8 ‘Pill Solves Complex Social Problem’
Medicalisation—or ‘Will fish-oil pills make my child a genius?’
In 2007 the British Medical Journal published a large, well-conducted, randomised controlled trial, performed at lots of different locations, run by publicly funded scientists, and with a strikingly positive result: it showed that one treatment could significantly improve children’s antisocial behaviour. The treatment was entirely safe, and the study was even accompanied by a very compelling cost-effectiveness analysis.
Did this story get reported as front-page news in the Daily Mail, the natural home of miracle cures (and sinister hidden scares)? Was it followed up on the health pages, with an accompanying photo feature, describing one child’s miraculous recovery, and an interview with an attractive relieved mum with whom we could all identify?
No. The story was unanimously ignored by the British news media, despite their preoccupation with both antisocial behaviour and miracle cures, for one simple reason: the research was not about a pill. It was about a cheap, practical parenting programme.
At the same time, for over five years now, newspapers and television stations have tried to persuade us, with ‘science’, that fish-oil pills have been proven to improve children’s school performance, IQ, behaviour, attention, and more. In fact, nothing could be further from the truth. We are about to learn some very interesting lessons about the media, about how not to conduct a trial, and about our collective desire for medicalised, sciencey-sounding explanations for everyday problems. Do fish-oil pills work? Do they make your child cleverer and better-behaved? The simple answer is, at the moment, nobody could possibly know. Despite everything you have been told, a trial has never been done in mainstream children.
The newspapers would have you believe otherwise. I first became aware of ‘the Durham trials’ when I saw on the news that a trial of fish-oil capsules was being planned in 5,000 children. It’s an astonishing testament to the news values of the British media that this piece of research remains, I am quite prepared to suggest, probably the single most well-reported clinical trial of the past few years. It was on Channel 4 and ITV, and in every national newspaper, sometimes repeatedly. Impressive results were confidently predicted.
This rang alarm bells for two reasons. Firstly, I knew the results of the previous trials offish-oil capsules in children—I’ll describe them in due course—and they weren’t very exciting. But more than that, as a basic rule, I would say this: whenever somebody tells you that their trial is going to be positive before they’ve even started it, then you know you’re onto an interesting story.
Here is what they were planning to do in their ‘trial’: recruit 5,000 children in their GCSE year, give them all six fish-oil capsules a day, then compare how they did in their exams with how the council had estimated they should do without the capsules. There was no ‘control’ group to compare against (like the Aqua Detox bath with no feet in it, or the ear candle on the picnic table, or a group of children taking placebo capsules without fish oil in them). Nothing.
By now you might not need me to tell you that this is a preposterous and above all wasteful way to go about doing a study on a pill that is supposed to improve school performance, with ￡1 million worth of generously donated capsules and 5,000 children at your disposal. But humour an old man, and let me flesh out your hunches, because if we cover the theoretical issues properly first, then the ‘researchers’ at Durham become even more amusingly absurd.
Why you have a placebo group
If you divide a group of kids in half, and give a placebo capsule to one group, and the real capsule to the other group, you can then compare how well each group does, and see whether it was the ingredients in the pill that made the difference to their performance, or just the fact of taking a pill, and being in a study. Why is this important? Because you have to remember that whatever you do to children, in a trial of a pill to improve their performance, their performance will improve.
Firstly, children’s skills improve over time anyway: they grow up, time passes, and they get better at stuff. You might think you’re clever, sitting there with no nappy on, reading this book, but things haven’t always been that way, as your mother could tell you.
Secondly, the children—and their parents—know that they are being given these tablets to improve their performance, so they will be subject to a placebo effect. I have already harped on about this at phenomenal length, because I think the real scientific story of the connections between body and mind are infinitely more interesting than anything concocted by the miracle-cure community, but here it is enough to remind you that the placebo effect is very powerful: consciously or unconsciously, the children will txpect themselves to improve, and so will their parents and their teachers. Children are exquisitely sensitive to our expectations of them, and anyone who doubts that fact should have their parenting permit revoked.
Thirdly, children will do better just from being in a special group that is being studied, observed and closely attended to, since it seems that the simple fact of being in a trial improves your performance, or recovery from illness. This phenomenon is called the ‘Hawthorne effect’, not after a person, but after the factory where it was first observed. In 1923 Thomas Edison (he of the lightbulb) was chairing the ‘Committee on the Relation of Quality and Quantity of Illumination to Efficiency in the Industries’. Various reports from several companies had suggested that better lighting might increase productivity, so a researcher called Deming went with his team to test the theory at Western Electric’s Hawthorne plant at Cicero, Illinois.
