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Why Yet Another Study of Homeopathy?

homeopathy ADHDThis post needs a bit of a background. A few weeks ago we noted that the Dean of Pharmacy at the University of Toronto was organizing a trial on using homeopathic preparations for the treatment of ADHD. A letter to the Dean asking how a Faculty of Pharmacy would get involved in studying something that is dismissed by the vast majority of the scientific community seemed appropriate. Eventually this letter was signed by more than ninety scientists and physicians and was sent off. There was no reply. In our view, not only is this a waste of funds, it adds an aura of respectability to a scientifically bankrupt notion. This is especially disturbing now in face of the measles outbreak since the private clinic where the study is to be carried out is a supporter of “nosodes,” the homeopathic “alternative” to vaccination. The original letter sent to Dr. Boon is reproduced below the following opinion piece that appeared in the Montreal Gazette.

Academic Freedom Comes With Academic Responsibility

Academic freedom is sacrosanct in universities. Researchers must be free to pursue their ideas, be they conventional or peculiar. But academic freedom also includes the freedom of others to question those ideas, and scholastic consideration dictates that those questions be addressed, especially when they are posed in a courteous letter signed by ninety scientists and physicians from around the world, including two Nobel Laureates.
The letter in question was sent to Dr. Heather Boon, Dean of the Leslie Dan Faculty of Pharmacy at the University of Toronto and focused on a study she was organizing to investigate the use of homeopathic preparations in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children. Those of us who signed the letter, along with the vast majority of the scientific community, believe that numerous studies have concluded that the effects of homeopathy do not extend beyond a placebo response. The letter sought Dr. Boon’s views on why a Faculty of Pharmacy was organizing a trial that legitimizes homeopathy, a practice that has no scientific plausibility.
Homeopathy is not an umbrella term for alternative modalities. It is a very specific practice that originated before the dawn of the scientific era when little was known about disease or chemistry. Samuel Hahnemann, a well-meaning German physician, concluded that a substance that causes symptoms in a healthy person cures those symptoms in a sick person if it is sufficiently diluted. His process involved thumping the solution into a leather pillow between dilutions, and finally using a drop to impregnate a sugar tablet that would then serve as a “homeopathic medicine,” the term deriving from the Latin for “similar” and “disease.”
Hahnemann could not have realized at the time that the final solution did not contain a single molecule of the original substance. Today, homeopaths have to contend with chemical knowledge and have proposed that the curative effects are to be explained by the sequential dilutions leaving an imprint on the solution, although they appear to be at a loss to explain how such an image is transferred to a sugar pill or how a molecular ghost can have healing properties.
Stymied by the implausibility of nonexistent molecules having therapeutic potential, homeopaths point to papers in the scientific literature demonstrating a larger than placebo effect, as well as to the millions around the world who use homeopathy with satisfaction. Neither of these is surprising. Toss a hundred coins into the air and count heads and tails. Maybe 45 heads, 55 tails. Maybe 48 tails 52 heads. But do this a hundred times, and one event may come out 30 heads and 70 tails. If this is the only one reported, the impression would be that the coins were not fairly weighted. So it is with studies of homeopathy. Just by chance alone, some results will indicate efficacy. That’s why we look at all the studies and come to the conclusion that we are looking at a placebo response, which of course is valuable and should not be dismissed. Indeed, couple the placebo response with the fact that homeopathic treatments are administered by caring people who spend a lot more time with patients than physicians can, and that they mostly target self-limiting conditions or diseases that have their ups and downs, and you have a formula for satisfaction.
ADHD is a serious condition that merits serious research. Apparently the University of Toronto researchers carried out a pilot study involving homeopathy that seemed to indicate benefit. That study, however, was unblinded, devoid of randomization, had no control group and relied on a subjective outcome, making any data derived from it essentially meaningless. Even if we were to attach some importance to the claimed reduction of symptoms, the effect was about half of that seen with conventional medication, making the homeopathic treatment clearly inferior. Furthermore the proposed study would use individualized treatments for each subject as determined by a homeopathic consultation, so at best the results would be ambiguous in terms of making any recommendation.
The study is actually to be carried out at the Riverdale Homeopathic Clinic, a private institution that also offers ear candling, cranial sacral therapy and “nosodes,” which are homeopathic versions of vaccines. No public funding is involved; support comes from a foundation dedicated to alternative medicine. Nevertheless, one wonders why with various nutritional and biofeedback treatments with significant potential for helping with ADHD needing exploration, a scientifically insolvent notion is being pursued. One also wonders why a Dean of Pharmacy at a major Canadian Institution did not take the time to respond directly to repeated requests for her comments on a contrary opinion expressed by a large number of notable scientists and physicians.

