by Vera Sharav
Alliance for Human Research Protection
The US Court of Appeals, 9th Circuit overturned a summary judgement by a lower court ordering a whistleblower lawsuit filed by Dr. Kenneth Jones against Harvard Medical School, its teaching hospitals, Brigham and Women’s and Massachusetts General Hospital, and Dr. Marilyn Albert (Principal Investigator) and Dr. Ronald Killiany to proceed to trial.
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].” US ex rel. Jones v. Brigham and Women’s Hospital and Harvard University.
He further alleged that Dr. Albert and Dr. Killiany violated federal regulations (43 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.”
In overturning the lower court and ordering the case to proceed to trial, the Court of Appeals cited the lower court failure to consider substantial evidence of research fraud, and failed to consider relevant testimony from three expert witnesses presented by Dr. Jones:
A statistician who confirmed that the alterations were responsible for the statistical significance of the study results, a medical researcher who identified that the altered results could not be justified and were changed to establish a predetermined outcome, and a third expert who confirmed that NIH would not have funded the study had the falsity of the data been revealed during the application process and that Harvard failed to adequately investigate allegations of research fraud.
The Court of Appeals decision states:
”the essential dispute is about whether Killiany falsified scientific data by intentionally exaggerating the re-measurements of the EC to cause proof of a particular scientific hypothesis to emerge from the data, and whether statements made in the Application about having used blinded, reliable methods to produce those results were true.”
Michael D. Kohn, one of the lead attorneys for Dr. Jones said:
“This is a major breakthrough holding universities accountable for the integrity of reported research results. 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.”
This case also underscores an inconvenient truth about the financial stakes that drive clinical trials. Those who are persuaded to serve as human subjects “for the good of humanity” and “to help medical progress” believe in the integrity and high mindedness of medical researchers–especially those at premier academic institutions. That trust, however, is all too often misplaced. Vulnerable human subjects are being shamelessly exploited in invalid, most often commercially driven experiments.
Indeed, the rationale behind the Harvard brain scanning experiment was to justify early interventions. Another example is Eli Lilly’s Alzeheimer’s imaging detection test (Amyvid) launched last month. http://www.ahrp.org/cms/content/view/842/98/
Inasmuch as no effective, safe treatment for Alzheimer’s exists, and ALL such screening tests have been demonstrably inaccurate and inconsistent, such an “early intervention” approach in clinical practice is unethical and controversial.
Read the Full Article Here: http://www.ahrp.org/cms/content/view/848/9/