A healthcare worker checks the temperature of residents of a slum area during a check-up campaign for COVID-19, Mumbai, July 6, 2020. Photo: Reuters/Francis Mascarenhas/Files.
A number of incidents in the history of health and medical science, from the Nuremberg doctors’ trials and the Tuskegee experiments to contested clinical trials and therapeutic regimes, have expanded and refined our approach to handling the complexities of health and medical research. And as we broaden our idea of what it means to be human, we gain a deeper understanding of the nature of our interconnected lives, as also the sense of what is ethical and just.
“Ethics is a multidisciplinary field, and its standards, like science, are shaped by the emerging evidence,” said Amar Jesani, editor of the Indian Journal of Medical Ethics and a member of many consultative bodies on bioethics. “That is why ethics guidelines evolve; they are not pre-fixed.”
Every advancement in medicine brings a new set of ethical dilemmas, while a changing world forces us to confront newer challenges. The invention of ventilators pushed us to think about end-of-life decisions and the definition of brain death. The outbreak of cholera in a congested city nudged us to reconsider urban planning. The discovery of vaccines has been accompanied by concerns of safety and disclosure during clinical trials, and acceptability, accessibility and affordability.
Over the years, changing ideas of fairness and equity have been codified into various foundational documents that have generated the guiding principles of biomedical research and health practice. The Belmont report in 1979 laid down the principles of respect for persons, beneficence 1 and justice, particularly in relation to vulnerable groups.
“In India, activists also contributed to the growth of bioethics by raising questions about research that was not done – for instance, in the wake of the Bhopal gas tragedy,” Anant Bhan, a bioethics and global health policy researcher and former president of the International Association of Bioethics, said. “Since the 1990s, we have been asking questions about who sets the research agenda, the ways in which drug trials are approved and conducted, and questioning global pharmaceutical patent regimes.”
According to Bhan, public health crises like the one we are now facing raise new ethical dilemmas that prompt multilateral bodies, including the WHO, and national bodies that govern public health and research to reformulate guidelines. But the guidelines often don’t cover many issues in between the silos of medical practice, clinical research and public health – not to speak of numerous allied activities that the state governs.
Where is our talisman?
The COVID-19 pandemic was preceded by a chain of public health emergencies, including epidemics in 2002, 2009, 2012 and 2014. They offered opportunities to learn how to plan for future outbreaks, and reflection by governments and multilateral agencies.
So the questions we are asking now – about resource allocation, the need for stringent lockdowns and enforced quarantines, information dissemination and transparency, access to care and protections for those who provide it – are not new. Yet we find ourselves on the back foot.
The American bioethics professor Joseph Fins called the COVID-19 pandemic a “stress test for bioethics”, acknowledging that even ethicists “ignored a tale of inequity unfolding around us”. Despite early pronouncements that this was a pandemic that would touch everyone equally, it’s clear today that this isn’t the case. And it’s become abundantly clear that the absence of an ethical approach to decision-making has widened this gap.
In our pandemic, ethics need to be considered in every aspect of crisis management, at every stage – immediate steps to contain and prevent; medium-term strategies of care and compensation; and long-term plans for well-being and rehabilitation. One might expect that ethics are the foundation for any action, by the state and by the individual.
However, there is today a tired acknowledgment that the failures of management have been undergirded by a lack of ethical and moral vision, a refusal to think in terms of Gandhi’s talisman that asks us to weigh every action in terms of how it would benefit the weakest, the most vulnerable.
Consider the ethics of the most visible response to the pandemic: the lockdown. At the broadest level, the Indian government’s response seems to have been guided not by a deep commitment to the wellbeing of all its people but by what Debraj Ray and S. Subramanian call a “politics of visibility: draconian on high-profile measures such as lockdown, weak on the measures that are less easily observed.” They describe the government’s actions as constituting nothing more than “a nationwide project of virtue signalling”.
“What I observed since the crisis started,” Jesani said, “was that there was absolutely no discussion or consideration of ethics – in the kind of response that was formulated in India… Did the government really consult public health experts?”
One key ethical concern, in his view, is that there was no time given for the most vulnerable groups in the country to prepare for the lockdown’s consequences, revealing a huge empathy gap between those who made policy and those who suffered it.
Jesani also called attention to how the lockdown and the ways in which it was enforced contravened the Siracusa principles, a covenant drafted in 1985 by the International Council of Jurists. It details how states need to weigh human rights considerations when they impose restrictions to deal with public health emergencies.
