WHO’s poor consultation with patients on HIV guidance has denied women choice in drug treatmentBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.f7601 (Published 07 February 2014) Cite this as: BMJ 2014;348:f7601
All rapid responses
Thank you to WHO HIV Department staff and its civil society partners for this rapid response. We address each point in turn.
1. “The major programmatic barriers to equitable access to ART for children and pregnant women” are in fact systemic problems. At the heart of women’s low ARV uptake rate are gender-based violence and inequalities, poverty,
food insecurity and criminalisation of HIV transmission: major human rights violations, which the WHO HIV Department, to date, does not adequately recognise and tackle. Trying to solve a systemic problem by avoiding it and shifting the problem to the people you intend to protect is no solution at all. What the ARV Guidelines now recommend are not scientifically proven, may not be wanted and will potentially cause longer-term health problems for those who take the medication. As ICW and others have argued for years, the reason pregnant women have not taken ARVs is because of all these violations, not some programmatic problem. WHO’s HIV Department needs to address these deeper rights issues.
2.Regarding “conditional” versus “strong” recommendations, we fully support the “strong recommendations” for perinatal ARVs for women and ARVs for children with HIV under 2. It is the “conditional recommendations” for Option B+ and treatment of all children with HIV under 5, which concern us. WHO’s HIV Department should be aware that WHO publications are treated as mandates in healthcare settings (almost) globally, regardless of the strength of recommendation. Women with HIV have already explained why no reference to basic principles of “voluntary”, “confidential” or “informed consent” was a serious omission[5, 6] in the “Global Plan”, bearing WHO’s name even if not an official WHO Guideline. These WHO documents effectively give many States carte blanche to test – and now treat for life – pregnant women with HIV and their children with HIV. One poignantly self-critical Malawian National AIDS Control Programme official at a UN, government and civil society meeting on gender equity, in Johannesburg in December 2012, commented thoughtfully “We have never thought to ask the pregnant women about their HIV test”. The Namibian Ministry of Health is appealing the ruling against their coerced sterilization practices. Whilst WHO has no legal authority over States’ practices, the HIV Department should reflect on the impact its publications will have on the lives of women and children whom it seeks to support.
3. With regard to the Guidelines Review Committee, the recent WHO guidance on Contraceptives and Human Rights clarifies the limitations of the GRADE system to assess human rights considerations.[9, 10] Option B+ revives the age-old question of care for individuals versus blanket public health policies,  relying on the widely-held misapprehension that the words ‘care’ and ‘treatment’ are interchangeable. Hippocrates said: “It is more important to know what sort of person has a disease than to know what sort of disease a person has.” Complex problems have different scientific interpretations and political preferences. Feasibility in implementation should never trump human rights. If problems with implementation exist, the HIV Department’s guidelines should seek to solve them whilst protecting, not jeopardising, people’s human rights.
4. Although claimed to be “one of [the] most comprehensive consultations with communities affected by HIV and representatives of civil society”, the consultation process was inadequate and did not focus, nor heed the effects, on those directly affected. Two thirds of those consulted were not women with HIV, half were not living with HIV and over 3/4 were not from low or middle income countries. When “nearly half of the respondents were of the opinion that children should initiate ART immediately after a positive diagnosis”, presumably over half were not of this opinion. Why then did the report pursue this recommendation?
5. Informed consent is also contentious. Community dialogues held with women (and men) with HIV in Uganda and Malawi may not be representative. Many people first diagnosed with HIV feel desperate and can assume that medication is paramount, especially for their children. Yet the wise doctor manages to care for the patient, putting her needs, immediate and longterm, first – which may mean delayed medication. Questions of availability or scarcity of ARVs should not cloud our judgment over when to start taking them for life. The right time to start treatment is an inexact science, as a poll last year of clinicians at the British HIV Association conference showed: 57% voted for starting ARVs at CD4 count of 350 (the UK model) and 43% preferred 500 (the US and WHO model). Given widespread reporting of prolonged side-effects of ARVs, Option B+ must be an informed choice for each individual woman and not imposed on her by others before she needs it. Several young people born with HIV, who have taken ARVs for around 20 years, advise caution in blanket treatment of all under 5s with HIV (Strachan S. Positively UK. Personal communication. 14 March 2014). The consultation report’s documented concerns about side effects mirrors their lived experiences.[14, p.33]
6. The elephant in the room for women with HIV remains gender-based violence (GBV), yet its enormity is rarely recognized. So although six of the seven top “Most Challenging Barriers for Individual ART Access” relate to GBV,* violence was not mentioned on this chart, [14, p36] nor by the WHO HIV Department’s Rapid Response. This a major omission, for reasons explained previously.[2, 15]
7. Finally, regarding new paediatric formulations and implementation research, we still question why these were not developed and piloted first, before launching the Guidelines, given the current profound adherence and resultant resistance problems.
