Judge Kermit V. Lipez of the U.S. Court of Appeals for the First Circuit last week reversed a summary judgment decision granted by the U.S. District Court for the District of Massachusetts to two Boston hospitals, Brigham and Women’s Hospital and Massachusetts General Hospital (“MGH”), and two Alzheimer’s disease researchers, Marilyn Albert, M.D. and Ron Killiany, Ph.D.
In 2006, Kenneth Jones, Ph.D., a chief statistician for a $15 million National Institutes of Health (NIH) grant for Alzheimer’s research, filed a qui tam lawsuit under the False Claims Act. Jones alleged that statements in the grant issued to the National Institute on Ageing and NIH were falsified, and that despite knowing this, the defendants failed to take corrective action.
This research is part of an ongoing study trying to determine whether changes in brain volume seen on structural magnetic resonance imaging (MRI) can ultimately help predict who will develop Alzheimer’s. As part of the research, Dr. Killiany and one other rater manually outlined brain structures, including the entorhinal cortex (EC) on 103 participants’ MRI scans. Based on Dr. Killany’s brain structure outlines, computer software would calculate the volume of EC, after which other team members would conduct statistical analyses to try to determine if volume changes of the EC would help predict who might develop Alzheimer’s in the future. Jones, however, alleged that Dr. Killiany falsified information submitted to NIH by manipulating his brain structure outlines to support his hypothesis.
According to Medscape: “Dr. Jones later expressed concern to his colleagues regarding quantitative differences between the data sets, stating that the alterations were substantial and that, according to his analysis, the alterations were responsible for the apparent statistical significance.” When Jones requested that the scans be re-measured, Dr. Albert refused because she believed that the additional set of measurements would cause more confusion.
Judge Lipez, stated:
“Distribution of revisions presents a genuine issue of material fact as to whether, as [one expert] put it, [Dr.] Killiany cherry-picked measurements to revise in a non-random fashion in order to produce data that would support his hypothesis on the role of EC volume and the prediction of prodromal Alzheimer’s.”
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