Dr Ron Ehrlich: [00:00:00] I’d like to acknowledge the traditional custodians of the land on which I am recording this podcast, the Gadigal People of the Eora Nation and pay my respects to their Elders – past, present and emerging.
Hello and welcome to Unstress. My name is Dr Ron Ehrlich. Well, today is a special edition. We’re actually going to be cutting in and out of a very special forum that was held in early April 2022, sponsored by the Australian Government, Health Department, or coordinated also with the National Health and Medical Research Council, the NHMRC, and the Therapeutic Goods Administration, the Chair of that, and the Chair of the ATAGI – a group administering immunisations is also involved here, and it follows on from a Healthy Bite that I did just a few weeks ago, which I make no excuse about coming back to again and again and again.
And it is the BMJ article which was published in 2022, in March. Now, BMJ, the British Medical Journal, is one of the oldest and most respected medical journals in the world, and it ran an article which said, an opinion piece, The Illusion of Evidence-Based Medicine.
Dr Ron Ehrlich: [00:01:25] Evidence-based medicine has been corrupted by corporate interests, failed regulation, commercialisation of academia argue these authors. Now, these authors are by no means on their own. One of the world’s most prolific, most cited researchers, Dr John Ioannidis, from Stanford University, from the Department of Medicine, has written on this subject many times. In 2005, he alerted us to the problem with evidence-based medicine. In 2016, he had an article about how evidence-based medicine has been hijacked.
Now, John Ioannidis is not a researcher in medical research in the science of medicine. If you write an article that is of value then it is cited. It’s cited. It’s called a citation. And for example, if someone has a few hundred citations, that’s considered quite impressive. I was emceeing a conference recently where one of the presenters was very proud to announce that he had been cited 6000 times, which was very, very impressive. And to put it in perspective, John Ioannidis’ work has been cited over 200,000 times.
So when I’m talking about a researcher whose opinion counts in the science of medicine, John Ioannidis certainly counts. And so when I read this article, this is not a fringe article that isn’t a theme that is recurring in medicine. To put the science in medicine into another perspective, not only are articles rarely cited but it is estimated that 70% of the articles on the science in medicine are not even reproducible. The fact that they’ve been published is one thing, but something has to be reproducible for it to be of true value.
Dr Ron Ehrlich: [00:03:22] It’s also worth mentioning at this point because this is the theme of today’s programme that the vast majority, over 70% of the science in medicine, is funded by Big Pharma. Now, Big Pharma clearly has, or rather the science in medicine, many friends. And you’re going to be hearing from quite a few of them today.
This forum, as I said, was organised in April 2022 and I just wanted to refresh your memory about some of the issues that we need to focus on here today. And I make no apologies about quoting directly from the article itself.
Dr Ron Ehrlich: [00:04:01] “The advent of evidence-based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this new paradigm, however, depends on reliable data from clinical trials, most of which are conducted by the pharmaceutical industry and reported in the name of senior academics.
The release into the public domain of previously confidential pharmaceutical industry documents has given the medical community valuable insights into the degree to which industry-sponsored trials are misrepresented. Until this problem is corrected, evidence-based medicine will remain an illusion.”.
Dr Ron Ehrlich: [00:04:46] Now, to put that into perspective, over the last 20 years, the pharmaceutical industry has been fined $17 billion for illegal marketing and fraud and literally has cost tens of thousands, if not hundreds of thousands of lives. And that is just a fact. Now, $70 billion would seem like a lot of money over 20 years.
But in fact, to an industry that has a revenue of $1.2 trillion a year, this would be considered petty cash. Now, it’s worth noting that many of the companies that have been fined are repeated companies that you will now be very familiar with. Pfizer, Merck, GlaxoSmithKline, AstraZeneca, you name it. I go on in the article again and I think it’s worth reading.
Dr Ron Ehrlich: [00:05:40] “Scientific process is thwarted by the ownership of data and knowledge because industry suppresses negative trial results, fails to report adverse events, and does not share raw data with the academic research community. Patients die because of the adverse impact of commercial interests on research agendas, universities, and regulators, many of which will be hearing from today.
The pharmaceutical industry has responsibility to its shareholders means the priority must be given to the hierarchical power structures, product loyalty and public relations propaganda over scientific integrity.”.
