Overview

The most important news now concerns the antiviral DDI, and the policies being developed about who will have access to it before full marketing approval, which is probably over two years away. This issue of AIDS TREATMENT NEWS will show how you can have input into decisions being made this month about DDI, and about the "parallel track" or other systems for early access while formal trials continue.

The DDI situation is moving very rapidly, and there is much confusion. We will bring out some hidden ethical issues concerning treatment access. We will show what probably will happen, what should happen, and why it makes sense to work on both at this time.

DDI is not new, as many think. It has a history, with published references back at least to 1981. In a later issue, we will include a bibliography of published articles about DDI.

This issue of AIDS TREATMENT NEWS also includes a historical overview of peptide T, by David Smyth of San Francisco. We first reported on peptide T over two and a half years ago (issue #22, January 16, 1987), after the drug had been given to four people in Sweden. Since that time peptide T has been the subject of unusually intense scientific controversy; the research in Sweden was stopped, for unknown reasons; and despite general agreement that the drug is safe, it is still in phase I (small dosage and toxicity studies) over two years later, with trials in Los Angeles and Boston. Although the evidence for peptide T appears weak at this time, the drug may have some usefulness. In any case its history illustrates a lack of practical judgment in the management of AIDS clinical research. When it was clear that the drug was safe, and that there were leading scientists on both sides of the efficacy debate, rapid efficacy testing should have been done. The scientific theories under dispute can serve only as guidelines as to what might work, and cannot substitute for experience.

The peptide T history is the first major article in 84 issues of AIDS TREATMENT NEWS not written by a member of our staff. We first met the author about a year ago, and were impressed by his knowledge of peptide T, and his determination to research this treatment thoroughly and become an expert in the drug and its history.