ORIGINAL LETTER

Dear Dr. Boon

The following originates from the McGill University Office for Science and Society and has been signed by scientists and physicians from the international community. We are all devoted advocates of academic freedom and support the right of researchers to pursue any field of study they feel has merit. But we also feel that it is fair to ask colleagues questions about how a particular study they are engaged in may contribute to the bank of scientific knowledge. It should be emphatically stated that those who have added their name to this letter, including two Nobel Laureates, in no way wish to interfere with your research. Everyone is just interested in your response to the concerns expressed here.
Those concerns deal with the trial we understand you are organizing to investigate a homeopathic approach to the treatment of ADHD. First, let us point out that the McGill Office for Science and Society accepts no funds from any vested interest; our only allegiance is to the scientific method and to evidence-based science. It makes no difference to us whether any substance, including homeopathic products, is regulated or not, as long as the decision is arrived at through proper scientific evaluation rather than emotion, “they say” or pressure from vested interests.
Along with the majority of scientists, we find the notion of nonexistent molecules having a physiological effect through leaving some ghostly impression in water that is then transferable to a sugar pill simply untenable. Even if some sort of “memory” effect prevailed, there is no reasonable explanation for how it could affect biology. Furthermore, after all the sequential dilutions and succussions, the original impurities in the solvent would be more extensively present in the final solution than any component from the original homeopathic source. After evaluating the scientific literature, including a comparison of 110 homeopathic studies with 110 conventional studies for a number of disorders and outcomes, the most likely conclusion is that any benefit attributed to homeopathy can be ascribed to a placebo response.
Generally, scientists look askance at homeopathy, but don’t bother much with it because they consider it to be harmless folly. Unfortunately, this is not the case when homeopaths recommend “nosodes” as alternatives to vaccination, or attack the use of antibiotics for infections, or offer unproven treatments for ADHD.
The reason for this extensive email is to solicit your rationale, given your training as a pharmacist, for the study you are carrying out. Is the motivation a concern that parents are wasting money and possibly sacrificing effective treatment by resorting to homeopathy for ADHD, and that the study may clarify the situation? Or is there a belief that there may be some factor other than a placebo response involved? In that case, what mechanism may be operative?
You allude to the results of a pilot study that warranted this further research. That study, however, was unblinded, devoid of randomization, had no control group and relied on a subjective outcome, making any data derived from it highly questionable. You also note that the reduction of symptoms found in the pilot study was about half of that seen with conventional medication, making the homeopathic treatment clearly inferior.
Basically, as you have gathered, we are curious about why, given the need to investigate natural therapies that may actually have a potential for benefit, and faced with a scarcity in funding, a Department of Pharmacy is interested in investigating a subject that has been addressed extensively in the literature and has been found wanting both in evidence and plausibility. There is also a concern that just the mounting of such a study by a highly reputable researcher at a top notch university will be used by homeopaths to justify diverse aspects of their practice, including steering patients away from evidence-based treatments.
Looking forward to your comments,
Regards
Joe Schwarcz
Director, McGill Office for Science and Society

David Harpp
Macdonald Professor of Chemistry
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How can a pharmacist believe the unbelievable?

pharmacistHow can anyone trained as a pharmacist, with courses in chemistry, biology, and physiology believe that ghostly impressions of molecules imprinted onto sugar can cure disease? Michelle Boisvert, a Quebec pharmacist, not only believes in the power of non-existent molecules, she runs HomeoCan, a company dedicated to selling “drugs” that contain no active ingredient. She has now had a run-in with the Quebec Order of Pharmacists resulting in her being fined $17,000 and being kicked out of the Order. This has a troublesome angle. She wasn’t kicked out because she is dispensing nonsense, but because she was using her position as a pharmacist to promote a commercial product.

Truth be told, you cannot be kicked out of the Order for selling homeopathic products because they are legal in Canada. But any pharmacist who dabbles in this medical oddity is either unethical or frighteningly scientifically illiterate. I know that many people defend homeopathy justifying it based on its popularity. Well, science is not a popularity contest, it is evidence-based. And the evidence is that “drugs” that contain no active ingredients cannot have any efficacy. Unfortunately many people are confused about what homeopathy is and think that it is just an umbrella term for “natural” or “alternative” practices. It is not that. Please do take a few minutes to read this excellent article that clarifies the practice of homeopathy by colleague Dr. Harriet Hall.
http://www.csicop.org/si/show/an_introduction_to_homeopathy

 

Dr. Joe Schwarcz

Ebola scams are sickening

ebolaWe’ve seen it before. A medical crisis emerges and the scam artists crawl out of the woodwork. Fearful citizens pop open their wallets and fork out hard-earned money for nonsensical “cures.” When it comes to a disease for which science cannot offer an effective treatment, quacks quickly rush in to fill the vacuum. This is just what is happening with Ebola. Claims about preventing infection, and even treating the disease, range from the laughable like eating organic dark chocolate to the totally inane recipe from a Norwegian homeopath for preparing a remedy from the body fluids of an Ebola victim. Homeopathy is based on the scientifically bankrupt notion that a substance capable of causing symptoms in a healthy person can cure those symptoms in an ill person if it is sufficiently diluted. This is nonsensical at any time, but handling the body fluids of an infected person is not a recipe for a cure, it is a recipe for disaster.

One would think that reasonable homeopaths, if such a term is ever applicable, would not support this absurd regimen. But homeopaths certainly have supported other “remedies” for Ebola, such as those concocted from various types of snake venom. Why? Because snake venom can cause intense bleeding, so in the perverse world of homeopathy, in an extremely diluted version it should be a remedy to stop hemorrhaging, a classic sign of Ebola infection. Of course the treatment is useless, but at least the only person at risk is the one collecting the snake venom. And that is unlikely to be the homeopath.

Homeopathic remedies are not the only ones being touted as effective tools in the battle against the Ebola virus. “Nanosilver” is also a hot item thanks to some clever pseudoscientific promotional lingo. Silver has been shown to have antimicrobial properties, begins the sales pitch, and then goes on to describe how silver is used in water purifiers and is even woven into socks to reduce odour caused by microbes. True enough. But deodourizing socks is a long way from destroying the Ebola virus in the body. Colloidal silver can, however, do something. It can cause an irreversible condition known as argyria in which skin colour is permanently altered by deposits of silver. Essential oils from plants won’t fare any better than silver in dealing with the Ebola virus. “Thieves oil,” a blend of cinnamon, rosemary, clove, eucalyptus and lemon oils, is hyped by some as an infection preventative. Seems like an appropriate name for a product that takes money and offers nothing in return.

Other plants, such as bitter kola, astragalus and elderberry are also said to contain compounds that can destroy the Ebola virus and are promoted by some hucksters as a treatment. They clamor for testing such herbal remedies and complain that while untested pharmaceutical products such as Zmapp are being fast-tracked, there is no will to test herbs. Yes, Zmapp is being fast-tracked because it has a plausible chance of working, backed by the solid science of monoclonal antibodies. Vague claims of herbal preparations “boosting immunity” will not do. The immune system is a complex network of organs, specialized cells, antibodies, vitamins, hormones and various other molecules. Nobody knows just what should be boosted to help fight the Ebola virus. This is not to say that herbal remedies have no potential. Honeysuckle tea, for example, has recently been shown to contain a “microRNA” that interferes with messenger RNA and is capable of silencing two genes that flu viruses need to replicate.

In Africa, there have been cases of desperate Ebola victims seeking out healers who claim to have herbal cures. There is at least one account of such a healer actually having exacerbated the problem when infected people came to be healed and ended up inadvertently spreading the disease including to the healer, who reportedly then died of Ebola.

