AIDSTruth.org

New study shows AIDS deaths under-recorded in South Africa

Eduard Grebe — Mon, 06 Jul 2009 08:30:25 +0000

Former South African President Thabo Mbeki disputed that there was a large AIDS epidemic in South Africa. (1) This was a cornerstone of his promotion of denialist policies. It was echoed by journalist Rian Malan in articles he wrote in Rolling Stone, the Spectator and Noseweek. (2) Mbeki expressed his scepticism when a state institution, the Medical Research Council, released a report titled Adult Mortality in South Africa. It presented unequivocal evidence that HIV was a growing and major cause of death in the country. (3) Mbeki's health minister, Manto Tshabalala-Msimang, tried to suppress the publication of this report. (4)

Over the last decade, the evidence of the country's large AIDS epidemic has accumulated. It is perhaps most succinctly explained with this graph, which demonstrates the unusual and disturbing changing age-pattern of death among adult women in South Africa from 1997 to 2004 , that can only be explained by the AIDS epidemic:

Source: http://www.tac.org.za/community/node/2182

The graph shows how in 2004 the vast majority of female adult deaths occur in young adults as opposed to older ones (compared with Brazil in 2004 and South Africa in 1997). The same pattern occurs in males, albeit that it is not quite as stark.

One of the arguments raised by Malan is that HIV was ranked quite low as a cause of recorded deaths in Statistics South Africa's mortality data and therefore was not a major cause of death. Malan is wrong: many doctors do not write HIV or AIDS as the cause of death on death notification forms (the source of Stats SA's mortality data). There are probably two reasons for this: (1) the disease is highly stigmatised and doctors do not want to put surviving family members at risk of discrimination, despite the fact that death certificate data is supposed to be confidential, and (2) patients with AIDS often die without finding out their status.

A new study has been published in AIDS that confirms this, i.e. that doctors often do not write HIV, AIDS or even a euphemism for these terms (such as retroviral disease or immunocompromised) on death notification forms of people who have died of AIDS.

Patricia Yudkin and her colleagues examined the medical records of all people 28 days or older who died in two suburbs in Cape Town from 1 June 2003 to 31 May 2004. 683 death notification forms were included in their final analysis. (5) Two doctors independently analysed the medical records to determine if AIDS was the cause of death. In the case of a conflicting diagnosis, a third doctor decided. They identified 129 deaths caused by HIV according to medical records. Yet only 35 (27.1%) were ascribed to AIDS on the death notification form. When the various euphemisms for AIDS were accounted for (known as interpretive coding) only 83 (64.3%) indicated AIDS.

With one exception (a 12% sample of all the mortality data published seven years ago), Stats SA reports since 2001 have classified a death as HIV/AIDS only if explicitly coded as such on the death notification form. They do not use interpretive coding because it would be extremely time-consuming to classify all the country's deaths this way.

Only one death was noted as AIDS on a death notification form but not classified as such by the study doctors, though even in this case the death was suggestive of HIV. The method of classification used by Yudkin et al. would still not have identified deaths of people who died of AIDS before presenting to a health facility or private doctor for diagnosis.

This study provides further evidence against the dogma that there is not a large HIV epidemic in South Africa.

References

1. Cherry M. Mbeki disputes AIDS statistics [Internet]. Nature Medicine. 2001 Nov ;7(11):1170.[cited 2009 Jul 4 ] Available from: http://www.popline.org/docs/1558/175308.html

2. Geffen N. Rian Malan Spreads Confusion about AIDS Statistics [Internet]. 2004 Jan 20;[cited 2009 Jul 5 ] Available from: http://www.tac.org.za/newsletter/2004/ns20_01_2004.htm

3. Dorrington R, Bourne D, Bradshaw D, Laubscher R, Timæus IM. The Impact of HIV/AIDS on Adult Mortality in South Africa [Internet]. 2001 Sep ;[cited 2009 Jul 5 ] Available from: http://www.mrc.ac.za/bod/complete.pdf

4. Cape Argus. Minister demanded 'corrective action' at MRC [Internet]. 2002 Apr 17;[cited 2008 Dec 29 ] Available from: http://www.capeargus.co.za/index.php?fSectionId=3571&fArticleId=ct200204...

5. Yudkin P, Burger E, Bradshaw D, Groenewald P, Ward A, Volmink J. Deaths caused by HIV disease under-reported in South Africa [Internet]. AIDS. 2009 Jun 10;[cited 2009 Jul 5 ] Available from: http://www.ncbi.nlm.nih.gov/pubmed/19521232

Justice After AIDS Denialism: Should There Be Prosecutions and Compensation?

Eduard Grebe — Wed, 01 Jul 2009 22:28:55 +0000

AIDSTruth member and Treatment Action Campaign treasurer Nathan Geffen writes in the Journal of Acquired Immune Deficiency Syndromes:

Edward Mabunda

Edward Mabunda died on April 9, 2003. At least another 600 people died of AIDS in South Africa that day.(1) Edward was just 36 years old. He left behind a wife and 3 children. He was also a leader in the Treatment Action Campaign (TAC). He became an icon of the movement because of the fiery poetry that he recited to thousands of people. His poems urged former President Thabo Mbeki to make antiretrovirals (ARVs) available in South Africa’s public health system. He died because he could not obtain these life-saving medicines in time.(2)

From 1999 to 2007, Mbeki and his Minister of Health Manto Tshabalala-Msimang obstructed and then undermined the implementation of highly active ARV treatment (HAART) and prevention of mother-to-child transmission of HIV in the public health system. Two studies, conducted independently of each other, conservatively calculated that over 300,000 people died because of Mbeki’s AIDS denialist policies.(3–5) Edward Mabunda was one of them. These studies could not account for additional deaths due to the promotion of quackery, often with the health minister’s support. They also did not consider the number of infections that occurred because of the confusion generated by the insipid state-funded prevention campaign and the messages by some outspoken Mbeki supporters dismissing the link between sex and HIV infection.(6) The Mbeki era also fostered a profound mistrust of scientific medicine, the consequences of which also cannot be quantified.

Read the full article in JAIDS.

Or, if you don't have a subscription, read it at Denying AIDS and other odditites.

Reference: JAIDS Journal of Acquired Immune Deficiency Syndromes: June 30, 2009 - Volume Publish Ahead of Print. doi: 10.1097/QAI.0b013e3181ab6da2

Patients returning after interrupting HIV care have a high risk of short-term illness and death

Eduard Grebe — Tue, 30 Jun 2009 23:10:50 +0000

Aidsmap reports:

HIV-positive patients who return to care after being lost to follow-up are five times more likely to die in the short term than patients who remain in HIV care, French investigators report in the online edition of AIDS.

“Increased efforts are needed to reduce loss to follow-up and encourage those patients who no longer attend clinic to return to care,” recommend the authors.

Thanks to effective antiretroviral treatment, the prognosis of many HIV-positive individuals is now near-normal. However, despite the benefits of treatment and care some patients stop attending their HIV clinic.

Read the full article on Aidsmap.

Ndiaye B et al. Characteristics of and outcomes in HIV-infected patients who return to care after loss to follow-up. AIDS 23 (online edition), 2009. doi: 10.1097/QAD.0b013e32832e3469

Abstract

The objective of this study was to evaluate the characteristics of and outcomes in HIV-infected patients who returned to care after loss to follow-up (LTFU) in Northern France, between 1997 and 2006. Among the 1007 patients who were followed, 135 patients (13.4%) were LTFU during the study period. Of these 135, 74 (54.8%) returned to care after LTFU. The median duration of LTFU was 19 months. Upon returning to care, 33 out of 74 patients (44.6%) had CD4 cell counts less than 200/mm3 and/or AIDS. Patients who returned to care after LTFU were five times more likely to die than patients who attended clinic regularly.

AIDS denial: A lethal delusion

Eduard Grebe — Mon, 22 Jun 2009 23:51:30 +0000

Jonny Steinberg writes in New Scientist:

ON 27 December 2008, a well-heeled 52-year-old woman died in a Los Angeles hospital. Her death certificate describes a body riddled with opportunistic infections typical of the late stages of AIDS. Christine Maggiore had tested HIV positive 16 years earlier, but she had shunned ART, the antiretroviral therapy that stops HIV replicating and prevents AIDS.

This was not the first time a death in Maggiore's family had made headlines: five years earlier her 3-year-old daughter Eliza Jane had died. The autopsy described a chronically ill little girl who was underweight, under-height, and had encephalitis and pneumonia - all AIDS-related. When pregnant, Maggiore had again rejected ART and she had breastfed Eliza Jane, another way of transmitting the virus.

Why, in 21st-century California, would a middle-class woman and her young daughter die like this when there is tried-and-tested treatment for their illness? The answer lies in a bizarre medical conspiracy theory that says AIDS is not caused by HIV infection (see Five myths about HIV and AIDS).

It is tempting to dismiss the so-called AIDS denialism movement out of hand, but it has a strong internet presence, with a plethora of websites and blogs that can mislead the unwary. While the movement has lately suffered some significant blows to its credibility, it has in the recent past wielded extraordinary influence, especially in southern Africa, the centre of the world's AIDS epidemic. "Denialism has been relegated to the fringes of the internet, but it isn't of no consequence," says John Moore, an immunologist at Weill Cornell Medical College, Ithaca, New York, and one of the world's foremost AIDS researchers. "It can still cost the lives of unsuspecting people."

Read the full article

Five myths about HIV and AIDS

Eduard Grebe — Mon, 22 Jun 2009 23:48:35 +0000

Jonny Steinberg writes in New Scientist:

Despite the overwhelming evidence that HIV causes AIDS, a hardcore group still denies it (see AIDS denial: A lethal delusion). We explore five of the most common myths about AIDS.

MYTH: AIDS is not caused by HIV

DEBUNKING: This is the biggie, of course. As long ago as 1983, researchers first isolated HIV from people with AIDS. By 1985, they had developed a test showing that the overwhelming majority of people with AIDS have antibodies to HIV in their blood. They also showed that people who test HIV-positive and initially appear healthy go on to develop AIDS the vast majority of the time unless they are treated.

Read the full article

Study shows the prognostic value of HIV viral load counts and CD4 counts for predicting AIDS and death

Eduard Grebe — Mon, 22 Jun 2009 13:34:11 +0000

Korenromp EL, Williams BG, Schmid GP, Dye C (2009) Clinical Prognostic Value of RNA Viral Load and CD4 Cell Counts during Untreated HIV-1 Infection—A Quantitative Review. PLoS ONE 4(6): e5950. doi:10.1371/journal.pone.0005950

The purpose of the study was to determine if the current World Health Organisation criteria for commencing HAART are appropriate. The study abstract concludes:

Findings support the current WHO recommendation (used with clinical criteria) to start antiretroviral treatment in low-income settings at CD4 thresholds of 200–350 cells/µL, without pre-treatment RNA monitoring – while not precluding earlier treatment based on clinical, socio-demographic or public health criteria.

Interestingly, the authors found:

Mean relative risks per 10-fold higher RNA were 2.0 (95% confidence interval (CI): 1.8–2.5) for AIDS (12 studies, 17 datapoints) and 2.5 (2.1–3.0) for death (9 studies, 10 datapoints). These prognostic risks did not vary over time after seroconversion, or with duration of follow-up, geographical region, baseline CD4, use of antiretroviral mono-/bi-therapy, or average clinical progression rates.

They also found:

In contrast, relative risks per 100 cells/µL lower CD4 increased with time after seroconversion, for both AIDS (10 studies, 14 datapoints) and death (7 studies, 8 datapoints): from 1.0 at seroconversion to an estimated 3.0 (95% CI 2.6–3.4) by 6 years for AIDS (p<0.0001 for trend), and to 2.8 (1.9–3.7) for death (p<0.0001). In multivariate regression, this pattern was not modified by duration of follow-up, geographical region, baseline CD4, use of antiretroviral mono-/bi-therapy or average progression rates.

In other words, viral load and CD4 count predict death. Coupled with the immense evidence that HAART reduces viral load and increases CD4 counts, these findings are, of course, incompatible with AIDS denialist theories.

Clarification on false claims made in emails circulating on the Internet

Eduard Grebe — Mon, 22 Jun 2009 13:32:54 +0000

We have learnt that Dr Jim Murtagh has made false claims about his relationship with some members of aidstruth.org in email correspondence with AIDS denialists. We do not wish to be drawn into the squabbles of people not associated with us. Nevertheless, we print the following clarification to rectify confusion generated by Dr Murtagh's emails:

Dr Murtagh is not a member of aidstruth.org. We are not affiliated with him. The members of aidstruth.org can be found on our About page.
This website receives no funding other than the personal contributions of some of its members to cover hosting costs.
Contrary to Dr Murtagh's claims, neither the Treatment Action Campaign (TAC) nor any other organisation in which members of aidstruth.org have a leadership role support Dr Murtagh financially or materially.
No members of aidstruth.org were aware that Dr Murtagh would make false claims in emails. We find such behaviour repugnant.
No leaders of the TAC are involved with Dr Murtagh or his dealings.
Contrary to suggestions in Dr Murtagh's emails, a judgment of the Cape High Court has found no evidence that the TAC has any financial relationship with the pharmaceutical industry. On the contrary, the court found it unlikely that the TAC would have such a relationship. The same court interdicted an individual and two organisations for falsely claiming the organisation was funded by the pharmaceutical industry.

Clark Baker - Ex-cop and homophobic right-wing blogger

Eduard Grebe — Thu, 11 Jun 2009 13:40:45 +0000

by Jeanne Bergman

Clark Baker is a former Los Angeles police officer who was fired in 1991 after being convicted of battering a jaywalking immigrant. The conviction was later overturned on appeal—not on the facts of the case but on grounds of prosecutorial misconduct.^¹ Baker has since worked as a licensed private investigator, often, he says, without pay. Baker has a few blogs and websites where he posts his own reactionary opinions^² as well as pieces by other conservative conspiracy theorists.

Baker says that he knew nothing about HIV/AIDS until 2008, when, through his relationship with an obstetrician named Gil Mileikowsky, he became involved with members of the Semmelweis Society International (SSI), a small group of physicians opposed to the abuse of professional peer review. SSI was embroiled in controversy: Miliekowsky had engineered the giving of its “Clean Hands” award to denialists Celia Farber and Peter Duesberg and many members, when they learned that these are HIV denialists, objected. Baker, who has no training or professional experience in science or medicine and apparently no college education at all, muscled his way into control of Semmelweis and rocketed to the forefront of the HIV dissident movement’s scientific and strategic leadership.

Baker has given varied accounts of how he became involved in HIV denialism. He writes that SSI then-president Roland Chalifoux, an osteopathic neurosurgeon, asked him “to conduct an independent investigation of Farber and Prof. Duesberg, citing [Baker’s] investigative experience, independence, and almost complete lack of knowledge about HIV and AIDS.”^³ But in a panel presentation in Nashville in April, 2009, he said that an AIDS physician asked him to investigate allegations that denialist Peter

Duesberg is guilty of genocide for the AIDS deaths of millions in South Africa. When his investigation progressed, he said, that same physician tried to get him to stop, presumably because Baker supported the denialists. Baker’s stories don’t match up, but in any case, his “investigation” resulted in an incoherent and error-riddled “report” that he called “HIV, AIDS, and Gallo’s Egg.” He has posted it widely on denialist websites and right-wing blogs.

In “Gallo’s Egg,” Baker lurches back and forth between copying internal Semmelweis emails about Farber and Duesberg and, in his “Investigator’s Response” to the issues raised, regurgitating well-worn denialist falsehoods and misinterpreted anecdotes. Throughout the document, Baker demonstrates his complete lack of basic knowledge about disease processes, viruses, the immune system, HIV screening and diagnosis, scientific research and publication protocols, and medicine. Here is a small sample of his compound errors of fact and analysis from a much longer list:

Baker claims that HIV doesn’t cause AIDS in chimps, and therefore it can’t cause AIDS in humans. This canard is wrong both factually and logically.^⁴
Baker challenges the proven fact that HIV is spread through sex by citing Nancy Padian’s study, reiterating other denialists’ misinterpretations of her evidence, which shows that safer sex prevented transmission of HIV in a sample of serodiscordant heterosexual couples.

