Articles tagged as "Human rights / ethics / law and intellectual property"

Universal access

Calmy A, Pizzocolo C, Pizarro L, Brücker G, Murphy R, Katlama C; Strategies in Resource-Limited Settings Working Group. The marriage of science and optimized HIV care in resource-limited settings. AIDS. 2008;22(17):2227-30.

 

Large-scale HIV management in resource-limited settings has been remarkably successful in a relatively short time frame. Once combination antiretroviral therapy became more universally available, national treatment programs were able to provide much of the needed therapy, originally prioritized towards patients with the most advanced and symptomatic disease. The current worldwide expansion of antiretroviral therapy is due to a large broad-based international effort in financing the antiretroviral drugs and infrastructure required for delivering treatment and care. The fears that HIV treatment would detract from other healthcare concerns or lead to widespread drug resistance have been unfounded but important treatment-related issues remain to be addressed immediately by relevant scientific communities. The fundamental scientific concerns fall into two categories: the comprehensive approach to care and treatment management in settings in which resources are limited, and the diversity of a variety of populations who are predominantly women, have heterogeneous viral subtypes and have exposure to different environmental co-pathogens. There is an urgent need to link science and clinical practice wherever it is taking place. We need to learn more about optimal treatment choices and monitoring schemes appropriate in diverse resource-limited settings. Relevant clinical data that are urgently needed include drug efficacy in genetically diverse populations, the most cost-effective and efficient monitoring of therapy, and interactions with drugs to treat common co-infections and diseases. Transfer of competencies must be done as this is essential for operational research. In addition, we must promote and strengthen national reference centres and develop high level skills for the next generation of scientists and clinicians. The international scientific community must address this urgent need with academic, social, scientific, and economic support for the necessary critical research and training so desperately needed.

 

Editors’ note: This is an urgent call for more science, more science capacity-building, and more operational research competencies transfer to enable clinical data collection, monitoring, analysis, and evaluation at the service of improved care. Key questions to address include how to improve adherence, when to switch therapies, optimal treatment for pregnant women, and important drug-drug interactions with anti-tuberculosis and anti-malarial agents.

 

 


 

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Perez F, Aung KD, Ndoro T, Engelsmann B, Dabis F. Participation of traditional birth attendants in prevention of mother-to-child transmission of HIV services in two rural districts in Zimbabwe: a feasibility study. BMC Public Health. 2008;8(1):401. [Epub ahead of print]

 

Prevention of mother-to-child transmission of HIV is among the key HIV prevention strategies in Zimbabwe. A decrease in use of antenatal care services with an increase in home deliveries is affecting the coverage of prevention of mother-to-child transmission interventions in a context of accelerated economic crisis. The main objective was to evaluate acceptability and feasibility of reinforcing the role of traditional birth attendants in family and child health services through their participation in prevention of mother-to-child transmission programmes in Zimbabwe. A community based cross-sectional survey was undertaken using multistage cluster sampling in two rural districts through interviews and focus group discussions among women who delivered at home with a traditional birth attendant, those who had an institutional delivery and traditional birth attendants. 45% of traditional birth attendants interviewed knew the principles of prevention of mother-to-child transmission and 8% delivered a woman with known HIV-positive status in previous year. Of the complete package of prevention of mother-to-child transmission services, more than 75% of traditional birth attendants agreed to participate in most activities with the exception of performing a blood test (17%), accompanying new-borns to closest health centre to receive medication (15%), and assisting health centres in documentation of the link between antenatal care and prevention of mother-to-child transmission services (18%). Women who delivered at home were less likely to have received more than one antenatal care service or have had contact with a health centre compared to women who delivered in a health centre (91.0% vs 72.6%; P<0.001). Also, 63.6% of the women who delivered in a health centre had the opportunity to choose the place of delivery compared to 39.4% of women who delivered at home (P<0.001). More than 85% of women agreed that traditional birth attendants could participate in all activities related to a prevention of mother-to-child transmission programme with the exception of performing a blood test for HIV. Concerns were highlighted regarding confidentiality of the HIV-serostatus of women. Although the long-term goal of antenatal care service delivery in Zimbabwe remains the provision of skilled delivery attendance, prevention of mother-to-child transmission programmes will benefit from complementary approaches to prevent missed opportunities. Traditional birth attendants are willing to expand their scope of work regarding activities related to prevention of mother-to-child transmission. There is a need to reinforce their knowledge on mother-to-child transmission prevention measures and better integrate them into the health system.

