HJLR Mar/Apr 2019

Healthcare Journal of Little Rock I  MAR / APR 2019 31 “The records the university released, however, show that twomonths after its initial report of a problem, the IRB suspended Pavuluri’s research and the university launched an audit of the protocol to determine what had gone wrong.” medication. He enjoyed taking part in Pavu- luri’s studies, he said, if only because he was paid to participate and got a day off from school to travel an hour or more each way to her clinic. “Every time I saw her, she was very nice, very sweet,” Luke said. But he said the lithium had side effects he didn’t like. He quickly went from being a skinny kid to an overweight preteen. He said he’s upset she prescribed the drug when he was so young. “I have these issues now and I don’t know if they will go away,”he said. “I don’t know if lithiumwas a direct cause of it, but it didn’t help anything.” An Adverse Event Pavuluri’s research program began to unravel in 2013, the lithiumstudy’s final year. The issue started with a patient who came to Pavuluri when her medications for manic symptoms no longer were effective. Records do not identify the patient, but Pavuluri said in the interview that she was a girl. Pavuluri had the girl withdraw from those drugs and put her on other medication to ease her into the lithium study. But she began to experience “heightened irritabil- ity,” according to records, and when symp- toms worsened, she was hospitalized — her first time for a manic episode. Pavuluri said the drugs weren’t an issue. She said the episode was caused by conflicts at home. Research guidelines require that a serious and unanticipated “adverse event” involv- ing a human subject be reported to the IRB, and Pavuluri did so in January. The univer- sity’s IRB chair at the time, James Fischer, a pharmacy professor, determined the study “likely contributed to the increased sever- ity”of her symptoms. According to records, he reported the incident to the NIMH and OHRP. It was the only adverse event reported during the study. ProPublica Illinois obtained hundreds of documents related to Pavuluri’s studies in response to Freedom of Information Act requests. But university officials withheld or redacted many records, citing federal and state laws regarding patient privacy and the confidentiality of research. Those records include some communi- cations between the university and the fed- eral agencies that likely would providemore detail about the extent of the research fail- ings and how the university responded. The university also withheld Pavuluri’s research protocols. The records the university released, how- ever, show that two months after its initial report of a problem, the IRB suspended Pavuluri’s research and the university launched an audit of the protocol to deter- mine what had gone wrong. In a letter to OHRP, Fischer commended Pavuluri for her “cooperation and forthrightness”in address- ing the issue. But as the IRB dug deeper into Pavulu- ri’s three studies, it found more problems. In subsequent letters, Fischer reported “serious non-compliance” in the study and by the IRB, and he proposed a corrective action plan. ByApril 2013, the university also had suspended Pavuluri’s other two active NIMH-funded studies, for aminimumof six months, while her research privileges were revoked.