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en:misc:talk-saine-novella [2013/04/15 08:06]
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en:misc:talk-saine-novella [2013/04/15 08:58]
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 //In a prospective,​ multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland,​ data from all patients (older than 1 year) consulting the physician for the first time were observed. Results: A total of 3,709 patients were studied, 73% contributed data to the 8-year follow-up. <wrap hi>​Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years. Physical and mental quality of life scores also increased considerably.</​wrap>​ Conclusion: <wrap hi>​Patients who seek homeopathic treatment are likely to improve significantly.</​wrap>​ These effects last for as long as 8 years.// //In a prospective,​ multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland,​ data from all patients (older than 1 year) consulting the physician for the first time were observed. Results: A total of 3,709 patients were studied, 73% contributed data to the 8-year follow-up. <wrap hi>​Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years. Physical and mental quality of life scores also increased considerably.</​wrap>​ Conclusion: <wrap hi>​Patients who seek homeopathic treatment are likely to improve significantly.</​wrap>​ These effects last for as long as 8 years.//
  
-Now, let’s look at the skeptics'​ claim that Randomized Controlled Trials (RCTs) have failed to reliably detect any effect above and beyond placebo effects. The first one, we will look at, is a 2011 study in which the outcome was __**life or death**__**:**+Now, let’s look at the skeptics'​ claim that Randomized Controlled Trials (RCTs) have failed to reliably detect any effect above and beyond placebo effects. The first one, we will look at, is a 2011 study in which the outcome was **life or death:**
  
 //​Background:​ Mortality in patients with severe sepsis remains high despite the development of several therapeutic strategies. The incidence of severe sepsis is between 70,000 to 300,000 patients in the United States each year. The aim of this randomized, double-blind,​ placebo-controlled trial was to evaluate whether homeopathy is able to influence long-term outcome in critically ill patients suffering from severe sepsis.// //​Background:​ Mortality in patients with severe sepsis remains high despite the development of several therapeutic strategies. The incidence of severe sepsis is between 70,000 to 300,000 patients in the United States each year. The aim of this randomized, double-blind,​ placebo-controlled trial was to evaluate whether homeopathy is able to influence long-term outcome in critically ill patients suffering from severe sepsis.//
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 Now the question he tried to answer -- “Is homeopathy clinically relevant?​” Dean reported://​“Homeopathy appears mostly as safe as reputed. Homeopathy does appear to be <wrap hi>​capable of influencing global outcome</​wrap>​ such as well-being and co-morbidity. Finally, economic benefits are noticeable.”//​ Now the question he tried to answer -- “Is homeopathy clinically relevant?​” Dean reported://​“Homeopathy appears mostly as safe as reputed. Homeopathy does appear to be <wrap hi>​capable of influencing global outcome</​wrap>​ such as well-being and co-morbidity. Finally, economic benefits are noticeable.”//​
  
-Now, let’s look at the most recent and most comprehensive review ever conducted on the effectiveness,​ safety, cost-effectiveness and real world outcome of homeopathy, which is referred to as **“**__**The Swiss Study**__**”** that was released in November 2011. It is reported -- //“This is a Health Technology Assessment (HTA) conducted over a period of seven years by scientists for the Swiss government. An HTA is an established scientific procedure, which in contrast with meta-analysis and systematic reviews examines not only the efficacy of homeopathy, but especially “its real-world effectiveness,​” its appropriateness,​ safety and economy.// //HTAs are therefore much wider in scope and politically more informative.//​ **For the evaluation of the effectiveness of homeopathy all available systematic reviews were examined.** All meta-analyses were prepared by the Institute for Social and Preventive Medicine of the University of Berne (where the Shang study actually came out in 2005), which is specialized on research on public health issues.+Now, let’s look at the most recent and most comprehensive review ever conducted on the effectiveness,​ safety, cost-effectiveness and real world outcome of homeopathy, which is referred to as **“The Swiss Study”** that was released in November 2011. It is reported -- //“This is a Health Technology Assessment (HTA) conducted over a period of seven years by scientists for the Swiss government. An HTA is an established scientific procedure, which in contrast with meta-analysis and systematic reviews examines not only the efficacy of homeopathy, but especially “its real-world effectiveness,​” its appropriateness,​ safety and economy.// //HTAs are therefore much wider in scope and politically more informative.//​ **For the evaluation of the effectiveness of homeopathy all available systematic reviews were examined.** All meta-analyses were prepared by the Institute for Social and Preventive Medicine of the University of Berne (where the Shang study actually came out in 2005), which is specialized on research on public health issues.
  
 //A total of 22 reviews were analyzed. The synopsis of study results found at least a <wrap hi>trend in favour of homeopathy in 20 of 22 reviews.</​wrap>//​ //A total of 22 reviews were analyzed. The synopsis of study results found at least a <wrap hi>trend in favour of homeopathy in 20 of 22 reviews.</​wrap>//​
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 Dr. Novella: Simply -- we don't find such evidence compelling, as I said, and there is nothing for me to examine -- these are historical cases, we have no idea about the validity of the data, how controlled it was, how selective it was, how randomized it was, were the disease entities even verified, did they know that they were treating people with cholera or with the flu? There is nothing for me to examine, this is the lowest grade possible evidence that I would not consider reliable at all and again I would reiterate that if 1/​10<​sup>​th</​sup>​ of the clinical effect that you're claiming from those epidemiological studies were true, it would be trivial to establish that in a well-designed clinical trial but when you look at the systematic reviews of homeopathic remedies in the flu, there is no effect, that tells me that data must be unreliable and if it's unreliable to that extent, I don't see why we should rely upon it at all. Dr. Novella: Simply -- we don't find such evidence compelling, as I said, and there is nothing for me to examine -- these are historical cases, we have no idea about the validity of the data, how controlled it was, how selective it was, how randomized it was, were the disease entities even verified, did they know that they were treating people with cholera or with the flu? There is nothing for me to examine, this is the lowest grade possible evidence that I would not consider reliable at all and again I would reiterate that if 1/​10<​sup>​th</​sup>​ of the clinical effect that you're claiming from those epidemiological studies were true, it would be trivial to establish that in a well-designed clinical trial but when you look at the systematic reviews of homeopathic remedies in the flu, there is no effect, that tells me that data must be unreliable and if it's unreliable to that extent, I don't see why we should rely upon it at all.
  
