AIDS Treatment News #163, November 23, 1992
John S. James
With the new administration, this critical problem could be fixed, allowing new treatments to come into use quickly if appropriate. As soon as there is evidence that a drug works very well, it is likely to move exceedingly rapidly into wider use. But if the same drug is never tested in people, or is only tested for toxicity in HIV-negative volunteers, the necessary evidence will not exist, and the drug will probably be delayed indefinitely.
The big danger now is inertia, because no force is yet available to make the changes needed. Pharmaceutical companies are interested in short-term gain from drugs already on the market or soon to be there. Most influential AIDS researchers, even when supported largely by federal grants and contracts, also have business ties with these companies -- a situation which has long distorted research policy and prevented potential new drugs from being fairly considered. The Washington, D. C., AIDS policy organizations have not historically included research issues in their "corporate culture," and might not be able to challenge the research community when necessary; yet these organizations will manage the articulation of the AIDS consensus which will go to the Clinton transition team and administration. Some candidates now discussed as potential "AIDS czar" have avoided treatment issues, apparently due to unwillingness to challenge their scientific colleagues. In short, all the conditions are in place for a nightmare of business as usual, which could leave us, in several years, about where we are today -- with no major new antivirals and little advance in AIDS treatment except for refinements in the use of AZT, ddI, and ddC.
AIDS activists can make the difference, by never letting the most critical issues in drug development be ignored. So far, however, early drug development is scarcely on the table among activists. It has been easier to focus on more immediate concerns, such as conditions for expanded access, or equity in access to clinical trials. These issues are also important, but without better drugs, they will not save many lives.
The facts about excellent candidate drugs not getting into the development pipeline, or not proceeding coherently to the first tests of antiviral activity in humans, have been public knowledge for years. Yet this issue has received little attention until now, because until this month there was no chance of resolving it successfully. Such a pervasive, systemic malfunction cannot be repaired without national commitment and high-level involvement and support. The FDA could not solve the problem by itself; neither could the NIH; neither could any private organization. The necessary national mobilization would have required engagement and cooperation of higher Federal officials, which was not available.
Our biggest enemy today is the inertia of 11 years of Federal AIDS mismanagement. What can defeat it is an ongoing determination to bring the most critical problems into the light of public and professional attention, to keep them there as long as necessary, and to insist that they be addressed. AIDS activists must take the lead in exposing the seriousness of neglecting the flow of new drugs into early clinical development.
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