strate the safety and efficacy of medications. The committee suggests that some or all of these issues be examined during the FDA approval process.

This report reviews the behavioral, ethical, legal, and social issues likely to arise if, and when, immunotherapies and sustained-release formulations become available for treating drug addiction. It identifies the relevant issues and lays out a research agenda for NIDA. Because these therapies are still early in development, no literature exists that the committee could analyze or synthesize as a way of identifying and defining the behavioral, ethical, legal, and social issues. Rather, the committee reviewed similar, but related, literatures to better understand the potential implications of these new medications. This process required some creative thinking and use of judgment and members’ expertise about what the issues are likely to be and which of them are most pressing.

The rest of this chapter provides a basic description of both immunotherapies and sustained-release formulations. In Chapter 2 the committee lays out considerations for clinical trials, focusing in particular on issues that are generally considered outside the usual FDA process.

Chapter 3 then considers a range of treatment issues, including the organization and delivery of care in alternative treatment settings, privacy, financing, and costs. Finally, in Chapter 4 the committee looks at potential adverse behavioral responses to the use of immunotherapies and at the difficult practical, ethical, and legal issues of consent, particularly for vulnerable populations.

MEDICAL BASIS OF IMMUNOTHERAPY

Vaccination (active immunization) for the prevention and treatment of human disease has a long and distinguished medical history dating back at least to the pioneering work of Jenner nearly 200 years ago. The World Health Organization (2003) suggests that clean water and vaccines have been the two greatest contributions to worldwide public health. Indeed, vaccines prevent illness or death in millions of individuals each year.

Vaccines work by stimulating an immune response to a disease-related organism or subunit(s). Over a period of weeks to months, immunization(s) lead(s) to the generation of protective antibodies in body fluids, which act as an early surveillance system to block or reduce the effects of an invading organism or substance, such as a toxin.

The next advance in immunotherapy came in the early 20th century. Before the advent of antibiotics, polyclonal antibodies in the form of a specific immune serum were used to treat infectious diseases. Although these antisera were highly effective in treating diseases, such as pneumococcal pneumonia and tetanus, they sometimes produce a serious adverse



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