Top AIDS Drug Regulator to Step Down : Health: The FDA’s Dr. Ellen Cooper asks for a job with less pressure. Even critics fear her departure will slow the development of new treatments.

Trapped in the cross-fire between scientists, drug companies and certain AIDS activists, Dr. Ellen Cooper, the U.S. Food and Drug Administration’s top AIDS drug regulator, has requested a transfer to a less-pressured post within the agency.

Cooper refused to comment on the move Friday, but friends, associates and an FDA spokesman confirmed her decision to step down. Many said her departure from her post as director of the FDA’s Division of Anti-Viral Drug Products in Bethesda, Md., a job she has held for three years, would be a severe blow to attempts to rapidly develop and license effective AIDS treatments.

“She told me: ‘I’ve had it. I’ve quit,’ ” said Dr. Donald Abrams, deputy director of the AIDS Program at San Francisco General Hospital and a member of the FDA’s anti-viral drug advisory committee. “I told her to take a week off. She said she needed a lot more than a week.”

Abrams called Cooper’s decision “a real loss,” adding: “Anybody who takes that position is going to be under a lot of pressure and scrutiny.”

FDA spokesman Jeff Nesbit said Cooper had asked to be relieved of her post in a letter delivered Thursday to Dr. Carl Peck, director of the FDA’s Center for Drug Evaluation and Research.

Cooper and the FDA had come under sharp attack this week from Martin Delaney, executive director of the San Francisco-based AIDS activist group Project Inform, for her handling of a Project Inform-led initiative to expedite the licensing of the experimental AIDS medications DDI and DDC. Some scientists at the National Institutes of Health also have privately criticized Cooper’s handling of the situation.

But many AIDS activists, including some who have crossed swords with Cooper in the past, came to her defense as word of her decision circulated. In addition, they flooded her office with phone calls asking her to stay on.

“We are heavily lobbying her to reconsider,” said Mark Harrington, a member of the treatment and data committee of ACT UP/New York, a gay activist group. “There is no one who could replace her. She has evolved so much over the past two years. Her departure would be a huge disaster for AIDS drug development.”

“We’ve spent three years developing a working relationship with her,” said David Barr, assistant director of public policy for Gay Men’s Health Crisis, a New York AIDS services organization. “This would slow everything down terribly.”

Cooper, a 40-year-old pediatrician and mother of four, has a bachelor’s degree in political science from Swarthmore College, a medical degree from Case Western Reserve University and a master’s degree in public health from Johns Hopkins University.

In a 1987 interview, she acknowledged that attacks by AIDS activists “bother me on a certain level” but added: “I understand the human need to have a scapegoat in frustrating circumstances.”

The latest attack on Cooper and the FDA was made by Project Inform’s Delaney, who on Wednesday accused the agency of taking “an extremely hard line” on expedited licensing of DDI, made by Bristol-Myers Squibb Co., and DDC, made by Hoffman-LaRoche Inc.

“If the FDA’s current views prevail, there will be no new AIDS drugs for a long time to come,” Delaney warned.

But Harrington said the battle over licensing DDI and DDC “is a stupid skirmish,” especially because both drugs are already available through compassionate-use programs to certain patients who fail to benefit from AZT, the leading drug available to AIDS patients.