Thursday, January 28, 2010






UPDATE: Wakefield's quack paper is retracted by Lancet. Can he try to republish it in Medical Veritas?

MMR doctor 'failed to act in interests of children'
General Medical Council finds Andrew Wakefield, who linked MMR with autism, failed in duties as responsible consultant
Published in the Guardian Newspaper


Dr Andrew Wakefield,  at the centre of the MMR controversy, "failed in his duties as a responsible consultant" and showed a "callous disregard" for the suffering of children involved in his research, the General Medical Council (GMC) has ruled.
Wakefield also acted dishonestly and was misleading and irresponsible in the way he described research that was later published in the Lancet medical journal, the GMC said. He had gone against the interests of children in his care, and his conduct brought the medical profession "into disrepute" after he took blood samples from youngsters at his son's birthday party in return for payments of £5.


The doctor, who was absent from today's GMC hearing, faces being struck off the medical register. The panel decided the allegations against him could amount to serious professional misconduct, an issue to be decided at a later date.
Wakefield said he was dismayed at the panel's decision. "The allegations against me and against my colleagues are both unfounded and unjust ... and I invite anyone to examine the contents of these proceedings and come to their own conclusion."
The panel chairman, Dr Surendra Kumar, was heckled by parents who support Wakefield as he delivered the verdicts.
One woman shouted: "These doctors have not failed our children. You are outrageous." She called the panel of experts "bastards" and accused the GMC of being a "kangaroo court". Another shouted: "This is a set-up."
In the late 1990s Wakefield and two other doctors said they believed they had uncovered a link between the MMR jab, bowel disease and autism. The research caused a big drop in the number of children given the triple jab for measles, mumps and rubella.
The hearing has sat for 148 days over two and a half years and reportedly cost more than £1m. A total of 36 witnesses gave evidence at the hearing.
The accusations relate to investigations for the study, based on 12 youngsters with bowel disorders, carried out between 1996 and 1998. At the time all three doctors were employed at the Royal Free hospital's medical school in London, with honorary clinical contracts hospital itself.
The GMC heard that vulnerable children were subjected to "inappropriate and invasive" tests by the doctors, who breached of "some of the most fundamental rules in medicine".
Wakefield did not have paediatric qualifications and had not worked as a clinical doctor for several years when he ordered the tests, the panel was told.
One of the key claims was that Wakefield accepted more than £50,000 from the Legal Aid Board for research to support a group of parents' attempts to fight for compensation.
It was alleged Wakefield applied for money so that five children and their families could stay in hospital during tests and for MRI scans for each child.
The money was paid into an account at the Royal Free for Wakefield's research, but, the GMC alleged, the cost of scans and hospital stays would have been met by the NHS.
Wakefield was accused of paying children £5 for blood samples at his son's birthday party, then joking about it afterwards.
All three doctors denied the allegations against them.


Monday, January 25, 2010












Still Crazy After All These Years: 
The Challenge of AIDS Denialism for Science
By Nicoli Nattrass
AIDS and Society Research Unit, University of Cape Town

Published in AIDS and Behavior
In his new book, Denying AIDS, Seth Kalichman observes that people are surprised by the persistence of AIDS denialists:‘‘Are they still around?’’ he is often asked. And it is a good question. Given the large body of scientific and clinical evidence on HIV disease and treatment(expertly summarized by Chigwedere and Essex in this issue of AIDS and Behavior) it is indeed strange that Peter Duesberg and his followers still claim HIV is harmless and that antiretrovirals cause rather than treat AIDS. While such dissident views were intellectually respectable in the 1980s when HIV science was new, they make little sense today. Thus Joseph Sonnabend, a doctor who treated some of the earliest AIDS cases in New York and was well known for arguing that environmental factors may be more important than a virus in driving AIDS, was quick to change his mind once antiretroviral treatment was shown to act against HIV and transform the health of his patients. Peter Duesberg, by contrast, refused to accept the evidence, thereby earning the label ‘denialist’ rather than ‘dissident’.

Duesberg may be pathologically contrarian in this respect, but he has an enduring appeal. Kalichman argues that this is in large part because his claim that HIV is harmless reinforces the normal process of denial most people undergo when faced with traumatizing information—such as a positive HIV test result.



Another reason is that Duesberg’s views are promoted in books, on denialist websites and blogs and by a persistent trickle of ‘Duesbergas-oppressed-hero-scientist’ stories from independent filmmakers and journalists. It is precisely because he holds a post at Berkeley and is an elected member of the National Academy of Sciences, that Duesberg has been able to build the media profile that sustains him. As Epstein argues, by ‘using his scientific credentials to buy him popular support, then using the popular support to push for recognition by his colleagues—Duesberg gained staying power’.


This has resulted in HIV science being represented as fundamentally contested in ways which it actually is not. And because of the threat AIDS denialism poses both to public health and to the authority of HIV science itself,scientists have found it necessary, time and time again, to respond to Duesberg’s claims, despite their long having been demolished. Chigwedere and Essex’s paper in this issue is one more such refutation in a long line of refutations. What makes their paper different is that in addition to marshalling the key evidence in support of the scientific consensus on HIV, they criticize Duesberg for inspiring South Africa’s ex-President Mbeki AIDS policies (thereby causing hundreds of thousands of unnecessary deaths) and they take him to task for suggesting (in a co-authored paper initially published in Medical Hypotheses but subsequently withdrawn by the publisher) that the African AIDS epidemic does not exist.

