Health Breaking News 314

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News 314

 

Why the Universal Declaration of Human Rights is still relevant, 70 years on 

How can the UN become a Thought Leader again? 

‘Transitioning from Global Fund Grants to Domestic Funds: a New Opportunity for Strengthening Health Products’ Procurement and Supply Chain Systems in Middle Income Countries?’ by Barbara Milani 

Tanzania is first African country to reach an important milestone in the regulation of medicines 

Could The Latest In Medical Treatment Be… A Roof? Medicaid Says Maybe 

Moving Work On Social Determinants Of Health From Health Funders To Health Funder Partnerships 

Journal of Public Health Volume 40, Issue suppl_2, December 2018 

Experts Call For Global Accountability Mechanism For Access To Essential Medicines 

A global accountability mechanism for access to essential medicines 

Pharma and medical device lobbies stonewall on transparency as doctors and patients call for fines on companies hiding clinical trial results 

OECD Report Presents Policies To Balance Innovation With Access To Medicines 

Latest numbers of DRC Ebola as of 12 December 2018 

Country-owned strategies to fight malaria 

So Close, Yet So Far: Why is HIV/AIDS Funding Decreasing? 

It is not our fault”: the plight of HIV positive adolescents in Cameroon – What difference can compassionate care make to HIV care for adolescents in LMICs? 

Vaccines in the fight against AMR and access by vulnerable groups 

Fostering synergies and strengthening joint efforts to fight AMR 

The role of specialist nurses in the fight against AMR 

Hospital pharmacists in the frontline against AMR 

EMSA’s View on Antimicrobial Resistance 

Medical students taking action on AMR 

How the new CAP can support the reduction in use of farm antibiotics 

Human rights in 2018 – ten issues that made headlines 

Rethinking global poverty reduction in 2019 

Associations between sex work laws and sex workers’ health: A systematic review and meta-analysis of quantitative and qualitative studies 

Nearly 30 million sick and premature newborns in dire need of treatment every year 

The Global Compact on Migration: Dead on arrival? 

163 states just approved the Global Compact for Migration. Now what? 

Indigenous IP And Climate Change Subject Of New Book 

No One Solution: A Climate Prize Hopes to Plant Many Seeds 

The most important country for the global climate no one is talking about 

Scientists decry lack of data on ocean pollution 

Two of 196 signatory countries to Paris Agreement have raised their climate ambitions

Transitioning from Global Fund Grants to Domestic Funds in Middle Income Countries

Preparing the transition of Middle Income Countries from Global Fund to domestic funds may provide new opportunities to strengthen procurement and supply chain management areas.  Reforming health products’ procurement procedures, price policies, domestic financial flows and national quality assurance procedures are likely to represent needed steps to capitalize on Global Fund supported health procurement. This will require renovated country ownership and a central role for WHO to implement efficiently collaborative regulatory projects

By Barbara Milani

Independent Consultant, Pharmaceuticals and Public Health – Programme & Policy Specialist

Transitioning from Global Fund Grants to Domestic Funds

A New Opportunity for Strengthening Health Products’ Procurement and Supply Chain Systems in Middle Income Countries?

 

The Global Fund financing model started off with unprecedented central ownership placed at national level for procuring quality assured health products at competitive prices. At the same time, by establishing clear procurement and supply chain management  (PSM) policies it has created a global market for quality assured medicines prequalified by WHO and/or registered by Stringent Regulatory Authorities. (1) Among the several requirements that the Global Fund placed on country systems, quality control of medicines has motivated several countries to strengthen national Quality Control laboratories to obtain WHO accreditation.

The Global Fund procurement policies embraced a much larger field of opportunities to strengthen health product management systems at the national level; either strategically building through disease specific grants or using Health System Strengthening dedicated grants. Many countries were supported to meet the most urgent needs such as central storage facilities and distribution systems meeting WHO Good Storage and Distribution Practices. Much of the potential to strengthen PSM remained underused due to weak proposal conceptualization. A 2017 Global Fund systematic analysis using a sample of 15 countries clearly recognized that supply chain management remains a major challenge. (2) Technical assistance is still required in several countries for quantification and procurement planning.  As reported by several organizations, risks of stock-outs and actual stock-outs are not unusual and technical assistance is often called in on an emergency level to solve or mitigate these risks.  (3) (4)

In the wider context of all Global Fund supported countries, the challenges raised for an unplanned transition are understandable. (3) (4) The positive element is that the Global Fund has set policy and guidance for co-financing and transition learning from the first experiences on transition. (5) (6) The policy reassures on the fact that the transition process has to be prepared and evaluated before enacting the actual transition.

