Faculty Bibliography

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

Reports that Canadian researcher Roger Poisson falsified data in a major breast cancer study coordinated by Bernard Fisher at the University of Pittsburg are raising questions about the quality of medical research, the honesty of medical researchers and the various ways studies are done. Leaders of the study and federal health officials reportedly delayed disclosing the situation

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, Dr. [Roger Poisson] said. 'It is a feeling of letdown and of frustration.' An official of the National Cancer Institute wrote to Dr. Fisher on Jan. 7, 1993, urging him to review the audit procedures and method of case selection for review. 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 re-audit, a factor that the cancer institute suggested had contributed to the study group's 'inability to detect problems.' Dr. Poisson wrote that he realized that 'there is no excuse to cut the corners' and that 'in the strict sense, I did bend the rules.' But he also said that he 'did not consider white lies for the purpose of practical logistics as a breach of my honor.'

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 federal officials was rambling and disorganized. His reply creates the impression of an emotionally charged researcher who deliberately ignored what he saw as trivial rules. In a written reply to the U.S. Public Health Service's Office of Research Integrity, which spearheaded the federal investigation, Poisson stated: 'I always feel sorry for a nice case to be denied the right to enter a good protocol just on account of trivial details: a difference of a few days in the date of surgery because the patient took a long time to decide . .

C4G1, a murine mAb reactive with the platelet gpIIb/IIIa integrin, was humanized for potential treatment of thrombosis-related disorders. The variable regions of light- and heavy-chain cDNAs from the C4G1 hybridoma were first cloned and sequenced. Humanized C4G1 Ab of the IgG1 isotype was constructed by combining the complementarity-determining regions of C4G1 with human framework and constant regions. The human framework was chosen to maximize homology with the C4G1 variable region sequence, and a computer model of C4G1 was used to aid design of the final framework sequence. Genetic constructs were also developed to produce Fab and F(ab')2 fragments of the humanized C4G1 Ab. The humanized IgG1 Ab as well as the Fab and F(ab')2 fragments showed equivalent binding affinities to their murine counterparts, indicating no loss in binding affinity during the humanization process. The humanized Ab and its fragments were also shown to inhibit platelet aggregation and to inhibit binding of fibrinogen to gpIIb/IIIa in vitro

In a development that reflects the changing demographic face ofthe AIDS epidemic in this country, heterosexual transmissionaccounted for the largest proportionate increase in AIDS cases reported last year, federal health officials said Thursday. Although the epidemic overall still mostly infects gay men, heterosexuals represented the largest proportionate increase in 1993, said Pat Flemming, chief of reporting and analysis in the CDC's AIDS division. Of the cases attributed to heterosexual transmission, almost half - or 49.7 percent - were attributed to a sex partner who had AIDS or was infected with HIV, the virus that causes the disease, the CDC said

In a development that reflects the changing demographic face of the AIDS epidemic in this country, heterosexual transmission accounted for the largest proportionate increase in AIDS cases reported last year, federal health officials said Thursday. In its first report on heterosexual transmission of AIDS in four years, the centers said that, in 1993, the cases of AIDS that could be attributed to heterosexual transmission were 6,056 for women and 3,232 for men. A disproportionate number were among blacks and Hispanics. A major challenge, the report said, is to help develop culturally and linguistically appropriate HIV-prevention messages for different racial and ethnic groups