2008 - Bad Science

by Ben Goldacre

  In 2005, exasperated by government inaction, a group of 199 leading medical practitioners in South Africa signed an open letter to the health authorities of the Western Cape, pleading for action on the Rath Foundation. ‘Our patients are being inundated with propaganda encouraging them to stop life-saving medicine,’ it said. ‘Many of us have had experiences with HIV-infected patients who have had their health compromised by stopping their anti-retrovirals due to the activities of this Foundation.’

  Rath’s adverts continue unabated. He even claimed that his activities were endorsed by huge lists of sponsors and affiliates including the World Health Organization, UNICEF and UNAIDS. All have issued statements flatly denouncing his claims and activities. The man certainly has chutzpah.

  His adverts are also rich with detailed scientific claims. It would be wrong of us to neglect the science in this story, so we should follow some through, specifically those which focused on a Harvard study in Tanzania. He described this research in full-page advertisements, some of which have appeared in the New York Times and the Herald Tribune. He refers to these paid adverts, I should mention, as if he had received flattering news coverage in the same papers. Anyway, this research showed that multivitamin supplements can be beneficial in a developing world population with AIDS: there’s no problem with that result, and there are plenty of reasons to think that vitamins might have some benefit for a sick and frequently malnourished population.

  The researchers enrolled 1,078 HIV-positive pregnant women and randomly assigned them to have either a vitamin supplement or placebo. Notice once again, if you will, that this is another large, well-conducted, publicly funded trial of vitamins, conducted by mainstream scientists, contrary to the claims of nutritionists that such studies do not exist.

  The women were followed up for several years, and at the end of the study, 25 per cent of those on vitamins were severely ill or dead, compared with 31 per cent of those on placebo. There was also a statistically significant benefit in CD4 cell count (a measure of HIV activity) and viral loads. These results were in no sense dramatic—and they cannot be compared to the demonstrable life-saving benefits of anti-retrovirals—but they did show that improved diet, or cheap generic vitamin pills, could represent a simple and relatively inexpensive way to marginally delay the need to start HIV medication in some patients.

  In the hands of Rath, this study became evidence that vitamin pills are superior to medication in the treatment of HIV⁄AIDS, that anti-retroviral therapies ‘severely damage all cells in the body—including white blood cells’, and worse, that they were ‘thereby not improving but rather worsening immune deficiencies and expanding the AIDS epidemic’. The researchers from the Harvard School of Public Health were so horrified that they put together a press release setting out their support for medication, and stating starkly, with unambiguous clarity, that Matthias Rath had misrepresented their findings. Media regulators failed to act.

  To outsiders the story is baffling and terrifying. The United Nations has condemned Rath’s adverts as ‘wrong and misleading’. ‘This guy is killing people by luring them with unrecognised treatment without any scientific evidence,’ said Eric Goemaere, head of Médecins sans Frontieres SA, a man who pioneered anti-retroviral therapy in South Africa. Rath sued him.

  It’s not just MSF who Rath has gone after. He has also brought time-consuming, expensive, stalled or failed cases against a professor of AIDS research, critics in the media and others.

  His most heinous campaign has been against the Treatment Action Campaign. For many years this has been the key organisation campaigning for access to anti-retroviral medication in South Africa, and it has been fighting a war on four fronts. Firstly, it campaigns against its own government, trying to compel it to roll out treatment programmes for the population. Secondly, it fights against the pharmaceutical industry, which claims that it needs to charge full price for its products in developing countries in order to pay for research and development of new drugs—although, as we shall see, out of its $550 billion global annual revenue, the pharmaceutical industry spends twice as much on promotion and admin as it does on research and development. Thirdly, it is a grassroots organisation, made up largely of black women from townships who do important prevention and treatment-literacy work on the ground, ensuring that people know what is available, and how to protect themselves. Lastly, it fights against people who promote the type of information peddled by Matthias Rath and his like.

