Rowers paddle down the Charles River past the campus of Harvard University in Cambridge, Massachusetts, March 7, 2017. Credit: Charles Krupa | AP

An internal investigation by Harvard Medical School has determined that 31 scientific publications from the laboratory of a high-profile cardiologist contain fraudulent data.

Piero Anversa and his colleagues were credited with finding a population of cells in the heart that suggested the organ has the ability to regenerate. His work, underwritten by millions of dollars in federal funding, helped lay the groundwork for major clinical trials, and cardiologists continue to study ways to repair the heart with stem cells.

But the cells Anversa described, so-called “c-kit” stem cells, don’t appear to work in the way he suggested, and subsequent research has found no evidence that they can regenerate heart tissue.

He and other members of his laboratory left the Harvard-affiliated Brigham and Women’s Hospital in 2015 under the shadow of the ongoing internal investigation over the integrity of the work performed in his lab.

“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 and Brigham said in a joint statement, without specifying the work affected.

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

“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,” said Jonathan Epstein, a cardiologist at the University of Pennsylvania’s Perelman School of Medicine. “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.”

Several journals said they had recently received communications from Harvard detailing findings of false or fabricated data from Anversa’s lab and were considering their policies before deciding whether to retract the articles.

The New England Journal of Medicine has published several papers co-authored by Anversa, including a dogma-challenging 2001 paper that found the heart can regenerate, and a controversial 2011 paper that reported evidence that there were stem cells in the lung similar to those Anversa had found in the heart. Spokeswoman Jennifer Zeis said the journal had received Harvard’s confidential report about problems with two papers published in 2001 and 2011 and was separately launching its own investigation into a 2002 study.

“Our goal is to obtain as complete information as is possible in order to make an informed decision about possible retraction,” Zeis said.

The Lancet also placed an “expression of concern” on a clinical trial in which researchers infused cardiac stem cells into patients’ hearts in 2014, due to concerns over the integrity of the data. Spokeswoman Emily Head said there was no update on the status of that paper, but that the journal had “received communication from Harvard and are investigating further.”

Suzanne Grant, a spokeswoman for the American Heart Association, said that “we have only just received and are evaluating the findings of the multiyear Harvard University investigation.” She noted that one paper co-authored by Anversa already had been retracted and that a dozen others had been corrected to include the disclosure that Anversa was part of the company Autologous, LLC.

A letter seen by The Washington Post that was sent to a co-author of a paper published in Circulation Research notes that the integrity of data presented in images of cardiac tissue provided by Anversa’s lab was “compromised.” The letter from Harvard says the questions raised “require” that the study should be retracted.

Roberto Bolli, a cardiologist at the University of Louisville School of Medicine who is a co-author of the Lancet paper and the editor in chief of Circulation Research, in which Anversa frequently published, said he and his colleagues are “victims of this scientific misconduct in Anversa’s lab.”

“It would be unfair to us in Louisville if our reputation was tainted by what happened in Boston,” said Bolli, who said his lab administered the cells that were created and characterized by Anversa’s lab into patients. “We don’t know yet the extent to which it [the fabrication] impacted the characterization of the cell product that was used.”

Brigham, part of Partners HealthCare System, disclosed to the Justice Department last year allegations that Anversa’s laboratory had fraudulently obtained federal grant funding. The hospital paid $10 million to settle allegations that Anversa, along with lab 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 Anversa lab had a scope of problems, including “improper protocols, invalid and inaccurately characterized cardiac stem cells, reckless or deliberately misleading record-keeping, and discrepancies and/or fabrication of data and images included in applications and publications.”

“This body of work has, for better or worse, been hugely influential,” said Eduardo Marbán, director of the Smidt Heart Institute at Cedars-Sinai Medical Center. “Despite the fact that several prominent laboratories failed to confirm key findings, c-kit positive heart cells were rapidly translated to clinical testing in heart failure patients. … One can only hope that no patients have been placed at risk in clinical trials based upon fraudulent data.”

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