Ben Goldacre Gets it Wrong About AIDS (Again)

"It was often difficult to distinguish adverse events possibly associated with zidovudine [AZT] administration from the underlying signs of HIV disease" - Physician's Desk Reference, 1994

"WARNING: RETROVIR (ZIDOVUDINE) [=AZT] MAY BE ASSOCIATED WITH HEMATOLOGIC TOXICITY INCLUDING GRANULOCYTOPENIA AND SEVERE ANEMIA PARTICULARLY IN PATIENTS WITH ADVANCED HIV DISEASE (SEE WARNINGS).

PROLONGED USE OF RETROVIR [=AZT] HAS BEEN ASSOCIATED WITH SYMPTOMATIC MYOPATHY SIMILAR TO THAT PRODUCED BY HUMAN IMMUNODEFICIENCY VIRUS. RARE OCCURRENCES OF LACTIC ACIDOSIS IN THE ABSENCE OF HYPOXEMIA, AND SEVERE HEPATOMEGALY WITH STEATOSIS HAVE BEEN REPORTED WITH THE USE OF ANTIRETROVIRAL NUCLEOSIDE ANALOGUES, INCLUDING RETROVIR AND ZALCITABINE, AND ARE POTENTIALLY FATAL (SEE WARNINGS)."

- from Glaxo Welcome AZT product information

This is the “missing chapter” about vitamin pill salesman Matthias Rath. Sadly I was unable to write about him at the time that book was initially published, as he was suing my ass in the High Court. The chapter is now available in the new paperback edition, and I’ve posted it here for free so that nobody loses out.

Although the publishers make a slightly melodramatic fuss about this in the promo material, it is a very serious story about the dangers of pseudoscience, as I hope you’ll see, and it was also a pretty unpleasant episode, not just for me, but also for the many other people he’s tried to sue, including Medecins Sans Frontieres and more. If you’re ever looking for a warning sign that you’re on the wrong side of an argument, suing Medecins Sans Frontieres is probably a pretty good clue.

Anyway, here it is, please steal it, print it, repost it, whatever, it’s free under a Creative Commons license, details at the end. If you prefer it is available as a PDF here, or as a word document here. Happy Easter!

This is an extract from

BAD SCIENCE by Ben Goldacre

Published by Harper Perennial 2009.

You are free to copy it, paste it, bake it, reprint it, read it aloud, as long as you don’t change it – including this bit – so that people know that they can find more ideas for free at www.badscience.net

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The Doctor Will Sue You Now

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, for libel. This strategy brought only mixed success. For all that nutritionists may fantasise in public that any critic is somehow a pawn 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 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.  Nobody 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 documents.

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 Institute in Palo Alto in California, and even then he had a tendency towards grand gestures, publishing a paper in the Journal of Orthomolecular Medicine in 1992 titled “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-documented benefits and equally well-documented 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 amassed 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 township 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 participants 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 titled “a medicine from hell”. 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 exposé 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 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 Washington 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 document 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 clearcut, 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 weaken 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 antiretroviral medication programmes, and even then the process was half-hearted. This madness was only overturned after a massive campaign by grassroots 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 sideeffects 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 assorted 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 succumbed 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 HIV/AIDS 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 identity 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 sex workers.

We mustn’t appear insensitive to the Christian value system, but it seems to me that engaging sex workers is almost the cornerstone of any effective AIDS policy: commercial sex is frequently the “vector of transmission”, and sex workers a very high-risk population; but there are also more subtle issues at stake. If you secure the legal rights of prostitutes 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 sex 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 amassed 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 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.

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 Frontières 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.

But 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, TAC 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 ilk.

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 an 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 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

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 fêted 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.

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Are the Toxic Effects of anti-viral Drugs 

Being Blamed on HIV?

