Failure to disclose conflicts of interest, substandard peer review and the involvement of some scientists in pharma profiteering weakens the public's trust in legitimate science and creates an environment in which denialism and pseudoscience flourish. We welcome the policy changes that some journals are implementing.
The New York Times reports:
The scientific integrity of medical research has been clouded in recent years by articles that were drafted by drug company-sponsored ghostwriters and then passed off as the work of independent academic authors.
Yet the leading medical journals have continued to rely largely on an honor system of disclosure to detect such potential bias, asking authors to voluntarily report any industry ties or contributors to their manuscripts.
But now, in light of recently released evidence that some drug makers have gone to great lengths to turn scientific articles into marketing vehicles for their products, some influential medical editors are cracking down on industry-financed ghostwriting. And they are getting help from some members of Congress.
by Jeanne Bergman
“House of Numbers” is a film with a hidden agenda: it tries to make viewers doubt the reality that the virus called HIV exists and causes AIDS. It conceals this agenda behind a false veneer of honest inquiry. The filmmaker, Brent Leung, told a Huffington Post blogger: “I am not a denialist. Posing questions is very different than denying something. … I traveled the globe speaking with scientists, activists, clinicians, journalists and patients asking questions. My main goal? To educate myself and others, and to generate discussion on important questions that have not yet been answered.” But Leung is an HIV denialist—he has said he is “neutral” on the issue of HIV/AIDS, which means he rejects the evidence-based science that has conclusively proved the existence of HIV and its causative role in AIDS, a fatal disease syndrome. His film is supported and promoted only by denialists. And Leung in fact got the information he sought from the legitimate scientists, doctors, and advocates he interviewed, but he then edited it out of the film to deceive and confuse viewers. The audience is manipulated to reach the wrong answers to the questions he ask. Since Leung leaves his own positions unstated, he dodges accountability for the film’s potential impact—namely, that people might decide that they don’t need to protect themselves or others from being infected with HIV, or that people living with HIV might reject medical care and the medications that could keep them healthy.
Here we summarize the fake “questions” Leung raises in the film, and provide real, evidence-based answers. Read more »
There can be few greater embarrassments for scientists than for a publisher to retract their papers forcibly. This is exactly what has happened to two AIDS denialist articles, one of them co-authored by Peter Duesberg and David Rasnick. Here is what happened.
In 2008, the Journal of AIDS (JAIDS) published an article by Pride Chigwedere  and colleagues of Harvard University, who estimated that delays in providing antiretroviral drugs in South Africa due to state-supported AIDS denialism had caused over 300,000 deaths. This publication confirmed the results of a previous study by South African professor and aidstruth.org member Nicoli Nattrass.  AIDS denialist Peter Duesberg, whose influence on the disastrous South African government policies was mentioned in Chigwedere’s article, submitted a response to JAIDS that was co-authored by four others including Rasnick. After this article was rejected because of its poor academic quality, Duesberg et al. submitted it to a different journal, Medical Hypotheses. Two days later, the editor accepted the paper. Medical Hypotheses does not practice peer review, a process in which several scientists check a submitted academic paper for quality and suggest needed improvements over a period of weeks or months. The Duesberg et al. paper was accepted without such a review process, after inspection only by the editor of Medical Hypotheses.
That Duesberg’s paper was not properly reviewed by experts is painfully obvious, as neither facts nor logic are allowed to temper the authors’ denialist speculations and opinions. For example, they argue that AIDS is not a problem in Africa because the total population of Africa has increased during the AIDS era. One could as easily conclude that cancers are never fatal, since the population of California has increased despite the presence of these diseases. Duesberg et al. also say antiretroviral medicines have not reduced AIDS mortality, an obvious lie since these drugs have drastically lowered mortality. Worse, Duesberg et al. say they derived this idea from a scientific article.  In fact, the article they cite states nothing of the sort; it actually shows that a newer combination of antiretroviral drugs is not substantially better than an older combination. Of course, both these combinations are better than Duesberg’s favored treatment option – nothing. Doing nothing in the face of HIV infection is, however, very often a death sentence, as it was to over 300,000 South Africans. [1,2] Read more »
From the New York Times:
Couched as a “personal journey” through the history of H.I.V. and AIDS, “House of Numbers” is actually a weaselly support pamphlet for AIDS denialists. Trafficking in irresponsible inferences and unsupported conclusions, the filmmaker Brent Leung offers himself as suave docent through a globe-trotting pseudo-investigation that should raise the hackles of anyone with even a glancing knowledge of the basic rules of reasoning.
Assembled from interview fragments with doctors, scientists, journalists and others, the film cobbles together an insinuating argument against the existence of H.I.V. as a virus and AIDS as the resulting disease. Among the many inflammatory claims is that diagnosis is a pharmaceutical-industry ruse to sell complex drug therapies (which the film then presents as the real cause of the syndrome we identify as AIDS). Evidence to support this and other highly dangerous contentions is found not in verifiable statistics (house of numbers, my foot) but in the impassioned anecdotes of individuals who have outlived the expectations of an H.I.V.-positive diagnosis.
