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.
Résumé
Le dépistage prénatal non effractif (DPNE) est une technologie remarquable ayant le
potentiel d'offrir une multitude d'avantages cliniques, notamment une réduction des
fausses couches, grâce à la diminution du nombre d'examens invasifs. Cependant, certains
soupçonnent que les avantages économiques et cliniques à court terme du DPNE ont été
surévalués, et ses limites et méfaits, minimisés. Il y a donc lieu d'étudier de quelle
façon les pressions sociales et les politiques influencent l'application concrète,
la mise en œuvre et l'utilisation d'innovations en soins de santé comme le DPNE. Malgré
les réserves quant à son rapport coût-efficacité, le DPNE est souvent présenté comme
un premier palier d'examen qui devrait être offert à toutes les femmes enceintes.
De nombreux facteurs ont contribué à un environnement translationnel problématique
au Canada, poussant à l'adoption de cette technologie comme premier palier d'examen.
Les gouvernements ont exercé des pressions pour qu'on commercialise le DPNE, en présentant
le secteur de la recherche financée par les deniers publics comme un possible moteur
de croissance économique. Afin d'optimiser la taille de leur marché, les acteurs du
secteur ont tout avantage à défendre la valeur clinique de cette technologie pour
en vanter les bienfaits pour le plus grand nombre de personnes possible. Nombre d'études
sur le DPNE ont été réalisées et financées directement par le secteur privé dans des
laboratoires sans supervision indépendante adéquate. Par ailleurs, la crainte pour
les médecins d'être tenus responsables s'ils ne recommandent pas un DPNE à leurs patientes
peut aussi provoquer l'adoption généralisée de la procédure. Combinée à ces pressions
de mise en application, la forte adhésion sociale pourrait mener à une « systématisation
» du DPNE et, par conséquent, nuire à l'autodétermination reproductive des femmes.
C'est pourquoi les décideurs devraient, avant de prendre des décisions relativement
au financement public du DPNE, exiger des preuves solides et indépendantes sur sa
pertinence clinique et sanitaire dans leur province ou leur territoire.
Key Words
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Article Info
Publication History
Published online: October 17, 2016
Accepted:
August 29,
2016
Received:
May 18,
2016
Footnotes
Conflicting Interests: None declared.
Identification
Copyright
Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.
