Do IRB's Work? Not for Pseudo-Medicines.

Do IRB's Work?  Not for Pseudo-Medicines.

Homeopathy is 100% total nonsense.  No qualifiers.  It is completely divorced from the reality of known anatomy and physiology. My colleagues sometimes refer to homeopathy as highly implausible. I prefer to think of it as laughably impossible.

There is no way for homeopathy to have any effect outside of self-delusion, be it by the patient or the treating provider.

It is no surprise that reviews of homeopathy find it useless.

There is a paucity of good-quality studies of sufficient size that examine the effectiveness of homeopathy as a treatment for any clinical condition in humans. The available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions in humans.

It is water. Water will treat no illness except dehydration.

 So one would think given prior plausibility that homeopathy is totally useless and that careful reviews that find homeopathy useless that it would be difficult in 2014 to do an ethical clinical trial using homeopathy.

In the US, ethical considerations include

Social and clinical value

Every research study is designed to answer a specific question. Answering certain questions will have significant value for society or for present or future patients with a particular illness.

Scientific validity

A study should be designed in a way that will get an understandable answer to the valuable research question… Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

Favorable risk-benefit ratio

Homeopathy fails all the above.

As for children? For clinical trials you need

• The trial must involve no more than a minor increase over minimal risk.

• The treatments must be appropriate to the condition or to medical care that the child would otherwise receive.
• The treatment must either yield "generalizable knowledge" about the specific condition that is vital for understanding or treatment.
• The study is a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem that specifically affects children.

A trial of homeopathy in children would seem to fail these as well.

That is why I wonder why an IRB would approve A Placebo Controlled Study of Homeopathic Treatment of Children and Youth With ADHD.

Doing homeopathic research in children would appear to violate multiple basic principals of ethical medical research. Maybe because the research is in Canada it is OK, although their ethical guidelines appear violated as well.

I keep wondering how, in this century, IRB’s can continue to approve the wasting of patients time and health testing pseudo-medicines completely at odds with reality and ignore the basic ethical guidelines of clinical research.  Oh yeah.  Pseudo-medicines do not have to pay attention to the same standards as the rest of the medical community.

Points of Interest 12/24/2014