Nancy Fern Olivieri

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Nancy Fern Olivieri, MD, FRCPC, 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]

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.[2][3]

Olivieri's scientific findings, which sparked the controversy, have been challenged on the basis of data from clinical trials conducted by Apotex.[4][5][6]

Deferiprone is approved for use in over 50 countries, but not in Canada.[7] It was approved in the US in 2011 under the FDA's accelerated approval program.[8]

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.[9]

Olivieri has advocated greater academic freedom and called for less control of research by pharmaceutical companies.[10] This situation was publicised extensively and was investigated by the Canadian Association of University Teachers.[9] 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."[11]

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 1757126Freely accessible. PMID 14872065. 
  2. ^ 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.
  3. ^ Hadskis, Michael (2007). "The Regulation of Human Biomedical research in Canada". In Downie, Jocelyn. Canadian Health Law and Policy (textbook). et al. (Third ed.). LexisNexis. p. 304. 
  4. ^ 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.
  5. ^ 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.
  6. ^ 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.
  7. ^ Savulescu J (2004). "Thalassaemia major: the murky story of deferiprone". BMJ. 328 (7436): 358–9. doi:10.1136/bmj.328.7436.358. PMC 341373Freely accessible. PMID 14962851.  Full Text.
  8. ^ FDA NEWS RELEASE: FDA Approves Ferripox (deferiprone) to Treat Patients with Excess Iron in the Body, Oct. 14, 2011 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm275814.htm
  9. ^ 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 
  10. ^ 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. 
  11. ^ http://www.aaas.org/aboutaaas/awards/freedom/freedom2009.shtml

Further reading

  • 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 

External links

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