Dear Editor

I want to thank Dr Olivieri’s core set of long-standing supporters for their letter [1] on the Introduction to the Olivieri Symposium that was recently published in the Journal of Medical Ethics.[2] Gallie et al. have been staunch supporters of Dr. Olivieri for years, and this support on her behalf has played a pivotal role in attempting to clarify perceived mistakes made in public and academic reporting on the Olivieri Affair.

In their recent letter, however, there are a number of plainly false charges that demonstrate either they have not read the Introduction closely enough or that their letter was hastily written (or possibly both). Gallie et al. charge that several events of fundamental ethical concern were left out of the Introduction and the authors accept some facts that are highly questionable. The purpose of this response is to clarify the errors and falsities within Gallie et al's letter. I also highlight the few points of legitimate disagreement they raise. 1. The Purpose of the Symposium Introduction The time line within the Introduction was included to provide readers unfamiliar with the Olivieri Affair with a snapshot of key events, not a systematic recounting of all events (as was noted). The purpose of the Introduction was always descriptive and informational in nature, and not concerned with putting forth normative arguments or conclusions. We invited leading bioethicists and individuals involved and/or familiar with the Olivieri Affair to address the ethical questions and issues surrounding and arising from this case. Gallie et al. charge that “Most surprisingly, they have fallen into a common error: emphasising the scientific argument, when that is not their expertise, and bypassing the fundamental ethical issue of the obligation to put concern for safety first.” This charge is largely unfounded. Firstly, the Introduction did not bypass the fundamental ethical issue in favour of emphasizing the scientific argument – in fact, we state the Olivieri Affair was “much more than a scientific disagreement over the interpretation of data” ([2], p.5). Secondly, the Introduction does discuss the ethical obligations to put safety first and support researchers in Olivieri's position – we clearly do on page 6 of the Introduction.[2] However, as was previously stated, we invited contributors to address what they saw as the fundamental ethical issues in the case; it was not the Introduction’s function to do this. (I address the issue of scientific arguments and expertise in §7). Gallie et al. think it ought to be concluded in a grand, sweeping fashion that “Thus their account both misleads in historical fact and misses the ethical point”. Not only is this leap in logic specious, as will be demonstrated throughout this response, the Introduction is not guilty of misleading or missing the point. 2. The Naimark Report Gallie et al. state that the Introduction failed to give the central conclusion of the Naimark Report[3], while the CAUT [4] and CPSO [5] Reports were given. In the time line, we state that the Naimark report finds that the HSC staff did not act improperly ([2], p. 5, see time line heading ‘December 1998’). This was the primarily conclusion of focus in the public reporting of the issue. However, Gallie et al. believe we should have also reported the fact that the Naimark Report declared that Dr Olivieri had failed to comply with her ethical obligations. They claim “this central finding of the Naimark report was the basis of HSC’s strong actions against Dr Olivieri during the next three years. It fueled the controversy from then onward, and the post-1998 story would be incomprehensible to a reader of JME who was unaware of it”. We chose to leave this out because other contributors to the symposium make this point explicitly.[6] Upon reflection, maybe this should have been made more explicit in the Introduction. However, Gallie et al's contention that the post-98 story would be incomprehensible to a reader who was unaware of the Olivieri Affair seems over dramatic. While this finding should have been more explicit, the overall time line is quite comprehensible to those unfamiliar with the case. Nevertheless, Gallie et al. go on to deride the Naimark Report and maintain “Naimark’s conclusions are strongly refuted by the CAUT and CPSO reports”. It is claimed that we failed to reference Naimark's discredited findings by the CAUT and CPSO reports. This is true, however, we also failed to reference those who have sought to discredit the findings of the CAUT report. The time line was complied using documents in the public domain and we attempted to provide the best accounting possible; such an attempt could not be reasonably expected to provide a systematic historical account (for arguments against the possibility of determining ‘historical facts’, see Jenkins [7]). When we did use the Naimark Report, the information used was on the whole cross-referenced with other documents in the public domain. Gallie et al. seem to resent the appearance that all three reports used in the Introduction are of equal probative value. No such representations were made or intended, but I can