The University of Illinois at Chicago and Dr. Nagamani ‘Mani’ Pavuluri, widely considered an expert on bipolar disorder in children, have both been accused of violating medical ethics during a clinical study that studied the affects of lithium on children suffering from bipolar disorder. This past November, Dr. Pavuluri and UIC were ordered to repay all $3.1 million granted to them by the National Institute of Mental Health (NIMH), something many experts say is unprecedented.
Doctor Violated Protocol
Dr. Pavuluri’s study took place between 2009-2013 and involved 103 children, some as young as 10 years old. The aim was to examine how a young brain functioned during a manic phase of bipolar disorder, then compare it to the brain after an 8 week course of lithium. After an initial review of Dr. Pavuluri’s grant application for the study, she was told by NIMH to correct several things before they would approve her for a grant. Dr. Pavuluri amended her application to correct the below listed flaws and was approved for $3.1 million in funding to conduct her research. However, she was found to have violated each of the things she specifically agreed to change in order to receive funding.
- Lowered the age of the study participants
Dr. Pavuluri was asked to correct the age range for participants. She amended her application to adhere to NIMH’s request for all subjects to be between 13-16 years old. Lithium use and the effects of withdrawal have not been studied on patients under 12 years old and the drug is only FDA-approved for use in patients 12 years or older.
- Enrolled children who had previously taken psychotropic medications
Dr. Pavuluri allowed children who had taken drugs such as Xanax, Celexa, Zoloft, and others, despite the study parameters specifically forbidding subjects who had taken any sort of psychotropic medication at any point in the past.
- Enrolled her own patients
The NIMH was concerned about Dr. Pavuluri studying the drug on patients with whom she had a prior history. In an amendment, she agreed to not enroll anyone who was a previous or current patient.
- Didn’t test for pregnancy in some female subjects
She later said that she didn’t have reason to believe certain patients were sexually active, so she didn’t test for pregnancy in all patients. Lithium has known side effects to a fetus.
Based on the study violations above, 86% of her study participants were ineligible, something that is not only unethical and extremely dangerous, but that renders her study findings scientifically baseless.
University Also Found at Fault
UIC is considered at fault because their Institutional Review Board, responsible for policing studies involving human subjects, failed to properly monitor Dr. Pavuluri’s work over the 4 year period in which she conducted the study. UIC’s IRB is also considered a collusive partner, after NIMH found that they approved Dr. Pavuluri’s use of younger subjects, as well as those who had a prior history with psychotropic meds without ever alerting or asking NIMH. All of this took place after Dr. Pavuluri was expressly asked to amend these items in her application and had done so in order to receive approval for NIMH funding.
In the repayment demand letter from NIMH to UIC and Dr. Pavuluri, they reminded the university that they personally had submitted information in 2013 that their IRB failed to give parents proper informed consent documents, specifically detailing ‘alternative procedures or course of treatment.’ They also noted that the University informed them that their IRB failed to ensure that the parental permission paperwork included a notification that lithium is not FDA approved for use in children under 12.
Despite the University’s 2013 findings that Dr. Pavuluri was violating protocol, she was allowed to continue seeing patients, was awarded as a university scholar (with a financial gift of $30,000), and was later listed as a top doctor on their website. They suspended her study, but did not punish her, nor prevent her from practicing medicine under the UIC name.
Dr. Pavuluri, now 55 years old, will retire from UIC in June of this year, but has allegedly told patients that she would like to open her own practice in the city’s Gold Coast neighborhood.