And these are my own words. Your health and my health suffer as a result. I go on. And this is really important because it’s the theme of today’s podcast.
Dr Ron Ehrlich: [00:06:40] “In medicine, those who succeed are likely to be key opinion leaders (KOLs) in marketing parlance, whose careers can be advanced through the opportunities provided by industry. Potential KOLs are selected based on a complex array of profiling activities carried out by companies.
For example, physicians are selected based on their influence on prescribing habits of other physicians. Oh, my God, that’s my own words. Now I should pause, not a quote. Oh my God. Today you are going to meet some KOLs. “KOLs are sought out…” I quote again.
Dr Ron Ehrlich: [00:07:24] “KOLs are sought out by industry for this influence and for the prestige that their affiliations bring to brand of the company’s product as well as paid members of the Pharmaceutical Advisory Boards and Speakers Bureau, KOLs present results of industry trials at medical conferences and continuing education. Instead of acting as independent, disinterested scientists critically evaluating the drug’s performance, they become what marketing executives refer to as (very important word here) “product champions.” You will be seeing product champions in action today.”
And I’m not suggesting for a moment I should as a disclaimer here, I’m not suggesting for a moment that any of these people are well-paid members of the Pharmaceutical Advisory Board or Speakers Bureau. I have no knowledge of that. I would not be surprised if they’re not. I really am not. I think sometimes people’s ego and reputation are more than enough pay for them without having any financial rewards.
So I’m not suggesting for a moment that these are well-paid members of the pharmaceutical brands. I have no knowledge of that. They may or may not be, but I have no knowledge. So product champions, key opinion leaders, KOLs, as it’s called in marketing parlance. I’ll continue to quote the article before we join the forum.
Dr Ron Ehrlich: [00:08:49] “Ironically, industry-sponsored KOLs appear to enjoy many of the advantages of academic freedom, supported as they are by the universities, the industry and journal editors for expressing their views, even when those views are incongruent with the real evidence.” Now, I’m not saying not congruent with the evidence, which is often provided by the drug companies. I’m talking about the real independent evidence.
“Regulators receive funding from industry and use industry-funded and performed trials to approve drugs without, in most cases, seeing the raw data. What confidence do we have in a system in which drug companies are permitted to mark their own homework rather than having their products tested by independent experts as part of a public regulatory system?
Unconcerned governments and captured regulators are unlikely to initiate necessary change to remove research from industry altogether and clean up publishing models that depend on reprint revenue, advertising and sponsorship revenue.” Now, I will pause here again.
This is my own comment put in here to say that this is where emergency use authorisations come in. If a drug company can get an emergency use authorisation approved for their particular product, be it a vaccine or a newly patented drug, then they are absolved of the normal regulatory. They don’t have to go through as many phases one, two, three, or four clinical trials and they will not be held liable for adverse reactions. That’s why gaining an emergency use authorisation is so important.
Dr Ron Ehrlich: [00:10:40] And another important thing to realise about emergency use authorisations is that if there are safe, effective treatments for the said condition, whatever it may be, then you are not allowed to issue an emergency use authorisation. So it highlights for you here why gaining emergency use authorisation and why pillorying any treatment which may be effective is so important.
So I again refer here to things like vitamin D, zinc, ivermectin, hydroxychloroquine, doxycycline, and azithromycin. And I mentioned those things because, well, we’ll touch on another government’s response to the pandemic in a moment before we go to the forum itself. In fact, no. I think this might be an ideal time to mention that.
Dr Ron Ehrlich: [00:11:36] Here we are. 26 months after the beginning of a pandemic. And as you will hear, the government has decided that now is the time to focus on high-risk individuals and early treatment. 26 months after the start of the pandemic. Now, there has been so much research done over the years, over many years, which has shown, for example, that vitamin D deficiency is at pandemic proportions.
And any regular listener will know that. I’ve often referred to a 2013 article from the Journal of Endocrinology, which drew people’s attention to the fact that between 40 and 70% of people who were admitted to intensive care units were deficient in vitamin D and vitamin C as well. But Vitamin D, and it is also known that vitamin D deficiency globally is at pandemic proportions and vitamin D is implicated in every disease. It is one of the master hormones and it’s a hormone and vitamin. So fat-soluble vitamins. Very important.