Editors’ note: When health professionals are not available, traditional birth attendants, usually elderly, married or widowed women with a minimum level of education, are a significant workforce in maternity care in high HIV prevalence settings. Legitimising and acknowledging their practice, training them to preserve confidentiality and support women in the process of disclosure to access HIV prevention and treatment programmes, integrating them into prevention of mother-to-child transmission programmes, and conducting operational research to assess their impact are key steps. Reaching the two-thirds of pregnant women with HIV infection who are not currently reached by prevention of mother-to-child transmission programmes is the objective and all able hands need to be on deck.

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Human rights

Amon JJ, Todrys KW. Fear of Foreigners: HIV-related restrictions on entry, stay, and residence. J Int AIDS Soc. 2008;11(1):8.

Among the earliest and the most enduring responses to the HIV epidemic has been the imposition by governments of entry, stay, and residence restrictions for non-nationals living with HIV. Sixty-six of the 186 countries in the world for which data are available currently have some form of restriction in place. Although international human rights law allows for discrimination in the face of public health considerations, such discrimination must be the least intrusive measure required to effectively address the public health concern. HIV-related travel restrictions, by contrast, not only do not protect public health, but result in deleterious effects both at the societal level - negatively impacting HIV prevention and treatment efforts - and at the individual level, affecting, in particular, labour migrants, refugee candidates, students, and short-term travellers. Governments should repeal these laws and policies, and instead devote legislative attention and national resources to comprehensive HIV prevention, care, and treatment programmes serving citizens and non-citizens alike.

Editors’ note: In the 2001 Declaration of Commitment on HIV/AIDS and in subsequent declarations, governments have committed to enact appropriate legislation to eliminate all forms of discrimination against persons living with HIV. HIV-related travel restrictions should be repealed immediately and entirely – they have no public health justification and are a human rights violation.


Enwereji EE. Sexual behaviour and inheritance rights among HIV-positive women in Abia State, Nigeria. Tanzan J Health Res. 2008;10(2):73-8.

In developing countries, culture favours males for economic ventures more than females. There is evidence that allowing HIV-positive women inheritance rights will mitigate negative economic consequences of HIV and other related risks. This study aimed to examine the extent to which HIV-positive women have access to family resources in Abia State, Nigeria. Data collection instruments were questionnaires, focus group discussions, and interview guides using 98 HIV positive women in networks of people living with HIV. Five key informants were also interviewed to authenticate women’s responses. Eighty-five (86.7%) of the women were denied rights to family resources. Thirty-eight (64.4%) of them had negative relationship with their family members for demanding their husbands’ property. Because of limited financial assistance, the women took two types of risks in order to survive in the communities. Twenty-five women (25.5%) earned their livelihood by acting as hired labourers to others in the farm. More that half (55.1%) of the HIV-positive women were practicing unprotected sex. Although as many as 79.6% of the women were aware of risks of unprotected sex, 54 (55%) of them practised it. The commonest reason for taking the risk was sex partners’ dislike for condom use. The high proportion of HIV-positive women who were denied access to family resources could suggest lack of care and support. If this denial continues, the government’s efforts to reduce HIV prevalence would yield no significant result. There is therefore a need for an organized community education programme that emphasizes the benefits of empowering women living positively with HIV economically.

Editors’ note: Denying women living with HIV access to family resources thwarts their economic empowerment and increases sexual risk. Enactment and effective implementation of inheritance laws are needed to ensure that women can own and/or control resources such as land, housing, and livestock after the death of their husbands. Their well-being and that of their children depend on it.


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Treatment

Hallett TB, Gregson S, Dube S, Garnett GP. The impact of monitoring HIV patients prior to treatment in resource-poor settings: insights from mathematical modelling. PLoS Med. 2008 Mar 11; 5(3):e53.

