2008 - Bad Science

by Ben Goldacre

  Medical journalists, despite what they may try to tell you, most certainly did not reveal the dangers of thalidomide: and in many respects it’s difficult to picture a world in which the characters who produce bogus MRSA hoax stories could somehow be meaningfully engaged in monitoring and administering drug safety, ably assisted, perhaps, by ‘leading experts’ from their garden sheds.

  What the MRSA episode reveals to me, alongside a gut-wrenching and cavalier grandiosity, is the very same parody that we saw in our earlier review of nonsense science stories: humanities graduates in the media, perhaps feeling intellectually offended by how hard they find the science, conclude that it must simply be arbitrary, made up nonsense, to everyone. You can pick a result from anywhere you like, and if it suits your agenda, then that’s that: nobody can take it away from you with their clever words, because it’s all just game-playing, it just depends on who you ask, none of it really means anything, you don’t understand the long words, and therefore, crucially, probably, neither do the scientists.

  Epilogue

  Although he was a very pleasant man, from my first telephone conversation with Chris Malyszewicz it was immediately clear that he lacked the basic background knowledge necessary to hold even a rudimentary discussion about microbiology. Patronising as it may sound, I feel a genuine sympathy for him, almost as a Walter Mitty figure. He claimed to have consulted for ‘Cosworth-Technology, Boeing Aircraft, British Airways, Britannia Airways, Monarch Airways, Birmingham European Airways’. After BA and Boeing, neither of which had any record of any dealings with him, I gave up contacting these organisations. He would send elliptical comments in response to detailed criticisms of his ‘analytic techniques’, such as they were.

  Dear Ben,

  As a quote:

  ‘I am surprised, but knowing what I know am not and knowing what I mean’.

  Thanks, Chris

  I have strong feelings on this story: I do not blame Chris. I am certain that the true nature of his expertise would have been clear to anybody who spoke with him, regardless of background knowledge, and in my view it is the media that should have known better, with their huge offices, chains of command and responsibility, codes of conduct and editorial policies: not one man, in a shed in his back garden, surrounded by kitchen fittings and laboratory equipment he barely understood, bought on bank loans he was struggling to repay, in a small conurbation just outside Northampton.

  Chris wasn’t happy with what I wrote about him, and what was said about him after the story was exposed. We spent some time on the telephone, with him upset and me feeling, in all honesty, quite guilty. He felt that what was happening to him was unfair. He explained that he had never sought to be an expert on MRSA, but after the first story the journalists simply kept coming back, and everything snowballed. He may have made some mistakes, but he only wanted to help.

  Chris Malyszewicz died in a car accident after losing control of his vehicle near Northampton shortly after the MRSA stories were exposed. He was heavily in debt.

  16 The Media’s MMR Hoax

  The MRSA swab scandals were a simple, circumscribed, collective hoax. MMR is something much bigger: it is the prototypical health scare, by which all others must be judged and understood. It has every ingredient, every canard, every sleight of hand, and every aspect of venal incompetence and hysteria, systemic and individual. Even now, it is with great trepidation that I even dare to mention it by name, for two very simple reasons.

  Firstly, at the quietest hint of a discussion on the subject, an army of campaigners and columnists will still, even in 2008, hammer on editors’ doors demanding the right to a lengthy, misleading and emotive response in the name of ‘balance’. Their demands are always, without exception, accommodated.

  But there is a second issue, which is less important than it seems at first: Andrew Wakefield, the doctor who many imagine to be at the centre of the story, is currently in front of the GMC on charges of professional misconduct, and between me finishing and you reading this book, the judgement will probably be out.

  I have no idea what that judgement will be, and being honest, although I suppose I’m glad they look into things like this in general, cases like his are two a penny at the GMC. I have no great interest in whether one individual’s work was ethically dubious: the responsibility for the MMR scare cannot be laid at the door of a single man, however much the media may now be trying to argue that it should.

  The blame lies instead with the hundreds of journalists, columnists, editors and executives who drove this story cynically, irrationally, and wilfully onto the front pages for nine solid years. As we will see, they overextrapolated from one study into absurdity, while studiously ignoring all reassuring data, and all subsequent refutations. They quoted ‘experts’ as authorities instead of explaining the science, they ignored the historical context, they set idiots to cover the facts, they pitched emotive stories from parents against bland academics (who they smeared), and most bizarrely of all, in some cases they simply made stuff up.

  Now they claim that the original 1998 Wakefield research has been ‘debunked’ (it was never anything compelling in the first place), and you will be able to watch this year as they try to pin the whole scare onto one man. I’m a doctor too, and I don’t imagine for one moment that I could stand up and create a nine-year-long news story on a whim. It is because of the media’s blindness—and their unwillingness to accept their responsibility—that they will continue to commit the same crimes in the future. There is nothing you can do about that, so it might be worth paying attention now.

