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Nancy Olivieri

January 07, 2023

Nancy Fern Olivieri (born 1954) is a prominent Toronto haematologist and researcher with an interest in the treatment of haemoglobinopathies. She is best known for a protracted struggle with the Hospital for Sick Children and the pharmaceutical company Apotex about the drug deferiprone.[1]

Early life

Olivieri was born to the Hamilton, Ontario, Doctor Fernando Olivieri and Victoria Olivieri.[2] Her paternal grandfather had immigrated to Hamilton from Italy in 1909.[2] Olivieri received a Bachelor of Science from the University of Toronto and an MD from McMaster University in 1978.[3] She has also pursued training in Internal Medicine and Hematology at McMaster, University of Toronto, and Harvard University.[3]

Deferiprone controversy

Starting in 1989, Olivieri was part of a group evaluating the use of a drug, deferiprone, in treating persons with the blood disorder thalassaemia.[1] Starting from 1985, this work included a clinical trial partly funded by Apotex. During the course of the trial, Olivieri became concerned about evidence that pointed to the drug being inefficacious for some patients. Olivieri informed both the research ethics board that was monitoring the study and Apotex, the drug maker. The research ethics board instructed Olivieri to inform participants about her concerns. Apotex responded by noting that Olivieri had signed a confidentiality agreement as part of the drug trial and that informing participants about her concerns, the validity of which Apotex disputed, would violate that confidentiality agreement. In 1996, Apotex threatened to vigorously pursue legal remedies against her if she disclosed her conclusions to patients.[1] Olivieri disclosed her concerns to her patients and Apotex ended the portion of the study in which she was participating. In 1998, the New England Journal of Medicine published a paper by Olivieri and seven other authors, with further study results suggesting that deferiprone led to progressive hepatic fibrosis.[4][5]

Olivieri's scientific findings, which sparked the controversy, have been challenged on the basis of data from clinical trials conducted by Apotex.[6][7][8]

Deferiprone is approved for use in over 50 countries, but not in Canada.[9] It was approved in the US in 2011 under the FDA's accelerated approval program.[10]

An investigation commissioned by the Canadian Association of University Teachers (CAUT) revealed that one of Olivieri's critics, Gideon Koren, had anonymously sent disparaging letters about Olivieri to the media and colleagues. Koren initially denied responsibility, but substantial DNA evidence tied him to the letters, and he was reprimanded.[11]

Olivieri has advocated greater academic freedom and called for less control of research by pharmaceutical companies.[12] This situation was publicised extensively and was investigated by the Canadian Association of University Teachers.[11] Olivieri was awarded the 2009 AAAS Award for Scientific Freedom and Responsibility 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."[13]

