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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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‘Business as usual’ for Dorel Industries after terminating go-private deal

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MONTREAL — Dorel Industries Inc. says it will continue to pursue its business strategy going forward after terminating an agreement to go private after discussions with shareholders.

« Moving ahead. Business as usual, » a spokesman for the company said in an email on Monday.

A group led by Cerberus Capital Management had previously agreed to buy outstanding shares of Dorel for $16 apiece, except for shares owned by the family that controls the company’s multiple-voting shares.

But Dorel chief executive Martin Schwartz said the Montreal-based maker of car seats, strollers, bicycles and home furniture pulled the plug on a deal on the eve of Tuesday’s special meeting after reviewing votes from shareholders.

“Independent shareholders have clearly expressed their confidence in Dorel’s future and the greater potential for Dorel as a public entity, » he said in a news release.

Dorel’s board of directors, with Martin Schwartz, Alan Schwartz, Jeffrey Schwartz and Jeff Segel recused, unanimously approved the deal’s termination upon the recommendation of a special committee.

The transaction required approval by two-thirds of the votes cast, and more than 50 per cent of the votes cast by non-family shareholders.

Schwartz said enhancing shareholder value remains a top priority while it stays focused on growing its brands, which include Schwinn and Mongoose bikes, Safety 1st-brand car seats and DHP Furniture.

Dorel said the move to end the go-private deal was mutual, despite the funds’ increased purchase price offer earlier this year.

It said there is no break fee applicable in this case.

Montreal-based investment firm Letko, Brosseau & Associates Inc. and San Diego’s Brandes Investment Partners LP, which together control more than 19 per cent of Dorel’s outstanding class B subordinate shares voiced their opposition to the amended offer, which was increased from the initial Nov. 2 offer of $14.50 per share.

« We believe that several minority shareholders shared our opinion, » said Letko vice-president Stephane Lebrun, during a phone interview.

« We are confident of the long-term potential of the company and we have confidence in the managers in place.”

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Pandemic funds helping Montreal businesses build for a better tomorrow

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Many entrepreneurs have had to tap into government loans during the pandemic, at first just to survive, but now some are using the money to better prepare their businesses for the post-COVID future.

One of those businesses is Del Friscos, a popular family restaurant in Dollard-des-Ormeaux that, like many Montreal-area restaurants, has had to adapt from a sit-down establishment to one that takes orders online for takeout or delivery.

“It was hard going from totally in-house seating,” said Del Friscos co-owner Terry Konstas. “We didn’t have an in-house delivery system, which we quickly added. There were so many of our employees that were laid off that wanted to work so we adapted to a delivery system and added platforms like Uber and DoorDash.”

Helping them through the transition were emergency grants and low-interest loans from the federal and provincial governments, some of which are directly administered by PME MTL, a non-profit business-development organization established to assist the island’s small and medium-sized businesses.

Konstas said he had never even heard of PME MTL until a customer told him about them and when he got in touch, he discovered there were many government programs available to help his business get through the downturn and build for the future. “They’ve been very helpful right from day one,” said Konstas.

“We used some of the funds to catch up on our suppliers and our rents, the part that wasn’t covered from the federal side, and we used some of it for our new virtual concepts,” he said, referring to a virtual kitchen model which the restaurant has since adopted.

The virtual kitchen lets them create completely different menu items from the casual American Italian dishes that Del Friscos is known for and market them under different restaurant brand names. Under the Prasinó Soup & Salad banner, they sell healthy Greek options and their Stallone’s Sub Shop brand offers hearty sandwiches, yet the food from both is created in the same Del Friscos kitchen.

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Downtown Montreal office, retail vacancies continue to rise

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Some of downtown Montreal’s key economic indicators are heading in the wrong direction.

Office and retail vacancies in the city’s central core continued to climb in the fourth quarter of 2020, according to a quarterly report released Thursday by the Urban Development Institute of Quebec and the Montréal Centre-Ville merchants association. The report, whose first edition was published in October, aims to paint a socio-economic picture of the downtown area.

The survey also found office space available for sublet had increased during the fourth quarter, which may foreshadow even more vacancies when leases expire. On the residential front, condo sales fell as new listings soared — a sign that the downtown area may be losing some of its appeal to homeowners.

“It’s impossible not to be preoccupied by the rapid increase in office vacancies,” Jean-Marc Fournier, the former Quebec politician who now heads the UDI, said Thursday in an interview.

Still, with COVID-19 vaccinations set to accelerate in the coming months, “the economic picture is bound to improve,” he said. “People will start returning downtown. It’s much too early to say the office market is going to disappear.”

Public health measures implemented since the start of the pandemic almost a year ago — such as caps on office capacity — have deprived downtown Montreal of more than 500,000 workers and students. A mere 4,163 university and CEGEP students attended in-person classes in the second quarter, the most recent period for which figures are available. Border closures and travel restrictions have also brought tourism to a standstill, hurting hotels and thousands of local businesses.

Seventy per cent of downtown workers carried out their professional activities at home more than three days a week during the fourth quarter, the report said, citing an online survey of 1,000 Montreal-area residents conducted last month.

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