The roll-out of antiretroviral treatment in developing countries concentrates on finding patients currently in need, but over time many HIV-infected individuals will be identified who will require treatment in the future. Hallett and colleagues investigated the potential influence of alternative patient management and antiretroviral treatment initiation strategies on the impact of antiretroviral treatment programmes in sub-Saharan Africa. The authors developed a stochastic mathematical model representing disease progression, diagnosis, clinical monitoring, and survival in a cohort of 1,000 hypothetical HIV-infected individuals in Africa. If individuals primarily enter antiretroviral treatment programmes when symptomatic, the model predicts that only 25% will start treatment and, on average, 6 life-years will be saved per person treated. If individuals are recruited to programmes while still healthy and are frequently monitored, and CD4(+) cell counts are used to help decide when to initiate antiretroviral treatment, three times as many are expected to be treated, and average life-years saved among those treated increases to 15. The impact of programmes can be improved further by performing a second CD4(+) cell count when the initial value is close to the threshold for starting treatment, maintaining high patient follow-up rates, and prioritising monitoring the oldest (> or = 35 y) and most immune-suppressed patients (CD4(+) cell count < or = 350). Initiating antiretroviral treatment at higher CD4(+) cell counts than the World Health Organization recommends leads to more life-years saved, but disproportionately more years spent on antiretroviral treatment. In conclusion, the overall impact of antiretroviral treatment programmes will be limited if rates of diagnosis are low and individuals enter care too late. Frequently monitoring individuals at all stages of HIV infection and using CD4 (+) cell count information to determine when to start treatment can maximise the impact of antiretroviral treatment.

Editors’ note: When testing a full range of treatment approaches is cumbersome, time consuming and potentially unethical, mathematical modelling can help inform policy-makers. This model shows that 15 additional years of life after starting treatment, rather than six years, can be achieved by early diagnosis, frequent CD4 count monitoring, and early initiation of treatment before the immune system is irreversibly damaged. This has implications for “knowledge of serostatus” campaigns, low-cost CD4 count monitoring, revision of treatment guidelines, and increased resource mobilisation.


Gruskin S, Ferguson L, Bogecho DO. Beyond the numbers: using rights-based perspectives to enhance antiretroviral treatment scale-up. AIDS. 2007;21 Suppl 5:S13-9.

Human rights analyses, concepts, and in particular rhetoric have played a consistent role in the global response to HIV for over two decades. Despite the longstanding recognition of human rights as essential to an effective response, recent global guidance, particularly with respect to the implementation of antiretroviral treatment scale-up efforts, falls short of meaningfully incorporating human rights norms and concepts. Applying human rights to antiretroviral treatment scale-up draws attention to who is gaining access to antiretroviral treatment, how they are gaining access, and over what period of time, not just how many people gain access. Deliberate consideration of the human rights principles of the interdependence of rights (including attention to the legal and policy environment), participation, non-discrimination, accountability, and key aspects of the right to health can help to identify and overcome some of the challenges to increasing and sustaining access to treatment and needed services, as well as to promote accountability and transparency for what is done and how it is done. Whereas a need remains to document evidence of the ways in which a lack of attention to human rights negatively influences the long-term outcomes of scale-up programmes, this paper focuses on the positive role human rights can play in antiretroviral treatment scale-up efforts, and offers suggestions for research and action moving forward.

Editors’ note: Identifying the challenges and overcoming barriers to increasing access to antiretroviral treatment services, and enabling people to make informed and appropriate choices, are rights-based actions. Monitoring and evaluation for accountability can foster change to ensure equitable access.

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Ethics

Smith CB, Battin MP, Francis LP, Jacobson JA. Should rapid tests for HIV infection now be mandatory during pregnancy? Global differences in scarcity and a dilemma of technological advance. Developing World Bioeth 2007;7:86-103.

Since testing for HIV infection became possible in 1985, testing of pregnant women has been conducted primarily on a voluntary, 'opt-in' basis. Faden, Geller and Powers, Bayer, Wilfert, and McKenna, among others, have suggested that with the development of more reliable testing and more effective therapy to reduce maternal-foetal transmission, testing should become either routine with 'opt-out' provisions or mandatory. Smith and colleagues ask, in the light of the new rapid tests for HIV, such as OraQuick, and the development of antiretroviral treatment that can reduce maternal-foetal transmission rates to <2%, whether that time is now. Illustrating their argument with cases from the United States (US), Kenya, Peru, and an undocumented Mexican worker in the US, the authors show that when testing is accompanied by assured multi-drug therapy for the mother, the argument for opt-out or mandatory testing for HIV in pregnancy is strong, but that it is problematic where testing is accompanied by adverse events such as spousal abuse or by inadequate intrapartum or follow-up treatment. The difference is not a 'double standard', but reflects the presence of conflicts between the health interests of the mother and the foetus - conflicts that would be abrogated by the assurance of adequate, continuing multi-drug therapy. In light of these conflicts, where they still occur, careful processes of informed consent are appropriate, rather than opt-out or mandatory testing.

