• Sanjay Basu | Governance

    Ongoing coverage of the International AIDS Conference in Bangkok is bewildering to those who are familiar with the current political battles in the HIV/AIDS arena, and no doubt disheartening or annoying to those reading from a distance. The AIDS industry is in full swing: government forces delivering glittering generalities; actors and ex-presidents discussing their "outrage" while eating five-course dinners in Bangkok hotel penthouses.

    Non-governmental organizations (NGOs) provide some context and much confusion. Some, like Doctors Without Borders or Partners In Health, push a consistent line that demonstrates their commitment and closeness to the poor who suffer from HIV and its related social pathologies [1, 2]. Others seem to care more about winning New York Times headlines than about the implication of what those newspaper stories will have for the poor. The American Foundation for AIDS Research in Manhattan, for example, produced a report that should have provided an evaluation of Thailand's generic production facilities within the context of technical suggestions and cross-border comparisons with other nations' production centers; instead the report was publicized in a manner divorced from its technical minutiae and left the impression that generic medicines from Thailand would kill millions [3]. This, in a context where the US AIDS Czar Randall Tobias is looking for any means to undermine generic manufacturing and return to an oligopoly system in the pharmaceutical industry [4].

    The heavy focus on drug access at the conference does, however, serve as one piece of good news, in spite of the fact that many believe it is "distracting" from other matters (an issue I will deal with later in this article). The fact that the discussion is not about whether antiretrovirals can be used in poor countries, but about how to get them there, is a marked shift from previous years. But that is not to say that efforts like the WHO's "3-by-5" Initiative (three million people gaining access to antiretrovirals by 2005) are not being undermined [4]. The battles will continue over this and related initiatives, but what are the rest of us to do as we watch the actors and ex-presidents deliver glittering generalities? What positive outcomes can come for the poor when the wealthy of Manhattan produce statements of "outrage" while consuming pad thai in the security-fenced sector of Bangkok?

    * Please click on the link below to read the full article. Comments can be sent to

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  • In May 2003, at its annual World Health Assembly, the World Health Organisation (WHO) announced a modest proposal: that it would provide the technical and organisational support to provide 3 million people in poor countries with antiretroviral treatment by the year 2005.

    This "3-by-5 initiative" was minor in one sense, in that it would provide treatment to only about 5 percent of those in need. But in another sense, it was a major step forward, particularly because the WHO proposed a novel manner of delivering the anti-HIV medicines: combining the drugs into a "fixed-dose regimen", a combination pill containing three drugs in one capsule, allowing an infected person to take only one pill twice per day for a complete HIV-treatment regimen. Fixed-dose combinations are cheaper and easier to take than the existing HIV treatment protocol; taking two fixed-dose combination pills a day for a year costs $140 per patient, compared to about $600 per year for the normal regimen of six pills per day [1].

    Previous excuses used to deny patients in poor countries access to antiretrovirals centred around two common arguments: that poor persons could not adhere to complex medication regimens and would therefore improperly take the drugs leading to drug-resistant forms of HIV, and that the infrastructure in poor countries is insufficient to support complex HIV care [2, 3].

    Yet those who continue to state these excuses are almost universally unfamiliar with the public health and biomedical data accumulated over the last several years, which definitively demonstrates that in the most resource-poor settings - including the poorest place in the western hemisphere (the central plateau of Haiti) and the slums of southern Africa (such as the Khayelitsha township in South Africa) - antiretroviral treatment has been delivered with higher adherence, extraordinary success rates and no evidence of drug resistance [4-9]. The success of these interventions has resulted in the exportation of these models throughout the world - and physicians everywhere are now waiting for the necessary medications to arrive.

    The WHO's generic combination pill would have improved and simplified treatment to the point where these models would have been even easier to adopt in most resource-poor settings.

    Why had a combination pill not been designed before? Because HIV treatment requires a number of different types of medications, and these types are patented by different companies in the US and UK. Ideal combination pills could not be produced when one company owned the patent to a necessary chemical and another company owned the patent to a secondary component.

    The patents, of course, are believed to be necessary to give inventors a fixed monopoly time in a marketplace to recoup costs on research and development (R&D). Yet, again, data demonstrate that such costs are recouped well in advance of the 20-year patents that the US Trade Representative is pushing on poor countries through bilateral and regional trade agreements [12].

    And the R&D claim ignores the fact that most AIDS drugs were produced through public financing (even through the clinical trials stages), and 85% of the basic and applied research for the top five selling drugs on the market were produced through taxpayer funding [13].

    According to the industry's own tax records (obtained from the Securities and Exchange Commission), Merck last year spent 13% of its revenue on marketing and only
    5% on R&D, Pfizer spent 35% on marketing and only 15% on R&D, and the industry overall spent 27% on marketing and 11% on R&D [14].

    Meanwhile, all of sub-Saharan Africa constitutes only 1.3% of the pharmaceutical market, so as one former pharmaceutical executive put it, allowing generics to enter this market would result in a profit loss to the patent-based industry equivalent to "about three days fluctuation in exchange rates" [15, 16].

