Friday, May 21, 2021

Drug Lab Debacles: (Part Three):The infamous, now defunct 'Motherisk' drug-testing lab at Toronto's Hospital for Sick Children - and the nefarious role played by a once widely-revered researcher named Gideon Koren. Dr. Nancy Olivieri provides her unique perspective in a commentary published recently by The Toronto Star...The deservedly defunct drug-testing lab tore apart families across Canada. But it didn't happen overnight. Dr. Olivieri explains why it was years in the making - and why its uncorrected effects may be felt for a long time.

PUBLISHER'S NOTE: In the Toronto Star recently, Dr. Nancy Olivieri ebbed a remarkable commentary, headed, "Decades after Motherisk wrongful convictions, we've cleared a woman but fixed nothing." As the Toronto Star notes 'Motherisk' is the scandal that tore apart families across Canada. Dr. Olivieri's commentary is invaluable because she explains from her personal experience how the 'Motherisk' scandal was years in the making.  Recently the Toronto Star which played a key role in exposing both  Charles Smith and Gideon Koren, who was at the heart  of the Motherisk debacle,  ran the story of  Joyce Hayman, one of Koren's 'Motherisk' victims, an example of a life "torn apart from Motherisk. A Timeline prepared by Toronto Star Reporter Rachel Mendleson, who did a wonderful job unearthing and reporting  Ms. Hayman's story, sets out clearly the nefarious roles played by 'Motherisk. Koren, and their employer the Hospital for Sick Children.  (This is edited version: The entire Timeline can be read at the link below - followed by Dr. Olivieri's commentary.) 



1985: Dr. Gideon Koren, a clinical pharmacologist and toxicologist, creates the Motherisk Program at Toronto’s Hospital for Sick Children. Within five years, Motherisk becomes a leading resource for pregnant and lactating women and their doctors about the effects of medication, alcohol and street drugs, and opens a research lab.

1999: The focus of the lab evolves from studying drugs in hair to selling its hair-testing services. Motherisk begins marketing the tests to child welfare agencies as a means of quantifying drug use and exposure. The lab would rake in millions of dollars performing hair tests on more than 25,000 individuals across Canada.

2008: The Goudge Inquiry into the mistakes of Sick Kids forensic pathologist Charles Smith that tainted more than a dozen criminal cases exposes the dangers of performing forensic services without proper training. No other departments are audited.

Oct. 14, 2014: The Ontario Court of Appeal overturns the cocaine-related convictions of Toronto mom Tamara Broomfield after expert evidence questions the reliability of Motherisk’s hair tests. Broomfield was convicted in 2009 of feeding her toddler cocaine based in part on Motherisk’s tests of the boy’s hair.

Nov. 2014: The Star publishes stories raising questions about Motherisk’s testing, which is now routinely relied on in child protection cases across the country. For weeks, Sick Kids and the government defend the reliability of the hair tests.

Nov. 26, 2014: The Ontario government appoints retired judge Susan Lang to lead an independent review into the “adequacy and reliability” of hair drug tests performed by Motherisk from 2005 to 2010.

March 5, 2015: Sick Kids suspends “all non-research operations” at Motherisk after learning it had been misled about Motherisk’s proficiency testing. The next month, the lab is shut for good.

April 22, 2015: Lang’s mandate is expanded to cover Motherisk’s hair testing between 2005 to 2015. The province directs Ontario’s children’s aid societies to stop relying on hair testing in child protection cases.

Oct. 15, 2015: Sick Kids CEO Michael Apkon issues a public apology for “unacceptable” practices at Motherisk.

Dec. 17, 2015: Lang’s scathing report on Motherisk finds the lab’s hair tests were “inadequate and unreliable” for use in child protection and criminal proceedings. She concludes that Sick Kids did not provide adequate oversight of Motherisk and failed to learn from the lessons of the scandal involving Charles Smith.

Jan. 15, 2016: Ontario launches an independent review to determine the role Motherisk’s flawed hair tests played in decisions to remove children from their families. Retired judge Judith Beaman is appointed to lead the $10-million Motherisk Commission, which is given a two-year mandate to probe 25 years of individual child protection cases, and provide counseling and legal support to affected families. Ontario’s attorney general identifies and reviews affected criminal cases. 

May 30, 2017: Ontario launches a review of the oversight and accountability of the province’s forensic labs to explore setting mandatory accreditation standards, as well as improving forensic training and increasing transparency.

