Wednesday, August 17, 2005

"The Dirty Little Secret of University Medical Research"

The Wall Street Journal reported several cases in which US federal prosecutors charged major universities with misusing National Institutes of Health (NIH) grant funds. (See temporarily free link here.)
The story focused on the case of Cornell University's Weill Medical College. The school's former "research subject advocate," Dr. Kyriakie Sarafoglou, had noticed irregularities in a $23 million grant for pediatric research. Dr. Sarafoglou alleged that nurses supported by the grant were caring for patients who were not involved in research projects; no children had been hospitalized or seen in outpatient clinics in programs that were funded for 180 hospital days and 600 outpatient visits; and "patients were being billed to the NIH tab even though they weren't taking part in clinical studies."
Dr. Sarafoglou complained to the program director, Dr. Maria New, and then to her "replacement as head of pediatrics at New York-Presbyterian." An internal investigation by Dr. Adam Asch found "no evidence that the budget was exorbitantly inflated," but criticized Dr. Saraglofou for her "confrontational and accusatory posture." Meanwhile, Dr. Saraglofou alleged she was being subject to retaliatory treatment, socially ostracized, and her office moved away from her colleagues.
So she then complained to the NIH. No NIH official was willing to act, but one informed her about "qui tam," lawsuits, in which individuals may sue for fraud on behalf of the federal government. Dr. Saraglofou's qui tam suit was taken over by federal prosecutors. They agreed with most her her allegations, and added more, e.g., that the Cornell pediatric research program enrolled adult subjects and charged the NIH for treatments that were reimbursed by Medicaid. In June, Cornell settled the suit for $4.4 million, admitting no wrong-doing. Cornell's lawyer declined to discuss details with the Journal.
The Mayo Clinic, University of Alabama at Birmingham, Harvard University, Johns Hopkins University, and Northwestern University have settled similar suits for multi-million dollar amounts since 2004. The Journal noted that "all the cases except Harvard's began with whistle-blowers."
Thus, as the article said, this case may illustrate the "dirty little secret of university medical research."
However, the responsibility for this secret should be attributed more to university administrators than scientists and doctors. To add a bit of context, when NIH makes a grant, responsibility for the conduct of the project is shared. The Principle Investigator (PI), the project's head scientist, takes responsibility for the scientific integrity of the project. However, an administrator of the organization for which the PI works takes responsibility for the project's financial integrity.
What also is distressing is the passive attitude of NIH officials to charges that the Institutes' money was being diverted. When the Journal approached Norka Ruiz Bravo, the NIH deputy director for extramural research, she responded "if people are going to cheat, they are going to cheat." That practically invites university officials to take research money for whatever they want.
Dr. Bravo added that the NIH prefers to work quietly with schools to solve problems so research can keep moving forward. Of course, research would move forward faster if the money meant to support it was not being siphoned off.
(An additional report on the Cornell case is available in Nature Medicine here.)

1 comment:

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