Don’t allow cannabis edibles that look like candy, medical officer of health says

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Cannabis products made in shapes that appeal to children — such as gummy bears or lollipops — should be banned when the sale of edibles becomes legal later this year, Toronto’s medical officer of health says.

The city’s board of health should also urge the federal government to ban cannabis vaping liquids that are offered in “youth-friendly” flavours that mimic candy or soft drinks, Dr. Eileen de Villa said Friday.

“One of the major objectives of the legislation is to actually protect health and, in particular, to protect youth from the potential harmful effects associated with cannabis,” de Villa said.

“We feel the best thing to do in terms of protecting youth, is to avoid having these edible products in a gummy bear, lollipop or other shapes that might be appealing to youth.”

De Villa added that there’s a need for clearly defined labelling, which includes both dosing information and warnings about the risks of combining cannabis edibles with alcohol or highly caffeinated drinks.

Consultations on those amendments are set to end next week.

Villa also supports on how much THC — the primary active component of cannabis — is available in one-time-use vaping devices, and would like them to include a mechanism that limits the maximum quantity inhaled in a single puff.

“The federal regulations already have quite a bit in this regard,” she said.

Industry consultant Mitchell Osak commended Toronto Public Health for what he deemed a list of prudent suggestions ahead of the products becoming legal.

“The recommendations are consistent with the federal government’s objective around safe and responsible usage and protection of youth,” said Osak, a managing director of business consulting and technology services at Grant Thornton LLP, who advises companies in the Canadian cannabis industry including licensed producers, investors and governments.

Despite their illegal status, edible cannabis products are currently being sold at stores throughout Toronto.

A spokesperson for one dispensary visited by the Star this week said its customers are being given “childproof” bags to prevent youngsters from accidentally eating cannabis products that come in the form of a candy or a cookie.

That doesn’t go far enough, says Osak, who believes that restricting the colour and design of the products is the right approach.

During a visit to a Cannabis and Fine Edibles (C.A.F.E.) location on Harbord St. this week, the Star observed a wide array of edibles ranging in potency from 55 to 300 milligrams of THC.

All of them exceeded the government’s proposed limit of 10 milligrams, which Osak described as “a little too cautious.” He’s concerned that such low levels of THC will push customers towards the black market.

Information labels on products sold at C.A.F.E caution users to start with a small portion in order to determine one’s tolerance level.

C.A.F.E. spokesperson David Thompson said “childproof” bags and information on packaging are some of the ways the underground cannabis retailer — which has several locations across the city — is trying to improve safety for customers.

“We make sure to try to place our edible dosing guidelines on each and every package that leaves the store,” Thompson said, adding, “We believe Health Canada’s position to begin at ultralow dose concentrations is warranted.”

He said C.A.F.E. is advising edible producers to read the regulations that are being discussed and to begin implementing the recommendations.

“Health Canada has to be a beacon and a responsible steward to affect change over time,” he said. “We do not see any of this as a problem.”

Jason Miller is a breaking news reporter based in Toronto. Reach him on email: jasonmiller@thestar.ca

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‘We’re holding up a floodgate’: B.C. fights off superbugs brought home by medical tourists

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The risks involved in medical tourism aren’t just personal. Having surgery abroad could also mean bringing back a drug-resistant superbug and putting people in this country at risk, B.C. officials warn.

That alert comes after the recent discovery that two patients at New Westminster’s Royal Columbian Hospital had been colonized with the multidrug-resistant yeast Candida auris. Though neither patient is infected with the bug, the two join just a handful of cases that have been identified in B.C. since 2017.

Dr. Linda Hoang, medical co-director for the Provincial Infection Control Network (PICNet), said most of these cases have come from travellers who have had treatment overseas, including medical tourists.

It means patients need to do serious research on the facilities they’re considering for surgeries or other treatments abroad, including looking for objective information about the presence of any drug-resistant microorganisms.

« It’s not only a problem in India or Southeast Asia. It is endemic in parts of the U.S. and parts of Europe, » Hoang told CBC News.

« It [antibiotic-resistant superbugs] is a global problem, and the only way to to be aware of them is to make sure that health-care professionals are informed and our residents are informed when they’re seeking health care outside of British Columbia. »

It’s a sobering reminder for those who travel abroad for medical treatments, whether it’s to skip the surgery wait list in B.C., access therapies that aren’t approved in Canada or save money on cosmetic therapy. Some of the top destinations for medical tourists from around the world include India, Mexico, Southeast Asia, Brazil and Turkey, according to the Medical Tourism Association.

But facilities in other countries can sometimes take a more haphazard approach to prescribing antibiotics, and overuse can trigger the evolution of resistance to these crucial drugs.

India a major source of bug

The two colonized patients at Royal Columbian were isolated after the bug was discovered, and the hospital has been aggressively cleaning all areas they had visited, using UV light for disinfection, according to Fraser Health.

C. auris was first identified in Japan in 2009, but it has popped up since then in countries around the world.

It acts much like any other yeast species, causing infections in wounds, the bloodstream and the ears, but the real problem is how to treat it.

« The only real reason why we’re concerned or interested in monitoring Candida auris is because of that potential resistance profile, making it difficult to treat with the anti-fungal agent that we have, » Hoang said.

The biggest risk of infection right now seems to come from Indian facilities, Hoang said.

A microscopic image, at left, shows Candida auris cells. At right is a culture of the yeast in a petri dish. (The Journal of Infection in Developing Countries)

The bug was confirmed for the first time in B.C. in July 2017 in a patient who’d been treated in India. As it turned out, that traveller also came back with infections from multiple other drug-resistant organisms.

B.C. doesn’t track whether infected people travelled abroad as medical tourists or simply required medical treatment because of an emergency during their voyages.

But patients who have had medical treatment outside B.C. for any reason are a major source of these superbugs, she said.

They include so-called CPOs — carbapenemase-producing organisms like Klebsiella, E. coli and Pseudomonas that have become resistant to broad-spectrum antibiotics, which Hoang describes as the « last resort » for treatment.

In 2017-2018, PICNet recorded more CPO cases than ever before, and more than half of them were from people who had accessed health care overseas, Hoang said.

‘There’s only so much we can do’

The key for anyone who chooses to have surgery abroad —​ and anyone who needs medical attention while travelling —​ is to let your B.C. doctor know when you return. That way, the doctor can check you for any drug-resistant bugs you may have picked up and give you the appropriate medication if you get sick.

Being open with that information protects everyone around you.

« If you require health care in British Columbia, you are running the risk of spreading that into our facilities. And that’s not a good thing for your neighbouring patients, who might be very sick and vulnerable, » Hoang said.

She said B.C. is aggressively monitoring returning travellers for drug-resistant superbugs, but the real key to stopping their spread will be eliminating the excessive use of antibiotics that allows these micro-organisms to evolve resistance.

« We’re basically holding up a floodgate, and unless the problems are addressed in these countries where antibiotics are used with minimal regulation and control, there’s only so much we can do, » Hoang said.

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Medical journal corrects two flawed articles by Dr. Gideon Koren

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A medical journal that for more than 20 years published advice about drug safety for pregnant women has issued a rare correction related to two questionable articles by the column’s lead author.

Canadian Family Physician (CFP), the official journal of the College of Family Physicians of Canada, published the correction in its January 2019 edition outlining concerns with the articles co-authored by Dr. Gideon Koren, former head of the SickKids’ Motherisk program and director of its discredited lab.

Former head of Motherisk program under investigation by medical regulator

The 177-word correction comes after a Star investigation that exposed flaws in medical publishing, including the inability and unwillingness of journals and research institutions to correct and preserve the integrity of the scientific record.

