logicp_writings/covidism/DrMalone_AmericanThoughtLeaders.md

In terms of theraputics, I sit on the active committee at NIH which is the foundation for NIH committe, I'm an observerThis is the committeee managing in patient and outpatient trials for new agents and repurporsed

They've opened Active 6, which is a federally sponsored Ivermectine study here in the states outpatient virtual trial structure

with our group from the DOD we attempted to include Ivermectine including arm in a trial pending with the INC but the FDA raised so many objections and asked us to perform fundamental studies about demonstrating the mechanism of action of Ivermectine so the DOD decided it just wasn't worth the time

So the landscape right now for theraputics and prophylactic drugs I'm going to stick my neck out, I've seen in close contact with Andy Hill who si doing meta analysis, I've seen the work of Tess Lawrie that's now published

I think the data keep getting stronger and stronger in favour of Ivermectine having some protective activity within a safe dosing range, nad that seems to be impacting a bunch of emerging economies which don't have access to vaccines and is impacting on severe disease and death

so great epidemiological data coming out of Indi awhere states had been using it and had low rates of attack, then they removed it because of a regim change (related?) and it went up, then they reimplemented it and they went down

There are many others, but this one has been getting press in part because of Pierre Kory's senate testimony. So Ivermectine and a whole host of antiinflammatories because what folks often don't understand about covid is that we have the SARS CoV2 infection event and typically that leads to a disease of varying severity, it's something in the range of 4-7 days afterwards, but that disease only happens in a subset of patients, maybe 80%, maybe 50%, taking across all age groups, maybe less and the disease is the hyperinflammatory respone to the virus, so the disease is really our reaction to the virus, the good news is with drugs is that we have a rich library of antiinflammatory drugs which appear to be quite useful at keeping people out of the hospital if used enough, or treating them in the hospital, the antiviral that's been licensed in the US, the WHO is not recommending (Remdesivir), and many physicsns in the states find it to be of limited use, so the idea of antivirals ofr this is really not panning out. This is often the case with respiratory viruses. We all remember tamiflu, this worked in theory, but you normally have to use it at a period where you aren't even aware that you have the flu.

The other thing that got a lto of attention is dexamethasone, coming out of a recovery trial at Oxford, and that trial showed that its utility is limited. You might have remembered the US when he recovered quickly, btu he wasn't severe, they put him on dexamethasone, but you don't normally need that unless you are already on oxygen, so it appears that in the states dexamethasone is being overused - it's often a first line go-to when you have a new inflammatory disease and over time additional agents comein in that are more specific. Dex is supper non-specific and it hammers the lymphyocytes, a lot of the populations taht you need to recover long term. Good to get out of the hospital short term, but nos tudy over the long term. That's the landscape as I seeee it. RNA vaccines got al ot of attention, they're remarkable, the adenoviral vector vaccines probably generate more protein voer time, they came out early and were identified with coagulation problems, those problems are now being seen with the RNA vaccines, and there is a odd spectrum of symptoms and the governments across the world have largely denied that there are any safety concerns. That's now not so tenable - we had the CDC coming out last week talking about the myocarditis and pericarditis showing up in the pediatric population, up to 18, and that is a significant safety risk, that only was recently identified about 2 monhs ago, its' taken 2 months to be verified, and there appear to be another bunch of adverse events that are buried within the admittedly flawed databases that we have that we're mining to identify adverse events that are associated with the vaccines, thrombocytopenia (low blade platelets), cerebral venous thrombosis, I think we're having some fo htese cardiac symptoms in older cohorts, bt they are subject to a thing called masking, when looking at epidemiological databases where if you have a confounding variable, like ym age cohort where cardiac events are not rare The probelm si that if you have a relatively rare event associated with a drug or vaccine, and it's in a cohort that has a high background for related things, it's realy hard to pick up what's coming from thr new drug as opposed to background levels, so It hink it may turn out over tim that that cardiac signal we were seeing in the youth population, it's realy easy to pick out because they have no other signals, but in other populations it will take more time for this to be clear..

