 Hello and welcome to NewsClick. Today we have with us Professor Satyajit Rat and we are going to discuss some of the drug trials which are on and some of the results which have come and also on some of the vaccine trials. Satyajit, good to have you with us as always. We are going to start with this hydroxychloroquine trial which the WHO has said that they are longer going to use on the one arm of the solidarity trials. What does it mean and why did this happen? So as far as one can make out from information in the public domain, the WHO solidarity trial which is essentially many medical centres from many countries participating with a common protocol in a WHO coordinated set of trials rather than just a hydroxychloroquine trial. So it's really a framework for COVID-19 related trials to be simultaneously held in multiple countries so that one can sort of leapfrog drug and vaccine development. What seems to have happened is that an examination seems to have come up with information that there are possibilities of side effects. Now I'm not actually sure, I haven't seen the information clearly enough to be sure exactly what side effects although given that hydroxychloroquine generates heart-related irregularities and similar side effects, one assumes that it is that. But WHO's trial related advisory group which recommended stopping the arm has apparently said that this is being done not because there is clear difficulty with hydroxychloroquine but simply out of an abundance of caution just to be on the same side. Now there's a twist to this very recently and the twist is how many participant medical centres are based in Australia and from those how many people have been affected in which category of death and severe illness and so on and so forth seems to be somewhat uncertain. So there is a 69 cases versus 73 cases and four centres instead of five centres difficulty going on. Part of the difficulty is also because the data collation and management is being done by a private company and this company, I'm missing the name, not biosphere but some similar name is being politely so far accused of a certain lack of transparency, they in turn are being indignant about this. There seems to be some data weaknesses that's a polite way of putting it and it's not very clear what the numbers have been. So given that the argument would still be that it is still unclear that whether there is any benefit or not. So let's be very clear about this. So far there is one positive finding and one negative finding that nobody will dispute. The positive finding is hydroxychloroquine does have side effects. Nobody is going to dispute this. So it's one thing for people with an illness for which hydroxychloroquine is an appropriate medicine to be taking that and dealing with the risk and the side effects. It's completely a different thing for completely healthy people to be taking hydroxychloroquine, a drug with known side effects and significant ones, as a prophylaxis, as a preventive. So that's what I'm calling the positive finding, that it does have side effects, nobody disputes this. The negative finding is... The Trump should be aware of it by now or he is not really familiar with science so it's all right. It's not clear whether the President of the United States of America is actually taking it or not. That he's saying he's taking it is not evidence. Particularly in his... So let's go further on the hydroxychloroquine. The negative finding about hydroxychloroquine that again everybody will agree with paradoxically is that currently there is no clear cut strong evidence that says that in a clinical situation either as a preventive or as a therapeutic hydroxychloroquine has demonstrated effects in COVID-19. Everybody who is advocating it is not advocating it because they think there is evidence to support it. They are advocating it because they think it's possible that it may have effects. And that seems to me remarkably wishy-washy basis on which national authorities are basing a propagation of hydroxychloroquine either as a therapeutic or as a preventive. So you are talking in this case of the ICMR strongly suggesting that they will go forward with hydroxychloroquine as a medicine in COVID-19 cases. So the most recent information in the public domain that I have seen is that ICMR says that ICMR has its own data and evidence that hydroxychloroquine does offer COVID-19 benefits. Now because that's just a statement in the public domain, we have no idea whether that's as a prophylaxis or as treatment. We have no idea what the numbers are. I find myself unable to comment because we don't know. So if they have it, does transparency demand that it should be in the public domain? Well, particularly when you appeal on the basis of science, not on the basis of belief. But on the other hand, ICMR's advice about hydroxychloroquine then is in the same category as the Ayush ministry's many advisories about many interventions for COVID-19 are both as preventive and as free. And we will politely leave it at that, not go further in the kind of advisories they might have issued. Coming back to the issue of drugs, among the repurposed drugs, earlier also said that antivirals would have some effect provided it's given early. Remdesivir could be a part of that. Some other antivirals are also being used. But apart from that, for instance, other medicines which have recently been talked about like blood thinners because clotting seems to be one of the major problems that people have encountered, particularly those with lung conditions and also pulmonary conditions and also about heart conditions. Do you think that makes some sense? Oh, I'm sure that it is worth trying. Clearly, there is a rationale because in severely ill COVID-19 affected individuals in whom, as we have noted earlier in these conversations, there is an extraordinary and interestingly wide diversity of symptoms and of organs affected, which includes blood clotting related difficulties. So clearly there is a rationale for testing these sorts of, shall we broadly call them supportive therapies in severely ill COVID-19 patients. Again, I have yet to see a formal clinical trial result, but there are an increasing number of anecdotal reports of these kinds of inventions being useful. Again, that's normal practice that hospitals, intensive care centers, especially academically inclined intensive care centers, will systematically plan and