RFK Jr. The Defender - June 03, 2021


Yale’s Dr Risch on Early Treatment


Episode Stats

Length

1 hour and 9 minutes

Words per Minute

148.42256

Word Count

10,350

Sentence Count

493

Hate Speech Sentences

1


Summary

Dr. Harvey Risch is perhaps the world s leading authority or one of them in the analysis of aggregate clinical data. He has published over 300 articles and over 40,000 citations on Google Scholar. Dr. Risch concluded that there is unequivocal evidence for the early and safe use of hydroxychloroquine early on in the Pandemic, in May of the pandemic, he published a meta-review looking at all the studies at that time. And he was urging public health authorities all over the country to look at it as an early intervention. The reaction of the medical cartel was to silence him and to try to discredit him. And I m very excited to have one of the greatest epidemiologists of the age, Dr. Harsha Risch, on the show today. In this episode, we talk about his work, his views, and his advice to public health officials on how to respond to the crisis in the early days of the epidemic, and how important it is to have early intervention in the first place. We also talk about the importance of early diagnosis and early treatment, and why early intervention is the best thing we can do to prevent long-term morbidity, morbidity and mortality from a pandemic like the one we have in the modern era. This is a must-listen to episode for anyone who wants to learn more about the crisis and its impact on public health and public policy, and our understanding of what we should be doing to prevent it in the future. Thank you for listening to this episode of the show. It was produced by the excellent folks at Yale School of Public Health and the amazing people at the Yale Public Health Podcast! Thank you, everyone! -Dr. Risch - your work is so important and important and so much more important than you'll ever get to know about it, so you don't have to wait for another episode like this to be heard on the podcast. - thank you, again and again, thank you for being a part of it. . Your support is so appreciated and appreciated, and we're looking forward to hearing from you! Dr. Steven Risch's work will be much more than you can be heard in the next episode of our next episode, coming soon! -- -- and we'll see you on the next one, next week, next time, we'll hear from you in the podcast, next Monday, on Monday!


