en:misc:talk-saine-novella
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| In another paper recently published in the high impact journal //Langmuir//, which is the journal of surfaces and colloids of the American Chemical Society, whose motto is -- “the most trusted, the most cited and the most read”. The authors wrote: | In another paper recently published in the high impact journal //Langmuir//, which is the journal of surfaces and colloids of the American Chemical Society, whose motto is -- “the most trusted, the most cited and the most read”. The authors wrote: | ||
| - | //Physicochemical studies of these solutions have unequivocally established the presence of the starting raw materials in nanoparticulate form <wrap hi>even in these extreme (super-Avogadro, >10 <sup>23</sup> ) dilutions</wrap>// //. We have demonstrated that lactose during grinding helped in the formation of nanoclusters.// | + | //Physicochemical studies of these solutions have unequivocally established the presence of the starting raw materials in nanoparticulate form <wrap hi>even in these extreme (super-Avogadro, >10 <sup>-23</sup> ) dilutions</wrap>// //. We have demonstrated that lactose during grinding helped in the formation of nanoclusters.// |
| Here you can see nanocluster of gold nanoparticles with lactose. | Here you can see nanocluster of gold nanoparticles with lactose. | ||
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| //Our conclusions arise from our experiments indicating that in the successive dilution process of manufacturing, beyond a certain stage, <wrap hi>the dilution is merely apparent and the concentration of the starting material in the diluted product reaches a zero asymptotic level no matter how much more the sample is diluted.</wrap>// | //Our conclusions arise from our experiments indicating that in the successive dilution process of manufacturing, beyond a certain stage, <wrap hi>the dilution is merely apparent and the concentration of the starting material in the diluted product reaches a zero asymptotic level no matter how much more the sample is diluted.</wrap>// | ||
| - | In a 2005 paper in Materials Research Innovations, entitled “ //The Structure Of Liquid Water; Novel Insights From Materials Research; Potential Relevance To Homeopathy//**”** we can read: | + | In a 2005 paper in Materials Research Innovations, entitled “//The Structure Of Liquid Water; Novel Insights From Materials Research; Potential Relevance To Homeopathy//**”** we can read: |
| //This paper <wrap hi>definitively</wrap> demolishes the objection against homeopathy. The burden of the proof on critics of homeopathy is to establish that the structure of processed remedy is not different from the original solvent. The principal conclusions of this paper concern only the plausibility of the biological action of ultradiluted water remedy, they are based on some very old (e.g. homeopathy) and some very new (e.g. metallic and nanobubble colloids) <wrap hi>observations which have been rejected on invalid grounds</wrap> or due to ignorance of the materials research literature and its theoretical basis.// | //This paper <wrap hi>definitively</wrap> demolishes the objection against homeopathy. The burden of the proof on critics of homeopathy is to establish that the structure of processed remedy is not different from the original solvent. The principal conclusions of this paper concern only the plausibility of the biological action of ultradiluted water remedy, they are based on some very old (e.g. homeopathy) and some very new (e.g. metallic and nanobubble colloids) <wrap hi>observations which have been rejected on invalid grounds</wrap> or due to ignorance of the materials research literature and its theoretical basis.// | ||
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| //In conclusion, our work and that of many other researchers suggests that <wrap hi>homeopathy is not only plausible, but constitutes one of the frontiers of medical science, and more specifically of complexity science, biophysics, and nanopharmacology.</wrap> For these reasons the tenet according to which ‘homeopathy is based on principles that are incompatible with well established science‘ cannot be accepted and <wrap hi>investigation of homeopathic treatments appears to be warranted and ethically justifiable.</wrap>// | //In conclusion, our work and that of many other researchers suggests that <wrap hi>homeopathy is not only plausible, but constitutes one of the frontiers of medical science, and more specifically of complexity science, biophysics, and nanopharmacology.</wrap> For these reasons the tenet according to which ‘homeopathy is based on principles that are incompatible with well established science‘ cannot be accepted and <wrap hi>investigation of homeopathic treatments appears to be warranted and ethically justifiable.</wrap>// | ||
| - | Now, that we have addressed the question of biological plausibility of these rather complex UMPs, the next question in order is to verify whether they are completely ineffective as medicine, as claimed by skeptic. | + | Now, that we have addressed the question of biological plausibility of these rather complex UMPs, the next question in order is to verify whether they are completely ineffective as medicine, as claimed by skeptics. |
| Let’s first look at the //in vitro// research. We find this 2007 //systematic assessment of the// //in vitro// //research on high potency effects which had an inclusive criteria of stepwise agitated dilutions <10//<sup>//−23//</sup>//; cells or molecules from human or animal. The results:// //From 75 publications, 67 experiments (1/3 of them replications) were evaluated. <wrap hi>Nearly 3/4 of them found a high potency effect</wrap>,... <wrap hi>Nearly 3/4 of all replications were positive.</wrap> Conclusion: Experiments with a high methodological standard... demonstrate an effect of high potencies.// | Let’s first look at the //in vitro// research. We find this 2007 //systematic assessment of the// //in vitro// //research on high potency effects which had an inclusive criteria of stepwise agitated dilutions <10//<sup>//−23//</sup>//; cells or molecules from human or animal. The results:// //From 75 publications, 67 experiments (1/3 of them replications) were evaluated. <wrap hi>Nearly 3/4 of them found a high potency effect</wrap>,... <wrap hi>Nearly 3/4 of all replications were positive.</wrap> Conclusion: Experiments with a high methodological standard... demonstrate an effect of high potencies.// | ||
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| My second epidemiological example relates to **pneumonia.** Before the introduction of antibiotics it was widely recognized that the average death rate from pneumonia was around 30%. | My second epidemiological example relates to **pneumonia.** Before the introduction of antibiotics it was widely recognized that the average death rate from pneumonia was around 30%. | ||
| - | In 1912, William Osler, the father of modern medicine, wrote: “ //The statistics at my clinic at the John Hopkins Hospital from 1889 to 1905 have been analyzed... there were 658 cases with 200 deaths, a mortality of 30.4%... a// //study of the pneumonia statistics at the London Hospital from 1854-1903 concluded that the fatality of the disease has not appreciably changed during this period...// //there is an extraordinary uniformity in the mortality// .” A recent meta-analysis on the mortality from pneumonia reported: | + | In 1912, William Osler, the father of modern medicine, wrote: “ //The statistics at my clinic at the John Hopkins Hospital from 1889 to 1905 have been analyzed... there were 658 cases with 200 deaths, a mortality of 30.4%... a// //study of the pneumonia statistics at the London Hospital from 1854-1903 concluded that the fatality of the disease has not appreciably changed during this period...// //there is an extraordinary uniformity in the mortality.//” A recent meta-analysis on the mortality from pneumonia reported: |
