====== Homeopathy: Great Medicine or Dangerous Pseudoscience? ======

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This is a transcription of a [[http://mediasite.uchc.edu/mediasite41/Play/f45177db9279460797ffe70714a3f5611d|video]] of a talk on homeopathy that took place on the premises of the University of Connecticut, March 22<sup>nd</sup>, 2013. The topic of the talk was //Homeopathy: Great Medicine or Dangerous Pseudoscience?//, the opponents were Dr. André Saine and Dr. Steven Novella.

Following the debate they both agreed to ask each other a question monthly, with the obligation that these Q&A will be posted on their mutual websites.

  * [[en:misc:talk-saine-novella-question01|Question 1 from Dr. Steven Novella to Dr. André Saine]]

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===== Introduction =====

Presenter: Good Afternoon! Welcome to the University of Connecticut Health Center & to a debate that we're having today on - **Homeopathy: Great Medicine or Dangerous Pseudoscience?** We are honored to have two of the experts debating this topic today. First of all Dr. André Saine who has been a student of homeopathy since 1976 and is likely the most knowledgeable person regarding homeopathic practice, research and literature and more particularly the early writings. He is an instructor and speaker on this topic, traveling throughout the world to do this. Since 1995 he has been the president of Québec Association of Naturopathic Physicians and has an active private practice in Montréal Canada.

Dr. Steven Novella is president of New England Skeptical Society and is a long time critic of the homeopathic medicine. He received his M.D. degree from George Washington University. Since 1996 he has been and is an assistant professor of Neurology and is an attending physician at Yale New Haven Medical Center. To start with today, we first welcome you from wherever positions you sit in, we hope everybody comes here with an open mind and listens carefully to the debate.

There was a roundtable discussion where these two gentlemen were involved in 2007, here at the Health Center and that's published in Complementary and Alternative Medicine, if you like to look it up. First of all, the format is very important for our debate, for us as listeners but also to our debaters and it would proceed in the following way: Each will have 30 minutes, starting with Dr. Saine. Then there will be 10 minutes each for the first rebuttal, 2 minutes each for the second rebuttal and then they'll have 20 minutes in which time they can cross-examine each other. Then there will be questions from the public, so, on your way in, you received cards -- Mr. Gold will be collecting cards throughout the presentation and he'll be bringing [them] up to the front so that we can sort of collate them; so that we have a concise question-and-answer period.

Then there will be a conclusion, there will be a vote asking you whether or not you feel more or less favorably about homeopathic medicine at this time, based on the debate; and there'll be some closing remarks. We respectfully, for the presenters, ask you that there aren't interruptions until the part in the question-and-answer period and we'll have to stick to that. Okay? Thank you so much for your interest. (Audience clapping) Dr. Saine!

===== André Saine, part 1 =====

Dr. Saine: Good afternoon, we can feel spring in the air and time of renewal. First, I would like to thank Dr. Mary Guerrera for the invitation on behalf of UConn, it’s quite an honor to be able to be called to this historic debate, which I would like to dedicate to **Samuel Hahnemann—the founder of homeopathy**—who exactly two hundred years ago, in 1813, was put in charge of a typhus hospital following the battle of Leipzig, which is a famous battle, and reported having treated 183 cases of typhus without a single loss. Such stunning result greatly impressed the Russian Government, then in occupation, but very strangely went unnoticed by the medical community. This is very particular in view of the fact that this deadly epidemic would eventually take half a million victims among Napoleon’s army and the German population.

Ladies and Gentlemen, today, we have a rare opportunity to critically examine two completely opposite views of homeopathy. In theory, if Dr. Novella and I use the best of scientific thinking, and stick only to facts and sound reasoning on this purely scientific question, we should come to the same conclusion -- as true scientists are self-critical, and true science is self-correcting.

I will now ask your unreserved attention for the next 30 minutes, as I will now present a very condensed summary of the evidence that supports homeopathy to be a great, and most scientific and beneficial medicine. So we will need all your neurons!

Let me first address the argument of implausibility, the core issue in this 200 year-old dispute, which focuses in particular on the fact that homeopaths use ultra-molecular preparations. Ultra Molecular Preparations or UMPs are prepared from solutions that went through a process of serial succussions and dilutions usually exceeding, in theory, Avogadro’s limit. Skeptics commonly assume that UMPs are indistinguishable from placebo and from each other. We find, in this 2003 thermoluminescence study of UMPs published in Physica A that:

//Ultra-high dilutions of lithium chloride and sodium chloride 10// <sup>//-30//</sup> //have been irradiated by x-rays and gamma-rays. It was found that, despite their dilution beyond the Avogadro’s number, the emitted light was specific of the original salts dissolved initially.//

In a 2008 paper, the team of Rustum Roy, professor emeritus of materials science at Penn State University, confirmed that it is possible not only to distinguish one UMPs from another but also one potency of the same remedy from another, with two different types of spectroscopy. They wrote:

//The results show that such materials can be easily distinguished from the pure solvent, and from each other, by the use of UV--visible spectroscopy and Raman spectroscopy. Spectra show clear differences between two different remedies and different potencies of the same remedy. This opens up a whole new field of endeavor for inorganic materials scientists interested in biological effects.//

Further, modern researchers are finding that UMPs are more than “just water,” as assumed by skeptics but instead are discovering new very interesting phenomena never observed before.

