This story was co-published with The Chronicle of Higher Education and the Chicago Sun-Times.
Illinois regulators have launched an investigation into a prominent former University of Illinois at Chicago psychiatrist whose research into children with bipolar disorder was shut down because of her misconduct.
The state Department of Financial and Professional Regulation has issued three subpoenas to UIC seeking records related to Dr. Mani Pavuluri, who resigned from the university in June amid controversy. She has since opened her own medical practice, the Brain and Wellness Institute, in Lincoln Park.
The subpoenas were issued by the IDFPR division that evaluates and grants doctors’ licenses. One was from the state’s medical disciplinary board, which reviews complaints about Illinois doctors and decides if discipline is appropriate. The board approved issuing the subpoena at a September meeting; it ordered UIC to provide records related to a clinical trial that Pavuluri oversaw studying the effects of the powerful drug lithium on children and teenagers.
ProPublica Illinois revealed in April that, in a rare rebuke, the National Institute of Mental Health ordered the university to repay $3.1 million in grant money it had received for the study.
The other two subpoenas are related to Pavuluri’s employment. One ordered UIC to provide Pavuluri’s “complete and unredacted personnel file,” including any complaints, disciplinary actions and investigative files. The other demanded Pavuluri’s “application and credentialing file,” including her references, background checks and medical education records.
The subpoenas, served in late August and early September, came after several ProPublica Illinois reports detailed Pavuluri’s research misconduct and the university’s failure to properly oversee her work. ProPublica Illinois recently obtained the subpoenas in response to a Freedom of Information Act request to the University of Illinois.
State investigations of doctors and other professionals are not made public unless the department imposes discipline. An IDFPR spokesman said the department does not acknowledge an investigation exists until that point.
“Should an investigation yield instances of clear non-compliance with Illinois statute and rules, official action will be taken and be made publicly available,” spokesman Eric Eizinger wrote in an email. Discipline can include a reprimand, probation, or the suspension or revocation of a medical license.
Thousands of complaints are lodged against health professionals each year by patients or other members of the public, law enforcement agencies or others. The department is currently prosecuting about 430 cases.
A UIC spokeswoman said the university “cannot comment on any ongoing investigation.” UIC officials have previously said that they suspended Pavuluri’s research and took other corrective steps when they realized she was not complying with protocols, and that the university “is committed to adhering to the highest standards for research integrity.”
University officials said this spring, and again in response to recent questions, that they did not file a complaint about Pavuluri with the state disciplinary board because “reporting was not required.”
University officials have also said that while there were problems with Pavuluri’s research, a review of her separate medical practice determined that she provided “high quality patient care.”
Reached at her new office, Pavuluri declined to comment.
In an earlier interview, she said her research mistakes were oversights and she made decisions in the best interests of her patients.
“I thought I was doing the right thing and not harming any child,” she said in the interview. “I treated them like an angel, all of them. I was careful and tried to do my best with each individual child.”
Pavuluri joined UIC’s psychiatry department in 2000 and founded the Pediatric Mood Disorders Program, which drew children from around the country with bipolar disorder and other mental illnesses.
She treated and oversaw the care of thousands of children, including 1,200 in the five years after her research first came under scrutiny in 2013, records show. While at UIC, she secured about $7.5 million in grant funding from the National Institutes of Health.
Pavuluri’s five-year study, “Affective Neuroscience of Pediatric Bipolar Disorder,” used imaging to look at how the brains of adolescents with bipolar disorder functioned before and after taking lithium. The scans were compared with brain images of healthy, unmedicated children.
But federal health officials late last year demanded that UIC return $3.1 million they had awarded her. Officials determined there had been “serious and continuing noncompliance” by Pavuluri, as well as failures by the university’s institutional review board, or IRB, a faculty panel responsible for reviewing research involving human subjects.
Among other findings, NIMH concluded that Pavuluri tested lithium on children younger than 13 though she was told not to, failed to properly alert parents of the study’s risks and didn’t ensure that some female subjects had pregnancy tests though that was part of the study protocol. Pavuluri also falsified data to cover up the misconduct, according to a letter the UIC chancellor wrote to another university official after reviewing a university panel’s investigation.
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. Another 132 children and teens participated as healthy control subjects, including her two sons, a violation of university protocol and generally accepted research practices, ProPublica Illinois found.
NIMH concluded that 86 percent of the children and teens in the study did not meet the eligibility criteria to participate because they were younger than 13, had previously used psychotropic medication or were ineligible for other reasons, records show.
The study began in 2009 and was almost complete, with the money spent, when it was halted in 2013. Two of Pavuluri’s other federally funded projects also were stopped at that time, and the university had to return nearly $800,000 that hadn’t yet been spent on those studies.
The ProPublica Illinois investigation found that UIC officials didn’t properly screen or monitor Pavuluri’s research. For example, the IRB approved lowering the minimum age of participants to 10 even though NIMH specifically prohibited it. Pavuluri, going even further afield from the protocol, enrolled a few children younger than 10. Pavuluri and a co-investigator were part of the panel tasked with monitoring the trial’s progress, even though investigators are not supposed to monitor the progress of their own work.
Following an internal investigation in 2015, UIC suspended Pavuluri’s research indefinitely and directed her to retract several scientific journal articles. UIC has declined to provide a copy of its investigative report, but following the investigation, Chancellor Michael Amiridis concluded that Pavuluri’s conduct reflected a “pattern of placing research priorities above patient welfare,” according to the letter he wrote.
The mother of one of Pavuluri’s research subjects said she is glad the state is investigating. She did not file a complaint with IDFPR.
“I would like to know that she will not be able to run something that way again where the patient comes second to the research,” the mother said.
Pavuluri’s research also has been under investigation by two divisions of the U.S. Department of Health and Human Services, according to subpoenas, emails and other documents: the inspector general’s office, which examines waste, fraud and abuse in government programs, and the Office of Research Integrity, which reviews claims of scientific misconduct.
Federal officials don’t comment about ongoing investigations. But the research integrity review could be nearing a conclusion, according to an email last month between federal and university officials obtained from UIC under the Freedom of Information Act.