  Rath has taken it upon himself to launch a massive campaign against this group. He distributes advertising material against them, saying ‘Treatment Action Campaign medicines are killing you’ and ‘Stop AIDS genocide by the drug cartel’, claiming—as you will guess by now—that there is an international conspiracy by pharmaceutical companies intent on prolonging the AIDS crisis in the interests of their own profits by giving medication that makes people worse. TAC must be a part of this, goes the reasoning, because it criticises Matthias Rath. Just like me writing on Patrick Holford or Gillian McKeith, TAC is perfectly in favour of good diet and nutrition. But in Rath’s promotional literature it is a front for the pharmaceutical industry, a ‘Trojan horse’ and a ‘running dog’. TAC has made a full disclosure of its funding and activities, showing no such connection: Rath presented no evidence to the contrary, and has even lost a court case over the issue, but will not let it lie. In fact he presents the loss of this court case as if it was a victory.

  The founder of TAC is a man called Zackie Achmat, and he is the closest thing I have to a hero. He is South African, and coloured, by the nomenclature of the apartheid system in which he grew up. At the age of fourteen he tried to burn down his school, and you might have done the same in similar circumstances. He has been arrested and imprisoned under South Africa’s violent, brutal white regime, with all that entailed. He is also gay, and HIV-positive, and he refused to take anti-retroviral medication until it was widely available to all on the public health system, even when he was dying of AIDS, even when he was personally implored to save himself by Nelson Mandela, a public supporter of anti-retroviral medication and Achmat’s work.

  And now, at last, we come to the lowest point of this whole story, not merely for Matthias Rath’s movement, but for the alternative therapy movement around the world as a whole. In 2007, with a huge public flourish, to great media coverage, Rath’s former employee Anthony Brink filed a formal complaint against Zackie Achmat, the head of the TAC. Bizarrely, he filed this complaint with the International Criminal Court at The Hague, accusing Achmat of genocide for successfully campaigning to get access to HIV drugs for the people of South Africa.

  It’s hard to explain just how influential the ‘AIDS dissidents’ are in South Africa. Brink is a barrister, a man with important friends, and his accusations were reported in the national news media—and in some corners of the Western gay press—as a serious news story. I do not believe that any one of those journalists who reported on it can possibly have read Brink’s indictment to the end.

  I have.

  The first fifty-seven pages present familiar anti-medication and ‘AIDS-dissident’ material. But then, on page fifty-eight, this ‘indictment’ document suddenly deteriorates into something altogether more vicious and unhinged, as Brink sets out what he believes would be a a appropriate punishment for Zackie. Because I do not wish to be accused of selective editing, I will now reproduce for you that entire section, unedited, so you can see and feel it for yourself.

  APPROPRIATE CRIMINAL SANCTION

  In view of the scale and gravity of Achmat’s crime and his direct personal criminal culpability for ‘the deaths of thousands of people’, to quote his own words, it is respectfully submitted that the International Criminal Court ought to impose on him the highest sentence provided by Article 77.1(b) of the Rome Statute, namely to permanent confinement in a small white steel and concrete cage, bright fluorescent light on all the time to keep an eye on him, his warders putting him out only to work every day in the p
rison garden to cultivate nutrient-rich vegetables, including when it’s raining. In order for him to repay his debt to society, with the ARVs he claims to take administered daily under close medical watch at the full prescribed dose, morning noon and night, without interruption, to prevent him faking that he’s being treatment compliant, pushed if necessary down his forced-open gullet with a finger, or, if he bites, kicks and screams too much, dripped into his arm after he’s been restrained on a gurney with cable ties around his ankles, wrists and neck, until he gives up the ghost on them, so as to eradicate this foulest, most loathsome, unscrupulous and malevolent blight on the human race, who has plagued and poisoned the people of South Africa, mostly black, mostly poor, for nearly a decade now, since the day he and his TAC first hit the scene.

  Signed at Cape Town, South Africa, on 1 January 2007

  Anthony Brink

  The document was described by the Rath Foundation as ‘entirely valid and long overdue’.

