Trials and tribulations

Print edition : July 31, 2020

A health worker takes a nasal swab of a person for a COVID-19 test at a hospital in New Delhi on July 6. Photo: Manish Swarup/AP

Municipal health workers going for screening of people at the Ambujwadi slum at Malad in Mumbai. Photo: Aadesh Choudhari

With the government not open about information on the nature of COVID-19 spread and the research community helpless without data from the sero-surveillance already done, the Indian people are left to face an uncertain future.

Deception and disinformation continue, and so does the accompanying bluster. The two together have been the hallmark of public information on COVID-19 given out by the Union Ministry of Health and Family Welfare (MoHFW) and also the Indian Council of Medical Research (ICMR), which was once an independent and autonomous voice on matters of health but has been rendered subservient to political bosses. The terse directive issued on July 2 by ICMR Director General Balram Bhargava to fast-track recruitment for trials, the conduct of trials and the approval process in order to launch the indigenous vaccine COVAXIN against COVID-19 (to be manufactured by the Hyderabad-based Bharat Biotech Ltd.) on the impossible deadline of August 15 had politics and nationalism written all over it (https://frontline.thehindu.com/dispatches/article31986304.ece). It was not difficult to see who was calling the shots. The severe criticism that followed immediately from the medical and research community drove the ICMR into damage control and walk-back mode, but that did not help it much as the announcement had already made the organisation a laughing stock.

The following imagery by a cartoonist friend of this author captures it succinctly: the top political boss fires at the foot of the subordinate to carry out the diktat; the submissive foot soldier takes evasive action by putting the foot in his mouth.

At the press briefing by the Ministry on July 9, nearly a month after the June 11 (mis-) briefing by Bhargava on the sero-surveillance results (whose complete disclosure is yet to be done despite calls from various quarters, particularly epidemiologists, for making the data public), the same sham was repeated, this time, however, by bureaucrats of the Ministry.

No new or important information regarding the spread of the disease, particularly the epidemiological reasons for the continuing increase in the number of infections in most of the States, was shared. The spokespersons merely resorted to cliched bytes: that the number of cases per million population is one of the lowest in the world; the number of deaths per million population is one of the lowest in the world; and, recoveries and the recovery rate were increasing steadily. With these falsehoods comes the usual bluster about how the government handled the pandemic in a country of 1.38 billion people and how, with the measures that were in place, the country will overcome the current crisis-scale epidemic.

As long as the testing rate (or, equivalently, the infection detection rate) remains low compared with most other countries, the “number of [confirmed] cases” that is put out every day carries no real significance, especially when there is evidence from all over the world that there is significant transmission from infected people in the “pre-symptomatic” stage (that will eventually become symptomatic) as well as from those who remain “asymptomatic” (in whom perceptible symptoms do not even develop) and do not get picked up by the restrictive testing strategy and protocol being followed. As the numbers tested each day increase both from ramped-up testing rate and more broadened testing criteria, the number of cases also increases, as has been the case in India (Fig.1).

As the virologist Shahid Jameel, who currently heads the Wellcome Trust-DBT India Alliance, said: “If you look at the number of daily cases, these have gone up at almost the same rate as daily tests.” Officials of the Ministry keep harping on the falsehood that cases and deaths per capita are low compared with other countries, but never acknowledge that India’s testing remains fairly low per capita compared with most countries. “That is cherry-picking data to suit a pre-determined narrative,” Jameel added. “The testing strategy is confined mainly to those with symptoms or their contacts. By tracing and isolating contacts we can limit the disease but get no view of an expanding outbreak.”

Way back in March, John P. A. Ioannidis, a professor of medicine and of epidemiology and population health at the Stanford University School of Medicine, wrote an article headlined “A Fiasco in the Making” in the online publication STAT, wherein he said: “The data collected so far on how many people are infected and how the epidemic is evolving are utterly unreliable. Given the limited testing to date, some deaths and probably the vast majority of infections due to SARS-CoV-2 are being missed. We don’t know if we are failing to capture infections by a factor of three or 300…and no countries have (sic) reliable data on the prevalence of the virus in a representative random sample of the general population.”

