Improving Access to Essential Medicines: How Health Concerns can be Prioritised in the Global Governance System

This paper discusses the politics of access to essential medicines and identifies ‘space’ in the current system where health concerns can be strengthened relative to trade. This issue is addressed from a global governance perspective focusing on the main actors who can have the greatest impact. These include developing country coalitions and citizens in developed countries though participation in civil society organisations. These actors have combined forces to tackle this issue successfully, resulting in the 2001 Doha Declaration on Public Health. The collaboration has been so powerful due to the assistance of the media as well as the decision to compromise with pharmaceutical companies and their host countries. To improve access to essential medicines, six C's are needed: coalitions, civil society, citizenship, compromise, communication and collaboration

Highly sensitive C-reactive protein levels in Iranian patients with pulmonary complication of sulfur mustard poisoning and its correlation with severity of airway diseases

Background: Sulfur mustard (SM) is a chemical warfare agent that can cause serious pulmonary complications. This study was designed to determine serum highly sensitive C-reactive protein (hs-CRP) and evaluate its correlation with lung function parameters in patients with chronic obstructive pulmonary disease (COPD) due to SM poisoning. Methods: Fifty consecutive SM patients with stable COPD and a mean age 46.3 + 9.18 years were enrolled in this cross sectional study. Thirty healthymen were selected as controls. Lung function parameters were evaluated. Serum hs-CRP by immunoturbidometry assay was measured in both the patients and controls. Results: In the case group, the mean forced expiratory volume in one second (FEV1) was 2.14 + 0.76 L (58.98%+17.51% predicted). The mean serum hs-CRP was 9.4+6.78 SD and 3.9+1.92 SDmg/L in the cases and controls, respectively, with significant statistical differences (p < .001). There was negative correlation between the serum hs-CRP and FEV1 levels (p ¼ .01). The serum hs-CRP levels were also correlated with Global Initiative for ChronicObstructive Lung disease (GOLD) stages (r ¼ .45, p < .001). Conclusions:Our findings suggest that the serum hs-CRP level is increased in SM patients with COPD and may have a direct correlation with disease severity. It may then be used as a marker for the severity of COPD in patients with SM poisoning

Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions

<p>Abstract</p> <p>Background</p> <p>New artemisinin combination therapies pose difficulties of implementation in developing and tropical settings because they have a short shelf-life (two years) relative to the medicines they replace. This limits the reliability and cost of treatment, and the acceptability of this treatment to health care workers. A multi-pronged investigation was made into the chemical and physical stability of fixed dose combination artemether-lumefantrine (FDC-ALU) stored under heterogeneous, uncontrolled African conditions, to probe if a shelf-life extension might be possible.</p> <p>Methods</p> <p>Seventy samples of expired FDC-ALU were collected from private pharmacies and malaria researchers in seven African countries. The samples were subjected to thin-layer chromatography (TLC), disintegration testing, and near infrared Raman spectrometry for ascertainment of active ingredients, tablet integrity, and chemical degradation of the tablet formulation including both active ingredients and excipients.</p> <p>Results</p> <p>Seventy samples of FDC-ALU were tested in July 2008, between one and 58 months post-expiry. 68 of 70 (97%) samples passed TLC, disintegration and Raman spectrometry testing, including eight samples that were post-expiry by 20 months or longer. A weak linear association (R²= 0.33) was observed between the age of samples and their state of degradation relative to brand-identical samples on Raman spectrometry. Sixty-eight samples were retested in February 2009 using Raman spectrometry, between eight and 65 months post-expiry. 66 of 68 (97%) samples passed Raman spectrometry retesting. An unexpected observation about African drug logistics was made in three batches of FDC-ALU, which had been sold into the public sector at concessional pricing in accordance with a World Health Organization (WHO) agreement, and which were illegally diverted to the private sector where they were sold for profit.</p> <p>Conclusion</p> <p>The data indicate that FDC-ALU is chemically and physically stable well beyond its stated shelf-life in uncontrolled, tropical conditions. While these data are not themselves sufficient, it is strongly suggested that a re-evaluation of the two-year shelf-life by drug regulatory authorities is warranted.</p

A Dynamic Knowledge Management Framework for the High Value Manufacturing Industry

Dynamic Knowledge Management (KM) is a combination of cultural and technological factors, including the cultural factors of people and their motivations, technological factors of content and infrastructure and, where these both come together, interface factors. In this paper a Dynamic KM framework is described in the context of employees being motivated to create profit for their company through product development in high value manufacturing. It is reported how the framework was discussed during a meeting of the collaborating company’s (BAE Systems) project stakeholders. Participants agreed the framework would have most benefit at the start of the product lifecycle before key decisions were made. The framework has been designed to support organisational learning and to reward employees that improve the position of the company in the market place

HIV/AIDS Drugs for Sub-Saharan Africa: How Do Brand and Generic Supply Compare?

BACKGROUND: Significant quantities of antiretroviral drugs (ARVs) to treat HIV/AIDS have been procured for Sub-Saharan Africa for the first time in their 20-year history. This presents a novel opportunity to empirically study the roles of brand and generic suppliers in providing access to ARVs. METHODOLOGY/PRINCIPAL FINDINGS: An observational study of brand and generic supply based on a dataset of 2,162 orders of AIDS drugs for Sub-Saharan Africa reported to the Global Price Reporting Mechanism at the World Health Organization from January 2004-March 2006 was performed. Generic companies supplied 63% of the drugs studied, at prices that were on average about a third of the prices charged by brand companies. 96% of the procurement was of first line drugs, which were provided mostly by generic firms, while the remaining 4%, of second line drugs, was sourced primarily from brand companies. 85% of the generic drugs in the sample were manufactured in India, where the majority of the drugs procured were ineligible for patent protection. The remaining 15% was manufactured in South Africa, mostly under voluntary licenses provided by brand companies to a single generic company. In Sub-Saharan African countries, four first line drugs in the dataset were widely patented, however no general deterrent to generic purchasing based on a patent was detected. CONCLUSIONS/SIGNIFICANCE: Generic and brand companies have played distinct roles in increasing the availability of ARVs in Sub-Saharan Africa. Generic companies provided most of the drugs studied, at prices below those charged by brand companies, and until now, almost exclusively supplied several fixed-dose combination drugs. Brand companies have supplied almost all second line drugs, signed voluntary licenses with generic companies, and are not strictly enforcing patents in certain countries. Further investigation into how price reductions in second line drugs can be achieved and the cheapest drugs can actually be procured is warranted

The Inadequate Treatment of Pain: Collateral Damage from the War on Drugs

Jason Nickerson and Amir Attaran examine the vast inequities in medical pain relief around the world and argue that the global control of licit narcotics be shifted from the International Narcotic Control Board to WHO

Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis

Reed Beall and Randall Kuhn describe their findings from an analysis of use of compulsory licenses for pharmaceutical products by World Trade Organization members since 1995