I will give you the simplified ‘myth’ version of the findings, as a rare compromise between pedantry and simplicity. When the researchers increased light levels, they found that performance improved. But when they reduced the light levels, performance improved then, too. In fact, they found that no matter what they did, productivity increased anyway. This finding was very important: when you tell workers they are part of a special study to see what might improve productivity, and then you do something…they improve their productivity. This is a kind of placebo effect, because the placebo is not about the mechanics of a sugar pill, it is about the cultural meaning of an intervention, which includes, amongst other things, your expectations, and the expectations of the people tending to you and measuring you.
Beyond all this technical stuff, we also have to place the GCSE results—the outcome which was being measured in this ‘trial’—in their proper context. Durham has a very bad exam record, so its council will be battling hard in every way it possibly can to improve school performance, with all manner of different initiatives and special efforts, and extra funding, running simultaneously with the fish-oil ‘trials’.
We should also remember that bizarre English ritual whereby GCSE results get better every year, yet anyone who suggests that the exams are getting easier is criticised for undermining the achievement of the successful candidates. In fact, taking the long view, this easing is obvious: there are forty-year-old O-level papers which are harder than the current A-level syllabus; and there are present-day university finals papers in maths that are easier than old A-level pipers.
To recap: GCSE results will get better anyway; Durham will be desperately trying to improve its GCSE results through other methods anyway; and any kids taking pills will improve their GCSE results anyway, because of the placebo effect and the Hawthorne effect.
This could all be avoided by splitting the group in half and giving a placebo to one group, separating out what is a specific effect of the fish-oil pills, and what is a general effect of all the other stuff we’ve described above. That would give you very useful information.
Is it ever acceptable to do the kind of trial that was being carried out in Durham? Yes. You can do something called an ‘open trial’, without a placebo group, and this is an accepted kind of research. In fact, there is an important lesson about science here: you can do a less rigorous experiment, for practical reasons, as long as you are clear about what you are doing when you present your study, so other people can make their own minds up about how they interpret your findings.
But there is an important caveat. If you do this kind of ‘compromise’ study, without a placebo group, ‘open label’, but in the hope of getting the most accurate’ possible picture of the treatment’s benefits, then you do it as carefully as you can, while being fully aware that your results might be distorted by expectation, by the placebo effect, by the Hawthorne effect, and so on. You might sign up your kids calmly and cautiously, saying in a casual, offhand fashion that you’re doing a small informal study on some tablets, you don’t say what you expect to find, you hand them out without fanfare, and you calmly measure the results at the end.
What they did in Durham was the polar opposite. There were camera crews, soundmen and lighting men flooding the classrooms. Children were interviewed for radio, for television, for the newspapers; so were their parents; so were their teachers: so were Madeleine Portwood, the educational psychologist who was performing the trial, and Dave Ford, Head of Education, talking—bizarrely—about how they confidently expected positive results. They did literally everything which, in my view, would guarantee them a false positive result, and ruin any chance of their study giving meaningful and useful new information. How often does this happen? In the world of nutritionism, sadly, it seems to be standard research protocol.
We should also remember that these fish-oil ‘trials’ were measuring some highly volatile outcomes. Performance at school in a test, and ‘behaviour’ (a word with a large semantic footprint, if ever I saw one) are huge, variable, amorphous things. More than most outcomes, they will change from moment to moment, with different circumstances, frames of mind, and expectations. Behaviour is not like a blood haemoglobin level, or even height, and nor is intelligence.
Durham Council and Equazen were so successful in their publicity drive, whether through an uncontainable enthusiasm for a positive result or simple foolishness (I really don’t know which) that they effectively sabotaged their ‘trial’. Before the first fish-oil capsule was swallowed by a single child, the Eye Q branded supplement and trial had received glowing publicity in the local papers, the Guardian, the Observer, the Daily Mail, The Times, Channel 4, the BBC, ITV, the Daily Express, the Daily Mirror, the Sun, GMTV, Woman’s Own, and many more. Nobody could claim that the children weren’t well primed.*
≡ In fact, it’s hard to overstate quite how large the fish-oil circus became, over the many years it ran. Professor Sir Robert Winston himself, moustachioed presenter of innumerable ‘science’ programmes for the BBC, personally endorsed a competing omega-3 product, in an advertising campaign which was ultimately terminated by the ASA since it breached their codes on truthfulness and substantiation.
You’re not an educational psychologist. You’re not the Head of Education at a council. You’re not the long-standing MD of a multi-million-pound pill business running huge numbers of ‘trials’. But I am quite sure that you understand very clearly all of these criticisms and concerns, because this isn’t rocket science.
