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Parents of at least eight children who participated in trial studies conducted by Dr. Mani Pavuluri, a pediatric psychiatrist at the University of Illinois in Chicago (UIC), contacted university officials after learning the doctor had violated research rules while experimenting with prescribing lithium to her patients.  This number is higher than what UIC initially disclosed, according to a subsequent media investigation into the matter.

Pavuluri was well-known as a leading clinician and helped UIC become one of the top centers for pediatric psychiatry with patients and their families coming from all over the nation to participate in her research studies.  Her federally-funded, five-year study titled “Affective Neuroscience of Pediatric Bipolar Disorder” included 101 children and adolescents who had been diagnosed with bipolar disorder. The psychiatrist examined imaging of the patients’ brains to determine how they functioned before and after ingesting lithium and compared these with the brains of those without the disorder.  She included her own two sons in the 132-patient control subject of healthy subjects, which violated the study’s protocol and the study ultimately ceased to exist after a patient became sick.

The National Institute of Mental Health ordered the university to repay its $3.1 million in grant funds after the agency discovered there had been “serious and continuing noncompliance” on the part of both Pavuluri and UIC’s institutional review board (IRB).  It was discovered that Pavuluri tested the powerful drug on children younger than thirteen although she has been explicitly instructed not to and did not alert her patients’ parents to risks associated with the drug.  She also falsified data to cover up her misconduct.

The psychiatrist officially resigned from UIC effective June 30.  However, according to information found online, Pavuluri currently has plans to open a new treatment center, called the Brain and Wellness Institute, in nearby Lincoln Park.

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The physician initially joined the psychiatry department at the University of Illinois College of Medicine in 2000 and founded the Pediatric Mood Disorders Program, which eventually became a nationally renowned clinic.  She was compensated $200,000 per year plus bonuses and began her infamous lithium study in 2009.  All three studies overseen by Pavuluri were given the red light in 2013.

UIC had previously returned nearly $800,000 that hadn’t yet been spent on the programs.  Then, late last year, repaid the $3.1 million out of a fund designated for research, administration, student scholarships, and building operations.  Officials have stated they are unsure what will have to lack funding as a result.

The university admitted to receiving a letter from one family involved in June 2014 that said it worried children enrolled in the three studies may have been put at greater risk than what had been explained in consent and parental permission forms.  The family didn’t file a lawsuit.  The investigation discovered there are documents, however, of at least seven other complaints filed that the university has yet to publicly acknowledge.  A UIC employee actually compiled a spreadsheet of concerned calls and wrote summaries of two of them, describing them as “complaints by parents regarding the treatment of their child as a research subject.”  This suggests there is more to the story than what at first meets the eye.

Sources:

Documents Raise New Concerns About Lithium Study on Children

3 million research breakdown at UIC, where a star psychiatrist put kids at risk

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