Proper Understanding of COVID-19 Threat for Balanced Policy Response

The COVID-19 crisis has appeared this year as one of the great disruptors of our times. To minimize distress and formulate the best policy it is important to have a proper understanding of the threat. This paper is written in six parts with the aim of promoting understanding for better policy. A basic theme of this paper is that there is need for precautions but not for panic. A balanced response based on combining essential precautions with protection of livelihoods and food security is needed. A panic-driven response which pushes for draconian measures is neither necessary nor desirable and in fact can be counter-productive.

In the first part of the paper we argue that the basic data base for policy decisions has been weak and in particular that the fatality rate has been overestimated. In part two we present the views of several scientists supporting further the view that the fatality rate has been overestimated and therefore draconian measures ( including prolonged lockdowns) based on this distorted understanding are not justified while a community, people-centric approach is likely to give much better results. In part 3 we look at the implications of draconian measures on people and their life, including on treatment of non-covid diseases and argue that draconian measures can be counter-productive. In part 4 we look at the various possible solutions and in particular examine the problems of the world vaccine industry which have a bearing on the availability of a safe and effective vaccine for COVID-19. The last or fifth section is in the form of some concluding remarks.

Part-1—Weak Data Base and Overestimation of Fatality Rate

This is a time of almost unprecedented disruption of normal life at a global level. It was stated in a WHO briefing on April 6 that more than a third of the world is currently under some form of lockdown as a result of the COVID-19 coronavirus pandemic. This increased further after some time. Hundreds of millions of people, including those living in some of the richest countries, have been in a state of unprecedented panic.

In such a situation the most obvious and important question is whether at a policy level the world has been able to respond in an effective and rational way. Unfortunately the answer is clearly in the negative. On the plus side, there is a huge scope for reducing distress if policy corrections can be made at a world level and in most countries.

It hardly needs to be emphasized that the first step is to have a proper understanding of the problem. This itself has been a problem area of much confusion. In this context one of the most discussed contributions has been written by a very senior scientist and a renowned expert on this issue Dr. John P.A loannidis. He is Professor of Medicine and Professor of Epidemiology and Population Health, Stanford University School of Health. His contribution, published on March 17 in STAT News, is titled ‘ A Fiasco in the Making’. Essentially here he has stated that as the pandemic takes hold we are making decisions without reliable data.

Dr. loannidis has said very clearly, “ The current coronavirus Covid-19 has been called a once-in-a-century pandemic. But it may also be a one-in-a-century evidence fiasco. At a time when everyone needs better information , from disease modelers and governments to people quarantined or just social distancing, we lack reliable evidence on how many people have been infected with SARS-CoV-2 or who continue to become infected. Better information is needed to guide decisions and actions of monumental significance and monitor their impact.â€

Dr. loannidis goes on to show how the prevailing fatality rate estimates are likely to be exaggerated and the actual fatality rate is likely to be much lower. As panic conditions result mainly from high fatality rate, there is actually scientific evidence that much of this panic , and the resulting mental health problems, are not based on any hard evidence.

Somewhat similar views regarding the likelihood of a significantly lower fatality rate and the need for avoiding sweeping counter-measures such as prolonged lockdowns have been expressed by some other very senior scientists as well including Dr. Sucharit Bhakdi who has been head of the Institute of Medical Microbiology and Hygiene, Germany and has corresponded with the German Chancellor for re-examining the response.

The German Network for Evidence Based Medicine is an association of German scientists, researchers and medical professionals. The network pointed out in a widely quoted statement on March 20 this year that in the majority of cases COVID-19 takes the form of a mild cold or is even symptom free. Therefore, it is highly unlikely that all cases of infections are recorded , in contrast to deaths which are almost completely recorded. This leads to an overestimation of the case fatality rate (CFR) . In addition, this statement pointed out, an overestimation of CFR also occurs when a deceased person is found to have been infected with SARS-CoV-2 but this was not the cause of death. The CFR of 0.2 currently measured for Germany is below the Robert-Koch-Institute (RKI) calculated influenza CFR of 0.4-0.5, but above the widely accepted figure of 0.1 per cent for which there is no reliable evidence.

In 2017-18 25,100 people died of influenza in Germany. This death corresponds to 5 million people with this infection with CFR of 0.5 calculated by the RKI for 2017-18. In order to reach 5 million within 15 weeks, the number of infected people would have to double every 4.4 days, similar to what was seen recently, but there was no panic in 2017-18, no overburdening was reported.