so with the RNA vaccines it's remarkable in terms of the amount of activity, but therea re these events and it's a little odd, physicians are starting to talk about the overlap of Long Covid the chronic symptoms that you have , and yuo don' tnecessarily have to have severe disease to get longer covid, there seems to be overlap between those symptoms those profile symptoms the disease associated symptoms and the vaccine associated symptoms

so long covid, covid and adverse events from the vaccines they have similiarty

physiciasn can do laboratory tests and show that these outcomes have similar profiles these genetic vaccines genetic covid vaccine related syndromes and long covid

so there's things going on there with the vaccines the problem is we don't know how severe they are in genera, the bell call distribution fo rseverity, and incidence and why don't we? well it's because the FDA elecfted that during this phase, of emergency use authorization, to not require the drug manufacturers rigorously capture adverse events and efficacy signals - so we're relying on really outdated and antiquated systems like a decade or so ago, or systems that are self reported like V Safe at the CDC, these only capture about 1% of events, bceause they're self-reported. And there are probelms in interpretating that data because someone might say my aunt died 2 days after vaccination and we're going to report this - and this is acontroversy becaue there are a lot of deaths being repoted in VAERS, but there are not verified as being vaccine reltaed, so there' sa real arm wrestling going on about what do those mean, both int he US and europe, so that's kind of where things are right now as I see it, and then thre's a whole cluster of issues around what would it take to actually get to herd immunity. in this ush in many countries, Canada for example, saying we're going to release restrictions once we reach 70% uptake. We don't have any data gfrom these trials about the impact of vaccination on transmission - so you can't really make ar eal calcaluation to say epidemiologically how much vaccine, how many people within a population have to be etiher infected or vaccinated, so that's on th surface, there' sa lot of other stuff underneath, and it's complex, it always is during an outbreak becaue there's never enough information.

15 questions for you, fo course. let's start with this one - given this example, that there's just a lot of, it could be an adverse effect, or what would have happend normally to somebody, but wouldn't some rigorous data collection around this actually help elucidate IF we would had had things done more rigorously from the get-go, we would be in a totally different situation in terms of reassuring the public. Can we start now? That could be done, and i've suggested to some philanthropic people that they could implement an trial registry - one type of clinical trial, we talk about double blind randomized controlled trials, you can also do more data-collection type trial sand you ask people to register at the tim they receive the agent, and you can implement this in a lot of ways, call center, cel phone, to follow up with those peopl ena dquery them about whether or not they are experiencing symptoms, etc so that you get instead of a purely voluntary offering, where we're at right now, you have something that' sa lot more structured where people are identified, put into a data collection tool, and they're followed over time - tahtis p ossible that basically that is what the scandinavian countries do anyhow, because of their structure of tehir socialized medicine - and often in these kinds of situations, we get the best data from finland, norway, scandinavia, because of the rigour with which their socialized medicine captures that data - we had hoped to get something like that from Israel, and the CDC and FDA had been very comforted by what looked like a rigorous data set from Israel, and the ability of the Israel government related epidemiolgoical monitoring to mine that database and identify signals - the cardiac events in the adolescent population were actually identified by a Oracle biostatistician working with peopl eat the FDA who were outside of all this and were data mining the VAERS data base publicly - they alerted the CDC and they identified it then and tracked it, they identified the Israelies and then the Israelies were able to identify it in their own databases - and how did that happen? The manner in which you query these databases is not trivial, because you can't just ask anything unde the sun or you'll end up with statistical noise - you end up with a massive amount of false information and false linkages, and you have to pick the signal from that

Given that the Israelies hadn't detected something gave reassurance up until this case, and now we're in a different world where we're relying on the Dutch and Norwegians and others for more rigorous data.

The Sfaety of COVID-19 vaccines - we should rethink the policy - in the abstract (redacted) for 3 deaths prevented by vaccination we need to accept 2 caused by vaccination

