Cancer Researcher No Longer The Hero Bernard Fisher Was Fired Amid Allegations Of Faulty Research.

Posted: July 07, 1994

WASHINGTON — All of Bernard Fisher's 75 years seemed to settle over him as he sat alone - tired, abstracted, ill-prepared - before the subcommittee on oversight and investigations.

When did he discover the researcher's fraud? Why hadn't he set the scientific record straight?

The silver-haired cancer warrior stammered, he faltered. He whispered.

What did he do when auditors warned him about problems at certain testing sites? Did he cut his own auditing budget? "Did you do it?" asked Rep. John Dingell, D-Mich., the House subcommittee chairman.

"I'll have to let you know sir," murmured the once proud, and sometimes arrogant, old doctor. "I don't know."

There was no trace left of the bravado with which he had led his landmark clinical trials, no trace of the fierce pragmatism that made him a hero of the women's health movement.

His scientific findings were still standing, borne out by new research. But his reputation was in ruins. Fisher slipped from the vast hearing chamber.

"Devastating," muttered one onlooker. Others shook their heads.

It was hard to believe that this humbled man had been, for decades, the bold field marshal of hundreds of staunchly independent surgeons, thousands of dedicated patients, millions of research dollars. A magnetic, autocratic genius, he rallied legions to his crusade: to stop breast cancer.

It was hard to believe that the vast clinical network he had built up and run from a crowded headquarters at the University of Pittsburgh had slipped out of his control. That Bernard Fisher had been undone by another scientist's fraud and his own blindness or hubris. Buoyed, then destroyed by outside forces, political forces. Fired. Leaving the future of his cherished work at the University of Pittsburgh in a cloud of questions.

"Is he over the hill? Is he indifferent? Is he lazy? Is he incompetent? Was he corrupt in the way he conducted his work? I have no way of answering that," said Dingell.

And Fisher hid from interviews during the three-month ordeal that led up to his appearance. Finally, in testimony last month under oath before Dingell's subcommittee, he faced questions that had haunted him since March.

One set of questions dealt with fraudulent data that had tainted his landmark research proving the merits of breast-sparing surgery called lumpectomy. The other set of questions dealt with increasing concern over the toxicity of tamoxifen, a drug he was testing on women to see if it prevented breast cancer.

He acknowledged certain inefficiencies. But he defended his own scientific integrity.

Throughout the ordeal, some in the scientific community have done the same, flatly refusing to believe Bernard Fisher could commit bad science.

"Do you think," asked the prominent New York cancer researcher Dr. James Holland, "the Pope takes money out of a collection box?"

*

Fisher was born in Pittsburgh in 1918 and grew up in that city of steel, rising at the confluence of rivers. It was at the University of Pittsburgh where he got his baccalaureate and medical degrees, where he became a surgeon and researcher in liver regeneration.

His odyssey really began on a day in 1958 when he interrupted his work, at a mentor's insistence, to attend a talk about a chemotherapy trial for patients with breast cancer.

Fisher was captivated. Before him opened two pathways of compelling interest.

One was the mystery of metastasis: he marveled at how little was known about how cancer cells spread through the body. The other was the new concept of the clinical trial.

In a day when many surgeons worked intuitively, and in isolation, Fisher was enthralled by the statistical power of large-scale studies, their ability to scientifically compare the merits of different treatments.

After years in the laboratory testing cancer in animals, pursuing trial work on chemotherapy and drawing on the findings of a few other doctors in Europe and America, he emerged with a new theory for the spread of breast cancer.

His paradigm challenged a view of the disease, held since Victorian times, that breast cancer spread by permeating surrounding tissues. Since the days of the 19th century surgeon William Halsted, doctors had been using radical mastectomy to remove the entire breast and other tissues they believed had been penetrated by the cancer.

Fisher, instead, saw the cancer's spread as systemic, taking place entirely through the blood and lymph systems. It led him to question the need for radical mastectomy in early stages of breast cancer. He opted instead for the breast-sparing surgery called lumpectomy, followed by therapies ranging from radiation to drugs and hormones.