Perhaps the greatest publicity for a supposed preventative has been garnered by vitamin C, a substance that in most minds is associated with health and justifiably so. An extreme deficiency of this vitamin causes scurvy and more mild deficiencies can lead to an increased release of the stress hormone cortisol from the adrenal glands. Cortisol raises blood sugar, suppresses the immune system and decreases bone formation. But none of this means that it can treat an Ebola infection. Yet that is the obvious implication of a product that has seen a meteoric rise in sales recently. The cleverly named Ebola-C sells for $34.95 for 60 tablets of vitamin C, 500 mgs per tablet. This is about ten times the price of no-name brands available everywhere. There is zero evidence that Ebola-C has any effect on the prevention or treatment of an Ebola infection.

The brains behind this marketing scam is New York businessman Todd Spinelli who claims to have gotten the idea from Dr. Oz. Well, I’m not one to come to the rescue of a guy who has dispensed a truckload of questionable advice, but in this case he did not claim that vitamin C could prevent Ebola infection. He did have a show on Ebola that included a segment in which he talked about stress and how vitamin C could reduce the negative effects of cortisol but he did not link this to Ebola. Of course it may be true that Spinelli heard him prattle on about vitamin C on the same program as his Ebola discussion and that sparked a marketing idea.
Some promoters of vitamin C supplements have rationalized that Ebola and scurvy have similarities in that both conditions are associated with excessive bleeding. Since vitamin C treats scurvy it may have an effect on an Ebola infection as well, they suggest. This is like arguing that since brain tumours are associated with headaches, they could conceivably be treated with aspirin. Makes no sense.

Even vitamin C supplement advocates, and there are many in the medical community, agree that small doses of oral vitamin C are ineffective in the battle against viruses. But some claim that massive intravenous doses, of the order of 30-50 grams a day, can wipe out viruses and should be tried on Ebola victims. They base this on baseless reports that large doses of vitamin C have cured victims of polio, Yellow Fever and Dengue Fever. Of course since intravenous vitamin C hasn’t been tried on Ebola patients, it is impossible to say categorically that it will not cure Ebola, but given what we know about infectious diseases, it’s a good bet that the only result of intravenous vitamin C would be diarrhea. Not the best thing for a dehydrated patient.

Joe Schwarcz

Interview with SETI Institute

I was interviewed for Big Picture Science. My part is at about 37 minutes in but I think the whole program is interesting!

 

Click Image to listen to Interview with SETI Institute: 

homeopathy

 

 

 

 

 

 

 

Dr. Joe Schwarcz

Oh..The Irony!

DuchyPrince Charles has properly derided global warming deniers, calling them a “headless chicken brigade.” He went onto say that it was “baffling that in our modern world we have such blind trust in science and technology that we all accept what science tells us about everything-until, that is, it comes to climate science.”

Now, this is coming from a man who believes in the ultimate absurdity that is homeopathy and through his Duchy Originals Company sells a range of herbal remedies devoid of evidence.

Charles grew up with nonsense. “When I was very small, I remember so well my grandmother having her wonderful leather pouch with all these homeopathic glass phials in it. It was such a feature of my life and as I got older I became more and more aware of the effectiveness of homeopathy and indeed of complementary medicine generally.’ And this man talks about relying on science. Why accept the science on climate change and not on homeopathy? Bizarre. Charles also promotes a ridiculous herbal “detox” remedy. Someone is in need of a mind detox.

Joe Schwarcz

Homeopathy Bugs Me, But Not The Bugs

PICBD“It’s natural medicine.” “Herbal remedies.” “It’s like…acupuncture.” “No chemicals.” “Energy healing.” “Yogurt.” Such were the common responses when we asked random people, including physicians, about their thoughts on homeopathy. All wrong. Homeopathy is none of these. Several opined something along the lines of “alternative medicine” and a few knew that it had something to do with the supposed healing ability of extremely dilute solutions. And one gave a quick, succinct answer. “Homeopathy is an affront to science.” Bang on!

Homeopathy has nothing to do with herbal remedies, many of which have legitimate uses. Rather it is a practice hatched in the dark ages of science based on the idea that substances that cause symptoms in a healthy person can cure those same symptoms in an ill person. Onions, which make eyes itchy and tearful, can be used to relieve the symptoms of hay fever. There is no logic to this, but this is not where it stops. Homeopaths, defying everything we know about toxicology, believe that diluting a solution containing a homeopathic remedy increases its potency. In fact, to potentiate the remedy, dilutions are carried out to an extent that the final product in most cases doesn’t even contain a single molecule of the original “remedy.”

Modern day homeopaths have to admit this, and use the argument that the sequential dilutions and the tapping of the solution against a leather pillow after each dilution leaves an imprint of the original substance on the solution. This idea holds no water. Water has no memory, but even if it did, why should it remember only the substance the homeopath has added? Why is there no memory of the hundreds of thousands of other substances that water came into contact with in rivers, lakes and sewers? And why should a ghostly image of a molecule, even if such a thing did exist, have any curing ability? Here’s a suggestion. Why not just add a bunch of homeopathic remedies to drinking water? They will become diluted and according to the tenets of homeopathy become more potent. Just drinking tap water should then resolve many ailments.

Obviously it’s easy to make fun of homeopathy. The concept is absurd. But millions of people around the world do rely on homeopathic medications. “Can they all be wrong?” The simple answer is “yes.” Popular ideas are not necessarily right. After all, bloodletting went on for thousands of years, and at one time the notion that the earth was the center of the universe was quite popular. And today, many believe that the earth was created less than six thousand years ago. Science, though, is not a popularity contest. It relies on facts, not on opinion. And the fact is that homeopathic medications contain no active ingredients. And more importantly, while hundreds of studies on homeopathy have been published, there are no repeated trials that have provided proof of efficacy. But while the tenets of homeopathy are marinated in pseudoscience, homeopaths can serve a useful function. They ask a plethora of caring questions and lend a sympathetic ear, both processes that can translate to a reduction in stress and anxiety as the ailment naturally resolves. Add a dose of placebo, and you’ve accounted for the success of homeopathy. But problems can arise. And Health Canada’s Natural Health Products Directorate is partly to blame by having given an uncritical free ride to homeopathic preparations, even issuing specific homeopathic drug identification numbers.