Hence it is clear that there is a strong need for avoiding panic and panic-driven draconian responses which also have a tendency of curbing transparency and contributing to the growth of authoritarianism. Instead we need transparent, democratic responses based on dialogue with communities and scientists/experts holding divergent opinions and understanding so that the best possible responses, based on extensive research and the best understanding of the existing knowledgebase, can be evolved. Also it is important to ensure that these responses are based entirely on public interest and are free from any narrow motives of greed and domination. Unfortunately the response of the world has so far not lived up to these ideals and so course correction is clearly needed.(Reference 1 or R1)

Basically we need a response where such medically needed norms of social distancing, quarantine, tests and treatment etc. are evolved which can co-exist with the basic requirements of protecting livelihoods and food security of people. While meeting special Covid-19 related medical needs ( particularly essential medicines and equipment, protection needs of medical and sanitation staff) , life-saving medicines and services should continue to be available at least at the same level as before for other serious diseases and injuries as well as for maternity and child-birth.(R1)

Dr. Peter Goetzsche, Prof. of Clinical Research Design and Analysis at the University pf Copenhagen recently made an interesting observation on the responses of various governments to the ongoing pandemic. He said, “ Our main problem is that no one will get in trouble for measures that are too draconian. They will only get in trouble if they do too little. So our politicians and those working with public health do much more than they should do.†However he adds that draconian measures cannot be applied beyond a point and so we have to think of different approaches which can be sustained.

Now increasingly several scientists are pointing out that this panic is not justified and existing estimates of Covid-19 deaths in some leading countries such as the USA and Italy are likely to be substantial overestimates.(R2)

Nina Schwalbe, Principal Visiting Fellow at the United Nations University
International Institute for Global Health is among those who have voiced such concerns. Writing in the web-site of World Economic Forum on April 4, she has pointed out that while calculating fatality percentage or rate, the denominator in the form of number of infections is underestimated, hence the fatality rate appears to be much higher than what it actually is. Due to lack of adequate tests—including in the USA—in many places only hospital patients are now counted as Covid-19 infection cases. This leaves out a large number of other infections. What is more, Schwalbe writes, even when we are testing, depending on the type of test used, we may only be counting people who are actively infected, not those who had it earlier and are currently immune.

Schwalbe concludes, “ By not counting the people who don’t need hospital care , we are massively over projecting the per cent of infected people who die of Covid 19. It is a dangerous message that is causing fear—all driven by a false denominator.†Schwalbe concludes by saying that the fear , anxiety, mental health problems caused by overestimates of fatality rate could have been avoided.

Another reason why fatality rate is getting exaggerated is that the number of deaths related to Covid-19 are being overestimated. In other words while the denominator is underestimated the numerator is overestimated in several official estimates. Senior scientists such as Dr. Jason Oke of Oxford University have pointed out that that the mere presence of this virus in a dead patient’s body is not evidence enough that this was the cause of death or the main cause of death. As this scientist along with Dr. Carl Heneghan says, “ Dying with the disease ( association) is not the same as dying from the disease ( causation).†( CEBM Research Evidence Service). Failure to make this simple but important distinction may be responsible for a lot of confusion and overestimates, as is also evident from the writings and video recordings of very senior scientists like Dr. Sucharit Bhakdi and Dr. John loannidis .

Dr. loannidis has not only questioned prevailing overestimates of fatality rate but in addition also highlighted some facts well-known in the scientific circle but which could not find adequate space in popular and media debates on this issue. He points out that ‘mild’ coronaviruses infect tens of millions of people every year and account for 3% to 11% of those hospitalized in the USA with lower respiratory infections each winter. As he says, these ‘mild’ coronaviruses may be implicated in several thousands of death every year worldwide, though the vast majority of these are not documented with precise testing.(R3).

Further he has pointed out that while the fatality rate of seasonal influenza is generally around 0.1 per cent , some of these coronaviruses that have been known for decades have been to cause very high fatality rates, as high as 8 per cent, when they infect elderly people in nursing homes. This was well before the appearance of COVID-19 . (R3)

Keeping in view the fact that a very high percentage of COVID 19 fatalities in western countries have involved elderly people in nursing homes, it is important to know that a very large number of nursing home fatalities were caused even earlier by coronaviruses. In fact in Italy as well as some other western countries, the proportion of very elderly people over 78 years of age and suffering from several other ailments has been very high among those recorded to have died from COVID-19, and many of these elderly people were staying in nursing homes. The panic of COVID-19 had a very disturbing impact on them, particularly in cases when with the panic-driven departure of some of the nursing staff there was a sharp deterioration in care. In the overall disturbed and panic conditions, some covid-like deaths got reported as COVID 19 , without much care of confirmation.

Coming back to this review of Dr. loannidis, this scientist has also drawn attention to some aspects about seasonal influenza which ought to be better known. Speaking about the USA situation he has written that in this season 1,073, 976 ( over one million) specimens have been tested and 222,552 ( 20.7 %) have tested positive for influenza. In the same period , the estimated number of influenza like illnesses is between 36,000,000 and 51,000,000,with estimates of deaths ranging between 22000 and 55000.

Here Dr. loannidis draws special attention to the fact that there is this wide range in seasonal flu death estimates even in the USA, a country known for better data collection , so that in a year these deaths may be 22000 or these may also be 55000, a difference of 30,000 , a difference of 2.5 times. Further Dr. loannidis says, “ Every year some of these deaths are due to influenza and some to other viruses, like common- cold coronaviruses†(R3).

