In a scathing new commentary, two physicians call on the research community to stop allowing clinical trials — studies involving human subjects — to be used for “highly implausible” alternative-medicine treatments, such as homeopathy and reiki.
The writers, Dr. David Gorski, a cancer surgeon at Wayne State University School of Medicine, and Dr. Steven Novella, a neurologist at Yale University, argue that not only have such clinical trials “led to the infiltration of pseudoscience” into academic medicine, but that they have also caused real harm.
And that harm is not just from people substituting an ineffective treatment, such as homeopathic “remedies,” for a proven one. As an example, they point to a clinical trial that compared a well-publicized alternative-medicine treatment that involves “extreme dietary modifications, juices, large quantities of supplements and coffee enemas” with standard chemotherapy for the treatment of advanced pancreatic cancer.
The results, which were published in 2010, were “disturbing,” write Gorski and Novella. “One year survival of subjects undergoing [the alternative-medicine] protocol was nearly fourfold worse than subjects receiving standard-of-care chemotherapy and worse than expected based on historical controls.”
Specifically, the study found that the patients in the alternative-therapy group survived an average of 4.3 months after the start of their treatment compared to 14 months for the patients on chemotherapy. After one year, 16 percent of the alternative-therapy patients were alive compared to 56 percent of the patients receiving the chemotherapy. In addition, the alternative-therapy patients reported a much lower quality of life than those being treated with chemotherapy.
Many scientists have tolerated — and sometimes even encouraged — clinical trials for scientifically dubious alternative-medicine treatments because they believe that such studies will finally prove to people that the treatments don’t work and get people to abandon them.
But that viewpoint is “misguided,” say Gorski and Novella.
“Acupuncture and reiki remain widely practiced and even embraced at academic institutions, and even homeopathy continues to be practiced, despite clinical trials and meta-analyses that demonstrate effects indistinguishable from placebo,” they write.
It’s also unethical to enroll patients in studies for treatments that have absolutely no scientific chance of being effective, argue Gorski and Novella. They point to two randomized, double-blinded, placebo-controlled clinical trials undertaken in Nicaragua and Honduras that tested homeopathic remedies on children with diarrhea.
“Both trials were performed even though the ingredients in the homeopathic remedies tested were not known to be effective against childhood diarrhea, two ingredients, arsenic and mercury, are definitely toxic, and the ingredients were diluted away to nonexistence,” write Gorski and Novella.
Needed: a new term
Clinical trials are not supposed to be undertaken until the preclinical data — laboratory research — provides compelling evidence that the treatment is biologically plausible and safe.
Indeed, as Gorski and Novella point out, “so integral to this process is biological plausibility based on preclinical data that the Declaration of Helsinki [a set of ethical principles developed by the World Medical Association] states, ‘medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.’”
“It should be noted,” Groski and Novella add,
that ‘biologically plausible’ does not mean ‘knowing the exact mechanism.’ What it does mean is that the mechanism should not be so scientifically implausible as to be reasonably considered impossible. In other words, the mechanisms should not violate laws and theories in science that rest on far sturdier and longer-established foundations that imperfect, bias-prone clinical trials.
For example, homeopathy violates multiple laws of physics with its claims that dilution can make a homeopathic remedy stronger and that water can retain the ‘memory’ of substances with which it has been in contact before. Thus, treatments like homeopathy should be dismissed as ineffective on basic scientific grounds alone.
That is why we propose the term science-based medicine (SBM) as opposed to evidence-based medicine (EMB). SBM restores basic science considerations to EBM and is what EBM should be.
Doctors need to take a stand, too
It’s not just the research community that needs to put its foot down about approving and funding scientifically dubious clinical trials, say Gorski and Novella. The medical community also needs to be honest with their patients about alternative medical treatments.
“Somehow this idea has sprung up that to be a ‘holistic’ doctor you have to embrace pseudoscience like homeopathy, reiki, traditional Chinese medicine, and the like, but that’s a false dichotomy,” says Gorski in a statement released with the commentary. “If the medical system is currently too impersonal and patients are rushed through office visits because a doctor has to see more and more patients to cover his salary and expenses, then the answer is to find a way to fix those problems, not to embrace quackery. Integrating pseudoscience with science-based medicine isn’t going to make science-based medicine better.”
The commentary was published online Wednesday in the journal Trends in Molecular Medicine. Both Gorski and Novella are editors for Science-Based Medicine, an organization and blog “dedicated to evaluating medical treatments and products of interest to the public in a scientific light, and promoting the highest standards and traditions of science in health care.”