AIDS RESEARCH ALLIANCE SKIRTS LAW IN HUNT FOR CURE

                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SUNDAY, February 9, 1992                   TAG: 9202090035
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A3   EDITION: METRO 
SOURCE: Los Angeles Daily News
DATELINE: LOS ANGELES                                LENGTH: Medium
AIDS RESEARCH ALLIANCE SKIRTS LAW IN HUNT FOR CURE
For nearly two years, Dr. Paul Rothman and an alliance of other Los Angeles doctors have been testing unapproved AIDS drugs on patients - ignoring laws they fear have delayed a cure.
"Our emphasis is on speed, as well as safety. We will sacrifice a little bit of safety for a lot of speed," Rothman said.
Now, the 41-year-old doctor is racing to cure himself of AIDS, taking a drug he said the government has not approved for use on humans.
If the experiment fails, Rothman said, the guerrilla research he helped pioneer would carry on at the Search Alliance, a non-profit group he began in June 1990 to test new treatments outside the government's supervision.
"I assume Search Alliance will outlive me," Rothman said recently, as he lay hooked by several tubes to a rumbling machine that eases disabling pain in his feet from a nerve disorder caused by AIDS.
"I'd like people to know there is an organization that is willing to do anything to find a cure for AIDS - regardless of the legality, regardless of the expense and regardless of the convenience," Rothman said.
In the 20 months since it was formed, he said, the Search Alliance has grown to include more than 40 doctors in Los Angeles, San Francisco, New York and New Mexico who have conducted trials on 12 different drugs and treatments.
Rothman readily acknowledged that Search members use unapproved drugs in human tests without permission from the Food and Drug Administration. By avoiding the FDA's review, he said, Search quickly can determine whether a drug is useful.
"The FDA delays us by years on any kind of medication, especially something that is completely new," he said.
While the doctors adhere to a scientific methodology, "we would lie and steal if we felt there was something valuable," Rothman said.
FDA spokesman Brad Stone said that he understands the plight of people with AIDS, but the law I'd like people to know there is an organization that is willing to do anything to find a cure for AIDS - regardless of the legality, regardless of the expense and regardless of the convenience. Paul Rothman Doctor, AIDS patient requires FDA approval of all experiments using unapproved drugs to ensure patient safety.
Before the FDA approves drugs for use by the public, it allows testing of the drugs in human trials. But the trials themselves must be approved by the agency, and doctors who perform them are required to apply for permission.
Critics say the agency moves too slowly in approving such trials - and time is not something people with AIDS have in abundance.
Stone said that the criticism is unwarranted. By law, the FDA has 30 days to review a drug experiment proposal and "very often with AIDS drugs we turn those things around in five days," he said.
The FDA never has taken action against the Search Alliance and was unaware that doctors affiliated with the organization are conducting human trials without permission, Stone said.
"When we become aware of a study that should be sanctioned, but is not, it might be something we'd look into," he said, adding that FDA investigators cannot act unless they receive a complaint or a tip.
Dr. M. Roy Schwarz, senior vice president for medical education and science at the American Medical Association, said that he is concerned about groups like the Search Alliance because of the possibility that patients could be harmed.
"Independent groups going off by themselves leave a great deal to be desired, in terms of the quality of trials or protecting the patients from harm," Schwarz said.
But Dr. Martin Finn, medical director of the Los Angeles County AIDS Programs, said he is familiar with how Search works and is confident its doctors safeguard patients.
"I certainly support them," Finn said. "They are not acting in a dangerous way."
Before a drug is administered to a patient, several panels of Search doctors examine the medication's record and must approve it, Rothman said. Some Search investigations end before a treatment is used on humans if doctors find it to be unsafe or without scientific value, he said.
"We go through a very meticulous process of writing a protocol and having it go through doctors who do research all of the time," he said.

by Bhavesh Jinadra by CNB