Study errors “may have placed you or your child at a greater risk of harm”: 2014 letter to parents

Three psychiatric studies of children contained a myriad of problems that may have put participants at greater risk than was disclosed by consent forms, according to a 2014 letter sent to hundreds of the participants and their families.

Through a public records request, we’ve obtained a copy of the letter — which lists a host of problems in the studies, ranging from enrolling ineligible patients, not informing families of the risks associated with the studies, and skipping tests intended to minimize the risks associated with lithium.

In 2013, Mani Pavuluri told the University of Illinois at Chicago that one of her study participants had been hospitalized — an event which prompted the university to halt three of her studies, launch a misconduct probe, and send letters to approximately 350 families of children participating in the research, notifying them of what happened.

The letter concludes:

These errors may have placed you or your child at a greater risk of harm than explained in the informed consent or parental permission documents signed by you.

The affected studies were known as “Affective Neuroscience of Pediatric Biopolar Disorder,” “Developing Brain Function in Adolescent Bipolar Disorder,” and “Brain Networks Modulating Affect Self-Regulation in Pediatric Mania.”

Here are some of the specifics, spelled out in the letter:

Failure to prevent individuals who did not meet the requirements from participating in the study…The purpose of these eligibility factors is to ensure the findings of the study are valid and to exclude participants at risk for serious untoward effects from the study tests. In the studies referred to above, Dr. Pavuluri enrolled subjects who did not qualify for the studies for one or more of the following reasons: age, prior medication exposure, psychiatric diagnosis, other medical conditions, or use of illicit drugs or alcohol.

In addition:

Failure to describe key research activities, alternatives to participating in the research, and the risks associated with the activities in the informed consent document. A physician in the course of providing care to a patient may use a medication outside the indications approved by the U.S. Food and Drug Administration (FDA), referred to as off-label use, or change the treatment when the physician feels it is in the patient’s best interest. However, these actions during a research study require a greater level of scrutiny…In the research study “Affective Neuroscience of Pediatric Bipolar Disorder,” the participants or their parents were not informed that administration of lithium in children less than 12 years of age was off-label or that withdrawal of other psychotropic medications may occur and the risks associated with the withdrawal.

There were other problems associated with administering lithium to research participants, the letter adds:

In the studies referred to above, Dr. Pavuluri failed to perform tests in several subjects intended to minimize the risks of lithium use.

There’s one section of the letter that’s redacted, which notes one of the consequences of these findings:

Further, as a consequence of the discovery of these findings, [redacted]. The University of Illinois at Chicago realizes that an important benefit to you for participating in research is to contribute to the advancement of medical knowledge in this area, and thus believes it is important that you be informed of this decision.

Obviously, it’s not clear what that consequence is. A spokesperson for the institution has told us Pavuluri is not currently conducting clinical research.

Pavuluri has since logged three retractions, most recently for misrepresenting young patients’ medication histories. The record request includes letters sent by Pavuluri to the two journals that have issued those three retractions, echoing the reasons presented in the retraction notices.

Like Retraction Watch? Consider making a tax-deductible contribution to support our growth. You can also follow us on Twitter, like us on Facebook, add us to your RSS reader, sign up on our homepage for an email every time there’s a new post, or subscribe to our daily digest. Click here to review our Comments Policy. For a sneak peek at what we’re working on, click here.