( The Lancet) Red: a missed opportunity

Abstract

The past 5 years have been essential to increasing access to antiretroviral treatment in resource-poor countries, and this experience has raised many challenges. The first was simply to start treating patients in the face of criticism and doubts expressed by the scientific community1Marseille E Hofmann P Kahn J HIV prevention before HAART in sub-Saharan Africa.Lancet. 2002; 359: 1851-1856Summary Full Text Full Text PDF PubMed Scopus (180) Google Scholar and major donors,2Donnelly J Natsios called racist; firing sought.Boston Globe. Sept 6, 2001; Google Scholar with little support from UN agencies. Although we welcome The Lancet's initiative to devote an issue to HIV/AIDS, we are disappointed that so much space was devoted to uncontroversial and apolitical statements by UN agencies. Behind the self-congratulation of multilateral agencies lies the fact that universal access is far from within reach, and strategies to ensure long-term quality care in resource-limited settings hardly exist. Ensuring free, long-term treatment access will require more than goodwill, and affordable medicines do not suddenly appear with the publication of new formularies. WHO's public-health approach to antiretroviral therapy focuses on the “Fours Ss”: when to Start, when to Substitute, when to Switch, and when to Stop.3Gilks C Crowley S Ekpini R et al.The WHO public health approach to antiretroviral treatment against HIV in resource-limited settings.Lancet. 2006; 268: 505-510Summary Full Text Full Text PDF Scopus (525) Google Scholar But who will pay the price of this strategy? Most countries are barely managing with the first and last S (starting and stopping). Although basic first-line therapy costs are as low as US$132 per patient per year, the main substitution for toxicity requires tenofovir, which is rarely registered, at least 2·5 times more costly, and not available as a triple fixed-dose combination. Basic second-line regimens currently cost at least ten times more (figure).4Campaign for Access to Essential Medicines.Untangling the web of price reductions: a pricing guide for the purchase of ARVs for developing countries. 9th edn. Médecins sans Frontières, Geneva2006http://www.accessmed-msf.org/documents/untanglingtheweb%209.pdfGoogle Scholar At these prices, 10% of patients on second-line therapy would represent over 60% of the national drug budget. What is WHO doing to address this issue? Price is only a part of the problem. Of the 13 drugs recommended by WHO, only six have been prequalified. There are no generic prequalified versions of any of the five antiretrovirals specifically recommended for second-line treatment (didanosine, atazanavir, lopinavir/ritonavir, saquinavir, and ritonavir), and only two originator companies offer a differential price for these products. With the World Trade Organization's TRIPS Agreement now in full force in major generic-producing countries such as India—on whose generic medicines around half of those receiving antiretroviral treatment in the developing world currently depend—it is unlikely that generic versions of these and other new drugs will be produced without a serious political struggle. The recent removal of the WHO representative in Thailand for suggesting that compulsory licensing should be considered an option for securing affordable second-line medicines shows how little progress has been made to confront these major political barriers.5Williams D World health: a lethal dose of US politics.Asia Times. June 17, 2006; (accessed Aug 31, 2006)http://www.atimes.com/atimes/Southeast_Asia/HF17Ae01.htmlGoogle Scholar That none of these issues were addressed by the major multilateral agencies who dominated The Lancet's special issue provides further confirmation of the lack of political courage where it is needed most. We declare that we have no conflict of interest.