October 17, 2018

Harvard, Brigham and Women's call into question 31 papers based on prominent cardiologist's research

Daily Briefing

    Harvard Medical School and Brigham and Women's Hospital have determined that 31 papers published by cardiologist Piero Anversa in prominent scientific journals contain falsified and fabricated data, and have called for the research to be retracted.

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    Anversa's contributions in the field of cardiology

    Anversa, who previously worked at the medical school and hospital, has been recognized for his research suggesting stem cells, known as c-kit cells, could be used to regenerate damaged heart muscle. The research paved the way for new start-up companies and further studies into ways to stem cells could be used to repair the heart, including an NIH-funded clinical trial, the New York Times reports.  

    Over the years, Anversa has collaborated with leaders in the field of cardiology and has co-authored more than 100 scientific papers in various journals. For instance, the New England Journal of Medicine (NEJM) in 2001 published a paper co-authored by Anversa that claimed the heart is capable of regeneration, and in 2001 published a paper reporting evidence of stem cells in the lungs.

    As a result of his research, the American Heart Association honored Anversa as a distinguished scientist.

    Concerns over the integrity of Anversa's work emerge

    However, the Times reports that subsequent studies have been unable to replicate the stem cell findings that came from Anversa's lab, prompting some experts to raise concerns over the research.

    For instance, The Lancet in 2014 issued an "expression of concern" over a 2011 paper Anversa co-authored on cardiac stem cell infusion. In the statement, The Lancet noted that Gretchen Brodnicki, Harvard Medical School's dean for faculty and research integrity, informed the journal of an investigation examining the integrity of the data included in the paper.

    In 2015, Anversa and members of his laboratory left Brigham and Women's Hospital amid an internal investigation into the integrity of the laboratory's work. Brigham and Women's in 2017 disclosed allegations to the Department of Justice (DOJ) that Anversa and two members of his laboratory—Annarosa Leri and Jan Kajstura—were aware or should have been aware that the laboratory's applications for federal grants included falsified and manipulated data. Brigham and Women's paid $10 million to settle the allegations.

    Harvard, Brigham and Women's call for retractions of 31 papers

    The mounting concerns prompted Harvard and Brigham and Women's to launch an internal, multi-year investigation into Anversa's lab and research findings.

    In a joint statement issued this week, the hospital and medical school said, "Following a review of research conducted in the former lab of Piero Anversa, we determined that 31 publications included falsified and/or fabricated data, and we have notified all relevant journals."

    Harvard recommended the journals retract the 31 articles, though it did not publicly state which articles are being called into question.

    Scientific journals to begin their own reviews

    A number of scientific journals confirmed receiving notifications from Harvard concerning potential problems with Anversa's research and have said they are reviewing their policies to determine whether they will retract the articles called into question, the Washington Post's "Speaking of Science" reports.

    Jennifer Zeis, a spokesperson for NEJM, said Harvard sent the journal a confidential report about flawed data in the 2001 and 2011 papers co-authored by Anversa. Zeis noted the journal is separately conducting a review of a 2002 paper co-authored by Anversa. "Our goal is to obtain as complete information as is possible in order to make an informed decision about possible retraction," Zeis said.

    Emily Head, a spokesperson for The Lancet, said the journal did not have an update on the status of the 2011 paper on cardiac stem cells, but noted the journal has "received communication from Harvard and [is] investigating further."

    Suzanne Grant, a spokesperson for the American Heart Association (AHA), said AHA "only just received and [is] evaluating the findings of the multiyear Harvard University investigation." Grant noted AHA retracted one paper Anversa co-authored and corrected dozens of other papers to include a disclosure about Anversa's affiliation with the company Autologous.

    Reaction

    Benoit Bruneau, associate director of cardiovascular research at the Gladstone Institutes in San Francisco, said the allegations are concerning. "A couple of papers may be alarming, but 31 additional papers in question is almost unheard-of." He added, "It is a lab's almost entire body of work, and therefore almost an entire field of research, put into question."

    Jonathan Epstein, a cardiologist at the University of Pennsylvania's Perelman School of Medicine, said, "There's been grave damage done to the field, and potentially a generation of young researchers who've come into the field of cardiac regeneration at a time that ideas that largely derived from what appear to be fraudulent papers have held a lot of sway." Epstein added, "Any clinical trials involving patients, based in whole or in part on work that is widely questioned should be seriously rethought and not go forward without due process or consideration."

    Roberto Bolli—a cardiologist at the University of Louisville School of Medicine, co-author of the paper published in The Lancet, and editor in chief of Circulation Research—said he and his colleagues are "victims of this scientific misconduct in Anversa's lab." Bolli said he and his colleagues "don't know yet the extent to which [the fabrication] impacted the characterization of the cell product that was used."

    Anversa and his lawyer could not be reached for comment, "Speaking of Science" reports (Johnson, "Speaking of Science," Washington Post, 10/15; Oransky/Marcus, STAT News, 10/14; Kolata, New York Times, 10/15).

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