Since then, while most of the countries have managed to scale up their testing rate, India’s testing rate, though ramped up significantly, continues to be one of the lowest (Fig. 2; India’s confirmed cases per million is barely visible at this scale on this plot as it is around 550, a misleading figure, as of July 2). But, even on the basis of this meaningless figure of confirmed cases, India ranks only 112 (according to worldometers/info/coronavirus/) among 215 countries. Malaysia and Nepal rank lower than India. As regards tests per million population, India, with its current rate (as of July 9) of about 8,000 tests per million population, ranks 138, lower than Malaysia and Nepal.

Similar is the case with deaths per million population, equivalently the crude case fatality rate (CFR). Crude CFR (the number of deaths divided by the total number of confirmed cases) is a poor metric for decision making on public health care measures and a particularly bad one for comparison between countries. The Ministry has claimed that India’s CFR of about 2.8 per cent is lower than that of many other countries because of the better hospital care, particularly for critical cases of COVID-19 needing intensive care unit (ICU) facilities.

The press release based on the presentation briefing said: “The proactive delineation of containment and buffer zones, aggressive testing, early and timely detection and adherence to clinical protocols and better ICU/hospital management also manifests in India having one of the lowest fatalities in the world. Deaths per million population in India is 15.31, which translates to a fatality rate of 2.75 per cent, whereas, the global [average] deaths per million population stands at 68.7”.

In a paper posted on the preprint repository medRxiv on May 15, which was updated on July 2, Manfred S. Green and his associates said that it was misleading to compare crude CFRs between countries. In their work, the researchers had compared the CFRs of six countries where age-structured data were available and arrived at the following conclusion: “In addition to the selection and information biases inherent in computing CFRs, the age structure of the cases dramatically impacts on the differences in the crude CFRs between countries. Failure to account for this source of confounding markedly distorts the country comparisons.”

The researchers found that adjusting for age substantially reduced the differences in the CFRs among the six countries they analysed. “Other factors,” the authors wrote, “such as the differences in the definition of the denominator [due to selection bias in the reported cases and the testing criteria], the definition of a case and the standard of health care are likely to account for much of the residual variation…. [These] suggest that differences in the standard of healthcare between these countries may not play as important a role in affecting the death rates…. Crude COVID-19 CFRs have no real use for between-country comparisons and should be avoided. In general, for comparisons between groups and countries, age-adjusted CFRs can be used, but age-specific COVID-19 CFRs are generally far more meaningful.”

As has been pointed out, the ideal comparison would be in terms of the infection fatality rate (IFR), the ratio of the number of deaths to the true number of infections. But as long as catching all the infections remains a difficult proposition, the true value of this metric will not be available for most countries, however broad based the testing strategies are. But estimates of IFRs, on the basis of projections from data of control (cohort) groups (Frontline, May 8), for most countries is around 1 per cent. For India, it is estimated to be 0.41 per cent, which reflects its demographic structure, which is dominated by younger age groups.

So, again, claiming ad nauseum that the number of recoveries has gone up (which now has overtaken the number of active cases) and the recovery rate is correspondingly increasing has no meaning (Figs. 3 & 4, which were shown at the briefing). At the risk of repeating what has been pointed out before, if the crude CFR is only 2.75 per cent, the recovery rate will approach 97-plus per cent; in fact, if we accept the IFR estimate of around 1 per cent, the recovery rate should eventually approach 99 per cent.

Community transmission

The Ministry spokesperson denied there was community transmission. The government continues to peddle this lie. But, now a new euphemism is used to describe the situation: “There is no community transmission; there are only pockets of outbreaks of infection in certain areas.” If this is not community transmission, what else is it? “When community transmission is taking place,” pointed out Jameel, “we will not discover new cases in the community [with the current testing strategy]. The testing strategy needs to be looked at.”

A senior scientist in the government hierarchy is reported to have said (on condition of anonymity) that, for some reason, there is a feeling within the Ministry that accepting that there is already community transmission is tantamount to admitting that lockdowns and other measures had failed.

