The federal judge in this case is
himself an Army Veteran. Just so
you'll know.




No jail in VA case
Doctor in drug-research scandal must pay $502,925 to pharmaceutical companies

By BRENDAN J. LYONS, Senior writer
First published in print: Saturday, March 28, 2009

ALBANY — A former Stratton VA Medical Center oncologist was sentenced to five years on probation Friday for his role in a drug-research scandal that killed at least one veteran and harmed dozens more.

Dr. James A. Holland, 51, a resident of Thomasville, Ga., and formerly of Voorheesville, pleaded guilty in April 2007 to a misdemeanor charge in which he admitted failing to protect his patients from a rogue researcher who falsified medical records to enroll them in drug studies.

In addition to the probation sentence imposed by U.S. District Senior Judge Frederick J. Scullin, Holland must also pay $502,925 to pharmaceutical companies that were defrauded as a result of the scandal.

Holland did not apologize to the veterans or their families during a brief statement to the judge, but said he had ''always assumed responsibility'' for his work and the people he supervised.

Assistant U.S. Attorney Grant Jaquith made a lengthy plea to the judge, outlining in detail what he said were Holland's efforts to make excuses when a drug company investigator discovered forgeries in medical studies at Stratton in late 2001. Jaquith said Holland has changed his story a number of times and offered conflicting information about whether he ever reviewed lab reports for a Rensselaer County Air Force veteran, James J. DiGeorgio, who died after being infused with experimental drugs.

A lab report showed DiGeorgio's failing liver and kidney functions were unfit to handle the powerful mix of experimental drugs, and he died 11 days later. Jaquith questioned whether Holland reviewed the lab report, which was dated, and why another lab report on DiGeorgio was not performed on the day of his infusion, which is standard.

''These were people at their most vulnerable, completely dependent on the defendant,'' Jaquith told the court. ''The defendant's recklessness resulted in the death of Mr. DiGeorgio.''

Jaquith asked Scullin to sentence Holland to the 12 months in prison he could have faced under federal sentencing guidelines, if not more.

But Scullin, himself a veteran, responded that he disagreed with the government's account of the facts in the case. He did not elaborate.

''It is indeed unfortunate, Dr. Holland, that your failure to tend to your responsibilities had to come to this,'' Scullin said. ''It should never have occurred and proper supervision could have prevented it.''

Federal prosecutors have cast Holland as an over-stretched researcher who cut corners while working 12-hour days as he oversaw a bustling VA research program and also his own drug research company, Triage Pharmaceuticals. They have accused him of pushing as many veterans as possible into drug studies, and turning a blind eye to an enormous amount of fraud that took place on his watch as those veterans' medical records were forged to make them qualify for drug experiments.

In numerous instances, and under the supervision of Holland and his predecessor at Stratton, Dr. William Hrushesky, the patients medical records were falsified so they could qualify for drug studies that may have hastened or caused their deaths, records show.

Hrushesky works for a VA hospital in South Carolina and has not been accused of wrongdoing.
Holland placed blame for the scandal on Paul H. Kornak, 57, a former research coordinator at Stratton who forged medical records while posing as a doctor and advising patients and their families on life-or-death medical decisions. Kornak had a felony criminal record for lying on a medical license application when he was hired by Hrushesky. Kornak falsified his undergraduate college transcripts to qualify for medical school and then never finished medical school.

Kornak was sentenced in November 2005 to a six-year prison term for his guilty plea to felony counts of mail fraud and negligent homicide in connection with the death of DiGeorgio, 71, from Brunswick.

Another 64 veterans were harmed by the forgeries, records show.

Federal authorities said the research violations took place over about three years, beginning in May 1999. But VA workers have told the Times Union the cancer program's problems, including endangering the lives of patients, stretched back years and involved other researchers, including Hrushesky.

Kornak said hospital officials urged him to enroll as many patients as possible in drug studies.

But Kornak's efforts were sloppy. They included altering medical records with white-out and handwriting in falsified information, including lab results. The forgeries should have been detected by the research coordinators like Holland who were charged with checking the records, prosecutors said.

In a pre-sentence hearing in July 2006, Jaquith questioned Holland at length about why he delegated his responsibilities to research coordinators who were not doctors. He especially pressed Holland on Kornak's role.

''Who's responsible for what he did?'' Jaquith asked.

''I'm responsible for all activities,'' Holland answered. ''I was chief of oncology and principal investigator for it. It's unfortunate. It's a horrendous occurrence for me that this happened; but I was captain of the ship and I'm responsible for anybody underneath me.''

Gaspar M. Castillo, Holland's attorney, has cast Holland as a victim of Kornak and blames hospital administrators who allowed Kornak to masquerade as a physician. Still, Holland admitted during the 2006 hearing that he had been told Kornak had a checkered history.

Holland's guilty plea in April 2007 has not derailed his medical career. He works for a cancer program at Archbold Medical Center in Thomasville, Ga.

Holland and Kornak were fired by the hospital in 2002 after a private drug company investigator noticed problems with the medical records of patients. But despite the investigator sounding an alarm, it took hospital officials months longer to uncover what was happening. Authorities have never offered a clear motive for the forgeries.
A Times Union investigation found that Stratton's cancer research program was the target of internal complaints dating to the mid-1990s. Hospital staffers said they were harshly retaliated against for warning hospital administrators as early as 1994 that cancer patients were being placed at risk and being enrolled in drug studies without signing consent forms indicating they knew the risks.
Two employees who complained, VA pharmacists Jeffrey Fudin and Anthony Mariano, brought their complaints to Congress, including former U.S. Rep. Michael McNulty, D-Green Island, and the FBI. They said their warnings were ignored and many of the administrators involved were later promoted.

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End of Albany Times Union Release
(treated as "local" news to avoid the AP)