There are countries for which the Global Fund contribution constitutes only a minimal fraction of the national programme operating budget (20% or less). However, this contribution can be vital for several reasons. In many cases the Global Fund contribution covers key activities that the national health system is currently unable to absorb. These activities range from community approaches addressing the epidemics in the most vulnerable and difficult to reach populations to the procurement of specific categories of health products.

De facto, the Global Fund systems have allowed countries to procure quality assured medicines even in small quantities through international procurement mechanisms bypassing price-related or government procedural limitations. In other instances, the Global Fund has mandated procurement of specific health products through certain channels. According to Global Fund policies, second line anti-tuberculosis medicines shall be procured through the Global Drug Facility, a United Nations-based  procurement agency which is pooling demand and consolidating a market for quality assured medicines for less than half a million patients per year globally.

In preparing the transition of Middle Income Countries, there are opportunities to strengthen PSM areas, which have been neglected during the rollout of grants. There is also an unprecedented possibility to prepare the transition in ways that support countries to reform their laws, regulations and procedures to procure and supply health products using modalities that meet WHO standards and obtain the “best value for money”. More specifically, domestic procurement of quality assured health products at competitive or internationally negotiated prices requires that government procurement procedures be reformed and adapted. These, among other aspects, shall enable timely procurement of health products, which are single/limited source or required in small quantities or for which internationally negotiated prices are available. These categories of products require distinct procurement methods beyond national tendering processes.  Assessing the current status of government procurement procedures for health products seems a starting point for preparing a step-wise transition. Reforming national procurement procedures for health products requires conceptualization and time.  Such processes are indeed framed within the legislative system of the country. (6)

Price policies should also be evaluated and reviewed. Especially in Middle Income Countries, price policies shall favour all measures to access quality assured health products at the most affordable price. These include among various interventions, mechanisms for procurement of health products at internationally negotiated prices as discussed above, but also training to enhance knowledge, reform and use of TRIPS flexibilities included in national laws. (6)

Another crucial aspect is the quality assurance of medicines and other health products. This requires major involvement and a renovated role of the World Health Organization to make use, expand and evaluate the WHO collaborative projects aimed at facilitating registration of quality assured medicines at the national level. (7) While the Global Fund has mandated quality standards for health products procured with its funds, the transition may result in procurement of locally registered medicines without recognition of the nearly two decades of work to expand access to generic affordable medicines through the WHO prequalification programme. (1) (3) (4) National disease programmes, through the implementation of Global Fund procurement procedures, have generally acquired the concept of quality assured medicines and its link with treatment’s efficacy and prevention of drug resistance. This may not be the case for unstructured and understaffed National Regulatory Agencies. Hence the need for WHO to offer, engage and measure participation in the WHO collaborative registration project seems the only way to interface with governments. Until now, the collaborative procedures for accelerated registration for medicines prequalified by WHO and registered by Stringent Regulatory Agencies (SRA) have been largely underused by the participating countries. Effective collaborative procedures to facilitate registration of quality assured medicines are very much needed. Countries preparing for a transition from Global Fund grant shall engage in such collaborative procedures.

Secondly, the Global Fund financing is often used to overcome limitations in procurement due to unreliable flow of domestic funds. In preparing for a transition, the domestic financial procedures need to be reviewed to enable reliable national procurement planning. Financial engagement and disbursement for health products shall be framed to allow the regular launch of national procurement processes and suppliers contracting.  Irregular availability of funds is detrimental to procurement planning, may discourage suppliers to apply for national tenders also for health products required in considerable quantities. Irregular financial flow makes any health products quantification and procurement planning exercise ineffective.

While several elements come into play to ensure an uninterrupted supply of essential health products to patients, it is important to highlight key elements that are likely to come up for any Middle Income Country transition.  Addressing the suitability of national health product procedures, price policies, quality assurance systems and domestic financial procedures shall be at the core of discussion. Moving in this direction requires renovated country ownership to make the best use of this opportunity to improve efficiency throughout the whole health system as well as a renovated role of WHO to address shortfalls in the functioning of National Regulatory Agencies.

