Ste-Justine defends drug trial, but promises ‘complete audit’

Ste-Justine Hospital officials defended on Friday their handling of a controversial clinical drug trial for children suffering from leukemia following a report by RadioCanada’s Enquête program.

Health Canada inspectors took the rare step of suspending the DEC-GEN study in November 2016 after uncovering 76 irregularities, of which 23 were of a critical nature, including the failure to declare the death of a patient to Health Canada, medical files that were poorly handled, inadequately trained staff and using medications that had expired.

“The children at Ste-Justine are not guinea pigs,” executive director Isabelle Demers said at a news conference as she read from a prepared statement. “Our actions have never placed the lives of your children — our children at Ste-Justine — in any danger. Never.”

Demers contends that RadioCanada implied unjustly that doctors did not adequately obtain the informed consent of parents.

In fact, Demers said, the consent process was rigorous.

Radio-Canada’s report, which aired Thursday night, included audio recordings by a patient’s parents in which a researcher at Ste-Justine is heard uttering the word “remission” nine times in seeking their consent for the trial.

A total of six patients with aggressive leukemia died before the study was suspended.

“Health Canada confirmed that the patient deaths resulted from the progression of the disease,” the hospital said, and “the observed adverse events were consistent with what was expected and described in the consent form.”

However, Health Canada concluded that the researchers had not established a safe dosage for the drug, and the frequency of the side effects among the children who took it was unusual.

No disciplinary action has been taken because no patient was harmed as a result of the 76 “observations” by Health Canada, hospital officials said.

Still, Ste-Justine will stop internally monitoring Phase I clinical trials and use external monitors in the future. It has also recruited a research quality director and hired an external firm to “conduct a complete audit of its research processes.”

Demers promised to make that report public.

No decision has been taken on whether to continue with the DEC-GEN trial, officials said.