[Federal Register Volume 71, Number 37 (Friday, February 24, 2006)]
[Pages 9555-9556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2667]



Office of the Secretary


AGENCY: Office of the Secretary, HHS.

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

[[Page 9556]]

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 
    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 
     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 
    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.


Director, Division of Investigative Oversight,
Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852.
(240) 453-8800,


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.
[FR Doc. E6-2667 Filed 2-23-06; 8:45 am]