To the editor—We write to correct inaccuracies in your October issue editorial and news article concerning the controversial clinical trial involving Nancy Olivieri, The Hospital for Sick Children (HSC) and Apotex Inc. Whereas there is no question that this case is complicated and that there are as many interpretations of the facts as there are involved parties, the allegation that the HSC administration "completely failed to support the efforts of Olivieri" is false and the implication that we did not support Olivieri's right to publish is unwarranted.

In a letter dated 24 May 1996, Apotex notified Olivieri (and her collaborator Gideon Koren) that they would not renew the contract supporting the trial of L–1 (Deferiprone). Apotex also warned Olivieri and Koren that they would pursue legal remedies if they breached the obligations in their previous three–year contract. In a letter dated 25 May, Olivieri and Koren informed the hospital that they had already sought legal counsel, who had advised them to contact the Canadian Medical Protective Association (CMPA). When Olivieri subsequently met with university officials on 6 June, and with hospital representatives on 18 July, she was represented by a lawyer from McCarthy Tetrault, the firm retained by the CMPA. It was not until the hospital board of directors initiated an independent external review that Olivieri requested legal assistance from the hospital in this matter. Olivieri has been continuously represented by lawyers from McCarthy Tetrault.

At the 18 July 1996 meeting, Olivieri and her lawyer requested that the hospital take a position against Apotex, backing her scientific findings. The hospital's opinion was that the conflict was a scientific dispute among Olivieri, Koren, Apotex and several other scientists regarding the effectiveness of L–1 and, as such, should be resolved through the scientific literature. The hospital supported and encouraged Olivieri's initiative to submit her findings for presentation at the December 1996 meeting of the American Society of Hematology, which she did. She also reported her findings in an article in the Medical Post (January 1997), in April 1997 at the Sixth International Conference on Thalassemia and Hemoglobinopathies, and at the December 1997 meeting of the American Society of Hematology and in the New England Journal of Medicine (339, 417; 1998).

After Apotex did not renew the L–1 clinical trial contract, Olivieri wished to continue to use L–1 to treat thalassemia patients at HSC and Apotex agreed to provide the drug under the Canadian government's Emergency Drug Release (EDR) program. Later, Apotex on several occasions contacted hospital officials requesting that the hospital help them gain access to the data generated while Olivieri treated patients under the EDR program, and HSC supported Olivieri in refusing these requests. Olivieri's complaint that her data was used without her permission was brought to The University of Toronto for adjudication (in keeping with the university's Procedures to Address and Manage Scientific Misconduct). An investigating committee was established and reported in September 1997, dismissing the allegation and exonerating the faculty member against whom the charge was made.

The connection between HSC and Michael Spino, now a vice president of Apotex, should be clarified. Spino was a member of The Hospital for Sick Children Research Institute for several years. When Spino began working for Apotex, he left the staff of the hospital but became an unpaid consultant to HSC. Since joining Apotex, Spino has not maintained a laboratory at HSC, but has done collaborative research in Koren's laboratory. Koren and Spino co–supervised a graduate student and a research technician. Spino was, and continues to be, a professor at The University of Toronto.

Arnold Naimark, former dean of Medicine and President of the University of Manitoba, has conducted a review to determine the facts and circumstances of this complex case. We anticipate that his report will further clarify facts in the case and make useful recommendations for future practice at the Hospital for Sick Children. [As Nature Medicine went to press this report was released and is available at http://www.sickids.on.ca/HSCWeb/zReview/TheReview). Further– more, a second–phase review is also planned to examine current hospital policies and procedures relating to the broader issues of clinical trials and third–party funding. The outcome of these reviews may also be of value to other institutions.