Bad Science Part 7

This chapter did not appear in the original edition of this book, because for fifteen months leading up to September 2008 the vitamin-pill entrepreneur Matthias Rath was suing me personally, and the Guardian Guardian, for libel. This strategy brought only mixed success. For all that nutritionists may fantasise in public that any critic is somehow a p.a.w.n of big pharma, in private they would do well to remember that, like many my age who work in the public sector, I don't own a flat. The Guardian Guardian generously paid for the lawyers, and in September 2008 Rath dropped his case, which had cost in excess of 500,000 to defend. Rath has paid 220,000 already, and the rest will hopefully follow. n.o.body will ever repay me for the endless meetings, the time off work, or the days spent poring over tables filled with endlessly cross-referenced court doc.u.ments. generously paid for the lawyers, and in September 2008 Rath dropped his case, which had cost in excess of 500,000 to defend. Rath has paid 220,000 already, and the rest will hopefully follow. n.o.body will ever repay me for the endless meetings, the time off work, or the days spent poring over tables filled with endlessly cross-referenced court doc.u.ments.

On this last point there is, however, one small consolation, and I will spell it out as a cautionary tale: I now know more about Matthias Rath than almost any other person alive. My notes, references and witness statements, boxed up in the room where I am sitting right now, make a pile as tall as the man himself, and what I will write here is only a tiny fraction of the fuller story that is waiting to be told about him. This chapter, I should also mention, is available free online for anyone who wishes to see it.

Matthias Rath takes us rudely outside the contained, almost academic distance of this book. For the most part we've been interested in the intellectual and cultural consequences of bad science, the made-up facts in national newspapers, dubious academic practices in universities, some foolish pill-peddling, and so on. But what happens if we take these sleights of hand, these pill-marketing techniques, and transplant them out of our decadent Western context into a situation where things really matter?

In an ideal world this would be only a thought experiment.

AIDS is the opposite of anecdote. Twenty-five million people have died from it already, three million in the last year alone, and 500,000 of those deaths were children. In South Africa it kills 300,000 people every year: that's eight hundred people every day, or one every two minutes. This one country has 6.3 million people who are HIV positive, including 30 per cent of all pregnant women. There are 1.2 million AIDS orphans under the age of seventeen. Most chillingly of all, this disaster has appeared suddenly, and while we were watching: in 1990, just 1 per cent of adults in South Africa were HIV positive. Ten years later, the figure had risen to 25 per cent.

It's hard to mount an emotional response to raw numbers, but on one thing I think we would agree. If you were to walk into a situation with that much death, misery and disease, you would be very careful to make sure that you knew what you were talking about. For the reasons you are about to read, I suspect that Matthias Rath missed the mark.

This man, we should be clear, is our responsibility. Born and raised in Germany, Rath was the head of Cardiovascular Research at the Linus Pauling Inst.i.tute in Palo Alto in California, and even then he had a tendency towards grand gestures, publis.h.i.+ng a paper in the Journal of Orth.o.m.olecular Medicine Journal of Orth.o.m.olecular Medicine in 1992 t.i.tled 'A Unified Theory of Human Cardiovascular Disease Leading the Way to the Abolition of this Disease as a Cause for Human Mortality'. The unified theory was high-dose vitamins. in 1992 t.i.tled 'A Unified Theory of Human Cardiovascular Disease Leading the Way to the Abolition of this Disease as a Cause for Human Mortality'. The unified theory was high-dose vitamins.

He first developed a power base from sales in Europe, selling his pills with tactics that will be very familiar to you from the rest of this book, albeit slightly more aggressive. In the UK, his adverts claimed that '90 per cent of patients receiving chemotherapy for cancer die within months of starting treatment', and suggested that three million lives could be saved if cancer patients stopped being treated by conventional medicine. The pharmaceutical industry was deliberately letting people die for financial gain, he explained. Cancer treatments were 'poisonous compounds' with 'not even one effective treatment'.

The decision to embark on treatment for cancer can be the most difficult that an individual or a family will ever take, representing a close balance between well-doc.u.mented benefits and equally well-doc.u.mented side-effects. Adverts like these might play especially strongly on your conscience if your mother has just lost all her hair to chemotherapy, for example, in the hope of staying alive just long enough to see your son speak.