8. In conclusion, HIV treatment is complex. A study of Australian HIV healthcare providers recently stated that treatment as prevention (essentially what Option B+ is) holds “significant ambivalence”. Unless and until the chronic, sustained and widespread experience of GBV and other violations are recognized and addressed, many women with HIV will not feel safe accessing ARVs for themselves or for their children. No government will achieve “zero new infections”. Numbers of ARV prescriptions do not match concordance in pill-taking. Maternal deaths due to HIV are not declining despite recent officially proclaimed “PMTCT” (Prevention of Mother to Child Transmission) successes. What chances do babies have, with or without HIV, without their mothers to nurture them through those early years?[19, 20] The last 5 words of the Global Plan title (“and keeping their mothers alive”), that women living with HIV campaigned so hard to add at the time of its publication, still haunt us.
1. Hsieh Amy C., Easterbrook Philippa J., Shaffer Nathan. et al Rapid Response. Re: WHO’s poor consultation with patients on HIV guidance has denied women choice in drug treatment. BMJ 2014;348:f7601
2. Joint United Nations Programme on HIV/AIDS (UNAIDS). Unite with women: unite against violence and HIV. Geneva, Switzerland: UNAIDS; 2014. http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspubl...
3. World Health Organization. Consolidated guidelines on the use of anti-retroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. Jun 2013. http://apps.who.int/iris/bitstream/10665/85321/1/9789241505727_eng.pdf.
4. The International Community of Women with HIV/AIDS (ICW). Mapping of Experiences to Access to Care, Treatment and Support in Kenya, Namibia and Tanzania. ICW; 2006. [Online] Available from: http://www.icw.org/files/Kenya%20ACTS%20mapping.doc
5. Chitembo A, Dilmitis S, Edwards O, Foote C, Griffiths L, Moroz S, et al. Towards an HIV-free generation: getting to zero or getting to rights? Reprod Health Matters 2012;20:5-13.
6. Welbourn, Alice. Personal View. WHO’s poor consultation with patients on HIV guidance has denied women choice in drug treatment. BMJ. 2014; 348 doi:http://dx.doi.org/10.1136/bmj.f7601
7. Joint United Nations Programme on HIV/AIDS (UNAIDS). Global plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive. Geneva, Switzerland: UNAIDS; 2014. www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication...
8. Salamander Trust. Integrating Strategies to Address Gender-Based Violence and Engage Men and Boys to Advance Gender Equality through National HIV Plans and Strategies. [Online] Available from: http://salamandertrust.net/index.php/Projects/GBV_Workshop_Johannesburg_...
9. World Health Organisation. Ensuring human rights in the provision of contraceptive information and services: Guidance and recommendations. Geneva, Switzerland: WHO; 2014.
10. World Health Organization. WHO handbook for guideline development. Geneva, Switzerland: WHO; 2012.
11. Easterbrook, Philippa J., Doherty, Meg C., Perriëns, Joseph H., Barcarolo, Jhoney L., Hirnschall, Gottfried O. The role of mathematical modelling in the development of recommendations in the 2013 WHO consolidated antiretroviral therapy guidelines. AIDS: January 2014 - Volume 28 - p S85-S92 doi: 10.1097/QAD.0000000000000111 http://journals.lww.com/aidsonline/Fulltext/2014/01001/The_role_of_mathe...
12. Egnew, Thomas R. Suffering, Meaning, and Healing: Challenges of
Contemporary Medicine. Ann. Fam. Med. 2009; 7, 170–175.
13. Lougheed T. Outside Looking In – Understanding the Role of Science in Regulation. Environmental Health Perspectives. 2009, 117,3 pp A105-A110
14. International HIV/AIDS Alliance. Community Consultation to inform the 2013 WHO consolidated antiretroviral therapy guidelines. International HIV/AIDS Alliance; 2013. http://www.aidsalliance.org/includes/Publication/1.%20Community%20Consul...
* The “Most Challenging Barriers for Individual ART Access” that relate to GBV: Stigma and discrimination around HIV status; Anticipated reaction from your close family, spouse or other sexual partner; Lack of confidentiality and privacy; Anticipated reaction from boss etc; from friends and acquaintances; from healthcare workers In: 14. Figure 20, p. 36.
15. Hale, Fiona, Vazquez, Marijo. Gender-based violence against women with HIV: a background paper UN Women, International Community of Women Living with HIV/AIDS, Development Connections. USA; 2012.
