Repurposing the Ladder

Abstract

Photo by Mufid Majnun on Unsplash\nINTRODUCTION\nIn 2007, the Nuffield Council of Bioethics introduced the “Intervention ladder” as a guiding framework[1] to evaluate the impact on individual liberty of various public health measures. One criticism of the ladder is that it reflects a narrow view of liberty, yet other researchers adapted the intervention ladder to incorporate a more autonomy-based view. Recently, academics and public health officials have used intervention ladders as guides in framing policies, particularly COVID-19 pandemic policies.[2] Analyzing the Indian COVID-19 vaccination drive under these two ladders can illuminate the concepts of liberty underlying those ladders and help determine the best framework on a philosophical basis.\nANALYSIS\nl.\xa0 \xa0 \xa0Case Study: The Indian COVID-19 Vaccination Drive\nOn January 16, 2021, India attempted a public vaccination drive.[3] The drug regulatory body Central Drugs Standards Control Organization (CDSCO) approved two vaccines, Covishield and Covaxin, for emergency use.[4] The approval was granted despite a clear lack of phase 3 clinical trial data for both of these vaccines.[5] Covishield, produced by the Serum Institute of India, is the Indian variant of the\xa0 Astra-Zeneca vaccine that has shown an average efficiency of 70.4 percent after trials in the UK.[6] Covaxin, manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology, was developed and manufactured in India. [7]\nCovishield relied on the safety and efficacy data from large trials conducted in Brazil, South Africa, and the UK with 24,000 participants and a small cohort for the Indian study.\xa0 Covaxin was given approval based only on phase-1 trial data. [8] An article published in The Lancet called for further efficacy data from the Covaxin study.[9] The officials associated with Bharat Biotech, as well as the Indian Council of Medical Research, maintained that fast production of the vaccine does not indicate a compromise in safety, even though they had little data to produce.[10] However, transparency is key to vaccination policy, which requires public participation.\nThe media reported that the Covaxin clinical trials compromised research integrity by providing a monetary incentive of around 7 euros, to research subjects. People’s University, a private medical college, and hospital, recruited survivors of the Bhopal Gas tragedy for the Covaxin study. The participants were told that they were being provided a vaccine against COVID-19 without clarifying that data was being collected for their clinical study. There was no record of informed consent from these participants for the Covaxin study.[11] \xa0 The media reported the death of a 42-year-old individual who received his first dose on December 23, 2020. [12]\xa0 Although it was reported that the cause of death was not linked to the vaccine, the death added to vaccine hesitancy. The vaccines were provided for free to the frontline healthcare workers with no choice on which vaccine the recipients would receive.[13] Similarly, in the US, some people do not have a choice between Pfizer or Moderna. In the UK and the US, data from phase 3 trials are known with a periodic follow-up after the administration of the second dose.[14] The WHO developed a tracking system for COVID-19 vaccine recipients which was updated on March 19, 2021, to reflect the results of Covaxin phase 3 trials.[15]\nIndia eliminated choice although the two vaccines approved for emergency use did not have the depth of research that those used elsewhere had.\xa0 The intervention ladder, discussed below, which uses proportionality and the harm principle to justify the lack of choice between the vaccines in the UK and the US, should not be applied to India’s vaccination policy.\nll.\xa0 \xa0 \xa0The Nuffield Intervention Ladder\nThe foundational principle underlying the Nuffield Intervention Ladder is Mill’s conception of individual liberty from the prominent work, On Liberty.[16] However, the Council recognizes that the intervention ladder is conceived on a broader interpretation of Mill’s liberty, using the principle of proportionality as a tool for justification i.e., the desired effect from the intervention is proportional to the loss incurred in liberty.[17]\xa0 As shown in Table 1, an ideal intervention that is least infringing would then be no intervention at all. An intervention that would be more difficult to justify would be one that significantly restricts individual liberty.\xa0 Intuitively, eliminating occupies the topmost rung on the ladder. The metaphor of the ladder suggests that as one climbs up the rungs of the ladder, stronger justifications would be required.\nTable 1: Examples of interventions at each level of the intervention ladder adapted and improvised from the Nuffield Council of Bioethics Report, 2007.