Fudin, whistleblower in VA research case
Specialist warned federal officials in 1990s of alleged violations of protocols
Jeffrey Fudin, a clinical pharmacy specialist who reported abuses of cancer research patients at Stratton VA Medical Center Hospital in the mid-1990s, leading to a federal investigation and the alleged retaliation against him and another whistleblower, died last week at age 63 following a battle with cancer.
Fudin and Anthony Mariano, another former pharmacist at the VA, had faced years of retaliation by hospital administrators after reporting the alleged medical protocol violations in the hospital’s once-troubled cancer program, according to records filed in a federal whistleblower court. Fudin, a Delmar resident, was later fired but had his job reinstated by a judge, a ruling the hospital continued to fight.
In 1995, Fudin warned hospital and Veterans Affairs officials that cancer patients at Stratton VA were unduly suffering and at risk of dying prematurely because they were being given drugs in violation of medical protocols. At least one patient may have died as a result of the alleged practices, which included giving certain drugs to patients whose medical backgrounds did not fit the criteria for use of both experimental and Fda-approved drugs, according to hospital and court records.
Fudin’s allegations, which were later supported by Mariano, who was the hospital’s pharmacy director at the time, were detailed in a series of Times Union’s stories published beginning in 2003. The newspaper’s series raised questions about how thoroughly federal officials investigated the troubled cancer program at the Albany VA hospital before a criminal investigation of the research program was launched in 2002.
Hospital officials had claimed at the time that Fudin’s allegations, which centered on former VA oncologist Dr. William Hrushesky, were not related to the federal criminal investigation. But some hospital workers had disputed that, contending veterans in the cancer program unwittingly may have been used as guinea pigs for years.
The criminal investigation centered on two researchers, Dr. James Holland and Paul H. Kornak, who were prosecuted on federal criminal charges. It was alleged they had altered medical records of cancer patients, including those of as many as five who may have died after being given experimental drugs.
Kornak, a former cancer specialist at Stratton VA, later pleaded guilty to criminally negligent homicide and fraud in connection with the research scandal that triggered nationwide reforms at Department of Veterans Affairs hospitals. Kornak was accused of masquerading as a doctor and systematically falsifying the medical records of ailing veterans to enroll them in experimental drug programs. Several of the veterans either died prematurely or suffered agonizing deaths as a result of the experiments, according to federal lawsuits filed as a result of the case.
After Kornak was indicted in 2003 on dozens of charges, including manslaughter and negligent homicide, U.S. authorities announced they were widening their investigation of Stratton’s cancer research program. Authorities also investigated whether Kornak should have been hired as a clinical researcher at the VA in 1999. At the time, his medical license had been revoked, and in 1993 he pleaded guilty to federal mail fraud charges in connection with the alleged forgery of a medical license application, records showed.
In 2003, Fudin and Mariano, the son of a decorated Korean and World War II Marine Corps veteran, were selected as grand marshals of the Memorial Day Parade in Albany. Neither were veterans but were selected because of the stories detailing their efforts to expose wrongdoing in the cancer research program.
Holland, who headed the cancer research program at Stratton VA Medical Center during the time when veterans were alleged to be used like guinea pigs, pleaded guilty to a misdemeanor in 2007, admitting he failed to protect his patients from Kornak.
In addition to the one veteran who died, 64 others suffered unduly or were harmed by the forgeries, which involved manipulating their medical backgrounds so they would qualify for drug studies that were lucrative for the hospital and which had furthered the researchers’ careers.
Instead of investigating the allegations, hospital administrators initially retaliated against the pharmacists and ended the pharmacy’s role in monitoring research drugs, according to court records. Mariano, who also had his office moved to a vacant floor on the hospital, had said he eventually was forced to leave his job.
In 1999, Fudin and Mariano met with the FBI, outlining their allegations of corruption in the cancer research program. Six years later, the FBI abandoned its investigation, concluding that corruption allegations raised by the two pharmacists were unfounded, according to internal agency records.
The FBI’S quick exit from the probe came before interviews were conducted with some witnesses, and despite hospital accounting documents — obtained by the Times Union — that appeared to support some of the allegations. The records indicated that in the 1990s, physicians in the cancer program may have augmented their government salaries with hundreds of thousands of dollars in research money. Thousands more in research funds were moved into non-research accounts and used for other hospital projects, including paving parking areas at the facility, the documents showed.
Fudin, in an online post on the day of his death last week, paid tribute to his family, including his wife Robin, and his friends and neighbors for their support as he had battled cancer.
“If you’re reading this, I am now resting comfortably and hopefully watching over those I most cherished while on earth,” he wrote in the post, adding a thanks to his wife for, among other things, having “supported and believed in me throughout the horrible whistleblowing ordeal at the VA in the 1990s through early 2000s.”