Feb. 26, 2018: The Motherisk Commission’s final report recommends sweeping changes to Ontario’s child protection system. After reviewing nearly 1,300 cases involving Motherisk’s evidence, the commission concludes that 56 families were “broken apart” by the lab’s flawed hair tests.

Sept. 2018: The Star finds an old news story about the case of Toronto mother Joyce Hayman, who was convicted of feeding her son cocaine in 1998 based on Motherisk’s hair tests. Despite previous efforts by the Ontario government to find affected criminal cases, Hayman’s conviction was missed. The Star tracks down Hayman, who was unaware of the problems at Motherisk. Veteran wrongful conviction lawyer James Lockyer vows to help Hayman clear her name.

Feb. 2019: Koren, who retired from Sick Kids in 2015, agrees to surrender his Ontario medical licence and never reapply in the face of an investigation by the province’s medical watchdog into into whether he committed “professional misconduct or was incompetent” while he was in charge of Motherisk.

April 12, 2021: The Ontario Court of Appeal quashes Hayman’s conviction for feeding her son cocaine and enters an acquittal. The court found Hayman “suffered an egregious miscarriage of justice” and that her conviction was “rooted in the now discredited work” of the former Motherisk lab. The Crown lawyer said Hayman “should not have been convicted.




"Decades after Motherisk wrongful convictions, we've cleared a woman but fixed nothing," by Dr.  Nancy Olivieri,  published by The Toronto Star on May 16, 2021. "Nancy Olivieri, a physician and a professor of pediatrics, medicine and public health sciences at the University of Toronto, graduates this month with an MFA in Creative Nonfiction from the University of King’s College, Halifax and is completing a book about her experiences. A television series about her story is currently in pre-production. The ongoing story is updated at the website and on Twitter: @DrNancyOlivieri.

GIST. I teach a course titled Health and Pharmaceuticals at the University of Toronto. When I first created the course 12 years ago, I joked that I should call it Health Despite Pharmaceuticals. But the course isn’t about health or pharmaceuticals anyway. It is about accountability: in particular, about failures of accountability within the world of health and pharmaceuticals.

In that world, the impact of a failure of accountability is usually immediate. Think, for example, of the painkiller Vioxx.

Its toxicity was concealed in clinical trials; easily approved and widely sold, the drug quickly accelerated the premature deaths of thousands.

Notably,  no researcher who misleadingly reported the safety of Vioxx was held accountable for these deaths; indeed, many ascended to prestigious positions in academia. Some of my students have trouble believing this.) 

But within the world of health and pharmaceuticals, the impacts of some failures of accountability take longer to emerge.

I was reminded of this when I read Rachel Mendleson’s recent account of Joyce Hayman, the mother wrongly convicted and jailed for allegedly feeding her son cocaine. Hayman was the victim of the fraudulent science and unreliable testimony of Dr. Gideon Koren, the titan of Big Pharma research and money who, for three decades, remained at the centre of power at Toronto’s Hospital for Sick Children. After Koren’s misdeeds were exposed, again by the Star, Koren relinquished his medical licence, thereby avoiding a regulatory review of his conduct, and left the country; he continues to enjoy a thriving career

Hayman, on the other hand, saw her children taken from her and at age 30 — without the $3,000 needed to appeal the guilty verdict based upon Koren’s “evidence” — watched her chances at a life in which, as she phrased it, “I could have still made it,” slip away. 

Like most people, I am haunted by the almost unbearable injustices of this story. But I am also personally troubled by its close resemblance to my own contemporaneous experience and that of my colleagues at Sick Kids Hospital, and the University of Toronto. Our struggle, which pales in comparison to Hayman’s, also hinged on the power exercised by Big Pharma over health care institutions. Indeed, Hayman’s tragic fate would not have occurred had my colleagues and I been successful in holding those in authority accountable for their deference to its most famous pharma-funded star researcher. Because Gideon Koren’s infamy did not begin with the Motherisk cocaine hair-testing scandal. 

Briefly, 30 years ago Koren was a co-investigator in my early trials of an experimental drug. As the drug began to show promise, Koren convinced drug company CEO Barry Sherman to supply modest additional funding to those trials, in exchange for worldwide patent rights. When I later raised concernsabout the drug’s safety, Sherman launched legal proceedings to prevent my disclosure of those concerns. Then, in the years Hayman was struggling to clear her name, Koren (with Sherman) spent several years attempting to destroy mine. 