| //Community-acquired pneumonia remains a major cause of mortality at 14% while hospital-acquired pneumonia carries a higher mortality between 50 and 70 percent.// //Worldwide, more children younger than five die of pneumonia than AIDS, malaria and tuberculosis combined.// | //Community-acquired pneumonia remains a major cause of mortality at 14% while hospital-acquired pneumonia carries a higher mortality between 50 and 70 percent.// //Worldwide, more children younger than five die of pneumonia than AIDS, malaria and tuberculosis combined.// | ||
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| Between 1847 and 1849, Dr. Jean-Paul Tessier, one of the distinguished allopathic practitioners of medicine in Paris, conducted at the St. Marguerite Hospital experiments to investigate homeopathy in the treatment of pneumonia. He wrote: | Between 1847 and 1849, Dr. Jean-Paul Tessier, one of the distinguished allopathic practitioners of medicine in Paris, conducted at the St. Marguerite Hospital experiments to investigate homeopathy in the treatment of pneumonia. He wrote: | ||
| - | “ //I presented myself neither as a partisan nor as an opponent of homeopathy but as a scientist guarding myself against the misguiding bias of blind passion, and endeavored to strictly adhere to the legitimate demands of a scientific inquiry// **.”** | + | “//I presented myself neither as a partisan nor as an opponent of homeopathy but as a scientist guarding myself against the misguiding bias of blind passion, and endeavored to strictly adhere to the legitimate demands of a scientific inquiry//.” |
| In total, he reported very detailed cases with 37 recoveries and 3 deaths, a mortality rate of 7.5%. Instead of being hailed as a hero by his allopathic colleagues, Dr. Tessier was ridiculed for his experiments and banished forever from the allopathic circles. This means that by simply switching from allopathy to homeopathy he was saving 23 more lives out of 100 patients with pneumonia. This is really incredible but at same time appears almost too good to be true. | In total, he reported very detailed cases with 37 recoveries and 3 deaths, a mortality rate of 7.5%. Instead of being hailed as a hero by his allopathic colleagues, Dr. Tessier was ridiculed for his experiments and banished forever from the allopathic circles. This means that by simply switching from allopathy to homeopathy he was saving 23 more lives out of 100 patients with pneumonia. This is really incredible but at same time appears almost too good to be true. | ||
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| - The Law of Infinitesimals | - The Law of Infinitesimals | ||
| - | Now, these laws, in the 200 years since Hahnemann developed them, have not been established by mainstream scientific investigation. They remain pre-scientific notions that have not yet been validated. The notion of 'like cures like', really, what is a manifestation of the idea that was popular at the time called sympathetic magic -- the notion that things will cure things that they look like or they are similar to. From a homeopathic site describing what this principle means //“In other words the substance produces symptoms of illness in a well person when administered in large doses; if we administer the same substance in minute quantities it will cure the disease in a sick person -- like cures like!”// Although they don't actually follow that rule because they don't give minute quantities they give nonexistent quantities as you would see. | + | Now, these laws, in the 200 years since Hahnemann developed them, have not been established by mainstream scientific investigation. They remain pre-scientific notions that have not yet been validated. The notion of 'like cures like', really, what is a manifestation of the idea that was popular at the time called sympathetic magic -- the notion that things will cure things that they look like or they are similar to. From a homeopathic site describing what this principle means -- //“In other words the substance produces symptoms of illness in a well person when administered in large doses; if we administer the same substance in minute quantities it will cure the disease in a sick person -- like cures like!”// Although they don't actually follow that rule because they don't give minute quantities -- they give nonexistent quantities as you would see. |
| - | Now many homeopaths or proponents of homeopathy have likened that principle to vaccines, when we give vaccines to patients we give them a small dose and that prevents the disease to the same thing that we are giving them, but that's a very superficial analogy that doesn't hold up. Vaccines actually give measurable doses of a substance that are known to provoke an immune response and essentially what's happening is that the immune response can then fight off a later exposure to that same thing. This is not analogous in any way to any of the principles of homeopathy or how homeopathy is practiced. | + | Now many homeopaths or proponents of homeopathy have likened that principle to vaccines -- when we give vaccines to patients we give them a small dose and that prevents the disease to the same thing that we are giving them, but that's a very superficial analogy that doesn't hold up. Vaccines actually give measurable doses of a substance that are known to provoke an immune response and essentially what's happening is that the immune response can then fight off a later exposure to that same thing. This is not analogous in any way to any of the principles of homeopathy or how homeopathy is practiced. |
| It is also important to recognize that Hahnemann and many homeopaths even till today don't actually treat what we, in modern times, consider to be a disease. Actually, the concept of a disease is a fairly new one, meaning it's only about a couple of hundred years old and it didn't really come to dominate medicine until after scientific methodology matured and became systematically applied to medicine only about a 150 years ago. | It is also important to recognize that Hahnemann and many homeopaths even till today don't actually treat what we, in modern times, consider to be a disease. Actually, the concept of a disease is a fairly new one, meaning it's only about a couple of hundred years old and it didn't really come to dominate medicine until after scientific methodology matured and became systematically applied to medicine only about a 150 years ago. | ||
| - | Homeopaths treat illness. They treat something that is not well defined patho-physiologically. They take what many call a holistic approach considering personality, temperament, sometimes superficial characteristics, in designing their treatment -- not based upon any modern concept that we would know of as a disease. | + | Homeopaths treat illness. They treat something that is not well defined patho-physiologically. They take what many call a holistic approach; considering personality, temperament, sometimes superficial characteristics, in designing their treatment -- not based upon any modern concept that we would know of as a disease. |
