In January, we posted the story of malfeasance at the Stratton Veterans Affairs (VA) Medical Center in Albany. Today, the NY Times published a major piece of investigative reporting on the affair, which now appears to be larger and more troubling than it did last month.
Then, the focus was on research coordinator Paul Kornak. Kornak was apparently hired despite having lost medical licenses in several states due to forged credentials, and a felony fraud conviction in Pennsylvania. Although Kornak apparently never completed medical training, the Stratton VAMC allowed him to perform physical examinations and identify himself as "doctor." The FDA found that Kornak had falsified patients' medical records in several drug studies, allowing patients to enroll in studies even though they should have been excluded. Kornak plead guilty to fraud and negligent homicide for the death of one patient in a chemotherapy study.
However, problems at Stratton predated Kornak's arrival. In the 1990's, two pharmacists repeatedly complained of major violations of research protocols, including enrollment of patients without consent, enrollment of patients who should have been excluded, and giving patients treatments not included in protocols. In response, the pharmacists were targeted by VA internal investigations, although none ever found any wrong-doing. An investigation of research at the hospital, conducted by Dr. Thomass Ferro, was allegedly rigged by administrators to find nothing wrong. Said Dr. Ferro, "there is always a hidden agenda to exonerate or convict in these internal investigations. In this case it was to exonerate." So Ferro did a cursory investigation, and even after he then "watered down" his finidings, his superiors edited his report to remove even "minor discrepancies."
Furthermore, how the VA responded on the national level to the problems at Stratton was even more troubling. When problems there first were noticed in 2003, the new VA Chief of Research and Development, Dr. Nelda Wray, ordered a nation-wide review of VA research. She halted research altogether at Fargo, ND, where there were problems with the Institutional Review Board. She ordered credentials checks on and ethics training for all researchers. But by2004, Dr. Wray, in turn was accused of ethics problems, and was forced out of her position. Her lawyer charged the investigation was "an easy and convenient way to stop sorely needed reforms."
Some major points:
- The response of the VA to staff complaints about research at the Stratton VAMC was apparently to punish the whistle-blowers, and cover up the complaints. This is all too reminiscent of the cases of physicians punished for complaining about quality, detailed in the landmark investigative series in the Pittsburgh Post-Gazette, The Cost of Courage.
- This response allowed wrong-doing to continue, resulting in, according to a court of law, the death of at least one patient.
- Thus, this case suggests how bad leadership of a medical organization can not only harm the research process, or suppress research results, but also directly harm patients.
- Furthermore, the allegations made by Dr. Wray's lawyers, if true, suggest that the problems go much deeper, or higher than the administration of one VA hospital.
Coupled with all the other stories we have been reporting, about not only the VA, but the NIH and the FDA at the federal level, about numerous for-profit companies, and not-for-profit hospitals and managed care organizations, this underscores how we need to get serious about restoring integrity to the leadership of health care organizations.
a study worth looking into… - This is a released-on-line version of a new meta-analysis of SSRIs in pediatric depression. Be warned that I’m not going to try to vet all their analytic t...
32 minutes ago