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A disagreement between two respected Canadian academics is raising some fundamental questions about when a disputed scientific issue has been studied long enough.

The debate centers on whether it’s still valid — or even ethical — to do research on products called nosodes, which are marketed as homeopathic “vaccines.”

Homeopathy is a controversial arm of complementary medicine. It is based on the belief that conditions can be cured or prevented by giving a person a substance that induces the same symptoms, but in highly diluted form. Though it has hordes of adherents, homeopathy is dismissed as quackery by traditional medicine.

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Dr. Mark Loeb, an infectious diseases researcher at McMaster University in Hamilton, Ontario, is seeking volunteers for a study that he thinks will show nosodes don’t activate an immune response and therefore cannot protect against diseases.

Tim Caulfield, a professor of health law and policy at the University of Alberta in Edmonton and a zealous debunker of quack science, argues there’s no need to run such a study. Science already knows the answer, said Caulfield, whose most recent book — on the impact of celebrity culture on health — is entitled “Is Gwyneth Paltrow Wrong About Everything?”

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“It is com-pleeeeeeeete scientific nonsense,” Caulfield said of homeopathy, drawing out the word for added emphasis.

“There is no need to study it. … I don’t need to run a physics experiment to demonstrate that flying carpets don’t fly.”

The alternative medicine system, devised in the late 18th century in Germany, is based on two theories scientists insist simply cannot work. One is the notion that “like cures like” and the other is that diluting a substance actually increases its potency.

Even the National Center for Complementary and Integrative Health — the part of the National Institutes of Health expressly charged with researching alternative medicine — appears skeptical about homeopathy.

“A number of the key concepts of homeopathy are not consistent with fundamental concepts of chemistry and physics,” the center’s website notes. “For example, it is not possible to explain in scientific terms how a remedy containing little or no active ingredient can have any effect.”

And yet Americans spent nearly $3 billion on homeopathic remedies and $170 million on visits to homeopaths in 2007, according to the National Health Interview Survey, a regular survey of the American public’s health conducted by the National Center for Health Statistics. The 2012 survey estimated that 5 million adults and 1 million children used homeopathy in the previous year.

In both the United States and Canada, homeopathic remedies are sold with the acceptance of the federal drug regulatory agencies.

In the US, manufacturers of homeopathic remedies are allowed to make health claims on their labels — even though the Food and Drug Administration does not require them to submit proof that the products can meet those claims.

In Canada, homeopathic remedies are licensed as natural health products. After taking a great deal of criticism over its handling of the products, Health Canada changed its rules regarding nosodes last year, requiring makers of the products to make clear they are not vaccines, should not be viewed as alternatives to vaccination, and haven’t been proven to prevent infection. The new labeling rules went into effect in July.

Critics on both sides of the border think the regulatory agencies should go further. And Loeb is hoping to provide solid evidence to make that case.

His plan is to test whether nosodes activate the immune system to protect against the diseases they purport to fend off.

He and colleagues will randomly assign about 150 people aged 18 to 24 to one of three groups. One group will get fake nosodes plus the two booster vaccines people in this age group are supposed to get. The second will get fake nosodes and fake vaccines — sterile saline solution. The third will get commercially sold nosodes and fake vaccinations.

That means researchers will be testing whether the immune system is stimulated by vaccines versus placebo versus nosodes.

The purpose of giving each group both vaccines and nosodes (real or fake) is to ensure no one knows who gets what while the study is underway. Randomized trials that are double-blinded — neither recipients nor researchers know — produce the best quality evidence.

The researchers will draw blood samples from the recipients before they receive their therapy and again three weeks later. They will be looking to see if volunteers produce increased levels of antibodies, T-cells, and B-cells — key players in an immune response.

“Of course our hypothesis will be that [nosodes] will be no different than placebo,” Loeb told STAT.

But Caulfield argued that people who believe in homeopathy will not be dissuaded, even by a well-done study. Further, he said the fact that a reputable university is studying nosodes will add to their cachet among people who believe they work.

“The concern is that just by running the trial you are legitimizing it,” he said in the interview, pointing to the fact that someone on Twitter sent him a link to McMaster’s advertisement that it was looking for volunteers as proof homeopathy isn’t, as Caulfield had denounced it, bunk.

