In this piece for Medscape, Jodi S. Cohen chronicles the research malpractice case of child psychiatrist Mani Pavuluri, who put vulnerable children at serious risk in a clinical trial. Pavuluri violated research rules by testing the powerful drug lithium on children younger than 13, failed to properly alert parents of the study’s risks, and falsified data to cover up the misconduct.
“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.
Officials documented other oversight shortcomings as well.
‘These are clearly egregious problems that occurred,’ said Michael Carome, a former senior official at the U.S. Department of Health and Human Services’ Office for Human Research Protections, or OHRP, who reviewed the case for ProPublica Illinois.”
(Article behind paywall)