| - | The Law of Cure -- again, these are notions were developed by Hahnemann at a time that we had, really, very little idea how human body works let alone how disease processes work. So he had notions that the remedy starts at the top of the body and works downward, works from within and then goes outwards, symptoms clear in reverse order of appearance -- none of these notions have any basis in scientific reality. | + | The Law of Cure -- again, these are notions that were developed by Hahnemann at a time that we had, really, very little idea how human body works, let alone how disease processes work. So he had notions that the remedy starts at the top of the body and works downward, works from within and then goes outwards, symptoms clear in reverse order of appearance -- none of these notions have any basis in scientific reality. |
| Homeopathy, actually, is an energy-based medicine. Hahnemann believed that what is transferred to the patient is the essence, not anything physical, but the essence of the treatments that he concocted. These are more of a spiritual treatment than a physical treatment. He believed that dilution and succussion release a spirit-like power or an essence from the remedy that would have a healing potential in the human person. | Homeopathy, actually, is an energy-based medicine. Hahnemann believed that what is transferred to the patient is the essence, not anything physical, but the essence of the treatments that he concocted. These are more of a spiritual treatment than a physical treatment. He believed that dilution and succussion release a spirit-like power or an essence from the remedy that would have a healing potential in the human person. | ||
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| So, let's move on to the Law of Infinitesimals -- this was the notion that substances become more potent when diluted, but only in their desired effects (the side effects were diminished) and that these effects were increased by succussion or shaking the remedy. | So, let's move on to the Law of Infinitesimals -- this was the notion that substances become more potent when diluted, but only in their desired effects (the side effects were diminished) and that these effects were increased by succussion or shaking the remedy. | ||
| - | Homeopathic remedies will typically exceed the dilutional limit -- this is an area where Dr. Saine and I agree. Yes, they do, in fact, dilute the remedies to the point where, from just normal chemistry, there shouldn't be any molecules of active ingredient or the original substance left -- that’s something I think is non-controversial. So, if there is no active ingredient remaining in the water then how is it possible that water can have a biological effect on the body. This is the big hang-up scientists have when thinking about homeopathy and when we say that homeopathy lacks basic scientific plausibility, this is what we mean! | + | Homeopathic remedies will typically exceed the dilutional limit -- this is an area where Dr. Saine and I agree. Yes, they do, in fact, dilute the remedies to the point where, from just normal chemistry, there shouldn't be any molecules of active ingredient or the original substance left -- that’s something I think is non-controversial. So, if there is no active ingredient remaining in the water then how is it possible that water can have a biological effect on the body? **This is the big hang-up scientists have when thinking about homeopathy and when we say that homeopathy lacks basic scientific plausibility, this is what we mean!** |
| So, in recent years, proponents of homeopathy have proposed a number of potential explanations for how water, that doesn't have any active actual chemical ingredients in it, could have a homeopathic effect, could have a physical or biological effect. One such notion is that the water itself remembers something about the chemicals that were diluted in it. So, for example, homeopathic qualities are stored in three dimensional structure of water, so the water molecules are like bricks and you are building some type of structure. The problem is this is simply not true, and it hasn’t been established by scientific evidence. There is no mechanism for the maintenance of such structures beyond very very brief moments, there is no mechanism for distinguishing which substances you want to have stored in the water memory and no mechanism for how these structures would survive and interact with the body. | So, in recent years, proponents of homeopathy have proposed a number of potential explanations for how water, that doesn't have any active actual chemical ingredients in it, could have a homeopathic effect, could have a physical or biological effect. One such notion is that the water itself remembers something about the chemicals that were diluted in it. So, for example, homeopathic qualities are stored in three dimensional structure of water, so the water molecules are like bricks and you are building some type of structure. The problem is this is simply not true, and it hasn’t been established by scientific evidence. There is no mechanism for the maintenance of such structures beyond very very brief moments, there is no mechanism for distinguishing which substances you want to have stored in the water memory and no mechanism for how these structures would survive and interact with the body. | ||
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| But before we get to that point, let's look at the evidence that is often proposed -- say, yes, water has memory, there is something more here than just plain water. So, there are certainly studies that purport to show differences between homeopathic water and non-homeopathic or regular water. The problem is the quality of these studies is not sufficient to establish this as a scientific conclusion. Dr. Saine wondered a lot how can skeptics maintain their skepticism in the light of the evidence that he was presenting. The short answer is that the evidences are of very poor quality and it’s not compelling. When scientists look at the evidence, they say, ok, this is at best preliminary, at best you are anomaly hunting, you are finding some anomaly, but you haven't really established that the effect is real, what it means and if it has any implication for homeopathic remedies. There are multiple steps missing in that chain of scientific reasoning, so, no, we are not compelled by preliminary anomalous results. | But before we get to that point, let's look at the evidence that is often proposed -- say, yes, water has memory, there is something more here than just plain water. So, there are certainly studies that purport to show differences between homeopathic water and non-homeopathic or regular water. The problem is the quality of these studies is not sufficient to establish this as a scientific conclusion. Dr. Saine wondered a lot how can skeptics maintain their skepticism in the light of the evidence that he was presenting. The short answer is that the evidences are of very poor quality and it’s not compelling. When scientists look at the evidence, they say, ok, this is at best preliminary, at best you are anomaly hunting, you are finding some anomaly, but you haven't really established that the effect is real, what it means and if it has any implication for homeopathic remedies. There are multiple steps missing in that chain of scientific reasoning, so, no, we are not compelled by preliminary anomalous results. | ||
