Program For Appropriate Technology In Health Research Articles

Development and Distribution of Drugs for NTDs: Efforts of One Pharmaceutical Company

The Pharmaceutical Industry is expected to play a proactive global role in combatting neglected tropical diseases (NTDs) and other tropical diseases affecting low-income countries. Such a role would include novel medicine R&D, manufacturing and distribution. In order to succeed in this role, several challenges need to be overcome: a) the economic challenge or cost benefit balance for the development of these medicines, and b) sparse in-house experience with these diseases within the Industry. During the last decade, the Product Development Partnership (PDP) model has become an effective strategy to address such challenges. Organizations such as the Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases initiative (DNDi), TB alliance, PATH (formerly the Program for Appropriate Technology in Health), and others have linked pharmaceutical companies, funding organizations, academic researchers and others, and have thus been able to successfully populate treatment pipelines directed at NTDs, Malaria, tuberculosis (TB), and human immunodeficiency virus (HIV)/AIDS. In this paper, our experience working with one of these organizations, DNDi, is described. We have been collaborating with DNDi in evaluating the actions of Eisai's antifungal compound, E1224, in a clinical study for treating Chagas Disease. In addition, other Eisai initiatives directed at NTDs and improving patients' access to medicines are introduced.

Perilous Uncertainty: Situating Women's Breast-Health Seeking in Northern Peru.

Breast cancer rates in Peru, as in other low- and middle-income countries, continue to rise, and survival rates are poor, in part because many women are diagnosed with late-stage disease. As part of a pilot project to improve breast cancer screening and diagnostic services in remote regions of Peru, the Program for Appropriate Technology in Health (PATH) partnered with Peruvian organizations to train community health workers in breast health promotion and providers in clinical breast exam (CBE). To inform these strategies, we undertook a qualitative study to determine factors that influence Peruvian women's decisions to seek CBE. Anthropological approaches incorporating the PRECEDE/PROCEED public health model guided our conversations with providers and women living in the region of the pilot intervention. Grounded theory analysis helped us uncover a central theme of uncertainty, a state of doubt and insecurity that created a sense of impotent worry and impeded clinical health-seeking behaviors.

Vaccination: rattling the supply chain

The first decade of this century was perhaps the most productive in the history of vaccine development, seeing the release of a plethora of new life-saving vaccines for rotavirus diarrhoea, types of meningitis and pneumonia, and for human papilloma-virus (HPV) infections that cause cervical cancer. We are in a very different situation now compared to 10 years ago;' says Dr Osman Mansoor at the United Nations Children's Fund (UNICEF) in New York. Mansoor, who is UNICEF's senior health adviser for the Expanded Programme on Immunization and New Vaccines, notes that more vaccines are in the pipeline. fact more than 80 vaccines are in the late stages of clinical testing, and 30 of them are designed to protect against major including dengue and malaria. At the same time, the global vaccine market is booming: since 2000, global revenue from the sale of vaccines has almost tripled reaching more than US$17 billion by mid-2008. While most of this expansion is accounted for by sales of new and more costly vaccines in industrialized countries, more vaccines are also reaching developing countries due to the efforts of the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization), a public-private partnership established in 2000 to increase immunization in poor countries. [ILLUSTRATION OMITTED] [ILLUSTRATION OMITTED] The World Health Organization (WHO) and UNICEF estimate that just over 80% of the world's children now have access to immunization, as measured by coverage of the third dose of DTP (diphtheria, tetanus and pertussis) vaccine, while an increasing number also have access to powerful new vaccines. In the past, countries relied on a package of vaccines against six diseases says Project Optimize Coordinator Modibo Dicko, referring to WHO's Expanded Programme on Immunization, which was launched in 1974. Now some countries are doubling the number of vaccines they offer. As encouraging as all this seems, the scaling up of immunization programmes and the introduction of new vaccines is putting an unprecedented strain on delivery systems that have not changed in decades. James Cheyne, a supply-chain consultant, who started his career in vaccine logistics in Burma (now Myanmar) in 1977, is in a good position to judge those systems since he has had a hand in designing several himself. Cheyne cites the unnecessary layering of distribution networks as one of his main concerns. Typically there is a central store that supplies the regional stores, which then feed the provincial stores and district stores that in turn supply the local health centres, he says, pointing out that while this layering made sense 30 years ago, because the lines of communication were weak, these days low-cost telecommunications technology has changed things. You don't need a store for each administrative level anymore because we have cell phones and the person from the health centre can call the central store directly; Cheyne says. Making better use of that kind of technology is a core aspect of the work being done by Project Optimize, a collaboration between WHO and PATH (formerly the Program for Appropriate Technology in Health), a nongovernmental organization. For Michel Zaffran, the director of Project Optimize, information technology is key in combating one of the biggest problems faced by vaccine distribution systems--overstock in supply. On the face of it the idea that immunization programmes are hampered by too much vaccine seems paradoxical. But, in fact, the overstocking of vaccines increases cold storage costs and generates waste (when vaccines are lost, damaged or not used before their expiry date, and when not all vials in a multi-dose vial get used). We want to have as little buffer stock as possible, but still we want to have enough vaccine to vaccinate the children, Zaffran says, arguing that this means putting in place information systems and technologies that give managers a real-time picture of how much stock they have throughout a country and whether the quantities meet the requirements of their immunization strategy. …