Editors’ note: The continued debate over mandatory, opt-out, provider-offered, and opt-in testing is non-productive. Technologies advances should never override respect for the principle of informed consent for medical procedures. Mandatory HIV testing is not an effective public health measure and has never been recommended by WHO/UNAIDS. Nevertheless, provision of antiretroviral treatment for women who need it, whether pregnant or not, is in the interests of both the woman and her children and should be a high priority.

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Research

WHO/UNAIDS/AAVP International Expert Group, Osmanov S. Executive summary and recommendations from WHO/UNAIDS and AAVP consultation on: ‘The inclusion of adolescents in HIV vaccine trials’, 16-18 March 2006 in Gaborone, Botswana. AIDS 2007;21:W1-10.

This report summarizes the discussions and recommendations from a consultation held in Gaborone, Botswana (16-19 March 2006), organized by the joint World Health Organization (WHO)/United Nations Programme on HIV/AIDS (UNAIDS) HIV Vaccine Initiative (HVI) and the African AIDS Vaccine Programme (AAVP). The consultation considered key challenges and strategies in enrolling adolescents into HIV vaccine clinical trials, relevant to developing countries, in particular in eastern and southern Africa. Approaches were identified that might address and resolve country-specific challenges related to scientific, legal, ethical, regulatory and community aspects of the involvement of adolescents in HIV vaccine trials. This executive summary is formulated for a broader dissemination of the outcomes of the meeting to the general clinical, scientific and regulatory community involved in the review, approval and monitoring of clinical trials and potential licensing of HIV vaccine candidates. Four major topics were discussed and recommendations developed with regard to: (i) criteria for products selection and clinical trial design; (ii) ethical and legal issues; (iii) community acceptance and participation; and (iv) regulatory considerations. The recommendations of this meeting were further discussed and endorsed by the WHO/UNAIDS HIV Vaccine Advisory Committee.

Editors’ note: UNAIDS is co-hosting with the Global Coalition on Women and AIDS, the International Centre for Research on Women and Tibotec, Inc. a consultation in December 2007 entitled ‘Making HIV trials work for women and adolescent girls’ at which the rationale, challenges and strategies for enrolling adolescent girls in HIV trials will be discussed. This article on the HIV vaccine trial context provides good background on the topic.

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Ethics in research

Slack C, Strode A, Fleischer T, Gray G, Ranchod C. Enrolling adolescents in HIV vaccine trials: Reflections on legal complexities from South Africa. BMC Med Ethics 2007;8:5.

Photo credit: UNAIDS/G.PirozziSouth Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research.  This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trigger a mandatory reporting response; networking among relevant ethics committees; and lobbying the National Regulatory Authority for guidance.

Editors’ note: The reflections in this article have relevance beyond HIV vaccine trials to any trials involving adolescents. They have an evolving capacity to understand and consent to experimental products and interventions. In the case of HIV, enrolling adolescents in trials of novel biomedical HIV prevention products is particularly important in high incidence settings where adolescents are at very high risk of HIV exposure. They would be the primary beneficiaries for any public health programme involving a successful biomedical prevention product.


Macrae DJ. The Council for International Organizations and Medical Sciences (CIOMS) Guidelines on Ethics of Clinical Trials. Proc Am Thorac Soc 2007;4:176-9.

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war crimes trials, more specifically the « Doctors’ Trial. » From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

Editors’ note: UNAIDS and WHO have just completed updating of the popular 2000 UNAIDS guidance document Ethical considerations in HIV preventive vaccine research with the assistance of an expert panel composed of members from Australia, Brazil, Great Britain, India, Israel, Nigeria, South Africa, Switzerland, Thailand and the USA. Entitled Ethical considerations in biomedical HIV prevention trials: UNAIDS/WHO guidance document, it is consistent with CIOMS and other international research ethics guidelines. Containing 19 guidance points, it will be translated initially into French, Portuguese, Spanish and Russian.

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Research ethics

Macqueen KM, Namey E, Chilongozi DA, Mtweve SP, Mlingo M, Morar N, Reid C, Ristow A, Sahay S, Hptn T, Team SO. Community perspectives on care options for HIV prevention trial participants. AIDS Care 2007;19:554-60.

