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Is the Covid response based on evidence?

It is being said that since money will not be adequate to initially provide this vaccine for all, the first priority will be to provide this to frontline warriors on the health front. But what if there are safety issues and the safety of frontline warriors is compromised?

Bharat Dogra | New Delhi |

When faced with a new health challenge, like that posed by Covid-19, the one aspect of policy on which there can be unanimity is to base policy carefully on available evidence. Just as significant underestimates of the threat can be harmful, significant overestimates can also create big problems and huge policy distortions.

Unfortunately, from the outset there have been serious questions regarding whether an evidencebased approach has been followed at the global level and at the level of most nations. The initial most widely discussed mathematical model (Imperial College), which predicted over 2 million deaths from Covid-19 in the USA alone and became the chief motivator for draconian measures, has been widely discredited by now and is recalled as the most influential research in history which also turned out to be the most wrong.

However, before it was discredited it had done great harm as draconian measures had already been taken in many countries on the basis of this highly flawed research. A serious question is – why couldn’t its serious flaws be pointed out before the damage was done? As it is, the professor who made the horribly wrong predictions had made hugely distorted predictions relating to pandemics on three previous instances as well.

He is now jokingly referred to as the professor of disasters, but the question remains as to why such flawed research was allowed to have a wide impact. Others say that flaws of this and related research were pointed out even at an early stage by eminent scientists but remained subdued. This is even more unfortunate. As a matter of fact, if we look carefully at the evolving debate on Covid-19 we see several instances of important evidence and policy flaws being pointed out without necessarily leading to corrections in policy response.

To get a proper understanding of disease profile, accuracy of tests is important. Atanu Biswas, Professor of Statistics, wrote some time back (April 21), “During the recent Covid-19 pandemic, there is a lot of buzz regarding the possible errors of diagnoses with both RT-PCR tests and the faster antibody-based tests, all over the world. To understand how serious these errors may be during a pandemic, we need to understand the nature of different types of errors.”

This is on top of diagnosisrelated errors in normal times, which are much higher than is commonly believed, even in more advanced countries. A British National Health System Survey of 2009 reported that 15 per cent of its patients were misdiagnosed, and according to a study published in the USA in 2014, each year approximately 12 million adults who sought outpatient medical care were misdiagnosed.

After flagging this wider concern, Biswas comes to the specific COVID test problems – “When a new test is rapidly created and deployed, as in the case of the current corona virus, its accuracy cannot be predicted beforehand. A test developed under controlled lab conditions might behave in a different way when applied in the real world, and this might enhance the likelihood of errors due to many unforeseen events.”

To this we may add that initially the novel corona virus test was developed and approved in very hurried conditions. Reports of problems relating to tests and quality of testing kits have appeared from time to time. In Delhi such controversies appeared to peak in the first week of June when the ruling Aam Aadmi Party (AAP) alleged retesting of samples by the Delhi government had revealed that a leading hospital run by the Central Government was giving out erroneous Covid-19 test reports.

The hospital refuted the allegation. This exchange coincided with the initiation of a report against eight testing labs for collecting samples against the protocol of the Indian Council of Medical Research. An AAP spokesperson said that 30 samples tested positive were re-examined by the Delhi government and 12 were found to be negative. Earlier there were reports of large number of testing kits being recalled from various parts of the country, or their use being stopped, as these were found to be faulty.

Another serious problem related to the frequency of faulty tests is that the possibilities of deliberate manipulation of data and misguidance based on this increase. Another controversy peaked around the same time related to research on hudroxychloroquine (HCQ) trials for treatment of Covid- 19. A controversial study which linked these trials to higher possibilities of death among Covid-19 patients was thoroughly exposed by over a hundred scientists for its numerous flaws and was withdrawn from publication in a prestigious medical journal.

Despite obvious flaws in the study, the WHO had earlier hurriedly suspended HCQ trials, but had to change this decision when the research paper was withdrawn. A leading Indian scientist and chief of CSIR Shekhar C. Munde said that the earlier WHO suspension was a ‘kneejerk’ reaction. He added that the WHO should have first analysed the data on its own before taking a decision on suspending the trial.

In fact, there has been a clear tendency on the part of some powerful persons and organizations of overemphasizing vaccinationbased solutions which leads also to at least relative discouragement of other solutions. Billionaires who have been overemphasizing vaccine- based solutions in critical areas of health including Covid-19 have emerged as leading funders of the WHO. But should this attitude persist in the wake of increasing safety and efficacy concerns relating to the Covid-19 vaccine?

The Economist reported recently (Jumping the Gun, April 28) that a leading manufacturer has already decided to start mass-producing an unproven Covid-19 vaccine on such a large-scale as to have 40 to 50 million doses ready by September. The prestigious journal noted that the established procedure so far has been to produce only proven, effective vaccines which have received regulatory approval and for which orders have been placed on this basis.

The Economist said the leading vaccine manufacturer is ‘gambling’ that the vaccine it has chosen to produce will be approved. ‘Gambling’ is a dangerous word, it may be added, in a context where the safety of many millions of people is concerned. In the race for a Covid-19 vaccine among several competitors, it has been seen that when exaggerated positive news relating to one vaccine goes around, the stocks of the company rise at least temporarily and in this short time also a lot of money can be made by a few.

The earlier concern was how the normal vaccine development period of ten years can be squeezed into ten months without compromising safety and efficacy concerns but now more concerns are being added to this. Very prominent scientists have raised serious questions.

Dr. Sucharit Bhakdi, one of the most cited scientists in Germany and Head of the Institute of Medical Microbiology and Hygiene, has said that the most obvious criteria that benefits must overwhelmingly outweigh any possible harm is not met in the case of Covid-19 vaccine. Despite such concerns very powerful interests are proceeding with the development and production of Covid-19 vaccines and if they have their way then many developing countries will have to consider within a few months whether they are willing to spend billions for buying this vaccine.

It is being said that since money will not be adequate to initially provide this vaccine for all, the first priority will be to provide this to frontline warriors on the health front. But what if there are safety issues and the safety of frontline warriors is compromised? Hence it will be extremely important to give full consideration to safety aspects and there should be no compromise on this.

Unfortunately, when billions of dollars are invested by powerful interests in this vaccine without its efficacy, desirability, urgent necessity and above all safety being confirmed, the likelihood increases that information regarding adverse impacts may be curbed or hidden. But availability of all important information is critical for evidence-based response and for policies most needed for human welfare.

In fact, such heavy premature investments also create interest groups dedicated to keeping risk-perceptions from Covid-19 at a high-level, even though the ground reality may be different.

(The writer is Convener of Save the Earth Now Campaign. His recent books include Protecting Earth for Children and Planet in Peril)

To Be Concluded