 

References

1 -Guide to Global Fund Policies on Procurement and Supply Management of Health Products, July 2017 Geneva,  Switzerland

https://www.theglobalfund.org/media/5873/psm_procurementsupplymanagement_guidelines_en.pdf

2 -Audit Report :The Global Fund’s In-country Supply Chain Processes, GF-OIG-17-008, 28 April 2017, Geneva, Switzerland

https://www.theglobalfund.org/media/6363/oig_gf-oig-17-008_report_en.pdf?u=636727911240000000

3 -Article: Transitioning in the context of universal health coverage: Reflections from STOPAIDS and partners event at World Health Assembly 71, Jenny Vaughan, 11th June 2018

https://stopaids.org.uk/2018/06/11/transitioning-in-the-context-of-universal-health-coverage-reflections-from-stopaids-and-partners-event-at-world-health-assembly-71/

4 -MSF calls on Global Fund Board to make urgent changes to prevent drug stock-outs and quality issues, Geneva, 13 November 2018

https://msfaccess.org/hundreds-thousands-peoples-treatment-risk-countries-transition-global-fund-support?tid=3Transitioning and co-

5 -The Global Fund Sustainability, Transition and Co-financing Policy, 35th Board Meeting, GF/B35/04 – Revision 1 Board Decision

https://www.theglobalfund.org/media/4221/bm35_04-sustainabilitytransitionandcofinancing_policy_en.pdf

6 -Guidance Note: Sustainability, Transition and Co-financing of programs supported by the Global Fund, 13 January 2017

https://www.theglobalfund.org/media/5648/core_sustainabilityandtransition_guidancenote_en.pdf

7 -Website : Prequalification of medicines: Collaborative Procedure for Accelerated Registration

https://extranet.who.int/prequal/content/collaborative-procedure-accelerated-registration

 

 

 

 

 

Health Breaking News 313

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News 313

 

Unhealthy conditions: IMF loan conditionality and its impact on health financing 

The problem with Public-Private Partnerships and the role of the EU 

CGD UPCOMING SEMINAR: Disrupting Health Product Distribution: The Emergence of Digital Innovators in Africa THURSDAY, DECEMBER 13, 2018 – 12:00PM TO 1:30PM 

International symposium on understanding the double burden of malnutrition for effective interventions 10 – 13 December 2018 IAEA Headquarters, Vienna, Austria 

WHO says spread of polio remains international health emergency 

The President’s Malaria Initiative and Other U.S. Government Global Malaria Efforts 

Congo Ebola outbreak is 2nd largest, 2nd deadliest 

DRC Ebola: Latest numbers as of 4 December 2018 

Are we on the cusp of a breakthrough in Ebola treatment? 

Measles cases spike globally due to gaps in vaccination coverage 

On World AIDS Day, a Moment for Celebration and Self-Reflection 

MPP: Accelerating access to treatment for children with HIV must be a public health priority 

The right to deworming: The case for girls and women of reproductive age 

‘Antimicrobial Resistance Knows No Boundaries’ 

First-ever UN report on disability and development, illustrates inclusion gaps 

The crisis of multilateralism and the future of humanitarian action 

Over 40 million people still victims of slavery 

Human Rights Reader 467 

Amit Sengupta (1958 to 2018) was a powerful voice for health equity 

UNPO Khmer-Krom Newsletter #2, November-December 2018 

No decline in discrimination against people of African descent in EU 

Ten harmful beliefs that perpetuate violence against women and girls 

Medicines Law & Policy: The TRIPS Flexibilities Database 

Putting People’s Health First: Improving Access to Medicines in Europe 

Amgen Cuts Repatha’s Price By 60 Percent. Will Value-Based Pricing Support Value-based Patient Access? 

