Ben Goldacre, The Guardian, Saturday 10 July 2010
This week the food and nutrition pills industries are complaining. They like to make health claims about their products, which often turn out to be unsupported by the evidence. Regulating that mess would be tedious and long-winded, the kind of project enjoyed by the EU, and so the Nutrition and Health Claims Regulation was brought in during 2006. Since then, member states have submitted tens of thousands of health claims on behalf of manufacturers about cranberries, fish oil, and every magical ingredient you can think of. This week it turned out that 900 have been examined so far, of which 80% have unsurprisingly been rejected.
“The regulation is killing this industry and the job losses are already being felt,” says the head of the International Probiotics Association. Even “established claims like cranberry for urinary tract health” are being rejected, say pill company PowerHealth: “there will be no information on packs for the consumer to assess what the product is supposed to do.” SlimFast, that great British institution, may have to change its name. All complain that the bar for evidence is being set too high.
Trusting nobody, and as a very boring man, I decided to read some adjudications. Excitingly these are all available in full on the EU website. I can only apologise, but the first thing I typed in was fish oil. Picture this as a long-running pseudoscience soap opera (and they are the best selling food supplement product in the UK, from the global $55bn food supplements market).
The pharmaceutical company want to claim that Eye-Q fish oil capsules improve working memory in children, and so they sent in references to 6 studies (the deliberations are in full online). Now firstly, the fact that they sent 6 studies in is interesting, because Equazen, the manufacturers of Eye Q, told me in 2006 that they had 20 positive studies showing that Eye-Q improves school performance and behaviour in children, although they refused to let me see them, so there is no possible way to find out what they did, what they measured, what kind of children participated, or indeed anything at all about these studies. If ever there was a time to roll out those well conducted trials, in which thousands of children volunteered their bodies for experiment, surely it was now, for the EU? Apparently not.
So they sent in 6 studies. 2 of these were conducted in children with developmental coordination disorder and ADHD. Whatever you might think about the value of these labels, and the extent to which they are overused – as with so many diagnostic categories in medicine and psychiatry – these are not mainstream children, and the results may not generalise, so it seems reasonable to take those with a pinch of salt.
Next, 3 of the 6 studies submitted – to support an application for a claim about working memory – did not look at working memory. I hope it’s not repressive or unfair of me to suggest that these can be fairly disregarded.
Lastly, there is a positive result for one sub-type of working memory, verbal working memory, tested with digit span (how many numbers you can remember): this comes from an unpublished trial of the company’s product. I don’t know how many trials they have today, but from a company that has 20 hidden trials in which to hunt for an isolated positive result in one subscale from one variable, this does not feel like compelling evidence.
I don’t think this is a regulator being unfair. What is unfair, I think, is taking these claims at face value. These companies want to make these claims to sell their products, and they will find a way, making them through journalists if need be, rather than through labels. What’s more, people want to buy these products: many of us enjoy the game, if you like, of pretending to ourselves that pills have medical effects, even though often we kind of know, somewhere inside our head, that the claims aren’t quite for real.
PowerHealth complain that if you prevent them making claims then people will buy from companies abroad that can. They’re right. In the field of addiction we use harm reduction strategies, like shooting galleries and prescribed opiates for heroin addicts, where the harmful effects of widespread vices that will never go away are at least contained. You’ll never stop companies making these claims. You’ll never stop people enjoying their claims. This game is at least 200 years old. The best solution I can foresee is an EU-mandated bullshit box, where people can say whatever they want about their product, where consumers can join in, but the game at last is clearly labelled.