attenuate the psychoactive effects of drugs of abuse by either reducing the amount of drug in the brain (immunotherapies) or by blocking drug effects at their site of action in the brain (sustained-release medications). Research in both human and animal subjects demonstrates that consumption of a blocked drug can fall dramatically or even cease. Another important characteristic of these medications is that they have long durations of action—a month or even longer per administration—which should reduce the problem of nonadherence found with medications that must be taken daily.

Recommendation 1 The National Institute on Drug Abuse should support basic immunology studies on increasing the stability and longevity of antibody blood levels and on developing combination therapies to simultaneously treat a variety of abused drugs.

OFF-LABEL USE

Clinical trials for Food and Drug Administration (FDA) approval of these medications will likely be performed in limited populations—such as adult males and nonpregnant females being treated for drug dependence or drug overdose—because the companies sponsoring such trials seek the least costly way to obtain FDA approval. Once a pharmaceutical is approved, however, the FDA has little effective control over the way it is used in the practice of medicine. However, it is foreseeable that parents and physicians will be interested in using immunotherapies “protectively” with children and adolescents—before they have ever used tobacco or illicit drugs or when use is still at subclinical levels of severity—even if these medications have not been approved for such purposes. Likewise, addiction programs with pregnant patients will be inclined to use these new medications despite the lack of testing in that population. The perception of potential benefits from protective use of immunotherapies for adolescents and pregnant women may be quite high, because the consequences of drug use or addiction can be long-lasting and severe in these populations, and they pose unique challenges. Moreover, the general record of safety of immunotherapies when established for some populations might lead health professionals to expect such safety for these therapies with populations not yet tested.

The potential unwanted behavioral responses from off-label uses of these new medications point to a need to consider expanding the criteria for evaluating pharmaceutical products by the FDA. The means now used by the FDA to measure safety and efficacy in clinical trials may not provide an accurate picture of the costs to society or benefits that these medications will produce in actual use.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement