Harvard Medical School and Brigham and Women’s Hospital have recommended that 31 papers from a former lab director be retracted from medical journals.

The papers from the lab of Dr. Piero Anversa, who studied cardiac stem cells, “included falsified and/or fabricated data,” according to a statement to Retraction Watch and STAT from the two institutions.

Last year, the hospital agreed to a $10 million settlement with the U.S. government over allegations Anversa and two colleagues’ work had been used to fraudulently obtain federal funding. Anversa and Dr. Annarosa Leri — who have had at least one paper already retracted, and one subject to an expression of concern — had at one point sued Harvard and the Brigham unsuccessfully for alerting journals to problems in their work back in 2014. Anversa’s lab closed in 2015; Anversa, Leri, and their colleague Dr. Jan Kajstura no longer work at the hospital.

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While the Brigham settled with the U.S. Department of Justice, the U.S. Office of Research Integrity, which oversees research misconduct investigations involving National Institutes of Health funding, has not made a finding in the case. The university and the hospital have not said which journals the 31 papers appeared in, but the journal Circulation retracted a paper by Anversa and colleagues in 2014, and The Lancet issued an expression of concern about another in the same year.

It is not clear how, or whether, the call for retractions by Harvard and the Brigham is related to the Brigham’s settlement with the government.

Dr. Piero Anversa was most recently affiliated with the Cardiocentro Ticino and University of Zurich. Brigham and Women's Hospital

“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 the Brigham told STAT and Retraction Watch.

Anversa has previously corrected eight of his papers, many for failures to disclose conflicts of interest. He “practically invented the field of cardiac stem cell therapy when he first reported that cardiac cells were capable of regeneration,” Cardiobrief and MedPage Today wrote about him last year.

Anversa’s work was based on the idea that the heart contains stem cells that could regenerate cardiac muscle. He and his colleagues claimed that they had identified such cells, known as c-kit cells. When various research teams tried to reproduce the results, however, they failed. Still, some scientists have tried to inject c-kit cells into damaged hearts, with mixed results at best.

“For 10 years, he ran everything,” said Jeffery Molkentin, a researcher at Cincinnati Children’s whose lab was among the first to question the basis of Anversa’s results in a 2014 paper in Nature. “It really is a relief that this has been corrected. I think this is good for everybody.”

For the most part, “the field has already worked this in,” Molkentin told STAT and Retraction Watch. “It’s like when Wall Street has worked in the next two interest rate hikes.”

“There are no stem cells in the heart. Quit trying to publish those results.”

Jeffery Molkentin, Cincinnati Children's

Still, he said, a small number of researchers continue to publish findings that agree with Anversa’s. “Maybe these 31 retractions will keep pushing the pendulum a little further to the right and these people will slowly start to back off even more,” he said.

“It’s just discouraging when you see these papers keep popping up,” Molkentin said. “There are no stem cells in the heart. Quit trying to publish those results.”

Anversa published at least 55 papers that listed Harvard as an affiliation. In 2014, a former research fellow described an atmosphere of fear and information control in his lab.

Anversa, who according to publications was most recently affiliated with the Cardiocentro Ticino and University of Zurich, could not be reached for comment. An email to his address at Cardiocentro Ticino bounced back. A number of Anversa’s co-authors either did not immediately respond to a request for comment, or declined.

“We are committed to upholding the highest ethical standards and to rigorously maintaining the integrity of our research,” Harvard and the Brigham said. “Any concerns brought to our attention are reviewed in accordance with institutional policies and applicable regulations.”

Anversa was born in Parma, Italy, in 1940 and received his medical degree from the University of Parma in 1965. He gained prominence as a stem-cell researcher at New York Medical College in Valhalla, N.Y., where he worked before moving to Harvard Medical School and the Brigham in 2007. Anversa became a full professor in 2010.

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Throughout his career, Anversa has received several commendations, including a research achievement award from the American Heart Association, which in 2004 also named him a “distinguished scientist.”

Although journals often act on retraction recommendations by universities, they do not always do so, and it sometimes takes a while. Journals retract roughly 1,400 scholarly papers each year, out of some 3 million total publications. Anversa’s total would put him in the top 20 list of scientists with the most retractions in the world. The 10 scientists worldwide with the most retracted papers have at least 39, and in one case — Japanese anesthesiologist Yoshitaka Fujii — 183 such articles.

So what do the calls for retraction mean for cardiology?

“What seems obvious to me is a need for transparency,” Yale cardiologist Dr. Harlan Krumholz told STAT and Retraction Watch. “The scientific community needs to know what was found, why papers were retracted, and what is recommended with regard to his work going forward. Also, what has happened to work that was based on his work. Without this knowledge it is hard to know what it means.”