There was some limited regulatory response in Europe, but it was generally as weak as that faced by the other characters in this book. The Advertising Standards Authority criticised one of his adverts in the UK, but that is essentially all they are able to do. Rath was ordered by a Berlin court to stop claiming that his vitamins could cure cancer, or face a 250,000 fine.

But sales were strong, and Matthias Rath still has many supporters in Europe, as you will shortly see. He walked into South Africa with all the acclaim, self-confidence and wealth he had ama.s.sed as a successful vitamin-pill entrepreneur in Europe and America, and began to take out full-page adverts in newspapers.

'The answer to the AIDS epidemic is here,' he proclaimed. Anti-retroviral drugs were poisonous, and a conspiracy to kill patients and make money. 'Stop AIDS Genocide by the Drugs Cartel' said one headline. 'Why should South Africans continue to be poisoned with AZT? There is a natural answer to AIDS.' The answer came in the form of vitamin pills. 'Multivitamin treatment is more effective than any toxic AIDS drug'. 'Multivitamins cut the risk of developing AIDS in half.'

Rath's company ran clinics reflecting these ideas, and in 2005 he decided to run a trial of his vitamins in a towns.h.i.+p near Cape Town called Khayelitsha, giving his own formulation, VitaCell, to people with advanced AIDS. In 2008 this trial was declared illegal by the Cape High Court of South Africa. Although Rath says that none of his partic.i.p.ants had been on anti-retroviral drugs, some relatives have given statements saying that they were, and were actively told to stop using them.

Tragically, Matthias Rath had taken these ideas to exactly the right place. Thabo Mbeki, the President of South Africa at the time, was well known as an 'AIDS dissident', and to international horror, while people died at the rate of one every two minutes in his country, he gave credence and support to the claims of a small band of campaigners who variously claim that AIDS does not exist, that it is not caused by HIV, that anti-retroviral medication does more harm than good, and so on.

At various times during the peak of the AIDS epidemic in South Africa their government argued that HIV is not the cause of AIDS, and that anti-retroviral drugs are not useful for patients. They refused to roll out proper treatment programmes, they refused to accept free donations of drugs, and they refused to accept grant money from the Global Fund to buy drugs.

One study estimates that if the South African national government had used anti-retroviral drugs for prevention and treatment at the same rate as the Western Cape province (which defied national policy on the issue), around 171,000 new HIV infections and 343,000 deaths could have been prevented between 1999 and 2007. Another study estimates that between 2000 and 2005 there were 330,000 unnecessary deaths, 2.2 million person years lost, and 35,000 babies unnecessarily born with HIV because of the failure to implement a cheap and simple mother-to-child-transmission prevention program. Between one and three doses of an ARV drug can reduce transmission dramatically. The cost is negligible. It was not available.

Interestingly, Matthias Rath's colleague and employee, a South African barrister named Anthony Brink, takes the credit for introducing Thabo Mbeki to many of these ideas. Brink stumbled on the AIDS dissident' material in the mid-1990s, and after much surfing and reading, became convinced that it must be right. In 1999 he wrote an article about AZT in a Johannesburg newspaper t.i.tled 'a medicine from h.e.l.l'. This led to a public exchange with a leading virologist. Brink contacted Mbeki, sending him copies of the debate, and was welcomed as an expert. This is a chilling testament to the danger of elevating cranks by engaging with them.

In his initial letter of motivation for employment to Matthias Rath, Brink described himself as 'South Africa's leading AIDS dissident, best known for my whistle-blowing expose' of the toxicity and inefficacy of AIDS drugs, and for my political activism in this regard, which caused President Mbeki and Health Minister Dr Tshabalala-Msimang to repudiate the drugs in 1999'.