Matthew Irwin, MD

In 1995, the number of people dying from AIDS in the United States began to drop. When deaths due to AIDS continued to drop in 1996, around the time protease inhibitors started to be prescribed widely, this was quickly offered as proof that the new drugs were working. However, U.S. Centers for Disease Control and Prevention (CDC) statistics clearly show that new AIDS cases started dropping in 1993, several years before protease inhibitor cocktails were introduced. This would seem to be the most obvious explanation for any decrease in AIDS death rates. Intriguingly, the drop in HIV-related deaths was more than 25% between 1995 to 1996, which was before the widespread use of HAART in the United States. (HAART = Highly Active Anti-Retroviral Therapy) Between 1996 and 1997, the drop was 42%, which was before the majority of patients were using HAART. One might argue that AIDS cases and deaths have dropped because the number of new HIV infections in the United States peaked in 1982²⁰. Both NIAID Director Anthony Fauci and Helene Gayle of the CDC have confirmed that the earlier decrease in U.S. new infections played a significant role in the decrease in deaths²².

In addition, in 1993 the number of AIDS cases doubled overnight when the definition of AIDS was changed for the third time. This is almost entirely because the 1993 definition change allowed people who had low T-cell counts, but no illnesses, to be listed as AIDS cases. Since then two-thirds of AIDS cases have been people who are clinically completely healthy. This created an artificial inflation of AIDS cases. These new cases were at low-risk, and thus the average life-expectancy of people diagnosed with AIDS would be expected to increase, no matter what medications were used. The CDC itself states that the new figures for AIDS prevalence have been artificially inflated by the definition changes:

"AIDS case reports received after January 1, 1993, were influenced by the expanded AIDS surveillance case definition and chiefly represent reporting of persons who had CD4+ cell counts below 200/uL with or without illness. This change greatly altered the pattern of case reports and was most pronounced in the first quarter of 1993."²¹

(For more on the drop in AIDS deaths go here.)
* In Canada low T-cell counts has not been added to the AIDS definition

AZT, 3TC, d4T , protease inhibitors and other drugs termed "antiretrovirals" have been hailed as breakthroughs in AIDS treatment. So what studies exist that support the widespread claims that new AIDS medications have revolutionized the treatment of AIDS? One would expect a lot of very clear and striking study results showing reduced illness and reduced death with statistically significant reductions. To most people's surprise, a careful search of the medical literature finds that these claims are not based on controlled studies, but rather on clinical observations and media reports. This is not to say that there are no studies of protease inhibitor cocktails. The problem is that they all ignore clinical health, and instead focus on viral load. Only two controlled studies have actually looked at clinical health. All of the others focused exclusively on viral load, which has been shown to be a questionable marker for the presence of HIV, let alone for clinical health reduction (seeProblems with HIV Science).

The two studies that do claim health benefits, and not just viral load reduction were published in 1997 and 1998 (Hammer, 1997; Cameron, 1998)^13,14. They did not find statistically significant reduced death rates. Both were stopped early, which biases the results in favor of the drugs. The Hammer study suffered from very incomplete reporting, making it difficult to assess toxicity or results. In addition, the Hammer study13 researchers broke their own study design in order to increase their study's statistical significance. By combining two separate treatment groups, the statistical "P value" was artificially increased. In addition, the gross underreporting of "AIDS-defining" events make this study of little or no value, since it only reports on one or two of the thirty one "AIDS-defining illnesses".

The second study by Cameron et al¹⁴ was of better quality, but many more of the study participants experienced toxicity rather than benefit. People given the full drug regimen had extremely high toxicities compared to placebo recipients, including 50% with diarrhea, another 52% with nausea, 29% vomiting, 28% circumoral parasthesia (numbness and tingling around the mouth), and 25% weakness. With these extremely high toxicities, it is easy to see how the double-blind could be penetrated by both patients and clinicians. Fully 21% of the people taking the triple drug combination dropped out of the study before the 4.5 months were up, which biases the results. In spite of all these favourable biases, although there was a reduction in opportunistic infections, the authors found little or no reduction in mortality, as a graph on page 546 clearly indicates. They mask this failure by lumping death statistics in with opportunistic infection statistics, citing reductions in the probability of "AIDS progression or death", a practice which seems designed to confuse or mislead people who read the study rather than to educate them. The toxicities described here occurred over the short space of 4.5 months, and the risk of giving these drugs for years on end has never been assessed.
Both these studies claim to have used a placebo (i.e. inert substance to take the place of an active medicine), but actually used a completely unproven combination of AZT with another DNA chain terminator like ddI or ddC. This alone eliminates these studies from any meaningful scientific discourse, unless the "placebo" combination has been shown to be at least safe, something that can only be done by testing it against a true placebo. This was not done.