ASM LabCap’s contributions to disease surveillance and the International Health Regulations (2005)

The revised International Health Regulations [IHR(2005)], which requires the Member States of the World Health Organization (WHO) to develop core capacities to detect, assess, report, and respond to public health threats, is bringing new challenges for national and international surveillance systems. As more countries move toward implementation and/or strengthening of their infectious disease surveillance programs, the strengthening of clinical microbiology laboratories becomes increasingly important because they serve as the first line responders to detect new and emerging microbial threats, re-emerging infectious diseases, the spread of antibiotic resistance, and the possibility of bioterrorism. In fact, IHR(2005) Core Capacity #8, “Laboratory”, requires that laboratory services be a part of every phase of alert and response.Public health laboratories in many resource-constrained countries require financial and technical assistance to build their capacity. In recognition of this, in 2006, the American Society for Microbiology (ASM) established an International Laboratory Capacity Building Program, LabCap, housed under the ASM International Board. ASM LabCap utilizes ASM’s vast resources and its membership’s expertise—40,000 microbiologists worldwide—to strengthen clinical and public health laboratory systems in low and low-middle income countries. ASM LabCap’s program activities align with HR(2005) by building the capability of resource-constrained countries to develop quality-assured, laboratory-based information which is critical to disease surveillance and the rapid detection of disease outbreaks, whether they stem from natural, deliberate or accidental causes.ASM LabCap helps build laboratory capacity under a cooperative agreement with the U.S. Centers for Disease Control and Prevention (CDC) and under a sub-contract with the Program for Appropriate Technology in Health (PATH) funded by the United States Agency for International Development (USAID). Successful activities of ASM LabCap have occurred throughout Africa, Asia, Central America and the Caribbean. In addition, ASM LabCap coordinates efforts with international agencies such as the WHO in order to maximize resources and ensure a unified response, with the intended goal to help build integrated disease surveillance and response capabilities worldwide in compliance with HR(2005)’s requirements.

