Breast cancer researcher faces panel.

Pioneering breast cancer researcher Bernard Fisher made a long-awaited appearance before the House Subcommittee on Oversight and Investigations on June 15. At the hearing, subcommittee Chairman John D. Dingell (D-Mich.) sharply questioned Fisher's management of the National Surgical Adjuvant Breast and Bowel Project (NSABP), a large, multicenter research program that has conducted several landmark breast cancer trials.

Fisher was removed as head of NSABP after media reports of research irregularities at the federally funded centers.

"NSABP was years behind in performing audits and in writing up and forwarding audit reports," Dingell said at the hearing. "More significantly, the follow-up to identified audit deficiencies was all but nonexistent."

Fisher, who was excused from testifying before Dingell's panel last April because of health problems, acknowledged his managerial headaches. And he admitted that he had trouble keeping tabs on the far-flung NSABP investigators, who practiced at about 500 medical centers in North America. "I deeply regret that there was data falsification by a physician at one of the hospitals participating in the NSABP," he told the panel.

This affair began when NSABP auditors discovered data anomalies in cases submitted by St. Luc's Hospital in Montreal (SN: 4/30/94, p.282). St. Luc investigator Roger Poisson has admitted that he faked data that were subsequently submitted to NSABP headquarters at the University of Pittsburgh. However, Dingell recited a laundry list of errors that NSABP, under Fisher's leadership, had committed, including failure to pick up, report, or correct data irregularities at a number of other clinical centers.

In his defense, Fisher told the panel that NSABP had grown tremendously after it took on the Breast Cancer Prevention Trial, a large study in which women at risk of breast cancer are given the hormonal drug tamoxifen to ward off the disease.

"In retrospect, the administrative infrastructure of NSABP did not keep pace with this tremendous growth," Fisher said. "There may have been some delays in our auditing and reporting functions," he added.

Dingell also questioned the practice of throwing "lavish" receptions at NSABP's annual meetings. Zeneca Pharmaceuticals, which manufactures tamoxifen, picked up the tab for these parties, which often cost $80,000. "Curiously, in 1991, the entire NSABP audit function was carried out on a budget of a little more than $80,000," Dingell noted.

"After a lifetime of dedication to science, I find that absolutely devastating," Fisher said.

No one has questioned Fisher's contribution to the annals of breast cancer research. By all accounts, he helped revolutionize the treatment of this disease, enabling more women to opt for the breast-conserving lumpectomy procedure.

At the same hearing, Ronald B. Herberman, interim director of NSABP, testified that officials at the University of Pittsburgh were taking steps to correct the administrative deficits that had dogged NSABP in the past. As part of its overhaul, NSABP now requires on-site audits of randomly selected cases. In the past, auditors copied the information they needed on-site and reviewed the case back at the Pittsburgh office.

And to dispel criticism that NSABP was too lax with problem institutions, Herberman said that the project would alert the National Cancer Institute (NCI) within 24 hours of finding data problems. The clinical center in question would then have 20 days to clean up its act.

Despite that good-faith effort, NCI recently announced that the University of Pittsburgh would have to compete against other institutions for federal grants to run and manage NSABP in the future.