Harvard Medical School will face trial for conducting research fraud after a U.S. Appeals Court overturned the decision of a lower court Tuesday and ordered the case to proceed. The claim, which involves one of the largest Alzheimer’s disease research grants ever awarded by the National Institutes of Health (NIH), was brought to court by a whistleblower lawsuit filed by Dr. Keith Jones, chief statistician for the NIH grant.
Dr. Jones blew the whistle on the Alzheimer’s study and its principal researchers after discovering that key measurements used to demonstrate the study’s reliability had been secretly modified to suit a predetermined outcome.
Researchers conducting the large Alzheimer’s study sought to identify early signs of the degenerative brain disease by scanning certain regions of the brain with MRIs.
According to Dr. Jones, without the fraudulent alterations, the study’s major findings were actually statistically insignificant. Dr. Jones insisted that the manipulated data undergo an objective reliability study and argued that the result could not be presented in a federal grant extension application worth $15 million. However, instead of heeding those warnings, Harvard officials terminated Dr. Jones, effectively ending his career.
Other allegations in Dr. Jones’ lawsuit indicate extensive research fraud including substantial deviations from research protocol, altered and re-traced MRI scans, and other data alterations. He also alleged the study’s principal leaders violated federal regulations by making false statements in their NIH grant application. Harvard University and its teaching hospitals, he claims, were aware of the falsifications but failed to take action or disavow the data.
The U.S. Court of Appeals for the First Circuit ruled that the lower court failed to consider substantial evidence of research fraud in the case and failed to consider the testimony of expert witnesses, including a statistician who confirmed the study’s results were contingent upon the fraudulent alterations, a medical researcher who demonstrated that the altered data could not be justified and that it was altered to meet a fixed outcome, and a third expert who testified that NIH would not have funded the study had it been aware of the falsified data.
One of Dr. Jones’ lead attorneys told the Alliance for Human Research Protection (AHRP) that “Fraud committed in order to obtain NIH funding not only robs taxpayers, but also sets back long-term medical research goals. The facts of this case indicate that the report of false data misdirected research efforts at other institutions.”
AHRP also added that the case shows how “Vulnerable human subjects are being shamelessly exploited in invalid, most often commercially driven experiments.”
Named as defendants in the case are Harvard Medical School, its teaching hospitals, Brigham and Women’s and Massachusetts General Hospital, and Dr. Marilyn Albert (Principal Investigator) and Dr. Ronald Killiany.