Chigwedere and Essex are clearly angry—the emotion is evident on every page. This is not merely because of the dangers Duesberg’s intransigence poses for public health but because of his refusal to change his views when the evidence demands it. This has long been a source of frustration for HIV scientists. For example, Robert Gallo, the co-discoverer of HIV, has described him as ‘like a little dog that won’t let go’ and John Moore, an eminent virologist at Weill Cornell Medical School, has likened Duesberg to Monty Python’s black knight who keeps fighting despite having all of his limbs cut off by his opponent. And the problem is far more than intellectual because disregarding evidence not only undermines scientific progress, but it threatens the social basis which makes such progress possible. Respect for the evidence and for the people who generate it is a core value in the scientific community—and it is precisely this that Duesberg flouts. Warren Winkelstein, one of the early HIV epidemiologists, recalls how, at a meeting of the National Academy of Sciences in Washington to discuss Duesberg’s theories, Duesberg would frequently get up, wander around the room and start talking to reporters. In his view, Duesberg simply ‘wasn’t listening to what was being said’. The message Duesberg was broadcasting then, and in all his statements on AIDS, is loud and clear: he alone is correct and the work of others is not worth considering.

It is no wonder, then, that Duesberg has earned himself pariah status in the scientific community. Yet his views continue to be promoted over the internet. Unlike academic journals, where respectability is obtained through peer review,impact factors and the credentials of those on editorial boards, information on the internet is easy to post and difficult to assess for its quality. Credibility and authority in this domain is shaped and reshaped in everyday rhetorical battles for the hearts and minds of readers. Here, techniques of persuasion have very little to do with the August rankings of journals, or the CVs of scientists. Rather, a central rhetorical strategy is to cast Duesberg as modern day Galileo, to confuse readers with what Ben Goldacre calls ‘sciency-sounding’ misinformation on HIV, and to offer a range of soothing-sounding ‘natural’ and ‘alternative’ remedies.

This has forced HIV scientists and physicians to engage with AIDS denialism in new ways. They have, for example, teamed up with AIDS activists to create a website, www.AIDStruth.org, dedicated specifically to countering AIDS denialism. In fact, the first posting on AIDStruth.org  was a detailed refutation of an AIDS denialist article promoting Duesberg’s views in Harpers Magazine. Scientists linked to AIDStruth.org have also responded to HIV misinformation in videos, for example complaining successfully to the British Broadcasting Corporation about a film falsely depicting antiretrovirals as having caused harm to children in New York, and more recently posting a critique of the documentary film, ‘House of Numbers’, for its misrepresentation of AIDS science. Other pro-science websites and bloggers also participate in the ongoing fight against AIDS denialism, notably: Ben Goldacre (a physician) on ‘Bad Science’ (http://www.badscience.net/), Seth Kalichman (a psychologist) on ‘Denying AIDS’ (http://denyingaids.blogspot.com/) and Nick Bennett (a physician) on ‘Correcting the AIDS lies’ (http://aidsmyth.blogspot.com/). Also important are blog postings by individuals in response to denialist views expressed on blogs and chat rooms. All are fuelled by a tangible sense of outrage over what they see as the dishonest tactics of AIDS denialism and the dangers it poses for those who are taken in by it.

Social scientists refer to activities in defense of science as ‘boundary work’. In the past, boundary work sought to develop and maintain public respect for science and to relegate ‘pseudo-science’, like phrenology, beyond the pale of academia. Such boundary work was conducted within academic institutions and in academic journals as well as in the public sphere through public lectures and in articles and letters in major newspapers. By contrast, boundary work in today’s information age is more diffuse, and decentralized—often fought at an individual level via cut and thrust debate on blog postings. Even so, classic forms of boundary work remain important—notably ensuring the quality of academic articles and responding to bad science when it does get published. Chigwedere and Essex’s paper in this issue falls into this latter category of boundary work. As they explain, their paper originated as a response to an article by Duesberg and others in Medical Hypotheses critiquing their earlier estimates of AIDS deaths attributable to Mbeki.

Medical Hypotheses has long been a source of concern in the scientific community because the articles are not peer-reviewed. When Duesberg’s paper appeared, restating his erroneous beliefs about HIV and denying the existence of the African AIDS epidemic, this was the last straw for many. In a classic piece of boundary work, twenty HIV scientists and activists wrote to the National Library of Medicine requesting that Medical Hypotheses be reviewed for de-selection from PubMed on the grounds that it was not peer-reviewed and had a disturbing track record of publishing pseudo-science. The National Library of Medicine responded by promising to review the journal, but in the meantime John Moore and Franc¸oise Barre´-Sinoussi (Nobel Laureat and codiscoverer of HIV), wrote to Elsevier, the publisher of Medical Hypotheses, about the issue. Elsevier immediately withdrew Duesberg’s article and instigated its own review of editorial policy at the journal.

This left Chigwedere and Essex in a rather strange position: their earlier article had been critiqued and used as a spring-board for further restating discredited claims about HIV medical science—but then withdrawn. How does one respond in such a situation? They could have ignored it on the grounds that the paper no longer had any published academic status. Yet precisely because AIDS denialists have alternative forums for promoting their views, and precisely because they regard such boundary work on the part of the scientific community and the publisher as evidence of the vast power of the so-called ‘AIDS establishment’ to suppress dissent, there remained a need to address Duesberg’s claims. Hence the publication of Chigwedere and Essex’s response in AIDS and Behaviour today.

It is also worth emphasizing that the Duesberg et al. paper was withdrawn because a group of credible AIDS scientists was able to point to a series of fundamental flaws that should have been picked up had the paper been peerreviewed. Although the paper contained a set of basic errors about the African AIDS epidemic (such as confusing adult HIV prevalence and population prevalence, misinterpreting death statistics and assuming that simply because the African population has risen that there is no epidemic), this was of minor concern in relation to Duesberg’s ongoing misrepresentation of HIV science and disregard for the evidence. Had AIDS scientists been asked to peer review the paper, they would have rejected it for its factual errors on the AIDS science alone.

Unlike HIV science, demographic modeling of the impact of AIDS and of HIV prevention and treatment interventions inevitably involves a range of assumptions and is much more contestable. Thus, while Chigwedere and Essex are on firm ground with regard AIDS causation and the clinical benefits of antiretrovirals, their earlier modeling of the number of lives lost due to Mbeki’s policies is less compelling. Indeed, one can contest their original analysis for estimating the impact of Mbeki’s policies over too short a period (2000–2005 rather than over the life of Mbeki’s presidency) and for using a rather simplistic and ad hoc demographic model rather than the more sophisticated and publicly available demographic models—such as the Spectrum model provided through UNAIDS and the ASSA2003 model provided by the Actuarial Society of South Africa.

