By Christopher Guadagnino, Ph.D.

Published April 1997

• React to this article in the Discussion Forum.

Bernard Fisher, M.D., is Distinguished Service Professor of Surgery, University of Pittsburgh School of Medicine, and Scientific Director of the National Surgical Adjuvant Breast and Bowel Project (NSABP). He is one of three researchers who were recently exonerated from nationally publicized scientific misconduct charges brought by the federal Office of Research Integrity (ORI) of the U.S. Public Health Service.

PND: Can you describe the process you went through when scientific misconduct charges were brought against you?

BF: I’ve done research for 40 years, almost all from government grants. The charges of scientific misconduct were brought against me by an official of the National Cancer Institute (NCI), bringing the charge to the Office of Research Integrity (ORI). I was accused of having used falsified data in my publications—not my falsified data—but data which had been falsified by another investigator from St. Luc Hospital in Montreal, Canada. In 1991, the NSABP discovered that one of its 5000 members in Montreal had altered entry data to make 99 patients out of 35,000 in over 22 studies eligible. We discovered this, reported it to the NCI, and suspended the investigator. He subsequently had a finding of scientific misconduct by the ORI after a 2 1/2 year investigation. I had my misconduct charge brought as a result of political pressures instigated by Congressman Dingell and his staff, who got involved in this affair. They went after the NCI. The NCI in turn used me as a scapegoat. They thought that I had used falsified data in papers that I had published, which was not true. That was the misconduct charge, specifically. We all knew from the beginning that their charges were unfounded. The government officials confused the use of patient data from St. Luc Hospital with falsified data.

PND: What specific details did the investigators fail to appreciate, in your view?

BF: Falsifications of data in science are just totally egregious because science depends upon honesty. I am not condoning in any way what happened in Montreal. But it is important to understand the nature of the falsifications. There are myriads of data points that one gets from a single patient. One of these points of eligibility related to the time from diagnosis to the time of randomization into a trial. In some of our studies for example, it was required that all patients be randomized within 30 days of diagnosis. Now, this investigator wanted to see more patients of his going into studies. It was confirmed that all of his patients were real patients, with real disease who received appropriate therapy. In some cases where he had patients that were 32 days after randomization or 34 days after randomization, he falsified the dates so that they would have been declared eligible for the study. Those dates were arbitrary when we established our protocols. We wanted to make certain that the people going into this trial were fairly uniform in terms of the timing. We were not writing about these dates in our publications. Therefore, I didn’t use falsified data because I was writing about the outcome of these patients, their survival, their disease-free survival, which had absolutely nothing to do with these dates. The NSABP personnel, the NIH, NCI, ORI and HHS all had knowledge of the falsifications from 1991, and these government officials could have informed the public.

PND: How was the integrity of the research affected?

BF: It wasn’t. Before we knew the extent of the falsifications, we presented to the government our reanalyses taking all St. Luc’s patients out of the analyses. It didn’t have any effect. Furthermore, the NSABP head biostatistician and I told the government that we would be using data from St. Luc Hospital in future publications and there was no objection. In March 1992 the government itself acknowledged that there was no public health crisis. By now declaring that there is no scientific misconduct in their final report, the ORI acknowledges that I used an appropriate way of handling data in my publications. If they didn’t understand that at the beginning, then obviously people were conducting inquiries and hearings without a full appreciation for what is well-recognized by the scientific community of the world.

PND: What are the appropriate agencies to conduct such inquiries?

BF: Let me just say that the whole process of the ORI is under scrutiny by the Congress and by the NIH. So it’s undergoing scrutiny. Any investigation must be conducted by people who are knowledgeable about what they are investigating.

PND: Such an investigation could harm the reputation of a researcher. How could this be avoided?

BF: This is devastating to an investigator to have those charges brought against him, particularly in the kind of area that this was conducted. It has been referred to in the press as a replay of McCarthyism. It could be avoided if there are enough people that will stand up and be counted. It’s the academic community who privately supported me greatly. One of the problems is that, just as I got my research sponsored by the government for 40 years to the tune of hundreds of millions of dollars, the scientific community gets money too. It would be pretty dangerous for them to publicly support me.

PND: Does an investigation like this hurt the credibility of medical research?

BF: Those perceptions were the result of political media-driven panic which occurred and led to the lack of confidence in science, and I don’t blame women for being upset with that, but they were essentially told to be upset by the nature of what was reported. The NCI carried out audits of all the NSABP data, they spent millions of dollars and they found all the data to be fine. The mechanism of the clinical trial is designed so it can handle this. We have known, ever since I started this—and I was one of the first in the United States to do clinical trials in 1958—that there was always the possibility that somebody could falsify data. But by the process of randomization which we were using, it is virtually impossible for any individual or institution to destroy the big studies. Also, I think that the integrity of people is not as bad as would be made from these kinds of things. You hear about the occasional charge of scientific misconduct but you don’t hear about the millions of people in the last 50 years who have honest research with no scientific misconduct.

PND: What advice would you have for a physician whose patient is a woman being diagnosed with breast cancer and she brings up her concern about the credibility of the medical research?

BF: The way one would respond to that is not to just say, "Oh, this is foolish," but rather to explain to her that the accomplishments have been the result of science. Our studies are large, they are prospective and randomized, the results have been replicated and they were peer reviewed over many years.

PND: How can this sort of perception be avoided in the future?

BF: Science must have integrity, so must the politicians, so must the press. They must have integrity and they must be educated. How? If you can bring up honest people who have respect for what is credible and ethical, then you’re going to have that in society. If you’re going through an era of society where nothing matters and you can do what you want and you can take narcotics and kids are doing it...I don’t know the answers to these things.

PND: What role ought investigations like this play in medical research, in your view?

BF: You should have some procedures in place. I’m not arguing against that and that’s not what I hope is coming out of this. What I’m saying is one needs the appropriate procedures. Now what is appropriate? There is great argument going on—it has gone on in most of my career—among government officials and scientists as to how this should be. Yes, there needs to be a process but it is being evolved and improved.

PND: What are your future plans?

BF: I certainly have not been able to work up to my potential. My future is to come back and make some contributions I had in progress which were curtailed: to go ahead and try to improve the fate of women with breast cancer.