Commentary
Sen. Carl Levin
The fight against heroin addiction has taken a major leap forward after a decade of struggle. The Food and Drug Administration (FDA) has announced the approval of a new anti-addiction drug , buprenorphine/naloxone, which, followed with the directives of a new law I authored along with Senators Hatch and Biden, makes a dramatic change in the way America fights heroin addiction.
This new anti-addiction drug, developed under a Cooperative Research and Development Agreement (CRADA) between the National Institute on Drug Abuse (NIDA) and a private pharmaceutical company, has been the subject of extensive successful research and clinical trials in the United States. The new law, the Drug Addiction Treatment Act of 2000, permits, for the first time, such anti-addiction medications to be dispensed in the private office of qualified physicians, rather than in a centralized clinic. That change can have a revolutionary reduction in the number of addicts, the crimes some of them commit, and the heroin-related deaths which have occurred.
This newly approved anti-addiction medication has already been in use in France, where significant success has been achieved in getting patients off of heroin, reducing drug-related crime and reducing heroin-related deaths. For example, user crime in France and arrests are down by 57 percent and there has been an 80 percent decline in deaths by heroin overdose.
It is estimated that there are approximately one million individuals in the U.S. who are addicted to heroin. The new office-based system is a revolutionary change and will make our communities better and safer places to live. It will open the door to tens of thousands of individuals to get rid of their addiction, but are now unable to or are reluctant to seek medical treatment at centralized methadone clinics, where their appearance amounts to an announcement of their addiction and which, for many addicts, are difficult to get to for their once- or twice-a-day dose. According to a report by the Department of Health and Human Services, many individuals who want get rid of their addiction will not go to centralized clinics, "....because of the stigma of being in methadone treatment....." The report went on to say that HHS was:
"....especially encouraged by the results of published clinical studies of buprenorphine. Buprenorphine is a partial mu opiate receptor agonist, in Schedule V of the Controlled Substances Act, with unique properties which differentiate it from full agonists such as methadone or LAAM. The pharmacology of the combination tablet consisting of buprenorphine and naloxone results in...low value and low desirability for diversion on the street. Published clinical studies suggest that it has very limited euphorigenic affects, and has the ability to precipitate withdrawal in individuals who are highly dependent upon other opioids. Thus, buprenorphine and Buprenorphine/ naloxone products are expected to have low diversion potential...and should increase the amount of treatment capacity available and expand the range of treatment options that can be used by physicians.
The compelling need for this new system of treatment is borne out in some astonishing data. A recent study by the U.S. Office of National Drug Control Policy (ONDCP), released in January of this year, shows that illegal drugs drain $160 billion a year from the American economy; and that the majority of these costs, $98.5 billion, stem from lost productivity due to drug-related illnesses and deaths, as well as incarcerations and work hours missed by victims of crime. The report found that illegal drug use cost the health-care industry $12.9 billion in 1998. Commenting on the release of the study, ONDCP Director John P. Walters said:
"Drugs are a direct threat to the economic security of the United States....and results in lower productivity, more workplace accidents, and higher health-care costs, all of which constrain America's economic output. Reducing substance abuse now would have an immediate, positive impact on our economic vitality. When we talk about the toll that drugs take on our country, especially on our young people, we usually point to the human costs: lives ruined, potential extinguished, and dreams derailed. This study provides some grim accounting, putting a specific dollar figure on the economic waste that illegal drugs represent."
Another recent study, released in September of this year, determined that the majority of drug offenders in our state prisons have no history of violence or high-level drug dealing. The study found that of the estimated 250,000 drug offenders in state prisons, 58 percent are nonviolent offenders. The authors concluded that these nonviolent offenders "....represent a pool of appropriate candidates for diversion to treatment programs ...." They went on to say that "The 'war on drugs' has been overly punitive and costly and has diverted attention and resources from potentially more constructive approaches."
