Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Critical Barrier 2: A Substance Abuse Treatment System that Limits Access to this Market


There was consensus among the pharmaceutical company representatives that the current substance abuse treatment system constitutes a great market barrier that severely limits opportunities for market penetration.

As reported in the case studies, sales of LAAM and naltrexone were restricted by the limited number of heroin and alcohol treatment programs and the limited capacity of these programs. Twenty-five percent of opiate addicts receive treatment from the methadone maintenance programs while less than 1 percent of people in the U.S. afflicted by alcohol abuse and dependence are in alcohol treatment centers. LAAM is restricted to maintenance programs as required by The Narcotic Addict Treatment Act of 1974. Distribution of naltrexone is limited to comprehensive treatment centers, which enhance patient compliance. These market restrictions severely limit sales of the drugs and create another barrier to pharmaceutical companies that are considering developing a pharmacotherapy for drug addiction. One major market advantage of Nicorette is that, with an over-the-counter formulation, patients do not need to visit a treatment center or a provider to obtain treatment, vastly expanding market potential.

The lack of medical treatment models is another shortcoming of the substance abuse treatment system that poses a major concern for pharmaceutical companies. The pharmaceutical company executives cited an "anti-medication" climate among publicly-funded treatment center staff that would severely limit sales of pharmacotherapies through treatment centers. Interviewees implicated the large number of non-physicians (a.k.a. "non-prescribers") as the main reason for the anti-medication sentiment at these treatment centers.

Our market analysis supports the finding that there is a large number of non-physicians at publicly-funded treatment centers. The 1991 NDATUS study of specialty substance abuse providers surveyed 9,000 treatment centers and found that there were only about 2.2 full-time equivalent psychiatrists and other physicians, respectively, per 1,000 enrolled patients (Office of Applied Studies, 1993). The most recent surveys that have examined staffing patterns confirm that the substance abuse treatment system involves little or no physician time in the treatment of patients.

For example, methadone treatment for heroin addiction would appear to be the most medically oriented model of drug treatment. However, the role of physicians in methadone clinics is generally small and circumscribed to initial diagnostic assessments (i.e., of heroin addiction), management of methadone dosage, and some primary health care services. Most clinic services are oriented to the behavioral and psychosocial needs of the patients, and are delivered by counselors, social workers, and, less often, psychologists (Institute of Medicine, 1990).

This sentiment was repeated in our LAAM and naltrexone (Trexan) case studies, which found that a major market barrier for both products has been that treatment decisions and funding for heroin addiction are often controlled by state-level substance abuse program administrators who often do not have clinical backgrounds.