Wednesday, May 2, 2018

Grant reversal

For nearly two decades, the University of Illinois at Chicago has touted child psychiatrist Mani Pavuluri as one of its stars: She founded a renowned clinic to treat children with bipolar disorder and secured millions of dollars in coveted federal funding to help unlock the mysteries of the disease.

Parents from around the country brought their children to see her. She helped boost the university as a leader in the field of child psychiatry.

But as Pavuluri’s reputation grew, she put some of these particularly vulnerable children at serious risk in one of her clinical trials. She violated research rules by testing the powerful drug lithium on children younger than 13 although she was told not to, failed to properly alert parents of the study’s risks and falsified data to cover up the misconduct, records show.

In December, the university quietly paid a severe penalty for Pavuluri’s misconduct and its own lax oversight, after the National Institute of Mental Health demanded weeks earlier that the public institution — which has struggled with declining state funding — repay all $3.1 million it had received for Pavuluri’s study.

In issuing the rare rebuke, federal officials concluded that Pavuluri’s “serious and continuing noncompliance” with rules to protect human subjects violated the terms of the grant. NIMH said she had “increased risk to the study subjects” and made any outcomes scientifically meaningless, according to documents obtained by ProPublica Illinois…

A ProPublica Illinois investigation, which included interviews and the review of hundreds of documents, revealed multiple layers of failure at the university. UIC didn’t properly screen and monitor Pavuluri’s research. Even after realizing she had broken rules meant to protect her subjects, it continued to promote her to the public and within the university.

Pavuluri’s study, which began in 2009 and was shut down in 2013, was designed to use imaging to look at how the brains of adolescents with bipolar disorder function during a manic state, and then again after eight weeks of treatment with lithium. The hope was that the results would provide new information to help identify the disease earlier, lead to treatment and potentially even reverse how the disorder affects the brain.

But Pavuluri, a professor of psychiatry, strayed from the approved guidelines and abandoned safety precautions written into the study protocol, according to a November letter from NIMH to UIC in which the agency said it had determined there was wrongdoing and demanded the repayment.

In all, 89 of the 103 subjects enrolled in the study — 86 percent — did not meet the eligibility criteria to participate, records show. Among other violations, Pavuluri:

Enrolled children younger than 10 though the study was approved only for boys and girls ages 13 to 16;

Included children who had previously used psychotropic medication though, under the protocol, that should have made them ineligible;

Managed the medical care of some of the children involved in her study though she was told to keep her clinical and research roles separate;

Failed to give some girls pregnancy tests before they began taking lithium even though consent forms said they would be tested. The drug can lead to an increased risk of birth defects.

Pavuluri isn’t solely at fault, according to NIMH. The agency determined that the university’s institutional review board, known as an IRB, a faculty panel responsible for reviewing research involving human subjects, conducted an “insufficient” initial assessment of Pavuluri’s research plans. The board didn’t even have a copy of her research protocol at its initial review…

UIC officials declined to be interviewed. But in response to written questions, they said that “internal safeguards did not fail” and that they suspended Pavuluri’s research and took other corrective steps when they realized she was not complying with protocols. They said the university “is committed to adhering to the highest standards for research integrity.”

They said that Pavuluri’s violations were isolated to her research work, and that a review of her psychiatry practice, where she treated children with mental health issues, concluded she provided “high quality patient care.”

University officials halted Pavuluri’s lithium research in 2013 and also shut down two other federally funded projects she ran, returning nearly $800,000 that hadn’t yet been spent on those two studies.

Yet they named her a university scholar later that year, an honor given to about half a dozen faculty each year who excel in research and teaching and show “great promise for future achievements.” The award included $30,000.

They allowed her to keep her prestigious position as a faculty chair and paid her a base salary of nearly $200,000 a year, plus bonuses. And over the past five years, they allowed her to treat and oversee the care of more than 1,200 children and teens.
The accolades didn’t stop even after UIC’s chancellor, having reviewed an internal research-integrity investigation into her grants, concluded in 2015 that her conduct reflected a “pattern of placing research priorities above patient welfare.”

As recently as January, just weeks after the university sent off the multimillion-dollar check, its psychiatry department boasted on its website that a survey had named Pavuluri a “top doctor.”

Pavuluri, 55, recently filed paperwork to retire in June. The decision came after a meeting with her supervisors to discuss the NIMH decision, records show, and after ProPublica Illinois began asking UIC about the matter.

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