  To remind ourselves, here is the story of MMR as it appeared in the British news media from 1998 onwards:

  Autism is becoming more common, although nobody knows why.

  A doctor called Andrew Wakefield has done scientific research showing a link between the MMR triple jab and autism.

  Since then, more scientific research has been done confirming this link.

  There is evidence that single jabs might be safer, but government doctors and those in the pay of the pharmaceutical industry have simply rubbished these claims.

  Tony Blair probably didn’t give his young son the vaccine.

  Measles isn’t so bad.

  And vaccination didn’t prevent it very well anyway.

  I think that’s pretty fair. The central claim for each of these bullet points was either misleading or downright untrue, as we will see.

  Vaccine scares in context

  Before we begin, it’s worth taking a moment to look at vaccine scares around the world, because I’m always struck by how circumscribed these panics are, and how poorly they propagate themselves in different soils. The MMR and autism scare, for example, is practically non-existent outside Britain, even in Europe and America. But throughout the 1990s France was in the grip of a scare that hepatitis B vaccine caused multiple sclerosis (it wouldn’t surprise me if I was the first person to tell you that).

  In the US, the major vaccine fear has been around the use of a preservative called thiomersal, although somehow this hasn’t caught on here, even though that same preservative was used in Britain. And in the 1970s—since the past is another country too—there was a widespread concern in the UK, driven again by a single doctor, that whooping-cough vaccine was causing neurological damage.

  Looking even further back, there was a strong anti-smallpox-vaccine movement in Leicester well into the 1930s, despite its demonstrable benefits, and in fact anti-inoculation sentiment goes right back to its origins: when James Jurin studied inoculation against smallpox (finding that it was associated with a lower death rate than the natural disease), his newfangled numbers and statistical ideas were treated with enormous suspicion. Indeed, smallpox inoculation remained illegal in France until 1769.*

  ≡ Disdain for statistics in healthcare research wasn’t unusual at the time: Ignaz Semmelweis noticed in 1847 that patients were dying much more frequently on the obstetrics ward run by the medical students than on the one r
un by the midwifery students (this was in the days when students did all the legwork in hospitals). He was pretty sure that this was because the medical students were carrying something nasty from the corpses in the dissection room, so he instituted proper handwashing practices with chlorinated lime, and did some figures on the benefits. The death rates fell, but in an era of medicine that championed ‘theory’ over real-world empirical evidence, he was basically ignored, until Louis Pasteur came along and confirmed the germ theory. Semmelweis died alone in an asylum. You’ve heard of Pasteur.

  Even when Edward Jenner introduced the much safer vaccination for protecting people against smallpox at the turn of the nineteenth century, he was strongly opposed by the London cognoscenti.

  And in an article from Scientific American in 1888 you can find the very same arguments which modern antivaccination campaigners continue to use today:

  The success of the anti-vaccinationists has been aptly shown by the results in Zurich, Switzerland, where for a number of years, until 1883, a compulsory vaccination law obtained, and smallpox was wholly prevented—not a single case occurred in 1882. This result was seized upon the following year by the anti-vaccinationists and used against the necessity for any such law, and it seems they had sufficient influence to cause its repeal. The death returns for that year (1883) showed that for every 1,000 deaths two were caused by smallpox; In 1884 there were three; in 1885, 17, and in the first quarter of 1886, 85.

  Meanwhile, WHO’s highly successful global polio eradication programme was on target to have eradicated this murderous disease from the face of the earth by now—a fate which has already befallen the smallpox virus, excepting a few glass vials—until local imams from a small province called Kano in northern Nigeria claimed that the vaccine was part of a US plot to spread AIDS and infertility in the Islamic world, and organised a boycott which rapidly spread to five other states in the country. This was followed by a large outbreak of polio in Nigeria and surrounding countries, and tragically even further afield. There have now been outbreaks in Yemen and Indonesia, causing lifelong paralysis in children, and laboratory analysis of the genetic code has shown that these outbreaks were caused by the same strain of the polio virus, exported from Kano.

  After all, as any trendy MMR-dodging north-London middle–class humanities-graduate couple with children would agree, just because vaccination has almost eradicated polio—a debilitating disease which as recently as 1988 was endemic in 125 countries—that doesn’t necessarily mean it’s a good thing.

  The diversity and isolation of these anti-vaccination panics helps to illustrate the way in which they reflect local political and social concerns more than a genuine appraisal of the risk data: because if the vaccine for hepatitis B, or MMR, or polio, is dangerous in one country, it should be equally dangerous everywhere on the planet; and if those concerns were genuinely grounded in the evidence, especially in an age of the rapid propagation of information, you would expect the concerns to be expressed by journalists everywhere. They’re not.

  Andrew Wakefield and his Lancet paper

  In February 1998 a group of researchers and doctors led by a surgeon called Andrew Wakefield from the Royal Free Hospital in London published a research paper in the Lancet which by now stands as one of the most misunderstood and misreported papers in the history of academia. In some respects it did itself no favours: it is badly written, and has no clear statement of its hypothesis, or indeed of its conclusions (you can read it free online if you like). It has since been partially retracted.