Corrections, the Star found, routinely take years to be published, if they happen at all.

The Star investigation prompted the Hospital for Sick Children to announce in December it will conduct a wholesale review of Koren’s vast body of work. In its review of 1,400 articles co-authored by Koren over 30 years, the Star identified what appear to be problems in more than 400 of his papers, including nearly 200 published in Canadian Family Physician.

The problems include inadequate peer review, failures to declare, perhaps even obscure, conflicts of interest and, in a handful of cases, lies about the methodology used to test hair for drugs. We identified just 18 instances in the 400 studies flagged by the Star where it appears journals have taken action, in the form of a correction or clarification.

The two articles being corrected by CFP, Nausea and vomiting of pregnancy. Evidence-based treatment algorithm and Treatment of nausea and vomiting in pregnancy. An updated algorithm, were not properly peer-reviewed, according to the correction, and failed to disclose a conflict of interest.

The correction also said the articles “did not provide satisfactory evidence that would have justified the recommendation” to prescribe Diclectin, a combination of antihistamine and vitamin B6, as a first-line of defence.

That recommendation was among the guidelines to treat morning sickness that were developed by Motherisk and endorsed and published by The Society of Obstetricians and Gynaecologists of Canada.

The journal withdrew its endorsement of the guideline in 2017, acknowledging in an editorial that it hadn’t subjected these regular articles to double-blind, peer reviews because of its “long-standing relationship with Motherisk.” The journal published regular articles under the title “Motherisk Update” from 1995 to 2016.

Until now, the two articles stood uncorrected in the literature.

Dr. Nav Persaud, a researcher and family physician at St. Michael’s Hospital, who co-authored a paper five years ago that questioned the recommendations in these two articles, said the medical profession in Canada has failed pregnant women with nausea and vomiting during pregnancy by issuing and recommending the faulty guideline. He said the two papers are not reliable and should be removed from the literature.

“I hope that this is a temporary measure on the road to doing what needs to be done,” Persaud said. “The fact that this is the second time that Canadian Family Physician has addressed this issue indicates that they should deal with it definitively.”

Visitors to each of the articles, which are still published on CFP’s website, are met with a note directing them to the correction. The correction guides them to a 2017 commentary written by Dr. Nick Pimlott, CFP’s scientific editor, that describes several concerns the journal had found with Koren’s work.

Neither Koren nor his lawyers responded to the Star’s request for comment.

Pimlott told the Star that the journal’s Editorial Advisory Board decided several months ago that these two articles did not meet criteria for retraction which he said is “commonly defined as conclusive evidence of scientific fraud or misconduct.”

“The Board felt that it would be important to provide clarification of the issue for CFP readers,” he said. “For this reason, a decision was made by the (board) to publish a correction.”

CFP’s correction says that for the two articles there was an undisclosed conflict of interest with Duchesnay, the manufacturer of Diclectin.

The articles, published in 2002 and 2007, were among 270 articles that the Star found referenced, in some way, “The Research Leadership for Better Pharmacotherapy during Pregnancy and Lactation.” This was not an actual fund, SickKids has said, but a name Koren created to describe “unrestricted funding he had available at different points in time.”

In 2015, SickKids said that the primary donor in the years leading up to the Motherisk scandal was Duchesnay. The hospital has said that in some cases where Koren used the “Research Leadership” name, he did not acknowledge funding from that drug company.

Persaud and co-authors had re-analyzed a 1997 Koren paper that underpinned his views of Diclectin and led to the guideline to prescribe the drug.

SickKids has confirmed some of Persaud’s findings, including that Koren’s 1997 paper overstated the number of subjects involved in that study. SickKids also said that an independent reviewer, hired by the hospital to assess the paper, concluded that its claim that the antihistamines in Diclectin have a protective effect against major malformations was not supported by the data. Antihistamines, the reviewer concluded, are neither protective nor harmful.

Pimlott said CFP is reviewing all Motherisk articles it has published.

Michele Henry is a Toronto-based investigative reporter. Follow her on Twitter: @michelehenry

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‘I scared them off’: Woman, 83, uses medical alert device to call for help after break-in

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An 83-year-old Oxford, N.S., woman who used the medical alert device she wears around her neck to call for help after men broke into her home says she scared off the home invaders.

Willena Payne was asleep on Dec. 9 when she was woken up by a loud bang around 1:30 a.m. She heard male voices going down into the basement of her home, and then coming upstairs toward her bedroom door.

« And this man was standing in the door into my bedroom and I just looked down and I said, ‘And who are you?’ And he just whirled around and started hollering, ‘Go, go, go, go, go!’ And you could hear footprints running and they disappeared, » Payne told CBC News.

Payne said at first, she wasn’t sure if she was dreaming. She went out to the porch and turned every light on and saw her back door was wide open.

It was then Payne realized someone had broken into her home. She tried calling a relative, but because it was so late, no one picked up.

After home invaders broke into her home late one night in December, it was too dark for Willena Payne to see the phone to call police. She said her medical alert device helped get help to her house fast. (Eric Woolliscroft/CBC)

« And so I thought, I got to call the RCMP. But then I couldn’t see the phone, 911 — I couldn’t see it on the phone … and I thought, oh, my Lifeline and I pressed that button, » Payne said, gesturing to her medical alert device.

« And I was standing right beside the phone when I pressed it. And she called me, the [dispatcher], and she said, ‘Are you all right? Do you need help?’ I said, ‘I’m all right, but somebody just broke into my house.’ And of course by then my voice was getting all shaky and weak. »

RCMP Cpl. Jennifer Clarke said police arrived within 10 or 15 minutes and checked the home.

Payne said she wasn’t sure how many people were inside because she wasn’t able to see them, but said there were at least two and their voices were male. 

« I scared them off, scared them to death I think because he just whirled around and started running and all I could hear were these footsteps running and they went out the door, » Payne said.

RCMP find tracks

In the snow outside, police saw tire tracks leaving the woman’s home. Later that day, during patrols in the area, they saw the same tire tracks pulling in and out of several other driveways. There was also a break and enter reported.

« It’s pretty clear what the intent of these individuals was, however this particular lady, I don’t believe the suspects realized that she was home and I don’t think they would have tried to get into her home if they knew she was there, » said Clarke. « At any rate, she’s very lucky.

« I’ve never heard of someone using a medic alert device to contact 911 before, but in this person’s case it was absolutely the best thing for her to do. »

The RCMP are still investigating and Clarke said they hope people will come forward with information.

Payne said her son told her later she was lucky she didn’t get hurt. She said she never even considered that possibility.

« I just hope nobody ever has to go through it and I just hope … the people that are running around breaking into places could please think of the people that are living there. »

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Ryane Clowe steps down as Growlers coach ‘due to medical reasons’

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Ryane Clowe was forced to leave his playing days behind in 2015 after doctors told him he shouldn’t play hockey again.

Now, the pride of Fermeuse, N.L., has stepped away from his duties as head coach of the East Coast Hockey League’s Newfoundland Growlers « due to medical reasons. »

It’s believed those reasons are linked to Clowe’s concussion history, which has caused him to miss several games this season.

« I’d like to thank the Toronto Maple Leafs for the opportunity to become the first head coach in Newfoundland Growlers history, » said Clowe in a news release.

« As a St. John’s native, I was extremely honoured and proud to have held this position but my health is first priority for both my family and I. »

Clowe reportedly suffered four concussions during his NHL playing days, with the last being on Nov. 6, 2014. He was in the second season of a five-year contract worth more than $24 million with the New Jersey Devils.

