PUBLISHER'S NOTE:What do Charles Smith and Gideon Koren have in common: Both brought prestige and money to Toronto's Hospital for Sick Children. Smith, through the Pediatric Forensic Pathology Unit which he founded, and Koren for the now defunct Motherisk hair-testing lab, which he founded. Both men were God-sends to the iconic hospital which relied on its reputation - built upon doctors such as Smith and Koren - to raise vast amounts of funds for its research and other activities. It's little wonder that when the stack of cards began to collapse, the hospital did its best to keep the respectful scandals - which led to horrific consequences for parents and children - far from public scrutiny. The following article by Toronto Star Investigative Rachel Mendleson, Staff Reporter Michele Henry, and Data Analyst Andrew Bailey, makes the point that the hospital has learned little from past experience. (Just like Sick Kids never learned the lessons of the sad Charles Smith saga - if it had, Motherisk would never have happened) It notes that the famed hospital only decided to review Koren's medical literature, after being confronted with the Star's research showing that Koren's research output was sorely flawed, as was the hair-testing lab infamous now shuttered lab. (As the article states: "Sick Kids acknowledged that while institutions rely on the good faith of scientists to disclose conflicts that could bias their work, “it is regrettable that the Hospital did not conduct any audits of Dr. Koren’s publications which may have identified disclosure issues sooner.” Bravo to the Star - and its talented investigative team - for exposing Koren and the hospital's destructive infamy.
Harold Levy: Publisher; The Charles Smith Blog.
----------------------------------------------------------
PASSAGE OF THE DAY: (1): "Sick Kids acknowledged that while institutions rely on the good faith of scientists to disclose conflicts that could bias their work, “it is regrettable that the Hospital did not conduct any audits of Dr. Koren’s publications which may have identified disclosure issues sooner.”
----------------------------------------------------------
PASSAGE OF THE DAY (2): "The hospital said it will conduct a “systematic examination” of Koren’s published work in an effort to “protect the integrity of the existing medical literature.” It will also undertake a “focused scientific review” of Koren’s hair-testing papers and his “primary research” related to the popular morning-sickness drug Diclectin — two of the problems areas the Star flagged — and will add “new measures to strengthen institutional oversight of publication disclosure practices.”
----------------------------------------------------------
PASSAGE OF THE DAY (3): "We found more than 60 papers that relate to drug and alcohol hair-testing that we deemed problematic because retired judge Susan Lang’s 2015 review of Motherisk exposed failings in the lab, including that hair test results were “inadequate and unreliable” but were used in thousands of child protection cases and a handful of criminal cases.Sick Kids said it is “in the process of identifying” publications related to the Motherisk drug-testing lab “that could potentially have therapeutic or diagnostic implications to conduct a review.” “The journals that have published these studies share responsibility for addressing this issue and to the extent our work results in any findings, our plan is to disclose same to the journals,” the hospital said. Lang, in her 2015 report, pinpointed five papers that falsely claimed that lab’s results had been verified with gold-standard testing, when in fact Motherisk rarely confirmed its screening test results before 2010, contrary to international standards for evidence presented in court."
-------------------------------------------------------------------
STORY: "Sick Kids orders ‘systematic’ review of Dr. Gideon Koren’s published works," by Toronto Star Investigative Rachel Mendleson, Staff Reporter Michele Henry, and Data Analyst Andrew Bailey, published on December 16, 2018.
PHOTO CAPTION: "Dr. Gideon Koren, founder and former director of Motherisk, attending a conference in the United Kingdom in 2017. He left SickKids in 2015 and is now working in Israel."
PHOTO CAPTION: "Justice Susan Lang, a retired Ontario judge, in 2015 conducted an independent review of the Motherisk lab and exposed failings in the lab, including that hair test results were "inadequate and unreliable."
PHOTO CAPTION: "Toronto's Hospital for Sick Children has announced a wholesale review of the work published by Dr. Gideon Koren.