It is hard to understand how this has happened since the Directorate’s stated goal is that “all Canadians have ready access to natural health products that are safe, effective and high quality, while respecting freedom of choice and philosophical and cultural diversity.” Safety is not an issue with homeopathic products because they contain nothing. I’m not sure what “high quality” means in this context, supposedly that the pills are produced in an environment free of contaminants. But what about efficacy? There is actually no requirement that homeopathic producers demonstrate this, which is lucky for them, because no proof of efficacy is to be had for homeopathic mercury, arsenic, “Berlin Wall,” or most alarmingly, homeopathic “vaccines” and mosquito repellants.

It seems that Health Canada has taken the view that freedom of choice is paramount as long as there is no safety issue. When it comes to a question of efficacy, regulators conveniently look the other way. In most cases there is no issue because in general consumers who use homeopathic preparations do so for mild conditions such as colds or minor aches and pains. But using homeopathic pills to deter insects from biting is potentially dangerous. Yet that is exactly what “Mozi-Q,” marketed as a natural homeopathic deterrent claims to do. Swallow a sugar pill and keep mosquitoes away! Not only that, it is also supposed to reduce the itching if you do get bitten.

What evidence is provided? There’s talk of how mosquitoes avoid delphinium flowers, which may or may not be true. But what does that have to do with swallowing pills sprayed with an extremely dilute extract of the plant? Are the nonexistent delphinium molecules exuding through the skin? And itching is supposedly relieved because a pill contains a trace of stinging nettle extract? According to the perverse theory of homeopathy, nettle causes stinging on contact with skin and therefore when diluted is a simple remedy for the same sensation. Simply asinine.

Mozi-Q also cites a reference to some homeopath who carried out a study in the 1960s, a study that cannot be found. What else? Supposedly Mozi-Q was tested over four seasons on people. How? Was there a control group? Why weren’t the results published? Pity the poor person who goes into a mosquito infected area thinking they are protected from bites by having swallowed a sugar pill. And remember that mosquito bites can be more than minor annoyances; they can transfer disease, such as that caused by the West Nile virus. And Health Canada thinks this is all right. It isn’t.

Given that the theory of homeopathy is based on the idea that the more dilute a preparation, the more potent it is, will you overdose if you forget to take your pill? Of course not. The only risk with homeopathy is an overdose of nonsense.

Joe Schwarcz

Homeopathic Mosquito Repellant-Concentrated Bunk

mosquito repellantIn the view of the vast majority of scientists, and certainly mine, any claim that homeopathic preparations have an effect beyond placebo is pure bunk. Homeopathic solutions are diluted to an extent that they essentially contain nothing and then are sprayed onto sugar pills from which they evaporate leaving behind, according to homeopathic dogma, some sort of ghostly image that has therapeutic value. This is scientifically insulting. Homeopathic products contain no active ingredients, there is no plausible way in which they can work and there is no evidence that they do work. But somehow this doesn’t bother Health Canada’s Natural Health Products Directorate which has given a free ride to homeopathic preparations, even issuing specific homeopathic drug identification numbers. It is hard to understand how this has happened given that the Directorate’s stated goal is that “all Canadians have ready access to natural health products that are safe, effective and high quality, while respecting freedom of choice and philosophical and cultural diversity.” Safety is not an issue with homeopathic products because they conatin nothing. I’m not sure what “high quality” means in this context, supposedly that the pills are produced in an environment free of contaminants. But what about efficacy? There is actually no requirement that homeopathic producers demonstrate this, which is lucky for them, because there is no way to demonstrate the efficacy of homeopathic sea water, homeopathic insulin, homeopathic chloroform or homeopathic table salt.
It seems that Health Canada has taken the view that freedom of choice is paramount as long as there is no safety issue and regulators look the other way when it comes to a question of efficacy. In most cases there is no big problem here because in general consumers who use homeopathic preparations do so for mild conditions such as colds or minor aches and pains. But using homeopathic pills to deter insects from biting is potentially dangerous. Yet that is exactly what Mozi-Q marketed as a natural homeopathic deterrent claims to do. Imagine that. Swallow a sugar pill and keep mosquitoes away. Not only that, it is also supposed to reduce the itching if you do get bitten. What evidence do they provide on their website? There’s talk of how mosquitoes avoid delphinium flowers, which may or may not be true. But what does that have to do with swallowing pills sprayed with an extremely dilute extract of the plant? Are the nonexistent delphinium molecules exuding through the skin? And itching is supposedly relieved by a pill that contains a trace of stinging nettle extract? According to the perverse theory of homeopathy, a substance that causes symptoms in a healthy person will relieve those symptoms in an afflicted person upon extreme dilution. Since stinging nettle causes a stinging sensation on contact with skin, it is supposed to relieve the same sensation when diluted. Nonsense. Mozi-Q also cites a reference to some homeopath who carried out a study in the 1960s, a study that cannot be found. What else? Supposedly Mozi-Q was tested over four seasons on people. How? Was there a control group? How were the results monitored? Why weren’t they published? Pity the poor person who goes into a mosquito infected area thinking they are protected from bites by having swallowed a sugar pill. And remember that mosquito bites can be more than minor annoyances; they can transfer disease, such as that caused by the West Nile virus. And Health Canada thinks this is ok. It isn’t.
Joe Schwarcz

Homeopathy Debate Follow-up: Andre Saine & Joe Schwarcz

After our debate on November 26, 2012, “Homeopathy: Mere Placebo or Great Medicine”, homeopath Andre Saine and colleagues asked me to answer some further questions, which I am pleased to do. I should point out that I have already addressed many of these issues in a series of columns I wrote for the Montreal Gazette and in an answer to a letter from the President of the Syndicat professionnel des homeopathes du Quebec who attacked me in a rather unprofessional fashion.