He took over as an assistant coach with the Devils in 2016, spending two seasons behind the bench before moving back home to Newfoundland as the Growlers kicked off operations in St. John’s.

According to the team, Clowe will stay on with the Leafs organization in some capacity.

Former Devils forward Ryane Clowe was forced to retire following multiple concussions. He spent parts of 11 seasons in the NHL with the San Jose Sharks, New York Rangers and New Jersey Devils. (Al Bello/Getty Images/File)

Clowe was dogged by medical issues since the season began, missing a long stretch of games throughout November.

The Growlers have thrived this season, both under Clowe and assistant coach John Snowden and currently sits third in the ECHL standings.

Snowden will take over as head coach for the remainder of the season.

Read more articles from CBC Newfoundland and Labrador

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Inside the flawed world of medical publishing that allowed a lie in a paper coauthored by Dr. Gideon Koren to pollute the scientific record

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In January 2000, a paper was published in a respected academic journal that trumpeted the successes of a Canadian lab in a burgeoning area of drug testing.

The researchers who wrote the paper claimed they had analyzed strands of hair to trace long-term exposure to illicit drugs, such as cocaine, and used gold-standard testing to verify its results.

Dr. Gideon Koren is one of Canada’s most prolific scientific authors. The Star’s review of more than 1,400 papers co-written by Koren over 30 years reveals the inability — and unwillingness — of journals and research institutions to preserve the integrity of the scientific record.
Dr. Gideon Koren is one of Canada’s most prolific scientific authors. The Star’s review of more than 1,400 papers co-written by Koren over 30 years reveals the inability — and unwillingness — of journals and research institutions to preserve the integrity of the scientific record.  (Toronto Star)

What everyone failed to notice — from the medical institution where the lab was housed to the federal agency that funded the study to the journal that published the article — was that the gold-standard claim was a lie.

In fact, Dr. Gideon Koren’s Motherisk lab at The Hospital for Sick Children rarely confirmed its results with gold-standard testing before 2010.

That lie was exposed in 2015, amid a scandal that tore apart vulnerable families and prompted two government-commissioned inquiries, which found Motherisk made millions selling its hair tests for use in criminal and child-protection cases despite the fact that it often failed to verify its preliminary results. This was contrary to international forensic standards for evidence presented in court.

The paper has been cited 54 times, as recently as May 2017. The journal told the Star this week that it will be “looking into these issues.”

Citations — when other researchers cite the study as a reference in their published work — is an indication of its influence.

A researcher’s publication record is the currency of modern-day science. It is the pre-requisite to securing competitive tenure-track positions at prestigious universities, the key to unlocking funding and the measure by which research institutions are assessed.

But it is a moment of reckoning for medical publishing. Last week, SickKids, which housed the Motherisk lab, announced it will undertake a wholesale review of Koren’s vast body of published work, after the Star presented the hospital with findings from this investigation that identified what appear to be problems in more than 400 of Koren’s papers, including the Jan. 2000 hair-testing article, collectively cited more than 6,000 times.

These papers appeared problematic because they have been inadequately peer-reviewed, failed to declare, and perhaps even obscure, conflicts of interest, and, in a handful of cases, contain lies about the methodology used to test hair for drugs.

We identified just 18 instances in the 400 studies flagged by the Star where it appears journals have taken action, in the form of a correction or clarification.

The Hospital for Sick Children announced last week it will undertake a wholesale review of Gideon Koren's vast body of published work.
The Hospital for Sick Children announced last week it will undertake a wholesale review of Gideon Koren’s vast body of published work.  (Richard Lautens / Toronto Star File)

Sick Kids’ announcement follows a similar cases in the U.S. There, a research misconduct scandal recently prompted the resignation of Dr. Jose Baselga, the former chief medical officer of Memorial Sloan Kettering Cancer Centre in New York City, after a New York Times-ProPublica investigation found he failed to disclose payments from healthcare companies. Elsewhere, Ohio State University cancer scientist Ching-Shih Chen resigned after he was found to have falsified data.

The Star’s review of more than 1,400 papers co-written over 30 years by Koren, one of Canada’s most prolific scientific authors, reveals the inability — and unwillingness — of journals and research institutions to preserve the integrity of the scientific record.

Several concerns about Koren’s research were identified in 2015 by a SickKids internal review. The hospital posted a summary of its findings on its website, and told the Star it sent a copy to the province’s medical watchdog, which is investigating Koren.

The Star’s investigation has found the system of medical publishing is one with little accountability, where the onus is on authors to voluntarily disclose conflicts of interest. Journals don’t vet these claims (or the authors who make them). Institutions have discretion to investigate allegations of misconduct as they see fit.

Corrections, if they happen at all, routinely take years to be published.

The Star’s findings are consistent with the systemic problems that have been identified by Retraction Watch, a pioneering organization with an online database of retractions and corrections.

Founded in 2010, the organization began collecting retractions, by searching journals online and in print, and, by the time the database went live in October 2018, it had amassed more than 18,000 retractions. This made it the most extensive catalogue of such notices available, says the site’s co-founder, Ivan Oransky, a doctor, journalist and professor at New York University.

Despite the commonly held belief in the power of peer-review and the ability of academic publishing to root out cases of misconduct and fraud, Oransky describes “the vaunted self-correction mechanism of science” as one that is “held together by spit and bubble gum.”

From the institutions who rely on researchers to bring in grant money to the journals and authors whose reputations and careers are at stake, “at every stage the incentives are against doing the right thing,” he said.

“I don’t know if the barrel is totally rotten, but there are a lot more rotten apples in the barrel than people would like us to admit.”

Koren, who retired from SickKids in June 2015, has continued to publish since his departure. Neither he nor his lawyers responded to emails and phone calls seeking comment for this story.

Koren, who now lives in Israel, had been working as a senior researcher for Maccabi Health, a healthcare provider. In late October, Physicians for Human Rights Israel, a medical ethics’ watchdog, wrote to Maccabi Health with concerns that Maccabi may not know about Koren’s role in two SickKids controversies, including the Motherisk scandal. On Dec. 5, Maccabi, in a letter obtained by the Star, wrote back saying it had appointed a committee to “examine the role of Professor Koren in these incidents.”

Israel Hayom, a national newspaper, reported on Dec. 18, that Maccabi Health said Koren will be on leave until the end of the investigation. Haaretz, another Israeli newspaper reported that day that Koren defended the Motherisk lab by saying it was clinical, not forensic, and “won praise.” He said, according to the newspaper, that claims of biased or misleading research were outright libel.

SickKids said last week that it is “regrettable” that an audit of Koren’s work had not been conducted sooner and that there should have been “closer oversight of his disclosure and publication practices.”

In the 30 years he spent at the helm of Motherisk, Koren’s staggering publication record helped make the program the foremost source of advice for generations of pregnant women and their doctors. He held editorial positions at more than 15 academic journals, attracted more than $29 million in grants from public and private sources, won prestigious awards and supervised up to a dozen graduate students per year, the Star found.

The institutions and journals that benefited now face possible problems in hundreds of papers in a case that reveals problems ailing the system of academic publishing, and provides a prescription for much-needed improvement.

***

The Star’s findings were in many ways foretold 15 years ago, when the University of Toronto’s dean of medicine tried — and failed — to get a journal to retract one of Koren’s papers.

In April 2002, at a faculty council meeting, Dr. David Naylor, who is now interim CEO at SickKids, recorded a finding of research misconduct against Koren related to a 1999 study published in the journal Therapeutic Drug Monitoring.