Durham defend themselves
Being a fairly innocent and open-minded soul, I went to the people behind the trial, and put it to them that they had done the very things which would guarantee that their trial would produce useless results. That is what anyone would do in an academic context, and this was a trial after all. Their response was simple. ‘We’ve been quite clear,’ said Dave Ford, Chief Schools Inspector for Durham, and the mastermind behind the project to give out the capsules and measure the results. ‘This is not a trial.’
This felt a bit weak. I call up to suggest that they’re doing a badly designed piece of research, and suddenly everything’s OK, because it’s not actually a ‘trial’? There were other reasons for thinking this was a fairly implausible defence. The Press Association called it a trial. The Daily Mail called it a trial. Channel 4 and ITV and everyone covering it all presented it, very clearly, as research (you can see the clips at badscience.net). More importantly, Durham Council’s own press release called it a ‘study’ and a ‘trial’, repeatedly.*
≡ As a testament to the astonishing foolishness of Durham Council, they’ve now even gone to the trouble of changing the wording of this press release on their website, as if that might address the gaping design flaws.
They were giving something to schoolchildren and measuring the result. Their own descriptive term for this activity was ‘trial’. Now they were saying it wasn’t a trial.
I moved on to Equazen, the manufacturer which is still being lauded throughout the press for its involvement in these ‘trials’ which were almost guaranteed—by virtue of the methodological flaws we have already discussed—to produce spurious positive results. Adam Kelliher, chief executive of the company, clarified further: this was an ‘initiative’. It was not a ‘trial’, nor was it a ‘study’, so I could not critique it as such. Although it was hard to ignore the fact that the Equazen press release talked about giving a capsule and measuring the results, and the word which the company itself used to describe this activity was: ‘trial’.
Dr Madeleine Portwood, the senior educational psychologist running the study, called it a ‘trial’ (twice in the Daily Mail). Every single write-up described it as research. They were giving ‘X’ and measuring change ‘Y’. They called it a trial, and it was a trial—but a stupid trial. Simply saying, ‘Ah, but this is not a trial’ didn’t strike me as an adequate—nor indeed a particularly adult—defence. They didn’t seem to think a trial was even necessary, and Dave Ford explained that the evidence already shows fish oils are beneficial. Let’s see.
The fish-oil evidence
Omega-3 oils are ‘essential fatty acids’. They’re called ‘essential’ because they’re not made by the body (unlike glucose or vitamin D, for example), so you have to eat them. This is true of a lot of things, like many vitamins, for example, and it’s one of the many reasons why it’s a good idea to eat a varied diet, pleasure being another.
They are found in fish oils, and—in slightly different form—in evening primrose oil, linseed oil and other sources. If you look at the flow charts in a biochemistry textbook you will see that there is a long list of functions which these molecules perform in the body: they are involved in constructing membranes, and also some of the molecules that are involved in communication between cells, for example during inflammation. For this reason some people think it might be useful to eat them in larger amounts.
I’m open to the idea myself, but there are good reasons to be sceptical, because there is a lot of history here. In the past, decades before the Durham ‘trials’, the field of essential fatty acid research has seen research fraud, secrecy, court cases, negative findings that have been hushed up, media misreporting on a massive scale, and some very striking examples of people using the media to present research findings direct to the public in order to circumvent regulators. We’ll come back to that later.
There have been—count them—six trials to date on fish oil in children. Not one of these trials was done in ‘normal’ mainstream children: all of them have been done in special categories of children with one diagnosis or another—dyslexia, ADHD, and so on. Three of the trials had some positive findings, in some of the many things they measured (but remember, if you measure a hundred things in a study, a few of them will improve simply by chance, as we will see later), and three were negative. One, amusingly, found that the placebo group did better than the fish-oil group on some measures. They are all summarised online at badscience.net.
And yet: ‘AH of our research, both published and unpublished, shows that the Eye Q formula can really help enhance achievement in the classroom,’ says Adam Kelliher, CEO of Equazen. All of it.
To take a statement like this seriously, we would have to read the research. I am not for one nanosecond accusing anybody of research fraud: in any case, if anyone did suspect fraud, reading the research would not help, because if people have faked their results with any enthusiasm then you need a forensic statistician and a lot of time and information to catch them out. But we do need to read published research in order to establish whether the conclusions drawn by the stakeholders in the research are valid, or whether there are methodological problems that make their interpretation the product of wishful thinking, incompetence, or perhaps even simply a judgement call with which you would not concur.
Paul Broca, for example, was a famous French craniologist in the nineteenth century whose name is given to Broca’s area, the part of the frontal lobe involved in the generation of speech (which is wiped out in many stroke victims). Among his other interests, Broca used to measure brains, and he was always rather perturbed by the fact that the German brains came out a hundred grams heavier than French brains. So he decided that other factors, such as overall body weight, should also be taken into account when measuring brain size: this explained the larger Germanic brains to his satisfaction. But for his prominent work on how men have larger brains than women, he didn’t make any such adjustments. Whether by accident or by design, it’s a kludge.
