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NIH director faces congressional scrutiny.

The continuing debate on scientific misconduct intensified last week with a dramatic confrontation between National Institutes of Health Director Bernadine P. Healy and Rep. John D. Dingell (D-Mich.), chairman of the House Subcommittee on Oversight and Investigations.

Dingell called the subcommittee hearing to address concerns about Healy's handling of the NIH Office of Scientific Integrity (OSI), which investigates allegations of scientific misconduct and fraud among NIH-funded researchers. At the hearing, he charged that Healy had "derailed" OSI investigations through several actions undertaken since she assumed the NIH directorship last April.

The brouhaha represents the latest eruption of a debate over whether scientists can adequately police their own ranks. Many scientists contend that Congress should not interfere with the scientific community's self-regulation. Many lawmakers argue that misconduct by federally funded researchers defrauds the agencies paying for the work, and that scientists too often have failed to investigate such cases rigorously.

Although the central aim of the hearing was to examine whether the new NIH director attempted to undercut OSI investigations, lawmakers started out by questioning her extensively on her own investigation last year of alleged scientific misconduct by a researcher at the Cleveland Clinic Foundation. Healy, who headed the clinic's research institute at the time, chaired an in-house panel that cleared the scientist of misconduct.

In a preliminary inquiry, Healy's panel found false statements in several grant applications written by the clinic scientist and sent to NIH. The scientist admitted that his applications contained descriptions of work he had not done, but he called those statements "honest mistakes," according to Healy's May 1990 report on the inquiry. The panel reprimanded him but concluded there was no evidence that he had intentionally misrepresented his research. "Rather, he exhibited a high level of carelessness and sloppiness that led to misstatements," Healy wrote in her report. She described those misstatements as "anticipatory writing."

At last week's hearing, Healy testified that she had been "haunted" by the case and had assembled an entirely new in-house panel to conduct a second inquiry the following month. That group, which did not include Healy, concluded in September 1990 that the scientist did "misrepresent the nature of experimental operations in his laboratory with the intent to mislead." The Cleveland Clinic notified OSi and set up another in-house panel to conduct a full-fledged investigation. That panel, which did not include Healy but considered her testimony, dismissed the charges against the scientist in October 1990.

OSI launched its own review of the case last December. Although NIH has not released the draft report, Suzanne Hadley - OSI's chief investigator at the time - testified last week that the federal probe revealed evidence of misconduct.

Furthermore, she said, "there were significant problems with that first inquiry [led by Healy at the Cleveland Clinic]." For one, Healy's panel included a scientist who had coauthored one of the questioned grant applications, creating a conflict of interest, Hadley said. "And then there was this rather curious concept of anticipatory writing. . . . The Cleveland Clinic Foundation, in the final analysis, didn't want to call something misconduct when it seemed to be manifestly misconduct as we know it," Hadley told the subcommittee.

Later in the hearing, Healy acknowledged that her preliminary inquiry was "inadequate." She said the scientist under scrutiny told her panel he had included some data that he "anticipated" obtaining before sending the proposals to NIH. Healy called this "inappropriate" but added that she still doesn't know whether the scientist deliberately misrepresented his work.

Dingell pointed out that OSI will next examine whether the clinic's research institute responded adequately to the allegations. "In this case, Dr. Healy's actions as director of the [Cleveland] institute and chairman of the first panel would necessarily be a subject of the investigation," he said. Healy removed herself from any decisions involving the Cleveland case when she joined NIH, but Dingell says the incident may color her judgment of other OSI investigations. Healy calls that suggestion "preposterous."

Several of her actions at NIH have raised concerns on Capitol Hill about OSI's functional independence. At a May 1991 meeting with Hadley and several others at NIH, Healy expressed strong reservations about the way OSI operates, referring to OSI staff as "the keystone cops" and characterizing OSI as "out of control," according to Hadley's testimony.

Hadley also told that subcommittee that Healy demanded a rewrite of a draft report on OSI's continuing investigation of Robert C. Gallo, a prominent AIDS investigator at the National Cancer Institute. Gallo's claim to the discovery of the AIDS virus has long been contested by a French research team. In early June, Healy told Hadley the draft report "reads like a novel," and instructed her to remove editorialized statements and to make it sound more like a scientific paper, Hadley said at the hearing. Hadley objected to the changes in a June 10 memo, saying they would "significantly vitiate the findings of the draft report." In a June 17 memo, Healy replied that she had never intended to change the substance or conclusion of the report, and had merely made some suggestions to improve its style.

At the hearing, Hadley described a recent series of events that she interprets as an attack on her integrity and a threat to her career. One involved her investigation of highly publicized allegations made in 1986 against Boston immunologist Thereza Imanishi-Kari. A draft OSI report, leaked to the press last March, concluded that Imanishi-Kari's lab notebooks contained bogus data (SN: 3/30/91, p. 196). In early June, NIH legal adviser Robert B. Lanman asked hadley for her notes on telephone conversations with Margot O'Toole, the whistleblower in the Imanishi-Kiri case. Healy testified that she asked Lanman to obtain the notes because she was concerned that Hadley and O'Toole had developed a friendship that could compromise the ongoing probe. Hadley denied that suggestion and said contact with O'Toole is a necessary part of the investigation.

In late June, said Hadley, OSI Director Jules V. Hallum asked her to return all her files on the Gallo and Imanishi-Kari cases to the central OSI office (she had been working from a satellite office) and told her that Healy had ordered him to "rein in Hadley." The next day, Hadley stopped working on those cases, saying she could not pursue them effectively without her files.

Last week, Healy characterized her actions as managerial decisions necessitated by numerous leaks of confidential draft reports, including the March release of the Imanishi-Kari document. "Everything that I did with regard to OSI was within the context of fulfilling my obligations to the Constitution," she told reporters after the hearing. She added that leaks of preliminary misconduct reports can destroy scientific careers.

Whether her actions represent managerial solutions or a campaign to undermine OSI remains an open question. But subcommittee staffers say lawmakers have seen enough to make their next move. Several staffers told Science News that Dingell plans to take steps to remove OSI from the NIH campus and place it under the aegis of the Inspector General's Office at the Department of Health and Human Services - a team known for its aggressive fraud investigations.
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Title Annotation:National Institutes of Health's Bernadine P. Healy to be questioned on her handling of the NIH's Office of Scientific Integrity
Author:Fackelmann, Kathy A.
Publication:Science News
Date:Aug 10, 1991
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