Fight Against Heroin Addiction : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 4)

Methadone and LAAM can interact adversely with tranquilizers, tricyclic antidepressants, alcohol, and other drugs. They can worsen low blood pressure and asthma. They can cause breathing difficulty and impaired circulation. Less serious methadone side effects include dizziness, vomiting, and sweating; LAAM can cause flu-like symptoms, diarrhea, and muscle aches.

Maintenance Works

"If your goal is to reduce drug abuse," says Nicholas Reuter, a consumer safety officer in FDA's Office of Health Affairs, "a properly administered maintenance program appears to be the most effective treatment." Reuter is executive secretary of the federal interagency review board that coordinates regulation of the programs. Last year, the board reviewed U.S. and international research on methadone — which has been studied extensively — following media reports that questioned the safety of methadone treatment.

According to MDD's Coulis, effectiveness of maintenance treatment can be measured by these outcomes: reduced heroin use, staying in treatment, and perceptions by both patient and doctor of improved well-being.

Reuter adds that patients receiving maintenance treatment have a death rate 10 times lower than untreated addicts and an incidence of needle-sharing of 14 percent, compared to 47 percent before treatment. In a recent Swiss study of people with HIV infection, he says, 24 percent of maintenance program cases progressed to AIDS, compared to 41 percent of untreated heroin abusers.

"Retention in treatment is crucial," Reuter says. "In a direct line with the time patients spend in treatment, their general health and social productivity improve, and their drug abuse and criminal activities diminish." He says some studies show that patients stay in maintenance programs at a rate two-and-a-half times that of patients in self-help residential programs, and five times that of patients in drug-free outpatient programs. Of those who stop treatment, more than 80 percent relapse within a year.

"While maintenance treatment can't guarantee relapse prevention even during treatment," Reuter says, "it is consistent with medical management of chronic diseases such as diabetes, heart disease, and arthritis."

Suspicion

Despite more than two decades of documented success of maintenance therapy, the idea of treating addiction with addictive medications is often viewed by the public with suspicion.

One source of this uneasiness is a misunderstanding of heroin addiction, says Robert Lubran, chief of the Quality Assurance and Evaluation Branch, Division of State Programs, in the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment.

"Many people," Lubran says, "don't realize that heroin addicts must fight their addiction all their lives. Others equate patients in maintenance programs with street addicts. In fact, the patients are at some level of recovery, which benefits society as well as the patient."

Another source of suspicion is the ineffectiveness of some programs, which Lubran attributes to poor medical or clinical practices, such as inappropriate medication dosing to control withdrawal, failure to properly screen and assess patients' needs for counseling and support services, and lack of qualified counseling staff. "Research indicates that a few patients may do all right with minimum services," he says. "Most do not."

Strong Medicines, Strong Rules

Narcotic maintenance treatment is regulated by FDA, the Drug Enforcement Administration, and state authorities. FDA approves only programs previously approved at the state level and registered with DEA. Currently approved are 791 maintenance programs and 282 hospital programs (see map), serving some 115,000 patients. Of these programs, 46 are approved to use LAAM. Maintenance medications are unique in drug regulation, and this type of regulation is unique in medical practice, says FDA Associate Commissioner for Health Affairs Stuart Nightingale, M.D., who chairs the programs' interagency review board.

"For no other class of drugs do we write and enforce rules that directly affect how they're used in treatment," Nightingale says. "With these medications, we specify rules for clinical practice, such as requiring physicians to prepare and sign a treatment plan for each patient and document all changes in dosing regimens."

Because of the implications for medical practice and other broad societal concerns, Nightingale says, "the interagency committee has been critical to the success of the federal coordination." The committee includes representatives from FDA, NIDA, SAMHSA, DEA, VA, the Office of the Secretary of Health and Human Services, the Office of the Assistant Secretary for Health, and the Office of National Drug Control Policy.

Treatment clinics must register with DEA and meet security rules because methadone and LAAM are controlled substances (drugs regulated by the Federal Controlled Substances Acts). DEA requires additional registration by the physicians who treat narcotic addiction with narcotics.

In light of the addictive potential and potential for overdose, both FDA and state authorities require safety measures and medication control rules in programs using methadone or LAAM. The Department of Health and Human Services, FDA's parent agency, must by law provide treatment standards for narcotics used to treat narcotic dependence. These are minimum standards, currently in the form of regulations. Individual states can, and some do, develop stricter rules.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.