Cesare Lombroso, a nineteenth-century pioneer of ‘biological criminology’, made similarly inconsistent fixes in his research, citing insensitivity to pain among criminals and ‘lower races’ as a sign of their primitive nature, but identifying the very same quality as evidence of courage and bravery in Europeans. The devil is in the detail, and this is why scientists report their full methods and results in academic papers, not in newspapers or on television programmes, and it is why experimental research cannot be reported in the mainstream media alone.
You might feel, after the ‘trial’ nonsense, that we should be cautious about accepting Durham and Equazen’s appraisal of their own work, but I’d be suspicious of the claims from a lot of serious academics in exactly the same way (they would welcome such suspicion, and I’d be able to read the research evidence they were drawing on). I asked Equazen for their twenty positive studies, and was told I would have to sign a confidentiality agreement to see them. That’s a confidentiality agreement to review the research evidence for widely promoted claims, going back years, in the media and by Durham Council employees, about a very controversial area of nutrition and behaviour, of huge interest to the public, and about experiments conducted—forgive me if I’m getting sentimental here—on our schoolchildren. I refused.*
≡ Although you wouldn’t know if I had signed, since I wouldn’t be able to tell you.
Meanwhile, all over the newspapers and television, everywhere you looked, going back to at least 2002, there were reports of positive fish-oil trials in Durham, using Equazen products. There seemed to have been half a dozen of these trials, in various locations, performed by Durham Council staff on Durham state school children, ytt there was no sign of anything in the scientific literature (beyond one study by a researcher from Oxford, which was on children with developmental coordination disorder). There were wildly enthusiastic Durham Council press releases that talked about positive trials, sure. There were Madeleine Portwood interviews with the press, in which she talked enthusiastically about the positive results (and talked too about how the fish oil was improving children’s skin conditions, and other problems)—but no published studies.
I contacted Durham. They put me on to Madeleine Port-wood, the scientific brains behind this enormous and enduring operation. She appears regularly on telly talking about fish oils, using inappropriately technical terms like ‘limbic’ to a lay audience. ‘It sounds complicated,’ say TV presenters, ‘but the science says…’ Portwood is evidently very enthusiastic about talking to parents and journalists, but she did not return my calls. The press office took a week to reply to my emails. I asked for details of the studies they had performed, or were performing. The responses appeared to be inconsistent with the media coverage. At least one trial seemed to be missing. I asked for methodological details of the studies they were doing, and results of the ones that were completed. Not until we publish, they said.
Equazen and Durham Council had coached, preened and spoon-fed a huge number of journalists over the years, giving them time and energy; as far as I can see there is only one difference between me and those reporters: from what they wrote, they clearly know very little about trial design, whereas I know, well, a fair bit (and now so do you).
Meanwhile I kept being referred to the durhamtrials.org website, as if this contained useful data. It had evidently bamboozled many journalists and parents before me, and it’s linked to by many news stories and Equazen adverts. But as a source of information about the ‘trials’, this site is a perfect illustration of why you should publish a trial before you make any dramatic claims about the results. It’s hard to tell what’s there. The last time I looked, there was some data borrowed from a proper trial published elsewhere by some Oxford researchers (which happened to be done in Durham), but other than that, no sign of Durham’s own placebo-controlled trials which kept appearing in the news. There were plenty of complicated-looking graphs, but they seem to be on special Durham ‘trials’, with no placebo-control group. They seem to describe improvements, with sciencey-looking graphics to illustrate them, but there are no statistics to say if the changes were statistically significant.
It’s almost impossible to express just how much data is missing from this site, and how useless that renders what is there. As an example, there is a ‘trial’ with its results reported in a graph, but nowhere on the entire site, as far as I can see, does it tell you how many children were in the study reported. It’s hard to think of a single more basic piece of information than that. But you can find plenty of gushing testimonials that wouldn’t be out of place on an alternative therapists’ website selling miracle cures. One child says: ‘Now I am not so interested in the TV. I just like reading books. The best place in all the world is the library. I absolutely love it.’
I felt the public deserved to know what had been done in these trials. This was probably the most widely reported clinical trial of the past few years, it was a matter of great public interest, and the experiments were performed on children by public servants. So I made a Freedom of Information Act request for the information you would need to know about a trial: what was done, who were the children, what measurements were taken, and so on. Everything, in fact, from the standardised and very complete ‘CONSORT’ guidelines which describe best practice in writing up trial results. Durham Council refused, on grounds of cost.
