Psychiatrist Mani Pavuluri:New Concerns About Lithium Study on Children

University of Illinois at Chicago (UIC) - Psychiatrist Mani Pavuluri enrolled 101 children and teens diagnosed with bipolar disorder in the lithium study before it was halted when one of the young subjects became ill. 

 

Newly obtained records raise additional concerns about the research and oversight of Pavuluri

 

Parents of at least eight children who participated in Pavuluri’s trials contacted UIC after learning she had violated research rules, a larger number than the university previously disclosed. 

 

Among other findings, NIMH concluded Pavuluri tested lithium on children younger than 13 though she was told not to and failed to properly alert parents of the study’s risks. A university investigation concluded she falsified data to cover up the misconduct, according to documents.

 

That family contacted UIC after receiving a letter in June 2014 that the university sent to families alerting them of problems with Pavuluri’s research. The letter explained that children enrolled in three of her studies may have been put at greater risk than what had been explained in consent and parental permission forms. That family didn’t file a claim, UIC has said.

 

Records obtained recently by ProPublica Illinois, however, show there were at least seven other families who contacted UIC after receiving the June 2014 letter. A UIC employee who compiled a spreadsheet of the calls also wrote summaries of two of them, describing them as “complaints by parents regarding the treatment of their child as a research subject,” according to an email obtained by ProPublica Illinois.

 

Records show Pavuluri’s research was riddled with oversight failures as the IRB approved changes to the study — including lowering the minimum age of participants to 10 even though NIMH specifically prohibited that.

 

There also were shortcomings in independent oversight as the study progressed. For one, Pavuluri and a co-investigator were members of the trial’s Data Safety and Monitoring Board, which is tasked with observing a trial’s progress and the safety of its participants. NIH policy recommends that board members “are in no way associated with the trial.”

 

Pavuluri’s research remains under investigation by the U.S. Department of Health and Human Services’ inspector general’s office, which examines waste, fraud and abuse in government programs, and the Office of Research Integrity, records show.

 

Jodi S. Cohen, "Documents Raise New Concerns About Lithium Study on Children," ProPublica, 3 July 2018, https://www.propublica.org/article/university-of-illinois-chicago-mani-pavuluri-lithium-study-complaints