Further he adds , “ In some people who die from viral respiratory pathogens more than one virus is found upon autopsy and bacteria are often superimposed . A positive test for coronavirus does not mean necessarily that this virus is always primarily responsible for a patient’s demise.â€

Also the number of influenza like illnesses is in this flu season is stated by him to be between 36 million and 51 million, again a huge number and a wide range.

On the web-site of the Centre of Disease Control (USA) it is mentioned that since 2010 annually , approximately, influenza has resulted in between 9 million to 45 million illnesses , between 1,40,000 and 8,10,000 hospitalizations and, between 12000 to 61000 deaths. This data draws attention to year to year big changes. In 2017-18 compared to the preceding year 2016-17, cases increased suddenly from 29 million to 45 million, and deaths from 38000 to 61000 ( as initially reported) and 80000, as reported in revised estimate. ( AP report in STAT News, Sept. 26 2018). Hence within a year deaths due to influenza could more than double, or increase by as much as 42000, while the number of cases of influenza increased by 16 million, or more in revised estimate. This is part of seasonal influenza for which lockdowns were never even thought of.

Hence there appears to be a lot of evidence to confirm that the fatality rate for COVID-19 has been grossly estimated and this is unlikely to be significantly higher than the fatality rate of seasonal flu. It is likely to be lesser by ten times or so compared to the high fatality rates presented by some international organizations which led to unfortunate panic and over-response in the form of very widespread and prolonged lockouts , causing immense avoidable distress to people in most countries of the world.

All these important observations point to the need for a lot of caution to avoid overestimating Covid-19 or novel coronavirus ( SARS -Cov-2) deaths. This is necessary both to avoid panic and panic-driven unduly harsh measures.

Part-2—Views of Senior Scientists

At a time when the debate on lockdown and extension of lockdown is escalating not just in India but in several other countries, it is useful to examine opinion of some very senior scientists on this issue. (R4)

Dr. Sucharit Bhakdi, a highly cited scientist, has been head of the Institute of Medical Microbiology and Hygiene in Germany. Recently he sent an open letter to German Chancellor Angela Merkel, calling for urgent re-examination of response to COVID-19. He said that it was difficult to find scientific rationale for the very sweeping measures that have been taken more in panic than on the basis of studies which firmly establish very high risks. The risk has been inflated by mistakes like assuming the presence of COVID-19 virus in a dead person to be necessarily the cause of death.
Earlier he had stated, speaking more in a global context, that some of the anti-COVID “measures are grotesque, absurd and very dangerous…The life expectancy of millions is being shortened. The horrifying impact on the world economy is threatening the existence of countless people. The consequences on medical care are profound. Already services to patients in need are reduced, operations cancelled, practices empty, hospital personnel dwindling.â€

Dr. Bhakdi is certainly not alone in the scientist and medical community to record their opposition to the prevailing response. He is in fact in the company of several eminent colleagues and their combined voices are attracting increasing attention not just because of their eminence and past record of academic accomplishments and public spirit but also because a lot of people sincerely feel that the emergence of such divergent views will lead to better policy-options at national and global levels.(R4).

Dr. David Katz, founder-director of the Yale University Prevention Research Centre said ( March 20, 2020, the New York Times , Is Our Fight Against Coronavirus Worse than the Disease), “I am deeply concerned that the social, economic and public health consequences of this near total meltdown of normal life –schools and businesses closed, gatherings banned—will be long-lasting and calamitous, possibly graver than the direct toll of the virus itself…The unemployment, impoverishment and despair likely to result will be public health scourges of the first order.â€

Michel T. Osterholm, Director of the Centre for Infectious Disease Research and Policy, University of Minnesota said ( March 21, 2020, Washington Post, Facing Covid-19 Reality—A National Lockdown is No Cure ) that if we consider the effects of shutting down and people rendered unemployed , “ the likely result would be not just depression but a complete breakdown , with countless permanently lost jobs , long before a vaccine is ready or natural immunity takes hold. The best alternative will probably entail letting those at low risk for serious disease continue to work, keep business and manufacturing operations going and ‘run’ society, while at the same time advising higher risk individuals to protect themselves through physical distancing and ramping up our health care capacity as aggressively as possible. With this battle plan we could gradually build up immunity without destroying the financial structure on which our lives are based.â€

Dr. Frank Ulrich Montgomery, former President of German Medical Association has said, “ I am not a fan of lockdowns. Anyone who imposes like this must also say when and how to pick it up again. Since we have to assume that the virus will be with us for a long time, I wonder when we will return to normal.†(R4).

Dr. Leonid Eidelman, former President of the World Medical Association, recently said in the context of the present crisis that a complete lockdown would cause more harm than good and will be counterproductive. If the economy is disrupted then inevitably resources for health care will also fall and overall health care will suffer instead of improving.

