship.
- A subinflationary budget will seriously jeopardize investments and collaborative arrangements that have been made in many areas of drug abuse research. NIDA has been working closely with SAMHSA and other agencies on a variety of initiatives that would have to be reassessed and probably curtailed. These include the NIDA - SAMHSA Blending Initiative that works to more rapidly translate research findings into community practice; and the Criminal Justice Drug Abuse Treatment Studies (CJ-DATS), designed to study treatments to help not only those who are incarcerated but also those transitioning back into community. Such treatments have been shown to positively impact both substance abuse and criminal recidivism.
- NIDA will also be forced to trim back the Social and Environmental Mapping Effort, which was designed in response to the growing recognition of the important role that social, cultural, economic, and built environments play in determining the overall risk for drug abuse and addiction. Examples of the critical factors that need to be studied and codified in this complex realm include parenting style, family demographics, academic performance, peer pressure, collective efficacy (i.e., a shared willingness among neighbors to intervene on behalf of the common good), and economic status.
- Among the programs that NIDA will be forced to forgo are:
- Those that focus on the evaluation, development, and implementation of new technologies applied in the prevention and treatment of drug abuse and addiction and
- The endophenotype mapping initiative. In order to realize the full potential of the genomic revolution it is imperative that we gain first a better understanding of the enormous biological diversity underlying diseases that present with like signs and symptoms. This calls for more refined methods to characterize and standardize molecular changes (i.e., biomarkers) that occur with drug exposure. NIDA is keenly interested in investigating global changes related to addiction within the molecular (messenger RNA), functional (neurotransmitter, neuronal circuits), and behavioral domains. If this important research component is not addressed, it could seriously hamper not only our genetics efforts, but our efforts to implement a more individualized treatment strategy as well.
4. How does your institute/center facilitate the transfer of health information to physicians, patients, and the general public?
- Physician outreach - NIDA Centers of Excellence. As part of strategies to encourage greater recognition by physicians of the presence of substance abuse in their patients and the need to refer them to treatment, NIDA established (in 2007) four Centers of Excellence for Physician Information at medical centers across the country. The purpose of these centers is to develop research-based educational materials for medical students and resident physicians to advance their general understanding of drug addiction as a manageable brain disease and how best to prevent, diagnose, and treat it. This outreach initiative corresponds to the "Health Professionals Substance Abuse Education Act," legislation intended to train doctors to recognize substance abuse and properly refer patients and their families.
- Training judges. NIDA supported the development of a judicial training curriculum for Chicago's Cook County criminal court judges, intended to inform judicial decision-making in the context of understanding addiction as a brain disease. NIDA has also brought criminal justice professionals (judges, prosecutors, public defenders, and drug court coordinators) together with researchers and treatment providers to facilitate improvement in treatment quality and to help implement new research-based treatment practices. NIDA's recently published and widely disseminated research-based guide for treating drug abusers within criminal justice settings provides 13 essential treatment principles and includes answers to frequently asked questions, along with resource information.
- NIDA - SAMHSA Blending Initiative. The landmark "Blending Initiative" aims to translate our research-based findings into effective community-based treatment programs. A hallmark of the initiative is ongoing cross-communication between researchers and practitioners, in partnership with SAMHSA, clinicians, and state alcohol and drug abuse directors.
- SAMHSA partnership. In 2002, NIDA entered into a $1.5 million/year agreement with SAMHSA to improve the translation of "science to service" via the Addiction Technology Transfer Centers. Five different treatment and assessment "products" have been developed.
- NIDA goes to back to school. Through this initiative, NIDA developed and maintains a science-based drug abuse education curriculum that offers free information about the science of drug abuse specifically designed for school-age children. In addition, teachers can access teaching aids and detailed drug-related curricula, and parents can learn about the latest research findings on drug abuse and addiction through easy-to-follow fact sheets and booklets.
- Dissemination efforts are coordinated among all NIDA divisions and take the form of summary documents; presentations to a variety of scientific, clinical, congressional, and lay audiences; and a continuously updated website. Particularly good examples of these efforts are (1) a recent 90-minute documentary, produced by HBO in partnership with the Robert Wood Johnson Foundation, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism, to help Americans understand addiction as a treatable brain disease and to spotlight new medical advancements and (2) the online NIDA Chat Day, which provided students and teachers in classrooms across the United States with the opportunity to ask questions of the Nation's top experts in the field of drug abuse and addiction.