We find in this 2004 paper published in the //Journal of Thermal Analysis and Calorimetry// that UMPs have unique physical-chemical properties. The authors wrote:

//We conducted thermodynamic and transport measurements of the solutions and of the interaction of those [ultra-molecular] solutions with acids or bases. We thus show that successive dilutions and succussions can <wrap hi>permanently alter</wrap> the physical-chemical properties of the water solvent. The nature of the phenomena here described still remains unexplained; nevertheless some significant experimental results were obtained.//

Now that we know that UMPs are more than just water with peculiar and totally unexpected physical-chemical properties, let’s look at another of skeptic common assumption, namely that UMPs are “diluted to the point that no active ingredient remains.” Again skeptics are contradicted by modern scientific research. The authors of this 2010 paper wrote:

//We have demonstrated for the first time by Transmission Electron Microscopy, … <wrap hi>the presence of physical entities</wrap> in these extreme dilutions, in the form of nanoparticles of the starting metals and their aggregates.// 

Here you can see pictures of Stannum metallicum or tin in dilutions equivalent to 10<sup>-60</sup> and 10 <sup>-400</sup>.

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.//

Here you can see nanocluster of gold nanoparticles with lactose.

//Whereas the ensuing processes such as succussion and sparging producing numerous large air bubbles aiding nanoparticle levitation to the liquid surface, <wrap hi>forming a monolayer that was preserved in the serial dilutions.</wrap>//

Here you can see the preparation process of succussion and then dilution with succussion and you can see the layer of nanobubbles and the nanoparticles accumulating with the nanobubbles.

//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:

//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.//

It is very hard to understand why skeptics still maintain that homeopathy’s underlying principles are not founded in basic research.

This statement is contrary to current scientific research, which clearly supports the biological plausibility of UMPs. Finally, we can conclude, regarding the argument of implausibility, with the following summary found in a 2012 paper entitled, “On the Plausibility of Homeopathic 'Similitude'//”//:

//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 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.//

Now let’s look at plant research. We find a 2009 critical review reporting:

//The literature on the applications of homeopathy for controlling plant diseases in both plant pathological models and field trials was reviewed. Results: A total of 44 publications on phytopathological models were identified. 19 papers with statistics... In general, <wrap hi>significant and reproducible effects with decimal and centesimal potencies were found, including dilution levels beyond the Avogadro’s number.</wrap>//

The next question that needs to be answered is whether homeopathy really works clinically. Let’s first look at veterinary research! There are eleven clinical conditions with positive evidence in RCTs including infertility, mastitis, infectious diseases in pigs, etc. and there are four clinical outcome studies with positive findings, including epilepsy in dogs and Cushing's syndrome.

Now, let’s look at observational studies, which often provide valuable information that is complementary to the results of clinical trials, and it is particularly helpful to evaluate real life outcome over periods of many years. In this 2005 review paper entitled “Research on Homeopathy: State of the Art” it is stated:

//Observational research of homeopathic practice documents <wrap hi>consistently strong therapeutic effects and sustained satisfaction in patients.</wrap> Historically, homeopaths were among the first to introduce double-blind experiments in human subjects.//

Now, let’s look at two large-scale prospective observational studies conducted over many years. The first one is out of the UK, in which the author reports:

//This was an observational study of 6544 consecutive follow-up patients during a 6-year period. The// //Results: Homeopathic intervention offered <wrap hi>positive health changes to a substantial proportion -- 71%.</wrap>//

The second study is from 2008 out of Germany and Switzerland; and the author reports:

//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:**

//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.//

//Methods: 70 patients with severe sepsis received homeopathic treatment or placebo. 5 globules in a potency of 200 C were given at 12-hour interval during the stay at the intensive care unit. Survival after 30 and 180 days was recorded.//

//Results: On day 180, survival was statistically significantly higher with verum homeopathy (75.8% vs 50%, P=0.043). No adverse effects were observed.//

Now, let's read British skeptic Goldacre’s comments regarding RCTs in homeopathy, he wrote in The Guardian:

“//This [RCT] trial has been done, time and time again, with homeopathy... you find, overall, that the people getting the placebo sugar pills <wrap hi>do just as well</wrap> as those getting the real, posh, expensive, technical, magical homeopathy pills.”//

It would be really interesting to ask Goldacre whether he would still consider that the 26% extra dead people in the sepsis placebo group of this last study are **really** doing just as well as those receiving homeopathy.

Now the second RCT I am presenting is most important as researchers were able to isolate the homeopathic response and remove from the equation (which is always present) the prescribing skill of the treating homeopaths. It is reported:

//Two publications, a randomized, partially blinded trial and a clinical observation study, conclude that homeopathy has positive effects in patients with attention deficit hyperactivity disorder (ADHD). Prior to the randomized, double blind, placebo controlled crossover study; they were treated with individually prescribed homeopathic medications. 62 of 83 patients [or 75% accuracy in prescribing], who achieved an improvement of 50% in the Conners’ Global Index (CGI), participated in the trial.//

//Results: At entry of the crossover trial, cognitive performance such as visual global perception, impulsivity and divided attention had <wrap hi>improved significantly under open label treatment (P<0.0001).</wrap>//

//Conclusion: The trial suggests <wrap hi>scientific evidence of the [long-term] effectiveness of homeopathy</wrap> in the treatment of ADHD, particularly in the areas of behavioral and cognitive functions.//

Now, let’s look at systematic reviews which tend to carry the most weight in the hierarchy of scientific evidence. Let’s see if skeptics’ claim that “systematic reviews do not show supporting evidence for homeopathy” is true!

