Brigham and Women’s Hospital (BWH) will pay $10 million to resolve allegations that one of their stem cell research laboratories fraudulently obtained grant funding from the National Institutes of Health (NIH), according to a press release.
As per federal regulations and institutional policy requirements, BWH conducted an investigation that identified data integrity concerns in federally funded grant applications submitted by the Anversa lab. After learning of and investigating the allegations of misconduct in the Anversa laboratory, BWH disclosed its concerns to the U.S. Department of Health and Human Services, Office of the Inspector General, and Office of Research Integrity.
“BWH independently evaluated the issues relative to the federal false claims requirements,” said Lori Schroth, media relations manager at BWH. “Following that evaluation, BWH self-disclosed this matter to appropriate government entities and ceased drawing implicated funds.”
The settlement resolves the allegations against Dr. Piero Anversa, who ran the laboratory, and Drs. Annarossa Leri and Jan Kajstura. Allegedly, the doctors knew or should have known that their laboratory published and relied upon manipulated and falsified information including microscope images and carbon-14 age data for cells, according to the press release. This information was used in applications for NIH research grant awards concerning the purported ability of stem cells to repair damage to the heart.
The settlement also resolves allegations that the laboratory followed improper protocols, inaccurately characterized cardiac stem cells, and kept recklessly or deliberately misleading records, according to the press release.
Drs. Anversa, Leri, and Kajstura are no longer affiliated with BWH, and the lab has since been closed.
“BWH is committed to ensuring that research conducted at the institution is done under the most rigorous scientific standards, and has made significant enhancements to research integrity compliance protocols as a result of this event,” said Schroth.
Acting U.S. Attorney William D. Weinreb said in the press release that 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.
“Medical research fraud not only wastes scarce government resources but also undermines the scientific process and the search for better treatments for serious diseases,” Weinreb said, according to the press release. “We commend Brigham and Women’s for self-disclosing the allegations of fraudulent research at the Anversa laboratory, and for taking steps to prevent future recurrences of such conduct.”