Dr. Wolfgang Wodarg is a physician specializing in Pulmonology and former Chairman of the Parliamentary Assembly of the Council of Europe (PACE). He has said, “ What is missing just now is a rational way of looking at things. How did you find out this virus was (so) dangerous?.â€

Here it may be pointed out that mortality from seasonal influenza at world level is also quite high. Until late 2017 the WHO estimated seasonal influenza was associated with a total of 250000 to 500000 deaths in world annually. Later other estimates put this mortality at between 290000 to 650000, that too when leaving out a part of the mortality. As a rough figure we may put this annual global mortality at around half a million. Imagine if these seasonal influenza deaths are put on TV on a daily or hourly basis ( over 1000 deaths per day, more in certain months) then one can imagine that this too can create a scare . So one needs to be careful about how public opinion can be manipulated.

All this is important for our world grappling with Covid-19 and has particular relevance in the context of the debate on lockdowns. Keeping in view all the evidence presented above, the best way forward is a balanced response which combines essential medical precautions with the need to protect life, livelihoods and food security. As even several scientists have pointed out, trying to impose draconian measures for a prolonged period in any part of the world may turn out to be counter-productive. (R4)

An important contribution to the debate on the most appropriate and reason-based response to COVID-19 has been made by 8 senior Indian scientists who have written a review article in the latest issue of the prestigious Indian Journal of Medical Research. This review article titled ‘ The 2019 novel coronavirus disease ( COVID—19) pandemic—A review of the current evidence’ has been written by Dr. Pranab Chatterjee ( lead author), Nazia Nagi, Anup Agarwal, Bhabatosh Das, Sayantan Banerjee, Swarup Sarkar, Nivedita Gupta and Raman. R. Gangakhedkar. All the 8 scientists are with leading institutions. This review article has been written in a global context, and not any specific country but its relevance to conditions of India and other developing countries in particular is apparent.

Expressing doubts about lockdown driven approach , this review article says that this is a drastic public heath measure. “ While the benefits of such a move remain to be seen, the long-lasting negative impacts of such a measure should not be underplayed. Such drastic measures can lead to social, psychological and economic stressors on the whole population, leading to long-lasting adverse health outcomes. Instead of coercive, top-down quarantine approaches, which are driven by the authorities, community and civil society led self-quarantine and self-monitoring could emerge as more sustainable and implementable strategies in a protracted pandemic like COVID-19.†(R5).

Further this review article notes, “ There have been elements of imposed travel restrictions and red-lining of affected areas, the long-term impacts of which on sectors like economy, agriculture and mental health remain to be seen. In this run to devise technological and medical solutions to yet another PHEIC ( Public Health Emergency of International Concern ), we have not focused on opportunities to strengthen health systems and community resilience through people centric approaches.â€

Speaking of the overall weakness and inadequacy of the global response this paper says, “ The emergence of SARS-CoV-2 has once again exposed the weaknesses of global health systems preparedness, ability to respond to an infectious threat , the rapidity of transmission of infections across international borders and the ineffectiveness of knee-jerk policy responses to emerging/re-emerging infectious disease threats.â€

Further these scientists say, “ The response mounted to the COVID-19 threat has largely been reactive. The lack of a reliable Early Warning, Alert and Response System, inability to mount transparent confinement measures, lack of community engagement for self-deferral and isolation and overdependence on quarantine measures have exposed the fissures in the ability of health systems across the world. It has clearly demonstrated the weak preparedness against emerging and re-emerging dangerous pathogens across the world.â€

Speaking of future tasks this important review article says, “ The infectious disease threats of our times are far from over, and if these are to be contained with lower magnitudes of loss to human life and economy, we need to invest in building up people centric health systems, which pre-empt and prevent, rather than work in reactive feedback loops driven by the burden of human misery.â€

This important review article should get wide attentions and its policy implications should also be carefully noted.

Part-3—Lockdown Adverse Impacts and Health

Lockdowns in different countries have different periodicity and stringencies. India is among the countries with a longer periodicity and higher stringency of lockdown with very little preparation time given to people before declaration of lockdown, but in addition at times it has on some occasions also witnessed large-scale violations of lockdown by desperate people.

There has been a big debate worldwide on the necessity and desirability of these lockdowns. One question that needs to be explored with a sense of urgency is whether a lockdown can even prove counter-productive in terms of its own stated aims.(R6). Everyone realizes that a lockdown has very sweeping implications and can cause a lot of difficulties to a very large number of people; hence its only justification is found in terms of its stated predominant aim of reducing the anticipated high mortality from a dangerous infectious disease, in the present case COVID-19.

However what happens if a prolonged lockdown of over a month itself leads to more deaths than it saves? Does such a possibility exist? In what ways can a lockdown lead to high mortality?

Firstly, we must look at all those patients who need emergency and life-saving medical care and medicines for non-COVID reasons. There include patients of heart disease and stroke, cancer, kidney ailments, diabetes, respiratory infections, other serious diseases, maternity and child-birth related care and complications, serious injuries, other infectious diseases like tuberculosis and HIV/AIDS etc. who need emergency medical care and/or very regular medicines and treatment regimes some of which are only possible in hospitals. A prolonged lockout can create a lot of problems for them in obtaining these medical services and medicines. Even already fixed surgeries and procedures may be cancelled.(R6).

