Mumbai: The number of Covid-19 cases is now reducing across India. But for most of April and May, many people across India were running around desperately to procure medicines such as ivermectin, azithromycin, favipiravir and steroids, and for plasma. It now turns out that all of those--as was very strongly advised by many doctors--should not be used, as per the new guidelines from the Director General of Health Services.

The Indian Council of Medical Research (ICMR) has not yet signed off on the guidelines and the health ministry itself has not put a clear stamp of approval on them. What do these new guidelines mean? Will they be implemented? How do we prepare now for what may hit us in the future? And what are the takeaways and learnings from these developments to ensure better and timely protocols in the future?

To discuss this, we are joined by two members of the medical profession who have been advocating very strongly for moderate, if not very careful, interventions. Sumit Ray is head of the department of critical care at the Holy Family Hospital in New Delhi and also its medical superintendent. He is an MBBS and MD from Delhi University and has a fellowship in critical care medicine from the Tampa General Hospital in the United States. I'm also joined by Lancelot Pinto, a consultant pulmonologist from the Hinduja Hospital in Mumbai. He has degrees in respiratory medicine and epidemiology from McGill University in Canada.

Edited excerpts:

Govindraj Ethiraj: Dr Ray, what is your response to these new guidelines?

Sumit Ray: I think these are more appropriate and should've probably come a little earlier, but better late than never. A lot of medication was being used with very, very little evidence, as we have discussed before. Going ahead, organisations like the ICMR and the health ministry must establish guidelines based more on evidence than panic and the need to 'do something'. And that has been the bane of this pandemic. At multiple levels, there is this effort to 'do something' rather than go by scientific evidence. At the beginning of the pandemic, one could understand [this]. There was panic; there was a lack of understanding of the disease process, but now it's more than one-and-half years since the disease [began]. There are enough studies to tell us what works and what doesn't. There must be continuing research and we should base evolving guidelines on stronger evidence.

GE: How do these guidelines get formulated? What is their source?

SR: When guidelines are made, there's an expert committee of several doctors and healthcare specialists of different types who sit together and gather evidence on what worked, on which subset of patients, and if it caused any harm. Both [effectiveness and harm] are important aspects. Most drugs have some side-effects or adverse effects. Many times, it is 'nothing is working, so let us give this'. But that 'this' could cause harm in the long or short term. Almost everything we use, including oxygen, can cause harm. So it has to be thought through, based on literature, net search, studies, and, if expert committee members have done research on that specific topic.

GE: Dr Pinto, you have been advising strongly against the use of steroids. Tell us how you see these guidelines and how you see this converting into action.

LP: These guidelines are extremely welcome. They summarise what a lot of us have been saying for some time now. Not only do the guidelines say what should be done, they also give clear indicators on what should not be done. And I think that's a far bigger problem when it comes to Covid. A lot of things got onto the guidelines and statements, but they were not taken off once the evidence was updated. For example, the blatant misuse of CT scans that we see very often has been clearly addressed in this guidance. And they have put forward the reasons for which a CT scan should be done, when it should be done, when it should not be done.

They're very clear about steroids -- about them being used only in individuals whose oxygen levels drop, how they should be titrated, and what the target saturations are. I think the utility of a simple guidance like this, which is almost like an infographic of nine pages and not a tome, is that it's almost like a flowchart where you see if somebody is 'mild', this is what you do; if 'moderate', this; where do you triage and how do you treat? It makes it very clear for the treating physician what to do. And, it also gives proponents of evidence-based medicine a solid framework on which to base their treatment decisions. So, I no longer have to apologise, no longer act like I'm somebody who is doing something different from what everyone else is doing. Now I have guidelines to say: 'Listen, the country's guidelines recommend this too. This is why I am not giving you these drugs.' I think it's a great step forward.

GE: Dr Ray, tell us how you've been treating patients in the most recent weeks and if you sense that patients have become more receptive to, let us say, simpler forms of treatment?

SR: Two things: One, as Dr Pinto says, the guidelines are helping us explain more easily to patients [and families] who understandably want multiple things to be done for their loved ones. Particularly in my field of critical care medicine where patients are very, very sick. The second thing that happened after the surge [waned] is that now we have more time to explain to the families. At the peak of the surge, there was very little time to spend with families to try and explain what was happening. And both these things [the surge petering out and the guidelines] have come together.

Having said that, personally, my practice, in terms of ICU patients, severely ill patients, hospitalised patients -- has not changed much over the last few months because we already practised what the guidelines say. And that's the other thing about guidelines -- they should guide us but they are not God's words. That's why it was important to question guidelines when they needed questioning, there have been problems with them before too. It's not [just] for Covid but otherwise too. Because, sometimes, there are many other interests [that go into] guidelines which constantly need questioning by doctors once they have read through, understood and researched them. Only then do guidelines change and that's what has happened in this case also -- because so many of us asked these questions about the guidelines there was pressure on the ICMR and the ministry to actually keep looking at them and try to change them. Not just evidence, questions raised by different people also help to write guidelines.

