Homeopathic Ethics

Homeopathic Ethics

I mentioned over at Science-Based Medicine a pair of trials that looked at the efficacy of homeopathy for preventing and treating  influenza.

Homeopathy is water. You know that, I know that. That studies are done on the efficacy of water, and that IRB's/ethics committees will approve such studies, demonstrates that reality based medicine doesn't understand the world of pseudo-medicine.

Flu still kills. The CDC tracks pediatric deaths. In 2013 111 children died of flu. In 2014 148. In 2016 89. This year 61. No often, but it can.

So how do we get IRB approval for Effectiveness of preventive treatment by Influenzinum in the winter period against the onset of influenza-like illnesses?

Influenzinum is a homeopathic remedy made from the influenza vaccine aka a nosode. Influenzinum didn't work. Influenzinum shouldn't work. To evaluate it for a potentially fatal illness defines unethical.

And they have tested homeopathic medications in children.  We get Homeopathic medicines for prevention of influenza and acute respiratory tract infections in children: blind, randomized, placebo-controlled clinical trial.

Are IRB's paying attention to what they are approving? The NIH guidelines have 7 principles to guide clinical research. Three are

  • Social and clinical value 
  • Scientific validity 
  • Favorable risk-benefit ratio

Homeopathy completely and totally fails all three. Treating infections, diseases with real potential for morbidity and mortality, with water, cannot be possible be ethical. Yet such studies get approved. Why?

When I saw Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis, I was intrigued as they included a homeopathy trial.

The exclusions listed on the ethics committee form for the homeopathy trial differ from those in the research protocol (box), but there is no evidence that the committee raised this. Moreover, some of the trial's exclusion criteria seem unjustified since homeopathic remedies beyond the C12 potency (that is, diluted 12 times at a ratio 1:100 resulting in a final dilution of 1:1024) contain no active molecules to, for example, interact with biological drugs.

They object that more patients should have been able to participate in pseudo-science fraud. The problem was not the study had exclusion criteria, the problem is that the study was approved at all.

They also noted the IRB failed to recognize that patients were being given alternative facts:

However, the information provided was problematic. The patient information (as revised after ethics review) stated that homeopathic remedies are "usually based on minerals or herbs." This implies that they contain active ingredients, but remedies beyond the C12 potency contain no active molecules. The patient information stated that "there is currently little clinical evidence about the efficacy of homeopathic remedies" but did not state that the totality of the available evidence fails to show that highly dilute homeopathic remedies are effective beyond placebo

When all pseudo-scientific studies are based on alternative facts.  

They did note that the study failed the fundamental principle that

an appropriate process of scientific critique has demonstrated that this research proposal is worthwhile and of high scientific quality.

It is a problem with most pseudo-medical studies: it appears that approval is a rubber stamp by committees that either have no understanding of pseudo-medicine or do not care.  The ethics committees are ignoring their fundamental ethical responsibilities. 

The solution? They suggest, among other ideas,

Ideally, ethics committees or other appropriate bodies should critically evaluate the quality of the evidence submitted by investigators and the research proposal.*

Which should kill most pseudo-medical, and all homeopathic, clinical trials in the crib.

While there will be a large grey area, some trials are sufficiently unlikely to prove informative that committees should be able to reject them.

Nice in theory, but PubMed suggests otherwise.  

If the ethics process permits poor quality research, the limitations of the research should be made explicit to patients so they can make an informed choice about participation.

If the ethics committee can't make an informed decision based on the explicit protocol, I am not certain a patient will be able to make a good decision.

There are pseudo-medical interventions that are, for the lack of a better term, pure fiction: homeopathy, reiki, acupuncture, chiropractic and more. We cannot ethically do research on pure fiction, or offer it to patients.

Not that it will ever happen. That ship has long sailed. We picked Sisyphus as out logo for a reason.

Points of Interest 04/05/2017
Points of Interest 04/04/2017

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