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• NIPT is the only ethical test
  Lars H Breimer
  Published on: 28 October 2020

• Published on: 28 October 2020

  NIPT is the only ethical test

  • Lars H Breimer, Consultant Clinical Chemist & Assoc Prof Örebro University Institution for Medical Sciences, Dept of Laboratory Medicine, USÖ

  Medethics-2020-106709 – see decision 23-July-2020

  NIPT is the only ethical test

  Abstract
  Bunnik et al and Schmitz interchange about the public funding of NIPT surprisingly lacks consideration of Wilson’s and Jungner’s classic principles of screening as well as broader issues relating to women’s autonomy. In addition, overall healthcare costs must be considered no matter the system of their financing (public purse, private insurance or direct cost to families).

  I have followed the interchange between Bunnik et al and Schmitz [1 – 3] because NIPT is a topic I have published on for 5 years now, most recently in English [4].
  The most important reason for making NIPT publicly funded and for it to replace First Trimester Combined (FTC) in screening is that NIPT is a much better test than FTC [4]. According to the principles laid down by Wilson and Jungner in their classic essay [5], in this situation screening should be done with a test with as low a false negativity as possible so that the pregnant can truly trust the message that she does not carry a foetus with a genetic abnormality. NIPT misses far fewer cases than FTC and is a classic rule-out test.
  Where it has been studied, the biggest unease with NIPT among pregnant women is the risk of sex-selection, that is that female foetuses are selectively aborted only because they are female [4, 6, 7]. Notwithstanding, Schmitz raises the spectre of “unease with NIPT causing discriminatory mes...

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  Medethics-2020-106709 – see decision 23-July-2020

  NIPT is the only ethical test

  Abstract
  Bunnik et al and Schmitz interchange about the public funding of NIPT surprisingly lacks consideration of Wilson’s and Jungner’s classic principles of screening as well as broader issues relating to women’s autonomy. In addition, overall healthcare costs must be considered no matter the system of their financing (public purse, private insurance or direct cost to families).

  I have followed the interchange between Bunnik et al and Schmitz [1 – 3] because NIPT is a topic I have published on for 5 years now, most recently in English [4].
  The most important reason for making NIPT publicly funded and for it to replace First Trimester Combined (FTC) in screening is that NIPT is a much better test than FTC [4]. According to the principles laid down by Wilson and Jungner in their classic essay [5], in this situation screening should be done with a test with as low a false negativity as possible so that the pregnant can truly trust the message that she does not carry a foetus with a genetic abnormality. NIPT misses far fewer cases than FTC and is a classic rule-out test.
  Where it has been studied, the biggest unease with NIPT among pregnant women is the risk of sex-selection, that is that female foetuses are selectively aborted only because they are female [4, 6, 7]. Notwithstanding, Schmitz raises the spectre of “unease with NIPT causing discriminatory messages especially about Down’s syndrome and those being obviously distressing” [2]. Sometimes it feels like special interest groups have hijacked the debate at the expense of women’s autonomy [4].
  The current Covid-19 pandemic has stressed the healthcare systems to breakpoint in most if not all countries affected and in some even beyond. The pandemic has not only meant that large resources has had to be put into Covid-19 but it has caused financial chaos with bankruptcies and reduced incomes. Companies are struggling to survive. We thus have a reduced tax base at the same time as tax money must be redirected to get the economy back on its feet. The reality which we live in is that there is a limit to what percentage of GDP but also absolute money a country can spend on health care. Before the pandemic most European countries spent 10 – 12 % of their GDP on health care with the USA as an outlier at 18 %, while 50 years ago it was only about 6 – 7 %. The absolute sums are probably more important than the percentages because certain costs, such as medicines and instruments, are becoming more and more uniform throughout the world.
  Bunnik et al are correct in justifying “public funding of NIPT because it will save the public money” [3]. Three studies – one each from Mexico, South-Korea and the USA [4, 8, 9, 10] – confirm the substantial financial aspects of managing Down’s syndrome. In healthcare systems where the costs directly hit the families, they can be ruinous. In systems where the tax-payers defray this cost we can expect to find an increased resistance to such expenses. This attitude will have been exacerbated in the path of the current Covid-19 pandemic.
  In short, in countries with limited resources or where costs of care fall on the individuals and their families, it is pressing to introduce fine rule-out tests.

  References:
  1. Bunnik EM, Kater-Kuipers A, Galjaard RH, de Beaufort ID. Should pregnant women be charged for non-invasive prenatal testing? Implications for reproductive autonomy and equal access. J Med Ethics. 2020 Mar; 46(3):194-8. doi: 10.1136/medethics-2019-105675.2019.

  2. Schmitz D. Why public funding for non-invasive prenatal testing (NIPT) might still be wrong: a response to Bunnik and colleagues. J Med Ethics 2019; doi: 10.1136/medethics-2019-105885

  3. Bunnik EM, Kater-Kuipers A, Galjaard RH, de Beaufort ID. Why NIPT should be publicly funded. J Med Ethics 2020; doi: 10.1136/medethics-2020-106218

  4. Breimer LH. Non-invasive prenatal testing: Special interest groups vs women’s autonomy. Ind J Med Ethics 2020; Published online on June 20, 2020. DOI:10.20529/IJME.2020.069.

  5. Wilson JMG, Jungner G. Principles and practice of screening for disease. Geneva: World Health Organization; Public Health Paper 34. 1968. Pp 163.

  6. Vanstone M, Cernat A, Nisker J, Schwartz L. Women's perspectives on the ethical implications of non-invasive prenatal testing: a qualitative analysis to inform health policy decisions. BMC Med Ethics. 2018 Apr 16;19(1):27-39.

  7. Hu T. Woman caught trying to smuggle 203 blood samples for baby gender tests into Hong Kong. South China Morning Post. 2017 Jul 28 [cited 2020 Jun 12]: Available from : https://www.scmp.com/news/china/society/article/2104458/woman-caught-try...

  8. Park GW, Kim NE, Choi EK, Yang HJ, Won S, Lee YJ. Estimating nationwide prevalence of live births with Down syndrome and their medical expenditures in Korea. J Korean Med Sci 2019 aug 12[cited2020 May 12]; 34(31):e207. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689486/

  9. Martínez-Valverde S, Salinas-Escudero G, García-Delgado C, Garduño-Espinosa J, Morán-Barroso VF, Granados-García V, et al. Out-of-pocket expenditures and care time for children with Down syndrome: A single-hospital study in Mexico City. PLoS ONE. 2019 Jan 10 [cited 2020 May 12]; 14(1): e0208076. Available from: https://doi.org/10.1371/journal.pone.0208076

  10. Kageleiry A, Samuelson D, Duh MS, Lefebvre P, Campbell J, Skotko BG. Out-of-pocket medical costs and third-party healthcare costs for children with Down syndrome. Am J Med Genet A. 2017 Mar; 173(3):627-37.

  Declaration of interest: The author reports no conflicts of interest. The author alone is responsible for the content and writing of the paper. This work was written independently; no company or institution supported the author financially or by providing a professional writer.

  Lars H Breimer, MA PhD, BM BCh, FRCPath, Dip Pharm Med
  Örebro University Institution for Medical Sciences
  School of Health and Medical Sciences
  Dept of Laboratory Medicine, Clinical Chemistry division
  Örebro University Hospital
  SE-701 85 Örebro, Sweden
  Tel: + 46 19 602 78 17 mobile: + 46 705 827 817
  e-mail: lars.breimer@regionorebrolan.se

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  Conflict of Interest:
  None declared.

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