The entire story can be read at the link below:
https://www.thestar.com/news/investigations/2018/12/16/sick-kids-orders-systematic-review-of-dr-gideon-korens-published-works.html
GIST: "Toronto’s Hospital for Sick Children has
announced a wholesale review of the vast body of published work by Dr.
Gideon Koren, the former director of the discredited Motherisk lab, amid
a Star investigation that identified what appear to be problems in more
than 400 of Koren’s papers. Sick Kids reacted
after the Star presented the hospital with the results of the
newspaper’s review that found these papers had been inadequately
peer-reviewed, fail to declare, perhaps even obscure, conflicts of
interest and, in a handful of cases, contain lies about the methodology
used to test hair for drugs. Many
of these articles stand in the scientific literature, despite two
government commissioned inquiries and an internal investigation by the
hospital into Motherisk, following concerns that were first raised about
the program by the Star four years ago. “Despite the actions
taken to date, fresh concerns have surfaced in the area of scientific
reliability and academic publication conflict of interest disclosures,”
Sick Kids said in a news release on
Friday. “Here SickKids wishes to acknowledge the investigative work of
reporters Rachel Mendleson and Michele Henry of The Star who brought
relevant findings to the organization’s attention. They have unearthed
publications where, on initial review, it appears that Dr. Koren did not
disclose industry support that appears relevant to the primary focus of
the publication or otherwise related to the published work.” Sick
Kids acknowledged that while institutions rely on the good faith of
scientists to disclose conflicts that could bias their work, “it is
regrettable that the Hospital did not conduct any audits of Dr. Koren’s
publications which may have identified disclosure issues sooner.” Koren
and his lawyers did not immediately respond to requests to comment for
this story and have not responded to questions over the past month
related to the Star’s broader investigation. Koren retired from Sick
Kids in June 2015 and is working in Israel. A
prolific author, Koren has published more than 1,500 research papers
over the last 40 years, Sick Kids has said. The Motherisk Program he
founded at the hospital in 1985 became a trusted source
of drug-safety advice for pregnant women and their doctors. Motherisk’s
affiliated hair-testing lab made more than $11 million from 2007 to
2015 alone, selling its drug and alcohol tests, primarily to child
welfare agencies, as evidence of parental substance abuse in child
protection cases. Sick Kids closed the Motherisk lab in 2015. The counselling function of the Motherisk Program continues at the hospital under new leadership. The
hospital said it will conduct a “systematic examination” of Koren’s
published work in an effort to “protect the integrity of the existing
medical literature.” It will also undertake a “focused scientific
review” of Koren’s hair-testing papers and his “primary research”
related to the popular morning-sickness drug Diclectin — two of the
problems areas the Star flagged — and will add “new measures to
strengthen institutional oversight of publication disclosure practices.” Koren held cross appointments in the faculties of medicine and
pharmacy at the University of Toronto. In an email, Vivek Goel,
Vice-President, Research and Innovation, at the university, said the
Sick Kids reviews “relate to the clinical testing done by the Motherisk
laboratory which is in its jurisdiction.” “If in the course of the
SickKids reviews, issues are identified that involve research conducted
under the auspices of the University, then we will be engaged, as
appropriate,” he said, adding that the university will “take appropriate
actions” if the hospital's findings involve individuals at U of T. The more than 400 papers
co-authored by Koren that the Star flagged as possibly containing
problems include research articles, conference papers, literature
reviews, editorials, book chapters, and magazine articles. We
found more than 60 papers that relate to drug and alcohol hair-testing
that we deemed problematic because retired judge Susan Lang’s 2015
review of Motherisk exposed failings in the lab, including that hair
test results were “inadequate and unreliable” but were used in thousands
of child protection cases and a handful of criminal cases. Sick
Kids said it is “in the process of identifying” publications related to
the Motherisk drug-testing lab “that could potentially have therapeutic
or diagnostic implications to conduct a review.” “The journals
that have published these studies share responsibility for addressing
this issue and to the extent our work results in any findings, our plan
is to disclose same to the journals,” the hospital said. Lang, in
her 2015 report, pinpointed five papers that falsely claimed that lab’s
results had been verified with gold-standard testing, when in fact
Motherisk rarely confirmed its screening test results before 2010,
contrary to international standards for evidence presented in court.
