AIDSTruth.org

Declines in Mortality Rates and Changes in Causes of Death in HIV-1-Infected Children During the HAART Era

Eduard Grebe — Tue, 29 Dec 2009 13:11:02 +0000

J Acquir Immune Defic Syndr. 2010 Jan;53(1):86-94.

Brady MT, Oleske JM, Williams PL, Elgie C, Mofenson LM, Dankner WM, Van Dyke RB; for the Pediatric AIDS Clinical Trials Group219/219C Team.

CONTEXT: Introduction of highly active antiretroviral therapy has significantly decreased mortality in HIV-1-infected adults and children. Although an increase in non-HIV-related mortality has been noted in adults, data in children are limited.

OBJECTIVES:: To evaluate changes in causes and risk factors for death among HIV-1-infected children in Pediatric AIDS Clinical Trials Group 219/219C.

DESIGN, SETTING, AND PARTICIPANTS:: Multicenter, prospective cohort study designed to evaluate long-term outcomes in HIV-1-exposed and infected US children. There were 3553 HIV-1-infected children enrolled and followed up between April 1993 and December 2006, with primary cause of mortality identified in the 298 observed deaths.

MAIN OUTCOME MEASURES:: Mortality rates per 100 child-years overall and by demographic factors; survival estimates by birth cohort; and hazard ratios for mortality by various demographic, health, and antiretroviral treatment factors were determined.

RESULTS:: Among 3553 HIV-1-infected children followed up for a median of 5.3 years, 298 deaths occurred. Death rates significantly decreased between 1994 and 2000, from 7.2 to 0.8 per 100 person-years, and remained relatively stable through 2006. After adjustment for other covariates, increased risk of death was identified for those with low CD4 and AIDS-defining illness at entry. Decreased risks of mortality were identified for later birth cohorts, and for time-dependent initiation of highly active antiretroviral therapy (hazard ratio 0.54, P < 0.001). The most common causes of death were "End-stage AIDS" (N = 48, 16%) and pneumonia (N = 41, 14%). The proportion of deaths due to opportunistic infections (OIs) declined from 37% in 1994-1996 to 24% after 2000. All OI mortality declined during the study period. However, a greater decline was noted for deaths due to Mycobacterium avium complex and cryptosporidium. Deaths from "End-stage AIDS," sepsis and renal failure increased.

CONCLUSIONS:: Overall death rates declined from 1993 to 2000 but have since stabilized at rates about 30 times higher than for the general US pediatric population. Deaths due to OIs have declined, but non-AIDS-defining infections and multiorgan failure remain major causes of mortality in HIV-1-infected children.

PMID: 20035164.

Read at JAIDS.

Science: HIV Natural Resistance Field Finally Overcomes Resistance

Eduard Grebe — Tue, 29 Dec 2009 12:58:18 +0000

Science 11 December 2009: Vol. 326. no. 5959, pp. 1476 - 1477

Dozens of studies have been examining people who fend off HIV despite repeated exposures in an effort to find genetic or immunologic factors that can help guide AIDS vaccine research. But all too often the leads point in contradictory directions, in part because investigators use different assays to probe their samples, and there is little coordination among them. Many labs also use wildly varying criteria to decide who qualifies as HIV-resistant, making it difficult to sort out which study subjects were truly exposed and uninfected, were exposed and have an occult infection, or were never exposed in the first place. At the first-ever meeting on natural immunity to HIV, held from 15 to 17 November, researchers attempted to hammer out these and other issues.

Read the article at Science.

doi: 10.1126/science.326.5959.1476

The effect of combined antiretroviral therapy on the overall mortality of HIV-infected individuals

Eduard Grebe — Sun, 20 Dec 2009 19:30:32 +0000

AIDS. 2010 Jan 2;24(1):123-37.

HIV-CAUSAL Collaboration.

OBJECTIVE: To estimate the effect of combined antiretroviral therapy (cART) on mortality among HIV-infected individuals after appropriate adjustment for time-varying confounding by indication. DESIGN: A collaboration of 12 prospective cohort studies from Europe and the United States (the HIV-CAUSAL Collaboration) that includes 62 760 HIV-infected, therapy-naive individuals followed for an average of 3.3 years. Inverse probability weighting of marginal structural models was used to adjust for measured confounding by indication. RESULTS: Two thousand and thirty-nine individuals died during the follow-up. The mortality hazard ratio was 0.48 (95% confidence interval 0.41-0.57) for cART initiation versus no initiation. In analyses stratified by CD4 cell count at baseline, the corresponding hazard ratios were 0.29 (0.22-0.37) for less than 100 cells/microl, 0.33 (0.25-0.44) for 100 to less than 200 cells/microl, 0.38 (0.28-0.52) for 200 to less than 350 cells/microl, 0.55 (0.41-0.74) for 350 to less than 500 cells/microl, and 0.77 (0.58-1.01) for 500 cells/microl or more. The estimated hazard ratio varied with years since initiation of cART from 0.57 (0.49-0.67) for less than 1 year since initiation to 0.21 (0.14-0.31) for 5 years or more (P value for trend <0.001). CONCLUSION: We estimated that cART halved the average mortality rate in HIV-infected individuals. The mortality reduction was greater in those with worse prognosis at the start of follow-up.

PMID: 19770621

Survival of Children with HIV in the United States Has Improved Dramatically Since 1990s, New Analysis Shows

Eduard Grebe — Sun, 20 Dec 2009 18:31:08 +0000

Mortality Rate Still Higher Than for Children without HIV

The death rates of children with HIV have decreased ninefold since doctors started prescribing cocktails of antiretroviral drugs in the mid-1990s, concludes a large-scale study of the long-term outcomes of children and adolescents with HIV in the United States. In spite of this improvement, however, young people with HIV continue to die at 30 times the rate of youth of similar age who do not have HIV, found researchers from the National Institutes of Health and other institutions.

Earlier studies have shown that adults with HIV are living longer because of improved multi-drug antiretroviral regimens known as highly active antiretroviral therapy (HAART). However, limited information has existed about the effectiveness of HAART in improving the survival of children with HIV. The current analysis, published in the Dec. 15 issue of the Journal of Acquired Immune Deficiency Syndromes, delineates the effects of HAART on the rates and causes of death for HIV-infected children and adolescents.

Conducted by the Pediatric AIDS Clinical Trials Group, the study was co-funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Allergy and Infectious Diseases (NIAID), both part of NIH. The study’s first author is Michael T. Brady, M.D., of Nationwide Children’s Hospital in Columbus, Ohio.

In 1994, the mortality rate for HIV-infected children and youth younger than 21 years of age in the United States was 7.2 deaths per 100 person years (a rate based on the number of children in the study and the total number of years each child was followed). By 2000, that rate had plummeted to 0.8 deaths per 100 person years and remained stable through 2006. The mean age at death for HIV-infected youth in the study more than doubled from 8.9 years in 1994 to 18.2 years in 2006.

Although this represents a dramatic improvement in survival, the death rate for children with HIV is approximately 30 times higher than that of similarly aged U.S. children who do not have HIV. Multi-organ failure and kidney disease are now major causes of death for HIV-infected children and adolescents. Infections also continue to cause deaths in this group of patients. However, the type of infections has changed, from infections traditionally associated with AIDS to infections that are more common in children without HIV infection.

"The findings are very encouraging, but they still show a need for improvement," said Alan Guttmacher, M.D., acting director of NICHD. "For both adults and children, combination antiretroviral therapy is highly effective in preventing the opportunistic infections and other complications resulting from HIV infection. We must now better understand and pursue treatments for children and adolescents to address the other conditions resulting from HIV infection."

"Basic research and clinical studies funded by NIH beginning in the 1980s laid the foundation for the development of the more than two dozen drugs now available to fight HIV, enabling many children infected with the virus to live into adulthood,"said NIAID Director Anthony S. Fauci, M.D. "Now we face the challenge of effectively treating the consequences of long-term HIV infection in people who have been infected since childhood."

Between 1993 and 2006, the researchers tracked 3,553 U.S. children and adolescents infected with HIV. Of those children, 298 died. Growing numbers of children with HIV began receiving HAART between 1994 and 2000, and death rates declined annually during that period. Nearly 60 percent of all deaths in the study occurred before 1997, before the advent of HAART for the treatment of children; moreover, children who died were almost four times as likely to have never received HAART as those who survived.

"A wonderful change has occurred: Most HIV-infected children now reach adulthood," said Lynne Mofenson, M.D., an author of the paper and chief of the Pediatric, Adolescent and Maternal AIDS branch at NICHD. "Will these children have a normal lifespan? Unfortunately, we don’t have all the answers yet. Currently, we don’t have the means to prevent all the complications of HIV infection."

In the early years of the study, secondary infections killed more than one-third of the children who died, but from 2002 to 2006, that proportion fell to less than one-fourth. Over time, children and adolescents with HIV became more likely to die of kidney failure, stroke, or AIDS-induced multiple organ failure.

To try to prevent these deaths, another long-term study of children with HIV called the Pediatric HIV/AIDS Cohort Study is being funded by NICHD, NIAID, the National Institute on Drug Abuse, the National Institute on Deafness and Other Communication Disorders, the National Heart, Lung, and Blood Institute, and the National Institute of Mental Health. This study is monitoring how children and adolescents with the virus grow and develop, what complications they experience, and whether they experience side effects from their medication.

"To keep these children healthy, we need to learn more about how HIV and anti-HIV drugs affect their growing bodies," said Dr. Mofenson. "We took a big leap in our understanding with this study, and the next pediatric cohort study will lead to even more improvements in understanding HIV infection and its treatment in youth."

In addition to Drs. Brady and Mofenson, the other authors of the article are James M. Oleske, M.D., M.P.H., of the University of Medicine and Dentistry of New Jersey; Paige L. Williams, Ph.D., of the Harvard School of Public Health; Carol Elgie of Frontier Science Technology and Research Foundation; Wayne M. Dankner, M.D., of Parexel International and Duke University Medical Center, and Russell B. Van Dyke, M.D., of Tulane University.

The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s Web site at http://www.nichd.nih.gov/.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Six-month gain in weight, height, and CD4 predict subsequent antiretroviral treatment responses in HIV-infected South African children

Eduard Grebe — Sun, 20 Dec 2009 16:00:00 +0000

AIDS. 2010 Jan 2;24(1):139-46.

Yotebieng M, Van Rie A, Moultrie H, Meyers T.

OBJECTIVES: Construct percentile curves for 6-month gain in weight, height, CD4 cell count, and CD4 percentage (CD4%) in children initiating ART, and to assess the association between lower percentiles and subsequent ART responses. DESIGN: Cohort of 1394 HIV-infected children initiating ART between April 2004 and March 2008, Johannesburg, South Africa METHODS: The generalized additive model for location, scale, and shape was used to construct percentile curves for 6-month gain in weight, height, CD4 cell count, and CD4%. Cox proportional models were used to assess the association between lower percentiles of each distribution and death, virological suppression, and treatment failure between 6 to 36 months post-ART initiation. RESULTS: Lower percentiles for gain in weight, CD4, and CD4% count after 6 months of ART, but not height, were associated with poor subsequent treatment outcomes independent of baseline characteristics, with increasing strength of association as percentiles decreased. Age-specific 6-month post-ART weight gain in our cohort was substantially higher compared with 6-month weight gain in non-HIV-infected American children of the Fels Institute cohort and the attained weight-for-age at 6 months post-ART plotted on WHO weight-for-age growth charts were not associated with subsequent treatment outcomes. CONCLUSION: Gain in CD4% in the first 6 months of ART was the best predictor of poor subsequent ART outcomes. In areas with limited access to CD4%, weight gain post-ART using our newly developed reference distributions for HIV-infected children on ART is a good alternative to CD4%, and clearly superior to the commonly used 'Road-to-Health' weight-for-age charts.

PMID: 19940744

Another myth debunked: HIV is a harmless passenger virus

Eduard Grebe — Thu, 17 Dec 2009 16:17:18 +0000

Fact: Studies in vitro, ex vivo and in vivo all support HIV's ability to deplete CD4+ T-cells.

There are some denialists that argue that HIV does exist but that it is merely a harmless passenger virus and that no evidence exists to claim otherwise. In fact, there are thousands of studies that support the cytopathic properties of HIV. While some aspects of how HIV destroys cells that are not fully understood, that it does so it beyond doubt. This is not unique to HIV, of course, as the effects of many diseases are known despite the mechanisms not being completely elucidated. Some of what is known (and supporting evidence will be cited) is the documented here. Since there are literally thousands upon thousands of papers on HIV, a representative few are cited here. This is by no means an exhaustive list.

Evidence shows us that AIDS the CD4+ T-cell depletion is due to HIV. This can be observed 1) in vitro (in cell cultures), 2) ex vivo (in tissues removed from animal models or patients), and 3) in vivo both in animal models and in infected individuals.

Read the full debunking here.

View the list of myths we debunk here.

Conspiracy beliefs about HIV associated with lower adherence.

Eduard Grebe — Thu, 10 Dec 2009 19:03:22 +0000

A new study has found poorer adherence to antiretroviral therapy among African-American men with HIV who hold conspiracy beliefs, e.g. that HIV is a man-made virus designed to kill Africans.

JAIDS. 2009 Dec 09.

Conspiracy Beliefs About HIV Are Related to Antiretroviral Treatment Nonadherence Among African American Men With HIV

Bogart, Laura M PhD; Wagner, Glenn PhD; Galvan, Frank H PhD; Banks, Denedria MSW

Background: Medical mistrust is prevalent among African Americans and may influence health care behaviors such as treatment adherence. We examined whether a specific form of medical mistrust-HIV conspiracy beliefs (eg, HIV is genocide against African Americans)-was associated with antiretroviral treatment nonadherence among African American men with HIV.

Methods: On baseline surveys, 214 African American men with HIV reported their agreement with 9 conspiracy beliefs, sociodemographic characteristics, depression symptoms, substance use, disease characteristics, medical mistrust, and health care barriers. Antiretroviral medication adherence was monitored electronically for one month postbaseline among 177 men in the baseline sample.

Results: Confirmatory factor analysis revealed 2 distinct conspiracy belief subscales: genocidal beliefs (eg, HIV is manmade) and treatment-related beliefs (eg, people who take antiretroviral treatments are human guinea pigs for the government). Both subscales were related to nonadherence in bivariate tests. In a multivariate logistic regression, only treatment-related conspiracies were associated with a lower likelihood of optimal adherence at one-month follow-up (odds ratio = 0.60, 95% confidence interval = 0.37 to 0.96, P < 0.05).

Conclusions: HIV conspiracy beliefs, especially those related to treatment mistrust, can contribute to health disparities by discouraging appropriate treatment behavior. Adherence-promoting interventions targeting African Americans should openly address such beliefs.

doi: 10.1097/QAI.0b013e3181c57dbc

PMID: 19952767

ART halves overall mortality of HIV-infected individuals

Eduard Grebe — Tue, 08 Dec 2009 15:06:54 +0000

AIDS. 2010 Jan 2;24(1):123-37.