Transcript

00:00:00.000 Hey, everybody.
00:00:01.000 I am very excited today to have one of the heroes of the age, Dr.
00:00:06.000 Harvey Risch from Yale.
00:00:09.000 And Dr.
00:00:10.000 Risch is a MD. He's a PhD.
00:00:14.000 He is the renowned professor of epidemiology at Yale School of Public Health.
00:00:19.000 He is perhaps the world's leading authority or one of them in the analysis of aggregate clinical data.
00:00:27.000 And on evaluating research data and study designs, he has published over 300 articles and has 40,000 citations on Google Scholar.
00:00:37.000 Dr.
00:00:37.000 Risch concluded that there is unequivocal evidence for the early and safe use Of hydroxychloroquine early on, I think in May of the pandemic, he published a very, very influential meta-review looking at all of the studies at that time on hydroxychloroquine, and he was urging public health authorities all over the country to look at hydroxychloroquine, to use it as an early intervention.
00:01:05.000 The reaction of the medical cartel was to silence him and to try to discredit him, and I'm Very, very happy that they haven't succeeded.
00:01:15.000 Welcome back to the show, Dr.
00:01:16.000 Risch.
00:01:17.000 Thank you.
00:01:17.000 Thank you.
00:01:17.000 Great to be with you.
00:01:18.000 One of the things I want to start out with is that your own colleagues in the Yale School of Public Health, I think 20 of them signed a letter or a petition about you, and their big complaint about you was that you were renowned as a cancer specialist,
00:01:34.000 which they were willing to concede that you were the leading Authority on the relationship between certain exposures and certain cancers, but they said that you did not know anything about epidemiology, and therefore you had no real platform or standing to talk about hydroxychloroquine, and that your meta review was therefore somehow discredited.
00:02:00.000 How do you respond to that?
00:02:02.000 Well, in reality, they did not do...
00:02:06.000 Due diligence.
00:02:07.000 They didn't do their homework about me.
00:02:08.000 They failed to understand that my PhD was in mathematical modeling of infectious epidemics, and I've published in that.
00:02:16.000 But even more so, what I published about the efficacy of the medication, it has nothing to do with infectious diseases at all.
00:02:24.000 It's about drug efficacy, and I've done plenty of those kinds of analyses in all of my studies that are cancer-related studies.
00:02:33.000 And so for them to extrapolate from infectious epidemic processes of viruses to worrying about whether a drug is effective is a misrepresentation, misunderstanding of what exactly was being analyzed in that paper.
00:02:49.000 And they provided no counter evidence and early outpatient COVID illness and preventing hospitalization and mortality.
00:02:58.000 Let's say you had Tony Fauci's job and you were running NIH and the COVID sort of national countermeasures, what would you advise the doctors would be the best standard of care?
00:03:13.000 At this point, with everything that we know about ivermectin, about hydroxychloroquine, about steroids, what would you say is standard of care?
00:03:21.000 So what we've learned a number of different things as time has progressed over the pandemic.
00:03:27.000 At first, we thought that Only high-risk patients, meaning people over, say, age 70 with chronic conditions or obesity or diabetes and so on, needed to have early treatment and that everybody else, if they got sick, could survive at home.
00:03:44.000 And if they got short of breath and weren't surviving, then they would be treated also.
00:03:48.000 However, we learned after a while that there are some patients Who will survive that way but not do so well and may have protracted what's called long COVID or remain with symptoms.
00:03:58.000 And it may be more reasonable since these treatments that we have acquired evidence of their efficacy and very low cost, it may be more reasonable to treat people starting at much lower ages.
00:04:12.000 In fact, maybe even everybody Because the treatments are, as long as they're not contraindicated, if people don't have the few infrequent conditions that might suggest not to use these drugs, the drugs are extremely well tolerated by the great majority of the entire population.
00:04:29.000 Hydroxychloroquine is recommended to be used for malaria, for example, in pregnant women, in children.
00:04:35.000 And people with other diseases and so on, it's very well tolerated.
00:04:40.000 It's been used for 50 years by hundreds of millions of people.
00:04:43.000 Ivermectin, very similar.
00:04:44.000 It's been used by hundreds of millions of people.
00:04:47.000 But now we know there's more than that.
00:04:48.000 So people can be treated with hydroxychloroquine, ivermectin, antibiotics such as doxycycline or azithromycin.
00:04:58.000 We also know that colchicine seems to provide benefit when used in outpatients.
00:05:04.000 Fluvoxamine has been found in a few studies now to provide benefit.
00:05:08.000 Bromhexine, which is not available in North America, but has been seen in randomized trials elsewhere in the world, provides benefit and steroids.
00:05:16.000 And so we have a whole now armamentarium of things to use early on in treatment of COVID that will prevent hospitalization and mortality for the great majority of people who get treated.
00:05:28.000 And that is our first step to use.
00:05:31.000 Now, For people who are over age, say 60 or 65 or 70, who consider themselves to be at high risk, a bad outcome if they were to get COVID, it's reasonable for them to consider being vaccinated.
00:05:48.000 Vaccines appear to be effective in reducing risk of hospitalization and mortality.
00:05:56.000 And we know this basically from where they have been employed in large scales, for example, in countries Israel and the UAE. Those countries both show very, very substantial reductions in mortality.
00:06:10.000 And that's the big ticket.
00:06:11.000 That's what matters here.
00:06:13.000 And so we have reason to think that those vaccines are appropriate to be used in older people or people with conditions that would put them at risk for bad outcomes from the COVID itself.
00:06:26.000 However, they are not adverse event free.
00:06:29.000 There have been other adverse events, particularly clotting problems and bleeding problems that have occurred from these vaccines, and we don't have a complete quantitative handle on how often that occurs, but it's happened often enough and systematically enough That those risks need to be evaluated for younger people who would survive, even without treatment, would survive very well from the COVID itself.
00:06:59.000 This is the risk trade-off, needs to be done by every person in managing their own risks and their own health, and it's not something that should be mandated.
00:07:08.000 The state, the country, has an interest in protecting people as a whole, and therefore has the potential interest for having People immune as much as possible to the epidemic, to the pandemic.
00:07:21.000 Now, if the vaccines provided benefit for reducing transmission, then there would be motivation for the state to say people should acquire immunity if they don't have it from having been infected with the disease itself, then from vaccination.
00:07:39.000 However, we know from Israel data and from UAE data That getting vaccinated reduces the risk of transmission by only about 50 to 60%, not like the 90% of benefit to the individual person, but only to the society by only 50 to 60%.
00:08:00.000 That is something that's not negligible and it's meaningful.
00:08:03.000 And therefore the vaccines have utility in general, but not to the degree of forcing people to have to take the vaccines and certainly not in the context Of places like many states in the United States that already have major amounts of immunity and which the vaccines are not adding appreciably to that.
00:08:21.000 So it should be a choice that people have to decide for themselves what their risks are for their own health and what the risks are that they might convey to the population in which they live based on the immunity that that population already has and whether doing so changes that in any substantial way.
00:08:42.000 And what you're saying is really interesting because there's a complexity in what an individual's choices should be.
00:08:51.000 Or what kind of recommendation you would make to an individual of different age groups and different cohorts?
00:08:56.000 And the calculation differs for every cohort, clearly, because the risk from the disease is lower for younger people, and the risk may be much higher from the vaccine for younger people.
00:09:08.000 That's what the clinical trials seem to indicate, that people with more robust immune systems, younger people, were at more risk from the vaccine.
00:09:18.000 You have two issues.
00:09:20.000 One is what should state policy should be and what should the aspirations of state policy?
00:09:26.000 Right now, the aspiration of the state policy is that everybody of all ages should be vaccinated.
00:09:32.000 And the question is, is that good state policy?
00:09:36.000 And then let's talk about what individual choices, you know, how you would make that assessment as an individual.
00:09:44.000 about whether to take the vaccine or not.
00:09:46.000 There are two data points that I would mention.