Caulfield criticized the study on Twitter.

When he learned Loeb — who has a reputation for doing terrific research — was leading the study, he reached out and the two men spoke.

Both described a civil conversation. But they didn’t change each others’ minds.

“This invites an interesting debate about how we — the scientific community, the research community, the academic community — should respond to pseudoscience,” Caulfield said afterward.

“Do we legitimize it by doing research on it? Or do we — as I think we should do — speak in one voice, one clear voice, and say: This is scientific bunk.”

Further, Caulfield argued that conducting the study may be unethical. His rationale: Research ethics require that there is what’s known as equipoise — scientific uncertainty — if a question is to be studied. There is no scientific uncertainty about nosodes, he insisted.

Loeb said he could find no previous study looking at whether nosodes triggered an immune response. And his arguments satisfied McMaster’s Institutional Review Board, which approved the study.

Dr. Ross Upshur, an ethicist and a professor at the University of Toronto’s Dalla Lana School of Public Health, disagreed with Caulfield on the issue of the study’s ethics — but agreed with him that regardless of the outcome of the study, it would not change the thinking of people who believe nosodes work.

Would he have approved the study if he had been on the McMaster review board? Upshur, who has conducted research with both Loeb and Caulfield in the past, said he could argue both sides of this debate, but said if pressed to make a call, he probably would have argued that the study wasn’t worth doing.

Dr. Peter Palese, a renowned influenza researcher at the Icahn School of Medicine at Mount Sinai in Manhattan, also understands Caulfield’s concern. He calls homeopathy “hogwash.” But Palese noted that Loeb conducts first-rate research, and there has been little of that done on homeopathy.

“If a guy like Mark Loeb does it, it is a service to the rest of us,” he said.

Loeb acknowledged the true believers will not be swayed by the findings of a clinical trial. But he said he hopes to generate evidence that will provoke regulators to take a harder line on nosodes.

“They’re licensed. They’re used around the world. And the lack of an immunological response, compared to placebo, would basically demonstrate the lack of a scientific basis for these [homeopathic] vaccines,” he said.

  • I have two relatives who were having allopathic medicine for Parkinson’s.
    These medicines were to prevent Parkinson’s from getting worse.
    Both had a shaking hand, till I gave them homeopathic hypericum 1M.
    One dose would STOP the shaking for 10 days.
    Allopathic (hopefully) keeps it getting worse

    • So… what you’re saying is that you did medical experiments on a human with no ethics board approval, no oversight, no medical qualification at all?

      And people wonder why homeopathy is a problem.

      So, to revisit your unverified story though, you took your relatives off the existing medication, allowed it time to flush from their bodies and treated them with homeopathic hypericum 1M. If this process wasn’t what you did you have literally no way of knowing if your intervention was even potentially the cause.

      As for hoping the actual medicine “keeps it getting worse”… That’s a horrible thing to hope for. But it is a thing we regularly see from the more fanatical homeopathy supporters.

    • I am not sure why you included (hopefully) in regard to Allopathic medicine. It hardly seems professional or kind.

      Parkinson’s as a serious disease is about more than ‘shaking hands’ Homeopathically, and different remedies would be required for different people.

  • Why study homeopathy if you, in your superior scientific judgement, have already decided that it is unscientific? Are you afraid it might turn out to have scientific validity? Oh, that’s right, there already are hundreds of studies that confirm its biological activity and effectiveness. But you have no interest in knowing that. What a joke.

    • Homeopathy is not only fully supported by studies, it’s a great labor-saving tool. For instance, it is not only unnecessary to wash one’s dishes, doing so is very harmful. This is due to the well-supported homeopathic principle that the more dilute a substance is, the more potent it is.

    • Lets test html in posts…

      Why study homeopathy if you, in your superior scientific judgement, have already decided that it is unscientific? Are you afraid it might turn out to have scientific validity?

      Well… no. The science is quite well established on this. It doesn’t work. That’s what this article is about. You did read it, right?

      Oh, that’s right, there already are hundreds of studies that confirm its biological activity and effectiveness. But you have no interest in knowing that.

      Actually there are thousands. All of poor quality. Of the good quality studies the vast majority land in the “there’s nothing here” group.