-Let me follow up with a research question -- I agree that the homeopathic community doesn’t invest enough in research. If Boiron, for example, invested the same percentage of their profit, which is billions of dollars, into homeopathic research there would be no shortage of funding for it. You have claimed that true homeopathy, the way it should be studied through individualized treatment, not cookie-cutter,​ therefore do you oppose over-the-counter homeopathic remedies which seem to violate the very principle you are using to excuse much of the negative clinical evidence and do you think that homeopathic community is abrogating their moral charge to do proper research in order to support for their own profession.+Let me follow up with a research question -- I agree that the homeopathic community doesn’t invest enough in research. If Boiron, for example, invested the same percentage of their profit, which is billions of dollars, into homeopathic research there would be no shortage of funding for it. You have claimed that true homeopathy, the way it should be studied through individualized treatment, not cookie-cutter,​ therefore do you oppose over-the-counter homeopathic remedies which seem to violate the very principle you are using to excuse much of the negative clinical evidence and do you think that homeopathic community is abrogating their moral charge to do proper research in order to support for their own profession?
  
-Dr. Saine: The use of combined remedies and complex remedies is not part of homeopathy, it's not considered homeopathy, so it's misrepresentation. So, if they say '​homeopathy',​ it's wrong, it should be called homeo-therapeutics. That was the rule, ut was done in 1930 to establish what was homeopathy versus all the other dry imitations. It's an imitation, but it's not homeopathy. Generally, homeopathy is based on a fundamental principle -- it has to have a proving -- these have no proving, it's not homeopathy, you need to have a proving. You need to take a case -- these are not used to take a case, so it's not homeopathy. And every chance I have, like now, to say, 'it should not be', I say it. I say it to the drug company, 'This is not homeopathy, you understand it, right? Change the name!'+Dr. Saine: The use of combined remedies and complex remedies is not part of homeopathy, it's not considered homeopathy, so it'​s ​misrepresentation. So, if they say '​homeopathy',​ it's wrong, it should be called homeo-therapeutics. That was the rule, it was done in 1930 to establish what was homeopathy versus all the other dry imitations. It's an imitation, but it's not homeopathy. Generally, homeopathy is based on a fundamental principle -- it has to have a proving -- these have no proving, it's not homeopathy, you need to have a proving. You need to take a case -- these are not used to take a case, so it's not homeopathy. And every chance I have, like now, to say, 'it should not be', I say it. I say it to the drug company, 'This is not homeopathy, you understand it, right? Change the name!'
  
-Another question: you wrote that systematic review shows negative results... you understand that homeopathic ​is individualized treatment, correct? Why do you quote systematic reviews when most of the studies in the systematic reviews are not related to homeopathy -- like the Shang study for instance; there were eight studies that were kept at the end, only one was individualized homeopathy, seven were not! So how can anybody call that kind of study or the study of Ernst or Cochrane? Most of the Cochrane collaboration studies were for labor, there was ADHD... none are pure homeopathy, there'​s none! There are some here and there... some studies but in terms of reviews there are none. Why do you keep referring to those?+Another question: you wrote that systematic review shows negative results... you understand that homeopathy ​is an individualized treatment, correct? Why do you quote systematic reviews when most of the studies in the systematic reviews are not related to homeopathy -- like the Shang study for instance; there were eight studies that were kept at the end, only one was individualized homeopathy, seven were not! So how can anybody call that kind of study or the study of Ernst or Cochrane? Most of the Cochrane collaboration studies were for labor, there was ADHD... none are pure homeopathy, there'​s none! There are some here and there... some studies but in terms of reviews there are none. Why do you keep referring to those?
  
 Dr. Novella: Well, I understand the distinction you're making between individualized homeopathic treatment and homeopathic remedies but that distinction,​ first of all, is not generally understood or made in the public and homeopathic remedies are produced, sold, regulated by the government as homeopathy. For example, you cannot put the word '​homeopathy'​ on Oscillococcinum and sell it in the pharmacy over-the-counter for flu! So therefore looking at the studies of that for the flu is absolutely relevant. Dr. Novella: Well, I understand the distinction you're making between individualized homeopathic treatment and homeopathic remedies but that distinction,​ first of all, is not generally understood or made in the public and homeopathic remedies are produced, sold, regulated by the government as homeopathy. For example, you cannot put the word '​homeopathy'​ on Oscillococcinum and sell it in the pharmacy over-the-counter for flu! So therefore looking at the studies of that for the flu is absolutely relevant.
  
-I agree that minority of the clinical studies ​are done are designed to be individualized but even when you just pull out those studies and look at them, they still do not rise to the level of replicateable ​effects that we would say, yes, this is a treatment effect that's real! And the same exact phenomenon exists for multiple other types of treatments that we look at, like acupuncture,​ for example, is another one, where the proponents say, 'well, you got to do in the right way', the cookie-cutter stuff that trials do is not appropriate but when they do that, it still doesn'​t show an effect. The burden is on homeopaths, if that is your point then you need to do the studies that show there is a consistent replicable significant effect and it hasn't been done and given an extreme implausibility no scientist should be compelled to accept it’s real.+I agree that minority of the clinical studies are designed to be individualized but even when you just pull out those studies and look at them, they still do not rise to the level of replicable ​effects that we would say, yes, this is a treatment effect that's real! And the same exact phenomenon exists for multiple other types of treatments that we look at, like acupuncture,​ for example, is another one, where the proponents say, 'well, you got to do in the right way', the cookie-cutter stuff that trials do is not appropriate but when they do that, it still doesn'​t show an effect. The burden is on homeopaths, if that is your point then you need to do the studies that show there is a consistent replicable significant effect and it hasn't been done and given an extreme implausibility no scientist should be compelled to accept it’s real.
  
