Wednesday, October 11, 2023

Toronto's Hospital for Sick Children: SickKids Hospital spent hundreds of hours reviewing disgraced Doctor Gideon Koren's research: Toronto Star Investigative Reporter Rachel Mendleson explains why the ‘disappointing’ review has sparked anger in Toronto’s medical community…"After more than four years and hundreds of hours spent poring over scientific articles, Toronto’s Hospital for Sick Children (SickKids) has completed its review of possible problems with research by one of its former doctors — the man behind one of the largest medical scandals in recent Canadian history. The hospital’s findings are just three paragraphs long, determining the matter “inconclusive.” The result has come as a disappointment to the former head of SickKids, who launched the probe in 2018; another prominent physician dismissed the hospital’s review as a “public relations exercise.”



PUBLISHER'S NOTE: "A bit of context: Charles Smith and disgraced and Gideon Koren shared one important connection (apart from both bring 'disgraced.')  They both were employed at one time or other by The Hospital for Sick Children, which, in turn, had been disgraced by the ignominy they both left behind them. Globe and Mail Health Reporter André  Picard vividly described this connection in a Globe and Mail 'opinion' piece which ran on January 12, 2016, under the heading, "After Motherisk report,  Sick Kids needs some  self reflection,: and reads, in part: "But what's most troubling of all is that the Motherisk story is oddly familiar. In 2008, an inquiry revealed that Charles Smith, a forensic pathologist at Sick Kids who was responsible for investigating suspicious child deaths, had grossly misinterpreted autopsy results and overstated his expertise. The tragic result there was that at least 13 people were wrongly convicted because Dr. Smith testified there was foul play (often shaken baby syndrome). Stephen Goudge, who led that inquiry, made some recommendations to Sick Kids Hospital (and to the health and research community more generally) that apparently need to be reiterated: Oversight is essential, and so, too, is training and the verification of credentials. Dr. Smith and Dr. Koren were passionate about their work and beliefs – often to the point of religious-like fervour. They built little empires and reputations as unassailable experts. This kind of hero worship ended up being costly, especially for parents who found themselves in their crosshairs. Parents have gone to jail and been deprived of their children. That this has happened, at least in part, because of managerial and administrative failures of the Hospital for Sick Children, which also has a world-class reputation, is deeply troubling. In the Motherisk case, there has been a summary apology, but some serious self-reflection is still in order. Children, their parents and the public deserve better from Sick Kids." After reading Toronto Star Investigative Reporter  Rachel Mendleson's excellent story on the iconic hospital's apparent reluctance to  confront allegations against Dr. Koren set out in the story (below), readers may be inclined to agree with me that some more 'self reflection', by the hospital is perhaps warranted. André  Picard's entire 'opinion' piece can be read at:


https://www.theglobeandmail.com/opinion/after-motherisk-report-sick-kids-needs-some-serious-self-reflection/article28117696/


Harold Levy: Published: The Charles Smith Blog.


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PASSAGE OF THE DAY: (Toronto Star Investigative Reporter Rachel Mendleson story._  "SickKids ordered a “systematic” review of the vast body of work published by Dr. Gideon Koren after a Star investigation identified possible problems in more than 400 articles Koren co-authoredRoughly 300 of Koren’s papers, the Star found, didn’t adequately disclose funding from pharmaceutical companies and, in some cases, contained lies about the way the SickKids program he founded, Motherisk, tested hair for drugs. In a three-paragraph statement posted on its website, the hospital said it “cannot confirm with certainty that undisclosed conflicts exist” or whether the research papers complied with the institution’s ethics guidelines. “The scientific review of these publications was exceptionally challenging due to a number of factors, including lack of access to data and the passage of time since the work was conducted,” the statement reads. Dr. David Naylor, who was interim CEO of SickKids when the hospital launched the review, said the brief statement on the findings left him at a loss. “Some colourful language comes to mind, but let’s just say that I was disappointed,” Naylor told the Star in an email."


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STORY: "SickKids hospital spent hundreds of hours reviewing a disgraced doctor’s research. Here’s why the ‘disappointing’ review has sparked anger in Toronto’s medical community," by Toronto-based Toronto Star investigative reporter Rachel Mendleson, published on October 10, 2023.


PHOTO CAPTION: Toronto’s Hospital for Sick Children ordered a “systematic” review of the vast body of work published by Dr. Gideon Koren after a Star investigation identified possible problems in more than 400 articles Koren co-authored.