Figure 1 shows that different demographic models can yield very different estimates of the number of AIDS deaths in South Africa and the number attributable to Mbeki. In earlier work, I used the ASSA model to argue that if Mbeki’s national government had rolled out antiretrovirals for HIV prevention and treatment at the same rate as the opposition-controlled Western Cape Province, then 343,000 AIDS deaths and 171,000 new HIV infections could have been averted. These figures are higher than those of Chigidere et al. [in part because of the longer projection period (1999–2007), but also because of differences in the design of the epidemiological models. This can be seen by comparing ASSA and Spectrum projections which used exactly the same policy inputs, but produced different outputs because of differences in the underlying modeling architecture. The ASSA and Spectrum estimates are more consistent with the general shape and pace of the AIDS epidemic than the Chigwedere et al. estimate, but even so, a large confidence interval should be placed around all such modeling work.

In short, there is a legitimate and open intellectual debate over how best to measure the number of lives lost in South Africa due to the delayed rollout of ntiretrovirals for HIV prevention and treatment. However, the fact that deaths and new HIV infections could have been averted had antiretrovirals been used sooner, is incontrovertible. Chigwedere and Essex are correct to emphasize this, and to point out, once again, that there is no scientific basis for AIDS denialism.

Saturday, January 23, 2010


Publisher attempts to rein in radical medical journal

23 January 2010
Editor rejects proposal to have submissions peer reviewed. Zoë Corbyn reports
The publisher of Medical Hypotheses has proposed that the irreverent journal should be revamped as an orthodox peer-review publication.
In a letter to the editor, Elsevier proposes a “revised and more focused aim and scope” for the journal and a “peer-review process for all submitted articles”.
To achieve this, it suggests a “review of editorial board membership” and development of a “wide pool of reviewers”.
“We would plan a relaunch once these changes have been implemented,” Elsevier says in the letter seen by Times Higher Education.

Medical Hypotheses, which was established more than 30 years ago, is the only Elsevier journal that does not currently subject its submissions to peer review.
Instead, its editor Bruce Charlton, professor of theoretical medicine at the University of Buckingham, decides what to publish on the basis of whether the submissions are radical, interesting and well argued.
The proposals for change follow recommendations from a panel of scientists set up by Elsevier to review the journal's future after it published a paper that denied the link between HIV and Aids.
The paper, written by well-known HIV/Aids denier Peter Duesberg, argued that there is “as yet no proof that HIV causes Aids” and says the claim that the virus has killed millions is “unconfirmed”.
It provoked outcry from researchers in the field, some of whom contacted Elsevier to object. The publisher retracted the paper and set up the review panel, whose members have not been named.
The panel took a dim view of Medical Hypotheses’ approach, recommending that it adopts a system of peer review and that its scope changes to curtail “radical” ideas.
“[Elsevier should] devise and publicise a safety net that guards against publication of baseless, speculative, non-testable and potentially harmful ideas,” it recommends, adding that the publisher should also “make it clear” when topics are off limits.
It suggests “novel ‘scientific’ hypotheses supporting racism, the subjugation of women, [and] eugenics” as examples of topics that may be deemed inappropriate.
“The likelihood that ‘radical ideas’ on such topics represent useful new concepts is vanishingly small, the likelihood that their foundation is unethical is great,” it says.
“Even if offered strong proof of concept, would you want to publish articles supporting them under any circumstances? ...their publication in a ‘scientific’ journal is an important political tool for groups needing the respectability of publication to support a noxious agenda.”
Professor Charlton said he has received more than 120 letters of support for retaining Medical Hypotheses in its current form, after he launched a campaign to save the title. He said neither he nor his editorial advisory board would tolerate the changes proposed.
“Medical Hypotheses has for 34 years been editorially reviewed and radical,” he said. “Therefore [the proposals] cannot possibly be acceptable.”
When initially contacted by THE, Elsevier suggested it had made no recommendation that the journal should move to a peer-review system.
Presented with the text of the letter to Professor Charlton, it said that “no decision on any change will be taken until we have gone through a consultation process”.

Friday, January 22, 2010




Review: 'House of 
Numbers' blurs facts on HIV

By Special to The Oregonian

January 21, 2010, 4:54PM

By personally interesting coincidence, the contrarian AIDS documentary "House of Numbers" opens just as a family friend is flying into Portland in advance of a benefit concert for her father, a local musician suffering from the disease. How fortuitous that I can report to her the film's controversial suggestion: Her dad's malady is not caused by the human immunodeficiency virus. In fact, HIV doesn't exist at all, but is used by researchers and drug companies who inflate infection statistics and terrify the public so government money will continue to flow.


For loved ones of the estimated 25 million who have died from AIDS, the claim might be considered a ludicrous, monstrous lie. But the director, producer, editor and narrator of "House of Numbers," Brent Leung, doesn't seem like a monster at all. He comes off as a pleasant young man conducting an open-minded inquiry into the research establishment's differing views about HIV, testing protocols and statistical science, a confusion that trickles down to the public. Of course, by the end of the film you'll likely be more confused about HIV/AIDS than ever, and that's just the way Leung wants it.



This slick film builds its case methodically, relying on globe-trotting field studies and interviews with a number of prominent AIDS researchers and activists to build legitimacy and to also, it seems, reveal damning contradictions. For example, in an incident in South Africa, Leung gets tested for HIV and is told that he will receive two identical tests. 


If one is positive and the other negative, then he will take a third, different test that is "most accurate." If the third test is most accurate, Leung asks, why not just take that one? Because, the nurse says, the less-accurate test results tell us the third test is most accurate. It is strongly inferred that this anecdotal experience shows that no HIV test can be believed.I am not qualified to refute every claim made in this movie, but I have seen enough topical documentaries to have a good idea when a filmmaker is not being entirely honest with viewers. Relying on selective editing, anomalies and anecdotes, unsupported conclusions -- early AIDS deaths were caused by overexposure to amyl nitrate? -- and suppression of inconvenient facts (revealing neither the post-filming death of anti-AZT activist Christine Maggiore from AIDS-related pneumonia, nor the reason for her notoriety) allows Leung to maintain a narrative casting suspicion on everything we think we know and the "experts" who propagate the "official" story.

