Two embattled and highly controversial stem cell researchers are suing the Brigham and Womens Hospital and Harvard Medical School for an ongoing investigation into their research. The investigation has already resulted in the retraction of one paper inCirculationand anexpression of concern about another paper in theLancet.

The suit was filed by Piero Anversa, the highly prominent stem cell researcher who is a Harvard professor and the head of a large lab at the Brigham, and his longtime colleague,Annarosa Leri, an associate professor of medicine at Harvard who has coauthored many papers with Anversa. The suit places the blame for any scientific misconduct relating to the two papers on a third colleague and coauthor,Jan Kajstura, their longtime collaborator. In an explanation of the problems relating to the Circulation paper,Anversa and Leri accuse Kajstura of doctoring data in a spreadsheet in such a way that they could not have detected it. For theLancet paper the two scientists say thatKajstura and another unnamed scientist in the lab altered two images. Kastura is no longer at the Brigham.

The news was first reported byCarolyn Johnson in theBoston GlobeandJessica Bartlett in the Boston Business Journal. The story has also been reported in depth by Ivan Oransky onRetraction Watch.

The lawsuit accuses Elizabeth Nabel, the president of the Brigham, and the individual members of the investigating panel, of inappropriate and illegal behavior and conflicts of interest.At one point the complaint alleges that the scientists on the panel lack substantial expertise in the relevant scientific areas, including cardiac stem cells. But then, when another member was added to the panel, Ulrich von Andrian, the complaint states that he suffers from serious conflicts of interest that impede his ability to participate in the investigation in an impartial manner. Nabel and von Andrian, along with other Harvard and Brigham figures, serve on the scientific advisory board of Moderna Therapeutics, a stem cell company pursuing an alternative modality for regenerative treatment of cardiac disease.

Anversa and Leri further allege that the investigation caused the withdrawal of a multimillion dollar offer to purchase their company, Autologous/Progenital. The investigation also ended efforts to recruit Anversa and Leri to the University of Miami and the Mt. Sinai School of Medicine in New York.

The complaint discloses that as a result of the ongoing investigation Anversa and Leri were subject to embarrassing questions from other prominent stem cell researchers, including Joshua Hare, Steven Houser, and Eduardo Marban. These researchers, the complaint states, had no need to know of the inquiry.

Anversa and Leri also criticizethe panel for expanding its investigation to at least 15 papers from the research group. There is no justification for expanding the investigation to encompass these additional papers at this late stage. Most were published before the inquiry process began in January 2013, and all were published before the investigation began in February 2014. It is unclear from the complaint why these papers should not have been subject to scrutiny.

As I reported in 2011, the Lancet paper reporting the results of theSCIPIO trial was the subject of considerable hype at the time of its original publication. ABC News, CBS News and other media outlets used phrases like medical breakthrough and heart failure cure. ABC News correspondent Richard Besser was so enthusiastic that anchor Diane Sawyer commented that she had never seen him so excited. The first author of SCIPIO, Roberto Bolli, said the work could represent the biggest advance in cardiology in my lifetime.

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Embattled Stem Cell Researchers Sue Harvard And Brigham And Women's Hospital