Study Finds Arthritis Drug Enbrel Overpatented, Overpriced in US 

French health groups challenge public funders INSERM and CNRS over unreported clinical trials 

Research into medical devices needs to be made transparent – statement by TranspariMED  

In Yemen, Lavish Meals for Few, Starvation for Many and a Dilemma for Reporters 

The future of the sweetened beverages tax in Portugal 

World is woefully short of 2 degree goal for climate change, according to UN report 

World Bank Group to Raise $200 Billion to Fight Climate Change 

Pollution by the numbers 

Legal tweak could wreck Amazon forest 

Health Breaking News 312

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News 312

In memory of the generous public health activist Dr Amit Sengupta, keen fighter of inequalities and humanitarian who always championed the weak and disadvantaged

 

An Irreparable Loss for the Broader Health Movement Globally and in India: People’s Health Movement’s tribute to Dr Amit Sengupta 

“One of the strongest pillars”: Dr Amit Sengupta, a leader of the public health movement, dies at 60 

The G20 Tango: What to Expect From the Buenos Aires Summit 

What to Watch at the UN Climate Talks 

Yes, climate change is a humanitarian issue 

China vows to improve action on climate change as it prepares for UN summit 

Making finance flows consistent with Paris objectives 6 December 2018 16:45 – 18:15 GMT +1 (CEST) Public event Bieszczady Room, COP24, Katowice 

In Nairobi, a landmark push for a global blue economy 

‘Lifestyle Drift’, Air Pollution and the World Health Organization by Ted Schrecker 

The European Alliance for Responsible R&D and Affordable Medicines: Manifesto European Elections 2019 /Nov 2018 ‘Putting People’s Health First: Improving Access to Medicines in Europe’ 

PHA4: Austerity measures are the biggest impediment to access to healthcare

Next Commission needs a vice-president for health, campaigners say 

WHO Africa’s Third Forum on health systems strengthening for UHC and the SDGs 

ROM TDR PARTNER, PROVIDED AS INFORMATION FOR SHARING: WHO Africa Innovation Challenge Promoting African Solutions for Africa’s Health. Deadline for submission: Monday 10 December 2018 at midnight (GMT+1) 

How Could Africa Be Affected by Product-specific Support for Farm Goods? 

‘No country is untouched’: Global Nutrition Report highlights compounding malnutrition 

Human Rights Reader 466 

UK pledges £50m to help end FGM in Africa 

UN Committee Adopts ‘Landmark’ Declaration Reinforcing Peasants’ Rights To Seeds 

Why the HIV epidemic is not over 

Pharmaceutical corporations failing children with HIV 

Silent Epidemic: a call to action against child tuberculosis 

Antibiotics resistance breaks global boundaries 

Malaria control campaign launched in Democratic Republic of the Congo to save lives and aid Ebola response 

Democratic Republic of the Congo begins first-ever multi-drug Ebola trial 

DRC Ebola: Latest numbers as of 27 November 2018 

From recognition to action: A strategic approach to foster sustainable collaborations for rabies elimination 

Relationships between intensity, duration, cumulative dose, and timing of smoking with age at menopause: A pooled analysis of individual data from 17 observational studies 

Are Other Countries to Blame for High US Drug Prices? 

Prescription for Change: The Pharma Giant Investing in Local Public School Students 

Thousands of European clinical trials are missing results. Here’s what advocacy groups can do to fix that 

‘Lifestyle Drift’, Air Pollution and the World Health Organization

The solution to pollution is to hold you children up out of the car exhausts?  Try exercising in less polluted areas?  (If you live in London, maybe drive to Somerset for your jog?)  One couldn’t make this stuff up

By Ted Schrecker

Professor of Global Health Policy, Newcastle University

‘Lifestyle Drift’, Air Pollution and the World Health Organization

 

In 2013 the International Association for Research on Cancer (IARC), WHO’s normally cautious cancer research arm, announced that it considers outdoor air pollution a Category 1 carcinogen – that is, the category for which evidence of cancer-causing properties is strongest.   (The full background monograph is available here.)  This turned out to be one of the most under-reported global health news stories of the new Millennium – like the estimate, the following year, that WHO considered air pollution responsible for shortening the lives of seven million people worldwide.

In 2016, a team of WHO researchers led by Annette Prüss-Ustün updated earlier estimates of the proportion of the global disease burden attributable to the environment, concluding that 23 percent of global deaths and 22 percent of global disability adjusted life years were attributable to environmental risks, although obviously only part of this toll reflects the impact of air pollution.  (I’m happy to say that we published a summary of this work in the Journal of Public Health.)  Importantly, the authors made the point that environmental risks are not primarily a problem of poor countries, or poor people: ‘The lower people’s socioeconomic status the more likely they are to be exposed to environmental risks, such as chemicals, air pollution and poor housing, water, sanitation and hygiene.’  This is certainly true of air pollution, with the highest annual mean concentrations of fine particulate matter occurring in low- and middle-income countries, and the highest urban concentrations of those particulates occurring in Indian cities, with high concentrations also observed in cities like Bamenda, Cameroon and Kampala, Uganda.