      Now, are you suggesting that we settle for poor quality studies? Because from that point of view we can probably bring back bloodletting and using the biological model of balancing the humours too.

      What a joke.

      Indeed. But I don’t think you get it…

    • Homeopathy is not only fully supported by studies, it’s a great labor-saving tool.

      The fact that there is more than one study that demonstrates that homeopathy is no better than a placebo counters your base point. Given your initial premise is false, the rest of your claims are built on an incorrect assumption. We can ignore the rest.

    • Ah! RGM, you are, unusually, half right!

      @Steverides, sorry, I was rushed. You’re post is indeed on the mark. 🙂 RGM is incorrect in referring to it as ironic, of course. More satirical.

  • Science is spending billions to ENFORCE homeopathy. The bizarre notion that a tiny fractional percent increase in carbon dioxide can move the earth’s climate is REQUIRED DOCTRINE. We are not allowed to question it, even though the theory is disproved by ALL data.

    Why does science hate other forms of homeopathy? Perhaps because they are competing with carbon homeopathy for prestige and loot?

  • How dare anyone challenge prevailing established science ?

    It is well known, for example, that stress and diet are the cause of Pyloric ulcers. Therefore, funding for research that it is anything else, particularly the absurd idea that some sort of undiscovered bacteria in the gut is involved, should be routinely denied. Quack researchers are not welcome and in addition…..OH….wait a moment.

    That’s right, the research was eventually allowed and researcher Barry Marshall discovered that the cause was indeed a bacterium, Heliobacter Pylori.

    We must avoid the self serving dogmatism that allows entire fields of medicine and new discoveries to be …discredited…because they counter accepted scientific research and/or belief.

    The attempt to impose such restrictions on research and medical practice, is the end result of something more correctly called “Scientism”, an ersatz pseudo scientific posturing which allows its adherents all the prestige and illusory inviolability of science without the proper knowledge or research.

    The over reliance on inadequate, supposedly scientific testing methods as the sole arbiter of decision, coupled perhaps with some notions of common sense, is completely inadequate to rise above the quagmire of Scientism and arrive on the firm ground of real established science.

    Reference: See “Beware Scientism’s Onward March” by chemist Lionel Milgrom for a complete exposition of the danger and fallacy of the Scientism cult.

    • Certainly science should be creative and searching beyond our current understanding. There has to be a basis for the study, though. We don’t just throw whatever we can get our hands on at the wall and see what sticks.

      To use your example, it is a reasonable supposition that there might be a connection between gut bacteria and ulcers. What is the proposed mechanism by which we think nosodes would work, that we should spend time researching them, as opposed to other things that have a more definitive, understandable hypothesis for working?

    • How dare anyone challenge prevailing established science ?

      Yet you would have us take this position with homeopathy. Hypocritical much?

  • The term ‘bunk’ has no place in the Scientific system because it reflects abject prejudice. The term ‘bunk’ is applied to those modalities for which Science, at its current level of knowledge has no explanation. The term ‘bunk’ could be applied to many things throughout the history of Science, but, because the term was not applied, we gained new knowledge.

    • The term ‘bunk’ has no place in the Scientific system because it reflects abject prejudice.

      You’ve got this backwards. Bunk has no place in the Scientific system.

  • Science is a system of enquiry. At its best it is an objective, curious, open-minded, rigorous system of enquiry and that means anything and everything can and should be studied.

    If Science had rejected based on current knowledge and beliefs in the past, we would never have had aviation, or indeed, many aspects of Science and Medicine which are now accepted as a given.

    Subjective, closed-minded, non-curious, prejudiced Science is a betrayal of all for which the Scientific system of enquiry claims to stand.

    Having said that the levels of prejudice at work in the Scientific system make it very difficult for objective studies to be carried out.

    • Science is a system of enquiry. At its best it is an objective, curious, open-minded, rigorous system of enquiry and that means anything and everything can and should be studied.

      Correct. This has been done with homeopathy and as we have gotten better at performing the science the efficacy of homeopathy has been found to be little more than observer error, confirmation bias, etc of the placebo effect.

    • @ Gold,

      Um, no, it hasn’t been done with Homeopathic medicine, that is the point. And you might like to inform the many MD’s and hospitals around the world who practice it, the medical schools and universities which teach it and the Governments which include it in State medical systems of your data because clearly they have found different data which is positive and which enables sign-off from their legal teams on this controversial issue.