    But the drug industry's fight for monopoly patent rights in this market and middle-income country markets is serious, as the growing inequality in poor countries under the context of neoliberalism increases the market-share for more expensive patent-based drugs among the elite [17].

    With all of this data accumulating, it would seem self-evident that the WHO's move to make a generic combination pill would not face much opposition. In reality, the new US AIDS "Czar", Randall Tobias, the former CEO of Eli Lilly, has almost totally undermined the WHO plan.

    While he and the White House initially pledged to support the initiative, no monies have flowed to date, and Tobias appears to be waiting until the program completely collapses from financial instability [18].

    Ironically, when President Bush claimed to pledge $15 billion to global AIDS efforts during the State of the Union Address last year (none of which has actually been apportioned to date), he quoted the price of the WHO generic pill as a basis for claiming that the US would support drug treatment for HIV-infected persons, since such treatment has become more affordable [19]. It now appears that the US will only pay if US patent-based pharmaceutical manufacturers are given the money - an effective subsidy of an already heavily-subsidized industry that is taxed at only one-third of the rate of other equivalent industries [13, 18].

    While the pharmaceutical industry has been lobbying the White House throughout this week to undermine the WHO initiative, Tobias has publicly stated that his concerns are not about the industry's interests, but about the safety of generics and the prospect that cheaper AIDS drugs would be smuggled illegally into Northern countries. "We need to have principles," he told the US Congress this week, "standards by which the purchase decisions can be made" [1].

    The WHO has taken care of the safety standards concern by inspecting and making a list of "approved" generics whose safety standards meet international guidelines [20]. But the US Department of Health and Human Sciences has now convened a conference in Botswana on March 29 that will question the WHO's approval process, drawing in "experts" from the patent-based industry to claim that the process every major academic public health expert in the field has supported is somehow inadequate and unsafe [18].

    The smuggling claim is more complex; while the company GlaxoSmithKline did have a shipment of AIDS drugs diverted from Sierra Leone early last year, it was later found that the shipment was partly still in Europe and simply mis-warehoused by GSK, and that the smuggling of the rest of the drugs took over a year for GSK to discover [21].

    Indian generic manufacturers have been shipping drugs for over two decades without a single case of "diversion", and the fact that generics create new formulations and new pill shapes, colours and boxes makes it easier for customs officials to detect any form of diversion, as they would for any other type of illegal smuggling [22]. The EU has passed a customs regulation to assist in preventing any future diversion; while the US could do the same. Taking care of the problem this way would ironically undermine Mr. Tobias' own arguments.

    It appears clear that Randall Tobias' agenda is not driven by data or rational thought, but by the industry whose combined soft- and hard-money campaign donations top the list of contributors in the US election cycle [23].
    Shining a light on the Czar's activity may begin to expose his practices to scrutiny and - as was done when he and the US Trade Representative tried to undermine a WTO accord for generic drug procurement earlier this year - may prevent disintegration of an important public health initiative [24].

    * Sanjay Basu is at the Yale University School of Medicine.
    Please send comments to [email protected]

    * Click on the link below for a list of reading materials and references.

    * Visit the Advocacy and Campaigns section of Pambazuka News to read more about the March 29 meeting in Botswana where activists fear that generic medicine treatment will be discredited.

  • Sanjay Basu | Governance

    There are few moments in the history of AIDS that can call for celebration. The recent decision of the South African government to begin rolling-out antiretrovirals is certainly near the top of the list. But many persons might be tempted to celebrate more widely as December 1st, World AIDS Day, arrives this year, if only because AIDS has received such mainstream appeal that funds now appear to be travelling in all directions, and new programs are announced nearly everyday. Bill Clinton, once the designer of trade sanctions stopping countries like Thailand and Argentina from importing AIDS medicines, now announces generic drug price negotiations. Randall Tobias, a former executive at multi-national drug company Eli Lilly now claims to advance a $15 billion U.S. foreign AIDS budget. If there is anything we can be certain of, it is that AIDS now travels as a key cultural commodity in the most established institutions. But is this cause for celebration?

    There is a temptation to announce that AIDS is finally “being taken care of”, that if the farther right-wing elements of U.S. foreign policy are placing the issue centrally, then something must certainly be getting done. The temptation is to call attention elsewhere, to claim that AIDS has received “enough attention” and may be distracting resources from other problems. But such a temptation is, sadly, completely out of order. Those who would rebut such statements would, rightly, point out that the $15 billion is not only disproportionately small, but has not actually been appropriated. They will point to the limitation of drug price negotiations and the sad fact that press releases consistently belie the sad truths about implementation and the non-existence of effective health programs in the vast majority of sites around the world. They will talk about the infusion of abstinence-only rhetoric; the problems at USAID; and the obstacles posed by the New Partnership for Africa’s Development (NEPAD), the Free Trade Agreement of the Americas (FTAA), Southern African Customs Union (SACU), and the new bilateral trade agreements. And they will be right.

    But there are other reasons to be concerned; reasons that will likely go unmentioned. These reasons can be revealed when we examine the institutions that now claim to command AIDS, and ask some very simple questions about them: how have they constructed and envisioned their “target populations”? What are the approaches they assume to be effective? Who is to blame, who is to be accountable, and on what basis do “AIDS programs” come to be constructed in these institutions?