The public chastisement was intended as a coda to Koren’s dispute with Dr. Nancy Olivieri, a blood diseases specialist at Sick Kids who, like Koren, held cross-appointments at U of T. Tensions boiled over while the pair was running a clinical trial with partial funding from the Canadian generic drug-maker Apotex. Olivieri voiced concerns about the efficacy of the drug, which Koren did not share.

Dr. Nancy Olivieri, a blood diseases specialist at SickKids who also held cross-appointments at U of T, was the subject of disparaging "poison pen letters" that DNA testing eventually proved were written by Koren.
Dr. Nancy Olivieri, a blood diseases specialist at SickKids who also held cross-appointments at U of T, was the subject of disparaging « poison pen letters » that DNA testing eventually proved were written by Koren.  (Carlos Osorio / Toronto Star File)

In 2000, the heads of SickKids and U of T suspended and fined Koren, who was also stripped of an endowed chair for “repeatedly lying” and sending anonymous “poison pen letters” to doctors and the media disparaging Olivieri and her supporters. He denied writing the letters until DNA evidence provided irrefutable proof.

A committee formed by the U of T Faculty of Medicine found that Koren had published the 1999 paper without consulting the other researchers, failed to disclose Apotex’s support for the trial, and had not discussed the safety concerns about the drug.

“I sincerely hope that resolution of this … brings the entire episode to an end,” Naylor told the faculty council in 2002, according to the meeting minutes.

Naylor said that he insisted Koren write to the journal to acknowledge his error and request the article be deleted from the scientific record. “He has done so, and also sent appropriate personal letters of apology,” Naylor said, according to the minutes of the faculty council meeting. “I consider the matter closed.”

The article was never withdrawn.

An erratum was published in April 2004, stating that “the specific industry sponsor, Apotex Inc., of Weston, Ontario, was not mentioned.”

Koren’s failure to consult with his co-researchers and discuss the safety concerns, were not addressed in this correction.

In response to questions from the Star for this story, Naylor said Koren contacted the editor, Dr. Steven Soldin, within weeks of being notified of Naylor’s decision.

Naylor said Soldin was made aware of the “inappropriate use of shared data” and the “non-disclosure issue,” but that Soldin declined to retract the article.

Soldin, who is now a senior scientist at the National Institutes of Health Research in Maryland, told the Star he doesn’t recall a conversation with Koren about the paper after it was published and said he was never contacted by any official from U of T.

“If the Toronto academic faculty felt strongly about something, they should definitely have spoken with me,” he said. “It’s got to be a serious conversation, or it’s not going to be taken seriously.”

The matter was still outstanding when, in early 2004, Koren became North American editor of Therapeutic Drug Monitoring, based in part on the recommendation of his predecessor, Soldin.

In February 2004, Naylor wrote to Olivieri with an update. In that correspondance, obtained by the Star, Naylor said he wrote a letter urging retraction of the 1999 article, and, “as agreed,” Koren passed it to the publisher. In a recent email to the Star, Naylor said that he reached out to the publisher who rejected his request.

The current journal editor, Dr. Uwe Christians, said he “cannot comment further on the matter,” but, in general, “the journal editor and editorial board have full editorial independence; the publisher is not involved in editorial decisions.”

Arthur Schafer, founding director of the University of Manitoba’s Centre for Professional and Applied Ethics, said Koren should have been fired for his conduct in the Olivieri affair. That U of T and SickKids allowed him to continue publishing after his proven research misconduct, apparently without adequate oversight and supervision, is “astonishing,” he said.

Naylor, speaking in his capacity as U of T’s former dean of medicine, said 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.”

“(Third) parties gave critical and wide public airing of Dr. Koren’s disclosure misconduct during and after these proceedings,” he said, referring to U of T’s investigation into the research misconduct allegations. “(His) aberrant conduct apparently continued regardless …. He was evidently impervious to discipline or criticism.”

A spokesperson for SickKids said that the issue surrounding the 1999 paper, “was addressed many years ago by the University of Toronto and the Hospital has no further comment.”

***

In his recent book, Doctors in Denial: Why Big Pharma and the Canadian Medical Profession are Too Close for Comfort, Dr. Joel Lexchin, a health policy expert at York University, writes that since the ’90s, pharma money has increasingly flowed to scientists who are regarded as having a favourable view of a company’s products and could be a willing, positive ambassador at conferences and dinners with colleagues.

Doctors who receive money from pharmaceutical companies “are almost uniformly resolute that they are promoting the product because they believe in its effectiveness and that they are independent and able to say what they believe,” Lexchin writes. He adds that “they sometimes indulge in self-censorship to avoid the risk of losing funding for research and attendance at conferences.”

In the U.S., federal law requires drug companies to disclose payments to doctors.

No such law exists in Canada.

Legislation, passed by Ontario’s former Liberal government last year to make these disclosures mandatory, has yet to be proclaimed by the new Tory government.

Dr. Andrew Boozary, an assistant professor at U of T and the co-founder of Open Pharma, a leading advocate for pharmaceutical payment transparency, said that there is no universal standard for disclosing conflicts of interest, ties to industry or anything else that could be seen to bias academic publishing.

When submitting a manuscript, authors are often asked to complete an online form that asks a simple “yes” or “no” question: “Are there any relevant conflicts of interest?”

Journal editors told the Star they rely on authors to be honest.

Koren has acknowledged in published papers and on one version of his C.V. that about 10 drug companies, including Pfizer, Duchesnay and Apotex, have provided him with money.

The Star found nearly 300 papers that contain concerns related to undisclosed, or possibly obscured, conflicts of interest. That includes roughly 30 papers that discuss morning sickness or Diclectin, the only medication approved by Health Canada to treat this condition, and do not acknowledge Koren’s long-term support from Duchesnay, the Quebec-based maker of the drug. Duchesnay provided funding to Koren beginning in 1994, according to his C.V.

Of the nearly 300 papers, about 270 cite “The Research Leadership for Better Pharmacotherapy During Pregnancy and Lactation.” SickKids, following its internal probe of Motherisk in 2015, said Koren created this name to refer to funds donated “by a variety of individuals and organizations.” In the years leading up to the Motherisk scandal, the primary donor was Duchesnay, the hospital said, and, in some cases where Koren used the “Research Leadership” name, he did not acknowledge funding from that drug company.

The Star requested a complete list of donors and the amount of money provided, but SickKids said this is “not possible,” because this was “not an actual fund set up at the hospital.”

In a statement, a spokesperson for Duchesnay confirmed the company “terminated its partnership with/and funding of” SickKids and Motherisk in 2015, but said “it is not our policy to announce the specific amounts it pays or has paid to Canadian health professionals for various consultations, speaker and research services.”

None of the other drug companies provided to the Star the amount or details of the funding to Koren or Motherisk.

Thomas Knudsen is editor-in-chief of the journal Reproductive Toxicology, which has published 13 papers co-written by Koren that the Star deemed problematic, because they relate to hair-testing, cite the Research Leadership name or discuss morning sickness or Diclectin without acknowledging support from Duchesnay.

Knudsen said that his editorial staff does not generally investigate conflict-of-interest disclosures. Peer reviewers are “not going to do a Google search” of the author, Knudsen said; their job is to review the science. Without a whistleblower or a note from a researcher’s institution, he asked, how was he supposed to know who or what to look into?

“We are not police officers,” he said.

“That’s up to the university.”

The journal published two more of Koren’s articles this year. A third was stopped by reviewers with concerns about the study design and conclusions. Knudsen recently rejected this study. He said that information provided by the Star about the findings of the news organization’s investigation into Koren’s papers, and the problems at Motherisk “made it easier” to render the “unfavourable” decision.

