ACT UP CALLS FOR NIH DEMONSTRATION MAY 21

A national demonstration for more effective AIDS research will take place May 21 at the headquarters of the National Institutes of Health (NIH), located in Bethesda, Maryland, near Washington, DC. NIH oversees most of the federal government's research into AIDS treatments through its AIDS Clinical Trials Group (ACTG). Other ACT UP chapters may hold simultaneous demonstrations at ACTG centers around the country.

Research problems (the quotes below are from an April 16 press release from ACT UP/New York) include:

* Lack of productivity. "After three years, not one single drug has been approved as a result of trials conducted by the ACTG. "

* Poor priorities. "More than 80 percent of people in ACTG trials were given AZT," which was approved three years ago. AZT itself was developed outside the ACTG -- as was aerosol pentamidine, after NIH refused to fund the critical trial.

* Conflict of interest issues. Almost all ACTG researchers have outside industrial consulting arrangements -- and many of them opposed recent proposals to require disclosure. Have these secret arrangements had undue influence on the closed meetings which set ACTG priorities and thereby influence the spending of hundreds of millions of dollars of public funds?

* Lack of small, rapid phase I/II tests for new drugs.

Note: One new and interesting demand of this demonstration is for tests of 30 or more new AIDS drugs each year in small phase I/II trials. Dozens if not hundreds of appropriate candidate drugs are ready. Almost none are being tested. We believe that the basic problem is that money, personnel, and other resources are being diverted to extra testing of existing drugs, because the latter have more commercial momentum.

* Poorly designed trials, delays in releasing lifesaving information, too little research on treatment for children, lack of enrollment of women and people of color, and other problems.

For more information about the demonstrations, call ACT UP/NY at 212/989-1114.

Note: A Critique of the AIDS Clinical Trials Group, an in-depth background paper on what is wrong with the Federal program of AIDS clinical trials, will be published next week by ACT UP/New York. Authors are Mark Harrington, Jim Eigo, and Ken Fornataro, all of ACT UP's Treatment + Data Committee. For a copy, send a 9 by 12 or larger self-addressed envelope with $1.65 postage to: Mark Harrington, 611 E. 11th St., Apt. #7-A, New York, NY 10009. (A donation to ACT UP would be appreciated, but is not required.)

For an introduction to the basics of what is wrong with the trials and what needs to be improved, see Mark Harrington's "Anatomy of a Disaster," Village Voice, March 13, 1990.

Comment

On November 11, 1988, a demonstration organized by ACT NOW, the national coordinating committee of ACT UP groups, brought at least 1,000 demonstrators to the headquarters of the U. S. Food and Drug Administration (FDA) and shut down the building for the entire day. Now activists are beginning to see problems associated with NIH as more serious impediments to effective AIDS treatment than problems at the FDA.

But moving the target to NIH involves much more than just a different subway stop and another government agency. The NIH demonstration presents new challenges which must be handled well:

* The public does not understand the NIH issues (by contrast to the FDA, which it can easily picture as the "heavy" keeping promising treatments away from patients). NIH issues center around scientific judgments and priorities; it is hard for the public to judge whether or not criticisms have merit. And FDA battles focus on known, existing treatments; it is harder to organize people around deaths caused by drugs which do not ex ist and perhaps never will, but should. It is our impression that awareness of research issues is not well developed even in the AIDS community, except in New York City, where ACT UP has taken a leading role in understanding what is happening in research, and informing others.

* Productivity of AIDS research has been slow to emerge as an issue because activists fear that too many people would just as well abandon treatment development and let people die. For those fighting for AIDS research budgets, there is seldom or never a right time to air criticism of the program. But now the glaring lack of new drugs out of the ACTG, and lack of hopeful signs for the future, are forcing the issue.

* Most NIH-related problems have nothing to do with the employees who work at NIH headquarters, who have long had a well-deserved reputation for dedication and usually could make more money in industry. Clinical trials at NIH itself ("intramural" trials) have long been models of humane, courteous patient care, and they have been medically and scientifically productive; ddI, for example, was first tested there by the National Cancer Institute. The problems have been with the "extramural" research contracted out to academic institutions through the ACTG. NIH employees do not decide who gets the money; that is done by outside experts in peer- review committees. In theory, the peer review system is excellent. In fact, it is highly vulnerable to manipulation and abuse by industrial interests, old-boy networks, and empire builders -- especially in AIDS, where outside scrutiny has been lacking due to the prevailing national unwillingness to deal with AIDS.

* Tactically the demonstration must be organized with special care, because both inpatients and outpatients are being treated at NIH, and critical scientific experiments are being conducted; shutting down certain buildings, as was done at FDA, could endanger patients and be a public-relations disaster. ACT UP demonstrations often work through autonomous organizations and affinity groups. Organizers responsible for this demonstration must make sure that everyone involved -- demonstrators, employees, police, press, etc. -- knows exactly what is legitimate and part of the ACT UP demonstration, and what is not.

Most of the problems associated with NIH do not really start at that agency. They arise instead from the national ambiguity about AIDS, and the resulting lack of high-level leadership and commitment. The ACTG program was set up several years ago, at a time when saving lives was not only unfashionable, but taboo even in the AIDS service community; virtually every organization assumed that its services would end only in death. This national lack of interest in practical saving of lives happened to mesh with the traditional value system of academic science, which most valued "pure" research, conducted without regard to the practical world. (Today's academic science is abandoning unworldliness in favor of money and deals -- not an improvement.)

ACT UP's NIH demonstration conveys the message that glaring research deficiencies can no longer be kept out of sight. If it lets people know that medical research is not immune to national denial and lack of leadership, that these failures do kill, then the demonstration will have served its purpose.