In search of evidence of a pharma-funded conspiracy, Baker contrasts the FDA’s decision to give Crixivan approval six weeks after Merck applied for it to “110 clinical tests before approving Splenda.” In fact, the FDA gave accelerated approval of Crixivan in 1996 after 14 clinical trials (clinical trials must precede the request for approval) and traditional approval in 1998, after additional longer and larger studies. ^⁵
Baker confuses the immune system’s creation of antibodies to external pathogens with “the autoimmunity response.”

Reviewing an internal Semmelweis email from member Kevin Kuritzky that describes a lecture by Duesberg, Baker concludes the “anecdote is doubtful,” because Duesberg teaches at Berkeley and Kuritzky was at Emory, “three time zones east.” Unfamiliar with academic settings, Baker may not know that professors often give lectures on campuses other than their own.^⁶
Baker improperly and randomly references single studies to make false claims. He charges, for example, that perinatal ARV prophylaxis “is dangerous for both mother and child,”^⁷ and cites just one 15-year-old AZT study. In fact, the evidence is overwhelming that ARVs effectively prevent vertical HIV transmission and pose no significant risk of harm to mother or baby.

Baker thinks the standard term “antiretroviral medications” is “Orwellian,” and that the “primary ‘medicine’ is AZT.” The term is an accurate description of the drugs’ purpose and effect, and, while some combination therapies still include AZT, zidovidine is neither “the primary medicine” nor is it toxic at currently prescribed dosages.
In an effort to dispute the accuracy of HIV testing, Baker writes: “To prevent terrorists from boarding planes (or HIV in our blood supply), HIV test sensitivities are set so that Jimmy’s orthodontics and Grandma’s titanium hips activate the alarms. Once those alarms sound, the tests brand them as suspected terrorists.” Baker’s thinking here is chaotic and disorganized—HIV screening tests react to the presence of antibodies in the bloodstream, not to metal, and are not used to screen for terrorists—but he is partially right to analogize the ELISA tests to pre-flight screening. What he doesn’t understand is that his analogy illustrates the screening function of the antibody test: it is not designed to diagnose HIV without confirmation. Both pass-through metal detectors and ELISA tests are highly sensitive screening technologies that react to potential problems that must then confirmed (or cleared) by additional tests. For HIV antibodies, the confirming HIV is the Western Blot (the gold standard), and for airport screening, a wand or pat search. In both cases, further positive results generate additional investigation.

Baker’s core thesis, which emerges only gradually and partially in “Gallo’s Egg” but that he states more aggressively elsewhere,^⁸ is that Dr. Robert Gallo’s work on HIV was fraudulent, and that the discovery of HIV and the determination that it causes AIDS by destroying the immune system was unsupported by evidence then and has not been replicated since. Baker is wrong on every one of these points. He doesn’t understand the nature of the controversy over the co-discovery of HIV by Gallo’s lab at the National Cancer Institutes and the Pasteur Institute’s Luc Montaignier and Françoise Barré-Sinoussi.^⁹ Baker apparently believes that Gallo’s discoveries were merely theories floated without evidence, and that they were never replicated. He refers to Gallo’s “original opinion” (as opposed to evidence-based findings) and claims that it is “disingenuous for any scientist to argue any research that is based upon Dr. Gallo’s theory without proof that HIV a) actually exists, b) kills white blood cells, and c) causes AIDS. Consensus, based upon unproven hearsay, is not proof.” He seems not to know that all of these things have indeed been proven, beyond any doubt. HIV has been isolated thousands of times since 1984, and that there is abundant, indeed overwhelming, published evidence that the retrovirus HIV actually exists (even Duesberg has shown this), and that HIV infection results in destruction of CD4+ T-cells (what Baker calls “white blood cells”). The result is a marked defect in the T-Helper arm of the immune system, without which opportunistic infections can rage unchecked.^¹⁰ This state is advanced HIV disease—AIDS—which, without treatment, will in almost all cases lead to death.^¹¹

Emboldened by the denialists’ enthusiastic admiration of “Gallo’s Egg,” Baker broadened his scientific theorizing. In a post on another of his websites, www.cwbpi.com, he reviews the narrative of HIV+ denialist Karri Stokely and concludes

that the antiretrovirals Combivir and Sustiva are actually addictive antidepressants—he specifies that they are SSRIs and MAOIs—because Ms. Stokely says that she was unwell for months after quitting treatment. “Intentional or not, by marketing this class of drugs (MAOIs and SSRIs) as ‘AIDS medications,’ the pharmaceutical industry has built into its HIV cocktails a mechanism that punishes HIV patients when they interrupt their drug use.”^¹² Incredibly, Baker seems actually not to know that the chemical composition and biological action of a medication are relevant to the classification of the drug. He does not know what kind of drugs Crixivan and Sustiva are, or what they do, or even why patients are urged to taper off many medications, not just antidepressants.

So what does Baker say is the cause of AIDS, if not HIV? “It’s a lifestyle disease,” he asserted in Nashville in April. And in a spasm of vicious homophobia on the Semmelweis website, which he took over and now uses as another of his personal blogs, he wrote that AIDS began when “a small group of promiscuous, addicted, nitrite-huffing, gonorrheal and syphilitic bath house veterans began to get sick.” ^¹³ “Faced with the imminent loss of funding, Gallo and his goons needed a new virus that they could frighten Americans with. At the same time, gay activists wanted the world to believe that their lifestyle had nothing to do with their symptoms. If lifestyle was blamed, individuals would be responsible.” ^¹⁴ Baker has exhumed the oldest and most stigmatizing lie about HIV disease: that gay men and other people get it not from an infectious pathogen but because they lead immoral, irresponsible lives. This scientifically illiterate homophobe is the man whom Duesberg, Farber, and the rest of the HIV denialists have embraced as their researcher, colleague and spokesperson.

Jeanne Bergman

AIDStruth.org

June 9, 2009

1 According to the L.A. Times, Baker’s conviction was overturned on appeal in 1994 when the Superior Court found that “the prosecutor improperly invited jurors to reform the Police Department after other LAPD officers were acquitted of beating Rodney King” just 8 months before. “The judges ruled that prosecutor David Sotelo's repeated references to the King case during an emotionally charged period had denied Baker a fair trial, and in effect made Sotelo an unsworn witness at the trial. The judges also found misconduct by Judge McBeth, saying she failed to curb Sotelo's remarks, and ruled that defense attorney Bob Wilson, by not objecting to the remarks, failed to provide effective counsel.” Ann W. O’Neill, “Court Voids Policeman's Conviction - Jurisprudence: Appeals panel throws out the case against a Valley traffic officer accused of assaulting a jaywalker.” L.A. Times, April 29, 1994.

2 See, for example, “Obama sows the Seeds of Fascism,” posted on Baker’s blog exlibhollywood.blogspot.com on May 2, 2009, or his tirade against affirmative action, Judge Sonia Sotomayor, and Barack Obama in “The Problem with Race, Empathy, and Social Justice,” posted on May 26, 2009.

3 exlibhollywood.blogspot.com; posted July 20, 2008.

4 Novembre, F.J. et al. Development of AIDS in a chimpanzee infected with human immunodeficiency virus type 1. Journal of Virology 71(5): 4086-4102. May 1997.

5 Not surprisingly, drugs urgently needed for life-threatening illnesses are handled differently by the FDA than are artificial sweeteners like Splenda. AIDS activists have pressured Pharma for expedited, responsive drug development protocols and access to affordable treatment from the earliest days of the epidemic. Baker lacks the most basic knowledge of the drug development and approval process.

6 Celia Farber, who told the NY Post’s gossip columnist that she is suing Kuritzsky and two others for libel, references the same email in the lawsuit in an attempt to impeach Kuritzsky’s truthfulness. She says Kuritzsky “falsely represented himself as a student of Dr. Duesberg” (posted at http://www.scienceguardian.com/blog/celia-farber-fights-back.htm). Clark Baker is proud of his close association to Celia Farber and has said that “evidence” he collected is the basis for her lawsuit. Baker and Farber are wrong: Kuritzsky didn’t write that he was a student of Duesberg’s—he just wrote that Duesberg gave a lecture. A competent journalist or investigator would have fact-checked this.

7 Emphasis in the original.

8 In a May 5, 2009, blog posting, Baker wrote that Gallo’s “unproven opinions have since become the basis for all of AIDS policy in the US and around the world at a cost that approaches $1 trillion in US taxpayer dollars since 1981. The fact that Dr. Gallo’s Institute of Human Virology still receives millions of research dollars annually despite having been found guilty of scientific misconduct in 1992 is equally troubling. But like Bernie Madoff’s pyramid scheme, Gallo’s initial fraud gave birth to a trillion dollar fraud scheme that is now simply too big to fail.”

9 At issue was whether Gallo had himself had first isolated the retrovirus, or if the retrovirus he found was from a sample sent to him by Montagnier that had contaminated Gallo’s culture. It has since been proven that Montagnier’s lab in fact first isolated HIV, using techniques developed by Gallo, and that Gallo was the first to show that HIV causes AIDS. Years later, the Office of Scientific Integrity Review, part of the US Department of Health and Human Services, concluded that Gallo had committed scientific misconduct by making statements about the French virus that were untrue, thereby promoting his own laboratory’s ascendance in HIV research. (HHS withdrew that finding in 1993, around the time Baker was appealing his conviction for battering a civilian.) For a thorough, if awkwardly written, overview of the history of the messy discovery of HIV see Anders Vahine’s “A Historical Reflection on the Discovery of Human Retroviruses,” Retrovirology 2009, 6:40 (www.retrovirology.com/content/6/1/40, and posted on www.AIDStruth.org.

10 Defects in the B-cell antibody producing arm of the immune system do not appear to be as severe as in the T-helper arm. Fungi, cancers, and certain viruses like CMV are characteristic of AIDS. For more on exactly how HIV damages the immune system and accurate responses to other denialist lies, see Nick Bennett’s posts on his blog, especially “Latest BMJ Rebuttal” on October 1, 2004, at http://aidsmyth.blogspot.com/2004_10_01_archive.html, and his June 8, 2009 post, “HIV Kills T Cells...And Doesn't Need Help to Do It” at http://aidsmyth.blogspot.com/2009/06/hiv-kills-t-cellsand-doesnt-need-he....

11 See http://www.avert.org/evidence.htm for a brief, cogent review of the proof that HIV exists and destroys the immune system.

12 www.cwbpi.com, posted May 25, 2009.

13 http://www.semmelweis.org/2009/06/02/doctors-without-boundaries. Emphasis mine.

14 ibid.

NIAID: Starting antiretroviral therapy earlier yields better clinical outcomes

Eduard Grebe — Wed, 10 Jun 2009 14:41:30 +0000

NIH/National Institute of Allergy and Infectious Disease

Interim review leads to early end of clinical trial in Haiti

A clinical trial has demonstrated that HIV-infected adults in a resource-limited setting are more likely to survive if they start antiretroviral therapy (ART) before their immune systems are severely compromised.

On May 28, 2009, an independent data and safety monitoring board (DSMB) met to conduct a planned interim review of an ongoing clinical study known as CIPRA HT 001, which is being conducted in Haiti. The DSMB found overwhelming evidence that starting ART at CD4+ T cell counts—a measure of immune health—between 200 and 350 cells per cubic millimeter (mm3) improves survival compared with deferring treatment until CD4+ T cells drop below 200 cells/mm3. In light of these results, the DSMB recommended that the trial sponsor—the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health—end the trial immediately, before its scheduled conclusion. NIAID agreed with the DSMB recommendation, and all study participants who have fewer than 350 CD4+ T cells/mm3 will be offered ART.

The study investigators say this new finding has the potential to change the standard of care for HIV infection in dozens of countries around the world where ART is initiated only when CD4+ T cell counts drop below 200 cells/mm3. Like the results of several recent epidemiologic studies in developed countries that examined the optimal time to begin ART, the new finding underscores the importance of identifying people who are HIV-infected earlier in the course of their infection and starting ART earlier.

"The public health community now has evidence from a randomized, controlled clinical trial—the gold standard—that starting ART at CD4+ T cell counts between 200 and 350 cells/mm3 in resource-limited settings yields better health outcomes than deferring treatment until CD4+ T cell counts drop below 200 cells/mm3," says NIAID Director Anthony S. Fauci, M.D.

"The number of people who meet the medical criteria for receiving ART likely will grow as treatment guidelines are revised as a consequence of this finding, challenging the global community to supply antiretroviral drugs to all who need them," adds Carl Dieffenbach, Ph.D., director of the NIAID Division of AIDS. "Today, only 30 percent of HIV-infected individuals in low- and middle-income countries who need ART are receiving it."

The clinical trial CIPRA HT 001 began in 2005. It is funded by NIAID through the Comprehensive International Program of Research on AIDS (CIPRA) and is being carried out by the Haitian Group for the Study of Kaposi's Sarcoma and Immune Deficiency Disorders (GHESKIO) Centers in Port-au-Prince, Haiti. The principal investigator is Jean William Pape, M.D., the director of the GHESKIO Centers and a professor of medicine at Weill Medical College of Cornell University.

The trial enrolled 816 HIV-infected adults ages 18 and older with early HIV disease and CD4+ T cell counts between 200 and 350 cells/mm3. Half of the participants were assigned at random to begin ART within two weeks of enrollment, and the other half were assigned to defer treatment until their CD4+ T cell counts dropped below 200 cells/mm3 or they were diagnosed with AIDS. This deferred treatment is in keeping with the standard of care in Haiti and the current guidelines of the World Health Organization (WHO). The first-line treatment regimen consisted of the anti-HIV drugs zidovudine, lamivudine and efavirenz.

At the time of the DSMB interim review, six participants in the early treatment group had died, while 23 participants in the standard-of-care group had died—nearly four times as many. The DSMB also found that, among participants who began the study without tuberculosis (TB) infection, 18 people in the early treatment had developed TB, while 36 people—twice as many—in the standard-of-care group had developed TB. These results were statistically significant.

In light of these results, the DSMB recommended that NIAID end the trial immediately and that the study team offer ART to all participants in the standard-of-care group who have fewer than 350 CD4+ T cells/mm3. The DSMB also recommended that the study team continue to follow all participants for another year and make every effort to ensure that participants receiving ART continue their therapy. NIAID concurred with these recommendations.

The study investigators are notifying all participants and have notified institutional review boards and national ethics committees involved with CIPRA HT 001 as well as the Haitian Ministry of Health about the findings of the DSMB. Investigators also have shared the information with WHO, the U.S. President's Emergency Plan for AIDS Relief, and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Questions and Answers: The CIPRA HT 001 Clinical Trial

A historical reflection on the discovery of human retroviruses

Eduard Grebe — Thu, 04 Jun 2009 00:03:36 +0000

by Anders Vahlne (Clinical Virology and Division of Clinical Microbiology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden)

Originally published in Retrovirology 2009 6:40; doi:10.1186/1742-4690-6-40.