See also

References

  1. ^ a b c Viens A, Savulescu J (2004). "Introduction to The Olivieri symposium". J Med Ethics. 30 (1): 1–7. doi:10.1136/jme.2003.006577. PMC 1757126. PMID 14872065.
  2. ^ a b "'Uncle Red': Barton Street's kid doctor". thespec.com. August 21, 2011.
  3. ^ a b "Nancy Olivieri - Institute of Medical Science - University of Toronto". ims.utoronto.ca.
  4. ^ Olivieri NF, Brittenham GM, McLaren CE, et al. (1998). "Long-term safety and effectiveness of iron chelation therapy with oral deferiprone in patients with thalassemia major". N. Engl. J. Med. 339 (7): 417–428. doi:10.1056/NEJM199808133390701. PMID 9700174. Full Text.
  5. ^ Hadskis, Michael (2007). "The Regulation of Human Biomedical research in Canada". In Downie, Jocelyn (ed.). Canadian Health Law and Policy (textbook). et al. (Third ed.). LexisNexis. p. 304.
  6. ^ M.A. Tanner, MRCP; R. Galanello, MD; C. Dessi, MD; G.C. Smith, MSc; M.A. Westwood, MD; A. Agus, MD; M. Roughton, MSc; R. Assomull, MRCP; S.V. Nair, MRCP; J.M. Walker, MD; D.J. Pennell, MD (2007). "A Randomized, Placebo-Controlled, Double-Blind Trial of the Effect of Combined Therapy With Deferoxamine and Deferiprone on Myocardial Iron in Thalassemia Major Using Cardiovascular Magnetic Resonance". Circulation. 115 (14): 1876–1884. doi:10.1161/CIRCULATIONAHA.106.648790. PMID 17372174. Full Text.
  7. ^ Brittenham G, Nathan D, Olivieri N, Porter J, Pippard M, Vichinsky E, Weatherall D (2003). "Deferiprone and hepatic fibrosis". Blood. 101 (12): 5089–90, author reply 5090–1. doi:10.1182/blood-2002-10-3173. PMID 12788794. Full Text.
  8. ^ Wanless I, Sweeney G, Dhillon A, Guido M, Piga A, Galanello R, Gamberini M, Schwartz E, Cohen A (2002). "Lack of progressive hepatic fibrosis during long-term therapy with deferiprone in subjects with transfusion-dependent beta-thalassemia". Blood. 100 (5): 1566–9. doi:10.1182/blood-2002-01-0306. PMID 12176871. Full Text.
  9. ^ Savulescu J (2004). "Thalassaemia major: the murky story of deferiprone". BMJ. 328 (7436): 358–9. doi:10.1136/bmj.328.7436.358. PMC 341373. PMID 14962851. Full Text.
  10. ^ FDA NEWS RELEASE: FDA Approves Ferripox (deferiprone) to Treat Patients with Excess Iron in the Body, Oct. 14, 2011 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm275814.htm
  11. ^ a b Jon Thompson; Patricia Baird; Jocelyn Downie, 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. (PDF), www.caut.ca, retrieved 8 December 2015
  12. ^ Olivieri N (2003). "Patients' health or company profits? The commercialisation of academic research". Sci Eng Ethics. 9 (1): 29–41. doi:10.1007/s11948-003-0017-x. PMID 12645227. S2CID 32796175.
  13. ^ http://www.aaas.org/aboutaaas/awards/freedom/freedom2009.shtml

Further reading

 
Scholia has a profile for Nancy Fern Olivieri (Q3335572).
  • Naylor, C.D.; The Research Committee Clinical Study Agreements Working Group of the Toronto Academic Health Science Council (2002), "Early Toronto experience with new standards for industry-sponsored clinical research: a progress report", Canadian Medical Association Journal, 166 (4): 453–456, PMC 99356, PMID 11873924

