Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process

Blake Murdoch, Vardit Ravitsky, Ubaka Ogbogu, Sarah Ali-Khan, Gabrielle Bertier, Stanislav Birko, Tania Bubela, Jeremy de Beer, Charles Dupras, Meika Ellis, Palmira Granados Moreno, Yann Joly, Kalina Kamenova, Zubin Master, Alessandro Marcon, Mike Paulden, François Rousseau, Timothy Caulfield

(2017) 39:1 Journal of Obstetrics and Gynaecology Canada 10–17.

Abstract:

Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the “routinization” of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT.

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About the Author:

Jeremy de Beer creates and shapes ideas about technology innovation, intellectual property, and global trade and development. As an interdisciplinary scholar, he has published five books and over three-dozen peer-reviewed chapters and articles across the disciplines of law, business, political science, international relations and public policy. He is also a co-founder and director of the Open African Innovation Research network, Open AIR, which connects dozens of researchers across African countries, Canada and elsewhere to scale up innovation by easing tensions between intellectual property and access to knowledge. Also a practicing lawyer and expert consultant, he has argued numerous cases before the Supreme Court of Canada, advised businesses and law firms both large and small, and consulted for agencies from national governments and the United Nations. 

Click here to visit his Faculty web page.

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