Dr. Kornak another VA who deserves his own page on our site
LBANY
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...Mr. Steubing jumped at the chance to participate in an experimental drug study at the Stratton Veterans Affairs Medical Center in Albany, believing it offered him the hope of surviving longer. The research coordinator, Paul H. Kornak, told Mr. Steubing that he was "just a perfect specimen," with the body of a man half his age, according to Jayne Steubing, Mr. Steubing's widow.
He was not, though. Because of a previous cancer and poor kidney function, Mr. Steubing was not even eligible to participate in the experiment, according to government documents. Mr. Kornak, however, brushed that obstacle aside. He altered Mr. Steubing's medical records, according to prosecutors, and enrolled him in the study. He also posed as a doctor.
In 2001, Mr. Steubing endured about six periodic treatments with an aggressive three-drug chemotherapy combination. Each infusion made him violently ill and forced his hospitalization. He died in March 2002.
Last month, at the federal courthouse in Albany, Mrs. Steubing glared at Mr. Kornak, 53, as he pleaded guilty to fraud, making false statements and criminally negligent homicide in the death of an Air Force veteran, James DiGeorgio. When Mr. Kornak admitted to falsifying the medical data of "subject initials CMS" - Carl M. Steubing - Mrs. Steubing's face crumpled.
Mr. Kornak, ... also agreed to cooperate in a widening investigation of the hospital's cancer research program. From 1999 to 2003, when he worked there, scores of veterans were, at the least, put at risk. But allegations of carelessness, fraud and patient abuse in the hospital's cancer research program predated Mr. Kornak, and employees say that administrators not only dismissed their concerns, but harassed them for standing up for the veterans.
"Research violations were a way of life at Stratton for 10 years," said Jeffrey Fudin, a pharmacist at the hospital. "Stratton officials turned a blind eye to unethical cancer research practices and punished those who spoke out against them. The whole Kornak episode could have been prevented."...
...It was also a culture whose descent into criminality forced the Department of Veterans Affairs nationwide to reckon with what an internal memorandum in 2003 described as "systemic weaknesses in the human research protections program, especially in studies funded by industry."
...Excluding simple chart reviews, about 80 percent of the department's human research is financed by industry. The private sector pumps considerable cash into the system. In Albany, it accounted for $500,000 of the $1.15 million in research funding in 2004...
...The Albany hospital's research program, however, stood to benefit from the enrollment of patients, pulling in $5,000 from the drug company Aventis for Mr. Steubing's participation.
Although veterans knew him as "Dr. Kornak," Mr. Kornak was not licensed to practice medicine. Mrs. Steubing first learned this a year after her husband's death when she read an article in The Times Union of Albany.
By 1993, Mr. Kornak had obtained and lost medical licenses in several states by forging his credentials and had pleaded guilty in Pennsylvania to felony fraud charges. The Albany hospital hired Mr. Kornak, who did attend some medical school, as a research coordinator, not as a physician. Nonetheless, he performed physical examinations, and his Veterans Affairs business card identified him as an M.D....
...According to the F.D.A., patients' medical records were altered in at least five experimental drug studies, enabling veterans like Mr. Steubing to be enrolled in studies for which they were either too sick or too healthy to qualify. A patient with coronary disease, for instance, was enrolled in a study that excluded heart patients because of a risk of hemorrhages. A patient with impaired renal function was administered a drug toxic to kidneys that probably contributed to his death, the agency said.
"It kills me to think that the V.A. system deceived us," said Mrs. Steubing, the director of an upstate school for emotionally troubled children. "You see these youngsters at Walter Reed now and everybody's raving about the care they get. Well, Carl was one of those kids once, with a Bronze Star, a Purple Heart. And at the end of his life, his treatment was the antithesis of what you see on TV. It was such a betrayal."
...as Mr. Kornak's homicide conviction indicates, the authorities have attributed one death directly to his fraud. In 2001, Mr. DiGeorgio, 71, declined precipitously and died within two weeks of being infused with experimental drugs that he should not have been given.
