Wednesday, July 12, 2023

Medical Research Controversy: 'Fatally flawed' medical research conducted by disgraced Doctor Gideon Koren and published by the prestigious journal 'The Lancet' remains uncorrected - with ominous consequences - The Toronto Star, Investigative Reporter Rachel Mendleson reports..."In 2020, the top brass at Toronto’s Hospital for Sick Children acknowledged that influential research co-authored by one of its former doctors was “fatally flawed.” Nothing short of scrubbing it from the scientific record would suffice. Three years later, the paper still stands uncorrected in the medical literature. And SickKids is under fire for retreating from its efforts to get a prestigious medical journal to retract what critics say contains misleading information about the use of codeine to treat postpartum pain. “They’ve really abdicated the responsibility,” said Dr. David Juurlink, the head of clinical pharmacology and toxicology at Sunnybrook hospital and the University of Toronto. “This isn’t just about a paper. It’s about the consequences of that paper and its implications for moms and babies all over the world.”


PASSAGE OF THE  DAY: "The hospital’s former interim CEO, Dr. David Naylor, co-signed the letters to The Lancet and the Canadian journals, requesting retraction. He continues to believe the problems with the case report warrant the most extreme corrective action in academic publishing, because it “did not present all the relevant facts of the case,” including the codeine level in the baby’s blood. The case report, Naylor said, “was far too definitive in claiming causation.” “The misframing of the findings, prominence of The Lancet, and very understandable concerns about avoiding harm to breast-feeding babies gave the publication an impact out of all proportion to a standard case report,” he said. In a recent presentation Juurlink (Dr. David Juurlink, the head of clinical pharmacology and toxicology at Sunnybrook hospital and the University of Toronto HL)  gave at Sunnybrook about the controversy over The Lancet paper, he said he is worried the case report led to doctors prescribing more powerful opioids to nursing mothers. He also expressed concern that it has caused some women who were taking opioids for postpartum pain to stop breastfeeding, despite scant evidence of babies harmed by morphine in breastmilk."


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STORY: "A ‘flawed’ medical journal article on postpartum pain was targeted for retraction from The Lancet. Here’s why that didn’t happen," by Reporter Rachel Mendleson, published by The Toronto Star on July 3 2023:  Rachel Mendleson is an investigative reporter at the Toronto Star with a special interest in data-based reporting, justice issues and public policy. Her investigation into unreliable drug and alcohol testing at the Hospital for Sick Children's Motherisk laboratory led to the lab being shut down and prompted reviews of affected child protection cases in several provinces. Rachel has previously worked for the Huffington Post, Maclean's and Canadian Business.'


SUB-HEADING: "The research blamed the death of a 13-day-old baby on morphine-laced breastmilk. A re-examination of the case found the explanation was “implausible.”


STORY: "In 2020, the top brass at Toronto’s Hospital for Sick Children acknowledged that influential research co-authored by one of its former doctors was “fatally flawed.” Nothing short of scrubbing it from the scientific record would suffice.


Three years later, the paper still stands uncorrected in the medical literature. And SickKids is under fire for retreating from its efforts to get a prestigious medical journal to retract what critics say contains misleading information about the use of codeine to treat postpartum pain.


“They’ve really abdicated the responsibility,” said Dr. David Juurlink, the head of clinical pharmacology and toxicology at Sunnybrook hospital and the University of Toronto. “This isn’t just about a paper. It’s about the consequences of that paper and its implications for moms and babies all over the world.”


The original paper, co-authored in 2006 in The Lancet by Dr. Gideon Koren, the disgraced former head of the SickKids’ now-shuttered Motherisk program, purported to show a potentially serious risk associated with breastfeeding while taking codeine.


Koren and his co-authors examined the death of a 13-day-old baby whose mother had been prescribed a combination of acetaminophen and codeine, a painkiller that converts to morphine when the body breaks it down. 


The researchers blamed the boy’s death on morphine-laced breastmilk. The report prompted health agencies around the world to caution against giving codeine to nursing mothers for pain relief.


Findings were ‘unreliable’

But in 2020, a re-examination of the case concluded that Koren’s explanation for the death was “implausible.” Juurlink co-authored the peer-reviewed research. It had a swift impact.


Two Canadian medical journals that had published columns by Koren and that were based on his work originally published in The Lancet, retracted those articles. Koren’s findings were “unreliable,” an independent review commissioned by the journals concluded. But the world-renowned The Lancet did not retract.


That The Lancet — a 200-year-old medical journal with almost unparalleled reach — remains unmoved underscores the challenge of rectifying flaws in academic publishing, critics say. In the world of medical publishing, prior Star investigations have shown, corrections are rare. Institutions and publications have discretion to investigate allegations as they see fit.


In this case, SickKids is facing criticism from Juurlink for conducting an allegedly “flawed” and “superficial” internal review of the paper that has allowed it to remain uncorrected.


At the time Jurrlink’s takedown of the codeine and breastfeeding research was published, SickKids CEO Dr. Ronald Cohn was among signatories of an unflinching letter to the editor of The Lancet. They called for its retraction.


The U.K.-based The Lancet took a different approach than the Canadian journals, and referred the allegations it received about the paper back to SickKids for investigation.


The journal’s spokesperson pointed to international publishing guidelines that say “authors’ institutions are best placed to lead independent investigations into scientific misconduct.”


“The Lancet Group takes issues relating to scientific misconduct extremely seriously,” the spokesperson added.


