Who is Mani Pavuluri?
Mani Pavuluri, a child psychiatrist at the U. of Illinois at Chicago, acknowledged mistakes in prescribing lithium to children, but said that she had treated each child enrolled in her study “like an angel.”
Why did Pavuluri expand the criteria for who could be included in the study?
Pavuluri, in an interview, said she had expanded the criteria for who could be included in the study because it was difficult to find enough subjects within the narrow age range. She said it also was difficult to find children with bipolar disorder who weren’t already taking other medication.
Did the IRB suspend Pavuluri's research?
The university also withheld Pavuluri’s research protocols. ADVERTISEMENT. The records the university released, however, 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 determine what had gone wrong.
‘Someone Who Could Fix Him’
An Adverse Event
- Pavuluri’s research program began to unravel in 2013, the lithium study’s final year. The issue started with a patient who came to her 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 int…
A Failure of Oversight
- The University of Illinois at Chicago is a federal research powerhouse, with one of the largest medical schools in the country. Over the past five years, the university has received a total of more than $950-million in federal research funding, placing it among the top 60 research universities during that period. The institution had faced trouble for lax research oversight before. In 1999 fe…
Stinging Criticism
- Pavuluri, in an interview, said she had expanded the criteria for who could be included in the study because it was difficult to find enough subjects within the narrow age range. She said it also was difficult to find children with bipolar disorder who weren’t already taking other medication. She said she also believed that a wider pool of subjects would strengthen her findings. “I thought it w…
The Fallout
- It’s difficult to know how unusual the federal government’s demand for reimbursement is; NIH said it does not track such actions. The agency would not provide a comparable example. An NIH spokeswoman said that the agency does not discuss its decisions about specific grants, but that it “takes seriously noncompliance with the terms and condition of award.” The university refunde…