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Transcript
When Is a Death After Vaccination “Unlikely”?
Well, Good Morning, CHD and I am really, really excited about today's guest. He's been an international hero of mine for such a long time. I followed his work. I've had the opportunity to collaborate with him before. This is Dr. Jacob Paliel. He is a pediatrician from India. Your qualifications are absolutely, absolutely amazing. You hold medical doctor's degree, MD in pediatrics, MRCP. And you went to, where did you go to school? You were in London, right? That's. Yeah, for the rc. Okay, okay. You also have master's in philosophy in hospital and health Systems management. You're currently a visiting professor at the International Institute of Health Management Research in Delhi, teaching research methods and critical appraisal of research. You were the head of the department of Pediatrics at St. St. Stephen's Hospital for. Oh, gosh, oh my goodness, it looks like 22 years, supervising 56 staff members, including 18 doctors. You've been in the thick of it. You're not, you're, you're not just a pointy headed epidemiologist like me that just sort of sits in an office all day. You've worked directly with children. So welcome to the show and thank you so much for giving up your evening in India for us.
Thank you, Brian. Thank you for calling me onto the show. And also I have to acknowledge the wonderful help you did with the rotavirus study that we did together and the statistical analysis that you helped with. Thank you very much. Oh, you're very, very welcome. Let's talk about adverse events following immunization. We call it AEFI and, and sids. You've worked a lot in this, in this particular realm. I know, you know, it's a difficult road. Nobody, nobody, especially in that sort of pro pharmacide, would ever, you know, talk about infant death and vaccination in the same same sentence. But tell us about your research in that area.
Well, that's an interesting problem because sudden infant death is when you, when a very healthy child is put to bed in the night and in the morning is found dead. Now, if there is a preceding history of having been given a vaccine a day or two before, then it's reasonable to kind of suspect that the vaccine may have caused the problem. But actually scientifically, it's nearly impossible to say that there was a causative relationship. What we have to then depend on is kind of a probability scoring, which the Brighton score does. So to be certain that it was the vaccine that caused the adverse event, say, for example, if you come to me with a fever and I Prescribe Tylenol or paracetamol to you and the next day you come out with a rash. You may well suspect that it is the paracetamol that caused the rash. But I may explain that you had come with a fever and that was the prodrome of xanthomas rash caused virus infection and therefore the paracetamol only reduced the fever, it didn't reduce the rash. So there is no relationship between the paracetamol and the rash that you have developed. Now, to be certain that it was the paracetamol that caused the rash, the only thing that we can do is various things that we could do. But one is to give you re challenge at a time when you're perfectly all right, give you the same paracetamol and if you come up with the same rash, then we are certain that it is related to the paracetamol. Otherwise it's only possible to say that the reaction is probable. Now you say it is probable if there is, you know, timely relationship between the drug that you have taken and there is no alternate explanation for the event that you have witnessed. If there is an alternate explanation, then it could be either the drug or it could be the alternate explanation. So you have to say that the relationship is possible, but you can't say it is probable. And if there is no timely relationship between the taking of the drug and there are alternate explanations, then you have to say that it is unlikely to be related.
So in that complex situation, now when the we used to have the triple antigen, the dtap, which you use, the DPT that we use, they added hepatitis B and H influenza B to it and made it into a pentavalent vaccine. Now when you add more and more antigens to the same vaccine, then the chances of there being adverse events is increased. When this was given in a small country called Bhutan in asia, there were 12 children who died suddenly after the vaccination. When this was given in Sri Lanka, there were five children who died in both these places. They withdrew the vaccine, but the WHO went and investigated. And in the investigation they reported that the vaccine was unlikely to have caused the reaction. They presented only the final summary that it is unlikely to have caused the reaction. But we had filed a case in the Delhi High Court for which they provided the full report. And when the full report was given, we saw that in the report it is said that the experts have deleted probable and possible from the classification. So because the child had died, there was no chance of re challenging the child. Right. So they concluded that it is unlikely to be related to the vaccine just because they had deleted possible and probable. Now, when this came to our attention, because it was given to the court, we got it published in the British Journal of Medicine. What did the WHO do? Well, they dug in again, they created another committee and in this committee they decided that in the future, for there to be, for one to say that there is a relationship between the vaccine and any reaction, there must be prior epidemiological studies which show that that reaction is possible. Now, when you have a vaccine, it's newly introduced, you do a small randomized control trial and if there are rare reactions, they don't show up there. The vaccine is licensed and after that there is the post marketing surveillance. Now, under the new scheme, if those reactions had not been recorded in that small trial that we did in the, the randomized control trial, all the reactions that happen in the surveillance, the post marketing surveillance, are classified as not an aefi, not adverse event following immunization. And thus you have actually made post marketing surveillance completely redundant. This has been published in the F1000 research. How they have developed this scheme, they eliminated classifications that could have implicated the vaccine in the Brighton criteria.