Thursday, January 21, 2010



The AIDS Beacon

Up-to-date news and information for AIDS patients and their families

By Nora Proops 




In the recent paper “AIDS Denialism and Public Health Practice,” Professor Myron Essex and Dr. Pride Chigwedere of the Harvard School of Public Health AIDS Initiative provide scientific evidence to refute AIDS denialist beliefs. They show that AIDS denialist policies like withholding antiretroviral treatment to HIV-infected individuals in South Africa has resulted in thousands of deaths in that country.


Denialists do not believe that HIV causes AIDS, that the disease has caused widespread deaths, or that antiretroviral drugs are effective. AIDS denialists, whose adherents have been likened by critics to Holocaust deniers, belong to a movement that has been largely propagated through the Internet.


To make their case, the authors provide a history of how the cause of AIDS was investigated, irrefutable data demonstrating antiretroviral efficacy, and population statistics that are consistent with those from AIDS.


The authors discredit unscientific practices of AIDS denialists, including their use of anecdotal cases and death notification, which they characterize as crude and misrepresentative forms of presenting information.



Essex and Chigwedere use the South African case as an example to illustrate the “grave implications of AIDS denialism for public health practice.” The researchers note that because they were denied antiretroviral drugs, 330,000 South Africans died prematurely and 35,000 newborn babies were infected with HIV between 2000 and 2005.


The researchers specifically identify the role former South African President Thabo Mbeki’s AIDS denialist policies played in these deaths. In 1999, he withdrew support from clinics that had begun using zidovudine (Retrovir or AZT) for preventing transmission of HIV from mothers to their children during childbirth.


Mbeki also restricted the use of donated Viramune (nevirapine) in 2000, blocked AIDS treatment grants from the Global Fund in 2002, and delayed implementing a national antiretroviral treatment program until 2004.


Essex and Chigwedere also argue that “denialist writings require close scrutiny and peer review before being published in scientific journals, especially when they have the potential to impact public health practice.” They point to one of the most famous AIDS denialists, Peter Duesberg, who served on a 2000 commission tasked by Mbeki to determine whether HIV causes AIDS. Duesberg has found a sounding board for his views in the journal Medical Hypotheses.


Medical Hypotheses, a journal lacking peer review, has come under fire from critics. Recently under pressure from AIDS activists, two articles were retracted from the journal due to their AIDS denialist claims. One article argued that AIDS is not a problem in Africa and the second stated that data in Italy does not show HIV as the cause for AIDS.


For more information, please read the news release on the AlphaGalileo Web site or access the AIDS and Behavior  journal article.

Monday, January 18, 2010



Simon Jenkins may scoff about swine flu estimates, but HIV/Aids has taught us not to wait to see how deep a pile of bodies gets




It is disappointing to see Simon Jenkins continue his attacks on scientistsattempting to explain complex concepts of risk about a new strain of virus to an ignorant public whose main source of information is an often hysterical media. From his opening paragraph Jenkins presents a unique interpretation of the dangers of swine flu based on his understanding of comments from public scientists. He accuses Sir Liam Donaldson of bandying "about any figure that came into his head, settling on '65,000 could die'". This figure was in fact a worst case scenario, as the article linked to in Jenkins' piece clearly indicates.
Jenkins cites BSE/CJD as a previous example of scare story about science that came to nought, claiming that "it would 'lead to 136,000 deaths' – a spurious exactitude used to convey plausibility". Again the cited article makes clear that this is an estimated upper limit in a worst case scenario. One might also be curious about where Jenkins came across the phrase "the absence of evidence is not the evidence of absence," which he calls a classic Rumsfeld-ism. In fact it is a misquote from Carl Sagan's Demon Haunted World, where it is used to illustrate the dangers of arguing from ignorance.
But this isn't about Jenkins' lack of scholarship, this is about a reflexive, unthinking attitude to science and risk assessment that can go drastically, horribly wrong. In the early 1990s, when Jenkins was editor of the Times, he supported the then Times science correspondent, Neville Hodgkinson, who advocated the arguments of Peter Duesberg, a now notorious individual, who doubted the links between HIV and Aids. At this point in time Duesberg's theories were already considered wrong by the scientific community, yet this did not stop the Times from lending its support.
In December 1993 Jenkins wrote an article in which he claimed that fears over Aids were simple scaremongering, predictions of fatalities were wrong, and drug company funding was distorting the public debate, thus, the link between HIV and Aids should be questioned. This position was untenable given the current state of the literature. Interestingly the arguments in that piece are almost identical to those Jenkins wields today against the dangers of swine flu.

What Jenkins fails to understand is that scientific arguments are not constructed by rhetoric, but by the tedious and often slow process of evidence-gathering and interpretation. Sometimes, especially so in the case of a rapidly spreading disease, an official response is required before the scientific picture is clear. This response is based on a risk assessment from the contemporaneous evidence and can often seem to be wrong given hindsight benefiting from up-to-date evidence. Even so, governments are not responding in the firm belief that the worst is happening, they will be prepared for a wide range of possibilities, from slight to serious. The impact of the epidemic will become more apparent as the state of knowledge improves and the response modified accordingly. However, it is undesirable for governments to sit back and wait and see how deep the pile of bodies becomes before a serious response begins.


Perhaps the best example of sitting back and waiting for disaster comes from the way in which South Africa dealt with Aids under Thabo Mbeki. Influenced by Duesberg and Hodgkinson, among others, Mbeki doubted the link between HIV and Aids and declined to make anti-retroviral drugs publicly available. It has been estimated that more than 300,000 deaths occurred because of this in South Africa alone.
Being wrong about an epidemic can be lethal. Jenkins might be right in assuming that the dangers of swine flu and BSE/CJD were overestimated, but he was wrong about Aids. Being right two out of three times might be a winning strategy in games of poker, but when being wrong results in hundreds of thousands of deaths it is hard to argue that the game is worth playing given the stakes.

