20-year-old study that claims a baby died from opioid poisoning through breast milk is still in question

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A controversial Canadian medical paper that blamed a baby’s death on codeine passed through breast milk is coming under fresh scrutiny, a full two decades after it was published. The paper initiated widespread changes in global approaches to pain management and breastfeeding guidance for new mothers.

The Lancet, a major medical journal, has now added an “expression of concern” to the journal on January 20 following “new allegations of falsification of toxicological data, authorship issues and ethical concerns” in the report of the 2006 case. This step has been taken after the recent publication of a. The New Yorker investigation lasted a year. On top of years of Canadian media coverage, in a highly criticized newspaper.

Although outside researchers say the paper should have been rejected long ago – and two other medical journals have already retracted similar versions – the case study has already been incredibly influential, leading to Government warningsChanges in drug labeling, a shift toward the use of more powerful and addictive forms of opioids, and countless women being asked to choose between a generic form of postpartum pain relief and safely breastfeeding their newborns.

lancet case study In 2005 the focus was on the poisoning of an infant in Ontario, and it was reported that the child’s mother had been prescribed Tylenol 3 and had given a lethal amount of morphine to her son through her breast milk.

Combination medications commonly given for postpartum pain management contain both acetaminophen and codeine, a mild opioid that is partially metabolized into morphine inside the body. (Some individuals, including the woman in the case study, are genetically predisposed to convert codeine faster and in larger amounts.)

For years after its publication, author Gideon Koren – the once-respected founder of the closed Motherisk drug testing laboratory – insisted that the case showed that maternally ingested codeine could be fatal to breastfed infants, despite growing concern over Koren’s explanation and questions from other scientists about its feasibility.

Discredited test amid growing concern

Koren has long been in the news amid allegations of flawed or false study findings and a series of scandals surrounding the Motherisk laboratory.

The former facility of the Hospital for Sick Children (SickKids) in Toronto initially gained worldwide attention by using hair strands to test for drug and alcohol use in mothers, but its testing methods were deemed “inadequate and unreliable” by an independent provincial review in 2015.

Nevertheless, the lab’s discredited tests were used in at least eight criminal cases and thousands of child protection cases – in many cases resulting in children being removed from their families – as The Toronto Star reported in 2017.

Motherisk Labs was closed in 2019, and Koren agreed to give up his medical license in Ontario the same year. He has not yet responded to CBC News’ request for comment.

Many longtime critics say that one of their most influential findings, from a 2006 case study in the Lancet, is simply implausible and should be retracted entirely.

David Juurlink, a renowned Canadian pharmacologist, toxicologist and drug safety researcher, recalled, “(According to Coren), it was a coincidence of genetics. The mother was taking codeine. She was converting it very efficiently into morphine. It was getting into the breast milk and that’s how the baby died.” “And I believed that narrative for a few years.”

But it wasn’t long before Jurlink and others were quickly troubled by the study’s surprising results. He has since raised concerns, saying that the report fails during investigation.

‘Impossible outcome’

Koren misinterpreted the toxicology results, Jurlink said, and did not consider that extremely high acetaminophen and codeine concentrations in the infant’s blood were “unlikely consequences” of breastfeeding. New Yorker journalist Ben Taub said that while the postmortem examination revealed that there was a “white curdled substance” in the child’s stomach, forensic testing found codeine, but not morphine – a result that, along with the “sheer quantity” of drugs in his blood, suggested direct administration.

Yet since Koren’s paper was published, claims that codeine-laced breast milk could cause infant death have resonated in global public health messaging.

2008, Canada’s Top Pediatrician and Obstetrician Started developing new guidelines While painkillers are safe during breastfeeding Health Canada issued a warning for nursing mothers and urged drug manufacturers to update codeine-based drug labeling to highlight perceived risks. (Neither Health Canada nor the Society of Obstetricians and Gynecologists of Canada responded to CBC News by deadline.)

Jurlink first called for the Lancet to be withdrawn in 2020. This called for an investigation by SickKids, which concluded at the time that “there was no violation of the lack of rigor, and there is no justification for a return to the ongoing scientific controversy,” the journal noted in its new expression of concern.

Yet in 2020, two Canadian medical journals Similar documents withdrawn Following Jurlink’s concerns, Coren published a case report based on it.

Their joint retraction notes that the original case has been cited more than 600 times since its publication and that its findings have had a “significant impact on the way postpartum analgesic medication is prescribed”. External peer reviewers recruited by Canadian journals provided clear evidence that the findings were unreliable.

The Lancet said it has referred the latest allegations about Koren’s paper to SickKids’ research integrity office for a new investigation. A spokesperson for the hospital told CBC News that SickKids will meet with the Journal and, “if necessary based on that discussion,” will launch a formal review.

Case study findings ‘essentially a myth’

Physician and researcher Dr. Nav Persaud, an assistant professor at the University of Toronto and a longtime critic of Coren’s other areas of research, questioned why it was taking so long for the influential medical journal to act on years of growing concern about his work.

“I still don’t understand why the Lancet is saying that they need to investigate the institution — in this case, SickKids Hospital — before they issue a retraction,” Persaud said.

This issue ultimately needs to be dealt with “definitely”.

“This is truly a tragic case, and you don’t want to ignore the fact that this particular issue began when an infant tragically died, and the investigation into that infant’s death has been botched.”

As the case study once again makes headlines, Jurlink stressed that Koren’s influence has led a generation of physicians and parents to believe that opioids prescribed to breastfeeding mothers to ease the pain of a C-section or episiotomy can harm, or even kill, babies. They worry that this may cause many mothers to avoid breastfeeding altogether, despite the benefits.

“One of the most disturbing aspects of this whole saga is that it is very easy to find examples of infants who have died, apparently by homicide — given a drug by a caregiver, given an opioid — and experts in the court system blame breast milk,” he said.

“It’s basically a myth, and it’s all based on a misinterpretation of a case from 20 years ago.”