  This story isn’t about Matthias Rath, or Anthony Brink, or Zackie Achmat, or even South Africa. It is about the culture of how ideas work, and how that can break down. Doctors criticise other doctors, academics criticise academics, politicians criticise politicians: that’s normal and healthy, it’s how ideas improve. Matthias Rath is an alternative therapist, made in Europe. He is every bit the same as the British operators that we have seen in this book. He is from their world.

  Despite the extremes of this case, not one single alternative therapist or nutritionist, anywhere in the world, has stood up to criticise any single aspect of the activities of Matthias Rath and his colleagues. In fact, far from it: he continues to be feted to this day. I have sat in true astonishment and watched leading figures of the UK’s alternative therapy movement applaud Matthias Rath at a public lecture (I have it on video, just in case there’s any doubt). Natural health organisations continue to defend Rath. Homeopaths’ mailouts continue to promote his work. The British Association of Nutritional Therapists has been invited to comment by bloggers, but declined. Most, when challenged, will dissemble. ‘Oh,’ they say, ‘I don’t really know much about it.’ Not one person will step forward and dissent.

  The alternative therapy movement as a whole has demonstrated itself to be so dangerously, systemically incapable of critical self-appraisal that it cannot step up even in a case like that of Rath: in that count I include tens of thousands of practitioners, writers, administrators and more. This is how ideas go badly wrong. In the conclusion to this book, written before I was able to include this chapter, I will argue that the biggest dangers posed by the material we have covered are cultural and intellectual.

  I may be mistaken.

  11 Is Mainstream Medicine Evil?

  So that was the alternative therapy industry. Its practitioners’ claims are made directly to the public, so they have greater cultural currency; and while they use the same tricks of the trade as the pharmaceutical industry—as we have seen along the way—their strategies and errors are more transparent, so they make for a neat teaching tool. Now, once again, we should raise our game.

  For this chapter you will also have to rise above your own narcissism. We will not be talking about the fact that your GP is sometimes rushed, or that your consultant was rude to you. We will not be talking about the fact that nobody could work out what was wrong with your knee, and we will not even be discussing the time that someone misdiagnosed your grandfather’s cancer, and he suffered unnecessarily for months before a painful, bloody, undeserved and undignified death at the end of a productive and loving life.

  Terrible things happen in medicine, when it goes right as well as when it goes wrong. Everybody agrees that we should work to minimise the errors, everybody agrees that doctors are sometimes terrible; if the subject fascinates you, then I encourage you to buy one of the libraries’ worth of books on clinical governance. Doctors can be awful, and mistakes can be murderous, but the philosophy driving evidence-based medicine is not. How well does it work?

  One thing you could measure is how much medical practice is evidence-based. This is not easy. From the state of current knowledge, around 13 per cent of all treatments have good evidence, and a further 21 per cent are likely to be beneficial. This sounds low, but it seems the more common treatments tend to have a better evidence base. Another way of measuring is to look at how much medical activity is evidence-based, taking consecutive patients, in a hospital outpatients clinic for example, looking at their diagnosis, what treatment they were given, and then looking at whether that treatment decision was based on evidence. These real-world studies give a more meaningful figure: lots were done in the 1990s, and it turns out, depending on speciality, that between 50 and 80 per cent of all medical activity is ‘evidence-based’. It’s still not great, and if you have any ideas on how to improve that, do please write about it.*

  ≡ I have argued on various occasions that, wherever possible, all treatment where there is uncertainty should be randomised, and in the NHS we are theoretically in a unique administrative position to be able to facilitate this, as a gift to the world. For all that you may worry about some of its decisions, the National Institute for Health and Clinical Excellence (NICE) has also had the clever idea of recommending that some treatments—where there is uncertainty about benefit—should only be funded by the NHS when given in the context of a trial (an ‘Only in Research’ approval). NICE is frequently criticised—it’s a political body after all—for not recommending that the NHS funds apparently promising treatments. But acquiescing and funding a treatment when it is uncertain whether it does more good than harm is dangerous, as has been dramatically illustrated by various cases where promising treatments turned out ultimately to do more harm than good. We failed for decades to address uncertainties about the benefits of steroids for patients with brain injury: the CRASH trial showed that tens of thousands of people have died unnecessarily, because in fact they do more harm than good. In medicine, information saves lives.