Monday, January 11, 2010

  















Research now confirms that the AIDS denialist policies of former South African President Thabo Mbeki contributed to the senseless death of hundreds of thousands of people. It is also well known that Mbeki's AIDS denialist policies were underwritten by University of California biologist Peter Duesberg and his companion David Rasnick. As part of their ongoing propagation of AIDS denialism, Duesberg and Rasnick are trying to publish a paper that refutes the impact of Mbeki's refusal to expand HIV testing, prevention and treatment in South Africa. Their paper titled "HIV-AIDS Hypothesis Out of Touch with South African AIDS – A New perspective" was originally rejected from a legitimate scientific journal and then published in a non-peer reviewed outlet (Medical Hypotheses), only to be retracted. [see posts on August 8, September 9, and September 11].


Nevertheless, Duesberg's article lives on in cyberspace and Duesberg continues to seek its publication. It is important to show yet again that Peter Duesberg is wrong on HIV/AIDS. Below is an excerpt from a new article by Pride Chigwedere and Max Essex published in the journal AIDS and Behavior. 


DISCLOSURE ALERT: I am the Editor of AIDS and Behavior and this paper was peer-reviewed. The full article is available FREE  online


AIDS Denialism and Public Health Practice
By Pride Chigwedere and Max Essex
Published in AIDS and Behavior

We recently published a paper estimating the human cost of not using antiretroviral drugs in South Africa Questioning whether HIV causes AIDS and the safety of using antiretroviral drugs (ARVs), the South African government led by former president Thabo Mbeki withdrew government support from Gauteng clinics that had begun using zidovudine (ZDV or AZT) for preventing mother-to-child transmission of HIV (PMTCT) in 1999, restricted the use of nevirapine donated free of charge by Boehringer Ingelheim in 2000, obstructed the acquisition of grants for AIDS treatment from the Global Fund in 2002, and generally delayed implementing a national ARV treatment program until 2004.








By considering the decreasing costs of ARVs, the increasing availability of international resources to fight AIDS, and comparing South Africa to neighboring Botswana and Namibia, we conservatively estimated the number of AIDS patients that could have received ARVs for treatment or PMTCT. Factoring in the efficacy of ARVs, we concluded that from 2000 to 2005 at least 330,000 South Africans died prematurely and 35,000 babies were infected with HIV as a result of Mbeki’s policies. Independently and using a different model, Nattrass arrived at similar estimates.

Duesberg and colleagues published a critique of the study in the Journal Medical Hypotheses which was subsequently retracted by the publisher pending an investigation of the quality and global health implications of the paper. Peter Duesberg is the most well known AIDS denialist who was part of President Mbeki’s commission tasked to determine whether HIV causes AIDS in 2000, and he has recently received attention from a mainstream magazine and a whistleblower award for his AIDS denialist
67 writings.1 Consistent with earlier writings, Duesberg and colleagues:

1) Deny that HIV causes AIDS; that instead, it is a harmless passenger virus;

2) Deny that ARV drugs are useful, and therefore Mbeki’s decisions could not have harmed anyone;

3) Deny that hundreds of thousands of South Africans have died from AIDS, and thus it does not make sense to attribute 330,000 deaths to Mbeki.

We choose to respond to the issues raised above for two reasons: first, some readers may be hoodwinked by Duesberg’s dishonest arguments and think that there is a genuine debate in light of the surge in denialist coverage, and second, to emphasize the grave implications of AIDS denialism for public health practice.

Does HIV Cause AIDS?

Duesberg has been denying that HIV causes AIDS for more than 20 years. President Mbeki joined the debate in 85 1999 initially by questioning whether AZT was safe for use by pregnant women, and then joined the denialists by questioning whether HIV was the ‘‘real’’ cause of AIDS as a way of broadening the debate from the usefulness of AZT to the usefulness of all antiretroviral drugs in fighting the AIDS epidemic, since they all target HIV. He then appointed Duesberg and others to a commission to examine whether HIV causes AIDS. Whether HIV causes AIDS is therefore at the very center of the policies implemented by Mbeki.

The evidence that HIV causes AIDS has been available for over 20 years. Careful epidemiological studies showing that individuals with a new, severe immunosuppressive disease clustered among homosexual men, intravenous drug users, female sexual contacts of drug users, hemophiliacs, other recipients of blood transfusion products, and newborn babies suggested that the cause was an infectious agent transmitted by body fluids. Early suggestions that illicit drugs or immune reactions to sperm were the cause could not explain all the patient groups affected by the immunosuppression.



Serological studies then suggested that the causative agent was likely to be a retrovirus, and this was confirmed by isolation and culture of the retrovirus from infected patients. Diagnostic assays were developed and much larger studies were then possible to identify HIV-infected persons using the presence of HIV antibodies, antigens, viral nucleic acids and virus, and to compare them to uninfected persons in longitudinal studies to learn the virology, immunology, pathology, and clinical and population features of the disease. HIV meets several standards of epidemiologic causality. 


HIV has satisfied Koch’s postulates, the traditional standard of infectious disease causation. To satisfy Koch’s postulates, one has to isolate the infectious agent from diseased animals, culture it in the lab, inoculate the agent into healthy animals which then develop disease, and reisolate the same infectious agent.