So I got readers of the column to ask for little bits of information, so that none of us was asking for anything very expensive. We were accused of running a vexatious ‘campaign’ of ‘harassment’. The head of the council complained about me to the Guardian. I was eventually told that my questions might be answered, if I travelled 275 miles north to Durham in person. Various readers appealed; they were told that much of the information they had been refused did not in any case exist.
Finally, in February 2008, after a disappointing fall in the rate of improvement in GCSE results, the council announced that there had never been any intention of measuring exam performance. This surprised even me. To be scrupulously precise, what they said, in answer to a written question from an indignant retired headmaster, was this: ‘As we have said previously it was never intended, and the County Council never suggested, that it would use this initiative to draw conclusions about the effectiveness or otherwise of using Fish Oil to boost exam results.’
To say that this contradicts their earlier claims would be something of an understatement. In a Daily Mail article from 5 September 2006 headlined ‘Fish Oil Study Launched to Improve GCSE Grades’ Dave Ford, the council’s Chief Schools Inspector, said: ‘We will be able to track pupils’ progress and measure whether their attainments are better than their predicted scores.’ Dr Madeleine Portwood, senior educational psychologist running the ‘trial’, said: ‘Previous trials have shown remarkable results and I am confident that we will see marked benefits in this one as well.’
Durham county council’s own press release from the beginning of the ‘trial’ reads: ‘Education chiefs in County Durham are to mount a unique back-to-school initiative today which they believe could result in record GCSE pass levels next summer.’ It reports that children are being given pills ‘to see whether the proven benefits it has already brought children and young people in earlier trials can boost exam performances too’. The council’s Chief Schools Inspector is ‘convinced’ that these pills ‘could have a direct impact on their GCSE results…the county-wide trial will continue until the pupils complete their GCSE examinations next June, and the first test of the supplement’s effectiveness will be when they sit their ‘mock’ exams this December’. ‘We are able to track pupils’ progress and we can measure whether their attainments are better than their predicted scores,’ says Dave Ford in the press release for the trial which, we are now told, was not a trial, and was never intended to collect any data on exam results. It was with some astonishment that I also noticed that they had changed their original press release on the Durham website, and removed the word ‘trial’.
Why is all this important? Well, firstly, as I have said, this was the most well-reported trial of that year, and the fact that it was such a foolish exercise could only undermine the public’s understanding of the very nature of evidence and research. When people realise that they are flawed by design, then exercises like this undermine the public’s faith in research: this can only undermine willingness to participate in research, of course, and recruiting participants into trials is difficult enough at the best of times.
More than that, there are also some very important ethical issues here. People volunteer their bodies—and their children’s bodies—to participate in trials, on the understanding that the results will be used to improve medical and scientific knowledge. They expect that research performed on them will be properly conducted, informative by design, and that the results will be published in full, for all to see.
I have seen the parent-information leaflets that were distributed for the Durham project, and they are entirely unambiguous in promoting the exercise as a scientific research project. The word ‘study’ is used seventeen times in one of these leaflets, although there is little chance that the ‘study’ (or ‘trial’, or ‘initiative’) can produce any useful data, for the reasons we have seen, and in any case it has now been announced that the effect on GCSE results will not be published.
For these reasons the trial was, in my opinion, unethical.*
≡ While we’re on the subject of ethics, Durham have claimed that to give placebo to half the children would itself be unethical: this is another very basic misunderstanding on their part. We do not know if fish oils are beneficial or not. That would be the point of doing some proper research into the area.
You will have your own view, but it is very hard to understand what justification there can be for withholding the results of this ‘trial’ now that it has concluded. Educationalists, academic researchers, teachers, parents and the public should be permitted to review the methods and results, and draw their own conclusions on its significance, however weak the design was. In fact, this is the exact same situation as the data on antidepressants’ efficacy being withheld by the drug companies, and a further illustration of the similarities between these pill industries, despite the food supplement pill industry’s best efforts to present itself as somehow ‘alternative’.
The power is in the pill?
We should be clear that I’m not—and I’m quite entitled to say this—myself very interested in whether fish-oil capsules improve children’s IQ, and I say this for a number of reasons. Firstly, I’m not a consumer journalist, or a lifestyle guru, and despite the infinitely superior financial rewards, I am absolutely very much not in the business of ‘giving readers health advice’ (to be honest, I’d rather have spiders lay eggs in my skin). But also, if you think about it rationally, any benefit of fish oil for school performance will probably not be all that dramatic. We do not have an epidemic of thick vegetarians, for example, and humans have shown themselves to be as versatile as their diets are diverse, from Alaska to the Sinai desert.