Together with Professor Ian Brighthope, who is the founder and president of the Australasian College of Nutrition Environmental Medicine. I was honoured to be co-signatory to letters which we sent to one of the participants, and several of the participants on today’s panel. Brendan Murphy, who was then a Chief Medical Officer in Australia and the TGA.
We sent articles saying we know that vitamin D deficiency is important, and is widespread. Just issuing vitamin D and zinc and C and magnesium will be an effective way of dealing with high-risk individuals reducing their risk. We got a letter back saying there’s no evidence to support that.
Dr Ron Ehrlich: [00:13:34] Ivermectin also, which had by the time it came to about August or September 2020, there were about 60 or 70 trials that were done in various locations, insufficient evidence, not enough rigour in the research done. And as you all know, the global media conspired to reduce this Nobel Prise winning, effective, cheap, accessible medicine to host.
Our proposal, I’ll come back to the report. Our proposal for the reforms includes the liberation of regulators from drug company funding. The TGA is an industry-funded body. So is the FDA in America. Taxation imposed on pharmaceutical companies to allow public funding of independent trials. Remember, the pharmaceutical industry’s revenue is $1.2 trillion a year.
I’m sure for the $70 billion that was they would have been fined that could have been diverted into public funding of independent trials, and perhaps more importantly, and on anonymized individual patient-level trial data posted along with study protocols on suitably accessible websites so that third parties, not drug companies, not the friends of Science, not self-nominated or commissioned, but third parties could rigorously evaluate the methodology and trial results. So that’s that article which today we are going to be focussed on key opinion leaders and product champions in action.
Michael Kidd: [00:15:13] I’m speaking to you from Ngunnawal country. And I’d like to start by acknowledging the traditional owners of the lands where each of us is meeting today. We pay our respects to Elders past and present, including to any Elders who are joining us for today’s call. My name is Michael Kidd. I’m Deputy Chief Medical Officer with the Australian Government Department of Health. And this special webinar is being organised by the Australian Government Department of Health in partnership with the National Health and Medical Research Council, the NHMRC.
We have participants online today from healthcare workers from across the country, researchers and clinicians scientists, people working in government, people working with our regulators, and people involved in guideline development. So you’re all very welcome to this webinar.
Michael Kidd: [00:16:03] This webinar is also being recorded and will be available on demand on the Australian Government Department of Health website health.gov.au. I’d like to thank and acknowledge our two Auslan interpreters, Bec and David, who will be interpreting today’s event, and also special thanks to those from the NHMRC and the Department of Health who’ve been involved in bringing everyone together for tonight’s event, and especially thanks to Melanie Shakespeare and to Divia Mattia.
A little bit of housekeeping. We had a very high number of people who wished to participate in today’s event, so we have moved to use the WebEx webinar module which means that microphones and cameras are switched off for participants other than those who are speaking during the event. So this means everyone who has a comment or questions if I can ask you to please enter your questions in the Q&A function. You can find the box to click for that at the bottom of the page that you’re looking at.
Michael Kidd: [00:17:18] We will have a number of presentations in the first hour and then the second now will be responding to your questions and inviting individual panellists to respond. If you do put in a question, it would be helpful if you could make sure that you identify yourself so we know who has asked the question and also if you can indicate who you would like to respond to your question, that would be helpful as well.
The purpose of this forum is to increase awareness and access to treatments for COVID 19 for people who are eligible right across Australia. We’re aiming to share information. We’re aiming to discuss approaches to COVID 19 treatment strategies and to share with you the clinical and scientific evidence about COVID-19 treatments, details on the appropriate use of COVID 19 treatments, and discussion about the continuing transition to community-based health care for people with COVID 19 in Australia wherever possible. Discussion on some of the key treatment issues, which I’ll be…
Dr Ron Ehrlich: [00:18:33] I just pause here to remind you that this is 26 months after the beginning of the pandemic. And our panel, a very senior panel, there are now finding that it is time to move to community-based treatment to protect those that are most vulnerable. We proceed.
Michael Kidd: [00:18:50] I’ll be facilitating equitable access to treatments for people right across Australia, no matter where they are. A reminder that you are welcome to share and use the information you learn through this forum. This is a public event. There may be a little bit of duplication across some of the speakers as we are seeking various views from different perspectives. And as I mentioned, the forum will be recorded and available for viewing on demand through the Department of Health website.