-You mentioned the studies looking at diarrhea and those are studies we have dealt into there is a few different studies and they did a very interesting thing especially the Mexican studyThey looked at the outcome at multiple endpoints like 1 week, 2 week, 3 weeks etc. and the results were statistically significant only at one of those time points but not at all the other time points. That’s the way of cherry picking the data and they didn't correct for multiple comparisons,​ right?So you are supposed to do a statistical fix when you do multiple comparisons and those were the ones we knew about and those were the ones who told us in the papers that they didSo again, as a scientist I look at that paper, I go 'this is crap' and this is not a study I will rely upon the results for. They made a basic statistical shell game by picking one time point on the timeline which by random fluctuation happened to peak over statistical significance. This is what I consistently find... when we look in details of the studies, they are fatally flawed, so I keep wondering why do you cite studies that have fatal flaws? And let me ask you a question -- were all those studies individualized treatment? Do you ever cite non-individualized treatment when they are positive or would you dismiss those even when they'​re positive or appear to be?+You mentioned the studies looking at diarrhea and those are studies we have dealt into. There is a few different studies and they did a very interesting thing especially the Mexican studyThey looked at the outcome at multiple endpoints like 1 week, 2 week, 3 weeks etc. and the results were statistically significant only at one of those time points but not at all the other time points. That’s the way of cherry picking the data and they didn't correct for multiple comparisons,​ right? So you are supposed to do a statistical fix when you do multiple comparisons and those were the ones we knew about and those were the ones who told us in the papers that they didSo again, as a scientist I look at that paper, I go 'this is crap' and this is not a study I will rely upon the results for. They made a basic statistical shell game by picking one time point on the timeline which by random fluctuation happened to peak over statistical significance. This is what I consistently find... when we look in details of the studies, they are fatally flawed, so I keep wondering why do you cite studies that have fatal flaws? And let me ask you a question -- were all those studies individualized treatment? Do you ever cite non-individualized treatment when they are positive or would you dismiss those even when they'​re positive or appear to be?
  
-Dr. Saine: If it's not genuine homeopathy I would say they use UMPs . It's not homeopathic,​ it's something else. They use ultra dilution, like Riley study with pollen -- it's not homeopathic,​ even though the title in the Lancet... the editor of the Lancet should refuse the article, this is not homeopathy, but they don't understand it, the editors, so they accept it and people think pollen is homeopathic -- it is not homeopathy.+Dr. Saine: If it's not genuine homeopathy I would say they use UMPs. It's not homeopathic,​ it's something else. They use ultra dilution, like Riley study with pollen -- it's not homeopathic,​ even though the title in the Lancet... the editor of the Lancet should refuse the article, this is not homeopathy, but they don't understand it, the editors, so they accept it and people think pollen is homeopathic -- it is not homeopathy.
  
 Dr. Novella: You accept our criticisms of the flaws of the study? Dr. Novella: You accept our criticisms of the flaws of the study?
  
-Dr. Saine: Oh, absolutely! Any criticism is very valid because it's important in the analysis of a study to be very very critical and I appreciate all your capacity to criticize the Jacobs studies or any study that will be produced. The idea would be, let’s reproduce it again but with better methodology,​ that's the next step! Not to necessarily to reject -- let's say ok, there might be some some problems with the methodology,​ let’s try again!+Dr. Saine: Oh, absolutely! Any criticism is very valid because it's important in the analysis of a study to be very very critical and I appreciate all your capacity to criticize the Jacobs studies or any study that will be produced. The idea would be, let’s reproduce it again but with better methodology,​ that's the next step! Not to necessarily to reject -- let's say ok, there might be some problems with the methodology,​ let’s try again!
  
-I know you are a very famous clinical neurologist,​ at Yale, and you are familiar with Parkinson'​s disease patients and placebo effect. I know you have read extensively on the placebo effect, and I agree with them it's not significant. But in your opinion, should a patient with Parkinson'​s disease -- well diagnosed -- improve objectively,​ substantially and for many continuous years from taking a placebo -- homeopathic remedy -- and if they would improve, how significant would that be, Single ​case? And would you be willing to examine them, to check their file, up to the time they were treated with homeopathy ​abd through the 2-4-5-6 years of follow-up?+I know you are a very famous clinical neurologist,​ at Yale, and you are familiar with Parkinson'​s disease patients and placebo effect. I know you have read extensively on the placebo effect, and I agree with them it's not significant. But in your opinion, should a patient with Parkinson'​s disease -- well diagnosed -- improve objectively,​ substantially and for many continuous years from taking a placebo -- homeopathic remedy -- and if they would improve, how significant would that be -- single ​case? And would you be willing to examine them, to check their file, up to the time they were treated with homeopathy ​and through the 2-4-5-6 years of follow-up?
  
-Dr. Novella: Single cases are very problematic because they are uncontrolled. Parkinson'​s disease is actually not a one ... technically,​ it should be one pathophysiological entity but there'​s a lot of things that can produce a case that looks like Parkinson'​s disease but isn'tIts pathophysiology is different! So we would have to know what does the patient actually have and also there'​s lots of variables that affect clinically how Parkinson'​s patients look. Their diet can affect the transport of dopamine into their brain; it could have a huge effect; lots of things about their medications for example. So that's a disease where there is a huge placebo effect -- that's been established actually -- because the brain, first of all, is an organ that interacts with the outside world just with your beliefs, your emotions and one of things that the brain does in response to emotions is secrete dopamine -- which can have an effect on Parkinson’s disease. I don't think we can draw any conclusions from any single case with Parkinson'​s disease because there are so many variables that would be difficult to control. You would need to do really rigorous, carefully blinded studies, before you could say there are some effects other than all the other potential sources of noise.+Dr. Novella: Single cases are very problematic because they are uncontrolled. Parkinson'​s disease is actually not a one ... technically,​ it should be one pathophysiological entity but there'​s a lot of things that can produce a case that looks like Parkinson'​s disease but isn'tIts pathophysiology is different! So we would have to know what does the patient actually have and also there'​s lots of variables that affect clinically how Parkinson'​s patients look. Their diet can affect the transport of dopamine into their brain; it could have a huge effect; lots of things about their medicationsfor example. So that's a disease where there is a huge placebo effect -- that's been established actually -- because the brain, first of all, is an organ that interacts with the outside world just with your beliefs, your emotions and one of things that the brain does in response to emotions is secrete dopamine -- which can have an effect on Parkinson’s disease. I don't think we can draw any conclusions from any single case with Parkinson'​s disease because there are so many variables that would be difficult to control. You would need to do really rigorous, carefully blinded studies, before you could say there are some effects other than all the other potential sources of noise.
  
 Presenter: Thank you, this will be our last question, Dr. Novella. Presenter: Thank you, this will be our last question, Dr. Novella.
  