But more than anything, at the risk of sounding like the most boring man you know, again: I wouldn’t start with molecules, or pills, as a solution to these kinds of problems. I can’t help noticing that the capsules Durham is promoting cost 80p per child per day, while it spends only 65p per child per day on school meals, so you might start there. Or you might restrict junk-food advertising to children, as the government has recently done. You might look at education and awareness about food and diet, as Jamie Oliver recently did very well, without recourse to dodgy pseudoscience or miracle pills.
You might even step away from obsessing over food—just for once—and look at parenting skills, teacher recruitment and retention, or social exclusion, or classroom size, or social inequality and the widening income gap. Or parenting programmes, as we said right at the beginning. But the media don’t want stories like that. ‘Pill solves complex social problem’ feels much more like a news story than anything involving a boring parenting programme.
This is partly due to journalists’ own sense of news value, but it’s also a question of how stories are pushed. I’ve not met Hutchings et al, the authors of the parenting study that kicked off this chapter—and I’m quite prepared to be told that they are in Soho House until 2 a.m. every night, schmoozing broadcast media journalists with champagne and nibbles—but in reality I suspect they are quiet, modest academics. Private companies, meanwhile, have top-dollar public-relations firepower, one single issue to promote, time to foster relationships with interested journalists, and a wily understanding of the desires of the public and the media, our collective hopes and consumer dreams.
The fish-oil story is by no means unique: repeatedly, in a bid to sell pills, people sell a wider explanatory framework, and as George Orwell first noted, the true genius in advertising is to sell you the solution and the problem. Pharmaceutical companies have worked hard, in their direct-to-consumer advertisements and their lobbying, to push the ‘serotonin hypothesis’ for depression, even though the scientific evidence for this theory is growing thinner every year; and the nutrition supplements industry, for its own market, promotes dietary deficiencies as a treatable cause for low mood (I myself do not have a miracle cure to offer, and repetitively enough, I think that the social causes of these problems are arguably more interesting—and possibly even more amenable to intervention).
These fish-oil stories were a classic example of a phenomenon more widely described as ‘medicalisation’, the expansion of the biomedical remit into domains where it may not be helpful or necessary. In the past, this has been portrayed as something that doctors inflict on a passive and unsuspecting world, an expansion of the medical empire: but in reality it seems that these reductionist biomedical stories can appeal to us all, because complex problems often have depressingly complex causes, and the solutions can be taxing and unsatisfactory.
In its most aggressive form, this process has been characterised as ‘disease-mongering’. It can be seen throughout the world of quack cures—and being alive to it can be like having the scales removed from your eyes—but in big pharma the story goes like this: the low-hanging fruit of medical research has all been harvested, and the industry is rapidly running out of novel molecular entities. They registered fifty a year in the 1990s, but now it’s down to twenty a year, and a lot of those are just copies. They are in trouble.
Because they cannot find new treatments for the diseases we already have, the pill companies instead invent new diseases for the treatments they already have. Recent favourites include Social Anxiety Disorder (a new use for SSRI drugs), Female Sexual Dysfunction (a new use for Viagra in women), night eating syndrome (SSRIs again) and so on: problems, in a real sense, but perhaps not necessarily the stuff of pills, and perhaps not best conceived of in reductionist biomedical terms. In fact, refraining intelligence, loss of libido, shyness and tiredness as medical pill problems could be considered crass, exploitative, and frankly disempowering.
These crude biomedical mechanisms may well enhance the placebo benefits from pills, but they are also seductive precisely because of what they edit out. In the media coverage around the rebranding of Viagra as a treatment for women in the early noughties, and the invention of the new disease Female Sexual Dysfunction, for example, it wasn’t just the tablets that were being sold: it was the explanation.
Glossy magazines told stories about couples with relationship problems, who went to their GP, and the GP didn’t understand their problem (because that is the first paragraph of any medical story in the media). Then they went to the specialist, and he didn’t help either. But then they went to a private clinic. They did blood tests, hormone profiles, esoteric imaging studies of *oral bloodflow, and they understood: the solution was in a pill, but that was only half the story. It was a mechanical problem. Rarely was there a mention of any other factors: that she was feeling tired from overwork, or he was exhausted from being a new father, and finding it hard to come to terms with the fact that his wife was now the mother of his children, and no longer the vixen he first snogged on the floor of the student union building to the sound of ‘Don’t You Want Me Baby?’ by the Human League in 1983: no. Because we don’t want to talk about these issues, any more than we want to talk about social inequality, the disintegration of local communities, the breakdown of the family, the impact of employment uncertainty, changing expectations and notions of personhood, or any of the other complex, difficult factors that play into the apparent rise of antisocial behaviour in schools.