To open the webinar, I’d like to invite the Secretary of the Australian Government Department of Health, Dr Brendan Murphy, to say some welcoming words. Brendan.
Dr Brendan Murphy: [00:19:34] Oh, and I’m actually joined here by Paul Kelly who’s just stepped out of the room but we’re here together in the Department. Paul’s just come back again. Look, this is a really important topic. I was very, very keen that we use the good offices of the joint Department of Health and NHMRC webinars that we’ve run so successfully on vaccinations really throughout the whole vaccination journey to get a significant focus and sharing of information on treatments.
It’s critical that we do this at this stage where we are now transitioning our COVID response into one of harm minimisation and making sure that we no longer we’re no longer trying to stop transmission but we’re in the business of trying to prevent severe disease in high-risk people. And that’s clearly whilst vaccination remains a crucial part of that approach and we can’t sort of neglect to keep pushing those additional doses of vaccinations that are required. The role of treatments is now of increasing importance. And it is an interesting space.
It is the space that changes as different variants change and different treatments become more or less effective. And we also have significant logistic challenges in getting timely access to treatments for those who need them. So as you know, we’ve been supplying Remdesivir from the stockpile from the beginning, and clearly, that’s still got a role in severe disease. It may have a role in early disease. Sotrovimab has been probably the most utilised specific treatment…
Dr Ron Ehrlich: [00:21:15] Now we’re hearing about, of course, Remdesivir, which is a drug that was developed some time ago, I think, for Ebola. Or in fact, this is an interesting quote from Sloan-Kettering specialist Peter Bach, who’s from Sloan Kettering, is one of the top cancer hospitals in America. Remdesivir should be in the public domain because the drug received at least $70 million in public funding towards its development.
The price puts to rest any notion that drug companies will do the right thing because it is a pandemic. The price might have been fine if the company had demonstrated that the treatment saved lives. It didn’t. It now costs $3,000 a course of treatment, and apparently, it reduces stay in ICU from 14 days to 11 days. But it does not save lives. And Sotrovimab is a monoclonal antibody, and the cost of that is something like $2,100 for a five-day course. I proceed. Well, let’s proceed.
Dr Brendan Murphy: [00:22:23] …which we’ve had now for several months, and has been widely deployed across state and territory health services, but we have only really provided it to the hospitals so far where it has been used and clearly has likely saved a number of lives. Sotrovimab, as you’ll hear, is now in an interesting space where its efficacy against the current predominant variant does seem to be reduced and that will change its focus.
But clearly the major focus today is on the oral treatments, which are going to have an important and increased role over the coming 12 months. We now have quite large numbers of COVID cases, most of them mild, most of them in young people but we still are seeing some deaths in old people and people with underlying disease. And these are the people we need to get these treatments to early enough in the course of their infection to be effective.
And what we’ve seen so far is add to our deployment from the stockpile just the state and territory public health units and hospitals are not sufficient, particularly in a model of care where we’re treating many or most of the COVID cases in the community. So we do have to shift to a new model of distribution. We’ve started that a little bit with Molnupiravir now, which we pre-deployed across aged care facilities and…
Dr Ron Ehrlich: [00:23:52] So Molnupiravir… Sorry, I interrupt here again, but Molnupiravir, it was made by Merck and Merck was the producer of Ivermectin and Ivermectin has been around for 40 years. It has received a Nobel Prise in Medicine in 2015 for human health, and it has been given over 4 billion times I think there have been 5000 adverse reactions in the 40 years.
So it’s a very safe, cheap and effective drug. It costs a five-day course around $2.50. And if it’s combined with a broad-spectrum antibiotic and zinc and vitamin D, extremely effective. But Molnupiravir is a patented drug. It’s around $700 for a five-day course. And this really is that product champion in action.
Dr Brendan Murphy: [00:24:46] …into ACCHOs And is now on the PBS. And we are starting to see a significant uptick in the use of Molnupiravir across community pharmacy prescriptions from those cutting edge GPs. Paxlovid at the moment is still not available in the community pharmacy setting but we are working very hard with Pfizer to try and get it onto the PBS as quickly as possible or at the very least in a model of distribution that can see it provided in a widespread distribution as we get increasing numbers of supply coming in later.
