Clinical trials are EFSA’s fool’s gold

There’s gold to be found in them health claims mountains, but prospectors from the European Food Safety Authority (EFSA) must be happy with the little chunks that add up to a lot, and stop searching for nuggets the size of your fist.

October 1st saw a change in the prospecting methods: Before it had been a more measured panning for gold, but now the blasting has begun. Hundreds of article 13.1 claims were rejected because studies have not been done in a healthy population.

In the past I have defended EFSA’s hard-line stance – if the science isn’t there to support an ingredient or product, then it shouldn’t get the health claim. There are few right-thinking people who would challenge this. But relying solely on one type of science blinkers us to what the science as a whole shows.

The over-reliance on clinical trials at the expense of the totality of the evidence is undermining an important regulation. Now is the time to reassess clinical trials as the ‘gold standard’ of nutrition science.

The value of the randomised clinical trial is immense, but only in the context of the overall science. Dismissing evidence from certain studies because they were not done in a healthy population is wrong.

Consider for a moment the practicalities of this – in order to observe an effect (a reduction in a specific protein that indicates increased risk of heart disease, for example) you often have to do these experiments in people with risk factors or already suffering from the disease. However, this then limits the results to those populations.

If we perform the study in ‘healthy’ people and at the end of it, they are still healthy – what then? It’s ineffective? Or it just helps maintain normal levels of the offending protein and leads to prevention of heart disease 20 years later via that route?

Plus, show me two people in the general population with the same health profile – we’re all different. My cholesterol may be slightly lower than yours. My blood pressure may be higher (particularly as I approach my publishing deadline). My omega-3 levels may be different, as, no doubt, will the numbers of bifidobacteria in my gut. I consider myself healthy. So, maybe, do you. I’ve had three cups of tea this morning – you?

One piece of the puzzle

To ignore the results from randomised clinical trials in such populations is wrong – they clearly show health improvements in the people who need improving. But this is only part of a wider problem with how health claims are being assessed.

I’ve commented before on randomised clinical trials for nutrients – They isolate one or a couple of nutrients and thereby pull them out of context. They then supplement at one or two dosage levels for a set period of time. And they are usually done in at-risk people.

Can a time-constrained randomised trial really capture a lifetime of consumption with respect to chronic disease?

I would say no. This is why we also need to include evidence from other types of studies, including epidemiology, and in vitro or in vivo mechanistic studies that explain what’s happening.

Interestingly, this is what EFSA has done for many, if not all, of the vitamins and minerals – the totality of the evidence was used. This represents double standards.

The cries of frustration from industry and other stakeholders come as no surprise. Criteria were not been clearly set out at the start; select guidance was issued only during or after decisions for certain dossiers; and there seems to be confusion as to what constitutes sufficient evidence. How much data is enough?

It almost seems like a no-win situation.

Consumers and industry strike gold

This is a discussion purely based on the science – if there isn’t enough, then no health claim. If there is, and from lots of complementary sources, it is wrong to reject a claim.

The health claims regulations offer fantastic opportunities for industry and consumers alike. The grey areas need to be turned into black and white so that everyone can benefit from this.

There’s gold to be found, but you’ll never find it at the end of the rainbow.

This topic and much more will be discussed at the NutraIngredients Health Claims 2010 conference to be held in Brussels on 10th December. For more information and to register, please click here.

Stephen Daniells is the acting senior editor for NutraIngredients and NutraIngredients-USA, and the science editor for FoodNavigator and FoodNavigator-USA. He has a PhD in chemistry from Queen's University Belfast and has worked in research in the Netherlands and France.

If you would like to comment on this article, please email stephen.daniells'at'decisionnews.com