00:09:48.000 One is the recent Lancet study showed that the risk of vaccination or the risk of death from COVID to people between four years old and 16 years old is about 1.6 per million.
00:10:03.000 There are Slightly higher calculations than the Lancet study.
00:10:10.000 I think one is one death for 275,000 in that cohort.
00:10:15.000 There's a very, very small number in that cohort.
00:10:18.000 The number of children that Pfizer tested was about, was 2,300.
00:10:27.000 And so there's no way to evaluate whether the risk from the vaccine is greater than the risk from COVID if you're in that age cohort.
00:10:37.000 And what we know about that age cohort is that they are probably more susceptible to vaccine injury.
00:10:44.000 The CDC number is under 400 have died from COVID. And that number is comparable to the annual numbers of deaths from COVID. Influenza that have occurred in past years.
00:10:58.000 So we're not talking about a big mortality epidemic in young children of anything that we've reacted to in any different way.
00:11:07.000 Yes, it's unfortunate.
00:11:08.000 We don't want anybody to die.
00:11:10.000 We certainly don't want children to die.
00:11:12.000 But the question is going to be what the comparable risks are for vaccinating children.
00:11:18.000 And there's just no real information about that.
00:11:22.000 And exactly as you said, testing 2300 Children from the vaccination is just not going to be nearly enough to provide evidence yet, and the only way we'll see this is going forward when children do get vaccinated, and there's now, I've heard anecdotally, so much social pressure in some circles for children clamoring to be vaccinated that, you know, in the 12 to 15 year age range, that we'll see going forward what happens.
00:11:49.000 There have, as I said, there have been these seven deaths From vaccinations in 12 to 15-year-olds, or actually even younger, that these deaths are ones that are just not expected.
00:12:01.000 For example, heart attacks in 15-year-olds are just not expected.
00:12:07.000 The deaths within a day or two of vaccination Are unlikely to have occurred just by chance and background rates.
00:12:16.000 And, you know, this is possible.
00:12:18.000 These numbers are very small.
00:12:19.000 So we don't know this yet.
00:12:20.000 We'll have to watch this going forward.
00:12:22.000 But there's reason to think that regardless of that, until we, you know, have evidence to prove that that is worse than letting children deal with the illness, that the illness itself is essentially mild for almost everybody, every child.
00:12:38.000 And therefore, there's no reason to I think that vaccination is necessary.
00:12:43.000 The children, by and large, do not spread the illness to other children.
00:12:47.000 They don't spread it to their parents or grandparents.
00:12:48.000 It usually goes the other direction.
00:12:50.000 We have evidence for that.
00:12:51.000 So there's very little reason to be concerned about vaccinating children at this point, and we should basically acquire more evidence.
00:13:00.000 The other thing is that even if a child does get sick and becomes symptomatic, most children are symptomatic only in terms of fever, headache, Tiredness that if a child becomes more significantly symptomatic, they can be treated.
00:13:16.000 We have these multiple drugs that can be used for children very effectively and they should be treated just like any adult who would get sick and sick enough that you'd worry about treating them.
00:13:27.000 So we have a way of dealing with this in children without vaccination.
00:13:32.000 And therefore, the unknowns of the vaccination are a big hurdle that we have to get through if we're going to use that.
00:13:39.000 And it's not clear that it's in either society's interest or in the individual children's interest to be vaccinated yet.
00:13:47.000 It appears that children actually internalize the COVID disease differently than adults and are much less likely to spread it.
00:13:57.000 In fact, I read recently that there has never been a single case of a document of a child passing the disease to an adult, whereas it does happen the other way around.
00:14:12.000 How do you explain that?
00:14:14.000 Well, first of all, I think these things are frequently hard to really prove, to document.
00:14:21.000 I think that one usually makes an assumption, oh, I was exposed to patients.
00:14:26.000 The doctor, I was exposed to positive patients.
00:14:28.000 Or my neighbor was sick with COVID and I got it from the neighbor.
00:14:32.000 Things like that are kind of anecdotal and plausible without providing scientific proof.
00:14:37.000 But what we know is that, as I said, children are not expressively symptomatic.
00:14:43.000 Fever, headache, tiredness aren't conveying You know, droplets of virus in the air, as opposed to coughing, sneezing, runny nose, and so on, which would be much more expressive.
00:14:56.000 Children are generally not expressive that way with this particular illness.
00:14:59.000 They might be with other kind of viral illnesses, but COVID, they don't do that, by and large.
00:15:05.000 So, for that reason, I believe the CDC has said also that children are not primarily responsible for spreading the illness.
00:15:14.000 It goes the other direction to children from adults.
00:15:17.000 And we've seen this also in data from Israel as to the decline in case counts after people have been vaccinated.
00:15:26.000 And in Israel, they started vaccination in the over 65s first and then successfully went to younger people down to age 16.
00:15:35.000 And what you see is over the weeks since January 16th, that All of the case counts in all age groups have gone down.
00:15:43.000 Well, they went down in children, even though the children weren't vaccinated.
00:15:47.000 It took a little bit longer, an extra week or two, for it to go down in the children, but it still went down, which says that the children are getting the infection from their parents, and the parents are going down, the older people are going down dramatically, and therefore the children's exposure to the infected adults is going down, and that's why the children who weren't vaccinated is going down just like the adults who were vaccinated.
00:16:10.000 One of the other variables that nobody really is looking at at all is the difference between the advantages of having a natural immunity compared to a vaccine immunity, which is a much narrower spectrum generally with the flu vaccine.
00:16:24.000 The flu vaccine will protect you against the variant against which you are vaccinated.
00:16:31.000 There's numerous studies that indicate that you're more likely to get the pandemic flu or another variant when it comes around.
00:16:38.000 Whereas if you get a natural flu infection, you are protected against all variants.
00:16:44.000 I think there's some science out there now that indicates that the same dynamic holds true for coronavirus as well.
00:16:53.000 I think that's true, that there's fewer antigens on just the spike protein That's made for by the vaccines to make antibodies to, whereas the whole virus itself has a much larger presentation of molecules on its surface that antibodies get made for.
00:17:14.000 And the spike protein appears to change more frequently from mutation to mutation, whereas the rest of the virus may change more slowly or not at all.
00:17:23.000 And so the repertoire of antibodies that's made from natural infection is larger.
00:17:29.000 However, we also know, for example, that the Novavax vaccine, which has been tested in, I think, in the UK and South Africa, and the US trial is still ongoing or finishing, that it was 90% effective in the UK trial and 50% or 55% effective in the South Africa trial against, largely, 93% was the South Africa variant strain.
00:17:57.000 Saying that, there are some differences in the effectiveness of these vaccines, but it's not zero.
00:18:03.000 It's not everything or zero.
00:18:05.000 And a 50 or 60% reduction in benefit in the context of people can still be treated if they get sick is still something worth considering for people choosing to be vaccinated.
00:18:18.000 So all of this is a continuum of managing the risks.
00:18:23.000 Yes, it is true that Natural infection appears to provide stronger benefit of immunity compared to the vaccine-based immunity, but both are still relevant for consideration.
00:18:37.000 And I'd like to return to one point that you made before on the state's interest in this, and that is that states and companies and so on have been making statements that it's in their interest To have immunity from vaccination of everybody.
00:18:58.000 Basically saying that their goal is to have everybody vaccinated.
00:19:03.000 But that is not a correct scientific statement.
00:19:05.000 The correct statement is their goal should be to have everybody immune or close to everybody immune.
00:19:11.000 Everybody who could tolerate being immune should be immune.
00:19:14.000 And that's a different question.
00:19:17.000 That question is solved not just by vaccination.
00:19:20.000 It is solved by natural immunity.
00:19:23.000 Which largely occurs because of previous infection, either symptomatic or asymptomatic infection.
00:19:30.000 And there's very little scientific reasoning, as far as I understand, for mandating vaccination for people who are already immune, in particular people who've had the illness, who developed a natural immunity from being infected.