So our nirvana would be to have both of these drugs – and they both have risks and benefits that you’ll hear about today – widely distributed and available for clinicians to prescribe for those people who are at most risk. And it’s clearly a contested space about the evolving clinical evidence, who we should use them for, who we should not use them for, and how we should use them. There are other things, obviously, the long-acting antibody which has got a very limited role, and we might touch on that later.
Dr Brendan Murphy: [00:25:53] But I think the focus of today will certainly be on the ongoing role of Sotrovimab but maximally on how we use the two currently available oral agents and how we maximise their use and get the best uptake across the community. We have made significant purchases of both of these drugs.
And we believe we have brought enough to meet the likely needs for the clinically indicated populations. I certainly am very keen to learn more about the clinical evidence from today and I’m looking forward to hearing the contributions and to ending up with a very much better informed clinical community at the end of it. So I’ll stop there. Thanks, Michael.
Dr Ron Ehrlich: [00:26:40] So another drug Paxlovid is a Pfizer drug. It’s also a patented drug. It certainly does have some more complications than Molnupiravir in terms of its limitation, because there are so many interactions with drugs that need to be careful of. It is a $560 five-day course. Molnupiravir $700, Sotrovimab $2,100, and Remdesivir over $3,000.
Still keep coming back to the cost of these drugs because this is such an important feature of this promotional forum which, spoiler here, are the two-hour forum basically talks about those four drugs. But let’s go on because it is interesting and there are some interesting points to be made.
Michael Kidd: [00:27:24] I’m now going to pass to Professor John Skerritt from the Therapeutic Goods Administration. John.
Prof John Skerritt: [00:27:30] Thank you, Michael, and good afternoon/evening, everyone. I’ve been asked to talk a little bit about the approved therapeutics and some reflections on them. So there’s actually quite a number of therapeutics, although with the emergence of Omicron back in November/December, there was evidence that some were no longer active against the original BA1 subvariant.
So going through evidence systematically for pre-exposure prophylaxis, we have the AstraZeneca Evusheld or a combination of antibodies, long-acting antibodies. There was some loss of activity against BA1 versus Delta but recent data suggests that that one may even be better against the BA2. So at the moment, we’re confident about that antibody. It’s obviously indicated for use where there hasn’t been a success in getting a good vaccine response in immunosuppressed people although ironically, the clinical trials were not done in immunosuppressed or vaccinated people.
But the evidence internationally is that it does seem to be filling that niche. Then there’s a series of monoclonal antibodies and it’s an unusual approach to use monoclonal antibodies to prevent a viral disease from progressing. Most virologists are used to using oral antivirals or injected antivirals.
And of the three antibodies that are authorised here in Australia, we have the Celltrion Regdanvimab antibody and the Roche combination Ronapreve. Both of those lost activity against Omicron BA1 so they’ve largely fallen away.
Dr Ron Ehrlich: [00:28:58] Now I have to interrupt here again because he said something that was quite important and that was that it is unusual to use these monoclonal antibodies and he did mention some other drugs there apart from the four that are the main focus. They are just really brief references.
But what I thought was so interesting about what Professor John Skerritt said, who is the head of the Therapeutic Goods Association, the TGA, is that it was unusual to be asked to use monoclonal antibodies to treat antivirals. And isn’t that interesting? Because of course when ivermectin was suggested for use, which is not just an anti-parasitic, but has been used throughout Africa, in Nile River fever, viral, various viruses, you know, so this anti-parasitic has been used as an anti-viral, which was quite unusual, but it was totally rejected.
I mean, not just discouraged but banned by the TGA as being totally ineffective. And this is where my reference to the emergency use authorisation comes in, because if Ivermectin was and is as effective as it is, then emergency use authorisations for these newly patented drugs would not have been approved.
So that’s a very important statement that Professor Skerritt made there, which said it was unusual to use these drugs in this way. But hey, the TGA thought it was worth a shot, particularly if the evidence was provided by the drug companies that we’re providing them with the information.
