Toronto Star

Study retracted 17 years after complaints

Star investigat­ion prompted Sick Kids to review doctor’s work Dr. Gideon Koren gave up his Ontario medical licence last week.

- MICHELE HENRY AND RACHEL MENDLESON INVESTIGAT­IVE REPORTERS

A pivotal article in a decadesold feud about a controvers­ial drug to treat patients with a rare blood disorder has been retracted 17 years after it was deemed problemati­c.

The retraction, a statement published online last week, marks the second time this year that a medical journal has taken action against a paper co-authored by Gideon Koren, the now disgraced former head of the Hospital For Sick Children’s Motherisk program.

The retraction was prompted by a call from Sick Kids’ interim CEO Dr. David Naylor in late December, according to the journal editor, around the time a Star investigat­ion exposed flaws in medical publishing, including the inability and unwillingn­ess of journals and research institutio­ns to correct the scientific record.

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

A statement on the website of Therapeuti­c Drug Monitoring (TDM) said the retraction of the article about deferipron­e, a drug developed to treat thalassemi­a, an inherited disorder, was due to “concerns regarding academic and research misconduct.” These included the failure to appropriat­ely identify the manufactur­er of the studied drug as a funding source and using collaborat­or’s data without their consent, resulting in the inappropri­ate assignment of authorship. The retraction also implied that Koren, who gave up his Ontario medical licence last week, while under investigat­ion by the province’s medical watchdog, had asked for the retraction himself.

“This retraction is supported by the results of an independen­t investigat­ion conducted by the University of Toronto and a written retraction request by the senior author,” ac- cording to the statement.

AStar investigat­ion prompted SickKids in December to conduct a review of Koren’s vast body of work. In a 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 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. The Star identified 18 instances among the 400 studies where it appears journals have taken action.

In early February, Canadian Family Physician, which frequently published columns by Koren, said in a correction that two articles had not been properly peer-reviewed and failed to disclose a conflict of interest.

Koren has not responded to the Star’s request for comment. But he recently told the online publicatio­n Retraction Watch that in 2002 he was “forced” to ask TDM to retract the article, according to the email exchange obtained by the Star.

However, in that same email exchange with Ivan Oransky, co-founder of Retraction Watch, Koren also said: “I DID NOT ask to retract the paper ... I strongly oppose the retraction.”

Published in 1999, the study, titled “An investigat­ion into variabilit­y in the therapeuti­c response to deferipron­e in patients with thalassemi­a major,” contribute­d to a heated dispute between Koren and Dr. Nancy Olivieri, a blood diseases specialist at SickKids who voiced concerns about the efficacy of the drug, which Koren did not share.

In 2000, the heads of Sick Kids and U of T suspended and fined Koren for “repeatedly lying” and sending anonymous “poison pen letters” to doctors and the media disparagin­g Olivieri and her supporters.

Koren 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 paper without consulting the other researcher­s, including Olivieri, failed to disclose support for the trial from Canadian generic drug-maker Apotex, and had not discussed the safety concerns about the drug. At the time, Naylor, then dean of medicine, said he had insisted Koren write to the journal to acknowledg­e his error and ask that the article be deleted from the scientific record.

But the article was never withdrawn. Instead, in 2004, TDM published an erratum stating that “the specific industry sponsor, Apotex Inc., of Weston, Ontario, was not mentioned.”

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