April 12, 2000
It is a pleasure to be with you today to discuss addiction and the progress we have made with methadone as well as our policy challenges and vision for the future. We applaud each of you who participated in this conference for your commitment and perseverance in ensuring that America implements an effective, science-based strategy for treating opiate addicts. Despite a lack of understanding by many, you continue to fight for what you know is right. The Office of National Drug Control Policy (ONDCP) commends your strength and courage. Opiate addiction is a chronic, recurring brain disease. The awful plight of opiate addicts deserves our firm, compassionate, immediate response.
Thanks to the leadership of the American Methadone Treatment Association, methadone treatment has been placed on our nation’s agenda. There is still considerable progress to be made, but we are heading in the right direction. AMTA has set the precedent for change.
At this stage in the debate, we need to examine our policy challenges and outline a vision for the future. We must act on current knowledge and continue working toward our goals. Our responsibility is to inform the public about scientific research in this arena so that the proper medical and political decisions will be made.
Our primary challenge is to expand treatment availability. Currently, five million people in the United States are chronic drug abusers and 20% are opiate addicts. Only 2.1 million receive treatment and 179,000 of this 2.1 million are in opiate treatment. Closing this gap, from both sides, is our goal. Sound science, which leads to enlightened policy, is helping us achieve it. We must reduce ignorant skepticism on the importance of treatment. Expanding opiate treatment is a critical step in overcoming our challenge. The methadone treatment community – those of you who are here today and your colleagues – can be the rising tide that lifts all ships.
Part I of this speech highlights those who have been visionaries in the methadone field – individuals who informed the discussion on opiate addiction through trailblazing efforts. They are responsible for the advent of methadone clinics in forty-two states. Part II examines what we know about addiction. Part III looks at the status of drug treatment and what we are doing to make it more available. Part IV provides an update on our past-year progress in implementing a new system of federal oversight for treatment programs, particularly methadone. Part V outlines policy issues that currently define the methadone debate. Part VI articulates our vision for the future of methadone treatment.
I. The Methadone Visionaries
In order to understand our progress with methadone, we must acknowledge the individuals who first broke social and policy barriers to introduce methadone treatment. In the fifties, Dr. Vincent Dole and Dr. Marie Nyswander were scientists instrumental in the reformulation of methadone as an opiate addiction medication. Dr. Mary Jeanne Kreek, who continues to work in her laboratory at Rockefeller University, later joined them. Over the past 40 years, the groundbreaking work of these 3 scientists has made methadone the most studied medication on the market – a medication of proven effectiveness. The work of these scientists continues through Dr. Kreek and numerous other researchers at some of the most outstanding universities in the U.S. and around the world.
It is also necessary to acknowledge Dr. Avram Goldstein for his benchmark science on the neurobiology of opiate addiction and Dr. Charles “Chuck” O’Brien for his research and scholarly contributions to training development for the education of medical students on addiction. Finally, we must recognize Mark Parrino, an outstanding leader of AMTA who has enabled our progress in this field.
II. Research on Addiction
Scientific research and clinical experience have increased our understanding of addiction. Consequently, what was once a sterile policy debate is now one based on science. Over 25 years of research by the National Institute on Drug Abuse (NIDA) shows that because of the chemical structure of opiates (and heroin in particular) these substances are able to rapidly enter the brain. Heroin crosses the blood brain barrier and attaches to natural opioid receptors. By binding to these receptors the drug initiates multiple physiological effects, including pain reduction, depression of heart rate, and slowing of respiration. The effects that heroin has on respiration are what lead to lethal outcomes in the case of an overdose. Heroin also acts on the brain’s natural reward circuitry to produce a surge of pleasurable sensations. It is, of course, the pleasurable effects that cause people to take drugs. And, NIDA research shows that prolonged drug use can actually change brains. These changes are thought to play an integral role in the development of addiction. Powerful technologies are giving us greater insight into these dramatic brain alterations.