-Dr. Novella: After this exchange, would you at least acknowledge that you have a little bit of a deeper understanding of why we still remain skeptical about homeopathy ​(laughter) ​and what is your feeling about what I said about the threshold of evidence that I would find compelling and do you really think that we have met that kind of threshold of evidence?+Dr. Novella: After this exchange, would you at least acknowledge that you have a little bit of a deeper understanding of why we still remain skeptical about homeopathy and what is your feeling about what I said about the threshold of evidence that I would find compelling and do you really think that we have met that kind of threshold of evidence?
  
-Dr. Saine: I support good science. Like yourself I despise bad science, bad analysis and the RCTs done published in literature is mostly crap, especially when it sponsored by the pharmaceutical company because they have ghost writers, it's just a complete corrupt system there.+Dr. Saine: I support good science. Like yourself I despise bad science, bad analysis and the RCTs donepublished in the literature is mostly crap, especially when it'​s ​sponsored by the pharmaceutical company because they have ghost writers, it's just a complete corrupt system there.
  
 Dr. Novella: What are your thoughts now about my level of skepticism? Dr. Novella: What are your thoughts now about my level of skepticism?
  
-Dr Saine: I appreciate very skeptic mind. However, here I present evidence on basic science, //in vitro//, plants overviews, animals, observational studies, genealogical evidence, RCTs, HTAs all in favor of homeopathy it seems that the overall signals say homeopathy is effective, let's try it more! You have nothing to lose! If you're in a critical stage in sepsis in hospital or your wife or your child, forbid it does happen, was in a critical state of Sepsis, we don't know, if this is an antibiotic resistant microbes, would you say no to receive homeopathy when we know there is a possibility?​+Dr Saine: I appreciate very skeptic mind. However, here I present evidence on basic science, //in vitro//, plants overviews, animals, observational studies, genealogical evidence, RCTs, HTAs all in favor of homeopathy ​-- it seems that the overall signals say homeopathy is effective, let's try it more! You have nothing to lose! If you're in a critical stage in sepsis in hospital or your wife or your child, forbid it does happen, was in a critical state of sepsis, we don't know, if this is an antibiotic resistant microbes, would you say 'no' ​to receive homeopathy when we know there is a possibility?​
  
 Presenter: Thank you very much both of you, for that lively discussion. Presenter: Thank you very much both of you, for that lively discussion.
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 ===== Questions from the audience ===== ===== Questions from the audience =====
  
-I apologize, I required format clarification. ​And second, I would like to say thank you all of you who submitted questions and I think it's probably unlikely that we're going to get to all of them but we will try. Some of them were addressed in this recent discourse and those I have, sort of, put aside. What I would like to do is kind of take a break and ask one of the questions that's kind of different... then I would like each of you to take a minute to respond to this particular question because it has to do with an opinion -- “Is it possible that homeopathy has not been sufficiently studied double-blind because there would be not great financial rewards for pharmaceutical companies and investors?​” This is a practical question!+Presenter: ​And second, I would like to say thank you all of you who submitted questions and I think it's probably unlikely that we're going to get to all of them but we will try. Some of them were addressed in this recent discourse and those I have, sort of, put aside. What I would like to do is kind of take a break and ask one of the questions that's kind of different... then I would like each of you to take a minute to respond to this particular question because it has to do with an opinion -- “Is it possible that homeopathy has not been sufficiently studied double-blind because there would be no great financial rewards for pharmaceutical companies and investors?​” This is a practical question!
  
-Dr. Saine: I can answer that. David Riley from Scotland went into homeopathy to disprove homeopathy and he came that it was better than placebo. And he says this -- “There is a very major implication here that '//​either the RCT model doesn'​t work, there is something wrong with it or homeopathy works!'​”//​ in either case it's a very big trouble for modern medicine -- because if homeopathy works it's basically the end of modern medicine to some degree. We're talking about a curative system versus a palliative system. It would be a very big problem for modern medicine, drug companies have major investment. If we treat a patient with migraine for instance, how much it is a drug for migraine per year? You would know better! (Laughing) a 100, a 1000, a 2000, a 5000, it’s a lot of money for drug companies they are losing every year!+Dr. Saine: I can answer that. David Riley from Scotland went into homeopathy to disprove homeopathy and he came that it was better than placebo. And he says this -- “There is a very major implication here that '//​either the RCT model doesn'​t work, there is something wrong with it or homeopathy works!'​”//​ in either case it's a very big trouble for modern medicine -- because if homeopathy works it's basically the end of modern medicine to some degree. We're talking about a curative system versus a palliative system. It would be a very big problem for modern medicine, drug companies have major investment. If we treat a patient with migraine for instance, how much is it -- a drug for migraineper year? You would know better! (Laughing) a 100, a 1000, a 2000, a 5000, it’s a lot of money for drug companies they are losing every year!
  
-Presenter: So, let me clarify, your answer to the question would be yes? (Laughing)+Presenter: So, let me clarify, your answer to the question would be 'yes'? (Laughing)
  
 Dr. Saine: Yes to the truth! Dr. Saine: Yes to the truth!
  
-Dr. Novella: Well, Boiron is a pharmaceutical company, they are making hundreds of millions, billions of dollars selling homeopathic medicines. They have the same exact incentives as any pharmaceutical company producing drugs, so the same would apply to them. Also I completely disagree, first of all, that there is a palliative versus curative system. Mainstream medicine attempts to identify and treat and cure the actual cause of disease whenever possible, so that is a false dichotomy. And I don’t think that it would be the end of medicine; if it worked, we would be doing it, we would just incorporate it and own itIt would be part of mainstream medicine; pharmaceutical companies make homeopathic remedies just like they make supplements. They will put anything on the market that is going to make them money. So I think that is a false premise in the question. I think the answer ​is what will improve research? What will lead to more research? ​Is when you change the regulation so that research is required to go to market. The only reason why pharmaceutical companies spend billions of dollars on research is because they have to! If the homeopathic producers had to do research to get on the market they would do it too.+Dr. Novella: Well, Boiron is a pharmaceutical company, they are making hundreds of millions, billions of dollars selling homeopathic medicines. They have the same exact incentives as any pharmaceutical company producing drugs, so the same would apply to them. Also I completely disagree, first of all, that there is a palliative versus curative system. Mainstream medicine attempts to identify and treat and cure the actual cause of disease whenever possible, so that is a false dichotomy. And I don’t think that it would be the end of medicine; if it worked, we would be doing it, we would just incorporate it and own itIt would be part of mainstream medicine; pharmaceutical companies make homeopathic remedies just like they make supplements. They will put anything on the market that is going to make them money. So I think that is a false premise in the question. I think the question ​is 'what will improve research'? What will lead to more research? ​It'​s ​when you change the regulation so that research is required to go to market. The only reason why pharmaceutical companies spend billions of dollars on research is because they have to! If the homeopathic producers had to do research to get on the market they would do it too.
  