Andre also queried how much I get for consulting fees with companies. The answer is zero. My salary comes from the university. He also asked why I would favour a lawsuit against a company that markets homeopathic products given that I had stated that placebos could indeed serve as effective medicine. The lawsuit is being funded totally by a group of lawyers who initiated it. The motive behind it is simple. Homeopathic medications are claimed to have active ingredients without any proof that they contain such. Therefore they are mislabeled. I had nothing to do with the suit but I do support it because I think all products that make medical claims should be held to the same standards of safety and efficacy. In comparison with the demands that regulatory agencies make for other drugs, homeopathic products are getting a free ride.

Part of the problem is that most people do not actually know what homeopathy is. They believe it is just some sort of general term for “natural medicine.” It is of course not that at all. Consumers are often shocked to learn that homeopathy is based on the principle of non-existent molecules having an effect. For example, Boiron’s flu remedy Oscillococcinum, is made by the repeated dilution of a single duck’s liver 200 times, equivalent to taking the liver and diluting it in a sphere of water far bigger than the observable universe. I have given a more detailed description of the folly of this remedy here.

Little wonder that Boiron has had to settle a class action lawsuit in California that alleged false advertising on behalf of Oscillococcinum. The company agreed to refund consumers a total of $5 million and has agreed to pay legal expenses and to add a disclaimer that their health claims have not been evaluated by the U.S. Food and Drug Administration. It also agreed to add an explanation of how the “active” ingredients have been diluted. Hopefully there will be a similar settlement of the Canadian lawsuit.

I believe that after digesting my previous remarks on the subject and perusing my answers below, Andre’s summary comment that “the future of medicine is homeopathy” will be seen in its true light.

Before tackling the questions, let me begin with a few preliminary observations.

It was back in 1865 that French physiologist Claude Bernard opined that “It is better to know nothing than to keep in mind fixed ideas based on theories whose confirmation we constantly seek.” He didn’t have homeopathy in mind but he certainly could have.

Embracing a fixed idea and sticking to it in the face of emerging contrary findings is a real stumbling block in the evolution of any scientific discipline. In true scientific methodology, errors are uncovered, and science rights itself. But in rare cases, an entire discipline can be based on a fundamental flaw, which I believe is the case for homeopathy. Its very underpinnings that relate to the effects of non-existent molecules inducing some sort of memory effect on water are scientifically implausible in the light of knowledge we have gained since the introduction of homeopathy by Samuel Hahnemann over two hundred years ago. Yet homeopaths today still embrace Hahnemann’s archaic ideas. No other scientific discipline has shown such a lack of evolution.

The argument that there has been no need for change because Hahnemann’s brilliant breakthrough cannot be superseded smacks of juvenile thinking and a lack of familiarity with the astounding amount of biological and chemical knowledge that has been acquired over the last two centuries. But it is unlikely that the cleft between homeopaths and their critics will ever be breeched because one side takes its nourishment from science while the other is mired in faith. Science versus faith arguments are not resolvable, but clearly both have merits and detriments.

Most visits to a physician are prompted by the patient experiencing a symptom or set of symptoms for which they hope to receive effective treatment. If they are fortunate, some sort of treatment will be devised and a cure will follow. The natural assumption is that the cure was due to the treatment. And it may well be. But there are a couple of other possibilities. Many illnesses are self limiting and resolve even in the absence of any intervention. If, however, there is some sort of intervention, it usually ends up getting credit. There is yet another possibility. That’s the placebo effect. Basically this is a “cure” that is not related to the pharmacological or physical effects of whatever intervention is undertaken, but is the result of the patient’s faith in the treatment and the physician’s belief that the treatment will be effective.

Patients are keen to believe that they are receiving appropriate therapy, and in response to patients’ claims of improvement, physicians may be readily deluded into thinking that they have offered effective treatment. While placebos do not affect the progress or outcome of disease, there is no doubt they can have a powerful effect on subjective phenomena such as pain or distress. And placebos do not necessarily have to be pills, potions or physical treatments, although there is evidence that the more invasive a treatment is, the stronger the placebo effect. Injections, for example, work better than pills. But a physician’s words and attitude can also serve as effective placebos. This was demonstrated in a fascinating fashion by a British family practitioner who designed a clever study as reported in the British Medical Journal in 1987.

Dr. K.B. Thomas studied 200 patients who presented with symptoms such as cough, sore throat, abdominal pain, back pain, leg pain, headache, fatigue, earache, neck pain and chest pain in whom no definite diagnosis could be made. Half the patients were dealt with in a so-called “positive manner,” in which they were given a firm diagnosis and were told with confidence that they would be better in a few days. The other half had a “negative” consultation in which no firm assurance was given, with the doctor saying, “I cannot be certain what is the matter with you.” Furthermore, each group was divided into two, with half the patients in each group being given a medication, the other half not. In the positive group the patients were told that they would benefit from the medication, in the negative group they were told that the drug may or may not help.

The results were stunning. Two weeks after the initial visit, 64% of those receiving a positive consultation got better compared with 39% of those who received a negative consultation. Even more interestingly, whether the patients were given a medication or not made no difference. So what are we to make of this? It seems the effect of a doctor as a placebo may be more powerful than the placebo effect of a medicine! It should come as no surprise then that homeopaths enjoy success even though their medications, which do not contain any pharmacologically active agents, are totally bogus. They are usually caring people who devote a great deal of time to their patients and confidently offer them positive outcomes. That’s the formula for an effective placebo.

Here then are the questions and my answers:

 

You said in the debate that a well-conducted randomized controlled trial (RCT) will be convincing. What was not convincing about the ADHD or the sepsis RCT presented by Andre Saine?

Essentially all of the questions posed here are very familiar to the critics of homeopathy and have been extensively answered in the scientific literature. Indeed, the cornerstone of science is the randomized controlled trial (RCT), or, more correctly stated, the PROPERLY CONDUCTED randomized controlled trial. Unfortunately, the literature is replete with RCTs that are extensively flawed. Either the blinding is faulty, the allocation of subjects isn’t truly random, there is a lack of proper accounting for drop outs, the sample size is inadequate or there are methodological problems with the statistics. Given that statistically significant results can occur by chance alone, a single outcome, even if the study is properly conducted, does not carry much weight. By convention, researchers abide by the P=0.05 factor in scientific studies, which means that once in twenty times the result can be due to chance alone. To give a specific example, if a hundred coins are tossed in the air, upon landing one might expect a result like 45 heads-55 tails, or perhaps 48-52, or 46-54. But if this is repeated twenty times, one might very well once get 40 heads and 60 tails. If this were the only trial reported, one would get the impression that the coins were biased.

