National Institute on Drug Abuse
Director's Report to the National Advisory Council on Drug Abuse
Dr. Harold Varmus and heads of selected NIH institutes testified before the Senate Labor and Human Resources Committee during hearings on the reauthorization (or "revitalization") of the agency on March 6 and 7. Committee Chairman, Senator Nancy Kassebaum (R-KS), said the government and NIH should work together to assure a more efficient conversion of research breakthroughs into practical applications and called the reauthorization of NIH a high priority.
Dr. Varmus described the organization and mission of NIH and stressed the many commonalities of the numerous Institutes and Centers. He gave a preview of the NIH budget priorities for 1997, including neuroscience, computer science technology, genetics, and applications related to degenerative diseases. Dr. Varmus also said that NIH should have "greater flexibility in setting its own priorities ... priority setting is best done in an atmosphere in which scientists who manage scientific programs are given maximum flexibility to choose those that show the greatest interest and the greatest importance."
Later the same day, NIDA Director Dr. Alan Leshner testified before this committee as a member of the Neuroscience Panel. Others on this Panel were Dr. Hall, Director, NINDS, and Dr. Kupfer, Director, NEI. In his oral statement, Dr. Leshner not only discussed neuroscience research as a central and critical component of NIDA's research portfolio, but he also emphasized that much of the basic brain research that is supported by other NIH Institutes is also of great interest and use to NIDA. Dr. Leshner stated that "... although we each have our own missionspecific portfolios, we also collaborate a great deal." He gave examples of how this cooperation and collaboration has already provided important information for multiple areas. He also pointed out that addiction is not just a brain disease but is one expressed in behavioral ways and in a social context. Further, all aspects of that complex relationship are critical to understanding and treating addiction. Therefore, NIDA's research spans a wide range of disciplines, from molecular and cellular biology, through the behavioral and social sciences. Neuroscience and addiction research are inextricably linked. As we move into the 21st century, our increasing knowledge of the brain and behavior will allow us to respond to the new challenges posed by new mind-altering drugs.
House Appropriations Hearings on the President's FY 1997 Budget Request
On Monday, April 22, Dr. Alan Leshner, Director, NIDA, testified before the Labor HHS/Education Subcommittee of the House Appropriations Committee. In his testimony, Dr. Leshner discussed the role of the brain in drug addiction and emphasized the importance of dissemination of research advances on drug addiction to the families, communities, practitioners, and policy makers who need it.
Dr. Leshner emphasized that major basic science advances are helping move us much more quickly toward NIDA's top priority goal of developing effective treatment medications for cocaine addiction. He said that these kinds of findings are a major breakthrough because they provide clear biological targets at which to direct anti-cocaine medication development efforts. As one example, Dr. Leshner mentioned that this year NIDA-supported researchers had successfully immunized animals against the stimulant effects of cocaine. As another example, he said that NIDA-supported researchers have recently shown that activation in the brain of one type of dopamine receptor, the D1 receptor, suppresses drug-seeking behavior, whereas activation of the D2 receptor stimulates drug seeking. Thus, he explained, D1 agonist compounds may be good candidates as anti-cocaine medications.
Dr. Leshner also told subcommittee Members that significant progress in identifying effective nonpharmacological behavioral treatments continues to be made. And he spoke of NIDA's substantial efforts devoted to the intersection between drug abuse and HIV/AIDS. As just one example, Dr. Leshner said, NIDA-supported researchers have developed outreach and intervention strategies that are very effective in changing risk behaviors associated with the spread of HIV, even among those drug users not in treatment.
President's FY 1997 Budget Request
It is estimated that in FY 1996, NIH will receive $11.939 billion dollars. For FY 1997 the President has requested $12.424 billion dollars for NIH. It is estimated that $18.0 million of this amount will be in third party payments for patient care costs at the clinical center, if this authority is granted. The authority to collect and keep third-party reimbursements for care provided at the NIH Clinical Center is sought in the President's budget request, with such payments being credited to the NIH Management Fund where they would remain available for one fiscal year after the fiscal year in which they are deposited.
It is estimated that in FY 1996, NIDA will receive $458.441 million (of which $153.3 million is part of the AIDS distribution). For FY 1997, the President has requested $466.3 million (of which $154.3 million is part of the AIDS distribution).
Excluding the increase for the new clinical center, the President's budget requests a 1.6% increase for NIH. This amounts to a $193 million dollar increase in program costs over FY 1996. Most of the boost will target research project grants. "NIH's highest priority continues to be funding investigator-initiated, peer-reviewed research project grants (RPGs)," the agency's budget documents state.