Talk a little bit more about what the Brighton criteria are and, and, and how they, you know, essentially they, to use American football term, they move the goalposts in order to essentially not find a relationship or, or suggest that there was no relationship. Yeah, so that's exactly what the Brighton was supposed to do. It only shows that there is a relationship which is likely. But they have removed those two classifications where it is even likely, and then come to the conclusion that it is unlikely. That is a problem with coming up with a single case of, say, sudden infant death. To be able to say whether there is a relationship. At best you can say there is possibly a relationship, but when you do an epidemiological study, then the proof is more certain. Now that's what we did with the pentavalent vaccine. When the pentavalent vaccine was introduced in India, it was introduced district by district and they were in the same areas, some of the children who were receiving the dpt, the triple antigen, and some who were receiving the new pentavalent vaccine. So when we went in to study this in that year, there were 45 million children who had received the DTP and 25 million children who received the pentavalent vaccine. So these are large samples going in millions right. Now we assumed, because we have no idea about what is the sudden infant death rate in India, we just assumed that DPT or the triple antigen does not cause any sudden infant death. And if there are any, there is any increase in deaths. With the giving of pentavalent vaccine, it is clear that pentavalen vaccine is the cause of that death. We found that the introduction of pentavalent vaccine in these 25 million children caused 4.7 deaths per 100,000 children each year. When we extrapolated this to the population, we realized that 7,000 to 8,000 children would die because of this vaccine. And these deaths are all within 72 hours of giving the vaccine. So there would be 7,000 to 8,000 extra deaths because of the introduction of this vaccine. Your baseline was your was your control vaccine. That that was not the pentavalent vaccine. You've got five different than types of antigens in that same vaccine. What are some of the other differences from giving like the DPT versus the pentavalent vaccine? Are there other components that are in excess there? I would assume that all the, the various agents that are used to dilute it, to increase the activity, the adjuvants, etc. May be there. So it's not very clear exact exactly what those differences are. But the fact that there are more antigens seems to indicate that there is more, there is more of a risk of sudden infant death. What's been the response to your, to this paper on the F in the F1000 Research Journal? The F1000 Research Journal talked about the change in the classification system. Yes. Making the. Whereas this was published in another journal. Then after this they introduced the injectable polio along with it and they called it the hexavac or the hexavalent vaccine. Now with the hexavalent vaccine, even right at the start, it was realized that there were increased numbers of deaths in children between 1 and 2 years of age. And so one of these vaccines had to be withdrawn. Subsequently, the European Medical Agency, which is like the FDA in the U.S. they insisted that the manufacturers, Glaxo, Smith and Klein, that they provide yearly PSUs or the periodic safety update reports in which they were to mention the number of vaccines given up to that time and the number of reports of deaths from sudden infant death in the first 20 days after vaccination. So this has been going on regularly over those years.
By the time of the 19th psurch, they provide a list of, you know, expected to observed deaths. Now expected deaths is what is the, the death rate from sudden infant death in Europe in that year? Okay. And if all those children have been vaccinated, say if it's 1 per thousand or 1 per 100,000, then if 100,000 children were vaccinated, you can expect one death. And so they provide a list of the number of deaths that were reported to them and the expected deaths for the number of vaccines that they have distributed in the 19th PSUR, because the deaths had accumulated and had gone beyond what was expected, they conveniently removed three of the deaths from the 16th PSUR. So the 16th PSUR is available there. They were deaths. By the time it comes to the 19th PSU, those deaths are deleted. The European medical agencies just seems to be filing these reports without looking at it, not providing enough of due diligence. So when we published this, they still didn't do anything about it, as far as we know. Okay, but that's really too bad. Did, how did they adjudicate? Did they justify removing the three deaths? Or, or was it, was it just something that they, they slipped them out? Well, they slipped them out and then they said that these children had meningitis, heart disease, etc. It must be remembered that these children were investigated and none of these problems were considered as the cause of death in the 16th report because each of these deaths are thoroughly investigated. But by the time the 19th report came and one we had published it, they said, oh, well, these children died because they had a heart disease or they had meningitis, all of which are very obvious conditions which could not have slipped the observation of the doctors who found these children dead. Yeah, right. Jacob, another area of research that you've done so much on is with the rotavirus vaccine. That is a vaccine that was added to the schedule in the United States in the early 2000s. And it was associated right off the bat with some very, very specific types of adverse event. It was one vers was removed from the market. It was replaced by a Merck version of the rotavirus vaccine. So tell us a little bit more about the work that you've done. I got to participate in this study, some of the work that you've done with the rotavirus shot and I think specifically into susception.
