Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS). (9/298)

Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered "developing" countries. Safeguarding the rights and welfare of individuals participating as research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS (UNAIDS) embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process.  (+info)

Narrowing the gap: access to HIV treatments in developing countries. A pharmaceutical company's perspective. (10/298)

The advent of new antiretroviral medicines means that the effects of HIV can now be curbed, but only one in twenty infected people have so far benefited. For those living in developing countries, the new treatments are practically unattainable. Governments, UNAIDS and pharmaceutical companies recognise this only too well and have rethought established assumption in order to try and overcome the challenges posed by cost, inadequate health services and unreliable local supply of medicines.  (+info)

The World Bank and pharmaceuticals. (11/298)

Within less than a decade the World Bank has become the largest single source of finance (loans) for health in low and middle income countries as well as a major player in the field of pharmaceuticals. Often 20-50% of the recurrent government health budget in developing countries is used to procure drugs. Drugs are among the most salient and cost-effective elements of health care and often a key factor for the success of a health sector reform. However, pharmaceuticals are frequently being used irrationally, mainly due to market imperfections in health care, such as information asymmetries, leading to serious health problems and a heavy financial burden on the health system. Lending priorities set by the World Bank could be used to promote public health sector reform, leading to the rational use of affordable and available drugs of good quality in developing countries. This report provides the first analysis of World Bank activity in the pharmaceutical sector worldwide. The analysis of 77 staff appraisal reports, describing the planning phase of World Bank country projects, shows that 16% of the total World Bank health, nutrition and population budget, or approximately US$1.3 billion, has been committed to loans or credits supporting pharmaceutical activities in the programme countries between 1989-95. Roughly US$1.05 billion has been committed to procurement of drugs and medical equipment. Only 5% of the total pharmaceutical sector lending is committed to software components such as drug policy work and rational use of drugs. No more than 45% of the projects were developed in collaboration with pharmaceutical expertise. The World Bank is recommended to improve its pharmaceutical sector involvement by promoting drug policy research and development including national and international dialogue on pharmaceutical issues to ensure rational use of both drugs and loans. In this, the World Bank has an advantage given its experience from working with both the private and the public sector, its in-house expertise in health economics, and lastly its ability to be listened to by governments through its power.  (+info)

A critical review of 'a critical review': the methodology of the 1993 World Development Report, 'Investing in Health'. (12/298)

Since its publication in 1993, the World Bank's World Development Report, Investing in Health, has been subjected to much criticism, particularly over the way it proposes to measure the health losses summarized in the concept of the 'burden of disease', and to establish priorities for health interventions according to the reduction in mortality and disability they could produce and what they would cost. Some of these criticisms are justified, and are recognized by the WDR; others arise from misunderstanding or misapplication of the concepts. Sifting these criticisms to arrive at a better understanding requires looking at what kind of analysis is involved, how the subjective elements of the exercise were determined, and how they can be used to choose which interventions deserve priority when a country cannot meet all its citizens' health needs.  (+info)

The safety evaluation of monosodium glutamate. (13/298)

L-Glutamic acid and its ammonium, calcium, monosodium and potassium salts were evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1988. The Committee noted that intestinal and hepatic metabolism results in elevation of levels in systemic circulation only after extremely high doses given by gavage (>30mg/kg body weight). Ingestion of monosodium glutamate (MSG) was not associated with elevated levels in maternal milk, and glutamate did not readily pass the placental barrier. Human infants metabolized glutamate similarly to adults. Conventional toxicity studies using dietary administration of MSG in several species did not reveal any specific toxic or carcinogenic effects nor were there any adverse outcomes in reproduction and teratology studies. Attention was paid to central nervous system lesions produced in several species after parenteral administration of MSG or as a consequence of very high doses by gavage. Comparative studies indicated that the neonatal mouse was most sensitive to neuronal injury; older animals and other species (including primates) were less so. Blood levels of glutamate associated with lesions of the hypothalamus in the neonatal mouse were not approached in humans even after bolus doses of 10 g MSG in drinking water. Because human studies failed to confirm an involvement of MSG in "Chinese Restaurant Syndrome" or other idiosyncratic intolerance, the JECFA allocated an "acceptable daily intake (ADI) not specified" to glutamic acid and its salts. No additional risk to infants was indicated. The Scientific Committee for Food (SCF) of the European Commission reached a similar evaluation in 1991. The conclusions of a subsequent review by the Federation of American Societies for Experimental Biology (FASEB) and the Federal Drug Administration (FDA) did not discount the existence of a sensitive subpopulation but otherwise concurred with the safety evaluation of JECFA and the SCF.  (+info)

Dracunculiasis eradication: delayed, not denied. (14/298)

By the end of 1998, Asia was free of dracunculiasis (Guinea worm disease), with Pakistan, India, and Yemen having interrupted transmission in 1993, 1996, and 1997, respectively. Transmission of the disease was also interrupted in Cameroon and Senegal during 1997. Chad reported only 3 cases during 1998. Dracunculiasis is now confined to only 13 countries in Africa. The overall number of cases has been reduced by more than 97% from the 3.2 million cases estimated to have occurred in 1986 to 78,557 cases reported in 1998. Because the civil war in Sudan remains the major impediment to eradication of dracunculiasis, the interim goal is to stop all transmission outside that country by the end of 2000. The most important operational need now is for national programs to improve the frequency and quality of supervision of village-based health workers in order to enhance the sensitivity of surveillance and effectiveness of case containment.  (+info)

Childhood mortality impact and costs of integrating vitamin A supplementation into immunization campaigns. (15/298)

Country-specific activity and coverage data were used to estimate the childhood mortality impact (deaths averted) and costs of integrating vitamin A supplements into immunization campaigns conducted in 1998 and 1999. More than 94 million doses of vitamin A were administered in 41 countries in 1998, helping to avert nearly 169,000 deaths. During 1999, delivery of more than 97 million doses in 50 countries helped avert an estimated 242,000 deaths. The estimated incremental cost per death averted was US$72 (range: 36-142) in 1998 and US$64 (range: 32-126) in 1999. The estimated average total cost of providing supplementation per death averted was US$310 (range: 157-609) in 1998 and US$276 (range: 139-540) in 1999. Costs per death averted varied by campaign, depending on the number and proportion of the child population reached, number of doses received per child, and child mortality rates.  (+info)

Rape in war: the humanitarian response. (16/298)

Women and children are vulnerable to sexual violence in times of conflict, and the risk persists even after they have escaped the conflict area. The impact of rape goes far beyond the immediate effects of the physical attack and has long-lasting consequences. We describe the humanitarian community's response to sexual violence and rape in times of war and civil unrest by drawing on the experiences of Medecins Sans Frontieres/Doctors Without Borders and other humanitarian agencies. Health care workers must have a keen awareness of the problem and be prepared to respond appropriately. This requires a comprehensive intervention protocol, including antibiotic prophylaxis, emergency contraception, referral for psychological support, and proper documentation and reporting procedures. Preventing widespread sexual violence requires increasing the security in refugee camps. It also requires speaking out and holding states accountable when violations of international law occur. The challenge is to remain alert to these often hidden, but extremely destructive, crimes in the midst of a chaotic emergency relief setting.  (+info)