So that's a risk benefit ratio - that gets to the core of all of this is typicall the advisory committee on immunization practices - and teh truth is the world is lookin to the United States for all this stuff - in a significant way includin the world health organization WHO ttypically the advisory committee on immunzation practices for the CDC for a new vaccine would be evaluating risk benefit in a rigorous way using quality-adjusted life years. This is an actuarial table tool that the insurance industry uses - you can understand why the iinsurance industry would wany to do this right, because that's hwo they make their nickle - and we typically use that kind of a tool to amke a risk benefit formal calculation for each popluation stratified special population so those are adults, elderly, adolescents, children, infants pregnancy and immunosuppressed - and you would do this calculationf or each of those groups and the ACIP would come out with a recommendation and say "this is good for use with the elderly" and that's pretty compelling in this case with these vaccines that even though there's adverse events, tehri risk of covid death or significant disease is pretty high - sot hat's a n easy one to say yes. adolescents in contrast have a really realy low probability of disease or death from COVID and some non-trivial level of adverse events - we were just talking about the cardiac - and so that calculation doesn't look so good - and the papre yoju're referring to - just to talk about history - you were talking to me about being deleted from LinkedIn and one of the things that's happened over the last week is that the authors of that paper sent it om e and said "hey robert what do you think about this' and so I posted it without editorial comment on linkedIn and Twitter and it generated a lot of discussion and obviously a lot of folks were pretty alarmed by that which you just read and um it brought out some academics who thought that they needed to react strongly against this paper and say no this can't possibly be true - this must be a statistical overstatment or misanalysis and it generated a whole lot of pushback from a subset of academics and then people that were responding to that linkedIn post decided that they would write those academics that they would write those academics write directly to the journal and say "this should be withdrawn". ANd the journal has now put a note on the manuscript saying that it's being reviewed (again) - the essence of their concerns, to my eye, and like I said I'm not a full biostatistician - i know enough to talk about them - btu the essence of tehir concern seemed to be this same concern where a database where the relatedness between a reported event and a vaccine is not determined - and in a lot of cases it's not determinable - but these conclusions in that paper are drawn in such a way that those academics feel very strongly they're inappropriate because the database didn't establish an unequivocable linkage between an event and the vaccine - thi sis always the case with those kinds of databases and you have to word the findings carrefully and say "we have deaths that are temporally associated or associated in some way but not necessarily causative" because you can't determine causation - especially not retrospectively particularly if you can't review the patient's chart - and so that is a great example I like to call the academic though police - the self-apppointed academic thought police - this has become a major problem throughout the whole sector is there are lots of academics that efel it is their mission to block publication of papers that might compromise in some ways the vaccine mission - an di think that's why it has become so hard to publish anything about repurposed drugs - and I think it's prbably valid, and you can watch it when you talk about ivermectin - there's a cohort of people that would rather take a drug than a vaccine - a prophylactic drug and if a drug is available for out-patient use that minimizes the risk of hospitalization disease and death then the risk benefit ratio for the vaccines become even more tenuous and I think that's what's underlying a lot of this.

The paper has since been retracted - it had undergone the standard process of peer-review I had a guest on recently Victor Davis Hanson and he was talking about the platonic noble lie - this was one of our topics okay - and it just and so this is just a pre-emptive - the point is we don't know, in a lot of cases, what the answer is - but tehre's scertain types of information that you're just not allowed to go there

Yes, and I've never experienced this before - it's reinforced by the social media platform s- and just to illustrate the point - one fo the things that' sjust really heartberaking is that i get calls from some of these patients who are crying an distraught - if you are someone who has expereinced symptoms after receiving vaccine - Im' not saying they're related - but imagine a mother who's had a cascade of symptoms she's not debilitated she's perhaps now worried about her ability to conceive because she's had menstrual alterations and what not - and she is surrounded by family friends social contacts that all believe taht the vaccines are fully-safe and that she must be crazy - there can't possibly be any relationship between vaccine uptake and her symptoms - so imagine that this person joins a facebook group tha twas created for people who believe that they have experienced symptoms afgter taking vaccines - they had built up to about 250,000 people and then Facebook deletes them. So the practical implication for this cohort of people who believe they've had post-vaccination syndrome - they're getting all sorts of social messaging that these are perfectly safe vaccines - they couldn't have had the symptoms that they are experiencing - they're getting that from all sorts of people raound them an dthey can't even communicate on social media with others and they're all isolated of course to discuss what their symptoms are as opposed to someon eelse's symptoms it is the ultimtae form of gaslighting - and for these kinds of people it is profoundly depressing - can yo appreciate what I ams saying - I feel this is fundamentally wrong as a physician - we are compromising people's physical health - and we can argue whether the symptoms are related or not related that's the essence of this complaint against this paper - that it can't be proven with these kdin of database - but these people, have symptoms, they've experienced something, and they're not able to get any resolution tehy're told that it's all in their head and they'e crazy - that's not right and this the consequences of what we're doing socially right now in this context and I thin it's driven by fear - i think we're driving ourselves a little bit mad with our fear over this pathogen - it's changed my body, I don't have the exercise tolerance I used to have - I didn't die and I'm 61 and I'm moderate risk group - but we're we fear it almost like it the africans feared ebola in the west-african outbreak and it's driving us to compromise some of our fundamentals including with this censorship initiative - i don't know what this looks like on the other side - we're eventually going to get through this but it's impacting society profoundly in many ways and people who have experienced it are disturbed by what they're seeing and the long-term meanings of that.