"The paradigm," says surgeon and author Dr. Susan Love. "He pushed it forward in a way no one else has done . . . He said, 'I don't think radical mastectomy is necessary. And he developed and did the studies to prove it."

By then, it was the 1970s. Fisher's science crystallized in the politics of the times.

"The women's health movement began talking about mastectomy as one of the examples of sexism in medical care in the United States," says women's health activist Cynthia Pearson. "It became, in a small way, a rallying cry."

Pearson, at her desk in the simple office of the National Women's Health Network here, runs her right finger down her right breast as if it were a scalpel, describing the terrible, disfiguring old Halsted radical mastectomy.

"I looked back in our newsletters, and we never called him a hero. But we quoted him in every second paragraph," Pearson says of Fisher.

He published hundreds of papers, delivered speeches, won awards.

From a research building at the University of Pittsburgh, filing cabinets in the hall, every single room stuffed, Fisher went on running his trials with a combination of charisma and autocracy, colleagues recall.

"He is a very, very complex man. He could charm you off your feet in no time," says a Texas colleague, Dr. Gabriel Hortobagyi. "At the same time, he had a reputation for arrogance . . . he can sweep you out of his path."

He led studies exploring treatments with drugs and hormones that helped cure the cancer or delay its return. His trials proved the merits of an anti- estrogen drug called tamoxifen that is now taken by millions of women recovering from breast cancer.

When he was fired, he was leading another revolutionary clinical trial, a controversial trial testing the ability of tamoxifen to prevent women from ever getting breast cancer. Thousands of healthy women had signed up to see if it would work.

But some activists, including Pearson, had started to worry. The drug was powerful, with many side-effects. Would it do more harm than good for healthy women, albeit women with a high risk of someday getting breast cancer?

Pearson remembers listening to Fisher explaining the prevention trial. Another woman suggested that maybe it would be better to wait until more information could be gathered.

Pearson remembers Fisher lashing out, "How long do you want to wait?"

But the seeds of the scandal were sown four years ago, when one of Fisher's own statisticians noticed a discrepancy on the chart of one breast cancer patient being treated by a researcher in a hospital in Montreal.

When Fisher contacted the researcher, Dr. Roger Poisson, the Canadian doctor admitted that he had falsified data for years to get unqualified patients into trials.

Concerned that Poisson's bad data might have affected the outcome of the lumpectomy trial, Fisher reanalyzed the study.

He determined the results were not changed.

He notified the federal officials at his granting agency, the National Cancer Institute, of the problem with the errant researcher.

And doggedly went back to his work.

Supporters said he followed proper channels in reporting the problems, but critics said he was uncooperative and lax in investigating reports of faulty research at other sites.

As months and then years passed, the problems continued to haunt him. Federal investigators, then the congressional subcommittee waded in. They found problems with Fisher's auditing system, potential problems with misconduct at another site, sloppy paperwork at a few more of the 500 centers that Fisher had been relying upon for data.

Fisher explained his balkiness by saying the public health was not at risk, that a reanalysis proved the findings remained valid.

"The findings convinced us and others at the NIH that none of our original conclusions were affected," Fisher recounted later, "and there was therefore no issue of public health."

Women who have based their own treatment on Fisher's breast-sparing trials have been reassured publicly that they should have no worries.

But Fisher himself is gone.

New minds and hands will lead the work at the University of Pittsburgh. The future of the university's $9 million grant from the NCI is uncertain. But trials, halted by the scandal, are reopening. The National Cancer Institute will be closely supervising them, now. Auditing procedures are being corrected, officials say.

And Cynthia Pearson, at her steel desk in the basement office of the National Women's Health Network, ponders the women's health movement and the place of this perhaps unlikely man in it: Bernard Fisher, with his surgeon's pride, his scientist's obsessions, his hatred of oversight, his disgust with politicians and pressure groups.

His vision. And now, what some call his blindness.

"We thought of him as a hero," says Pearson. "Unfortunately he was a hero in a system with no checks and balances."

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