Guest post by Frank Van der Kooy
Some serious flaws in the scientific reporting of two acupuncture clinical trials, for the treatment of infertility and allergic rhinitis, were recently published on this blog. The overly positive way in which the researchers made their mostly negative results public, was also of concern. Both these studies were published by the researcher of the year, Prof Caroline Smith, of the National Institute of Complementary Medicine (NICM), Australia. The stream of comments and discussions that followed made me think of another commonly overlooked aspect when it comes to acupuncture clinical trials. Conflict of interest! In both these studies the authors declared to have no conflicts of interest and in other studies by this author this also seems to be the case. The question can be asked: If you are a practicing acupuncturist who runs a clinical trial of acupuncture, isn’t that, by default, a serious conflict of interest? The intention of this article is not an in-depth discussion of what a conflict of interest is, but rather to compare medical doctors with acupuncturists turned researchers. Let me explain.
Some medical doctors (GPs, surgeons etc.) decide to leave their practice after practicing 10-20 years to become full time researchers (and visa versa). Universities accept these people with open arms because they bring with them a wealth of knowledge regarding the practical side of medicine and healthcare in general. They are thus seen as an asset to any medical research project including clinical trials. Can the same be said about an acupuncturist? They also bring with them years of experience and thus they should also be a major asset to any acupuncture clinical trial. But I am afraid not!
Why? Medical doctors have a multitude of tools (drugs, surgical procedures, diagnostic tools etc.) at their disposal to treat all types of medical conditions. When will their background constitute a conflict of interest? When they publish a positive clinical trial of a specific medical intervention in which they have a vested interest. e.g owning shares in the company producing the medical intervention (financial interest) or if they have been staunch supporters of this intervention during their years of practice (emotional interest). Just imagine that you have prescribed a specific intervention to hundreds of patients over a long period of time, and you swore by it, and now you have to face them with a negative clinical trial result – that will be difficult. The former is easy to declare whilst the latter might be slightly more difficult.
Doctors also tend to focus on a specific disease e.g. cancer and will perform research with the existing tools at their disposal but also try to find new tools in order to improve the risk-benefit profile of the disease treatment. Thus, for a doctor there is the possibility that they might run into a conflict of interest, but due to the multitude of medical interventions out there this is by no means a given.
What about acupuncture practitioners turned researchers? An acupuncturist only has one tool at their disposal to treat all medical conditions. I can hear them say; but we stick needles in different places and depths etc. depending on the medical condition! Yes, but the fact remains that they can only stick needles into people – and that is a single intervention. So is this by default a conflict of interest? I would argue, yes, it is like having only one drug to treat all medical conditions. If you have treated hundreds of patients for various medical conditions with acupuncture and now suddenly you publish a negative clinical trial, you will not only be red faced when you run into your former patients – who paid for your evidence based acupuncture treatment – they might even sue you for misleading them. As an acupuncturist, you cannot allow the single tool that you have to be ineffective, otherwise people might start to question acupuncture. The fact that they have to protect acupuncture means that an acupuncturist will by default have a conflict of interest – no matter what medical condition they aim to treat.
If you have been emotionally and financially invested in acupuncture as a cure-all for 10-20 years, it will be very difficult, if not impossible, to publish a negative result as an acupuncture researcher.
Another aspect is that the acupuncture fraternity is a very tight knit community, where negative results are frowned upon because of everyone’s financial and emotional interests. Surely they will expel you from this community, if you publish negative results?
So how do acupuncture researchers go about running clinical trials? An example: Professors Smith and Bensoussan, both at the NICM, are currently registered as practicing acupuncturists. This means that they can legally practice acupuncture and, because they have been active for decades, they are also well known in the acupuncture fraternity. It is unknown, whether they are still actively practicing in their own practice or part-time in someone else’s practice, or if they have a financial stake in their former or someone else’s practice. Based on the fact that they are still registered as active acupuncturists, I can conclude that they do have an emotional and/or financial interest in the positive outcome of their acupuncture clinical trials.
Because of this inherent conflict of interest, and due to current strict clinical trial regulations, which makes it quite difficult (although not impossible) to fabricate or falsify data, they go for the next best thing – which is the design of their clinical trial e.g. the A+B versus A design. But it doesn’t stop there. As soon as a clinical trial fails to give a positive result, the results will be inflated to make it sound positive.
Why? Because they must prevent themselves from cognitive dissonance, they need to protect the single tool that they have, they must keep the acupuncture fraternity happy and they have to protect themselves against potential lawsuits from former (current) patients or a decrease in patient numbers (and thus financial income). On top of that – how would the media and the public react to an acupuncture clinical trial if the lead researcher declare that they have their own acupuncture clinic? Surely these factors together amount to a conflict of interest and should be declared as such?
So what, in this context, is the main difference between a doctor and an acupuncturist? A doctor has a multitude of medical interventions. He or she might have a conflict of interest, if they work on a specific intervention in which they have a vested interest. An acupuncturist only has one intervention and therefore they have a vested interest by default – which they never seem to declare!