WHO now appears to be taking air pollution much more seriously.  Unfortunately, its approach reflects the individualized, behavioural approach taken by the organization to noncommunicable diseases as a whole, as this screenshot from its website shows:

The solution to pollution is to hold you children up out of the car exhausts?  Try exercising in less polluted areas?  (If you live in London, maybe drive to Somerset for your jog?)  One couldn’t make this stuff up.

This posting also appears on Prof. Schrecker’s blog ‘Health as if Everybody Counted

Health Breaking News 311

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News 311

 

What happens when development cooperation becomes development competition 

Fran Baum: Why the 4th People’s Health Assembly is an important event for global health equity 

PHA4: Health assembly calls for people’s lives above profit 

Medicare For All: Sounds Good, But What Does It Mean? 

No More Lip Service; It’s Time We Fixed Primary Care (Part One) 

No More Lip Service; It’s Time We Fixed Primary Care (Part Two) 

Roadblocks ahead on the WHO Roadmap on Access to Medicines and Vaccines? 

Will Ever WHO’s Roadmap for Medicines Move into Action? The Threat of Neoliberal Polices, Corporate Interests Collusion by Daniele Dionisio

One trend in access to medicines may be cause for concern 

The Bumpy Road To Selection Patents In India 

Ethics violations and research waste widespread at German medical universities – new study 

The UK is Finally Cracking Down on Unreported Clinical Trials. Now Other European Countries Must Take Action Too by Till Bruckner 

TB, NCDs, and the Lessons of HIV 

North and South Korea team up to tackle TB and malaria  

World Malaria Report 2018: 3 critical questions 

WHO and partners launch new country-led response to put stalled malaria control efforts back on track 

DRC Ebola: latest numbers as of 20 November 2018 

Congo health workers face violence as Ebola virus spreads 

Ebola In The DRC Is More About The DRC Than It Is About Ebola 

Outbreak: Ebola spreads to Congolese city of 1.2 million sparking containment fears 

The Ugandan communities a border away from Ebola 

Social Capital Formation in the West African Ebola Pandemic: Tapping Faith-Community Trust Reserves is an Essential Tactical Strategy in Outbreak Control by Richard A. Nisbett, E Julu Swen, M. Scott Gilpin 

European Medicines Agency recommends fexinidazole, the first all-oral treatment for sleeping sickness 

NEWER, SIMPLER TREATMENTS FOR SLEEPING SICKNESS 

Hundreds of thousands of children set to be protected against the leading cause of pneumonia in Haiti  

Child rights: the right approach for governments to protect children from harmful marketing 

Billionaires vs. Poverty: Behind a Push to Use Data to Boost Economic Opportunity in Cities 

Food grains rot in India while millions live with empty stomachs 

Yemen crisis: 85,000 children ‘dead from malnutrition’  

Tracking and lifting donor nutrition funding 

5 Ways the G20 Can Support Climate Action and Sustainable Development 

‘Lifestyle drift,’ air pollution and the World Health Organization 

 

The UK is Finally Cracking Down on Unreported Clinical Trials

The medical research community has known about the problem of missing clinical trials for decades. However, across Europe, there has been very little tangible progress on the issue. Relevantly, a just released British initiative, as reported in this article, could serve as ‘take-home’ message and pave the way for medical researchers, doctors and patients in Italy and other European countries to speak up and demand that politicians, funding agencies and other public institutions take action to finally resolve this problem

By Till Bruckner, PhD

 Founder of TranspariMED

 An Initiative that Works to End Evidence Distortion in Medicine

The UK is Finally Cracking Down on Unreported Clinical Trials

Now Other European Countries Must Take Action Too

 

On 30 October, a British parliamentary committee released a report calling on the government to launch a “national audit programme of clinical trials transparency” and impose sanctions on institutions and individuals who fail to register trials or report their results. If adopted by the government, the committee’s recommendations will ensure that every single clinical trial conducted within the UK is registered and publishes its results.