"My husband trusted and confided in the V.A. in Albany, and he wouldn't go nowhere else," Judith DiGeorgio, his widow, said. "It's a disgrace what they did to him." ...
After Mr. Kornak's guilty plea, the hospital director, Mary-Ellen Piché, circulated a letter to the staff noting "many improvements in research since the events," among them that "credentials of researchers have been checked and confirmed" and that researchers have undergone ethics training.
Mr. Kornak, as it turns out, was so trained. As a certified clinical research professional, he had passed an examination covering such ethical topics as informed consent and clinical fraud....
Speaking Up, to No Avail
Years before Mr. Kornak arrived at the Albany hospital in 1999, Mr. Fudin, a clinical pharmacist there, started expressing his concerns about the treatment of cancer patients.
Beginning in 1993, Mr. Fudin variously alleged that patients were placed in experimental studies without their consent, that patients who were ineligible for studies were nonetheless enrolled, and that patients were given "alternative therapies" that should have been classified as research. Veterans, he said, may have died as a result.
The former pharmacy manager, Anthony Mariano, shared his subordinate's concerns.
"Every violation, I hand-delivered packets of information to the chief of research, threw them down on his desk and demanded he do something to stop the research," Mr. Mariano said.
Instead, Mr. Fudin and Mr. Mariano found themselves under internal investigation. In 1996, Mr. Fudin was accused of patient abuse for refusing to dispense a certain cancer therapy. Mr. Fudin said he thought the therapy amounted to unsafe experimentation on patients. He was cleared of the charge, faced a second charge and again was cleared.
But the recommendations were shelved, he said. "The solution to the Kornak problem yet to come was in that document," he said.
Both Mr. Fudin and Mr. Mariano faced additional internal investigations. Mr. Fudin was dismissed in 2001, and an administrative law judge ordered him reinstated in 2002.
Mr. Mariano, meanwhile, was criticizing a cost-saving drug substitution policy involving hypertension medication that he contended was harming patients who suffered from congestive heart failure. In 1999, after he published an article in a federal medical journal questioning the department's drug policies, he was, at one point, reassigned from the pharmacy to a locked psychiatric ward and given no duties. ...
Convicted, Then Hired
In 1993 in Harrisburg, Pa., Judge William W. Caldwell of United States District Court sentenced Mr. Kornak to a $2,500 fine and three years of probation for forging his credentials to obtain a medical license. Apparently, Mr. Kornak's history of fraud began with the falsification of a college transcript, and lie followed lie until he lost a medical license in Iowa, was denied one in New Jersey and was arrested in Pennsylvania. ...
...Six years after Judge Caldwell's pronouncement, Mr. Kornak answered an advertisement for a research assistant position at the Albany veterans hospital's research institute....
...Mr. Kornak told Dr. Hrushesky that he had lost his medical license because he could not document a year of medical school in Poland, according to the journal. Mr. Kornak "gave us a résumé with an M.D. on it and a lot of gaps," Dr. Hrushesky told the journal. "We decided to give him a chance."...
...At the Albany veterans hospital, Dr. Holland inherited Mr. Kornak as a research associate. Mr. Fudin, the pharmacist, and other employees said Dr. Holland was swamped by the cancer patient load. According to an F.D.A. letter to Dr. Holland, he delegated far too much responsibility to unqualified subordinates in numerous drug studies....
...Mr. Kornak never gave them any indication that Mr. Steubing did not qualify for the study, Mrs. Steubing said. Instead, he encouraged Mr. Steubing to continue with the regimen even though it was devastating him.
"Kornak would say: 'You're going to beat this. The odds are in your favor,' " Mrs. Steubing said. "Little did we know that what they were doing to Carl was probably hastening his death rather than extending his life."... .
US Attorney's Press Release
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.
USA v. Kornak 1992 Docket Report
USA v Kornak 2003 Docket Report.pdf
This page was last updated on 01/18/2009 11:44 AM
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