 Presenter: So based on your answers I'm going to stay along this particular ring. On a topic of today'​s medicines, do approved ones go through clinical trials? Do they meet the scientific standards you describe, Dr. Novella? Presenter: So based on your answers I'm going to stay along this particular ring. On a topic of today'​s medicines, do approved ones go through clinical trials? Do they meet the scientific standards you describe, Dr. Novella?
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 Presenter: So who specifically are you working with? Presenter: So who specifically are you working with?
  
-Dr. Novella: This is the science-based ​medicine; this is my group of people who try to educate the public.+Dr. Novella: This is the Science-based ​Medicine (http://​www.sciencebasedmedicine.org/​); this is my group of people who try to educate the public.
  
 Presenter: So you're lobbing specifically to FDA or.. Presenter: So you're lobbing specifically to FDA or..
  
-Dr. Novella: We are not a lobbying group or an academic group but we have started up a group which is technically not a lobbying group we do get involved. We have written to educate the public about the problems of pharmaceutical companies hiding data and we have openly advocated, for example, clinical trial registries. So pharmaceutical ​compant ​has to register a clinical trial and that data is owned by the public. They can't say 'we own this data' and if it's negative we are going to sweep it under the rugsthey can't do that anymore.+Dr. Novella: We are not a lobbying group or an academic group but we have started up a group which is technically not a lobbying group, [but] we do get involved. We have written to educate the public about the problems of pharmaceutical companies hiding data and we have openly advocated, for example, clinical trial registries. So pharmaceutical ​company ​has to register a clinical trial and that data is owned by the public. They can't say 'we own this data' and if it's negative we are going to sweep it under the rugs -- they can't do that anymore.
  
 Presenter: Thank you. Presenter: Thank you.
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 Dr. Novella: Well, that's what we advocate that they should not. There is a www.clinicaltrials.gov where you can register all clinical trials and we want to make that mandatory. Dr. Novella: Well, that's what we advocate that they should not. There is a www.clinicaltrials.gov where you can register all clinical trials and we want to make that mandatory.
  
-Presenter: ​I agree! It should be mandatory! I use that as a resource all the time.+Presenter: ​This question is about water memory -- to give Dr. Saine an opportunity here. The question is and this is interesting ​as a scientist -- “How do you erase water memory that exists before preparing your homeopathic remedy?”
  
-This question is about water memory -- to give DrSaine an opportunity hereThe question ​is and this is interesting as scientist ​-- “How do you erase water memory ​that exists before preparing your homeopathic remedy?”+Dr. Saine: The concept of water memory ​didn't start with Benveniste. It started, actually, with Hahnemann. He didn't use the word '​memory'​ but in 1930 the French researchers used the word '​memory'​ and it's being used since that time, but it means that something from the original substance creates an impression, is impregnated in the solvent ​-- the water or it could be lactose or alcohol or a mixture and so onSo, there is something that is transmittedWe know the phenomena of epitaxy. Epitaxy ​is a phenomena in the materials science, where you have information that is transmitted from a solid to a liquid without exchange of material. That phenomena is very well known and used in semiconductors. So there is a phenomena there. Why we don't have all memory of water from the river -- because we use pure distilled ​water, the highest level of water to start with, it's very simple. And the remedies -- we know by our experiments ​that the chemical properties augment with time, but they can be destroyed too; if you expose them to certain electromagnetic fields, they are destroyed, this is well-documented.
  
-Dr. SaineThe concept of water memory didn't start with BenvenisteIt started actually with Hahnemann. He didn't use the word '​memory'​ but in 1930 the French researchers used the word '​memory'​ and its being used since that time, but it means that something from the original substance creates an impression, is impregnated in the solvent -- the water or it could be lactose or alcohol or a mixture and so on. So, there is something that is transmitted. We know the phenomena ​of epitaxy. Epitaxy is a phenomena in the materials science, where you have information ​that is transmitted from a solid to a liquid without exchange of material. That phenomena is very well known and used in semiconductors. So there is a phenomena there. Why we don't have all memory of water from the river, because we use pure distilled water, the highest level of water to start with, it's very simple. And the remedies -- we know by our experiments that the chemical properties augment with time, but they can be destroyed too; if you expose them to certain electromagnetic fields, they are destroyed, this is well-documented.+PresenterThank youWhat types of studies do you think can be conducted by practicing homeopaths today that would add to research to support ​the validity ​of homeopathy?
  
-PresenterThank you! What types of studies do you think can be conducted by practicing ​homeopaths ​today that would add to research ​to support the validity ​of homeopathy?+Dr. Sainethink we need to just design trials that are conducted by genuine ​homeopaths ​and pure scientists, people like Dr. Novella -- he is a very good scientist. So you use people who have good idea of science and people who have good idea of homeopathy and combine those two and you design very very high quality methodological trials. One we talked about in 2007 will be rabies. I was in Grenada in 2008 and there is an American university -- Saint George University in Grenada and there is rabies on the island and the American Medical Veterinary School there gets about 5000 cases of rabies in the pets from the island. What [do] they do? They destroy them! We could design a very good quality double-blind study -- will be life or death -- either they die or they don't die with homeopathy. Actually there was a researcher in Algeria, in the 1940s, before the war, French researcher, ​that did experimental rabies and treated them with homeopathy with great success. I don't like that study because then you damage animals but [in the] other one, you save the animals. Another good study would be very easy -- sepsis, double-blind or pneumonia... there are so many people with pneumonia, especially antibiotic resistant pneumonia, easy for homeopathy ​to do a double-blind randomized controlled trial, so easy, not expensive -- you save lives, lots of lives!
  