16. Persson Asha. Significant ambivalence: perspectives of Australian HIV service providers on universal treatment-as-prevention (TasP) for serodiscordant couples, Critical Public Health. 2014: http://dx.doi.org/10.1080/09581596.2014.886005
17. AccessHIV. CROI 2014: Women’s Issues. [Online] Available from: https://www.youtube.com/watch?v=ebemECUmcc0
18. Mnyani CN et al. A 15-year review of maternal deaths in a background of changing HIV management guidelines. 21st Conference on Retroviruses and Opportunistic Infections, Boston, abstract 67, 2014.
19. Nakiyingi JS, Bracher M, Whitworth JA et al. Child survival in relation to mother’s HIV infection and survival: evidence from a Ugandan cohort study. AIDS. 2003 Aug 15;17(12):1827-34
20. Melissa A. Bright, PhD, Melanie S. Hinojosa, PhD, Caprice Knapp et al. Adverse childhood experiences and health outcomes in childhood/adolescence: co-morbidity of physical, mental and learning disorders, Institute for Child Health Policy, University of Florida, Gainesville, FL American Psychosomatic Society 2014 Conference Abstract no. 1369
Nukshinaro Ao, Coordinator, Women of Asia-Pacific Plus,
Louise Binder, Canada,
Jane Bruning Positive Women Inc. NZ,
Daisy David, WAP+ Core Group Member, S. Asia,
Mamoletsi Moletsi, ICW Lesotho,
Sethembiso Mthembu, Her Rights Initiative, South Africa,
Hajjarah Nagadya Uganda,
Angelina Namiba, Positively UK, UK
Thembi Nkambule, ICW Swaziland,
L’Orangelis Thomas Negrón, Puerto Rico,
Susan Paxton APN+ Advisor, Australia,
Kousalya Periasamy, President, Positive Women's Network India;
Silvia Petretti Deputy CEO Positively UK, Coordinator, PozFem UK,
Violeta Ross, RedBol, Bolivia,
Sita Shahi, ED, National Federation of Women living with HIV and AIDS, Nepal;
Martha Tholanah ICW Zimbabwe,
Patricia Ukoli, Nigeria,
Alice Welbourn, Salamander Trust, UK
Competing interests: All of the authors are women living with HIV, and some are employed to work on behalf of charitable organizations supporting women living with HIV.
We note Alice Welbourn’s concerns  about two key recommendations in the 2013 WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV Infection  – the initiation of antiretroviral therapy (ART) for all children with HIV under five years, and of lifelong ART for all pregnant or breastfeeding women with HIV. Specific concerns were that those most affected by these recommendations – women with HIV, were not widely consulted; that analysis of the benefits, harms and challenges to the successful implementation of the two recommendations were lacking; and finally that the voluntary nature of taking ART was insufficiently emphasized.
Overcoming the major programmatic barriers to equitable access to ART for children and pregnant women were important considerations for these two recommendations. While there has been huge success in the global scale-up of ART among adults - children and pregnant women have been left behind. In 2012, only 34% of children eligible for ART had received treatment – a stark contrast to the 64% coverage rate in adults . Uptake of ART among pregnant women has also been lagging behind other adults, with less than 50% of those eligible receiving ART in ten priority countries .
Both recommendations were based on the strong operational and programmatic advantages of removing the CD4 barrier for initiating ART in children under five years of age, and for pregnant women, to facilitate an expansion of ART coverage. This was despite the lack of clear scientific evidence for individual clinical benefits from initiating ART regardless of CD4 count in children between two and five years, and for lifelong ART in pregnant women. For this reason, the Maternal and Child Health Guidelines Development Group (whose membership included representatives from civil society) made a clear distinction between the “strong” recommendations (based on high/moderate quality of evidence for individual health benefit) issued for initiating ART regardless of CD4 count in all children less than two years, and all pregnant women; and the “conditional” recommendations (based on low quality of evidence, and recognition of the context-specific nature of this recommendation) to initiate ART regardless of CD4 count in children between two and five years, and for pregnant women to continue lifelong ART after the risk of vertical transmission has passed .
These recommendations were developed in accordance with procedures established by the WHO Guidelines Review Committee, using the internationally agreed standard of the GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation) where recommendations are formulated based on the best evidence available, as well as the overall balance of benefits and harms, acceptability based on values and preferences expressed by the community and caregivers, equity and human rights implications, issues of feasibility in implementation, resource use and cost-effectiveness [4,5].