In 2000, the now infamous International AIDS Conference took place in Durban. Mbeki's presidential advisory panel beforehand was packed with AIDS dissidents', including Peter Duesberg and David Rasnick. On the first day, Rasnick suggested that all HIV testing should be banned on principle, and that South Africa should stop screening supplies of blood for HIV. 'If I had the power to outlaw the HIV antibody test,' he said, 'I would do it across the board.' When African physicians gave testimony about the drastic change AIDS had caused in their clinics and hospitals, Rasnick said he had not seen 'any evidence' of an AIDS catastrophe. The media were not allowed in, but one reporter from the Village Voice Village Voice was present. Peter Duesberg, he said, 'gave a presentation so removed from African medical reality that it left several local doctors shaking their heads'. It wasn't AIDS that was killing babies and children, said the dissidents: it was the anti-retroviral medication. was present. Peter Duesberg, he said, 'gave a presentation so removed from African medical reality that it left several local doctors shaking their heads'. It wasn't AIDS that was killing babies and children, said the dissidents: it was the anti-retroviral medication.

President Mbeki sent a letter to world leaders comparing the struggle of the 'AIDS dissidents' to the struggle against apartheid. The Was.h.i.+ngton Post Was.h.i.+ngton Post described the reaction at the White House: 'So stunned were some officials by the letter's tone and timing-during final preparations for July's conference in Durban-that at least two of them, according to diplomatic sources, felt obliged to check whether it was genuine.' Hundreds of delegates walked out of Mbeki's address to the conference in disgust, but many more described themselves as dazed and confused. Over 5,000 researchers and activists around the world signed up to the Durban Declaration, a doc.u.ment that specifically addressed and repudiated the claims and concerns-at least the more moderate ones-of the 'AIDS dissidents'. Specifically, it addressed the charge that people were simply dying of poverty: described the reaction at the White House: 'So stunned were some officials by the letter's tone and timing-during final preparations for July's conference in Durban-that at least two of them, according to diplomatic sources, felt obliged to check whether it was genuine.' Hundreds of delegates walked out of Mbeki's address to the conference in disgust, but many more described themselves as dazed and confused. Over 5,000 researchers and activists around the world signed up to the Durban Declaration, a doc.u.ment that specifically addressed and repudiated the claims and concerns-at least the more moderate ones-of the 'AIDS dissidents'. Specifically, it addressed the charge that people were simply dying of poverty: The evidence that AIDS is caused by HIV-1 or HIV-2 is clear-cut, exhaustive and unambiguous...As with any other chronic infection, various co-factors play a role in determining the risk of disease. Persons who are malnourished, who already suffer other infections or who are older, tend to be more susceptible to the rapid development of AIDS following HIV infection. However, none of these factors weaker the scientific evidence that HIV is the sole cause of AIDS...Mother-to-child transmission can be reduced by half or more by short courses of antiviral drugs...What works best in one country may not be appropriate in another. But to tackle the disease, everyone must first understand that HIV is the enemy. Research, not myths, will lead to the development of more effective and cheaper treatments. The evidence that AIDS is caused by HIV-1 or HIV-2 is clear-cut, exhaustive and unambiguous...As with any other chronic infection, various co-factors play a role in determining the risk of disease. Persons who are malnourished, who already suffer other infections or who are older, tend to be more susceptible to the rapid development of AIDS following HIV infection. However, none of these factors weaker the scientific evidence that HIV is the sole cause of AIDS...Mother-to-child transmission can be reduced by half or more by short courses of antiviral drugs...What works best in one country may not be appropriate in another. But to tackle the disease, everyone must first understand that HIV is the enemy. Research, not myths, will lead to the development of more effective and cheaper treatments.

It did them no good. Until 2003 the South African government refused, as a matter of principle, to roll out proper anti-retroviral medication programmes, and even then the process was half-hearted. This madness was only overturned after a ma.s.sive campaign by gra.s.sroots organisations such as the Treatment Action Campaign, but even after the ANC cabinet voted to allow medication to be given, there was still resistance. In mid-2005, at least 85 per cent of HIV-positive people who needed anti-retroviral drugs were still refused them. That's around a million people.