see why they may think this is the case. They cite the controversy surrounding the Naimark Report as evidence of why it should not be viewed as worthwhile as the CAUT and CPSO reports. However, it seems far from obvious that since these reports discredit the conclusions of the Naimark Report that all of the information contained therein is false. We encouraged readers to look at all the reports. Personally, I believe the CAUT report is a much better and balanced report. However, just because the CAUT report says that the Naimark Report came to erroneous conclusions does not make it the case that the report should not be referenced at all. Given that we state that the Hospital for Sick Children and the University of Toronto should have done more to support Dr. Olivieri, one might infer that we tended to believe the CAUT report was better than the Naimark report. But again, it was not the purpose of the Introduction to make pronouncements on which report was better. If the specific information used from the Naimark Report is false (all incidences of the use of the Naimark Report are referenced), please inform the JME and an amendment or retraction can be made. Chastising us for not rejecting the entire report, and everything contained in it, is not sufficient to reasonably ground a charge that time line is misleading in historical fact. 3. The College of Physicians and Surgeons (Ontario) Report In the Introduction, we reported that College of Physicians and Surgeons (Ontario) [CPSO] report determined that Dr Olivieri was found to have done nothing wrong in her role as investigator of the L1 trial. This report arose out of a complaint from a physician at the Hospital for Sick Children against Dr. Olivieri. While the CPSO report dealt with a great deal of the events of the Olivieri Affair, it was not a report or inquiry into the entire Olivieri Affair per se (i.e. the scope of the CPSO committee was to investigate the charge against Dr Olivieri, not conduct a review of all events in the Olivieri Affair). Gallie et al. claim that we should have also reported the further fact that the CPSO found Dr Olivieri’s conduct “exemplary”. I take Gallie et al’s (implicit?) point that having been found to have done nothing wrong and being found to have acted in an exemplary fashion are different enough to merit mention. We choose to leave this out because other contributors to the symposium make this point explicitly.[6] Maybe it was an oversight not to include this laudatory epithet and only to report that Dr. Olivieri was found to have done nothing wrong. Personally, I believe Dr Olivieri acted in an exemplary fashion and showed extreme courage and moral fortitude. So, the absence of the word exemplary from our discussion of the CPSO report was honestly inadvertent. Nevertheless, it would be wrong to claim that the Introduction did not give the impression that Dr Olivieri acted in an exemplary fashion. We state that Dr Olivieri had great conviction in standing up and speaking out against the academic medical complex ([2], p.6). 4. Dr Koren Gallie et al. claim that we were wrong to state that Dr Olivieri received “two letters” from Dr. Koren because “these two ‘letters’ have been discussed in three separate wider-ranging inquiries, each casting serious doubt on their authenticity and citing evidence that they were not written on the 1996 and 1997 ‘dates’ they bear, but instead in the fall of 1998. Dr Olivieri never received either letter, and learned of them only after the Naimark report was published. Dr Koren himself later acknowledged that he had destroyed evidence relevant to determining the actual dates on which the ‘letters’ were typed.” We did not refer to these two letters, nor did we imply that Dr Olivieri ever received these two letters when Dr Koren originally reported. We only state that “[Dr Koren] inform[ed] Dr Olivieri that he will not continue in collaborative and data interpretation work with her” ([2], p.4). Gallie et al. claim we failed to explicitly report that Dr. Koren in later publishing findings that L1 was effective and safe on a re-analysis of data and that was failed to state that “these 1997 publications had been drafted by Apotex staff and he had agreed to be listed as senior author. This was a year in which Dr Koren held a $250,000 research grant from Apotex, but he did not disclose in these publications that he was funded by Apotex, nor did he disclose to the university the source or purpose of the grant”. Again, we made no representations as to the validity of Dr. Koren’s research. We merely reported that he published these findings. Indeed, the aforementioned information provides good cause to be concerned over issues of conflict of interest. However, since we did not make or imply that this research invalidated or called into question Dr. Olivieri’s findings, it was felt that we could not make room for this further information. Moreover, given the subsequent treatment of Dr Koren (i.e., being disciplined over professional and research behaviour), it is unlikely one would think that Dr Koren’s research would invalidate Dr Olivieri’s findings simply on reporting that contrary findings