712 Bulletin of the World Health Organization | September 2004, 82 (9) W HO /H . B OW ER Therapeutic feeding centre, Regional Hospital in Herat, Western Afghanistan. News Insecurity and lack of funds hamper progress on Afghan health service Ambitious Afghan Government plans to provide basic health-care services to 25 million Afghan people who have one of the lowest health standards in the world are being hampered by a lack of funds and mounting insecurity, govern- ment and humanitarian officials said. Abdullah Sherzai, Deputy Minister of Public Health, told the Bulletin that his ministry was still waiting for almost half the funds needed for this year’s budget alone. Donors, like USAID and The World Bank, have approved the Afghan Government plan. But some donors are not providing enough funds for this, preferring more visible projects with more immediate results, such as build- ing a big hospital in Kabul and other cities, officials say. “Out of a total US$ 200 million we budgeted for the provision of the Basic Package of Health Services (BPHS) this year, only 50–60% of the money has been disbursed,” Mr Sherzai said, speak- ing from Kabul in August. The Basic Package initiative, developed by the Afghan Government in cooperation with nongovernmental organizations (NGOs), and United Nations agencies including WHO, aims to provide a standardized set of basic health services at primary level to im- prove the health status of Afghans. Maternal mortality is alarmingly high, with about 1700 women dying for every 100 000 live births because of com- plications that could easily be prevented. The situation is worse in remote areas. The country has one of the highest infant mortality rates in the world — with 165 deaths per 1000 live births. One in four children die before their fifth birthday. Life expectancy at birth is only 46 years. Most Afghans, particularly those in rural areas, do not have access to health care because more than two decades of war have destroyed or damaged the majority of health facilities and educa- tional institutions, and many health-care workers have been displaced or killed. Dr Khalid Shibib of WHO’s Emergency and Humanitarian Action Department said that although access to health care in Afghanistan has been improving slowly, it is not very dif- ferent to many other underdeveloped countries. A serious problem is a lack of mental health resources and a shortage of professional mental health care workers. A team of researchers warned in August that the prevalence of mental disorders in Afghanistan was alarming and required immediate attention by donors and policy-makers (JAMA 2004;292:575-93). “With decades of war, the people of Afghanistan have gone through uniquely traumatic experiences that have affected their mental health,” said Dr Barbara Lopes Cardozo, a psychia- trist at the Centers for Disease Control and Prevention in Atlanta. “In our study of the mental health, social functioning, and disabil- ity in postwar Afghanistan, we found 713Bulletin of the World Health Organization | September 2004, 82 (9) News significantly high levels of depression, anxiety and post-traumatic stress disor- der,” Dr Cardozo said. “Sixty-eight percent of people showed signs of depression, 72% had symptoms of anxiety, and 42% had symptoms of post-traumatic stress. As a comparison, levels of depression in the United States are lower at 8–10% and 1–2% for post-traumatic stress,” Dr Cardozo said. Increasing attacks on humanitarian workers — 32 aid workers have been killed since March 2003 — have put much of the country off-limits to international health-care workers and jeopardize much-needed investment. “For quite some time we have been unable to get to people in rural areas mainly because of the security issue”, said Jessica Barry from the International Committee of the Red Cross (ICRC) which provides vital trauma and surgical services in Afghanistan. “Because of insecurity in rural areas, our work remains limited to large urban centers”, Ms Barry said. In July, a leading humanitarian organization, Médecins Sans Frontières pulled out of Afghanistan after five of its workers were killed in Badghis province. But despite the lack of security and shortage of funds, major progress has been made in many areas including policy-making and measles vaccinations, and towards polio eradication. “The number of polio cases in the country has been reduced to only three this year because of relentless efforts made by WHO, the Afghan Govern- ment and others,” said Ahmed Shadoul, a medical officer at WHO Afghanistan. A good acute flaccid paralysis sur- veillance system to check for polio is in place all over Afghanistan with more than 450 sentinel sites and about 4400 reporting points. In August, WHO launched an ini- tiative to reduce in less than two years the incidence of leishmaniasis, a disabling disease transmitted by sand fly which often leads to facial disfigurement. Kabul has 67 500 cases, more than anywhere else in the world. The project is in cooperation with the Massoud Foundation, an Afghan nongovernmental organization, and Dutch non-profit group HealthNet International and was funded by a dona- tion from the Belgian Government. O Khabir Ahmad, Karachi