00:19:44.000 So I can't understand the rationales for why the states or companies In general, are mandating vaccination when what they should be doing is evaluating immunity and requesting immunity from everyone in order to set the workplace safe and the environment safe for people to be in.
00:20:10.000 And if there's any concern, That an unvaccinated susceptible person could be infected because the infection somehow still gets out because not everybody was immune.
00:20:20.000 Those people can be protected by vaccination.
00:20:23.000 They have free choice to be vaccinated for free.
00:20:27.000 And to the degree that the vaccines work, which we believe they do, then they are perfectly free to protect themselves in that environment.
00:20:36.000 And so the motivation for becoming vaccinated In a mandated environment is a personal prevention motivation that's a rational choice for people who want to make that choice.
00:20:50.000 It doesn't need to be mandated for people who feel that they're at risk.
00:20:53.000 And they are the only ones that the mandate is attempting to protect.
00:20:57.000 So there is no rationale for mandating it in companies, and the states that are looking at it should basically back off the mandate issue and basically say that It's our interest for everybody to be as immune as possible.
00:21:11.000 And how you get your immunity is up to you.
00:21:14.000 But it's your choice.
00:21:15.000 Try to be as immune as possible.
00:21:17.000 If you think it's in your interest to be vaccinated, then, by all means, get vaccinated.
00:21:22.000 But we want everybody to be as immune as possible to protect our workplace.
00:21:26.000 And for the people who choose to be at risk, it's their choice, and they can be vaccinated if they choose.
00:21:32.000 One of the unknowns for people who choose a vaccine or don't One of the unknowns that would be useful for people is to know how durable the vaccine is, because we now have some idea that the natural immunity is extremely durable.
00:21:48.000 That 17 years later, one study has shown that if you got I exposure to any kind of coronavirus 17 years ago that you probably have T cell immunity today.
00:22:02.000 And not only that, but you have it for a much broader spectrum of variants.
00:22:08.000 And you and I talked the last time we spoke about a study that I think you mentioned that showed that if you had natural immunity, It would defend you against a variant that was 20% different in terms of the DNA that it shared with the variant that you were exposed to.
00:22:30.000 Whereas a vaccine-based immunity may only give you protection against variants that have different DNA by 3%.
00:22:39.000 Can you just talk about that for a second?
00:22:41.000 Well, to be honest, I can't really speak to that because the...
00:22:47.000 I know it's been estimated that these more detrimental variants only differ by 3% in their spike protein, but what matters really is the structure and shape of the whole protein itself and just the slightest change in a crucial part of the protein might make Antibodies irrelevant might make them so it doesn't work at all.
00:23:07.000 And that might be a negligible change in terms of all of the RNA or DNA bases for its coding.
00:23:14.000 So it doesn't really make sense to me to worry about that.
00:23:17.000 I worry about the empirical results of seeing how well the vaccines and the natural immunity works for suppressing risks of hospitalization and mortality.
00:23:28.000 And I think that these are really empirical questions.
00:23:32.000 What we've seen is that the UK variant seems to be more transmissible, about 60 or 70% more transmissible than the original strain in the US. And so it has, in many places, pushed out the original strain.
00:23:47.000 And so for people who are getting infected in the last few weeks or months, it's a lot more of the UK strain around.
00:23:53.000 The Brazil and South Africa strains are around, but they don't seem to be spreading anywhere near The UK strain.
00:24:00.000 And there's some virology theory, and I'm not a virologist, so I don't claim expertise in this, but there's some evidence that a more spreadable strain like the UK strain tends to push out the less spreadable ones like the Brazil and South Africa strain.
00:24:16.000 And whether the new India strain is going to do something different, we don't know.
00:24:20.000 It will probably spread, but the UK strain may or may not push that one out.
00:24:25.000 These things all affect The degree of immunity that a population has.
00:24:30.000 And so if a population could be immune, say, in 85% or 90% to the original strain, and then a new strain tries to make its way in and starts infecting, and it turns out that the population is only 60% immune to the new strain because there's only that much overlap, then it'll make a bump in growing into the population that was previously immune.
00:24:55.000 However, What's not recognized is that when a population has achieved 85% what we call herd immunity, 85% immunity, that even a virus like the UK strain that's 70% more transmissible is going to push the infection curve upward, but not above where the infection blows up, where it takes off again like an original wave.
00:25:23.000 It will make a bump.
00:25:24.000 And then people will develop the immunity to that, and the bump will go back down.
00:25:28.000 And that's what's likely to be seen.
00:25:30.000 And in fact, there has been some evidence of that in states in the United States where the UK strain has started to spread.
00:25:37.000 However, it's a little difficult to discern whether that is a reason for the bumps that have been seen in the last month or six weeks versus what I'll call rollout bumps.
00:25:48.000 When vaccines are newly rolled out, in the two weeks after each vaccination, People's immune systems decline, their white cells decline for about two weeks as their immune systems try to cope with the vaccine and making the antibodies for the vaccine.
00:26:07.000 And that puts them at increased risk of actually being symptomatic with COVID or perhaps other respiratory diseases.
00:26:15.000 And so one sees this, that in the two week period after vaccination, that people have larger frequencies of diagnosis And this has been shown in 80 countries around the world in what I'll call rollout bumps in mortality and case counts.
00:26:31.000 It's been seen in nursing homes across the U.S., where suddenly, after vaccination programs have started, that multiple people start getting diagnosed with COVID, totally unexpectedly.
00:26:44.000 And so this is what's happening.
00:26:45.000 It's an immune system reduction that's transient, but it still leads to increases.
00:26:51.000 So these bumps that have been seen in the case counts in states across the US and across the world are either from the new variants that are trying to make their way in but not getting very far, Or are the vaccine bumps, rollout bumps from the vaccines?
00:27:09.000 Either way, they're transient.
00:27:11.000 And this is the main picture, that they go up a little bit and then they come right back down.
00:27:16.000 In retrospect, how would you have, at the beginning of the pandemic, how would you have protected people in nursing homes?
00:27:26.000 I think 40% of the deaths that we saw in our country were the people who were confined to nursing homes.
00:27:32.000 I think most people who look at that policy Agree now that there was something wrong with it.
00:27:38.000 What should we have done?
00:27:41.000 Well, for sure we should never have put infected people, residents of the nursing homes that went to hospital, back into those nursing homes.
00:27:50.000 There needed to be some kind of alternative facility, either a separate isolated section of the nursing homes or some completely different facilities for putting those people until they had fully recovered and were no longer infected.
00:28:05.000 So that was the first major mistake, especially in New York State, that happened.
00:28:09.000 Additionally to that, we pretty quickly knew that we had treatment, early treatment for COVID, from hydroxychloroquine, azithromycin or doxycycline, zinc, vitamin D, especially in older people, needed to be supplemented to get their immune systems up and active and working.
00:28:30.000 So we already knew, rudimentarily speaking, Back in April, May, that we had these medications.
00:28:36.000 And these things were used very effectively by doctors who did treat nursing home patients when they got infected.
00:28:43.000 And Dr.
00:28:44.000 George Fareed in Southern California was doing this.
00:28:47.000 He had nursing home patients and went aggressively.
00:28:50.000 And in fact, what he discovered is that nursing home patients who are generally much older, you know, in their 80s, say, typically, are very immunologically fragile.
00:29:03.000 And need to be treated very quickly, quicker than you would tell from symptomology.
00:29:10.000 And so what he did is he tested their finger oxygen levels, you know, with a pulse oximeter.
00:29:18.000 He would test them three times a day.
00:29:20.000 And anybody who showed evidence of their oxygen level declining, he started treating.
00:29:25.000 Before they were symptomatic, before they had fever, he started treating them.
