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March 6, 1997

Fisher cleared by Office of Research Integrity

Breast cancer researcher Bernard Fisher and two other Pitt professors have been cleared of scientific misconduct charges by the federal government's Office of Research Integrity (ORI).

Following an investigation that took nearly three years, the ORI concluded that Fisher, biostatistics professor Carol Redmond and adjunct research associate professor of surgery Lawrence Wickerham did not knowingly include false data in research studies of the National Surgical Adjuvant Breast and Bowel Project.

Fisher co-founded NSABP and led the internationally renowned, Pitt-based breast cancer research group for more than 30 years. He resigned as chairperson in 1994 at the insistence of National Cancer Institute officials, following reports of falsified data in several NSABP studies. One of those studies was a landmark 1985 clinical trial that found lumpectomies to be as effective in preventing recurrence of breast cancer as disfiguring mastectomies.

Reanalyses by the National Cancer Institute and NSABP agreed that the findings of the project's studies remain accurate despite the falsified data, which was contributed by a researcher at Montreal's St. Luc Hospital.

Fisher said this week that he was "extremely pleased" by the outcome of the ORI investigation. "The sad thing about this is that so much taxpayers' money was spent, that this investigation dragged on for two years and nine months, and especially that so many women were unnecessarily made to feel concerned about the treatment of breast cancer.

"Breast cancer research is going to feel the effects of what was done for quite some time," he said. "Who knows how many women will have been shortchanged by not getting the kind of data that they could have had much earlier?" In a March 4 written statement, Chancellor Mark Nordenberg said he also was pleased with the ORI investigation results.

"The dismissal of misconduct charges against these three Pitt faculty members resolves one of the final chapters in the follow-up to findings of data falsification and fabrication in a Montreal hospital that participated in a large multi-center set of clinical trials related to treatment of breast cancer," Nordenberg wrote. "The falsifications and fabrications were first reported to federal authorities in 1991 by Dr. Fisher…Subsequently, it has been demonstrated that the falsifications and fabrications committed in Montreal did not invalidate any of the scientific or clinical findings of NSABP, which draws on the participation of several hundred institutions and many thousands of patients suffering from breast and bowel cancer throughout the United States and Canada." Nordenberg noted that Fisher remains a Distinguished Service Professor of Surgery in Pitt's medical school and scientific director of NSABP. "Dr. Redmond is currently on leave of absence from her professorship of biostatistics in Pitt's Graduate School of Public Health while holding a visiting appointment at the Medical University of South Carolina. We hope that she will return to Pittsburgh. Dr. Wickerham continues his association with NSABP through his appointment at Allegheny General Hospital and holds the position of adjunct research associate professor of surgery in Pitt's School of Medicine," the chancellor's statement continued.

"The University takes this opportunity to express again its high esteem for the scientific achievements of Drs. Fisher, Redmond and Wickerham. We regret that ORI's process has taken so long, but we know that participants in NSABP activities, including the researchers, clinical staff, and volunteer clinical subjects, will re-affirm their commitment to a project that has made such important contributions over the past several decades to the treatment, prevention and management of breast and bowel cancer." Fisher said of the chancellor's statement: "I'm pleased that he [Nordenberg] did that. I really am." Redmond declined to comment, except to say that she is enjoying her work in Charleston, S.C., but was pleased that the chancellor would welcome her return to Pittsburgh.

The University Times could not reach Wickerham for comment.

ORI Acting Director Chris Pascal said he could not release the final report of ORI's investigation to the press without the approval of Fisher, Redmond and Wickerham. Fisher said he did not have a copy of the whole report and referred questions about it to his Washington, D.C., attorney, Robert P. Charrow.

Charrow said yesterday that he would not release the report while Fisher is pursuing his current lawsuit against the University and a number of federal agencies, including the National Cancer Institute and the National Institutes of Health. April 7 is the scheduled trial date in the lawsuit, which charges that Pitt and the agencies violated Fisher's rights to due process and freedom of speech in dismissing him as NSABP chairperson.

Pascal sent a copy of the ORI's report to Charrow along with a cover letter dated Feb. 28. The letter concluded: "ORI has not made a finding of scientific misconduct on the part of your client." Pascal declined to discuss the specifics of Fisher's case but said the letter's negative wording was not unusual for ORI. "In general, when we make a finding of no misconduct or that no misconduct was found, it doesn't mean that there weren't problems identified with the research or with papers or whatever," Pascal said. "It just means that if there were problems, they didn't rise to a level of intentional misrepresentation that meets the definition of scientific misconduct." What Fisher describes as his "bizarre and Kafka-esque ordeal" began in March 1994 when the Chicago Tribune reported that researcher Roger Poisson of St. Luc's Hospital in Montreal submitted fraudulent data to several NSABP studies. Later, falsified data from other institutions turned up in NSABP studies.

It was Fisher and his staff who discovered the falsified data and reported their findings in February 1991 to the National Cancer Institute. But following a public furor over the news reports, National Cancer Institute officials notified Pitt that it was considering moving NSABP headquarters to another site and ordered the University to remove Fisher as chairperson.

Pitt's administration says that Fisher resigned. Fisher contends that the University fired him to appease the National Cancer Institute as well as Congressional critics led by U.S. Rep. John Dingell, who was then chairperson of the House subcommittee on oversight and investigations.

Dingell's subcommittee held public hearings on NSABP in April and June 1994. During the hearings, Dingell blasted Fisher for, among other things, delays in publishing corrected revisions of the NSABP studies minus the tainted data.

This week, Fisher said he will continue to fight to clear his name and for protections of scientific freedom. "What happened to me is what happens when politics and science interface, and that's going on more and more frequently. You're dealing with political appointees who are put in positions where they're making decisions about scientific matters that they know precious little about.

"There will always be another Joe McCarthy, there will always be another John Dingell — there will always be this kind of person. But we must have safeguards against these politically motivated attacks against academic freedom," Fisher said.

— Bruce Steele

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