The fuzzy grey line - Freedom of choice, safety & efficacy

I invite you to consider the curious case of Dr X.

Dr X is a proponent of 1023 Juice – a therapy which he believes can cure disease Y.

Dr X can demonstrate (through whatever mechanism you care to choose) that 1023 juice is completely safe – by which I mean it causes no harm to those who take it.

There is currently no evidence that 1023 Juice can treat does cure Y, although Dr X articulates a mechanism through which he claims it works.

The question arises - should Dr X be allowed to sell 1023 Juice to the public?

This is not the most subtle thought experiment, but it is useful to illustrate problems with arguments commonly used by proponents of alternative medicine, 

Anyone following the #ten23 hashtag will know a number of homeopaths have characterised the campaign in terms of freedom of choice - see here for a short, representative example which I’ve blogged about before. There are several quotes in the article about freedom of choice and democracy, such as:

A democratic society is based upon the premise of freedom of expression and equality. The UK is a democratic society and seeks to allow its citizens the freedom and choice, one of the most of which concerns our healthcare.

I don’t think this line of reasoning gets homeopaths very far. Let me try to explain why.

I presume no one except fanatical libertarians believe there should be absolute freedom of choice in healthcare. By this I mean no restriction of any kind on the healthcare people can choose for themselves or their families.

Extreme examples serve to demonstrate why (and please note I am not comparing these to homeopathy, merely using them to illustrate the absurdity of the absolute position).

Without any restrictions, the mentally ill could choose bloodletting to relieve their symptoms. Those brainwashed by religious cults could advocate the choice of ritual beating or physical abuse of children to cure all manner of conditions.

And, to choose a less extreme example but one I think most homeopaths would agree demonstrates the need for some restrictions on freedom of choice, ‘Big Pharma’ could sell whatever drugs it liked to whomsoever it liked without restriction, under the banner it was providing ‘what customers want’.

If one rejects the absolute position, then it follows that there some restrictions of on people’s freedom to choose healthcare are justified.

So, what might these restrictions be?

Safety of the therapy involved is probably the least controversial option. That is, people should be free to choose treatments which are not harmful to them. The extreme examples above are notable for the harmful effects they have to the individual involved without demonstrable benefit.

I hope homeopaths and proponents of alt med will be comfortable with this, and I think they may favour a more stringent safety restriction of this kind than many advocates of mainstream medicine. The safety of alternative remedies is a major argument deployed in their favour, since it is claimed they lack the harmful side effects caused by ‘Big Pharma’ with their mainstream medicines and drugs.

The other obvious candidate is efficacy – that is, proof that the therapy does what it claims it to do. 

And, I think from the arguments I have read, proponents of alternative and mainstream medicine will give different answers to the question ‘Should there be restrictions on freedom of healthcare choice on the basis of efficacy?’

The response of the latter will be complex – some may say efficacy of treatment should be shown before people can choose it. Or, adopting a softer position, the efficacy of treatment should be well understood and advertised before the choice is offered.

In some cases, proponents of mainstream medicine will allow proof of efficacy to trump the safety restriction. If the benefits of a therapy are well-established and significant enough, some harmful effects can be permitted, as with chemotherapy.

From what I have read and heard, the response of the alternative medicine proponents is likely to be different – where efficacy is not proven and providing the treatment causes no harm, its sale should be permitted. Freedom of choice is more important.

And this is where I think Dr X is so useful. I ask again – should he be allowed to sell 1023 Juice?

Safety, that is the absence of harmful effects to the patient, is clearly proven. Yet, I think it becomes clear that this definition of safety will not do.

If people are allowed to choose Dr X’s therapy before its efficacy is proven, there is a high chance that they will believe themselves cured.

This will not directly cause harmful effects in the patient, but it may prevent them seeking other treatments whose efficacy is established. If Y were cancer or malaria, the harmful effect would be significant. Moreover, if the disease in question were Aids, there is a significant chance that others will be infected, thus causing major harm to others who have no opportunity to exercise a choice.

The line between safety and efficacy is not a thick black one – it is a fuzzy, grey one because ineffective treatments cause harm in less obvious or measurable ways. 

Homeopaths who resort to freedom of choice arguments are hiding this complexity, and it is absolutely vital they are called on it.

The 1023 campaign is trying to raise awareness, promote clearer labelling and highlight the contorted position Boots has got into selling such remedies. It is not trying to ban homeopathy, despite wilful characterisations to the contrary. 

However, I leave you with one final question to puzzle over. Boots much quoted response states that they supported calls for more scientific research into the efficacy of homeopathic medicines, adding: "This would help our patients and customers make informed choices about using homeopathic medicines."

My question is this – would you be comfortable if Dr X continued to sell 1023 Juice while further research were carried out’?