HJLR Mar/Apr 2019

research breakdown 30 MAR / APR 2019 I  Healthcare Journal of Little Rock   lithium on children by imaging their brains before and after they took the mood stabi- lizer. The drug had long been used to treat bipolar disorder in adults, but its effective- ness in children was less understood. Pavuluri’s early requests for funding were denied. During reviews and consultations with NIMH staff, Pavuluri was “made keenly aware of critical human subjects issues,” records show. Those issues included the “significant risk”of providing lithium to chil- dren under 13 and the importance, in this study, of not providing direct medical care to the research subjects.The roles of researcher and clinician, according to documents, were supposed to be separate so the treatment of the children wouldn’t be influenced by the needs of the study. She amended the application to resolve NIMH’s concerns. UIC got the $3.1 million grant, and the five-year study — “Affective Neuroscience of Pediatric Bipolar Disor- der” — began in January 2009. Activity in her research lab picked up and, soon after, walked in circles around their living room and heard voices in his head. He thought he sawother people when he looked in amirror. “When he was on lithium, he turned into a different kid,”saidMallard. “I told Dr. Pavu- luri, ‘I don’t care what you have to do, get him off this stuff.’” Luke took the lithium for at most two months, according to the family’s records. Then Pavuluri switched his medication. The family’s records show that he continued to see Pavuluri for therapy for several more years and enrolled in at least one other study she led; UIC officials said that study has not been called into question. Luke, now 19, is six feet tall, with floppy dark hair that he brushes away when it falls into his square-rimmed glasses. He gradu- ated from high school, has taken commu- nity college classes and currently works at a local pizza restaurant. He said that he hopes to become a therapist to help children. On a recent evening, he sat at his kitchen table and described his years of therapy and she secured two more NIMH grants. Around the same time the lithium study began, CynthiaMallard was distraught. Her 10-year-old son, Luke, was defiant at school and had trouble controlling his emotions. “I wanted to find someone who could fix him,”Mallard said. Mallard first took her son for counseling near their home in Bourbonnais, south of Chicago. When that didn’t help, she sought referrals and decided to try to get Luke into Pavuluri’s UIC practice; she knew of Pavulu- ri’s reputation. But every timeMallard called for an appointment, she said, she was told Pavuluri wasn’t seeing new patients. She pleaded and was told Luke could get an appointment if he entered a clinical trial, she said. “They told me I could get Dr. Pavuluri to see him every week if I were to get in the study,” she said. Pavuluri prescribed lithium, and Mal- lard, a developmental therapist, immedi- ately noticed changes in her son. He paced, Lithium side effects “But he [Luke] said the lithi- um had side effects he didn’t like. He quickly went from being a skinny kid to an over- weight preteen. He said he’s upset she prescribed the drug when he was so young.”