‘The findings are unreliable’
Medical journals retract columns co-authored by disgraced former Sick Kids doctor,
Two Canadian medical journals are retracting columns about a seminal Toronto case that prompted health agencies around the world to caution against giving codeine to nursing mothers for pain relief.
The rare and significant step to retract the two columns from the scientific record came after an independent review found “clear evidence that the findings are unreliable.”
The editors of Canadian Family Physician and Canadian Pharmacists Journal published a joint retraction notice on Wednesday. It is the latest in a series of corrective actions medical journals have taken in recent years against papers coauthored by Dr. Gideon Koren, the disgraced former head of the Hospital for Sick Children’s now-shuttered Motherisk program.
“Given the complexity of the science, the significance of the case report and the serious implications of retraction, we sought an independent peer review,” the journal editors said in the retraction notice for the columns, published in 2006 and 2007. “We agree with the findings of the reviewers and therefore retract the papers.”
The columns are based on a Toronto case report first published in The Lancet in 2006, which sparked widespread concern that dangerous levels of morphine, a by-product of codeine, could pass through breast-milk. Koren is the lead author of The Lancet report, which blamed the 2005 death of a newborn baby boy, whose mother was prescribed codeine following childbirth, on morphine-laced breast-milk.
Ontario’s former deputy chief coroner is a co-author on all three papers. He did not respond to a request for comment.
In the retraction notice, the Canadian journal editors said they launched the review after two pharmacologists at Sunnybrook Hospital disputed the findings, “calling into question that newborns can develop opioid toxicity from breastfeeding.”
In a peer-reviewed paper published in May, co-authors Dr. David Juurlink and Dr. Jonathan Zipursky re-examined the case and found the explanation of how the baby died “implausible.”
Juurlink and Zipursky cited information from the coroner’s report that was not included in the case report and columns co-authored by Koren: the codeine level in the boy’s blood. They did not offer an alternative explanation for how the baby ingested the drug that apparently killed him.
In an email on Wednesday, a Sick Kids spokesperson said CEO Dr. Ronald Cohn “had requested retractions from these journals and is supportive of the action they have taken.”
The hospital launched an internal review of Koren’s vast body of published work in late 2018, after an investigation by the Star and Ryerson University’s School of Journalism identified possible problems with more than 400 papers he co-authored. The spokesperson said that review is “nearing completion” and that the hospital will share its findings “when they are available.”
Koren retired from Sick Kids in 2015 amid a scandal involving Motherisk’s hair testing lab that tore apart families and prompted two government-commissioned inquiries.
He replied to an email requesting comment for this story with a link to an article he co-authored in July responding to the paper by Juurlink and Zipursky. The article is published in Motherisk International, a journal Koren launched earlier this year in Israel, where he is listed as a full professor at Ariel University’s medical school in the West Bank.
“We believe that the claim by Zipursky and Juurlink that this is an improbable cause of death stems from fundamental flaws in their understanding of perinatal toxicology,” Koren said in the article.
He said that “many more deaths” would have occurred if the U.S. Food and Drug Administration hadn’t warned about the risks of codeine and breastfeeding following the Toronto case report first published in the Lancet.
In an email on Wednesday, the baby’s mother, Rani Jamieson, said, “The decision to retract the two original papers reflects a massive failure on the part of both Canadian Family Physician and the Canadian Pharmacists Journal.”
Jamieson previously told the Star that the new paper “just presents baseless speculation” and that Juurlink and Zipursky, “are very clearly insinuating that (her son) Tariq had been given his fatal overdose through another channel,” but that they omit “any information that would cause people to doubt their claims.”
In making their determination, the independent reviewers commissioned by the Canadian journal editors considered the columns, the case report and the paper by Juurlink and Zipursky, as well as responses of “Koren and colleagues to the concerns about the case report” raised in that new paper and “correspondence from the parent of the child,” according to the retraction notice.
Both reviewers concluded that the pair of columns published in the journals met the “retraction criterion” established by the Committee of Publication Ethics of “clear evidence that the findings are unreliable, either as a result of major error (eg, miscalculation or experimental error),” the retraction notice states.
In a joint interview, the journal editors described the months-long review process they undertook together as “challenging”
but “fair.”
“It’s about getting the correct information to our readers,” said Dr. Ross Tsuyuki, editor of Canadian Pharmacists Journal. “We took the high road. We stuck to our principles … We did the right thing.”
In an email on Wednesday, Zipursky said, “We’re gratified by the editors’ decision, and also by the thoughtful, science-based approach they took in coming to it.”
The Lancet, a premier medical journal that first published the case report, did not respond to a request for comment. Earlier this year, a group of academics, including the CEO of Sick Kids and the former dean of medicine at the University of Toronto, joined Juurlink and Zipursky in calling for The Lancet, along with the Canadian journals, to retract the papers they published on the case.
“The original interpretation published in Lancet is simply and unquestionably wrong. That article has now been cited hundreds of times, and it represents the cornerstone of an entire branch of pediatric pharmacology that has been manufactured out of whole cloth,” Juurlink, the head of clinical pharmacology and toxicology at Sunnybrook and U of T, said Wednesday. “Retraction is the only responsible option.”
“The original interpretation published in Lancet is simply and unquestionably wrong. That article ... represents the cornerstone of an entire branch of pediatric pharmacology that has been manufactured out of whole cloth.”
DR. DAVID JUURLINK CO-AUTHOR OF NEW PAPER