A congressional subcommittee with primary responsibility for oversight of the Food and Drug Administration has for the first time voted to subpoena agency records that include names of patients.
Rep. Ted Weiss (D-N.Y), chairman of the House human resources subcommittee, said he recommended the action because the FDA, in a departure from 20 years' practice, has refused to supply Congress with complete records of recent experimental drug trials.
"For twenty-three years now we have been getting the information we need from the FDA," said Weiss. "There has never been one single instance in which any information relating to a patient has been disclosed. This is just an attempt on the part of the Reagan administration to give us as little information as possible."
Public Health Service officials said yesterday that it is their firm policy to keep names associated with clinical drug trials confidential. But FDA sources acknowledged that in the past they have often forwarded to Hill committees information with names added.
Health service officials said the subpoena would scare people out of participating in new-drug trials. Widespread discrimination has made confidentiality a special concern for AIDS patients on experimental drugs, although none of the records in dispute involve drugs for AIDS treatment.
"We cannot count on this government not to leak information, just because it is sensitive," said Lowell T. Harmison, deputy assistant secretary for health. "We would be willing to provide everything except the names."
Weiss, who in contrast to some administration officials has advocated legislative guarantees of confidentiality for AIDS patients, said that the Health and Human Services Department was attempting to use this issue to mask a slow response to his requests for information.
The General Accounting Office recently reported several instances where the FDA was unable to comply with requests from Congress in a timely fashion, but FDA officials say that is not why they are concerned about the subpoena now.
"In the past we would give them records and we knew they would not use the names in any way," said a senior FDA official who asked not to be identified because he was not designated as a spokesman. "But AIDS has brought the concern over confidentiality to a head. If patients using a new pain reliever have their names released, none will be fired or harmed by the information. If you say a person is on AZT and he has AIDS, that's completely different."
Weiss said that the subpoena, for records of bad reactions to five drugs, would not be delivered before Dec. 1. The drugs are lovastatin, used to lower cholesterol; meretal, an antidepressant; tha, an Alzheimer's drug; bersed, a sedative used before operations, and supral, a painkiller.
But Weiss stressed that a compromise was still possible.
"We have constantly attempted to compromise with them," he said. "We suggested we will take initials; they don't need to give us the names but just the right to check original documents if we need to."
Congress has the legal right to demand the documents, but scientific researchers have always been upset by any attempts to break confidentiality.
"The relationship between doctors and patients is one of the most solemn in society," said Dr. Samuel Broder, chief of clinical oncology at the National Cancer Institute. "If you can't look your patient in the eye and promise them confidentiality, your clinical trials won't have a chance."
In order to guarantee confidentiality, FDA officials have been removing the names of patients before they turn documents over to Congress. But that process can take weeks, in some cases months. Weiss and others say that waiting has interfered with their responsibility to oversee the functions of the FDA and examine new data on drug trials.
"These things are carried out as quickly and efficiently as can possibly be done," said Harmison. "This is a policy matter and a protection right for patients."
"If it's a policy matter, it's one that they have just discovered," Weiss said in response.