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ABSTRACT
Controversies are part and parcel of the process of evidence-based interventions represent a problem for any notion of a ‘pure’ evidence-based intervention outside the purview of issues such as social norms, economic boundaries and moral dilemmas. This paper provides a detailed case-study of the recent debate and controversy regarding the roll out of HIV prophylaxis (PrEP) by the NHS in England. We describe and analyze the legal, scientific and social battles that followed when the NHS first refused to commission PrEP. In many ways they mirror the controversy that emerged during the early access to HIV treatment in the US in the nineties as published in previous research. We add to this body of research by detailing the particularities of the controversy in the UK, the specific role of a discourse on resource use, how opponents morally framed and used the evidence and the productive aspects of certainty and uncertainty.
Disclosure statement
No potential conflict of interest was reported by the authors.
Notes
1. For the FDA statement on the approval of Truvada see: https://www.fda.gov/media/83586/download.
2. See the CDC guidelines for this definition: https://www.cdc.gov/hiv/pdf/PrEP_fact_sheet_final.pdf.
3. is defined as a relationship wherein one is HIV positive and the other is HIV negative.
4. See the CDC guidelines for this definition: https://www.cdc.gov/hiv/pdf/PrEP_fact_sheet_final.pdf.
5. The BBC made a documentary on the ongoing controversy of the rollout of PrEP by the NHS. See the BBC webpage for details; https://www.bbc.co.uk/mediacentre/proginfo/2018/26/people-vs-nhs.
6. See PrEPWatch.org’s own webpage: https://www.prepwatch.org/resource/global-prep-tracker/.
7. See PrEPWatch’s online webpage and data: https://www.prepwatch.org/resource/global-prep-tracker/.
8. See the NHS first statement on PrEP, https://www.england.nhs.uk/2016/03/prep/.
9. See the updates as well as information on the IMPACT trial, https://www.england.nhs.uk/commissioning/spec-services/npc-crg/blood-and-infection-group-f/f03/prep-impact-trial-questions-and-answers/#what-is-meant-by-10000-participants.
10. See the NHS’ statement on the results of the PROUD study as well as the arguments used for not commissioning PrEP through the NHS, https://www.england.nhs.uk/2016/03/prep/.
11. See the statement of the NHS’, https://www.england.nhs.uk/2016/03/prep/.
12. See the statement of the NHS’, https://www.england.nhs.uk/2016/03/prep/.
13. See the NHS’ statement published on March 21st, 2016, https://www.england.nhs.uk/2016/03/prep/.
14. See the NHS’ statement published on March 21st, 2016, https://www.england.nhs.uk/2016/03/prep/.
15. See the NHS own webpage on this matter: https://www.england.nhs.uk/commissioning/pub-hlth-res/.
16. See the NICE PrEP guidelines here: https://www.nice.org.uk/advice/esnm78/chapter/Key-points-from-the-evidence.
17. See the NICE guidelines for the full overview of PrEP as it is framed by NICE: https://www.nice.org.uk/advice/esnm78/chapter/Key-points-from-the-evidence.
18. See the full NICE statement here: https://www.nice.org.uk/advice/esnm78/chapter/full-evidence-summary#context-2.
19. For their respective web pages see, https://www.iwantprepnow.co.uk/, http://prepster.info/.
20. See the online transcripts of the court hearings here: https://www.judiciary.uk/wp-content/uploads/2016/08/nat-v-nhs-judgment.pdf . For a look at the final verdict made, see the online transcript here: https://dpglaw.co.uk/wp-content/uploads/2016/11/National-Aids-Trust.pdf.
21. See the online transcription here: https://www.judiciary.uk/wp-content/uploads/2016/08/nat-v-nhs-judgment.pdf.
22. See the NHS statement on the IMPACT trial and why it is needed, https://www.england.nhs.uk/commissioning/spec-services/npc-crg/blood-and-infection-group-f/f03/prep-impact-trial-questions-and-answers/#what-is-the-prep-impact-trial.
25. See the NHS IMPACT updates, https://www.england.nhs.uk/commissioning/spec-services/npc-crg/blood-and-infection-group-f/f03/prep-trial-updates/#june.
26. See the NHS statement on the expansion of slots from 13.000 to 23.000, https://www.england.nhs.uk/commissioning/spec-services/npc-crg/blood-and-infection-group-f/f03/prep-trial-updates/.
27. See the NAT’s statement on the number of people being turned away due to lack of slots in the IMPACT trial, https://www.nat.org.uk/press-release/first-year-anniversary-opening-impact-trial-we-need-end-nhs-rationing-prep.
28. See the NHS May 2016 update, https://www.england.nhs.uk/2016/05/prep-provision/.
29. See the NHS May 2016 update, https://www.england.nhs.uk/2016/05/prep-provision/.
Additional information
Notes on contributors
Tony Sandset
Tony Sandset is a postdoctoral researcher at the Faculty of Medicine, University of Oslo, where he received his PhD in Cultural History. His current research focuses on knowledge translation within the field of HIV care and prevention. Specifically, his focus is on how medical knowledge from randomized controlled trials is mediated, how evidence is generated in HIV prevention and how new medical technologies informs subjectivities, desire, and sexuality. Another of his research areas pertains to the intersection between race, gender, class and HIV care and prevention. Relating race, class and gender to how medical knowledge is disseminated and translated from research to clinical and community usage is of particular interest here.
Sietse Wieringa
Sietse Wieringa’s field of research is the concept of evidence based medicine and how clinical knowledge is developed. His research aims to discover the epistemological assumptions in knowledge creation, based on the concept of mindlines: collectively shared, mostly tacit knowledge that is shaped by many sources including accumulated personal experiences, education (formal and informal). It involves ethnographic methods focusing on guideline developing panels and online communities of clinicians as well as organizing several seminars on the subject.