One must rightfully ask how this entire multi-billion dollar industry of anti-AIDS medications was established with studies that have statistically insignificant results. When billions of dollars and thousands of careers are at stake, the potential for bias is enormous, and one must be very careful about making conclusions from such incomplete reporting.

Are the effects of AZT and other "antiretrovirals" being blamed on HIV?

The argument thus far is simply that the new protease inhibitor cocktails have not been proven to benefit patients. Many prominent scientists, however, take the argument quite a bit further. They argue that the very drugs used so wantonly with people diagnosed "HIV positive", could very well be causing much of the illness and death that is blamed on "HIV".

Although the newer "antiretrovirals" like ddC, ddI, and d4T, have analogous mechanisms of action and similar toxicities to AZT, they have not been studied as extensively and therefore are not discussed in as much detail in the studies outlined below. The major exception to this is "HIV Dementia" as discussed near the end of the essay. (See glossaryof brand names below under which these drugs are sold.)
Glaxo Wellcome puts the following warning in large, bold-faced, capital letters at the start of the section in the 1999 Physician's Desk Referencethat describes AZT (referred to under the name Retrovir or Zidovudine):

RETROVIR (ZIDOVUDINE) MAY BE ASSOCIATED WITH SEVERE HEMATOLOGIC TOXICITY INCLUDING GRANULOCYTOPENIA AND SEVERE ANEMIA PARTICULARLY IN PATIENTS WITH ADVANCED HIV DISEASE (SEE WARNINGS). PROLONGED USE OF RETROVIR HAS ALSO BEEN ASSOCIATED WITH WITH SYMPTOMATIC MYOPATHY SIMILAR TO THAT PRODUCED BY HUMAN IMMUNODEFICIENCY VIRUS.

AZT's brand names are Retrovir and Zidovudine, and it continues to be one of the most commonly used drug in people diagnosed HIV-positive. Up until 1993 it was used by itself, in about triple the dose used today, but today it is used in combination with other drugs. Many other drugs that are often used in combination with AZT used AZT as a model and have similar toxicities.

An earlier version of the Physician's Desk Reference, published in 1992 made the connection even clearer:

It is often difficult to distinguish adverse events possibly associated with Zidovudine administration from underlying signs of HIV disease or intercurrent illness.

Warnings like these should bring about a great deal of concern, especially given the litany of contradictions and confusion surrounding the science of "HIV" as the cause.

Allow me to translate some of the above warnings. "Granulocytopenia", also called "neutropenia" means that the primary cells of the immune system, neutrophils, have been depleted, along with some other cells, eosinophils and basophils, which are less numerous but still important to immune function. This condition can be mild, moderate, or severe. The clinical course of severe neutropenia, as described in the basic pathology textbook, Pathologic Basis of Disease by Robbins (5th Ed.), which is used in most medical schools to study pathology, describes what happens to people with severe neutropenia.

CLINICAL COURSE: The symptoms and signs of neutropenias are those of bacterial infections. ... In severe agranulocytosis with virtual absence of neutrophils, these infections may become so overwhelming as to cause death within a few days." (Robbins, p.631).

This sounds disturbingly similar to a description of AIDS. Although CD4 T-cells are the first cells supposedly attacked by "HIV", "later stages of HIV infection" are often associated with loss of neutrophils. Robbins also states, in italics, that "the most severe forms of neutropenias are produced by drugs." AZT was claimed to specifically attack HIV replication by interfering with DNA replication. What is not mentioned in any textbook is that AZT has been found in five studies performed after its rushed FDA approval to be equally toxic to T-cells, the very cells whose absence is blamed on HIV, by inhibiting T-cell DNA replication in exactly the same fashion². AZT may cause an initial increase in T-cells, but in relatively short time the T-cells, neutrophils, and other immune system cells begin to decline. This artificially increased T-cell count was shown to have no bearing on survival in the best and most well-controlled study available on AZT, the Concorde Study⁹, which also found that people who were given AZT earlier died faster. This study will be reviewed below.