European countries can learn a lot from the British example.

While the UK government has yet to issue a formal response, the report has already had a strong impact on universities and other public institutions in the country. Several universities have begun reviewing their policies and processes, and in some cases are systematically uploading all missing results onto trial registries. Some National Health Service Trusts are reportedly also starting to review their trial registry entries.

The committee proposed using records by the UK’s Research Ethics Committees to check whether trials have been registered and reported. As ethics approval is required to run any clinical trial in the UK, ethics approval documents capture each and every trial conducted within the country. The Health Research Authority in London already centrally collects all ethics approval documents, so the audit programme would not impose additional costs or bureaucracy on trial sponsors or investigators.

In addition, the committee proposed changing the law so that fines can be imposed on pharma companies, universities and public bodies that fail to post trial results onto trial registries. The Health Research Authority has already declared its willingness to impose sanctions.

The cost of the programme is estimated to be a maximum of £2.4 million per year – a tiny amount compared to the £424 million the National Health Service misspent on Tamiflu before data from eight previously hidden trials showed the drug to be essentially useless. (Other estimates put the programme’s cost as low as £150,000.) As the committee noted, “this is a small price to pay compared with the sums of money involved in policy decisions that draw on clinical trials evidence”.

Compared to the UK, other European countries are still lagging far behind in clinical trial transparency. According to data aggregated by the EU Trials Tracker, an online tool, European universities in particular have a terrible track record at posting trial results onto EudraCT, the European trial registry. A full 89% of trials sponsored by European universities are currently missing results there.

For example, Agostino Gemelli University Polyclinic, Vita-Salute San Raffaele University, and even the Istituto di Richerche Farmacologiche Mario Negri have not posted a single trial result.

Some observers assume that the problem will be resolved when the EU Clinical Trials Regulation comes into force in late 2019 or early 2020. Sadly, this assumption is mistaken. While the regulation will require all trial sponsors to post the results of some trials onto EudraCT within 12 months of trial completion (6 months for paediatric trials), there are two important caveats.

First, enforcement of the regulation will be the responsibility of individual EU member states. I am not aware of any member state that is currently preparing to impose fines once the regulation comes into force. Unless these changes, the regulation will remain a toothless paper tiger.

Second, the regulation only covers a minority of clinical trials, so-called ‘CTIMPs’. Most trials conducted in Europe – including all trials of medical devices, non-drug treatments, and Phase IV trials – are not CTIMPs, and are therefore not covered by the regulation (note that these trials cannot be registered on EudraCT and are thus often listed on other registries such as Clinicaltrials.gov.). So even if member states enforce the regulation, the results of many trials of great importance to patients, clinicians, and public health institutions are likely to remain invisible.

So what can medical researchers in Italy and other European countries do? Below are three simple steps.

  1. Talk publicly about this problem, and how it can be fixed

The debate around hidden clinical trials is far more advanced in the UK than in other European countries. This is not a coincidence. Dr Ben Goldacre, a campaigning doctor, has worked tirelessly for years to bring the issue to the attention of British policy makers and the public. Thanks to his efforts, research funders, universities, and even companies based in the UK routinely top global transparency rankings. In addition, we now know how to fix this problem: we need effective national monitoring plus real sanctions.

  1. Ask politicians to stop wasting public money

Policy makers are extremely busy and may struggle to understand how missing clinical trials affect systematic reviews and meta-analyses, and why that matters. Ethical arguments too can fail to resonate. In contrast, when you point out that public money is being spent on medical research that does not report results, and that this money is being completely wasted, policy makers start to listen. Requiring all clinical trials to post their results onto registries within 12 months is a common-sense solution that can improve public health at virtually no cost – an attractive message for political leaders.

  1. Challenge public institutions to curb research waste

National laws should require all trial sponsors to post their results. However, new laws can take a long time to draft, adopt and enforce. In the meantime, strong impact can also be achieved by insisting that medical research funders ensure that all clinical trials supported by tax money post their results within 12 months. For example, the Italian Ministry of Health has not yet signed up to World Health Organization best practices in trial transparency. It should be encouraged to immediately do so. Equally, universities and public institutions should be publicly challenged on their trial reporting performance and be encouraged to fix the problem. The EU Trials Tracker makes it easy to discover who is posting their trial results – and who is not.