Of course generally provisions are kept for serious patients to obtain special passes and also to maintain supply of medicines but despite this many of them are likely to face a much more difficult situation in terms of accessing essential medicines and medical services. Even if passes can be obtained and transport arranged, there may be lack of cash for paying for medicines and medical services as livelihoods and payments get disrupted during lockouts. As several hospitals and medical facilities are not functioning at earlier levels or else have been diverted to concentrating on Covid patients even several of those patients who have cash may not be able to access essential medical care.

The WHO has pointed out, citing two specific studies, that during the 2014-15 Ebola outbreak in West Africa the overall health systems were overwhelmed and as a result the extra deaths ( over and above the normal number) related to some diseases like measles, malaria, HIV/AIDS and tuberculosis were higher than deaths caused by Ebola itself. The number of institutional child births came down drastically.

Secondly, prolonged lockdowns lead to disruption of livelihoods , particularly in developing countries like India with predominant informal sector workforce unprotected by job security and social security. This leads to higher levels of poverty, hunger and malnutrition. This itself can be a big killer over a much longer period than the periodicity of the lockout. This also leads to increasing physical and mental stress. Migrant hungry workers with small children have to walk long distances. Jobless, cashless parents are locked in with hungry children. Researchers have already given warnings about the possibility of a significant rise in suicide rates.(R6).

Due to all these factors there can be a significant increase in mortality. The total number of deaths in the world in a year is 57 million ( 570 lakh). If there is a 5 per cent rise in mortality due to the combined impact of all the factors listed above, ( not an unrealistic estimate, given the seriousness of all these factors) then this will lead to 2.8 million ( 28 lakh) extra deaths in the world in one year. This can be called lockdown related deaths.

This also raises the issue of whether the programs and efforts to reduce other infectious diseases will be adversely affected in the Covid-centered days and to what extent. The most obvious example is that of tuberculosis which causes 0.44 million ( 4.4 lakh) deaths a year in India alone. The per day tuberculosis mortality in India is around 1090. Most of the TB patients die a very painful death in very difficult conditions. There are also increasing risks of multi-drug resistance TB. TB is certainly curable but TB patients have to take medicine very regularly over a period of several months. Most TB patients are very poor. They need free medicines. Experience has shown that regular contact with patients plus motivation of patients are necessary , apart from access to free medicines, to ensure completion of entire treatment course. If lockdown disrupts treatment, this will be very harmful. If lockouts and related factors lead to a 10 per cent hike in TB mortality, this in itself will lead to increase of 44000 TB deaths in India in one year. (R6).

The other aspect of the debate relates to whether lockdowns actually succeed in reducing even Covid deaths in a significant way, particularly in conditions of developing and poorer countries like India. In these countries a significant number of people have very cramped and congested housing conditions where social distancing is not easy to maintain. A large number of migrant workers are willing to take desperate steps, including walking several hundred kms. with children to unite with families and communities back home. While lockdown is seen as a way of managing Covid but managing a prolonged lockout itself becomes a serious issue which distracts from the original aim of reducing Covid infection risk.(R6).

Hence possibility of lockdown turning counterproductive certainly exists. Ischaemic heart disease and stroke caused 15.2 million deaths in 2016. Chronic obstructive pulmonary disease caused 3 million deaths in 2016. All cancers taken together caused 9.6 million deaths. Lung cancer ( along with trachea and bronchus cancers ) caused 1.7 million deaths. Lower respiratory infections caused 3 million deaths . Diabetes caused 1.6 million deaths. HIV/AIDS caused 1 million deaths.(All data here is for 2016).

All these are diseases which require hospital care and strict adherence to prescribed medicines. Denial of immediate or emergency treatment in the case of these diseases as well as several other diseases can lead to death and disability. Similarly denial of emergency care for several serious injuries can lead to death and disability. (R7).

In addition there is pressing need for the health system to maintain as far as possible the same level of care for maternity and child-birth as otherwise maternal and infant mortality rates can go up (R7).

All these facts and factors have to get due consideration by various countries while planning to meet the wider health challenges in COVID-19 times, or else the costs for people can be very high.

Part 4—Debate on Vaccines

In recent years a large number of public health personnel ranging from senior scientists to grassroot workers have been drawing attention to the dangers of mortgaging public health responsibilities to those guided by the motives of maximizing private profits. One area of particular concern in this context has been that of vaccines. While the great role of vaccines in promoting public health by providing protection from disease is very widely acknowledged, time and again attention has been drawn to the perils associated with the increasing concentration of vaccines production in the hands of a few multinational companies and their collaborators, some of them even dressed up as philanthropists.(R8)

Recent research in India has thrown up the highly disturbing fact that as a result of the arbitrary misuse of technology by these powerful sections, as many as 491000 children in India were afflicted by non-polio acute flaccid paralysis ( NPAFP) over a 17 year period 2000-2017, a tragedy that was almost entirely avoidable if the required care was taken to ensure the safest use of available technologies. While these children lived in various states of India, perhaps the highest number of afflictions were in Uttar Pradesh and Bihar. NPAFP is described in a research paper as “clinically indistinguishable from polio paralysis but twice as deadly.†Several of these children who suffered from this affliction later died.

