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.