The difficulty in fulfilling the postulates was because HIV does not cause disease in animals other than humans and it is unethical to infect healthy persons with HIV just to satisfy Koch’s guidelines. However, the postulates were satisfied when the HIV virus was isolated from AIDS patients, cultured in vitro, and upon accidental inoculation into previously uninfected lab workers who subsequently developed AIDS, the exact laboratory HIV clone was reisolated from the patients. Using a causal model developed for chronic disease, HIV satisfies all of Sir Bradford Hill’s guidelines for assessing causality: numerous studies comparing infected and non-infected persons have shown that AIDS develops only in those infected with HIV (very strong association, consistency and specificity); follow-up cohorts have shown that the time relationship is that HIV infection always precedes AIDS (temporality); higher level of virus as measured by viral load correlates with and predicts severity of disease (biological gradient) ;treatment that suppresses virus leads to clinical improvement (experiment); there is an almost unique pathophysiological mechanism of how HIV leads to AIDS through the loss of CD4 lymphocytes (specificity and plausibility; and numerous studies on HIV-1,HIV-2, SIV, SHIV and other viruses satisfy the coherence and analogy guidelines.

The above data have been presented and debated over the last 25 years. Duesberg’s response has been to ignore or deny the data that does not support his position, and to cherry-pick statements from studies and present them out of context to suggest that the evidence for HIV causation is unconvincing. His early argument was that HIV had not satisfied Koch’s postulates for infectious disease causation, and he also indicated several aspects of the pathogenesis that were not understood then.



However, when lab workers accidentally inoculated themselves with the virus and satisfied the postulates, Duesberg refused to accept the data and now conveniently does not discuss the postulates. Similarly, early on, Duesberg agreed that hemophiliacs were the best group to test whether HIV causes AIDS because most of them did not have the drug use exposures that Duesberg considered causes, and both HIV-positive and HIV-negative hemophiliacs had received transfusions, hence ‘‘foreign-protein contaminants.’’

When Darby and colleagues published mortality data in the complete UK population of 6,278 hemophiliacs showing that those with HIV had 10 times the mortality of those without with 85% of the deaths attributable to HIV, journal editors who had hoped this was an honest debate asked whether Duesberg was going to concede defeat. He did not. He just moved the goal posts and suggested that AZT was the cause of AIDS; the approach that he had agreed to of using ‘‘hemophilia as the best test’’ was no longer relevant.



While the other points raised by Duesberg pertain to pathogenesis and not causation, most of the mechanisms are understood today. Thus, molecular techniques were developed and it became possible to isolate and quantify free virus in plasma; the dynamics between virus and CD4 cells and how this relates to disease progression were unraveled; highly effective medications that work by suppressing virus were developed and are now in widespread use; and opportunistic infections similar to those in the US were reported from Africa and Asia. Duesberg has moved on from those arguments.

One of his remaining arguments is that if there is no AIDS vaccine, which some predicted we would have soon after the discovery of HIV in 1984, then HIV does not cause AIDS. The same reasoning could of course be used to argue that Plasmodium falciparum does not cause malaria, as there is no malaria vaccine.

What therefore causes AIDS, in Duesberg’s opinion? His answers are inconsistent and contradictory. On the one hand, he seems to argue that AIDS (the syndrome) does not exist at all, labeling it ‘‘a fabricated epidemic,’’ since all opportunistic infections that define it already existed before AIDS. On the other hand, he also concedes that AIDS exists and offers causes, and seems unbothered by posing mutually exclusive arguments at the same time.



In his earlier writings, he accepted that there is statistical association between HIV and AIDS (although he argued this was insufficient for causation) and even considered the HIV-antibody test as useful surrogate to identify patients at risk of AIDS; today, he denies that and argues that HIV is a passenger virus with no relationship whatsoever to AIDS. In the same contradictory way, Duesberg has argued that HIV is not the cause of AIDS because ‘‘in most individuals suffering from AIDS, no virus particles can be found anywhere in the body’’; yet at about the same time that he published this, he was involved in a disagreement with other AIDS denialists who had challenged the very existence of HIV where he defended that ‘‘HIV has been isolated by the most rigorous method science has to offer.’’ Duesberg clings to the early argument that AIDS is caused by use of recreational drugs, but as explained above, this hypothesis was discarded when AIDS was seen in patients that had never used drugs including hemophiliacs, transfusion recipients, babies, and some African populations.


For hemophiliacs, he suggests that ‘‘foreign-protein contamination’’ through blood products is the cause, yet does not explain how AIDS from transfusion has virtually been eliminated just by incorporating the HIV test into blood screening. The strangest cause he proposes is that AIDS is caused by AZT and other antiretroviral drugs, even though AZT was only used after 1987 and used primarily on persons already with AIDS rather than healthy persons. To this, Duesberg replies that there was no AIDS in persons other than illicit drug users before 1987.In babies, he moves from arguing that there is no AIDS in babies and HIV cannot cause AIDS in babies (as it would otherwise kill itself together with its host), arguing that there is immunosuppression in babies but it is different and characterized by B cell deficiency, then that babies with AIDS are born to drug-addicted mothers.


Nevertheless, there are data showing that pediatric AIDS is real and has killed over 250,000 children per year since 1998, that it has the same immunological profile of CD4 deficiency as in adults, and that HIV-negative babies born to drug addicts do not get AIDS. What of Africa, the worst affected continent, which has comparatively much less recreational drug use and until this decade did not have ARVs in large supply? Duesberg suggests that the cause is ‘‘protein malnutrition, poor sanitation and subsequent parasitic infections.’’

However, AIDS has affected the well-off and over-nourished Africans, not just the undernourished, and this raises the question why the same explanation does not apply to other less-developed countries outside Africa that do not have as much AIDS, or earlier time periods when poverty and the attendant sanitation and nutritional problems were not any less in Africa (and other places). Moreover, AIDS is a particular type of immunosuppression with selective depletion of CD4 lymphocytes, and neither homosexuality, illicit drugs, ARVs, blood transfusions, malnutrition, nor living in Africa cause this.



In short, any explanation other than that HIV causes AIDS seems better to Duesberg—he therefore moves from the claim that AIDS does not exist to a multiplicity of causes even if it means creating a different cause for different geographies, different time periods, and different demographic groups, and without producing a shred of evidence. This is what is called denialism— ‘‘the rejection of objective reality to sustain a flawed,
hurtful, and ultimately dangerous belief system’’.

Are ARVs Effective in PMTCT and AIDS Treatment?


