Five things to know after James Ramsey was ousted as president of University of Louisville.
In another attack on the University of Louisville’s vaunted spinal cord research program, a former neurosurgery professor says in a lawsuit that he was fired in retaliation for reporting patient care and safety issues to the federal government.
In a suit filed in Jefferson Circuit Court last week, Daniel Graves said he was terminated in violation of the Kentucky whistleblower protection law for reporting human subject procedures that he says he believed compromised patient care and possibly violated state and federal regulations.
Graves was a clinical professor who worked under Dr. Susan Harkema, a nationally acclaimed researcher in U of L’s Kentucky Spinal Cord Injury Research Center. Last month a federal agency took the unusual step of pulling funding for a $914,000 study led by Harkema, citing concerns about the validity of the data and unresolved problems with oversight
Responding to the lawsuit, U of L spokesman Gary Mans said in an email that the university never fired Graves. Mans said that his contract expired this month and the university offered him a one-month extension through September to allow him to finish his work on another grant that is expiring.
The university also supplied a document that suggests Graves overspent his budget.
Graves, who lives in Richmond, Texas, and is unemployed, declined to respond to Mans or to comment on his suit, which names as defendants Harkema and the university as well as Scott Whittemore, the spinal cord center’s director, and Dr. Joseph Neimat, chair of the neurosurgery department.
Graves’ attorney, Ellen Bowles of Louisville, didn’t respond to calls and emails seeking comment.
University officials have sought to minimize the actions of the National Institutes on Disability and Rehabilitation Research, which cited “numerous instances of non-compliance and serious non-compliance” of protocol in a Harkema-led study on the impact of a muscle relaxant on mobility of paralyzed subjects.
In a statement to alumni, university health executives said that while there were “areas of research activities that could be improved,” no patients were injured because of the research.
But the newspaper’s review of three other paralysis studies led by Harkema found similar issues, including ones that a bioethicist said could damage the credibility of the research.
According to U of L’s own reports to the U.S. Office of Human Research Protections, the university’s Biomedical Institutional Review Board found eight “serious violations” of protocols in those studies, including three that were listed as “not resolved.”
The board’s audit found:
» “Adverse events” for one study had not been tracked or monitored by the research team.
» “No follow-up records” were present in research records, making it “nearly impossible to see which protocol procedures” had been completed.
» One study did not comply with its own data safety monitoring plan, which is designed to ensure the safety of human subjects.
» Non-physicians, including nurses, physical therapists and a researcher, were ordering medical tests in two of the studies despite laws that allow only licensed doctors to practice medicine.
» Monitors had to provide instruction throughout the process to key study personnel.
In an interview, Leigh Turner, a professor at the University of Minnesota’s Center for Bioethics & School of Public Health, who reviewed the reports for the newspaper, said that “some very fundamental things did not take place.”
He questioned how an institution “can confidently claim nobody was hurt if adverse events are not properly recorded” and why the research team wasn’t properly trained before the studies started.
He and Thomas E. Ball, executive director of the National Association of IRB Leaders, who also reviewed the reports, said the failure to follow protocol could render the results meaningless and unpublishable. The research team “basically voided its data,” Ball said.
In an email, Mans said that all of the issues were resolved by June 1. He said it isn’t unusual for research personnel to receive educational sessions throughout a study because circumstances for each study are different.
He said Harkema maintained and recorded all required information but that it wasn’t in one place so it could be readily reviewed by auditors.
And in a report last winter, Dr. William M. Pierce Jr., the university’s executive vice president for research and innovation, said the U of L Human Subject Protections Program found that allegations concerning patient safety were “unfounded” and no subjects were injured from the research.
That is disputed by two physicians who were associated with the studies — Dr. Steve Williams, the former chief of Spinal Cord Medicine at U of L, and Dr. Michael Stillman, an internist who was assistant professor of neurosurgery. Both now teach and practice at the University of Washington.
In his lawsuit, Graves, 56, who says that his career has been damaged and that he has suffered stress and humiliation, asks for compensatory and punitive damages.
He said that he made “good faith reports” to both the university and the Department of Health and Human Services about his concerns.
In the study for which the federal funding was discontinued, Harkema’s team was trying to measure whether taking Baclofen, a muscle relaxant, helped paralyzed subjects suspended from a harness stand and step on a treadmill.
The other three studies were funded by foundations. In one, researchers tested whether implanting epidural stimulating electrodes improved the performance of subjects, while in another, Harkema’s team looked at the effect of epidural stimulation on cardiovascular and respiratory function as well as the ability to control leg function below the injury level.
Harkema, who is paid about $285,000 a year at U of L, told the Kentucky Center for Investigative Reporting that all the private foundations that have partnered with her over the years remain her partners.
Kim Eisner, executive director of the Craig Neilsen Foundation, one of the funders, said, “We are aware of the situation and monitoring it.”
Laura Fahey, a spokeswoman for Helmsley Charity Trust, which last year pledged $15 million to the U of L Foundation for spinal cord research, did not respond to several calls and emails.
Reporter Andrew Wolfson can be reached at (502) 582-7189 or email@example.com