The effect of combined antiretroviral therapy on the overall mortality of HIV-infected individuals

The HIV-CAUSAL Collaboration

Abstract

Objective: To estimate the effect of combined antiretroviral therapy (cART) on mortality among HIV-infected individuals after appropriate adjustment for time-varying confounding by indication.

Design: A collaboration of 12 prospective cohort studies from Europe and the United States (the HIV-CAUSAL Collaboration) that includes 62 760 HIV-infected, therapy-naive individuals followed for an average of 3.3 years. Inverse probability weighting of marginal structural models was used to adjust for measured confounding by indication.

Results: Two thousand and thirty-nine individuals died during the follow-up. The mortality hazard ratio was 0.48 (95% confidence interval 0.41-0.57) for cART initiation versus no initiation. In analyses stratified by CD4 cell count at baseline, the corresponding hazard ratios were 0.29 (0.22-0.37) for less than 100 cells/μl, 0.33 (0.25-0.44) for 100 to less than 200 cells/μl, 0.38 (0.28-0.52) for 200 to less than 350 cells/μl, 0.55 (0.41-0.74) for 350 to less than 500 cells/μl, and 0.77 (0.58-1.01) for 500 cells/μl or more. The estimated hazard ratio varied with years since initiation of cART from 0.57 (0.49-0.67) for less than 1 year since initiation to 0.21 (0.14-0.31) for 5 years or more (P value for trend <0.001).

Conclusion: We estimated that cART halved the average mortality rate in HIV-infected individuals. The mortality reduction was greater in those with worse prognosis at the start of follow-up.

doi: 10.1097/QAD.0b013e3283324283

PMID: 19770621

Still Crazy After All These Years: The Challenge of AIDS Denialism for Science

Eduard Grebe — Mon, 07 Dec 2009 18:09:17 +0000

AIDSTruth contributor Nicoli Nattrass writes 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?”[1, p. 1] 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 [2, p. 25]. Peter Duesberg, by contrast, refused to accept the evidence, thereby earning the label ‘denialist’ rather than ‘dissident’ [1, 2].

Duesberg may be pathologically contrarian in this respect, but he has an enduring appeal. Kalichman [1] 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 ‘Duesberg-as-oppressed-hero-scientist’ stories from independent film-makers 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’ [3, p. 142].

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 [see e.g. 4–8]. 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’ [in 6, p. 1644] and John Moore [9], 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’ [in 10, p. 131). 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.

Read the full article on SpringerLink.

doi:10.1007/s10461-009-9641-z

The Lancet: a new South Africa takes responsibility

Eduard Grebe — Mon, 07 Dec 2009 14:56:40 +0000

The Lancet has hailed the new approach evident in South Africa in which the government has decisively turned away from the AIDS denialism associated with former President Thabo Mbeki.

The Lancet, Volume 374, Issue 9705, Page 1867, 5 December 2009

HIV/AIDS: a new South Africa takes responsibility

On Dec 1 the usual activities surrounding World AIDS Day will take on a special significance for South Africans. In a high-profile event in Pretoria, the South African National AIDS Council (SANAC) is bringing together people who work in HIV/AIDS, those who have been affected by HIV, and government officials, including President Jacob Zuma, Deputy President and SANAC Chair Kgalema Motlanthe, and the Minister of Health Aaron Motsoaledi. Zuma will give a televised address on HIV/AIDS to the nation. Under the motto “I am responsible, we are responsible, South Africa is taking responsibility”, a new era in the country's response to HIV/AIDS is being publicly heralded. In a key-messages booklet, SANAC calls on everyone to know their HIV status by frequent testing; on communities to stop stigma and discrimination against people living with HIV; and on itself to ensure that the government is taking responsibility for people to receive counselling, provide condoms, and give access to treatment for tuberculosis and HIV.

Already on Oct 29, in what has been widely praised as a landmark speech, Zuma left no doubt about the decisive departure from the previous government's stance of denialism and indifference: “South Africa must work harder to implement the national strategy to tackle HIV/AIDS…all South Africans need to know their HIV status and be informed of the treatment options available to them…there should be no shame, no discriminations, and no recriminations”. The non-governmental organisation Treatment Action Campaign called Zuma's speech, which came almost 10 years after Thabo Mbeki made his HIV/AIDS denial clear before the same National Council of Provinces, as “one of the most important speeches in the history of AIDS in South Africa”.

This extremely welcome and long-awaited change in attitude, and its appropriate urgency, is accompanied by a burst of behind-the-scene activities at the Department of Health and SANAC. In a press conference last month, Motsoaledi explained that there are moves ahead to integrate health facilities for tuberculosis and HIV/AIDS, that antiretroviral treatment (ART) guidelines are being revised to initiate treatment for those with a CD4-cell count below 350 cells per μL, and that there are plans for comprehensive integrated antenatal care, which include prevention of mother-to-child transmission—all actions that were called for in The Lancet's recent South Africa Series. The revised ART treatment discussions even came ahead of new WHO recommendations, published on Nov 30. South Africa's National Strategic Plan for HIV/AIDS and sexually transmitted diseases aims to reduce the rate of infections by 50% and cover 80% of the people who need ART by 2011. In October, Cabinet committed to accelerate the response to meet these targets by 2011.

Additionally, Motsoaledi and others in his department are busy identifying and rectifying managerial and attitudinal deficiencies in district-level health-care facilities and have created an expert group to advance the National Health Insurance agenda.

This integrated multilevel approach to tackle the long-neglected burden of HIV/AIDS—based on, and emboldened by, scientific assessment—is a refreshing and brave shake up by a politician. It raises hope and excitement, especially among scientists, academics, and clinicians, who have been ignored and alienated for far too long. However, the task is enormous. South Africa remains the country with the largest HIV-positive population, 5·7 million, according to 2008 UNAIDS figures. Average antenatal prevalence is 29·3% but four districts record a prevalence above 40%, and 79% of maternal deaths tested for HIV were HIV-positive. What is needed to make these ambitious plans a reality is adequate resources, both financial and human, and buy-in by all involved. The South African World AIDS Day motto rightly asks for everyone to take responsibility and play his or her part.

When we asked for serious discussions and decisive actions in a Comment accompanying the launch of The Lancet Series, we could not have hoped for a swifter indication of serious engagement. And although the ultimate test will be in the actual delivery of preventive efforts and treatment for all, and evidence of an effect on new infections and mortality, a first very important and encouraging step towards these goals has been made. South Africa has shown how science and policy working together make the best advocates for change—change for a healthier future.

Article reproduced by permission of Elsevier.

doi:10.1016/S0140-6736(09)62065-1

In Memoriam, Lambros Papantoniou

Eduard Grebe — Wed, 02 Dec 2009 16:38:17 +0000

by George N. Pavlakis, Rockville, MD USA

What do you do about someone who claims to be an expert, serving up half-truths, twisting the facts in credible-sounding sentences and misleading a patient? There must be some rules that apply to someone who professes to be an expert and induces patients to stop their doctor-prescribed medication. These must be applied to prevent harm to more patients. And what if these actions lead to the patient’s death?

Such is the case of Lambros Papantoniou, a journalist living in Washington, a diplomatic correspondent for several Greek media institutions for more than 30 years and a man loved by all who met him. Even in the higher political echelons of Washington, he was affectionately known as “Mr Lambros”.

During a hospital stay approximately ten years ago, Lambros was diagnosed with AIDS and given anti-retroviral therapy. Following this, his interest in the AIDS problem skyrocketed, and he sought information on it. Although he was a diplomatic correspondent, he reported on AIDS issues several times.

Unfortunately, Lambros attracted the attention of Andrew Maniotis, a scientist and self-proclaimed expert on many fields, and AIDS denialist. Dr. Maniotis is not a medical doctor, nor a pathologist, as he occasionally describes himself. He is not a tenured professor, nor a tenure-track candidate for a higher academic career. At times he denies he is an “AIDS denialist,” but this term accurately describes public opinions. He does not shy away from controversy and publicizes naïve opinions that contradict the established knowledge and medical science, trying to nullify the medical gains of generations of researchers and doctors.

Maniotis claims that Lambros was like a brother to him. With such brothers, who needs enemies? The two men became friends, and Maniotis visited Lambros often in the last few years, his influence growing stronger and stronger, ultimately convincing him that HIV did not exist. Lambros stopped taking his medication and the result was devastating. After his death, Lambros’s family and friends found his medication in his refrigerator, untouched since 2007. Instead of his life-saving doctor prescribed medicine, Lambros was convinced to consume Maniotis-promoted vitamins.

During 2007, increasingly influenced by Maniotis, Lambros became more aggressive in interrogating scientists and government officials about AIDS. In his attempts to discredit Dr. Robert Gallo, Maniotis urged Lambros to seek an interview with Gallo, hoping to confront him with an AIDS denialist agenda and publish articles containing slander and misinformation.

Dr. Gallo took the bait and spoke with Lambros openly and frankly. To his credit, Lambros published a series of articles in which he reported on the issue ethically and to the best of his ability. Undaunted by this failure, Maniotis intensified his efforts to convince Lambros of his outlandish ideas on AIDS. Lambros was finally convinced and published an extensive interview, in which Maniotis disputes all scientific facts about HIV and AIDS, advising HIV positive people, like Lambros himself, to stop taking their doctor-prescribed medication and to rely on vitamins and other unproven methods.

Unfortunately, Lambros’ non-scientific background and his personal vulnerability as an HIV positive person got the best of him, and he became more and more a spokesperson of the AIDS denialists, putting his complete trust in Maniotis.

This trust eventually cost him his life. He simply stopped taking his medication. Already hospitalized once, Lambros’s health depended on blocking HIV through anti-retroviral drugs. Without this protection, the virus continues to damage the immune system, until the patient becomes vulnerable to a multitude of common infectious agents, which would ordinarily be blocked by a functioning immune system. With the medication, he likely would have lived a longer and healthier life.

Having finally succumbed to Maniotis’ 'freindship', at several White House and State Department briefings in Washington, Lambros asked hostile nonsensical questions repeating the statements of Maniotis verbatim. He asked whether anyone had actually seen the virus. He accused the medical profession of poisoning the “so-called AIDS” patients with drugs.

In retrospect, Lambros’ increasingly erratic behavior can be partially explained by his deteriorating health. HIV ultimately landed him at Howard University Hospital under unclear circumstances. The most likely scenario is that he was found confused and disoriented and was taken to the closest emergency room. He had developed encephalitis, a common outcome of end-stage HIV infection. He was later transferred to Georgetown Hospital, where he died of encephalitis. During his more lucid moments at the hospital, Lambros told his friends he was dying of AIDS.

In the meantime, Maniotis, having the trust of Lambros’s family, was calling both hospitals and arguing about prescribed treatments, accusing medical personnel of trying to kill Lambros, all while denying the existence of AIDS. The doctors found the situation highly distracting and asked that Maniotis does not contact them. The Greek Embassy had to intervene and tell Maniotis to back off.

During this last period of his life, Lambros was clearly very sick and confused, making several statements reflecting this confusion. To their shame, AIDS denialists are promoting these statements on the Internet in order to build up their own agenda, disrespecting the memory of a sick and confused man, and, of course, not acknowledging their part in his death.

"Nobody really knows why he's gone," claims Maniotis. But in the end, Lambros knew, and so do we. He died of encephalitis following the collapse of his immune system, an outcome of HIV infection. We know from millions of other cases that, had he taken his anti-retroviral medicine and prevented further damage by HIV, he could have had many more productive years.

Some of us who knew him also feel a bit guilty at times about not being able to protect him more from predators like Maniotis.

Consequently, we feel that along with celebrating his contributions, his achievements, his life of giving, of helping many people in his community, we also need to tell his true story. Lambros was a defender of our democratic ideals, a stalwart defender of the truth, a man who gave freely of himself, his time and the limited money he had, helping countless people in his neighborhood in Washington, in cities throughout the U.S. and in Greece. He is missed even by those he criticized.

We must honor him by not allowing his death to be used to hurt others. We must not be silent, as silence did not become Lambros himself.

As a generation of AIDS activists realized some time ago, Silence = Death.

Rian Malan still getting AIDS stats wrong

Eduard Grebe — Tue, 01 Dec 2009 13:09:43 +0000

by Nathan Geffen, 1 December 2009

Substantially updated by the author on 7 December 2009

In a piece published in Rapport newspaper and on politicsweb, Rian Malan claims:

[D]on't trust anything the Aids bwanas say - especially not Nathan Geffen of TAC. Earlier this week, he informed the world that Zuma's mistake "was of little consequence," because other data showed that SA's death rate has doubled since l997. Hmmm. It is true that annual death registrations rose from 316,000 in 1997 to around 600,000 in 2007, but it is absurd to claim, as Geffen did, that this was almost entirely the result of Aids.

Over the same period, completeness of registration rose from around 67 percent to 81 percent, according to Stats SA, while our population rose by close on seven million. If you adjust the raw numbers accordingly, Geffen's apparent doubling shrinks to an increase of around 15 to 20 percent.

He then published a correction:

Correction: I am informed that my mathematical skills leave much to be desired. If you run the numbers in the penultimate paragraph correctly, the real increase in SA death registrations since l997 comes out at around 30 percent - still a tragedy by any reckoning, but still way short of the doubling claimed by Geffen.

First let's deal with the numbers. Malan continues to get it wrong, even in his correction. AIDS deaths have conservatively increased 6-fold since 1997, from approximately 50,000 to well over 300,000 in 2006 as well as 2007 and maybe even over 350,000, meaning the real increase in deaths -which is way more than 30%- recorded or otherwise, was mainly due to AIDS. The ASSA2003 interventions model calculates under 150,000 AIDS deaths in 2000 and about 360,000 in 2007. Approximately 45% of deaths in 2006 and 2007 were due to AIDS. The model probably overestimates AIDS deaths but not substantially enough to give any material support to Malan's argument. But even a 30% increase in mortality, as Malan acknowledges, is a tragedy.

Far more knowledgeable people than either Malan or myself work on the ASSA model. They take into account all the available data: recorded deaths, improved registration, population growth and much else. Of course, as with any model, there is a good deal of uncertainty, but it is the best we have to go on - and far better than Malan, who admits his mathematical skills leave much to be desired.

In Malan's Rolling Stone article in 2001, his arguments were based on outright AIDS denialism, in which he confused the different types of testing algorithms needed for diagnosis of an individual patient versus epidemiological surveys. His articles in 2003 in Spectator and Noseweek continued in the same vein. But with each subsequent article he has come closer and closer to admitting the massive scale of the HIV epidemic. His latest acknowledgement that AIDS is responsible for a 30% increase in mortality is almost mainstream. Yet his writing style remains unrepentant and he brushes off as a triviality the realisation that he is not mathematically competent to do this work.

He also misrepresents me. Nowhere did I write that real deaths had doubled in my recent article that he appears to be referring to. I wrote, accurately, that recorded deaths increased over 90% in a decade. I also wrote, "Improved death registration and population growth can account for only a small portion of this increase. The vast majority of additional deaths are due to the HIV epidemic."