Yeah, that's a very interesting problem because when the vaccine was originally introduced, it was tested in about 14,000 children. They found three excess deaths in the randomized trial amongst those who were vaccinated, but it was not statistically significant. They went ahead and marketed it and in the post marketing surveillance, they found that for every 100,000 children, there were 10 deaths. So there were, there were 10 cases of interception. So there was one case of interception for every 10,000 children vaccinated. Now, how do you know whether, once you've marketed the vaccine, and there is no randomized controlled trial, nothing to look at against which you say that this is an increase in deaths, how would you say, how would you identify that it is the vaccine that's causing the deaths? They have a very clever statistical tool called the self controlled case, Self controlled case series, which is the sccs. So this is a very clever way of looking at whether the vaccine is the cause of this problem of intersusception, because intersusceptions can occur even in the absence of the vaccine. So interocerceptions for the audience is a condition where the mucosa, or the inner lining of the intestine swells up because of the vaccine. And because of the swelling, the intestine telescopes into itself and as a result, there is intestinal obstruction, there is necrosis of the intestine. The child passes blood and mucus and could well die unless a pediatric surgeon or an interventional radiologist acts immediately. So that is a fairly serious condition. Now, you must remember that rotavirus is a watery diarrhea. The treatment of rotavirus generally consists of giving a dilute solution of salt and sugar. So it is a mild disease. In three or two or three days, it gets better if you don't get dehydrated. Right. And in its place for prevention, you are giving a vaccine that has the potential of causing this gruesome form of death. In the developed countries, if they are picked up fast, there is likelihood that the problem would be solved and the child will not die. But in India and in Asia, if the public are not informed that this can cause blood and mucus to be passed in the stool, the public would consider that this is just another coincidental dysentery or infective diarrhea and not take the child to pediatric surgeon. In developing countries like India, there are no pediatric surgeons. In rural areas, you have to travel hundreds of miles before you can find one. And if you think that your child has only an infective diarrh, you're not likely to go looking for this pediatric surgeon. And usually by the time you reach him, it's too late. So it is important that the public are informed that the passage of blood and mucus in the stool is an indicator of possible interception and has to be treated immediately. We have developed a vaccine. The original vaccine cost 1 in 10,000 cases of interception and that vaccine was withdrawn. Subsequently, they found other strains of the vaccine and that caused about 1 in 50,000 cases. There were intersusceptions. So they licensed that vaccine in India. They developed a strain of the vaccine which they studied in 4,500 children with 2,000 children kept as controls. 4,500. Given the vaccine, approximately for a disease that happens 1 in 10,000. Studying 4,500 children is not likely to create any cases of interception. However, the vaccine trial in India had 10 times as many interceptions as the vaccine which was withdrawn. There was one per thousand extra cases of interception even in this small sample of 4,500. Further, they did the study in three centers and in one center the incidence was 20 times higher than that in Delhi. The center was well known. So the what they did was they took the average of all these and published it without giving the segregated data. But the evidence clearly shows that the children in that Tamil Nadu, that south Indian state of Tamil Nadu, the chance of interception is astronomical because it's 20 times higher than that in Delhi and the average in India is 10 times higher than the vaccine that was withdrawn. Anyway, they went ahead and licensed the vaccine and they said they would do good post marketing surveillance. Now how would you know whether the vaccine is causing a problem or not? They did this sccs, the self control case series, right? What you do there is if you have a case of interception, you ask that child when they had the vaccine. Now, if the vaccine is not the cause of the interception, and you have a large number of children with interception, you will find that the interceptions are not related to having taken the vaccine. So they will be. Some child will say that it has been a month since they've taken a vaccine. One will say it's two days since they've taken a vaccine. Another will say it's a year since they've taken a vaccine. It will be evenly distributed over the period of time, right? Whereas if you look at a place where there is a higher risk, high risk area of say the first three weeks after interception, if they are related to the vaccine, there will be an increase in the incidence of interception in that high risk period. So you compare the number of interceptions in that high risk period with other periods which you have studied over the year.
