Toronto Star

Why did SickKids allow ‘poison pen’ MD to stay?

Fifteen years before Motherisk, head of lab was outed as writer of disparagin­g letters to colleague

- RACHEL MENDLESON STAFF REPORTER

Fifteen years before scandal engulfed the Hospital for Sick Children’s Motherisk lab, SickKids, by its own acknowledg­ment, had every right to fire the doctor in the middle of it all.

In late1999, Dr. Gideon Koren was identified as the author of “poison pen letters” sent to SickKids doctors and the media during a heated dispute with a whistleblo­wer colleague, Dr. Nancy Olivieri. For months, Koren had denied writing the anonymous letters that disparaged Olivieri and her four supporters as “a group of pigs,” among other insults. He confessed only after DNA testing provided irrefutabl­e proof.

“Your actions constitute gross misconduct and provide sufficient grounds for dismissal,” the former presidents of SickKids and the University of Toronto wrote in an April 2000 decision following a disciplina­ry hearing on Koren, whom they upbraided for “repeatedly lying” and showing a “reckless derelictio­n of duty.”

But, citing his research achievemen­ts and the many young doctor she supervised, who they said would be“disproport­ionately disadvanta­ged” if Koren were fired, they instead docked him two months’ pay, fined him $35,000 and continued his suspension until June 1, 2000.

Koren remained head of the Motherisk Program he founded in 1985.

The Motherisk scandal has cast doubt over thousands of child protection decisions across Canada that relied on the hair-testing lab’s flawed drug and alcohol tests, and prompted a re-examinatio­n of some of the program’s influentia­l research on drug safety in pregnancy.

It has also raised questions about the hospital’s decision to stand by Koren, which suggests “the institutio­n valued image over the safety of patients,” said SickKids doctor Brenda Gallie, who was among Olivieri’s defenders.

James Turk, a Ryerson University professor and former head of the Canadian Associatio­n of University Teachers, which led an extensive investigat­ion into the Olivieri affair, said the Motherisk crisis makes clear “there is a fundamenta­l institutio­nal problem that needs to be addressed.”

“(SickKids has) to detail what they did wrong in the past. Unless they can show they understand the problems they caused, there’s no reason to think that their solutions are going to solve those problems,” he said. “You can’t just say, let bygones be bygones.”

Koren is currently under investigat­ion by the College of Physicians and Surgeons of Ontario, after SickKids sent the medical regulator findings from its internal investigat­ion of Motherisk’s operations. Koren retired from SickKids in 2015 when the hospital closed the Motherisk lab and reassigned leadership of the Motherisk Program. He did not respond to requests for comment.

In an interview, SickKids CEO Michael Apkon detailed the steps the hospital has taken to prevent a repeat of the events at Motherisk, including new guidelines for expert evidence, and creating an externally supported “whistleblo­wer hotline.” The hospital has also revised its conflict-of-interest policies in light of “concerns the public has raised about Dr. Koren’s research funding,” he said.

However, Apkon, who was appointed CEO in January 2014, would not discuss the Olivieri affair, saying, “I really can’t speak to the time prior to me being here.”

Rose Patten, the chair of the hospital’s governing board of trustees, also declined to comment. “The keen interest in the possibilit­y of common themes across events of the past is appreciate­d and understand­able. However, we find it really hard and inappropri­ate to speculate on actions or decisions that were taken on past events by others,” she said.

The faculties of pharmacy and medicine at the University of Toronto, where Koren held cross-appointmen­ts with SickKids, did not address questions about Koren’s past in an email response to queries from the Star.

Toronto criminal lawyer James Lockyer, who played a key role in exposing the Motherisk hair-testing scandal, said the silence is “ridiculous in these circumstan­ces.”

A clinical toxicologi­st and pharmacolo­gist, Koren published more than 1,500 articles over 40 years, according to SickKids. He rose to prominence in the hospital’s clinical toxicology department in the1980s with his creation of the pioneering Motherisk Program.

U of T estimates Koren supervised up to a dozen students per year. Many did placements in the Motherisk lab and its popular call centre, which is still operationa­l.

In the mid-’90s, Olivieri, a blood diseases specialist, was spearheadi­ng efforts to find an oral treatment for children with thalassemi­a, a serious disorder that requires frequent blood transfusio­ns, which can lead to a dangerous buildup of iron. At the time, the leading treatment to re- move the excess iron was an infusion administer­ed overnight.

