How complementary or alternative therapies become Medicine

Originally posted in response to a discussion on complementary and alternative therapies.

I welcome any product which has a beneficial therapeutic effect into the realm of Medicine (capital M). If someone demonstrates, scientifically, that, for example, Manuka honey has a sustained, positive effective on the regulation of (in this case) neutropenic cells, then that is Medicine and will likely become part of the standard therapeutic protocol for neutropenics.

For me the issue isn't that might or might not be an effect caused by products in "naturopathic" products, but that claims about them are being made without scientific evidence. If you want to develop a new therapeutic product and market it, there is a process through which you must travel, whether you are making claims about ibuprofen, IVIG products, antibiotics or naturopathics.

1. The developer/promoter has to demonstrate the therapy causes less harm than the condition it purports to treat.
2. The developer/promoter has to demonstrate the therapy causes the therapeutic effect it claims to cause.
3. The developer/promoter has to demonstrate the therapy has a benefit which no existing therapy for the condition has. For example
   • It has a greater therapeutic effect than existing therapies
   • It has fewer side-effects than existing therapies
   • People who cannot take existing therapies are able to take the new therapy

Let's exemplify this using Manuka honey. I'm going to assume that (1) has been fullfilled on the basis that lots of people eat honey, although there are issues here: some people do have problems eating honey, and honey which isn't pasteurised can become a reservoir for pathogens, but let's assume we have passed this stage. Obviously, this stage is important, as the research a couple of years ago into a particular monoclonal antibody demonstrated, where participants (except the control) reacted extremely unfavourably to the product.

Therapeutic claims (2) and (3) are more of a challenge. We have already noted that the placebo effect occurs; there's not (in my opinion) enough research around the placebo effect and how it works, but, for example, in 15% of people a sugar pill is as effective a codeine (a relatively mild opiate) in pain control. So it's clearly important that one is able to differentiate between the placebo effect and the effect of the therapy.

The only way that we have to differentiate at the moment is through double-blind trials. A double-blind trial is where neither the people administering care to the patient nor the patient themselves know whether they are getting the new therapy or a placebo. This prevents the carers from treating the patient differently depending on whether they are on the "real" stuff or not (such differences are typically unconscious but demonstrable when the therapy is only single-blind), and allows the experimenters to differentiate between effects reported by the test (therapy) group and the those reported by the control (placebo) group.

In one study, the product being explored was a painkiller and they carried out a pseudo-double-blind experiment. It was set up as a double-blind (so the patients and the nurses were not told what product the patient would be getting), but they put a twist on it and "accidentally" revealed to half of the test group and half of the control group that they were getting the real therapy (I think they did it by putting red dots on their folders or something, it was quite clever). This left them with four groups: Test A (actual therapy, ignorant), Test B (actual therapy, knows), Control A (placebo, ignorant), Control B (placebo, thinks getting active ingredient). Test B showed the greatest effect, followed by Test A and Control B (about the same) and then Control A.

In short, a proper double-blind test is required to remove the mind of the patient and carers from the investigative equation. Obviously, this has to be done ethically (all participants must be told that they may or may not be getting the active ingredient), and convincingly (this was challenging with acupuncture, but they came up with a way of delivering blind needle inserts or skin pressure which were indistinguishable to participants), but without it you don’t know if you are measuring the response of the patient’s brain to the therapy, to the behaviour of the carer or to knowledge.

Until a series of double-blind tests have been carried out, making a claim about the therapy as to (2) or (3) is impossible. Once that claim is asserted (for example, "SCIG reduces joint pain and incidence of infection in adult patients with CVID and is better tolerated than other therapies") to the satisfaction of the scientific community (typically represented by regulatory bodies, such as the MHRC in the UK or FDA in the US), with a satisfactory safety profile, then a licence is issued.

Uses for other reasons (eg. use of SCIG in some autoimmune conditions) are "off-licence" until the company have demonstrated that the condition also responds favourably to the treatment (in fact, SCIG would be unlikely to have a sufficient effect on many autoimmune conditions compared with IVIG because the dose for autoimmune diseases is typically significantly larger than in, say, CVID).

So, with regards complementary and alternative therapies, UNTIL they have fullfilled the requirements listed above, they are considered folk medicine (lower case m) and are outside the realm of Medicine (capital M). I would now consider St John's Wort, as an example from the above, part of Medicine because someone has done some research (and in fact you should find that St John's Wort now has warnings that it shouldn't be taken with certain antidepressants).

Someone suggested that pharmaceutical companies wouldn’t undertake this research because the results are not patentable, so they wouldn’t make any money. I would firstly make the point there is no reason it has to be "big pharma" doing biomedical research. This is exactly the type of research which it is ideal for governments to fund as it is clearly in the interests of the citizens for them to be protected from bogus claims and to gain the benefits of patent-free therapeutics.

That said, "big pharma" are doing research in this area and examining molecules from biologicals (term for folk medicines) to see if they have actual therapeutic effects. Once that is established, they explore why and then try to find a derivative molecule which is more potent and/or safer than the original: the derivative molecule is patentable and could be a source of significant income. This was the pattern seen in the 1950s with the explosion of antibiotic drugs.

To summarise, once therapies have been proven to be effective, they are no longer "complementary" or "alternative", just Medicine. It can be difficult to differentiate between placebo and actual effects because the human brain is so dynamic and adaptive. I don't object to people using complementary and alternative medicines, provided they don't make claims about them, particularly (and I don't think this was the case in this event) where those claims are intended to promote or sell a product. Exploring the complementary/alternative therapies domain provides a pool of untapped folk knowledge and therapeutics which may provide future breakthroughs in therapeutic opportunities.