Understanding the neurobiology of addiction has led to the development of effective tools to treat opiate addiction and help manage physical withdrawal symptoms that accompany sudden cessation of drug use. We now know that withdrawal and physical dependence are only a minor part of the problem that must be addressed when treating opiate addicts. In fact, withdrawal symptoms can be effectively managed through the use of modern medicines. Recognizing that addiction is, at its core, a consequence of fundamental changes in brain function means that a major goal of treatment must be to compensate for brain changes through medication or behavior modification.
Addiction is not just a brain disease. The social context in which drug dependence expresses itself is critically important. The case of thousands of returning Vietnam veterans who were addicted to heroin illustrates this point. In contrast to addicts on the streets of America, many of the veterans who became addicted did so in a totally different setting from the one to which they returned. At home in the United States, veterans were exposed to very few of the conditioned environmental cues that had been associated with drug use in Southeast Asia. Conditioned cues can be a major factor in causing recurrent drug cravings and relapse even after successful treatment.
Addiction is not an acute illness. For most people, it is a chronic relapsing illness with an increasingly volitional dimension as recovery proceeds. Total abstinence for the rest of one’s life is relatively rare following a single experience in treatment. Relapses are not unusual. Addicts suffer setbacks, just as a diabetic or arthritis sufferer does. Thus, addiction must be approached like other chronic illnesses, requiring management and monitoring. This approach has serious implications for how we evaluate treatment. Viewing addiction as a chronic illness means that a good treatment outcome is no drug use over long periods of abstinence. Behavioral and psychosocial interventions must be implemented in conjunction with pharmacological interventions to maximize successful treatment outcomes for addiction.
III. Status of Drug Treatment
A significant treatment gap – defined as the difference between individuals who would benefit from treatment and those receiving it – exists. According to recent estimates drawn from the National Household Survey on Drug Abuse (NHSDA), the Uniform Facility Data Set (UFDS), and other sources, approximately five million drug users needed immediate treatment in 1998 while 2.1 million received it. Certain parts of the country have little treatment capacity of any sort. Likewise, some populations – adolescents, women with small children, and racial as well as ethnic minorities – are woefully under-served. According to the Child Welfare League of America, in 1997 only ten percent of child welfare agencies were able to locate treatment within a month for clients who needed it. According to Substance Abuse and Mental Health Services Administration (SAMHSA), 37 percent of substance-abusing mothers of minors received treatment in 1997. Some modalities, namely methadone, fall short of needed capacity; only 179,000 patients were in methadone treatment at the close of 1998. Furthermore, while treatment should be available to those who request it, society also has a strong interest in helping populations that need treatment but will not seek it. Drug-dependent criminal offenders and addicts engaging in high-risk behavior are important candidates for treatment.
Ultimately, calculations of the treatment gap should include both actual demand and populations that society has a special interest in treating due to the high social cost associated with their drug abuse. Starting in 2000, a new methodology, based on clinical criteria, will be employed in the NHSDA. This approach will provide improved national estimates by August 2001. More precise numbers will be helpful in determining the magnitude of the treatment gap and targeting resources to the areas where the gap is greatest.
Limited funding for substance-abuse treatment is a major factor that restricts the availability of treatment. Over the last decade, spending on substance-abuse prevention and treatment rose to an estimated annual level of $12.6 billion. Of this amount, public spending is estimated at $7.6 billion. The public sector includes Medicaid, Medicare, federal agencies like the Veterans Administration, the Substance Abuse Prevention and Treatment (SAPT) Block Grant, and other state and local government expenditures. Private spending is estimated at $4.7 billion and includes individual out-of-pocket payment, insurance, and other non-public sources. One of the main reasons for the higher outlay in public spending is the frequently limited coverage by private insurers. The lack of coverage and recent changes in payment structures affect attitudes, resources, treatment plans, and the quality of treatment. Private and public insurers are not working collaboratively; thus, more public resources are utilized, and government funds – which were intended to be a safety net – have become a primary option for many individuals.
In addition to resource limitations, other factors confine treatment, including restrictive policies and regulations, incomplete knowledge of best practices, resistance to treatment on the part of certain populations in need, and limited information on treatment at the state and local level. Action in the following areas can make treatment more available:
- Increasing Substance Abuse Prevention and Treatment (SAPT) Block Grant funding to close the treatment gap.