00:29:30.000 And what he did is he achieved a massive protection of the people in the nursing homes so there were virtually no deaths because he was treating them very aggressively that way because those people needed to be reached quickly before their immune systems couldn't cope with the infection.
00:29:47.000 And that's a perhaps dramatic sounding approach, but is necessary in that particular environment where the people are much more susceptible To, you know, immune overload from the virus early in the infection.
00:30:03.000 And I think those were the keys that I see for how to manage the most high-risk people.
00:30:09.000 High-risk people, but at lower risk, can be managed with early treatment.
00:30:13.000 And that's what we've been maintaining and what we have very strong evidence for that's been acquired over this year.
00:30:19.000 We've seen now that, in fact, it's a virtual open secret that hydroxychloroquine, ivermectin, and these other drugs Work very effectively for early outpatient treatment, particularly of high-risk people.
00:30:31.000 And so the telemedicine groups have been treating this very widely, and multiple of these telemedicine groups.
00:30:40.000 One group reported to me that they had treated 70,000 patients in the last year, another one 20,000 patients.
00:30:47.000 Doctors' Clinic in Houston reported treating 20,000 patients with hydroxychloroquine.
00:30:51.000 Dr.
00:30:52.000 Freed and Dr.
00:30:53.000 Tyson in Southern California was treated 4,000.
00:30:56.000 Dr.
00:30:56.000 Zelenko has treated 3,000.
00:30:58.000 Doctors in Florida have treated thousands.
00:31:01.000 More than 120,000 patients have been treated early as outpatients with hydroxychloroquine over the last year with handfuls of deaths in total out of all of this.
00:31:12.000 So we know that this is working.
00:31:14.000 And it's just a question of penetrating into general knowledge that these drugs are available for people to treat.
00:31:22.000 Now, of course, not everybody among those 120,000 were high-risk patients.
00:31:26.000 Most probably might have survived one way or another without treatment.
00:31:30.000 But among those, about 40%, we estimate, are likely to be high-risk.
00:31:34.000 And so that's about 15,000 people whose lives were saved by this availability and utility of early outpatient treatment using all of these various drugs in a clinical setting with clinicians who have the experience of treating patients early, not by people in hospital
00:31:50.000 not by people in hospital academics who've never treated a COVID outpatient, not by people marshalling theoretical arguments why these drugs may or may not work, but people in the field, doctors in the field, who routinely use these drugs day in, day out, and know for certain from their large-scale and know for certain from their large-scale experience about how well these drugs work.
00:32:11.000 And this is how the pandemic should have been managed early on.
00:32:15.000 By early treatment, you mean After you have an indication that you're sick, either a blood test or a change on your pulse oximeter, you immediately start treating that person with that drug regimen.
00:32:29.000 In a nursing home setting, a change in pulse oximeter measured two times, say, that below 93, there are different thresholds, but say 93% is what Dr.
00:32:44.000 Fareed used.
00:32:45.000 For people at more average high risk, I would say that symptomatic diagnosis or positive PCR diagnosis is sufficient to institute treatment.
00:32:57.000 The treatments are so benign that one should err on the side of safety for these.
00:33:03.000 Yes, there are contraindications.
00:33:05.000 There are some people who cannot or should not take hydroxychloroquine.
00:33:08.000 But they are very infrequent.
00:33:11.000 There are some genetic conditions that lead to that.
00:33:13.000 They're perhaps on other medications that they need to be on and therefore the hydroxychloroquine would be contraindicated.
00:33:19.000 They can be on ivermectin or fluvoxamine or colchicine.
00:33:23.000 All of these are, you know, part of the clinical expertise and discretion of doctors who are engaged in treating outpatients early And they know how to manage each individual patient based on individual recipes.
00:33:36.000 And this has been written up.
00:33:38.000 Dr.
00:33:39.000 McCullough has led these clinical treatment groups in two papers now that have been published on these recipes for early outpatient treatment.
00:33:47.000 There's now close to 60 authors on those papers, mostly of doctors who've been using these treatments, both in the United States and Italy and other places, very effectively In treating COVID early.
00:33:59.000 And so it's not a cookie cutter.
00:34:02.000 It's not just saying hydroxychloroquine works, end of story.
00:34:06.000 Hydroxychloroquine is a major important component of this regimen, and so is ivermectin, and so probably are steroids.
00:34:14.000 And aspirin or other Drugs to treat clotting issues that can arise.
00:34:20.000 All of this can be done in outpatient settings, and this is part of doctors who are actually engaged in treating high-risk outpatients, and this is how the disease should be managed, and not by letting patients sit at home and wait until they have to be hospitalized, which is a catastrophic mistake in policy and contrary to everything we know in clinical medicine about treating any infectious disease or any disease for that matter.
00:34:42.000 Somebody knew, and NIH knew, I think as early as 2001 or 2005, there was a study published at that point, which was an in vitro study.
00:34:53.000 It was a petri dish study that showed hydroxychloroquine killed coronavirus in a petri dish.
00:35:00.000 At that point, they knew that there was probably some benefit from the molecule.
00:35:04.000 Instead of doing those kind of studies at the outset of the coronavirus pandemic, There was an orchestrated effort that was really strange by governments and by health officials to try to suppress and deny access hydroxychloroquine even beginning as early as January 2020.
00:35:32.000 Yes, I think there's evidence that There was pushback and public messaging against hydroxychloroquine even before President Trump made his statements about it in March.
00:35:42.000 So I agree with you.
00:35:45.000 There appears to have been a concerted effort not to study hydroxychloroquine in randomized controlled trials supported by or stimulated by NIH, and there were trials that did get underway in outpatients,
00:36:02.000 and these trials were I would say largely contrived to fail that people in reviewing medical evidence typically assert that randomized controlled trials provide the best evidence.
00:36:18.000 But that's only true when randomized controlled trials are done well.
00:36:22.000 Part of doing them well is they have to be so large that the randomization does something.
00:36:26.000 So large means generally 500 people or more in each arm of the trial.
00:36:31.000 The placebo group and the treatment group have to be 500 or more.
00:36:34.000 So when you see a study with 50 people in each arm, it's almost useless.
00:36:38.000 The randomization is almost useless.
00:36:41.000 In addition, the studies changed their endpoints midway in the trial.
00:36:45.000 They gave the medications to patients three days or later after they said that the people got the medications so that the medications were largely ineffective.
00:36:57.000 And they hid that information in the trials.
00:36:59.000 There was lots of ways to sabotage a randomized trial in full public view without basically anybody but sophisticated readers being able to pick up on the fact that the trial was mismanaged in a way to distort its results towards no effect.
00:37:16.000 And this was the case for the outpatient trials.
00:37:19.000 But before that even happened, the trials that were investigating hydroxychloroquine were trials of hospitalized patients.
00:37:27.000 It makes no sense to study hospitalized patients when the goal of the treatment is to prevent people from getting hospitalized.
00:37:34.000 This was a complete misdirection and came about because of some interference in the rational thinking about how to treat and how to study the treatments for outpatients with COVID. You know, you can address where the motivations from that came from,
00:37:50.000 but there was a fact that the first studies that came out were studies of hospital outpatients And then the recommendations were made for outpatients who had not been studied based on results in hospitalized patients, which is irrational, and why I wrote my paper in May in the first place, because it made no sense.
00:38:09.000 And in addition to that, there were studies that had to be this extraordinary scenario where the three highest gravitas journals in the world, New England Journal of Medicine, Lancet, and JAMA, all simultaneously published, which is another question, how did that happen?
00:38:29.000 These studies that attacked hydroxychloroquine and that all turned out to be really egregiously fraudulent.
00:38:37.000 Well...
00:38:39.000 One thing that we've learned is that there's lots of dedicated special interests in medicine that have tilted the playing field on the basis of evidence.
00:38:49.000 And the financial interests in this are so large that they've had a lot of effect on doing that play field tilting, including the lack of fair and objective reviews of papers in journals, the medical journals and We've heard reports from Dr.
00:39:11.000 Horton from The Lancet, from Dr.