In 2004, medical historian, Michael Dean, published the first systematic review of all clinical trials of homeopathy published in the medical literature from 1821 until 1998. He found and analyzed 45 prospective trials and 205 controlled trials. Some of the main findings of his extensive research and analysis are:

//Homeopathy has a long history of scientifically conducted trials. The use of placebo was largely developed by Hahnemann, who had recognized as early as 1805 the need of a washout period.//

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.

//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>//

//Final conclusion: the ‘real-world effectiveness’ (effectiveness likely, questionable or unlikely), homeopathy falls within the category: <wrap hi>‘effectiveness likely’</wrap>. With pharmaceutical costs being what they are, the use of <wrap hi>homeopathy has the potential to lower pharmaceutical spending</wrap>. Following this overall review, the Swiss Government decided to include homeopathy in the Swiss statutory health insurance.//

Apparently, skeptics have not read this HTA carefully. Because they still claim that it’s not effective.

Likely the most compelling evidence of the effectiveness of homeopathy is found in the extensive records in times of epidemics. In 2003, I began reviewing the literature on homeopathy in times of epidemics; I have so far uncovered over 7,000 references of which 2,000 have been incorporated into this comprehensive text of now over two thousand pages, entitled “The Weight of Evidence”. All epidemics in which homeopathy has been involved since 1797 have been included in this extensive review of the literature. The main finding of this research is that:

//Results obtained by homeopathy during epidemics <wrap hi>reveal a very important and clear constancy: a very low mortality rate</wrap>. This constancy remains, regardless of the physician, time, place or type of epidemical disease, including diseases carrying a very high mortality rate, such as cholera, smallpox, diphtheria, typhoid fever, yellow fever and pneumonia.//

Let’s look at two diseases: First, **cholera**: The mortality from cholera in the nineteenth century was on average around **50% with or without treatment** and this regardless of the treatment received, other than homeopathy. On the other hand, homeopaths consistently had an incredibly low mortality rate. For instance, during the 1849 epidemic in Cincinnati, the mortality record obtained by two homeopaths was made public by public request.

Dr. Pulte and Dr. Erhmann reported having treated in total 2,646 cases with 35 deaths, or <wrap hi>a mortality rate of only 1.3%</wrap>, despite having 60-70 cases that were in a deep stage of collapse. After the epidemic they were accused by a skeptic of having falsified their records.

A public commission was set to inquire the charge, which was chaired by Alphonso Taft, who must have been a very credible person as he later became Attorney General and Secretary of War under President Grant and whose son became the 27<sup>th</sup> President of The United States. The commission confirmed that the results reported by the two homeopathic physicians were correct, as they had reported. The homeopathic physicians had kept a list of names and addresses of all the patients they had treated.

How is it possible that a 50 times lower mortality went unnoticed by the medical authorities of the nation, as this story attracted national attention, particularly in view of the fact that Cincinnati lost 7,500 persons to cholera within 15 months, which was 8% of its population and cholera would eventually return again. They had a very bad epidemic in 1832 already when a great portion of population has been wiped out already.

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:

//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.//

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//.”

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.

However, the mortality rate under good homeopathy should be less than 2 or 3%.

A survey conducted in 1928 among homeopathic physicians reported a death rate of <wrap hi>2.8 percent</wrap> among close to 11,526 patients.

Dr. P. P. Wells of Brooklyn, New York, commented that a death rate of even 2 or 3 percent is still too high under “right” homeopathy and gives the example of Dr. Reiss, who in his practice between 1843 to 1848 in the hospital of Linz, Austria, officially documented with the Government. He reported a mortality rate of 1%.

He continues (Wells), “ //We believe this because we have the proof of this in our own experience. In a practice of this system which reach forty-three and two-thirds years, which most of the time has been very large, and of a general character as to the diseases treated, of which, no doubt, pneumonia has made an average part, I have// //**not lost one case**// .”

In the 1930’s, two American physicians reported having treated in their joint practice 250 cases of //all// types and degrees of severity, with but 4 deaths (and a 1.6% mortality rate), all of the four being over 70 years of age.

I have personally confirmed the experience of my predecessors. I have treated over 180 cases of pneumonia, of which about 10% were in critical condition, without a single death. It is actually hard to conceive someone dying of pneumonia, having a Hahnemannian homeopath at the bedside, even the most critical case.

Thank you for your unreserved attention and I hope that this condensed summary of the evidence in favor of the effectiveness of homeopathy will incite to put your blinded passion aside and stimulate curiosity as it is found in true scientists. (Audience clapping)

===== Steven Novella, part 1 =====

Dr. Steven Novella: Thank you for having me back at UConn, thanks for inviting me to this exchange and thank you Dr. Saine to agreeing to talk to me on a subject I find very interesting. Yes, I am a skeptic; I heard I got some laughter from the audience. Skeptic is not a bad word it just means we really want to know what is true, that’s all! I have no dog in this hunt; it doesn’t affect me personally at all! My reputation is based only on the fact that I try to educate the public about science and when I formulate opinions about scientific questions, there is a certain process, a methodology that we follow and I want to know what the real answer is, what's the actual answer. **Does Homeopathy work?** That’s a very interesting question and I will follow scientific evidence wherever it goes.