***

SickKids vowed to communicate the results of its recently announced review to “all involved journals.” This could prove a monumental task. The more than 400 papers identified by the Star as containing possible problems were published in roughly 75 journals and co-authored by more than 450 doctors, nurses and academics.

In these cases, publications can be slow to act, if they do at all, said Oransky of Retraction Watch.

Retractions, the most severe form of punishment a journal takes, are rare.

Corrections, known as “errata” or “corrigenda,” are more common.

But they can take years to materialize, are difficult to find and tend to be opaque.

In a search of three online scientific article databases, the Star found corrections related to 18 of the more than 400 articles we flagged.

Most are not appended to the online versions of the original articles.

The problems in the system were evident in our search for corrections related to five hair-testing papers that retired judge Susan Lang identified in her 2015 report on Motherisk as containing lies about using the gold-standard testing to confirm results.

Justice Susan Lang, the retired Ontario judge who conducted the independent review of the Motherisk lab, identified five hair-testing papers in her 2015 report as containing lies about using the gold-standard testing to confirm results.
Justice Susan Lang, the retired Ontario judge who conducted the independent review of the Motherisk lab, identified five hair-testing papers in her 2015 report as containing lies about using the gold-standard testing to confirm results.  (Bernard Weil / Toronto Star File)

In her report, Lang said that Koren told her that he had sent erratum letters to the affected journals explaining the inaccuracies in these articles.

SickKids reiterated Koren’s claim in the press release last week.

Three years later, the Star’s online search found corrections related to two of those articles: an erratum related to a 2007 article published in Therapeutic Drug Monitoring, and a corrigendum related to a 2009 article published in Forensic Science International.

When asked why Forensic Science International did not publish a correction related to the 2000 paper discussed at the beginning of this story, the editor, Dr. Christian Jackowski said “no further corrigendum/erratum was published or provided by the author.”

The editor of a third journal, on request, sent the Star the corrigendum that was published in relation to a 2007 article.

None of these notices mentioned that the Motherisk lab has been discredited.

They claim that, despite the fact that results were not confirmed with gold-standard testing, this did not affect results.

Dr. Ronald Cohn, SickKids pediatrician-in-chief, took issue with Koren’s assertion that the gold-standard lie “had no impact on the results” of the study.

That prompted Therapeutic Drug Monitoring, one of the journals, to also issue an “expression of concern,” a stronger statement, about one of the articles.

Jackowski, the editor of Forensic Science International, said he told a SickKids official that he would additionally publish a letter to the editor stating the hospital’s position. But it was never submitted, he told the Star. SickKids told the Star it did send the letter, but would reach out to the journal again to clear up any misunderstanding.

Meanwhile, Dr. Togas Tulandi, the editor of Elsevier’s Journal of Obstetrics and Gynaecology Canada, which published an opinion piece by Koren in 2017, said that he was unaware of Koren’s research misconduct until he was contacted by the Star. He said his associate is “looking into it” and the journal may “withdraw (Koren’s) article.”

Therapeutic Drug Monitoring, which Koren edited until 2015, has recently taken the most aggressive approach of any journal towards Koren’s articles; Christians said the current president of the society that runs the journal asked Koren to step down as editor after he learned of the Motherisk scandal. Koren “accepted the termination without question,” he said.

In 2017, the journal reviewed all of the roughly 90 articles Koren co-authored, and sent 19 to independent reviewers for additional scrutiny. In seven, the reviewers recommended action, such as requesting proof of confirmation testing and ethics-board approval from the authors.

Christians said that the follow-up on these actions was delayed by the transition to a new editor, but that it “is now being prioritized.”

Following the Star’s inquiries, Christians said he is now considering retracting the 1999 paper that resulted in the research misconduct finding against Koren.

***

Naylor said Koren’s case is an “ugly and outsized” example of the systemic problems with conflicts of interest and protecting the scientific record.

The “only way to move forward,” he said, is for institutions to keep better tabs on researchers’ financial relationships, ensure the penalties for not disclosing are clear and collaborate with journal editors to “work out a more explicit system” to share information and “oversight of the processes for correcting the scientific record.”

Naylor said it would be “a huge help if all industry payments made directly to physicians were simply disclosed publicly by the payers.”

Koren continues to submit manuscripts to journals to be considered for publication.

He published a study in August about a severe form of morning sickness. The paper acknowledges he is “a consultant for Duchesnay.”

In September, Koren was singled out among the world’s “hyperprofilic” authors in an article in Nature. These were researchers who wrote more than 72 papers in any year from 2000 to 2016 — roughly one paper every five days — which, the study authors noted, “many would consider implausibly prolific.”

Lead author, Stanford University professor John Ioannidis, said the study is an attempt to understand hyper-prolific authorship, for better or worse.

Koren responded to a request from the study authors to comment on his output. He credited teamwork, 16-hour work days, and two “very supportive work environments.”

“I perceive myself as an individual who is highly committed to scientific discovery,” he said. “I do not feel I have to apologize for my high productivity.”

With files from Tania Pereira, May Warren, Stefanie Marotta, Jason Miller and Brendan Kennedy.Ryerson note: The Star’s investigation into Koren’s publications was conducted in partnership with Ryerson University School of Journalism students Stefanie Phillips, Emerald Bensadoun, Kate Skelly and Alanna Rizza.

Rachel Mendleson is a Toronto-based investigative reporter. Follow her on Twitter: @rachelmendleson

Michele Henry is a Toronto-based investigative reporter. Follow her on Twitter: @michelehenry

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Coerced sterilization reports sparking concern in Canada’s medical community

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Reports detailing allegations of coerced and forced sterilizations of Indigenous women are « deeply concerning » and describe serious violations of medical ethics, the president of the Canadian Medical Association said Thursday.

« This should not be happening, » Dr. Gigi Osler said in an interview. « For me, to read these stories, it reinforces my desire and commitment for change to make sure … we are looking after our vulnerable groups and in this case, Indigenous women. »

No one should have a procedure performed on him or her without free, prior and informed consent, Osler said, adding that pressuring women into being sterilized is not only a violation of a victim’s human rights but also a violation of medical ethics.

She said Thursday that the association supports Ontario Sen. Yvonne Boyer’s call for a national study of the issue and it also plans to participate in a federal, provincial and territorial working group pitched by the federal government.

Working group proposed

Last week, Indigenous Services Minister Jane Philpott and Health Minister Ginette Petitpas Taylor sent a letter to ​provincial and territorial ministers, as well as members of the medical community, to express concern over recent reports on forced and coerced sterilizations of Indigenous women and to propose a working group of senior officials on measures to improve cultural safety in health systems.

It also said the federal government sees merit in the working group of senior officials to oversee measures to improve cultural safety in health systems.

Osler responded to the ministers to say she shares concerns about 2017 findings published by Boyer and Manitoba Metis researcher Dr. Judith Bartlett on coerced sterilization in the Saskatoon Health Region and from the United Nations Committee Against Torture.

UN committee recommends Canada criminalize involuntary sterilization

Earlier this month, the UN committee said all allegations, including recent ones in Saskatchewan, must be impartially investigated and those responsible must be held to account. It also said governments need to use legal and policy measures to stop women from being sterilized against their will.

Other medical professionals are examining coerced sterilization reports as well.

The College of Physicians and Surgeons of Ontario said the reports are troubling to the medical profession and Canadians as a whole, adding they are « entirely inconsistent » with the professionalism it sees from a vast majority of health care workers.

« As the largest physician regulatory body in Canada, we are prepared to partner with government to bring attention to this issue at the national level and make clear that such practices are simply unacceptable, » it said in a statement.

The Society of Obstetricians and Gynaecologists of Canada also confirmed it received a letter last week from the federal ministers.