Activists drive access to treat- ment campaign at conference At the international AIDS conference in Barcelona two years ago, activists smashed the stands of the Group of Eight (G8) richest countries and heck- lers drowned out United States Health Secretary Tommy Thompson to press their demands for a sharp increase in AIDS funding. Since then, donors — in particular the United States which has pledged 15 billion dollars — have increased spending on HIV/AIDS for developing countries and embraced the idea that treatment must go hand-in-hand with prevention. Now that treatment is on the way, activists at this year’s AIDS conference in Bangkok called on governments to guar- antee access to treatment for everyone. Thailand, the host country, came under fire as activists accused the Thai and other governments of failing to pro- vide adequate treatment and support for HIV-positive intravenous drug users and other vulnerable HIV-positive groups. Former South African president Nelson Mandela made an impassioned appeal for more support for HIV- positive people with tuberculosis — the chief cause of death for people with AIDS in Africa. Activists called for more to be done to protect women and called for swift development of preventive micro- bicide products due to come on the market in the next few years. Armed with banners and whistles, hundreds of activists marched through the Bangkok conference halls calling on the G8 to recognize AIDS is a life-long condition and make recent substantial financial commitments for antiretro- viral (ARV) treatment for developing countries a long-term prospect. Activists also raised concerns about the way science has not kept pace with the epidemic, underscoring lingering uncertainty over how to ensure rapid scale up and coordination of ARV treat- ment now that the funding is available. Dr Jim Yong Kim, head of WHO’s HIV/AIDS programme, told the con- ference that although the situation still looked bleak — six million people had died and there were 10 million new HIV infections — there had been “real progress”. Dr Kim said 20 billion dollars had been pledged for AIDS — more than for any other global health campaign in history — the cost of ARV drugs has dropped significantly in two years and people in worst-hit regions are more likely to go for an HIV test. Like many other activists Rolake Nwagwu, 34, an HIV-positive Nigerian attending the Bangkok conference, told the Bulletin that it was her own personal struggle to get treatment that spurred her to campaign for access to health care. Rolake campaigns in her native country to raise awareness about AIDS by fighting the stigma and discrimina- tion that discourage many Nigerians from being tested for HIV and by fight- ing for better access to ARV treatment. Initially Rolake spent all her money on ARV drugs, but broke off treatment because she found — like most HIV- positive people in developing countries — it was too expensive. “In the town where I live, AIDS is a taboo. For years I couldn’t speak to anybody about how to deal with the disease,” Rolake said in reference to the Nigerian town of Kaduna. Now, she is a campaigner with the Pan-African Treatment Access Move- ment and writes a popular column en- titled: “In Moments Like This — Living with HIV” in Nigeria’s most widely read newspaper, the Sunday Punch. “I do what I do — not just to help other Nigerians — but first, to help myself, and then four million other infected Nigerians. Whatever I do or don’t do now will haunt me later when my entire generation dies off and I have no access to affordable health care,” Rolake said. O Melanie Zipperer, Bangkok Contributions are welcome for the Letters section, in response to articles that have appeared in the Bulletin or on matters of major public health importance. Letters are usually between 400 and 850 words, with a maximum of six references; they will be edited and may be shortened. Manuscripts should be submitted to the Bulletin via our submissions web site accessed at http://submit.bwho.org or via a link from www.who.int/bulletin where there are “Help” and “FAQ” (frequently asked questions) buttons to assist authors. 714 Bulletin of the World Health Organization | September 2004, 82 (9) News Bulletin board: have your say Readers now have the opportunity to comment on recently published articles that have appeared in the Bulletin, in the form of an informal letter to the editor. These comments will then be published on the Bulletin’s web site, after quick editorial review, under our new “Bulletin board” section and a selection will be chosen to appear in the print version of the journal. Please visit our web site at http://www.who.int/bulletin/en/ to access the latest articles and email your contributions to: bulletin@who.int. WHO to unveil global clinical trials register WHO will unveil the world’s first global clinical trials register in November in a transparency drive that has gained momentum after recent accusations that drug companies suppressed vital data. Dr Tikki Pang, Director of WHO’s Research Policy and Cooperation department said that, initially, registra- tion under the new scheme would be voluntary but that a legal requirement may be necessary later to