But above all we should pay tribute to the genius of this huge fish-oil project, and every other nutritionist who has got their pills into the media, and into schools, because more than anything else, they have sold children, at the most impressionable time of their lives, one very compelling message: that you need to take pills to lead a healthy normal life, that a sensible diet and lifestyle are not enough in themselves, and that a pill can even make up for failings elsewhere. They have pushed their message directly into schools, into families, into the minds of their worried parents, and it is their intention that every child should understand that you need to eat several large, expensive, coloured capsules, six of them, three times a day, and this will improve vital but intangible qualities: concentration, behaviour and intelligence.
This is the greatest benefit to the pill industry, of every complexion. I would prefer fish-oil pills to ritalin, but fish-oil pills are being marketed at every child in the country, and they have undoubtedly won. Friends tell me that in some schools it is considered almost child neglect not to buy these capsules, and its impact on this generation of schoolchildren, reared on pills, will continue to bear rich fruit for all the industries, long after the fish-oil capsules have been forgotten.
Calming down: the apothecary industrial complex
Generating news coverage as a means of increasing brand awareness for a commercial product is a well-trodden path (and it also drives those contentless ‘scientists have found the equation for…’ stories that we shall see in a later chapter). PR companies even calculate something called ‘advertising equivalents’ for the exposure your brand gets for free, and in a period when more newsprint is generated by fewer journalists, it’s inevitable that such shortcuts to colourful copy are welcomed by reporters. News and features stories about a product also carry far more weight in the public imagination than a paid advert, and are more likely to be read or watched.
But there is another, more subtle benefit to be had from editorial coverage of your pseudo-medical product: the claims that can be made in advertising and on packaging for food supplements and ‘borderline medical products’ are tightly regulated, but there are no such regulations covering the claims made by journalists.
This rather clever division of labour is one of the more interesting features of the alternative therapy industry. Take a moment to think of all the things that you have come to believe are true, or at least have heard claimed regularly, about different supplements: glucosamine can treat arthritis; antioxidants prevent cancer and heart disease; omega-3 fish oils improve intelligence. These claims are now common currency, a part of our culture as much as ‘dock leaves for stinging nettles’; but you will rarely, if ever, see them being made explicitly on packaging or in advertising material.
Once you realise this, it makes the colour supplements a marginally more interesting read: the alternative therapy columnist will make a dramatic and scientifically untenable claim for glucosamine, stating that it will improve the joint pain of a reader who has written in; the pill company, meanwhile, will have a full-page advertisement for glucosamine, which merely states the dose and possibly makes a bland claim at the level of basic biology, rather than about clinical efficacy: ‘Glucosamine is a known chemical constituent of cartilage.’
Sometimes the overlap is close enough to be amusing. Some examples are predictable. The vitamin pill magnate Patrick Holford, for example, makes sweeping and dramatic claims for all kinds of supplements in his ‘Optimum Nutrition’ books; yet these same claims are not to be found on the labels of his own-brand ‘Optimum Nutrition’ range of vitamin pills (which do feature, however, a photograph of his face).
Alternative health columnist Susan Clark—who has argued, among other things, that water has calories—is another shining example of this fine line that journalists can sometimes tread. She had a column in the Sunday Times, Grazia and the Observer for several years. In the course of these columns she recommended one company’s products, Victoria Health’, with notable frequency: once a month, regular as clockwork, by my reckoning. The papers deny that there was any impropriety, as does she, and I have no reason to doubt this. But she had done paid work for the company in the past, and she has now left her newspaper jobs to take up a full-time position at Victoria Health, writing their in-house magazine. (It’s a scene that is eerily reminiscent of the well-known free flow of employees in America between the pharmaceutical industry regulator and the boards of various pharmaceutical companies: in fact, at the risk of hammering a point home too hard, you will have noticed by now that I am telling the story of all the pill industries, using examples from mainstream media, and you couldn’t put a cigarette paper between them.)
The Royal Pharmaceutical Society was expressing concern at these covert marketing strategies in the mainstream pharmaceutical industry as long ago as 1991: ‘Barred from labelling products with detailed medicinal claims unless they submit to the licensing procedure,’ it said, ‘manufacturers and marketing companies are resorting to methods such as celebrity endorsements, free pseudomedical product literature, and press campaigns that have resulted in uncritically promotional features in large-circulation newspapers and magazines.’
Access to the unpoliced world of the media is well recognised as a major market advantage for Equazen, and it is an advantage that they press home hard. In the press release announcing the company’s acquisition by the pharmaceutical company Galenica, they declared: ‘Coverage of research showing the benefits of our Eye Q has appeared numerous times on national television and radio…that is widely credited with being instrumental in the significant growth of the UK omega-3 sector since 2003.’ To be honest, I would prefer to see a clearly labelled ‘nonsense box’ on all packaging and advertising, in which alternative therapy producers can freely make any claims they want to, instead of this misleading editorial coverage, because adverts are at least clearly labelled as such.