This resistance, of course, went deeper than just one man; much of it came from Mbeki's Health Minister, Manto Tshabalala-Msimang. An ardent critic of medical drugs for HIV, she would cheerfully go on television to talk up their dangers, talk down their benefits, and became irritable and evasive when asked how many patients were receiving effective treatment. She declared in 2005 that she would not be 'pressured' into meeting the target of three million patients on anti-retroviral medication, that people had ignored the importance of nutrition, and that she would continue to warn patients of the side-effects of anti-retrovirals, saying: 'We have been vindicated in this regard. We are what we eat.'

It's an eerily familiar catchphrase. Tshabalala-Msimang has also gone on record to praise the work of Matthias Rath, and refused to investigate his activities. Most joyfully of all, she is a staunch advocate of the kind of weekend glossy-magazine-style nutritionism that will by now be very familiar to you.

The remedies she advocates for AIDS are beetroot, garlic, lemons and African potatoes. A fairly typical quote, from the Health Minister in a country where eight hundred people die every day from AIDS, is this: 'Raw garlic and a skin of the lemon-not only do they give you a beautiful face and skin but they also protect you from disease.' South Africa's stand at the 2006 World AIDS Conference in Toronto was described by delegates as the 'salad stall'. It consisted of some garlic, some beetroot, the African potato, and a.s.sorted other vegetables. Some boxes of anti-retroviral drugs were added later, but they were reportedly borrowed at the last minute from other conference delegates.

Alternative therapists like to suggest that their treatments and ideas have not been sufficiently researched. As you now know, this is often untrue, and in the case of the Health Minister's favoured vegetables, research had indeed been done, with results that were far from promising. Interviewed on SABC about this, Tshabalala-Msimang gave the kind of responses you'd expect to hear at any North London dinner-party discussion of alternative therapies.

First she was asked about work from the University of Stellenbosch which suggested that her chosen plant, the African potato, might be actively dangerous for people on AIDS drugs. One study on African potato in HIV had to be terminated prematurely, because the patients who received the plant extract developed severe bone-marrow suppression and a drop in their CD4 cell count-which is a bad thing-after eight weeks. On top of this, when extract from the same vegetable was given to cats with Feline Immunodeficiency Virus, they succ.u.mbed to full-blown Feline AIDS faster than their non-treated controls. African potato does not look like a good bet.

Tshabalala-Msimang disagreed: the researchers should go back to the drawing board, and 'investigate properly'. Why? Because HIV-positive people who used African potato had shown improvement, and they had said so themselves. If a person says he or she is feeling better, should this be disputed, she demanded to know, merely because it had not been proved scientifically? 'When a person says she or he is feeling better, I must say 'No, I don't think you are feeling better'? 'I must rather go and do science on you'?' Asked whether there should be a scientific basis to her views, she replied: 'Whose science?'

And there, perhaps, is a clue, if not exoneration. This is a continent that has been brutally exploited by the developed world, first by empire, and then by globalised capital. Conspiracy theories about AIDS and Western medicine are not entirely absurd in this context. The pharmaceutical industry has indeed been caught performing drug trials in Africa which would be impossible anywhere in the developed world. Many find it suspicious that black Africans seem to be the biggest victims of AIDS, and point to the biological warfare programmes set up by the apartheid governments; there have also been suspicions that the scientific discourse of HIVAIDS might be a device, a Trojan horse for spreading even more exploitative Western political and economic agendas around a problem that is simply one of poverty.

And these are new countries, for which independence and self-rule are recent developments, which are struggling to find their commercial feet and true cultural ident.i.ty after centuries of colonisation. Traditional medicine represents an important link with an autonomous past; besides which, anti-retroviral medications have been unnecessarily-offensively, absurdly-expensive, and until moves to challenge this became partially successful, many Africans were effectively denied access to medical treatment as a result.

It's very easy for us to feel smug, and to forget that we all have our own strange cultural idiosyncrasies which prevent us from taking up sensible public-health programmes. For examples, we don't even have to look as far as MMR. There is a good evidence base, for example, to show that needle-exchange programmes reduce the spread of HIV, but this strategy has been rejected time and again in favour of 'Just say no.' Development charities funded by US Christian groups refuse to engage with birth control, and any suggestion of abortion, even in countries where being in control of your own fertility could mean the difference between success and failure in life, is met with a cold, pious stare. These impractical moral principles are so deeply entrenched that Pepfar, the US Presidential Emergency Plan for AIDS Relief, has insisted that every recipient of international aid money must sign a declaration expressly promising not to have any involvement with s.e.x workers.