- Using funding under SAMHSA’s Targeted Capacity Expansion program; expanding services to vulnerable and underserved populations; reaching out to those at risk of HIV/AIDS; and increasing community options for sanctions among criminal and juvenile justice clients.
- Using regulatory change to make proven modalities more accessible: reforming regulation of methadone/LAAM treatment, maintaining and improving program quality; training treatment professionals and physicians to employ the proper administration of opiate agonists and emerging pharmacotherapies; conducting demonstrations of administration by doctors of opiate agonists; and providing comprehensive evaluation of the impact of regulatory reform on treatment access, quality, and cost.
- Continuing to examine possible changes in policy to remove barriers, such as lack of parity in insurance coverage. For example, the President recently announced that the Federal Employees Health Benefits Plan (FEHB) would provide parity for both substance abuse and mental health services.
- Reviewing policies, practices, and federal statutory requirements, such as the statutory exclusion of Medicaid funding for Institutes for Mental Disease (IMD), which may affect access to residential treatment services for substance abuse.
- Prioritizing research, evaluation, and dissemination – including state-by-state estimates of drug-treatment need, demand, and treatment resources; dissemination of best treatment practices; guidance on ways to increase retention and reduce relapse; and foster progress from external coercion to internal motivation.
- Reducing stigma associated with drug treatment.
IV. Update on Federal Oversight of Treatment Programs
To improve treatment accountability, ONDCP is piloting an information system with treatment programs around the country that will be expanded by the Department of Health and Human Services (DHHS) into the National Treatment Outcome Monitoring System (NTOMS). Under NTOMS, treatment performance will be measured and compared. In addition, an agreement has been negotiated with the states to establish a common set of outcome measures to be applied to programs receiving federal funding. In addition, “A Notice of Proposed Rule Making” – published in the Federal Register on July 22, 1999 – proposed a new system of federal oversight for opioid treatment programs. This approach would transfer regulatory oversight from FDA to SAMHSA, provide greater flexibility to practitioners, and require program accreditation as a means of implementing best practice guidelines.
Treatment services are being fostered through: manuals created by NIDA, Treatment Improvement Protocols and addiction curricula by the Center for Substance Abuse Treatment (CSAT), clinical guidelines by the Department of Veterans Affairs (VA), and a comprehensive curriculum for treatment by the Federal Bureau of Prisons (BOP). State and local treatment programs with promising results are applying these resources. CSAT has joined with the Certification Board for Addiction Professionals of Florida and a number of national stakeholder organizations to develop core competencies for substance-abuse counselors. Ultimately, these efforts will lead to a body of certified professionals equipped with manuals reflecting the most advanced approaches to treatment.
V. Policy Issues
The most significant policy issues confronting the future of methadone treatment in this country are: 1) Buprenorphine, 2) office-based opiate therapy, and 3) accreditation. We must concentrate our efforts on these critical challenges and be cogniscent of them as we define, adjust, and implement our vision.
In an effort to give treatment providers another effective tool to combat heroin addiction, the National Institute on Drug Abuse (NIDA) is working with other HHS agencies, including the Center for Substance Abuse Treatment (CSAT) and the Food and Drug Administration (FDA), and the pharmaceutical industry to bring to market Buprenorphine-naloxone. This medication has the potential for administration in less traditional environments, thereby expanding treatment to populations who either do not have access to methadone programs or are unsuited for them, such as adolescents. Buprenorphine would not be a replacement for methadone or LAAM, but rather another treatment option for both physicians and patients.
We must continue addressing the laws and regulations that limit physicians from using narcotics to treat narcotic diseases. We have an opportunity with Buprenorphine to reduce the stigma of addiction by incorporating drug treatment into regular medical practice. This medication can be instrumental in normalizing drug treatment. With educated practitioners and accepted standards of training, Buprenorphine can set a precedent for the social acceptance of opiate addiction treatment.