00:39:13.000 Angel when she was editor of the New England Journal, about the effect of pharma companies having so much financial pressure on these journals in terms of advertising and financial contributions and support to the journals that they were able to publish papers in the journal that would not stand scrutiny in a more objective way.
00:39:40.000 I think the best video of this was done by Dr.
00:39:46.000 Jason Fung in Canada in 2017, I believe it's still on the internet, talking about pharma involvement in interference with messaging about drug efficacy and the publication of papers in medical journals.
00:40:02.000 And so if the editors of those journals are complaining about this problem years ago, You know, it's just ramped up in the last year that we've been facing.
00:40:12.000 And so what we see, I've personally had papers that eventually got published, but sat for four to six months with journals that slow walked every aspect that normally, and I'm an editor of a number of scientific journals, and when a paper is accepted for publication, it's usually on the internet within a few days to a week or two, you know, today.
00:40:37.000 And these papers were being accepted by these journals and then sitting for six, eight, ten weeks before anything, before final notice of acceptance, even though the reviewers had already said they're accepted and the journal itself said it's accepted, but nothing, no further messages for six, eight, ten weeks before they would appear.
00:40:55.000 There's no reason for that other than slow walking and some kind of interference behind the scenes in these journals.
00:41:02.000 And unfortunately, it's made the Credibility of the whole medical literature suspect today, and this is why preprint servers, MedArchiveServer and BioArchiveServer and other preprint servers, have basically become the source of manuscripts for review.
00:41:24.000 Yes, they're not peer reviewed, but unfortunately today, peer review is potentially corrupted enough that one can't draw Conclusions about what gets out there.
00:41:34.000 And so everybody has to review the papers for themselves.
00:41:38.000 So we take the preprint server papers and we look for their flaws and we look for their strengths and we evaluate the evidence as best we can.
00:41:46.000 And that's all we can do now in the current context.
00:41:50.000 That's where the evidence is.
00:41:51.000 Can you talk a little bit about what happened with the surges here and the fraud that happened with those three journals?
00:42:00.000 Well, we don't really know The motivation and the financial behind the scenes going on with why those papers got through publication.
00:42:13.000 Obviously, the real bottom line is when papers are published, it's a confluence of the reviewers think that the paper says enough scientifically to be publishable, and the reviewer wants to see the message of the paper be published.
00:42:32.000 Both things have to occur.
00:42:34.000 If a reviewer doesn't want to see the message published, the reviewer will nickel and dime the faults of the study to the point where it's simple to make a review negative.
00:42:45.000 So reviewing is very subjective and it's very easy to tilt the review depending on one's proclivities as a reviewer.
00:42:53.000 And so both factors have to be present, scientific validity plus a reviewer desire to see the message.
00:43:00.000 And once you have a distorted playing field where reviewers are looking for positive messages against a medication, then it's very easy to distort papers, to push forward papers that show that negativity and to withhold and suppress papers that show objective benefit.
00:43:18.000 And so this is the playing field.
00:43:20.000 This is the behind the scenes of journal reviewing that I'm saying, that journals that want to see messages of these medications doing harm are more likely to publish this.
00:43:32.000 And in fact, there's now been papers looking at political contributions of reviewers and journals to political parties showing that they're extremely lopsided, that most of the political contributions made by Editors of journals, if I recall this paper correctly, were almost all on one side and not on the other politically, which speaks to political motivations more than scientific ones of the journals.
00:43:58.000 Regardless of that, we shouldn't be talking about political motivations for reviewing science.
00:44:02.000 The science should speak for itself.
00:44:04.000 But unfortunately, with financial issues lurking in the background, it's been very difficult to be objective about what comes out.
00:44:12.000 And the Surgisphere papers We're clearly identified by dozens, if not hundreds, of scientists around the world as being improbable as far as real data are concerned.
00:44:25.000 The journals requested the authors to provide proof that they were real data.
00:44:30.000 They refused to do that or were unable to do that, and so the papers were rejected because of prima facie evidence that if an author can't provide proof that the data are real, then the data can't be real.
00:44:43.000 Yeah.
00:44:44.000 If you get natural infection and you have long-term immunity and broad-spectrum immunity, and it turns out that the vaccine is a very ephemeral immunity and that it is a narrow spectrum, meaning that you now have to get vaccinated for every new variant, the risks are then very different, right?
00:45:08.000 Because you have to evaluate The risk from a single infection when you're a child, which is very low, and perhaps getting a lifetime immunity against the risk of having to get a new vaccine or perhaps multiple boosters per year for the rest of your life.
00:45:28.000 So, you know, this is all in the great unknown.
00:45:31.000 I think that we learn over time how things play out.
00:45:37.000 There is evidence from the SARS virus One, measurements of T cells, that immunity is highly retained on that basis.
00:45:48.000 We are learning now more about memory B cells, that even though antibodies can decline over 9 to 12 months after natural infection, that the memory B cells still appear to retain knowledge and are primed for that exposure,
00:46:06.000 and that if a person is reinfected With a virus that's close enough to the original strain that those B cells will go into overdrive, making circulating antibodies to attack the new virus.
00:46:22.000 And that's how the immune system works in its normal fashion.
00:46:26.000 What we've seen is that over the last year, in people who have been infected, or at least who test positive for infection, that the risk of getting Infected later on is very low.
00:46:41.000 Yes, there have been some numbers of cases that appear to be second infections.
00:46:46.000 One has to search for them to find them.
00:46:49.000 They're not common.
00:46:50.000 So at least 90%, if not 95%, benefit of subsequent infection by whatever strains are out there compared to the original strain immunity from the original infection.
00:47:02.000 How long that lasts?
00:47:04.000 We don't know if it's 17 years.
00:47:06.000 It's probably at least one year and it may be longer.
00:47:09.000 In children, we don't really know yet because the infection has only been around for a year or so.
00:47:17.000 Childhood illnesses that tend to generate these kinds of strong immunity tend to last for long periods of time.
00:47:25.000 Immunity tends to last for long periods of time.
00:47:27.000 But again, it's an empirical thing that this virus is not one that's been with humanity In its current form for very long, and so we don't know how this is going to roll out over a long time.
00:47:40.000 It could very well be that once you get this as a child, and it's basically a minor cold, you know, like illness or headache and fever and whatever illness that lasts three or four days, and that's it for most young children.
00:47:57.000 Yes, there are rare ones for whom it's more severe, but for most children, then That's what they get for life.
00:48:03.000 Going forward, that may be the end of it, even as variants occur, because those variants, again, even though they may be more salient for vaccine specificity, may not be as salient for natural immunity specificity.
00:48:19.000 This is empirical.
00:48:20.000 There's no real way to guess these things other than to stay on alert and measure them and try to make the best inference one can.
00:48:31.000 And so we're in the middle of the transient phase where, in my personal opinion, I'm optimistic that this is going to largely go away over the summer, that there'll be bumps from some of these variants, that they won't be horrendous, that the herd immunity, which started last fall in almost every state across the US, is going to be maintained throughout the summer.
00:48:57.000 That going into next fall, when the seasons change, will be the one time to worry about whether anything transpires then.
00:49:05.000 And there's no way to predict it, but I don't see at this point that it's largely to recur in any major way like it did last winter or spring because of the massive amount of immunity that we will have then, we have now basically, and will have then compared to the lack of immunity that we had last spring.
00:49:26.000 Prior to President Trump's statement, President Trump kind of contaminated hydroxychloroquine for half the country by endorsing it.
