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Kornak
Case Summary - Paul H. Kornak
[Federal Register: February 24, 2006 (Volume 71, Number 37)]
[Notices]
[Page 9555-9556]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe06-81]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Debarment
ACTION: Notice.
SUMMARY: Notice is hereby given that the Deputy Assistant Secretary for
the Office of Acquisition Management and Policy of the Department of
Health and Human Services (HHS) has taken final agency action in the
following case:
Paul H. Kornak, Stratton VA Medical Center, Albany, New York: Upon recommendations from the Office of Research Integrity (ORI), Acting
Assistant Secretary for Health for the Department of Health and Human
Services (HHS), the Office of Research Oversight (ORO), and the Under
Secretary for Health, Department of Veterans Affairs (VA), that were
based on the criminal convictions of making and using a materially
false statement, in violation of 18 U.S.C. 1001(a)(3); mail fraud, in
violation of 18 U.S.C. 1341 and 1346; and criminally negligent
homicide, in violation of 18 U.S.C. 13 and New York Penal Law Sec.
125.10, the HHS debarring official has permanently debarred Mr. Paul
Kornak, former
research coordinator at the Stratton VA Medical Center. This action is
taken pursuant to the HHS government-wide nonprocurement debarment and
suspension regulation at 45 CFR part 76. As such, Mr. Kornak is
excluded for life from participating in any and all Federal agency
transactions, both procurement and nonprocurement, as set forth in part
76.
Of the 48 criminal charges contained in his Indictment, Paul Kornak
pled guilty to the three criminal charges listed above. See United
States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436
(FJS), U.S. District Court (N.D.N.Y.) (January 18, 2005). In addition
to the 71-month term of imprisonment imposed, Mr. Kornak was directed
to pay restitution to two pharmaceutical companies and the VA in the
amount of approximately $639,000.
As part of his guilty plea, Mr. Kornak admitted to the following
facts:
In August 2000, Mr. Kornak applied for employment to the VA, submitting a false ``Declaration for Federal Employment'' form. Mr.
Kornak denied that he had been convicted or on probation in the
preceding 10 years, whereas in fact, he had been convicted of mail
fraud in 1992 and placed on probation for 3 years.
By October of 2000, Mr. Kornak was responsible for
organizing, coordinating, implementing, and directing all research
elements in the Stratton VA Medical Center oncology research program.
Specifically, Mr. Kornak was the site coordinator at the Stratton VA
Medical Center for the ``Iron (Fe) and Atherosclerosis Study'' (FeAST),
cancer studies known as Tax 325 and Tax 327, and a bladder cancer
study. The FeAST study was a clinical trial that tested a novel
procedure for controlling atherosclerosis, also known as hardening of
the arteries, by reducing the iron in the body through blood drawing.
The Tax 325 cancer treatment study involved the administration of
pharmaceutical products to patients with metastatic or locally
recurrent gastric cancer previously untreated with chemotherapy for
advanced disease. The Tax 327 study involved the administration of pharmaceutical products to patients with metastatic hormone refractory
prostate cancer. The purpose of the bladder cancer study, which was co-
sponsored by the National Cancer Institute, National Institutes of
Health, was to compare the use of difluoromethylornithine (DFMO) to the
use of a placebo in patients with low grade superficial bladder cancer
according to time to first recurrence of the tumor and toxicities.
From May 14, 1999, to July 10, 2002, in connection with
the above protocols, Mr. Kornak participated in a scheme to defraud the
sponsors of the clinical studies in that ``he would and repeatedly did
submit false documentation regarding patients and study subjects and
enroll and cause to be enrolled persons as study subjects who did not
qualify under the particular study protocol.''
Mr. Kornak caused the death of a study subject when he
``failed to perceive a substantial and unjustifiable risk that death
would occur when he knowingly and willfully made and used
documents falsely stating and representing the results of [the study
subject's] blood chemistry analysis, which false documents
purported that [the study subject] met the inclusion and exclusion
criteria for participation in Tax 325 when the actual results did not
meet the inclusion and exclusion criteria and showed impaired kidney
and liver function, and [the study subject] thus was administered the
chemotherapeutic drugs docetaxel, cisplatin, and 5-FU in connection
with Tax 325 on or about May 31, 2001, and died as a result thereof on
or about June 11, 2001.''
Based on the criminal conviction and the facts admitted to above,
HHS and VA believe that a debarment period longer than the standard
length of debarment is warranted in this case. Mr. Kornak admitted to a
dishonest handling of the research records and demonstrated a complete disregard for the well-being of vulnerable human subjects under his
care. In pleading guilty to criminally negligent homicide, Mr. Kornak
admitted that a reasonable person would have perceived a substantial
and unjustifiable risk of death if an ineligible subject were enrolled
in the cancer study in question and that his failure to perceive such a
risk in enrolling the ineligible subject constituted a gross deviation
from the standard of care.
Moreover, a longer debarment period is warranted in this case
because of an established pattern of misconduct and criminal behavior
on the part of Mr. Kornak. As stated above, Mr. Kornak has a prior
conviction of mail fraud. In addition, the Office of Personnel
Management excluded Mr. Kornak from all Federal nonprocurement
transactions for an indefinite period, effective July 22, 1993.
Nonetheless, beginning in 1999, Mr. Kornak actively participated in
federally sponsored research protocols in violation of the imposed
exclusion.
A lifetime debarment of Mr. Kornak is necessary to protect the
public interest overall. Given the scope of his criminal conviction,
his longstanding pattern of criminal behavior, and his total disregard
for the safety and well-being of human subjects, Mr. Kornak's
responsibility to engage in transactions with the Federal Government
cannot be assured at any time in the future.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative Oversight
Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
(240) 453-8800
or
Peter Poon
Health Science Specialist
Office of Research Oversight
Veteran's Health Administration, VA
811 Vermont Ave., NW. (10R), Suite 574
Washington, DC 20420
(202) 565-8107
Chris B. Pascal, Director
Office of Research Integrity.
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