It’s about ‘reputation management’

SickKids launched an inquiry and found that Koren’s case study is the subject of “scientific disagreement” and there was no breach of research conduct, according to Cohn. Beyond that, details of SickKids’ inquiry are scarce.


SickKids declined the Star’s request to obtain a copy of its inquiry report through freedom-of-information legislation, arguing that it is excluded from disclosure because it relates to research. The Star is appealing that decision.


The Lancet is standing by the paper, citing the SickKids review, which determined that retraction “is not warranted,” a spokesperson for the journal said.


For many journals and research institutions, “it’s all about reputation management,” said Ivan Oransky, co-founder of Retraction Watch, an organization with an online database of retractions and corrections.


“Retractions are bad for their reputations,” Oranksy said. “So they fight tooth and nail.”


Cohn declined an interview request for this story. In an email, he said the hospital’s inquiry read all the material made available, as well as interviewing Koren and his co-authors.


“Counter arguments about the assumptions of Dr. Juurlink’s analysis were provided,” he said.


Mother defends ‘responsible decision’ not to retract

Juurlink responded that SickKids “could have resolved the issue by seeking an independent assessment of the science.”


“Yet for some reason they chose not to,” he said, adding that the co-authors of The Lancet paper the hospital consulted were all “in positions of conflict.”


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. The hospital launched a wholesale review of Koren’s vast body of published work in 2018, after the Star identified possible problems in more than 400 papers he co-authored.


At least eight medical journals have taken corrective action to address problems in articles Koren co-authored during his time at SickKids and in the years since he left the hospital, according to the Retraction Watch database.


Koren did not respond to requests for comment for this story.


The baby’s mother, Rani Jamieson, has previously rejected the conclusions of Juurlink’s re-examination of the case.


She said in an email that her family “has complete faith in and stands by the SickKids investigation,” and supports The Lancet’s “responsible decision” to leave the paper available “for the world to be warned” about what happened to her son.


The hospital’s former interim CEO, Dr. David Naylor, co-signed the letters to The Lancet and the Canadian journals, requesting retraction.


 He continues to believe the problems with the case report warrant the most extreme corrective action in academic publishing, because it “did not present all the relevant facts of the case,” including the codeine level in the baby’s blood. The case report, Naylor said, “was far too definitive in claiming causation.”


“The misframing of the findings, prominence of The Lancet, and very understandable concerns about avoiding harm to breast-feeding babies gave the publication an impact out of all proportion to a standard case report,” he said.


In a recent presentation Juurlink gave at Sunnybrook about the controversy over The Lancet paper, he said he is worried the case report led to doctors prescribing more powerful opioids to nursing mothers. He also expressed concern that it has caused some women who were taking opioids for postpartum pain to stop breastfeeding, despite scant evidence of babies harmed by morphine in breastmilk.


In their 2020 paper, Juurlink and his Sunnybrook colleague, Dr. Jonathan Zipursky, looked at blood-codeine levels in the coroner’s report — information that was not published in The Lancet report. They said the baby’s codeine level can’t be explained by the mother’s genetics, and suggest the drug was metabolized to morphine by the baby, as opposed to the mother. The Sunnybrook doctors did not offer an alternative explanation of how the baby ingested the drug that apparently killed him."


The entire story can be read at:


a-flawed-medical-journal-article-on-postpartum-pain-was-targeted-for-retraction-from-lancet-heres-why-that-didnt-happen.html


PUBLISHER'S NOTE: I am monitoring this case/issue/resource. Keep your eye on the Charles Smith Blog for reports on developments. The Toronto Star, my previous employer for more than twenty incredible years, has put considerable effort into exposing the harm caused by Dr. Charles Smith and his protectors - and into pushing for reform of Ontario's forensic pediatric pathology system. The Star has a "topic" section which focuses on recent stories related to Dr. Charles Smith. It can be found at: http://www.thestar.com/topic/charlessmith. Information on "The Charles Smith Blog Award"- and its nomination process - can be found at: http://smithforensic.blogspot.com/2011/05/charles-smith-blog-award-nominations.html Please send any comments or information on other cases and issues of interest to the readers of this blog to: hlevy15@gmail.com. Harold Levy: Publisher: The Charles Smith Blog;

SEE BREAKDOWN OF SOME OF THE ON-GOING INTERNATIONAL CASES (OUTSIDE OF THE CONTINENTAL USA) THAT I AM FOLLOWING ON THIS BLOG, AT THE LINK BELOW: HL

https://www.blogger.com/blog/post/edit/120008354894645705/47049136857587929

FINAL WORD: (Applicable to all of our wrongful conviction cases): "Whenever there is a wrongful conviction, it exposes errors in our criminal legal system, and we hope that this case — and lessons from it — can prevent future injustices.

Lawyer Radha Natarajan;

Executive Director: New England Innocence Project;

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FINAL, FINAL WORD: "Since its inception, the Innocence Project has pushed the criminal legal system to confront and correct the laws and policies that cause and contribute to wrongful convictions. They never shied away from the hard cases — the ones involving eyewitness identifications, confessions, and bite marks. Instead, in the course of presenting scientific evidence of innocence, they've exposed the unreliability of evidence that was, for centuries, deemed untouchable." So true!


Christina Swarns: Executive Director: The Innocence Project;


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YET ANOTHER FINAL WORD:


David Hammond, one of Broadwater’s attorneys who sought his exoneration, told the Syracuse Post-Standard, “Sprinkle some junk science onto a faulty identification, and it’s the perfect recipe for a wrongful conviction.”


https://deadline.com/2021/11/alice-sebold-lucky-rape-conviction-overturned-anthony-broadwater-1234880143/

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