WASHINGTON — Yielding to a congressional subpoena, an angry Health and Human Services Secretary Otis R. Bowen reluctantly agreed Monday to turn over to a House oversight subcommittee 15,000 pages of documents that contain partial identification of patients who have taken drugs now under review by the government.
Bowen, flanked by other top federal health officials, warned that the move marks a dangerous departure from precedent and threatens to "undermine" public confidence at a time when AIDS has heightened sensitivity over patient confidentiality.
The House Committee on Government Operations' subcommittee on human resources sought the records in an effort to improve its oversight of the agency's work. The subcommittee reviews drug trials conducted by the Food and Drug Administration, a division of HHS, and maintains that it needs more precise records to make sure cases are being handled and analyzed properly.
In the past, charged subcommittee Chairman Ted Weiss (D-N.Y.), the FDA has "overlooked reports of very dangerous drug reactions in its own files."
In many circumstances, he said, patients' names or initials "are the only means by which cases are uniquely designated" and the only way that the congressional overseers can keep them straight in an evaluation. He pledged that the records requested will be kept private.
The dispute reflects the tensions and mistrust between the Health and Human Services department and Weiss's subcommittee. Weiss has complained that the agency is not forthcoming about its "lapses" and uses patient confidentiality to cloak its operations.
Illustrating the extent of the animosity, the two sides were unable to agree even on the background for the current dispute. HHS officials said that, aside from a few "accidental" slips, they have never in the past released any patient identities to Congress. Subcommittee staff members assert that they have received "thousands" of medical documents--with names or at least initials--from the department for review in the last few years, and that the new request would create no new precedent.
Bowen said that the department will deliver today individual records--largely from physicians' reports--on virtually all those people who voluntarily tested or suffered adverse reactions to one of five drugs that have been studied: Merital, an anti-depressant; THA, an experimental drug for Alzheimer's disease; Versed, a sedative; Mevacor, a compound that lowers cholesterol, and Suprol, an anti-inflammatory drug.
The records, as required by Weiss's subcommittee, will include patients' initials. Federal health officials charged that even this partial identification, when combined with other particular aspects of medical cases, will endanger patients' confidentiality, particularly for those from smaller communities.
HHS has fought the release of those initials, offering to devise an identifying code as a substitute. But subcommittee officials charged that it would not be verifiable and would cause more delays in the review process.
"I take this step only under the sternest protest," Bowen said, remarking that he was only complying because "I don't look good in a striped (jail) suit."
Federal officials noted that drugs now being tested on the AIDS virus will go through the same review process these five drugs did. "This is a blow against confidentiality . . . in light of the potential discrimination which people with AIDS may face," Bowen said.
'Patients Being Used'
Weiss would not discuss any relationship between this dispute and the review of AIDS drugs, saying that "AIDS patients are again being used, this time to veil attempts to deny Congress full and timely access to needed information that has nothing to do with AIDS patients."
Weiss stressed that in the two decades that the subcommittee has overseen food and drug records, he knows of no breach of patient confidentiality.
"We're looking for unpurged documents that we can rely on. . . . We're not in the business of name-gathering," Weiss said.