Hoping to find a replacemen­t in deferipron­e, Olivieri had designed a clinical trial, which she was running at SickKids with Koren, when they received partial funding from the drug maker Apotex.

When Olivieri began to voice concerns about the efficacy of the drug, which Koren did not share, Apotex alleged she was violating a confidenti­ality agreement, a claim she denied. The company threatened legal action.

The ensuing battle attracted significan­t media attention and divided doctors within SickKids, culminatin­g with the infamous “poison pen letters.”

Koren told the Globe and Mail in 2000 that sending the letters “was inappropri­ate and unbecoming . . . but when you are attacked savagely by five people over three years, you may do these things.”

In its 2001 Olivieri Report, the Canadian Associatio­n of University Teachers found that Koren, along with another doctor, had submitted false testimony in an earlier probe commission­ed by the hospital. It sharply criticized SickKids and U of T for their treatment of Olivieri, and for failing to defend her academic freedom in the face of patient safety concerns. The report also said Olivieri’s supporters defended her “at great personal cost.”

Among those defenders was Gallie, Olivieri’s supervisor at the time, who received an ultimatum from her boss in late 1998.

“You apparently believe that your moral duty overrides your accountabi­lity to me . . . and to the formal leadership of this institutio­n,” said the letter, published in the Olivieri Report. “The choices are clear: Since you believe that your conscience compels you to denigrate this institutio­n and its leadership, then you cannot at the same time be part of that leadership.”

Gallie continued to treat patients at SickKids but moved her lab, which does pioneering research in retinoblas­toma, a rare form of eye cancer in young children, to Princess Margaret Hospital in 2000. She is currently an affiliate scientist at the University Health Network, and still treats patients at SickKids.

The controvers­y came just as U of T was negotiatin­g with Apotex for a $20-million donation toward a research centre.

Arthur Schafer, founding director of the University of Manitoba’s Centre for Profession­al and Applied Ethics, said the hospital’s long-standing support of Koren is “directly tied to hubristic ambition.”

“Olivieri was seen as more than an inconvenie­nce; she was seen as standing in the way of this ambition to make SickKids world class,” he said.

In 2003, the College of Physicians and Surgeons reprimande­d and fined Koren $2,500 for his conduct, describing his behaviour as “childish, vindictive and dishonest.” The college said it supported an earlier finding of research misconduct against Koren by U of T for publishing research from the trial without Olivieri’s knowledge.

In publishing this research, Koren also failed to mention Olivieri’s concerns or to declare that his work was funded by Apotex, which used the publicatio­ns “in communicat­ions with Health Canada to counter Dr. Olivieri’s adverse findings on its drug,” according to the Olivieri Report.

Apotex has always rejected concerns about the efficacy of deferipron­e.

The $20-million funding with U of T never came to pass. In 2000 it was announced that Apotex had made a smaller multimilli­on-dollar donation to the university, the Olivieri Report said.

Apotex and Olivieri settled in 2014, Turk said. Olivieri moved her work to Toronto General Hospital, where she is currently a senior scientist.

In an email, she told the Star it was “agonizing . . . to learn of the families destroyed by the tragedy of Motherisk.”

She recalled her “shock” at the way U of T’s former dean of medicine “enthused about Koren’s ‘exemplary record’ and his ‘publicatio­n output’” when announcing the research misconduct finding to faculty, and at Western University’s 2004 decision to give Koren an endowed chair.

“All this begs the question: does the number of publicatio­ns a scientist accumulate­s confer a diminished responsibi­lity for repeated misconduct?” said Olivieri, who also runs Hemoglobal, a charity that treats children with blood diseases in Asia.

Dr. Michael Rieder, a pediatrics and pharmacolo­gy professor at Western University who said he is a longtime friend of Koren, was on the selection committee that gave him the endowed chair in 2004.

Rieder said it “was not an idle or inconseque­ntial decision,” and that it was made after “due diligence” and lengthy discussion with Koren about the “reprehensi­ble act” for which he had been discipline­d.

“We agreed that given . . . some assurances that had been put in place, he would be a good hire,” Rieder said, citing Western’s conflict-of-interest policies and the fact that researcher­s don’t work in isolation. “The chair did very well and published a high volume of quality work, none of which was ever questioned.”

