Nancy Olivieri

Last updated
Nancy Fern Olivieri
Born1954
Hamilton, Ontario
NationalityCanadian
Alma mater University of Toronto

McMaster University

Harvard University
Awards AAAS Award for Scientific Freedom and Responsibility (2009), John Maddox Prize (2023)
Scientific career
Fields Hematology
Institutions University of Toronto

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

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]

Awards and honours

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]

Olivieri is the 2023 recipient of the John Maddox Prize in recognition of her “determination to act with integrity…in the face of extreme pressure from the company producing it, ultimately at great personal cost” in the Deferiprone controversy. [14] The Maddox Prize is awarded by the UK-based Sense about Science charity in partnership with Nature (journal).

See also

Related Research Articles

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<span class="mw-page-title-main">Thalassemia</span> Family of inherited blood disorders

Thalassemias are inherited blood disorders that manifest as the production of reduced or zero quantities of hemoglobin. Symptoms depend on the type of thalassemia and can vary from none to severe, including death. Often there is mild to severe anemia as thalassemia can affect the production of red blood cells and also affect how long the red blood cells live. Symptoms of anemia include feeling tired and having pale skin. Other symptoms of thalassemia include bone problems, an enlarged spleen, yellowish skin, pulmonary hypertension, and dark urine. Slow growth may occur in children. Clinically, thalassemia is classed as Transfusion-Dependent Thalassemia (TDT) or non-Transfusion-Dependent Thalassemia (NTDT), since this determines the principal treatment options. TDT requires regular transfusions, typically every two to five weeks. TDTs include Beta-thalassemia major, nondeletional HbH disease, survived Hb Bart's disease, and severe HbE/beta-thalassemia. NTDT does not need regular transfusions but may require transfusion in case of an anemia crisis.

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Beta thalassemias are a group of inherited blood disorders. They are forms of thalassemia caused by reduced or absent synthesis of the beta chains of hemoglobin that result in variable outcomes ranging from severe anemia to clinically asymptomatic individuals. Global annual incidence is estimated at one in 100,000. Beta thalassemias occur due to malfunctions in the hemoglobin subunit beta or HBB. The severity of the disease depends on the nature of the mutation.

<span class="mw-page-title-main">Apotex</span> Canadian pharmaceutical company

Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding CA$2.5 billion. By 2023, Apotex employed close to 8,000 people as Canada's largest drug manufacturer, with over 300 products selling in over 115 countries. Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure.

Gideon Koren, FACMT, FRCP(C) is an Israeli-Canadian pediatrician, clinical pharmacologist, toxicologist, and a composer of Israeli folk music. He was a doctor at the Hospital for Sick Children and a professor at the University of Toronto. In 1985, Koren founded the Motherisk Program in Toronto, which was later shut down amid controversy. Furthermore, multiple scientific papers authored by Koren have been subject to concerns regarding academic and research misconduct, leading to the retraction of six research articles and editorial expression of concerns on multiple others. Koren currently has relinquished his licence to practice medicine due to an ongoing investigation into whether he committed “professional misconduct or was incompetent” while he was in charge of the Hospital for Sick Children’s Motherisk laboratory.

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Deferiprone, sold under the brand name Ferriprox among others, is a medication that chelates iron and is used to treat iron overload in thalassaemia major. It was first approved and indicated for use in treating thalassaemia major in 1994 and had been licensed for use in the European Union for many years while awaiting approval in Canada and in the United States. On 14 October 2011, it was approved for use in the US under the FDA's accelerated approval program.

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<span class="mw-page-title-main">Delta-beta thalassemia</span> Medical condition

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References

  1. 1 2 3 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. 1 2 "'Uncle Red': Barton Street's kid doctor". thespec.com. August 21, 2011.
  3. 1 2 "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. 1 2 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
  14. ↑ Cressey, Daniel. "Scientists honoured for facing down lawsuits to reveal findings". Research Professional News. Retrieved 25 October 2023.

Further reading

July 2024 mention in Indian Journal of Medical Ethics Founding member of charity RxISK.org which power blogs Rxisl blog and David Healy blog

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