This was also accurate. Only a careless reading of my wording would imply that total deaths (i.e. recorded plus unrecorded) have doubled due to AIDS. This might seem a minor "He said, I said" spat, but it demonstrates a lack of integrity in public engagement. Despite our overall success, I am sure there is much fair criticism that can be directed at TAC about our actions over the last decade, but manipulating AIDS statistics is not one of them.

Without any sense of irony, Malan concludes, "we should just ignore those who try to manipulate us with numbers and support Zuma's common-sense plan to stamp out the disease." Actually, it is because of the people who Malan falsely accuses of manipulation that we finally have a common-sense AIDS plan. While we were fighting for it, Malan was supporting Mbeki on AIDS.

Some of my colleagues have been weary about me responding to Malan. They have warned me that he is being a contrarian so that he can promote his new book and that a response is exactly what he wants. But I think Malan is a talented wordsmith whose writing style convinces some people; it is them I aim my articles at. But being clever with words does not imply competence and Malan's articles on AIDS are littered with errors.

According to Wikipedia Malan stated, "I get a kick out of it when the Treatment Action Campaign attacks me; it's like sport." I do not know if he really said this, but it does appear to be sport for him.

For TAC and me, it is a waste of precious time and aggravating. Many people find AIDS statistics impersonal. But I do not; they remind me of Christopher Moraka, who testified before Parliament in 2000 that he could not get medicines to treat his systemic thrush. He died a couple of months later. Or Edward Mabunda, TAC's late firebrand poet. And Ronald Louw, a close friend and brilliant lawyer based at UKZN who died a few years ago of AIDS. No, this debate is not sport for TAC or me.

Killer syndrome: The Aids denialists

Eduard Grebe — Tue, 01 Dec 2009 12:48:40 +0000

Rob Sharp reports in The Independent on the presistence of AIDS denialism

A middle-aged man walks into an East London café and apologises for being late. With his clipped hair and bus-driver's uniform of thick overcoat, shirt, and branded tie, he looks like any other public service employee. But soon he delivers a speech of startling ferocity against the medical establishment.

Mike explains that he runs a London-based health website on which he posts articles and links to information that questions whether HIV causes Aids, disputes the existence of HIV, and denies the fact that unprotected sex helps to spread it. He offers support for those who, he says, are "negotiating with medical authorities over taking a different approach to dealing with their circumstances." He claims to get thousands of hits on his site and has helped advise several people who have been diagnosed with HIV and are launching legal action against their local health authorities, in the belief that they have been unfairly treated by the doctors who are trying to help them.

Mike is an Aids denialist. He shares the view of a global network of academics and campaigners that follow the proclamations of Peter Duesberg, a cell biologist at the University of California, Berkeley, who believes HIV does not cause Aids. And, alarmingly, 2009 has been a good year for the denialist community.

In the first week of November, a record number of Aids denialists from 28 countries, including Britain, attended the Rethinking Aids conference in Oakland, California. One of the main draws of the conference was a screening of a controversial new documentary by Canadian-born director Brent Leung, House of Numbers, which gives a platform to denialist theories.

Over the last two months it has been screened at the Cambridge and Raindance Film Festivals - decisions that provoked a storm of criticism online. The Spectator was forced to cancel a debate and screening of the film on 28 October after some of the participating speakers pulled out. And yet despite widespread outrage, the film has undoubtedly encouraged those who espouse denialist theories in the UK.

So who are the Aids deniers and what do they believe? According to Seth Kalichman, a psychologist at the University of Connecticut, whose exposé of the movement, Denying Aids, was published in March, denialists anywhere in the world generally share several common beliefs. They say that the "myth" that HIV causes Aids is the product of conspiracies between governments and the pharmaceutical industry; that antiretroviral medication is toxic; and that one day the orthodox medical theories on HIV will crumble.

So far, so typically crackpot. But the movement has gained some damaging traction - and the propagation of denialist theories can have deadly repercussions. Aids charities warn that reading material which argues that HIV does not cause Aids can dissuade potential sufferers from getting tested for HIV, and even lead HIV-infected people to ignore HIV-positive results and cause them to reject antiretroviral therapies.

"Denying the link between HIV and Aids is scientific illiteracy," says Yusef Azad, director of policy and campaigns at the National Aids Trust, Britain's leading HIV/Aids charity. "But worse than that, it is profoundly dangerous and has caused countless unnecessary deaths. Just because something is on the internet does not mean it is even remotely true. More than two decades of peer-reviewed scientific research demonstrates in some detail how HIV attacks the immune system and causes Aids if left untreated."

Read the full article on The Independent's website.

McGill Daily on the dangers of denialism

Eduard Grebe — Fri, 27 Nov 2009 00:14:33 +0000

Stephanie Law writes in the McGill Daily:

Christina Maggiore died of an AIDS-related illness on December 27, 2008. She was a successful businesswoman who started a multimillion-dollar import/export clothing company, and a freelance consultant for U.S. government export programs. Maggiore is most notorious for her role as an HIV-positive activist who promoted the idea that HIV is not the real cause of AIDS. She was an HIV-denialist.

Maggiore was diagnosed with HIV in 1992. In 1994, she met Peter Duesberg, a molecular biology professor at the University of California at Berkley. Duesberg convinced Maggiore that HIV does not lead to AIDS. A year later, Maggiore started one of the largest networks of HIV-denialists and skeptics, called Alive & Well AIDS Alternatives.

Maggiore refused antiretroviral treatment for HIV because she did not think HIV would lead to AIDS and AIDS-related illnesses. She did not take the recommended treatment for pregnant HIV-positive women to prevent mother-to-child transmission. Her child died at the age of three from Pneumocystis jirovecii pneumonia. The Los Angeles County coroner and various other independent pathology experts concluded that the death was a direct result of her untreated HIV that had progressed into AIDS.

W hen asked about Maggiore, Mark Wainberg, director of the McGill University AIDS Centre, becomes enraged: “Christina Maggiore and her daughter died because they didn’t get treated…. Their story is tragic, but the reality is, Christina Maggiore was so misguided in believing this concoction of bullshit, that it cost not only her life, which is her business, but also the life of her three-year-old kid, and that is everybody’s business.”

Maggiore and her daughter’s deaths are only two of many that result from denying the causal link between HIV and AIDS.

Read the full article.

Constantine and Weiss pinpoint misrepresentations

Eduard Grebe — Thu, 26 Nov 2009 20:22:29 +0000

Statements by Professor Niel Constantine and Professor Robin Weiss about the Misrepresentation of their Interviews in “House of Numbers.”

Posted November 23, 2009, to HouseofNumbers.org

The sections on HIV antibody tests in “House of Numbers” contain fragments of interviews with a number of different people, put together in a way that confuses viewers rather than clarifying what HIV testing protocols are and how they work. The editing of the interviews to try to create doubts about the worth of HIV diagnostic assays is surely intentional. Questioning HIV diagnostics is one of the main tactics of HIV denialism.

The talking heads in these sections of the video include an eager-to-please but inexpert woman working in a temporary testing tent in a South African mall, several legitimate scientists, and HIV denialist Liam Scheff and filmmaker Brent Leung. The section jumbles together bits of speech about the use of HIV antibody testing for different purposes—for screening the blood supply, for screening individuals for HIV infection and confirmatory testing, for diagnosis and for prognosis. It also scrambles remarks about different generations of tests; about tests of different qualities—those manufactured under FDA oversight and those produced in uncontrolled conditions; about different types of HIV antibody tests—conventional and rapid tests, ELISA and Western Blot; and about the use of these tests under different countries’ government protocols—Germany, South Africa, Britain, the USA. The resulting mess of words creates confusion – as it was intended to.

The history, variety, and protocols of HIV antibody testing can be confusing to non-experts. Leung and his team have exploited this in the film. But any of the legitimate scientists or clinicians in the film, asked a clear question by an ethical interviewer who would try to present their views accurately, could easily explain how HIV antibody testing works, what protocols are used to maximize accuracy in different places and at different times, the distinctions between screening and diagnostic assays, the differences between ELISAs and Western Blots, and so on. But Brent Leung sought to confuse, not clarify. He wanted to make it seem like the tests are unreliable and that the scientists he interviewed didn’t know disagreed with each other about HIV tests. The reality is very different. HIV antibody tests are extremely accurate, and various confirming protocols (two or three different types of tests) are used in different places.

Two scientists who were interviewed by Leung, then edited to appear as if they held antagonistic views, are Niel Constantine, Professor of Pathology at the University of Maryland, and Robin Weiss, Professor of Viral Oncology in the Division of Infection and Immunity at University College, London. Professors Constantine and Weiss both say that their interview footage as edited misrepresented what they know and what they said. In fact, contrary to the impression created in “House of Numbers”, they agree with one another about the nature, value, and accuracy of HIV antibody tests. Here are their statements.

Dr. Constantine's Statement

“What Mr. Leung has done is take our statements completely out of context. For example, he and I were discussing the use of rapid HIV tests and their accuracy. I explained that the tests were excellent, but that some individuals were assembling rapid HIV tests from individually purchased components and making these tests in their garages for sale. Such tests, that had not been subjected to the quality assurance measures required by organizations such as the FDA, were inferior and should not be used. That is, only tests that were approved by expert organizations should be used. Hence, my statement in the film "Now if I tell you that the test you took was lousy and didn't mean a thing." Mr. Leung used this to imply that I was stating that HIV tests were useless.”

-- Niel T. Constantine, Ph.D., Professor of Pathology, University of Maryland School of Medicine

Dr. Weiss's Statement

“The sound bites were extracted out of quite a long interview with me and presented out of context. In my recollection (I don't have a tape of the interview) Leung was pressing me about HIV antibody tests in reference to screening blood donations. When I said ‘I don't think the Western Blot is a useful diagnostic test; I don't think it's worth doing’, I was referring to relatively high throughput screening for blood banks, and in the mid 1980s we did not yet have commercial dip stick Western Blot kits available. In retrospect, it would have been better for me to say: ‘I don't think the Western Blot was a useful primary screening test’.

“I also cited what I regarded as a dogma that a Western Blot test was essential as a confirmatory test; ELISA tests made by two different manufacturers can also provide a confirmed result. For instance, in some UK labs the Wellcozyme ELISA using a competition format was used for primary screening and was then followed up with a confirmatory assay using the Abbott standard direct-binding ELISA instead of a Western Blot.

“It strikes me that similar false contrast and out of context quotes have been crafted together throughout the programme. Furthermore, Leung doesn't seem to understand or acknowledge that doubts about the precision or reliability of tests that were devised as research tools in 1984 (the first year in which we could grow HIV in reasonable amounts in the lab) really have little relevance to the reliability of subsequent mass produced commercial tests, which had to go through extensive quality control before they were marketed or used in clinics and blood banks. It's rather like saying that Roentgen's original fuzzy X-ray pictures are a valid reason for debunking today's radiological imaging systems for hospital diagnosis.”

-- Robin A Weiss, Ph.D., Professor of Viral Oncology, Division of Infection and Immunity, University College London

The following text is an annotated transcript of the sections of the video about HIV antibody testing, to provide a context for Professor Constantine’s and Professor Weiss’ statements. Annotations in italics.

Scene: Brent Leung is getting an HIV test in a South African mall.

African woman tester: “We always say to our clients: even if you have tested here, you can go to other centers and go and verify your test. We cannot say you’re 100%. Because you find clients going from area to area doing these tests, and they come with stories that I was negative at a certain area and positive with you.” She seems to be talking about people who are HIV+ testing repeatedly at different sites in hopes of getting negative results.

Leung: “And how do they decide if they are positive or negative?”

Tester: “We cannot tell, because we are using a rapid test.” This answer doesn’t mean the rapid test is useless, but that it requires confirmation.

Audio: Sinister background music.

Leung, narrating to impose a particular interpretation on the interview snippets: “It occurred to me that perhaps the HIV epidemic is reported to be so widespread in South Africa and other poor nations simply because they use these inaccurate tests.”

Image: flooded African shantytown.

James Chin, MD, MPH- Chief of Global HIV Surveillance World Health Organization 1987-92: “There’s the saying that if you knew how sausages, what sausages are made of, most people would hesitate to sort of eat them because they wouldn’t like what’s in it; and if you knew how HIV numbers are cooked, uh.. or made up, you would use them with extreme caution.”

This is a completely different topic—how HIV statistics are estimated—but the insertion of this sentence here makes it seem that Chin is discussing HIV tests.

Caption: London, England. View of London, Thames from above.

Leung: “I decided to investigate HIV testing protocols used throughout the developed world.”

Harold Jaffe MD, Director, CDC AIDS Division 1992-95 Head of Public Health Dept. Oxford 2004- Present: “When we are testing people for HIV, the first thing we do is a screening test and it’s usually a test called the “ELISA” Jaffe’s sentence is cut off here.

Niel T. Constantine PhD- Director, Clinical Immunology Institute of Human Virology: “But there are also now available rapid assays that can be used as screening methods.”

Liam Scheff, HIV denialist: “Because they’re faster, and we all know, faster and cheaper is more efficient.”

And people don’t need to wait two weeks for highly accurate results. Is this bad?

Claudia Kücherer, MD, Molecular Biologist, Robert Koch Institute, Germany: “If an ELISA is positive, it does not mean that the patient is HIV positive. So that’s a problem.” But what did she then go on to say as an explanation of this statement? We are not shown, as Leung only manipulates sound bites.

Robin Weiss PhD- Professor of Viral Oncology University College London: “If we’re using antibodies as a screening test to tell who is infected or not, uh, very occasionally you can get false positives.”

Niel T. Constantine: “So screening tests by themselves should not be used as a definitive measure of infection; that’s why we use a screening test to pick up all the cases, but we use a confirmatory test to eliminate any false positives.

Back to the South African testing booth:

Tester: “Take it easy… I’ll pierce at the site.” She pricks Leung’s finger.

*Leung [voice over]: “It should be emphasized that most of the developing world uses only screening tests to confirm an HIV diagnosis; there are not confirmatory tests.” Leung is presumably referring to the use a second ELISA test from a different manufacturer, in contrast to a Western Blot, for confirmation. This is a highly accurate protocol and necessary where resources are limited.

Robert C. Gallo: “This has a margin of error done properly that’s extremely low. In other words, it’s one of medicine’s better tests.”

Robin Weiss: “I don’t think the Western Blot is a useful diagnostic test; I don’t think it’s worth doing.” See Dr. Weiss’s explanation of this sentence.

Niel T. Constantine: “Did he give a reason? You know anybody can say anything, I think it’s stupid to drive a car. But come on you gotta give a reason!”

In the background, Leung starts to say, “He said…”

Robin Weiss: “It’s a useful prognostic test. Once you know that someone is infected, then you can follow their antibody responses well with Western Blots.” This is a true, accurate statement.

Niel T. Constantine: “I’d say he’s absolutely wrong, it has a complete usefulness.” With what statement is Professor Constantine disagreeing here? The film doesn’t show

Footage pans backs and forth between the two men in a blurred, swinging motion, juxtaposing them to impose a sense of concurrency and argument.