In response to the concern that “those most affected by these recommendations were not widely consulted”, the guideline recommendations were developed following one of most comprehensive consultations with communities affected by HIV and representatives of civil society ever undertaken to inform the development of a WHO guidelines. Led by the International HIV/AIDS Alliance and the Global Network of People Living with HIV (GNP+), multiple approaches were used to seek the widest possible input from civil society, men and women living with HIV, and caregivers, including an online e-survey (1088 respondents), a moderated e-forum discussion with civil society networks (955 participants) held in six UN languages, and focus group discussions co-led by the International Community of Women Living with HIV (ICW) and Coalition of Women living with HIV/AIDS (COWLHA), held with women living with HIV and their partners in Malawi and Uganda, focusing specifically on the experiences of pregnant women with lifelong ART (option B+) [6,7]. Finally, a series of workshops were organised by CHIVA (Children’s HIV Association) South Africa and CiviTALK in partnership with local organisations in several rural and urban areas to further explore the acceptability and preferences of pregnant or postpartum women with HIV, and parents and caregivers of children receiving ART . Over a third of the e-survey respondents were female, half were individuals living with HIV, and almost a quarter were from low-income countries. There was broad support across the different consultation approaches for the offer of lifelong ART to pregnant women, as well as for earlier treatment initiation in children under five years, while recognizing the considerable operational challenges. A full report of all these consultations is available online  and in a journal article , together with the lessons learnt in the conduct of a large community consultation.
In response to the concern that “the voluntary nature of taking ART was insufficiently emphasized”, one of the core guiding principles of the 2013 Consolidated ARV Guidelines (Chapter 2)  and all previous WHO ARV guidelines is that access to HIV care and treatment should be recognized as fundamental to realizing the universal right to health, and that the recommendations should be implemented based on core human rights and ethical principles. In particular, we stress that informed consent – notably for HIV testing and initiating ART – should always be obtained; that adequate safeguards must be in place to ensure confidentiality; and that care is provided in an environment that minimizes stigma and discrimination.
We acknowledge that there are many challenges faced by caregivers in managing ART in children as well as in implementing the recommendation to offer lifelong ART to pregnant women, and are working actively with partners to find solutions. This includes, for example, the more rapid development of innovative drug formulations particularly for young children, such as palatable heat-stable lopinavir/r and fixed drug combinations, which was the focus of a recent WHO Paediatric Conference on Antiretroviral Drug Optimization . WHO is promoting integration of ART care with maternal and child health services, as well as decentralization and task-shifting of paediatric care as essential means to deliver care closer to those in need and reduce the burden of HIV in the lives of children and their families [2,10]. WHO is also strongly engaged with supporting implementation research to monitor outcomes in countries where these recommendations are being implemented. Following the launch of the guidelines in June 2013, key populations, communities affected by HIV and civil society, have also continued to be active in WHO sponsored regional dissemination workshops in all the regions, as well as in supporting the process for adaptation and implementation of the recommendations for use at country level.
We all share a common goal of providing the best care to the greatest number of women and children living with HIV, and their families. Full involvement of communities, including networks of women living with HIV, is essential to the successful implementation of these new recommendations for children and pregnant women, and we value continued open dialogue and partnership with all members of civil society.
1. Personal View. WHO’s poor consultation with patients on HIV guidance has denied women choice in drug treatment. BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.f7601 (Published 7 February 2014
2. World Health Organization. Consolidated guidelines on the use of anti-retroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. Geneva: World Health Organization; 2013. http://apps.who.int/iris/bitstream/10665/85321/1/9789241505727_eng.pdf.
3. UNAIDS. Report on the global AIDS epidemic 2013. Geneva, Switzerland: UNAIDS; 2013. http://www.unaids.org/en/media/unaids/contentassets/documents/epidemiolo...
4. World Health Organization. WHO handbook for guideline development. Geneva: World Health Organization; 2012.
5. Easterbrook PJ, Irvine CJ, Vitoria M, Shaffer, Muhe LM, Negussie EK, et al. Developing the WHO 2013 consolidated antiretroviral guidelines. AIDS 2014; 28 (in press).
6. International HIV/AIDS Alliance. Community Consultation to inform the 2013 WHO consolidated antiretroviral therapy guidelines. International HIV/AIDS Alliance; 2013. http://www.aidsalliance.org/includes/Publication/1.%20Community%20Consul...
7. Hsieh AC, Mburu G, Garner ABJ, Telschik A, Ram M, Mallouris C, et al. Community and service provider views to inform WHO 2013 consolidated antiretroviral guidelines: key findings and lessons learnt. AIDS 2014:28 (in press).
8. Ngobeni F, Armstrong A, Penazzato M, Muhe L, Baller A, Nelson L, et al. The values and preferences of pregnant women living with HIV: The acceptability of option B+. 17th ICASA Conference, Cape Town, South Africa. [Abstract PB476]. 7-11 December 2013: Cape Town, South Africa.
9. World Health Organization. March 2014 supplement to the 2013 Consolidated Guidelines on the use of anti-retroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. Geneva: World Health Organization; 2014
10. Health systems implications of the WHO 2013 consolidated antiretroviral guidelines and strategies for successful implementation. Holmes C, Pillay Y, Mwango A, Perriens J, Ball A, Barrenche O, et al. AIDS 2014:28:S00-
Competing interests: No competing interests