So, I too am going to break up my talk into two parts: Talking first about the plausibility of Homeopathy and then what does the clinical evidence tell us -- does Homeopathy actually work? For just a very brief background: homeopathy is based upon several laws developed by Samuel Hahnemann, a little bit over 200 years ago:

  - The Law of Similars 
  - The Law of Chronic Disease 
  - 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 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.

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 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.

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!**

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.

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.

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.

And we know this historically, there is countless examples of this level of research.

N-rays is the favorite example of skeptics, this is from the turn of the century -- French scientists just thought they discovered a new type of X-rays, that they called N-rays and this was seen by 20 different labs that N-rays really exist -- until you blinded the observation and the effects utterly vanished and that's why you probably never heard of N-rays -- because they don't exist! But there was this level of evidence showing that they do exist -- because this level of evidence is not compelling, it's mostly wrong, it's mostly delusional and it's mostly false positive.

There was one attempted replication of this study and the advantage of that replication was that they actually did statistical analysis, which the original Rey’s study did not do, and what they found was there was no statistically significant difference -- that's negative. So this one replication that we have was actually negative. So, the plausibility of water memory remains exceedingly low and has not been established by any strike of imagination. But what does it even really mean? What are the implications? Let's say, that these ultra structures in water molecules last for some period of time. What would that even mean?

What we are talking about is that those structures would have to survive for a long period of time, they would have to be very stable. When you put the homeopathic solution onto a sugar pill and then it absorbs into it and then evaporates, it would have to then transfer it over to the sugar pill. So we will need to have the same kind of structures, I guess, in sucrose and then when you eat it, and it dissolves in the acid in your stomach it would have to survive that and then it would have to survive absorption into your bloodstream and passage through the liver and that information would somehow have to find its way to whatever part of your body it has its physiological effect. That's a lot of missing steps from the research. Showing there is some transient differences in the luminescence in ice crystals of deuterium is a long way away from showing that that supports a biological effect of homeopathic remedies.

Some homeopathic remedies are dissolved in ethanol, not water. So there have been studies looking at ethanol as well, but all such studies, again, have significant methodological flaws. They are mostly not blinded. In case you you haven't caught on by now, 'not blinded' means nobody's going to trust the result, because in science not blinded is not reliable. You can't rule out that there is just researcher bias.

What about nanoparticles? Dr. Saine was very impressed by the Indian research showing that there are nanoparticles in homeopathic remedies, thinking that this now refutes the view of the mainstream scientific community that ultra-dilutions don't have any active ingredients left. Well, again -- this was a small study that was uncontrolled and unblinded. In fact, one of the authors, Dr. Kane of that study emailed a colleague of mine at Science Based Medicine -- Dr. Hall and said, //“Hey, you guys are skeptics of homeopathy but we just did this study showing that there are these nanoparticles in homeopathic remedies and we want to engage with you and talk to you, what do you think about this?”// And she wrote back, //“that’s great we would love to talk with you, here is my first question: why wasn't this study blinded or why weren't there any controls?”// and the response was -- //“we don't talk to nasty skeptics.”// End of discussion, refused to engage in even a very basic way, the most basic scientific question -- why didn't you do a controlled study? Uncontrolled, unblinded, small study, looking for anomalies! Of course, you will find anomalies! Every time you do research you will find anomalies. And going from that to say homeopathy works or it’s even plausible. That’s why I'm still a skeptic and that's why this is not compelling to anybody who is a reasonable unbiased scientist, in my opinion. This is why the scientific community doesn't accept homeopathy after 200 years -- because they never get beyond this level of evidence. This is just the most preliminary, this is the kind of stuff that should have been done 200 years ago -- or let's cut them a break and say 100 years ago, after the scientific methodology was better established. Now, 200 years after the fact we are still getting these just completely unconvincing exploratory studies. It's not very convincing at all.

Despite these preliminary anomaly hunting kind of studies that are equivalent of N-rays, homeopathy remains in the minds of the general scientific community as being implausible in the extreme. You would have to rewrite major swabs of scientific knowledge in order to have homeopathy be plausible and we don't rewrite the textbooks without good solid evidence.

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.

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.

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 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 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.

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.

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 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.

There is all the same level of evidence. But whenever you drill down and you try to find a study that shows a clinically significant effect, that's statistically significant in a large rigorous trial that stands up to replication -- they don't exist. You never get all of those things at once. You can get one or two of those things but you never get all four at once. You can see -- 'high statistical significance, oh, but wait, that was unblinded.' Or, 'oh, there is a statistical significant effect but it's clinically insignificant' and therefore probably just in the noise of doing clinical trials. Or what looks like an impressive study but it was small and it doesn't stand up to replication. But you never get all four of those things at once -- a clinically significant effect, a statistically significant effect that stands up to replication in rigorous trials -- that's because homeopathy doesn't work and the principles of homeopathy are not real. Thank you! (Audience clapping)

Presenter: We are now beginning the rebuttal phase of the debate and Dr. Saine lost some time from his last presentation. Would you like us to shorten your time for this part?

Dr. Saine: Yeah! I think you told me it went 3 minutes over.

Presenter: Right, so he will have seven minutes and he can only rebut what was previously presented.

Dr. Saine: Did you say 7 minutes, 7 weeks or 7 years. (Laughing)

Presenter: 7 Minutes.

===== André Saine, part 2 =====

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 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. (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?”//

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!

27% dropout over eight years is not much! Actually, it doesn’t say 27% percent dropout, it says there were 73% that did 8 years, maybe some did seven years and some did six years! It's not a dropout!