Faced with a modest increase of $166 million dollars in research project funding, NIH has revised its financial management plan to increase the total number of grants. Budget documents state: "Average direct cost increases for RPGs will be revised to 2% in 1997, down from previous annual increases of 4% in part to reflect the declining inflation rates for biomedical research."
At a March 19, 1996 HHS press conference, Dr. Varmus noted that "through my consultations with extramural investigators, its very clear that they would rather have a slight reduction in the increase in noncompetitive awards to allow us to increase the number of new competing awards." He predicted that the FY 1997 RPG success rate will be 24% under the President's plan.
Research training is also slated for an increase in the FY 1997 request. Support for NIH training activities would increase 2.4% or $15 million dollars, to a $404 million dollar total under the President's plan.
One of President Clinton's high priority research areas for FY 1997 is research on "the biology of brain disorders." In budget documents, NIH says: "This research employs animal models, neuroimaging, and clinical studies in an effort to understand many disorders such as pain, addiction, mental illness, neurodegenerative disease, diseases of the aging brain, such as Alzheimer's and damage to the sensory system."
The President signed H.R. 2196, National Technology Transfer Improvements Act, into law on March 7. Introduced by Representative Connie Morella (R-MD), the new law P.L. 104-113 is designed to make it easier for the federal government to enter into CRADAs with private industry. Such agreements allow government and industry to work together to develop science projects and spell out how to distribute royalties among the creative team. It allows a private company to secure the exclusive license for one kind of use for any product that is the result of any such agreement. In return, the federal government is entitled to royalties from the product.
Methamphetamine Control Act
On March 12, Senators Charles Grassley (R-IA) and Dianne Feinstein (D-CA) introduced S. 1607, Methamphetamine Control Act of 1996. This bill would increase the regulation of precursor chemicals necessary to produce methamphetamine and increase the penalties for possession of controlled chemicals or paraphernalia used to make methamphetamine.
NIDA Director's Meeting with Senator Levin
At his request, Senator Carl Levin (D-MI) was briefed on March 28, 1996, by Dr. Alan Leshner, Director, NIDA, on cocaine medications and research advances in this area.
Briefing for Senate Minority Staff on Medications Development
At the request of Senator Moynihan's staff, Dr. Alan Leshner, NIDA Director; Dr. Frank Vocci, Acting Director, MDD, NIDA; and Dr. Tim Condon, Acting Deputy Director, OSPC, NIDA briefed staff to Senators Moynihan, Biden, and Kennedy on progress on medications development and related research issues. This briefing was held on April 11, 1996 in Senator Moynihan's office.
Other Items of Interest
GOP Releases Drug Strategy
On March 28, 1996, the Republican Leadership released a report by the Task Force on National Drug Policy entitled "Setting the Course: A National Drug Strategy." The report states that treatment must remain an important element, but more needs to be done to eliminate duplication and waste. A renewed strategy needs to look at establishing more effective evaluation techniques to determine which treatment programs are most successful, with accountability the key element. Research is not addressed in any depth, but is mentioned in the section "Focus on Treatment Programs that Work" with the following language:
"Another major component in pursuing effective treatment alternatives is basic and applied research into the causes of drug abuse and methods for treating or preventing addiction. In addition to current efforts, one contribution that major pharmaceutical companies can make in this area, in addition to efforts to control the diversion of legal drugs with high abuse potential, would be to support research efforts on drug addiction."
The President's New National Drug Control Strategy
President Clinton and General Barry R. McCaffrey, the new Director of the Office of National Drug Control Policy (ONDCP), released the new National Drug Control Strategy on April 29 in Miami, Florida. General McCaffrey said that the first of the five goals of the 1996 strategy is to motivate America's youth to reject illegal drugs and substance abuse. He emphasized that this is a strategy oriented to youth. The second goal is to reduce drug related crime and violence. Other goals include reducing the health, welfare, and crime costs from illegal drugs; shielding America's frontiers from the threat of drugs; and breaking foreign and domestic sources of supply.
The strategy discusses emerging drugs, including methamphetamine, "...a dangerous drug bringing about violence and loss of physical and mental control." A separate methamphetamine strategy was released the same day to increase penalties, stop the sale of component chemicals, and increase DEA agents assigned to stop trafficking. The budget to implement the overall strategy is $15.1 billion.
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