  Another good measure is what happens when things go wrong. The British Medical Journal is probably the most important medical journal in the UK. It recently announced the three most popular papers from its archive for 2005, according to an audit that assessed their use by readers, the number of times they were referenced by other academic papers, and so on. Each of these papers had a criticism of either a drug, a drug company or a medical activity as its central theme.

  We can go through them briefly, so you can see for yourself how relevant the biggest papers from the most important medical journal are to your needs. The top-scoring paper was a case-control study which showed that patients had a higher risk of heart attack if they were taking the drugs rofecoxib (Vioxx), diclofenac or ibuprofen. At number two was a large meta-analysis of drug company data, which showed no evidence that SSRI antidepressants increase the risk of suicide, but found weak evidence for an increased risk of deliberate self-harm. In third place was a systematic review which showed an association between suicide attempts and the use of SSRIs, and critically highlighted some of the inadequacies around the reporting of suicides in clinical trials.

  This is critical self-appraisal, and it is very healthy, but you will notice something else: all of those studies revolve around situations where drug companies withheld or distorted evidence. How does this happen?

  The pharmaceutical industry

  The tricks of the trade which we’ll discuss in this chapter are probably more complicated than most of the other stuff in the book, because we will be making technical critiques of an industry’s professional literature. Drug companies thankfully don’t advertise direct to the public in the UK—in America you can find them advertising anxiety pills for your dog—so we are pulling apart the tricks they play on doctors, an audience which is in a slightly better position to call their bluff. This means that we’ll first have to explain some background about how a drug comes to market. This is stuff that you will be taught at school when I become president of the one world government.
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  Understanding this process is important for one very clear reason. It seems to me that a lot of the stranger ideas people have about medicine derive from an emotional struggle with the very notion of a pharmaceutical industry. Whatever our political leanings, everyone is basically a socialist when it comes to healthcare: we all feel nervous about profit taking any role in the caring professions, but that feeling has nowhere to go. Big pharma is evil: I would agree with that premise. But because people don’t understand exactly how big pharma is evil, their anger and indignation get diverted away from valid criticisms—its role in distorting data, for example, or withholding life-saving AIDS drugs from the developing world—and channelled into infantile fantasies. ‘Big pharma is evil,’ goes the line of reasoning, ‘therefore homeopathy works and the MMR vaccine causes autism.’ This is probably not helpful.

  In the UK, the pharmaceutical industry has become the third most profitable activity after finance and—a surprise if you live here—tourism. We spend £7 billion a year on pharmaceutical drugs, and 80 per cent of that goes on patented drugs, medicines which were released in the last ten years. Globally, the industry is worth around £150 billion.

  People come in many flavours, but all corporations have a duty to maximise their profits, and this often sits uncomfortably with the notion of caring for people. An extreme example comes with AIDS: as I mentioned in passing, drug companies explain that they cannot give AIDS drugs off licence to developing-world countries, because they need the money from sales for research and development. And yet, of the biggest US companies’ $200 billion sales, they spend only 14 per cent on R&D, compared to 31 per cent on marketing and administration.

  The companies also set their prices in ways you might judge to be exploitative. Once your drug comes out, you have around ten years ‘on patent’, as the only person who is allowed to make it. Loratadine, produced by Schering-Plough, is an effective antihistamine drug that does not cause the unpleasant antihistamine side-effect of drowsiness. It was a unique treatment for a while, and highly in demand. Before the patent ran out, the price of the drug was raised thirteen times in just five years, increasing by over 50 per cent. Some might regard this as profiteering.