| - | Take for example, the water memory -- studies attempting to replicate it have essentially been negative. High sensitivity spectroscopy -- no difference between homeopathic remedies and just regular water. NMR study of homeopathic solutions reviewing that evidence, the authors said: //“In conclusion, published results from NMR research on homeopathy indicating differences between homeopathic solutions and control samples could not be reproduced.”// Now, reproduction is one of the essential components of science. Most studies that are performed and published and this has been established by reviewing the literature -- most published studies are in fact wrong. The conclusions in those studies are not correct. When you look at phenomena that have been clearly established -- you know, either 'yes, it's real' or 'no, it's not real', whether the treatment is effective, whatever. And when you look back over the previous 20-30 years of published studies; if you look at every study published on that same question, you will find that the majority of them came to a wrong conclusion; and they tend to be wrong in the positive direction, so most of the literature, the scientific literature, is wrong and falsely positive. And that's been clearly established by reviewing large segments of the literature. | + | Take for example, the water memory -- studies attempting to replicate it have essentially been negative. High sensitivity spectroscopy -- no difference between homeopathic remedies and just regular water. NMR study of homeopathic solutions reviewing that evidence, the authors said: //“In conclusion, published results from NMR research on homeopathy indicating differences between homeopathic solutions and control samples could not be reproduced.”// Now, reproduction is one of the essential components of science. Most studies that are performed and published and this has been established by reviewing the literature -- most published studies are, in fact, wrong. The conclusions in those studies are not correct. When you look at phenomena that have been clearly established -- you know, either 'yes, it's real' or 'no, it's not real', whether the treatment is effective, whatever. And when you look back over the previous 20-30 years of published studies; if you look at every study published on that same question, you will find that the majority of them came to a wrong conclusion; and they tend to be wrong in the positive direction, so most of the literature, the scientific literature, is wrong and falsely positive. And that's been clearly established by reviewing large segments of the literature. |
| - | So, well, how do we know anything in science? You know it, because it takes a long time to establish that something is really real. It's doesn't just seem to be real, the science tells us that it actually is real and you do that by designing better and better studies, doing follow-up studies, following up the implications, by doing the exact replications and by doing the replications looking at same question from a different point of view and then, eventually, we hammer out the answer -- is there really an effect here or not? So when you take preliminary studies which are considered to be just exploratory in the minds of scientists and you have some anomalous results you can't go -- boom -- homeopathy is proven, there is a mechanism for homeopathy! No, you're skipping about 10 to 20 years of follow-up research and replication that would really answer the question for us. So the same is true of pretty much all of the evidence that Dr. Saine presented in favor of the plausibility of homeopathy. | + | So, well, how do we know anything in science? You know it, because it takes a long time to establish that something is really real. It doesn't just seem to be real, the science tells us that it actually is real and you do that by designing better and better studies, doing follow-up studies, following up the implications, by doing the exact replications and by doing the replications looking at same question from a different point of view and then, eventually, we hammer out the answer -- is there really an effect here or not? So when you take preliminary studies which are considered to be just exploratory in the minds of scientists and you have some anomalous results you can't go -- boom -- homeopathy is proven, there is a mechanism for homeopathy! No, you're skipping about 10 to 20 years of follow-up research and replication that would really answer the question for us. So the same is true of pretty much all of the evidence that Dr. Saine presented in favor of the plausibility of homeopathy. |
| The thermoluminescence studies, for example, of Louis Rey in 2003. Well, first he used ice of deuterium (heavy water; water with heavy hydrogen in it), because that would have greater signal to look at, and he froze it down to cold temperatures and then subjected to radiation and then melted it and looked at the radiation that was given off as it melted. But this was a small study that was not blinded and there was no statistical analysis and he did not adequately account for possible confounding factors. And when this study was reviewed by other experts in the field, they found that the study was very non-compelling -- no statistical analysis, not blinded. That is the most preliminary of evidence, you cannot make any conclusions on this. | The thermoluminescence studies, for example, of Louis Rey in 2003. Well, first he used ice of deuterium (heavy water; water with heavy hydrogen in it), because that would have greater signal to look at, and he froze it down to cold temperatures and then subjected to radiation and then melted it and looked at the radiation that was given off as it melted. But this was a small study that was not blinded and there was no statistical analysis and he did not adequately account for possible confounding factors. And when this study was reviewed by other experts in the field, they found that the study was very non-compelling -- no statistical analysis, not blinded. That is the most preliminary of evidence, you cannot make any conclusions on this. | ||
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| What about the clinical evidence? Even if we put plausibility aside, even if you're of the mind that, 'okay, so we don't know how it works or even how it could work', and sure, it violates the major laws of science, but let's just put all of that aside. We don’t know everything. Does it work? Let’s just look at the remedies and see if they work! | What about the clinical evidence? Even if we put plausibility aside, even if you're of the mind that, 'okay, so we don't know how it works or even how it could work', and sure, it violates the major laws of science, but let's just put all of that aside. We don’t know everything. Does it work? Let’s just look at the remedies and see if they work! | ||