Robin Weiss: “You don’t need a Western Blot! And it’s become a dogma in HIV research that you need one ELISA followed by a western; you don’t. You need two different kinds of ELISAs made in two different formats.” Professor Weiss here emphasizes the need for using two independent tests to obtain confirmation of HIV status. Most countries still use an ELISA followed by a Western Blot, a long established and highly reliable procedure. Professor Weiss simply says that there is an alternative method that could now be used and expresses his opinion that using two ELISAs is the better option.

Leung: “Would you ever want to confirm somebody is positive using just ELISAs? “

Claudia Koshered: “No. Never. It’s not…It’s against the rules, it’s against the recommendations.” In Germany, that is true, but not everywhere. Different nations make different decisions on many aspects of health care all the time.

Liam Scheff: “It’s a turbulent sea of argument about how can we use this test, when can we use this test, why does this test have no standard?” Tests made by different manufacturers are slightly different, and are read differently. However, all approved tests are very accurate. It is a profound logical error to say that if screening or measuring tests vary, the thing they screen for or measure does not exist

Niel T. Constantine: “Now if I tell you that the test you took was lousy and didn’t mean a thing, would that make any difference for everybody to hear?” See Dr. Constantine’s statement about the proper context for this comment: he is referring to bootleg tests that are not reliable.

Leung: “It’ll make a difference for me.”

Niel T. Constantine: “Yeah I know.”

Science, pseudoscience and professional responsibility

Eduard Grebe — Thu, 26 Nov 2009 15:05:04 +0000

by Dr John Moore, PhD (Originally published by health-e)

Surveys have consistently shown that over 40% of Americans do not believe in evolution. It is not surprising, then, that our society is vulnerable to being fooled by people who misrepresent scientific or historical facts.

We are now all too familiar with the crazed activities of the 'Birthers', an ad hoc, right wing political group refusing to accept President Obama was born in the United States. Earlier this year, we saw media coverage of the insane views of a clique that refuses to accept American astronauts walked on the moon 40 years ago. The "9/11 Truth Movement" flourishes on the internet, arguing that the World Trade Center and the Pentagon were not hit by hijacked jetliners, but were blown up by the CIA at the behest of Israeli intelligence. Conspiracy groups like these usually do little real damage to society, although the activities of the "9/11 Truth Movement" foster anti-Semitism and insult the memories of the nearly 3000 Americans who died on 9/11. Unfortunately, other equally bizarre and factually unfounded, internet-based conspiracy groups can, and do, harm, even kill, significant numbers of people. This is not just an American problem, as the ripple effects of conspiracy theories spread worldwide via the internet. Indeed, the most serious consequences of one such group’s actions have been felt in Africa.

A small group of misguided and, in some cases malicious, individuals have long promoted the view that HIV does not cause AIDS or, in an even more bizarre twist of the truth, that HIV does not even exist. An even nastier variation of the theme is that HIV was created by the US government as a device to kill "undesirables", such as people with black skins or who are gay. None of these opinions is true, and there is not a shred of credible scientific or historic evidence to support them. Unfortunately, the Mbeki administration in South Africa put in place policies based around the premises that HIV is harmless but anti-retroviral drugs are dangerous. This decision caused over 330,000 unnecessary deaths during the first half of this decade. And yet the "AIDS Denialists" even question this death toll, a tactic no different from Holocaust Deniers asking "Did six million really die". Many Americans and Europeans have also died, persuaded by the "AIDS Denialists" that they did not need to take anti-retroviral drugs to treat their HIV infections. Distrust of the federal government and the medical establishment among African American communities has adversely affected AIDS prevention and treatment programs in the USA, in no small measure due to the crazy belief that HIV was created as a weapon of selective genocide. Indeed, this particular rumor even re-surfaced in the last Presidential election campaign. Real people die real deaths as a direct result of the pseudo-science promoted by the "AIDS Denialists".

In a similar vein, groups that claim vaccination is harmful have harmed global immunization programs, and thereby caused avoidable deaths worldwide. A conspiracy theory group often called "The Mercuries" has been particularly vociferous in its argument that a mercury-containing preservative found in some vaccines causes autism. There is less mercury in a vaccine shot than in a tuna fish sandwich, and the mercury present in the fish is in a more dangerous chemical form. Overall, a now vast body of solid scientific evidence has proven that autism has no connection whatsoever to any vaccine or vaccine component. This is now settled science within the professional community, which understands that the cause of autism is based in human genetics. But despite the facts, the distrust of vaccines that has been created by “The Mercuries” and other anti-vaccine conspiracy groups is now damaging efforts to counter swine flu by vaccination, both in America and, increasingly, elsewhere. The polio vaccine eradication campaign has been harmed, notably in Nigeria, by rumors that the vaccine is contaminated with dangerous chemicals, or even with HIV, or that it was designed by “white people to sterilize black people”. As a result, this dangerous infection has still not been eradicated from Africa, where it lingers on, killing and paralyzing yet more people.

The mindsets of the "AIDS Denialists" and "The Mercuries" are similar to each other. Both groups are irrational on the science, twisting the facts to a perverse extent and stubbornly ignoring and rejecting all the evidence that speaks against their views. Each group is bolstered by a very small number of scientists whose paper qualifications provide them with a superficial, wafer-thin veneer of academic credibility. The two conspiracy groups contain individuals who will resort to threats of violence and who harass those who dare to speak up against them. A common tactic of both groups is to smear scientists and physicians who recommend AIDS drugs or the use of vaccines as being nothing more than paid tools of the pharmaceutical industry. Yet both the "AIDS Denialists" and "The Mercuries" are supported by promoters of “alternative (i.e., quack) therapies" who have a financial interest in damning approved anti-HIV drugs or licensed vaccines. “Ambulance-chasing” lawyers have also been heavily involved with the anti-vaccine groups, fostering the hopes of grieving parents that they (and the lawyers) might receive a payout from a scientifically ill-informed jury.

The conspiracy theory groups also receive the support of a small, but noisy, subset of media professionals who seem attracted to the personalities involved, smelling stories in the controversies. This has been particularly problematic recently in the anti-vaccine arena, where some American chat shows and right wing news programs have given undue attention to “The Mercuries”. Bizarre as it may seem, the views of medically unqualified Hollywood celebrities are given equal, or even greater, weight on these shows than those of expert physicians and scientists. Science and pseudoscience should never be “balanced” in this way. To make an analogy: if a film star claimed that we should not fly on a jetliner because mercury contamination could make the wings fall off, we would simply laugh, preferring to listen to the views of qualified aeronautical engineers and metallurgists (and to our own experience as travelers). Yet, nowadays, film stars’ views on vaccine composition are given huge weight by some chat show hosts.

The "AIDS Denialists" and "The Mercuries" are no different from the "Birthers", the moon-landing hoaxers, the "9/11 Truth" members and the Holocaust Deniers in the irrationality of their views and their belief in government conspiracies and cover-ups. Indeed, some members of the various groups flit from one conspiracy-themed web site to another, seeking and finding solace in a variant form of irrationality. One of the very few academic supporters of the" AIDS Denialism" movement also investigates the Loch Ness Monster, Alien Crop Circles and other such fringe or paranormal themes. It would be funny if it were not so tragic.

What can be done about dispelling this kind of damaging nonsense? America has a strong tradition of free speech, so dangerous views will continue to be promoted, however harmful they are to public health and the best interests of society. The internet is the territory of the conspiracist, and it is likely to remain so. But media professionals should not be so unquestioning of the science when they provide airtime or column inches to those with fringe views. Controversy may help sell advertising, but at what cost?

A particular concern is that the ideas that HIV is harmless and that vaccines cause autism have been underpinned by a very few academics or physicians working in American or European universities or hospitals. These “thought leaders” for the conspiracy groups should now be made to face the professional consequences of their scientifically unsupportable actions. Is academic freedom such a precious concept that scientists can hide behind it while betraying the public so blatantly? When the facts are so solidly against views that kill people, there must be a price to pay. Post-tenure review of the progress of academic careers is something the university system could put in place if it chose to. How can bona fide universities justify their employees teaching students, even medical students, that HIV is harmless? How can academic and medical institutions still employ people whose views lead to the deaths of over 330,000 South Africans? Shielding the proponents of pseudoscience by doing nothing is a dereliction of a duty to the public. It is also moral cowardice. It is now time for Africa to speak out and demand action against those who have been responsible for so many deaths on this continent.

Call for Mandatory Disclosure of Pharmaceutical Industry-Funded Events for Health Professionals

Eduard Grebe — Thu, 26 Nov 2009 13:52:56 +0000

We endorse this call for mandatory disclosure.

Mandatory Disclosure of Pharmaceutical Industry-Funded Events for Health Professionals

Robertson J, Moynihan R, Walkom E, Bero L, Henry D (2009) PLoS Med 6(11): e1000128. doi:10.1371/journal.pmed.1000128

Summary Points

There are moves internationally to ensure greater disclosure of gifts and educational events for doctors paid for by pharmaceutical manufacturers. However, there is no agreement on appropriate standards of disclosure. In Australia, since mid-2007, there has been mandatory reporting of details of every industry-sponsored event, including the costs of any hospitality provided.
Examination of the Australian data shows that although expenditure at individual events is often modest, cumulative expenditure is high, particularly in the case of medical specialists prescribing high cost drugs—oncologists, endocrinologists, and cardiologists.
Although a significant advance, the new Australian reporting standards do not allow assessment of the educational value of sponsored events, and do not include details of speakers or educational content for most events. However, doctors in training are often present at these events.
At present, the standards of disclosure are inadequate and should not be tied to an arbitrary monetary value of gifts or sponsorship. Reporting standards should require the names of the speakers presenting, whether sponsors played a role in suggestion or selection of speakers or the development of the content of presentations, and the nature of any direct or indirect financial ties between the speakers and the sponsors.

For boxes, tables and figures, visit the original article on Plos Medicine.

Background

We are in a period of unprecedented scrutiny of the relationships between the pharmaceutical industry and doctors [1]–[4]. Legislators are now considering how they might become involved in the regulation of these practices. This is a telling comment on the perceived failure of the medical profession to regulate itself and of self-regulation by industry. But reliable and comprehensive data on the nature and extent of industry sponsorship are rare. Several states in the US have mandatory disclosure laws for physician payments, but these data have proved difficult to access and analyse [5]. The US Congress is considering new mechanisms for revealing industry–professional interactions (the so-called “Sunshine” Acts) [6],[7].

One of the first countries to move towards greater transparency was Australia. The pharmaceutical industry representative body, Medicines Australia, has a self-regulatory Code of Conduct that sets standards for the ethical marketing and promotion of prescription pharmaceutical products for its member companies. In addition to monitoring of promotional activities, a Code of Conduct Committee adjudicates on complaints regarding pharmaceutical company activities [8]. In 2007, the Australian Competition Tribunal placed disclosure requirements on Medicines Australia. It approved that body's Code of Conduct for industry–professional relationships on the condition that details of every sponsored event, including the costs of any hospitality, were posted on their website [9],[10]. Reporting commenced in July 2007 and data are updated six monthly [8].

In this Policy Forum we examine the Australian data and argue that although a definite advance, the Australian disclosure requirements fall short of what is required. We propose more comprehensive reporting standards, which should have application to other settings and jurisdictions.

Australian Experience of Pharmaceutical Company Disclosures

In Australia, the emphasis in disclosure is on monitoring the level and type of sponsorship of educational events rather than documenting the dollar value of gifts and other payments to physicians. Since 2007 pharmaceutical companies have been required to report all functions (educational events) provided or sponsored for health professionals. They are required to disclose the following: the venue; the professional status of attendees; a description of the function and duration of the educational content of events; the nature of the hospitality; the total cost of hospitality; the numbers of attendees; and the total cost of the function [11].

The first report, covering the period July to December 2007, provided details of 14,649 events (Table 1) [12]. This total is equivalent to almost 600 events per week nationally, at a cost of around AUD$1 million/week (US$879,074.00). Put another way, the pharmaceutical industry spends, on average, around AUD$1,000 annually on each doctor through sponsorship of such events. The top five companies in terms of the numbers of sponsored events were Astra Zeneca, Pfizer, Sanofi Aventis, Janssen Cilag, and Eli Lilly (Table 1). The most generous of the active companies (those with >100 functions in 6 months) was Bristol Myers Squibb, with an average cost per head of AUD$95.26. In contrast, Alphapharm (a generics manufacturer) sponsored 441 events (mostly in professional rooms with a sandwich lunch) at an average cost per head of AUD$18.24 (Table 1).

Hospitality (food, beverages, travel, accommodation) accounted for around AUD$17 million of the total of AUD$31 million spent on functions. Thirty-five percent of sponsored events (n = 5,174) were held in restaurants, hotels, or function centres. The average cost per head was much higher when the venue was a restaurant (AUD$71.35) than in a hospital (AUD$12.11). In 7.2% of cases (n = 1,062) expenditure exceeded AUD$100 per head (examples are given in Box 1). There were 74 events (0.5%) with total outlays per head on hospitality in excess of AUD$500.

Medical specialists were present at 62% (n = 9,018) of events, family physicians at 30% (n = 4,437), nurses at 26% (n = 3,820), and pharmacists at less than 5% (n = 621) of events. Registrars (medical specialists in training) were present at 19% (n = 2,827) of events; in 179 instances they were the only attendees. The medical subspecialties most often featured were psychiatry (17.9%), and oncology (15.2%), who received industry hospitality roughly three times as often as any other subspeciality (Table 2). The largest per head expenditure was directed at endocrinologists, oncologists, and cardiologists (Table 2). Companies spent considerably more on restaurant meals for doctors (AUD$76.73) than for nurses (AUD$48.78).

Companies reported no responsibility for the educational content in only 9% of events (n = 1,287). Likewise, continuing medical education (CME)/continuing professional development (CPD) points were allocated to 9% of events (n = 1,270). Just over 20% of all events were described as “journal club” or “grand rounds” (n = 3,035), mostly conducted in hospitals. The majority of events (n = 10,723, 73.2%) were a mix of meetings of various kinds, including workshops and in-service training activities; only 4% (n = 591) were described as “conferences.” Table 3 shows the topics discussed, the most common being cardiology, diabetes, oncology, psychiatry, and respiratory medicine. The most common specific topics were hypertension, osteoporosis, breast cancer, type-2 diabetes, and depression. All represent large and important markets for pharmaceutical products. Topic descriptions, where provided, often matched the product portfolio of the sponsor, although there were few mentions of specific drug names (n = 582, 4%).

Importantly, Australian companies are not required to disclose the names of the speakers, whether sponsors played a role in their selection or in the choice of the content of presentations. They are also not required to disclose the nature of any financial ties between their companies and the speakers.

Why Do We Need Better Disclosure?

The information provided by Medicines Australia points to a high level of contact between pharmaceutical manufacturers and health professionals, particularly doctors. The per-person expenditure was greatest for medical specialists who prescribe high cost drugs—oncologists, endocrinologists, and cardiologists. Generally, expenditure at individual events was modest; however the cumulative expenditure and the overall level of contact was high. The available information suggests that companies exert influence over the educational content of events in most cases, and doctors in training are often present at these functions. There is substantial evidence that attendance at company-sponsored events modifies prescribing practices [13]–[15]. The presence of doctors in training and students (in hospital-based sessions) may lead to a process of enculturation whereby they come to regard repeated contact with pharmaceutical companies as a normal and acceptable part of their professional practice. The data reviewed here indicate that, from a company perspective, it is cheap and easy to sponsor meetings in hospitals and health centres, and the return on this “investment” is likely to be high. Equally, it is straightforward for administrators to limit sponsorship of such activities, should they choose to do so. It is difficult to see a role for pharmaceutical companies at hospital grand rounds.