The medical research community has known about the problem of missing clinical trials for decades. However, across Europe, there has been very little tangible progress on the issue. It is high time for medical researchers, doctors and patients in Italy and other European countries to speak up and demand that politicians, funding agencies and other public institutions take action to finally resolve this problem.

 

By the same Author on PEAH

tillbruckner@gmail.com

Waste in Medical Research Threatens SDG Health Targets

 

 

 

Tapping Faith-Community Trust Reserves as a Tactical Strategy in Ebola Pandemic Control

Ebola viral disease requires community engagement by multisectoral alliances. During the West African pandemic of 2014-2016, we disseminated 35,000 culturally-appropriate booklets to faith communities in Liberia and adjacent countries. Local pastors, teachers and clinicians used them to promote health awareness and prevention. Booklets were shared with other faith communities. Revised booklets were shared in the 2018 Equateur outbreak in the Democratic Republic of the Congo. Here, we describe our approach and advocate for the inclusion of faith communities in public-health emergencies.  Inclusion interpolates public-health perspectives into faith communities and helps achieve our common goal of health equity

By Richard A. Nisbetta,1, E Julu Swenb, and M. Scott Gilpinc

a,1 University of Liberia-PIRE Center Africa, ranisbett@gmail.com  Corresponding author

b Discipleship Resources International of the United Methodist Church, Liberia juluswen004@gmail.com

c Wesley College and Foundation, Tanzania sgilpin@wesleycollegetz.com

Social Capital Formation in the West African Ebola Pandemic: Tapping Faith-Community Trust Reserves is an Essential Tactical Strategy in Outbreak Control

 

Ebola viral disease (EVD) is the quintessential infectious disease of poverty. It thrives where impoverished humans and animal hosts co-exist in close-quartered, resource-poor settings. It exploits the lack of modern hygiene, the absence of clinical protective barriers, and the compassion of caregivers. Community mobilization plays a pivotal role in EVD control.1  The 2018 Equateur outbreak in the Democratic Republic of Congo (DRC) began in early May. Media sources purport that EVD victims have left clinical quarantine and taken flight to faith communities, and otherwise sought prayers and healing from faith leaders.2

The West African Ebola Epidemic of 2014-2016 sickened more than 28,000 and took the lives of over 11,000 persons, with 11,000 cases and 4800 deaths in Liberia. Near the beginning of that epidemic, the Liberian Council of Churches proclaimed that the Ebola “plague” was a punishment from God for corruption and immoral acts (homosexualism [sic]) and called for prayer, fasting and repentance.3 Here, we review our efforts and the lessons learned from walking alongside the Liberian United Methodist Church (UMC) to inform national leadership, to conduct educational outreach, and to disseminate printed materials—grounded in an ecumenical ethos—among various national and transboundary faith communities. Our experience offers a pathway for incorporating frontline faith leaders of any religion into prevention and control efforts in any society, thereby aligning the goals of those partners seeking health equity.

The United Methodist Church (UMC) in Liberia has around 600 churches, 1,000 clergy and 240,000 congregants in the 15 Liberian counties. Moreover, there are about 16,000 students in UMC primary and secondary schools, 4,000 in United Methodist University, and the UMC operates a national acute care hospital along with primary care clinics in its 22 administrative districts.  To reach these end-users, we developed a booklet covering the natural history of EVD, previous outbreaks, symptoms, transmission and prevention.4  It contained a section of frequently-asked questions regarding transmission, prevention, and protection and was aimed at a general audience in a high-context society, utilizing local idioms and analogies. The UMC Liberia Publishing Team printed 6,000 booklets. Along with emergency food and hygiene supplies, the booklets were distributed in each of the 22 administrative districts around the country with larger allotments to those districts with more churches and clinics, and/or higher school enrollment. It was used in personal conversations, pastoral counseling, meetings with church groups/health committees, congregation-wide training and informational sessions, and in community-wide meetings sponsored by local churches, schools and clinics.

