A Veterans Administration researcher based in New York was sentenced to almost 6 years in jail after he admitted to doctoring patient test results – an extreme punishment for an extreme crime, experts say.
The VA's Paul Kornak was convicted of criminally negligent homicide and sentenced to 71 months in jail in November after he admitted to altering a patient's blood test results so the patient could be enrolled in a cancer drug study, even though his kidney and liver function were impaired. The patient died during the study.
Experts say cases like Kornak's, in which a person is convicted of harming someone through research misconduct, are exceedingly rare. But one critic of the pharma industry says they point to serious flaws within the clinical trials system that may harm patients on a much larger scale, and penalties similar to the one Kornak received may be warranted for other researchers -- and corporations -- when drugs hurt people.
"I think it puts all researchers on warning that they're going to be held personally responsible for what they do," said John Abramson, a clinical instructor at Harvard Medical School and author of "Overdosed America."
Kornak admitted to doctoring records for at least 27 patients from 1999 to 2002 as coordinator for clinical trials at the Stratton Veterans Affairs Medical Center in Albany, New York. According to his 2003 indictment, the researcher—who posed as a physician but never finished his medical training—received thousands of dollars from drug companies for every patient he enrolled in a study.
Grant Jaquith, one of the assistant U.S. attorneys who prosecuted the case, told
Due at least in part to Kornak's indictment, the VA has instituted new oversight mechanisms and employee training, and is in the process of having all of its human research sites independently accredited.
Oversight of clinical trials in academic medical centers is usually more stringent than in the community, but even in academia "things slip by from time to time," said Jerome Kassirer, distinguished professor at Tufts University School of Medicine and author of "On the Take," a 2004 book on the drug industry's involvement in medical practice. "I'd like to see more oversight of clinical trials as done in the community," he added. "I just don't think we know enough about what happens out there."
Cases where a person is hurt in the course of a clinical trial by a researcher's misconduct are extremely rare, said Gerald P. Koocher, an academic dean and professor of psychology at Simmons College in Boston who has studied scientific misconduct extensively. Most commonly, he said, research misconduct involves fabrication, falsification, and plagiarism. Misconduct may be considered fraudulent if it involves misuse of federal funds.
In December 2003, Congress created an Office of Research Oversight to monitor the VA, reporting directly to the Undersecretary of Health. The Program in Research Integrity Development & Education, which goes by its acronym, "PRIDE," also was created that year. The program includes training and education for all VA employees on research ethics.
Such education is key to preventing misconduct from happening in the first place, said Joel Kupersmith, chief research and development officer at the VA. VA employees have now received the training, and undergo retraining every year.
Still, to Harvard's Abramson, Kornak's case is just the tip of the iceberg. He pointed to last week's disclosure by the