Thursday, May 10, 2012

Harvard To Be Tried for Alzheimer's Research Fraud

Subject:     Harvard To Be Tried for Alzheimer's Research Fraud
Date:     Thu, 10 May 2012 10:16:50 -0400
From:     Veracare <>

Alliance for Human Research Protection (AHRP)
Advancing Honest and Ethical Medical Research


The US Court of Appeals, 9th Circuit, overturned a summary judgement by a lower court citing its failure to examine substantial evidence and expert testimony presented in a whistleblower lawsuit filed by Dr. Kenneth Jones against Harvard Medical School, and its teaching hospitals, Brigham and Women's and Massachusetts General Hospital, and Dr. Marilyn Albert (Principal Investigator) and Dr. Ronald Killiany. The Court ordered the suit to proceed to trial.
US ex rel. Jones v. Brigham and Women's Hospital and Harvard University.

The case involves the largest Alzheimer's disease [AD] research grants awarded by the National Institutes of Health (from 1980 through 2007) for a large project aimed at identifying early physical signs of Alzheimer's by scanning certain regions of the brain with MRIs.

Dr. Jones was the chief statistician for the NIH grant. He blew the whistle after realizing that measurements used to demonstrate the reliability of the study had been secretly altered. Without these alterations, Dr. Jones explained, there was no statistical significance to the major findings of the study. When he insisted that the altered measurements be subjected to an independent reliability study, and that the manipulated results could not be presented as part of a $15 million federal grant extension application, he was terminated and his career came to an end.

The allegations in the suit concern multiple research fraud: data manipulation, significant deviations from the protocol, altered and re-traced MRI scans. To get positive results, Dr. Jones alleges, Dr. Killiany "fraudulently altered the MRI study data prior to 1998 to produce false results of a statistically significant correlation between conversion to AD and volume of the EC [entorhinal cortex]."

He further alleges that Dr. Albert and Dr. Killiany violated federal regulations (42 CFR 50.103(c)(3) by making false statements in the NIH grant application. Statements that "were predicated on falsified data that the defendants, knowing of this falsity, failed to take corrective action or disavow the data."


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