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Investigating Research and Accessing Reproductive Material

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Notes

  1. The CAFÉ study compared three newer neuroleptic drugs (Zyprexa, Risperdal, and Seroquel) that in a previous study (the CATIE trial) had been found to be less effective and not better in terms of side effects than a traditional neuroleptic developed in the 1950s, perphenazine. The CATIE study was funded by the National Institutes of Mental Health (NIMH). It also was particularly unfavourable to Seroquel, AstraZeneca’s product. The CAFÉ study, in which Seroquel was tested at a different dosage, was funded by AstraZeneca. Commenting on the CAFÉ trial, Dr. Bernard Carroll, former chairman of the FDA Psychopharmacologic Drugs Advisory Committee and former chairman of the Department of Psychiatry at Duke University Medical Center, wrote: “I am struck by how the entanglement with a commercial entity has influenced the scientific agenda of these academic investigators. There is little doubt that AstraZeneca’s participation shaped the study design and the reporting” (Carlat 2010, under “Comments”). AstraZeneca’s use of other clinical trial reports has also been the object of much criticism and the company has been prosecuted in the United States for its promotional practices surrounding Seroquel, resulting in a US$647 million settlement (Feeley 2011). See the article by Carl Elliott (2010) in Mother Jones, which raises more general questions about the ethics of including research subjects in clinical trials that may amount to little more than marketing endeavours.

  2. Earlier related decisions include (but are not limited to): MAW v Western Sydney Area Health Service (2000) NSWLR 231, AB v Attorney-General for the State of Victoria [2005] VSC 180, In the matter of Gray [2000] QSC 390, Jocelyn Edwards; Re the estate of the Late Mark Edwards [2011] NSWSC 478, and Baker v State of Queensland [2003] QSC.

  3. See, for example: AB v Attorney-General for the State of Victoria (2005) 12 VR 485, Baker v State of Queensland [2003] QSC 2, and the extensive discussion of this in Re Section 22 of the Human Tissue and Transplant Act 1982 (WA) [2013] WASC 3, 2 January 2013.

  4. Jocelyn Edwards had at least three applications before the Courts and there is the series of cases represented by AB v Attorney-General for the State of Victoria [2005] USC 180 and YZ v Infertility Treatment Authority [2005] VCAT 2655 which dealt with a series of applications by a woman who wanted to access stored sperm and remove it to the ACT where she believed she could obtain treatment.

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  1. Faculty of Law, University of Toronto, 39 Queen’s Park Crescent East, Toronto, Ontario, Canada, M5S 2C3

    Trudo Lemmens

  2. Law School, University of Adelaide, North Terrace, Adelaide, 5005, Australia

    Bernadette J. Richards

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  1. Trudo Lemmens
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  2. Bernadette J. Richards
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Correspondence to Bernadette J. Richards.

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Lemmens, T., Richards, B.J. Investigating Research and Accessing Reproductive Material. Bioethical Inquiry 11, 11–19 (2014). https://doi.org/10.1007/s11673-013-9503-2

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