Hum. Reprod. Advance Access originally published online on July 29, 2005
Human Reproduction 2005 20(11):2994-2999; doi:10.1093/humrep/dei209
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OPINION |
Consensus statement on the bio-safety of urinary-derived gonadotrophins with respect to Creutzfeldt–Jakob disease
1 Professor of Reproductive Medicine and Surgery, Leeds General Infirmary, Leeds LS2 9NS, UK and 2 BL Consult ApS, Ingersvej 4, DK-2920 Charlottenlund, Denmark
3 To whom correspondence should be addressed. E-mail: Lumholtz{at}mail.com
Human transmissible spongiform encephalopathies (TSE) encompass a group of rare neurodegenerative diseases. In April 2004, a group of international experts and regulators met in Buenos Aires, Argentina, to review the safety and to reach consensus on the use of urinary-derived gonadotrophins with respect to TSE. Iatrogenic transmission of Creutzfeldt–Jakob Disease (CJD) from pituitary-derived gonadotrophins has been reported, no infectivity in urine has been demonstrated, and no definite cases of transmission via urine have been reported. It is currently not possible to monitor donor urine or finished product for the presence of prions. Therefore the assessment of risk has to be based on the likelihood of infection in urine, the source of the urine, and the capacity of the manufacturing process to remove any adventitious infection. Urine for the production of medicinal products should be obtained from sources that minimize the possible presence of materials derived from subjects suffering from human TSE. As no strong evidence for TSE infectivity in urine exists, it can be concluded that the risk of disease-generating prions and TSE infectivity being present in donor urine is low. Current evidence indicates that, with respect to the risk of TSE infection, urinary-derived gonadotrophins appear to be safe.
Key words: Creutzfeldt–Jakob disease (CJD)/ovulation induction/prion/transmissible spongiform encephalopathies (TSE)/urinary-derived gonadotrophin
* Chairman of the Conference on the Bio-safety of Urinary Derived Medicinal Products, April 26–27, 2004, Buenos Aires, Argentina. Chairmen, presenters and panelists in Buenos Aires: Dr D.Asher, Rockville, MD, USA (regulator); Prof. A.Balen, UK (reproductive physician), Dr S.Chen, Cleveland, OH, USA (neuroscientist); Dr A.Farrugia, Woden, Australia (regulator); Prof. R.Gabizon, Jerusalem, Israel (neurologist); Prof. P.Gambetti, Cleveland, OH, USA (neuropathologist); Dr T.Hayakawa, Tokyo, Japan (regulator); Dr W.Keye, USA (reproductive physician); Dr R.Knight, Edinburgh, Scotland (neurologist); Dr I.B.Lumholtz, Copenhagen, Denmark (Chairman); Dr M.Macnaughton, Tranent, Scotland (toxicologist); Dr P.A.McAnulty, Copenhagen, Denmark (toxicologist); Dr R.Paulson, USA (reproductive physician); Prof. M.Pocchiari, Rome, Italy; Dr R.Rohwer, Baltimore, MD, USA (neurologist); Dr S.Ruiz, Madrid, Spain (regulator); Prof. J.Safar, San Francisco, CA, USA (neurologist); Dr D.Scott, Bethesda, MD, USA (regulator); Prof. A.Sunde, Trondheim, Norway (Chairman ESHRE); Dr A.L.Taratuto, Buenos Aires, Argentina (neuropathologist); Dr C.van Gelderen, Buenos Aires, Argentina (regulator); Dr L.Weber, Buenos Aires, Argentina (regulator); Prof. R.G.Will, Edinburgh, Scotland (neurologist); Prof. G.Zanusso, Verona, Italy (neurologist).