Scott Ehlers, Drug Policy Foundation, [email protected], http://www.dpf.orgIn a surprise display of bipartisan unity in dealing with addiction as a health, rather than a criminal justice matter, Senators Orrin Hatch (R-UT), Carl Levin (D-MI), and Daniel Moynihan (D-NY) have joined forces to expand the provision of maintenance therapy for opiate dependency. The three senators are cosponsoring S. 324, the "Drug Addiction Treatment Act of 1999," which was introduced on January 28 and referred to the Senate Judiciary Committee.
The bill would, for the first time since the passage of the Harrison Narcotics Act of 1914, allow a general practitioner to maintain an opiate-dependent patient on a narcotic, in this case a Schedule IV or V drug. The sponsors of the bill are particularly interested in allowing physicians to prescribe buprenorphine and a buprenorphine/naloxone combination to maintain or detoxify patients. Buprenorphine is a mild, Schedule V narcotic that has been used in maintenance therapy for heroin addicts in France.
Under the Narcotic Treatment Act of 1974, physicians must now get a DEA registration and approval by the US Department of Health and Human Services to use approved narcotics in drug abuse treatment. Additionally, state agencies are involved in the regulation process. This burdensome regulatory scheme has resulted in "a treatment system consisting primarily of large methadone clinics located in big cities, and preventing physicians from treating patients in an office setting or in rural or small towns, thereby denying treatment to thousands in need of it," according to Sen. Levin (CR, p. S1091).
The current system also prevents new FDA-approved addiction treatment drugs from being utilized. Alan Leshner, Director of the National Institute on Drug Abuse, noted in a memo to Sen. Levin that the burdensome regulations have prevented drugs like LAAM from making an appreciable impact on the "treatment gap" since the drug's introduction in 1993.
S. 324 would require a physician to: (1) notify the Secretary of Health and Human Services ("Secretary") that s/he intends to dispense approved drugs for maintenance or detoxification treatment; (2) have, "by training or experience," the ability to treat and manage opiate-dependent patients; (3) have the capacity to refer patients to appropriate counseling and other services; and (4) limit the number of patients treated at one time to 20, unless the Secretary changes the number through the regulatory process.
The bill would require drugs in Schedule IV or V to: (1) be approved under the Food, Drug and Cosmetic Act or section 351 of the Public Health Act for maintenance or detoxification treatment; and (2) not be subject to an "adverse determination" by the Secretary and Attorney General.
To determine the effectiveness of the law and whether it should remain in effect, the Secretary is required to determine the effectiveness of the treatments and if treatment availability has increased. The Attorney General is required to monitor doctor and patient compliance with the regulations, including the diversion of prescribed maintenance drugs. The Secretary or Attorney General can end the program at any time, and states can prevent physicians from treating patients through the passage of legislation.
Although buprenorphine maintenance won't help many of the persons being maintained on methadone today, it could help lower-level, younger users who haven't developed a high tolerance to opiates, according to Dr. Marc Shinderman, medical director of the Center for Addictive Problems in Chicago. He added, "This legislation would allow patients and doctors to develop a therapeutic alliance in an office-based setting, and provide a low-threshold treatment option which is now not possible with methadone due to governmental over-regulation."
Edith Springer, Senior Trainer at the Harm Reduction Training Institute and a board member of the Drug Policy Foundation, also welcomed the legislation. "Although the bill doesn't go far enough in allowing doctors and patients to decide on the treatment of their choice, passage of this legislation would set a precedent that can only help us. Some people have found buprenorphine to be helpful and patients should have it available as a mode of treatment."