Federal regulators reviewing the death of a child enrolled in a clinical trial at the University of Chicago have ordered the school to improve its system for ensuring the safety of such research by the end of May.
The 15-year-old boy died last September, a day after receiving an experimental treatment for osteoporosis at the U. of C. Although the school said subsequent tests showed the child died from an unrelated case of pneumonia, university officials in the meantime launched an investigation, notified federal regulators and stopped adding patients to trials involving the drug, called pamidronate.
The federal Office for Human Research Protections said it found that before the trial began, the school’s safety review board failed to relay a suggestion by one of its members that the researcher should monitor more closely young patients on pamidronate. Regulators also found that the informed consent form used in the study did not detail the drug’s possible side effects, which include seizure and an irregular heartbeat.
In a letter sent to U. of C. officials late last month and obtained Friday by the Tribune, the regulators said informed consent forms for the study “failed to include a description of all the reasonably foreseeable risks associated with … the administration of pamidronate.”
The agency directed the university to submit a plan for improving the informed consent process by May 31. The school already has taken steps to ensure more effective communication of safety concerns by review board members, the letter said.
In a statement Friday, U. of C. officials said they “will fully respond to the OHRP letter.”
The school’s statement said the teen patient suffered serious disorders, including cerebral palsy, asthma, bronchitis, mental retardation and seizures. Pamidronate has never been associated with sudden, unexpected death in children, it said.
Experts agreed that the drug, approved for use in adults but still experimental in children, does not appear to be harmful.
“There are theoretical risks, it’s true,” said Dr. Horacio Plotkin, an expert on pediatric bone diseases at Children’s Hospital of Omaha who has studied pamidronate for nine years. “Our experience showed that it never caused a clinical problem.”