In terms of stability of the molecules of water-bounded model, skeptics always come with nanoseconds whereas the study shows that the structure of new physical-chemical properties of water that were studied with spectrometry, increase with time, it's not nanoseconds -- at 500 days those properties are increased. I could show you the graph of that, but we don't have the time.

You mentioned Cochrane's collaboration review on ADHD -- one of the three studies was pure homeopathy -- that was the Swiss study! The other one was done with Sankaran, that's not Hahnemannian homeopathy! You cannot compare homeopathy, which is a very particular way of practicing, with something that is speculative. The two other studies were not homeopathic studies, they don't relate to homeopathy and that's the problem with Ernst, who is your main witness -- he does not understand homeopathy! Your main witness is not a homeopath, he is not even trained in homeopathy, even though he claims he took two months of lectures and six months of training -- while in Germany, you need to have two years of study to be able to pass the exam -- he never wrote the exam, but he claimed to be a trained homeopath for almost 20 years!

In terms of Benveniste, it's very interesting that skeptics mention that Benveniste was contradicted by the literature later on and so on, but it's interesting that they don't cite that there were confirmations of the work of Benveniste -- that was confirmed by 17 different experiments over 25 years over multicentre in Europe and is so well-confirmed, the study of histamine with basophils, that the book is closed on it. The work of Benveniste is confirmed throughout the literature. I cannot believe that you bring it up! You should review the literature on the particular subject to make sure that you are up-to-date -- this was done in 1999, 2000, 2003 and 2009 at the four different studies by independent researchers. Thank you! (Audience clapping)

===== Steven Novella, part 2 =====

Dr. Novella: Ok, that was a spirited rebuttal! It's important to recognize that I'm not trying to prove that homeopathy doesn't work. Proponents of homeopathy have to prove that it does work, that's how science operates. The burden of proof is on somebody who is trying to change the science books who's trying to show that here is a new phenomenon that exists, it's real. It exists in physics, it has an effect on body and we should be using this as a medicine. Okay, show it to a reasonable threshold of scientific evidence. I never set out to prove it doesn’t work, I am just trying to answer the question -- have the homeopaths met their burden of proof to show that it exists and it does work? And they haven't, they are so far away from it, that it's unbelievable, they're not even near that threshold of showing that it's real and that it works.

In terms of the Swiss versus the UK study, you'll notice, I didn't bring up the UK or the Swiss study in my slides, I was simply responding to Dr. Saine touting the Swiss study, which was not reliable. I usually don't rely upon governments to tell me about science, first of all, I usually rely upon scientists reviewing scientific literature, that's what I rely upon. And when scientists review the homeopathic literature, the bulk of those reviews show that there is insufficient evidence to conclude that homeopathic remedies are more effective than placebos -- that is uncontested, that is the conclusion.

The only thing that is contested is what kind of spin you put on it -- do you say we need to do more research or we can't rule out an effect and it might be reasonable to use this or the uncontrolled studies show that some patients feel better. There are all kinds of spin you can put on it, but there isn’t a single indication for which any specific homeopathic remedy or just homeopathic treatment in general has been shown to have these statistically significant, clinically significant effects above and beyond placebos in rigorous trials that stand up to replication. That’s the threshold to accept something is real in medicine and science and it doesn't exist for homeopathy. They haven't met their burden of proof.

Homeopaths tend to try to make their case with studies that are flawed, preliminary, small, weak, that have curious things about them like using the wrong endpoint like 180 days versus 30 days and speculate endlessly about long-term effect. Okay, but this is odd, you have not established any of these things that you are speculating about. If this was not homeopathy, if this was a drug, I would conclude that this doesn't work! This would not pass the FDA and shouldn't be used in clinical practice based upon this level of evidence. So, that is the position that we take -- that homeopaths have not met their burden of proof and we are not inventing this threshold or these rules or this way of analyzing the data just for homeopathy; this is science-based medicine, this is evidence-based medicine, this is how it gets applied across the board. The gap between skeptics or science-based proponents and those who are convinced that a treatment which isn't in the mainstream, like homeopathy, works, is a deep appreciation of how complicated and how flawed the medical literature and the scientific literature is.

Let me give you a couple of additional examples: There is a well-established publication bias, a positive bias in the literature; it's called the “file drawer effect”. If you have a positive study you are much more likely to publish it than if you have a negative study. A journal editor is much more likely to publish the positive study than a negative study because it gets them better headlines; it proves their impact factor more -- well established. There are mechanisms for estimating the publication bias -- you could look at what's called “a Funnel plot” -- remember the bell curve I told you about; if you do that, if you plot out where all the results are against the quality of the study, it may appear that all the negative studies that statistically should be there, are missing or they're underrepresented! Where are all the negative studies? And we see this all the time, it's because people aren't bothering to publish the negative studies. Well, if you don't do that analysis and you just do a meta-analysis without doing a Funnel plot or any kind of the statistical measure of publication bias, your results will be unreliable. These are lessons that have been learned over the years as we incrementally improve our understanding of the complexity of medical and scientific research.