Comparative crossover study of the PATH Woman's Condom and the FC Female Condom®

Background Only one female condom [FC1 Female Condom (FC1)] is currently marketed, but it is poorly utilized, perhaps due to difficulty with insertion, discomfort and suboptimal functional performance during intercourse. The Program for Appropriate Technology in Health (PATH) Woman's Condom (WC) was developed in an effort to overcome these obstacles. Study Design This was a randomized crossover study to evaluate the functional performance, safety and acceptability of the FC1 and WC. Seventy-five couples were assigned to one of two condom use sequences (WC/FC1 or FC1/WC) at three centers. Four condoms of the first type were used by couples in four acts of intercourse at home over a 2–4-week period. After a follow-up visit, these procedures were repeated with the second assigned condom type. In a substudy of participants ( n=25), a colposcopy was performed prior and subsequent to the first condom use of each of the two condom types. Condom performance was evaluated by calculating measures of function from questionnaires completed by the couple after each condom use. Safety was evaluated by reported urogenital symptoms with a given condom during or immediately following condom use and colposcopic signs of genital irritation in the substudy. Acceptability of each given condom type was measured by questionnaire. Results Total condom failure (slippage, breakage, etc., divided by the number of female condoms opened) was 31% for the WC and 42% for the FC1. Total clinical failure (slippage, breakage, etc., divided by the number of female condoms used) was 17% for the WC and 24% for the FC1. The proportion of condom failures was 10.9 percentage points less, and the proportion of clinical failure 6.7 percentage points less, when couples used the WC compared to the FC1 [90% CI: −18.5 to −3.3 and −12.6 to −0.8, respectively). Fewer women reported symptoms of urogenital irritation when using the WC vs. the FC1 either overall or when analyzing each use of the condom [woman as unit: −20 percentage points (90% CI: −30.5 to −9.3); condom use as unit: −12.3 percentage points (90% CI: −18.0 to −6.7)]. A similar result was seen for signs of urogenital irritation [woman as unit: −20 percentage points (90% CI: −42.7 to 4.8)]. Among participants with a preference, WC was preferred over the FC1 by twice as many males and by 2.6 times as many females. Conclusions While both female condoms were safe and acceptable in short-term use, the PATH Woman's Condom leads to less failure, was associated with fewer adverse events, and was more acceptable than the FC1 Female Condom.

Expanding access to emergency contraception through state systems: the Washington State experience.

Access to family planning and reduction of unintended pregnancy are long-standing priorities for Washington States Department of Health (DOH) and Department of Social and Health Services (DSHS). Working together to ensure that all pregnancies are intended (consciously and clearly desired at the time of conception) the two agencies provide family planning counseling and a broad choice of contraceptive methods through a range of health and social service programs. When a dedicated product for emergency contraception became available in 1998 widespread integration of relevant information and services became one more strategy the agencies used to realize the goal of reducing unintended pregnancy in the state. Since 1997 the Program for Appropriate Technology in Health (PATH) has collaborated with state colleagues to increase access to emergency contraception. In a series of interviews conducted in December 2003 PATH asked administrators managers and others who were involved in the initial process to describe the experience. The story that emerged described here is one of strong high-level support for family planning services that created an ideal platform for expanding emergency contraception services establishing collaborations between relevant agencies and increasing the number of state programs and the range of service providers offering emergency contraception services. The result was an innovative approach to service delivery that made it possible to reach underserved and low-income populations including those not served by Title X--funded clinics. Our objective in sharing Washington States experience is to stimulate further state-level innovation for expanding access to emergency contraception. (excerpt)

Expanding Access to Emergency Contraception Through State Systems: The Washington State Experience

Access to family planning and reduction of unintended pregnancy are long-standing priorities for Washington States Department of Health (DOH) and Department of Social and Health Services (DSHS). Working together to ensure that all pregnancies are intended (consciously and clearly desired at the time of conception) the two agencies provide family planning counseling and a broad choice of contraceptive methods through a range of health and social service programs. When a dedicated product for emergency contraception became available in 1998 widespread integration of relevant information and services became one more strategy the agencies used to realize the goal of reducing unintended pregnancy in the state. Since 1997 the Program for Appropriate Technology in Health (PATH) has collaborated with state colleagues to increase access to emergency contraception. In a series of interviews conducted in December 2003 PATH asked administrators managers and others who were involved in the initial process to describe the experience. The story that emerged described here is one of strong high-level support for family planning services that created an ideal platform for expanding emergency contraception services establishing collaborations between relevant agencies and increasing the number of state programs and the range of service providers offering emergency contraception services. The result was an innovative approach to service delivery that made it possible to reach underserved and low-income populations including those not served by Title X--funded clinics. Our objective in sharing Washington States experience is to stimulate further state-level innovation for expanding access to emergency contraception. (excerpt)