For all these reasons, more than one RCT that deals with the same question in the same fashion and arrives at the same result is required before one raises the possibility of legitimate evidence. And only when a sufficient number of RCTs show consensus in a meta analysis do we consider that the point has been made. There is yet another issue. While peer-reviewed journals are regarded as the gold standard for scientific evidence, it should be recognized that not all such journals are equal. There are some 6500 peer-reviewed journals in circulation in the world, many with very weak criteria for accepting papers. A study about homeopathy published in a homeopathic journal cannot be regarded the same way as if it were published in The Lancet, JAMA or the New England Journal of Medicine. Yes, the paper may be peer-reviewed, but the “peers” asked to referee a paper destined for publication in a homeopathic journal are not likely to be totally objective. Indeed, it might be quite difficult to induce a main-line scientist to review the article. There are also journals that are commonly referred to by homeopaths that are not peer reviewed at all. For example, papers by Rustum Roy, commonly referenced by homeopaths actually appear in Materials Research Innovations, which is Roy’s own journal.

There is no argument that there have been individual published papers alleging a positive effect for homeopathy. But almost all of these are to be found in journals that cater to “alternative” modalities. It is curious to note that in such journals there are no reports of negative results. This is quite unlike mainstream scientific publications which commonly feature negative findings. It seems somewhat odd that when homeopaths carry out a study they never encounter a failure, while this is common in conventional science.

In summary, the studies that are claimed to provide proof of homeopathy just don’t stand up to the rigours of science. They either have not been repeated, are methodologically flawed, or report results that can be due to random chance. All of these issues have been discussed in much greater detail than is possible here and the so-called positive studies have been dissected by numerous experts. I would urge interested readers to take the time and digest the following before accepting the notion that homeopathy is supported by properly carried out randomized trials. The first is by surgical oncologist Dr. David Gorski who systematically dissects some recent attempts by homeopaths to scientify their discipline. This is followed by comments from physician Dr. Ben Goldacre, the U.K’s premier science commentator and physicist and engineer A. P. Gaylard.

http://scienceblogs.com/insolence/2012/12/17/just-how-stupid-do-homeopaths-think-we-are/

http://www.guardian.co.uk/science/2007/nov/16/sciencenews.g2

http://apgaylard.wordpress.com/2009/09/06/a-homeopathic-refutation-part-one/

http://apgaylard.wordpress.com/2009/09/13/a-homeopathic-refutation-%E2%80%93-part-two/

http://apgaylard.wordpress.com/2009/09/25/a-homeopathic-refutation-part-three/

If homeopathy turns out to be a great medicine as homeopaths have claimed for more than 200 years what are the implications for our society as a whole and each individual?

If homeopathy turns out to be the great medicine that homeopaths have claimed, we will have to rewrite all of our chemistry, biology and physics texts and assume that basically everything we know about the workings of the world is wrong. If this turns out to be the case I will eat my hat or anything else that is offered.

Your claim from the beginning is that homeopathy is ‘unscientific’, that the pills have nothing in them and are therefore a placebo. Dr. Saine came up with study after study, all good SCIENCE, to refute your claims, but your brushed them away as if they meant nothing. If good science won’t convince you that homeopathy is scientific, what will?

I did not brush the placebo effect aside at all. It is perhaps the most important effect in medicine, conventional or alternative. As far as the studies go, Andre Saine’s interpretation of what is good science differs from mine and from that of the majority of the scientific community. I’ve already laid out the major points above and the question of the validity of studies relating to homeopathy has been in great detail in the references I provided. It must be remembered that “scientific” studies can be found to support almost any claim, but the nature of the studies has to be carefully scrutinized before jumping to conclusions.

http://www.skepticblog.org/2011/01/31/homeopathy-pseudoscience-at-the-huffpo/

If homeopathy is quackery as you say, can you define what is a quack and which aspects of it apply to Hahnemann?

A quack is either a fraudulent or scientifically ignorant promoter of ideas or practices that do not conform with knowledge that has been acquired through the proper practice of the scientific method. I would not call Hahnemann a quack. Medical knowledge at the time was virtually non-existent and within his empirical framework homeopathy made sense. His patients did better than those who were brutalized by conventional medicine at the time, and it is easy to see how he came to the wrong conclusion based on correct observations. Hahnemann could not have been aware of the fact that his solutions were so dilute that they didn’t even contain a single molecule of the original substance. Avogadro’s number, namely the number of molecules in a mole of a substance, was not determined accurately until Millikan’s famous oil drop experiment a hundred years after Hahnemann. The number was named after Avogadro, not by him. It is a myth propagated by homeopaths that Hahnemann was a great chemist who knew all about molecules.

An appropriate analogy here would be the theory of “phlogiston” which made sense to noted scientists like Robert Boyle and Joseph Priestly because it explained their observations about combustion. But the discovery of oxygen provided a much better explanation. Similarly, in the context of the times, before a proper understanding of molecules was developed, and before the full benefits of placebos were appreciated, Hahnemann’s ideas were not outlandish. He was without doubt a good man who did his best to help patients with methods that in all likelihood were superior to the “heroic” medicine practiced by other physicians at the time. But given what we know today about molecules, pathology, disease processes, drug mechanisms and mind-body reactions, the notion of “like cures like” and Hahnemann’s proposed inverse dose-response relationship has to be relegated to the junk heap of science. But junk can be dangerous. See following:

http://www.quackometer.net/blog/2012/12/will-any-homeopath-say-homeopathy-is-no-substitute-for-radiotherapy.html

When evaluating published RCTs, what criteria are you using to know if the researchers are actually testing genuine homeopathy? 

