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January 18, 2005 United States Attorney Glenn T. Suddaby announces that Paul H. Kornak pled guilty today, in United States District Court in Albany, to making a false statement, mail fraud, and criminally negligent homicide. Kornak, 53, resides in Clifton Park.

January 18, 2005

PRESS RELEASE

United States Attorney Glenn T. Suddaby announces that Paul H. Kornak pled guilty today, in United States District Court in Albany, to making a false statement, mail fraud, and criminally negligent homicide. Kornak, 53, resides in Clifton Park.

Kornak's admissions in connection with his guilty plea included the following:

Beginning in February of 1999, Kornak was employed by Albany Research Institute, Inc., at the Stratton Veterans Affairs Medical Center, Albany, New York, initially as a Research Assistant and then as Study Director of VA Cooperative Studies. Beginning in October of 2000, Kornak was employed by the Department of Veterans Affairs (at the Stratton Veterans Affairs Medical Center) as a Program Specialist, with duties which included coordination of research protocols.

On or about August 15, 2000, in his application for federal employment, Kornak falsely said he had not been convicted, imprisoned, on probation, or on parole within the preceding ten years. In fact, Kornak had been convicted of mail fraud in 1992 in United States District Court for the Middle District of Pennsylvania and placed on probation for 3 years.

Stratton VA Medical Center participated in VA Cooperative Study # 410, the Iron (Fe) and Atherosclerosis Study (AST), known as FeAST. The FeAST study was a clinical trial (research project) testing a new procedure for controlling atherosclerosis, also known as hardening of the arteries, by reducing iron in the body through blood drawing.

Stratton VA Medical Center also was a participating site in two cancer treatment studies sponsored by Aventis Pharmaceuticals, Inc., to test docetaxel, also known by the brand name of taxotere: Tax 325 studied the use of docetaxel in combination with other drugs to treat patients with gastric cancer; Tax 327 compared docetaxel with other drugs for treating prostate cancer.

Stratton VA Medical Center also was a participating site in a study co-sponsored by ILEX Oncology, Inc., and the National Cancer Institute, Division of Cancer Prevention, regarding the use of difluoromethylornithine (DFMO) in treating bladder cancer.

Kornak was the site coordinator at the Stratton VA Medical Center for the FeAST, Tax 325, Tax 327, and DFMO studies. Each study provided for payments being made to participating sites based upon the enrollment, participation, and evaluation of qualified patients, and such payments were made in connection with the studies at the Stratton VA Medical Center.

From about May 14, 1999 - July 10, 2002, in connection with conducting and coordinating clinical trials and studies at the Stratton VA Medical Center, including the FeAST study, Tax 327, Tax 325, and the DFMO study, Kornak participated in a scheme to defraud the sponsors of the clinical trials and studies, including the Cooperative Studies Program of the VA, Aventis Pharmaceuticals, Inc., and ILEX Oncology, Inc.; to deprive the Albany Research Institute, Inc., Stratton VA Medical Center, United States Department of Veterans Affairs, and citizens of the United States of their right to his honest services; and, to obtain money and property from the sponsors, Albany Research Institute, Stratton VA Medical Center, and Department of Veterans Affairs by means of false pretenses, 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.

On March 20, 2001, to execute the scheme to defraud, deprive, and obtain money and property, Kornak caused a case report form for study subject number C2352 to be sent to Aventis via Federal Express. Kornak had made and used false documents which were very important to the determination of whether C2352 was eligible to participate in the Tax 325 study – a laboratory report, a blood chemistry form, and a patient registration form, each of which falsely reflected the date and result of a test for creatinine, and a radiology display report and a past medical/surgical history in an outpatient progress record, from each of which information had been deleted.

From May 25, 2001 - June 11, 2001, Kornak was involved in the treatment of James J. DiGeorgio at the Stratton VA Medical Center, and did, with criminal negligence, cause the death of Mr. DiGeorgio, in that Kornak failed to perceive a substantial and unjustifiable risk that death would occur when he made and used documents falsely representing the results of blood chemistry analysis of a sample provided by Mr. DiGeorgio on May 25, 2001. The false documents purported that Mr. DiGeorgio 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 Mr. DiGeorgio thus was administered chemotherapeutic drugs in connection with Tax 325 on May 31, 2001, and died as a result thereof on June 11, 2001.
Kornak's participation in the scheme to defraud resulted in losses to entities alleged to amount to the following: Aventis Pharmaceuticals, Inc. -- $ 488,907.58; ILEX Oncology, Inc. -- $ 14,017.47; and the Department of Veterans Affairs -- $ 133,850.00.

The maximum potential penalties for each count principally are:

Sentencing is scheduled for 11:30 a.m. on May 27, 2005, before Chief United States District Judge Frederick J. Scullin, Jr., in Albany. Kornak was released pending sentencing on conditions including a $50,000 bond.

The investigation arose after a routine review of records at Stratton VA Medical Center concerning the DFMO study by representatives of ILEX uncovered irregular documents. Management of the VA Medical Center notified the Office of the Inspector General of the Department of Veterans Affairs, which formed a team of criminal investigators, health care inspectors, an oncologist, and a medical examiner. The Food and Drug Administration Office of Criminal Investigations assisted, too. Hundreds of patient medical records were analyzed and numerous interviews conducted. United States Attorney Suddaby said: "The conviction of Paul H. Kornak today is the result of the dedication and hard work by an investigative team lead by the Northeast Field Office of the VA Office of Inspector General. We honor our veterans' devotion to duty by dedicating our efforts to ensuring that wrongdoing which affects them is uncovered and addressed. We appreciate very much the diligence of the VA Office of Inspector General, the assistance of the Food and Drug Administration Office of Criminal Investigations, and the cooperation of Aventis and ILEX."

Bruce Sackman, Special Agent in Charge, VA Office of Inspector General, Northeast Field Office, also praised the work done in this case: "The Office of Inspector General (OIG) is pleased that the case against Paul Kornak has concluded with an admission of guilt. This is a reflection of the countless hours of investigative work by the OIG and the U.S. Attorney's Office." Mr. Sackman stated that this was a very serious crime, as Kornak placed ineligible veterans into research studies by altering their medical records. Mr. Sackman thanked the management and staff of the Stratton VA Medical Center for their cooperation throughout the investigation, and advised that, since the inception of the investigative effort, the VA Medical Center has instituted several improvements to it research program to ensure patient safety, including increasing the number of physicians that monitor these programs.

The investigation continues. The case is being prosecuted by Assistant U.S. Attorneys
William C. Pericak and Grant C. Jaquith.


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