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Part A: Questions and Answers Regarding the History and Evolution of Methadone Treatment of Opioid Addiction in the United States
Question 4: How have U.S. regulations about treatment for heroin addiction evolved?
Answer: U.S. regulations about treatment for heroin addiction evolved through three time periods:
U.S. regulations about treatment for heroin addiction have evolved from strict prohibition of medical prescription of heroin to treat addiction, which began in 1914 and continued into the 1960s. Initial pilot studies testing methadone maintenance treatment for heroin addiction began in 1964, and methadone maintenance treatment was formally approved in 1972. Scientific advances prompted major reviews of Federal regulations by the Institute of Medicine in 1995 (Rettig and Yarmolinsky, 1995) and the National Institutes of Health in 1998. Both reports recommended reducing Federal regulations and improving patients’ access to treatment. The Drug Addiction Treatment Act of 2000 (Substance Abuse and Mental Health Services Administration, 2000b) made significant changes in U.S. regulations about treatment for heroin addiction, reducing Federal regulations and paving the way for new pharmacotherapies to treat heroin addiction.
1914-1972
Although heroin became a controlled substance under the Harrison Act of 1914, the law did not expressly prohibit the medical prescription of heroin to treat addiction. The U.S. Government concluded that the Harrison Act intended to prohibit such medical uses of controlled substances, prosecuting individual doctors who prescribed the drugs. In 1919, the U.S. Supreme Court upheld the Government’s position in Webb v. United States. In response, about 40 localities opened municipal narcotic clinics to treat addiction using a variety of methods, including medical prescription of narcotics, but by the mid-1920s, these clinics had all been closed by the Federal Government (Hentoff, 1965; Courtwright, 1992). A decade later, the U.S. Public Health Service established narcotics hospitals in Lexington, Kentucky, and Forth Worth, Texas, to treat heroin addiction. From 1935 through the 1960s, the Kentucky facility was the "single most important treatment and research facility in the country (Courtwright, 1992). In 1949, researchers at the Kentucky hospital first demonstrated that methadone could be effective in withdrawing patients from heroin, but relapse rates were as high as 90 percent in subsequent studies. A 1964 pilot study by Drs. Vincent P. Dole and Marie E. Nyswander first demonstrated that methadone maintenance could be an effective medical intervention for heroin addiction (Joseph, Stancliff, and Langrod, 2000).
1972-2000
Methadone maintenance treatment for heroin addiction was first approved by the U.S. Food and Drug Administration in 1972, subject to three levels of Federal regulation:
- Food and Drug Administration rules that pertained to all prescription drugs
- Drug Enforcement Administration rules that governed all controlled substances
- Unique Department of Health and Human Services rules limiting methadone maintenance treatment to strictly controlled opioid treatment programs, which also were subject to additional State or local rules
2000-Present
The Drug Addiction Treatment Act of 2000 (Substance Abuse and Mental Health Services Administration, 2000b) revised Federal regulations governing methadone maintenance treatment, making them both more rigorous and more practical. While treatment providers have more latitude in planning individualized treatment regimens and prescribing methadone dosages, they also must document and analyze outcomes and correct shortcomings (Marion, 2005). The law also authorized office-based dispensing of treatment medications providing physicians met specific licensing, certification, training, and best practices requirements. Buprenorphine, a new pharmacotherapy to treat heroin addiction (Substance Abuse and Mental Health Services Administration, 2000a), was approved for office-based dispensing by the Food and Drug Administration in 2002.
References
Courtwright D. A century of American narcotic policy. In: Institute of Medicine. Treating Drug Problems: Volume 2. Washington, DC: IOM, 1992, pp. 1-62. Available online at: books.nap.edu/openbook.php?isbn=0309043964. [Accessed March 23, 2006.]
Hentoff N. The treatment of patients - I. The New Yorker 1965;June 26:32-77.
Joseph H, Stancliff S, Langrod J. Methadone maintenance treatment (MMT): a review of historical and clinical issues. The Mount Sinai Journal of Medicine 2000;67(5 & 6):347-64. Available online at: www.mssm.edu/msjournal/67/6756.shtml. [Accessed March 23, 2006.]
Marion IJ. Methadone treatment at forty. NIDA Science & Practice Perspectives 2005;3(1):25-31. Available online at: http://drugabuse.gov/Perspectives/vol3no1.html. [Accessed March 23, 2006.]
National Institutes of Health. Effective Medical Treatment of Opiate Addiction: Consensus Development Conference Statement. Bethesda, MD: NIH, 1998. Available online at: http://consensus.nih.gov/1997/1998TreatOpiateAddiction108html.htm. [Accessed March 22, 2006.]
Rettig R, Yarmolinsky A (eds.). Federal Regulation of Methadone Treatment. Washington, DC: Institute of Medicine, 1995, pp. 1-16. Available online at: books.nap.edu/catalog.php?record_id=4899. [Accessed March 22, 2006.]
Substance Abuse and Mental Health Services Administration. About Buprenorphine Therapy. Rockville, MD: SAMHSA, 2000a. Available online at: http://buprenorphine.samhsa.gov/about.html. [Accessed March 23, 2006.]
Substance Abuse and Mental Health Services Administration. Drug Addiction Treatment Act of 2000. Rockville, MD: SAMHSA, 2000b. Available online at: http://buprenorphine.samhsa.gov/data.html. [Accessed March 23, 2006.]
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