|Dr. Susan Harkema|
News of the accomplishment spread quickly. She was featured in Time magazine and interviewed on "Good Morning America" and CNN. The publicity attracted more funding and patients to U of L.
But in March, a federal agency revoked funding from one of her studies, citing concerns about oversight and data validity. Meanwhile, the U.S. Office for Human Research Protections has its own review underway, a spokeswoman told Kate Howard of the Kentucky Center for Investigative Reporting. The scrutiny could have lasting consequences on future research.
In discontinuing the $914,000 study it funded, the National Institute on Disability, Independent Living and Rehabilitation Research cited an internal U of L audit and "numerous instances of non-compliance" of rules that must be followed. Elizabeth Woeckner, president of Citizens for Responsible Care and Research, a nonprofit watchdog group, told Howard she’s rarely seen a federal agency pull funding.
"In my experience, it’s a cold day in hell," Woeckner said.
A U of L review board found multiple problems with the study, which measured the effect of a muscle relaxer, Baclofen, on paralyzed patients using treadmills. Among the problems: U of L investigators found evidence of more than 150 possible "adverse events" that researchers failed to report, including a participant who reported severe pain in a knee pain that was discovered to be fractured. Some participants signed the wrong consent forms. In addition, research records had no follow-up data and no information about patients' medication compliance, Howard notes.
Inconsistencies led some patients to pay for therapy when insurance stopped covering part of the treatment, even though the study consent form never mentioned additional costs. Harkema maintained in an interview with Howard last month that staffers explained the potential for extra costs both orally and in a separate handout.
Despite the findings, the board decided that Harkema’s study should continue.
Harkema began recruiting patients for the Baclofen study in 2012. The study's goal was to measure the success of the drug in patients who perform locomotor training, which uses harnesses to help paralyzed patients stand and step on a treadmill.
Researchers sought to determine if patients using the drug saw different outcomes during 80 sessions of treadmill training over a span of four months.
Problems arose when two doctors involved with the study sent complaints to federal and university regulators. Steve Williams, a doctor who worked with Harkema on the study, alleged problems with Harkema’s ethics and research.
Last fall, Williams sent letters to U of L’s Institutional Review Board, a university-level organization that oversees all research studies, and to the National Institute on Disability, Independent Living and Rehabilitation Research about four of Harkema’s studies. Only the Baclofen study used federal funds.
Williams, who has since left U of L for a position at the University of Washington, told Howard that university officials weren’t willing to admit Harkema’s studies were sloppy. He alleges that Harkema's studies take advantage of a "vulnerable population."
"The research enterprise did not do their job protecting human subjects, and they let their concerns about other research funding … bias what they knew they should do, to do the right thing to protect people," Williams said.
Harkema rejects Williams's assertions. She told Howard that no patients were put at risk. She downplayed the effect of the federal action and said she voluntarily put the study on hold.
Harkema said concerns about her study were overblown, and the scrutiny arose after a few disgruntled ex-colleagues blitzed regulators with exaggerated accusations.
"I think that these are very disgruntled, unhappy individuals, who are making some incredibly bad choices out of their own selfishness," she said.
Harkema insisted that her data was not compromised. She admitted that follow-up records were merely disorganized. "Every allegation related to patient safety or risk was unfounded," she said.
Harkema said she voluntarily stopped enrolling patients in all four of her studies after Williams and another researcher complained. Enrollment in two of them has since resumed after Harkema said the university auditors and private funders found no reason to stop them.
In its letter to U of L, National Institute on Disability, Independent Living and Rehabilitation Research Director John Tschida cited problems outlined in the U of L review. They raised questions about the researchers' ability to reliably measure the potential benefits of Baclofen in that context.
"This is pretty egregious,” Milton Corn, deputy director for research and education at the National Library of Medicine, told Howard. Corn declined to comment on U of L’s research -- he’s not connected to the study’s funding agency -- but he called discontinuing any study "draconian."
"It’s much more common to try to work with the investigators and help them repair something that’s flawed and probably can be fixed," he said. "I think to say we want to discontinue this implies they really were very upset."
For now, Harkema is awaiting clearance from the federal Office For Human Research Protections. If she gets it, Harkema said she’ll resume the study, albeit without federal money.