Prof John Skerritt: [00:30:31] …and that brings us to Sotrovimab, which was actually the first of the monoclonal antibodies that we authorised back in August last year. It’s hard to believe that it’s been around in Australia for almost seven or eight months. And as people are aware, there is concern about whether it retains activity against BA2. And the bottom line is we simply don’t have clinical trials to know what this means in vivo.
But in vitro, there’s now five studies that have largely looked at neutralising antibodies as a surrogate for activity, and all of them show decreases in activity of B2 versus BA1. They vary between 16 fold, which is a study from VIR, which is GSK, the commercial partner’s research team.
Dr Ron Ehrlich: [00:31:20] Now again, an important point. I know I keep interrupting, but I can’t help myself here. There actually is quite a lot in this that is worth commenting on. But the GSK partner for research, are companies, drug companies, like GSK, the makers of Sotrovimab, employ independent companies to do research for them “independently.” But there is some question about the efficacy of the drug and the fact that there are five trials.
Now that’s another one. Because when Dr Tess Lawrie, who is an epidemiologist in the World Health Organisation, a consultant with 20 or 30 years of experience in this area, she did a meta-analysis of Ivermectin which had 68 studies in it, and one or two were considered perhaps not of the highest standard quality.
And that’s what tore the meta-analysis apart, according to the authorities, 68 studies. But here GSK provided five studies given to them by a company that they employed and this apparently was enough to convince the TGA that this was worth a go, even though wait, there’s more.
Prof John Skerritt: [00:32:32] Up to some people would talk about a 50 fold decrease inactivity or even not detectable activity. Now GSK’s view is that the drug should still be effective operating through effective functions such as cell cytotoxicity and recruitment of a host immune system.
But again, I repeat that there isn’t human clinical data. So quite recently USFDA has revoked their emergency use authorisation. That happened in stages. So initially it was for the states in the northeast of the US that had more than 50% BA2. As BA2 has spread from northeast to southwest across the US in states and territories. 36 hours ago the FDA has fully revoked the use of Sotrovimab across the USA.
And because we don’t always know where people have BA1 or BA2 because we’re not doing full sequencing on every individual, they’ve made the decision to revoke the authorisation in the US and recommend alternatives. However, GSK very recently – and we’ve just put out a press release on this 2 hours ago – GSK a very recently submitted an application to TGA and a number of other regulators for a double dose of Sotrovimab.
Dr Ron Ehrlich: [00:33:46] Now. I’m sorry to interrupt again, but I can’t help it. I really can’t help it. So let’s get this straight. The FDA has discontinued the use of Sotrovimab because it’s no longer effective. Now for the FDA to do that, and that’s an industry-funded body as well, then it really has to be questioned. But now the TGA feel that that’s perhaps not the wisest thing to do, particularly when GSK, the company, still advocates that there’s another mode of efficacy here.
The research may not have been in, but apparently, maybe that’s not a problem for the TGA. If we’re coming from GSK, the drug companies and the drug company is actually suggesting “Let’s double the dose.” And the TGA has just done a press release to confirm that that’s probably what they’re recommending. Product champions, key opinion leaders. You’re seeing it in action, folks.
Prof John Skerritt: [00:34:46] Normally it’s administered at 500mgs. This is an application for a single dose of 1000mgs a gram of Sotrovimab and they are submitting population pharmacokinetic data to suggest that even though that’s only a double dose, it may give higher in vivo activities in the one to retain activity against BA2.
Clearly, we are looking at that data as a high priority and notwithstanding Easter and Anzac Day in the coming weeks, we are hoping that a view will be able to be formed later in April about that data. The challenge is, of course, we don’t have human clinical data to show whether that efficacy against BA2. So it will be a rather difficult evaluation.
Prof John Skerritt: [00:35:31] There are other products around. Obviously, Tocilizumab is an antibody, but it’s different. It’s an interleukin 6 receptor antagonist to modify disease progression. It’s not at least from first principles affected by Omicron or other variants. And of course, the other antiviral, the Molnupiravis and the Paxlovid that we’ll talk about today. All corticosteroids used off label should also not from first principles be affected by BA1 versus BA2.
Now what’s been said about the two antivirals, the oral antivirals – and I’ll turn to them – they are similar but different in their mechanism. The Paxlovid product is a peptidomimetic inhibitor of pro replication enzyme, whereas the Molnhupiravis is actually a nucleoside analogue. But they both inhibit replication.
