Investigators at the National Institutes of Health have concluded that a scientist at an Ohio research institute then headed by NIH director Bernadine Healy made false statements about his brain research last year in seeking and obtaining a million-dollar NIH grant.
The NIH finding reverses a determination by Healy, in her previous capacity as research director of the Cleveland Clinic Foundation, that the scientist had not intentionally misrepresented his work.
It also threatens to bring to a head a simmering conflict between Healy and the NIH`s Office of Scientific Integrity, whose report on the Cleveland case specifically faults Healy`s conclusion that the scientist in question was guilty of nothing more than carelessness.
Congressional investigators are questioning whether the OSI`s unprecedented criticism of the NIH director is related to the abrupt withdrawal earlier this month of a key OSI investigator from two highly publicized cases of possible scientific misconduct.
Suzanne Hadley, who wrote the report critical of Healy in the Cleveland case, withdrew over investigations of fraud in scientific articles co-authored by Nobel Prize winner David Baltimore and NIH AIDS researcher Dr. Robert Gallo.
Sources said Rep. John Dingell (D-Mich.), who chairs the House subcommittee that oversees NIH, will summon Healy and Hadley to testify later this week about the friction between them and about the NIH`s handling of the Gallo and Cleveland cases.
”It`s been a long and painful road,” one source said of the Dingell subcommittee`s struggle to convince the NIH, the government`s principal biomedical research agency, of its obligation to investigate and punish fraud and other kinds of misconduct among scientists.
”We thought we were getting pretty close,” the source said. ”We were satisfied that OSI was up and running and making significant progress. What we see now is the emasculation of OSI by NIH. It`s a major setback.”
One of the subcommittee`s current worries, the source said, is the extent to which Healy shares Dingell`s view of the seriousness of wrongdoing in the laboratory.
”Certainly, one of our concerns is with the new director,” the source said. ”The bias that we see in the Cleveland Clinic case is similar to the bias we`re seeing against OSI.”
NIH and other sources say Healy has privately characterized the OSI, which is responsible for investigating suspected fraud by government and non- government scientists who receive NIH funds, as ”out of control” and
”running amok.”
In addition to supporting more than 2,000 scientists who work on its sprawling campus in Bethesda, Md., the NIH dispenses about $7 billion in research funds annually to universities and other non-government institutions like the Cleveland Clinic.
An NIH spokesman said the agency would have ”no comment at all” on the Cleveland case. But other sources said it was shortly after Healy took over the NIH in April that the OSI determined that the Cleveland scientist had lied about his research.
Solely on the basis of the grant application containing what the OSI determined to be false statements about experiments performed and data obtained, the scientist was awarded $792,000-a substantial sum under current budget conditions-to finance his continuing research on brain receptors.
Another $377,000 in NIH funds would have been paid directly to the Cleveland Clinic for ”overhead” expenses if the fraud had gone undetected, according to sources familiar with the case.
Before assuming the NIH directorship, sources said, Healy announced her intention to recuse herself from any decision-making in connection with the Cleveland Clinic Foundation, which is still headed by her husband, Dr. Floyd P. Loop.
Dr. Ralph Straffon, the foundation`s chief of staff, said he had sent NIH a written response to the report, which was received by the clinic in May, but that he was constrained by law from discussing either the report or the response.
The OSI`s finding that the Cleveland researcher had falsified the application was endorsed not only by Hadley but by a panel of NIH scientists assembled to assess the evidence in the case; by Hadley`s former boss, OSI director Jules Hallum; and by deputy NIH director William Raub.
The Tribune reported last Sunday that Hadley withdrew from the Gallo and Baltimore cases earlier this month after refusing an order from Healy to rewrite sections of the draft report on the Gallo investigation in ways she believed would significantly weaken its conclusions.
Healy, a 46-year-old cardiologist, served as chief of research at the Cleveland Clinic for six years before being chosen by President Bush in February to head the NIH.
Sources said the Cleveland case was initiated last year after a junior scientist there informed superiors that his section chief had claimed in applying for NIH funds to have obtained non-existent research data and to have performed experiments that never took place.
In a letter to the section chief following a one-day inquiry by a four-person panel, Healy admonished the man for carelessness and sloppiness in preparing the grant application and for what she termed the ”anticipatory writing” of his research results.
The OSI report authored by Hadley criticized the Healy inquiry on several counts, including its failure to examine previous drafts of the application and the inclusion on the inquiry panel of a scientist who was a collaborator of the section chief on the grant application.
Hadley`s strongest criticism of the Healy panel, however, concerned its use of euphemisms such as ”anticipatory writing” in avoiding the conclusion that the statements contained in the application were false and therefore represented scientific misconduct.
When the section chief complained that Healy`s admonition of carelessness was unjustified, the clinic began a second inquiry without Healy. That inquiry found the man had been guilty of unethical behavior in misrepresenting his research.
That finding led to a full-dress investigation by the clinic, which concluded that while the researcher had indeed made misleading statements in the application, he had not done so with the intention of deceiving the NIH.
The third panel, of which Healy was also not a member, concluded that the scientist, and the Cleveland Clinic, were under no obligation to return the $1,169,000 awarded on the basis of the application to the federal government. As required by federal regulations, a report on the Cleveland Clinic`s internal investigations was forwarded to the OSI last October. After studying the report, one source said, the OSI investigators decided that ”the evidence and the findings” in the case ”just didn`t match.”
The OSI began its own investigation of the Cleveland case, and because Healy`s name was then being mentioned as a possible nominee for NIH director the OSI investigators discreetly advised NIH higher-ups of her role in the affair and the potential for embarrassment to the Bush administration.