An additional reason for telling the story of this tragedy now is that some of the leading agents involved in this fiasco are very active today also in the race for COVID-19 vaccine. (R8).

The tragic story starts in the late eighties when the world was preparing to embark on a campaign against poliomyelitis (polio) disease. At that time there were 350,000 cases in around 125 countries, affecting children under 5 years of age. 1 in 200 infections led to irreversible paralysis. Among those who suffered paralysis, 5 to 10 per cent died. (R8).

It was decided that instead of the more expensive and safer vaccine used in rich countries, oral vaccine will be used in this campaign which was mainly in developing countries like India. However there was a curious, suspicious start as the existing capacity to produce oral vaccine within India was sabotaged. Now India became entirely dependent on imports. Soon it was seen that there was a pressure to concentrate the country’s scarce health resources on just one program of oral polio vaccine and what is more the rounds of giving oral dose were increased like never before so that some experts feared that vaccine much in excess of safe limits was being given to children. On the one hand a safer alternative had been rejected on the plea that oral vaccine was cheaper but now we were being asked to administer such high doses that even safety limits were being crossed while the expenses were increasing. We were being asked to pay more for harming our children! It wasaround the same time it was seen that the number of cases of NPAFP started increasing much beyond the expected norm.( R8).

The situation worsened with the introduction around 2005 of a high-potency monovalent vaccine that contained five times the number of type 1 viruses compared to those contained in the previously used vaccine. With this new introduction the number of cases of NPAFP started increasing even more rapidly. The extra cases were sometimes five to six times of the expected number. In a single year the number of extra cases could go up to 40000 or even 50000.

It was by counting the number of such cases that the children afflicted by NPAFP ( extra cases above expected norm) has been estimated at 491000 over the period 2000-17 in India alone.

Meanwhile similar disturbing reports were coming in from other countries as well.
A question is—if the number of NPAFP cases is 491000 in India alone, what is the total number of afflictions in all the countries where similar methods were used.

While there are several reports and research papers on this , the most comprehensive and discussed paper was published in the reputed International Journal of Environment Research and Public Health on 15 August, 2018. This paper is titled Co-relation between Non-Polio Acute Flaccid Paralysis Rates with Pulse Polio Frequency in India. This paper has been written by Rachana Dhiman, Sandeep C. Prakash, V. Sreenivas and Jacob Puliyal. The last mentioned author in particular has made an outstanding contribution to unearthing this evidence. The estimate of 491000 extra afflictions is taken from this paper which has presented a table on afflictions for each of the 17 years. There was first a big increase in extra NPAFP cases and later, when pulse polio was greatly reduced or stopped, a decrease in extra NPAFP cases. This paer concludes, “ Our findings suggest that increase in NPAFP ( and a later decrease in such cases) was indeed an adverse effect of the pulse polio immunization programme.†(R9).

Other researchers who have contributed much to the understanding of this tragedy include S. Sathyamala whose analysis for Uttar Pradesh data revealed that mortality rate for patients with NPAFP was twice the mortality rate for wild polio. A study of M.A.Gupta and J.A Mathew ( with Puliyel) revealed that in 2005 when one-fifth of the cases wee followed up at 60 days in Uttar Pradesh, 8.5 per cent of them had died and 35 per cent were found to have been left with residual paralysis. Yet another study by N.Vashisht and P.Sreenivasan 9 (with Puliyel) revealed that NPAFP rate increased sharply when more than six rounds of pulse polio were used in a year. They mentioned the likely possibility that repeated doses of the live vaccine virus delivered to the instentine may colonize the gut of the child and alter the viral microbiome of the instentine, and this can result in strain shifts of entero-pathogens. It is possible, they said, that the new neurotropic enteroviruses colonizing the gut may induce paralysis.(R9).

I addition there have been equally distressing reports regarding the very harmful impacts of other vaccines including the HPV Vaccine, the dengue vaccine etc. In the recent debate on COVID-19 there has been a lot of emphasis on finding vaccine for COVID-19. However at the same time there is need for this discussion to take place more in the context of the needs of poor and developing countries and their people. Under the existing dominating world system of vaccine development and production, how will the interests of making available rational and safe products at low cost to the people of these countries be protected? (R10)

In recent years it has been seen in the health programmes of one developing country after another that the dominating influence of multinational companies and their networks in the vaccine sector has increased and this process has been facilitated by some private billionaires who present themselves as philanthropists but in fact promote their own narrow interests and agendas. This has happened to such an extent that the national government no longer decide the vaccines agenda; for all practical purposes it is these powerful outside agents and the international vaccine networks dominated by them who have their way.

All this should be seen within the wider framework of how various vested interests have tried to dominate vaccine production and research to carve out markets and maximize profits. This is explained well in an editorial of the Indian Journal of Medical Research (written by Jocob M. Puliyel and Yennapu Madhavi.

