Harvard teaching hospital to pay $10 million to settle research misconduct allegations

Brigham and Women’s Hospital and its parent healthcare network have agreed to pay $10 million to the U.S. government to resolve allegations it fraudulently obtained federal funding.

The case, which involves three former Harvard stem cell researchers, dates back several years. In 2014, Circulation retracted a paper by Piero Anversa, Annarosa Leri, and Jan Kajstura, among others, amidst a university investigation into misconduct allegations. Anversa and Leri — whose lab was described as filled with “fear” by one former research fellow — later sued the hospital for notifying journals of that investigation. They lost.

In the agreement announced today by the Department of Justice (DOJ), Partners Healthcare and Brigham and Women’s Hospital have agreed to pay the government $10 million to settle allegations that the researchers fraudulently obtained funding from the National Institutes of Health:

The settlement resolves allegations that Dr. Anversa, along with Dr. Annarosa Leri and Dr. Jan Kajstura, knew or should have known that their laboratory promulgated and relied upon manipulated and falsified information, including confocal microscope images and carbon-14 age data for cells, in applications submitted for NIH research grant awards concerning the purported ability of stem cells to repair damage to the heart. The government alleges that problems with the work of the laboratory included 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. The government contends that, at the direction of these BWH scientists, the Anversa laboratory included false scientific information in claims to NIH in order to obtain and use funds from NIH grants.

John Thomas, a partner with Gentry Locke who represents whistleblowers who raise allegations of misconduct, told us that other cases have settled for large amounts – such as a recent settlement with Columbia University for $9.5 million. But there are other elements that make this latest announcement noteworthy, he said.

Specifically, most settlements involve some “black and white failure” in research administration, such as misrepresenting a researcher’s qualifications on a grant, misreporting effort, or conducting the research at a different facility (such as the Columbia case), said Thomas. The latest decision, in contrast, “goes to the science itself.”

As a result, he said:

This demonstrates the government is still willing to step in even when it’s not an administrative issue, even when it goes to the merits of the actual misconduct allegations. I think it shows that when the government awards grants, one of the things it’s intending to get is good and honest science. The science matters.

We reached out to Anversa and Levi; in response, we received a statement from their attorney:

It is outrageous that BWH has sought to unfairly tarnish the reputations of Drs Anversa and Leri, scientists who have pioneered groundbreaking work in cardiac stem cell reproduction and who have litigation pending against BWH and its president, Betsy Nabel.

Neither Dr. Anversa nor Dr. Leri was involved in the settlement process.  BWH “self-reported” allegations in its own way for its own purposes.  It has long been known that Drs. Anversa and Leri relied on the work of a senior scientist in the lab in presenting data for grants and in publications.  No one has ever shown that either Dr. Anversa or Dr. Leri participated in the fraud or was aware of it at the time.

BWH’s allegations and settlement cannot take away from Drs. Anversa and Leri’s contributions to the science of stem cell replication.  There are Phase II trials being conducted by NIH currently on stem cell treatments based on their work.  Taxpayer money was rightly used to further the fight against heart disease, a leading cause of death in this country.

According to the U.S. Attorney’s Office, Brigham and Women’s Hospital brought the allegations to the government’s attention:

After learning of the allegations of research misconduct in the Anversa laboratory, BWH investigated the allegations, disclosed its concerns to the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) and Office of Research Integrity, and then worked cooperatively with OIG and the Department of Justice to explain the bases for the allegations.

The three researchers — Anversa, Leri, and Kajstura — are no longer based at Brigham and Women’s Hospital. Earlier this year, Anversa and Leri published a paper about cardiac progenitor cells that lists an affiliation at the Swiss Institute for Regenerative Medicine.

In today’s statement, Acting U.S. Attorney William D. Weinreb said:

Individuals and institutions that receive research funding from NIH have an obligation to conduct their research honestly and not to alter results to conform with unproven hypotheses.

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