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.
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?”
“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.
Regardless of intent, looks like a respected researcher taking homeopathy seriously. This can only help homeopathy. https://t.co/bbJtU7csyB
— Timothy Caulfield (@CaulfieldTim) October 3, 2016
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.
About the Author Reprints
Measuring for antibodies is NOT an accurate way to test for “immune response.” I support vaccination choice. Lack of alternative diminishes choice – esp. when the alternative is as safe or safer than bottled water. Vaccination and homeopathy work on the same principle of alike fighting alike (example: making remedy for snake bite from snake venom). Vaccinations produce antibodies at the cost of weakening the body with the other contents of the vaccine. Nosodes do not produce antibodies and work at a deeper level than that for disease prevention. Like vaccinations, nosodes do not prevent disease 100% of the time. However, nosodes are safer in that there isn’t harmful stuff within them; vaccinations have harmful stuff within them. There’s evidence of people exposed to diseases who don’t come down with the disease, and don’t have antibodies that prevented the disease. Their body’s intelligence prevented the disease at a deeper level than antibodies prevent disease. Preventing the disease at a deeper level leaves the immune system at it’s strongest. If a study was done, it’d likely show that deaths from the Corona virus were all by people who have received vaccinations in their lifetime. Vaccinations weaken the immune system due to the other stuff in it. So people without vaccinations are better at fighting off novel diseases.2% of people don’t respond to vaccinations anyway (https://forums.webmd.com/3/parenting-exchange/forum/3868/5y). No sense making those people continue to get vaccinations after that is figured out – NONE.
Astonishing about of misinformation, Sheila Bliss. Where do I start?
1) Yes, measuring antibody titer is a correct way to measure immune response. There are others, such as cell-mediated immune response assays. There’s no need to put immune response in quotes, by the way. I studied it professionally.
2) Homeopathy is not the same thing as immunization. Homeopathy would work against laws of physics and chemistry, as water would have to have some kind of mysterious memory. There is no evidence for any such memory.
3) Vaccines do not have any harmful stuff. If you’re thinking thiomersal, it is not used anymore in most vaccines as preservative.
4) Corona virus – you’re assuming much without any supporting data. It’s more dangerous to older people because they have weaker immune systems and weaker constitution. Simple.
Occam’s razor works.
@Tapani,
You said: 1) Yes, measuring antibody titer is a correct way to measure immune response.
Correct in what way when it is clear that someone with high titer levels can still contract the disease? Surely the point is that vaccine theory is based on the erroneous belief that high titers means immune response/protection? Clearly not. Have you read this study?
Severe tetanus in immunized patients with high anti-tetanus titers.
Severe (grade III) tetanus occurred in three immunized patients who had high serum levels of anti-tetanus antibody. The disease was fatal in one patient. One patient had been hyperimmunized to produce commercial tetanus immune globulin. Two patients had received immunizations 1 year before presentation. Anti-tetanus antibody titers on admission were 25 IU/ml to 0.15 IU/ml by hemagglutination and ELISA assays; greater than 0.01 IU/ml is considered protective. Even though one patient had seemingly adequate anti-tetanus titers by in vitro measurement (0.20 IU), in vivo mouse protection bioassays showed a titer less than 0.01 IU/ml, implying that there may have been a hole in her immune repertoire to tetanus neurotoxin but not to toxoid.
You said: Homeopathy is not the same thing as immunization.
No, it is not. Firstly, vaccines do not immunize or all vaccinated would never get the disease, boosters would not be required because vaccines would not wear off.
Secondly, the claim was not that Homeopathic medicine and vaccination are the same but they are based on the same principle of Like Treats Like, where a little of something which causes symptoms or disease, can be instrumental as a medical treatment. Radiotherapy and chemotherapy both cause cancer and are used to treat cancer. Ritalin causes the same symptoms in healthy people as it is meant to treat in patients, as indeed do a number of cardiovascular medications.
You said: Homeopathy would work against laws of physics and chemistry, as water would have to have some kind of mysterious memory. There is no evidence for any such memory.