Office-Based Opiate Therapy (OBOT)
Drug addiction is a disease. As such, its treatment should be part of medical practice. Consequently, drug treatment should be available in physicians’ offices. Mainstreaming opiate-based treatment by offering office-based opiate therapy will help eliminate the stigma associated with opiate addiction and treatment, while encouraging the inclusion of addiction education in medical school curricula and physician training. Office-based opiate therapy will ensure that the training and clinical standards applied to mainstream medical practice will be applied to drug treatment. The regulations that govern physicians’ clinics should be the same that regulate opiate-based treatment. In addition, OBOT will enable physicians to conduct comprehensive assessments of patients to determine what treatment is best rather than supporting a preferred or available modality. The resources for curing other medical diseases should be available to addiction. The most efficient way for this shift to occur is through office-based opiate therapy.
Today, accreditation is being pilot-tested in approximately 170 programs across the United States. We are seeking data about the impact of accreditation on the quality of care in methadone treatment programs. We can hypothesize that granting credentials to clinics and workers will improve the level of care and ensure high standards of treatment. If accreditation can improve methadone delivery in treatment programs and facilitate mainstreaming drug treatment, it should be a fundamental component of methadone policy in this country. Research currently underway will direct our actions.
VI. Vision for the Future
The future of methadone treatment can be separated into two areas: program and policy. Our programmatic concerns focus on where programs must be started and how they should be developed. Our policy vision examines how policies can enable mainstreaming drug treatment.
The most recent data available reveals that 179,000 patients were in methadone treatment at the end of 1998. However, 980,000 individuals are addicted to heroin. The primary way to close this gap is to mainstream opiate addiction treatment. We must be able to provide treatment to anyone who needs it by offering needs-based services in medical clinics nationwide. We should also enforce user and program accountability to ensure that the quality of treatment is not compromised.
Finally, we must unify all programs. Treatment facilities must offer comprehensive services. Programs can, of course, specialize in certain kinds of treatment, but a patient should have access to all modalities to ensure that that individual is receiving the best choice for him.
Our first mission, from a policy perspective, is to challenge the eight states that do not offer methadone treatment – Idaho, Mississippi, Montana, New Hampshire, North Dakota, South Dakota, Vermont, and West Virginia – to do so. Methadone should be accepted in every state and we are in the process of reaching out to the leadership of these states to make this change happen. Addiction is a relapsing brain disease. There is no reason why treatment for this ailment should be isolated from other types of care. Methadone can be critical for an addict’s reentry into society. Restricting methadone erects unnecessary barriers to recovery. As policy makers, we bear responsibility for removing obstacles to individual and communal health.
The second issue on our policy agenda is to review policies, practices, and federal statutory requirements, such as the statutory exclusion of Medicaid funding for Institutes for Mental Disease (IMD), which may affect access to residential treatment services for substance abuse. At the National Assembly on Drugs, Alcohol Abuse, and the Criminal Offender this past December, Donna Shalala asserted that she would review the IMD exclusion. We commend her initiative. No disease should be excluded from coverage.
At the Office of National Drug Control Policy, we are committed to reducing demand, specifically through prevention and treatment. Prevention spending has increased 52 percent since FY96 and funds for treatment increased 32 percent since FY96 to a record $3.15 billion in FY01. We are leveraging our resources to accomplish our goals and our efforts are paying off.
We are making significant progress toward mainstreaming drug addiction treatment. Our hope is to offer addicts the same level of care as individuals afflicted with other diseases. Administration of opiate-addiction therapy, including Buprenorphine, in physicians’ offices, as well as accreditation of clinics offering drug treatment, will help this country integrate drug treatment into the medical approach to all diseases.
Our primary challenge is expanding treatment availability. Increasing the accessibility of opiate treatment is a crucial step in helping us achieve our goal. Because twenty percent of the addicted population in this country is opiate addicts, the standards established with opiate treatment can set a precedent in this field of drug treatment. We must work to dispel the misunderstandings surrounding treatment, as well as ensure that opiate-addiction therapy is a standard component of all medical practices. Thank you for your dedication and commitment. The tireless efforts and hard work of this community are making all the difference.