asks question about how this breeds conspiracy theories

They've experienced something, their friends have experienced something, and yet they're tol dthat they couldn't have - I posted something tha twent viral on LinkedIn (20,000 likes on LinkedIn is a big deal). And all it was was I posed a question - what will happen to public trust in the public health system if it turns out that Ivermectin is safe and has theraputic benefit and the vaccines turn out to not be perfectly safe. And it generated a blizzard of respones - now I elected not to add the third leg to that stool which is the controversy abotu the lab leak hypothesis - wihch was another exMAPLE OF SOMETHING that was shut down very hard and censored an dnow it's come forward that there's some merit to that - deonstrated by the current president seeking investigation on that - if any 2 or 3 of those come to pass, and I think all 3 will, in my opinion - where do we go from there in therms of public trust in the world pulic health system? I don't know the asnwer, and what I got back from epople was a lot of folks saying "we can't trust the government anymore - we can't trust the world health organization -

The fear that i've had from the get-go with warp-speed and the vaccine development enterprise - as a vaccinologist - i spent my entire career in vaccines - I developed the mRNA technology when Iw as 28 - I was involved in HIV vaccines - my fear has been that we would end up with problems - how can yuo not if you cut corners and rush things, particularly the safety issues - what would happen thte entire vaccine enterprise - pediatric vaccines - the fundamental bedrocks of public health - if we basically validate the criticisms of those that have been labelled antivaxxers nad that's sort of apejorative over simplification too - that term - we're labelling and excluding the whole block of debate and discussion by labelling it that way - but what if what we do in doing this validates what they're saying about pharma and the FDA and the government playing fast and loose with lives - with vaccines? I'm having people write me saying i'm not going to vaccinate my kids anymore, I can't believe in this whole enterprise. I herad a statistic on the Highwire that the baseline self-identified antivaxxer has been historicall 3% of the population, and according to them in the latest survey it's bumped up to 40% of the population self identifying as anti-vaxxer? where does that go? And by shutting down, this infromation and this discussion I mean to lock me out of linkedIn because I have been carefully, respnosibly raising concerns and questions and trying to engage in discussion about this, and I'm a bonafide, you can't say that I'm not an expert, some might even say That I am THE expert, but to block my ability to communicate, let alone all the others that have contacted me and said "hey I can't say the thing that you've been saying" - so speak for me - they don't even have me as a voice - that's profoundly disturbing - we can't get to scientific truths if we can't discuss things.

Appeal for LinkedIn post - received response which claimed he was sharing information tha was misleading or inaccurate - restored but will be migrating most of his stuff to Twitter and a person blog

You are a trained bioethicist and you already started addressing some fo the ethical questions or conundrums aroun dwhat's happening - can you give me a little bit of scope of this?

Thank you for that and that lead-in. Personally for me I think this is one of the most important topics - the bioethics of the use of an eexperimental medicine or experimental vaccine. The genesis of this whole thought thread was a 2 hour conversation with a Canadian physician a numebr fo weeks ago where he just poured his heart out about what he was seeing with his patients and what was going on in Canada - and I was left saying "thanks for sharing this, but I can't help you, I don't have anything" I woke up that Sunda morning with an a-ha moment and I thought I know what I can do for this guy, I can write a piece about bioethics - the bioethics of vaccination under emergency use authorization. And so I dug into the rich literature that exists, as well as federal law, that goes back to the Helsinki accords, the belmont report, etc. And looked into what are the fundamental principles of bioethics as they relate to an experimental produce.