look for these, what appear to be small interventions, but that will, if they are even moderately successful, make a lot of difference to patients who are critically sick. So I suspect that at least for some patients, these kinds of interventions are going to be useful. And this would also explain why the oxygenation levels are low, but the patients are not that badly off initially. And could it be that because blood clotting does affect that in the lung is one of the reasons? Yes, I know that's being said. And quite frankly, I haven't quite understood the logic that connects those two pathways. So for me, the happy, hypoxic COVID-19 patient to use sort of hospital speak, that the reduction in oxygenation levels is quite drastic. And yet the patient is not feeling as horribly ill as those levels would lead the doctors to expect. That scenario still remains somewhat of a mystery to me and I would be very interested as in when people working on this field in clinical research begin to find at least indications of what combination of circumstances in the bodies of these patients lead to this outcome. Coming back to the vaccine, the other issue that's of course of great interest to everybody. Do you think that there is any further revelations in terms of results that have come? For instance, we discussed earlier that we have yet to see the modern results. And they have been a lot of criticism later that they were supposed to be 46 or 45 patients, which was supposed to be tested. Why only eight results were declared or 12 results declared? So does it mean that this are the good ones to show and the others were not that controversy doesn't seem to have resulted in any later data releases were modern? Not again, not that I have seen. And for me, it's interesting that there is so much of understandably obsessive focus on what ought to be careful, cautious evaluation. First of the safety and second of the simply the immunogenicity, meaning the ability to generate an immune response, not the ability to protect, mind you, just to generate an immune response. On those phases of human trials, for all of these vaccines, instead, we are now obsessively focusing on every small piece of either data or its absence. And it says something about just how anxious the world is for there to be a vaccine. And countries to actually try and push this things up in the belief that they will control the vaccine market. The US has been sort of driving off Sanofi earlier now as to Zenka as well. So they seem to be going around the world with with money bags and saying, hey, we get the first dibs and we'll give you so many billion dollars and try to buy companies which they didn't succeed. So do you think all of this is also the reason why it gets so hyped up? Apart from the share price in modern it doesn't have any medicine or vaccine in the market. But it's now this share price is somebody I think 30 billion dollars or something, the total market capitalization of modern it's a very, very high. Absolutely. There is no question that the profit motive of major biotech and pharma industry is playing an enormous outsize role in a great deal of the discourse around this. But let me make two points about this. One, we have now come to the point where we begin to look at one individual apparently in the vaccine trial, who has complained that he or she, they would have felt more seriously unwell with the vaccine. And the response of one individual has now become a major talking point. And that says something both about transparency and about the stakes involved. But less, less likely and more seriously. It's also interesting from the point of view of the rest of the world that yesterday's issue of science, I think carries a large opinion piece, a perspective piece, I think it's called. It's authored amongst others by Anthony Fauci and Francis Collins, the former as the official point person of the US government for infectious diseases director of the National Institute of Allergy and infectious diseases. And Francis Collins as the director of the National Institute of Health. They have written a perspective that is somewhat at odds with a completely market oriented approach to vaccine distribution and dissemination. They have now laid out a very tentative and not very long on detail, but at least a kind of initial conversation about public private partnerships and how vaccines will be made available via combinations of public sector and private sector commitments to the poorest of this world. Now, as I said, it's a very long on good intentions and short on detailed piece, but the very fact that senior American academics in the forefront of the anti COVID-19 research effort, who speak for the government in a variety of ways, have now begun to put themselves into situations where the accessibility of vaccines is an issue that they are beginning to discuss. I think these are the early steps that are going to shape the international political economic discourse as we go forward with the emergence of more than one vaccine candidates as moderately successful in terms of how to make these vaccines accessible. You know, it's an interesting issue that Fauci Institute, what you talked about in the NID is a partner in the modern trials, and it has also not issued any statement. It's really kept quiet, even after the modern press release. And modern as market cap is no more than $200 billion. So say $30 billion was insulting to modern. So I apologize for that mistake. Now coming back to the issue that you raised public private partnership. Now the voluntary patent pool was the World Health Assembly's resolution that all countries backed except the United States talked about a voluntary patent pool in which countries with institutions and companies and hand over their vaccines and medicines. And the United States actually gave a note of virtually a note of dissent. It says that this is against intellectual property and which is what drives modern science, et cetera, et cetera, et cetera. So it was the only holdout to that. So do you think it shows that the American administration is not in favor of considering it a public good, but would like to use it for the strategic interest. If you deal to me say, yes, sir, you are the greatest God, sir, then we'll give you the vaccine. Otherwise you can line up wherever you want. Do you think that would be where it might end up? Well, certainly the political leadership