Pharma Politics and Pandemic Management in Russia: Interview with Olga Zvonareva

The miniseries “Inequality in the (Post-) Pandemic City” probes how different dimensions of inequality are shaped, exacerbated, materialized, or co-exist in globally diverse urban contexts. In this series, we provide insights from researchers, scholars and specialists and ask how the effects of the pandemic, including the virus itself or the intervention measures associated with it, are impacting people and communities, particularly in relation to economic, political, social, cultural, environmental and knowledge-based inequalities.

Olga Zvonareva is Assistant professor of Health, Ethics, and Society at Maastricht University in the Netherlands, as well as an Associate Professor at Siberian State Medical University and Tomsk State

University in Russia. She is the author of recently published book ‘Pharmapolitics in Russia: Making drugs and rebuilding the nation’ and coeditor of ‘Health, technologies and politics in post-Soviet settings: Navigating uncertainties’.

 

The debates around COVID-19 vaccines and vaccination programs have highlighted both the inherent inequalities in the global system we live in and the politicization of medical and technological fields. Could you please comment on the geopolitics and politicization of biomedical innovations and how does it affect global inequalities? 

 

The term politicization implies that there can be biomedical innovating unstained by politics. Yet we see that research and development for health is always shot through with political concerns and conflicts of interest and engaged in societal transformations.

 

Let us take a look at the not-so-distant past. Medicine was one of the fields where Cold War struggles had been intense, albeit not necessarily as visible as in space and nuclear arms races. Pharmaceuticals became the U.S. weapon to win loyalty of the nations uncertain about their side in the global fight between capitalism and communism[1]. For example, in 1957, Senator Hubert Humphrey argued for employing pharmaceuticals to free people in ‘developing’ countries from both disease and the communist threat. American pharmaceutical industry was central for this undertaking. It was to provide antibiotics and vaccines, simultaneously promoting and disseminating the American ideal of free enterprise. The USSR side, in turn, relied on its socialized healthcare system to do similar work of transmitting the message of the superiority of the Soviet society. I would like to provide a quote here to illustrate that politicization of medicine was well-recognized at the time: ‘Soviet socialized medicine must … be considered an important and integral component of [the Soviet] challenge. … This challenge is … not limited to the political, economic, or even military spheres; it is also part and parcel of Soviet propaganda and of its claim of having, among other things, pioneered and developed an advanced form of “socialized” health service unique in many of its features and possible only under Soviet conditions”[2]. This was written by Mark Field, a prominent analyst of Soviet medicine, in 1967.

So, politicization of medicine and medical innovations is not unique to the ongoing COVID-19 pandemic. Perhaps, more unique is the convergence of different forms of politicization and the pressing need to change our ways of thinking about and doing health politics.

Take, for starters, Sputnik V vaccine. Its release for use in general population in Russia occurred on the basis of scant and poor-quality data, ahead of completing clinical trials. This move invited criticisms of the state political interference that introduces bias into knowledge production and curbs innovation; reminiscent of accounts of Soviet science. Some responded to these criticisms with accusations of nationalism and of equating science with bio-bureaucratic practices specific to the history of Western science. Debate is still unfolding but one can be said for certain: trust to Sputnik V is rather low, including among Russian citizens themselves.

 

Now let us turn to pharmaceutical companies some of which have developed COVID-19 vaccines. Pharmaceutical industry has long been accused of a number of things, including careful curation of medical knowledge through ghostwriting medical journal articles and cultivating relationships with key opinion leaders who educate physicians about drugs. Now, in the midst of global pandemic all the questions with regards to the credibility of industry-produced knowledge are being asked again: are end-points in vaccine clinical trials selected to maximize chances of gaining regulatory approval rather than providing meaningful information for decision-making? Are cases excluded from the efficacy analysis to make relative risk reduction more impressive? And, most importantly, when will we have access to raw (patient-level) trial data that would permit independent analyses? Many stakeholders in public health and health care have demanded access to raw data from trials of (bio)pharmaceuticals for years. But multinational pharmaceutical industry has used its power to resist any attempt to subject its research to public scrutiny leading some commentators to suggest that no claims issued by industry can be trustworthy.