The New York Times writes in an editorial titled Hope in South Africa:
For years, South Africa was an international laughing stock for its tragically absurd approach to the deadly AIDS epidemic. Now, that nationalnightmare may be ending.
The new government of President Jacob Zuma seems to have a clearer-eyed view of the problem, its remedies and the need to improve the overall health care system than its predecessor did. Fixing what’s broken will not be easy, but we are encouraged by signs of a commitment to do so.
To see how far South African leaders have come, one needs to recall where the country was.
The former president, Thabo Mbeki, compiled a record that is still hard to fathom: he embraced crackpot theories that disputed the demonstrable fact that AIDS was transmitted by a treatable virus. He insisted that antiretroviral drugs were toxic and encouraged useless herbal folk remedies instead. He even claimed he knew nobody with the disease, although nearly 20 percent of the adult population is said to be living with H.I.V.
A number of studies showing a benefit to starting antiretroviral therapy earlier have been reported recently. These have resulted in important changes to guidelines including that infants should be treated immediately upon diagnosis and that adults should be treated as soon as their CD4 counts fall below 350 cells/mm3.
Determining the optimal time to start treatment is one of the most important unanswered questions about antiretroviral treatment. A large open-label treatment trial called START has begun and will likely answer this question within the next few years. It is open to HIV-positive volunteers with CD4 counts > 500 cells/mm3. Volunteers will be randomised to either start treatment immediately or defer treatment until their CD4 counts drop to below 350 cells/mm3 or treatment is clinically indicated.
A few of the studies showing the benefits of earlier treatment than guidelines previously recommended are listed below:
Effect of early versus deferred antiretroviral therapy for HIV on survival
Kitahata MM, Gange SJ, Abraham AG, Merriman B, Saag MS, Justice AC, Hogg RS, Deeks SG, Eron JJ, Brooks JT, Rourke SB, Gill MJ, Bosch RJ, Martin JN, Klein MB, Jacobson LP, Rodriguez B, Sterling TR, Kirk GD, Napravnik S, Rachlis AR, Calzavara LM, Horberg MA, Silverberg MJ, Gebo KA, Goedert JJ, Benson CA, Collier AC, Van Rompaey SE, Crane HM, McKaig RG, Lau B, Freeman AM, Moore RD; NA-ACCORD Investigators.
BACKGROUND: The optimal time for the initiation of antiretroviral therapy for asymptomatic patients with human immunodeficiency virus (HIV) infection is uncertain. METHODS: We conducted two parallel analyses involving a total of 17,517 asymptomatic patients with HIV infection in the United States and Canada who received medical care during the period from 1996 through 2005. None of the patients had undergone previous antiretroviral therapy. In each group, we stratified the patients according to the CD4+ count (351 to 500 cells per cubic millimeter or >500 cells per cubic millimeter) at the initiation of antiretroviral therapy. In each group, we compared the relative risk of death for patients who initiated therapy when the CD4+ count was above each of the two thresholds of interest (early-therapy group) with that of patients who deferred therapy until the CD4+ count fell below these thresholds (deferred-therapy group). RESULTS: In the first analysis, which involved 8362 patients, 2084 (25%) initiated therapy at a CD4+ count of 351 to 500 cells per cubic millimeter, and 6278 (75%) deferred therapy. After adjustment for calendar year, cohort of patients, and demographic and clinical characteristics, among patients in the deferred-therapy group there was an increase in the risk of death of 69%, as compared with that in the early-therapy group (relative risk in the deferred-therapy group, 1.69; 95% confidence interval [CI], 1.26 to 2.26; P<0.001). In the second analysis involving 9155 patients, 2220 (24%) initiated therapy at a CD4+ count of more than 500 cells per cubic millimeter and 6935 (76%) deferred therapy. Among patients in the deferred-therapy group, there was an increase in the risk of death of 94% (relative risk, 1.94; 95% CI, 1.37 to 2.79; P<0.001). CONCLUSIONS: The early initiation of antiretroviral therapy before the CD4+ count fell below two prespecified thresholds significantly improved survival, as compared with deferred therapy. 2009 Massachusetts Medical Society
Timing of initiation of antiretroviral therapy in AIDS-free HIV-1-infected patients: a collaborative analysis of 18 HIV cohort studies
When To Start Consortium, Sterne JA, May M, Costagliola D, de Wolf F, Phillips AN, Harris R, Funk MJ, Geskus RB, Gill J, Dabis F, Miró JM, Justice AC, Ledergerber B, Fätkenheuer G, Hogg RS, Monforte AD, Saag M, Smith C, Staszewski S, Egger M, Cole SR.