Dr Ron Ehrlich: [00:36:23] Now, it is worth pointing out that so does Ivermectin. In fact, that’s exactly how ivermectin works. That inhibits replication of the virus. The only difference is that it’s cheap and accessible and off-patent and Paxlovid and Molnupiravir are patented drugs. So and it’s actually been shown, I think that Ivermectin is more effective than Molnupiravir and Paxlovid. But again, it’s off-patent.
Prof John Skerritt: [00:36:50] Remdesivir has a similar mechanism, but of course, it’s not an oral drug. And while back in 2020, it was the very first COVID treatment to be authorised globally, it was authorised back then for the treatment of severe COVID. And there is an application in front of us and other regulators for its use in progression as a treatment that is administered randomly.
And again, that’s under decision. Under decision. And we’re hoping that there’ll be a decision reached later this month. Now, much has been made of the relative efficacy of Molnupiravir and Paxlovid, but I do want to make a few points.
Prof John Skerritt: [00:37:33] They have been tested – because of the different times of the different countries and the different locations in which the clinical trials were done. They were tested against different circulating strains of Omicron, different disease pressures, there were different hospitalisation criteria, different patient inclusion criteria. And indeed, if you look at the placebo arm hospitalisation and serious illness, there was quite a different rate for the two placebo arms of those trials.
So I do not believe that there is a valid back to back comparison of the two treatments. Indeed, Molnupiravir has been a poor cousin because of the lower published trial efficacy, but in the last three or four days, there’s been a study or announcement with some data to be published that shows that there is essentially four viral elimination within three days. So it also has the advantages over Paxlovid but it doesn’t have the same set of drug/drug interactions.
Prof John Skerritt: [00:38:28] Paxlovid or specifically the ritonavir component actually does interact with a number of commonly used medicines. And even though it’s a five-day course it is important for prescribers to be well aware of these drug interactions which are listed on the product information. Both drugs are not recommended – both Paxlovid and Molnupiravir are not recommended in pregnancy and breastfeeding and in women of childbearing potential.
And particularly Molnupiravir it’s recommended that sexually active women of childbearing potential use contraceptive and also their male partners use contraception both during and within three months after treatment. There are a number of other treatments coming down the pipeline. I won’t highlight them all. There is another monoclonal antibody called Bebtelovimab from Eli Lilly that is approved with an emergency use authorisation in the US.
And it’s now the preferred monoclonal antibody in the US for treating BA2. But we don’t have a regulatory application for that Eli Lilly drug. It’s not authorised for use in hospitalisation. So it’s again a drug for use in progression. I’ll leave it there and thanks very much.
Dr Ron Ehrlich: [00:39:45] Now, of course, the reference to emergency use authorisation is so important in this whole pandemic. The emergency use authorisation is the key, literally the key which unlocks billions of dollars worth of sales, because not only do you need to go through, you don’t have to jump through the hoops of the regulatory trials, but you are also absolved of any adverse reactions and that is what is. So it’s rushed to market and you’re free of any adverse reactions.
And remember, these drug companies have been found repeatedly to be guilty of fraud, illegal marketing and cost tens of thousands of lives. But we can go on. We’re almost there. We’re just going to hear now from Dr Paul Kelly, the Chief Medical Officer of Australia.
Dr Paul Kelly: [00:40:37] There is a global shortage of many of these medications. Someone mentioned I can’t remember, but that some of the oral medications are now being allowed to be made generically, which will obviously assist that. But the monoclonal antibodies in particular are in very short supply for various reasons partly because it is difficult to make large volumes of them and they are extremely expensive.
So suffice to say there is a limitation globally, we’ve done pretty well in getting stocks that we’ve had. We have stock still, but the oral medications are the ones that are going to be in a much better and larger supply. And we’ve mentioned that in relation to Molnupiravir being on the PBS already.
Michael Kidd: [00:41:16] Thanks. Thanks, Paul. Thanks. Thanks, John.
Michael Kidd: [00:41:19] Paul, if Brendan was in the room, I’d be asking him this question. But a number of people have talked about the lack of community awareness of these oral treatments. And, you know, we’ve had a lot of press conferences talking about vaccines and vaccine availability.
