When clinical trials fail to maintain the highest ethical standards, the fallout can be disastrous and long-lasting for the “human subjects.”
Luke Mallard, 19, and his mother understand this all too well. When Luke was 10, he took part in a clinical trial for pediatric bipolar disorder at the University of Illinois at Chicago. The doctor conducting the trial, Mani Pavuluri, prescribed the powerful drug lithium for his mood disorder.
In so doing, Dr. Pavuluri violated federal guidelines for the research, according to a ProPublica Illinois story by reporter Jodi S. Cohen in Sunday’s Sun-Times.
The drug wasn’t supposed to be given to kids under 13, and Pavuluri knew it. And UIC, which has gotten nearly $1 billion in federal research money over the past five years, should have known better, too.
Mallard’s mom told ProPublica that while Luke was on lithium, he paced, walked in circles, heard voices in his head and thought he saw other people when looking in a mirror.
Pavuluri, a respected child psychiatrist, told ProPublica she thought she was doing the right thing and not harming any child. But the National Institute of Mental Health, which initially declined to fund the doctor’s study, had warned her of the “significant risk” of lithium for children under 13. Pavuluri got the funding, $3.1 million, only after amending her proposal.
UIC shut down the study in its fourth and final year after the university conducted an audit triggered by an “adverse event” for a participant, a girl. Two other studies being done by the doctor also were shut down. Then in November of last year, NIMH rightly demanded — and got back — its money.
The lithium study never should have gotten off the ground. From the outset, the university’s institutional review board did an “insufficient” evaluation of the doctor’s research plan, the NIMH found.
The review board didn’t even have a copy of her research protocol. And four months after the trial began in 2009, the review board approved lowering the age minimum for the trial to 10, in direct violation of the federal agency’s rules.
There were almost too many ethical lapses to count. The doctor also provided direct medical care to some kids in the study, which went against protocol. Eighty-six percent of the participants did not meet eligibility standards. Some children enrolled were younger than 10. Girls were not given pregnancy tests (lithium can lead to an increased risk of birth defects) before they were prescribed the drug.
Kids and parents were not told in consent forms that lithium is not approved by the FDA for children under 12 and that there are alternative treatments for bipolar disorder. How did the review board overlook the omission?
When federal evaluators came to town to size up the university’s methods for protecting human subjects in research, they found university review boards “sometimes lacked sufficient information to make the determination required for approval of research.”
It’s a little scary that such a vaunted research behemoth blundered so badly. People — the “human subjects” — put almost blind faith in doctors and medical institutions.
UIC says it has tightened oversight, and its reputation probably won’t be tarnished for long. The doctor soon will retire from UIC. She might open a private practice.
There’s no telling, though, how long it will take the kids to get over the betrayal.
“I have these issues now, and I don’t know if they will go away,” Luke Mallard told ProPublica’s Cohen. “I don’t know if lithium was a direct cause of it, but it didn’t help anything.”
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