Psychiatric Drug Facts via :

“Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems… Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision.” Dr. Peter Breggin

Jun 9, 2012

Medical Research Ethics Exemplar: Nancy Olivieri

via FAIR Protecting Whistleblowers Who Protect The Public Interest:
Medical Research Ethics Exemplar Dr. Nancy Olivieri Honoured
"On Friday 25th May, Dr. Nancy Olivieri received an honorary degree from the Faculty of Medicine at the University of Dalhousie. This is the most recent of numerous honours and awards that Olivieri has received over the years.

"The university recognized Olivieri "...for taking a courageous stand that helped bring issues of medical ethics to the forefront of our collective consciousness, and for her national and international research in blood disorders. In both of these realms, Dr. Olivieri has chosen to look beyond herself in order to advance the greater good." read more  

via The American Association for the Advancement of Science
"Triple A-S" (AAAS), is an international non-profit organization dedicated to advancing science around the world by serving as an educator, leader, spokesperson and professional association. In addition to organizing membership activities, AAAS publishes the journal Science, as well as many scientific newsletters, books and reports, and spearheads programs that raise the bar of understanding for science worldwide."  

AAAS Award for Scientific Freedom and Responsibility
2009 Award Recipient Nancy Olivieri, M.D.

Nancy Olivieri is honored for her indefatigable determination that patient safety and research integrity come before institutional and commercial interests and for her courage in defending these principles in the face of severe consequences.

The AAAS Award for Scientific Freedom and Responsibility, established in 1980, honors scientists, engineers, and their organizations whose exemplary actions, sometimes taken at significant personal cost, have served to foster scientific freedom and responsibility. The recipient receives $5,000 and a commemorative plaque.

In 1997, while conducting a clinical trial of a drug that showed promise in improving the lives of patients suffering from thalassemia—a blood disorder that can be fatal if not treated—Dr. Olivieri discovered possibly life-threatening side effects of the medication. She informed the pharmaceutical company of this risk and of her intention to notify the hospital’s Research Ethics Board, her patients, and other clinicians. The company, disagreeing with her findings, informed Dr. Olivieri that such actions would be in violation of a confidentiality agreement she had signed and that they would seek “legal remedies” if she carried out her intentions.

After publishing her findings, she suffered a series of adverse actions from the company and the hospital, including being relieved of one of her positions and referral to a physicians’ disciplinary board. The press received anonymous letters accusing her of misconduct, later traced to a colleague who received money from the company. The university where she had an appointment, which had been promised a large donation by the company, supported her only after an investigation by the Canadian Association of University Teachers completely vindicated her, as did the physicians’ board. Dr. Olivieri continues to fight legal battles brought against her by the drug company.

Her struggle in defending these principles has brought world attention to the importance of scientific integrity for public health and safety. Editors of leading biomedical journals have imposed new publishing standards, the university changed its policies on industry-supported research, and her findings regarding the drug have stood.

Dr. Olivieri currently serves as a Senior Scientist and Director of the Hemoglobinopathy Program at the University Heath Network and a Professor of Pediatrics, Medicine and Public Health Sciences at the University of Toronto, Canada.

More on Dr. Olivieri's story via The Journal of Medical Ethics
The Olivieri symposium
The Olivieri debacle: where were the heroes of bioethics?
F Baylis Correspondence to:
 Professor F Baylis
 Department of Bioethics and Department of Philosophy, Dalhousie University, Halifax, Nova Scotia, Canada B3H 4H7;
an excerpt: 
In 1998, as the controversy involving Dr Olivieri, the HSC, the University of Toronto, and Apotex continued to escalate, the board of the HSC mandated a review of the facts and circumstances in the controversy. Dr Arnold Naimark agreed to conduct the review. Part way through the review process, because of ongoing controversy about his perceived conflicts of interest as well as concerns about the legitimacy of a single person review committee, he appointed two associate reviewers well known to the Canadian bioethics community, Professor Bartha Maria Knoppers and Dr Frederick Lowy.
The final report of the Naimark committee, submitted in November 1998, suggests that the role of bioethics in helping to resolve the controversy was, at best, very limited. In a 160 page document, there are but a few paragraphs that discuss the role of bioethics:

Dr Buchwald [director of the HSC Research Institute] had asked Ms Mary Rowell, bioethicist, for assistance in understanding the issues involved in the controversy. On June 29, 1998, Dr Buchwald clarified the terms under which he had asked Ms Rowell to assist him. He stated: “I need to understand the perceptions of the issues by each party and their views regarding the chronology of what occurred. I asked you to determine what would be perceived as an appropriate process
to resolve the issues ... and to make recommendations to me on how to proceed with the resolution... . I also asked that you be prepared to advise me regarding your view of any ethical issues that may come to light and also the process for solving them and preventing a future occurrence...”.In the latter part of August, 1998 Ms Rowell wrote to Dr Goldbloom [vice president, academic and clinical development] and Mr Strofolino [president and chief executive offier (CEO) of HSC] about the mounting controversy. She touched on the various issues and grievances that had been raised about the Apotex/Olivieri affair and outlined the steps needed to resolve the crisis. She indicated that there was considerable dismay about management’s unresponsiveness and resistance to mediation of the issues. The damage being done to the reputation of the hospital was particularly worrisome.9

