Abuses Endangered Veterans in Cancer Drug Experiments

SSKRP ATTORNEYS IN THE NEWS

By DEBORAH SONTAG

New York Times

02/06/2005

ALBANY - Carl M. Steubing, a decorated Battle of the Bulge veteran whose experience of war made him a pacifist but also instilled in him a zest for living life at full tilt, took his diagnosis of gastroesophageal cancer in 2001 as a challenge.

With a thatch of white hair and a rich baritone voice, Mr. Steubing, at 78, was not ready to succumb to illness. A retired music educator and wedding photographer, he remained active as a church choir director, expert cook, painter, golfer and fisherman. He was married to a woman 24 years his junior, and they had seven children and three grandchildren between them.

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, who is scheduled to be sentenced in May, 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."

According to Mr. Kornak's lawyer, E. Stewart Jones, there was a "clear systems failure," permitting a research culture where "rules weren't followed, protocols weren't applied and supervision was nonexistent."

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.

Mr. Kornak, who declined to be interviewed, does not appear to have derived financial gain from his fraud. 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.