Following Lang’s report, Sick Kids said the hospital’s research
integrity adviser reviewed these papers and found that Koren violated
some of the guidelines that govern the use of federal research funds,
which it reported to the Secretariat for Responsible Conduct of
Research, which oversees the Canadian Institute for Health Research. Koren
sent letters identifying “corrigendum” — or correction — to the editors
of the journals in which these articles appeared, and corrigenda were
published in relation to three of the papers. However, Sick Kids
said that pediatrician-in-chief Ronald Cohn took issue with Koren’s
claim in the corrections that “the fact that not all positive results
had been (confirmed with gold-standard testing) had no impact on the
results,” and wrote to the journals. One of the journals, Therapeutic
Drug Monitoring, revised its position and this past summer issued a more
severe “expression of concern” in relation to a 2007 article on cocaine
detection in maternal and neonatal hair. The Star, in its ongoing
investigation, found that Therapeutic Drug Monitoring, which Koren
edited from 2003 to 2015, has recently flagged six more
of his papers as requiring further scrutiny. Sick Kids said it is
“looking into these articles,” following questions from the Star. The
hospital’s promise to investigate Koren’s work on Diclectin comes five
years after Dr. Nav Persaud, a researcher and family physician at St.
Michael’s Hospital, co-authored a paper exposing inaccuracies in a 1997
article Koren co-authored on the safety and effectiveness of the drug. Persaud
praised Sick Kids for undertaking a thorough review of Koren’s work,
but said, “It’s sad that it took questions from journalists for this to
happen.” “Many red flags have been raised over the years, and
hopefully this announcement from Sick Kids means that the red flags will
be heeded,” he said. The Star’s review identified roughly 30
articles that reference morning sickness or Diclectin but do not
disclose his financial ties to the manufacturer of the drug, Duchesnay.
Koren has served as a paid consultant to the Quebec-based pharmaceutical
company, which was also a long-time sponsor of the Motherisk Program,
until the relationship ended in 2015. The hospital reassigned
oversight of Motherisk in the spring of 2015 after the Star asked about a
morning sickness booklet — co-authored by Koren — posted on the
Motherisk website that recommended the drug Diclectin but failed to
disclose financial support from Duchesnay. The Star found about
270 papers that reference, in some way, “The Research Leadership for
Better Pharmacotherapy during Pregnancy and Lactation.” Sick Kids
disclosed in 2015 that Koren created this name to refer to donated
funds, and that the primary donor in the years leading up to the
Motherisk scandal was Duchesnay. Sick Kids said Friday that the
hospital “was unaware that Dr. Koren had published on morning sickness
and/or Diclectin without disclosing his relationship with Duchesnay.” “The
responsibility for disclosing relationships (conflicts of interest) in a
publication rests with the author,” Sick Kids said. In addition
to reviewing the financial disclosures on nearly 20 years of Koren’s
published work, the hospital told the Star it is “undertaking an
analysis of Dr. Koren’s industry funding over time with a view to
aligning funds on hand with dates of disclosures, for purposes of
notification.” Sick Kids will also review the science behind seven of his studies on the effectiveness of Diclectin. Following questions from the Star last month, Sick Kids interim CEO, Dr. David Naylor, sent a letter
to Koren asking him to contact journals to inform them of papers about
morning sickness or Diclectin in which he did not disclose support from
Duchesnay as well as all papers referencing The Research Leadership for
Better Pharmacotherapy during Pregnancy and Lactation in which he did
not disclose funding sources. Naylor, in the letter which has been
posted on the Sick Kids website, also warned Koren to “cease and desist”
from identifying himself in publications as being affiliated with Sick
Kids.