ensure that all clinical trials are centrally registered. “Eventually, some sort of enforce- ment procedures may be essential,” Dr Pang said. The plan is to unveil plans for the global register at the Ministerial Sum- mit on Health Research to be held in Mexico City, 16-20 November. Health research councils in coun- tries like Brazil, India and South Africa could assist in ensuring that trials in their countries be incorporated into the register, he said. He rejected the notion that the monitoring of clinical trials in develop- ing countries was less advanced than in the developed world. Dr Pang said WHO had the potential to establish binding interna- tional procedures because it represented 192 governments: “Our advantage is our official link with national governments”. Earlier this year, a lawsuit against pharmaceuticals giant GlaxoSmithKline (GSK) filed by New York State attorney- general Eliot Spitzer propelled the issue of missing trial data to centre-stage. In the lawsuit, GSK was accused of suppressing negative trial data on anti- depressant paroxetine in children, con- ducted by SmithKlineBeecham before its 2000 merger with GlaxoWellcome. The lawsuit underscored the wider problem of how to ensure that all clinical data are published and easily accessible to the public. In response, the Pharmaceutical Research and Manufacturers of America adopted new voluntary guidelines in June urging members to “commit to the timely communication of all mean- ingful results of clinical trials, whether those results are positive or negative”. But Kay Dickersin, Director of the Center for Clinical Trials and Evidence-Based Healthcare at Brown University, said US regulators, the Food and Drug Administration (FDA), already had legal requirements for drug companies to register trials on a government database. “There’s an obscure 1997 law and an even more obscure law from 1993, but neither have ever been enforced”, Professor Dickersin said, adding: “The FDA lacks teeth. It’s a regulatory agency, not an enforcement body”. FDA spokesperson Susan Cruzan confirmed that the FDA had never enforced existing provisions on clinical trials but said regulators were now considering whether to ask legislators for new enforcement powers. Dr Pang said he hoped WHO’s register could play a key role in making the registration of clinical data legally binding globally. He said the Framework Conven- tion on Tobacco Control which was adopted at the World Health Assembly in 2003 could provide a precedent and legal model for clinical trials, as coun- tries which ratify the convention are obliged to enforce its provisions. Dr Pang said WHO was also look- ing to national health research orga- nizations, research funders, consumer organizations and publishers for help. “For example, ethics review boards in the United States and other coun- tries might insist that a trial be assigned a registry number. We’ve talked to the Rockefeller Foundation, Bill and Melinda Gates Foundation, the Canadian Insti- tutes of Health Research, the Wellcome Trust and the Medical Research Council in Britain, among others,” Dr Pang said. WHO plans to use an existing numbering system, the International Standard Randomized Controlled Trial Number Register (ISRCTN), for the new global clinical trials register. At present the register contains all WHO-sponsored trials in reproductive health and childhood diseases. Those in tropical diseases will be next, and vac- cine trials are likely to follow. With its global launch, the register will be open to any organization con- ducting clinical trials. Dr Pang said the register in the form of a database administered by the British publishing house Current Controlled Trials Ltd may not be a long- term solution because it is run by a pri- vate company which could in theory go bankrupt, and because it charges a fee. “A few hundred dollars may be trivial to a pharma giant, but it matters more to researchers from the South. For that reason, we are considering using our own numbering system, something like the ISBN number used in book publishing,” Dr Pang said. “The service must be free to users. In particular, we want the database to be used by members of the lay public,” he said, citing an inquiry he received from a person whose son had a rare, fatal disease, and who was desperate to find a trial to enrol him in. “We could fill that need.” WHO scientist Dr Metin Gülmezoglu said companies would be offered incentives in the form of access to WHO research, but enforcement is an unresolved problem. “We’re hoping national governments will help on that.” GSK spokeswoman Mary Anne Rhyne said the company was now lead- ing the way in disclosure of data, and intends to cooperate with a future trials registry, but “the devil is in the detail” of the disclosure rules. Currently, the company often publishes summaries of trial results, not raw data. Vera Hassner Sharav of the US Alliance for Human Research Protection said the practice of summarizing trials has caused “an erosion of science into pseudoscience.” “Companies are agreeing to go along with this process,” she said, “be- cause they think they can control it.” O Owen Dyer, London
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