There is also a researcher bias. Just last year Simmons et al. published a study, a very interesting study, where they made up a hypothesis that they knew to be wrong -- “listening to music about age will make you actually become physically younger”//.// They made an impossible hypothesis and what they demonstrated was that by varying four variables of how you design and conduct research, you can manufacture a statistically significant positive result, most of the time. 60% of the time you can create a positive research from data that we know is negative and these variables are very innocent -- When do you stop collecting data? Which comparisons are you going to make? What statistical analysis are you going to use? Every researcher has to make those decisions when they design and execute a study and they could, very innocently, we are not talking about fraud, we are talking about just innocently choose the way of looking at the data and comparisons to make, that make their curves look good, make the data look good which means that they're picking a signal out of the noise. Researchers do this unconsciously. Even if you are researching something that has zero effect whatsoever, you can manufacture positive results 60% of the time just by playing with the variables that all the researchers play with and then differentially publish a positive ones and not the negative ones. So when we look at the literature or any question we expect there to be this massive positive bias both from researcher bias and from publication bias and Dr. Unitus when he looks at the literature and says “There it is!” You see the positive bias and the error in the literature, when you go back at the questions that have already been settled. 

So, how do we know anything that's true in the medical literature? Well, you need really rigorous studies, you need to have large data sets so statistical flukes are ruled out, you need to have a clinically significant effect size, so that you make sure there isn't just some systematic error in the way you're looking at the data and you need to replicate those studies -- if the effect is real it will replicate. Effects that are statistical flukes don't replicate. Until we've done multiple replications we have no idea if the effect is real or not, all we know is 'ok, that's interesting, this is worth more research' -- that's really the only thing we should reasonably conclude based upon that.

When you have a phenomenon that over decades fails to reach the threshold, does never seem to replicate high quality studies, you begin to wonder why we are still studying this, it doesn't seem to be real. The research is going in circles, it's not getting anywhere.

The research of Jacques Benveniste was found to be fraudulent. It was probably due to a research assistant of his who was trying to make her mentor happy by cooking the books, if you will... don't know how conscious it was but when her ability to author the entries in the books was blinded and essentially when the experiments were set up that she couldn't cheat, the effect went away. So when you dial up the rigor of the study to remove the potential for bias, potential for fraud and the effect goes away, that’s a pattern we see in something that is not real. The book is not closed on this, this has not been established to the satisfaction of the general scientific community because once you factor out the fraud and the potential for fraud, there just isn't anything there that's very compelling. In fact that research assistant may have been present at other labs that replicated the same research, that really wasn't an independent replication, if you had the same person involved.

The problem is that often proponents of homeopathy -- and we've seen this with many other pseudo sciences that we investigate -- they prematurely settle upon the conclusion that 'all right, this has been established, it's real, let’s move on'. So, no! Wait, wait, wait! It hasn't been established, we don't know whether this is real or not, you haven't reached that threshold that we generally accept as the threshold for compelling evidence that is probably true.

I never said that observational data was worthless or not useful! Observational data is just not useful for establishing efficacy, we don't use it that way, but you can use it to establish things if you have really good, solid evidence that triangulates well, but it has to be put to the context of plausibility and of efficacy trials and when you do that with homeopathy, again, it doesn't work. If these historical cases of curing every case of pneumonia etc., if there was any reality to that at all, if it was a tenth to that effect, it should be a trivial matter to establish it in randomized control clinical trials that would be compelling to objective scientists and it hasn't been done. You have to wonder why that is! Thank you! (audience clapping)

Dr. Saine: Regarding the Freis study, the ADHD study, you said the group that was the verum was open label -- open label before the trial, double-blind afterwards! Let's be clear about it, so it is a double-blind randomized study, divided in a random way and it was double blind. The Swiss study and HDA is not a government study, it's a government- commissioned study through the scientists! It's probably the highest level of evidence that the government can use to know, for policy! Thank you. (Clapping)

Dr. Novella: According to your own slide, the p value in that code was on the open label data, that's what achieved the p value of .001. But that statistical significance was attached to the open label data, I am just going by your own quote, that was on your own slide...[some reaction from Dr. Saine] then change your slide.

The Swiss study was not a scientific study, it was just a review of the evidence by a committee. Again the UK committee found that the evidence was not compelling for homeopathy, maybe I am wrong about the 'witchcraft' statement, and the last time I read through that it wasn't the conclusion; I would be happy to correct myself if that is a mistake... but that's irrelevant because they concluded the homeopathy doesn't work, is not plausible, shouldn't be used and shouldn't be researched. That's what they concluded. But in any case they were basing their conclusion on the data that actually tells us if something works, the best evidence, the most rigorous control evidence. The Swiss acknowledged that [it] didn't support homeopathy's efficacy that’s why they emphasized the data, the type of analysis that is uncontrolled and unblinded because that's the realm where placebo effects predominate and... yes, there are placebo effects, the placebo effects contaminate the literature, it's a very complicated phenomenon... I actually have an hour-long lecture just on placebo, because it's very difficult to understand, but the bottom line is, there are nonspecific therapeutic effects and then there is a lot of the statistical illusion, a lot of bias in reporting, etc. So, you have to thoroughly control for placebo before you conclude that the treatment itself has an actual effect and even the Swiss committee that was trying to spin as positive as they could, couldn't conclude that the data shows that there is efficacy for homeopathy. Thanks! (audience clapping)

===== Cross-examination =====

Presenter: At this point in the debate we have 20 minutes of cross-examination and this is where each speaker will alternatively ask a question and they're only allowed one minute to answer the question. So you need to pay attention to the timers here they will be queing you that you're going over time and we hope that you respect our request as the audience. If you have other questions that come up as you doing this, please be sure to put them on your cards and pass them so we can get ready for the end that we have a good group now. Thank you!

