SAN FRANCISCO CHRONICLE (SF) - TUESDAY November 15, 1988 Edition: FINAL Section: NEWS Page: A4 Word Count: 927
Randy Shilts, National Correspondent

The report also characterizes the system for testing AIDS drugs as "too unwieldy to move rapidly" and federal budget and personnel agencies as "too inflexible" to allow government scientists to speed up research on potential AIDS treatments.

The report, entitled "AIDS Drugs: Where Are They?," was quietly released late last month by the Committee on Government Operations, which conducted lengthy hearings on the problems of developing and testing drugs to treat AIDS patients. The report was obtained by The Chronicle yesterday.

'TURNED THEIR BACKS'

"The (Reagan) administration's political leaders have turned their backs on the 1.5 million Americans infected with HIV (the AIDS virus) by ignoring the imperative for AIDS therapies," the committee's chairman, Representative Ted Weiss, D-N.Y., said yesterday. "The gravity of this epidemic has passed them by."

Weiss accused the Reagan administration of lacking "a sense of urgency" in dealing with AIDS treatment research.

In response, Dr. Anthony Fauci, associate director of the National Institutes of Health for AIDS and the Reagan administration's top AIDS official, conceded yesterday that the agency had encountered problems gearing up for the drug tests. He said, however, that the agency has become much more efficient in recent months.

The congressional investigation focused on the National Institute of Allergy and Infectious Diseases, or NIAID, the agency of the National Institutes of Health that is responsible for putting AIDS drugs into clinical trials.

DELAYS CITED

Citing delays in conducting tests for several promising AIDS drugs, the committee concluded that the NIAID system for putting treatments into trials is "complex and prolonged," with a ponderous decision-making process that has "unduly delayed (treatments), denying access by (HIV-infected) persons to potentially therapeutic drugs."

The problems of red tape are compounded by staff shortages that have made it impossible for NIAID to speed drugs into testing even when they are given the highest priority designation by government scientists, the committee found.

The lack of staff, for example, has led to an 18-month delay in the testing of an aerosol version of pentamidine, an antibiotic that has been shown to be extremely effective in preventing the form of pneumonia that is the greatest single killer of AIDS patients.

UNDERSTAFFING

The delays stem from the refusal of the Office of Management and Budget to give the National Institutes of Health the staff needed to "chaperone" the necessary paperwork through the complicated approval processes at NIAID and the Food and Drug Administration, the committee found.

Staff requests for AIDS drug trials from NIAID officials had been cut more than 90 percent by top NIH officials, leading inevitably to the delays, according to the committee.

"In the judgment of the committee, the failure to allocate adequate staff to the NIAID AIDS program is indistinguishable from withholding life-prolonging medications from persons with life-threatening illnesses," the committee concluded.

'BUSINESS AS USUAL'

The staff shortage is exacerbated by a "business-as-usual attitude" at the Office of Management and Budget and the Office of Personnel Management, which has led to long delays in filling staff positions that have already been approved.

Meeting paperwork requirements for hiring new employees has added many months to the time it takes the National Institutes of Health to add new researchers, the report found.

The committee said such problems stem from an "appalling" lack of federal leadership on AIDS issues, leaving each federal agency to deal with AIDS as it sees fit.

NO CLEAR MANDATE

"The committee believes the absence of a clear mandate for urgent action from the highest levels of the adminstration . . . may well have had a direct negative impact on the effort to develop drugs to treat persons with HIV infection, AIDS and ARC," the report concluded.

Fauci, who is also director of NIAID, said part of the problem stems from the sluggish budget process.

"By the time a request made it up to the top of the decision-making ladder to OMB, it was no longer enough, and we had to start another request," Fauci said.

Like many federal health officials, Fauci endorsed the idea of giving NIH scientists greater flexibility in circumventing hiring guidelines.

"We have enhanced cooperation, but I'm still not 100 percent satisfied with it," he said. "I want to make sure it stays that way and it's not just a blip on the curve."

Fauci said that new initiatives, formulated since the congressional investigation, would respond to other shortcomings cited in the report.

RECENT ACTION

On Sunday, for example, Fauci announced a policy to recruit more women, children, intravenous drug users and minorities into AIDS drug tests.

"When you talk about AIDS, nothing is ever quick enough, but when you look at this in perspective, you'll see that we've put this (drug trial) together very rapidly," said Fauci.

"We're constantly fine-tuning and re-examining our programs," he said. "Within the past year, our speed, functioning and efficiency have improved dramatically."

Representatives for AIDS advocacy groups generally agreed that NIAID is improving in its efforts to research AIDS drugs, but many hailed the report for stressing the need to put the research on a more urgent footing.

"This clearly has not been viewed with a sense of urgency," said Martin Delaney, director of Project Inform, a group that dispenses information on AIDS treatments. "This is no way to conduct research in an emergency. Too many lives depend on this."

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