-Dr. SaineI think we need to just design trials ​that are conducted ​by genuine homeopaths and pure scientistpeople like Dr. Novella, ​he is a very good scientist. So you use people who have good idea of science and people who have good idea of homeopathy and combine those two and you design very very high quality methodological trials. One we talked about in 2007 will be rabies. I was in Grenada in 2008 and there is an American university ​-- Saint George University in Grenada and there is rabies on the island and the American Medical Veterinary School there gets about 5000 cases of rabies in the pets from the island. What they do? They destroy them! We could design a very good quality double-blind study -- will be life or death -- either they die or they don't die with homeopathy. Actually there is a researcher in Algeria in the 1940s before the war, French researcher, that did experimental rabies and treated ​them with homeopathy with great success. I don't like that study because than you damage ​animals ​but other one you save the animals. Another good study would be very easy -- sepsis, double-blind or pneumonia... there are so many people with pneumonia, especially antibiotic resistant pneumonia, easy for homeopathy to do a double-blind randomized controlled trial, so easy, not expensive -- you save liveslots of lives!+PresenterThere'​s a couple of other questions on the pneumonia trial that was supported ​by other members of the audiencethen that could be a good way. Dr. Novella, ​this one is interesting to me -- “Why ​do homeopathically ​treated animals ​improve since animals are not influenced by placebo effectsince they don't think about their treatment?​”
  
-PresenterThere's a couple of other questions on the pneumonia trial that was supported by other members ​of the audiencethen that could be a good wayDr. Novellathis one is interesting ​to me -- Why do homeopathically treated animals improve since animals ​are not influenced by placebo effect, since they don'​t ​think about their treatment?+Dr. NovellaThat's a false premise to that question -- that animals are not subject to placebo effect. Most placebo effects have nothing to do with the person being treated knowing ​that they'​re being treated or having expectation. Expectation and knowing that you're being treated is part of itbut it's not the only source of placebo effectsThere are statistical effects like regression to the meanlike when you choose to treat people or animals, there is probably ​one part of their disease that is likely ​to get better just by the normal course of the illness and also there are people treating these animals and evaluating them to decide who's getting better and who'​s ​not getting better, so placebo effect ​is in full play with animals and babies -- that's the other population that's brought up. Only there'​s a few pieces that are missing because ​they don'​t ​know that they are being treated but you still get 80 to 90% of the placebo effect from studying them and they still need to be properly double blinded; that’s why studies are double-blinded. The person doing the study and evaluating the outcome, they all need to be blinded as well.
  
-DrNovella: That'​s ​false premise to that question ​that animals are not subject to placebo effectMost placebo effects have nothing ​to do with the person being treated knowing that they'​re being treated or having expectation. Expectation and knowing that you're being treated is part of itbut it's not the only source of placebo effectsThere are statistical effects like regression to the mean, like when you choose to treat people ​or animals, there is probably one part of their disease ​that is likely to get better just by the normal course of the illness and also there are people treating these animals and evaluating them to decide who's getting better and who's not getting better so placebo effect is in full play with animals and babies, that's the other population that's brought upOnly there'​s a few pieces that are missing because they don't know that they are being treated but you still get 80 to 90% of the placebo effect from studying them and they still need to be properly double blinded, ​that’s why studies are double-blinded. The person doing the study and evaluating the outcome, they all need to be blinded as well.+Presenter: Thank youThis is a question ​from an attorney who specializes in medical malpracticePerhaps you could make a statement in response ​to the statement -- “25 years of practice, sued many doctorshospitals and drug manufacturersHe has never sued a homeopathic physician ​or homeopathic manufacturer. I submit ​that western medicine ​is the real pseudoscience.” Do you wanna respond ​to that?
  
-PresenterThank you! This is a question ​from an attorney who specializes ​in medical malpracticePerhaps ​you could make a statement ​in response to the statement -- “25 years of practice sued many doctors, hospitals ​and drug manufacturers. He has never sued homeopathic physician or homeopathic manufacturer. I submit ​that western medicine ​is the real pseudoscienceDo you wanna respond to that?+Dr. SaineI did a debate last November at McGill University with Dr. Joe Schwarcz, whom you know and we had to answer questions from the public afterwards and one of the questions from the public was //“if homeopathy ​is true like you said in the debate, what are the implications for an individual and what are the implications for the society?​”//​ I thought it was very benign ​question ​so I started to answer the question and I say, listen, this has to be viewed ​in global perspective of the origin of homeopathy and allopathySo when you hit the context of modern medicine right now, like he says, it's the corruption ​in the research, the iatrogenic diseases, I did not even think about some aspects... For instance, in 1955 there was an introduction of psychotropic drugs and each ten years there was a new generation ​of psychotropic drugs that were introduced ​and since 1955 in United States, the rate of people with Chronic Mental Diseases ​has augmented by 8 times! 800 percent more Americans that are chronically mentally ill! How? So now with molecular biology they are understanding that when you use an agent that blocks ​receptor, what happens to the cell, a neuron ​that is blocked? The receptor increases in size! What happens when the receptor increases in size? It becomes pathological,​ it creates a long-term pathology and anything can go in the cell now that was protected before by a small receptorNow you have a chronic pathology ​that is perhaps irreversible!
  
-Dr. SaineI did a debate last November at McGill University with Dr. Joe Schwarcz,​whom you know and we had to answer questions from the public afterward sand one of the questions from the public ​was //“if homeopathy ​is true like you said in the debate ​what are the implications ​for an individual ​and what are the implications ​for the society?”// thought it was a very benign question so I started to answer the question and I saylistenthis has to be viewed in global perspective of the origin ​of homeopathy ​and allopathySo when you hit the context of modern ​medicine ​right now, like he says, it's the corruption in the research, the iatrogenic diseases, I did not even think about some aspects... For instancein 1955 there was introduction of psychotropic drugs and each ten years there was a new generation of psychotropic drugs that were introduced and since 1955 in United States, ​the rate of people with Chronic Mental Diseases has augmented by 8 times! 800 percent more Americans ​that are chronically mentally ill! HowSo now with molecular biology they are understanding ​that when you use an agent that blocks a receptor, what happens to the cell, a neuron ​that is blocked? The receptor increases in size! What happens when the receptor increases in size? It becomes pathological,​ it creates ​long-term pathology and anything can go in the cell now that was protected before by a small receptorNow you have a chronic pathology that is perhaps irreversible!+Dr. NovellaIt's hard to response ​to one person’s anecdotal experience about their own practice. Give me a public ​scientific study that I can examine for details. There is a standard of care in medicine but I don't know what the standard of care is in homeopathy. And in order to sue someone ​for malpractice you have to demonstrate that that they did something which was substantially ​and demonstrably below the standards of care. What would that be for a homeopath? I am not sure. So there are probably culturalsocietal or regulatoryperceptual differences that would lead to more lawsuits. Again, medicine is hard, doing good medicine is very difficult. We are pushing ​the limits ​of what we can understand ​and what we can handleI think that '​Western ​medicine' ​is another false dichotomyscience-based medicine is at least trying to do the best we can with the best evidence we haveIt’s self-correctiveit's examining everything ​that we do. We know about receptors getting larger from chronic treatment because we are asking questions like -- What is the real effect ​of treatments ​that we are givingBecause we want to know and yes it's really complicated but still the evidence is clear that when you practice science-based medicine within ​the standard of careyou have good outcomes, at least chance of better outcome. And the fact that our life expectancy has dramatically increased to about 40 to 80 over the course of hundred years of science-based medicine is pretty decent evidence for that.
  
