Scientific Characters: Rhetoric, Politics, and Trust in Breast Cancer Research

Introduction: Trust and Character in Datagate

Introduction Trust and Character in Datagate March 13, 1994, was a disheartening day in the high-­ stakes world of breast cancer research. The Chicago Tribune broke the news with a front-­ page headline proclaiming “Fraud in Breast Cancer Study: Doctor Lied on Data for Decade.”1 Before this announcement, only a small cadre of medical researchers and government investigators knew that Dr. Roger Poisson, former head of cancer research at Montreal’s Saint-­ Luc Hospital, had previously confessed to falsifying more than one hundred pieces of data used in fourteen U.S.-­ funded cancer clinical trials.2 But following the Tribune’s story, “all hell broke loose,” as patients, physicians, politicians, federal investigators , health-­ care workers, journalists, advocates, and citizens clamored to assess the misconduct’s ramifications for North America’s premier breast cancer research.3 They would soon learn that some of the falsifications occurred in Project B-­ 06,the highly influential lumpectomy study that had formed the basis of the National Institutes of Health’s (NIH) 1990 consensus statement endorsing breast-­ conserving lumpectomy with radiation for early-­ stage breast cancers.4 Hailed as a major triumph for ­ women’s health care, the B-­ 06 project had demonstrated that preserving a breast through lumpectomy and radiation was as effective as removing one or both of those iconic markers of femininity, hence sparing women unnecessary pain and disfigurement.5 No wonder reports that a researcher had falsified data in a federally funded clinical trial of such magnitude spurred public outcry, enraged women’s health advocacy groups, and troubled members of the medical establishment.Harmon Eyre,then deputy vice president of the American Cancer Society (ACS),pronounced the situation“an unmitigated disaster for American women.”6 2 Introduction As news of the tainted data spread, Dr. Bernard Fisher, then overseer of the B-­ 06 project and a towering giant of cancer research,tumbled from empyrean heights. Never mind that it was Fisher’s team who first discovered that Poisson had contributed faulty data to the landmark lumpectomy study, previously published in 1985 and 1989 in the usually unassailable New England Journal of Medicine.7 Never mind that Fisher was not himself accused of falsifying data; the former member of the President’s Cancer Advisory Panel was soon forced to resign from a position he had held for more than thirty-­ five years, was shredded routinely in the mass media, and was called to testify before Congress.8 Meanwhile, patients fumed, politicians grandstanded , and many stakeholders felt ill-­ equipped to adjudicate the implications of the flawed data for breast cancer treatment.When the storm began to settle, Fisher was cleared of all wrongdoing, and reanalysis of B-­ 06 data reaffirmed the value of breast conservation.9 Yet, in the fracturing of rhetorical agency that occurs in such disputes, Fisher’s character, like that of other principals in the controversy,was redefined,challenged,and circulated by ensemble—and the process was often muddled and mean.As administrators , politicians, investigators, scientists, patients, activists, journalists, and concerned citizens attempted to make sense of what had happened and to assess the integrity of the now-­ tarnished research, they asked questions, raised challenges,assigned blame,attributed responsibility,launched and responded to attacks, and ultimately exposed the norms of scientific practice to public scrutiny. Throughout it all, character comprised a sustained topic of debate, showing how scientific knowledge is indelibly shaped by perceptions of the personal temperament, trustworthiness, overall integrity, and transparency of those who produce it. The controversy that followed widespread publicity of Roger Poisson’s data falsification spanned seven years and involved at least two nations,four federal agencies, thirteen academic journals, and eighty-­ nine collaborative research sites.10 Its stakeholders included 19 coauthors, 2,163 research participants , the more than 200,000 North American women annually diagnosed with breast cancer and their loved ones, physicians, patients, investigators , health-­ care workers and advocates, and the broader global citizenry.11 As the controversy unfolded,the reputations of physician-­ scientists,clinical trials, breast cancer research, and governmental oversight agencies underwent steady assault; and because of the life-­ and-­ death stakes of the outcome of Datagate in terms of breast cancer treatment, patients were inextricably yoked to assessments of scientific character and credibility.Dubbed “NSABP Datagate”by one breast cancer survivor who merged the acronym of the research cooperative that conducted the then tarnished study—the Trust and Character in Datagate 3 National Surgical Adjuvant Breast and Bowel Project (NSABP)—with the charge of compromised data, the controversy tapped...