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

Neil R. Cashman, Michael G. Tyshenko, Ricky Cheung, Willy Aspinall, Michelle Wong, Daniel Krewski

Research output: Contribution to journalArticle (Academic Journal)peer-review

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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.
Original languageEnglish
Pages (from-to)109-127
Number of pages19
JournalInternational Journal of Risk Assessment and Management
Issue number2
Early online date19 Jul 2019
Publication statusE-pub ahead of print - 19 Jul 2019

Bibliographical note

The acceptance date for this record is provisional and based upon the month of publication for the article.


  • prion disease
  • variant Creutzfeldt-Jakob disease
  • urine
  • recombinant
  • fertility
  • transmission
  • expert elicitation
  • uncertainties

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