Another noteworthy feature of the final report submitted by the Naimark committee is the absence of any comment on the roles and responsibilities of the bioethics department at HSC and the Joint Centre for Bioethics at the University of Toronto (of which the HSC bioethics department is an affiliate member). One possible explanation for this omission is that while the Naimark committee knew of Ms Rowell’s involvement in the case, they did not know there was a bioethics department at HSC (and so did not contact the director, Dr Christine Harrison), and did not know of any formal affiliation agreement between the HSC and the Joint Centre for Bioethics (and so did not contact the director, Dr Peter Singer). (Neither C Harrison, director of the bioethics department at HSC, nor P Singer, director of the Joint Centre for Bioethics at the University of Toronto, are among those included in the list of contacts in the Naimark final report.)

This explanation is, however, implausible. Dr Frederick Lowy—an associate reviewer with the Naimark committee—was the founding director of the Joint Centre for Bioethics (indeed, this fact added to the original concerns about conflict of interest with the review process). Dr Lowy initiated the process that led to the HSC bioethics department becoming an affiliate member of the Joint Centre of Bioethics. As well, the other associate team member, Professor Knoppers, was very familiar with the work of the bioethics department and the Joint Centre for Bioethics. Therefore, knowledge of the scope and nature of bioethics practice within HSC and its relation to the Joint Centre for Bioethics, was available to the Naimark committee. Thus, ignorance of the bioethics resources available at HSC and the University of Toronto cannot explain the Naimark committee’s failure to meet with, and report on, the contributions (or lack thereof) of the directors of the HSC bioethics department and the University of Toronto’s Joint Centre for Bioethics.

A second possible explanation for this omission is that the director of the HSC bioethics department and the director of the Joint Centre for Bioethics were not involved in the case and so there was nothing on which to report. In 1999, the Canadian Association of University Teachers commissioned an independent committee of inquiry to investigate the case involving Dr Olivieri. The committee of inquiry issued its findings in 2001 and, by most accounts, this 540 page document is a more accurate, careful, and complete report of the facts and circumstances than the earlier 160 page report published by the Naimark committee. The committee of inquiry report confirms that Dr Harrison, the director of the bioethics department at HSC, was not involved in the case (Thompson J, et al,1 p 257). This left the more junior member of the department, Ms Rowell, to deal with the issues alone. This fact is striking when one considers that Ms Rowell has reported that “she was treated so rudely by the hospital executive when she raised concerns about the Olivieri affair that she considered resigning”.10 Indeed, she did eventually resign.

As for any possible involvement in the Olivieri dispute by the Joint Centre for Bioethics, the committee of inquiry concluded that “The Joint Centre, as a centre, appears not to have been engaged or to have spoken publicly on the controversy. Its silence is hard to understand” (Thompson J, et al,1 p 258). Further, Dr Singer, the director of the Joint Centre for Bioethics, declined the invitation to meet with the committee of inquiry. Reflecting on this, the committee of inquiry reported:

The Joint Centre for Bioethics is a partnership between the university and a number of health care institutions. Staff bioethicists of HSC and other hospitals are members of the joint centre. Its website states: “Our mission is to provide leadership in bioethics research, education, and clinical activities”. The efforts by Apotex to deter Dr Olivieri from informing patients about risks she had identified, and the lack of effective support for her by HSC and the university, gave rise to one of the most significant and highly publicised bioethical disputes in Canada in many years. Yet the Joint Centre for Bioethics appears not to have provided leadership in this matter.Dr Peter Singer, director of the joint centre, declined to meet with this committee of inquiry and, instead, informed us in writing that: “The involvement of the joint centre was through the work of two of its members–Dr Christine Harrison and Professor Mary Rowell–who are the Bioethicists at the Hospital for Sick Children. I understand that they have already met with you in this matter.” (Thompson J, et al,1 p 257)

Dr Singer is a senior figure in Canadian bioethics. His decision not to meet with the committee of inquiry and to remain silent is difficult to understand, especially in view of the centre’sStatement of Mission, Vision, Values and Goals which states: “Our mission is to provide leadership in bioethics research, education, and clinical activities... . The JCB does not advocate positions on specific issues, although its individual members may do so”.11

Ms Rowell has also chosen to remain silent and she has never publicly told her story. The closest she has come to doing so was at the 13th Annual meeting of the Canadian Bioethics Society in the fall of 2001. During the question period, after a plenary lecture entitled A Reflection on the “Place” of Bioethics12 criticising the Canadian bioethics community at large for its silence on two internationally prominent ethics cases originating in Toronto—one involving Dr Nancy Olivieri, the other involving Dr David Healy 13, 14—Ms Rowell spoke passionately from the floor about the unbearable stress and lack of institutional support she experienced while involved in this case in her official capacity as bioethicist. She indicated that she had no choice but to leave her position at the hospital.