The wheels of time
Of course, these Durham trials are not the first time the world has seen such an extraordinary effort to promote one food supplement’s powers through media stories on inaccessible research. David Horrobin was a 1980s pharmaceutical multi-millionaire—one of the richest men in Britain—and his Efamol food supplements empire (built, like Equazen’s, on ‘essential fatty acids’) was worth an eye-watering ￡550 million at its peak. The efforts of his company went far further than anything one could find in the world of Equazen and Durham Council.
In 1984, staff at Horrobin’s US distributors were found guilty in court of misbranding their food supplement as a drug; they were circumventing Food and Drug Administration regulations which forbade them from making unfounded claims for their supplement pills in advertising by engineering media coverage that treated them as if they had proven medical benefits. In the court case, paperwork was produced as evidence in which Horrobin explicitly said things like: ‘Obviously you could not advertise [evening primrose oil] for these purposes but equally obviously there are ways of getting the information across…’ Company memos described elaborate promotional schemes: planting articles on their research in the media, deploying researchers to make claims on their behalf, using radio phone-ins and the like.
In 2003 Horrobin’s researcher Dr Goran Jamal was found guilty by the GMC of fraudulently concocting research data on trials which he had performed for Horrobin. He had been promised 0.5 per cent of the product’s profits should it come to market (Horrobin was not responsible, but this is a fairly unusual payment arrangement which would rather dangle temptation in front of your eyes).
As with the fish-oil pills, Horrobin’s products were always in the news, but it was difficult to get hold of the research data. In 1989 he published a famous meta-analysis of trials in a dermatology journal which found that his lead product, evening primrose oil, was effective in eczema. This meta-analysis excluded the one available large published trial (which was negative), but included the two oldest studies, and seven small positive studies sponsored by his own company (these were still unavailable at the last review I could find, in 2003).
In 1990 two academics had their review of the data binned by the journal after Horrobin’s lawyers got involved. In 1995 the Department of Health commissioned a meta-analysis from a renowned epidemiologist. This included ten unpublished studies held by the company which was marketing evening primrose oil. The ensuing scene was only fully described by Professor Hywel Williams a decade later in an editorial for the British Medical Journal. The company erupted over a leak, and the Department of Health forced all authors and referees to sign written statements to reassure it. The academics were not allowed to publish their report. Alternative therapy, the people’s medicine!
It has since been shown, following a wider but undisclosed review, that evening primrose oil is not effective in eczema, and it has lost its medicines licence. The case is still cited by leading figures in evidence-based medicine, such as Sir Iain Chalmers, founder of the Cochrane Collaboration, as an example of a pharmaceutical company refusing to release information on clinical trials to academics wishing to examine their claims.
David Horrobin, I feel duty bound to mention, is the father of the founding director of Equazen, Cathra Kelliher, nee Horrobin, and her husband and co-director Adam Kelliher specifically cited him in interviews as a major influence on his business practices. I am not suggesting that their business practices are the same, but in my view the parallels—with inaccessible data, and research results that wind up being presented directly to the media—are striking.
In 2007 the GCSE results of the children in the Durham fish-oil year came in. This was an area of failing schools, receiving a huge amount of extra effort and input of all forms. The preceding year, with no fish oil, the results—the number of kids getting five GCSE grades A* to C—had improved by 5.5 per cent.
≡ ‘Nutritionist’, ‘nutrition therapist’, ‘nutritional therapy consultant’ and the many variations on this theme are not protected terms, unlike ‘nurse’, ‘dietitian’ or ‘physiotherapist’, so anyone can use them. Just to be clear, I’ll say it again: anyone can declare themselves to be a nutritionist. After reading this book, you will know more about the appraisal of evidence than most, so in the manner of Spartacus I suggest you call yourself one too; and academics working in the field of nutrition will have to move on, because the word doesn’t belong to them any more.
After the fish-oil intervention the rate of improvement deteriorated notably, giving only a 3.5 per cent improvement. This was against a backdrop of a 2 per cent increase in GCSE scores nationally. You would have expected an improvement from a failing region whose schools were receiving a large amount of extra assistance and investment, and you might also remember, as we said, that GCSE results improve nationally every year. If anything, the pills seem to have been associated with a slowing of improvements.
Fish oils, meanwhile, are now the most popular food supplement product in the UK, with annual sales for that single product worth over ￡110 million a year. And the Kellihers recently sold Equazen to a major pharmaceutical corporation for an undisclosed sum. If you think I have been overly critical, I would invite you to notice that they win.