How a ProPublica reporter found the families swept up in a drug study gone wrong

Jodi Cohen had never heard of researcher Dr. Mani Pavuluri before she got a tip in January 2018 to look into her work.

Cohen, a reporter with ProPublica Illinois, was told that Pavuluri’s employer, the University of Illinois at Chicago (UIC), had been forced a month earlier by the National Institute of Mental Health (NIMH) to pay back all of a $3.1 million grant the university received for a study Pavuluri had run looking at the impact of the powerful drug lithium on children with bipolar disorder.

To find out why the university had to take that highly unusual step, Cohen sent a Freedom of Information Act request to the university. What she found in those documents she received helped expose what had till then been a quietly disgraced study on the effects of lithium on children with bipolar disorder. The story, and several follow-up stories, led to additional government investigations about what went wrong with the lithium study — investigations that are still ongoing.

Even though they were highly redacted, the documents showed that Pavuluri’s study — which ran from 2009 until 2013 before it was shut down — was riddled with “serious and continuing noncompliance” with federal rules intended to protect human subjects. The errors she made with the study “increased risk to the study subjects.”

The records showed that as Pavuluri struggled to get enough patients to participate in the study to make the results meaningful, she lowered the age of children who could take part in lithium tests to younger than 13 — with UIC’s institutional review board’s approval — even though she was told she should not do so by NIMH.

Other documents showed that Pavuluri did not properly alert parents of the study’s risks, and she falsified data to cover up the misconduct.

All that by itself would have made for a powerful story of a misguided researcher and poor oversight by her university.

But Cohen knew even before her FOIA was answered that she would need to find some of the participants in the study to truly explain why what Pavuluri did — and what UIC allowed to happen — was so egregious.

“I didn’t know if anyone would reach out,” Cohen said in a recent interview. “I felt like it was a needle in the haystack since there were only a few hundred people who participated” in the study.

Knowing HIPAA rules would allow UIC to redact any evidence of who the participants were, Cohen and ProPublica engagement reporter Logan Jaffe set out to find participants any way they could for that first story.

Jaffe searched for any news stories that Pavuluri might have been part of, and found one from a local TV station that included an interview with a the mother of a 10-year-old boy, Luke Mallard, who was set to take part in one of her studies.

His mother, Cynthia, seemed upbeat in the news clip.

“I called his family expecting to hear all these great results,” Cohen said. “But his mom just started getting very upset on the phone.”

The study had not gone well for Luke Mallard, and the family had cut short his involvement in the study to get him off the lithium.

“When I met with the family, I realized this was a big deal,” Cohen said. “I realized it wasn’t just a bureaucratic snafu.”

Cohen found another family after she learned that Pavuluri had written a book. She went to Amazon.com to see if any families who might have participated in a study had written a review, and she found one, a five-star review by the mother of a girl who had been seen by Pavuluri in her clinical practice.

The mother, who asked to remain anonymous, told Cohen she thought Pavuluri was a “lifesaver” and still thought highly of her work with her daughter.

Cohen found a third family through her participation in several Facebook parenting groups. She did a search and found a mother, Rebecca Sikorski, who had recommended Pavuluri in response to a question from another mother seeking mental health help for her child.

She called Sikorski, but, as with Cynthia Mallard, found that Sikorski would no longer recommend Pavuluri after she found out about problems with the study.

The first story Cohen wrote about Pavuluri’s research on April 26 involved all three families.

But Cohen and Jaffe knew there would be more to the story, and they wanted to hear from more families.

In that first story, and on Facebook parenting and community groups and in other social media, they asked any other families whose children were involved in the study to contact them.

In addition, they co-published their ProPublica story with the Chicago Sun-Times and the Chronicle of Higher Education.

“Using co-publishers really, really helped,” Cohen said. “Having a local partner and a national partner was incredibly helpful. We ended up hearing from people who read the story in all three publications.”

In the wake of the first story, Cohen and Jaffe heard from 12 more families who had taken part in Pavuluri’s research, and their stories helped Cohen dig even deeper into what had happened.

Among the families who reached out was Aline, the mother of a 10-year-old boy, Wilson, who had taken part in the study. There was more: Aline had kept an online journal of Wilson’s participation over several years.

Jaffe came up with the idea of running a story, which ran in October, almost entirely based on excerpts from the journal, with annotation by both Aline and Wilson about what was happening when the events occurred.

“We had never done anything like that before,” Cohen said. “But it really worked.”

Working on the story on and off for over a year now has been a real learning experience, Cohen said. It has served as a tutorial on ways to find those who could explain the impact of a research project that potentially harmed underage research subjects.

“I learned a lot about engagement (working on the story) and the most effective ways to reach people,” she said.

It was also a lesson in the value of not just filing FOIA requests for documents but also filing follow-up requests based on each piece of new information she learned. In all, Cohen has so far filed a dozen FOIA requests, with several pending, including appeals to the state.

In particular, she still hopes to win the battle to obtain documents that better explain how the public university’s own oversight failed to reign in Pavuluri when she deviated from federal protocols and standards.

“You have to work with what you have, though,” she said. “But I’m still working on it. There’s more to come.”