The evidence from this analysis of Australian data suggests that disclosure requirements should not stipulate thresholds—set dollar amounts below which disclosure is not required. Physician-reporting requirements such as those in Vermont and Minnesota in the US, which exempt payments of less than US$100, could obscure the broad cumulative influence of a number of smaller payments [5],[16]. The literature indicates that it is not only the size of the gift that matters—it is the sense of reciprocity that it engenders [17].

The types of activities described here need to be viewed within the broader context of other forms of pharmaceutical industry interaction with doctors, including face-to-face contact with representatives, advertising in medical journals, consultancies, membership of advisory boards, and stock holding [18]–[20]. While lavish gifts and generous travel support have been a focus of attention in the past, these have been progressively discouraged by industry and professional guidelines. It is likely that the frequent, more modest, sponsored educational events will become increasingly important and influential, and the principal form of contact between industry and health professionals.

There are a number of organisations that will benefit from more comprehensive disclosure of these activities. Professional organisations and accreditation bodies will have accurate data on the level and type of contact their members have with pharmaceutical companies. This will enable them to counter the undesirable effects of such relationships through the development of guidelines, or the evolution of practice standards or disciplinary codes. They will benefit from sequential data to determine if practices are changing over time. The public, the media, and consumer groups will have access to reliable data on which to base their judgements about industry-health professional contact and, when appropriate, to lobby for change. Individual health professionals could have access to information on which to judge their own practices against those of their peers. If legislation is thought necessary, governments will have data on which to monitor its impact.

Proposals for Greater Transparency

The Australian reporting standards are deficient in not including details that enable a judgement about the educational value of company sponsored events. We believe that reporting schemes should require the following details: the names of the speakers presenting, whether sponsors played a role in suggestion or selection of speakers or the development of the content of presentations, and the nature of any direct or indirect financial ties between the speakers and the sponsors. This type of information is routinely requested by professional journals; so there are ample precedents and it is particularly relevant when judging the appropriateness of educational events.

We experienced considerable difficulty in accessing the Australian data, which are compiled in portable document format (pdf). As suggested in the US Sunshine Acts it is important that summary reports listing each function are accessible to the public in a searchable, downloadable, and analysable format [5]–[7].

Whether there should be a central register or database that identifies attendees at company-sponsored functions is more controversial. The data could be compiled from the records of names collected by the pharmaceutical companies. Reports could be provided to health professionals, which would enable them to compare their practices with their peers. We are not here advocating public disclosure of this information, but individuals could be asked to provide reports in particular circumstances—for instance when ethics committees are considering the industry ties of an investigator.

In Box 2 we have summarised the main data elements that we think should be included in disclosure programs. What we suggest is consistent with the recent Institute of Medicine (IOM) Report on conflicts of interest [21]. This report recommended that the US Congress create a national program requiring companies and their foundations to publicly report payments to physicians and other prescribers, biomedical researchers and their institutions, but did not suggest specific data elements. Some authors of the report argued that this database should also provide explanatory material about payments received (e.g., for an educational or marketing purpose) and information on all financial ties (e.g., equity ownership, patent rights) in addition to industry payments and gifts [22].

While it may be unrealistic and undesirable to ban contact between pharmaceutical companies and health professionals we should work to make those relationships completely transparent. We welcome further debate on this topic.

Acknowledgments

Thanks to Joanne Knight for her contribution to coding the data.

Author Contributions

ICMJE criteria for authorship read and met: JR RM EW LB DH. Agree with the manuscript's results and conclusions: JR RM EW LB DH. Designed the experiments/the study: RM. Analyzed the data: JR EW DH. Collected data/did experiments for the study: EW. Wrote the first draft of the paper: RM. Contributed to the writing of the paper: JR RM EW LB DH. Developed the data coding scheme, checked all data entries, designed and co-ordinated data analyses, interpreted the data: JR. Conceptualization and interpretation: LB. Helped design the data collection instrument and analysis plan: LB.

References

1. Association of American Medical Colleges (2008) Industry funding of medical education: report of an AAMC task force, June 2008. Available: https://services.aamc.org/Publications/showfile.cfm?file=version114.pdf&prd_id=232&prv_id=281&pdf_id=114 . Accessed 8 May 2009.

2. Greenland P (2009) Time for the medical profession to act. Arch Intern Med 169: 829–831. Find this article online

3. Harris G (2008 October 4) Top psychiatrist didn't report drug maker's pay. New York Times; A1.

4. Rothman DJ, Chimonas S (2008) New developments in managing physician-industry relationships. JAMA 300: 1067–1069. Find this article online

5. Ross JR, Lackner JE, Lurie P, Gross CP, Wolfe S, et al. (2007) Pharmaceutical company payments to physicians. JAMA 297: 1216–1223. Find this article online

6. (2009) Senate Bill S.301. Physician Payments Sunshine Act of 2009. Available: http://thomas.loc.gov/cgi-bin/bdquery/D?d111:3:./temp/~bdhqHM:L&summ2=m&/bss/111search.html . Accessed 13 May 2009.

7. (2008) House of Representatives Bill H.R.5605. Physician Payments Sunshine Act of 2008. Available: http://thomas.loc.gov/cgi-bin/query/D?c110:9:./temp/~c110EAsKeZ . Accessed 13 May 2009.

8. Medicines Australia (2009) Educational Event Reports. Available: http://www.medicinesaustralia.com.au/pages/page136.asp . Accessed 8 May 2009.

9. Australian Competition and Consumer Commission (27 June 2007) Australian competition tribunal affirms ACCC's decision on extra reporting for Medicines Australia Code. Press release number MR 163/07. Available: http://www.accc.gov.au/content/index.phtml/itemId/790845/fromItemId/621589?pageDefinitionItemId=16940 . Accessed 8 May 2009.

10. Medicines Australia (28 March 2008) Medicines Australia sets world-first in transparency. Press release. Available: http://www.medicinesaustralia.com.au/pages/images/MR%20Mar%202803%20MA%20sets%20precedent65.pdf . Accessed 13 May 2009.

11. Medicines Australia (2009) Glossary - educational event report table contents. Available: http://www.medicinesaustralia.com.au/pages/page144.asp . Accessed 8 May 2009.

12. Medicines Australia.Member company reports, and non-member company reports, 1 July–31 December 2007. Member reports: Available: http://www.medicinesaustralia.com.au/pages/page230.asp ; Nonmember reports: Available: http://www.medicinesaustralia.com.au/pages/page500.asp . Accessed 8 May 2009.

13. Wazana A (2000) Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 283: 373–380. Find this article online

14. Steinman MA, Harper GM, Chren MM, Landefeld CS, Bero LA (2007) Characteristics and impact of drug detailing for gabapentin. PLoS Med 4: e134. doi:10.1371/journal.pmed.0040134.

15. Hemminki E, Karttunen T, Hovi SL, Karro H (2004) The drug industry and medical practice – the case of menopausal hormone therapy in Estonia. Soc Sci Med 58: 89–97. Find this article online

16. Ross JS, Nazem AG, Lurie P, Lackner JE, Krumholz HM (2008) Updated estimates of pharmaceutical company payments to physicians in Vermont. JAMA 300: 1998–2000. Find this article online

17. Katz D, Caplan AL, Merz JF (2003) All gifts large and small. Am J Bioeth 3: 39–46. Find this article online

18. Gagnon MA, Lexchin J (2008) The cost of pushing pills: A new estimate of pharmaceutical promotion expenditures in the United States. PLoS Med 5: e1. doi:10.1371/journal.pmed.0050001.

19. Norris P, Herxheimer A, Lexchin J, Mansfield P (2005) Drug promotion: what we know, what we have yet to learn. Geneva: World Health Organization. Available: http://www.who.int/entity/medicines/areas/rational_use/drugPromodhai.pdf . Accessed 13 May 2009.

20. Blumenthal D (2004) Doctors and drug companies. N Engl J Med 351: 1885–1890. Find this article online

21. Institute of Medicine (2009) Policies on conflict of interest: Overview and evidence. In: Lo B, Field MJ, editors. Conflict of interest in medical research, education, and practice. Washington (D.C.): The National Academies Press. pp. 51–78.

22. Bero L, Krughoff R, Loewenstein G (2009) Appendix F: Model for broader disclosure. In: Lo B, Field MJ, editors. Conflict of interest in medical research, education, and practice. Washington (D.C.): The National Academies Press. pp. 325–330.

23. Medicines Australia (2008) Code of Conduct Annual Report 2008. Available: http://www.medicinesaustralia.com.au/pages/images/Code-of-Conduct-2008-Annual-Report.pdf . Accessed 8 May 2009.

Pregnancy, not nevirapine cause of liver toxicities in HIV-positive women

Eduard Grebe — Thu, 19 Nov 2009 15:20:02 +0000

Michael Carter writes on aidsmap:

Results of US research “challenge the notion that nevirapine is uniquely associated with hepatotoxicity during pregnancy.” The study did however show that pregnancy itself increased the risk of liver toxicities in women with HIV. The research is published in the November 27th edition of AIDS.

Increased risk of hepatotoxicity in HIV-infected pregnant women receiving antiretroviral therapy independent of nevirapine exposure.

Ouyang DW, Shapiro DE, Lu M, Brogly SB, French AL, Leighty RM, Thompson B, Tuomala RE, Hershow RC.

OBJECTIVE: To estimate whether the association between nevirapine (NVP) and hepatotoxicity differs according to pregnancy status in HIV-infected women. METHODS: The present analysis included HIV-infected pregnant women on antiretroviral therapy (ART) from two multicenter, prospective cohorts - the Women and Infants Transmission Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials protocol P1025 - and HIV-infected nonpregnant women from one multicenter, prospective cohort - the Women's Interagency HIV Study. Using multivariate Cox proportional hazards regression, the interaction between NVP and pregnancy status in terms of hepatotoxicity was investigated. NVP use was dichotomized as use or no use and was further categorized according to ART exposure history. We investigated two outcomes: any liver enzyme elevation (LEE; grade 1-4) and severe LEE (grade 3-4). RESULTS: Data on 2050 HIV-infected women taking ART were included: 1229 (60.0%) pregnant and 821 (40.0%) nonpregnant. Among the pregnant women, 174 (14.2%) developed any LEE and 15 (1.2%) developed severe LEE as compared with 75 (9.1%) and 5 (0.6%), respectively, of the nonpregnant women. In multivariate adjusted models, NVP was not significantly associated with risk of LEE, regardless of pregnancy status; however, pregnancy was associated with an increased risk of any LEE (relative risk 4.7, confidence interval = 3.4-6.5) and severe LEE (relative risk 3.8, confidence interval = 1.3-11.1). The association of pregnancy and LEE was seen, regardless of prior ART and NVP exposure history. CONCLUSION: No significant association between NVP and LEE was observed, regardless of pregnancy status, but pregnancy was significantly associated with increased hepatotoxocity in HIV-infected women.

PMID: 19617813 [PubMed - in process]

The Shameless Rian Malan

Eduard Grebe — Thu, 19 Nov 2009 14:17:00 +0000

by Nathan Geffen, 19 November 2009

In 2001, Rian Malan wrote an article in Rolling Stone questioning the accuracy of HIV tests in order to disparage the evidence of a growing HIV epidemic in South Africa. In 2003 he published similar articles in the Spectator and Noseweek. All these articles were replete with errors. I subsequently debunked the latter two in a January 2004 article.

One of Malan's errors was particularly serious. He presented miscalculated, massively understated estimates of AIDS deaths which he falsely attributed to Stats South Africa. As I wrote then, the mistake was so serious and obvious that it raised questions about Malan's basic competence as a research journalist -or more disturbingly- about his motives and integrity.

In Mbeki's 2004 State of the Nation speech he quoted from Malan and spoke warmly about him. It was not explicitly about HIV, but to anyone following the debate at the time, it was clear that Mbeki was grateful for Malan's support on AIDS.

In the last year and especially the last few weeks, following the speeches of President Jacob Zuma and Minister of Health Aaron Motsoaledi, state-supported AIDS denialism has been destroyed. If Malan had any shame, he would have stayed out of the public light after supporting an ideology responsible for the deaths of hundreds of thousands of people. But he is shameless and his denialist scribblings have continued (see this rebuttal of Malan by Eduard Grebe in 2007).

His latest appeared on Politicsweb on Friday 13 November. Malan pointed out, correctly, that Zuma and Motsoaledi quoted a wrong and over-stated estimate for the 2008 deaths. The mistake, based on Home Affairs data, was an honest one. In contrast to the untruths in Malan's articles, it was not in service of a deadly ideology. On the contrary, Zuma's speech and Motsoaledi's dense-with-statistics 47-slide presentation, were for the most part superb and demonstrated renewed political will to combat the epidemic.

Yet Malan wrote this jaundiced rant, “This country is full of HIV consultants and researchers and specialist HIV hacks who are paid a lots of money on account of their supposed expertise. The state president says that the Aids equivalent of an atom bomb has detonated among our people AND THERE'S NO REACTION AT ALL FROM ANY OF THEM. They all knew, like I did, that Zuma's number was bullshit, but they were perfectly happy to let it stand, cos big Aids numbers are good for business, innit? NOT ONE OF THOSE MOTHERS SAID ANYTHING! They think you are stupid and want to keep you that way.”

He also confirmed his AIDS denialism, “In other words, there is no apocalypse. No massive Aids related death surge. If anything, death registrations are stable.”

Actually, as I explained in an article on Politicsweb, there has undoubtedly been a massive AIDS-related death surge; we have simply reached the crest of that surge thanks to the ARV programme. And if the programme falters AIDS deaths will grow again. Only a shameless denialist like Malan could tell such an obvious lie – again. He is also guilty of exactly what he accuses others of: distortion of statistics to promote his career. If there is to be a commission of inquiry into AIDS denialism, Malan should be questioned about his motives and actions.

AIDS and mortality in South Africa

AIDSTruth — Wed, 18 Nov 2009 08:59:17 +0000

By Nathan Geffen, 16 November 2009

On 2 November 2009, Statistics South Africa released the latest mortality data, which goes up to 2007 (Stats SA, 2009). This table gives the number of recorded deaths per year:

Year	Number of recorded deaths by Stats SA
1997	317,131
1998	365,852
1999	381,820
2000	415,983
2001	454,847
2002	502,031
2003	556,769
2004	576,700
2005	598,054
2006	612,462
2007	601,033

You do not need to be a statistician to be astounded by this. Recorded deaths have increased over 90% in a decade. Improved death registration and population growth can account for only a small portion of this increase. The vast majority of additional deaths are due to the HIV epidemic. A huge body of evidence shows this. For example, there has been a three-fold increase in TB deaths over the same period and TB is the leading cause of death in people with HIV. Also the age pattern of the deaths --younger instead of older adults comprise the bulk of them-- and the drop in the median age of death from 51 in 1997 to 44 in 2007 are consistent with the way AIDS works. (For more detailed evidence see Dorrington et al. 2006, Dorrington et al. 2001 and Stats SA, 2002).

