Investigation Clears Fisher of Scientific Misconduct Charges In NSABP Studies

PITTSBURGH--Nearly three years after it began its investigation, thefederal Office of Research Integrity (ORI) has cleared Dr. Bernard Fisherof any scientific misconduct, stating that he did not include false datain his NSABP reports.

"Although I am pleased to get out a little bit from the cloud thatI was under, the real harm that was done is more pervasive," Dr. Fishersaid in an interview with Oncology News International. "Millions ofdollars of taxpayer's money were spent on this investigation that couldhave been put into research."

As a result of the charges, ongoing NSABP trials were put on hold, includingthe tamoxifen prevention study, "and women with breast cancer willpay the price in the next few years," Dr. Fisher said. Perhaps mostimportant, he added, the publicity caused women needless worry about theirchoice of lumpectomy plus radiation over mastectomy.

This "bizarre story of government and politics run amok,"as Fisher describes it, began in 1991 when he notified the NCI of fraudulentdata from St. Luc Hospital in Montreal. In keeping with the "intentto treat" principle, the patients from St. Luc were included in thefinal analysis of the affected NSABP studies, including the landmark lumpectomystudy. "It must be emphasized that falsified data were not includedin any publications," Dr. Fisher said.

On March 13, 1994, an article in the Chicago Tribune appeared, accusingDr. Fisher of knowingly including false data in his reports; this spurredRep. John Dingell (D-Mich) to initiate a Congressional hearing on the issue.

Under pressure from Congress, the NCI ordered the ORI investigation,and the University of Pittsburgh, in turn, removed Dr. Fisher from hisposts as director and principal investigator of the NSABP. (He is currentlyDistinguished Service Professor in the Department of Surgery at the Universityof Pittsburgh School of Medicine.)

Dr. Fisher has filed suit against the NIH, NCI, ORI, and the Universityof Pittsburgh seeking full reinstatement and unspecified damages. The mainissue, he said, is the lack of due process in the investigation. "Duringthree years of investigations, no one from the ORI, NCI, or Universityof Pittsburgh ever spoke to me or gave me a chance to speak."

The suit also alleges violations of Dr. Fisher's first amendment rightsin terms of academic freedom and freedom of speech. "I was being toldwhere to publish and what to publish, and my papers were subjected to prepublicationreviews," he said. "I am taking a stand so that this will nothappen to other scientists in the future."

Finally, the suit is about his desire to be back at his work with restoredresponsibility and renewed vigor. "Women are still dying of breastcancer, and as long as I have the ability to work, I want to continue todo research in this field."