Redefining the non-communicable disease framework to a 6 × 6 approach: incorporating oral diseases and sugars.

The WHO Global Oral Health Status Report, published in 2022, highlighted the alarming state of oral health worldwide and called for urgent action by integrating oral health into non-communicable diseases (NCDs) and universal health coverage initiatives. 3·5 billion people have oral diseases, surpassing all other NCDs combined. The detrimental role of sugars as a risk factor for oral diseases and other NCDs has also been well documented. Despite the evidence, oral diseases and sugars are not part of the current NCD framing, which focuses on five diseases and five risk factors (ie, 5 × 5). Oral diseases and sugars remain sidelined, disproportionately affecting poor and disadvantaged populations. In this Viewpoint, we advocate for the integration of oral diseases and sugars into the current approach towards the prevention and control of NCDs. An expanded 6 × 6 framework would recognise growing evidence and would reiterate the need to strengthen action, resource allocation, and policy development for NCDs. We present the evidence and rationale for, and benefits of, an expanded NCD framework and detail recommendations to guide efforts towards improved priority, investment, and equitable health outcomes for NCDs, including oral health.

The ethical, social, and cultural dimensions of screening for mental health in children and adolescents of the developing world.

Despite their burden and high prevalence, mental health disorders of children and adolescents remain neglected in many parts of the world. In developing countries, where half of the population is younger than 18 years old, one of every five children and adolescents is estimated to suffer from a mental health disorder. It is then essential to detect these conditions through screening in a timely and accurate manner. But such screening is fraught with considerable ethical, social, and cultural challenges. This study systematically identifies, for the first time, these challenges, along with potential solutions to address them. We report on the results of an international multi- and inter-disciplinary three-round Delphi survey completed by 135 mental health experts from 37 countries. We asked these experts to identify and rank the main ethical, social, and cultural challenges of screening for child and adolescent mental health problems in developing nations, and to propose solutions for each challenge. Thirty-nine significant challenges emerged around eight themes, along with 32 potential solutions organized into seven themes. There was a high degree of consensus among the experts, but a few interesting disagreements arose between members of the panel from high-income countries and those from low- and middle-income nations. The panelists overwhelmingly supported mental health screening for children and adolescents. They recommended ensuring local acceptance and support for screening prior to program initiation, along with careful and comprehensive protection of human rights; integrating screening procedures into primary care; designing and implementing culturally appropriate screening tools, programs, and follow-up; securing long-term funding; expanding capacity building; and task-shifting screening to local non-specialists. These recommendations can serve as a guide for policy and decision-making, resource allocation, and international cooperation. They also offer a novel approach to reduce the burden of these disorders by encouraging their timely and context-sensitive prevention and management.

Understanding and acting on the developmental origins of health and disease in Africa would improve health across generations.

Data from many high- and low- or middle-income countries have linked exposures during key developmental periods (in particular pregnancy and infancy) to later health and disease. Africa faces substantial challenges with persisting infectious disease and now burgeoning non-communicable disease.This paper opens the debate to the value of strengthening the developmental origins of health and disease (DOHaD) research focus in Africa to tackle critical public health challenges across the life-course. We argue that the application of DOHaD science in Africa to advance life-course prevention programmes can aid the achievement of the Sustainable Development Goals, and assist in improving health across generations. To increase DOHaD research and its application in Africa, we need to mobilise multisectoral partners, utilise existing data and expertise on the continent, and foster a new generation of young African scientists engrossed in DOHaD.

Criteria to assess potential reverse innovations: opportunities for shared learning between high- and low-income countries.

BACKGROUND: Low- and middle-income countries (LMICs) are developing novel approaches to healthcare that may be relevant to high-income countries (HICs). These include products, services, organizational processes, or policies that improve access, cost, or efficiency of healthcare. However, given the challenge of replication, it is difficult to identify innovations that could be successfully adapted to high-income settings. We present a set of criteria for evaluating the potential impact of LMIC innovations in HIC settings. METHODS: An initial framework was drafted based on a literature review, and revised iteratively by applying it to LMIC examples from the Center for Health Market Innovations (CHMI) program database. The resulting criteria were then reviewed using a modified Delphi process by the Reverse Innovation Working Group, consisting of 31 experts in medicine, engineering, management and political science, as well as representatives from industry and government, all with an expressed interest in reverse innovation. RESULTS: The resulting 8 criteria are divided into two steps with a simple scoring system. First, innovations are assessed according to their success within the LMIC context according to metrics of improving accessibility, cost-effectiveness, scalability, and overall effectiveness. Next, they are scored for their potential for spread to HICs, according to their ability to address an HIC healthcare challenge, compatibility with infrastructure and regulatory requirements, degree of novelty, and degree of current collaboration with HICs. We use examples to illustrate where programs which appear initially promising may be unlikely to succeed in a HIC setting due to feasibility concerns. CONCLUSIONS: This study presents a framework for identifying reverse innovations that may be useful to policymakers and funding agencies interested in identifying novel approaches to addressing cost and access to care in HICs. We solicited expert feedback and consensus on an empirically-derived set of criteria to create a practical tool for funders that can be used directly and tested prospectively using current databases of LMIC programs.

The World's Youngest Cadaveric Kidney Transplant: Medical, Surgical and Ethical Issues.