In the mid-1990s, while Ms. Hayman was first accused, and then went to prison, Koren was busy submitting copious files of false information about me to a hospital inquiry. (He was believed; the administration tried, unsuccessfully, to remove my medical licence.) 

Koren’s other creative initiatives included writing anonymous threatening hate mail to my colleagues and the media; his authorship (after months of denial) was dramatically identified through DNA on a stamp he’d licked

I was defended by the courageous efforts of a few colleagues and supported by two faculty associations. Our lawyers worked for years to ensure that Koren was, ultimately, found guilty of gross professional misconduct by the administrations of Sick Kids Hospital and the University of Toronto. But even with those resources — vastly more than Hayman’s — achieving accountability was a losing struggle. The administrations “reprimanded” Koren and forced him to apologize, docked him two months’ pay and a nominal fine, then gave him six months off work (four with pay). With a few honourable exceptions, including the Star, little moral outrage arose: Canada’s “national newspaper” reported that Koren was “irreplaceable.”

This irreplaceable individual next proceeded to appropriate, distort and secretly publish our scientific data to favourably reflect on the drug’s safety. For this, Koren was again found guilty, of research misconduct, only after many more years of struggle by the University of Toronto. And again, accountability proved an elusive goal: then-dean of medicine C. David Naylor, enthusing to university council about Koren’s publication output (“unmatched in the faculty of medicine”) and his “exemplary record,” closed the case without ensuring that the offending paper was retracted. (It was only retracted 17 years later.)

End of story.

Well, not quite the end.

Over the next 15 years, Koren travelled the world advising on (what else?) drug safety. He was provided with many awards, most importantly The Richard Ivey Chair in Molecular Toxicology, through which Koren was billed as bringing, “international recognition and prestige,” to Western University, and from which he published one paper every two weeks. Every two weeks. This phenomenal rate of publication should have raised some red flags, but didn’t. That is, until the Toronto Star identified “possible” problems in more than 400 of Koren’s papers prompting an announcement – two-and-a-half years ago – of an internal review of the questionable publications, including a paper apparently related to Hayman – years too late to avoid the loss of her children and her conviction. 

How many others were harmed by research and ethical misconduct within Koren’s “vast body of work”? Full accountability on this, too, is awaited.

I wish I could recall how often international colleagues asked me about this ethical mess. Nonplussed, many would exclaim: “You mean he wasn’t fired?” Indeed, Koren wasn’t fired, or held accountable. Most importantly, all those years, he kept control of Motherisk, the pulpit from which he destroyed many families, until the program was shut down in April 2015.

In apologizing to Joyce Hayman, the court called her conviction “a faulty criminal process.” Yes, it was that. But it was more. A tragic story. But not just a “bad apple” narrative. More accurately it should be titled “Repeated Failures of Institutional Accountability.” Had we succeeded in our efforts to convince powerful administrators to hold Koren properly accountable, he would not have been able to blight the lives of innocent people. We did everything we could. It wasn’t enough, for Hayman or for the other victims of Motherisk.

An old story? Not to any of the Motherisk victims. But the lessons of Hayman’s wrongful conviction also parallel the many failures of accountability during COVID. The unnecessary third wave. The deaths that did not have to happen. Everything, ultimately, can be traced to the failure of those in authority to understand that the exercise of power, without wisdom and integrity, betrays society. Inevitably, the greatest price is paid by the most vulnerable.

And there is another is another reason that this story remains relevant today. Today, many of Koren’s enablers, unsurprisingly, remain in leadership positions. Thomas Paine would have recognized them: “a body of men holding themselves accountable to nobody (who) ought not to be trusted by anybody.” 

Maybe, just maybe, it’s time for some of them, with some of our political leaders, to enrol in my Health and Pharmaceuticals course. There, they might begin to understand the lesson of Joyce Hayman’s tragedy: that failures of accountability are, in many ways, as lethal as any virus."

The entire Commentary can be read at:

PUBLISHER'S NOTE: I am monitoring this case/issue. 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: Information on "The Charles Smith Blog Award"- and its nomination process - can be found at: Please send any comments or information on other cases and issues of interest to the readers of this blog to:  Harold Levy: Publisher: The Charles Smith Blog;

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;
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;