Also noticeable is that the number of deaths appears to have stabilised from 2005 to 2007 and perhaps has even begun to decrease slightly. This is most likely due to the state's antiretroviral (ARV) treatment programme.
Unfortunately because the public sector programme has not been well monitored and there are numerous treatment providers in the private sector, there is not accurate data on the number of people on treatment. But by using several sources of data, including figures published by the Department of Health, medical aid data and public sector ARV procurement data it is possible to make reasonable estimates. Muhammad Aarif Adam of Sanlam and Leigh Johnson of the Centre for Actuarial Research have made plausible calculations of the number of people on treatment in the middle of each year up until mid-2008, shown in the next table (Adam and Johnson, 2009).

Year	No people on treatment
2001	6,000
2002	15,000
2003	26,000
2004	47,000
2005	109000
2006	229,000
2007	371,000
2008	568,000

The programme began in earnest in 2004 and the stabilisation of the death rate has coincided with it. If you consider that many, perhaps most, of the people on the programme would be dead by now that would easily account for stemming rising deaths. Make no mistake; there has been a massive surge in deaths in South Africa for more than a decade and AIDS deaths continue to be very high; deaths might have stabilised but at a very high number. Life-expectancy declined to the low-50s. At least though, we are implementing the most effective known scientific medical intervention to mitigate the effects of the disease and it now appears that life-expectancy is increasing again.

But many unnecessary deaths occurred because of the delayed rollout of the ARV treatment programme. Two studies have conservatively estimated that former President Thabo Mbeki's AIDS denialist policies cost well over 300,000 lives (Nattrass, 2008; Chigwedere, 2008). Mbeki did not pursue this deadly policy without help though. Officials in government, civil servants and even some journalists supported his policy, tried to give it legitimacy and for a time succeeded in quashing the demand for a treatment rollout from health workers and AIDS activist organisations, like the Treatment Action Campaign (TAC). Thankfully, we have moved beyond this awful era of South African history.

PS: The last two weeks have seen what I believe is the final death-knell of state-supported AIDS denialism. Both President Zuma and Minister of Health Motsoaledi have delivered important speeches showing their intention to fight the epidemic. On page 35 of his presentation Motsoaledi quoted mortality data for 2008 from Home Affairs which appears to be far too large. I am unaware of how this number was derived and it appears to be an error. In other respects Motsoaledi's speech was excellent and his mistake is of no great importance.

References

Adam M and Johnson L. 2009. Estimation of adult antiretroviral treatment coverage in South Africa. September 2009, Vol. 99, No. 9 SAMJ

Chigwedere P. 2008. Estimating the Lost Benefits of Antiretroviral Drug Use in South Africa. JAIDS Journal of Acquired Immune Deficiency Syndromes. 49(4):410-415, December 1, 2008.

Dorrington R et al. 2001. The impact of HIV/AIDS on adult mortality in South Africa.

Dorrington R et al. 2006. The Demographic Impact of HIV/AIDS in South Africa.

Nattrass N. 2008. AIDS and the Scientific Governance of Medicine in Post-Apartheid South Africa. African Affairs 2008 107(427):157-176.

Statistics South Africa. 2002. Causes of death in South Africa 1997-2001 : Advance release of recorded causes of death.

Statistics South Africa. 2009. Mortality and causes of death in South Africa, 2007: Findings from death notification.

The Lancet reviews AIDS denialist film "House of Numbers"

Eduard Grebe — Tue, 17 Nov 2009 19:32:10 +0000

Talha Burki writes in The Lancet Infectious Diseases:

Strange, perhaps, for The Lancet Infectious Diseases to review House of Numbers. It is a threadbare documentary that claims there is no connection between HIV and AIDS. It arrives at this conclusion through a toxic combination of misrepresentation and sophistry. At best, it is a misguided and misbegotten film; at worst, it is downright malevolent.

All of which makes a fine case for ignoring it. HIV/AIDS denialism is an ideology in disgrace; the ravings of what Stephen Lewis—former UN Special Envoy for AIDS in Africa—describes as a “lunatic fringe”. To debate House of Numbers is to attend the film with an honesty and dignity that is entirely alien to its nature. Far better to leave it mouldering in the clutches of cranks and conspiracy theorists.

Only, denialism kills. A study published in the Journal of Acquired Immune Deficiency Syndromes found that South Africa's former reluctance to roll-out antiretroviral-drug programmes—a consequence of former President Thabo Mbeki falling under the sway of the denialist movement—cost more than 330 000 lives. Today, South African policy is very different; “the era of denialism in South Africa is completely over”, stated Barbara Hogan upon her appointment as Health Minister after Mbeki's removal. But it is not inconceivable that the denialist movement might gain ground elsewhere, with similarly catastrophic results.

House of Numbers purports to be an investigative piece by Brent Leung, a filmmaker with “unanswered questions” about the AIDS pandemic. But the disreputable credo of denialism is easy to recognise. The belief system can be summarised as follows: AIDS is not caused by HIV. It is instead a disease related to poverty, malnutrition, and homosexual lifestyles. Antiretroviral drugs are poisonous—“AIDS by prescription” claims Peter Duesberg, spearhead of the denialist movement, and a prominent figure in this film—the pharmaceutical industry is in on the conspiracy, as are the major health organisations. “Could it be that the real epidemic is extreme poverty not HIV?”, Leung disingenuously asks.

If you have a subscription to The Lancet, read the full article here.

The Lancet Infectious Diseases, Volume 9, Issue 12, Page 735, December 2009

doi:10.1016/S1473-3099(09)70316-0

How to spot an AIDS denialist

Eduard Grebe — Fri, 13 Nov 2009 13:00:00 +0000

by Seth Kalichman (Originally published in the New Humanist)

Imagine that you or someone you love just received an HIV positive test result. The news is devastating. After a short time you begin to face the diagnosis. You turn to the Internet for answers. Searching the words “AIDS diagnosis” brings up thousands of websites. A whirlwind of information spins your mind. One credible-looking website, Aids.org, reads: “There is no cure for AIDS. There are drugs that can slow down the HIV virus and slow down the damage to your immune system. There is no way to ‘clear’ HIV from the body. Other drugs can prevent or treat opportunistic infections (OIs). In most cases, these drugs work very well. The newer, stronger ARVs have also helped reduce the rates of most OIs. A few OIs, however, are still very difficult to treat.”

With a click of the mouse, an equally credible-looking site, Aliveandwell.org, asks: “Did you know … Many experts contend that AIDS is not a fatal, incurable condition caused by HIV? That most of the AIDS information we receive is based on unsubstantiated assumptions, unfounded estimates and improbable predictions? That the symptoms associated with AIDS are treatable using non-toxic, immune-enhancing therapies that have restored the health of people diagnosed with AIDS and that have enabled those truly at risk to remain well?”

Which do you trust? Which do you believe? Which would you want to believe? Would you choose to believe there may be hope offered by medical treatments or would you prefer to believe that HIV is harmless? This simple example illustrates the lure of AIDS denialism.

AIDS denialism tells us what anyone would want to hear – that HIV does not cause AIDS and that if you live a “healthy lifestyle” (whatever that is) you won’t get AIDS. None of which is true. In fact, there are an estimated 33 million people in the world living with HIV infection. In 2007 there were nearly three million new HIV infections and two million people died of AIDS. People are living longer and healthier lives with HIV infection as a result of earlier detection through HIV antibody testing and the remarkable success of HIV treatments. Indeed, countries that launched aggressive testing and treatment programs, such as Brazil and Botswana, have reduced suffering and prolonged life. In contrast, South Africa delayed testing and treatment programs as a result of former President Thabo Mbeki’s AIDS denialism, policies that resulted in over 300,000 unnecessary deaths and over 35,000 infants senselessly infected with HIV. There is no rational basis for disputing these established facts, and yet rejecting the reality of AIDS is the mission of AIDS denialists.

AIDS denialism is one of several incarnations of denialism. All denialism is defined by rhetorical tactics designed to give the impression of a legitimate debate among experts when in fact there is none. Holocaust deniers claim that historians disagree about the evidence for Nazi mass gassings and systematic murder of Jews. Global warming denialists say that climatologists are torn by the evidence about climate change. 9/11 “Truth Seekers”, as clever a piece of branding as “pro-life”, say the collapse of the Twin Towers resulted from controlled demolition. Vaccine hysterics tell us that the science is split on whether vaccinations cause autism. And AIDS denialists say that scientists are in disagreement about whether HIV causes AIDS.

It is easy to be fooled by AIDS denialists. Not only do they tell us what we want to hear, they use methods of persuasion to create the illusion of debate. Just as HIV attacks our immune defences that would otherwise destroy it, AIDS denialists appeal to our sense of scepticism. Indeed, AIDS denialists refer to themselves as dissident scientists and sceptics. Denialists misuse science and rely on pseudoscience to call established fact into question. Denialists also exploit what is not known about how HIV causes AIDS to suggest that HIV may not cause AIDS at all. The more sophisticated efforts of AIDS denialism, like the “documentary” House of Numbers, are most disturbing because they use every trick in the denialist playbook to juxtapose pseudoscience with established science. The best way to recognise AIDS denialism is to know their common tricks of persuasion.

There are two sides to every debate. But just asserting there is a debate does not mean there is one. AIDS denialists rely on a small band of fake experts, mostly retired academics who proclaim that HIV does not cause AIDS. There is not a single instance of an “expert” offered by AIDS denialism that has ever actually done research on AIDS. In rare examples, denialist experts have a history of credible science only to have later gone off the deep end. The most credentialled AIDS denialists are Nobel Laureate Kari Mullis, who developed the PCR technology for sequencing the genetic code, and Peter Duesberg, Professor of Biochemistry and Molecular Biology at the University of California-Berkeley and member of the National Academy of Science. Although credentialled, neither is credible. Aside from saying HIV cannot cause AIDS, though he has done no research on AIDS, Mullis has shared his experiences on LSD and encounters with an alien fluorescent raccoon, and Duesberg, who did important work on cancer in his early career, now claims that there is no genetic basis for any cancer. Both have demonstrated an outright disregard for scientific evidence.

But beyond these two high-profile mavericks most of the “experts” in AIDS denialism are out-and-out pseudoscientists. My favourite is Henry Bauer, Emeritus Professor of Chemistry and Science Studies at Virginia Tech University, who claims to have proven that HIV cannot cause AIDS. Professor Bauer is also a self-proclaimed international expert on the existence of the Loch Ness Monster. Detecting fake experts requires looking beyond college degrees and achievements from decades gone by. Do not confuse credentials with credibility. Saying that there is no genetic basis for any cancer, describing extraterrestrial experiences, and searching for big green monsters in Scottish waters should matter when examining the credibility of someone making important claims about the causes of a devastating disease.

In the 1980s legitimate scientists disagreed about AIDS. For AIDS deniers, everything old is new again. AIDS denialists rely on selected research findings from the days when not much was known about AIDS. The first tests for HIV antibodies were less reliable than current testing technologies. There were early debates about what caused AIDS and good ideas that turned out to be dead ends. The drug AZT was prescribed in massive and often toxic doses. But none of this is true any more. Though there remain many debates in medical science about how HIV causes AIDS, there is no longer a debate about whether HIV causes AIDS. Unfortunately, outdated scientific literature is not purged when new knowledge emerges. AIDS deniers use this information to create the illusion of a live debate. Denialists select old findings that support their flawed logic because they have no evidence of their own. Cherrypicking is another favourite rhetorical technique of denialists. This involves selecting a lone scientific finding, presenting the results out of context, and deploying it as evidence for their own conclusions.

Another popular denialist manoeuvre is to call for a definitive single study, analogous to the creationist demand for a definitive transitional fossil to prove evolution. Peter Duesberg for example, asserts that “There is not a single controlled epidemiological study to confirm the postulated viral etiology of AIDS.” He is right about this. No one scientific study ever “proves” anything. Scientists are cautious to draw conclusions from even a series of experiments. To establish that HIV causes AIDS required countless laboratory, clinical, and epidemiological studies, all converging to a definitive conclusion. There is no single scientific paper proving that HIV causes AIDS, just as there is also no single physics experiment proving that a man could land on the moon, no single study that proves excessive exposure to the sun causes skin cancer or one study that proves smoking causes lung cancer. Rather there are tens of thousands of studies containing a wide range of evidence that, taken together, make an overwhelming case.

AIDS denialists will also demand even more specific evidence, only to change the demand once the evidence is produced. One example of this “pushing back the goalpost” technique was the former Sunday Times journalist and prominent AIDS denier Neville Hodgkinson’s claim that HIV tests are invalid because HIV has never been isolated. When scientists provided evidence that HIV has been isolated, the demand changed; Hodgkinson argued that the isolated virus was “impure”. Denialists now demand that the virus be isolated in “pure form”, that is uncontaminated by proteins. The demand for a pure virus devoid of cellular proteins is impossible to meet as it defies the biological nature of viruses. Such shifting of the grounds of debate allows denialists to claim that they are the ones following the evidence, and it is the AIDS establishment – an alliance of careerist researchers and greedy drugs companies – who are propagating pseudoscience.

All denialism is entrenched in conspiracy thinking. A spectrum of such thinking motivates AIDS denialism, covering everything from a government conspiracy to invent HIV for genocide against Africans and gays to a pharmaceutical industry conspiracy to sell toxic drugs. One of my favourites is the flamboyant conspiracy thinking of vitamin entrepreneur Matthias Rath, who said “The people and the governments of the world have to decide whether they are ready to stop being manipulated by the pharmaceutical industry and embrace instead the scientific knowledge that is now available to fight the global HIV/AIDS epidemic with effective, safe and affordable natural means.” The “natural means” Rath is referring to, of course, are the useless vitamins that he peddles to the poor. Though Rath has now been prevented from marketing his phony cure in Africa, and famously lost his libel suit against Ben Goldacre when he exposed his fraudulent practices, great damage was done and he continues to agitate for AIDS denialism through his spurious Health Foundation.

But while some denialists are clearly charlatans out to make a quick buck out of other people’s misery, many are perfectly genuine, which is what makes them especially dangerous. They can be persuasive because they actually believe what they say. Evidence means nothing to them. Their thought process resembles what psychiatrists call an “encapsulated delusion”, where despite what appears to be otherwise rational thinking there is an intractable maladaptive belief system that is impermeable to contrary evidence. Many of these people have themselves been diagnosed with HIV, and cling to the hope that this is not a death sentence. This adds a particular poignancy to their claims. A potent irony also hangs over denialism; year on year AIDS deniers who have tested positive for HIV succumb to AIDS-related illnesses. The most visible of such cases was Christine Maggiore, the founder of the Alive and Well movement that claims there is no causal link between HIV and AIDS. Maggiore believed that HIV does not cause AIDS even after the AIDS-related death of her three-year-old daughter and right up until her own death of AIDS in 2008. AIDS denialists are therefore a mixed bag of rogue scientists, pseudoscientists, conspiracy theorists, and snake-oil salesmen. There are also vocal AIDS denialist activists, primarily HIV positive people who are in deep denial of their diagnosis and seek the insulating bubble offered by AIDS denialism.