Some of Anversa’s work has already been retracted or corrected.

Suzanne Grant, a spokeswoman for the American Heart Association/American Stroke Association, said that one 2012 paper published in the journal Circulation and co-authored by Anversa was retracted in 2014. The AHA has corrected a number of other Anversa papers, mostly by adding additional disclosures.

Grant said the AHA was evaluating Harvard’s findings and “would again take appropriate action” if needed.

Harvard also flagged two Anversa papers — one from 2001 and the other from 2011 — to the New England Journal of Medicine, and the publication is separately investigating images published in a 2002 paper, spokeswoman Jennifer Zeis said.

Seil Collins, a spokesman for the Lancet journals, said the publication group was investigating the 2011 paper that had already been tagged with an expression of concern after receiving new information from Harvard.

This story is a collaboration between STAT and Retraction Watch. It has been updated with information from some journals. Reporter Andrew Joseph contributed.

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  • Many of the folks commenting below are obviously angry. Perhaps they were considering the therapy? The point here is that this reporter did about as shoddy a job of fact finding as the doctor did in false reports. The findings were from several years ago and finally came to a head in court. This research has continued all over the world with a remarkable degree of advancement and should not be thrown out with the bath water. Do your own homework and don’t rely so heavily on others. It is not junk science. Our bodies have amazing healing powers that are being revealed

  • The big labs in the field also share some blame because they let Anversa “run the field” for ten years . No one would confront him and many were at his bidding.

  • It occurs to me that one possibly sure-fire way to reduce the incidence of this kind of scientific misconduct is to pass Federal legislation subjecting all information and data on or in support of grant applications (and renewals) to the penalties of criminal perjury, both for individual researchers and the Chief Financial Officers at their institutions.

    Perhaps this would make people would think twice before hitting ‘submit’.

    • The fining, as seen here, of the institution for many times the money provisioned in funding may well be the critical step. A great assistant to persons like Prof Anversa is the financial prowess of million dollar grants.

    • The more cutting edge a paper is, the more likely that years later it will be found to have aspects that are “not quite right” in hindsight reflecting the immaturity of the field at the time it was written. That is why if you open a cutting edge journal, such a Nature, from 40 years ago, the average paper is chock full of things that today would be considered incorrect interpretations of the data. Your statement indicates you have zero understanding of the Scientific Method.

  • After reading this article and having a friend who is supposed to have this so-called stem cell procedure for her Amylodosis, I wonder. Especially since the retractions do not say anything except there are no stem cells in the heart. Well where do they suppose to get the stem cells from, which by the way, are not going to cure her. Why are scientists even allowed to publish if the results of their scientific test have not shown that the procedure is good for the people that is is being done on.

    My advice to my friend would be to not have the procedure that she is against anyway, until someone can prove that it actually works, or that it will provide some sort of conclusion to her disease or others that the procedure is being used to cure.

    Also, when will the retractionist publish their findings and let everyone know exactly why the papers written are incorrect or why they think they are incorrect. This is vital information that doctors who are using or intend to use this procedure need to know as well as the patients they intend to do the procedure on. Everyone needs to be aware of the facts as to whether or not this procedure is factual on paper and in its use.

    Everyone is making money without caring about the lives of the innocent people undergoing these procedures.

    I’m just saying.

  • It is too late now! Here in the US, we have chiropractors and acupuncturists peddling Stem Cell Therapies, based on misdealing “Science.” Trump Appointee, Rick Perry moved his profitable stem cell clinic to Mexico, to avoid “Regulations.” Our healthcare resembles a criminal conspiracy, thanks to these bought and paid for quackademics.

  • I would agree that there are no c-kit positive stem cells in heart. However, there are cells that are telomerase-positive with extensive differentiation capabilities, that are located in the heart as well as every other organ in the body. Suggest to not to make blanket statement, such as “there are no stem cells in heart” without examining other cells in heart as well.

    • I agree. It is the arrogant, pompous attitude of mainstream doctors and the agenda they are promoting that ridicule and shame anyone who may have a piece of the puzzle.

  • I agree with Ricardo (earlier today). This man stole research money directly; and who knows how much public and private dollars went into fruitless investigations following him down his non-existent track. It’s unfortunate in many ways that the research institution ends up paying a settlement: in many ways they are a victim as well (and yes they should have been paying more attention). The government backs off -they have their money – everyone breathes a sigh of relief, and the researcher pops up somewhere else. In this case I want want my pound of flesh.

    • Healthcare Fraud is not illegal anymore, it is just good business, as long as it is profitable. This is true even when people die!

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