| - | Well, the clinical evidence is not compelling either and it falls under the same failure, the same flaws as the plausibility studies that have been done. One 2000 review wrote, //“there is some evidence of homeopathic treatments are more effective than placebo; however the strength of this evidence is low because of the low methodological quality of the trials. Study of high methodological quality were more likely to be negative then the lower quality studies.”// So systematic reviews are great but they are very difficult to do well and meta-analysis actually combine data and re-analyze it are fraud with errors and most of them actually, again, do not predict the outcome of later definitive trials. | + | Well, the clinical evidence is not compelling either and it falls under the same failure, the same flaws as the plausibility studies that have been done. One 2000 review wrote, //“there is some evidence of homeopathic treatments are more effective than placebo; however the strength of this evidence is low because of the low methodological quality of the trials. Study of high methodological quality were more likely to be negative then the lower quality studies.”// So systematic reviews are great but they are very difficult to do well and meta-analysis actually combine data and re-analyze it are fraud with errors and most of them, actually, again, do not predict the outcome of later definitive trials. |
| Meta-analysis is very tricky to do, but if you do a best evidence synthesis, you look at the patterns in the literature -- ok, is the pattern that we are seeing consistent with the real effect or the kind of fake effect that clinical research tends to produce? Remember, most studies that are published are wrong, most are false-positive and you need to do 10-15-20 years of increasingly good, methodologically tight, rigorous clinical trials before you get to finally get to the answer -- is this real or isn’t it real? And what you get when you look at the homeopathic researches, a lot of low-quality studies, but the better the quality of study the more likely they are to be negative and that is the pattern we see in medicine when the treatment doesn't work. That's why we conclude homeopathy probably doesn't work because that's the pattern we find when you look at all the literature. | Meta-analysis is very tricky to do, but if you do a best evidence synthesis, you look at the patterns in the literature -- ok, is the pattern that we are seeing consistent with the real effect or the kind of fake effect that clinical research tends to produce? Remember, most studies that are published are wrong, most are false-positive and you need to do 10-15-20 years of increasingly good, methodologically tight, rigorous clinical trials before you get to finally get to the answer -- is this real or isn’t it real? And what you get when you look at the homeopathic researches, a lot of low-quality studies, but the better the quality of study the more likely they are to be negative and that is the pattern we see in medicine when the treatment doesn't work. That's why we conclude homeopathy probably doesn't work because that's the pattern we find when you look at all the literature. | ||
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| The most recent and comprehensive review of the homeopathic clinical literature out there was published in 2010 by Edgar Ernst -- //A Systematic Review Of Systematic Reviews.// And what he found was the finds of the currently available Cochrane reviews of studies of homeopathy do not show that homeopathic medicines have effects beyond placebo. They are indistinguishable from placebo, that's what the evidence shows and this is true no matter what you're looking at, no matter what treatment, what disease, what entity you are looking at. | The most recent and comprehensive review of the homeopathic clinical literature out there was published in 2010 by Edgar Ernst -- //A Systematic Review Of Systematic Reviews.// And what he found was the finds of the currently available Cochrane reviews of studies of homeopathy do not show that homeopathic medicines have effects beyond placebo. They are indistinguishable from placebo, that's what the evidence shows and this is true no matter what you're looking at, no matter what treatment, what disease, what entity you are looking at. | ||
| - | Dr. Saine was impressed with the Freis 2005 study in sepsis, I'm not impressed by it and this explains the difference between why he believes that homeopathy works and I do not believe that homeopathy works! What he told you was that mortality at 180 days was significant (p=0.043) which I will add is barely significant and in a small study and a barely significant result is not compelling, one or two extra deaths in the placebo group and boom, you have your barely statistical significant result. But there is something else very odd about this study; they looked at 30-day mortality and 180-day mortality for sepsis. Now sepsis is an acute illness -- if it's going to kill you, it’s going to kill you right away it, it’s going to kill you in few days. Most clinical trials looking at the efficacy of sepsis treatments use 30-day mortality as the gold standard because, again, if you are going to die from sepsis you are going to be dead by 30 days. The 30-day data was not statistically significant, so homeopathy apparently didn't help people live up to 30 days from their acute sepsis episode but somehow magically it helped them live more than 180 days! It doesn't make sense. When we see clinical trials that don't make sense where the gold standard outcome is negative and some other outcome that doesn't really help us very much is barely statistical significant in a small study, that’s just a statistical anomaly, that’s not a real effect! No matter what the treatment was and this is important for me to emphasize, I don't care if we're talking about homeopathy, we are talking about a pharmaceutical drug, doesn't matter what your talking about! This evidence, if I didn't tell you this is a homeopathy, this is a treatment X, no difference in 30 days in sepsis, but there is this barely statistical significant result at 180 days in a small study, no clinical scientist is going to be compelled by this evidence. This is preliminary unconvincing evidence. | + | Dr. Saine was impressed with the Freis 2005 study in sepsis, I'm not impressed by it and this explains the difference between why he believes that homeopathy works and I do not believe that homeopathy works. What he told you was that mortality at 180 days was significant (p=0.043) which I will add is barely significant and in a small study and a barely significant result is not compelling, one or two extra deaths in the placebo group and boom, you have your barely statistical significant result. But there is something else very odd about this study; they looked at 30-day mortality and 180-day mortality for sepsis. Now sepsis is an acute illness -- if it's going to kill you, it’s going to kill you right away it, it’s going to kill you in a few days. Most clinical trials looking at the efficacy of sepsis treatments use 30-day mortality as the gold standard because, again, if you are going to die from sepsis, you are going to be dead by 30 days. The 30-day data was not statistically significant, so homeopathy apparently didn't help people live up to 30 days from their acute sepsis episode but somehow magically it helped them live more than 180 days! It doesn't make sense. When we see clinical trials that don't make sense, where the gold standard outcome is negative and some other outcome that doesn't really help us very much is barely statistical significant in a small study, that’s just a statistical anomaly, that’s not a real effect. No matter what the treatment was and this is important for me to emphasize, I don't care if we're talking about homeopathy, we are talking about a pharmaceutical drug, doesn't matter what your talking about. This evidence, if I didn't tell you this is a homeopathy, this is a treatment X, no difference in 30 days in sepsis, but there is this barely statistical significant result at 180 days in a small study, no clinical scientist is going to be compelled by this evidence. This is preliminary unconvincing evidence. |