When home is no longer safe: intimate-partner violence

In a preface to the World Report on and Health issued by WHO in 2002 Gro Harlem Brundtland then WHO Director-General wrote: Violence pervades the lives of many people around the world and touches all of us in some way. To many people staying out of harms way is a matter of locking doors and windows and avoiding dangerous places. To others escape is not possible. The threat of violence is behind those doors well hidden from public view. On Nov 24 WHO exposed this hidden violence to public view in their report on the WHO Multicountry Study on Womens Health and Domestic Against Women. The report analyses data collected in household surveys by trained female interviewers from over 24 000 women in 15 sites in 10 geographically culturally and economically diverse countries. The study confirms that violence against women is pervasive and that violence by intimate partner rather than by other perpetrators is the dominant form in womens lives. The study was coordinated by WHO with a core team of experts from the London School of Hygiene and Tropical Medicine the Program for Appropriate Technology in Health (PATH) and WHO itself. WHO started developing the study in 1997 and worked to overcome the many methodological and ethical challenges. In particular measures were needed to ensure privacy confidentiality and safety both for the women and the interviewers. (excerpt)

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Psychosocial support for breast cancer survivors: Supporting women in Ukraine

When Program for Appropriate Technology in Health (PATH) first discuss the idea of psychosocial support for breast cancer survivors it was met with official skepticism but a profound expression of need on the part of individual women. Now 15 groups represent 11 oblasts (provinces) with 10 of these groups officially registered as nongovernmental organizations. In Ukraine where current economic circumstances are extremely difficult breast cancer survivors have started to play a valuable role in complementing the efforts of medical providers to meet the psychological needs of breast cancer patients and their need for more information. By being willing to go public about their illness breast cancer survivors are effective role models for newly diagnosed women serving as living proof that they not only survived breast cancer but also have gone on to live normal productive lives. (excerpt)

The performance and utility of rapid diagnostic assays forPlasmodium falciparummalaria in a field setting in the Lao People's Democratic Republic

Rapid diagnostic assays for malaria have the potential to improve the management and control of the disease in developing countries. The objectives of the present study were to evaluate, in a field setting, the performance of several such assays for Plasmodium falciparum infection and to examine the usefulness of these assays in identifying subjects for treatment trials in rural field sites. Residents of 12 villages in Laos who presented with fever were eligible for inclusion. Blood was collected by fingerprick for a dipstick assay, developed by the Program for Appropriate Technology in Health (PATH), performed and interpreted in the field by local healthcare workers. Compared with ‘blinded’ reference microscopy (N=196), the sensitivity and specificity of the PATH assay were 96.2% and 93.0%, respectively. Two rapid diagnostic assays (PATH and OptiMAL) were also performed on the subset of subjects eligible to participate in an in-vivo treatment trial (N=97), and the results again compared with those of ‘blinded’ reference microscopy. In this subset, a subject was considered a ‘true positive’ if found positive by microscopy or the alternate rapid assay. Using this modified reference standard, the sensitivity and specificity of the PATH assay were 96.7% and 94.4%, and those of the OptiMAL assay were 91.8% and 100%, respectively. Both of the rapid assays tested therefore appear suitable for use in rural field settings by local healthcare providers and can accurately identify participants for treatment trials.

Increasing Access to Emergency Contraception through Community Pharmacies: Lessons from Washington State

In 1997, the U.S. Food and Drug Administration endorsed the use of a combination estrogen and progestin oral contraceptive for emergency postcoital contraception.' In 1998, the agency approved the first dedicated emergency contraceptive product for use in the United States, and in 1999 it approved the first progestin-only emergency contraceptive pill.2 Despite emergency contraception's safety, effectiveness and unique ability to reduce unintended pregnancy, it has been vastly underused. One study conducted in 1997 found that only one in 10 health professionals routinely discussed emergency contraception with their clients, and that 41% of Americans were completely unaware of its existence.3 The Institute of Medicine advocates an aggressive effort to reduce the number of unintended pregnancies, by increasing access to contraceptive information and services and by broadening the range of health care professionals and institutions that promote and provide contraceptive services.4 In response to this mandate, five organizations in Washington State-the nonprofit organization Program for Appropriate Technology in Health (PATH), the Washington State Pharmacists Association, the University of Washington Department of Pharmacy, the Washington State Board of Pharmacy and the Seattle office of the advertising firm DDB World-