were published. Gallie et al. also claim that “the Time line does not mention that Dr Koren was disciplined for professional misconduct by the CPSO (as well as by the hospital and the university)”. This is simply false. In fact, the Introduction states that Dr. Koren was disciplined by the Hospital for Sick Children and the University of Toronto, in addition to being cautioned (which is a form of discipline) by the CPSO ([2], see, p.5, time line heading ‘1999/2000’). It is incorrect and misleading to say that this information was omitted from the Introduction. It was an inadvertent omission that we did not include the fact that Dr Koren was disciplined again by the University of Toronto for scientific misconduct in connection with a 1999 journal article favorable to L1. As was stated at the end of the time line, any omissions were unintentional. However, it seems that this minor omission is not crucial for the general picture a reader unfamiliar with the case needed to know, given we did mention that Dr. Koren was disciplined by the Hospital for Sick Children, the University of Toronto (the first time), and the College of Physicians and Surgeons (Ontario). 5. Apotex’s Legal Warnings/Threats Against Dr Olivieri Gallie et al. charge “The Time line does not mention that Apotex sent a whole series of legal warnings”. This is simply false. In fact, we mention these legal warnings on three separate occasions. Examination of the time line will reveal that we indicate:
a) the initial legal warning Apotex made against Dr Olivieri,
b) a subsequent legal threat made by Michael Spino, and
c) Dean Aberman’s request to Apotex to stop their legal threats ([2], see p.3, time line headings ‘May 1996’ and ‘June 1996’). It is incorrect and misleading to say that this information was omitted from the Introduction. 6. The Relationship Between Apotex and the University of Toronto Gallie et al. charge that “The Time line also omits that, simultaneously, the university and Apotex were in negotiations for a multimillion-dollar donation to enable the university to build a new biomedical science”. Because of space considerations we choose to present this information not in the timeline, but in section III of the Introduction. In fact, we explicitly state in the Introduction that ‘…at the time of the Olivieri Affair, Apotex was in discussions with the University of Toronto about a multimillion dollar donation’ ([2], p.6). Moreover, in the same section, we also explicitly state the involvement of the president of the university with Apotex. We state that “… the president of the University of Toronto had lobbied the Prime Minister of Canada on behalf of Apotex in 1999 [and] there was a major outcry and further talk of distrust of close ties between public institutions and corporate interests” ([2], p.6). If the crux of Gallie et al’s complaint is that this information should have appeared in the time line and not in the next section of the Introduction, it would seem that such a complaint is trivial and unreasonable. What is of importance is that this information was included in the Introduction. It is simply erroneous and misleading to give the impression that such information was omitted from the Introduction. 7. Providing Information about a Disease in a Bioethics Article Gallie et al. seem to find it problematic that the Introduction included basic scientific information about thalassemia (for the purposes of informing those readers who may not be familiar with the disease). The problem seems to stem from the fact that the Introduction was not written by scientific experts in the disease, and somehow this fact is supposed to relate to "fudging the ethics". Firstly, we never claimed to be experts on thalassemia (although one of the authors does have a medical degree). The purpose of including such information was to provide general, background information about the disease, its treatment, and the impetus for the research for an oral iron chelator. In reality, Gallie et al’s mention (on two occasions) that the authors of the Introduction are not experts in thalassemia is a fallacious attempt to discredit the Introduction without warrant. (It is an instance of an argumentum ad verecundiam fallacy, for those interested in logic). The fact that the authors are not experts in thalassemia has absolutely no baring on the putative errors Gallie et al. seem to find with the Introduction. It would be just as silly for me to argue that since Gallie et al. are not moral experts or possess a PhD in philosophy that they should not be able to comment on ethical matters. Now, if there is an error about the scientific information included that is grossly misleading about thalassemia and its treatment, then that would be an issue worthy of mention and deserving correction. However, since they fail to mention any such errors one can only assume that this is not the source of the problem. Secondly, it does not follow that one needs to be a scientific expert to provide general information on a disease or its treatment. We were not providing expert opinion on the topic. We were not making pronouncements about an issue where thalassemia experts