Sero-surveillance

To a query on making public the data relating to the sero-surveillance conducted in May, the Ministry spokesperson put a new spin on them. He said they were old, pertaining to a situation in April end. The ICMR would soon launch a second round of sero-surveillance, he said. While it is good that a second round will be conducted, it is being done without disclosing the results of the first one to the nation, in particular the research community and epidemiologists. As was pointed out in Frontline (issue dated July 17), the protocol adopted for the sero-survey called for multiple rounds of surveillance.

It was also stated at the briefing that the research paper on the sero-survey was under peer review. But it is reliably learnt that the paper is yet to reach Indian Journal of Medical Research (IJMR), a journal of the ICMR, to which it was meant to be submitted for peer review. Apparently, following the controversy set off by the paper, which had claimed that the COVID-19 pandemic in India would peak in November, the ICMR has mandated that any paper by ICMR scientists has to be vetted by the Director General before publication. It is learnt that it is yet to go past that hurdle. The work on peaking was funded by the ICMR and the authorship included a couple of ICMR scientists. The ICMR distanced itself from the work and even claimed that it had not funded it. But the paper states clearly that the work was funded by the ICMR.

Coming to the basic question, what are the epidemiological reasons for the increasing number of cases in the country? As pointed out earlier, the [confirmed] caseload will increase as the number of tests a day continually increases and, as seen in Fig.1, the growth curves of the two nearly mirror each other. But how much does the unlocking and movement of people in and out of regions for work, business, trade and other reasons contribute to this increase?

As has been pointed out in a paper posted on medRxiv on June 14 by researchers of the University of Michigan COVID-India Group, these factors would vary significantly from State to State, variations which are important for State-level non-pharmaceutical (NPI) interventions get masked by national trends as revealed by Ministry-level data. But such nuanced State-level data, relevant for detailed epidemiological analysis, are perhaps not easily available as one has not come across any such detailed analysis by Indian or foreign researchers as compared with work that became available in the early phases of the pandemic as it spread within China, and from regions of China to other parts of the world.

“The expanding outbreak in India does have the unlock component,” said Jameel, “but I feel it also has to do with people not following guidelines—masks in public, distancing and hand hygiene. This can get difficult for vulnerable sections of society, especially in urban slums. Even those wearing masks wear it incorrectly. The sheer density of our country must have a role.”

Airborne transmission

In fact, with the recent letter to the World Health Organisation (WHO) signed by 239 scientists pointing to the significant role of airborne virus in disease transmission, the densely populated habitats of large sections of the Indian population are also probably accentuating the spread. Airborne transmission—meaning virus carrying respiratory aerosols, which are droplets of sizes less than 5 micrometre that can go floating and wafting around with air currents in closed spaces with poor ventilation even when individuals maintain the required physical distancing—now seem to have a role. Following this letter, the WHO has taken cognisance of this and is apparently considering revising its guidelines for preventing the spread of infection.

“Equally important is trust and communication,” Jameel added. “There is a lack of both because the state is seen as having abandoned people—[in terms of] food, jobs, etc. There is a lot of mixed messaging too. There also seem to be no clear SOPs [standard operational procedures] for testing and treating. While these will evolve with time as more information becomes available, is there even a credible group of people who understand the disease and its epidemiology who are being consulted?” Jameel asked. “The response appears to be more political than public health and data/evidence-based.”

This correspondent asked Jameel what he thought was the reason for the near total lack of data-based epidemiological analysis to show the factors that were driving the current spread? Is it because the country lacked expert epidemiologists or was there an absence of adequate publicly available data? Jameel said: “The old adage is all models are wrong but some are useful. Models also depend on available data. When data are not released as they come and some are held back to avoid creating fear and may be released later, models will get messed up.”

So, with the government not open about information on the nature of COVID-19 spread in the country, and the research community rendered helpless, the people (including perhaps clinicians and health care workers) are left to face an uncertain future probably until the end of the year.

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