 Hello and welcome to NewsClick. Today we have with us Professor Satyajit Rath and we are going to discuss again all the COVID-19 what is happening in the world, particularly as we now have a new medicine for COVID-19, Malnupiravir. Satyajit, this seems to be a new welcome edition and the first time we seem to find something which is effective in the first five days that you show symptoms. If it is given within that, it seems to have a certain degree of efficacy which we have not till now found in any other antiviral drug. So do we consider this new drug from Merck as a welcome addition to what we have in our kitty at the moment, particularly as the older claims of certain drugs, particularly as we have found with both, with drugs like ivermectin and of course hydroxychloroquine have been completely shown to be useless in terms of double blind trials. So do you think this is a welcome addition? So yes, I think it's a welcome addition, but I would like for all of us to keep three points in mind. Firstly, the fantasies about hydroxychloroquine, ivermectin and their cousins and poor relations are a separate category of drugs. Remdesivir, Favipiravir, which our regular audience will remember we discussed over the past year and now Molnupiravir are a separate category of drugs. These vir-ending words, Remdesivir, Favipiravir, Molnupiravir are all chemicals which get incorporated by mistake in the virus copying program. So we know how they work. We've been working on them for a long time. That's the category of a very small handful of drugs that works against other viral infections such as herpes infections, such as hepatitis virus infections and such as influenza virus infections. The last rule, these are all antivirals in that sense which work and you have been arguing in our show that these have to be taken early before a large number of copies exist in our body. Otherwise it will get overwhelmed by the number of copies that the virus has tend to make because our cells produce the number of copies and we produce a very large number of copies. Now that's the second point that I was gonna make which is exactly what you've said but I have a practical footnote to add to that which is that if we are going to take an antiviral drug very early then an injectable antiviral drug like remdesivir, which at the very least must be given by skilled medical personnel if not in a hospital. You see it's simply impractical at large scale usage for everybody who has very mild to moderate symptoms of COVID-19 and therefore, and we've discussed this issue earlier the public health interest would be best served by finding an orally absorbed drug of this kind. Molnupiravir is the first of that category of drug. That's the second point. So is it a great surprise? Is it a breakthrough discovery? No, it's nothing of the sort. It's all incremental science. Remember that Molnupiravir was discovered with US government support. In fact, with US Defense Department support as much as 10 years ago, eight years, seven, eight years ago at Emory University with public funding against unless I'm mistaken, viruses such as Venezuelan encephalitis virus and you know, oddball viruses of that kind you can imagine why Defense Department funding. It was then repurposed for influenza. It was tested against other coronaviruses. It has been tested since 2019 for COVID-19. So this is all slow incremental work. So you will ask, where did Merck get into this picture? So the answer is Emory University's innovation center having used public funding, handed it over to, I'm now forgetting the company name. So small drug development company, really small company. Ridgeway, Ridgeback, something like that. And how did Merck get into this? As usual, Merck bought it. So this is not a drug that Merck has invented. Let us be clear about that. However, it is a drug that Merck has put money into the last mile of development into the phase three clinical trial. That the clinical trial has been successful, orally absorbed drug clinical trial has been successful, is unsurprising, but very, very reassuring and a very good finding. No question about that. There's a third point you want to make. This background must be kept in mind. You have to, yeah, it's a three point. This is your third point or is there a third point coming? So the third point, thank you. So the third point is that this is not a SARS-CoV-2 or COVID-19 specific drug. It is, as I pointed out, a drug that can be used against a wide variety of RNA viruses, little bit DNA viruses, and the drug will have, in all likelihood, the possibility of side effects that are connected to exactly this activity. So let me remind our audience. What are the side effects? So let me remind our audience. The earlier US presidential dispensation, which had any number of issues of turmoil, shall we say politely, also had one of its major drug development and related people resigning, a gentleman called Dr. Bright. And one of the many points on which he resigned was that the administration, the former US administration, was promoting ill-founded drugs such as hydroxychloroquine and not doing the science-based sensible thing. But, and the but is important, but he was also unhappy with the fact that this drug was being very strongly promoted down the pipeline because he was worrying that it's safety testing might be compromised as a result because it belongs to a category of chemicals that have been reported to have birth-controlled effects. We may have people writing in and saying, no, I'm mistaken because I'm pulling this out of my incidental memory, but I don't think I'm entirely off target. So the fact of the matter is that there will be side effects. On the other hand, let's keep in mind that the way the drug is to be taken is to be taken for a few days. So who will I say should not be taking the drug pregnant women who have COVID-19? For example, simply to err on the side of caution. All of this is up in the air because the drug is not going to be available to any of us for a very long time. And by then it may well be that all safety testing data will have come into the public domain and we won't have to worry about it. But since we are discussing the drug speculatively, I'm pointing out that there are pros and cons in all of this. And of course, a major limiting factor is the issue that currently, I gathered the asking price for approximately a week of therapy is somewhere around 700 US dollars. This is the point I wanted to come back to or come to on the question of safety trials. And of course, when you accelerate the process of getting clearance, emergency use clearance particularly, then we know that safety trials can be compromised. So therefore this question is very much there. So let me however add an optimistic footnote to that. And that again connects to my earlier point that this drug has been in development for other viral diseases long before COVID-19. In fact, if memory serves me correctly, the drug was licensed for full scale efficacy trials against influenza before the COVID epidemic started. So I'm assuming that that was done on the basis of adequate safety studies because there was no hurry about giving those approvals. So by and large, I am optimistic about the development process and the consequences of the drug. What is of clear practical interest and concern is as you point out the price. We'll come to the price, but what you're saying is that since you did drag a rider that pregnant women should not take it at the moment. And hopefully by the time more trials