Harvard Medical School To Be Tried for Alzheimer’s Research Fraud | Health Impact News
by Vera Sharav
Alliance for Human Research Protection
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/