« We will work together with the government and other concerned parties to ensure that all women experience safe and respectful childbirth, » CEO Jennifer Blake said.

Class action lawsuit filed

This week, sterilization victims expressed concern in response to the proposed working group, fearing it does little to nothing to immediately prevent the human-rights violation from happening to other women.

Prime Minister Justin Trudeau defended his government’s response to date during a roundtable interview on Friday with The Canadian Press.

« There are complex issues that feed into this and we have to at least get a handle on many of them to understand exactly that question ‘How could this happen? »‘ Trudeau said.

A proposed class action lawsuit was filed this week against the Government of Alberta on behalf of Indigenous women who say they were subjected to forced sterilization.

Another is also underway in Saskatchewan, launched by Indigenous-owned national firm Maurice Law. It names the Saskatoon Health Authority, the Saskatchewan government, the federal government and a handful of medical professionals as defendants.

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Jail medical staff gave Teresa Gratton methadone doses way above guidelines, and this caused her death

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Teresa Michelle Gratton’s first dose of methadone should have been no more than 10 milligrams.

But the medical staff inside the maximum-security jail where Gratton was being held indefinitely as an immigration detainee started her at 30 milligrams.

Teresa Michelle Gratton, pictured here in an undated family photo, was being held indefinitely as an immigration detainee at the maximum-security jail in Milton. She died of “acute methadone intoxication” after receiving two doses of methadone from the jail’s doctors. Provincial guidelines for methadone treatment say Gratton should have received a much lower dose than she did.
Teresa Michelle Gratton, pictured here in an undated family photo, was being held indefinitely as an immigration detainee at the maximum-security jail in Milton. She died of “acute methadone intoxication” after receiving two doses of methadone from the jail’s doctors. Provincial guidelines for methadone treatment say Gratton should have received a much lower dose than she did.  (Gratton family photo)

That’s what caused her death.

Gratton died of “acute methadone intoxication in the setting of ischemic heart disease,” according to the coroner’s report, which was given to the Star by Gratton’s husband.

Provincial guidelines for methadone treatment say someone in Gratton’s position should have received a much lower dose than she did. The coroner states in his report that other factors may have contributed to her death, including Gratton’s pre-existing high blood pressure. She ultimately died of a heart attack in hospital. Three doctors who reviewed the coroner’s report for the Star say it’s clear she died of a methadone overdose.

Gratton, a U.S. citizen and permanent resident of Canada who lived in London, Ont., was not serving a criminal sentence or awaiting trial, though she was treated the same as those who were. She had been sent to a maximum-security jail because the Canada Border Services Agency was contemplating deporting her and feared she would not show up for her deportation if it were ordered. The agency based its decision on Gratton’s criminal convictions from 2013, for which she was sentenced to six months of house arrest. Some have argued she should not have been detained in the first place.

The 50-year-old grandmother was found unresponsive in her cell at the Vanier Centre for Women in Milton just after midnight on Oct. 30, 2017. About 40 hours earlier she was given her first dose of methadone, a long-acting opioid often used to treat addiction to shorter-acting opioids. Gratton had depended on prescription painkillers for many years, but the jail’s medical staff was trying to wean her off them. She received her second dose of methadone the morning before she died.

“I suspect if the physician who prescribed this could do it over again, he or she would start on a lower dose,” said Dr. David Juurlink, a medical toxicologist and senior scientist at the Institute for Clinical Evaluative Sciences, and one of three opioid-specializing doctors who reviewed Gratton’s coroner’s report at the Star’s request. All agreed she should have been started on a lower dose of methadone or a different drug altogether.

Gratton’s death was ruled accidental. A coroner’s inquest has been ordered but has not been scheduled.

Read More:

Family of immigration detainee who died in jail still waiting for answers

The Star first reported on Gratton’s case last December, and again in March when two women who were incarcerated with Gratton came forward to raise concerns about her treatment in the jail. But this is the first time her official cause of death has been reported.

Herb Gratton, Teresa’s husband and partner of more than 30 years, said he is frustrated and angry, but he mostly just misses his wife. “The system had her,” he said in a recent interview. “They were supposed to be responsible.”

Herb, who is a Canadian citizen from the Caldwell First Nation, says this time of year is particularly difficult. His wife was the one who organized the family get-togethers and did most of the cooking.

“Christmas does not seem like Christmas,” he said. “I can’t find a reason to celebrate. I have my children, my grandchildren. But there’s a void. No matter who’s around or what’s around, I can’t fill it, you know?”

Herb Gratton, the husband of Teresa Michelle Gratton, says he is frustrated and angry about how his wife died. But he says he mostly just misses her. "Christmas does not seem like Christmas," he said. "I can't find a reason to celebrate."
Herb Gratton, the husband of Teresa Michelle Gratton, says he is frustrated and angry about how his wife died. But he says he mostly just misses her. « Christmas does not seem like Christmas, » he said. « I can’t find a reason to celebrate. »  (Anne-Marie Jackson)

A mother of three who had lived in Canada since 2003, Teresa Gratton suffered from osteoarthritis and fibromyalgia, a long-term condition of the central nervous system that causes widespread pain. She relied on the opioid hydromorphone and was prescribed a high daily dose by her doctor months before she was incarcerated. When she couldn’t get her opioids from a doctor she got them on the street, her husband said. A month before her death she pleaded guilty to forging her doctor’s signature in an attempt to get an extended supply of hydromorphone. She also took several other prescribed medications, including ones for anxiety and depression.

The jail’s medical staff decided Gratton should not be on opioids. The coroner’s report references a physician’s note in Gratton’s medical file that reads: “SUD (substance use disorder), I agree, no indication for long-term opioid therapy.”

First they cut her dose by more than half. A week later they tapered her dose further and then withdrew her opioids completely for 10 days before giving Gratton her first dose of methadone.

Thirty milligrams, the amount Gratton received in each of her two doses, is the maximum starting dose for methadone treatment, according to guidelines published by the College of Physicians and Surgeons of Ontario. However, the guidelines state that if a patient has been “recently abstinent from opioids,” as Gratton was, the maximum starting dose should be no more than 10 milligrams. The guidelines do not specify how many days qualify as recent abstinence, but they do say that patients who have not used opioids “even for a few days” are at a higher risk of overdose.

The guidelines also state that patients who are also on benzodiazepines or any sedating drugs, as Gratton was, should be considered at a “higher risk for methadone toxicity” and therefore should be given a lower starting dose.

Two doctors, Dr. Abraham Shedletzky and Dr. Laura Middlestadt, are among the medical staff who work inside the jail. It’s not clear who oversaw Gratton’s treatment or if either doctor administered the methadone. The coroner’s report doesn’t name any doctor as being responsible for Gratton’s treatment. Middlestadt declined to comment for this story. Shedletzky did not respond to multiple interview requests.

Juurlink said he didn’t understand why the jail’s medical staff, even if they believed Gratton should be on a lower dose of opioids, would have tapered her off the drugs entirely. “Her brain and body would have become accustomed to that amount of hydromorphone,” he said. “She would have been physically dependent on it, and when you take it away people get horribly sick.” Tapering should be done slowly and generally with the patient’s consent, he added.

Even if there were compelling reasons to reduce Gratton’s opioid dose and replace it with methadone, Juurlink said someone in Gratton’s position shouldn’t be off opioids for as long as she was. “That’s 10 days of putting this patient through hell.”

Gratton wrote her husband regularly during her time in jail. In her letter she describes the agony of her withdrawal symptoms, which included vomiting, diarrhea, severe muscle pain, constant sweating and depression.