Dr. Saine: Two-part question, Steve! First part, since our subject is the well- being of our fellow human beings, the outcome of this debate carries a certain amount of responsibility. In light of this responsibility, can you state that you have investigated homeopathy thoroughly and with an open mind and have found out beyond reasonable doubt that this is nothing else than placebo? Second part, Hahnemann has written over a thousand pages of text on homeopathy -- aside from his Materia Medica Pura, aside from Chronic Diseases, aside from his Organon. There have been many scientific studies -- Scientific Foundation Of Homeopathy, The Trials Of Homeopathy, The Swiss Study, //The New Direction Of Homeopathic Research, The Emerging Science Of Homeopathy, The Fundamental Research In Ultra-high Dilutions In Homeopathy, Lecture On Solution Chemistry, Ultrahigh Dilutions in Physiology and Physics// , I could bring tons and tons of books -- which one of these have you read, thoroughly?

Dr. Novella: None of them, I have not read any of those books, but I have read hundreds of articles on homeopathy. I have, with an open mind, thoroughly investigated both the clinical evidence, which is my expertise -- evaluating clinical trials. I'm not a physicist, I'm not a chemist, so I listen to what the physicists and chemists have to say, I don’t interject my own opinion, but I'm a clinician and a researcher and I do know how to evaluate clinical science so that's how I spend most of my time -- reading clinical trials of homeopathy for rigor and outcome and seeing what they conclude. Now, if homeopathy worked and the evidence showed it does work, then I would have no reason not to say 'Yes, hey, look at that, homeopathy works, there is something really interesting going on here!' As a practitioner I'm always looking for new ways to treat my patients and something as benign as homeopathy, in terms of the remedies themselves, not necessarily the practice of homeopathy, but the treatments themselves are nontoxic. Hey, I always love to have non-toxic options to give to my patients, so there is a huge incentive, if anything, for me to be open to homeopathy, but if that's what the evidence showed. The evidence simply doesn’t show that it works.

My question for you: Is there one homeopathic remedy or treatment approach that has been shown to work for any condition, to a reasonable threshold, where there is replicable, statistically significant, clinically significant, well-designed clinical trials, the kind of evidence that I laid out, where I and the scientific community generally sets their threshold. Is there efficacy data showing that homeopathy unequivocally works for anything?

Dr. Saine: It's an excellent question. First, you have to understand homeopathy -- most of the RCT trials, that are done in homeopathy, are done by scientists that do not know what homeopathy is, like Ernst, for instance. So therefore, they don't conduct a proper trial of homeopathy. There are very very few RCTs that were done with proper homeopathy. One is the three trials that Jacobs did with children with diarrhea in Nepal, Nicaragua and Mexico. She did a meta-analysis and it was statistically significant. So this is one, a very good one, done in three different places, with a meta-analysis. The other one is Freis study, which is excellent because they first see who responded to homeopathy, then divide the group into two groups -- placebo and the verum homeopathy, blind and they crossover and then they could see that there was a huge difference between the two groups and the group that got the homeopathy later on also got better. This is probably the best trial of homeopathy. Of course, it needs to be replicated and needs to be replicated in the same way, with very good genuine homeopathy.

Dr. Novella: So the answer is NO!

Dr. Saine: There is...

Dr. Novella: Both of those studies were terrible and the meta analysis was unreliable...

Dr. Saine: You use Ernst as one of your main references, a foremost expert of homeopathy, who has incidentally altered at least five systematic reviews and meta-analysis on homeopathy, of course, all with negative findings. In view of the following three facts:

  - For many years, if not decades he called himself a trained homeopath, when he was not, which incidentally is illegal in Germany for a practicing physician to falsely use this title.
  - He is constantly misrepresenting homeopathy for referring to it, when it is not, in most of his papers, related to homeopathy, that’s in pure review journal as it, as I recall, is on adverse effects.
  - Richard Horton, the editor-in-chief of Lancet, said - “//Prof. Ernst seems to have broken every professional code of scientific behavior.”// How you, as a man of science, a champion of science-based medicine, can use this man as your main witness to tell you what is homeopathy?

Dr. Novella: First of all, I personally know Edgar Ernst, he is a good guy, he is a professor of complementary and alternative medicine, he does have training in homeopathy, maybe not up to your satisfaction but these are all your //ad hominem// types of points that you are trying to make here... I don't rely upon him, I rely upon the evidence. I could look at the evidence for myself that's where my expertise is! And he is not the only one to do systematic reviews. I can go out of my way and quote somebody other than Ernst in a couple of systematic reviews -- he's not the only one to have done that. Ernst's methods are fine. He has published over 1000 papers, he has a team of people -- at least he did before he semi-retired -- that were experts at doing systematic reviews and meta-analysis.

One further point, even if I accept your point that most studies in homeopathy are not good studies of homeopathy because they don't understand it, all you are saying is that literature is not good -- that doesn't add up to 'homeopathy works!' Again, I am not trying to prove it doesn't work, you have to prove it does work and saying the studies aren’t good doesn't prove that it works. It just shows you that the studies out there are not very good. But even when you look at the best studies, the most rigorous studies, they never add up to an effect, like the diarrhea studies you pointed out to, they were extremely flawed, when you look at the details.

Dr. Saine: And I agree with you!

Presenter: Excuse me! It’s his turn to ask you a question.

Dr. Novella: Let's go to the plausibility for a second, I am going to ask you a similar question -- do you say, especially after my criticism of specific studies that you cited, would you say that the scientific community should accept, based upon existing data, that there is a plausible mechanism for how homeopathic remedy could have a physiological effect in the human body?