But “instead of a public health response, the government’s approach ended up making it a law and order problem,” Bhan said.
According to Maxwell Smith and Diego Silva, “The nuance necessary in planning and preparing for how isolation will be deployed in an ethical manner depending on the type of infectious disease and potential pandemic makes it difficult to plan for such differences unless one explicitly considers them in advance.” A commentary on the British Medical Journal blog by ethicist David Shaw addressed the need to “triage” ethical issues during a pandemic.
In the ‘Indian lockdown’, one of the most restrictive in the world, there was no indication that the government had considered such issues, and the few measures taken after the migrants’ crisis unraveled followed public interest suits initiated by civil society. B.R. Shamanna, a professor of public health and epidemiology at the University of Hyderabad, acknowledged that the pandemic has thrown up new issues in health governance. The need for portability of government schemes across state lines was particularly in evidence as migrants were unable to access benefits in their adoptive towns.
“I was surprised that the government went for a pan-India lockdown,” Jesani continued. “To be very frank, [the decision makers] were so obsessed with the virus, they forgot the people completely.”
Health NGOs and community organisations stepped into the yawning gap created by the government’s decision, patching together relief efforts in the absence of state direction. “We need circumscribed lockdowns, and we need to think of support systems. That would have been the ethical way,” Jesani said.
Lives on the front line
The ‘front line’ has become a cliché but in the public imagination, it’s the site of our “war” against the virus. (Some have argued against the use of the war metaphor as detrimental to a cooperative mindset while another group has pointed to its value in mobilising common cause.) The ‘front line’ has been the centre of attention and where the ethics of care has been debated to some extent.
Practitioners encounter the difficult decisions of whom to test, whom to treat and where to focus attention and resources. Stories from Italy, where doctors were forced to make decisions about whom to ventilate demonstrated the difficulty of triaging in resource-constrained situations. Medical workers are supported when a disinterested party – like a hospital ethics committee – offers guidance on such issues in a culturally sensitive manner, but few hospitals in India have such committees.
“For years, the duty to care has been taken for granted. … No one thought about the need to protect those who provided medical care; the entire focus was on the patient,” said Justice T.N.C. Rangarajan, a retired judge of the Andhra Pradesh high court who chairs several institutional ethics committees.
The umbrella of ethics needs to consider workplace protections even for those who have a duty to care – often seen as a responsibility they must endure without complaint. Sandhya Srinivasan, consulting editor of the Indian Journal of Medical Ethics and longtime health rights activist, has argued that an ethical reconsideration requires us to recognise that healthcare service providers are not just doctors.
As agitating ASHA workers in Karnataka and elsewhere remind us, those at the very front of the line are often ancillary workers, whose rights and needs are often ignored. Srinivasan described the work of the Centre for Bioethics and Culture in Pakistan: it has worked to expand the definition of ‘health worker’ to include cleaners, attendants, nursing aides and community health volunteers, among others.
Another ethical issue Srinivasan raised relates to medical decision-making, where doctors are still required to draw on the evidence base but often have to resist pressure from government and patients to try untested therapies.
The tentative nature of knowledge around the novel coronavirus has led to a situation where medical practitioners have to accept the limits of their ability to treat its infection, and ethics demands open and truthful communication with patients and caregivers. Few hospitals have clear communication protocols and there is little training in ethical physician-patient interaction.
This is complicated by the diversity of the patient population and the tendency to adopt a paternalistic attitude towards patients from marginalised groups, often bypassing consent requirements even in experimental treatments. This has been happening both in clinical and community health settings. Jesani cited the Mumbai municipality’s unilateral decision to dose all of Dharavi’s residents with hydroxychloroquine as a prophylactic despite the contrary evidence of its efficacy.
“Ultimately, with the intervention of NGOs and health activists, they were able to contain the spread through the participation of the community, with open communication within a month,” Jesani said.
The pandemic has also made even more visible the political, cultural and economic fault-lines that exist in healthcare delivery in India, with the government unable to effectively commandeer the resources of a burgeoning private health sector even in a situation labelled an emergency. Capping the cost of tests, ensuring standards, making beds available for the treatment of COVID-19 – all happened under a pall of confusion and much back-and-forth, instead of being part of a carefully thought-out protocol.