\n\nA voluntary vaccination policy is one public health intervention that is acceptable and justifiable in terms of the principle of proportionality as well as Mill’s Harm Principle, with emphasis on diminishing individual liberties when actions might result in harm to others.[18] Although a vaccination policy in the context of a global pandemic seems justifiable through the lens of the intervention ladder, the Indian modus operandi is unique because of inherent problems with the original conception of the intervention ladder. By pausing to elaborate and reflect on the Indian context as a case study, we can demonstrate that individual liberty should not be the sole variable in framing justifiability.\nlll.\xa0 \xa0 \xa0Critiquing the Nuffield Intervention Ladder & Adding a Precautionary Approach\nIn his paper, ‘Snakes and Ladders: State Interventions and the Place of Liberty in Public Health Policy’, Angus Dawson criticizes the intervention ladder’s focus on individual liberty,.[19]\xa0 and its inability to account for the different treatment of incentives and disincentives and the role of information. Public health institutions require public participation to restrict the infectious spread of COVID-19. The lack of transparency and minimal information surrounding the vaccines have been a major hurdle in increasing public participation. It is contradictory to think that the public does not require information about interventions and have the ability of self-determination to guide them, when in fact self-determination presupposes possession of relevant information.\nA voluntary vaccination policy can be seen as sitting on either the lowest rung (providing information) or the rung of enabling choice, as a vaccination campaign does both. However, in India, the precautionary principle should also be applied as providing the choice should not permit ‘harm’. The precautionary principle holds that anything that poses a risk to human health or the environment should be avoided or accompanied by precautionary measures.\xa0 In India, because the clinical trials were smaller and there is less proof of safety and efficacy, a vaccination requirement, or a public health campaign to encourage vaccination violates the principle. The proportionality principle governing the intervention ladder only requires that the benefits of the intervention justify the restrictions on liberty. The intervention ladder should prevent requiring healthcare worker vaccination without a choice of vaccine because a free choice requires transparency and more information than is available from the small early-stage clinical trials. Actions surrounding the vaccines in India do not reflect proper precaution or a proportionate and thus acceptable restriction on liberty. If there is no ability to choose between the two possible vaccines, then they should not be mandatory for healthcare workers.\nThe Indian government and its officials have urged healthcare worker compliance by invoking the seriousness of the pandemic and the alarming rates of mortality rather than providing transparent data pursuant to the regulatory mechanisms of the vaccine clinical trial. For a healthcare worker, the duty to provide service and a stronger obligation to do so in the time of a pandemic already imposes certain restrictions on their liberty. The lack of choice in opting for a preferred vaccine puts it on a higher rung on the intervention ladder and thus requires stronger justifications. This case study reveals how the same public health intervention falls on different rungs of the intervention ladder depending on the target group in consideration. Or to put this simply, choice is contextual.\nTable 2: The ethical values at stake when it comes to “choice”\n\nlV.\xa0 \xa0 \xa0An Autonomy-Based Intervention Ladder\nLiberty and autonomy differ slightly: liberty revolves around the constraints on the ability to act, whereas autonomy stresses on the independence and the authenticity of the willingness to act.[20] It is thus possible for an individual to be autonomous but unfree, as can be seen from the inability to opt for a preferred vaccine.[21] Figure 1 shows an adapted schematic of an autonomy-based intervention ladder as proposed by Griffiths et al.\n\nFigure 1: An adapted schematic of the autonomy-based intervention ladder proposed by Griffiths, P.E and West, C.\nIn comparing the original intervention ladder with their proposal, we see that the autonomy-based model allows for a negative scale in terms of its effects on autonomy. Thus, on this ladder, actions can be autonomy-enhancing or autonomy-diminishing. Such a model challenges the one-directional view of the ladder and rearranges interventions on a scale that ranges from negative to positive. A few interventions that were shown to have restrictive effects on liberty now have reinforcing effects when viewed through the lens of autonomy. Thus, providing information and educating can be seen as positive reinforcements for autonomous choice rather than infringing on individual liberty.\nThe autonomy-based intervention ladder requires the State to implement interventions an