Dr. Saine: We don't know the full mechanism. There are three aspects to mechanism, one is the remedy -- the UMPs -- is there validity to UMPs? Scientific research shows, yes, from multicentre, from many different types of spectroscopy. I just showed some examples today. So, yes, there seems to be some validity to the UMPs that is biologically plausible. The second thing is the interaction between the UMPs and human beings. Do we know anything about that? We know nothing about this. Third is the response of human beings to UMPs. We nothing about this, we don't know the mechanism. One thing you have to understand is, homeopathy has a very very low budget internationally, about 1 to 2 million a year to do research in homeopathy, which is one hundred thousandth the amount of money that they spend on allopathy. We spend one to two million, that's the amount of grants we can have... it's very very difficult to do research but the research we had so far has been solid to develop the base of homeopathy.

It is interesting to note that since the middle of the 19th century neither you nor any other skeptic has ever commented with an in-depth analysis on the extraordinary results obtained by homeopathy in epidemics, namely a consistent and extremely low mortality rate. Can you please explain your complete silence on the overall extraordinary results, consistently and predictably obtained by homeopathy in epidemics, which I briefly addressed in the debate and have been greatly authenticated by a number of reputable independent medical historians.

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?

Dr. Saine: The use of combined remedies and complex remedies is not part of homeopathy, it's not considered homeopathy, so it's a misrepresentation. So, if they say 'homeopathy', it's wrong, it should be called homeotherapeutics. 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 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.

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 study. They 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 did. So 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. 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 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 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't. Its 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.

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 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 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 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.

===== Questions from the audience =====

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 is it -- 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!

Presenter: So, let me clarify, your answer to the question would be 'yes'? (Laughing)

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 it. It 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?

Dr. Novella: Some do, some do not! There is at least a system in place, now it's imperfect because humans are imperfect, government isn't perfect and regulations aren't perfect and we are in a process, both my own group and scientific community in general, of trying to improve the system by changing the rules to eliminate the pharmaceutical companies trying to wiggle around the regulations that already exist. So we are just as skeptical with the pharmaceutical industry and the data that they produce. They also have publication bias, they try to hide data, they try to design studies to give their drug the best chance of working and we call them on their own shenanigans, absolutely!

Presenter: So who specifically are you working with?

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..

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.

Audience: They can’t do that any longer?

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: 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?”

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 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.

Presenter: Thank 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. Saine: I think 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!

Presenter: There's a couple of other questions on the pneumonia trial that was supported by other members of the audience, then 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 effect, since they don't think about their treatment?”

Dr. Novella: That'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 it, but it's not the only source of placebo effects. There 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 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.

Presenter: Thank you. This is a question from an attorney who specializes in medical malpractice. Perhaps 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 a homeopathic physician or homeopathic manufacturer. I submit that western medicine is the real pseudoscience.” Do you wanna respond to that?

Dr. Saine: I 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 a 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 allopathy. So 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 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 a long-term pathology and anything can go in the cell now that was protected before by a small receptor. Now you have a chronic pathology that is perhaps irreversible!

Dr. Novella: It'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 cultural, societal or regulatory, perceptual 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 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 have. It’s self-corrective, it'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 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.

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. 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.

Presenter: Thank you both very much and thank you to the audience. They each have a couple of minutes of closing remarks. Before they give their closing remarks, I will sign off at this point. Note that you'll be notified, this link will be provided to you, as well as to the rest of the world, so that you can watch this again and think about it some more. Thank you very much for involvement.

I was reminded that I was supposed to ask for a vote, so if you came in to the session today with an open mind and believe that you are more favorably disposed to the idea of homeopathy, can you please raise your hand. Have you changed your ideas? For those that already came in believing and your mind has not changed, you are not supposed to participate in this particular question, ok? So, more favorable, can you please raise your hand? Three. Less favorable, can you raise your hand -- and we have two. Now for the closing arguments that might change your mind again.

===== Closing remarks =====

Dr. Saine: Homeopathy is not only great medicine but the best medicine and is likely the greatest discovery of all time. Why? Because homeopathy directly addresses the capacity of the organism to regulate itself in a gentle, pleasant and durable manner, without endangering life or the environment.

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 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.

Genuine homeopathy has showed throughout its history consistency with:

  - The laws and principles of chemistry, physics, and biology. 
  - The fundamental principles of medicine. 
  - The pure scientific method and, 
  - Its results are consistent throughout its history. 

Homeopathy is rational, safe, efficacious, predictable, beneficial, wise, and likely the greatest gift for suffering humanity.

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'.

I also presented basic research //in vitro// and [plant research showing that UMPs can trigger physiological response and finally I have summarized the clinical, observational and epidemiological research showing the efficacy and real world effectiveness of homeopathy. What more will it take for the scientific community to recognize the validity of homeopathy?
However, don’t be surprised if skeptics don’t change their view on homeopathy despite the overwhelming evidence in its favor as they are so entrenched in their belief that homeopathy doesn’t work, that it can’t work.

As Goethe said, "You see only what you know."

They have created, for more than 200 years, a giant strawman, by their flagrant misrepresentation of homeopathy, which greatly invalidates all their arguments.]((Due to time constraint, this part of Dr. Saine's written conclusion was skipped during the debate; with his permission, it was included in this transcription))

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 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.

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 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 work. Thank 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!