Abstract

The discovery of HIV-1 as the cause of AIDS was one of the major scientific achievements during the last century. Here the events leading to this discovery are reviewed with particular attention to priority and actual contributions by those involved. Since I would argue that discovering HIV was dependent on the previous discovery of the first human retrovirus HTLV-I, the history of this discovery is also re-examined. The first human retroviruses (HTLV-I) was first reported by Robert C. Gallo and coworkers in 1980 and reconfirmed by Yorio Hinuma and coworkers in 1981. These discoveries were in turn dependent on the previous discovery by Gallo and coworkers in 1976 of interleukin 2 or T-cell growth factor as it was called then. HTLV-II was described by Gallo's group in 1982. A human retrovirus distinct from HTLV-I and HTLV-II in that it was shown to have the morphology of a lentivirus was in my mind described for the first time by Luc Montagnier in an oral presentation at Cold Spring Harbor in September of 1983. This virus was isolated from a patient with lymphadenopathy using the protocol previously described for HTLV by Gallo. The first peer reviewed paper by Montagnier's group of such a retrovirus, isolated from two siblings of whom one with AIDS, appeared in Lancet in April of 1984. However, the proof that a new human retrovirus (HIV-1) was the cause of AIDS was first established in four publications by Gallo's group in the May 4^thissue of Science in 1984.

Background

Unfortunately the omission of the American scientist Robert C. Gallo from the 2008 Nobel Prize in Medicine or Physiology for the discovery of HIV by many has been viewed as a final scientific verdict handed down by the Nobel committee of the Karolinska Institutet on an old controversy between the Institute Pasteur and NIH and that previous settlements were for political reasons only. Also, the decision to omit Gallo has resulted in the resurrection of false allegations in the media that Gallo and coworkers at NIH had rediscovered or even stolen the French HIV isolate previously sent to them from the Pasteur Institute. Thus, it could be interpreted as if the Nobel committee finally had put right an unjust settlement previously obtained between the French and American scientific groups. There is no doubt or controversy about the fact that the French group was first to isolate this new virus. This is what the Nobel committee chose to award.

Two years ago I had the privilege to painstakingly and thoroughly go through all the literature related to the discovery of HIV. Since the motivation for the Prize by the Nobel Committee is very limited and the fact that the Committee members cannot comment on how they came to their decision, I think it is important that the medical community gets the correct historical facts about this important discovery. Therefore, I have written this article. I would say that what I present below is a fair and accurate account on the events and work that led to the discovery of a new virus as the cause of AIDS. Regarding whom should get the credit for the discovery of HIV, this review should enable the reader to come to his or her own conclusion. Mine, however, is different from that of those of my fellow faculty members that presently make up the Nobel Committee for the Nobel Prize in Physiology or Medicine. I will here show that by going through the literature it is evident that Gallo's group was not only first to show that HIV is the cause of AIDS but that the French group had not been able to discover this new virus without the active assistance of, as well as, previous work by Gallo. It will also be evident that Gallo and his associates had no reason to "steal" any French isolate. Last year this journal published another account of the 2008 Nobel Prize [1].

Paving the way for the discovery of HIV

Isolation of a virus means infection, propagation and (usually cell free) transmission of an infectious agent in cultured cells. New viruses, for which there are no susceptible cells in culture, have lately also been detected solely by molecular techniques, e.g. hepatitis C virus by using a random-primed complementary DNA library from an infected patient (Michael Houghton) and subtypes of human papilloma viruses by using hybridization under low stringency and subsequent DNA cloning (Harald zur Hausen).

The difficulty in isolating a new virus is choosing the right cell culture and detection systems and to obtain specimens containing the virus. With a susceptible cell culture system and a detection system available, isolation of a new virus is not only possible but also rather straightforward. In the case of HIV, before the successful isolation of the first human retrovirus (human T-cell leukemia virus, now human T-cell lymphotropic virus type I; HTLV-I) by Robert C. Gallo [2], neither was at hand.

After the discovery of reverse transcriptase from animal oncogenic RNA viruses (then called oncorna viruses and now called retroviruses) a large number of publications on putative discoveries of retrovirus detections in human malignancies appeared in the early 1970-ties. However, they were all either owing to contaminations in the laboratories with animal retroviruses or the mitochondrial DNA-polymerase γ, the latter when the reports were based on reverse transcriptase activity alone. DNA-polymerase γ is a normal cellular DNA polymerase which uses RNA as a primer but not as a template. Therefore, like reverse transcriptase, the activity of DNA-polymerase γ was sensitive to a ribonuclease treatment [3-5]. This cellular enzyme was not known at the time. In 1972 Gallo's group [3] reported that stimulated normal human lymphocytes contained a ribonuclease sensitive DNA polymerase distinct from viral RNA-directed DNA polymerase, an enzyme that Gallo's group characterized further in a number of publications. The enzyme prefers Mn²⁺. Unlike DNA polymerases α and β, the preferred primer-template for DNA-polymerase γ is (dT)≅15·(A)n over (dT)≅15·(dA)n! This third cellular DNA polymerase was independently from Gallo discovered by Art Weissbach and they later named it DNA-polymerase γ[6].

From the numerous and erroneous reports on retroviruses in various human cancers, the notion of human cancer viruses became in ill repute and rather than talking of "human tumor viruses" people in science talked of "human rumor viruses". In fact, as narrated by Gallo in one of his reviews[7], when Gallo first submitted their report on HTLV-I to Journal of Virology it was rejected right away by the editor Robert Wagner "insisting that they should cease, and not continue to perpetuate the controversy, strongly implying that we all know human retroviruses do not exist".

In his quest to find a human retrovirus in lymphoma/leukemia Gallo developed sensitive and generalized techniques for the detection of reverse transcriptase to discriminate it from cellular DNA polymerases [8,9].

To isolate T cell lymphotropic viruses one needs to be able to culture T lymphocytes. Working with conditioned medium to grow lymphocytes, Gallo together with two of his post doctorial fellows Doris Morgan, Frank Ruscetti discovered T cell growth factor (TCGF) later named interleukin 2 (IL-2). Hence, the first report of IL-2/TCGF was by Robert Gallo was published in 1976 [10]. The first paper by Kendal A. Smith on IL-2/TCGF did not appear before 1978[11].

I sincerely doubt that anyone would have been looking for a retrovirus as the etiological agent for AIDS had HTLV-I not previously been isolated. I will therefore shortly recapitulate the history of the discovery of this virus.

The discovery of the first human retrovirus

Reverse transcriptase activity was detected by Gallo's group in a T-cell line established (using IL-2) from a patients diagnosed originally with mycosis fungoides in1979. To show that this was indeed a new human retrovirus Gallo and coworkers set out to show that the same virus could be isolated from primary tissue samples of the same patient by culturing primary T-cells with IL-2; demonstrate that the virus was novel, i.e., not any of the known animal retroviruses; show it could infect human T cells in vitro; demonstrate specific antibodies to the virus in the serum of the patient; demonstrate that proviral DNA could be found integrated in the DNA of the cells from which the virus was isolated; and provide evidence that this was not a one-time affair by showing serological evidence of specific antibodies not only in the patient but in some others as well.

Most or all these results were obtained by the time Gallo submitted the first paper to PNAS allowing it to quickly be followed with several other reports[12]. The paper on the first isolation of HTLV-I [2] was submitted (communicated) for publication in PNAS on August 4^th1980 and appeared in the December issue of the same year. The second paper from Gallo and his group (especially Bernard J. Poiesz, another post doctorial fellow) on the isolation of HTLV-I now from fresh cultured cells from a patient with Sezary T-cell leukemia was submitted to Nature on May 1st 1981 and appeared in the November 19th issue of that journal[13]. In the February 19th 1982 issue of Science (submitted October 6th 1981) Gallo's group [14] reported that five of six tested ATL patients in Japan had antibodies to HTLV-I (only HTLV at the time).

On the 26th of June 1981 (six months after the Poiesz et al. paper from Gallo's group was published) Hinuma et al. submitted (communicated) a paper to PNAS showing antibodies against an antigen in a T-cell line, MT-1 from a patient with adult T-cell leukemia (ATL), in all 44 patients with ATL examined and in 32 of 40 patients with malignant T-cell lymphomas using indirect immunofluorescence[15]. The antibodies were also detected in 26% of the healthy adults examined from ATL-endemic areas but in only a few of those examined from ATL-non-endemic areas. Extra-cellular type C virus particles were detected in pelleted cells of the MT-1 T-cell line. Hinuma called this virus adult T-cell leukemia virus (ATLV). Characterization of the virus as a retrovirus was published in the March issue of PNAS, submitted (communicated) November 23rd 1981. In this paper[16] also proviral DNA was detected in fresh peripheral lymphocytes from all of five patients with ATL but not in those from healthy adults. This paper was submitted more than a month later than the Gallo paper showing antibodies to HTLV-I in Japanese ATL patients.

On July 13th of 1981 Miyoshi et al. (Hinuma last author) submitted a paper to Nature (published December 24th 1981) on the transmission of virus from MT-1 cells (female) to cord blood cells of a male infant transforming (immortalizing) the latter cells[17].

In the November 4^th1982 issue of Nature Gallo's group together with the Japanese colleagues Nakao, Miyoshi, Minowada, Yoshida and Ito reported that HTLV-I and ATLV was one and the same virus[18] and decided to call both viruses HTLV-I.

As is evident from the above Gallo was truly the first to isolate the first known human retrovirus and to report it. In 1982, Gallo and co-workers reported the discovery of the second human retrovirus, HTLV-II, in a patient with hairy cell leukemia. However, no malignancy or other disease has yet been clearly linked to the infection of this virus.

The isolation of what is now called HIV-1 (will also be referred to as HIV, LAV, IDAV-1, IDAV-2, LAV-1, HTLV-III and ARV) and the demonstration of this virus as the cause of AIDS

In May of 1983 Françoise Barré-Sinoussi et al. published a paper in Science [19] describing the isolation of a putative new human retrovirus from the lymph gland of a patient suffering from persistent generalized lymphadenopathy, which is regarded as a precursor condition of AIDS. They called this new virus LAV (later LAV_BRU) for lymphadenopathy virus and BRU from the first three letters of the patient's last name. Since this has been viewed as a seminal paper for the discovery and characterization of HIV, I will here describe this paper in detail.

Cells from a lymph node of patient B.R.U. was cultured under the conditions described by Gallo [2,13], i.e. culture medium with T-cell growth factor (TCGF or IL-2), and were stimulated with phytohemaglutinin (PHA). They also added antiserum to human α-interferon to neutralize possible endogenous interferon. (The latter is not necessary, and is not used by others.) After three days, the culture was continued in the same medium without PHA. After 15 days in culture reverse transcriptase (RT) activity was detected in the culture supernatant, using the protocol by Gallo [2,13]. Importantly, the ionic conditions were the same as for isolating HTLV-I previously described by Gallo (1 and 2; in contrast to other animal retroviruses HTLV-I has a Mg²⁺-dependent and not Mn²⁺-dependent reverse transcriptase). Virus production continued for 15 days and decreased thereafter, in parallel with the decline of lymphocyte proliferation. A standard and routine procedure in clinical virology when trying to isolate a virus is to passage the cells to fresh ones, usually when the original cells start to die, and particularly if they do not yet show any signs of being infected. Hence, to show virus transmission, cells from patient B.R.U. after three days in culture were also co-cultured with lymphocytes from a healthy donor of the Blood Transfusion Center at the Pasteur Institute. Also with these co-cultures, RT could be detected after 15 days of culture (not before) and amounts of RT remained stable for 15 to 20 days. Transmission of cell-free supernatants from the original culture of B.R.U. cells was successfully obtained using 3-day-old cultures of T lymphocytes from two umbilical cords. There is no mentioning of cytopathic effects in any of the cultures or that fresh T lymphocytes from healthy donors were added to make the virus isolation possible or to save the virus isolate except for the virus transmission experiment described above.

The virus isolate had a density of 1.16 (same as HTLV-I) in a sucrose gradient. Electron micrographs of the virus from the umbilical cord lymphocytes were reported to be of typical C-type virus, i.e. with a spherical core (same as HTLV-I). Of note, HIV is a lenti retrovirus having a conical or cylindrical core structure and does not have type C virus morphology.

Two experiments were performed to distinguish the new isolate from HTLV-I. The first was by immunofluorescense using serum from the patient as well as a goat anti HTLV-I p24 (capsid protein) and mouse monoclonal anti HTLV-I p19 (matrix protein). The two latter anti-sera, as well as two HTLV-I producing cell lines were from Robert C. Gallo as acknowledged by the French group in the paper. The sera were tested against two different cultures of normal blood lymphocytes, against the two lines of HTLV-I producing cells, and against virus producing cells from the co-culture of T lymphocytes of patient B.R.U. and the healthy donor and against infected cord blood lymphocytes. In addition cells from a lymph node from a person (patient 2) who presented with multiple adenopathies and who had been in close contact with an AIDS case was also tested. No RT activity was detected in the latter patient's cultured lymphocytes. The anti-HTLV-I sera from Gallo (anti p19 and p24) reacted with the HTLV-I producing cell lines only. Serum from patient B.R.U. reacted with 90–100% of the HTLV-I producing cell lines and with 90–100% of the co-cultured cells from B.R.U and the healthy donor, as well as, the cells from patient 2. The B.R.U. serum reacted with only 0.5 to 2% of the infected umbilical cord lymphocytes. It is noteworthy that B.R.U.'s serum reacted with 90–100% of the co-cultured cells from B.R.U and the healthy donor since we know that only the CD4 positive cells should be infected. The B.R.U.'s serum also reacted with 90–100% of the HTLV-I producing cells! If this were to be due to a possible double infection with HIV and HTLV-I again only CD4 positive cells should be positive. More likely something unrelated to either HIV or HTLV-I was detected by the B.R.U. serum, in my opinion most probably mycoplasma, a common contaminant in cell culture. The 0.5 to 2% positive infected umbilical cord lymphocytes may indicate retrovirus-infected cells. However, the lack of reactivity with the p19 and p24 sera with these cells is not a proof that the B.R.U. virus was not HTLV-I. The few percentages of possibly positive cells could simply have been missed with the specific antibodies but detected with the patient's sera containing antibodies to all viral proteins. The paper does not present any photos of the fluorescent cells.

The other experiment performed to distinguish the new virus from HTLV-I was immunoprecipitation of lysates of infected cord lymphocytes, as well as, virus released from the infected cells with the same sera used for immunofluorescense and in addition serum from patient 2. Serum from B.R.U. and patient 2 (whose lymphocytes were RT negative) precipitated a protein of the apparent size of 25,000 from extracts of the infected cord lymphocytes and from the supernatants of these cells. Serum from a healthy donor did not precipitate this protein, nor did the anti HTLV-I p19 or p24 sera. The sera from B.R.U. and patient 2 did not precipitate the p25 protein from an extract of one of the HTLV-I producing cell lines. However, neither did the goat anti HTLV-I serum from what I can determine from the figure presented! Thus, there is no positive control indicating that they indeed had an HTLV antigen to precipitate. If the goat antiserum indeed precipitated a p24 protein from the HTLV-I producing cell extract, the band of p24 precipitated was extremely week, indicating that the serum was not very good at precipitating HTLV-I p24, at least not in the hands of Barré-Sinoussi and coworkers. The HTLV-I producing cells were all infected as opposed to only 0.5 to 2% of the cord blood cells. So, if the cord blood cells were infected with HTLV-I and not a new virus, the goat antiserum would still have had a hard time precipitating any protein! An appropriate control would have been a serum from a HTLV-I infected individual. The size of the protein they precipitated is in fact 24,000, the same as that of HTLV-I. The core protein of both HIV and HTLV-I is 24,000.

In reality, in my view there is no evidence whatsoever in this paper that a new human retrovirus has been isolated! With the data presented, the virus they isolated could well have been HTLV-I or in particular HTLV-II. The paper was obviously written in haste, as acknowledged by Montagnier[20], and contains numerous errors and omissions in the figures legends.

After having a first manuscript being rejected by Nature, Gallo suggested to Montagnier to send it to Science and even strongly endorsed the paper to the journal (the book of Nikolas Kontaratos shows a facsimile of Gallo's letter to the editor of Science[21]).