Another strongly worded warning appears in the 1996 edition of the USP DI: Drug Information for the Health Care Professional:

Because of the complexity of this disease state, it is often difficult to differentiate between the manifestations of HIV infection [sic] and the manifestations of zidovudine (AZT). In addition, very little placebo controlled data is available to assess this difference. (pages 3032-3034)¹⁵

An example of a study that documented the toxic effects that AZT has on people's immune systems was published in the Annals of Hematology in 1994¹⁷. AZT was given to 14 health care workers who were exposed to HIV-contaminated blood through needle sticks and similar accidents. As we saw in previous studies, the likelihood of any of them contracting HIV is extremely remote, about 1 in 333, which is even less than the probablity of finding someone who is HIV positive when randomly picking from the general population^12,18,19. Thus it is no surprise that none of them actually became "HIV positive" as a result of their needle stick. This is not the reason for including this study here, however. This type of study is important because the toxicity observed cannot be blamed on HIV, as is quite likely to happen in people diagnosed "HIV positive", so the toxicities are openly admitted to be caused by AZT and documented as such. Fully half of the 14 workers had to quit the drug because of severe toxic side effects, and the study was stopped early before more damage was done. Only 11of the 14 people could continue to take the drug for more than four weeks. Neutropenia developed in 36% (4 of 11) of the people who completed 4 weeks of AZT treatment. The three people who could not make it to four weeks dropped out due to "severe subjective symptoms". One worker had to be stopped prematurely because his neutropenia was so severe that he developed an upper respiratory tract infection. What is truly remarkable in this study is that these side effects developed in only 4 weeks, while patients with "HIV positive" status often take AZT and other similar drugs for years. The dosage of AZT included in current protease inhibitor "cocktails" is much lower, which may be one reason why people are "living longer with HIV" today than they were when high doses of AZT were regularly given to everyone diagnosed "HIV positive" whether or not they showed any sign of illness.

An article in the New England Journal of Medicine⁴ looked at the muscle wasting caused by AZT and compared it to muscle wasting, called "myopathy", that has been presumed to be caused by HIV. Their comments in the abstract are revealing: "We conclude that long-term therapy with Zidovudine can cause a toxic mitochondrial myopathy, which... is indistinguishable from the myopathy associated with primary HIV infection...". Robbin's text on pathology also contains sections on mitochondrial myopathy, stating that this kind of muscle wasting results in severe weakness. It also states that "this group may also be classified as mitochondrial encephalomyopathies." Encephalomyopathy, in lay language, means widespread damage to the brain and spinal cord.

"HIV Dementia": Although most retrospective studies have not found AZT to be associated with "HIV dementia", these studies were uncontrolled and thus open to all sorts of confounding variables and biases. One of the better controlled studies did find that "HIV dementia" was twice as likely to happen in people taking AZT. In this study, published in the journal Neurology⁵, the authors state:

among subjects with CD4+ cell counts < 200/mm3, the risk of developing HIV dementia among those reporting any antiretroviral use (AZT, ddI, ddC, or d4T) was 97% higher than among those not using this antiretroviral therapy

Because the authors include only people with low CD4 T-cell counts in their comparison, it is less likely that people took AZT because they were already sick. They go on to discuss sensory neuropathy, which is a degeneration of sensory nerves:

In addition, the findings of our analysis seem to confirm previous observation of a neurotoxic effect of antiretroviral agents. Numerous studies have linked the use of ddI, ddC, and d4T to the development of toxic sensory neuropathies, usually in a dose-response fashion.

These studies are but a sample of the evidence that suggest that AZT and other "antiretrovirals" used as monotherapy or as parts of protease inhibitor cocktail regimens are causing a variety of AIDS-like symptoms which are being blamed on HIV. Unfortunately, the beliefs about HIV are so strong that many of the authors of the studies come out supporting the use of the drugs. A notable exception is the article in Pharmacology and Therapeutics, which provides a thorough and devastating critique².

Note: As this goes to press, a review just published (Ann Intern Med. 2000;133:447-454) reveals new evidence that "HAART may actually promote the clinical expression and development of [opportunistic] infections, as well as AIDS-related malignant conditions and other noninfectious diseases" This review article cites 95 references, where authors list several opportunistic infections and malignancies usually known as AIDS defining conditions that afflicted patients only after initiation of HAART therapy lowered viral load and increased CD4 cell counts. See Appendix 3.