| - | What about homeopathy in ADHD, well, you can find studies to support anything, if you're willing to cherry pick the literature, there are tens of thousands of studies published every year and again it's all over the place and it should be, because that's what you expect. Even if the research, even if we assume zero fraud and zero error in the clinical research, we should expect just by random statistical variance, that there is a bell curve of outcomes for anything you choose to look at and that as the quality of studies get better, the variance gets less until you get a clustering of the best studies of the real effect. But if you are willing to just cherry pick the low-quality studies you can support just about any position that you can dream of! But when you do systematic reviews you're looking at all of the evidence systematically. The most recent systematic review, and the Cochrane Systematic Review is pretty much the gold standard, not that they always get it right, but they're better than most. They concluded that //“The folds of homeopathy evaluated do not suggest significant treatment effect with the global symptoms, core symptoms of inattention, hyperactivity, impulsivity or related outcomes, such as anxiety in ADHD” -// doesn't work//.// That's what the most recent most thorough systematic review shows. | + | What about homeopathy in ADHD, well, you can find studies to support anything, if you're willing to cherry pick the literature, there are tens of thousands of studies published every year and again it's all over the place and it should be, because that's what you expect. Even if the research, even if we assume zero fraud and zero error in the clinical research, we should expect just by random statistical variance, that there is a bell curve of outcomes for anything you choose to look at and that as the quality of studies get better, the variance gets less until you get a clustering of the best studies of the real effect. But if you are willing to just cherry pick the low-quality studies you can support just about any position that you can dream of. But when you do systematic reviews, you're looking at all of the evidence systematically. The most recent systematic review, and the Cochrane Systematic Review is pretty much the gold standard, not that they always get it right, but they're better than most. They concluded that //“The forms of homeopathy evaluated do not suggest significant treatment effect with the global symptoms, core symptoms of inattention, hyperactivity, impulsivity or related outcomes, such as anxiety in ADHD” -// doesn't work//.// That's what the most recent most thorough systematic review shows. |
| - | What about observational studies or historical studies which are epidemiological and also therefore observational? Observational basically means that you are just gathering data but you're not doing any experiment, therefore you are not controlling for variables and therefore they can’t be blinded. So observational studies are not efficacy trials, we do not use them in medicine to decide if something has an effect, if it works. We use them for other reasons; we use them to see just what's happening in the real world. They are reasonable to use if you're comparing two treatments that have already been established to work through double-blind placebo-controlled efficacy trials. Where you have treatments that have proven efficacy, then an observational trial makes sense. But they cannot and should not be used to establish efficacy. | + | What about observational studies or historical studies which are epidemiological and also therefore observational? 'Observational' basically means that you are just gathering data but you're not doing any experiment, therefore you are not controlling for variables and therefore they can’t be blinded. So observational studies are not efficacy trials, we do not use them in medicine to decide if something has an effect, if it works. We use them for other reasons; we use them to see just what's happening in the real world. They are reasonable to use if you're comparing two treatments that have already been established to work through double-blind placebo-controlled efficacy trials. Where you have treatments that have proven efficacy, then an observational trial makes sense. But they cannot and should not be used to establish efficacy. |
| - | It doesn't really matter also how statistically significant they are -- something you can throw out, oh, look, it's statically significant to P=.0001 or whatever -- if it is not blinded it doesn’t matter -- all you are measuring is systematic bias. You need blinding to eliminate the systematic bias -- without blinding you can get to any statistical significance you want -- its meaningless! | + | It doesn't really matter also how statistically significant they are -- something you can throw out, oh, look, it's statically significant to P=.0001 or whatever -- if it is not blinded, it doesn’t matter -- all you are measuring is systematic bias. You need blinding to eliminate the systematic bias -- without blinding you can get to any statistical significance you want -- its meaningless! |
| - | So, I would conclude from all of this, that homeopathy still lacks plausibility and homeopathy doesn't work -- based upon all the evidence that we have. I do want to comment on some of the things that Dr. Saine mentioned. So I noted with eight year follow-up study -- first of all, this was an unblinded observational study, so you just asked people 'How do you feel?' or 'What happened with you?' -- not the kind of evidence that we can use to establish efficacy. The thing is, when we look at these studies carefully and this is what we do every day, if you go to the Science-Based Medicine website, and we write about everything in medicine, not just homeopathy, it’s just one tiny area that we discuss. What we are talking about -- there is a method for evaluating scientific studies, whether they are preclinical, clinical, experimental, observational and there is a number of quality criteria checklist -- How properly blinded was it? Was the blinding assessed properly? One of the things that often gets missed is what was the dropout rate? How many people were lost to follow-up for one reason or another? General rule of thumb is -- if you get above 5% or 10%, you have to start to question the quality of the study and the study he was quoting, I noted the dropout rate was of 27%. 