Use of Immunotherapies and Sustained Release Formulas for Treating Drug Addiction

United States

Bioethics Taskforce Report - National Advisory Council on Drug Abuse Meeting
Council Members: Drs. Dorothy K. Hatsukami, Scott Reines, Jose Szapocznik, Claire Sterk, David Vlahov, NIDA Staff Members: Drs. Timothy Condon, Susan Weiss, Gayathri Dowling, Lucinda Miner, and Kay Nimit 

The National Institute on Drug Abuse commissioned a report from the National Research Council (NRC) and Institute of Medicine (IOM) to investigate "the behavioral, legal and social questions likely to arise from the unique characteristics of immunotherapies and sustained release formulations for the treatment of drug addiction, if and when these medications become available." These issues include concerns regarding who should be given these medications and under what circumstances. The report, New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions and the executive summary for this report are available. The taskforce was asked to review the report, determine whether they would recommend endorsement of the NRC/IOM Committee's recommendations, and come to a consensus on the recommendations that should receive high priority by NIDA.

The taskforce recommends to the National Advisory Council on Drug Abuse (NACDA) endorsement of the general principles of the NRC/IOM report. The members of the taskforce also wanted to emphasize that they strongly encourage the continued development and testing of these promising medications that can have considerable public health potential. Although the taskforce approved of the framework of the agenda that was proposed by the NRC/IOM committee, it was noted that some of these recommendations will become more relevant as the field develops and should be considered at that time (e.g., research on the potential effect of immunotherapy medications on illicit drug markets). Therefore, the taskforce would also like to make the following suggestions to provide a timeline for the recommendations that were made by the NRC/IOM Committee.

• The first step would involve research that results in and includes clinical trials for immunotherapies and depot medications. In order to achieve this goal the taskforce recommends the development of an RFA or PA to: 1) Support of basic immunology studies on increasing the stability and longevity of antibody levels and developing combination therapies to simultaneously treat a variety of abused drugs (Recommendation 1); 2) Support of preclinical studies addressing the potential safety and efficacy of these medications when given to vulnerable populations (e.g., pregnant women and their fetus, adolescents, etc.). Long-term studies should be done with laboratory animals of different ages, as well as their offspring before trials with vulnerable human populations (Recommendation 2). Taskforce members noted that these preclinical studies should be completed as rapidly as possible, so that safety and efficacy trials can be conducted in vulnerable human populations, particularly in adolescents; 3) Support research on the behavioral consequences of use of these medications (Recommendation 6); and 4) Support research on pre-marketing testing to determine how the availability of medications affect perceived risk of drug use (Recommendation 7). As stated in the report, some of these research protocols can involve partnerships among small businesses, biotechnology companies, academia and federal government and be supported through existing funding programs such as Strategic Program for Innovative Research on Cocaine (and Other Psychomotor Stimulants), Cooperative Research and Development Agreements, Small Business Technology Transfer and Small Business Innovation Research.
• After determining safety and efficacy of these medications, the second step would be translation of these findings into the field, which would involve determining methods of adoption and clinical effectiveness. The taskforce also recommends that NIDA actively involve leading treatment providers as advisory members at this stage. The Clinical Trials Network should be considered as one of the venues to conduct research to support of clinical effectiveness studies and financing models that integrate the new pharmacotherapies with psychosocial services in specialty addiction and primary medical settings (Recommendation 5). These trials can also be utilized to examine the behavioral consequences, such as increased potential for accidental overdose and changes in drug use patterns (e.g., Recommendation 6).
• A subsequent step would involve post-marketing surveillance. The taskforce recommends that NIDA work with SAMSHA, the FDA and other agencies that undertake data collecting to monitor the consequences of the introduction of these medications on the market. Consequences include examining the extent to which the availability of immunotherapy medications might reduce the perceived risk of drug use and the effects of such changes on drug use behavior in various populations (Recommendation 7), the potential effect of immunotherapy medications on illicit drug markets and market-related behaviors (Recommendation 8), and nature and extent of off label use (Recommendation 3).
• Finally, once these medications show promise, the taskforce recommends a formation of an oversight policy committee in cooperation with the Food and Drug Administration to develop guidelines for the use of medications, with particular attention to off-label use (Recommendation 3 and 10), to inform policies related to issues of discrimination due to long-lasting markers in the blood or urine (Recommendation 4), to determine the standards to be applied when immunotherapy medications are considered for use in the criminal justice and child welfare systems including due process protections when there is a government-imposed treatment requirement (Recommendation 9), and to monitor how and with whom the medications are being used.