A more thorough description of the French isolate LAV from patient BRU and two new retrovirus isolates from two patients with AIDS was given at a Cold Spring Harbor meeting held in September of 1983. A proceedings, however not peer reviewed, from the meeting was published not until September of 1984[22]. The oral presentation by Luc Montagnier at this meeting is to my mind the first report on a new third human retrovirus, in that electron micrographs on the isolate LAV from patient BRU clearly showed virus with conical cores. A selective tropism of LAV to CD4 positive T-cells (as is the case for HTLV-I) was also demonstrated.

The first publication in a peer reviewed journal indicating the isolation of a new retrovirus, distinct from HTLV-I and HTLV-II, isolated from two siblings with hemophilia B of whom one with AIDS, appeared in Lancet in April of 1984 and was written by the French group[23]. Again the immunological and molecular characterization of the isolated virus does not convincingly separate the isolated virus from HTLV-I. However, an electron micrograph clearly depicts a virus with a lenti retrovirus type morphology having a cylindrical or conical core, distinctly different from the larger spherical core of HTLV-I, and HTLV-II. The paper, however, fails to conclusively link the new virus as the causative agent of AIDS.

In conclusion, by April of 1984 the Pasteur group headed by Luc Montagnier had reported on a new human T-lymphotropic retrovirus distinct from HTLV-I and HTLV-II as judged by morphology and which was present in a few patients with AIDS and lymphadenopathy, as well as, in people at risk of acquiring AIDS. The virus infected CD4-positive T-lymphocytes, the very cells affected in AIDS. Although clearly associated with AIDS, they had not yet shown that the new virus was an etiological agent, and the only one at that, of this new disease.

On May 4^thof 1984 four papers by Robert C. Gallo's group were published in Science describing a new human retrovirus virus as the probable cause of AIDS. All four papers were submitted the 30^thof March 1984. One paper[24] describes the isolation of the new virus from cultured lymphocytes obtained from 48 different individuals. The culturing technique was what had previously been described by Gallo and which Montagnier's group also used. The new cytopathic (large multinucleated cells) virus isolates were collectively designated HTLV-III and was characterized by having a Mg²⁺-dependent reverse transcriptase, being transmittable by co-cultivation of T cells with irradiated donor cells or with cell free fluids, having distinct morphology by electron microscopy, and by expressing specific viral antigens (indirect immune fluorescence) using a serum obtained from a patient with pre-AIDS (described in an adjoining papers 25 and 26; this serum did not react with cells infected with HTLV-I or HTLV-II), as well as, antisera prepared against purified, whole disrupted HTLV-III. The 48 HTLV-III isolates were obtained from 18 of 21 tested patients with unexplained lymphadenopathy and leukopenia, with an inverted T4/T8 lymphocyte ratio (designated pre-AIDS), 3 of 4 clinically normal mothers of juvenile AIDS patients, 3 of 8 juvenile AIDS patients, 13 of 43 adult AIDS patients with Kaposis sarcoma, 10 of 21 adults AIDS patients with opportunistic infections, and 1 of 22 clinically normal homosexual donors. Importantly, this homosexual donor, from whom HTLV-III was isolated, developed AIDS six month after the virus isolations were performed. This means that these isolations were performed not later than September of 1983. HTLV-III could not be isolated from any of 115 clinically normal heterosexual donors.

In a second accompanying paper [25] antibody reactivity to HTLV-III antigens in patients with pre-AIDS and AIDS was determined by an enzyme-linked immunosorbent assay (ELISA) as well as a Western electrophoretic blotting technique using a lysate of sucrose gradient purified HTLV-III from a cell line continuously producing HTLV-III. [26] as antigen. The number of sera that gave positive scores in the ELISA were: 43 of 49 (88%) of patients with AIDS (two of whom had developed AIDS after blood transfusion), 11 of 14 patients with pre-AIDS, 3 of 5 intravenous drug users (of which one positive was also homosexual), 6 of 17 homosexual men. It is noted in the paper that these homosexual men had been seeking medical assistance; they probably were not representative of the homosexual population. Out of 186 controls only one scored positive in the ELISA (1 of the 164 normal subjects). The controls also included 3 patients with hepatitis B virus infection, 1 with rheumatoid arthritis, 6 with systemic lupus erythematosus, 4 with acute mononucleosis, and 8 patients with lymphatic leukemias. Of the latter some were positive for HTLV-I. None of these 22 control patients scored positive in the ELISA or Western blot. Of note, in Western blot the antigen most prominently and commonly detected among all of the sera from AIDS patients had a molecular weight of 41,000 (now designated gp41). It was presumed that this is a virus envelope protein (which later turned out to be correct). Others, including myself, have later confirmed that gp41 is extremely reactive in ELISA of sera from HIV infected individuals. In fact we have found that an ELISA having as only antigen a peptide with the amino acids GKLICT, representing an epitope of gp41, reacts positively with the majority of sera from HIV infected individuals.

The French group did not detect gp41 in their immune precipitation studies using purified LAV. Their inability to detect this protein in their ELISA or immune precipitation experiments is probably the main reason that their positive scores with AIDS and pre-AIDS sera were so low. HIV is an enveloped virus and hence fragile. Most certainly they had lost the virus envelope in their purification of the virus.

Taken together, these two papers from Gallo's group for the first time convincingly demonstrated that AIDS was caused by a new human retrovirus distinct from HTLV-I and HTLV-II. It also provided with a blood test (ELISA) by which blood donors could be screened and a confirmation assay (Western blot) for those who tested positive in the ELISA. The authors speculate that the virus they found could well be the same virus that was previously detected by the French group, but direct comparisons had not yet been performed.

A third paper. [26] describes the establishment of cell lines continuously producing HTLV-III. A total of 51 single cell clones (designated H1 to H51) were obtained from a neoplastic aneuploid T-cell line (HUT-78). The clones were tested for susceptibility to concentrates of HTLV-III. All clones were susceptible and permissive for the virus, but virus yields and cell proliferation varied considerably. The best clones (H4 and H9) were used for the long-term propagation of HTLV-III from patients with AIDS and pre-AIDS. Five different isolates using the H4 or H9 clones are presented. Four were obtained by co-cultivating the patients T-cells with the H4 cells and one by infecting H9 cells with a cell free concentrated culture fluid harvested from T-cell cultures from a patient (W.T.) who had lymphadenopathy. One was from an AIDS patient from Haiti (R.F.) and four were from the US. In the paper they also report that some of the 48 isolates described in the accompanying paper[24] also could be propagated in the H4 and H9 clones. The importance of this paper is that for the first time it was shown that one could propagate HIV in large quantities as a source for antigen in a blood test, as well as, for in depth characterization of the virus. It was this paper, and the patent which was based upon it, that later caused the controversy between the NIH and the Pasteur Institute. It turned out that the HTLV-III producing H9 clone selected for the blood test was in fact a pick-up of a French HIV isolate sent to Gallo in September of 1983. This will be discussed later.

The fourth of the Gallo Science papers [27] describes a first attempt to serologically characterize HTLV-III using Western blot and sera from AIDS and pre-AIDS patients. The paper describes for the first time a virus protein of approximately 130,000 (in fact it is 120,000 and now designated gp120). Also a protein of 55,000 (p55) is described and correctly concluded to be a precursor protein for the capsid protein p24.

Lastly, a photomontage of electron micrographs of HTLV-I, HTLV-II, and HTLV-III with budding virus particles, immature virus particles and mature virus particles is shown. Although the budding and immature virus particles are very similar for all three viruses, the mature HTLV-III viruses are distinctive from those of HTLV-I and HTLV-II.

Three more papers on antibody reactivity to LAV/HTLV-III in patients with AIDS or pre-AIDS were published in the summer of 1984. June 9^th, Montagnier's group[28] published an ELISA based on purified virus particles. The presented results were: 18/48 (37.5%) of AIDS patients, 38/51 (74.5%) of pre-AIDS patients and 8/44 (18%) of homosexual men without pre-AIDS, but only one of 100 unselected blood donors were positive. In a note added in proof they claim that by modifying their assay now 75% of AIDS patients and 90% of pre-AIDS patients scored positive. In the Lancet issue of June 30^thGallo's group[29] publish their second report (the first being the one in Science above) on ELISA and Western blot confirmatory assay in a double-blind seroepidemiological study. The composite result of the two assays gave: 34 of 34 AIDS patients were positive (100%), 16 of 19 (84%) of lymphadenopathy (pre-AIDS), 3 of 14 (21%) at risk for AIDS, and none of 14 controls were positive. Lastly, Kalyanaraman et al. [30] published a paper the 20^thof July in Science submitted May 4^th1984. This paper was from Donald Francis group at the Center for Disease Control, Atlanta, in collaboration with Montagnier's group at Pasteur. The assay they used was based on immuno-precipitation. The positive scores were: 51 of 125 (41%) of AIDS patients; 81 of 113 pre-AIDS patients, 0 of CDC workers, and 0 of 189 random blood donors. Of 100 blood samples collected in 1978 from homosexual men in San Francisco, only one was positive as opposed to 12 of 50 such sera collected in 1984.

In the July 6^thissue of Science (submitted April 6^th1984), Donald Francis' group in collaboration with Montagnier's group reported on the isolation of a retrovirus from a blood donor-recipient pair with AIDS [31]. In an elegant experiment, using a competition radioimmunoassay they clearly show that the viruses they isolated were closely related to LAV but not to HTLV-I or HTLV-II. This is the first paper to show transmission of HIV-1 from one patient to another. This is also the first time, beside the electron microscopic pictures of LAV, Montagnier convincingly shows that LAV is antigenic distinct from HTLV-I.

On August 24^th1984 Jay Levy in San Francisco[32] published a paper in Science (submitted May 31^st) reporting that using the Gallo protocol they had isolated a retrovirus with lenti retrovirus type morphology designated ARV for AIDS associated retrovirus in 22 of 45 patients with AIDS. Positive virus cultures were also received from 5 of 10 patients with lymphadenopathy (pre-AIDS), 3 of 14 male sex partners of AIDS patients, 2 of 9 clinical healthy homosexual men, and 1 of 23 clinically healthy heterosexual men. When tested in immune fluorescence with slides containing acetone fixed cells infected with ARV, HTLV-I or LAV, 78/86 (91%) of AIDS patient's sera were positive to ARV infected cells, 22 of 40 (55%) to LAV, and 8 of 60 (13%) to HTLV-I. None of 56 controls reacted to any of the virus-infected cells. The fixed ARV infected cells were from a cell line (HUT-78) successfully established to continuously produce ARV.

The LAV/HTLV-IIIB contamination story and the patent feud between the Pasteur Institute and NIH

Right before the first public announcement by Barré-Sinoussi at a conference at Cold Spring Harbour in May of 1983 of the Pasteur group's findings, the Pasteur Institute filed a patent for the virus they had isolated. Before going public with the four Science papers, the NIH filed for a patent for the blood test described in one of the papers to be published in May of 1984. The United States patent office quickly allowed the American patent, shortly to be followed by allowances from European patent offices, and a number of American companies started to produce and sell blood tests. The approval of the Pasteur patent was delayed, principally because the French had not reduced their patent to practice, i.e. showed that they had a working blood test in the patent application. This led to a patent feud between the NIH and the Pasteur Institute starting in August of 1985. To solve this feud, the governments of both countries had to become involved. The patent fight came to an end on March 31^st, 1987, when President Ronald Reagan and French Prime Minister Jacques Chirac signed an agreement to settle the arguments. The financial outcome of the agreement, however, did not turn out to the satisfaction of the French, and when it became clear that the US patented blood test was based on a laboratory contamination of a French virus the deal was re-negotiated in 1994. It should be stated right away that neither of the scientists at the time stood to gain from respective patent.

The ground for the feud was the following. Montagnier sent his first isolate LAV_BRUto Gallo in July of 1983. In May of 1984 Gallo's coworker Sarngadharan brings one of Gallo's five HIV strains (HTLV-III_B) that grew well in a continuous cell line to Montagniers laboratory in Paris. In July of 1984 Montagnier sends Gallo a second sample of LAV_BRUsince Gallo had complained that the first didn't grew well at NIH. Gallo then found and reported[33] that HIV was extremely variable; every isolated strain was different from the other also when obtained from the same individual but at different times. However, the two strains LAV_BRU(received in July of 1984) and HTLV-III_Bisolated on either side of the Atlantic Ocean where strikingly similar. Gallo's reaction to this was that Montagnier must have contaminated his cultures with the American isolate, i.e. that the Pasteur group had had a so-called "pick-up" of HTLV-III_Binto his poorly replicating LAV_BRU. Gallo gave Montagnier a call, but the latter denied that this could have happened in his laboratory. Since the LAV_BRUobtained by other laboratories, before HTLV-III_Bhad been introduced to the Pasteur laboratory, had a genome more or less identical to the French isolate, it was concluded that the contamination must have happened in Gallo's laboratory. Gallo found this very strange, since LAV_BRUreplicated very poorly and could not be transferred to a continuously producing cell line like they had achieved with HTLV-III_B. On Sunday, November 19^th, 1989, the Chicago Tribune published a 16 pages account by journalist John Crewdson of the discovery of HIV. The article concludes that HTLV-III_Bis LAV_BRU. Crewdson implied in not so subtle words that Gallo had stolen the virus from the French. This started three separate investigations for scientific misconduct by Popovic and Gallo that didn't end until November of 1993.

The explanation came in 1992. Sequencing the original isolate LAV_BRUreceived in NIH in 1983, Gallo found that it was different from the LAV_BRUreceived in July of 1984. The original LAV_BRUwas as expected of the slowly replicating CCR5 co-receptor using genotype whereas LAV_BRUfrom 1984 was of the rapidly replicating CXCR4 using genotype. In fact the 1984 LAV_BRUwas identical to LAV_LAI. Thus, the contamination had originally occurred in the Pasteur laboratory. According to Montagnier at least six other laboratories received the LAI sample (under the name BRU) from his group and experienced the same contamination. [34]. Montagnier speculates that this was due to Mycoplasma pirum contamination of the cultures infected with LAV_LAI. In his review "A history of HIV discovery" in Science. [34] Montagnier writes: "This physical association makes a fraction of the LAI virus highly infectious, and, in fact, this fraction can be neutralized with antibodies against M. pirum. As mycoplasmas are common contaminents of cultured cells, an infectious pseudotype virus (LAI associated with M. pirum) may have caused several contaminations between 1983 and 1984 in different laboratories".

In Gallo's laboratory LAV_BRUhad contaminated a pool of viruses from different AIDS patients. Pooling viruses was the idea of Mika Popovic in order to get the "survival of the fittest" to grow out in the continuous cell line H9, a subclone of the HUT-78 cell line. The virus that grew best was named III_Bbecause it was from the B-pool of two pools in culture.

Many probably thought that the finding that a contamination had taken place already in the Pasteur laboratory was "convenient" for Gallo. However, to "steal" the French virus Gallo must have had a motive. One would have been that they couldn't culture any virus from AIDS patients and were becoming desperate. However, Gallo had already recognized that the French group was first to isolate a new retrovirus from AIDS patients. More so he endorsed the publication of the first Pasteur paper, which (although in my opinion erroneously) claimed so. Secondly, Gallo's group already had 48 (sic!) isolates many growing short term in their laboratory of which five were growing in continuous cell lines [24,26]. Gallo's misfortune was that he decided to choose the III_Bfor the blood test and for further characterization of the virus. Had he chosen a Haitian strain, which he also had growing long term in the laboratory at the time, we now know that he would have chosen a virus, which was as much of a prototype strain for HIV-1.