Of the juveniles who land behind bars in state institutions, more than 60 percent of them reported using drugs once a week or more, and over 40 percent reported being under the influence of drugs while committing crimes, according to a report from the Bureau of Justice Statistics. Drug-related incarcerations are up and we are building more jails and prisons to accommodate them -- more than 1000 have been built over the past 20 years. According to the July 14, 1999 Office of National Drug Control Policy Update, "Drug-related arrests are up from 1.1 million arrests in 1988 to 1.6 million arrests in 1997--steady increases every year since 1991."
In a September 3, 2001 interview with the New York Times, then-Drug Enforcement Administration nominee Asa Hutchinson underscored the need for drug rehabilitation for nonviolent offenders, saying that we are "not going to arrest [our] way out of this problem."
I believe that the system that we have finally put in place will effectively put America on the right road to fighting and winning the heroin addiction war. It has been a long and difficult road for over a decade. First, in providing the resources to help speed the development and delivery anti-addiction drugs that block the craving for illicit addictive substances. Second, in authoring a law that would allow for such medications to be dispensed in an office-based setting rather than centralized clinics, by physicians who are certified in the treatment of addiction.
In 1996, the Senate adopted my amendment to the budget resolution to steer $500 million over six years to the National Institute on Drug Abuse, which resulted in substantial increases in funding for research conducted by the National Institute on Drug Abuse. Then, in 1997, Senator Moynihan and Senator Bob Kerrey joined me in convening a panel of experts to present their expert views at a Drug Forum on Anti-addiction Research, in an effort to assess the level of progress and needed support to expedite new anti-addiction discoveries. In October, 2000, the Drug Addiction Treatment Act, was enacted into law. Today, we are taking a giant step forward with the Food and Drug Administration's approval of this new anti-addiction drug, which will allow for the appropriate and long awaited, conventional, office based approach to addiction treatment in this country.
The protections in the new law against abuse are as follows: Physicians may not treat more than 30 patients in an office setting; appropriate counseling and other ancillary services must be offered; the Attorney General may terminate a physician's DEA registration if these conditions are violated; and the program may be discontinued altogether if the Secretary of HHS and Attorney General determine that this new type of decentralized treatment has not proven to be an effective form of treatment.
This great success would not have been possible without the scientific genius, leadership and steadfast support of many individuals, including, Dr. Alan Leshner, who, during his 7-year tenure as Director of NIDA, energetically led the government initiated partnership that produced buprenorphine/naloxone for the treatment of heroin addition; Dr. Frank Vocci, a brilliant scientist who heads up Medications Development at NIDA and whose tutoring has led me to a better understanding of the science of addiction; Dr. Charles Schuster of Wayne State University, a past director of NIDA who has conducted clinical trials on buprenorphine/naloxone, the results of which have been presented in testimony before Congress. Dr. Schuster has been my resource and my guide on this issue from the very beginning and his advice and expertise continues today;
Dr. James H. Woods, Director of Drug Addiction Research Projects at the University of Michigan, has long been a progressive force in the area of addiction research, and has been an effective voice in the formulation of legislative policy in the area of addiction both at home and abroad; Dr. Herbert Kleber, Professor of Psychiatry and at Columbia University and one of the nation's foremost experts on drug addiction and treatment provided invaluable assistance to me in putting together this new system of treatment; Dr Chris-Ellyn Johanson, President-elect of the College on Problems of Drug Dependence and Professor in the Department of Psychiatry and Behavioral Neuroscience at Wayne State University. Dr. Johanson has made major contributions to the understanding the basis of the buprenorphine therapeutic effects in the treatment of heroin abuse and dependence; and Dr. Stephanie Meyers Schim, former president of the Michigan Public Health Association, who has helped us to understand that drug addiction is a public health problem that is in crisis and that our health policies should reflect this reality.
Carl Levin (D) has served in the U.S. Senate for the state of Michigan since 1978.