      There is not a snowball’s chance in hell that any MD, hospital, academic institution or Government in the world, well certainly the First World, would touch Homeopathy if the following were correct – ” observer error, confirmation bias, etc of the placebo effect.”

      Ergo, you are still wrong. Damn. Maybe work on getting those various institutions to drop Homeopathy and you might be able to make a case. Until then, fear not, the world will not end and the sky will not fall and Homeopathy will continue to heal and cure as it has done for more than two centuries. And doing it cheaply and without killing anyway. Maybe conventional science/medicine could take points.

    • Um, no, it hasn’t been done with Homeopathic medicine, that is the point.

      Pretty sure it has been done. So much so that there are systematic reviews and stuff out there now…

      Look! Citations!

      The National Health and medical Research Council Homeopathy Review.

      Conclusion: “Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.” (pdf)

      The UK House of Commons
      Science and Technology Committee – Fourth Report
      Evidence Check 2: Homeopathy

      Overall conclusion

      33. By providing homeopathy on the NHS and allowing MHRA licensing of products which subsequently appear on pharmacy shelves, the Government runs the risk of endorsing homeopathy as an efficacious system of medicine. To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy. Homeopathy should not be funded on the NHS and the MHRA should stop licensing homeopathic products. (Paragraph 157)

    • Um, no, it hasn’t been done with Homeopathic medicine

      Anyone with a keyboard and access to a search engine can demonstrate for themselves that this claim is patently false.

      And you know it.

      The fact that the best research we have to date doesn’t agree with your position does not mean that the research hasn’t been done. Or done enough.

      Research happens. Eventually a consensus is reached and either new research comes out in new interesting areas or no effect is seen and things get put aside. Homeopathy, for the most part, is being put aside. Even the research being discussed in the article above is not expecting to find anything but it’s being done anyway. This is what you’re wanting. The reason for the article is that the science is fairly clear on this already. It’s not a thing, why waste the limited resources? Research something that is new or replicate something that is interesting to add more weight to its confirmation (or fail to and create more questions around it.)

      Regardless of the protestations from Ros, there is already a consensus around homeopathy. It doesn’t work.

  • The medical community should study hash oil. Even if they think it is just a new class of placebo. Many report various classes of improvements.

    • The medical community is studying hash oil (and many other things to do with marijuana. There’s some interesting things coming out of it but it’s looking like it is not nearly the panacea that most proponents claim it is.

  • As Dr. Loeb stated, the purpose of this trial is not for supporters/believers of homeopathy, but for regulatory authorities who allow or tolerate these nosodes to be sold to consumers and make general health claims. Hopefully, this well-designed trial will make waves with drug regulators in various countries and persuade them to take a second look at how they regulate nosodes. Those who believe in nosodes will always believe in them, regardless of evidence.

    I don’t know much about nosodes, but if I had to guess, supporters of these products likely tell people how little we know about the immune system (which is true in many respects) and then do some hand-waving to convince them that nosodes work through some alternative, little-studied/undiscovered pathway that can lead to immunity. This trial, which examines well-known correlates of immunity for certain vaccinations, will put a dent in the armour of this argument, at least for those with rational minds.

    • If you took the time to do some basic research into Homeopathic medicine, and yes, it would require quite a few hours, days, weeks even, then you would better understand the concept of nosodes.

    • Ros,

      You know very well that the basic research has been done. It’s been being done for the last 200 years since its invention.

      In that time science has undergone a continual process of self improvement until we have what we refer to as the Scientific Method. You know this also.

      Today, research into homeopathy continues. For the most part it is done poorly and rarely replicated. Amongst this research there are also good quality studies and when meta analysis or systematic reviews are done to filter out the good from the poor we find that homeopathy doesn’t live up to its claims.

      So, please, take your own blinkers off, and stop claiming that we just need to do the basic research.

      If you’re going to claim that the Scientific Method isn’t enough or can’t test homeopathy then please present a standardised process that would allow for replicable testing.

      If you’re going to claim that the Scientific Method can’t test homeopathy because it’s individualised “medicine” then you’ve not read the research. This is tested also. Asserting it can’t won’t make your position true.