Now that is the basis of the self controlled case series. But there is a problem with studying rotavirus but using this statistical tool because interceptions naturally occur in the second six months of life. The vaccine is given at six weeks and 10 weeks and 12 weeks or in the first six months of life when there should be hardly any cases of interception. Now if you compare that period with the Period when naturally interceptions are high, they don't form a good control period. Because unless you have as many interceptions and more interceptions in that period, when you should have no interceptions in the first six months, then you will likely say that there is no relationship between the vaccine and interception because it is not more than the interceptions in the second six months. So they in this statistical tool have made provisions to prevent this problem. They compare the number of interceptions and look at the interceptions all the other children to find out what is the normal rate of interceptions at the age at which the child has been vaccinated. All the other children kind of form a control which says at what age how many interceptions occur. And for this type of analysis they bring in also children who are not been immunized. So you can know what is the normal rate of interception even when there is no vaccination. So they have made provision to prevent that problem which arises because there is a greater increase of interception in the next in the second six months of life. They have published a paper in the New England Journal of Medicine where they have looked at 587 cases of intercusception. 212 had not received the vaccine. 370 odd children had received the vaccine. And they did an analysis and said that there was no relationship that the number of interceptions in the high risk period three weeks after vaccination was no different from that in the control period. Now this was the paper which you helped us to analyze. We looked at it and said we just looked at the age at which interceptions occur in the children who are unvaccinated compared to the children who are vaccinated. We found that children who are vaccinated develop intersusception much earlier. Now this has been published by other people also. So now it is very clear that unvaccinated children do not form a good control group for these vaccinated children because they develop interceptions at a completely different age. So all we did was we removed children who were not vaccinated and did the same analysis. The case series, the SCCS study, just having removed the children who are unvaccinated. And we found that there was a clear relationship between vaccine and interceptions. Now this is very important because this analysis and the same method has been used by a large number of trials to show that the vaccine has not caused interception. Now that we have shown that that is a flawed method of analysis. All those studies need to be reanalyzed. Regulatory agency, say statistician or a scientist from the nih. The FDA needs to pull up all Those old papers and reanalyze the data having removed the children who were not vaccinated. Because this is crucial so that even internationally it is possible that there is more intersusceptions than has been reported. This Velo study, this Indian vaccine, is a problem. The data from Velo needs to be provided, which is segregated from the rest of the data, rather than an average of all the data. Three centers where it was done right. So that we can know whether the population in Tamil Nadu are particularly susceptible, which is. It seems to be about 20 times higher risk of interception than in other parts of India. So I would hope that some regulatory agencies would ask for these data from the Indian scientists and also call the data from all the other centers where these trials have been done and reanalyze the data and publish the data which is specific to Vellore also, so that we can know exactly what those risks are, so that parents from these places can be warned beforehand. At least they know what to look out for and they can come immediately that the child starts passing blood than mucus in the stool. Absolutely. Absolutely. And it's all about protecting children. Yeah. And you know, I'm so thankful that you are doing this work and, and that you're looking out for children in these different districts in India, in the rural health districts as well. Jacob, if you could comment on, you know, your, your thoughts on vaccine science and vaccine safety science from your unique place world. Being a pediatrician in India, seeing, you know, the disparity, the differences in socioeconomic status. Just give us, give us kind of your, your viewpoint.
Well, it is a fact that we have excellent scientists all over the world who are dedicated to science. That is why we have the data which was all collected for the pentavalent vaccine. The children who received the dpt, the children who received the pentavalent vaccine differently so that we could analyze it. We had scientists in the European Medical Agency, which insisted that the periodic safety update reports be provided year on year for about 19 years. And so in everything we find that there are good scientists. But unfortunately, if any of the data goes against the narrative that the pharmaceutical companies want, then that science is kind of suppressed. And that is very unfortunate. The reason it is unfortunate is that they seem to have control over all the regulatory agencies because they fund them. They have control over the World Health Organization because they fund them. And because of that, and even the medical journals, they are funded heavily by drug manufacturers. So for proper science to be published, I think these agencies need to become leaner and meaner. They need to cut off a lot of lab so that they don't need to be dependent on these pharmaceutical companies for the regulation that they are supposed to do off the pharma. And if we have that situation, then we have everything in place for proper science to flourish. But unfortunately, as long as we are dependent on Big Pharma for funding regulatory agencies and the World Health Organization, I don't think we will ever see and research which is very relevant to the population does not get published if it goes against the narrative that the pharma companies want. So that is, I think, the main situation. And once these things are shown up, I would hope the FDA or other agencies will investigate and try and get the data out. Well, thank you so much. I couldn't agree more. One of the things that my cry to the FDA, to the CDC, and I've been investigating the CDC since about 2001 is release the data, release the information. If vaccines are so safe and effective, then let independent scientists verify that rather than hide that. So, Jacob, I applaud you in your work in the environment that you're in that you've taken your talents as a pediatrician, as a specialist and done this. Thank you on behalf of the health freedom community for what you've done and your contributions to science. Well, I thank you for your help in part of this research and also for calling me on. Thank you. You're very welcome. And thank you everybody for joining us for this important episode of Doctors and Scientists. Look up Jacob Puliyel's Dr. Jacob Puliyel's work directly. We'll put links to his papers directly into the show notes so you can see his