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Title: Prion disease risk uncertainties associated with urine-derived and recombinant fertility drugs

Authors: Neil R. Cashman; Michael G. Tyshenko; Ricky Cheung; Willy Aspinall; Michelle Wong; Daniel Krewski

Addresses: Department of Neurology, Faculty of Medicine, Vancouver Coastal Health, University of British Columbia, Canada ' McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, 600 Peter Morand, Ottawa, ON, K1G 3Z7, Canada ' Health Canada, 100 Eglantine Driveway, Ottawa, Ontario K1A 0K9, Canada ' Aspinall and Associates, Cleveland House, Tisbury, UK; Cabot Institute and School of Earth Sciences, Bristol University, Bristol, UK ' Office of Research, Faculty of Medicine, University of British Columbia, 317-2194 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada ' McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa, 600 Peter Morand, Ottawa, Ontario, K1G 3Z7, Canada; Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada; Risk Sciences International, 55 Metcalfe Street, Suite 700, Ottawa, ON K1P 6L5, Canada

Abstract: The detection of prion protein in widely used urine-derived fertility drugs has raised the possibility that prions from urine donors with (asymptomatic) prion disease could be present in these drugs. A high level of uncertainty exists regarding this issue. An international expert panel provided judgments related to prion disease transmission through fertility drug use in a structured expert elicitation. The elicitation gauged expert judgements about the uncertainty surrounding potential prion disease risks associated with urine-derived fertility drugs and emphasised the scientific ambiguity surrounding disease transmission risk factors associated with urine-derived fertility drugs. Group aggregated responses indicate that the theoretical risk of prion disease transmission with urine-derived fertility drugs was judged to be very low. The experts judged recombinant fertility drugs produced with bovine serum to possess 10-fold lower risk compared to urine-derived fertility drugs. Fertility drugs made without fetal bovine serum were judged to present a risk approximately 1,200 times lower compared to urine-derived counterparts. This elicitation indicates recombinant fertility drugs carry relatively less risk than urine-derived fertility drugs. However, the associated uncertainties are significant and pro-active surveillance of possible new routes of transmission of human prion disease warrants consideration of new scientific data as it becomes available.

Keywords: prion disease; variant Creutzfeldt-Jakob disease; urine; recombinant; fertility; transmission; expert elicitation; uncertainties.

DOI: 10.1504/IJRAM.2019.101292

International Journal of Risk Assessment and Management, 2019 Vol.22 No.2, pp.109 - 127

Received: 13 Dec 2018
Accepted: 14 Dec 2018
Published online: 30 Jul 2019 *