It has been questioned whether Gallo indeed had all those isolates. Considering that Gallo published this and that he and his laboratory was scrutinized for almost five years by three different investigations, had Gallo not had those isolates he would for sure have been found guilty of scientific misconduct and expelled from the NIH. Going through 13 foot high pile of Gallo's lab records including laboratory note-books, some 10,000 man hours of interviews with laboratory personal and other witnesses, all the Office of Research Integrity (ORI; a non-scientist office of government consisting of lawyers and administrators) could come up with in criticism was for Mika Popovic that he wrote "ND" in two occasions in one published table (in paper 25), and found him therefore guilty of scientific misconduct. The table legend didn't define "ND" and it was the ORI's understanding that "ND" meant, "not done" and that Popovic indeed had performed the experiment. However, Popovic insisted that by "ND" in his notebook he meant, "not determinable". The paper was written while Popovic was on holiday back in Czechoslovakia. Following Popovic's appeal to the Research Integrity Adjudications Panel the decision of ORI's was reversed. Gallo was temporarily criticized by the ORI for having written a sentence in the discussion of the same paper that LAV_BRUhad not yet been growing well enough to make possible comparisons with III_Bwhen in fact a technician of Popovic's had done so. These charges were later dropped by the ORI. In its decision on the Popovic case the Departmental Appeals Board's Research Integrity Adjudications Panel writes: "One might anticipate that from all this evidence, after all the sound and fury, there would be at last a residue of palpable wrongdoing. This is not the case". It is safe to say that whatever Gallo claimed he had, he had.

Conclusion

There is no doubt that Luc Montagnier's group at the Pasteur Institute in Paris was the first to isolate the causative agent of AIDS. Montagnier, however, got the idea to try to isolate a retrovirus indirectly from Robert Gallo and Myron Essex. The protocols he used for virus isolation and RT detection were developed by Robert Gallo and the reagents he used to discriminate the new virus from HTLV-I and HTLV-II were obtained from Robert Gallo. Moreover, it is well known that Francoise Barré-Sinoussi had spent time in Robert Gallo's laboratory to learn to culture lymphocytes. Robert Gallo was the first to convincingly show that the new human retrovirus (HIV) was the causative agent of AIDS, and the only one at that. He also was also the first to provide a blood test to screen blood donors for HIV infection. The rapid implementation of the latter in the US and Europe probably saved hundreds of thousands of lives.

References

View references at Retrovirology.

© 2009 Vahlne; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

The electronic version of this article is the complete one and can be found online at: http://www.retrovirology.com/content/6/1/40

British Chiropractors try to silence science writer who called their claims "bogus"

Eduard Grebe — Mon, 01 Jun 2009 13:36:23 +0000

Complainant-friendly British libel laws are increasingly being used to silence the critics of alternative medicine. The British Chiropractic Association (BCA) has won an initial judgement against Simon Singh, a prominent science writer, after he called their fantastical claims, wholly unsupported by the scientific evidence, for chiropractic (e.g. that it can treat otitis media in children) "bogus". The court held that Singh had to show the BCA knew their claims to be false. This judgement is dangerous for free speech and the public interest, since if it is allowed to stand, it would seem to encourage anyone who makes bogus claims - but who sincerely believe themselves - to sue for libel when they are called out. The Guardian writes:

The consequences of letting the libel law loose on scientific debate are horrendous. Science proceeds by peer review. A researcher's colleagues must submit his or her ideas to scrutiny without fear of the consequences. If they think they could lose their homes and savings in the libel courts, however, they will back off.

For alternative therapists are not the only ones answering their critics with lawyers. NMT, an American health giant, is suing a British doctor for questioning one of its treatments.

After the Singh ruling, the Sense About Science lobby group fears the commercial pressure to rush out new treatments will lead companies to quash doubters with writs in London courts and put public health at risk.

Watching recent libel cases has been like hearing rumours about parliamentary expenses. For years, I have wondered what it will take to turn a neglected scandal into a public outrage. After Eady ordered the censorship of a New York author's book on terrorism, which had not even been published in Britain, the US Congress began drafting a law which will guarantee that English libel judgments have no validity in America. The United Nations has condemned the judges' practice of welcoming rich libel tourists from across the world to their hospitable courts and urged Britain to allow free speech on matters of public interest.

In the Commons, MPs have railed against the absurdity of a legal system which forced a Danish newspaper to pay £100,000 for criticising the shady financial practices of the Icelandic bank Kaupthing, which duly collapsed six months later along with the rest of the Icelandic economy.

None of their despairing pleas has moved the government or persuaded the judiciary to reform itself. Maybe the Singh case will.

If he goes ahead with an appeal this week, bloggers, academics and the massed ranks of the scientific great and good are ready to join him. They have grasped what too many still fail to realise: the greatest threat to freedom of speech in Britain is not the state or the security services or the press barons, but a fusty and illiberal legal system, which has become a public menace.

Read Nick Cohen's full article.

Mark Hoofnagle reviews Denying AIDS in Denialism Blog

Eduard Grebe — Tue, 26 May 2009 17:00:24 +0000

Mark Hoofnagle reviews Seth Kalichman's Denying AIDS for the Denialism Blog. He writes,

Seth Kalichman is a better man than I. Kalichman is a clinical psychologist, editor of the journal Aids and Behavior and director of the Southeast HIV/AIDS Research and Evaluation (SHARE) product, and he has devoted his life to the treatment and prevention of HIV. Despite a clear passion for reducing the harm done by HIV/AIDS, to research this book he actually met, and interviewed, prominent HIV/AIDS denialists. I confess I simply lack the temperament to have done this. To this day, when I read about HIV/AIDS denialists, and the the 330,000 people who have died as a result of HIV/AIDS denialism, I see red. I think violent, bloody thoughts.

Read the rest of the review

The dangers of denying HIV: John Moore reviews Seth Kalichman's Denying AIDS in Nature

Eduard Grebe — Mon, 25 May 2009 15:08:00 +0000

Nature 459, 168 (14 May 2009) | doi:10.1038/459168a; Published online 13 May 2009

John P. Moore

Denying AIDS: Conspiracy Theories, Pseudoscience, and Human Tragedy

by Seth Kalichman

Springer: 2009. 205 pp. $25

Inadequate health policies in South Africa have reportedly led to some 330,000 unnecessary AIDS deaths and a spike in infant mortality, according to estimates by South African and US researchers. This carnage exceeds the death toll in Darfur, yet it has received far less attention. Seth Kalichman, a US clinical psychologist, shows in Denying AIDS how words can kill. His marvellous book should be read alongside Nicoli Nattrass's Mortal Combat, covering similar ground but from the perspective of a South African.

The tragic events in South Africa have been exacerbated by AIDS 'denialists' who, Kalichman alleges, assert that HIV is harmless and that antiretroviral drugs are toxic. The author discusses the psychology of denialism, which he says is "the outright rejection of science and medicine". He recounts the history of an HIV-infected US woman whose daughter died from an AIDS-related disease, and who recently died herself, to demonstrate the downward path from "ordinary psychological denial to malignant denial to denialism". Kalichman dismisses denialists' attempts to portray themselves as intellectually honourable dissidents who question accepted wisdom. He draws clear distinctions between dissidence and denialism; the latter, he says, is merely a destructive attempt to undermine the science.

These attitudes are not unique to HIV. Denialism, notes Kalichman, is "partly an outgrowth of a more general anti-science and anti-medicine movement". Groups that support intelligent design, doubt global warming, claim that vaccines cause autism, argue that cigarettes are safe, believe that the terrorist attacks of 11 September 2001 were an intelligence-agency plot or deny the Holocaust all use similar tactics.

Kalichman asserts that influential groups within the AIDS denialist movement include academics, pushers of 'quack' cures and supportive journalists. He describes the academics involved as "deranged and disgruntled university professors who turn to pseudoscience as a platform to gain attention", noting that pseudoscience may include "sightings of UFOs, alien abductions, astrology, psychic predictions ... [and] outlandish claims about the cause and cure of diseases".

Kalichman describes how quacks, like some of the academics involved, misrepresent their qualifications to create an illusion of authority. One, he claims, treats AIDS with hyperthermia, massage, oxygen, music, colour, gem, aroma, hypnosis, light and magnetic fields, each word followed by "therapy". Another allegedly distributed a product in Zambia called Tetrasil, a pesticide used in swimming pools, until the Zambian government intervened. Kalichman concludes that "taking money from the poor for bogus treatments is beyond criminal" and castigates journalist supporters of the denialist viewpoint for neglecting their professional obligations to verify facts and avoid sensationalist stories. In a powerful ending, Kalichman claims that extreme right-wing politics influences the AIDS denialist movement.

Professional institutions continue to tolerate the conduct of academic denialists, despite the suffering that has resulted. The standard excuse for inaction has been freedom of expression — the First Amendment of the United States Constitution. But free speech has recognized limits, and causing death is one. In 2006, as Kalichman records, a group of concerned scientists and activists created a website, AIDSTruth (http://www.aidstruth.org), to provide evidence to counter the denialists' words. The international legal and human-rights communities should now investigate the deadly impact of AIDS denialism. Action might have widespread benefits: Paul Offit's tour de force, Autism's False Prophets, claims that pseudoscientists and quacks have used similar tactics to parasitize the suffering of desperate parents by persuading them that vaccines cause autism. As Kalichman says, denialism "will not break until the public is educated to differentiate science from pseudoscience, facts from fraud".

John P. Moore is professor of microbiology and immunology at the Weill Medical College of Cornell University, New York 10021, USA.

Prof Moore's honorarium for this book review will be donated to the same charity that receives Seth Kalichman's royalties for the book – the Family Treatment Fund administered by the Massachusetts General Hospital and Harvard University.

POZ Magazine reviews Denying AIDS

Eduard Grebe — Mon, 25 May 2009 15:05:57 +0000

From POZ.
(Un)deniable Evidence
by James Wortman

A college professor takes on AIDS naysayers in his latest book.

Despite overwhelming scientific findings, some people remain convinced that HIV doesn’t cause AIDS and that antiretrovirals are toxic poisons. Led by vocal skeptics such as former South African President Thabo Mbeki and the late Christine Maggiore, AIDS denialism continues to flourish, especially with the help of the Internet.

To counter this strengthening movement, Seth Kalichman, PhD, a social psychology professor at the University of Connecticut, wrote Denying AIDS: Conspiracy Theories, Pseudoscience, and Human Tragedy ($25, Copernicus Books), which examines AIDS denialism’s origin, agendas and potentially damaging influence on HIV prevention and treatment.

Kalichman believes that the scientific community’s decision to stay quiet over the years has only fueled the denialists’ power. “[For too long] scientists have believed that if you ignore the denialists, they will go away,” he told POZ. “The HIV community really has a role in combating this misinformation.”

All royalties will help the Family Treatment Fund provide AIDS meds for people living with HIV/AIDS in Africa.

Scientists distance themselves from AIDS denialist film

Eduard Grebe — Thu, 23 Apr 2009 23:37:23 +0000

Update: Read an account of the film 'House of Numbers' by a member of the AIDSTruth team.

Scientists who appear in a new film 'House of Numbers' have distanced themselves from the film after it transpired that the filmmaker is an AIDS denialist, and that he manipulated the final product in order to mislead viewers and promote denialist myths. The director, Brent Leung, deceived a number of prominent scientists into granting him interviews, pretending that the film would be a history of AIDS research. However, Leung also interviewed a number of prominent AIDS denialists and edited the film in such a way as to create the false impression that uncertainty exists about AIDS science and that AIDS denialism is a credible position.

The scientists have released a statement raising strong objections to the film.

The film has been screened at two film fesitvals (in Nashville and Boston), with AIDS denialists attending the screenings, and at times behaving abusively towards members of panels convened by the film festivals as a community response. See this article in Bay Windows for a report on the screening in Boston, where denialists stormed the stage during the panel discussion. Scientists were invited to "debate" the film with Leung and/or other denialists, but have refused to do so. See this article on why AIDSTruth opposes debating denialists. Also see this article in the Tenessean and this blog post by Seth Kalichman for further background.

Although the film is unlikely to gain much attention outside these film festivals, it is dangerous and has the potential to mislead people with HIV into disregarding their doctors' advice.

A statement about the film, ‘House of Numbers', by people who appear in it

We are writing to state our strong objections to 'House of Numbers' and the agendas it promotes. We consider the film as being harmful to the best interests of the general public and, in particular, people with HIV infection or at risk for acquiring it.

We all appear in the film, having granted interviews to its Director, Mr. Brent Leung, during the period 2006-2008. Mr. Leung was deceptive in his interactions with us. He informed us that his film was intended to present the true history of AIDS research, and an accurate summary of the science of HIV infection. He also told several of us that he intended the film would expose and counter many of the myths about HIV and AIDS that have been promoted by a small clique of individuals we refer to as "AIDS denialists".

The reality is that his film does none of those things. Instead, it presents the AIDS denialist agenda as being a legitimate scientific perspective on HIV/AIDS, when it is no such thing. His film perpetuates pseudo-science and myths.

AIDS denialists individually or collectively promote several notions that have no basis in science or the facts. Among these views are that HIV either does not exist or is harmless; that therapies for HIV infection are themselves the cause of AIDS; that drug abuse causes AIDS; that HIV was created by the US government to kill Africans and African-Americans as an act of genocide; that diagnostic tests for HIV infection do not work. None of these beliefs is true. AIDS denialism has caused the deaths of hundreds of thousands of South Africans, and many more individuals in the USA and other countries. For more information on the dangers of AIDS denialism and the damage it has caused, we encourage you to review material posted at http://www.aidstruth.org .

The scientific facts are: HIV is a natural virus that entered the human population from chimpanzees many years ago. HIV diagnostic assays are highly accurate and reliable. Untreated HIV infection eventually kills most of the people who acquire it, by causing AIDS, but anti-retroviral therapy dramatically prolongs the lives of those who have access to it. While good nutrition is important for general health and well being, it is not sufficient to prevent or treat HIV infection and it cannot cure AIDS. For accurate sources of information on these central points, please refer to material posted at the following sites:

http://en.wikipedia.org/wiki/Origin_of_AIDS

http://www.sciencemag.org/cgi/content/abstract/1126531

http://www.cdc.gov/hiv/resources/factsheets/

http://www.nlm.nih.gov/medlineplus/ency/article/003538.htm

http://www.aidsfactsheet.com/facts.htm

We have viewed the film's trailer, and we are aware of reports about the film's contents that are circulating on the internet after Mr. Leung gave an advance showing to AIDS denialists (a courtesy he did not extend to us). We believe that 'House of Numbers' presents some of our views out of their proper context. By editing our interviews to suit his preconceived agenda, Mr. Leung attempts to portray AIDS scientists as divided and disorganized, and he seeks to present legitimate differences of scientific opinion on various aspects of HIV/AIDS in a way that disguises the wider and more substantive points on which we all agree and which we have stated strongly, here and elsewhere (http://www.nature.com/nature/journal/v406/n6791/full/406015a0.html).

'House of Numbers' is an inaccurate portrayal of the truth about HIV and AIDS. Mr. Leung persuaded us to take part in it by acting deceitfully and unethically. None of us would have agreed to be interviewed for the film had we known it would promote the AIDS denialist agenda, and include members of that small clique as participants of supposedly equivalent credibility.

We register our protest about 'House of Numbers' out of respect for the millions of people who have already died from AIDS. This film could cause more unnecessary deaths, if any of those who watch it are persuaded that it is not necessary to reduce their risks for acquiring HIV infection, or take the appropriate therapies if they do become infected.