Estimating the human cost of not using ARVs in South Africa rests on the efficacy of ARVs when used for PMTCT and AIDS treatment. Mbeki entered the AIDS debate by questioning whether AZT was safe and useful for pregnant women, and Duesberg argues this position for all ARVs.

There are two observations to make from the way Duesberg argues the case. First, he discusses how and when AZT was first discovered and its mechanism of action inhibiting DNA synthesis, then cites some anecdotal cases, and concludes that all ARV drugs are toxic and not useful. Mechanisms of action are interesting to scientists but this is the wrong evidence to evaluate for efficacy. If one were to ask how best to treat hypertension, for example, the answer does not come from the interesting neurobiology of the hypothalamic blood pressure control centers, the crystal structure of angiotensin, or how Captopril was initially discovered.


The relevant standard of proof, the gold standard, is the clinical trial where the drug in question is compared to placebo (or alternative treatments) in a randomized controlled manner and a priori chosen outcomes analyzed]. This is why the US Food and Drug Administration requires clinical trial data before licensing any new drug. By choosing mechanisms of action, Duesberg is using inappropriate evidence, but purposefully so as to obfuscate the argument.



After deciding on the standard of proof—which is the clinical trial—the second step is to agree on how to assess the results from many such trials done in different countries and populations. Duesberg’s method is narration, where he ignores the data he dislikes, cherry-picks the statements he likes from different publications, and selectively interprets them to support his position, disregarding even the main conclusions of the studies.
Narrative reviews, while very common and perhaps relatively less demanding to perform, have the drawback that it may be unclear whether all the relevant evidence has been used or the reviewer selected studies that support a desired conclusion, and whether the apportionment of weight to studies was based on objective criteria such as sample size. The relevant standard here is a meta-analysis, that is, a systematic review with statistical synthesis of all relevant available data. When a meta-analysis is performed well, there is an a priori protocol specifying the question asked, the databases to be searched for publications, justifiable inclusion and exclusion criteria, the data to be extracted from studies, the quality assessment score to be used for each study, and models for statistical analysis.


For Duesberg to convince impartial readers that ARVs are useless or toxic when used for PMTCT and AIDS treatment, he has to produce a properly conducted meta-analysis (the objective standard for summarizing evidence) of clinical trials (the highest grade of evidence for assessing efficacy) where the drugs were used. Obviously, he cannot produce this because numerous clinical trials and meta-analyses have already been conducted and the evidence, as shown below, is unanimous in that the benefits of ARVs outweigh the side effects.

To quote an example from our work, we recently published ‘‘Efficacy of Antiretroviral Drugs in Reducing Mother-to-Child Transmission of HIV in Africa: A Meta-Analysis of Published Clinical Trials.’’ The question asked was how efficacious have ARVs been in PMTCT in Africa, first to generate an efficacy estimate directly relevant for policies on the continent that is worst affected by HIV/AIDS, and second, to pre-empt the debate on what is feasible in Africa (due to drug compliance, C-section rates, breastfeeding, late antenatal presentation, etc.) by considering only studies performed in Africa. The key result of this meta-analysis is that ARVs reduce mother-to-child transmission of HIV from 21% (combined placebo estimate) to 10.6% (combined ARVs estimate) at 4–6 weeks after birth. From all the studies that reported toxicity, ARV regimens for PMTCT are well tolerated by both the mothers and babies.

The quantity of this evidence is 10 clinical trials with a combined sample size of over 7,000 HIV-infected pregnant women, and over 800 transmission endpoints. The type of evidence is high grade, that is, randomized clinical trials rather than observational, cross-sectional, or case reports. The Jadad quality of the individual clinical trials is high.
The efficacy of using ARVs versus placebo is 50%. Using the US Institute of Medicine categories of certainty in assessing evidence, the evidence establishes that ARVs are efficacious in reducing MTCT in Africa, and the evidence favors rejection of the hypothesis that ARVs, in the doses used, are toxic to the mothers or babies. Example diagrams are shown in the published paper [click here]



Contrary to what Duesberg suggests, there are unanimous data (all trials conducted in Africa published by December 2006) to demonstrate the usefulness of ARVs in PMTCT in Africa, and other groups have arrived at the same conclusions for ARV use in PMTCT generally.

Likewise, extensive clinical trials data demonstrate the efficacy of ARV drug combinations in treating AIDS. The results from use of drugs in combination were so dramatic that the term ‘‘HAART,’’ for Highly Active Anti-Retroviral Therapy, was coined. Many systematic reviews have been conducted and updated by the Cochrane Collaboration and other groups, and the data are unanimous regarding efficacy. In addition, data are now available from the use of ARVs at the program level in African countries and these support the efficacy observed in clinical trials. Several studies have systematically reviewed the data just for developing countries and Africa, and others compared low and high-income countries.


In short, if Duesberg wishes to demonstrate that certain ARVs are no better or worse than placebo or other treatments, he has to conduct a meta-analysis that considers all available evidence, rather than his approach of discussing the molecular biology of DNA chain termination and somehow inferring that ARVs are not beneficial.




Moreover, for Duesberg to totally discredit the paper on the human cost of not using ARVs, he has to argue that all ARVs are totally ineffective when used for AIDS treatment and PMTCT because if some ARVs are even marginally effective, then it means that some South Africans could have benefited, however, small the benefit, had Mbeki not obstructed drug use.



Population Growth and AIDS Deaths



The third of Duesberg and colleagues’ arguments is that there is no evidence of large-scale deaths in South Africa, and therefore whatever policies Mbeki implemented, they did not lead to deaths. To support this, they present two arguments: one, that the population of South Africa increased over the last 30 years, and two, the statistics of reported AIDS deaths in South Africa. Regarding the first argument, it is true that the population of South Africa increased over the last 30 years. The population in a country is determined by the balance between the number of live births, the total number of deaths, and net migration. Without doing an analysis of the above determinants, it not possible to use such aggregate population trend data to infer that the number of AIDS deaths was small. If this reasoning is sound, then it should be applicable to other countries and diseases as well. Is it logical to infer that AIDS deaths are few in any country that has increased its population over the last three decades?