We mustn't appear insensitive to the Christian value system, but it seems to me that engaging s.e.x workers is almost the cornerstone of any effective AIDS policy: commercial s.e.x is frequently the 'vector of transmission', and s.e.x workers a very high-risk population; but there are also more subtle issues at stake. If you secure the legal rights of prost.i.tutes to be free from violence and discrimination, you empower them to demand universal condom use, and that way you can prevent HIV from being spread into the whole community. This is where science meets culture. But perhaps even to your own friends and neighbours, in whatever suburban idyll has become your home, the moral principle of abstinence from s.e.x and drugs is more important than people dying of AIDS; and perhaps, then, they are no less irrational than Thabo Mbeki.

So this was the situation into which the vitamin-pill entrepreneur Matthias Rath inserted himself, prominently and expensively, with the wealth he had ama.s.sed from Europe and America, exploiting anti-colonial anxieties with no sense of irony, although he was a white man offering pills made in a factory abroad. His adverts and clinics were a tremendous success. He began to tout individual patients as evidence of the benefits that could come from vitamin pills-although in reality some of his most famous success stories have died of AIDS. When asked about the deaths of Rath's star patients, Health Minister Tshabalala-Msimang replied: 'It doesn't necessarily mean that if I am taking antibiotics and I die, that I died of antibiotics.'

She is not alone: South Africa's politicians have consistently refused to step in, Rath claims the support of the government, and its most senior figures have refused to distance themselves from his operations or to criticise his activities. Tshabalala-Msimang has gone on the record to state that the Rath Foundation 'are not undermining the government's position. If anything, they are supporting it.'

In 2005, exasperated by government inaction, a group of 199 leading medical pract.i.tioners 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 advertis.e.m.e.nts, some of which have appeared in the New York Times New York Times and the and the Herald Tribune 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 a.s.signed 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 HIVAIDS, 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 Medecins 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 gra.s.sroots organisation, made up largely of black women from towns.h.i.+ps 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 ma.s.sive 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 circ.u.mstances. 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' doc.u.ment 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 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 prison 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. 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 prison 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 Signed at Cape Town, South Africa, on 1 January 2007 Anthony Brink Anthony Brink The doc.u.ment 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 a.s.sociation 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 pract.i.tioners, 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 pract.i.tioners' 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 n.o.body 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, b.l.o.o.d.y, 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 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 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 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 1990 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 Inst.i.tute 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 ill.u.s.trated 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. - 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 Inst.i.tute 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 ill.u.s.trated 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 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 a.s.sessed 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. 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 a.s.sessed 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 rofec.o.xib (Vioxx), diclofenac or ibuprofen. At number two was a large meta-a.n.a.lysis 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 a.s.sociation a.s.sociation between suicide attempts and the use of SSRIs, and critically highlighted some of the inadequacies around the reporting of suicides in clinical trials. 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.

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 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. 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 pa.s.sing, 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.

But the pharmaceutical industry is also currently in trouble. The golden age of medicine has creaked to a halt, as we have said, and the number of new drugs, or 'new molecular ent.i.ties', being registered has dwindled from fifty a year in the 1990s to about twenty now. At the same time, the number of 'me-too' drugs has risen, making up to half of all new drugs. to about twenty now. At the same time, the number of 'me-too' drugs has risen, making up to half of all new drugs.

Me-too drugs are an inevitable function of the market: they are rough copies of drugs that already exist, made by another company, but are different enough for a manufacturer to be able to claim their own patent. They take huge effort to produce, and need to be tested (on human partic.i.p.ants, with all the attendant risks) and trialled and refined and marketed just like a new drug. Sometimes they offer modest benefits (a more convenient dosing regime, for example), but for all the hard work they involve, they don't generally represent a significant breakthrough in human health. They are merely a breakthrough in making money. Where do all these drugs come from?