-Dr. NovellaIt's hard to response to one person’s anecdotal experience about their own practice. Give me a public scientific study that I can examine for details. There is a standard of care in medicine but I don't know what is the standard of care is in homeopathy. And in order to sue someone for malpractice you have to demonstrate that that they did something which was substantially and demonstrably below the standards of care. What would that be for a homeopath? I am not sure. So there are probably culturalsocietal ​or regulatory, perceptual differences that would lead to more lawsuitsAgain medicine ​is hard, doing good medicine is very difficultWe are pushing ​the limits of what we can understand and what we can handle. I think that '​Western medicine' ​is another false dichotomy, science-based medicine is at least trying ​to do the best we can with the best evidence we haveIt’s self-corrective,​ its examining everything that we do, we know about receptors getting larger from chronic treatment because ​we are asking questions like -- What is the real effect ​of treatments that we are giving? Because we want to know and yes it's really complicated but still the evidence is clear that when you practice science-based medicine within the standard of care, you have good outcomes, at least a chance of better outcome. And the fact that our life expectancy has dramatically increased to about 40 to 80 over the course of a hundred years of science-based medicine is pretty decent evidence for that.+PresenterThank you! We have time for one last question; this is relevant ​to our medical school. So, it's interesting,​ the question ​or the statement is and we would like both of you to comment on this//“Uconn requires medical students to take classes and hands-on seminars in camp which is complementary and alternative ​medicine. I feel this is as silly as requiring PhD astrophysicist to study astrology because many people in the US believe in astrologyDo the two analysts believe ​that the UConn requirement ​is -- A. Progressive or B. A regression ​to medieval times.”// Keep in mind we are here at the University ​of Connecticut and medical students ​are going to take that this to heart, so please use your care.
  
-Presenter: Thank you! We have time for one last question this is relevant to our medical school. So, it's interesting,​ the question or the statement is and we would like both of you to comment on this. //“Uconn requires medical students to take classes and hands-on seminars in camp which is complementary and alternative medicine. I feel this is as silly as requiring PhD astrophysicist to study astrology because many people in the US believe in astrology. Do the two analysts believe that the UConn requirement is -- A. Progressive or B. A regression to medieval times.”// Keep in mind we are here at the University of Connecticut and medical students are going to take that this to heart so please use your care. +Dr. Saine: Let's put it this way -- it's not progressing forward. In countries like Brazil where homeopathy is offered in university at medical schools, 85% of medical students say that homeopathy should be **mandatory** because they'​re exposed ​[to it], they see it and every medical student should be taught homeopathy ​-- not an introduction,​ pure homeopathy to every student -- because they'​re exposed to it. So the future will answer that question ​-- whether ​UConn was progressive backward or forward. I am predicting it was way ahead of its time!
- +
-Dr. Saine: Let's put it this way -- it's not progressing forward. In countries like Brazil where homeopathy is offered in university at medical schools, 85% of medical students say that homeopathy should be __**mandatory**__ because they'​re exposed, they see it and every medical student should be taught homeopathy not an introduction,​ pure homeopathy to every student -- because they'​re exposed to it. So the future will answer that question ​where UConn was progressive backward or forward. I am predicting it was way ahead of its time!+
  
 Dr. Novella: First of all, that requirement is being imposed upon medical schools by the American Medical Students Association which has a pro-CAM social interest group and they were able to lobby the credentialing committee to say that medical schools have to teach CAM in order to keep their credentialing. So I don’t know if this came within UConn or they were just responding, like the Yale is, to this externally imposed commandment to do this. My view is -- I spent a lot of time studying CAM and teaching about it -- Complementary and Alternative Therapy because it's part of culture now and it’s out there. I think it's reasonable to teach **about** it as long as you are not promoting unscientific or pseudoscientific beliefs, conclusions;​ you're not abusing the science. I think it will actually be very helpful to teach medical students how to distinguish science from pseudoscience in their own profession. Dr. Novella: First of all, that requirement is being imposed upon medical schools by the American Medical Students Association which has a pro-CAM social interest group and they were able to lobby the credentialing committee to say that medical schools have to teach CAM in order to keep their credentialing. So I don’t know if this came within UConn or they were just responding, like the Yale is, to this externally imposed commandment to do this. My view is -- I spent a lot of time studying CAM and teaching about it -- Complementary and Alternative Therapy because it's part of culture now and it’s out there. I think it's reasonable to teach **about** it as long as you are not promoting unscientific or pseudoscientific beliefs, conclusions;​ you're not abusing the science. I think it will actually be very helpful to teach medical students how to distinguish science from pseudoscience in their own profession.
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 Homeopathy is often referred to as the science of therapeutics,​ because it was developed systematically,​ step-by-step,​ carefully over more than 50 years by a very meticulous scientist by the name of Samuel Hahnemann and careful experimentation and verifications by millions of physicians and patrons for more than 200 years. Homeopathy is often referred to as the science of therapeutics,​ because it was developed systematically,​ step-by-step,​ carefully over more than 50 years by a very meticulous scientist by the name of Samuel Hahnemann and careful experimentation and verifications by millions of physicians and patrons for more than 200 years.
  
-The great compelling beauty of homeopathy, as a system of medicine, is that are no theories or abstractions,​ it is a purely phenomenological approach to sickness. Hahnemann has indeed developed a purely descriptive method of science, which allows for new growth and change in knowledge.+The great compelling beauty of homeopathy, as a system of medicine, is that there are no theories or abstractions,​ it is a purely phenomenological approach to sickness. Hahnemann has indeed developed a purely descriptive method of science, which allows for new growth and change in knowledge.
  