 

Finally, when we look at scientists’ practices, we notice similar claims to sovereignty as in the cases of states and industry. Scientists decide what research is warranted and how to conduct it, guarding their authority to independently make such decisions. For the sake of brevity, I am painting the situation with very broad strokes, but a pattern is discernable: concerns raised by outsiders tend to be dismissed as rooted in ignorance, while uncertainty, inherent to science, is contained to prevent ambiguities and doubts from ‘leaking out’ (http://somatosphere.net/forumpost/dangerous-practices/). When such leaks (inevitably!) happen, conflicts over authority escalate, with outsiders assuming deliberate manipulations and even deception and scientists mobilizing against the threat of interference by those unfamiliar with scientific methods and stakes.

 

In the sense of politicization, state efforts to govern innovations, industry profit-pursuing practices, and science’s quest for authority may not be all that different. A question that needs answering then is not how to safeguard biomedical innovating from politics, but rather how to respond to their interconnections in a transparent and equitable way.

 

Knowing your expertise on Russian healthcare system and pharmaceutical industry, could you please comment on the COVID-19 pandemic in Russia and its management, including the vaccination program?

 

When speaking about management of any problematic health situation, we rely on numbers to make the situation visible and, consequently, manageable. Numbers tell us something about how the situation develops, how different settings compare, and how effective interventions have been. No such metric can be taken as a direct reflection of reality; all rely on certain assumptions and approximations. But in the case of Russia numbers are even more problematic than usual.

 

Reported COVID-19 deaths are modest, equivalent to about 0.04% of the country’s population, and Russia appears to be doing much better than, for instance, Spain and the U.S. These low numbers have been used by officials to back up their claims that everything is under control, Russian healthcare system is doing well, and control measures introduced (or not introduced) are correct. Many citizens have been struggling, however, to reconcile these optimistic statements with media reports of overcrowded hospitals that refuse to accept any more patients and with personally encountered challenges in having their or their close one’s condition recognized as COVID-19. A recent study published in February 2021 validated doubts in low COVID-19 mortality in Russia and has painted a much bleaker picture.  Instead of officially reported numbers of COVID-19 deaths, the study looked at excess mortality. Excess mortality here refers to the number of deaths from all causes that exceeds the pre-pandemic average (and also makes comparisons between countries more meaningful). The estimate of excess mortality in Russia from April to November 2020 corresponds to 0.18% of the country’s population, instead of 0.04% suggested by official COVID-19 mortality figures.

 

So, one conclusion we can make is that Russia’s COVID-19 losses are likely to be much higher than official reports suggest. Additionally, there is another conclusion that is of at least equal importance. There is nothing surprising in that excess mortality exceeds reported numbers of COVID-19 deaths; this is the case for many countries (see, for example, data presented here. Using available data, though, one can compute the ratio of excess deaths to reported COVID-19 deaths reported by countries. And this is where Russia stands out. The ratio of 6.5 calculated for Russia is the largest ratio across all countries for which data are available. In other words, reported count of COVID-19 deaths for Russia appears to be one of the least trustworthy indicators.

 

This is of paramount importance for pandemic management. When officially presented reality diverges so greatly from both people’s lived experiences and reasonable estimates, one cannot possibly count on wide public cooperation in managing the COVID-19 situation. Taking control measures seriously is difficult for many, when it is entirely unclear whether the situation is good or bad, how it is changing, and who says so. Results of a survey published on 1 March 2021 by Levada-Center leave little room for optimism in this regard: more than half of Russians (56%) are not afraid of contracting COVID-19 despite close encounters with the disease (only 28% of respondents do not know anyone who has was sick with COVID-19). Moreover, the number of those who are willing to be vaccinated with Sputnik V continues decreasing from 38% in December to 30% in February.

 

What new insights on inequalities and urban healthcare in Russia has the pandemic brought about?

 

Everything we know about differential ability of people to minimize their health risks and care for themselves applies here. In spring and summer 2020 it became very visible that those with the least means, financial security, and support are often least capable to protect themselves during the pandemic. What can an urban holder of a precarious unofficial job do to support their daily living apart from getting into a bus every morning along with other people with similarly constrained choices? How should a lonely elderly woman living in a small village procure food apart from venturing into larger town with its shops, despite her fears? Parenthetically, people who find themselves in circumstances that force them to continually take risks with their health may not experience COVID-19 as something of immediate danger to them. On the one hand, multiple pressing concerns can take precedence. On the other hand, it is hardly possible to constantly worry over health consequences of own actions that one cannot avoid taking. Consequently, vulnerable people left during pandemic to their own devices may well be among those who do not perceive COVID-19 infection prevention and control measures as relevant.