00:49:36.000 But even before he did that, you had Canada and France passing rules that took a medication that was once an over-the-counter medication, it was ubiquitous, it was safer than aspirin, safer than Tylenol, used in Every country in the world for 60 years, and they removed it from being an over-the-counter medication to being a poison, essentially, where you had to get a prescription.
00:50:05.000 And at the same time, you had FDA, despite all the studies saying that it worked, declaring that it didn't work.
00:50:13.000 Tell me your reaction to that and what impact that had on global mortalities.
00:50:18.000 Well, my reaction to that is there's no reason any status should have changed Unless somebody had an interest in changing the status.
00:50:27.000 In France, I believe there's even been prosecutions of the Minister of Health there for having ties to the pharmaceutical industry, and one can only infer that there was pressure brought on that person to change the status.
00:50:42.000 In Canada, I don't know what the connections were, but this goes back to the fair playing field discussion that we had before.
00:50:53.000 As they say, follow the money in all things.
00:50:56.000 These are not rational, objective things.
00:50:59.000 There was no major study showing harm before the status of the medication was changed in these countries.
00:51:06.000 So there was no rationale, no scientific rationale, that would have instigated a change in status.
00:51:11.000 So it had to be some other grounds for changing the status.
00:51:15.000 And I'm not privy to the internal workings of any of those countries.
00:51:20.000 Maybe nobody is.
00:51:22.000 It's hard to know for sure.
00:51:24.000 There are stories even in African countries that people are going to pharmacies systematically purchasing hydroxychloroquine and then destroying it.
00:51:36.000 Yes, I've heard anecdotal reports of that, of it disappearing off the shelves by purchase and then fires outside of town, bonfires burning up all the supplies.
00:51:48.000 There have also been fires in Production plants in Taiwan and in India making the ingredients for manufacturing of hydroxychloroquine.
00:51:59.000 Those are kind of suspicious events.
00:52:02.000 Hard to know.
00:52:03.000 One of the really suspicious things is that I think the world's largest producer of hydroxychloroquine was Sanofi.
00:52:15.000 And they gave virtually 100% of their stock to Tony Fauci, the national stockpile, and presumably got a big tax deduction on them, but then he locked it in there and wouldn't let anybody touch it.
00:52:29.000 And that would off-limits a lot of the global, a significant part of the global supply of hydroxychloroquine.
00:52:38.000 It would really seem like there's just this really sinister, deliberate Attempt to remove the public accessibility to a drug that they knew, that people knew there was very, very good reason to believe that it would have saved a lot of lives and maybe even eliminated the pandemic.
00:53:01.000 Well, the reasoning is, you know, if you're cynical, the more something is countered to your financial interests, the harder you push against it.
00:53:10.000 But there's never been a shortage of hydroxychloroquine.
00:53:13.000 That between the 60 or more million doses that are in the strategic national stockpile that could be released if there really were a shortage, not even for COVID patients, for rheumatoid arthritis patients, other patients who use it daily, large numbers in the United States and around the world who use hydroxychloroquine daily for their treatment without adverse effect.
00:53:35.000 The drug has been available throughout and can be manufactured easily and quickly That with the ingredients for manufacture, the generic companies can manufacture hundreds of millions of doses per month.
00:53:51.000 So it's not like the drug has been scarce.
00:53:56.000 It's been claimed to be scarce as a reason for not prescribing it, but that basically is another straw fake argument when in fact there's plenty of it around and available and it's so cheap.
00:54:10.000 Figuring out the truth from these things, it sounds like it's conspiratorial when you get to these kinds of events, but the bottom line is that it's never been scarce one way or another in the United States.
00:54:23.000 Peter Corey and Dr.
00:54:26.000 McCulloch have both said that those medications, hydroxychloroquine and ivermectin, were given widely to patients in early treatment At the time that they were discovered to be effective, we could have saved maybe 500,000 lives out of the 600,000 now attributed to death from COVID. That would be my estimate also,
00:54:51.000 that hydroxychloroquine with zinc, vitamin D, and maybe antibiotic as well, is good for about at least 85% Mortality reduction, maybe more.
00:55:05.000 As I said, all the clinicians who've been using it for the year in outpatients have seen probably well over 95% mortality reduction, if maybe 98% mortality reduction.
00:55:18.000 But even the more simple-minded way of just saying hydroxychloroquine and zinc and vitamin D and antibiotic alone is For sure, I think is evidence of at least 85% mortality reduction.
00:55:32.000 So that gets you 500,000 out of 600,000.
00:55:35.000 Ivermectin is similar.
00:55:37.000 It's probably good for 80% mortality reduction, again, in combination with the other medications.
00:55:44.000 And in fact, there's no reason why hydroxychloroquine and ivermectin Should not be used together as part of the first-line approach to treating high-risk patients.
00:55:54.000 They are perfectly compatible with each other and can be used with each other unless they're in the rare people with contraindications.
00:56:01.000 They can be used together.
00:56:02.000 What happens when FDA declares that the drug is useless?
00:56:08.000 Well, the FDA actually did worse than that.
00:56:10.000 If the drug were useless, it wouldn't be a problem if the drug is safe.
00:56:15.000 And given that we've had 60 years of usage of hydroxychloroquine in tens of billions of doses by hundreds of millions of people, you know, in pregnant women, in young children, infants, adults with illnesses, and so on.
00:56:30.000 We know this drug is completely safe.
00:56:33.000 Clinicians know how to prescribe it.
00:56:35.000 They know who might be contraindicated.
00:56:37.000 And they know, you know, that it's a safe drug.
00:56:41.000 Rheumatologists use it universally.
00:56:44.000 Ophthalmologists are completely comfortable with it because they see the annual follow-ups of the rheumatoid arthritis patients who take this drug daily.
00:56:52.000 And so there's a whole swath of the medical community that knows that this is a safe drug.
00:56:58.000 So this drug should have been out there from the beginning.
00:57:02.000 I'm sorry, I'm missing your question again.
00:57:05.000 Yeah, you know, what's the impact of the FDA? Oh, yes.
00:57:09.000 What is the impact of the global impact of the FDA? So a drug that's this safe in the context of an emergency should have been released for general usage with the barest amount of evidence of benefit.
00:57:26.000 There's no evidence of harm.
00:57:29.000 So even the smallest amount of benefit would be useful going forward If it didn't work, okay, stop.
00:57:37.000 You haven't done any harm.
00:57:38.000 So it should have been tried.
00:57:40.000 And the FDA pushback saying, oh, you need multiple large randomized controlled trials before we'll allow this to go out is a complete charade.
00:57:52.000 Because it isn't necessary to prove efficacy.
00:57:55.000 It's necessary to prove safety.
00:57:57.000 And safety was proven from massive history and experience.
00:58:01.000 So they set up a fake goalpost.
00:58:05.000 Furthermore, they attempted to undermine the safety by putting up a fraudulent website, which is still there today.
00:58:11.000 The FDA's website says, warning, hydroxychloroquine should not be used for outpatient treatment.
00:58:19.000 That's the bold letters.
00:58:20.000 And then underneath that, it says, We base this warning on adverse events observed in hospitalized patients.
00:58:26.000 And the reason that's a fraud is because hospitalized COVID is a totally different disease than outpatient COVID. Outpatient COVID is like the flu.
00:58:34.000 It's viral replication.
00:58:36.000 It's all of the symptoms that one gets in the initial phase of an illness like the flu.
00:58:42.000 Whereas hospital disease is people who can't breathe, whose lungs are filled up with immune system debris.
00:58:50.000 Where the virus has gone all through the circulation, gone to the heart, gone to the kidneys, gone to everywhere in the body, causing havoc.
00:58:58.000 And so there's no sense that hydroxychloroquine is going to be effective for a totally different disease, for inpatient disease.
00:59:06.000 And yet the FDA having information based on adverse events that had occurred in hospitalized patients who have all this other havoc of what the virus is doing and can't separate that from the hydroxychloroquine use in hospitalized patients, uses that to make assertions about hazard in outpatients for which it had and has no systematic data.
00:59:27.000 At the time that the FDA put out this warning on July 1st, there had been no systematic data on usage of hydroxychloroquine in outpatients because the FDA's EUAs, their emergency use authorizations, Limited the hydroxychloroquine use to clinical trials and inpatients only since March.
00:59:48.000 So there was no systematic data of adverse events in outpatients to actually make any recommendations about hazard.