 The most similar remedy is chosen according to a well-confirmed principle. So the facts of the patient -- the symptoms of the patient -- and the facts of the proving are mixed together. There is no theory, just the principle of similarity joining them. The most similar remedy is chosen according to a well-confirmed principle. So the facts of the patient -- the symptoms of the patient -- and the facts of the proving are mixed together. There is no theory, just the principle of similarity joining them.
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 Homeopathy is rational, safe, efficacious,​ predictable,​ beneficial, wise, and likely the greatest gift for suffering humanity. Homeopathy is rational, safe, efficacious,​ predictable,​ beneficial, wise, and likely the greatest gift for suffering humanity.
  
-Because we fully don’t understand the mechanism of a phenomena doesn’t at all invalidate it, and we might never fully understand the mechanism of homeopathy, as we may never understand the universe, life, consciousness;​ we may never understand energy. What is energy?+Because we don’t ​fully understand the mechanism of a phenomena doesn’t at all invalidate it, and we might never fully understand the mechanism of homeopathy, as we may never understand the universe, life, consciousness;​ we may never understand energy. What is energy?
  
-Today, I presented research clearly establishing that the process of serial dilutions and succussion used in homeopathy results in durable and measurable changes in the solutions therefore supporting the plausibility of UMPs and making it clear that homeopathy can be investigated like any other natural phenomena and completely discredit such blatant statement that it doesn’t work because it can’t work.+Today, I presented research clearly establishing that the process of serial dilutions and succussion used in homeopathy results in durable and measurable changes in the solutionstherefore supporting the plausibility of UMPs and making it clear that homeopathy can be investigated like any other natural phenomena and completely discredit such blatant statement that 'it doesn’t work because it can’t work'.
  
-I also presented basic research //in vitro// and so on. Skeptics carry a great responsibility as for more than 200 years they have stalled scientific progress in one of the most important ​branch ​of human endeavors. I hope this is only the beginning of discussion between homeopaths and skeptics. As I said earlier, true scientists should come to the same conclusion as long as they stick to facts and use sound reasoning.+I also presented basic research //in vitro// and so on. Skeptics carry a great responsibility as for more than 200 years they have stalled scientific progress in one of the most important ​branches ​of human endeavors. I hope this is only the beginning of discussion between homeopaths and skeptics. As I said earlier, true scientists should come to the same conclusion as long as they stick to facts and use sound reasoning.
  
-Skeptics are not going come out of the deep hole they have dug themselves and for humanityunless they can be self-critical like true scientists. Thank you, thank you, thank you! (audience clapping)+Skeptics are not going come out of the deep hole they have dug themselves and for humanity ​-- unless they can be self-critical like true scientists. Thank you, thank you, thank you! (audience clapping)
  
 Dr. Novella: Thanks to Dr. Saine, thanks to UConn for hosting this very interesting discussion. There are lot of things in the history of science, really interesting ideas that have been discarded over time because they turned out not to be true even after decades, sometimes even centuries of people thinking that they were true. Dr. Novella: Thanks to Dr. Saine, thanks to UConn for hosting this very interesting discussion. There are lot of things in the history of science, really interesting ideas that have been discarded over time because they turned out not to be true even after decades, sometimes even centuries of people thinking that they were true.
  
-Isaac Newton wrote more words about alchemy than about math or about physics he was convinced that it was real. He spend the bulk of his scientific energy ​and investigating it and it turned out to be 100% completely nonsense. History is littered with ideas that were investigated,​ shown to be wanting and discarded. Homeopathy is one of those ideas. It simply hasn't been discarded because of cultural inertia because there are people who believe that it works and are not listening to the scientific evidence which is showing that science has essentially moved beyond the notions that homeopathy was based upon and the clinical evidence that shows in fact, not surprisingly,​ if you look at the basic sciencethat it doesn'​t work. I know it's very hard it’s very difficult to wrap your mind around the notion that a treatment that seems to work whether you're a practitioner or a patient; when a treatment seems to work, every neuron in our brain screams this is real, this happened, this is a fact. But we know that could also be 100% illusion. Our brains manufacture,​ construct our concept of reality for us and unless we subject it to a very rigorous filter of scientific methodology,​ we can’t know that something works or that it doesn'​t work. When you subject that filter to homeopathy there is one clear screaming answer -- it’s not real, it doesn'​t work! If this was the best invention for medicine to save the humanity -- all the things that homeopaths say it is; if it was half a tenth as effective as they said it is it was we wouldn'​t still be here debating -- it would be easily demonstrable in clinical trials. The fact that it hasn't is because it doesn'​t workThank you. (audience clapping)+Isaac Newton wrote more words about alchemy than about math or about physics ​-- he was convinced that it was real. He spend the bulk of his scientific energy investigating it and it turned out to be 100% completely nonsense. History is littered with ideas that were investigated,​ shown to be wanting and discarded. Homeopathy is one of those ideas. It simply hasn't been discarded because of cultural inertia because there are people who believe that it works and are not listening to the scientific evidence which is showing that science has essentially moved beyond the notions that homeopathy was based upon and the clinical evidence that shows -- in fact, not surprisingly,​ if you look at the basic science ​-- that it doesn'​t work. I know it's very hardit’s very difficult to wrap your mind around the notion that a treatment that seems to work whether you're a practitioner or a patient; when a treatment seems to work, every neuron in our brain screams this is real, this happened, this is a fact. But we know that could also be 100% illusion. Our brains manufacture,​ construct our concept of reality for us and unless we subject it to a very rigorous filter of scientific methodology,​ we can’t know that something works or that it doesn'​t work. When you subject that filter to homeopathythere is one clear screaming answer -- it’s not real, it doesn'​t work! If this was the best invention for medicine to save the humanity -- all the things that homeopaths say it is; if it was half a tenth as effective as they said it is it waswe wouldn'​t still be here debating -- it would be easily demonstrable in clinical trials. The fact that it hasn't is because it doesn'​t workThank you. (audience clapping)
  
 Presenter: We thank both of you for your thoughtful discussion and for visiting us today and sharing with us! Thank you so much! Presenter: We thank both of you for your thoughtful discussion and for visiting us today and sharing with us! Thank you so much!
en/misc/talk-saine-novella.txt · Last modified: 2018/07/24 11:04 by legatum