have been done, by the time it comes to the market, hopefully this question will be settled. So that you raise, since you raise a flagger mentioning it, coming to the question of price, and that was of course for all of us a key issue, particularly the price in countries like India. Now, there have been studies which show the entire cost of this anti-viral drug should be $20 for the course. Instead of that, Merck is selling it for $700 for a course. Of course, when it comes to India, we don't know what the price is going to be. From what I can see, what is appearing at the moment, price seems to be much lower. We don't know what the final, as you said, what the final price is going to be. But there are five companies, Indian companies who are very much in the fray. And Merck is in talks with them, licensing them, not only for India, for a lot of other countries, so that this drug will probably see two different pricing, one for the US and the quote unquote rich countries market, and assuming that they have learned the lesson from the HIV major battle with the AIDS drugs, that they will have to consider a differential pricing for the markets, hopefully a much lower price for the Indian and other developing countries markets. With the Indian companies, the five companies supposedly, the major source of drugs that will be sold to the other countries. Of course, we have seen that this particular issue has not been so successful when it comes to vaccines, that it was thought that India will be the supplier of vaccines for the rest of the world. And we found that actually, when Indian cases really rose very high, that the vaccines did not go to other countries. And that was a big, big blow to the COVAX program, which the World Health Organization was running. We have now come back to saying India will start supply of vaccines. And the major issue of course is that we did not up the vaccine supply as much as we should have, didn't invest enough and even now, we have to see what our investments on this count is going to be. But whether the drug manufacture will take a similar path, we don't know. Good point is, these are drugs which, as Satyajit has said, are drugs which are well known. In the sense that the production process is not difficult, they are what we call small molecules. And small molecules are something that pharmaceutical companies, India, elsewhere, really know how to manufacture. And small molecules of technology transfer to other countries also is relatively easier. Good points to say yes, if a five day, six day dose succeeds in at least not putting us after that into hospital. That's a really welcome sign because at the moment, we are not talking of quote unquote magical cures. There aren't any. But we are talking about serious illnesses, hospitalization being avoided. That's what the vaccines can do. That's what this antivirals also seem to be able to do. So Satyajit, on those points, I think some cause for optimism and hopefully we will not enter into the same battle as we had over the antiretrovirals where as you know, the world had a huge battle on the question of patents and other forms. And ultimately the global South one, mainly because at that point of time, Indian retrovirals were not at the patents, most of them. So given that some hope for the world as yet. Absolutely yes. Just no question about that. Again, a couple of points extending the issues you raised further. Firstly, let's take on board the argument that Mark will make about the differential pricing between $20 as a reasonable profit over production cost versus $700 as a cost of innovation risk. In effect, what Mark will say is we've taken a risk in investing in a drug which is not incorrect, but it is still a societal decision about how much of a risk based profit margin should be added and should it be more than 30 times as much as the production costs or should it be much more modest? That's the first issue. The second issue of whether there will be enough to access and you give the example of the vaccine shortage being sourced from India, but you also pointed out with drugs such as the HIV drugs or indeed these drugs that they are manufactured by classical chemical technology manufacturing processes. And I think therefore that there is room for the expectation that large scale rapid manufacture will be fairly straightforward and therefore supplied limitations may not be a problem for these drugs as they have been for vaccines. That's the second point of science and technology. A third final point of caution I would make is let us all also keep in mind that these drugs because they interfere with viral genetic code copying, if they are not given for adequate time and adequate concentration rather than causing a catastrophic failure of the virus growth, they may simply increase the proportion of errors in virus copies. And what that will do if given suboptimally is increase the pool of virus mutants. And in the context of vaccines, our audience will remember we've been discussing the role of mutant virus copies in perpetuating the spread of the virus. These are issues we should keep in mind not because this is a limitation of the drug in scientific terms, but more because the higher the price of the drug, the more likely the drug is to be taken in suboptimal inadequate short-term amounts and dosages. And here I'm pointing out the flip side of that as a potential possibility. But all in all, a good development. So essentially stronger case for making the drug available at a cheaper price so that it is affordable, not only in the poorer countries, but also in the richer countries because there are also poor people there. So those are some of the riders we have. Also, let's face it, when you talk about societal risks, then of course, private profit should be trumped by public good. That is a principle which no country has opposed at least publicly. We know they do sabotage in different ways as the WTO prescriptions have been regarding essentially COVID-19 drugs. We didn't have a drug, we had vaccines and the argument there are, these are biologicals in some sense, much more complex to manufacture and replicate. Now these arguments don't hold here. And as we know, it was public domain science which really developed this medicines. It's a privatization of public domain science which can cause the price to be high. And there again, the United States government has a role, so does the world because once we know what the drug is, replicating it is not a problem. So therefore, this cannot be kept secret. The only issue then is can the patent regime work against it? And the argument is that all countries, even the World Health Organization, WTO, everybody is accepted when it comes to patents, epidemics, Trump patents. And this is an epidemic, this is a societal challenge. Therefore, the WTO exceptions regarding the patents still work either health emergency or an epidemic. Both of these are true. Therefore, this is a classical case where countries can actually license without any fear. As long as the patent is known, drug manufacture is known. It doesn't seem to be a problem. This can be very easily done. Question is finally, political will to do so. Thank you very much Satyajit for being with us, explaining the complexities of the political economy of medicine. And that's really what the issue is here. And we hope that we'll be able to bring this and other such issues before our viewers. So do keep visiting NewsClick and do see our COVID-19 show that we do with Satyajit every week.