"The methods used by economically well-off nations to gain control over economically poor countries by accessing their markets and creating demand for medical technologies/vaccines, irrespective of local needs, have been documented extensively. As a new product is being readied, research is published to highlight the number of deaths in the country caused due to the absence of that vaccine. The estimates are often outright exaggerations or reflect poor research design. The limitations of such models have been pointed out previously.

"In the face of bourgeoning and aggressive marketing of vaccines of doubtful utility, we have a widening demands-supply gap in Expanded Programme on Immunization (EPI) vaccines. Over the last few decades, due to the decline of the public sector and the growing disinterest of the private sector, the number of firms supplying EPI vaccines has declined drastically both in India and abroad, prompting the UNICEF to express its serious concerns about the short supply of EPI vaccines. Private manufacturers prefer to sell them as ‘value-added cocktail vaccines’ at exorbitant prices in the open market, rather than supply to EPI. The universal tendency to combine EPI vaccines with non-EPI vaccines not only creates an artificial scarcity for affordable EPI vaccines, but also creates a backdoor method for the entry of expensive and perhaps unnecessary non-EPI vaccines into the universal immunization programme, riding piggyback on the EPI vaccines.... Only a ban against combinations of EPI and non-EPI vaccines, and a stipulation that only those private manufacturers who supply EPI vaccines to the government will be allowed to sell them in any form in the open market will save the EPI as well as the consumers. Dire situations call for drastic action.... Within the emerging scenario where expensive vaccines swallow up the less expensive options, India could emerge as the ethical EPI vaccine supplier to the world."

For India to be able to play such a noble role, we should first defeat the nefarious designs of those who seek to sabotage the indigenous production and R and D in the area of vaccines , as several such steps have been taken in recent decades and these have damaged the national interest in this important sector badly.

In the rush for combination vaccines preferred by marketing campaigns of some multinational companies it is sometimes forgotten that some of the benefits of single vaccines may be partially lost. Quoting several studies, Dr. Y. Madhavi, former Principal Scientist at the National Institute of Science, Technology and Development Studies, wrote in her paper," Vaccines and Vaccine Policy for Universal Health Care’, (Social Change, June 2013), , "Scientific literature show that in general the safety and efficacy aspects of combination vaccines are not proven beyond doubt, and it is reported that they are less protective when compared to their individual components. In pentavalent vaccine (DPT-HB-Hib), lower immunological responses to Hep-B and Hib were observed when compared to their separate administration."

Dr. Madhavi also raises the question whether the universal immunisation programme (UIP) is being used to provide huge markets for those vaccines of dubious benefits to India which can not find a significant market on their own merit - "Why is it that every combinations vaccine is a product of a combination of a UIP vaccine and a non-UIP vaccine? Is it because lack of demand-pull for individual new vaccines (for example, Hepatitis B, Hib) is sought to be covered up by the UIP vaccines that enjoy higher legtimacy? Virtually all combinations are a means by which new vaccines are gaining a back-door entry through the captive UIP market by riding piggyback on UIP vaccines such as DPT, measles, IPV, OPV etc. If a new vaccine can stand on its own merits (especially epidemiological merit), why does it need a piggyback ride?"
Another crucial question is whether these efforts, aided and abetted by international organisations, are part of a larger design for big inroads of vaccine multinational companies and their subsidiaries into India’s captive market for UIP. What is already well known is that many public sector vaccine making plants in India were arbitrarily shut down at least temporarily or vaccine manufacture there was stopped for considerable time. The controversy reacted its peak in 2007-08 when vaccine production including DPT was stopped in three public sector units. This closure was condemned by the Parliamentary Standing Committee. In addition legal action was initiated against it. In the process hope for continuation of vaccine production in public sector units was renewed.(R10).

The pressures to introduce Pentavalent vaccine as a replacement for DPT may also be related to snatch away the DPT market from public sector units. This, moreover, may be one of several other efforts to give a larger role to private sector, multinational companies and imports to sell their expensive, patent-protected combinations in India, using the captive market of UIP and in other ways.

In the process the costs of immunisation may well be increased several fold. Often international financial support for more expensive immunization is given for a short time to make this acceptable and after that a poor or developing country is forced to find its own resources to support an unnecessarily expensive and much more risky immunisation programme providing huge benefits to private sector and foreign companies, ignoring the potential available in the country for a much cheaper, less risky, self-reliant, reliable programme based on public sector and rational products.(R10)

In other words, serious health hazards are being accepted in the ruthless promotion of big business interests. Developed countries do not themselves use some combination vaccines but their companies and lobbyists have been pushing these ruthlessly in India and some other developing countries. They seem to have several powerful collaborators sitting in high positions in developing countries. With their help health risks for children are being played down using crude methods, while benefits are being exaggerated in equally questionable ways. Hence it is important for citizens and experts to join hands to protect critical health and child interests in developing and poor countries.(R10).