The journey of a drug First of all, you need an idea for a drug. This can come from any number of places: a molecule in a plant; a receptor in the body that you think you can build a molecule to interface with; an old drug that you've tinkered with; and so on. This part of the story is extremely interesting, and I recommend doing a degree in it. When you think you have a molecule that might be a runner, you test it in animals, to see if it works for whatever you think it should do (and to see if it kills them, of course).

Then you do Phase I, or 'first in man', studies on a small number of brave, healthy young men who need money, firstly to see if it kills them, and also to measure basic things like how fast the drug is excreted from the body (this is the phase that went horribly wrong in the TGN1412 tests in 2006, where several young men were seriously injured). If this works, you move to a Phase II trial, in a couple of hundred people with the relevant illness, as a 'proof of concept', to work out the dose, and to get an idea if it is effective or not. A lot lot of drugs fail at this point, which is a shame, since this is no GCSE science project: bringing a drug to market costs around $500 million in total. of drugs fail at this point, which is a shame, since this is no GCSE science project: bringing a drug to market costs around $500 million in total.

Then you do a Phase III trial, in hundreds or thousands of patients, randomised, blinded, comparing your drug against placebo or a comparable treatment, and collect much more data on efficacy and safety. You might need to do a few of these, and then you can apply for a licence to sell your drug. After it goes to market, you should be doing more trials, and other people will probably do trials and other studies on your drug too; and hopefully everyone will keep their eyes open for any previously unnoticed side-effects, ideally reporting them using the Yellow Card system (patients can use this too; in fact, please do. It's at http:yellowcard.mhra.gov.uk http:yellowcard.mhra.gov.uk).

Doctors make their rational decision on whether they want to prescribe a drug based on how good it has been shown to be in trials, how bad the side-effects are, and sometimes cost. Ideally they will get their information on efficacy from studies published in peer-reviewed academic journals, or from other material like textbooks and review articles which are themselves based on primary research like trials. At worst, they will rely on the lies of drug reps and word of mouth.

But drug trials are expensive, so an astonis.h.i.+ng 90 per cent of clinical drug trials, and 70 per cent of trials reported in major medical journals, are conducted or commissioned by the pharmaceutical industry. A key feature of science is that findings should be replicated, but if only one organisation is doing the funding, then this feature is lost.

It is tempting to blame the drug companies-although it seems to me that nations and civic organisations are equally at fault here for not coughing up-but wherever you draw your own moral line, the upshot is that drug companies have a huge influence over what gets researched, how it is researched, how the results are reported, how they are a.n.a.lysed, and how they are interpreted.

Sometimes whole areas can be orphaned because of a lack of money, and corporate interest. Homeopaths and vitamin pill quacks would tell you that their pills are good examples of this phenomenon. That is a moral affront to the better examples. There are conditions which affect a small number of people, like Creutzfeldt-Jakob disease and Wilson disease, but more chilling are the diseases which are neglected because they are only found in the developing world, like Chagas disease (which threatens a quarter of Latin America) and trypanosomiasis (300,000 cases a year, but in Africa). The Global Forum for Health Research estimates that only 10 per cent of the world's health burden receives 90 per cent of total biomedical research funding.

Often it is simply information that is missing, rather than some amazing new molecule. Eclampsia, say, is estimated to cause 50,000 deaths in pregnancy around the world each year, and the best treatment, by a huge margin, is cheap, unpatented, magnesium sulphate (high doses intravenously, that is, not some alternative medicine supplement, but also not the expensive anti-convulsants that were used for many decades). Although magnesium had been used to treat eclampsia since 1906, its position as the best treatment was only established a century later in 2002, with the help of the World Health Organisation, because there was no commercial interest in the research question: n.o.body has a patent on magnesium, and the majority of deaths from eclampsia are in the developing world. Millions of women have died of the condition since 1906, and many of those deaths were avoidable.

To an extent these are political and development issues, which we should leave for another day; and I have a promise to pay out on: you want to be able to take the skills you've learnt about levels of evidence and distortions of research, and understand how the pharmaceutical industry distorts data, and pulls the wool over our eyes. How would we go about proving this? Overall, it's true, drug company trials are much more likely to produce a positive outcome for their own drug. But to leave it there would be weak-minded.

