ACT UP / NEW YORK PROPOSES NATIONAL RESEARCH AGENDA

At the June 4-9 V International Conference on AIDS in Montreal, ACT UP / New York released "A National AIDS Treatment Research Agenda", a 16-page document proposing public-policy changes in treatment research. The authors, in ACT UP's Treatment + Data Committee, are very well informed not only about new medical developments, but also about the procedures and politics of the Federal agencies and other organizations involved.

It is impossible to summarize this proposal adequately; but to give an idea of its scope, we will list the "12 Principles for a New AIDS Drug Testing System", which makes up one of the document's four sections. Note that the document contains explanatory material about each of these principles; it had to be omitted here because of limited space. The 12 principles:

1. People with AIDS, HIV, and their advocates must participate in designing and executing drug trials.

2. A comprehensive, coordinated, compassionate drug development strategy must ensure that all promising agents are evaluated thoroughly and, if found effective, distributed rapidly.

3. Resources must be focused on drugs which treat or prevent opportunistic infections, not just on antiretroviral drugs.

4. End the exclusion of women, poor people, people in rural areas, people of color, drug users, prisoners, hemophiliacs and children from experimental treatments. Expand staff and facilities in areas with high concentration of HIV-infected people so trials can take place there.

5. End the exclusion of AZT intolerant individuals from trials for infections or other antivirals.

6. Protocols should be flexible enough to accommodate new knowledge about HIV infection, allowing subjects to receive state-of-the-art care for opportunistic infections (OIs) as such standards evolve.

7. Trials must be designed for the real world: prophylaxis permitted, placebos avoided, efficacy criteria and endpoints humane.

8. Clinical costs associated with trials and not paid for by sponsors should be funded by third party payors to insure that personal income is not a de facto exclusion criterion.

9. The Orphan Drug Act should be reformed so that products developed at public expense are priced fairly. In return for its multimillion-dollar investment in AIDS research, the government is entitled to demand low-cost drugs for AIDS. This will make treatments accessible to people who can't afford AIDS drugs in both the US and worldwide.

10. The community-based clinical trials network, NIH, FDA and other drug development agencies require increased staff, funding and facilities to wage a successful effort against AIDS.

11. Establish an accurate, up-to-date, accessible international directory of clinical trials and promising experimental treatments for HIV and for AIDS-related opportunistic infections.

12. Promising new treatments for HIV and AIDS-related infections should be made accessible to anyone without regard to personal income.

Another section of the document, "AIDS Clinical Research Priorities," lists "5 Drugs We Need Now" (DDI, EPO [already approved -- see below], fluconazole, foscarnet, and GM-CSF), and "7 Treatments We Want Tested Faster" (ansamycin, CD4-exotoxin, CD4-immunoadhesin, diclazuril, hypericin, passive immunotherapy, and peptide T). A short description is given for each drug.

Other sections of the proposal are "New Models for Clinical Trials," and "AIDS Drug Development Disasters."

For a copy of the proposal, send a self-addressed #10 or larger envelope with two ounces postage to:


Mark Harrington
611 E 11th St., Apt. 7A
New York, NY 10009