BACKGROUND: We report here the first successful transplant from a preterm cadaveric donor. This was performed in November 1994. The donor, who had been born at about 33 weeks of gestation, was diagnosed as having agenesis of the corpus callosum. The transplant was carried out 10 days after the donor's birth. The recipient was a 17-month-old boy with a diagnosis of Denys-Drash syndrome (WT1 mutation). METHOD: We describe and analyze the ethical, social, cultural, medical and surgical issues encountered and how these were addressed. The major issue of determining death in a beating heart, very young donor was dealt with in the absence of worldwide experience and guidelines. RESULTS: The transplanted recipient has lived with the grafted pair of kidneys for more then 22 years. He has led a relatively normal life. CONCLUSIONS: It is possible for immature preterm deceased donor kidneys to be transplanted into a 17-month-old recipient and for the grafted kidneys to grow with the recipient and function for 22 years. There were challenges in ethically determining the death of the donor, in surgical techniques to obviate potential surgical complications, and in postoperative care of the recipient, but these were managed successfully.

Progress in human embryonic stem cell research in the United States between 2001 and 2010.

On August 9th, 2001, the federal government of the United States announced a policy restricting federal funds available for research on human embryonic stem cell (hESCs) out of concern for the "vast ethical mine fields" associated with the creation of embryos for research purposes. Until the policy was repealed on March 9th, 2009, no U.S. federal funds were available for research on hESCs extracted after August 9, 2001, and only limited federal funds were available for research on a subset of hESC lines that had previously been extracted. This paper analyzes how the 2001 U.S. federal funding restrictions influenced the quantity and geography of peer-reviewed journal publications on hESC. The primary finding is that the 2001 policy did not have a significant aggregate effect on hESC research in the U.S. After a brief lag in early 2000s, U.S. hESC research maintained pace with other areas of stem cell and genetic research. The policy had several other consequences. First, it was tied to increased hESC research funding within the U.S. at the state level, leading to concentration of related activities in a relatively small number of states. Second, it stimulated increased collaborative research between US-based scientists and those in countries with flexible policies toward hESC research (including Canada, the U.K., Israel, China, Spain, and South Korea). Third, it encouraged independent hESC research in countries without restrictions.

Declaration on mental health in Africa: moving to implementation.

Urgent action is needed to address mental health issues globally. In Africa, where mental health disorders account for a huge burden of disease and disability, and where in general less than 1% of the already small health budgets are spent on these disorders, the need for action is acute and urgent. Members of the World Health Organization, including African countries, have adopted a Comprehensive Mental Health Action Plan. Africa now has an historic opportunity to improve the mental health and wellbeing of its citizens, beginning with provision of basic mental health services and development of national mental health strategic plans (roadmaps). There is need to integrate mental health into primary health care and address stigma and violations of human rights. We advocate for inclusion of mental health into the post-2015 Sustainable Development Goals, and for the convening of a special UN General Assembly High Level Meeting on Mental Health within three years.

A survey of international legal instruments to examine their effectiveness in improving global health and in realizing health rights.

Many global health issues, almost by definition, do not recognize state borders and therefore require bi-lateral, or more often multi-lateral international solutions. These latter solutions are articulated in international instruments (declarations, conventions, treaties, constitutions of international bodies, etc). However, the gap between formal adoption of such instruments by signatory states and substantive implementation of the articulated solutions can be very wide. This paper surveys a selection of international legal instruments, including those where the sought after positive outcomes have been achieved, and those that have been ineffective, with little or no real progress being made. The paper looks for commonalities, both in the nature of the problems and the forms of the international legal instruments, to seek answers as to why some instruments ultimately succeeded where others failed. It also provides some guidance to law/ treaty makers to help ensure that they frame future instruments in such a way as to maximize the probability that those instruments will have a substantive positive impact on global health and health rights.

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.

Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries. This paper seeks to fill the gap in research on emerging markets by analyzing factors that influence innovative activity in the indigenous biopharmaceutical sectors of China, India, Brazil, and South Africa. Using qualitative research methodologies, this paper a) shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b) identifies common challenges that indigenous entrepreneurs face, c) highlights the key role played by the state, and d) reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration. It suggests that biopharmaceutical innovators in emerging markets are capitalizing on opportunities to participate in the drug development value chain and thus developing capabilities and relationships for competing globally both with and against established companies headquartered in developed countries.

Stakeholder involvement in expensive drug recommendation decisions: an international perspective.

OBJECTIVES: To describe stakeholder involvement in the priority setting and appeals processes across five drug reimbursement recommendation committees. METHODS: We conducted qualitative case studies of how five independent drug advisory committees from Canada, Israel, England and Wales, Australia, and the USA made funding decisions for six expensive drugs. Interviews with 48 informants were conducted with committee members, patient groups, and industry representatives. RESULTS: Different stakeholders were allowed, in varying degrees, to participate in the formal mechanisms for revisions and appeals of decisions. Participants identified a number of stakeholder groups who were already involved in the process, as well as stakeholders whom they believed should be included in the decision-making process. CONCLUSIONS: A central component of a legitimate and fair priority setting process is to make priority setting explicit and to involve both pertinent values and stakeholders in decision-making. Study participants believed that the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes would contribute to a fair and legitimate drug reimbursement process.

Incentives for organ donation: proposed standards for an internationally acceptable system.

Incentives for organ donation, currently prohibited in most countries, may increase donation and save lives. Discussion of incentives has focused on two areas: (1) whether or not there are ethical principles that justify the current prohibition and (2) whether incentives would do more good than harm. We herein address the second concern and propose for discussion standards and guidelines for an acceptable system of incentives for donation. We believe that if systems based on these guidelines were developed, harms would be no greater than those to today's conventional donors. Ultimately, until there are trials of incentives, the question of benefits and harms cannot be satisfactorily answered.