of the US government appears quite unambiguously of that position. I don't think there's any great doubt about that. Nor, to be honest, is it particularly surprising given given the long track record of the US government in protecting its so-called intellectual property rights of its industry. It's why I'm finding this recent write up interesting because one can interpret it in a variety of ways. One can interpret it as a sort of second string tactic, a plan B to function as a negotiation ploy. One can interpret it as the sheer ethical indignation of these officials as individuals and they are putting a little bit of pressure perhaps on the much more hard-line political leadership. One can interpret it in a variety of ways and that makes it an interesting point of conversation. So as we go forward, we will hear from political leadership in response to this piece. We will hear from other scientific leadership from within that's not as closely aligned to the government nor to Moderna and many of whom have very strongly advocated a completely public good approach to the vaccine and how this part of the progressive community within the US responds, how the US partner governments particularly in Europe respond to this, all of this is going to be interesting. And it's going to be important and consequential because as we go forward into what I have been calling the vaccine wars, the vaccine negotiations going towards the end of this calendar year, these are the initial tactical positionings that will show us the configurations of that struggle. In fact, President Xi and President Macron both have come out openly saying they should be public good and most countries of the European Union have also said so that's already on the record but coming back to the last question I have a few. Satya, you have also been part of the intellectual property rights debate and now you're really talking about patents for remdesivir. Other antivirals which are being tested, we already used them in the AIDS campaigns and they are available because we have the ability as India to supply them to any country in the world and with a compulsory license allowed by the Doha declaration of WTO. So that's already there and in fact we don't need any patent pool for instance if we want to supply those retrovirals but remdesivir will need a compulsory license and so will any Moderna vaccine or a similar vaccine coming out right now. So we also have other countries, not India alone, other countries also have the instrument of compulsory license on which they can rely on. Oh absolutely and as a matter of fact, I would take the position that the COVID-19 pandemic, if the COVID-19 pandemic does not fulfill the section 3D conditions for compulsory licensing, I cannot imagine. That's a different condition, section 84 and section 92 of the Indian Patent Act. So if COVID-19 pandemic situation does not fulfill the condition for just off the cuff compulsory licensing, I cannot imagine what does. So that if we cannot invoke compulsory licensing in a COVID-19 situation then we are essentially making a mockery of the law. Because we are basically saying, we cannot imagine a situation in which we can actually invoke it. Yeah basically surrendering to US multinationals and to the US government which is treated as you know after the use of the next of our compulsory license, we have fallen foul of USTR 301. Of course we have always fallen foul of it for different reasons. But this has been a specific example given on compulsory licensing and you make a very important point that if these provisions don't, we don't know what will. And that's exactly the Doha Declaration which was signed in 2001, if you remember in WTO, which said two things. It said public, it said epidemic, not pandemic. It said epidemic. And it also said health emergency. And if COVID-19 is neither an epidemic or a health emergency, we would be very, very surprised. So that's a clear declaration that exists, an instrument that exists. And from what you discussed with us earlier that it is possible for countries such as India and other countries also to duplicate what's happening once we know something works. Duplicating is much easier. And remdesivir is actually a small molecule. So it's not a one of the biologics which are more complex and more difficult. So it shouldn't be much of a problem to also use it or redevelop it again in India. Certainly, certainly, quite frankly, I'm a little less deeply concerned about drugs such as remdesivir than I am about the vaccines. Because of a concern that I have expressed previously, which is that you refer to just now, which is that antivirals will have a modest effect in treating the severely ill people. This is not to say that they're not important. It's simply to say that that's a more restricted effect. For me, the vaccines and the vaccines in the plural are going to be the major to use a term that Mr. Trump has somewhat trivialized. The true game changers are going to be the vaccines. And therefore it's on the vaccines and their wide accessibility that I think attention needs to be focused. And that's the reason why I have been focused on arguing that all Indian academic efforts at developing vaccine candidates for COVID-19 in India need to be strongly supported. Because whether they succeed all the way or not, they provide clear and present evidence that allows us to argue against the patentability of these vaccines in the first place, since this is widely understood art. And therefore, I think that it is that landscape of struggle that's going to take interesting shape as we go forward. Sir, good Satyajit, what you're pointing out is not only the political struggle, which we can use compulsory licensing, but also the struggle, the scientific struggle or the struggle in the laboratories we have to wage in order to make some of this possible. So one without the other will not work. We come back to the key of the science movement and the health movement, that science and people's health and movements have to work together. Thank you very much Satyajit for being with us. And we hope that as it continues, it's going to go on for quite some time as it looks like, we'll have you with us repeatedly and certainly before we have successfully meted back the COVID-19 pandemic. Thank you very much. This is all the time we have news click today. Do keep watching this click and do also look at our science shows.