There is on-going global debate and policy-setting concerning researchers’ obligations to meet the health needs of people participating in HIV prevention trials in resource-poor settings. The perspectives of local community stakeholders on this issue are poorly understood as most of what is presented on behalf of communities where research takes place is anecdotal commentary. Using qualitative methods (130 in-depth interviews and 20 focus groups) MacQueen and colleagues assessed perceived fairness of different strategies to meet the health needs of women who become HIV-infected during a hypothetical vaginal microbicide trial. Respondents included HIV prevention research participants, community stakeholders and health-care service providers in ten sites in seven countries (South Africa, Malawi, Tanzania, Zimbabwe, Zambia, India, US). Many respondents perceived referrals to be a potentially fair way to address care and treatment needs but concerns were also voiced about the adequacy of local health-care options and the ability of trial participants to access options. Most respondents viewed the provision of antiretroviral treatment by researchers to HIV-infected trial participants as unfair if treatment was not sustained beyond the end of the trial. The results underscore the importance of effectively linking trial participants to sustainable, community-based treatment and care.

Editors’ note: This formative research with women in ten communities in Africa, India and the USA informed policy, not only at Family Health International, but among other research and community partners around the world. More information on the issues of standard of prevention and access to care is available from UNAIDS through two publications: Ethical considerations for biomedical HIV prevention trials and Good Participatory Practices in biomedical HIV prevention trials.


Tarantola D, Macklin R, Reed ZH, Kieny MP, Osmanov S, Stobie M, Hankins C. Ethical considerations related to the provision of care and treatment in vaccine trials. Vaccine 2007 Jun 21;25(26):4863-74.

Ethical principles of beneficence and justice combined with international human rights norms and standards create certain obligations on researchers, sponsors and public health authorities. These include treatment provision for participants enrolled in clinical trials of vaccines, drugs and other new preventive and curative technologies and methods. However, these obligations are poorly defined in practical terms, inconsistently understood or inadequately applied. Vaccine clinical trial designs normally define standards of prevention applicable to the population where the trial is to take place. The present document addresses specifically the setting of standards applicable to care and treatment in vaccine trials. The lack of clear guidance on how to achieve the optimal synergy between the development of new health technologies, on the one hand, and the promotion and protection of ethical and human rights principles, on the other, is a barrier to the progress of health research and therefore to the advancement of public health. The World Health Organization and UNAIDS have engaged in a series of consultations in Africa, the Americas, Asia and Europe to reflect on how this aim could best be achieved. This document highlights the outcome of these consultations. It proposes a structured approach to consensual decision making in the context of the clinical trial of vaccines against such public health challenges as HIV and newly emerging or threatening epidemics. A structured approach involving investigators and sponsors in a consultative process with trial communities and other stakeholders in research will ensure that the needs and legitimate expectations of trial participants are appropriately met, obligations towards them are delivered and, as a result, ethical research is facilitated in the interest of public health.

Editors’ note: Who will provide and who will pay for the treatment and care of people who become infected during a biomedical HIV prevention trial has been hotly debated now for ten years. UNAIDS in collaboration with WHO has revised Ethical considerations for biomedical HIV prevention trials and in collaboration with the AIDS Vaccine Advocacy Coalition, and a Working Group with diverse membership, has created Good Participatory Practices in biomedical HIV prevention trials. Both of these documents make it clear that providing access to antiretroviral treatment for those who seroconvert in an HIV prevention trial is the accepted standard.

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Universal access

Boisseau C, Degui H, Bruneton C, Rey JL. [Poor access to antiretroviral treatment in French-speaking Africa: situation in 2004]. Med Trop (Mars) 2006;66:589-92.

Boisseau and colleagues carried out a survey by questionnaire and interview with persons in charge of purchasing in central structures and AIDS control programs in 18 French-speaking African countries between June and October 2004. Survey data showed that a total of 3300 patients received antiretroviral treatment during the study period. This corresponds to a treatment rate of 0.1 to 9.6% of the number of patients requiring antiretroviral treatment. All countries reported interruptions of the antiretroviral supply for a variety of reasons. The main causes were budgetary issues and procedural complexity involving financial aid. The prices charged to the patients varied greatly in function of national policies. Cost price also varied in function of the negotiating leverage of the purchasing central. The authors conclude that in order to improve general access to antiretroviral treatment and to reduce the number of supply shortages more training will be required in management and distribution of medicines. They conclude that it would also be useful to improve communications between the persons in charge of national purchasing structures.