Donald Abrams, MD - Professor, University of California San Francisco

Francoise Barre-Sinoussi, PhD - Professor, Institut Pasteur, Paris, France

David Baltimore, PhD - Professor, California Institute of Technology

Niel T. Constantine, PhD - Professor, University of Maryland School of Medicine, Baltimore

Robert C. Gallo, MD - Professor, University of Maryland School of Medicine, Baltimore

Hans R. Gelderblom, PhD - Professor, Robert Koch-Institut, Berlin, Germany

Harold Jaffe, MD - Professor, University of Oxford, UK

Claudia Kücherer, PhD - Robert Koch - Institute, Berlin, Germany

Daniel R. Kuritzkes, MD - Professor, Harvard University, Boston

Reinhard Kurth, MD - Professor, Robert Koch - Institute, Berlin, Germany

Jay Levy, MD - Professor, University of California San Francisco

Joseph B. McCormick, MD - Professor, University of Texas School of Public Health

John P. Moore, PhD - Professor, Weill Medical College of Cornell University, New York

Nancy Padian, PhD - Professor, University of California Berkeley

Peter Piot, MD - Professor, Imperial College of Science, Technology and Medicine, London, UK

Robert R. Redfield, MD - Professor, University of Maryland School of Medicine, Baltimore

Robin A. Weiss, PhD - Professor, University College London, UK

Ben Goldacre: The Doctor will sue you now

Eduard Grebe — Mon, 13 Apr 2009 16:08:56 +0000

This is an extract from Bad Science by Ben Goldacre, Published by Harper Perennial 2009. You are free to copy it, paste it, bake it, reprint it, read it aloud, as long as you don’t change it – including this bit – so that people know that they can find more ideas for free at www.badscience.net.

The Doctor Will Sue You Now

This chapter did not appear in the original edition of this book, because for fifteen months leading up to September 2008 the vitamin-pill entrepreneur Matthias Rath was suing me personally, and the Guardian, for libel. This strategy brought only mixed success. For all that nutritionists may fantasise in public that any critic is somehow a pawn of big pharma, in private they would do well to remember that, like many my age who work in the public sector, I don't own a flat. The Guardian generously paid for the lawyers, and in September 2008 Rath dropped his case, which had cost in excess of £500,000 to defend. Rath has paid £220,000 already, and the rest will hopefully follow. Nobody will ever repay me for the endless meetings, the time off work, or the days spent poring over tables filled with endlessly cross-referenced court documents.

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

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

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

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

This man, we should be clear, is our responsibility. Born and raised in Germany, Rath was the head of Cardiovascular Research at the Linus Pauling Institute in Palo Alto in California, and even then he had a tendency towards grand gestures, publishing a paper in the Journal of Orthomolecular Medicine in 1992 titled "A Unified Theory of Human Cardiovascular Disease Leading the Way to the Abolition of this Disease as a Cause for Human Mortality". The unified theory was high-dose vitamins.

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

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

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

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

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

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

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

At various times during the peak of the AIDS epidemic in South Africa their government argued that HIV is not the cause of AIDS, and that anti-retroviral drugs are not useful for patients. They refused to roll out proper treatment programmes, they refused to accept free donations of drugs, and they refused to accept grant money from the Global Fund to buy drugs. One study estimates that if the South African national government had used anti-retroviral drugs for prevention and treatment at the same rate as the Western Cape province (which defied national policy on the issue), around 171,000 new HIV infections and 343,000 deaths could have been prevented between 1999 and 2007. Another study estimates that between 2000 and 2005 there were 330,000 unnecessary deaths, 2.2 million person years lost, and 35,000 babies unnecessarily born with HIV because of the failure to implement a cheap and simple mother-to-child-transmission prevention program. Between one and three doses of an ARV drug can reduce transmission dramatically. The cost is negligible. It was not available.

Interestingly, Matthias Rath's colleague and employee, a South African barrister named Anthony Brink, takes the credit for introducing Thabo Mbeki to many of these ideas. Brink stumbled on the "AIDS dissident" material in the mid-1990s, and after much surfing and reading, became convinced that it must be right. In 1999 he wrote an article about AZT in a Johannesburg newspaper titled "a medicine from hell". This led to a public exchange with a leading virologist. Brink contacted Mbeki, sending him copies of the debate, and was welcomed as an expert.

This is a chilling testament to the danger of elevating cranks by engaging with them. In his initial letter of motivation for employment to Matthias Rath, Brink described himself as "South Africa's leading AIDS dissident, best known for my whistle-blowing exposé of the toxicity and inefficacy of AIDS drugs, and for my political activism in this regard, which caused President Mbeki and Health Minister Dr Tshabalala-Msimang to repudiate the drugs in 1999″.

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

President Mbeki sent a letter to world leaders comparing the struggle of the "AIDS dissidents" to the struggle against apartheid. The Washington Post described the reaction at the White House: "So stunned were some officials by the letter's tone and timing during final preparations for July's conference in Durban that at least two of them, according to diplomatic sources, felt obliged to check whether it was genuine. Hundreds of delegates walked out of Mbeki's address to the conference in disgust, but many more described themselves as dazed and confused. Over 5,000 researchers and activists around the world signed up to the Durban Declaration, a document that specifically addressed and repudiated the claims and concerns-at least the more moderate ones-of the "AIDS dissidents". Specifically, it addressed the charge that people were simply dying of poverty:

The evidence that AIDS is caused by HIV-1 or HIV-2 is clearcut, exhaustive and unambiguous... As with any other chronic infection, various co-factors play a role in determining the risk of disease. Persons who are malnourished, who already suffer other infections or who are older, tend to be more susceptible to the rapid development of AIDS following HIV infection. However, none of these factors weaken the scientific evidence that HIV is the sole cause of AIDS... Mother-to-child transmission can be reduced by half or more by short courses of antiviral drugs â€¦ What works best in one country may not be appropriate in another. But to tackle the disease, everyone must first understand that HIV is the enemy. Research, not myths, will lead to the development of more effective and cheaper treatments.

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

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

It's an eerily familiar catchphrase. Tshabalala-Msimang has also gone on record to praise the work of Matthias Rath, and refused to investigate his activities. Most joyfully of all, she is a staunch advocate of the kind of weekend glossy-magazine-style nutritionism that will by now be very familiar to you. The remedies she advocates for AIDS are beetroot, garlic, lemons and African potatoes. A fairly typical quote, from the Health Minister in a country where eight hundred people die every day from AIDS, is this: "Raw garlic and a skin of the lemon-not only do they give you a beautiful face and skin but they also protect you from disease." South Africa's stand at the 2006 World AIDS Conference in Toronto was described by delegates as the "salad stall". It consisted of some garlic, some beetroot, the African potato, and assorted other vegetables. Some boxes of anti-retroviral drugs were added later, but they were reportedly borrowed at the last minute from other conference delegates.

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

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

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

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

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

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

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

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

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

In 2005, exasperated by government inaction, a group of 199 leading medical practitioners in South Africa signed an open letter to the health authorities of the Western Cape, pleading for action on the Rath Foundation. "Our patients are being inundated with propaganda encouraging them to stop life-saving medicine," it said. "Many of us have had experiences with HIV infected patients who have had their health compromised by stopping their anti-retrovirals due to the activities of this Foundation." Rath's adverts continue unabated. He even claimed that his activities were endorsed by huge lists of sponsors and affiliates including the World Health Organization, UNICEF and UNAIDS. All have issued statements flatly denouncing his claims and activities. The man certainly has chutzpah.

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

The researchers enrolled 1,078 HIV-positive pregnant women and randomly assigned them to have either a vitamin supplement or placebo. Notice once again, if you will, that this is another large, well-conducted, publicly funded trial of vitamins, conducted by mainstream scientists, contrary to the claims of nutritionists that such studies do not exist. The women were followed up for several years, and at the end of the study, 25 per cent of those on vitamins were severely ill or dead, compared with 31 per cent of those on placebo. There was also a statistically significant benefit in CD4 cell count (a measure of HIV activity) and viral loads. These results were in no sense dramatic - and they cannot be compared to the demonstrable life-saving benefits of anti-retrovirals - but they did show that improved diet, or cheap generic vitamin pills, could represent a simple and relatively inexpensive way to marginally delay the need to start HIV medication in some patients.

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

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

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

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

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

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

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

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

I have.

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

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

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

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

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

I may be mistaken.

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Village Voice: The AIDS-Babies-as-Guinea-Pigs Story Is Finally Over. Right?

Eduard Grebe — Thu, 02 Apr 2009 18:26:37 +0000

Elizabeth Dwoskin writes an interesting analytical piece in the Village Voice on the "babies as guinea pigs" "scandal" manufactured by AIDS denialists over the participation of New York foster children in clinical trials. Also see our previous coverage.

Researchers publish video of HIV transfer between T-cells

Eduard Grebe — Mon, 30 Mar 2009 07:26:59 +0000

In what is surely a serious blow to AIDS denialists, researchers have published video microscopy of HIV transferring between T-cells:

Quantitative 3D Video Microscopy of HIV Transfer Across T Cell Virological Synapses

Wolfgang Hübner,¹ Gregory P. McNerney,³ Ping Chen,¹ Benjamin M. Dale,¹ Ronald E. Gordon,² Frank Y. S. Chuang,³ Xiao-Dong Li,⁴ David M. Asmuth,⁴ Thomas Huser,³^,4 Benjamin K. Chen¹^* The spread of HIV between immune cells is greatly enhanced bycell-cell adhesions called virological synapses, although theunderlying mechanisms have been unclear. With use of an infectious,fluorescent clone of HIV, we tracked the movement of Gag inlive CD4 T cells and captured the direct translocation of HIVacross the virological synapse. Quantitative, high-speed three-dimensional(3D) video microscopy revealed the rapid formation of micrometer-sized"buttons" containing oligomerized viral Gag protein. Electronmicroscopy showed that these buttons were packed with buddingviral crescents. Viral transfer events were observed to formvirus-laden internal compartments within target cells. Continuoustime-lapse monitoring showed preferential infection throughsynapses. Thus, HIV dissemination may be enhanced by virologicalsynapse-mediated cell adhesion coupled to viral endocytosis.

Science 27 March 2009:
Vol. 323. no. 5922, pp. 1743 - 1747
DOI: 10.1126/science.1167525

Thabo Mbeki, HIV/AIDS and bogus scientific controversies

Eduard Grebe — Mon, 23 Mar 2009 20:28:38 +0000

by Martin Weinel (Originally published on Politicsweb.)

Almost every day governments around the world have to make political decisions that depend on scientific or technical knowledge. Where and how to store nuclear waste? How to respond to global climate change? Should a particular medicine be made freely available to the whole population or should its use be highly restricted or even banned? These and countless other 'science policy decisions' show that policy making is highly dependent on scientific knowledge.

The difficulty, however, is knowing how much weight to give to scientific knowledge. In some cases this appears straightforward. For example, there is a scientific consensus that prolonged exposure to high doses of radiation from nuclear waste is lethal for human beings. Thus, if somebody suggests storing nuclear waste in cardboard boxes in down-town Johannesburg, the suggestion would be immediately rejected based on our knowledge of the effects of radiation. In other cases, particularly those where people with specialist knowledge - i.e. the experts - disagree about scientific issues it is not so easy. For example, there is disagreement between experts about whether cross-fertilisation between genetically modified crops (GM crops) and unmodified crops represents a real risk and if it does, which measures are most suited to prevent cross-fertilisation. As such, although no-one can point to conclusive scientific evidence that shows cross-fertilisation will occur, critics of GM crops can point to the uncertainties behind the claims of GM proponents and by doing so urge policy-makers to adopt a precautionary approach.

Put another way, it seems that a scientific consensus should constrain policy makers more tightly than a scientific controversy. In the case of radioactive waste, the scientific consensus means that, if it has to be stored, then it should be stored in containers that reduce the emission of radiation as far as possible and in places that offer protection from radiation should the containers be damaged. This is not to say these constraints fully determine the policy but to acknowledge that they do set some limits within which policy makers must work. For example, while safe storage might be theoretically feasible, policy-makers might choose to abstain from using nuclear power altogether.

If there is no consensus amongst the experts then the effect of scientific knowledge is less powerful and political judgement more important. If it is unclear whether genetically modified crops do cross-fertilise with unmodified plants then a decision to introduce GM crops carries an unknown risk of affecting bio-diversity. Policy makers can either choose to accept this risk, perhaps pointing to some other benefits, or they can decide not to allow GM crops to be planted. Both positions fit with at least some of the available evidence and, because both sides in the argument have at least some scientific credibility, neither puts a binding constraint on the policy debate.

The observation that scientific controversies create a space that scientific consensus effectively closes down has not been lost on political strategists, campaigners and lobby groups. During his presidency, George W. Bush famously abstained from acting on climate change by referring to a controversy among scientists about the causal role of humans. Frank Luntz, a Republican pollster, made the rationale behind this stance explicit when he was quoted in an editorial of the New York Times on 15 March 2003:

Should the public come to believe that the scientific issues are settled' their views about global warming will change accordingly. Therefore, you need to continue to make the lack of scientific certainty a primary issue.

The question is whether or not the Bush administration was correct to invoke scientific uncertainty in this way. If there is a genuine scientific controversy then allowing a greater role for political judgements is the correct way to proceed. But what if there is a consensus within the scientific community and the policy makers create the impression of a controversy in order to delay or avoid a decision. In this case, it would seem odd to allow such an inauthentic scientific controversy to have a powerful effect on policy.

But how can we tell whether a controversy is authentic or not? If we define a genuine controversy as one that the relevant scientific community would accept as real then an inauthentic scientific controversy is one in which the degree of publicly invoked disagreement does not represent genuine uncertainty within the community of relevant experts. In the case of global climate change, we can see that even though science of global climate change is beset with many uncertainties, the International Panel on Climate Change (IPCC) - probably the most authoritative and representative expert institution on question of climate change - has unequivocally endorsed the view that human use of fossil fuels is at least partly to blame for the change in climate patterns that is observable around the globe. This is not to say that what these experts say is true or right - they might be wrong - but their advice is the best scientific advice that we got on this matter and that, at this moment, it tells us that anthropogenic climate change is happening. Politicians should take this into account in deciding on their actions.

Another example of such an 'inauthentic scientific controversy', although arguably less strategically inspired, was observable in South Africa a few years ago: the 'controversy' about the safety of AZT when used to reduce the risk of mother-to-child transmission of HIV.

On 28 October 1999, President Thabo Mbeki told the members of the National Council of Provinces:

Two matters in this regard [the demand to make AZT available in the public health service] have been brought to our attention.

One of these is that there are legal cases pending in this country, the United Kingdom and the United States against AZT on the basis that this drug is harmful to health.

There also exists a large volume of scientific literature alleging that, among other things, the toxicity of this drug is such that it is in fact a danger to health. These are matters of great concern to the Government as it would be irresponsible for us not to heed the dire warnings which medical researchers have been making.

I have therefore asked the Minister of Health, as a matter of urgency, to go into all these matters so that, to the extent that is possible, we ourselves, including our country's medical authorities, are certain of where the truth lies.

To understand this matter better, I would urge the Honourable Members of the National Council to access the huge volume of literature on this matter available on the Internet, so that all of us can approach this issue from the same base of information.

Apparently the first argument, related to pending legal cases, turned out to be wrong. But President Mbeki obviously did not believe that this was a strong argument in any case as he only mentioned it briefly and it never appeared again in his public speeches. The second argument is much more elaborated and represented one of government's main arguments against the introduction of AZT (or Nevirapine for that matter as the Minister of Health, Tshabalala-Msimang, would tell Parliament in a statement on 16 November 1999). In this case, the idea of a scientific controversy is invoked when President Mbeki claims that 'a large volume of scientific literature' exists which alleges that AZT is so toxic that it is a 'danger to health' and not, as one of its proponents put it, a 'medicine from heaven'. The contributors to this body of literature were apparently 'medical researchers'.

Identifying this as an inauthentic controversy requires more work but can be done. The initial problem is that President Mbeki is acting, so it seems, merely as a journalist: he just reports or describes what some medical researchers are saying in order to bring it to the attention of the government and the medical authorities in South Africa.