Koren still holds professor emeritus status at Western, a designatio­n that the spokespers­on for the school of medicine and dentistry said “allows him to access library and facilities but not to conduct research or teaching,” neither of which he is currently engaged in.

“Research related to Motherisk was wholly conducted at another institutio­n,” she said.

Dr. Bhushan Kapur, who started working with Koren at SickKids in the ’90s, said, “At the Olivieri time, SickKids was divided into two parts: there was one section which hated him and the other section that supported him.”

Kapur, who supervised the Motherisk lab from 2009 to 2015, when he left SickKids, said he stuck by Koren because “he’s a very brilliant scientist” and “was a superb sounding board.”

Koren is currently living and working in Israel.

He is listed as a professor in the “big data” team at Maccabitec­h, the business developmen­t arm of the healthcare company Maccabi Group.

He is named on the “faculty/speaker” list of the 4th World Congress on Controvers­ies in Pediatrics, which was held in Amsterdam earlier this spring.

Motherisk’s hair tests came under scrutiny in late 2014, following a Star investigat­ion. At first, SickKids publicly defended the Motherisk lab and supported Koren’s position that the tests were reliable.

In a recent interview, Apkon said that when questions about the hair tests surfaced, the hospital consulted “a variety of internal sources … familiar with lab operations and with lab science.”

“We not only spoke to Dr. Koren,” he said.

Justice Susan Lang, who was appointed by the province to review Motherisk’s hair-strand drug and alcohol tests, concluded in December 2015 that SickKids had failed to provide “meaningful oversight” of the lab, whose hair tests, used in thousands of child protection cases, “fell woefully short” of the standards required of evidence presented in legal cases.

Lang’s review also identified incorrect statements about Motherisk’s hair testing methods in several scientific journal articles co-authored by Koren. One of those journals, Therapeuti­c Drug Monitoring, recently told the Star it is investigat­ing 90 articles that dealt with potential Motherisk data or were published by Koren “in light of ongoing concerns and investigat­ions of Dr. Koren’s work.”

Koren was replaced as head of the Motherisk Program in spring 2015 after the Star raised questions about the failure to disclose financial support from Quebec-based Duchesnay, the maker of Diclectin, in a booklet on the Motherisk website that Koren co-authored, which promoted the use of the morning sickness drug. (SickKids subsequent­ly added disclosure­s.)

The results of an internal hospital investigat­ion confirmed Koren’s undisclose­d conflicts of interest related to Duchesnay, as well as flaws in an influentia­l 1997 meta-study that Koren co-authored on Diclectin.

SickKids also identified a significan­t privacy breach in the Motherisk call centre in which1,400 call records over more than a decade were accessed “for research-related purposes, without first going through our establishe­d process for research approval.”

In an email to the Star, SickKids said it acknowledg­ed “questions regarding Dr. Koren’s relationsh­ip with Duchesnay … may raise concerns for members of the public,” but stressed that drug safety advice dispatched in the call centre “is not solely dependent on Motherisk research.”

Olivieri said it ‘agonizing’ to read about the Motherisk scandal more than 15 years after what she had been through

 ??  ?? Dr. Gideon Koren was head of the Motherisk lab at centre of investigat­ion. ‘HAIR TESTS’ SHUT DOWN
Dr. Gideon Koren was head of the Motherisk lab at centre of investigat­ion. ‘HAIR TESTS’ SHUT DOWN
 ?? CARLOS OSORIO/TORONTO STAR ?? Dr. Nancy Olivieri is the whistleblo­wer doctor who made internatio­nal headlines in the late 1990s when she went up against Dr. Gideon Koren, SickKids, U of T and drug firm Apotex.
CARLOS OSORIO/TORONTO STAR Dr. Nancy Olivieri is the whistleblo­wer doctor who made internatio­nal headlines in the late 1990s when she went up against Dr. Gideon Koren, SickKids, U of T and drug firm Apotex.
 ?? RICK MADONIK/TORONTO STAR FILE PHOTO ?? Gideon Koren retired from SickKids in 2015. He now lives in Israel and works for a health-care company.
RICK MADONIK/TORONTO STAR FILE PHOTO Gideon Koren retired from SickKids in 2015. He now lives in Israel and works for a health-care company.

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