27% were lost to follow-up. That completely invalidates the results of study because that essentially means you can't randomize because people who were lost to follow-up are not randomized, there was some reason why they were lost to follow-up and that introduces a bias into the outcomes. So generally we ignore the outcomes of studies that have a massive dropout rate like that. | + | So, I would conclude from all of this, that homeopathy still lacks plausibility and homeopathy doesn't work -- based upon all the evidence that we have. I do want to comment on some of the things that Dr. Saine mentioned. So I noted with eight year follow-up study -- first of all, this was an unblinded observational study, so you just asked people 'How do you feel?' or 'What happened with you?' -- not the kind of evidence that we can use to establish efficacy. The thing is, when we look at these studies carefully and this is what we do every day, if you go to the Science-Based Medicine website, and we write about everything in medicine, not just homeopathy, it’s just one tiny area that we discuss. What we are talking about -- there is a method for evaluating scientific studies, whether they are preclinical, clinical, experimental, observational and there is a number of quality criteria checklist -- How properly blinded was it? Was the blinding assessed properly? One of the things that often gets missed is -- what was the dropout rate? How many people were lost to follow-up for one reason or another? General rule of thumb is -- if you get above 5% or 10%, you have to start to question the quality of the study and the study he was quoting, I noted the dropout rate was of 27%. 27% were lost to follow-up. That completely invalidates the results of study because that essentially means you can't randomize because people who were lost to follow-up are not randomized, there was some reason why they were lost to follow-up and that introduces a bias into the outcomes. So generally we ignore the outcomes of studies that have a massive dropout rate like that. |
| - | The follow-up study that had the p value of .0001, that was an open label trial. I want to make sure you understand that 'open label' means unblinded and usually uncontrolled, it's open -- so the patients were not blinded to what treatment they were getting. Dr. Saine also was very impressed with the Swiss study and I have in fact read the study and looked at it in great detail because they were a number of homeopaths that were quite impressed with that study and were touting it as a pretty solid support for homeopathy. First, I would point out that there was a study that was published, the UK study that did the same thing that the Swiss did! They looked at all of the evidence preclinical, clinical; everything for homeopathy, did a thorough review to advise the government. This is the House of Commons Science & Technology Committee, evidence shock to homeopathy and they concluded and these were their words that //“homeopathy is witchcraft”// and that was their conclusion -- “ //there was no plausibility to homeopathy and the clinical evidence shows that it is indistinguishable from placebo.”// | + | The follow-up study that had the p value of .0001, that was an open label trial. I want to make sure you understand that 'open label' means unblinded and usually uncontrolled, it's open -- so the patients were not blinded to what treatment they were getting. Dr. Saine also was very impressed with the Swiss study and I have in fact read the study and looked at it in great detail because there were a number of homeopaths that were quite impressed with that study and were touting it as a pretty solid support for homeopathy. First, I would point out that there was a study that was published, the UK study, that did the same thing that the Swiss did. They looked at all of the evidence preclinical, clinical; everything for homeopathy, did a thorough review to advise the government. This is the House of Commons Science & Technology Committee, evidence shock to homeopathy and they concluded and these were their words that //“homeopathy is witchcraft”// and that was their conclusion -- “ //there was no plausibility to homeopathy and the clinical evidence shows that it is indistinguishable from placebo.”// |
| - | So, now how is this possible that a Swiss committee looked at the same set of evidence that the UK House of Commons committee looked at and came to such different conclusions? Well, if you actually read the details of the Swiss report, they didn't really come to different conclusions they just put an entirely different spin on, in the same results. What they did was they said okay so efficacy trial show that it's indistinguishable from placebo, we have to grant you that, because that's what the evidence shows. So, we are going to focus on the observational trials, the cost-effectiveness and essentially they are saying that blinded controlled data is negative, so we are going to focus on unblinded, uncontrolled data because that gives us the results we want. That suggests that they were somehow biased in pro-homeopathy direction, while in fact they were! This was not a just government committee, this was a committee packed by homeopaths, created by homeopaths specifically to create this outcome, because, partly as a reaction to the UK House of Commons Committee paper, and partly because of the Swiss government, I think it was two years earlier, removed homeopathy from the treatments that they would support -- based upon their previous reviews of homeopathic evidence. So the homeopaths essentially made up a new committee stacked it and came to a totally pro-homeopathy conclusion by doing what I just said -- ignoring or downplaying the blinded, controlled, reliable evidence and trying to trump up the uncontrolled, unblinded, unreliable evidence. | + | So, now how is this possible that a Swiss committee looked at the same set of evidence that the UK House of Commons committee looked at and came to such different conclusions? Well, if you actually read the details of the Swiss report, they didn't really come to different conclusions they just put an entirely different spin on, in the same results. What they did was they said okay so efficacy trials show that it's indistinguishable from placebo, we have to grant you that, because that's what the evidence shows. So, we are going to focus on the observational trials, the cost-effectiveness and essentially they are saying that blinded controlled data is negative, so we are going to focus on unblinded, uncontrolled data because that gives us the results we want. That suggests that they were somehow biased in pro-homeopathy direction, while in fact they were! This was not a just government committee, this was a committee packed by homeopaths, created by homeopaths specifically to create this outcome, because, partly as a reaction to the UK House of Commons Committee paper, and partly because of the Swiss government, I think it was two years earlier, removed homeopathy from the treatments that they would support -- based upon their previous reviews of homeopathic evidence. So the homeopaths essentially made up a new committee, stacked it and came to a totally pro-homeopathy conclusion by doing what I just said -- ignoring or downplaying the blinded, controlled, reliable evidence and trying to trump up the uncontrolled, unblinded, unreliable evidence. |
| Now when you have a phenomenon in science that seems to be there when you're looking at it in an unblinded uncontrolled way, but then it vanishes like a will-o'-the-wisp every time you do a blinded controlled study -- that's in effect a phenomenon that is not real, that is the standard scientific conclusion that we come to. The same thing is true of ESP. | Now when you have a phenomenon in science that seems to be there when you're looking at it in an unblinded uncontrolled way, but then it vanishes like a will-o'-the-wisp every time you do a blinded controlled study -- that's in effect a phenomenon that is not real, that is the standard scientific conclusion that we come to. The same thing is true of ESP. | ||