in the field disagree or where there is a high level of uncertainty. In fact, in this information we cite Dr Olivieri’s work, and one of her supporters, Dr David Weatherall, as authorities in the field. If the inclusion of basic, background information about a disease in the context of a bioethics article is problematic, many bioethicists are certainly guilty of this! 8. Omitting the “Fundamental Ethics Issue” Gallie et al. conclude their letter by returning to the alleged omission that we did not mention the “fundamental ethical issue”, viz., informed consent and patient safety. If one examines the concluding paragraph of the Introduction, we covered all of the issues Gallie et al. say we omitted. Gallie et al. state “Dr Olivieri identified a risk of lack of sustained efficacy and therefore possible harm, and insisted on informed patient consent and valid clinical trials to address the potential harms.” In fact, we acknowledge this to be the case ([2], pp. 2-3, time line heading ‘March 1996’). This information was not omitted from the Introduction. Gallie et al. also state “Apotex prematurely terminated the trials and repeatedly tried to silence her with legal warnings”. In fact, we also acknowledge this to be the case ([2], pp. 2-3). This information was not omitted from the Introduction. Gallie et al. conclude that “The fundamental ethical issue is the failure of Dr Olivieri’s hospital and university to support her ethically correct approach to clinical science.” In section III, we state that ‘HSC and U of T should have supported Dr Olivieri more... and protected her ability to do what she thought (and had sufficient warrant to believe) was required by a morally responsible researcher’ ([2], p.6). Although we tried to deal only with descriptive matters in the Introduction (leaving the evaluative judgments for contributors), even we could not resist making this conclusion. I am unsure as to why Gallie et al. fail to see it. 9. Concluding Remarks We certainly welcome more input from those individuals involved with the Olivieri Affair. As it states in the Introduction, “there are many lessons to be learnt from the Olivieri Affair. We hope this symposium will begin a fair and productive examination of these which will lead to better ethical evaluation and regulation of research, not just in North America but globally” ([2], p.6). However, what is quite unhelpful is input that asserts demonstrably false and misleading accusations. No one benefits from this. That being said, Gallie et al. do raise a few legitimate points that will be of interest to those interested in the Olivieri Affair (I have noted where I believe these few points have been made). I thank them for elucidating these points. It is the rest of their letter, however, I find of little value. According to the Oxford English Dictionary, a symposium is a “meeting or conference for discussion of some subject; hence, a collection of opinions delivered, or a series of articles contributed, by a number of persons on some special topic” [8]. However, it is more than this. A symposium, an institution dating back at least to ancient Greece, is not merely a collection of opinions on the same topic, but a co-operative attempt to engage in dialogue to elucidate the problem or issues under consideration. It is foolhardy to think one could isolate individual components of a symposium as ‘mini-attempts’ to provide a complete picture or answer to all questions or issues. For instance, that would be like reading Plato’s Symposium without reading all of the speeches or reading one of the speeches as being representative of the whole story! Attempting to pull out individual contributions as being disconnected from the whole is to take a wrongheaded view. Taken as a whole, the Olivieri symposium meets its aim of being a fair and productive examination of the events and issues involved. The Introduction contributes to it being so.

References

1. Gallie BL, Durie P, Ranalli P, Dick J, Chan HSL. Introduction to the Olivieri Symposium – Don’t Fudge the Ethics [electronic response to Viens and Savulescu; Introduction to The Olivieri symposium] jmedethics.com 2004http://jme.bmjjournals.com/cgi/eletters/30/1/1#169 2. Viens AM, Savulescu J. Introduction to The Olivieri symposium. J Med Ethics 2004;30(1):1-7. 3. Naimark A, Knoppers B, Lowy F. Clinical trials of L1 (deferiprone) at The Hospital for Sick Children: a review of the facts and circumstances. Toronto: Hospital for Sick Children; 1998. 4. Thompson J, Baird P, Downie J. Report of the Committee of Inquiry on the case involving Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex, Inc. Toronto: James Lorimer and Company Ltd; 2001. 5. The College of Physicians and Surgeons of Ontario Complaints Committee: Decision and Reasons. Claimant: Dr. Laurence Becker; respondent: Dr. Nancy Olivieri. Dec 19: No 44410. 2001. 6. Schafer A. Biomedical conflict of interest: a defence of the sequestration thesis – learning from the cases of Nancy Olivieri and David Healy. J Med Ethics 30(1):8-24. 7. Jenkins K. Re-thinking History. 1991. London: Routledge. 8. Oxford English Dictionary. 2003. Oxford: Oxford University Press.