GE: Can you give us some examples of guidelines for non-Covid cases as you say?

SR: The four-yearly 'Surviving Sepsis' guidelines are a classic example, as Dr Pinto would also know. Basically, septicaemia, sepsis, is one of the causes of high mortality in the ICU. And there were drugs which were proposed in the early 2000s, classically a drug called Xigris by Eli Lilly. The 2004 guidelines were funded by the company. Lots of us asked questions, there was not enough evidence, and it was an expensive drug. Because it was in the guidelines, a lot of doctors were pushed into using it but many of us kept questioning. By 2008, in the next 'Surviving Sepsis' guidelines, it became a suggestion, and by 2012, it had been taken off the guidelines.

[This was] Because there was immense pressure on the guidelines committee to change [the guidelines], because there was not enough evidence [to support the drug's use] and there was suspicion of industry influence on the guidelines. Oncology is another example of a [field] where there is a lot of pressure on guidelines -- industry pressure, pharmaceutical industry pressure, and so on.

GE: Can the questioning happen if the guidelines are formed in a more closed group?

SR: When it is more in the public domain, obviously the questions raised become more public. And it becomes easier to keep a check on these things. Restricted to certain smaller groups, as you rightly said, there is a tendency to [use/give into] influence. Having said that, there are certain aspects of guidelines which probably need to be questioned from within the profession. As a journalist, you would start questioning it only when somebody from the profession starts questioning it. So it's absolutely essential that there is continuous skepticism about new drugs, new modalities, because there is lots of influence [in play from] Big Pharma when they introduce new medications. And to tell you, honestly and personally, every time a new and expensive therapy is introduced, I get very anxious and nervous. Just the idea that if it becomes part of the guidelines you have to send a few more poor Indians into debt makes me very, very anxious. And a new drug that is very expensive makes me anxious.

GE: Dr Pinto, are these guidelines too little, too late?

LP: I think it's going to take some time for the guidelines to actually percolate and that's true for any disease – especially when people have been habituated to writing some prescriptions, when the general public has heard of certain drugs. And there's so much hearsay in a disease like Covid. There are WhatsApp groups, and there are forwards. And it's a disease where 85% of people get better, no matter what you do. So individuals who have had family members take X, Y, Z drugs and get better would strongly believe that X, Y, Z drugs worked in that situation. And that could possibly be the same story with healthcare providers. So, we have a lot of doctors who will often say that 'I really believe this drug works despite the guidelines saying it doesn't'. Sometimes, maybe there is some element of truth, which is why guidelines do get updated down the road. But the translation of guidelines into practice for any disease tends to take some time to disseminate. At the same time, this is a step forward and now needs to be disseminated as much as possible.

GE: But if we had acted in time, then maybe people would not have become seriously ill or died.

LP: I would have to agree that the international guidelines or the international consensus on most of these drugs happened some time back. Take plasma, for example. I think we used it for about 8 to 10 months more than the rest of the world. Remdesivir, I think, was taken off a lot of the [global] guidelines some time back. Drugs like favipiravir have not been used in most parts of the world. So I do agree that some of this is coming late. But the fact is that most of us were prescribing drugs based on evidence, irrespective of what the guidelines said. Now, having the guidelines align with our practices makes life a lot easier. And yes, even if it does come late, this is not the end of Covid. So if this is a trend that not only stays consistent for Covid but also maybe spills over into other diseases, and if we have in place a whole process for making and updating guidelines for, say, tuberculosis and other diseases, I think that would all be a great step forward.

GE: So, Dr Ray, how can we react faster to changing global guidelines?

SR: You have to have transparency in the whole system, on how you make guidelines, and the intellectual and academic ability to accept that what you did earlier was not right. And that should be true of the experts who make the guidelines and us practitioners too. So the first thing is to allow yourself to be questioned – which is not very common, unfortunately, in India. Our whole education system is such that we don't like being questioned. Teachers, senior doctors, we don't like being questioned by our juniors. So, it's almost like a cultural thing. And so this has to get into our system that yes, one was wrong, and not because the way one wanted to do things was wrong, but because the evidence was just building up. And once the evidence reaches a certain point of consensus, you have to change the practice.

