» PAVULURI
Pavuluri sought an amendment to expand the age of participants, for example, the IRB should have made sure that NIMH already approved that change, Kiswani said.
“There are supposed to be controls and policies and procedures in place so these types of occurrences don’t happen,” said Kiswani, who left UIC in 2014. “In this particular situation, both are responsible: the institution for failing to follow the rules for changes in scope and the investigator for not knowing her responsibility as a principal investigator.”
Carl Elliott, a professor of bioethics at the University of Minnesota, agreed the NIMH’s determination of wrongdoing “sounds at least as critical of the IRB as it does” of Pavuluri.
And he noted that the problems began even before her research got underway.
“It baffles me how an IRB could give its ethics approval without reading the protocol,” said Elliott, who also reviewed the case at ProPublica Illinois’ request. “If it doesn’t have the protocol, they can’t really know what it is they are approving. It doesn’t make any sense at all.”
Pavuluri said she is shouldering more than her share of blame when the university also was at fault.
“It was in their interest to kind of maybe see this as one person’s mistake [ rather] than the responsibility of the IRB as well,” she said.
Pavuluri said she expanded the criteria of 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.
Also, she said, “I thought it would be a better scientific outcome if I have power in the study in the higher numbers.”
While her transgressions remained unknown to the public, she obliquely addressed them in a chapter of the book “Women in Academic Psychiatry,” which features 16 leading women psychiatrists discussing their careers. In it, she described her large laboratory as a “three- ring circus” where she oversaw a flurry of grant submissions and a staff of faculty and students.
Asked to name her obstacles, she wrote: “I could not attend to some IRB amendments that were due or problem- solve the nuances in the large laboratory. No matter how angelic I was with my research subjects, or how hard I worked day and night, things crashed. Here, I learned my main lesson, which is the need to have a tight grip on research supervision. No work is done till the paperwork is done.”
A university panel investigating the integrity of Pavuluri’s research was less forgiving.
UIC refused to release the panel’s report or even say who took part in the review.
University officials also declined to answer questions about girls not being given pregnancy tests and other shortcomings with laboratory tests, citing the federal investigation.
Pavuluri said some of the younger children did not get pregnancy tests because she didn’t think they were sexually active.
But, after reviewing the panel’s report, UIC chancellor Michael Amiridis wrote in a July 2015 letter that the violations of protocol “collectively represent serious deviations that violate accepted ethical guidelines and professional standards in clinical practice.”
Amiridis said Pavuluri’s behavior “repeatedly put subjects at risk and damaged the credibility of the research data.”
He cited her “reckless disregard” in deciding who to enroll in the study, the lack of pregnancy and laboratory testing and “falsification and fabrication of research
data in an attempt to obfuscate evidence of noncompliance with the research protocols.”
Amiridis ordered a review of her clinical practice, barred her indefinitely from conducting research and directed her to retract several scientific journal articles based on the three studies.
Three of Pavuluri’s journal articles were retracted after she told the editors that UIC had concluded she had “intentionally and knowingly made false statements” about participants’ medication histories and that the falsehoods “seriously compromised” the results and conclusions. The retractions were covered in about a half- dozen posts on the Retraction Watch website, which monitors scientific misconduct.
UIC officials said the review of Pavuluri’s clinical practice did not uncover any problems and there was no reason to report her to the state’s medical- licensing board.
But UIC informed federal authorities it had reason to think additional children had been harmed in her studies. Reports from parents and other evidence led the investigative panel to conclude that “claims by [ Pavuluri] that no subjects were harmed in her studies were false,” according to an email from OHRP to UIC.
That conclusion was based on issues raised by parents who contacted UIC in the months after the university informed them of the problems with Pavuluri’s research, according to a response to an open- records request. 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.
A spokeswoman said the agency does not discuss its decisions about specific grants but “takes seriously noncompliance with the terms and condition of award.”
UIC refunded the grant with money from a fund that is supposed to support such areas as research, administration, student scholarships and building operations. Campus officials said they knew of no other time when UIC had to reimburse grant funds for failing to comply with guidelines on research integrity or the use of human subjects.
They acknowledged the $ 3 million payout will affect other spending but said they do not yet know what they won’t fund as a result. UIC’s yearly operating budget is more than $ 2.3 billion.
The financial hit comes as the institution has seen state funding decline about 10 percent this year following a nearly two- year budget stalemate that left universities across the state scrambling. The University of Illinois system recently requested $ 585 million in state funding for capital projects that would address “only the most urgent priorities.”
Pavuluri is now set to end her UIC career. She was called in to a meeting in February with Anand Kumar, head of UIC’s psychiatry department, and Todd Van Neck, an associate dean in the College of Medicine, to discuss NIMH’s ruling and its demand that the money be returned, emails show.
That evening, Pavuluri sent an email thanking them for giving her “options for the next step.” Most of the email was redacted, but it concludes: “I will cherish, co- operate and be grateful as the loyal UIC employee as I seek the opportunity to keep serving.”
Kumar responded days later, saying he shared her questions with the leadership team and came to the conclusion that, “under all of the circumstances,” it did “not seem realistic” for her to stay at UIC in a different role — specifically an untenured position that would have allowed her to still treat patients.
Later in February, Pavuluri submitted retirement paperwork indicating her last day will be June 30. She will collect a pension and receive a $ 35,512 vacation payout, records show.
In spite of the controversy, Pavuluri has passionate defenders. One woman, whose 21- yearold daughter has been treated by Pavuluri since she was 11, called Pavuluri a “lifesaver.” She said her daughter had been hospitalized four times before seeking treatment from Pavuluri but hasn’t been hospitalized since. She participated in a research trial that did not involve lithium.
“It breaks my heart to think someone would speak poorly of her or cast judgment on her,” said the mother, who did not want to be identified to protect her daughter’s privacy. “I know people have to be held to what they are supposed to do, but never would she put a child in harm’s way for the sake of research. Never, ever.”
Another parent, Rebecca Sikorski, didn’t know about any of these concerns when she took her 12- year- old daughter to see Pavuluri toward the end of last summer. She was impressed that the clinic was promoted as being involved in “cutting- edge” research.
“If their main practitioner of bipolar disorder is being investigated, I would have wanted to know that,” Sikorski said.
At her daughter’s last appointment, in February, Pavuluri told them she was retiring from UIC and hoped to open her own practice in the Gold Coast.
Asked why she is retiring, Pavuluri said in the interview that UIC officials are upset about repaying the grant money. She said the years of investigation have been “traumatic.”
“I feel it is best if I give up my wonderful ability to really do the best I could. I tried really hard,” she said, choking back tears.
She said it was difficult to talk about the issue. “It is giving me PTSD.” Jodi S. Cohen is a reporter for ProPublica Illinois. If you or your child participated in one of Dr. Mani Pavuluri’s studies, she’d like to hear about your experience. Please email her at uicresearch@ propublica. org.