The Ontario College of Physicians and Surgeons has formally reprimanded University of Toronto professor of medicine Dr. Gideon Koren. He had written anonymous harassing letters about Dr. Nancy Olivieri and three colleagues during Olivieri's dispute with the Hospital for Sick Children, the University of Toronto and Apotex Inc. He then had lied repeatedly to conceal his responsibility. The college also cited him for additional misconduct, in research.
The penalty had been jointly proposed to the college discipline committee through prior agreement between counsel for Koren and counsel for the college. In its decision, the discipline committee said it was "deeply troubled by this case" and "seriously considered administering a more severe penalty" than that proposed to it, as it wished "to express unequivocally its condemnation of Dr. Koren's misconduct."
"It defies belief that an individual of Dr. Koren's professed character and integrity could author such vicious diatribes against his colleagues as he did in the 'poison pen letters'," the committee wrote in its decision.
The committee described Koren's actions as "childish, vindictive and dishonest" and noted that "only when confronted with irrefutable scientific evidence of his guilt did he admit he was the perpetrator" of the letter campaign.
Although Koren's lawyer said his client felt "extreme remorse," the committee pointed out that it "did not hear directly from Dr. Koren as to his remorse and the agreed statement of facts were silent on this issue."
The college's finding of research misconduct was in relation to a study on a drug to treat a blood disorder in children that Koren and Olivieri had once collaborated on. Olivieri identified risks that the drug was ineffective and caused liver damage, and voiced her concerns despite legal warnings from its maker, Apotex. Koren differed and, contrary to accepted norms, published an article on the drug using data from other researchers, including Olivieri, without their knowledge or consent.
The Koren case only came to the college's discipline committee after three of the victims of the anonymous letter campaign appealed the decision of the college's complaints committee not to refer the Koren matter for discipline. The independent appeal board agreed with Drs. Peter Durie, Brenda Gallie and Helen Chan, and ordered the college to forward the matter to the discipline committee.
The facts before the discipline committee on research misconduct were confined by the prior agreement between legal counsel to a public report University of Toronto dean of medicine David Naylor had made to his faculty council. Dean Naylor reported that Koren had violated university policy in publishing his article on Apotex's drug without the "consent, review or participation" by Olivieri and two others who had generated the data. Naylor directed Koren to arrange for the journal's editor to have the article deleted from the scientific record and to send appropriate personal letters of apology.
The discipline committee did not have before it the facts that Koren had violated additional university and international norms of conduct in this publication. In The Olivieri Report, the committee of inquiry found that in this publication, Koren failed to disclose Apotex's financial support for his research. He also failed to cite previous publications by Olivieri and others on risks of the drug, even though he was fully aware of this information.
In a recent journal article, the Report's authors, Jocelyn Downie, Patricia Baird and Jon Thompson note that in his statement to the faculty council, Naylor did not address the additional, serious aspects of research misconduct by Koren. They note that Koren had received hundreds of thousands of dollars in funding from Apotex after the company had terminated the drug trials in its efforts to prevent Olivieri from disclosing risks to patients, as well as the hundreds of thousands of dollars in funding he had received during the trials.
They further note that Naylor's public statement did not address the fact that Koren had earlier appeared as senior author of conference abstracts favourable to the drug that had been drafted and coauthored by Apotex staff. His statement also did not address the fact that Koren had failed to disclose the source or purpose of a grant of $250,000 he had received from Apotex, in the same academic year the trials were terminated and the abstracts published at a conference where the company had tried through legal warnings to prevent Olivieri's participation.
The Olivieri Report found that, ever since Apotex's dispute with Olivieri over disclosure of risks of its drug began in 1996, the company has been relying on Koren's scientific opinions to defend its drug's reputation with regulatory agencies and in court actions. This reliance results in Koren's misconduct, addressed and unaddressed, continuing to be a matter of public interest.