The director of the National Cancer Institute conceded Wednesday that federal officials failed to intervene quickly enough after learning that a major government-funded study on breast cancer had been tainted by false information.
But NCI Director Samuel Broder insisted that the results of the study remain valid.
In testimony before a congressional subcommittee, he said that the "best" available science still supports the conclusion that lumpectomies are an effective and appropriate alternative to mastectomies in the treatment of breast cancer.
"I assure you that this remains an appropriate and safe procedure," Broder told the House Energy and Commerce subcommittee on oversight and investigations.
The discovery of the false data and subsequent revelations about the length of time it took to disclose what clearly was a major case of scientific deception have deeply shaken the medical community and prompted angry outcries from consumer advocacy organizations and women's groups.
"We're dealing with an enormous ethical lapse . . . that just shatters our confidence in the scientific community and . . . strikes at the heart of women's worst fears," said Rep. Olympia Snowe (R-Me.).
"Scientific misconduct, however rare, cannot be tolerated," added Rep. Henry A. Waxman (D-Los Angeles).
Broder agreed that the NCI's supervision of the long-term project coordinated by the University of Pittsburgh had been lax and he outlined a series of measures taken since then to ensure closer oversight in the future.
"We are very sorry that this has happened and we assure you that such errors will not happen again," he said.
The assurances were not enough, however, to mollify either consumer groups or panel members, who called for an independent re-evaluation of the breast cancer research to restore public confidence in NCI and its parent organization, the National Institutes of Health.
The widening scandal has already brought about the downfall of one of the medical community's most respected researchers--Dr. Bernard Fisher of the University of Pittsburgh--and cast a cloud of doubt over the integrity of the research being conducted by the National Surgical Adjuvant Breast and Bowel Project, a broad-based network of doctors and hospitals in the United States and Canada that has been a pioneer in the field of breast cancer treatment.
It has also led to renewed calls for closer oversight by Congress. Energy and Commerce Chairman John D. Dingell (D-Mich.) and other lawmakers have long been dissatisfied with what they regard as the lenient way in which the NIH has handled allegations of fraud and misconduct.
"Many in the scientific community have resisted outside scrutiny. . . . But as we see today, scientific misconduct is a very real problem and . . . NIH's capability and willingness to manage and oversee federally funded research continues to be the key question," Dingell said.
The scandal first came to the attention of investigators in 1990, when a researcher in Pittsburgh found a medical record discrepancy that later led to the discovery that a Canadian researcher, Dr. Roger Poisson of St. Luc Hospital in Montreal, had entered false data so that ineligible patients could be enrolled in the study.
That discovery in turn raised questions about the validity of the landmark study's 1985 conclusion that a lumpectomy, the surgical removal of cancerous tissue in a woman's breast, was just as effective in treating breast cancer as a mastectomy, the removal of the entire breast.
Researchers later concluded that the study's results were valid even after Poisson's data was discounted. But troubling questions arose over the way Fisher and NCI handled the subsequent investigation, keeping silent until last month when the scandal was disclosed by the Chicago Tribune.
In defense of the NCI, Broder said that the agency ordered the breast cancer researchers to re-evaluate the 1985 study's data, publicly disclose its findings and remedy other lapses--including deficient auditing and reporting practices.
Initially, however, the orders were ignored and administrators of the study failed "to respond to constructive criticism by NCI staff," Broder said.
Subsequent investigations by NCI also revealed other problems with the Pittsburgh project, including "irregularities" in a still ongoing series of trials to determine the effectiveness of the drug tamoxifen in preventing breast cancers, he added.
The drug is still being administered to healthy women with high risks of contracting breast cancer, despite what Dingell said is evidence that tamoxifen has been associated with the deaths of at least four women from uterine cancer. Fisher, he said, had been aware of the four cases but had failed to report the information to the NCI.
Broder said that the NCI should have been informed of the deaths sooner. He acknowledged, however, that in part because of Fisher's towering stature and the Breast and Bowel Project's reputation, the NCI had been slow to act. In part because of "a mistaken belief that somehow the lapses by a senior research group were temporary," NCI "failed to compel these actions, forcefully and in a timely way," he conceded.
He added that new safeguards announced earlier this week should prevent such lapses from recurring. They include the creation of a new monitoring branch to oversee research by the recipients of federal grants, surprise annual inspections of research facilities and a requirement that grantees report any evidence of fraud to NCI within 24 hours of discovery.
"We will not ever again hesitate to exercise (our) authority whenever necessary," Broder said.
But these assurances were not enough to satisfy Jill Lea Sigal, a 32-year-old consultant from Alexandria, Va., who six months ago was diagnosed as having breast cancer.
In testimony that brought a hush to the crowded hearing room, Sigal recounted how she was "devastated" to learn--through newspaper articles--that her decision to have a lumpectomy instead of a mastectomy may have been based on flawed information.
"How many women . . . made a decision about their surgery based on this study as I did? How many women must now wonder, as I do, if they will die because they have made the wrong decision?" she asked in a voice choked with emotion.