Congress Looks At AIDS Research Delays

On April 28 and 29, Representatives Ted Weiss (D-NY) and Nancy Pelosi (D-SF) held hearings on AIDS research delays and treatment-access problems. These hearings were held in Washington, D.C. by the Subcommittee on Human Resources of the House Government Operations Committee, chaired by Mr. Weiss. Witnesses included top Federal officials in both NIH and FDA, as well as AIDS physicians and treatment advocates.
AIDS Treatment News has already reported the most spectacular single revelation from these hearings--the
admission of Dr. Anthony F. Fauci, who is in charge of the AIDS clinical trials run by the U.S. government, that lack of a
single staff person delayed testing and approval of aerosol pentamidine for over a year, while similar delays postponed dextran sulfate and other potential AIDS treatments even after they had been given the highest priority by the government's own scientific advisory committees.
These hearings mark the first time members of Congress were well prepared on AIDS research issues, the first time top Federal AIDS officials had to answer to anyone in authority who would not take "fluff" answers and the most shallow of bureaucratic self-justification as revealed, unquestioned truth.
The New York Times reported the hearings on page one (Saturday, April 30), but most of the press ignored them. For
example, none of the San Francisco daily papers mentioned the hearings at all--despite over a thousand AIDS deaths already in the city, thousands more inevitable unless the research gets results, and--if that weren't enough local relevance--the fact that Nancy Pelosi's Congressional district includes most of San Francisco. (Even San Francisco's gay newspapers largely ignored the hearings, suggesting that the press default stemmed not from conspiracy or homophobia, but from the great difficulty of the press and public alike in getting a grasp on AIDS treatment research and access issues.)
Congress will eventually publish the full text of the hearings, several hundred pages, but few will read the fine print. So to convey the impact of the information we interviewed Dr. Steve Morin, a legislative assistant to Congresswoman Pelosi and one of the staff people involved in the hearings, which were arranged and conducted by the Human Resources Subcommittee chaired by Mr. Weiss.
"The Subcommittee put (top Federal officials) under oath, and subpoenaed their records", Morin explained--meaning that for the first time the officials could not simply deflect or ignore the questions and deliver the Reagan Administration
line. Morin told us that the message he most wanted to get out is that there are people who care and are working to overcome the obstacles blocking progress in AIDS treatment research. We asked Dr. Morin for his overview of the hearings, and his sense of what was most important there. Our own comments are in parentheses.

The Interview

"The first witness was a father of an infant with AIDS. He testified anonymously behind a screen, for fear of
identification and discrimination. He told about the lack of access of his infant daughter to AZT, in essence because the
FDA did not approve the use of AZT for infants. He described his repeated efforts to try to get the drug for his daughter,
how he ran into bureaucratic difficulties at every step, how she was now on a respirator and expected to die.
"The next witness was Iris Davis, MD, a black woman from Brooklyn. She talked about lack of access to experimental protocols for women, IV drug users and ethnic minorities. In Brooklyn these groups are rarely included in clinical trials. The trials tend to go to academic centers, not to the centers that treat the majority of the people with AIDS infections.
"Then Nan Hunter from the ACLU spoke about access to clinical trials for women and ethnic minorities. The trials
are seen as offering hope, and the hope was not being offered equally.
"The second panel started with Tom Merigan, M.D., from Stanford University, where he is Principal Investigator of
Stanford's AIDS Clinical Trials Unit. He spoke from the perspective of planning and oversight of drug trials, especially the work at Stanford on DDC. He expressed some optimism about that program.
Dr. Merigan said the investigators run the program by participating in initial review of candidate drugs, devising
the protocols, and setting priorities. He said that a total of $64 million in annual funding would be needed for the original
19 AIDS Treatment Evaluation Units, part of the Federal government's AIDS clinical trials program.
"Ms. Pelosi tried to pin down Merigan on community consultation issues, what kind of input did they have from
potential participants in the trials. He tried to sidestep the issue as best he could."
(We commented that as far as we knew, the Stanford program had no community input.)
"They have none. He said that the goal is to work for a better patient-physician relationship. In essence it was
beyond his way of thinking to involve the AIDS community in the actual planning (of clinical trials).
"Ms. Pelosi raised the issue of dextran sulfate with Merigan, and that started quite a debate. My memory is that he
was very critical of the Japanese for not accepting blood samples to test the pharmacological issue of absorption.
Apparently the Japanese government just didn't want the contaminated blood coming in to the country. Various lack of
cooperation has delayed researchers' ability to say anything definitive out of Donald Abrams' studies.
"Dr. Mathilde Krim, Chairman of the American Foundation for AIDS Research and a leading advocate for more effective and humane treatment development, presented a series of recommendations. Many would require leadership from the administrative branch of government. NIAID (the National Institute of Allergy and Infectious Diseases, part of the
National Institutes of Health) should have independent construction authority, as it did not have the facilities to do the research it was being asked to do.
"Ms. Pelosi posed the question (San Francisco AIDS activist) John Fox has posed in our community meeting. When a drug is past phase I, known to be safe, makes theoretical sense that it could be effective but there's no efficacy data, should people be allowed to have access to it? Krim has historically waffled on this question, but she's coming around to a position where she couldn't come up with any good reasons why they shouldn't. It does give people hope, so perhaps these substances should be made available.
"Dr. Krim also described critical staffing shortages at NIAID and the FDA."
(We commented that there was some cynicism in the AIDS community about the FDA's need for more staff, since it already has enough to move against safe and plausible treatment options, without any reason to believe that they are harmful or ineffective.)
"Mr. Weiss and Ms. Pelosi cross-examined Fauci (on staffing problems at NIAID, not FDA), and the total staff
working on AIDS drug development, that includes everybody, amounted to 22. This count includes some who may not actually be working on AIDS.
"It's quite unbelievable that they are expected to coordinate all these trials, make these complex decisions about
candidate drugs, staff the meetings, bring in scientists to advise, collect and analyze data, with a staff this small."
(The New York Times, April 30, page 1, quoted Congressman Weiss as commenting to Fauci that, "The dimensions of the shortfall is such that you can't possibly meet your needs".)

(Part II of this interview will appear in AIDS Treatment News #58.)