  The paper described twelve children who had bowel problems and behavioural problems (mosdy autism), and mentioned that the parents or doctors of eight of these children believed that their child’s problems had started within a few days of them being given the MMR vaccine. It also reported various blood tests, and tests on tissue samples taken from the children. The results of these were sometimes abnormal, but varied between children.

  12 children, consecutively referred to the department of paediatric gastroenterology with a history of a pervasive developmental disorder with loss of acquired skills and intestinal symptoms (diarrhoea, abdominal pain, bloating and food intolerance), were investigated.

  …In eight children, the onset of behavioural problems had been linked, either by the parents or by the child’s physician, with measles, mumps, and rubella vaccination…In these eight children the average interval from exposure to first behavioural symptoms was 6.3 days (range 1-14).

  What can this kind of paper tell you about a link between something as common as MMR, and something as common as autism? Basically nothing, either way. It was a collection of twelve clinical anecdotes, a type of paper called a ‘case series’—and a case series, by design, wouldn’t demonstrate such a relationship between an exposure and an outcome with any force. It did not take some children who were given MMR and some children who weren’t, and then compare the rates of autism between the two groups (this would have been a ‘cohort study’). It did not take some children with autism, and some children without autism, and then compare the rates of vaccination between the two groups (this would have been a ‘case-control study’).

  Could anything else explain the apparent connection between MMR, bowel problems and autism in these eight children? Firstly, although they sound like rare things to come together, this was a specialist centre in a teaching hospital, and the children had only been referred there because they had bowel problems and behavioural problems (the circumstances of these referrals are currently being examined by the GMC, as we will see).

  Out of an entire nation of millions of inhabitants, if some children with a combination of fairly common things (vaccination, autism, bowel problems) all come together in one place which is already acting as beacon for such a combination, as this clinic was, we should not naturally be impressed. You will remember from the discussion of the unfortunate Dutch nurse Lucia de Berk (and indeed from reading news reports about lottery winners) that unlikely combinations of events will always happen, somewhere, to some people, entirely by chance. Drawing a target around them after the fact tells us nothing at all.

  All stories about treatment and risk will start with modest clinical hunches like these anecdotes; but hunches, with nothing to back them up, are not generally newsworthy. At the publication of this paper, a press conference was held at the Royal Free Hospital, and to the visible surprise of many other clinicians and academics present, Andrew Wakefield announced that he thought it would be prudent to use single vaccines instead of the MMR triple vaccine. Nobody should have been surprised: a video news release had already been issued by the hospital, in which Wakefield made the same call.

  We are all entitled to our clinical hunches, as individuals, but there was nothing in either this study of twelve children, or any other published research, to suggest that giving single vaccines would be safer. As it happens, there are good grounds for believing that giving vaccines separately might be more harmful: they need six visits to the GP, and six unpleasant jabs, which makes four more appointments to miss. Maybe you’re ill, maybe you’re on holiday, maybe you move house, maybe you lose track of which ones you’ve had, maybe you can’t see the point of rubella for boys, or mumps for girls, or maybe you’re a working single mum with two kids and no time.

  Also, of course, the children spend much more time vulnerable to infection, especially if you wait a year between jabs, as Wakefield has recommended, out of the blue. Ironically, although most of the causes of autism remain unclear, one of the few well-characterised single causes is rubella infection itself, while the child is in the womb.

  The story behind the paper

  Some fairly worrying questions have been raised since then. We won’t cover them in detail, because I don’t find ad hominem stories very interesting to write about, and because I don’t want that aspect of the story—rather than the research evidence—to be the reason why you come to your own conclusion about the risks of MMR and autism. There are things which came ou
t in 2004, however, which cannot fairly be ignored, including allegations of multiple conflicts of interest, undeclared sources of bias in the recruitment of subjects for the paper, undisclosed negative findings, and problems with the ethical clearance for the tests. These were largely uncovered by a tenacious investigative journalist from the Sunday Times called Brian Deer, and they now form part of the allegations being investigated by the GMC.

  For example, it is investigating whether Wakefield failed to disclose to the editor of the Lancet his involvement in a patent relating to a new vaccine; more worrying are the concerns about where the twelve children in the 1998 Royal Free study came from. While in the paper it is stated that they were sequential referrals to a clinic, in fact Wakefield was already being paid £50,000 of legal aid money by a firm of solicitors to investigate children whose parents were preparing a case against MMR, and the GMC is further investigating where the patients in the study came from, because it seems that many of Wakefield’s referrals had come to him specifically as someone who could show a link between MMR and autism, whether formally or informally, and was working on a legal case. This is the beacon problem once more, and under these circumstances, the fact that only eight of the twelve children’s parents or physicians believed the problems were caused by MMR would be unimpressive, if anything.