I’m not sure what this question really means. What is genuine homeopathy? The RCTs that are examined in meta analyses are ones that are designed by homeopaths so one would assume they are testing “genuine homeopathy.” Basically such studies come down to testing one placebo against another. I know that homeopaths often claim that their practice is so individualized that it is not amenable to randomized trials, but that is just a convenient “out.” I would be interested in hearing what would constitute a trial of “genuine homeopathy.”

You have high regards for the Shang meta-analysis. Can you comment on what Andre Saine said about the 6-8 studies being “non-homeopathic” studies.

It is not only I who has a high regard for this major meta analysis that was published in The Lancet, but everyone else who is well versed in scientific methodology. It was predictable that homeopaths and particularly manufacturers of homeopathic medications like Boiron Laboratories would attempt to skewer the study. They did try that with the following claim:

“In August 2005, the weekly journal The Lancet published a new study on the effectiveness of homeopathy. In its editorial the journal drew some surprisingly controversial and unfavourable conclusions on homeopathy. It concerns an analysis which like the 3 previous meta-analyses concludes that homeopathic medicine is effective. However, to arrive at the opposite conclusion, the authors implicitly removed series of trials afterwards, retaining just 14 (8 on homeopathy) of the 220 initial trials (110 of which were on homeopathic medicine).”

This criticism is invalid. Shang et al examined all the trials and relied only on eight which were of the highest quality. The rest just did not meet the scientific criteria. They certainly did not “implicitly remove” a series of trials afterwards. The surviving 8 homeopathic trials were simply the ones that made the cut. Shang’s conclusion was that there is “weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.”

It is noteworthy that Klaus Linde, the author of a previous meta-analysis that has been used by homeopaths to support their arguments sent the following letter to The Lancet: “We congratulate Aijing Shang and colleagues on their meta-analysis examining the clinical effects of homoeopathy. Their methods largely reproduce those of our meta-analysis on the same topic published in The Lancet 8 years ago. We agree that homoeopathy is highly implausible and that the evidence from placebo-controlled trials is not robust. Our 1997 meta-analysis has unfortunately been misused by homoeopaths as evidence that their therapy is proven.”

Andre Saine just reiterates the criticisms that have been aimed at the meta analysis apparently without being aware that these have been dealt with extensively by many, including Shang himself. It is fruitful to read through Shang’s reply which I’ve reproduced here:

Are the clinical effects of homoeopathy placebo effects? — Authors’ reply:

Homoeopathy dates back to the late 1700s when Samuel Hahnemann first formulated the principles of similars and potentisation. At that time, homoeopathy might well have been superior to conventional medicine, considering that bloodletting was the standard treatment for many disorders. Contrary to what Harald Walach and colleagues suggest, homoeopathy and allopathy thus both started from a poor evidence base. Our study showed that more than 200 years later, based on more than 200 placebo-controlled trials, it has become clear that the clinical effects of homoeopathy are compatible with the placebo hypothesis and probably due to the non-specific effects of complementary and alternative medicine discussed by Walach and colleagues. By contrast, with identical methods, we found that the benefits of conventional medicine are unlikely to be explained by unspecific effects.

We followed the approach of Klaus Linde and colleagues1 in assuming that, if the clinical effects of homoeopathy are placebo effects, the positive results seen in placebo-controlled trials of homoeopathy must be explained by bias in the conduct and reporting of trials. When these biases were taken into account in the analysis, little evidence remained for a specific effect of homoeopathy. Linde and Jonas now seem to discover major limitations with the approach they pioneered: they argue that, if homoeopathy works for some but not all conditions, our study could produce a false-negative result. Their argument is not supported by the evidence. The homoeopathy trials analysed in our study, including the large trials, and large trials of higher quality, covered diverse conditions ranging from childhood diarrhoea, warts, the common cold, to chronic headache. There was little evidence that treatment effects varied according to clinical topic (p=0·66). An important strength of our study is the inclusion of a carefully matched sample of conventional medicine trials. If the fact that a therapeutic system may work in some but not other conditions leads to false-negative results, why did this not happen in the case of conventional medicine?

We agree that the larger trials of higher methodological quality (references 46, 55, 71, 80, 84, 94, 96, 97 in web appendix 1 and 23, 25, 45, 53, 66, 72 in web appendix 2) should have been identified, and are grateful for the opportunity to rectify this oversight. Our study was not a standard meta-analysis of Cochrane reviews, which are typically based on fewer than 10 trials,2 but a large comparative study of 110trials of placebo-controlled trials of homoeopathy and 110 carefully matched trials of conventional medicine. In this situation it is difficult to report on every variable that may be of interest. This is also illustrated by Linde and colleagues’ 1997 article,1 which included 89 homoeopathy trials. Linde and colleagues failed to identify the trials that were adequately concealed, the trials that reported predefined outcome measures, or the five trials that they included in a “worst case” scenario (high methodological quality, indexed in MEDLINE, higher dilution).

Contrary to the claims of Peter Fisher and colleagues, we clearly stated the matching criteria and made all the references available in web appendices and provided additional information on outcomes in a webtable. A list of excluded studies, with reasons for exclusions, is now also available from http://www.ispm.ch.

We strongly reject Fisher and colleagues’ notion that our conclusions were based on “eight anonymous trials”. Following the same logic, Linde and colleagues’ study,1 which they and others have repeatedly quoted as proving the efficacy of homoeopathy, would be based on the five “anonymous trials” included in the worst case scenario. We estimated treatment effects in trials as large as the largest trials identified, based on an analysis of 110 trials. As for the analysis restricted to eight large trials of higher quality, we found no convincing evidence that homoeopathy was superior to placebo.

Neither of the two studies mentioned by Fisher and colleagues were regarded as large and of high quality. The influenza trial did not meet our prespecified quality criteria and the asthma trial was available as an abstract only and excluded. In response to Walach and colleagues, two of the larger homoeopathy trials of higher methodological quality assessed individualised classic homoeopathy, including the 1997 trial by Walach and colleagues (reference 96 in web appendix 1).