In the context vaccine some serious concerns have been raised by Prof. Michel Chossudovsky , Professor of Economics (Emeritus) at the University of Ottawa and founder-director of the Centre for Research on Globalization (CRG). He pointed out in a review of the year 2009 HINI swine flu pandemic that very exaggerated number of infections and deaths were forecast by very powerful organizations and persons so that orders for millions of vaccines were placed with multinational companies and finally millions of vaccines had to be destroyed as these were not needed. Wolfgang Wodarg ( also quoted above) has said that this false pandemic was likely to be a great medicine scandal. According to some senior scientists this led to a huge misallocation of scarce health funds. (R4).

Chossudovsky has also drawn attention to some recent trends. One is the growing power, resources and linkages of vaccine producing multinational companies and global networks. He has also drawn attention to ID2020 Agenda, described by Peter Koenig as “an electronic program that uses generalized vaccination as a platform for digital identity.†Chossudovsky adds, “ ID2020 is part of a ‘world governance project’ which, if applied, would roll out the contours of what some analysts have described as a Global Police State encompassing through vaccination the personal details of several billion people worldwide.â€

Clearly while vaccination has a very important health role, any attempts to concentrate vaccination in the hands of very big business interests, opening up this important sector to manipulation by them, should be resisted, as health activists have been pointing out for several years.(R4).

Charting out a recent sequence of events CRG researchers have pointed out that a simulation of a coronavirus epidemic was organized in October 2019 in Baltimore, invoking a frightfully large number of deaths till a vaccine appears. The new coronavirus pandemic was declared a global public health emergency in January 2020 with undue haste at a time when confirmed cases outside China numbered only 150.

Speaking of future many researchers say that instead of placing our fate and health in the hands of highly centralized big business interests we should rationally examine a range of treatments being suggested and tested by independent scientists who are free of domination of big interests. Not just medicine but also vaccine development outside the confines of big business is possible if various developing countries pool their scientific talent and resources for working on no-profit, no patent, free dissemination of knowledge basis to benefit all humanity , including the poorest people, concentrating only on entirely rational and safe products .

Part 5—Conclusion

Some aspects of COVID-19 remain a mystery. Why did a new member of the well-known coronavirus family known generally known for limited seasonal damage attract such extreme reaction right from the start when there was no reason to conclude that its fatality rate is very high? Why was a situation of panic created deliberately? Tuberculosis which is a highly infectious respiratory disease and kills 1.5 million every year and has a fatality rate of 15 compared to less than 0.5 for COVID-19 has never attracted such panic reaction. Pneumonia kills 900000 children below five years of age very year, also killing many elderly people but it has never attracted such attention. Up to 50 million people, mostly poor workers, suffering from serious respiratory/ lung occupational diseases are involved in a grim struggle for survival all the time but they have never attracted such attention.

Even when some independent reputed scientists started coming forward to place matters in perspective, why did some highly placed officials in some international organizations go on making sweeping statements on exaggerated threat without giving the reasons and evidence for what they were saying? Why did they make statements to deflect attention from real criticisms? Do some powerful forces have a strong interest in prolonging the crisis?

Hence all the more reason to be careful in policy formulation. There is all the place for adequate precautions but absolutely no place for panic. We need a balanced approach which combines adequate covid-care and precautions with protecting the livelihoods and food security of people and meeting all their basic needs.

References

• Statesman—April 9, 2020, Covid response should be measures, by Bharat Dogra
• . National Herald—COVID-19 crisis—Have we overestimated the threat by Bharat Dogra
• STAT News March 17 2020, A fiasco in the making/ by Prof. John P.A.loannidis
• Newsclick, April 15 2020, Ignore no scientific view on COVID-19, pick the best option, by Bharat Dogra
• Indian Journal of Medical Research, 2020, review article on COVID-19 by Dr. Pranab Chatterjee and co-authors
• The Wire.in—May 3 2020, Can a long lockdown be counter-productive, by Bharat Dogra
• The Statesman—April 15 2020, Challenge of the wider health crisis, by Bharat Dogra
• The New Leam—May 3 2020—Handing over public health to private profit—May 3 2020, by Bharat Dogra.
• International Journal of Environment Research and Public Health—August 15 2018—paper by Rachana Dhiman and co-authors.
• Frontier newsmagazine web-site—May 8 2020, Protecting the national interest in vaccine sector is important, by Bharat Dogra

Note About the writer—Bharat Dogra is Convener of Save the Earth Now Campaign. He was first Convener of National Campaign for People’s Right to Information, first Chairperson of Jan Hith Trust and former Chairperson of AAA Program for Homeless Persons. He has written regularly for 48 years , emphasizing peace, justice and environment protection and reporting from remote villages, resulting in about 9000 published articles/reports and 400 books/booklets. This work has been recognized in the form of about 40 awards and fellowships. He has written biographies of India’s freedom fighters and profiles of people’s movements. Latest books include Protecting Earth for People, Planet in Peril and Man Over Machine ( Gandhian Thinking), Sachai ki Kasam (Truth Above All- short stories in Hindi) and Kathin Daur Mein Ummeed ( Hindi poems—Hope in Difficult Times). Contact-bharatdogra1956@gmail.com. Web-site—bharatdogra.in