Malaria vaccine news

GlaxoSmithKline (GSK) is to join forces with the Malaria Vaccine Initiative at the Program for Appropriate Technology in Health (PATH), an American non-profit organization, to speed up the development of its malaria vaccine for children. So far, PATH has only pledged $6.7 million, a fraction of the cost of vaccine development. However, GSK chief executive Jean-Pierre Garnier said the partnership was evidence of the company's drive to find new models for product development in developing countries. The vaccine candidate has been in development since 1983 and is considered the most advanced for protecting Africans against Plasmodium falciparum. Clinical trials in adults show 70% efficacy for short-term protection. A GSK spokesman said that vaccines did not normally take so long to develop but malaria was a particularly difficult case. He estimated the malaria vaccine might be ready for launch in 2007 or 2008. CK (http://id.medscape.com/34452.rhtml?srcmp=id-030201)

Lives renewed: The emergence of a Breast cancer survivor movement in Ukraine

Breast cancer is the leading cause of cancer deaths among women in Ukraine. In addition to the physical toll that breast cancer takes, the psychological and emotional needs of women diagnosed with the disease are great but rarely addressed. Since 1997, with initial technical assistance from the Program forAppropriate Technology in Health (PATH), a nascent breast cancer survivor movement has emerged in Ukraine, which aims to challenge societal stigmatisation of the disease. As of mid-2001, survivor groups have been formed in 15 cities, representing 12 of the country's 25 provinces, and groups in eight cities have begun implementing Peer Support Volunteer programmes through which survivors provide information and emotional support to newly diagnosed women in hospital. Survivors also are playing an important role in raising public awareness about the disease through public events, outreach activities and the media. The groups have also forged alliances with key medical professionals specialising in cancer care, both to educate them about the potential role that survivors' groups can play in assisting patients, as well as to enlist thier active support for these efforts. Solidifying the groups' organisational structures and strengthening their management and fund-raising skills have been vital to success.

Accuracy and costs of rapid human immunodeficiency virus testing technologies in rural hospitals in Zambia.

To evaluate the accuracy and costs of newer rapid human immunodeficiency virus (HIV) antibody tests in primary health care settings in rural Zambia. Three rural hospitals participated in this study. During a baseline assessment period, HIV testing practices were recorded on 250 consecutive clients at each hospital. Baseline evaluation was compared with 250 subsequent consecutive clients tested using a testing algorithm consisting of an initial screening HIV Dipstick test (McDonald Scientific [PVT] Limited, Harare, Zimbabwe) followed by confirmatory testing of all reactive specimens using the HIV Capillus test (Cambridge Diagnostics, Galway, Ireland), in conformity with World Health Organization HIV testing recommendations. Quality control was performed at a national university teaching hospital laboratory. A total of 1,500 clients was entered, with an HIV seropositivity rate of 53.2%. Most HIV testing was performed on patients with signs and symptoms suggestive of HIV infection. Same-day results were provided for only 16%. The HIV Dipstick testing algorithm sensitivity was 96.9%, and specificity was 98.0%. Counselor dissatisfaction was greater with the Dipstick algorithm as a result of 5.3% discordant results. Use of the HIV Dipstick testing algorithm cost between US $3.00 and US $3.80 per client tested. The accuracy of HIV testing in unsophisticated rural laboratories in Zambia is acceptable. Although HIV Dipstick testing algorithm costs were relatively high for a developing country, this HIV testing procedure is currently the most economical method available in Zambia. Accurate, less costly HIV testing algorithms are still needed.