BACKGROUND: The CD4 cell count at which combination antiretroviral therapy should be started is a central, unresolved issue in the care of HIV-1-infected patients. In the absence of randomised trials, we examined this question in prospective cohort studies. METHODS: We analysed data from 18 cohort studies of patients with HIV. Antiretroviral-naive patients from 15 of these studies were eligible for inclusion if they had started combination antiretroviral therapy (while AIDS-free, with a CD4 cell count less than 550 cells per microL, and with no history of injecting drug use) on or after Jan 1, 1998. We used data from patients followed up in seven of the cohorts in the era before the introduction of combination therapy (1989-95) to estimate distributions of lead times (from the first CD4 cell count measurement in an upper range to the upper threshold of a lower range) and unseen AIDS and death events (occurring before the upper threshold of a lower CD4 cell count range is reached) in the absence of treatment. These estimations were used to impute completed datasets in which lead times and unseen AIDS and death events were added to data for treated patients in deferred therapy groups. We compared the effect of deferred initiation of combination therapy with immediate initiation on rates of AIDS and death, and on death alone, in adjacent CD4 cell count ranges of width 100 cells per microL. FINDINGS: Data were obtained for 21 247 patients who were followed up during the era before the introduction of combination therapy and 24 444 patients who were followed up from the start of treatment. Deferring combination therapy until a CD4 cell count of 251-350 cells per microL was associated with higher rates of AIDS and death than starting therapy in the range 351-450 cells per microL (hazard ratio [HR] 1.28, 95% CI 1.04-1.57). The adverse effect of deferring treatment increased with decreasing CD4 cell count threshold. Deferred initiation of combination therapy was also associated with higher mortality rates, although effects on mortality were less marked than effects on AIDS and death (HR 1.13, 0.80-1.60, for deferred initiation of treatment at CD4 cell count 251-350 cells per microL compared with initiation at 351-450 cells per microL). INTERPRETATION: Our results suggest that 350 cells per microL should be the minimum threshold for initiation of antiretroviral therapy, and should help to guide physicians and patients in deciding when to start treatment.
PMID: 19361855 Read more »
Fact: HIV tests for antibodies or the virus itself are highly reliable (both in terms of sensitivity and specificity).
There are two important measures when considering the accuracy of an HIV test or any screening or diagnostic test: sensitivity and specificity.
Sensitivity is a measure of how likely it is that the test will return positive results if the person being tested has HIV. A highly sensitive test is calibrated to capture every positive sample, but will probably produce some false positives because it is so sensitive that may react to other substances as well.
Specificity is a measure of how likely it is that the test will return negative results if the person being tested does not have HIV. A highly specific test will only react to the substance being tested for and exclude all true negatives, but it will also produce false negatives.
David Rasnick is a co-author with Peter Duesberg and others of an article in Medical Hypothesis which claims that HIV is not the cause of AIDS. The abstract of the article states, "we call into question the claim that HIV antibody-positives would benefit from anti-HIV drugs, because these drugs are inevitably toxic and because there is as yet no proof that HIV causes AIDS." 
We note an undeclared conflict of interests in this article by David Rasnick. Rasnick was a researcher for a company called the Rath Health Health Foundation Africa. This organisation promoted and distributed (and in terms of South African law, sold) micronutrient products as alternatives to antiretroviral treatment in South Africa. It also conducted an unauthorised clinical trial using these products as alternatives to antiretrovirals on people with HIV. The company never published the results of this trial in a peer-reviewed medical journal, but instead published adverts purporting to report the trial's results, a practice that is considered unethical in medical research. Rasnick is described in these adverts as one of the researchers on the trial. Read more »
AIDS denialists have claimed that the lack of disease progression in chimpanzees infected with HIV is evidence that the virus is at worst a passenger in human beings and cannot be the cause of AIDS. This was, for example, implied by the journalist Celia Farber in her AIDS denialist piece published in Harper's in 2006.
In the response to Farber, to which several of the AIDSTruth.org team contributed, we wrote:
It is true that HIV replicates inefficiently in chimpanzees, to a much lower level than it does in humans so it usually does not cause disease. However, there are recorded examples of HIV causing immunodeficiency in these animals.
Many agents which cause disease in man are unable to cause disease in a host of other species because they fail to infect, or infect poorly, or produce a different response. HIV has probably been in the chimpanzee population for a very long time. Therefore it is plausible that natural selection has rendered it less harmful.
Fact: HIV has been shown to be exogenous throughout 20+ years of research.
An endogenous retrovirus is one whose genetic material has been incorporated into that of the host. This happens when the genome of the virus incorporates itself into the chromosome of the host's sex cell (sperm or egg) – or its progenitor – and thus, upon fertilization becomes part of the normal genome found in every cell in the body of the host. Over time, the endogenous retroviral genome usually accumulates deleterious mutations rendering it incapable of productive infection. One myth used by denialists is that HIV is one of these endogenous retroviruses. However, several lines of evidence from the published scientific literature refute this claim, and prove that it is an exogenous virus, found only in CD4+ T-cells and a few other CD4+ cell types (such as macrophages) and not found in most other host cells. Read more »
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:
AIDSTruth member and Treatment Action Campaign treasurer Nathan Geffen writes in the Journal of Acquired Immune Deficiency Syndromes:
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.
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.
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).
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.
Study shows the prognostic value of HIV viral load counts and CD4 counts for predicting AIDS and death
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: Read more »
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: Read more »
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 opinions2 as well as pieces by other conservative conspiracy theorists. Read more »
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. Read more »
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.
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 4th issue of Science in 1984.