(Accessed 21 Sep 2019)
The case for a universal hepatitis C vaccine to achieve hepatitis C elimination
The introduction of highly effective direct-acting antiviral (DAA) therapy for hepatitis C has led to calls to eliminate it as a public health threat through treatment-as-prevention. Recent studies suggest it …
Authors: Nick Scott, David P. Wilson, Alexander J. Thompson, Eleanor Barnes, Manal El-Sayed, Adele Schwartz Benzaken, Heidi E. Drummer and Margaret E. Hellard
Citation: BMC Medicine 2019 17:175
Published on: 18 September 2019
Contemporary Clinical Trials
Volume 84 September 2019
Research article Abstract only
Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations
Luke Gelinas, Brian Crawford, Ariella Kelman, Barbara E. Bierer
Clinical trials for investigational new products to treat rare and ultra-rare diseases typically involve a limited number of research sites recruiting from a small pool of patients dispersed over a large geographical area. When remote access is not possible and participants must be present at a trial site, participation in research may require individuals and their families/caregivers to travel great distances, often at significant cost personally and financially and, frequently, for the duration of the trial. This article addresses the ethical and practical issues associated with the practice of sponsors offering financial and other assistance for relocation to trial sites from significant geographical distances, providing both foundational analysis of the ethical issues as well as actionable policy-level guidance on how to best approach these situations.
Volume 43, Issue 4 Pages: 709-954 October 2019
The ethical contours of research in crisis settings: five practical considerations for academic institutional review boards and researchers
Kathryn Falb, Betsy Laird, Ruwan Ratnayake, Katherine Rodrigues, Jeannie Annan
First Published: 22 August 2019
The number of research studies in the humanitarian field is rising. It is imperative, therefore, that institutional review boards (IRBs) consider carefully the additional risks present in crisis contexts to ensure that the highest ethical standards are upheld. Ethical guidelines should represent better the specific issues inherent to research among populations grappling with armed conflict, disasters triggered by natural hazards, or health‐related emergencies. This paper seeks to describe five issues particular to humanitarian settings that IRBs should deliberate and on which they should provide recommendations to overcome associated challenges: staged reviews of protocols in acute emergencies; flexible reviews of modification requests; addressing violence and the traumatic experiences of participants; difficulties in attaining meaningful informed consent among populations dependent on aid; and ensuring reviews are knowledgeable of populations’ needs. Considering these matters when reviewing protocols will yield more ethically sound research in humanitarian settings and hold researchers accountable to appropriate ethical standards.
Globalization and Health
[Accessed 21 Sep 2019]
| 18 September 2019
A multidisciplinary review of the policy, intellectual property rights, and international trade environment for access and affordability to essential cancer medications
Authors: Sangita M. Baxi, Reed Beall, Joshua Yang and Tim K. Mackey
In 2015, the World Health Organization (WHO) Expert Committee approved the addition of 16 cancer medicines to the WHO Model List of Essential Medicines (EML), bringing the total number of cancer medicines on the list to 46. This change represented the first major revision to the EML oncology section in recent history and reinforces international recognition of the need to ensure access and affordability for cancer treatments. Importantly, many low and middle-income countries rely on the EML, as well as the children’s EML, as a guide to establish national formularies, and moreover use these lists as tools to negotiate medicine pricing. However, EML inclusion is only one component that impacts cancer treatment access. More specifically, factors such as intellectual property rights and international trade agreements can interact with EML inclusion, drug pricing, and accessibility. To better understand this dynamic, we conducted an interdisciplinary review of the patent status of EML cancer medicines compared to other EML noncommunicable disease medicines using the 17th, 18th, 19th, 20th, and 21st editions of the list. We also explored the interaction of intellectual property rights with the international trade regime and how trade agreements can and do impact cancer treatment access and affordability. Based on this analysis, we conclude that patent status is simply one factor in the complex international environment of health systems, IPR policies, and trade regimes and that aligning these oftentimes disparate interests will require shared global governance across the cancer care continuum.
Volume 11, Issue 5, September 2019
Science, innovation and society: what we need to prepare for the health challenges of the twenty-first century?
International Health, Volume 11, Issue 5, September 2019, Pages 317–320, https://doi.org/10.1093/inthealth/ihz047
A little over 30 y ago, human immunodeficiency virus (HIV) was first identified as the cause of acquired immune deficiency syndrome (AIDS). Within a decade the nature of the infection, the pathogenesis and a series of combination therapies had been developed that transformed a deadly infection into a challenging but manageable condition. The challenge was then to ensure that everyone who needed these lifesaving therapies had access to them. With more than 20 million people…
Volume 11, Issue 5, September 2019
The urgent case for expanded development assistance for health
Jeffrey D Sachs
International Health, Volume 11, Issue 5, September 2019, Pages 321–323, https://doi.org/10.1093/inthealth/ihz059
The low-income developing countries require increased development assistance for health (DAH) to achieve Sustainable Development Goal 3, ‘Healthy Lives for All’. DAH has a proven track record. DAH expanded during 2001–2008, with significant health gains in the LIDCs, but then stopped expanding in the wake of the 2008 financial crisis. The Global Fund to Fight AIDS, TB and Malaria requires around US$31.8 billion during 2021–2023 to maintain a trajectory to end the three epidemics by 2030, yet donors have so far signaled that they are prepared to offer less than half that sum, around US$14 billion.