Faculty Bibliography

The officials plan to audit all documents at the University of Pittsburgh, which coordinated the surgical study. Auditors will also check the original records at many of the 89 hospitals in the United States and Canada where 1,843 women took part in the study that helped change the way breast cancer is treated. It declared that a partial mastectomy and radiation are just as effective as the more disfiguring full mastectomy. The University of Pittsburgh has also re-analyzed its data -- excluding those from [Roger Poisson] -- and said that the study's original conclusion remains valid. The cancer institute has reviewed this re-analysis and so far found its methodology correct. However, in a further effort to reassure the public, it will audit some raw data. The Pittsburgh study, published in 1985, found many women with early breast cancer can be treated with a partial mastectomy, which is also called a lumpectomy, together with radiation

By reviewing medical records, interviewing doctors and patients and testing their blood, epidemiologists traced the cluster in July 1992 to a surgeon-in-training who had not been immunized against the viral liver infection. Over the 10 months, the surgeon, who has not been identified, had been involved in operations on 142 patients at both the U.C.L.A. Medical Center and the Wadsworth Veterans Administration Hospital. Of these, 18, or 13 percent, developed hepatitis B infection. Of at least 155 patients operated on by other surgeons at the two hospitals, none developed hepatitis B. Like H.I.V., the virus that causes AIDS, the hepatitis B virus is transmitted by blood and through sexual contact. But unlike H.I.V., hepatitis B can be prevented by a vaccine. Dr. [Quentin R. Stiles] recently told a group of surgeons that they face a greater risk from hepatitis B than from H.I.V. When he asked how many in the audience had been immunized against hepatitis B, fewer than half said they had, and most of them were younger surgeons. Immunizing surgeons against hepatitis B 'is the kind of thing we ought to be insisting upon,' Dr. Stiles said

Of the 36 states that have the death penalty, 28 require the presence of a doctor at the execution, according to the report. Twenty-three states require that a physician pronounce or determine death in executions, a violation of the widely respected ethical opinions of the American Medical Association. The AMA's ethical guidelines prohibit doctors from assisting in, witnessing or attending executions. The guidelines also ban doctors from rendering technical advice to workers carrying out an execution, and from monitoring, on site or at a distance, the heartbeat or other vital signs of the condemned during the execution process. Since the Supreme Court allowed reinstatement of the death penalty in 1976, many states have allowed executions by injection of drugs. Doctors have been called on to prescribe the lethal drug, insert the needle and tubing to deliver it, and to inspect, test and maintain lethal injection devices, the report said

Of the 36 states that have the death penalty, 28 require the presence of a doctor at the execution, according to the report. Twenty-three states require that a physician pronounce or determine death in executions, a violation of the widely respected ethical opinions of the American Medical Association. The AMA's ethical guidelines prohibit doctors from assisting in, witnessing or attending executions. The guidelines also ban doctors from rendering technical advice to workers carrying out an execution, and from monitoring, on site or at a distance, the heartbeat or other vital signs of the condemned

The AMA's ethical guidelines prohibit doctors from assisting in, witnessing or attending executions. The guidelines also ban doctors from rendering technical advice to workers carrying out an execution, and from monitoring, on site or at a distance, the heartbeat or other vital signs of the condemned during the execution process. The AMA clearly distinguished between pronouncing and certifying death in an execution. To the AMA, pronouncing a death requires the doctor to monitor the condemned person during execution and determine the exact moment of death; certifying, which does not require the doctor to be present at the execution or to monitor the death, is considered ethical

Among the cancer institute's concerns was that the data irregularities 'went undetected for more than a decade.' Another concern was the relatively small number of cases that Dr. [Bernard Fisher]'s team selected for reaudit

The studies have been continuing for more than two decades and have cost taxpayers tens of millions of dollars. The U.S. government has taken steps to be repaid $1 million from St. Luc's Hospital, a small community hospital in Montreal, where federal officials say the principal investigator, Dr. Roger Poisson, falsified data on more than 100 of the 1,511 patients he enrolled in his part of 22 studies from 1975 to 1991. Yet the reply that Poisson made to accusations from the federal officials who investigated his role was rambling and disorganized. His reply creates the impression of an emotionally charged researcher who deliberately ignored what he saw as trivial rules of the study more than a dispassionate scientist who strove for objectivity and precision. He described the pressures he felt in asking a patient to participate in the study. 'People who are not on the front line of the battle have no idea how frustrating it can be to prepare an eligible patient for the trial, with several pep talks and a great deal of discussion, explanation for the informed consent and to convince the patient to participate and -- at the last moment -- to realize that the patient' is ineligible for what he perceived to be a technicality, Poisson said. 'It is a feeling of letdown and of frustration

Federal health officials have commissioned three statisticians to analyze independently data from a flawed breast cancer study in the hope that the re-analysis will assure the public that the original conclusions remain valid. The study helped change the way breast cancer is treated by concluding that lumpectomies followed by radiation are as effective as full mastectomies in preventing spread of the disease in many women with early breast cancer

Even the centers that coordinate large studies involving many hospitals deal primarily with derivative data. The coordinating centers often do not get original documents, except when they conduct random audits or when suspicions are raised about the nature of a scientist's research. The flawed breast cancer study was coordinated at the University of Pittsburgh by Dr. Bernard Fisher, a respected surgeon and senior cancer researcher who was a pioneer in developing some of the standard treatments for the disease. The studies have been continuing for more than two decades and have cost taxpayers tens of millions of dollars. The U.S. government has taken steps to be repaid $1 million from St. Luc's Hospital, a small community hospital in Montreal, where federal officials say the principal investigator, Dr. Roger Poisson, falsified data on more than 100 of the 1,511 patients he enrolled in his part of 22 studies from 1975 to 1991