When Ms Rowell spoke at the Canadian Bioethics Society annual meeting, I was reminded of an observation made by my friend and colleague, Dr Benjamin Freedman, in his writings on bioethical heroism: “Working at the intersection between conflicting claims of patients, staff, and administration, bioethicists must often find themselves under pressure to compromise their ideals, to ‘get along by going along’”.15 What pressure had Ms Rowell been under? Where had it come from? How unbearable had it been? At what point had she come to believe that she had (perhaps unintentionally) compromised her ideals? Was she living with moral residue?16

And, what about the director of the bioethics department, Dr Christine Harrison, and the rest of the Canadian bioethics community? At no time has Dr Harrison spoken publicly about her involvement in this case. It is known, however, that she did not speak publicly about the case or the issues raised by the case and furthermore that she was a member of the ad hoc subcommittee of the medical advisory committee (MAC) of the Hospital for Sick Children—the committee that advises the board of trustees on disciplinary action against staff physicians. The MAC established a fact finding subcommittee following receipt of the Naimark report. The significant limitations of the subcommittee’s review are discussed in the 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 (Thompson J, et al,1 p 336).

As for the non-response from the Canadian bioethics community at large, while initially only two members of the bioethics community, Dr Harrison and Ms Rowell, may have had intimate knowledge of the events at HSC, by the fall of 1998 there was considerable information in the public domain to which other members of the Canadian bioethics community could have responded. Only one person, however, is known to have taken up the cause: Professor Arthur Schafer, the director of the Centre for Professional and Applied Ethics at the University of Manitoba. At the invitation of Dr Olivieri and colleagues, Professor Schafer became actively involved in the controversy. He participated in news conferences and media interviews. He also participated in two fund-raising events organised by Doctors for Research Integrity to help pay the mounting legal bills of Dr Olivieri and her colleagues. For each of these events he prepared a report: Medicine, Morals and Money: the High Road or the Bottom Line (A Schafer, unpublished ms, 1998) and later Medicine, Morals and Money: Dancing with Porcupines or Sleeping beside Elephants (A Schafer, unpublished ms, 2001).

Less well known is the fact that a group of bioethicists at Dalhousie University, including myself, wrote to the president of the HSC, the dean of the faculty of medicine at the University of Toronto, and the director of the University of Toronto Joint Centre for Bioethics (copied to a number of individuals including all three members of the Naimark committee), asking them to clarify their respective institution’s policies and commitments in relation to the physician/researcher’s duty to disclose risks to research participants and the freedom of bioethicists to speak out against unethical practices. In this letter we were careful not to take a position on the merits of the specific case, as not all of the relevant facts were known to us. Rather, this was a carefully worded letter with several objectives: to let these institutions know that members of the bioethics community were watching the case, to elicit certain facts relevant to our concerns, and to show support for our bioethics colleagues. We wrote:

... bioethicists have professional responsibilities that must never be compromised by the conditions of their employment. These responsibilities include preventing unethical behaviour, where possible, confronting such behaviour if it does occur, and further ensuring that measures are introduced to preclude the recurrence of unethical behaviour. These obligations may require bioethicists to advocate on behalf of persons or for a particular position on a controversial issue and, if other means have failed, to draw public attention to the matter. The institutions for which bioethicists work or with which they have formal affiliation must support bioethicists when they engage in debate and speak out against unethical practices, so that the professional integrity of bioethicists is not compromised (correspondence with M Strofolino, A Aberman and P Singer, 26 November 1998).

The president of the HSC, the Dean of the faculty of medicine, the director of the Joint Centre for Bioethics and others answered our letter. The response from the HSC was brief:

We are confident that the policies and practices at the Hospital for Sick Children support the integrity of research and of our bioethicists. However, we have chosen not to respond publicly on these other related issues until after Dr Naimark submits his report (correspondence from Mr M Strofolino, 3 December 1998).

After the Naimark report was published we sent a follow up letter to the president. This letter was referred to Dr Buchwald. His response was equally brief and he suggested we consult theTri-Council Policy Statement on Ethical Conduct for Research Involving Humans (national guidelines for all research involving humans). Similarly, the original responses from the dean of medicine and the director for the Joint Centre for Bioethics directed us to various policy documents. None of the letters directly engaged the substance of our letter.

For complicated (and perhaps ultimately indefensible) reasons, we decided not to pursue further communication. Instead, we returned to our academic pursuits and published on the roles and responsibilities of bioethicists. In retrospect, I believe this was a mistake. 

read here
video is cued up to Dr. Olivieti's acceptance speech upon receiving an honorary degree from University of Dalhousie

watch here 
credit it for angel doctor in scrubs 

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