What I'm about to tell you is what I teach medical students and doctors-here and there-in a lecture I rather childishly call 'drug company bulls.h.i.+t'. It is, in turn, what I was taught at medical school,* and I think the easiest way to understand the issue is to put yourself in the shoes of a big pharma researcher.

- In this subject, like many medics of my generation, I am indebted to the cla.s.sic textbook - In this subject, like many medics of my generation, I am indebted to the cla.s.sic textbook How to Read a Paper How to Read a Paper by Professor Greenhalgh at UCL. It should be a best-seller. by Professor Greenhalgh at UCL. It should be a best-seller. Testing Treatments Testing Treatments by Imogen Evans, Hazel Thornton and Iain Chalmers is also a work of great genius, appropriate for a lay audience, and amazingly also free to download online from by Imogen Evans, Hazel Thornton and Iain Chalmers is also a work of great genius, appropriate for a lay audience, and amazingly also free to download online from www.jameslindlibrary.org www.jameslindlibrary.org. For committed readers I recommend Methodological Errors in Medical Research Methodological Errors in Medical Research by Bjorn Andersen. It's extremely long. The subt.i.tle is 'An Incomplete Catalogue'. by Bjorn Andersen. It's extremely long. The subt.i.tle is 'An Incomplete Catalogue'.

You have a pill. It's OK, maybe not that brilliant, but a lot of money is riding on it. You need a positive result, but your audience aren't homeopaths, journalists or the public: they are doctors and academics, so they have been trained in spotting the obvious tricks, like 'no blinding', or 'inadequate randomisation'. Your sleights of hand will have to be much more elegant, much more subtle, but every bit as powerful.

What can you do?

Well, firstly, you could study it in winners. Different people respond differently to drugs: old people on lots of medications are often no-hopers, whereas younger people with just one problem are more likely to show an improvement. So only study your drug in the latter group. This will make your research much less applicable to the actual people that doctors are prescribing for, but hopefully they won't notice. This is so commonplace it is hardly worth giving an example.

Next up, you could compare your drug against a useless control. Many people would argue, for example, that you should never never compare your drug against placebo, because it proves nothing of clinical value: in the real world, n.o.body cares if your drug is better than a sugar pill; they only care if it is better than the best currently available treatment. But you've already spent hundreds of millions of dollars bringing your drug to market, so stuff that: do lots of placebo-controlled trials and make a big fuss about them, because they practically guarantee some positive data. Again, this is universal, because almost all drugs will be compared against placebo at some stage in their lives, and 'drug reps'-the people employed by big pharma to bamboozle doctors (many simply refuse to see them)-love the unambiguous positivity of the graphs these studies can produce. compare your drug against placebo, because it proves nothing of clinical value: in the real world, n.o.body cares if your drug is better than a sugar pill; they only care if it is better than the best currently available treatment. But you've already spent hundreds of millions of dollars bringing your drug to market, so stuff that: do lots of placebo-controlled trials and make a big fuss about them, because they practically guarantee some positive data. Again, this is universal, because almost all drugs will be compared against placebo at some stage in their lives, and 'drug reps'-the people employed by big pharma to bamboozle doctors (many simply refuse to see them)-love the unambiguous positivity of the graphs these studies can produce.

Then things get more interesting. If you do have to compare your drug with one produced by a compet.i.tor-to save face, or because a regulator demands it-you could try a sneaky underhand trick: use an inadequate dose of the competing drug, so that patients on it don't do very well; or give a very high dose of the competing drug, so that patients experience lots of side-effects; or give the competing drug in the wrong way (perhaps orally when it should be intravenous, and hope most readers don't notice); or you could increase the dose of the competing drug much too quickly, so that the patients taking it get worse side-effects. Your drug will s.h.i.+ne by comparison.

You might think no such thing could ever happen. If you follow the references in the back, you will find studies where patients were given really rather high doses of oldfas.h.i.+oned antipsychotic medication (which made the new-generation drugs look as if they were better in terms of side-effects), and studies with doses of SSRI antidepressants which some might consider unusual, to name just a couple of examples. I know. It's slightly incredible.