So, what can we do about AIDS denialism? There will always be crazy people who say crazy things. AIDS denialists only do harm when people listen to them. The best defence against AIDS denialism is improved public understanding of science and medicine. We all need to know how to recognise cranks and crackpots and their sinister rhetorical devices. When searching for reliable information make sure it does not rely on old, most likely outdated, sources. Find credible sources of current information and trust them, but keep pressing them with questions. Familiarise yourself with the basic facts of HIV and AIDS and be sceptical of far-fetched conspiracies. Be informed and think critically, but don’t fall for global conspiracy hysteria or accept pseudoscience because that is what you want to hear. We know that drugs companies make huge profits, and that scientists rely on research grants and can be fallible. This does not mean there is a global conspiracy to misrepresent the science. AIDS researchers and the pharmaceutical industry, believe it or not, are in it to save lives.

And finally, hard as it might be for believers in free speech and open debate, if you encounter AIDS denialism, do not enter into a debate. AIDS denialists want to create the impression that there is a debate regarding HIV causing AIDS and debating feeds the illusion. This debate was exhausted years ago. Now it merely serves as a distraction from the ongoing struggle to explain how and why HIV causes AIDS and trying to prevent it. In the words of The Who, and the title of Richard Wilson’s excellent book on scepticism, “Don’t Get Fooled Again”.

To see the AIDS Denialist Hall of Fame, visit the article at New Humanist.

Seth Kalichman's book Denying AIDS: Conspiracy Theories, Pseudoscience, and Human Tragedy is published by Springer/Copernicus - all royalties from the book are donated to buy HIV treatments in Africa.

Warning about pseudo-scientific review of alternative AIDS medicines

Eduard Grebe — Thu, 12 Nov 2009 17:10:44 +0000

A website that is advertised via Google ads, is promoting alternative, unproven and untested medicines for the treatment of HIV. The website is http://www.hivsecrets.com. Upon registering with it, a report titled HIV Alternative Therapies Report is made freely available for download. This report is written by a Ms Shirley Wyand. Ms Wyand has no known expertise in the science of HIV/AIDS.

The report is replete with misconceptions. For example, it states, "Since Western medical science offers no cure and few treatments for AIDS, people living with HIV are open to other options, and a tradition of gathering and sharing treatment information already exists." On the contrary, antiretroviral treatment is a very effective chronic treatment for HIV. There are also many effective medicines that treat AIDS-related opportunistic infections. There are no alternative treatments for HIV that have been shown to be effective. Indeed, once a medicine is shown to be effective it is no longer an alternative one.

Another example of the report's misconceptions is that it promotes an untested product called Revivo tea. This products advertisements touting its efficacy for the treatment of HIV have recently been banned in South Africa by that country's Advertising Standards Authority.

We urge people with HIV to be extremely cautious about following any of Ms Wyand's advice.

HIV/AIDS is leading cause of death of women of reproductive age: UN report

Eduard Grebe — Thu, 12 Nov 2009 16:48:14 +0000

The World Health Organization's report Women and health: today's evidence, tomorrow's agenda identifies HIV/AIDS as the leading cause of death among women of reproductive age: "Globally, the leading cause of death among women of reproductive age is HIV/ AIDS. Girls and women are particularly vulnerable to HIV infection due to a combination of biological factors and gender-based inequalities, particularly in cultures that limit women’s knowledge about HIV and their ability to protect themselves and negotiate safer sex."

Here is an extract from the report:

This section is copied without footnotes or graphs. To download the full report, see below.

Women and HIV/AIDS

Globally, HIV is the leading cause of death and disease in women of reproductive age. Of the 30.8 million adults living with HIV in 2007,a 15.5 million were women. The prevalence of HIV infection in women has increased since the early 1990s and is most marked in sub-Saharan Africa.

Total number of people living with HIV/AIDS in 2007 was 33 million, including two million children younger than 15 years.

Southern Africa is most affected; in 2005–2006, median HIV prevalence among pregnant women attending antenatal care was above 15% in eight Southern African countries. Infection was acquired primarily through heterosexual transmission.

In all regions, HIV disproportionately affects female sex workers and injecting drug users, as well as the female partners of infected males.

Women’s particular vulnerability to HIV infection stems from a combination of biological factors and gender inequality. Some studies show that women are more likely than men to acquire HIV from an infected partner during unprotected heterosexual intercourse. The risk posed by this biological difference is compounded in cultures that limit women’s knowledge about HIV and their ability to negotiate safer sex. Stigma, violence by intimate partners, and sexual violence further increase women’s vulnerability. Fewer young women than young men know that condoms can protect against HIV. Furthermore, while women generally report increased condom use during high-risk sex, they are generally less likely to protect themselves than men are.

The youngest women are the most vulnerable. They not only face barriers to information about HIV – and in particular how they can protect themselves from infection – but in many settings they often engage in sexual activity with older men who are more sexually experienced and more likely to be infected.

Female drug users and sex workers are particularly vulnerable; stigma, discrimination and punitive policies only increase their vulnerability. The rate of HIV infection among female sex workers is high in many parts of the world, and a large proportion of women who use drugs also engage in sex work. In prisons, the proportion of drug users among females is higher than among males. The use of contaminated injection equipment is particularly prevalent among women, resulting in higher rates of HIV infection.

Economic vulnerability is another key factor driving HIV infection among women. Economic vulnerability is sometimes associated with migration, which increases high-risk behaviours among women who may be driven into sex work by economic necessity. On a more positive note, in recent years women have benefited from increased access to HIV prevention, treatment and care. Data from 90 low- and middle-income countries suggest that, overall, women are slightly advantaged in terms of access to antiretroviral therapy: at the end of 2008, 45% of women in need and only 37% of men in need received antiretroviral therapy. In 2008, 45% of pregnant women living with HIV received antiretrovirals to prevent mother-to-child transmission of HIV, up from 10% in 2004. Nonetheless, challenges remain: only 21% of pregnant women received HIV testing and counselling, and only one third of those identified as HIV-positive during antenatal care were subsequently assessed for their eligibility to receive antiretroviral therapy for their own health.

To download the full report or executive summary, visit this page: http://www.who.int/gender/documents/9789241563857/en/index.html

South African health minister reveals "shocking" AIDS figures; blames Mbeki denialism for worsening the crisis

Eduard Grebe — Wed, 11 Nov 2009 12:58:05 +0000

South Africa's Mail & Guardian newspaper reports:

"In 11 years -- from 1997 to 2008 -- the rate of death has doubled in South Africa. That is obviously something that cannot but worry a person," Health Minister Aaron Motsoaledi told reporters at Parliament in Cape Town.

He said that in 1997 the total number of deaths stood about 300 000. Last year the figure was 756 000.

Motsoaledi said the figures called for a "massive change in behaviour and attitude" toward Aids among South Africans.

"On the figures, it's shocking. As to whether it has been affected by what we did in the past 10 years, to me that's obvious," he said, according to the South African Press Association.

Read the full article.

Anthony Mbewu is made director of GFHR: Is this an appropriate appointment?

Eduard Grebe — Wed, 04 Nov 2009 12:55:35 +0000

Anthony Mbewu with Matthias RathAnthony Mbewu, the current President of the Medical Research Council of South Africa (MRC), has been appointed the Executive Director of the Swiss-based Global Forum for Health Research (GFHR).

The South African government under former President Mbeki and former Health Minister, Manto Tshabalala-Msimang, pursued an AIDS denialist ideology that was responsible for at least 300,000 premature deaths and tens of thousands of preventable HIV infections. [1-2] Mbeki and Tshabalala-Msimang were the main protagonists in this crime against humanity. But there were several politicians and civil servants whose actions and inactions helped extensively. Anthony Mbewu was one of them. An appointment to a top position in Geneva hardly seems appropriate for someone with his questionable track record. This included misrepresenting the relative importance of HIV as a cause of death, supporting the vitamin salesman Matthias Rath, playing down the known benefits of antiretroviral treatment, promoting absurd conspiratorialist thinking and over-promoting multi-vitamins and traditional medicine as potential responses to AIDS.

Matthias Rath, with the support of Tshabalala-Msimang, conducted unauthorised experiments on people with HIV, imported and distributed his products unlawfully and claimed multivitamins alone reversed the course of AIDS, in contrast to antiretrovirals which he claimed were toxic. Anthony Mbewu helped establish Rath's presence in South Africa.

Rath at the MRCIn 2004, Mbewu had a series of meetings with Rath that led to Rath giving a workshop and committing to pay R200,000 to the MRC, of which over R60,000 was eventually paid. The minutes of the meetings with Rath are illuminating. They include plans to run a clinical trial using multivitamins to treat cancer. At one point the minutes record Mbewu stating, “NAPWA (National Association of People with Aids) [is a] good group. TAC [Treatment Action Campaign] is paid by pharma cartel. NAPWA has an open mind and will be an great advocacy tool as a counter-balance to attack.” NAPWA was a corrupt organisation that served Manto Tshabalala-Msimang's interests by opposing antiretroviral treatment. TAC, the organisation that led the campaign for antiretrovirals, never received money from pharmaceutical companies and eventually won an interdict against Rath for propagating this claim.

The minutes are replete with pseudoscientific assertions and evince an AIDS denialist agenda. There is additional questionable behaviour: In one meeting Mbewu introduced Rath to Denova, a marketing company of which Mbewu's wife, Priscilla Reddy (also an MRC employee) was a director. [3] (This reference has links to meeting minutes, commitments to pay and photos of Rath and Mbewu.)

Mbewu presented on HIV to the Parliamentary Health Portfolio Committee on 16 March 2005 and stated:

The importance of nutrition in mitigating the impact of HIV and AIDS cannot be understated. The Tanzanian/Harvard University clinical trial by Fawzi et al published recently in the New England Journal of Medicine is a case in point. This blinded, randomised controlled clinical trial showed that amongst over 1000 HIV positive women; those assigned to receive daily multivitamin over the subsequent 5 years showed a 30% reduction in death and progression to AIDS compared to those who did not receive multivitamin. This implies that multivitamins can reduce the socioeconomic impact of HIV and AIDS by both reducing the annual death rate, as well as reducing the rate at which patients deteriorate to the point of needing active medical care. In addition, the widespread use of traditional medicines in AIDS could have direct benefit, if efficacious in reducing mortality; as well as indirect benefit in stimulating the industry of producing and distributing natural medicines.

He then stated:

Little is known about the length of survival of patients on antiretroviral therapy in resource poor settings. Data from ACTG studies in the USA, using regimens similar to those we use in South Africa suggest that median survival once started on ARVs is likely to be of the order of several years but this is very tentative.

As the TAC has explained, “these statements are misleading. He has contrasted multivitamins with antiretrovirals and in effect argued that there is more reliable evidence of the usefulness of multivitamins than antiretrovirals. This is false. The opposite is actually the case. Little is known of the effect of multivitamins on people with HIV. While Mbewu correctly identifies that a Tanzanian study found them to be beneficial, he fails to point out that these benefits were small relative to antiretrovirals. He claims little 'is known about the length of survival of patients on antiretroviral therapy in resource poor settings', while actually little is known about the survival benefits of multivitamins and a lot is known about the survival benefits of antiretrovirals in resource poor settings.” [4]

Mbewu and Rath enjoying dinnerMbewu also cast doubt on the size of the AIDS epidemic at a point when denialist scepticism was crucial to President Mbeki's resistance to introducing ARVs. He has been quoted stating, “The nation is in poor health, with just as many if not more deaths from heart disease and strokes than AIDS ... AIDS is a major problem, but heart disease and strokes are much bigger.” [5] Yet the claim that “heart disease and strokes are” a much bigger problem than AIDS had been shown to be false by a report published by the MRC. [6] (See also Professor Solly Benatar's criticisms of Mbewu's statements about AIDS mortality. [7])

The GFHR press release announcing Mbewu's appointment describes one of his achievements: “In 2003 he chaired the Task team that developed South Africa’s Comprehensive Care, Management and Treatment for HIV and AIDS programme that has enrolled 871 914 patients on antiretroviral therapy.” [8]

The statement is either cynical or callous. It shows a poor knowledge of the history of AIDS denialism in South Africa and appears designed to whitewash Mbewu's discreditable role in fostering it. This task team was appointed after a massive campaign by civil society led by the Treatment Action Campaign (TAC) to get the South African government to develop a treatment plan. It included several large marches as well as civil disobedience in which activists were beaten up, arrested and sprayed with water cannons. Finally the Cabinet relented and while Mbeki was out of the country, it ordered Tshabalala-Msimang to produce a treatment plan. Mbewu was appointed to head the task team by Tshabalala-Msimang because he was a politically reliable ally, the commissar whose job it was to ensure that the people doing the committee's real work were watched and controlled (thankfully not very successfully). To imply that Mbewu was responsible for South Africa's antiretroviral programme is a grave insult to the people who actually made the programme happen. The mealy-mouthed language and nutritional pseudoscience that made it into the report were Mbewu's doing.

GFHR describes itself as “an independent, international organization committed to demonstrating the essential role of research and innovation for health and health equity, benefiting poor and marginalized populations.” We question whether the appointment of Anthony Mbewu is consistent with that mission and call on GFHR to require Mbewu to account for his questionable and discreditable history.

References

1. Nattrass, N. 2008. AIDS and the Scientific Governance of Medicine in Post-Apartheid South Africa. African Affairs 2008 107(427):157-176. http://afraf.oxfordjournals.org/cgi/content/abstract/107/427/157 ^back^

2. Chigwedere, P. et al. 2008. Estimating the Lost Benefits of Antiretroviral Drug Use in South Africa. JAIDS Journal of Acquired Immune Deficiency Syndromes. 49(4):410-415, December 1, 2008. http://journals.lww.com/jaids/pages/articleviewer.aspx?year=2008&issue=1... ^back^

3. TAC. 2006. Release of Documents showing collusion between some government officials, including MRC Head Anthony Mbewu, and Matthias Rath. http://www.tac.org.za/community/node/2203 ^back^

4. TAC. 2006. Submission to African Peer Review Mechanism. http://www.tac.org.za/Documents/AfricanPeerReviewMechanismReportFinal-20... ^back^

5. Pretoria News, 17/2/2005. Quoted in TAC Submission to African Peer Review Mechanism. ^back^

6. Dorrington et al. 2001. The impact of HIV/AIDS on adult mortality in South Africa. http://www.hst.org.za/publications/452 ^back^

7. SAPA. 2005. MRC Man's statement supports AIDS denial. http://70.84.171.10/~etools/newsbrief/2005/news0211.txt ^back^

8. Global Forum for Health Research. 2009. Appointment of new Executive Director: Prominent South African researcher to head Global Forum for Health Research http://www.globalforumhealth.org/Media-Publications/Archive-news/Appoint... ^back^

"House of Numbers" Lies about Research Findings on T Cells Destruction and AIDS

Eduard Grebe — Mon, 02 Nov 2009 12:39:48 +0000

by Jeanne Bergman

The lynchpin of Brent Leung’s argument in “House of Numbers” that HIV does not cause AIDS is the headline of a 2007 article on ScienceDaily.com that read, “Sudden Loss Of T Cells Is Not Trigger For AIDS, New Study Suggests.” [1] The screen shows the article’s headline and first paragraphs for 12 seconds (a very long time in “House of Numbers”), while Leung, in a voice-over, intones, “In late 2007, ScienceDaily reported that three prominent research teams had published papers in the Journal of Immunology, challenging the theory that the sudden loss of T-cells triggers disease and AIDS.” Since T cell destruction is understood to be the primary mechanism by which HIV destroys the immune system, this seems to seriously challenge the HIV/AIDS paradigm.