5. In your professional judgment, what are the major practical and cultural barriers to effectively translating research findings into long-term health outcomes? What is your strategy for overcoming these obstacles?
NIDA is working across disparate groups/fields to eliminate barriers to treatment, including those tied to stigma, diffusion of research results, and inclusion of the criminal justice system.
- Stigma. NIDA's strategy is to continue to work closely with our constituents, legislators, and other stakeholders to raise awareness among the public that addiction is a brain disease, that it targets youth, and that it impacts a variety of health problems, including HIV/AIDS, cancer, mental health, heart disease, and others.
- Parity issues. Mentally ill individuals, including patients suffering from substance abuse and addiction, face an obvious double standard when trying to seek medical care. This is a major practical and cultural barrier to the effective translation of research and demands a new approach - - one that favors science and inclusiveness rather than prejudice and discrimination.
- The pharmaceutical gap. Tremendous health benefits would accrue to public and private enterprises that joined forces to develop new medications or to re-evaluate those previously approved for new indications in the substance abuse and addiction field. While some examples of successful cooperation exist, the industry as a whole has been reluctant to commit fully to such ventures because of the stigma associated with drug abuse and the perception that the rates of return would not justify their investment.
- Barriers between treatment providers. Most treatment systems address substance abuse and other mental illnesses separately yet research on comorbidity clearly shows the benefits of treating both conditions concurrently. Physicians are most often the front line of treatment for mental disorders other than drug abuse, whereas drug abuse treatment is provided by a mix of treatment providers with different backgrounds in assorted venues, most of which have no medical support. Our strategy is to increase medical community representation in the treatment of the substance abusers and to provide research that documents the benefits of and delineates strategies for integrating substance abuse treatment with that of other mental disorders. It also includes educating medical students and physicians on drug abuse screening and interventions.
- Criminal justice system barriers. NIDA, in collaboration with our colleagues from within HHS and the Department of Justice, has developed the Criminal Justice - Drug Abuse Treatment Research Studies (CJ-DATS) program to serve as a research infrastructure for integrating drug abuse treatment and services within the criminal justice system, particularly during important transition times, such as re-entry into the community. NIDA's innovative programs to train judges about the neuroscience of addiction and treatment are also designed to lift barriers to helping criminal justice populations end the vicious cycle of drug abuse and crime.
- Research on drug courts. Since their inception in 1989, drug treatment courts have been subject to empirical and process evaluations to provide quantitative and qualitative data regarding their effectiveness. Most findings suggest that drug treatment courts have achieved success in lowering rates of recidivism among drug offenders. However, research on drug court outcomes must continue in order to monitor and optimize their efficacy in ever changing scientific, social, and criminal environments.
- Prevention network into school systems. Significant obstacles hinder the implementation of prevention initiatives that go beyond ineffective "scare tactics" in the school system. Few middle schools, for example, use proven prevention programs. NIDA has convened work groups to discuss the implementation and application of school-based prevention programs, identify issues, and develop recommendations regarding prevention research and practice and new materials and services.
6. Please explain ways in which your institute/center attempts to find routes through which research findings can be most effectively transferred to and used by industry, with the goal of expanding upon the findings to develop a tangible endproduct?
- Scientific Advisory Board. NIDA engages an outside workgroup composed of experts from science, industry, academia, and government to inform its medications development strategy with real-world recommendations.
- Through contracts. NIDA evaluates potential addiction treatment medications by conducting preclinical (i.e., animal pharmacological, toxicological, and pharmacokinetic) studies and clinical trials for academic and private-sector (pharmaceutical company) partners.
- NIDA's Strategic Program for Innovative Research on Drug Addiction
Pharmacotherapy (SPIRDAP) initiative. SPIRDAP facilitates collaboration with industry and encourages researchers to work with industry to expedite development of effective medications for addiction.
7. What are the research training needs in your areas of science? Please provide examples of innovative research training initiatives within your institute/center to address these needs. Do you have evidence of problems in the training pipeline that could hamper research and U.S. competitiveness?