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| Dr. Saine: Oh! Listen, Steve, I presented evidence and sound reasoning and I don't think you contradict me. Perhaps on the Freis study, you have a point, but it could be very well discussed, the Freis study, because if you treated initially with homeopathy you could have long term outcomes that may be you don’t understand because you don’t practice homeopathy. So, this point, I will give you. | Dr. Saine: Oh! Listen, Steve, I presented evidence and sound reasoning and I don't think you contradict me. Perhaps on the Freis study, you have a point, but it could be very well discussed, the Freis study, because if you treated initially with homeopathy you could have long term outcomes that may be you don’t understand because you don’t practice homeopathy. So, this point, I will give you. | ||
| - | However, I feel that you want to prove fact does not exist -- like you cannot fly because gravity, because metal is like this and it would crack -- but airplanes are flying all over the place, even if you try dispprove it, it is a fact. There are so many facts that you can’t come with theoretical arguments. It cannot be because biology doesn’t reason that way! We don’t know this so therefore, it cannot work. | + | However, I feel that you want to prove a fact does not exist -- like you cannot fly because of gravity, because metal is like this and it would crack -- but airplanes are flying all over the place, even if you try dispprove it -- it is a fact. There are so many facts that you can’t come with theoretical arguments. 'It cannot be because biology doesn’t reason that way!' 'We don’t know this so therefore, it cannot work.' |
| - | There are two different worlds of arguments -- one is facts and sound reasoning and the other one is theoretical argument, based on what -- lots of false assumptions, lots of false premises. I will give you one -- Law of Infinitesimals -- where did you get this? It does not exist in the wayback literature -- where did you get this? I'll tell you where you got this from -- Oliver Wendell Holmes, 1841, that's where you got it, because you don't know it comes from there but he invented it! Not homeopaths! So skeptics create literature of their own and it's been transmitted generation from generation but they don't know where the truth is anymore. I am going to go up in the reverse order of your presentation and you tell me what time is up because I can go on for years (Laughing) | + | There are two different worlds of arguments -- one is facts and sound reasoning and the other one is theoretical argument, based on what -- lots of false assumptions, lots of false premises. I will give you one -- Law of Infinitesimals -- where did you get this? It does not exist in the wayback literature -- where did you get this? I'll tell you where you got this from -- Oliver Wendell Holmes, 1841, that's where you got it, because you don't know it comes from there, but he invented it! Not homeopaths! So skeptics create literature of their own and it's been transmitted generation from generation but they don't know where the truth is anymore. I am going to go up in the reverse order of your presentation and you tell me what time is up because I can go on for years. (audience laughing) |
| - | British study you said //“witchcraft”,// the conclusion, I dare you to demonstrate that publicly that they concluded that! The word 'witchcraft' was mentioned one time during the inquiry, question 183 by the chairman, and the question was the following: //“So if a significant number of people believe in witchcraft, we should seriously consider that?”// | + | British study -- you said //“witchcraft”,// the conclusion. I dare you to demonstrate that publicly that they concluded that! The word 'witchcraft' was mentioned one time during the inquiry, question 183 by the chairman, and the question was the following: //“So, if a significant number of people believe in witchcraft, we should seriously consider that?”// |
| - | A question, a single question! It’s not a conclusion, it's not even a part of conclusion, it’s the only single time it is mentioned in the study. The study is this big, I have it in my briefcase, I can show it to you! So, I am surprised that somebody who is science-based, a champion of science-based like you, comes with such a deviated conclusion about such an important study. First, you cannot compare the Swiss study with the British study. One, it's a government study where they commission scientists. There were 10 scientists on the committee -- three were homeopaths, there were neurologists, there were mathematicians, there were specialists of statistics, but there were only three homeopaths.%%[*%%This was corrected.] The British study -- three members of the 14 members of the committee sat on the three meetings -- only three of 14 -- and only one of the three voted for the study -- only of the 14 voted for the study. It was rejected by 70 out of 70 members of the parliament -- it was not abided by the government, it was rejected! Why should you call it if the government itself rejects the study! You cannot compare the two studies! | + | A question, a single question! It’s not a conclusion, it's not even a part of conclusion, it’s the only single time it is mentioned in the study. The study is this big, I have it in my briefcase, I can show it to you! So, I am surprised that somebody who is science-based, a champion of science-based like you, comes with such a deviated conclusion about such an important study. |
| + | |||
| + | First, you cannot compare the Swiss study with the British study. One, it's a government study where they commission scientists. There were 10 scientists on the committee -- three((the number was corrected by the later statement of Dr. Saine)) were homeopaths, there were neurologists, there were mathematicians, there were specialists of statistics, but there were only three homeopaths. The British study -- three members of the 14 members of the committee sat on the three meetings -- only three of 14 -- and only one of the three voted for the study -- only of the 14 voted for the study. It was rejected by 70 out of 70 members of the parliament -- it was not abided by the government, it was rejected! Why should you call it if the government itself rejects the study! You cannot compare the two studies! | ||
| Observational study -- I would refer you to the New England Journal Of Medicine, it's called -- Randomized, Controlled Trials, Observation Studies and The Hierarchy of Research Designs by John Concato et al, where he said //“the value of observation studies...it's important to point that in the hierarchy of research designs, for well-designed observational studies, especially over a long term like this -- six years and eight years --// //__**do not**__// //systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.”// **Do not** overestimate, in the long term! | Observational study -- I would refer you to the New England Journal Of Medicine, it's called -- Randomized, Controlled Trials, Observation Studies and The Hierarchy of Research Designs by John Concato et al, where he said //“the value of observation studies...it's important to point that in the hierarchy of research designs, for well-designed observational studies, especially over a long term like this -- six years and eight years --// //__**do not**__// //systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.”// **Do not** overestimate, in the long term! | ||
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