1. An emergency use authorization product is an experimental product, it's not yet licensed.
2. If you're going to be administering experimental products to patients, that falls under clinical research, medical research, and so you have to follow the guidelines for medical research which is codified in Federal regulations. The first clause in the common rule is that there has to be complete disclosure of risk. You know intuitively what that means because if you buy a bottle of Aspirin and you pull out a little piece of paper and you look at that and you say holy moly this aspirin is going to kill me, gastric erosions etc.. but the truth is that the ones that are common are up at the top, and we all take Tylenlon or aspirin or something similar. That's the level of disclosure of adverse event risk that must be rpovided to patients provided in clinical research. That level of information, as we've discussed, is censored - it is not available. SO we are not meeting the criteria for full disclosure of risk. Second - disclosure has to be comprehensible and comprehended. I can't - early on I referred to thrombocytopenia - and that's low platelets. These risks need to be conveyed using language that people can comprehend. Third - you cannot coerce, you cannot entice - the patient or subject has to freely accept the experimental medicine of their own volition. All this messaging about "you must take this vaccine or aunt may could get infected, it's safe, etc.." all the peer pressure - that's coercion. Now, it gets evn more florid, with those nations - we're going to give out ice cream cones to get the kiddies to come and take the jab. That's beign done, that's coercion and enticement. Then there's the last little codicile in all this - we call it the age of consent. So, we here in the states generally agree that the age of consent is 18. If you are at or below the age of consent, you have to have consent from your parent or guardian to provide consent to take an experimental medicine, because you are not able to give consent by definition. We cannot, by law, have infants, children and adolescents receiving experimental products without authorization from their parents. Now those listening to this might say "well we have this special case of an epidemic and we have to al get vaccine" - what's the logic behind that? We're told we have to all get vaccinated to reach herd immunity - that is a fallacy. We have not even gathered the data to calculate in these clinical trials what would give us herd immunity - what would herd immunity mean - ti would mean that we have - so there's sterilizing immunity which meeans that if we get infected, we don't spread it to anyone else. We are not producing virus and shedding virus. Just today the WHO made an announcement,c lear and unequivocal - you have to start using a mask because none of these vaccines are preventing infection, they're preventing disease. They're not preventing transmission - and they may be reducing transmission, but by how much we don't know - so we can't calculate the percent uptake required to reach herd immunity, if we could reach herd immunity with these vaccines. So there's a underlying logic that's been pushed out globally about why we have to take vaccine and how many of us have to take vaccine, and it's not actually supported by data. And to my mind, that's a problem, and it's kidn of gone all throughout this outbreak where key public health officials have felt comfortable substituting their opinion for evidence-based medicine. And that always has to happen at the start of an outbreak because we have no data - someone's got to have an expert opinion. We're past that point, we have a lot of data, and it's tim we start relying on evidence to make public health decisions, and we're not doign it. So my mind, from bioethics, we're failing to meet the code of federal regulation, federal law, let alone fundamental precepts that go back to the end of WWII. We are not providing full disclosure of risk, we are not doing so in a way which is that's readily comprehended by the public, and we are enticing, compelling, coercing and otherwise not respecting the rights of the individual what happens to their body, and in my mind that's bedrock - is we all ahve in WEstern Society, the righ tto choose, the state does not own our body, we do. Particularly for an experimental product, and I argue that we've crossed the line - a bioethical line, it may very well be federal law that we have crossed, inadvertently, I'm sure for all the best reasons, but if you go bcak, read the code, read the nuremberg code, what we're doing is not aligned with fundamental principles - and this happens time to time during war, in crisis, cultures decide that it's okay to bend the rules on some fundamentals of ethics , whether it's torture, interment of populations, whatever - I believe they almost universally end up regretting it. So I'm trying to responsibly, ethically, from within the credibility that I have in my CV, and because of my role in inventing this technology - to alert people that I believe that we're pushing and crossing some key lines here that we really should be respecting.

More questions for you, at this point, so we'l lhave to invite you back. Any final thoughts?

Yeah, if I can speak to your audience. Like I said, it's your body, and my general recomendation is that in my opijnion these vaccines are saving lives, aprticularly in the elderly. I get asked the question all the time if I someone should take the vaccine, and my recommendation is that you know your body best, you and your medical care provider, adn yuo have the right to accept or not accept a vaccine product, particularly an experiemntal one, adn you make your own decision. I can't advise you, and in the end neither can your own physician. I suggest strongly that you take the time to get informed, do the best you can, and then make the decision that you feel is right for you.