Fostering Integrity in Research (2017) / Chapter Skim
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Appendix D: Detailed Case Histories
Appendix D: Detailed Case Histories
Pages 265-286
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From page 265... ...
Issues covered in the cases include individual and institutional conflicts of interest, data falsification and fabrication, whistleblower retaliation and protection, insufficient or abusive mentoring, ghostwriting, authorship roles, institutional and administrator responsibilities, journal responsibilities, implementation of the federal government's research misconduct policy, and the costs and impacts of research misconduct. Some cases mentioned in the report are not included in the appendix because the shorter descriptions already sufficed to illustrate the issues being described.
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From page 266... ...
Its verdict finding Wakefield guilty of serious professional misconduct and decision to strike him from the medical register are not available in document form, having been read aloud at a May 2010 hearing, so a news report of this hearing is cited.
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From page 267... ...
. Wakefield's recent basis of this claim is a 2014 article by Brian Hooker published in Translational Neurodegeneration in which Hooker reevaluates data collected by the CDC and suggests African American boys who received the MMR vaccine before 24 months and after 36 months of age showed higher risks for autism (Hooker, 2014, retracted)
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From page 268... ...
PAXIL CASE Synopsis and Rationale for Inclusion: The Paxil case illustrates issues related to biomedical ghostwriting and unacknowledged conflicts of interest. In this practice, the listed authors of an article reporting on a clinical study may consist solely of prominent academicians, yet unacknowledged industry-supported researchers may have undertaken key tasks associated with the research, including aspects of concept design, subject enrollment, monitoring, data collection and interpretation, and writing the article.
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From page 269... ...
. The Food and Drug Administration recently released draft guidance on publications reporting use of approved products for off-label indications: Guidance for Industry Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products -- Recommended
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From page 270... ...
Ultimately, the students decided to turn Goodwin in, which led to a university investigation finding that data in several grant applications had been falsified, a ruling confirmed by the Office of Research Integrity (ORI, 2010)
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From page 271... ...
THE HWANG STEM CELL CASE AND THE UNIVERSITY OF PITTSBURGH: COAUTHOR RESPONSIBILITIES AND INSTITUTIONAL RESPONSES Synopsis and Rationale for Inclusion: The Hwang case raises several important research integrity issues, including data fabrication and falsification, abuse of mentorship status, whistleblower retaliation, and endangering the health of trial participants. The University of Pittsburgh's role in this case highlights the need for institutional oversight and defined standards for authorship roles.
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From page 272... ...
Hwang in late 2003, offering editorial input and support to Hwang's 2004 paper that had earlier been rejected by Science. Following the acceptance of the paper, Schatten and Hwang began discussing a follow-up paper in which Hwang claimed his laboratory team had "created human embryonic stem cells genetically matched to specific patients" (Sang-Hun, 2009)
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From page 273... ...
Throughout the entire investigation, Hwang maintained that his laboratory did "create stem cells matched to individual patients," but acknowledged that mistakes were made throughout the research process. His achievement of the first cloned dog, Snuppy, was never discredited (Nature, 2005)
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From page 274... ...
. THE TRANSLATIONAL OMICS CASE AT DUKE Synopsis and Rationale for Inclusion: The case of Duke University researchers Joseph Nevins and Anil Potti, which stretched out over several years and attracted national media attention, illustrates shortcomings and deficiencies in current approaches to research integrity on the part of researchers, research institutions, government agencies and journals (CBS News, 2012)
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From page 275... ...
. In 2007, at the same time questions were being raised about the data underlying the Nevins-Potti research, Duke University and Duke University Medical Center investigators not associated with Nevins or Potti launched three clinical trials based on the results, and an additional trial was launched at Moffitt Cancer Center (IOM, 2012)
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From page 276... ...
report discussed further below, Duke "did not institute extra oversight or launch formal investigations of the three trials during the first 3 years after the original publications triggered widely known controversy about the scientific claims and after concerns started to develop about the possible premature early initiation of clinical trials" (IOM, 2012)
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From page 277... ...
. Its Translational Medicine Quality Framework emphasizes new science and management approaches to ensure data provenance and integrity, the incorporation of adequate quantitative expertise, explicit management accountability in the institution beyond the individual lab for research affecting patient care, and enhanced conflictof-interest reviews.
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From page 278... ...
Individual Researchers Anil Potti's misbehavior is at the center of the case. Prior to ORI's conclusion of research misconduct, Joseph Nevins and Robert Califf had both said that it is highly likely that Potti intentionally fabricated or falsified data (CBS News, 2012)
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From page 279... ...
. The evidence now available, some that has come to light only after Freedom of Information Act requests and court depositions, suggests that Duke University and its leadership failed in virtually all of these responsibilities: for undertaking clinical studies outside the established review structures; for the failure to pursue internal investigation of serious, documented concerns until forced by outside forces to do so; for withholding from an external committee the full Baggerly/ Coombes critique; for referring responsibility for rechecking Potti's work back to the laboratory of his (explicitly conflicted)
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From page 280... ...
. As for the clinical trials that were undertaken based on the fabricated work, 117 patients were ultimately enrolled.
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From page 281... ...
. The IOM report also points out that NCI felt constrained in communicating what it knew and the extent of its concerns with Duke and others early in the case, particularly before officials were aware that the agency was supporting aspects of the clinical trials (IOM, 2012)
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From page 282... ...
2010. Letter to Harold Varmus: Concerns About Prediction Models Used in Duke Clinical Trials.
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From page 283... ...
2004. Evidence of a pluripotent human embryonic stem cell line derived from a cloned blastocyst.
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From page 284... ...
2015. New Nature papers debunk STAP cells.
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From page 285... ...
2005. Journal defends stem cell article despite photo slip.
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