Comparatively, we’ve heard a lot less in the public domain about these treatments. And we’re doing a lot of work, of course, promoting the treatments to prescribers and to our community pharmacists. But do you want to comment about what the Health Department is doing to try and raise awareness amongst the wider community?
Dr Paul Kelly: [00:41:59] I know I did a social media recording today for the general public on this exact topic, on these treatments. And look, I think it’s a fair criticism, Michael, and I’m prepared to take it on board. We have taken it on board as an issue we need to deal with. This seminar is part of that changed posture I think in terms of being much more open about treatments, what’s available, what can be used and so forth. And so this obviously is targeted more at a practitioner level, but it’s a fair criticism and we need to do more work in that area and we are doing it. I’ll leave it there. Thank you.
Dr Ron Ehrlich: [00:42:34] So there it is. I wanted to share with you key opinion leaders and product champions in action. Just so happened to be the head of the Australian Health Department, Dr Brendan Murphy, who used to be Chief Medical Officer when the pandemic started. Professor John Skerritt, Head of the Therapeutic Goods Association, and others, including Paul Kelly, who is the Chief Medical Officer now.
And it was so interesting to contrast that with, let me give you an example of a contrasting government response, because you may recall that the Delta variant started as the Indian variant. So it began in the Indian subcontinent.
And of course, with a population of I think it’s 1.2, 1.3 billion and the crowds that we are associated in any Indian street, you would have thought that a virulent strain like the Delta variant would have absolutely devastated the population. I mean, in the same way, we saw images in Wuhan in the early days of I remember a few people dropping dead. In the street. I watched it on the news or the hospitals or morgues in northern Italy or in New York in the early days. So Western media are not shying away from those kinds of images, terrifying as they are, that would push people towards vaccinations as the only alternative.
Dr Ron Ehrlich: [00:43:57] But in India, the vaccination rates are certainly nothing like what they are in Australia. So what happened? Well, let’s take a state like Uttar Pradesh, which has a population of about 240 million. That puts it about half the size of Europe, or about two thirds the size of America. And what did that government do in Uttar Pradesh?
Well, what they did was they issued a kit which was focussed on public health. So for any regular listener aware of the Ps of the pandemic, you will remember me saying that whatever those other Ps are – profit, patents, peer pressure, politics, power, psychosis.
I’ve maintained, and I still do, that public health is right at the bottom of the list here in this country. The approach to early treatment 26 months after the beginning of a pandemic could hardly be described as putting people at high risk at the top of the list. But in Uttar Pradesh, the response was very different. In 2020, very early on, in late 2020th October 2020, they issued medical kits to those that were vulnerable.
And those kits included vitamin D, zinc, multivitamin, vitamin C, ivermectin, and doxycycline, a cheap antibiotic that’s focussed on respiratory infections. And we did not see images of people dying by the thousands or even millions in the street. And to any so-called experts which say it was underreported.
I would respond I don’t believe that because the media would have had a field day rushing to the streets of India, which they would have had access to, and photographing it and scaring the hell out of all of those people to go and get in our society to go and get their boosters. It just didn’t happen because that government put public health at the top.
Dr Ron Ehrlich: [00:45:59] Anyway, I wanted to share with you that forum. It’s available to the public. It’s a two-hour forum. I don’t I think I’ve given you the highlights and I hope you found it stimulating. I think it’s really important to appreciate how public health is administered in our country. And I think it also surprises me how many people have wittingly or unwittingly become marketing and compliance officers. For an industry that has repeatedly shown to be guilty of illegal marketing and fraud.
And the emergency use authorisations are basically a carte blanche to an industry which had shown itself to be morally very much left wanting. And they are the ones that are issuing these drugs, and they are the ones that have a $1.2 trillion industry with fines of billions of dollars seen as nothing more than inconvenient marketing costs at best, or petty cash at worst. So there we are. I hope this finds you well. Until next time. This is Dr Ron Ehrlich. Be well.
This podcast provides general information and discussion about medicine, health, and related subjects. The content is not intended and should not be construed as medical advice or as a substitute for care by a qualified medical practitioner. If you or any other person has a medical concern, he or she should consult with an appropriately qualified medical practitioner. Guests who speak in this podcast express their own opinions, experiences, and conclusions.