In response to Flávio Dantas and to Walach and colleagues, the pattern seen for trials of classic, individualised homoeopathy was closely similar to that seen for all trials of homoeopathy (figure). Our study affirms the poor reporting of clinical trials highlighted previously.3 The assessment of their methodological quality is therefore compromised, but it is clear that large, multicentre trials tend to be of higher quality than small trials.4 Dantas argues that homoeopathic laboratories “do not spend nearly as much money on marketing and product promotion as pharmaceutical companies”. Interestingly, we have been pursued by public relations firms paid by the manufacturers after our publications on rofecoxib (Vioxx)5 and homoeopathy. We agree with Dantas that we need to compare homoeopathy and allopathy: this was the aim of our study. We also need to be prepared to accept the results of well designed studies, even if they challenge our own fervently held beliefs.

References

1 Linde K, Clausius N, Ramirez G, et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350: 834-843. Summary | Full Text | PDF(136KB) | CrossRef | PubMed

2 Sterne JAC, Gavaghan DJ, Egger M. Publication and related bias in meta-analysis: power of statistical tests and prevalence in the literature. J Clin Epidemiol 2000; 53: 1119-1129. CrossRef | PubMed

3 McNamee D, Horton R. Lies, damn lies, and reports of RCTs. Lancet 1996; 348: 562. Full Text | PDF(19KB) | CrossRef | PubMed

4 Kjaergard LL, Villumsen J, Gluud C. Reported methodological quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med 2001; 135: 982-989. PubMed

5 Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004; 364: 2021-2029. Summary | Full Text | PDF(193KB) | CrossRef | PubMed

How can you explain that a homeopathic substance, which, according to you, is supposed to be placebo, can work effectively on animals and plants?

The straight forward answer here is that homeopathic substances do not work on animals or plants. This is a myth that has been created by repetition. There are no quality studies that show homeopathy working in animals, but humans do have an astounding ability to see what they want to see and believe what they want to believe. Animals can recognize when they are being cared for and can respond to interventions even if these are physiologically inactive. Again, Andre seems to be unaware of the massive amount of literature that exists on this issue. To simplify, a vet who is using homeopathic remedies, is using his authoritative position to convince the animal owner that the animal being treated with homeopathy is getting better. This can lead to a placebo effect by proxy where the animal’s owner is assured that the treatment will work and therefore becomes less anxious. An animal can sense this and responds to its owner’s more positive attitude. This can provide the illusion of efficacy but the animal remains medically untreated. Here are a couple of interesting analyses:

http://www.sciencebasedmedicine.org/index.php/is-there-a-placebo-effect-for-animals/

http://aillas.blogspot.ca/2008/08/does-apparent-effectiveness-of.html

What is your opinion on homeopathic and naturopathic schools being represented at McGill Graduate Schools and Professional Fairs?

These schools are legal educational institutions so there is no reason not to make students aware of their existence, especially given that admission requirements are much lower than for medical school. My experience has been that the few students who have gone in this direction have done so after failing to get into a medical school. There are, however, undoubtedly some students who find the naturopathic approach attractive and make this a first career choice. They should, however, have full knowledge of what they are getting into as well explained in the December 14 entry of science based medicine:

http://www.sciencebasedmedicine.org/

In many countries such as Switzerland, homeopathy is part of medicare, therefore considered effective enough for public health benefit. How can it be called placebo-based?

There is no requirement of efficacy to include homeopathy in a health care system. In a democratic society governments will cater to public desires whether these are scientifically legitimate or not. Since homeopathy is cheaper than conventional medicine, it can alleviate government spending on health care. Most people visit homeopaths for minor conditions that generally resolve by themselves or for chronic conditions that have stymied conventional doctors but which would not be helped by further visits. But there is always the concern about including a treatment that has not been properly validated in national health care systems which are publicly funded. This issue is coming to the fore in the United Kingdom where homeopathy has been on the National Health Service but a House of Commons Science and Technology Committee that has examined the situation has recommended that homeopathy be removed from the National Health Service.

http://www.sciencebasedmedicine.org/index.php/homeopathy-gets-a-reality-check-in-the-uk/

Can you comment on the Swiss study?

This was not a study but an opinion rendered by a group who judging by their affiliations and publications have a favourable view of alternative therapies. The report summary was written by Gudrun Bornhöft and Peter Matthiessen: Chair in Medical Theory and Complementary Medicine, University of Witten/Herdecke, Germany, Ursula Wolf, Institute for Complementary Medicine (KIKOM), Inselspital, University of Berne, Klaus von Ammon, Stephan Baumgartner and André Thurneysen, Institute for Complementary Medicine (KIKOM), Inselspital, University of Berne, Marco Righetti, Medical Practice, Zurich, Stefanie Maxion-Bergemann: PanMedion Foundation, Zurich. Dr. Righetti, who is listed as “Medical Practice” actually practices homeopathy and has written voluminously on the subject. There were many foxes in charge of this henhouse. Again, Andre appears to be totally unaware of just how much astute scientific criticism has been piled on the Swiss ‘”study.” Here is some interesting reading:

http://www.smw.ch/content/smw-2012-13594/

http://www.sciencebasedmedicine.org/index.php/the-swiss-report-on-homeopathy/

http://www.zenosblog.com/2012/05/that-neutral-swiss-homeopathy-report/

http://onlinelibrary.wiley.com/doi/10.1111/j.2042-7166.2012.01160.x/abstract

Isn’t it true that the only non-war statue in Washington DC is of Samuel Hahnemann?

There is an impressive statue of Hahnemann in Washington but it certainly is not the only non-war statue in DC. There are numerous statues, even in Congress, that have nothing to do with war. Indeed, outside the National Academy of Science building, there is an interesting statue of Albert Einstein who of course opposed war.

Is there any value in observational, animal and in vitro studies?

Absolutely. These all contribute to evidence-based science.

Have you ever been to a homeopath?

Only incognito. A remarkable experience. Not a positive one.

Someone in the audience wanted to know if you would submit a proving on your own?

No problem. I would be willing to take any homeopathic product.

 

As is evidenced by the foregoing, it is my view that homeopathy is a form of unscientific, fanciful thinking that is pursued by generally well-meaning individuals who have put critical thinking on the back burner and appear to be oblivious of the established fact that the placebo response occurs consistently in 30-40% of cases likely due to expectation of relief by the patient.

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