Editors’ note: Patient access and adherence to treatment are known preoccupations of treatment programmes but antiretroviral drug shortages and financing problems are management concerns at the level of central procurement that have to be urgently addressed for effective supply chain management.


Deng R, Li J, Sringernyuang L, Zhang K. Drug abuse, HIV/AIDS and stigmatisation in a Dai community in Yunnan, China. Soc Sci Med 2007 Jan 23; [Epub ahead of print]

The latest data indicate that between 540,000 and 760,000 people are infected with HIV in China. Although minority nationalities represent 8.1% of China's total population, they account for more than 30% of the reported HIV cases. Deng and colleagues examined stigma and discrimination against drug abusers and people living with HIV in a Dai minority nationality community in Yunnan, China. The authors used qualitative research methods, which included participatory observations, in-depth interviews, focus-group discussions, transect walking and community mapping. A combination of different sampling strategies was used to maximise diversity of the initially selected sample. The data revealed deeply entrenched stigma and overt discrimination against drug abusers and people living with HIV that manifested in familial, work, civil and institutional contexts. The stigma reflected pre-existing cultural, religious sanctions against "deviant behaviours". Intervention programmes that were insensitive to the local culture and religion may have also contributed in part to the stigmatisation of drug abusers and people living with HIV. The major impact of stigma was that it created a vicious cycle of social isolation, marginalisation and thus addiction relapse. This in turn reinforced the stigmatisation and discrimination against drug abusers and thus hindered efforts towards prevention and control of HIV.

Editors’ note: Stigma and discrimination drive the epidemic underground, undermining HIV prevention and delaying treatment provision to those most in need. Sustained efforts to overcome them are essential to progress towards universal access.

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Evidence- informed decision making

Tantivess S, Walt G. Using cost-effectiveness analyses to inform policy: the case of antiretroviral therapy in Thailand. Cost Eff Resour Alloc 2006;4(1):21. http://www.resource-allocation.com/content/4/1/21

Much emphasis is put on providing evidence to assist policymakers in priority setting and investment decisions. Assessing the cost-effectiveness of interventions is one technique used by policymakers in their decisions about the allocation of scarce resources. However, even where such evidence is available, other considerations may also be taken into account, and even over-ride technical evidence. ART is the most effective intervention to reduce HIV-related morbidity and prolong mortality. However, treatment provision in the developing world has been hindered by the high costs of services and drugs, casting doubts on its cost-effectiveness. Tantivess and Walt look at Thailand's publicly-funded antiretroviral initiative which was first introduced in 1992, and explore the extent to which cost-effectiveness evidence influenced policy. The authors review the development of the national ART programme in Thailand between 1992 and 2004. They examine the roles of cost-effectiveness information in treatment policy decisions. Qualitative approaches including document analysis and interview of key informants were employed. Two significant policy shifts have been observed in government-organised ART provision. In 1996, service-based therapy for a few was replaced by a research network to support clinical assessments of antiretroviral medication in public hospitals. This decision was taken after a domestic study illustrated the unaffordable fiscal burden and inefficient use of resources in provision of ART. The numbers of treatment recipients was maintained at 2000 per year throughout the 1990s. It was not until 2001 that a new government pledged to extend the numbers receiving the service, as part of its commitment to universal coverage. Several elements played a role in this decision: new groups of dominant actors, drug price reductions, a pro-active civil society movement, lessons from experience on treatment benefits, and global treatment advocacy. Unlike previous policy discourse, human rights, ethics and equity notions were explicitly raised to support therapy extension. In summary, in the early decision, moving from a relatively limited ART service to a research network was clearly influenced by cost-effectiveness data. But in the 2001 decision to include ART in the universal coverage package, cost-effectiveness arguments were over-ruled by other considerations. The authors conclude that Thai ART policy was shaped by many factors, and was not a simple rational process which relied on evidence.

 Editors’ note: This article clearly illustrates why UNAIDS’ preferred terminology is ‘evidence-informed’ decision making rather than ‘evidence-based’ decision making. Further, the decision this week by the Thai government to approve a generic version of Abbott Laboratories’ protease inhibitor Kaletra (lopinavir/ritonavir), a second line drug, demonstrates that when equity of access for people who fail first line regimens has been prioritised by a government, cost and other considerations can drive decisions about intellectual property.

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