In general, there has been little direction from government bodies on practising ethical healthcare in a pandemic. It has fallen to civil society groups such as Jan Swasthya Abhiyan (JSA) and the People’s Health Movement to spotlight ethical gaps and raise public awareness about issues related to inequity. Jesani recalled the JSA’s public interest suit demanding access to hospitals and raising questions about testing protocols, and pushing the government to make the private sector more accountable.
“If the nation is in crisis, you can take away my individual rights, but you cannot do anything to the private hospitals? How can the private health sector continue to focus on profits at such a time?” he asked.
He also pointed to the disregard for non-COVID-19 related health conditions that require ongoing care but which is now difficult to access. The international health community has raised this issue as well, with David Shaw pointing to the millions of cancer patients that may have been ‘missed’ in Western hospitals taken over by the pandemic. In India, we can only guess at the large numbers of chronically ill patients whom the lockdown sidelined.
A pandemic preparedness plan rooted in a broad vision of ethical care would have envisioned such needs, and provided for them.
Hope and expediency
In April, the Indian Council of Medical Research (ICMR) issued new guidelines – culled mostly from a 2015 document – for research during the COVID-19 pandemic. Meant to cover clinical trials of new drug therapies, including repurposed drugs and new vaccine candidates, the document draws on lessons from previous infectious disease outbreaks vis-à-vis consent, protection of health workers and vulnerable populations.
However, given the somewhat chequered history of clinical trials for new therapies, particularly vaccines, in India, activists have been suspicious of the promise of an early vaccine and government efforts to fast-track tests. “In the name of an emergency you can’t take shortcuts to generate evidence,” as Bhan said.
Shamanna also warned of what has come to be called “vaccine nationalism”, falling into a competitive mindset that frames vaccine development as a “race” that will be “won” by the country that puts most resources into the game at the earliest stages. “Of course, in such a situation, decision-making has to be relatively quick, yet scientific integrity has to be maintained,” he said.
However, others are more hopeful about changes the pandemic has prompted in the research ethics space. “In the 25 years that I have been involved in institutional ethics committees, I have seen the thinking become more complex and nuanced,” Justice Rangarajan said. “In the early days we focused only on obvious harm to the patient, but now we look at protocols in much more detail, obviously more conscious of the broader human rights discourse.” Other areas where he believes there has been progress are biosafety and institutional liability.
Shamanna also sees some positive developments in health governance. “The pandemic has forced ICMR to finally come out with a formal set of guidelines for telemedicine – something we need now that so much non-COVID-19 care is happening remotely,” he said. He added the pandemic had pushed ethics committees to consider important procedural questions like expedited reviews, using digital platforms for meetings and simultaneously approving phase 2 and 3 clinical trials – all somewhat contentious issues requiring debate.
When the pandemic passes, what – if anything – will be different? How will we view the world and its interconnections, which have now become so apparent? Will we acknowledge ethical shortcomings and prepare lessons for the future, when disease X strikes? Will we shift our thinking of all cadres of health workers, such as ASHAs, as instrumental resources to be deployed as needed and dismissed with nothing more than the discordant banging of pots and pans? Or will we train a compassionate imagination on the impact of showy policies on the most vulnerable and then revise the way we do things?
“I’m skeptical,” Bhan said. For change to happen, “we need a deeper engagement with the politics of health, the social and cultural determinants … and the kind of reflective decision making that is needed for this is rare.”
Srinivasan said with some cynicism that “we should not even assume that ethics plays any role at policy and governance levels”, but she holds some hope from activists “and the occasional good actor from within the system, who is willing to stand on principle and do the right thing.”
She is buoyed by some positive developments in the ethics of practice and research, pushed by NGOs and taken up by visionary bureaucrats, such as accessible anti-retroviral therapy for HIV patients, availability of generic drugs and greater scrutiny of clinical trials.
This said, it’s hard to not be cynical, and impossible to ignore the lack of ethics in all we have seen, mostly on the part of those who have pledged to protect and serve. Even as I write this, I see a news alert that several state governments have slashed health budgets.
In a recent essay in the Journal of the American Medical Association, Donald Berwick asked an uncomfortable question: “How do humans invest in their own vitality and longevity? In wealthy nations, science points to social causes, but most economic investments are nowhere near those causes.” Instead, he continued, “imagine for a moment that the moral law within commanded [a] shared endeavour for securing the health of communities.”
What would it take for such an imagination and commitment to take hold in India’s corridors of power?
Usha Raman is a writer and academic based in Hyderabad.