A contentious Canadian medical study that linked a baby’s death to codeine transmitted through breastmilk is facing renewed scrutiny twenty years after its publication. The Lancet, a renowned medical journal, has issued an “expression of concern” regarding the 2006 case report, citing new allegations of data falsification, authorship disputes, and ethical issues. This move follows an investigative report by The New Yorker and ongoing media coverage in Canada.
Despite criticism and retractions by other medical journals, the study has had a significant impact on pain management practices and breastfeeding advice worldwide. It focused on an infant’s poisoning in Ontario in 2005, suggesting that the mother’s intake of Tylenol 3 led to a fatal morphine dose in her breastfed baby.
The study’s lead author, Gideon Koren, faced allegations of flawed research findings and controversies related to the now-defunct Motherisk lab. The lab, known for testing maternal drug and alcohol use using hair samples, was discredited for unreliable practices. The lab’s tests were utilized in criminal and child protection cases, resulting in the separation of families.
Koren, who closed the lab in 2019 and surrendered his medical license, has been urged to retract the Lancet study by critics, including pharmacologist David Juurlink. Juurlink and others have raised concerns about the study’s validity, highlighting misinterpretations in the toxicology results and implausible conclusions about the risks of codeine in breast milk.
The widespread impact of the study led to revised guidelines on painkillers for breastfeeding mothers and warnings from health authorities. Health Canada emphasized the importance of cautionary measures based on available data at the time. Calls for a retraction of Koren’s work have intensified, with external reviewers disputing the reliability of the findings.
The Lancet has referred the recent allegations to SickKids Hospital for investigation, signaling a potential reevaluation of the study. As discussions around the study resurface, stakeholders stress the need for a conclusive resolution to address the lingering repercussions of the controversial research.