External links

January 07, 2023
nancy, olivieri, nancy, fern, olivieri, born, 1954, prominent, toronto, haematologist, researcher, with, interest, treatment, haemoglobinopathies, best, known, protracted, struggle, with, hospital, sick, children, pharmaceutical, company, apotex, about, drug, . Nancy Fern Olivieri born 1954 is a prominent Toronto haematologist and researcher with an interest in the treatment of haemoglobinopathies She is best known for a protracted struggle with the Hospital for Sick Children and the pharmaceutical company Apotex about the drug deferiprone 1 Contents 1 Early life 2 Deferiprone controversy 3 See also 4 References 5 Further reading 6 External linksEarly life EditOlivieri was born to the Hamilton Ontario Doctor Fernando Olivieri and Victoria Olivieri 2 Her paternal grandfather had immigrated to Hamilton from Italy in 1909 2 Olivieri received a Bachelor of Science from the University of Toronto and an MD from McMaster University in 1978 3 She has also pursued training in Internal Medicine and Hematology at McMaster University of Toronto and Harvard University 3 Deferiprone controversy EditStarting in 1989 Olivieri was part of a group evaluating the use of a drug deferiprone in treating persons with the blood disorder thalassaemia 1 Starting from 1985 this work included a clinical trial partly funded by Apotex During the course of the trial Olivieri became concerned about evidence that pointed to the drug being inefficacious for some patients Olivieri informed both the research ethics board that was monitoring the study and Apotex the drug maker The research ethics board instructed Olivieri to inform participants about her concerns Apotex responded by noting that Olivieri had signed a confidentiality agreement as part of the drug trial and that informing participants about her concerns the validity of which Apotex disputed would violate that confidentiality agreement In 1996 Apotex threatened to vigorously pursue legal remedies against her if she disclosed her conclusions to patients 1 Olivieri disclosed her concerns to her patients and Apotex ended the portion of the study in which she was participating In 1998 the New England Journal of Medicine published a paper by Olivieri and seven other authors with further study results suggesting that deferiprone led to progressive hepatic fibrosis 4 5 Olivieri s scientific findings which sparked the controversy have been challenged on the basis of data from clinical trials conducted by Apotex 6 7 8 Deferiprone is approved for use in over 50 countries but not in Canada 9 It was approved in the US in 2011 under the FDA s accelerated approval program 10 An investigation commissioned by the Canadian Association of University Teachers CAUT revealed that one of Olivieri s critics Gideon Koren had anonymously sent disparaging letters about Olivieri to the media and colleagues Koren initially denied responsibility but substantial DNA evidence tied him to the letters and he was reprimanded 11 Olivieri has advocated greater academic freedom and called for less control of research by pharmaceutical companies 12 This situation was publicised extensively and was investigated by the Canadian Association of University Teachers 11 Olivieri was awarded the 2009 AAAS Award for Scientific Freedom and Responsibility 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 13 See also EditList of whistleblowersReferences Edit a b c Viens A Savulescu J 2004 Introduction to The Olivieri symposium J Med Ethics 30 1 1 7 doi 10 1136 jme 2003 006577 PMC 1757126 PMID 14872065 a b Uncle Red Barton Street s kid doctor thespec com August 21 2011 a b Nancy Olivieri Institute of Medical Science University of Toronto ims utoronto ca Olivieri NF Brittenham GM McLaren CE et al 1998 Long term safety and effectiveness of iron chelation therapy with oral deferiprone in patients with thalassemia major N Engl J Med 339 7 417 428 doi 10 1056 NEJM199808133390701 PMID 9700174 Full Text Hadskis Michael 2007 The Regulation of Human Biomedical research in Canada In Downie Jocelyn ed Canadian Health Law and Policy textbook et al Third ed LexisNexis p 304 M A Tanner MRCP R Galanello MD C Dessi MD G C Smith MSc M A Westwood MD A Agus MD M Roughton MSc R Assomull MRCP S V Nair MRCP J M Walker MD D J Pennell MD 2007 A Randomized Placebo Controlled Double Blind Trial of the Effect of Combined Therapy With Deferoxamine and Deferiprone on Myocardial Iron in Thalassemia Major Using Cardiovascular Magnetic Resonance Circulation 115 14 1876 1884 doi 10 1161 CIRCULATIONAHA 106 648790 PMID 17372174 Full Text Brittenham G Nathan D Olivieri N Porter J Pippard M Vichinsky E Weatherall D 2003 Deferiprone and hepatic fibrosis Blood 101 12 5089 90 author reply 5090 1 doi 10 1182 blood 2002 10 3173 PMID 12788794 Full Text Wanless I Sweeney G Dhillon A Guido M Piga A Galanello R Gamberini M Schwartz E Cohen A 2002 Lack of progressive hepatic fibrosis during long term therapy with deferiprone in subjects with transfusion dependent beta thalassemia Blood 100 5 1566 9 doi 10 1182 blood 2002 01 0306 PMID 12176871 Full Text Savulescu J 2004 Thalassaemia major the murky story of deferiprone BMJ 328 7436 358 9 doi 10 1136 bmj 328 7436 358 PMC 341373 PMID 14962851 Full Text FDA NEWS RELEASE FDA Approves Ferripox deferiprone to Treat Patients with Excess Iron in the Body Oct 14 2011 https www fda gov NewsEvents Newsroom PressAnnouncements ucm275814 htm a b Jon Thompson Patricia Baird Jocelyn Downie 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 PDF www caut ca retrieved 8 December 2015 Olivieri N 2003 Patients health or company profits The commercialisation of academic research Sci Eng Ethics 9 1 29 41 doi 10 1007 s11948 003 0017 x PMID 12645227 S2CID 32796175 http www aaas org aboutaaas awards freedom freedom2009 shtmlFurther reading Edit Scholia has a profile for Nancy Fern Olivieri Q3335572 Naylor C D The Research Committee Clinical Study Agreements Working Group of the Toronto Academic Health Science Council 2002 Early Toronto experience with new standards for industry sponsored clinical research a progress report Canadian Medical Association Journal 166 4 453 456 PMC 99356 PMID 11873924External links EditNancy F Olivieri BSc MD FRCPC University Health Network Research Hemoglobal a charitable organization founded by Nancy Olivieri and David Weatherall Retrieved from https en wikipedia org w index php title Nancy Olivieri amp oldid 1072533424, wikipedia, wiki, book, books, library,

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