Homeopathy does not run counter to physics and what makes you think modern chemistry is a complete field with nothing more to be discovered? For example, any chemist will tell you that a synthetic ingredient is chemically identical to the natural ingredient. However, what they won’t tell you is that there is a difference at the molecular level: ergo, synthetic and natural are NOT the same even though claimed to be. The science is never settled.
And there actually is evidence that water can receive, record, retain and release information but you probably have not read it. Homeopathy works even if we do not yet know how. And unlike most medication is not toxic.
You said: Vaccines do not have any harmful stuff.
You cannot make such a statement. We have no idea what outcomes there might be from using animal, human and bird material in culturing vaccines, in ways and form impossible in nature. And while the toxic ingredients in vaccines have been studied in the singular, they have not been studied in combination, and as every good chemist knows, something alone is not the same and something combined. Neither have there been studies on toxic levels for vaccine ingredients where a child receives not one but six, eight or more vaccines in one session.
You said: If you’re thinking thiomersal, it is not used anymore in most vaccines as preservative.
The key word is most. Let us be honest, it is still used in some vaccines.
You said: Corona virus – you’re assuming much without any supporting data. It’s more dangerous to older people because they have weaker immune systems and weaker constitution. Simple.
It is more dangerous to those suffering serious and chronic disease, not simply the aged. But then so is the common cold.
So how did it go? What were the results? Considering this article was punished in 2016, surely the study is complete by now?
I would think that Dr. Loeb’s research would be most valuable to LEGISLATORS. Armed with the study’s results experts like Dr. Caulfield could credibly argue that homeomathic “remedies” and practitioners of homeopathy should be given protection of any type. Practitioners of homeopathy should NOT be licensed to practice and should not be allowed to prescribe any controlled substances. Homeopathic practice should not be outlawed, any more than palm reading or alleged “psychics”. People should be allowed to seek care from whatever type of “caregiver” they, as consenting adults, choose. However, homeopathic practice – and alleged “medicines” – SHOULD NOT be funded by any sort of government paid or backed medical coverage. Private insurance companies should be allowed to determine whether or not they wish to continue paying for “care” performed by non-licensed practitioners. The results of Dr Loeb’s research should be invaluable in educating lawmakers about the pseudoscience of homeopathy.
I never cease to be astonished at the ignorance of those opposing Homeopathy. To equate Homeopathic medicine with palm-reading demonstrates a total lack of any kind of informed position and understanding.
Let us be clear, whatever the strength of the pharma industry opposition to Homeopathic medicine, this is a modality which, for more than two centuries in rigorously documented case after case, empirically demonstrated, has healed and cured, and, more to the point, the Homeopathic doctors involved have often been Allopathic doctors as well.
Pray, please tell us which doctor trained in Allopathy has ever used palm-reading as an adjunct medical modality? NONE.
However, there are thousands of Allopathic doctors around the world, tens of thousands of them, particularly in Europe, who practice both medical modalities. Tell me, do you think that they, and some of them rank amongst the most noted allopathic doctors, equate Homeopathic medicine with palm reading?
I suggest you do some research so you can at least pretend you know what you are talking about. Meanwhile, as the second most used medical modality in the world, Homeopathy will continue to heal and cure and it will do so despite the lies and propaganda thrown at it. It was ever thus. The chemists hated Homeopathy from the beginning because its success diminished their profits.
Indeed, in an age where the third biggest killer is Allopathic medicine, most of it from prescribed medication, we need Homeopathy and other alternative medical modalities more than ever. Watch views change when the last antibiotic bites the dust and Homeopathy demonstrates, as it has done for centuries, efficacy.
It appears Dr. Mark Loeb may have been beaten to the punch on this one. It appears a study into Nosodes has already been done with interesting results.
https://goo.gl/9rJ1IW
Ah, the Science Post. (Category science, health, pseudo-satire.)
Peer-reviewed journal? No.
I reckon, drop them a fiver and they’ll publish anything that sides with their view.
And that Brian Elk isn’t to be trusted either.
Rather harsh on Lancet, though, considering the editor withdrew that paper after polite requests from their sponsors.
What is more, it seems to give quite the wrong idea those selfless skeptics who help us understand things. Instead it just giives credence to the same old propaganda:
http://bit.ly/2dJiJQl
@Will, you do realise that the site is actual satire right? Your response suggests you aren’t aware of this.