The reason why this also counts as an inauthentic scientific controversy is that President Mbeki is not, in fact, acting as a reporter; instead, he acts as a creator of the controversy. The revealing statement is found in the last paragraph of the above quote when the President urges the Members of the National Council to lift themselves up to the same level of understanding by 'accessing' - and presumably reading - the 'large volume of literature on this matter on the Internet' for themselves. Whether Mbeki really found the literature he was referring to on the Internet or whether it was given to him by people such as Anthony Brink, Anita Allen or Zigi Visser does not really matter. What matters is that the President's knowledge about AZT comes not from the scientific community itself but from reading the scientific literature. By forming a judgement on AZT, he has to rely on his own expertise on the matter, which is insufficient, as I will argue below.

President Mbeki confirmed that he was reading the scientific literature on his own in the welcome speech to members of the Presidential Advisory Panel on AIDS in May 2000 when he reflected on how he started to immerse himself into the scientific literature (which he probably did wholeheartedly only after his speech in late October):

[...] I faced this difficult problem of reading all these complicated things that you scientists write about, in this language I don't understand. So I ploughed through lots and lots of documentation, with dictionaries all around me in case there were words that seemed difficult to understand. I would phone the Minister of Health [who holds a couple of degrees in health-related disciplines] and say, 'Minister, what does this word mean?' And she would explain.

So what exactly is the problem with accessing scientific literature on your own and reading it? While President Mbeki's effort to read scientific literature himself is admirable, the decisive question is how reliable are the conclusions that can be reached solely from reading the academic literature.

Perhaps surprisingly, it is entirely wrong to assume reading alone can give you enough specialist knowledge - expertise - to intervene on a scientific matter. The problem is not so much to understand the content of scientific papers: well written scientific papers can be unexpectedly accessible and simply reading the abstract might sometimes be enough for even the uninitiated to gain a rough but sufficient understanding of what the paper is about. The real problems start, however, when it comes to judging the credibility of a paper and its relative importance to a scientific field. While to the outsider journal articles and books - written material in short - might seem to embody the essence of science, science is predominantly an oral culture. The publication of results is important but it is only the first hurdle. Having them read and believed is even more important but this attribution of credibility and importance is much harder to outsiders to pick up as it takes place in the personal encounters between scientists at conferences, workshops and other meetings. Other markers of credibility, which do not necessary involve face-to-face contact, but which nevertheless presuppose familiarity with the field, include the prestige of a lab, a research group or institution, the standing and reputation of the co-authors and the methodological assumptions and techniques that are conventionally used in different settings.

In short, to know which papers and results to trust and to judge their relative importance in a scientific field, one needs to immerse oneself into the 'culture' of a particular scientific community. Without immersion an isolated reader simply lacks the necessary, often tacit, knowledge needed to know what to read and whom to trust.

In the case of AZT, President Mbeki never immersed himself in the community of experts on anti-retroviral drugs and prevention of mother-to-child transmission of HIV. Instead he assumed that reading alone gave him enough expertise to declare AZT a 'danger to health'. President Mbeki created an inauthentic scientific controversy by referring to the 'warnings of medical researchers' as this gave the impression that a scientific controversy about the safety of AZT was ongoing and that no scientific consensus constrained the policy options of the government. While any positive claim can be challenged if enough effort is made, it remains that for all practical purposes it was a 'certainty' in 1999 (and is still one today) that the benefits of anti-retrovirals in their use to prevent mother-to-child transmission largely outweighed the existent risks. By relying on the reading of scientific literature to make a judgement about AZT's safety, President Mbeki made a mistake.

Had the President done what politicians usually do when they are confronted with technical matters that are well beyond their own expertise -seeking the advice of experts on the matter - he would have discovered at least two things. First, he would have learned that the vast majority of scientists with expertise on AZT and other anti-retroviral drugs shared the view that the benefits of anti-retroviral drugs largely outweigh the risks when it comes to the prevention of mother-to-child transmission. In this regard, the composition of Presidential Advisory Panel on AIDS, which was established in May 2000, did not even approximately reflect the opinion within the scientific community. As a leading South African scientist told me last year:

Out of the 33 people on the panel about 16 of them were dissidents [people who do not believe that HIV causes AIDS and/or that anti-retroviral drugs have some therapeutic effect], which is about the sum-total, the grand sample of dissidence, this is the census, and then the 16 scientists were a small sample from across the globe.

Second, had President Mbeki asked experts directly he would also have learned more about those he had apparently chosen to trust as reflected, again, by the composition of the AIDS Advisory Panel. He would have learned, for example, that they not only represented a very tiny minority as the above quote shows, but also that some of them had hardly any direct expertise of anti-retrovirals or HIV/AIDS. He would also have learnt that their credibility within the expert community was very low and that this was not because the scientific mainstream feared their theories like the church feared the theories of Galileo, but rather because their theories had been shown to be wrong on many occasions.

The consequences of Mbeki's mistake were grave. By creating an 'inauthentic scientific controversy' and delaying the introduction of a widely supported policy, Mbeki's actions have led, according to recent estimates, to the unnecessary infection of about 35,000 babies with HIV in South Africa between 2000 and 2005 (Chigwedere et al. 2008, see also Nattrass 2008).

This shows that inauthentic scientific controversies can have devastating effects. It is for this reason, if not other, that recognising such controversies and preventing them from influencing policy-making matters.

References

Chigwedere, Pride et al. (2008) 'Estimating the lost benefits of antiretroviral drug use in South Africa', Journal of Acquired Immune Deficit Syndrome 49(4): 410-415. <http://www.harvardscience.harvard.edu/medicine-health/articles/south-african-aids-policy-tied-330000-lives-lost>

Nattrass, Nicoli (2008) 'AIDS and the scientific governance of medicine in post-apartheid South Africa', African Affairs 107(427): 157-176. <http://afraf.oxfordjournals.org/cgi/content/abstract/107/427/157>

South Africa acts against AIDS denialist Matthias Rath

Eduard Grebe — Mon, 16 Mar 2009 20:30:09 +0000

Under South Africa's previous administration, the country's health department failed to act against vitamin entrepreneur and AIDS denialist Matthias Rath, when his foundation conducted unauthorised clinical trials and distributed vitamins to AIDS patients, while advising them to stop taking antiretroviral drugs. The Treatment Action Campaign took successful legal action, and the Court ordered the state to take action against Rath. Now, the era of denialism seems finally to be over, as the Department of Health (under a new Minister) has informed the TAC that criminal cases have been opened as a result of its investigation of Rath. Here is the TAC's press release:

On 13 June 2008, the Cape High Court ordered the Minister of Health (then Manto Tshabalala-Msimang) to take steps to prevent Rath and his agents from conducting unauthorised clinical trials and from publishing advertisements about the medicinal effects of Rath's product VitaCell. The state was also ordered to investigate these unlawful actions by Rath.

The court case arose because of the state's failure to investigate or stop Rath's unlawful activities. The court also interdicted Rath and several of his agents from continuing the above activities. The applicants in the case were TAC and the South African Medical Association (SAMA).

Last year, TAC member Sylvia Fynn discovered that the South African National Civics Organisation (SANCO) was continuing to distribute Rath's medicines from a facility in Durban. SANCO was also discouraging patients from taking ARVs. Fynn photographed a bin where patients had thrown away their scientifically proven medicines, apparently with the intention of using Rath's medicines. The Southern African HIV Clinicians Society (HIVSOC) also collected information on Rath's activities in Durban. Both the TAC and HIVSOC sent our information to the Department of Health. We have since communicated extensively with the Department. We have been impressed by the co-operation we have received from Department officials.

We are pleased to announce that the Department is attempting to implement the court order. We have received a letter, signed on 27 February, from Dr J. Gouws of the Department's Law Inspectorate stating:

I thank you for the information shared ... I wish to inform you that following the order of the Cape High Court ... the Department has embarked on investigation against Matthias Rath and Dr Rath Health Foundation Africa to ensure compliance with the said Court Order.

The said investigations are at an advanced stage and we have had successes in this regard. On the strength of our investigations, criminal cases have been opened by the Department for the alleged contraventions of the [Medicines Act] and are being investigated by the South African Police Services (SAPS) in Durban. Our investigations continue parallel to the SAPS investigation and we are hoping for more success.

The TAC welcomes and thanks the commitment and co-operation of the Department of Health over the last few months in this investigation. We also thank the Southern African HIV Clinicians Society for collecting evidence of continued infringements of the court order. Bringing charlatanism under control following the era of state-supported AIDS denialism is an immense challenge, but by taking action against Rath the Department of Health is sending the right message to other charlatans. This is an important first step.

We hope that a warrant of arrest will soon be issued for Rath. While it is unlikely it will ever be executed because Rath has left South Africa, it will be important symbolically to close this tragic affair, which has directly cost the lives of several of Rath's patients and indirectly cost the lives of countless others who were confused by the false messages of Rath, supported by former Minister of Health Tshabalala-Msimang.

Robert Gallo on the discovery of HIV as the cause of AIDS

Eduard Grebe — Mon, 16 Mar 2009 20:14:25 +0000

Another myth debunked: HIV can be detected post-mortem

Eduard Grebe — Tue, 10 Mar 2009 02:54:33 +0000

In the light of recent developments, we have addressed the myth that HIV cannot be detected post-mortem on our Debunking denialist myths page.

Myth #15: HIV cannot be detected post-mortem

HIV can be detected post-mortem with a high degree of accuracy. This is very important because deceased tissue donors need to be tested to ensure that tissue recipients are not infected with HIV. See:

Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid.

We cannot live by scepticism alone

Eduard Grebe — Tue, 10 Mar 2009 02:25:22 +0000

Scientists have been too dogmatic about scientific truth and sociologists have fostered too much scepticism - social scientists must now elect to put science back at the core of society, writes Harry Collins in Nature.

One can justify anything with scepticism. Recently a philosopher acting as an expert witness in a court case in the United States claimed that the scientific method, being so ill-defined, could support creationism. Worse, scientific and technological ideas are nowadays being said to be merely a matter of lifestyle, supporting the idea that wise folk may be justified in choosing technical solutions according to their preferences - an idea horribly reminiscent of 'the common sense of the people' favoured in 1930s Germany. Some social scientists defend parents' right to reject vaccines and other unnatural treatments because a lack of danger cannot be absolutely demonstrated. At the beginning of the century, President Thabo Mbeki's policies denied anti-retroviral drugs to HIV-positive pregnant mothers in South Africa. Some saw this as a justified blow against Western imperialism, given that the safety and efficacy of the treatment cannot be proven beyond doubt.
A third wave of science studies would mean breaking away from now-routine and secure criticism, and instead taking the risks involved with the synthesis and generalization that build human culture. Mbeki claimed that anti-retroviral drugs had not been proven to reduce mother-to-child transmission of HIV, and pointed out that some scientists claim the drugs are poisonous. He was right. The hard problem for social studies of science is to show why, although he was right in logic, he was wrong for all practical purposes. Just showing there is some doubt about an issue, or another side to the story - at which we social scientists are nowadays unbeatable - does not inform you what to do in a case such as this.

Christine Maggiore died of AIDS

Eduard Grebe — Mon, 09 Mar 2009 16:11:28 +0000

Christine Maggiore's death certificate states that the immediate cause or condition resulting in her death was disseminated herpes viral infection. Bilateral bronchial pneumonia is given as the underlying cause, and oral candidiasis is given as a significant condition contributing to death. Based on her statements and her career, Maggiore was HIV-positive (see her book, and note that Alive and Well, the group she started, is described on its website as having been "founded in 1995 by a group of HIV positive diagnosed men and women"). In HIV-infected people, all of the above conditions are AIDS-defining opportunistic infections, and in combination they are hauntingly typical of AIDS in the years before ARVs. Many people who have died of AIDS shared the same constellation of opportunistic infections that killed Ms Maggiore. HIV-negative individuals almost never have all of these opportunistic infections simultaneously.

Maggiore's physician in the weeks prior to her death was Ilona Abraham, MD, of Encino, California. She signed the death certificate and states that Maggiore was in her care from December 16, 2008, to December 23, 2008, when she last saw her alive. Abraham graduated from Semmelweis Medical School in Budapest, Hungary, in 1967. She has an extensive history of malpractice cases and disciplinary actions, and no expertise in HIV. Abraham practices bogus "anti-aging" medicine, and treats her patients with untested and unproven treatments such as chelation and homeopathy. Abraham supported Maggiore's denialism and clearly misdiagnosed and mistreated her.

Maggiore's daughter, Eliza Jane Scovill, also died of AIDS when she was 3. This cause of death, following an autopsy, was recorded on the child's death certificate. Eliza Jane had no known risk of HIV exposure other than perinatal transmission from her mother. Maggiore's husband, Robin Scovill, reached an out-of-court settlement last week in a case he and Maggiore had brought against the Coronor's office. Maggiore stated on various denialist web sites that her lawsuit was a challenge to the finding that Eliza Jane died from HIV/AIDS. In fact, the revised lawsuit was not about the cause of her daughter's death, but about whether the LA Coroner's office and its staff violated the family's right to privacy after the child died. We note that the Maggiore family chose to make public many details of the lives and health of the whole family - mother, daughter, son and husband - so there is an irony in any lawsuit that alleges a privacy violation. The lawsuit was settled for $15,000, with no admission of wrongdoing, presumably to save the cost of a trial. Hence the LA Coroner's verdict that Eliza Jane Scovill died of HIV/AIDS remains the official verdict on, and the truth about, the death of Eliza Jane Scovill.

Unfortunately, no autopsy was performed on Maggiore's body, and she was cremated. Presumably, her family made these decisions. AIDS denialists often claim that they are victims of conspiracies and cover-ups. But they have been anything but transparent in the way they have handled the horrible and unnecessary death from HIV/AIDS of Christine Maggiore.

Christine Maggiore's name has been added to AIDStruth.org's list of Denialists who have Died of AIDS.

Children on HAART do extremely well at South African clinic

AIDSTruth — Thu, 12 Feb 2009 12:10:59 +0000

At the 16^th Conference on Retroviruses and Opportunistic Infections (CROI) Dr Tammy Meyers presented data from a large cohort of children on highly active antiretroviral therapy (HAART) at Harriet Shezi Children's Clinic in Chris Hani Baragwanath Hospital, Soweto, South Africa.(1)⁠ Of 2,102 chidren initiated on HAART over a four year period (April 2004 - March 2008), 1734 (82%) are alive and in the programme. Most of these children started HAART with severely compromised immune systems. Based on studies of untreated children at this stage of HIV disease(2)⁠(3)⁠, it is fair to say that nearly all would have been dead had they not been placed on HAART. By the end of the study, half the children had been on HAART for at least 17 months.

Analysis shows that more than 90% of the cohort had less than 400 copies of HIV per millilitre of blood after 18 months on the programme,¹ indicating that treatment was effective. On average, CD4 percentage rose from 11% to over 25% (in children CD4 percentage, rather than CD4 count is used because it is more stable). HIV-positive children on average weigh less and are shorter than HIV-negative children of the same age. The children in the cohort showed remarkable improvements in both these measures.

132 (6%) children died. Most deaths occurred within the first 90 days of treatment, indicating that many started too late. Meyers made the excellent point that infants should now be treated immediately upon diagnosis. This is based on the findings of the CHER study, published last year, which showed that treating infants treated immediately upon diagnosis (as opposed to deferring treatment until their CD4 percentage met the current SA guidelines for initiating treatment) had much lower mortality.(4)⁠ The factors at baseline that predicted death were being severely underweight, having a high viral load, being on TB treatment and being young. But even among some of these categories children did well. For example, 28.6% of children were on TB treatment, a much greater percentage than the number of deaths.

Both clinical trials and cohorts of children have previously been published showing excellent results on HAART. For example, a widely publicised successful cohort on 94 Haitian children was reported in 2005.(5)⁠ The contribution of the Harriet Shezi study is that this is a very large African cohort in a resource-limited operational setting.