    Even the oldest data on AIDS provide clear answers to these questions if we examine them for what they are instead of for what we want them to be. At present, the assumptions of institutions are to institute educational programs, add some antiretrovirals for those already infected, and perhaps offer “culturally competent” videos to reduce stigma in the community of concern. Such is the standard format of AIDS programming today. My contention is that such programming is based on questionable premises. If we look to data from Haiti, we hear the stories of persons who are not simply individuals making “risky decisions”, but those who must engage in sex for the sake of achieving greater priorities than long-term personal health: for tonight’s food, for tomorrow’s money, for some means of security. In South Africa, male miners are housed in all-male barracks, worked six days per week, and have letters sent to them informing them that their wives have left or entered prostitution for money. They are given alcohol and prostitutes to prevent them from rebelling, and are called “denialists” (equating their mentality to that of elite politicians) by social scientists who argue that they should be more worried about a disease that will kill them several years in the future than about their 42% injury rate.

    Are “behaviour change”, “education”, and stigma-reducing videos the most appropriate interventions we have available to us in such contexts? Perhaps. But data suggest otherwise. A recent systematic review of evidence in the British Medical Journal indicates that “providing information about health risks changes the behaviour of, at most, one in four people - generally those who are more affluent”. Data on HIV reveal that most persons know of its means of transmission, yet lack the personal agency to act on such knowledge, as the conditions of their lives dictate that dictate that, as Paul Farmer has stated, "their risk stems less from ignorance and more from the precarious situations in which hundreds of millions live". Even the BBC, in their recent worldwide poll, can confirm such claims. So why can’t our responsive institutions?

    The public response from institutions is that “structural violence” - or the structural realities of poverty, inequality and other problems of power - are simply too difficult to address. Such claims ignore that AIDS activists have changed massive structures for years, from the entire development process of medicines to the housing and healthcare policies of the largest multinational companies in southern Africa. The private reality is that to expose the root responsibilities behind AIDS - rather than focusing on individual behaviours and “cultural” problems - is to expose the institutions who now claim to champion interventions for the disease. The Clinton Foundation would rather not admit its role in creating an intellectual property system that takes public research and development dollars into private hands and leaves the diseases of the poor to market failure; for them, AIDS is a unique issue to be negotiated selectively, rather than addressing the industry that spends 27% of its profits on marketing and 11% on R&D even as it ranks #1 in the world and makes 19% profits as a percentage of revenue (three times the Fortune 500 average). The World Bank would rather not deal with the association between their policies on agriculture and the subsequent migration of workers and break-up of stable unions; for them, AIDS is an issue of building narrow and specific health services with a few token antiretroviral projects and some “bereavement counselling” for the masses.

    The institutions who are claiming to champion AIDS do not understand what AIDS activists have long realized: that AIDS is not merely a unique circumstance, but a massive symptom of a much larger disease. That is why the AIDS drug victories in South Africa are not merely celebrated by AIDS activists there, but by land-reform and water rights movements. It is because AIDS drugs are not merely medically necessary, but are also metaphorical: they represent broader inequalities in the distribution of resources. And for institutions to address that would be to admit that AIDS does not “compete” with malnutrition or cholera or respiratory infections. Rather, to truly address AIDS is to address the resource inequalities that drive all of these syndromes forward in the poorest of places in the world.

    What, then, are the tasks for this coming year? I would argue that they are two-fold: (1) to turn research and action towards “structural interventions”, and (2) to change the meaning of what it means to use terms like “blame” and “stigma”. The first task is straightforward but rarely pursued: our research agendas and program implementation still focuses on information and educational speeches, rather than testing how primary commodity prices and housing scenarios and migration patterns affect AIDS, and how the campaigns to reform these resource inequalities can be replicated systematically. The second task is more difficult. Many social scientists and public health workers are wonderful at describing social problems and blame and stigma among the “marginalized”. But few ask what it means to be a marginalized person who must deploy the language of the mainstream, stigmatizing and blaming themselves and their peers for the sake of reducing their “marginalization” and struggling to reach the level of “individual responsibility” needed to be accepted in another social world.

    What we need is more than description, but a turn to local geographies to ask how the process of becoming “marginalized” occurs, and why so many of the poor must resort to the language of the rich to stigmatize themselves and subsequently adopt the language of individual “responsibility” for the sake of survival. The answer, once again, becomes one of resources and institutions and power inequalities. We need to examine the basic processes of power, not merely its end pathologies. Because only in our understanding of the processes of power can we hope to find the answers to offer the institutions, and only in our understanding of the processes of power can we hope to take back the meaning of AIDS.

    * Please send comments on this editorial - and other events in Africa - to References for this editorial can be found by clicking on the link below.

    * Sanjay Basu is at the Yale University School of Medicine, where he studies the influence of trade agreements and health system reform on the spread of infectious and metabolic diseases. For more information: http://www.worldaidsday.org/
    - http://www.unaids.org/wad/2003/Epiupdate2003_en/EpiUpdate2003_en.pdf
    - http://www.un.org/events/aids/worldaidsday2003.html

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