    • @citizen gold,

      At the most basic level, here is the reality, MD’s and hospitals, around the world, particularly in Europe, practise Homeopathy; some medical schools teach it and many universities, particularly in First World Europe and many Governments include it in State medical systems.

      Common sense, logic and experience dictate that NONE of that could happen if those bodies had not accessed the required research to demonstrate to their legal teams that Homeopathy was NOT pure placebo and not fraudulent in any way – hence the sign-off, in this age of litigation and the reality of it being practised, taught and embraced.

      Those who cannot cope with Homeopathy because, for the moment, Science is not advanced enough to understand how it works, are forever going on about there being no research evidence for efficacy when patently there is. I can access it, various MD’s, hospitals, medical schools, universities, Governments can access it but you cannot. How strange. Or, how selective on your part.

      The other simple reality is that the only evidence required is CURE and Homeopathy has been demonstrating cure for more than two centuries. You can find, if you really want to research with an open mind, copious Government records from the 19th and 20th centuries which record such cures, particularly in epidemics. And if you do some real research, you will find data even more recent.

      And since the current Scientific system cannot or will not countenance that Homeopathic medicine can work, it is fanciful for you to claim that the basic research has been done. It is even more fanciful in light of the fact that Science is suited to studying Allopathic medicine and even there it fails miserably, with former editors of The Lancet and The New England Journal of Medicine, both saying, along with other noted medical professionals, that much, possibly MOST research is just plain wrong.

      And, your much touted ‘research’ clearly does not prevent conventional Allopathic medicine from being a major killer today, third or fourth in the developed world, most of it from prescribed medication.

      It is laughable, if it were not so tragic, to see the energy wasted on decrying Homeopathy which cures and does no harm, when millions are injured or dead every year because of Allopathic medicine.

    • At the most basic level, here is the reality…

      This is one of those “I reject your reality and substitute my own” posts isn’t it.

      You can’t even falsehoods, the unsubstantiated claims, the inflated claims, the logical fallacies…

  • this is similar to debating Creationists on evolution. No one’s mind gets changed, and we give credibility to unscientific 100% implausible dribble

    • Similar perhaps, but with the difference that this is a blinded experiment. That has not been the case with the other thing.

    • Since there are holes miles wide in the theory of Evolution as the only answer, perhaps pondering some aspects of Creationism with an open mind, and no, I don’t mean God did it, might provide answers to issues currently without explanation.

      Approaching with an objective and open mind and avoiding the kneejerk hysteria to religion, would be both wise and useful.

      Evolution is certainly a part of the answer but not the complete answer. So, what is? That question is open-ended.

    • “Since there are holes miles wide in the theory of Evolution as the only answer, perhaps pondering some aspects of Creationism with an open mind, and no, I don’t mean God did it, might provide answers to issues currently without explanation.”

      1. When something is science is referred to as a (uppercase T)Theory the non-science minded need to think of it as fact. The (lowercase t)”theory” you use would be an hypothesis in scientific terms. Science uses the term Theory to show that there is still a possibility that it may be overturned one day, but to date it has failed to be disproven for so long that there is no expectation it ever will be and it’s better to put research resources into other places.

      2. Creationism literally boils down to “God did it”. If that’s not what you meant then “Creationism” was likely the wrong choice of word for your point.

  • Someone could argue that the way you look at the immune system activation is wrong or incomplete. Or that the homeopathic treatment is just acting on the immune system in a more subtle way.
    He could ask the homeopathic industry/advocates to finance the study. If they feel confident enough ….
    The killer (literally) experiment would be to treat half of a number of advocates/supporters of homeopathy with the vaccine + the homeopathic treatment, and the other half with just the latter. Then you infect all of them with the target quick and efficient deadly pathogen. And then you count how many survived

    • If the homeopathy supporters survive more than placebo? Can you try change your position or only would protect your dogma with the pseudoskeptic agenda?

    • Similar research already exists as a matter of Government record where you can compare outcomes during the great Flu Pandemic, and Cholera and Typhoid and other epidemic outbreaks between Homeopathic and Allopathic treatment of patients, where, generally, the success rate of Homeopathic treatment was vastly higher than Allopathic.

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