Similarly, is it logical to infer that there has been no increase in the number of persons dying of cardiovascular diseases and cancer or that the absolute numbers of death from these diseases are small in the US, whose population has increased over the last half century?



This argument does not support Duesberg’s assertions at all. The second part of the argument quotes Statistics South Africa, which recorded an average of 12,000 deaths per year in South Africa between 1997 and 2006. The shortfall is that these data are ‘‘Findings from Death Notification.’’ First, as explained by surveillance experts, ‘‘In resource-poor countries with underdeveloped health infrastructures, reports of AIDS or HIV cases are usually not complete enough to be considered reliable measures of the scope of the epidemic’’. This simply means that the death notification system in South Africa had/has much underreporting. Indeed, the ‘‘former so called independent homelands of Transkei, Boputhatswana, Venda and Ciskei (TBVC) were not included in the reporting system until 1994’’ when the reporting system began centralization, and a new death certificate was introduced in 1998 to improve reporting. 


The second shortfall is that of misclassification of deaths. AIDS patients die of the resulting opportunistic infections and cancers, and these immediate causes of death are often recorded without noting the underlying acquired immunodeficiency. According to the Medical Research Council (SA), up to 61% of HIV deaths are misclassified and the majority of them are recorded as tuberculosis and lower respiratory tract infections, which become the leading causes of death. It is apparent that Duesberg selected highly deficient statistics. [This section continues. Click here to download the entire article]


Implications
There are several implications to draw from this work. First is the translation of denialism into public health practice. One of Duesberg’s first papers questioning whether HIV causes AIDS was published in the prestigious journal Science in 1988. Some researchers initially took this as a genuine scientific debate but as Koch’s postulates were fulfilled, randomized controlled trials demonstrated the high efficacy of ARV, there was much success in PMTCT, and studies elucidated the dynamics between virus and CD4 cells, Duesberg maintained his arguments and it became clearer that he was not just a dissident scientist but a denialist. When Mbeki took up the denialists’ position in 2000, there was international outcry.




Not only was he lending his ear to discredited scientists, but AIDS denialism was crossing into national health policy through a head of government. Participants at the 2000 International AIDS Conference in Durban (SA), news outlets, scientific journals, and the public were outraged and some went as far as saying that South Africa was tripping into anarchy, descending into an abyss. South Africa did descend into that abyss. Mbeki withdrew support from clinics that had started using ARVs, restricted use of donated ARVs, obstructed Global Fund grants, and generally delayed implementing a national ARV program. Two independent studies have estimated that Mbeki’s policies led to at least 330,000 premature deaths. When AIDS denialism infiltrates public health practice, the consequences are tragic.


The second implication follows directly from the first and concerns accountability. Mbeki implemented negligent policies that led to the premature death of hundreds of thousands. His reasons, as stated by himself and health minister Tshabalala-Msimang, were that he questioned whether HIV causes AIDS and whether ARVs are safe, and neither ever publicly backed down from this thinking. The science behind Mbeki was Duesberg and other denialists.


Duesberg is still arguing for AIDS denialism and defending Mbeki and the policies that led to more than 330,000 deaths. By any reasonable standard, this requires some form of accountability.


Seth Kalichman has likened the AIDS denialists to the Holocaust deniers and Edwin Cameron likened letting AIDS patients die without medications to those who silently enabled the evils of Nazi Germany and apartheid South Africa to go unchecked.


John Moore and Nathan Geffen have called for AIDS denialists to be put on trial and Mark Wainberg has argued that denialists should be charged with public endangerment and ‘‘people like Peter Duesberg belong in jail.’’


Zachie Achmat has called for a commission of enquiry such as the Truth and Reconciliation Commission that was tasked with handling the apartheid era crimes. For how are South Africans ever going to trust their health system again?


How can a modern government be penetrated by denialists to the extent of implementing policies that kill hundreds of thousands?


William Makgoba suggested that impeding AIDS treatment was collaborating in committing genocide, and
Wycliffe Muga has asked whether Mbeki’s killing of 330,000 by obstructing life-saving medications is much different from Sudan’s President al Bashir’s killing a similar number in Darfur through obstructing humanitarian aid and militias. Is this not a crime against humanity?


Does the International Criminal Court not have a role, for it was established to handle those cases where national courts may be unable or unwilling to prosecute? 


Whatever the most appropriate avenue is, what seems apparent is the need for accountability.


The third implication somewhat generalizes the argument. AIDS denialists are dangerous to the general population; many have been persuaded into risky behaviors, ineffective alternative remedies, and other harmful actions, although there is no easy way of evaluating how many. Similarly, denialists can impact public or national health policy and South Africa is one extremely tragic case.


However, denialists seem ineffective against physicians as a group. The reason is that if an AIDS patient goes to a physician, and the physician decides not to treat, the physician is held for malpractice. The medical profession is practiced only by those who have earned defined credentials. The standards of practice are generally known and deviant practitioners are disciplined by the medical societies and deregistered by states.
Moreover, the law of torts offers patients a private right of redress against negligent doctors. The above seem absent in public and global health. The practitioners are ill defined and there are no laws restricting practice to persons with specified credentials. The concept of standards of practice is not well developed, and there are no bodies tasked with self-regulation and discipline.


The concept of public health malpractice has not yet been developed. Thus, at a general level, AIDS denialism in South Africa has also exposed the deficiencies of public health practice—it is open to unqualified practitioners, negligent policies go unchecked, and the consequences are tragic. How to rectify this is beyond the scope of this paper; here it suffices to point out the deficiencies of public health in terms of standards, practitioners, and accountability, as exposed by the South Africa example.


Last, Duesberg was able to publish his paper (which was later withdrawn) only because it was not reviewed by peers knowledgeable on the subject. Denialist writings require close scrutiny and peer review before being published in scientific journals, especially when they have the potential to impact public health practice.
When AIDS denialism enters public health practice, the consequences are tragic. The implications start in honest science but extend to the need for accountability and, perhaps, public health reform.


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