The film then cuts to a clip of researcher John P. Moore saying, “The details of HIV pathogenesis, how HIV kills people, are still being worked out.” The placement of this interview fragment implies that Moore would agree that T cell destruction does not lead to AIDS and death (though, of course, he does not agree: JPM – personal communication). Next, Leung is shown in a lab, theorizing that, “If the sudden loss of T-cells in HIV positive individuals can’t explain why people get disease, then there must be co-factors that cause people to get sick and die. Or, factors that have absolutely nothing to do with HIV.” And the film goes on to propose other causes for AIDS—poverty, poppers, AZT.

But the research Leung cites to claim that T cell loss does not cause AIDS does not say what Leung says it did. On the contrary, it affirms that in humans T cell destruction leads to AIDS and death. The document on the screen was indeed from ScienceDaily, a popular science news website. However, the headline and first paragraph of that article, which was itself based on a press release from Tulane University, did not accurately represent the research: notably, it failed to mention that the research was done with non-human primates. Leung and his crew disregarded the rest of the ScienceDaily article, which clearly recorded that non-human primates were used and stated that the particular strain of SIV infecting these particular simian species behaves differently from HIV in humans. (Some other strains of SIV do cause AIDS in other simian species, notably in macaques) In the simian species used in this particular study, the animals rebound from the T cell destruction caused by the infecting virus, whereas humans generally don’t when they are infected with HIV. Leung also ignored the actual Journal of Immunology articles that ScienceDaily linked to—which is remarkable since his entire case against HIV’s causality rests on them. [2]

The articles misrepresented by Leung said that three teams of researchers studied SIV-infected sooty mangabeys, rhesus macaques, and African green monkeys, respectively, and found that soory mangabeys and African greens have non-pathogenic infections: they can recover from T cell depletion, which is why they do not get AIDS. (Rhesus do progress rapidly to AIDS.) The researchers explicitly contrasted non-human primate T cell recovery with the disease progress in HIV-infected human beings, who cannot recover from T cell depletion without treatment, and who therefore progress to AIDS and death. The three research teams suggest that while some non-human primates have evolved to adapt to the virus over many centuries, it is still new in humans: we have not yet evolved to recover from T cell destruction. The researchers see their findings as suggestive for therapies to control immune system activation and promote recovery from HIV-related T cell destruction.

We contacted ScienceDaily and they have corrected the misleading headline and paragraph. The headline now reads, “Progression Of SIV Infection In Monkeys Points To Differences Between Human And Simian Forms Of AIDS.” [3] The summary of the research clarifies the distinction between the virus in humans and simians:

Another major question raised by the study is why monkeys with SIV, unlike HIV-positive humans, are generally resistant to progression to AIDS after infection with the virus.

The answer, the authors propose, is that thousands of years of host/virus co- adaptation has enabled monkeys, the natural hosts of SIV, to effectively limit T cell immune activation and apoptosis, a mechanism that leads to progression of the disease. By contrast, humans, who were introduced to the virus fairly recently, have not had the opportunity to develop such protective adaptations.

ScienceDaily has also added an Editor's Note:

This story has been modified from its original version, which can be accessed here:http://web.archive.org/web/*/http://www.sciencedaily.com/releases/2007/09/070923193631.htm (via the Internet Archive's Wayback Machine). This version clarifies that the research described in the story examined the differences in how the simian and human forms of AIDS progress. The purpose of the story was NOT meant to suggest that the sudden loss of T cells is not the trigger of AIDS in humans, nor was there any intent to support the erroneous belief that HIV somehow does not cause AIDS. We regret any confusion that this may have caused. Links to the abstracts of the journal papers referred to above are provided below.

There is very little actual research cited in “House of Numbers.” It is shocking that Leung so radically misrepresented the only legitimate “evidence” for his HIV denialist theory, and that his source in fact affirms that HIV destroys T cells in humans, causing AIDS.

November 1, 2009

Notes

1. Tulane University (2007, September 26). Sudden Loss Of T Cells Is Not Trigger For AIDS, New Study Suggests. ScienceDaily. ^back^

2. Ivona V. Pandrea, Rajeev Gautam, Ruy M. Ribeiro, Jason M. Brenchley, Isolde F. Butler, Melissa Pattison, Terri Rasmussen, Preston A. Marx, Guido Silvestri, Andrew A. Lackner, Alan S. Perelson, Daniel C. Douek, Ronald S. Veazey, and Cristian Apetrei. Acute Loss of Intestinal CD4+ T Cells Is Not Predictive of Simian Immunodeficiency Virus Virulence. Journal of Immunology, 2007; 179: 3035-3046.

Shari N. Gordon, Nichole R. Klatt, Steven E. Bosinger, Jason M. Brenchley, Jeffrey M. Milush, Jessica C. Engram, Richard M. Dunham, Mirko Paiardini, Sara Klucking, Ali Danesh, Elizabeth A. Strobert, Cristian Apetrei, Ivona V. Pandrea, David Kelvin, Daniel C. Douek, Silvija I. Staprans, Donald L. Sodora, and Guido Silvestri. Severe Depletion of Mucosal CD4+ T Cells in AIDS-Free Simian Immunodeficiency Virus-Infected Sooty Mangabeys. Journal of Immunology, 2007; 179: 3026-3034.

Jeffrey M. Milush, Jacqueline D. Reeves, Shari N. Gordon, Dejiang Zhou, Alagar Muthukumar, David A. Kosub, Elizabeth Chacko, Luis D. Giavedoni, Chris C. Ibegbu, Kelly S. Cole, John L. Miamidian, Mirko Paiardini, Ashley P. Barry, Silvija I. Staprans, Guido Silvestri, and Donald L. Sodora. Virally Induced CD4+ T Cell Depletion Is Not Sufficient to Induce AIDS in a Natural Host. Journal of Immunology, 2007; 179: 3047-3056. ^back^

3. Tulane University (2007, September 26). Progression Of SIV Infection In Monkeys Points To Differences Between Human And Simian Forms Of AIDS. ScienceDaily. ^back^

Maggiore's labs

Eduard Grebe — Sun, 01 Nov 2009 07:00:00 +0000

"House of Numbers" offers new information about the late Christine Maggiore's experience with HIV testing. In the movie, her oral narrative and the dated lab reports on screen simply don't line up. What the film clearly shows by including the lab work is that Maggiore was HIV infected, and the reports suggest that her immune system controlled the virus well for some time. Commentary are placed in the blocks.

Christine Maggiore: “In 1992, I was encouraged by a doctor to take what’s called an HIV test as a mater of social responsibility, and I was shocked and devastated and horrified when the results came back positive. It was one of those moments that everyone fears their whole life. A week later, I take the same test to an AIDS specialist. He looks and says, this isn’t a positive test. I don’t know what this test means.”

The screen shows a lab report from Patricia O’Connell, NP, for Christine Maggiore, dated 02/24/92. Resolution is not good, but it looks like two bands—P24 and P120/160—of a Western Blot were reactive, the rest non-reactive. This VERY clearly is a positive test. The test interpretation instructions are below and she has a positive WB according to this test’s criteria (p24 and gp120).

Maggiore: “So I take the test again, and this time my results come back from the lab marked “’indeterminate.”

The screen shows part of a lab report in, with “Western blot” and “indeterminate” highlighted in yellow—bands from only 2 (GAG, ENV) of 3 groups positive. But it appears to have been a pretty thorough set of tests, include T-4 count etc. Interesting how shot is edited: column headings missing, no date, etc. NB: The second WB has different criteria – the same two bands are present but without a POL band this test will not be listed as positive. CD4 count (1040) and CD4/CD8 ratio (1.28) are comparable to an uninfected person and typical of someone who is controlling the virus very well immunologically. No date though.

Some denialists claim Maggiore refused treatment at this time, but with this CD4 count it would never have been offered. Indeed, Maggiore herself characterized the advice of her doctor at the time as 'wait 'til you get sick, and then we'll give you AZT.' This quote also contradicts another denialist myth, that asymptomatic people with HIV were routinely offered antiretroviral treatment.

Maggiore: “I’m faced with a decision: do I want to wait six weeks to test again, or do it right away? I opted for right away. My results that time come back positive.”

The screen shows another lab report, dated 9/23/93—nineteen months later. This is hardly “right away.” It is REACTIVE on every line—8 of 8 bands positive.

Maggiore: “Took it again, came back negative.”

The screen shows a lab report dated 08/09/93-six weeks BEFORE the test shown above. So the sequence of events she is narrating is not supported by the paperwork shown. The name on this report is Christina Maggiore, not Christine. Only a fragment is visible. NB: can’t tell if this one is an ELISA screen or a WB. It looks like an ELISA.

Maggiore: “I took it again—positive”

On screen, another lab report dated Sept. 29, 1993. This seems to be the one she took “right away”—six days after the solidly positive test. Sept 29, 93: HIV-1 EcG Confirmation [can’t read] Positive HIV-1 Ab 3g (?0 EIA 9.9 ]

Maggiore: "I’m very much opposed to the concept of mandatory testing of any population, because the tests are scientifically shown to be unreliable and inaccurate."

Landmark speech by South African President Jacob Zuma

Eduard Grebe — Fri, 30 Oct 2009 12:09:20 +0000

The Treatment Action Campaign's statement on the South African president's unequivocal repudiation of AIDS denialism in a speech to the upper house of the country's parliament:

Yesterday, President Jacob Zuma made one of the most important speeches in the history of AIDS in South Africa. In front of the National Council of Provinces (NCOP), he unequivocally acknowledged the devastation of AIDS on our country. With this speech state-supported AIDS denialism has been banished. The Treatment Action Campaign welcomes the ushering in of this new era, almost exactly ten years since former President Mbeki made a speech that began the era of state-supported denial in front of the NCOP.

President Zuma acknowledged that government’s efforts so far have been insufficient to curb the devastation of the epidemic. The reality of this has been declining health outcomes and increasing mortality. We have a crippled health system and a ballooning epidemic from the years of AIDS denialism and inaction by former President Thabo Mbeki and former Health Minister Manto Tshablala-Msimang. However, today’s speech puts that behind us and provides hope that President Zuma will urgently tackle the epidemic with renewed commitment to meet the treatment and prevention targets of the HIV & AIDS and STIs National Strategic Plan 2007-2011 (NSP).

In his speech, President Zuma acknowledged that the fear and shame that have surrounded the epidemic must be overcome. The spread of the epidemic is intimately connected to government’s ability to safeguard our human rights. All South Africans must feel secure to know their status and access and adhere to treatment without fear of discrimination.

President Zuma emphasized the need for behaviour change to reduce new infections by 50% from 2007 to 2011, the NSP prevention target. Changing behaviour must be facilitated by increased access to prevention services and by reducing the vulnerabilities to HIV infection in our society. Converting knowledge to behaviour change will be directly linked to these interventions.

A theme of the speech was that to turn the tide of the epidemic political will is needed not only by government but also by the citizens of South Africa. TAC and other civil societies have developed an active cadre of HIV activists in South Africa but this commitment to tackling the epidemic needs to be adopted throughout our society. As South African citizens we must actively engage with our own health and the health of each other. As active citizens we can overcome the stigma and discrimination that have driven the epidemic.

Key challenges remain to meeting the ambitious targets of the National Strategic Plan (2007 - 2011) for the treatment and prevention of HIV. But with the renewed political will demonstrated by President Zuma demonstrated by President Zuma and the leadership of Minister of Health, Aaron Motsoaledi, we believe these targets are achievable.

Joseph Sonnabend: House of Numbers is an AIDS denialist film

Eduard Grebe — Fri, 30 Oct 2009 11:52:58 +0000

Joe Sonnabend writes in his POZ blog:

House of Numbers is the title of a documentary film which according to its promotional material will "rock the foundations on which all conventional wisdom on HIV/AIDS is based"

I have seen the film. It is completely unable to achieve this grandiose objective. It is in fact an AIDS denialist film, despite the contention to the contrary by Brent Leung who made it.

The denialists are a disparate group who remarkably continue to believe that HIV cannot be the causative agent of AIDS either because it is harmless or because it does not exist. There are even those who believe that AIDS itself does not exist as a distinct disease entity. Of course there is no shortage of people with strange views that fly in the face of solid evidence. We can mostly just ignore them. But sometimes these views can be dangerous, and then we really do have to confront and challenge fallacious assertions that can lead to harm.

The Spectator is a weekly UK publication that had arranged a showing of the House of Numbers to be followed by a panel discussion of the film with audience participation. I had agreed to be one of the four panel members together with the filmmaker. Several people asked me not to participate in this event, probably with the thought that it was wrong to associate in any capacity with individuals who hold such outrageous views. There was also much activity on UK blogs, generally denouncing the Spectator event. It seems that a lot of people just did not want it to happen.

Two of the panel members withdrew so the event has now been cancelled. This is a pity. The film is as I said, dangerous. It is dangerous specifically because it presents antiviral treatments as only toxic with no mention of their benefits. Therefore it is justified to be very concerned that some people who need treatment may be dissuaded from receiving it after seeing the film.

I do accept that it is right to not prohibit individuals from expressing their views, no matter how distasteful. But when these views carry danger it is particularly important that they be challenged with valid information. It is absolutely wrong to ignore the film and allow it a free hand in spreading misinformation. As I have experienced when I was a member of President Mbeki's panel in S. Africa, it is impossible to argue with those who hold such denialist views. They are impervious to reason. It is therefore pointless to engage them in discussion. However, when their position is presented to the public, then it is right to try to expose the fallacy of their views to those who might be influenced by them and thus may come to harm as noted above regarding HIV infected people in need of treatment.

I should explain why this is definitely a denialist film despite the protestations of its director that it is not.

In providing a more or less equal, uncritical and essentially neutral platform to those holding denialist views together with those who do not, the filmmaker, presenting himself as an unbiased observer merely asking questions, puts forward the impression that the issue of HIV's role in causation remains unsettled. Although the film does not explicitly reject HIV as playing a causative role in AIDS, it most certainly leaves one with the impression that this, and even the existence of the virus, is merely conjecture. This is a misleading presentation of the well established causative link between HIV and AIDS as something that is just a theory, on a par with the theories of Dr Duesberg or of those who claim that HIV does not exist.

This is absurd and as I explained, also dangerous.

Read the full post.