Of course, another trick you could pull with side-effects is simply not to ask about them; or rather-since you have to be sneaky in this field-you could be careful about how you ask. Here is an example. SSRI antidepressant drugs cause s.e.xual side-effects fairly commonly, including ano.r.g.a.s.mia. We should be clear (and I'm trying to phrase this as neutrally as possible): I really really enjoy the sensation of o.r.g.a.s.m. It's important to me, and everything I experience in the world tells me that this sensation is important to other people too. Wars have been fought, essentially, for the sensation of o.r.g.a.s.m. There are evolutionary psychologists who would try to persuade you that the entirety of human culture and language is driven, in large part, by the pursuit of the sensation of o.r.g.a.s.m. Losing it seems like an important side-effect to ask about. enjoy the sensation of o.r.g.a.s.m. It's important to me, and everything I experience in the world tells me that this sensation is important to other people too. Wars have been fought, essentially, for the sensation of o.r.g.a.s.m. There are evolutionary psychologists who would try to persuade you that the entirety of human culture and language is driven, in large part, by the pursuit of the sensation of o.r.g.a.s.m. Losing it seems like an important side-effect to ask about.

And yet, various studies have shown that the reported prevalence of ano.r.g.a.s.mia in patients taking SSRI drugs varies between 2 per cent and 7.3 per cent, depending primarily on how you ask: a casual, open-ended question about side-effects, for example, or a careful and detailed enquiry. One 3,000-subject review on SSRIs simply did not list any s.e.xual side-effects on its twenty-three-item side-effect table. Twenty-three other things were more important, according to the researchers, than losing the sensation of o.r.g.a.s.m. I have read them. They are not.

But back to the main outcomes. And here is a good trick: instead of a real-world outcome, like death or pain, you could always use a 'surrogate outcome', which is easier to attain. If your drug is supposed to reduce cholesterol and so prevent cardiac deaths, for example, don't measure cardiac deaths, measure reduced cholesterol instead. That's much easier to achieve than a reduction in cardiac deaths, and the trial will be cheaper and quicker to do, so your result will be cheaper and and more positive. Result! more positive. Result!

Now you've done your trial, and despite your best efforts things have come out negative. What can you do? Well, if your trial has been good overall, but has thrown out a few negative results, you could try an old trick: don't draw attention to the disappointing data by putting it on a graph. Mention it briefly in the text, and ignore it when drawing your conclusions. (I'm so good at this I scare myself. Comes from reading too many rubbish trials.) If your results are completely negative, don't publish them at all, or publish them only after a long delay. This is exactly what the drug companies did with the data on SSRI antidepressants: they hid the data suggesting they might be dangerous, and they buried the data showing them to perform no better than placebo. If you're really clever, and have money to burn, then after you get disappointing data, you could do some more trials with the same protocol, in the hope that they will be positive: then try to bundle all the data up together, so that your negative data is swallowed up by some mediocre positive results.

Or you could get really serious, and start to manipulate the statistics. For two pages only, this book will now get quite nerdy.

I understand if you want to skip it, but know that it is here for the doctors who bought the book to laugh at homeopaths. Here are the cla.s.sic tricks to play in your statistical a.n.a.lysis to make sure your trial has a positive result.

Ignore the protocol entirely Always a.s.sume that any correlation proves proves causation. Throw all your data into a spreadsheet programme and report-as significant-any relations.h.i.+p between anything and everything if it helps your case. If you measure enough, some things are bound to be positive just by sheer luck. causation. Throw all your data into a spreadsheet programme and report-as significant-any relations.h.i.+p between anything and everything if it helps your case. If you measure enough, some things are bound to be positive just by sheer luck.

Play with the baseline Sometimes, when you start a trial, quite by chance the treatment group is already doing better than the placebo group. If so, then leave it like that. If, on the other hand, the placebo group is already doing better than the treatment group at the start, then adjust for the baseline in your a.n.a.lysis.

Ignore dropouts People who drop out of trials are statistically much more likely to have done badly, and much more likely to have had side-effects. They will only make your drug look bad. So ignore them, make no attempt to chase them up, do not include them in your final a.n.a.lysis.