The other is also culturally accepting the fact that if a guidance said something at a certain point of time and it has changed now, that doesn't mean that the experts were wrong at that time. They based their guidelines on the evidence present and so that may also be true. The fear among us, those who make the guidelines, is that if we change it now, people will think we didn't know what we were talking about. But that's not true. Evidence in science is constantly building. And then you have certain people (I don't want to take names here), who will say that look here, allopathy could not do this, could not do that. Well, [there are] lots of things in Western medicine that we cannot achieve but that does not mean that there is [not] a scientific process of building evidence and research and then coming to the guidelines.

GE: Dr Pinto, we are now seeing the dreaded second wave ease off. How should we be using this time to prepare for the coming months? Perhaps, working on the next set of guidelines, for Covid itself, or some variation of it, or TB?

LP: So I think it would be nice to have a framework, or some sort of a body which constantly updates guidelines, which creates living guidelines. For example, look at the UK. There's something called the NICE guidelines, and when the NICE guidelines say something, most people do not feel the need to really cross-check it or go into great detail. By and large, they assume that a lot of that will be true. As we speak, there are newer drugs [for Covid]: there's this antibody cocktail which has come to the market now; there is 2DG which is a new drug; the Recovery Trial just published that aspirin does not necessarily make a difference. So we need to constantly update based on the knowledge that's available and I think that's our best bet moving forward. And we need to do it really soon. Because, as Dr Ray has pointed out, there are competing interests, there are conflicts of interest, there is an industry which would want the maximum number of people to have their drug. So we need to move in faster than them. We need to spread information before misinformation spreads.

GE: How do you look ahead in the context of Covid itself, assuming we are gearing up for a third wave?

LP: So, the media is going to have a very important role. I think a lot of headlines talk about 'wonder drugs', 'life-saving drugs' -- these superlative adjectives that we love to use drive a lot of the market. Somebody hears a buzzword here and a buzzword there, and suddenly you realise things are being blackmarketed, and are unavailable. I think it would be nice if the media did its own research very early, in the phase of a drug being launched. It'd be nice if in the drugs that are scrutinised and then cleared by the government, there is some degree of transparency. Why has the drug been approved, what were the studies, what was the information that was used – that should be put in the public domain so that anybody can critically appraise the drug and put it out there. I think this whole process of rationally dissecting every therapy being promoted would make a big difference to how we manage the future waves.

SR: So, why are the NICE guidelines accepted so easily in the NHS and across the world? There are two reasons. One, there are large research platforms that are very flexible and dynamic. They keep moving very rapidly. And, second, the conflicts of interest or competing interests are not there. It's a very good public health system where researchers are not influenced by industry profits but by the best they can do for the people and the health system. That is the kind of research platform that the ICMR and the government needs to build. That would really help debunk a lot of the data. Or get in new data, new evidence, etc. And as I said, till date – I have been practising for more than 25 years – I haven't seen a magic bullet. There is no drug which will work perfectly and change everything for every patient of that disease. It's always a subset of patients it may benefit. Benefit does not [even] mean that every patient of that subset will do better, it means that a subset within that subset will do better than the others. So, as Dr Pinto said, the hype over drugs, created not only by the industry but also by the profession itself, claims that Western medicine can do way more than it actually can. So, there needs to be a toning down of that kind of hyperbole.

GE: How do you think that we could be preparing for the third wave in the context of having more active guidelines? And also, what is your message to those who watch, listen or read on how they should deal with medicines?

SR: I have said this earlier -- patients and their families should be asking 'why you are giving this medicine' rather than 'why are you not giving this medicine'. So there are very few drugs that work in Covid and then too in a specific subset. There are different subset of patients, different medicines, different timepoints. So, if a doctor is prescribing multiple drugs, then there has to be rationale. Why are they using a steroid, at what time point are they using it or why are they using remdesivir? Because there are very few drugs, and these are basically [given] to the really hospitalised and sick ones. The basics of critical care do not really change even for Covid. Except for a few minor changes, which are specific to the disease. Other than that, how we treat a critically ill patient with respiratory illness in the ICU is similar to what we do in Covid, with minor changes that only a certain amount of training and exercise can tell us. So excessive drugs have not shown much benefit.

GE: How can we be more proactive and ensure that guidelines have to be formulated for, let's say, the next batch of medicines?

LP: I think the first step would be to acknowledge whoever wrote these particular guidelines. Laud that person. Going by what they have done so far, they clearly understand the current literature and I don't see any reason why they will not be able to update it. Maybe these individuals should meet every 15 days or so, have a virtual meeting, and talk about what have been the latest developments in that past week or so.

SR: And have the courage to question political decision-makers in making guidelines. Like it was done in the USA. [When] Trump was promoting certain drugs, [he] was challenged by the scientific community. That needs to be done everywhere, across the world, every country, even in India. And to question and resist that because people in power want to show that they are 'doing something'. And in that, sometimes, stuff which is unscientific gets pushed. So, the scientific community, the research community, and the doctors, should have the courage to oppose that.

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