Ste-Justine won’t release report on halted clinical trial
Health Canada suspended study of drug following the death of six patients
Ste-Justine Hospital is refusing to make public an external report on how it conducted a clinical trial that was shut down by Health Canada despite promises to become more transparent. Isabelle Demers, interim director of Quebec’s largest pediatric hospital, told reporters on Oct. 5 that she would release the report in response to a question about re-establishing trust in the Côtedes-Neiges institution. Demers made the pledge at a news conference that was televised live during which she defended the way Ste-Justine handled the clinical trial to evaluate an experimental drug on children with leukemia. Health Canada took the rare step of suspending the study after six patients died. Although the federal ministry did not conclude that the children died because of the clinical trial, inspectors nonetheless uncovered 76 irregularities, 23 of which were of a critical nature. One of the children died during the Health Canada inspection in the fall of 2016. Ste-Justine held the news conference following the broadcast of an exposé by Radio-Canada’s investigative program, Enquête. A couple of weeks later, the Montreal Gazette filed a formal request under Quebec’s access-to-information law for a copy of the external report. Ste-Justine had commissioned Biovalorem, a firm in Indianapolis specializing in “regulatory compliance in the pharmaceutical, biotech, medical device, vaccines and health-care industries,” to review how researchers conducted the clinical trial of the DEC-GEN therapy. Specifically, Biovalorem was to “conduct a complete audit of (Ste-Justine’s) research processes,” according to the hospital. Demers vowed to make that report public. On Nov. 23, Ste-Justine denied the Montreal Gazette’s request for the Biovalorem report, citing the private company’s wishes to protect its competitive edge, among other concerns. “In light of the comments made by Biovalorem in support of its objection to the disclosure of this document, we conclude that doing so would risk ... causing a loss to a third party, or provide a noticeable advantage to another (company) or undermine substantially the competitiveness of (Biovalorem),” Anne de Ravinel, who is responsible for access-to-information requests at Ste-Justine, wrote in a letter rejecting the request. The Montreal Gazette intends to appeal Ste-Justine’s refusal before Quebec’s access-to-information commission. Anne-Julie Ouellet, director of communications at Ste-Justine, explained in an email on Wednesday the hospital changed its mind about releasing the Biovalorem report. “At the press conference, Isabelle Demers had, in good faith, thought she could share the document,” Ouellet said. “However, it turned out that legal constraints prevent Ste-Justine from divulging the said document.” Ouellet reiterated the hospital’s desire to become more transparent. “Under no circumstances has Ste-Justine put the interests of a private company ahead of its obligations to the public,” Ouellet said. “Ste-Justine simply does not have the power to override its legal obligations regarding access to information.” “The institution continues to provide high-quality care and services to families,” she continued. “In addition, measures are being deployed to share the results of its research with the public in order to move toward greater transparency. Soon, a section of the (hospital’s) website will be dedicated to this end.”