From 2009-2013, Dr. Pavuluri conducted a study on the effects of lithium in children with bipolar disorder. The study was abruptly cancelled when one of the subjects reported an illness serious enough to notify federal officials. Initially UIC would not disclose the total number of study participants.
Test subjects were given 8 weeks of lithium following a manic episode and then exposed to brain scans to monitor changes. UIC failed to properly oversee the study, only finding out later that their star pediatric psychiatrist had violated FDA standards, general research standards, and university rules to carry out her study.
Doctor Shows Blatant Disregard for Rules
It was revealed that Dr. Pavuluri gave lithium to study participants who were under the federally-advised age of 12. In fact, a review by the National Institute of Mental Health (NIMH), the federal organization who funded the study, found that 86% of participants were technically ineligible for participation. She also didn’t test for pregnancy in all of her female subjects, and didn’t properly notify the parents of subjects of the risks associated with taking lithium.
In addition to the serious issues already discovered by the NIMH and shared by ProPublica, the news outlet also discovered that the study consisted of 101 test subjects who had been diagnosed with bipolar disorder, as well as 132 healthy control subjects, making the study larger than initially believed. ProPublica also learned that 2 of the healthy control subjects were Dr. Pavuluri’s 11 and 14 year-old sons, a clear violation of general research standards and university policy.
UIC is also disputing the number of families involved in the study who have come forward to complain to the university. When questioned by ProPublica in April, UIC said that they had only received 1 complaint since mailing a June 2014 letter to study participants. However, according to evidence obtained by journalists, 8 families have notified UIC of their dissatisfaction with the study since receiving that letter.
Repayment of Study Funding Taken Out of Student Scholarship Fund
In December, the NIMH demanded that UIC repay the entire amount granted to study ($3.1 million). The University has repaid its debt by returning $800,000 in unused study funds and by taking the remainder from a University account intended to fund student scholarships, among other expenses.
Finding out that a major medical research institution allowed such obvious misconduct to occur in plain sight is unsettling. It brings into question many of the other findings that UIC has contributed to medical science. Even more disturbing is that it allowed children to be given serious medications against the FDA’s prescribing guidelines and without properly notifying their parents. To solely place the blame on Dr. Pavuluri is to ignore the role that management must play in properly supervising employees.
Dr. Pavuluri is still practicing medicine and is currently the director of the Brain and Wellness Institute in Lincoln Park. The company’s website describes her as an expert in Bipolar Disorder and also references her past studies in which she was awarded federal funding for her research. There is obviously no mention of the scandal that caused her June resignation from UIC.
Free Chicago Medical Malpractice Attorney Consultation
ProPublica is still seeking stories from participants in Dr. Pavuluri’s bipolar disorder study and asks interested participants to reach out to them at firstname.lastname@example.org.
If you are the parent or guardian of a child involved in Dr. Pavuluri’s UIC study on bipolar disorder and lithium use and would like to discuss whether you have legal options, please contact the medical malpractice attorneys at Levin & Perconti in Chicago for a FREE consultation. Call us at (312) 332-2872 or complete our online case evaluation form.