A LIKELY EXPLANATION FOR THE "COURSE" OF AIDS

Based partly on this evidence, a compelling argument can be made that much of what we call AIDS is a self-fulfilling prophecy which might happen as follows:

a) The severe, acute psychological stress of being diagnosed "HIV Positive" is quickly transformed into a severe, chronic psychological stress of living with a prediction of a horrifying decline that could start at any time. This causes a suppression of the immune system, with selective depletion of CD4 T-cells, as is well documented in the field of Psychoneuroimmunology⁷. In addition, people are more likely to be tested for HIV when there is already some health problem present, so that the psychological stress adds to significant stress due to the illness already present. These illnesses are often severe and chronic in nature. It is not necessary, however, for prior illness to be present. These factors have been studied in healthy people where they create the very same immunosuppression and immune dysregulation that may later be called "AIDS".

b) After testing positive, people are often put on a variety of powerful medications as a preventative measure and/or for treatment of actual infections. These include long-term regimens of the most potent broad-spectrum antibiotics, as well as "antiretroviral" agents like AZT, ddI, ddC, and protease inhibitors. Although the toxicities of the "antiretrovirals" have been outlined above, antibiotics also often have debilitating side effects which are easily blamed on HIV, including immune suppression. Perhaps more significantly, they lead to a complete disruption of the normal microbial flora present in the gastrointestinal system. The healthy balance of flora in the gastrointestinal tract and elsewhere in the body is one of the most important protectors against infection⁸. If this is not enough, these antibiotics also often lead to the development of multidrug-resistant strains of bacteria, fungi, and viruses, which can later ravage a person's system, especially if their immune system is not functioning very well.

c) Once the immune system starts to crack under the strain of the emotional stress, previous health problems (if there were any), and disrupted natural defenses, the diagnosis of AIDS is made. If not already on "antiretrovirals", then the person will now definitely be started on them, with all of the toxic effects described above.

d) The new "cocktails" are to be given until the patient dies, with no exceptions*, if possible. This is because of the theory that mutant, drug resistant, HIV will flourish if they go off of their treatment. Patients who abandon "antiretroviral" treatment would then, theoretically, be a public health threat because they might infect others with their superpowerful, mutated "HIV". Thus, aside from considering their own health, the patient has a larger social responsibility to stay on the "cocktail", no matter how debilitating the "side effects" are. It is heavily stressed that the patient must not miss a single dose, if at all possible. When the patient's health begins to fail, the failure is blamed on the effects of this "mutated HIV", possibly due to the patients poor compliance. Rarely are the drug toxicities and complications caused by the treatment held responsible.

* Recently, HIV specialists have begun to relax the demand for rigid adherence to treatment. They have started prescribing "strategic treatment interruptions" to allow patients to recover from drug toxicity and to see if their "restored" immune systems can cope unaided. [editor's note] See Appendix 3.

The idea that mutated strains of HIV are capable of causing health problems has been disproven by the work of David Rasnick, a scientists who holds nine patents in protease inhibitor research. Dr. Rasnick, who published his results in the Journal of Biological Chemistry¹¹, strongly disagrees with claims that protease inhibitors are helping people diagnosed "HIV positive", and instead maintains that they are causing symptoms blamed on HIV. His research shows that any decline in health is not due to "mutated HIV", and that the protease inhibitor cocktails themselves are more likely culprits.

Some people seem to respond well (at least temporarily) to these "antiretroviral" regimens. The reasons for this are unclear, but may be related to:

1. Direct actions of the drugs on many possible pathogens (including, possibly, HIV).
2. Toxic substances have been observed to stimulate the release of T cells from the bone marrow, before eventually exhausting the supply and causing immune cell depletion and anemia. The initial rise in CD4 counts seen in this case would be interpreted as improved immune function when it is actually the beginning of immune exhaustion.
3. Relief of the severe psychological stress due to the powerful belief that these drugs are "life-saving". This is often reinforced by rising CD4 counts and falling "viral load", which are doubtful and non-specific markers of actual health.
4. In a study from 1950 syrup of ipecac, which normally causes nausea and vomiting, cured women who were already suffering from nausea and vomiting¹⁶. The women were told that it was a new drug that eliminated nausea and vomiting, and this belief was apparently powerful enough so that their symptoms went away. Thus it was shown that if people believe in a drug, it can have positive effects, at least for a short while, even if it is normally highly toxic. If administered over a longer period, however, the initial benefit may fade, while the toxicities remain. This phenomenon could explain the anecdotal stories of success with AZT and other "antiretrovirals", as well as how some of the toxic symptoms caused by these drugs, could be later blamed on HIV.

