The Harvard investigation revealed fraudulent data in papers written by a cardiology researcher;



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An internal investigation by Harvard Medical School found that 31 scientific publications from a reputed cardiologist's laboratory contained fraudulent data.

Piero Anversa and her colleagues have been credited with the discovery of a population of cells in the heart suggesting that the organ has the capacity to regenerate. His work, funded by millions of dollars in federal funding, has laid the groundwork for large-scale clinical trials and cardiologists continue to explore ways to repair the heart with stem cells.

But the cells described by Antwerpa, called "c-kit" stem cells, do not seem to work as he has suggested, and subsequent research has found no evidence that they can regenerate heart tissue.

In 2015, along with other members of his lab, he left Brigham and Women 's hospital, affiliated with Harvard, under the shadow of the ongoing internal investigation into the current situation. integrity of the work done in his laboratory.

"After a review of the research carried out in Piero Anversa's former laboratory, we determined that 31 publications included falsified and / or fabricated data, and we informed all relevant journals," said Harvard and Brigham in a statement. joint communiqué, without specifying the work. affected.

Antwerpa has published more than 100 scientific articles and its collaborators have included leaders in the field. He has also been honored as a distinguished scientist by the American Heart Association. Efforts to reach Antwerpa through his lawyer were unsuccessful.

"Serious damage has been done on the ground, and potentially a generation of young researchers interested in the field of cardiac regeneration at a time when the ideas that flowed largely from what appears to be fraudulent papers have a lot of weight, "said Jonathan Epstein, a cardiologist at the Perelman School of Medicine at the University of Pennsylvania. "All clinical trials involving patients, based in whole or in part on work that has been widely questioned, need to be seriously rethought and not pursued without a proper process or consideration."

Several newspapers reported receiving reports from Harvard detailing the results of false or manufactured data from the Antwerpa laboratory and considering their policy before deciding whether to remove the items.

The New England Journal of Medicine published several articles co-authored by Antwerpa, including a 2001 article on dogma, which showed that the heart could regenerate, and a controversial article in 2011 reporting evidence of stem cells in the lungs similar to those that Antwerp had found in the heart. Spokesperson Jennifer Zeis said the paper received Harvard's confidential report on issues related to two articles published in 2001 and 2011 and launched its own investigation into a 2002 study.

The Lancet placed an "expression of concern" in a clinical trial in which researchers infused heart stem cells into patients' hearts in 2014, due to concerns about data integrity. The spokeswoman, Emily Head, said the newspaper had "received a communication from Harvard and was investigating".

Suzanne Grant, a spokeswoman for the American Heart Association, said, "We have just received and are evaluating the findings of the multi-year survey conducted at Harvard University." She pointed out that an article co-authored by Anversa had already been withdrawn and that a dozen others had been corrected to include the disclosure that Antwerpa was part of Autologous LLC.

The Washington Post, in a letter to a co-author of an article published in Circulation Research, notes that the integrity of the data presented in the heart tissue images provided by the Antwerpa laboratory was "compromised" ". The letter from Harvard states that the questions "require" that the study be retracted.

Roberto Bolli, a cardiologist at the Faculty of Medicine at the University of Louisville, co-author of The Lancet Paper and Editor-in-Chief of Circulation Research, in which Antwerpa frequently published, stated that he and his colleagues were "victims of this scientific misconduct in the laboratory of Antwerpa. "

"It would be unfair to us in Louisville if our reputation was altered by what happened in Boston," said Bolli, who said his lab was administering the cells created and characterized by the Antwerp lab. . "We do not yet know to what extent it [the fabrication] impact on the characterization of the cellular product used. "

Brigham, part of the Partners HealthCare System, leaked allegations to the Justice Department last year that the Antwerp lab has fraudulently obtained federal funding. The hospital paid $ 10 million to settle the allegations that Antwerpa, together with laboratory members Annarosa Leri and Jan Kajstura, knew or should have known that their laboratory had created and used manipulated or falsified microscope images and other data in grant applications.

The Government alleged that the Antwerpa laboratory presented a number of problems, including "invalid and poorly characterized cardiac stem cells, imprudent or willfully misleading recordkeeping, as well as anomalies and / or data fabrication and images included in applications and publications ".

"This work has had considerable influence, for better or for worse," said Eduardo Marbán, director of the Smidt Heart Institute at Cedars-Sinai Medical Center. "Despite the fact that several leading labs could not confirm the key findings, c-kit-positive heart cells were quickly translated into clinical trials in patients with heart failure. … One can only hope that no patient has been exposed to risk during clinical trials based on fraudulent data. "

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