Patient Safety, Conflict of Interest, and Academic Integrity: the Olivieri Affair
An open letter to the Canadian bioethics community...
I've recently read the Summary of the Report (and sections of the Report itself), published by the Canadian Association of University Teachers and written by Jon Thompson (UNB), Patricia Baird (UBC), and Jocelyn Downie (Dalhousie), on the "Case Involving Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc." (The summary is 46 pages long; the report itself runs to 527 pages.)
The events chronicled in the Report are disturbing. The Report includes a detailed account of the relevant events, seventy-seven factual Findings (including significant findings of fault), and 31 Recommendations. The Recommendations imply a need for immediate action on the part of Canadian universities and teaching hospitals, granting agencies, and federal and provincial governments, to provide improved protection for research subjects within the context of research studies funded, fully or in part, by corporations.
The Thompson Report has a great deal to commend it. First, the authors are unflinching in their criticism of those whose actions were either neglectful or dishonest. This is crucial, since at least some of these instances of neglect or dishonesty may have put research subjects at risk. The authors pull no punches in attributing blame to both persons and institutions. Further, the Report is, by all appearances, a fair and even-handed evaluation of the events in question. It gives credit where credit is due, even to those of whom it is strongly critical (including the President of U of T and the Dean of Medicine). Similarly, the authors, despite being strongly supportive of Dr. Olivieri's decision to inform her patients of her worries regarding Deferiprone, are openly critical (p. 29) of her choice to sign the 1993 contract with Apotex, despite the inclusion of a confidentiality clause the terms of which were clearly problematic.
The Thompson report is not, of course, a perfect document. For example, the Report has troublingly little to say about the aspects of the Olivieri affair that relate to corporate ethics. Its observations in this regard are limited to a single paragraph (in Section B, Lessons to be Learned) entitled "For Industry" (pg. 18). This lacuna is not surprising, perhaps. The focus is primarily upon what went wrong at the University of Toronto and at one of its affiliated teaching hospitals, rather than upon what went on (or what may have gone on) behind closed corporate doors. And while the authors of the Report bring to bear considerable background and expertise in health care ethics and health law, they have no background in business ethics. I think this is an unfortunate gap. It seems that much of what went wrong in the Olivieri case has its roots in corporate practices; and no doubt part of the solution lies in helping pharmaceutical corporations establish ethically-appropriate 'best-practices' in the realm of research contracts. So this is a limitation of the Report; but it is by no means a fatal flaw.
I encourage all Canadian bioethicists -- and anyone else interested in the protection of human research subjects -- to familiarize themselves with the contents of the reports related to the Olivieri matter, including both the recent Thompson Report and the earlier Naimark Report (commissioned in 1998 by The Board of Trustees of the Hospital for Sick Children).
This is an issue of particular significance for the Canadian bioethics community. As perhaps the most notorious scandal related to the well-being of Canadian research subjects to come to light in the last decade, the Olivieri affair -- and the Thompson Report -- should serve as a catalyst, as an opportunity for the bioethics community to play a vocal, public role. We are called upon to protect research subjects. If we do not have the expertise, and the authority, to comment on this case, in the hopes of preventing further such tragedies, who does? Further, we should be interested not just because the subject matter is of academic interest, but because of the role played by ethicists in this and other controversies. The Thompson Report comments on the role played by bioethicists in the Olivieri affair, and makes recommendations for ensuring that bioethicists are provided with the working conditions conducive to the special role they are called upon to play within health care institutions (see pgs. 19, 43, 45, 210, 250 of the Report).
If you believe, as I do, in the importance of this matter, here's how you can help:
It is crucial that these reports (especially the later, more comprehensive Thompson Report) be read, and taken seriously, by people with the power to implement their recommendations. I suggest that you consider writing (via regular mail, fax, or e-mail) to one or more of the key people listed under "Key Contacts" above. I've provided as much contact information as I can. In addition, consider writing to the president of your own university and/or health care institution. The Thompson Report contains lessons for all institutions involved in health-related research.
Feel free to make use of -- to copy and modify -- one of the letters found under "Sample Letters" above. These are provided in order to make it easier for you to take action. Now is a time when we can all use a little help in doing the right thing.
Chris MacDonald, Ph.D. (firstname.lastname@example.org)
Note: A version of this letter also appears in Vol. 7, No. 1 of the Newsletter of the Canadian Bioethics Society.