Scientific studies attempting to document positive effects of protease inhibitor (PI) "cocktails" are of questionable value. Every one has been stopped early, like stopping a sporting event when the home team is ahead. This skews any attempt at finding benefit. Even worse, all of the studies of protease inhibitor combination therapy have been stopped before statistically significant reductions in mortality is even reached¹. In addition, the control groups' "placebos" were 2 antiretroviral drugs with no protease inhibitor. If the "antiretrovirals" are part of the problem then these so-called "placebo controlled" trials will not reveal it very well. Stopping the trials early was also the case with AZT monotherapy, until the Concorde study finally went to completion and found greater deaths and "adverse events" in the group that got AZT as a preventative measure. The other group, in which people were only given AZT after being diagnosed with an AIDS-defining condition, had about 25% fewer deaths. Of the 172 Concorde participants who died all but 3 were on AZT at some point^1,9,10. (For more discussion of the Concorde see Appendix 1)

Appendix 1: Concorde: MCR/ANRS randomized double-blind controlled trial of immediate and deferred zidovudine [AZT] in symptom-free HIV infection. Although the difference in survival between the participants who started AZT immediately (Imm) and those who were deferred (Def) until the onset of AIDS-Related Complex (ARC) or AIDS was not considered significant by the Concorde report (estimated 3-year probabilities of death were 8% Imm and 6% Def), other "events" were. "Adverse events", such as leukemia, anemia, neutropenia, etc., were at least 300% higher in the Imm group over the three year trial. A fact that is often missed when reading the Concorde report is that of the 172 (96 Imm, 76 Def) participants who died all but 3 were on AZT at some point. This is because 418 participants in the Def group switched to AZT part way through the trial; 74 for "personal reasons", 204 due to low CD4 count and only 109 (26%) due to progression to ARC or AIDS, which was the point of the trial. Ironically, one of Concorde's finding was that CD4 counts are not a useful marker for disease progression. In other words, people who weren't really sick were put on AZT, their T-cells rose, and in spite of this more of them had "adverse events" and more of them died. Was the cause of death HIV or AZT? (9)

Appendix 2: Glossary of generic & brand names, (class of drug) for "antiretrovirals"

3TC: Epivir®, lamivudine (NA)
abacavir: Ziagen® (NA)
AZT: ZDV, Retrovir®, Zidovudine (NA)
ddI: Videx®, didanosine (NA)
d4T: Zerit®, stavudine (NA)
delavirdine mesylate: Rescriptor® (NNRTI)
efavirenz: Sustiva® (NNRTI)
indinavir sulfate: Crixivan® (PI)
nevirapine: Viramune® (NNRTI)
nelfinavir mesylate: Viracept® (PI)
ritonavir: Norvir® (PI)
saquinavir mesylate: Invirase®, Fortavase® (PI)
Combivir®: combines AZT & 3TC (NAs)

Appendix 3: Inflammatory Reactions in HIV-1-Infected Persons after Initiation of Highly Active Antiretroviral Therapy 

Joseph A. DeSimone, MD; Roger J. Pomerantz, MD; and Timothy J. Babinchak, MD
Ann Intern Med. 2000;133:447-454.

This is a review article with 95 references, where authors list several opportunistic infections and malignancies usually known as AIDS defining conditions that afflicted patients only after initiation of HAART therapy lowered viral load and increased CD4 cell counts. HIV researchers have created an ironic new name for this: "Immune Restoration Syndrome". The authors of this review state: "Although patients receiving HAART have reduced plasma HIV-1 viral load and increased CD4+ T-lymphocyte counts, they still develop AIDS-defining events, particularly in the first 2 months of treatment. A delay in restoration of immune function may account for the development of opportunistic infections. It is possible, however, that HAART may actually promote the clinical expression and development of such infections, as well as AIDS-related malignant conditions and other noninfectious diseases. Several authors have recently reported cases that may represent progression of previously quiescent disorders to symptomatic diseases after initiation of HAART."

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