“I’d rather be dead than to keep going through this pain,” she wrote in one letter. “These doctors … think I don’t need to be on any of my narcotics. If something bad should happen to me please sue the hell out of them.”

The coroner’s report says that Gratton filed a complaint to the Office of the Ombudsman of Ontario regarding the reduction of her opioids by the jail’s medical staff. A spokesperson for the ombudsman said that for confidentiality reasons she could not confirm whether a complaint had been filed.

Juurlink also pointed to Gratton’s concurrent use of clonazepam, which she took to treat panic attacks, as a reason she should have been started on a much lower dose of methadone. Clonazepam belongs to the benzodiazepine class of drugs. It is a tranquilizer that, when combined with methadone, increases the risk of overdose.

“You have a one-plus-one-equals-five kind of effect,” Juurlink said. “They’re both depressants of the central nervous system and it’s really quite dangerous to combine opioids with drugs like that, especially for a patient who, for all intents and purposes, is opioid naive.” Juurlink said Gratton would have lost whatever opioid tolerance she might have had during her 10 days without the drug.

A spokesperson for Ontario’s Ministry of Community Safety and Correctional Services, which is responsible for provincial jails, said no one from the ministry would be interviewed for this story. They also declined to answer specific questions about Gratton’s case, citing the pending inquest.

From the 2017 Star Investigation | Teresa Michelle Gratton died Oct. 30 while being indefinitely detained in a maximum-security jail by the Canada Border Services Agency. Her grieving family wonders why she was there at all.

The spokesperson provided a written statement, which reads, in part: “Decisions about health care matters are between inmates and medical staff. The ministry does not interfere with medical decisions or direct medical professionals.”

Dr. Ramesh Zacharias, the coroner, writes in his report that it’s unclear whether Gratton should be considered “a completely naive user in the context of methadone maintenance therapy.” Zacharias notes that although Gratton had not consumed opioids for 10 days before her first dose of methadone, “prior to that period she was a longtime user and abuser of hydromorphone.”

Dr. Meldon Kahan, medical director of the Substance Use Service at Women’s College Hospital, said it is “unusual” for just two doses of 30 milligrams of methadone to cause death. However, given Gratton’s recent abstinence from opioids and the fact she was on other sedating medications it “might have been more prudent” to start her on a different drug or a lower dose.

Kahan said it would have been better for the jail’s medical staff to prescribe buprenorphine, another long-acting opioid used to treat addiction, rather than methadone.

“It’s much safer than methadone,” he said. “It’s much safer than simply stopping the opioid, and it’s much safer than keeping them on the opioid that they’re already on.”

Juurlink agreed, calling buprenorphine “an infinitely safer medication.”

A ministry spokesman refused to say whether buprenorphine was available to doctors inside the jail.

Gratton died after suffering a heart attack in hospital roughly nine hours after she was found unresponsive in her cell. Zacharias writes in his report that he couldn’t attribute methadone intoxication as the sole cause of death because of uncertainties around Gratton’s tolerance, his inability to determine the peak concentrations of methadone in her blood when she lost consciousness, and because her body did not immediately respond to naloxone — a drug that can reverse the effects of opioids — when it was administered by paramedics. It’s not clear for how long Gratton had been unconscious when her cellmate, who had been sleeping, alerted jail guards.

Zacharias also notes that a methadone overdose can itself increase the risk of a heart attack.

The doctors who reviewed the report for the Star said it’s clear an overdose of methadone was the cause of death, whether or not she suffered other heart complications. Juurlink said that the vomiting and diarrhea Gratton experienced during her withdrawal would have left her with lower potassium and magnesium, which would have “amplified” the effects of methadone on her heart. “Methadone can kill you in more than one way,” he said.

Besides how she died, there are also questions about why Gratton was detained in the first place and why she was held in a maximum-security jail — questions that could be raised as part of the inquest.

The CBSA’s grounds for stripping her permanent residency were for “serious criminality,” which is defined in part as any conviction that leads to a “term of imprisonment” of more than six months.

Gratton came to be in police custody in September 2017 after she was arrested for shoplifting at Walmart, but the CBSA’s finding of “serious criminality” was related to convictions from 2013, when she pleaded guilty to forging a former employer’s signature on cheques for amounts ranging from $100 to $250. (Gratton admitted forging the signatures, but she believed the man owed her the money for house cleaning, according to a court transcript.) She also pleaded guilty to unlawfully being in the man’s house, although she did not break in. She was given a nine-month conditional sentence, which included six months of house arrest but no jail time.

The CBSA interpreted Gratton’s conditional sentence as a “term of imprisonment” of more than six months, meaning she would have no right to appeal her deportation. On Oct. 19, 2017 — 11 days before Gratton died — the Supreme Court of Canada struck down such interpretations, ruling it was unreasonable for immigration authorities to equate conditional sentences, such as house arrest, with jail time.

Immigration authorities have also not clarified why Gratton, who was not considered a danger to the public and had no history of violence, was classified as a “high-risk” detainee and sent to a maximum-security jail. By the CBSA’s own policies her minimal, non-violent criminal record should have made her eligible for the Immigration Holding Centre, a far less restrictive facility.

A CBSA spokesperson has said the agency decided maximum-security jail was a “better choice” for Gratton due to “various case-specific factors.” The spokesman would not explain the factors that led to their decision, citing a need to protect Gratton’s privacy.

The location of detention for immigration detainees is decided solely by the CBSA and not subject to any external oversight.

Brendan Kennedy is a Toronto-based investigative reporter. Follow him on Twitter: @BKennedyStar

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Medical insurance fraud widespread, as employees, providers rip off benefit plans

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Employers and their insurance providers are reeling at the proliferation of fraud rings — groups of employees that work together to abuse and exploit benefit plans, with medical services providers as their eager accomplices.

« You’re sitting in the lunchroom when a co-worker comes in and says, ‘I’ve got $1,000 worth of massage receipts, $2,000 worth of physiotherapy receipts, submit them all, and we can share the money,' » explains Gary Askin, a former commander with the Waterloo, Ont., police force who now works as a fraud investigator with Sun Life.

Cash, cash cards, purses, designer sunglasses, coats, and iPads are examples of what people have been able to get with fraudulent health benefit claims.

« They’ll say there’s no need to worry about getting caught, because they know the provider, and if the insurance company calls them, they will validate the claim. »

Askin refers to fraud ring organizers as « recruiters » and says the schemes can grow quickly, as employees reap rewards and spread the word.

Former police commander Gary Askin now works with insurance giant Sun Life, investigating cases of benefits fraud. (John Lesavage/CBC News)

« They rationalize it by saying ‘you didn’t get a raise last year,’ or ‘don’t worry, it’s just the insurance company’s money.’ They make some very compelling and convincing arguments. »

Sun Life estimates that 85 per cent of its fraud losses involve collusion with a medical services provider.

Clinics that offer massage, physiotherapy, orthotics and compression stockings are most commonly used. Sun Life « delisted » a whopping 1,500 providers across Canada last year alone, after proving they had been involved in false claims. Claims from those clinics are no longer accepted.

« You’re stealing from your employer, » says Dave Jones, Sun Life’s head of group benefits. « You are stealing from the wallet of money, if you can think of it that way, that’s used to pay for your health care, and the health care of your family, and the health care of your friends and colleagues at work. »

The industry association has recently launched a public awareness campaign called « Fraud=Fraud, » to educate Canadians about the problem. The website features a link to a page of email addresses and phone numbers, where suspected cases can be reported to authorities.