00:59:56.000 And that's, of course, because there were no adverse events to speak of in use in outpatients, because we know that it doesn't do that from all of the 50-60 year history.
01:00:06.000 So the FDA put up this fake warning, which has corrupted the entire world.
01:00:11.000 It's led to essentially the reasons for the deaths, the majority of the deaths in the United States and the deaths all over the rest of the world, who've relied on the FDA's corrupt warning on its website.
01:00:24.000 And that's the bottom line as to why we have so many deaths in the world today, because of the FDA's corrupt and fake fraudulent warning on its website.
01:00:35.000 What does that say about health regulators?
01:00:39.000 It says that there's some reason that there's been dishonesty in the FDA, and we know that there's been episode after episode of dishonesty in the FDA, going back to the Obama administration and before, where on both sides,
01:00:56.000 both political parties have complained about political meddling inside the FDA. And this is the problem, that there's meddling Inside the FDA that distorts and corrupts the decisions that it's made.
01:01:12.000 I've heard people refer to the FDA as pharma's PR department, that the FDA is not doing objective honest reviews.
01:01:21.000 In fact, Congress got so fed up with the FDA's reviews and stonewalling evidence, mandating large randomized trials as the only form of evidence To consider for review of medications that in 2016,
01:01:37.000 Congress passed the 21st Century Cures Act, which says, among other things, that government agencies are required to use real-world data in order to review medications for usage and cannot limit their evidence base only to randomized trials.
01:01:55.000 And they did this because, as I said, that limiting to randomized trials is a shibboleth.
01:02:00.000 It has naive You know, the simple-minded view that randomized trial is good, everything else bad.
01:02:08.000 But that is not science.
01:02:09.000 The science shows that well-conducted, non-randomized, but controlled trials give every bit as good evidence as randomized trials.
01:02:18.000 And we know this now from reviews of 10,000 studies done by the Cochrane Library Commission in England, published in 2014.
01:02:26.000 We have this from Dr.
01:02:29.000 Friedan, who was director of the CDC, published in 2017 saying this.
01:02:34.000 It's known that randomized trials are not the only form of evidence and are not necessarily the best evidence.
01:02:41.000 And therefore, there has to be evaluation of all relevant evidence in review of medications for approval.
01:02:48.000 And so for the FDA to make this fake demand of saying we're only going to review EUA requests when there's evidence of large randomized controlled trials is Basically stonewalling the rest of the evidence for some benefit.
01:03:05.000 The Cochrane review that you're talking about actually looked at the outcomes of 10,000 randomized control trials and compared those to other trials and found out there was no difference in their capacity to predict an outcome outcome.
01:03:21.000 In other words, that it was not a higher quality vehicle for projecting health outcomes from certain exposures or certain treatments.
01:03:36.000 That's right, mostly for treatments.
01:03:38.000 And what they showed is that the non-randomized trials of the same treatments and outcomes compared to the randomized trials show, on average, very similar magnitudes of benefit.
01:03:51.000 Or harm.
01:03:52.000 That they produced very similar, within 10%, on average, the same results.
01:03:59.000 You know, I, as an epidemiologist, and spent a whole career reviewing evidence, and we go back to Sir Austin Bradford Hill's methods of reviewing evidence from 1965 that set the stage for the whole field of how one reviews epidemiologic evidence using everything that's known about That's been measured and understood, including the empirical evidence, the biological theories, what's known in the world in general about the disease.
01:04:29.000 Everything goes into the evaluation of evidence.
01:04:32.000 There's no limit.
01:04:34.000 Hill didn't say, oh, we only do randomized trials and throw out all other evidence.
01:04:38.000 That would be absurd.
01:04:39.000 That would be like throwing out 90% of science and saying, we're only going to look at this evidence because we have some special relationship to the evidence.
01:04:49.000 Well, in fact, There is a special relationship to the evidence because the kind of trials that are being, you know, required to be done can only be done by organizations that have many millions of dollars to be able to carry out such large trials.
01:05:01.000 And so we're at that point.
01:05:03.000 We, of course, have a bias that comes with that cash flow.
01:05:07.000 And interests.
01:05:08.000 Not just by, but interests.
01:05:10.000 Right.
01:05:11.000 Let me ask one other question.
01:05:14.000 The, you know, we've had national policies that Instead of saying, we're going to do early treatment and we're going to consult with doctors all over the world and we're going to have communication systems where people, where doctors, medical people from every country in the world can report their results and we're going to try to figure out the best treatment, the Coronavirus Task Force and Anthony Fauci decided to focus on non-medical interventions.
01:05:43.000 In order to reduce the spread of COVID. In other words, masks, lockdowns, and social distancing.
01:05:52.000 And I don't know if you've looked at the science that they use, that they cited or used to support those interventions, but I'd love your opinion because we have looked at the science and it's not impressive.
01:06:07.000 Right.
01:06:08.000 Not impressive is a good way of putting it.
01:06:10.000 I'd say it's weak.
01:06:12.000 There are lots of studies of masking, for example, but masking, there's two different issues.
01:06:19.000 Masking can have a potential benefit for the wearer and it can also have a potential benefit in restricting spread of the illness to people in the environment.
01:06:28.000 Most of the studies that have looked at masking have measured, attempted to measure benefit for the wearer.
01:06:33.000 The reason for that is it's much easier to do because you do a trial of masking and then you interview the people that have been in the trial And you find out what's happened to them.
01:06:44.000 Whereas trying to find out the benefit of people in the environment from masking people, who are the people in the environment?
01:06:52.000 It's much more difficult to corral everybody who's been around people who've been masked and interview them.
01:06:57.000 So it's a lot harder study to do.
01:06:59.000 And so there's fewer of those studies.
01:07:00.000 The two main studies of that kind don't show very impressive results.
01:07:05.000 One was the Danish mask study and the other was the Marines barracks study.
01:07:11.000 And both of them don't, as far as I understand, don't show very strong evidence of reduction in spread of infection by mask wearing, compliant mask wearing in those populations.
01:07:24.000 The studies of benefit for the mask wearer also don't show a lot of benefit.
01:07:31.000 But, you know, I think that if one just steps back for a minute and thinks about what the masks do or the kind of masks That we have available to consumers.
01:07:42.000 We have to realize that masking doesn't force air to go through the mask.
01:07:50.000 Some of it will, but a large amount of it will go around the edges.
01:07:55.000 And so what that means is if you're talking face to face to someone who is infected, that you as a mask wearer are likely to be protected by Much of the air that comes out and goes straight towards you, at least for a little while, because you're breathing air that comes in from the sides, and that is less contaminated for a little while, indoors, say.
01:08:18.000 But after a while, all that mixes, and so you get it every way.
01:08:21.000 And the same thing is true if you're infected and you have a mask, it goes out the side.
01:08:26.000 So the person right in front of you isn't going to be exposed right away, but eventually, as the air mixes, then they'll get exposed eventually anyway.
01:08:34.000 So masks could be beneficial for a casual conversation, you know, 15 seconds or 30 seconds with somebody in the hall, but might not be effective for an hour conversation of somebody at your desk.
01:08:48.000 And certainly outdoors, where there's a lot more air motion, masks aren't providing any more benefit than the air motion itself.
01:08:56.000 And indoors, if there's good airflow, you know, six air changes per hour or whatever, you know, the Air conditioning, heating will do, then the masking may not add much to that over the air motion itself.
01:09:10.000 So you're really not in a circumstance where physically you can expect masks to do all that much, except for brief encounters indoors.
01:09:20.000 And that, I think, is my general understanding of what masking is doing.
01:09:26.000 And I say that not having measured particles coming out of masks and so on.
01:09:30.000 I'm not an expert in masking.
01:09:33.000 Dr.
01:09:33.000 Harvey Risch, thank you so much for being with us.
01:09:37.000 Thank you for your courage and your commitment to good science and public health.
01:09:43.000 Thanks very much.