GIST: "After more than four years and hundreds of hours spent poring over scientific articles, Toronto’s Hospital for Sick Children (SickKids) has completed its review of possible problems with research by one of its former doctors — the man behind one of the largest medical scandals in recent Canadian history.


The hospital’s findings are just three paragraphs long, determining the matter “inconclusive.”

The result has come as a disappointment to the former head of SickKids, who launched the probe in 2018; another prominent physician dismissed the hospital’s review as a “public relations exercise.”


SickKids ordered a “systematic” review of the vast body of work published by Dr. Gideon Koren after a Star investigation identified possible problems in more than 400 articles Koren co-authored.


Roughly 300 of Koren’s papers, the Star found, didn’t adequately disclose funding from pharmaceutical companies and, in some cases, contained lies about the way the SickKids program he founded, Motherisk, tested hair for drugs.


In a three-paragraph statement posted on its website, the hospital said it “cannot confirm with certainty that undisclosed conflicts exist” or whether the research papers complied with the institution’s ethics guidelines.


“The scientific review of these publications was exceptionally challenging due to a number of factors, including lack of access to data and the passage of time since the work was conducted,” the statement reads.


Dr. David Naylor, who was interim CEO of SickKids when the hospital launched the review, said the brief statement on the findings left him at a loss.


“Some colourful language comes to mind, but let’s just say that I was disappointed,” Naylor told the Star in an email.


In response to questions for this story, hospital spokesperson Sarah Warr said, “SickKids acknowledges the views that others may hold regarding the review of Dr. Gideon Koren’s work. 


However, SickKids stands by its review processes,” which reflect national standards.


Koren did not respond to a request for comment for this story.


 He retired from SickKids in 2015 amid a national scandal involving unreliable hair-testing evidence from Motherisk that tore apart vulnerable families and prompted two government-commissioned reviews.


Before it was engulfed in scandal and shuttered in 2015, Motherisk was viewed for decades as a trusted source of advice about the safety of medications and the effect of drugs and alcohol during pregnancy and lactation.


Warr said SickKids spent “hundreds of hours reviewing Dr. Koren’s research.” She provided the names of five scientific journals the hospital said it contacted regarding a dozen publications since 2010 “that may have undisclosed conflicts of interest,” but refused to identify the specific articles it flagged or provide further details on the review process.


The lack of transparency makes it “impossible to know” whether the review adequately addressed the concerns that prompted it, Naylor said.


“I have great confidence in the leadership team at the hospital, but it’s hard not to worry that some important scientific or ethical issue was missed when there was so little information given about the process leading to this conclusion,” he said.


Koren was ‘impervious to discipline’

The Journal of Clinical Pharmacology, which published several articles co-authored by Koren that the Star identified in its 2018 investigation as containing possible problems, was among the scientific journals that SickKids contacted.


Editor Joe Bertino said he reviewed the articles and determined that no corrective action was required. He said he is satisfied with the hospital’s response to the concerns about Koren’s publications.


SickKids and the University of Toronto, where Koren held cross-appointments, have faced criticism for allowing Koren to remain in a position of power despite the highly publicized ethical breaches he committed decades earlier, including research misconduct.


Naylor, who was the university’s dean of medicine at that time, has previously said that he rejects the suggestion that the university’s “handling of this case somehow accounted for Koren’s ongoing failures to disclose industry funding sources and personal payments,” adding that Koren was “evidently impervious to discipline or criticism.”


Dr. Nav Persaud, who co-authored a paper exposing inaccuracies in a 1997 article Koren published on the safety and effectiveness of the popular morning-sickness drug Diclectin, dismissed the hospital’s review of Koren’s publications as “a public relations exercise.”


“I’m not sure they have appropriately followed through given the magnitude of the problem,” said Persaud, who is a researcher and family physician at St. Michael’s Hospital. “SickKids benefited from the standing that Motherisk enjoyed for many years. And now SickKids should do the right thing in acknowledging that Motherisk was, in fact, a source of misinformation.”


The Star’s 2018 investigation into Koren’s publications was conducted in partnership with Toronto Metropolitan School of Journalism students Stefanie Phillips, Emerald Bensadoun, Kate Skelly and Alanna Rizza."


The entire story can be read at:


https://www.thestar.com/news/investigations/sickkids-hospital-spent-hundreds-of-hours-reviewing-a-disgraced-doctor-s-research-here-s-why/article_48c44029-ee2a-5a66-aadb-ddaf14e31536.amp.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;