 

COVID-19 infection control measures exposed and intensified multiple axes of inequalities, including digital inequality. With the onset of lockdown, provision of many public services switched entirely to an online mode. One had to make a request and provide all supporting documentation online or, where it was still possible to have an in-person meeting, making an appointment, nonetheless, had to be done electronically. Needless to say, people without access to technological means and/or skills to navigate online environments were cut off. Migrants faced, perhaps, deepest uncertainties when state organizations such as Office for Migration Affairs literally locked their doors admitting only those with electronic appointments. Many migrants had no way of communicating with the state anymore because the primary online channel for such communication, Gosuslugi.ru portal, requires Individual insurance account number (SNILS), which many of them do not have.

 

It is also important to highlight problems encountered by Russian medical professionals. They rarely speak up about these problems, expecting administrative sanctions. But a study conducted by sociologists in European University at St.Petersburg (EUSPb) sheds light on realities of their daily work. One crucial insight is that medical professionals do not trust the healthcare system they work in. Excessive bureaucratic control amidst pandemic has resulted in an avalanche of contradictory rules by different authorities and inadequate support and protection for frontline workers. Such management approach fails to take into account changing details of the situation on the ground and lacks flexibility and responsiveness. In this context healthcare workers were forced to develop their own informal protocols to protect themselves and their patients. Problems with insufficient personal protective equipment were also often solved privately because open reports and public appeals were discouraged as running contrary to the official reports of pandemic management successes. In the EUSPb study, healthcare workers tended even to emphasize their fears of administrative sanctions more than fears of getting infected with COVID-19.

 

What long term effects might this pandemic have on the healthcare system and medical industry in Russia?

 

With regards to industry, the process of Sputnik V vaccine testing legitimized research and development practices that were hardly imaginable before the pandemic. Pharmaceutical R&D has long been one of the most heavily regulated domains. There are established ethical rules and international guidelines for design, conduct, safety and reporting of clinical trials, such as ICH Good Clinical Practice Guideline. More or less global consensus has been established over what kinds of research need to be conducted before it is possible to declare a medicine safe and effective and how ethical soundness of this research is to be secured. Initial Sputnik V testing broke many of these conventions. We witnessed self-experimentation when scientists from Gamaleya Research Institute of Epidemiology and Microbiology injected themselves with the COVID-19 vaccine they were developing. We witnessed that this trial along with some others reported in the media was conducted without receiving a legally required approval by relevant authorities. Apart from vaccine testing, questionable research practices were noted in healthcare organizations. For example, Moscow Healthcare Department initiated a program of hydroxychloroquine distribution for healthcare workers. Not only this program was initiated at the time when available research already pointed to lack of grounds for using hydroxychloroquine in COVID-19 treatment and prevention; it also was iteratively branded as prevention program, then as clinical trial (without receiving an approval for conducting a trial, though), then as some uneasy mixture of both. Now, after all these practices were accepted without question by regulators, they are here to stay.

With regards to Russian healthcare system, we may expect to see more horizontal action. When during the initial stages of pandemic medical professionals found themselves under total bureaucratic control but without much support, they began to invent ways to help themselves and their colleagues. Via chats and closed forums information was shared about new clinical recommendations published in the world together with tips about how to reorganize work of medical organizations and departments under COVID-19 pandemic conditions. Medical professionals self-organize to obtain useful knowledge and inform each other about creative solutions to common challenges. Maybe, this emerging solidarity will provide much needed impetus to shift the balance of power in healthcare system management towards currently silenced medical professionals.

 

In your opinion, what policies and measures should be implemented in order to address the COVID-19 related healthcare problems and mitigate the existing inequalities, both in Russia and beyond?

 

First, we certainly need more openness and collaboration in medicines development. At the very least, accessibility of patient-level data from clinical trials needs to be mandated. This would allow to check the claims of safety and efficacy made by pharmaceutical industry and will increase the overall transparency of medicines development process.

Second, opinions and experiences of healthcare workers have to be systematically taken into account in healthcare management. For healthcare system to operate effectively under conditions of emergency, it needs constant feedback from medical professionals. Only by learning from this feedback and working accordingly, can healthcare system respond in an adequate way to pandemic challenges.

 

[1] Tobbel, Dominique (2009) ‘Who’s winning the human race?’ Cold War as pharmaceutical political strategy. Journal of the History of Medicine and Allied Sciences, 64(4): 429-73

[2] Geltzer, Anna (2012) In a distorted mirror: The Cold War and U.S.-Soviet biomedical cooperation and (mis)understanding, 1956-1977. Journal of Cold War Studies, 14(3):39-63