An image from the CLHIA’s public education campaign. Many employees don’t realize that criminal charges as well as termination of employment can be among the consequences of benefits fraud. (CLHIA)

One case that made headlines in 2018: the Toronto Transit Commission fired 250 employees after discovering they were all involved in a scam related to orthotics. The service provider — who facilitated the entire escapade — has been sentenced to two years in a federal penitentiary plus three years on probation.

Meanwhile, a Toronto firefighter was sentenced to six months in jail for submitting $32,000 in forged receipts. A professor at York University appealed her firing after falsifying invoices for $8,000 worth of massage and physiotherapy, but lost.

How it’s done

A typical scam might involve compression stockings. The fraudulent provider is aware that a particular company’s benefit plan will cover four pairs in a year, at a cost of $220 each.

When an employee arrives with their prescription, the provider presents a new and enticing offer: pay for all four, submit the receipt and be reimbursed in full by the benefit plan — but receive just one pair of compression stockings and collect some « incentives » on the side.

Insurer Green Shield Canada sent an undercover investigator into one such meeting in an Ontario city last August to pose as an employee. She recorded the meeting with a hidden camera.

« I can give you the website, you can choose what kind of shoes, » the provider tells the investigator, who selects a pair of Ugg boots.

« Show it to your husband too, OK? » he adds, well aware that the plan will also cover a spouse’s medical needs as well.

Sun Life’s Dave Jones says the company’s fraud team includes close to 100 investigators, some of them former police officers, others are data scientists. (Ed Middleton/CBC News )

Green Shield’s Brent Allen says providers often encourage scam participants to max out on their plans’ provisions. He’s seen employees collect all manner of goods.

« We wouldn’t think it’s acceptable to steal from our employer outright, » he says.

« If you saw somebody walking out with an iPad that the employer had bought, you would be offended by that. Then why is it OK to go to a provider and get an iPad that that employer paid for? »

Life and death decisions

Allen attributes the fraud epidemic to greed.

« There’s a lot of money in our industry, » he says. « People are going to want to take pieces of it. »

In total, private insurers paid out $34 billion in health claims last year, according to the Canadian Life and Health Insurance Association (CLHIA). Estimates for the number of fraudulent claims range from two to 10 per cent, meaning between $600 million and $3.4 billion is being stolen annually.

Those costs can be paid indirectly by honest, innocent employees.

« There are life-saving drugs available under these plans that can cost hundreds of thousands of dollars, » Allen points out.

And employers can’t afford to be paying hundreds of thousands of dollars for claims that aren’t real when they have somebody truly in need. It’s forcing employers to make decisions about whether they cover expensive drugs that could be the difference between somebody living or dying, working or not working. »

Data and artificial intelligence

The CLHIA’s public awareness campaign includes advertising on Facebook, LinkedIn and Twitter. A professionally produced commercial shows an employee being escorted out of the office by security with a box of their belongings, while shocked co-workers stand and stare.

« You were appreciated and liked, soon to be rewarded with a promotion and raise. But you threw it all away, » intones a sombre voice-over. « So if you’re thinking about falsifying your health or dental claim, think again. »

But as schemes become more sophisticated, so do detection methods. Green Shield uses an artificial intelligence program to spot fraudulent claims. Sun Life has a team of almost 100 investigators, using special software to make connections between suspicious clinics and employees using them.

« These are resources I would’ve died for in policing, » says investigator Gary Askin. « We’ve got more data scientists working for Sun Life than any police service in the country, with the exception possibly of the Mounties. »

The industry association hopes its awareness campaign will generate a number of tips regarding cases of suspected fraud. The message they’re trying to send is clear: if you’re not prepared to do the time, don’t do the crime.

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Tilray stock jumps on medical cannabis collaboration with pharma giant

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Tilray Inc. shares jumped Tuesday after the B.C.-based company took another step to strengthen its medical marijuana business outside Canada through a new collaboration with Novartis pharmaceutical group’s Sandoz AG.

« Tilray is a global company, and we’re thrilled to build upon the success and momentum from our existing agreement with Sandoz Canada by taking our partnership global, » Tilray chief executive Brendan Kennedy said Tuesday.

Under its original agreement, announced in January 2018 after several months of talks, the companies began shipping non-combustible medical products with the Tilray and Sandoz/Novartis brands to customers in Canada last June.

The new global arrangement allows Tilray to use the Sandoz supply chain, sales force and global distribution network to distribute Tilray medical cannabis products, Kennedy said.

The number of countries that have legalized medical cannabis has more than doubled to 35 from 15 in 2010, when Kennedy got into the business.

« It’s very clear to me how we go from 35, to 40, to 50, 60 countries globally … and this agreement enables us to ensure that our products get into the hands of more patients around the world, » Kennedy said.

Tilray shares rose 17 per cent, or $11.33 US, to $77.22 in early afternoon trading on the Nasdaq market, but remained well below their 2018 high of $300 US set on Sept. 19.

More states legalize medical cannabis

Kennedy thinks Germany — with a larger population and economy than Canada — is a major opportunity because any doctor in that country is allowed to write a prescription to any patient for any illness with insurance coverage for medical cannabis products.

The United States is more difficult, because its federal law is more restrictive, but Kennedy said there are also encouraging trends in that country. These include the electoral defeat of a staunch House of Representatives opponent of medical marijuana in November and the removal of Jeff Sessions as the U.S. attorney general.

In addition, there are now 33 states that have legalized cannabis for medical purposes, 10 that have legalized it for recreational use by adults, and favourable revisions to the U.S. Farm Bill that have been passed by both houses of the U.S. Congress.

Jean Marc checks out a sample at a cannabis store in Winnipeg on October 17. Interest in publicly traded cannabis companies has been stoked by Canada’s legalization of recreational use of marijuana and its plan to make consumable forms of the drug legal next year. (John Woods/Canadian Press)

« We are hopeful that President Trump will sign it this week. That will provide an excellent opportunity for Tilray to capitalize on … hemp-derived CBD (cannabidiol) in the U.S. »

CBD has significant medical benefits with little to no psychoactive effects — unlike THC, which is scientifically known as delta-9-tetrahydrocannabinol and generally known as the ingredient in pot that gives users a high.

Kennedy said the U.S. Drug Enforcement Administration and the U.S. Federal Drug Administration have also given approvals for Tilray to export medical cannabis from Canada for a clinical trial in the United States, where Sandoz has a major pharmaceutical sales operation.

High profile partnerships

The Sandoz announcement follows recent additions to Tilray’s international advisory board, which includes former finance ministers from Canada, Australia and Germany and politically connected representatives from the United States — former Vermont governor Howard Dean and former lieutenant governor of Maryland Michael Steele.

Interest in publicly traded cannabis companies has been stoked by Canada’s legalization of recreational use of marijuana and its plan to make consumable forms of the drug legal next year.

In addition, there have been a number of partnerships and tie-ups between cannabis companies and more established producers of consumer goods including beer makers Molson Coors and Constellation Brands, and cigarette maker Altria Group Inc.

Under the new agreement Tuesday, Sandoz may support Tilray’s commercialization of non-smokable and non-combustible medical cannabis products and work together on developing new products.

They may also partner to educate pharmacists and physicians about medical cannabis products.

Tilray Canada is a subsidiary of Tilray Inc., which is which is listed on the Nasdaq stock market and has operations in Australia, New Zealand, Germany, Latin America, Portugal and Canada.

In Canada, Tilray’s operation in Nanaimo, B.C., is licensed to produce dried cannabis and cannabis extracts, including both bottled oil and capsules, for medical purposes in Canada.

The company also has a licensed facility in Enniskillen, Ont., that it intends to use to service the adult market for dried cannabis, and it’s seeking a licence for a processing facility in London, Ont.

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