In the field of drug abuse, NIDA has identified several important areas that need training development: (1) clinical researchers, (2) inter- and transdisciplinary researchers, (3) underrepresented populations, and (4) underrepresented scientific areas (i.e., HIV/AIDS and chemistry).
(1) There is an unmet need for clinician researchers to conduct clinical and basic neuroscience, as well as treatment and prevention research. NIDA has addressed this gap by developing and participating in a variety of career development mechanisms:
- Offering K awards that specifically target clinicians and/or patient-oriented research in both early and mid-career stages;
- Participating in the loan repayment program aimed at increasing our Nation's stock of clinical research scientists;
- Releasing a research education program announcement (PA) to build capacity for addiction research training in medical schools and universities.
(2) There is growing recognition of the need for scientists trained in multiple disciplines, and in translational approaches to optimize basic and clinical science discoveries. Such training can require additional time, and demands career opportunities that can further trans- and interdisciplinary research.
- NIDA continues to have a prominent role in the NIH Blueprint and Roadmap training initiatives, serving as the lead institute responsible for the Blueprint and Roadmap RFAs issued in 2006. There are currently sixteen institutional training grants being funded under these mechanisms. The purpose of these 3 Blueprint and 1 Roadmap RFAs was to promote translational and/or interdisciplinary research areas that go beyond the mission of any single institute. This approach should significantly improve collaboration across fields and disciplines and provide new scientific opportunities that will ultimately benefit the public's health.
(3) There is a continuing need for research training that includes representation from diverse populations.
- NIH requires all institutional training programs to include plans for recruiting and retaining underrepresented minority trainees and follow-up reporting through annual progress reports and competitive renewal applications.
- NIDA also offers administrative supplements to existing grants of independent investigators to promote training of underrepresented groups.
- NIDA, in conjunction with two other institutes, released a research education program announcement (PA) to develop mentoring programs and/or provide a network of senior mentors for underrepresented groups seeking to engage in HIV research. The research generated by these programs is expected to address the disproportionate impact of HIV/AIDS on individuals from underrepresented racial and ethnic populations.
- NIDA's Office of Special Populations coordinates this program and others, including a summer training program offering extramural and intramural participation for students beginning as early as high school. These opportunities are promoted at various scientific and constituent meetings, as well as through the NIDA website.
(4) Finally, there are several additional areas of need that NIDA recognizes as particularly important for the Nation's research competitiveness.
- Chemists are needed to develop compounds for medicinal and research purposes. NIDA is helping to support NRSA institutional training programs that include chemists, and has issued a special PA to facilitate the entry of chemists into the drug abuse field. Called Chem-Start, this program encourages innovative applications and pilot projects to jump - start research in this field.
- NIDA has used this approach successfully in the areas of neuroimaging (I-START), behavioral sciences (B-START), and drug abuse/AIDS research (A-START).
- NIDA has created the 2008 Avant-Garde Award to encourage individual scientists to propose transformative, novel approaches to the study of HIV/AIDS and drug abuse. Avant-Garde awardees will bring exceptional creativity, cross-disciplinary expertise, and new insight to this complex and urgent problem.
On a more general note, there is NIH-wide concern about the increasing age of scientists (PhDs, MDs and MD/PhDs) obtaining their first R01 or independent research grant and the resulting impact on their career trajectories. This situation, together with the relative lack of tenure track academic positions available, could substantially weaken the Nation's competitiveness in scientific areas. These issues and others are discussed in the 2005 publication by the National Academy of Sciences: Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research.
In response to this concern, the NIH has initiated two new types of awards:
- The New Innovator Award is a high profile award for new investigators of exceptional creativity who propose bold and highly innovative new research approaches that have the potential to produce a major impact on broad, important problems in biomedical and behavioral research.
- The Pathways to Independence Award is designed to facilitate the transition of junior investigators to independent careers. There are two phases to this award: the initial 1 - 2 year mentored phase will allow investigators to complete their supervised research work, publish results, and search for an independent research position; and the second independent phase will allow awardees who secure an assistant professorship, or equivalent position, to establish their own research program and apply for NIH investigator (R01) grants.