Details

There were 3,553 children in the clinic database. 369 were excluded because they were in the clinic before the start of the cohort period. Another 389 were excluded because they had no follow-up. This left 2,795, of whom 2,216 were initiated on HAART. 91 were excluded from the study because they had no further visits after initiation. 23 were excluded because they were over 15. Of the remaining 2,102 included in the analysis, 1,734 were alive and active at study end. 132 died. 104 transferred and 132 were lost to follow up.

Interestingly of the 579 who did not start HAART (presumably in most cases because they were ineligible according to SA guidelines), 264 are alive and active in the programme. 78 died (double the proportion in the treatment cohort). 189 were lost to follow up (more absolutely than the treatment cohort) and 67 transferred.

At baseline: 51% of the cohort were males. Median viral load was over 100,000 [IQR log viral load: 4.6-5.8]. Median CD4 percentage was 11.5 [IQR: 6.9-16.2]. Weight for age Z-score median was -2.12 [IQR: -3.3 to 1.14]. Height for age Z-score median was -2.6 [IQR: -3.6 to -1.7]. Median age was 4.3 years.

The median follow-up time on HAART was 17.05 months [IQR 5.7-29.2]. The mortality rate within the first 90 days was nearly 15 per 100 child years (CY) and about 2 per 100CY after that (might be slightly inaccurate based on reading off graph). The mortality rate was markedly higher in children under 18 months, over 30 per 100CY within the first 90 days and 5 per 100CY after that. Viral load after 18 months given in the summary is a Kaplan Meier estimate. Based on a graph reading, the median CD4 rose to between 25 and 30%.

An important conclusion by the authors is that a high percentage of children starting HAART are co-treated for TB, warranting investigation of drug interactions.

References

1. Moultrie H, Yotebieng, M, Kuhn L, Meyers T. Mortality and Virological Outcomes of 2105 HIV-infected Children Receiving ART in Soweto, South Africa [Internet]. In: 16th Conference on Retroviruses and Opportunistic Infections. 2009. [cited 2009 Feb 11 ] Available from: http://www.retroconference.org/AbstractSearch/Default.aspx?Conf=18&Abs=35418

2. Little K, Thorne C, Luo C, Bunders M, Ngongo N, McDermott P, Newell M. Disease progression in children with vertically-acquired HIV infection in sub-Saharan Africa: reviewing the need for HIV treatment [Internet]. Curr HIV Res. 2007 Mar ;5(2):139-53.[cited 2009 Feb 11 ] Available from: http://www.ncbi.nlm.nih.gov/pubmed/17346131

3. Cross Continents Collaboration for Kids Analysis and Writing Committee. Markers for predicting mortality in untreated HIV-infected children in resource-limited settings: a meta-analysis [Internet]. AIDS. 2008 Jan 2;22(1):97-105.[cited 2009 Feb 11 ] Available from: http://www.ncbi.nlm.nih.gov/pubmed/18090397

4. Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, Jean-Philippe P, McIntyre JA. Early antiretroviral therapy and mortality among HIV-infected infants [Internet]. N Engl J Med. 2008 Nov 20;359(21):2233-44.[cited 2009 Feb 11 ] Available from: http://www.ncbi.nlm.nih.gov/pubmed/19020325

5. Severe P, Leger P, Charles M, Noel F, Bonhomme G, Bois G, George E, Kenel-Pierre S, Wright PF, Gulick R, Johnson WD, Pape JW, Fitzgerald DW. Antiretroviral Therapy in a Thousand Patients with AIDS in Haiti [Internet]. N Engl J Med. 2005 Dec 1;353(22):2325-2334.[cited 2008 Dec 8 ] Available from: http://content.nejm.org/cgi/content/abstract/353/22/2325

1. Based on a Kaplan Meier estimate

"With the stroke of a pen" – Andrew Maniotis's bizarre email to the Gates Foundation

AIDSTruth — Sat, 07 Feb 2009 17:12:09 +0000

Sometimes AIDS denialists do such a good job of discrediting themselves that we don't have to do much to counter them. See this email from Andy Maniotis to the Bill and Melinda Gates Foundation, with an attached document that he claims to have also sent to President Obama (while offering to serve as Mark Dybul's replacement).

From: Andy Maniotis [redacted]

Date: Fri, 6 Feb 2009 12:21:38 -0600
To: [redacted]
Subject: With the stroke of a pen

Dear Mr. or Mrs. Gates,

I am deeply concerned about the information you have been receiving regarding the scientific basis upon which several of your global policies are based.

Mr. Dybul, Mr. Bush's World AIDS coordinator has just been fired. In a letter to President Obama's team, I have offerred to serve as his replacement.

I would appreciate you forwarding the three short documents to Mr. Gates, or to Mrs. Gates, because I believe they deserve to have complete information regarding several of the assumptions your organization is pursuing. Mr. Gates releasing mosquitos yesterday to make his valid point illustrates to me the depth and sincerity of his vision, and the extent to which he is willing to "wake people up." Malaria-one of Man's greatest diseases, was once thought to be caused by "bad air" thus its name. I am suggesting that you will find that several current "plagues" will be found to be based on different mechanisms which suggest different strategies, instead of pursuing supernatural beings in the case of certain viral diseases, and the universally failed approaches to vanquish them.

I hope these documents will serve a similar purpose as releasing mosquitoes on a Western audience: I hope that like the mosquitoes, the following information will cause some concern for alarm as well.

With much thanks in this important matter,

Sincerely,

Andrew Maniotis, Ph.D.
Visiting Associate Professor of Bioengineering: Program of tumor mechanics and tissue regeneration;
212 SEO, MC 063
University of Illinois at Chicago, Chicago, IL 60607
Secure Email: [redacted]
University Email: [redacted]
Cell: [redacted]

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with the stroke of a pen.pdf	485.02 KB

Video: Consequences of HIV/AIDS Myths

AIDSTruth — Fri, 30 Jan 2009 00:27:32 +0000

A short video commissioned by the US State Department:

Video: Debunking HIV/AIDS Myths

AIDSTruth — Fri, 30 Jan 2009 00:25:31 +0000

A short video commissioned by the US State Department:

Study Refutes Claims on NYC foster children's participation in AIDS Drug Trials

AIDSTruth — Wed, 28 Jan 2009 11:23:37 +0000

The claims made by some denialists over 'experimentation' on New York City foster children (and which convinced some civil rights campaigners and City Council members) have been comprehensively debunked in an independent report conducted by the Vera Institute of Justice.

Update: The Vera report is available here (or read only the executive summary). The NYC Administration for Children's Services' press release has been appended to this story.

The New York Times reports:

An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race.

...

After interviewing dozens of people involved in the trials and reviewing hundreds of thousands of pages of case files, documents and correspondence, the Vera Institute concluded that none of the 532 children in the trials died as a direct result of the medications. (Twenty-five children receiving treatment as part of the trials died during the trial years.)

The report also found that foster children were not removed from their families by the city because a parent had refused to consent to a child’s treatment, as some had alleged.

In addition, the study said that researchers did not specifically select foster children for enrollment in the trials. And while the foster children were overwhelmingly black and Hispanic, as some critics emphasized, that profile mirrored the demographics of children with H.I.V. infection in the city at the time.

Read the full New York Times article.

Press release of New York City Children's Services

Children’s Services Welcomes Finding of Report on Children in Foster Care Enrolled in Clinical Trials for HIV/AIDS Medication

The NYC Administration for Children’s Services today welcomed the release of a report by the Vera Institute of Justice related to the enrollment and participation of New York City children in foster care in clinical research trials for HIV/AIDS in the late 1980s-1990s. The report, commissioned in 2005 by Children’s Services Commissioner John B. Mattingly, provides the public with a full, independent accounting of this important issue following a public inquiry into the matter. Currently, there are no NYC children in foster care enrolled in clinical trials.

Children’s Services believes that the findings overall show that child welfare officials in previous administrations acted in the interests of children in the city's care, including these findings: The mortality rate for the 532 foster children in the trials was lower than that of all HIV-infected children in NYC during those same years; evidence that child welfare officials followed then-current written policies to obtain parental consent for nearly 80 percent of children participating in the trials; the representation of African American and Latino children in foster care who participated in the clinical trials was comparable to the representation of African American and Latino children in the total population of NYC children with HIV/AIDS.

“We believe Vera’s report emphatically shows that child welfare officials who oversaw the enrollment of these children in trials during the 1980s and 1990s were doing so in an attempt to save lives during a terrible epidemic,” said Commissioner John B. Mattingly. "The city’s efforts to get these children into clinical trials where they could receive the only medication available to them saved many children.”

Titled “The Experiences of New York City Foster Children in HIV/AIDS Clinical Trials,” Vera’s report provides a thorough accounting of children’s participation in the trials during earlier city administrations, at a time when NYC was the epicenter of the pediatric AIDS crisis, with one-third of the 9,000 children in the United States with HIV living in the city. The majority of these NYC children were black and Latino; many of them were placed in foster care because their parents were infected, had died or were otherwise unable to care for their children. In the early days of the epidemic, the medications under development to address the disease were tested only on adults, and were not available for HIV-infected children. To ensure that children in the city’s care had access to newly available anti-HIV medications, the officials of the city’s child welfare agency (then a part of the Human Resources Administration, HRA -- becoming a separate agency as ACS in 1996) approved foster children’s participation in clinical trials.

Commissioner Mattingly said the report demonstrated the City's commitment to build trust with the public. “We believe that Vera’s exhaustive study will answer many of the critical questions that the NYC community had about the participation of children in the clinical trials.”

Children’s Services also has worked for the past few years to strengthen the Agency's clinical trials policy to ensure the safety and protection of children who may need to participate in trials in the future.

The report, which is available on the Web site of the Vera Institute of Justice (www.vera.org) details the following key findings:

532 children in foster care participated in the trials or studies; 80 died while in foster care; 25 while enrolled in a medication trial. There is absolutely no evidence that clinical trial medications directly caused a child’s death

The mortality rate (from any cause) of foster children in the trials was lower than that of other HIV-infected children in NYC during those same years.

The city’s Human Resources Administration followed then-current written policies to obtain consent for children participating in the trials in 78 percent of the cases.

Latino and African American children were not targeted for participation in clinical trials. Most children in foster care at the time were Latino and African American, and their rate of participation in the trials reflected the distribution of those children in care.

Children in foster care did not appear to be overrepresented in the clinical trials. The majority of children in clinical trials for HIV/AIDS during this period were not in foster care – only 30 percent of the participants in the trials in NYC were in foster care.

No children were removed from their families because a parent refused to consent to the child's participation in a trial or study. There was absolutely no evidence that parents, guardians, or foster parents were forced to enroll children in the clinical trials.

The report did find some situations in which there were violations of state and federal regulations and city policy for enrollment, monitoring and file retention. These include:

The Institutional Review Boards of the hospitals conducting the trials did not consistently apply federal regulations related to the use of an independent advocate for children enrolled in clinical trials.

Some case records and medical records maintained by contract foster care agencies could not be located despite New York State regulations requiring retention of such records.

Record keeping by the HRA Pediatric AIDS Unit, responsible for monitoring HIV-infected foster children, was inconsistent.

Three children out of the 532 who participated in the trials were enrolled in a Phase 1 clinical trial of an HIV vaccine that had not been approved by the then-child welfare commissioner.

A small percentage of children participated in trials that were not recommended or reviewed by a Medical Advisory Panel.

It is also important to note that while Vera conducted a comprehensive and exhaustive review of available records, including child welfare case management records provided by Children's Services, the researchers were unable to review children’s hospital records because the New York State Department of Health would not allow access to hospital records due to concerns about patient confidentiality. Requests by ACS for access to these records were made repeatedly, in various forms, with several suggestions for strategies to preserve confidentiality. Each time the request was denied. It is possible that such records may contain supplemental information on the above findings, especially where there are gaps around the issues of consent, approval and enrollment.

“We now have a largely complete review of the actions of the child welfare side of these trials in New York City. The absence of records detailing involvement of the medical community, which I believe would have confirmed the foster care results, is regrettable,” said Commissioner Mattingly.

In addition to commissioning the study by Vera, Children’s Services also asked a group of NYC AIDS activists, advocates, physicians and child welfare experts – many of whom also represent and work closely with communities of color -- to consult with the Agency on the development of a new clinical trials policy and to advise Vera as the research was underway. This group, known as the HIV/AIDS Community Advisory Board, is co-chaired by Debra Fraser-Howze, founding member of the National Black Leadership Commission on AIDS; Ana Oliveira, former Executive Director, Gay Men’s Health Crisis and current Executive Director of the New York Women’s Foundation; and Ernesto Loperena, Executive Director, New York Council on Adoptable Children.

Dr. Robert Johnson, interim Dean of the New Jersey Medical School and an expert in pediatric and adolescent AIDS, was solicited by ACS to provide expert advice regarding past and present standards of pediatric HIV diagnosis and management, standards of appropriate medical documentation and record-keeping, and to advise on the new policy.

As a result of the inquiry, ACS, in consultation with the HIV/AIDS Community Advisory Board, Dr. Johnson and other medical experts, has revised its policies regarding foster children’s participation in future clinical trials. Although no NYC foster children are currently enrolled in clinical trials, ACS believes that clinical trial participation is appropriate for NYC foster children under certain conditions and given appropriate safeguards. The new ACS clinical trials policy prohibits, for example, participation by children in foster care in any Phase 1 clinical trials in which the safety of drugs is tested.

ACS has also instituted systematic methods to oversee contracted foster care agencies’ documentation of healthcare-related services and to ensure proper storage and retrieval of records. In addition, the Agency has substantially overhauled its internal record retention procedures and policies.

The BBC report on clinical trials, which aired in 2004 and contributed largely to the public inquiry, was later the subject of an apology letter by the network. Children’s Services can make a copy of that letter available.

Vera's report is available at http://www.vera.org/cyj/hivtrials-pubs.html. For information on how to contact members of the HIV/AIDS Community Advisory Board, please contact the ACS Press Office at 212-341-0999.

Contact: Sharman Stein or Sheila Stainback at: 212-341-0999

CD4 Counts Decline Despite Nutritional Recovery in HIV-Infected Zambian Children With Severe Malnutrition

AIDSTruth — Mon, 26 Jan 2009 17:06:55 +0000

New research in Zambia further undermines the idea that AIDS in Africa is caused by malnutrition. Severe malnutrition did not reduce the CD4 counts of children without HIV. HIV-infected children with severe malnutrition may respond well to nutritional rehabilitation, despite low CD4 counts, but nearly all require early antiretroviral therapy to prevent disease progression.

CD4 Counts Decline Despite Nutritional Recovery in HIV-Infected Zambian Children With Severe Malnutrition.

Hughes SM, Amadi B, Mwiya M, Nkamba H, Mulundu G, Tomkins A, Goldblatt D.

OBJECTIVE. The objective of this study was to establish the contribution that severe malnutrition makes to CD4 lymphopenia in HIV-infected and uninfected children and to determine the changes in CD4 count during nutritional rehabilitation. METHODS. Fifty-six children with severe malnutrition and with and without HIV infection were recruited from a pediatric ward in Lusaka for measurement of CD4 counts on admission, on discharge, and at final nutritional recovery. RESULTS. HIV-uninfected children with severe malnutrition had normal CD4 counts. In contrast, CD4 counts in HIV-infected children with severe malnutrition were reduced, more so in those without edema compared with those with edema. Mean CD4 count of HIV-infected SM children fell despite nutritional recovery so that at the time of full nutritional recovery, >85% of HIV-infected children required antiretroviral therapy. CONCLUSIONS. Severe malnutrition did not reduce the CD4 counts of children without HIV. HIV-infected children with severe malnutrition may respond well to nutritional rehabilitation, despite low CD4 counts, but nearly all require early antiretroviral therapy to prevent disease progression.

PMID: 19124582 [PubMed - as supplied by publisher]