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Case study 2

 

The case involving Dr Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotec Inc. (7–10)


In 1993, Dr Olivieri, a leading haematologist and researcher at the Hospital for Sick Children (Sick Kids), Toronto, signed a contract with the pharmaceutical giant, Apotec Inc. to sponsor her research studies on a new drug for patients with thalassaemia.

However, in 1995/6, Dr Olivieri became concerned about the safety of her subjects when her analyses suggested that the new drug could be ineffective, and might even accelerate liver damage. She informed Apotec that she would have to communicate these potential risks to her subjects.

Apotec disagreed with her findings, terminated her studies abruptly and issued repeated warnings of legal action if she were to disclose these risks without permission, as per their confidentiality agreement.

Nathan DG, Weatherall DJ. Academic Freedom in Clinical Research. New England Journal of Medicine. 2002 Oct 24;347(17):1368–71. Available from: https://doi.org/10.1056/NEJMsb020394

Schafer A. Biomedical conflicts of interest: a defence of the sequestration thesis-learning from the cases of Nancy Olivieri and David Healy. J Med Ethics. 2004 Feb;30(1):8–24. Available from: https://jme.bmj.com/content/30/1/8

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 Apotec Inc. [Internet]. Canadian Association of University Teachers; 2001 [cited 2019 Mar 4]. Available from: https://www.caut.ca/docs/af-reports-indepedent-committees-of-inquiry/the-olivieri-report.pdf?sfvrsn=0

Patricia Chisholm. Olivieri Medical Dispute Settled | The Canadian Encyclopedia [Internet]. The Canadian Encyclopedia. 2003 [cited 2019 Mar 4]. Available from: https://www.thecanadianencyclopedia.ca/en/article/olivieri-medical-dispute-settled

Answer the following question.

Multi-choice

Question

What would you do if you were Dr Olivieri? (Choose the best option)

Answers

Agree with your sponsor’s decisions and do nothing more.

Inform all the subjects straight away.

Consult the research ethics committee.

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