The booklets were shared with other faith communities including Baptists, Catholics and Muslims. Copies were distributed to Methodist partners in Sierra Leone and 30,000 copies printed in French were distributed to Francophone populations in Guinea, Cote d’Ivoire, Senegal, Nigeria, and Cameroon.  The French version was revised, and 5,000 copies tribute in the DRC by UMC partners in 2018.

cover of the French version of the Ebola handbook discussed in the article

The advent of the West African EVD outbreak was marked by rumors, misinformation and fear-of-the-unknown. The booklet was disseminated when fear thrust faith leaders into health-leadership roles because government messaging was neither helpful nor hopeful. Official government communications were interpreted by locals as “There is no cure; don’t touch anyone or be intimate.” Naturally, the booklets were embraced, offering knowledge for empowerment and informed decision-making, and, most importantly, hope. As the booklets were deployed and re-supplied, those who had seen and used the booklets commented, in the aggregate, that it was “written in clear, simple style,” “easily understood,” was “devoured like it was hotcakes,” “answered our questions,” would have a “lasting role for teaching” and an “enduring impact” on church and society.

Madon et al. 5 aptly described the challenges that poverty poses for global-health implementation science as “a bewildering constellation of social constraints and health threats.” Globally, faith communities are seldom absent where poverty flourishes and faith leaders are often well positioned to act as cultural mediators. Faith leaders have high literacy and numeracy and sustaining commitments to service and provision of care. For example, during the EVD timeframe, members of our team conducted a health-oriented roundtable at a Nairobi, Kenya conference of 18 academicians representing the dozen Methodist theology schools in Africa. The unanimous sentiment was that health was not only a salient development issue for their clergy but also a vital part of their ministry and pastoral care duties. They expressed the desire for more information and training and recognized the need to work closely with public health and clinical partners in the provision of care, prevention and control.

In seeking to treat, prevent and control the infectious diseases of poverty, we must cultivate cultural competence and promote multi-stakeholder alliances; moreover, we must engage and empower faith leaders by including them in program design prior to, or at worst, at the very beginning of, health emergencies. Global-health practitioners in resource-constrained settings characterized by high medical and religious plurality must recognize that faith leaders are critical stakeholders who should be integrated into partnerships and should take an intersectoral and ecumenical approach to health care delivery, surveillance, prevention design and control activities. Though faith leaders are often quarantined, the fact remains that in the face of palpable fear and uncertainty, for people to take refuge in and recourse among their faith communities is both highly rational and predictable. As Oly Ilunga Kalenga, The DRC Minister of Health, wrote once the Equateur outbreak had been officially declared contained in late July 2018: “Church and traditional leaders are your best allies to carry public health messages that require communities to change age-old habits and challenge their traditions.” 6

Frontlines practice requires an expansive, inclusive perspective on medical cosmology, community dynamics, leadership structures, and the role of faith leaders as natural helpers. Best-practices public health offers preferential options for the poor.7  Frontlines practice facilitates social capital formation. When we align with the priorities of faith communities, we not only tap into their trust reserve of social capital as collateral but also we introduce public health perspectives into faith communities which enhances prospects for our shared goal of health equity.

Authors’ Statements and Declarations

RAN, the corresponding author, wrote the booklet and prepared the first and final drafts of the manuscript. EJS edited the booklet and oversaw Liberian printing and distribution and edited the submission. MSG coordinated the fund raising, oversaw USA printing of the booklets, arranged shipment and distribution to partners in other African countries, and edited the submission. All authors read and approved the final manuscript and are guarantors of the paper.

Acknowledgements

We’d like to thank active partners Dr. Sten Vermund, then Director of the Institute for Global Health at Vanderbilt University School of Medicine, and now Dean of the Yale University School of Public Health; Rev. Dr. John Innis, then Bishop of the Liberian Annual Conference (LAC) of the United Methodist Church (UMC) and now retired; Dr. Steve Bryant and Robin Pippin of the UMC Discipleship Ministries; and Dr. Amos Nascimentos of the UMC General Board on Higher Education and Ministry. We are grateful to the donors who made possible the printing and dissemination of "The Ebola Virus Disease Fact Book" including: Canterbury United Methodist Church of Birmingham, Alabama; EBSCO Industries of Birmingham, Alabama; Heartspring Methodist Foundation of Houston, Texas; Independent Presbyterian Church Foundation of Birmingham, Alabama; and The Thompson Family Foundation of Birmingham, Alabama. Dr. Yed Esaie Angoran of the West Africa Central UMC Conference of Côte d'Ivoire, translated the English version into French and was responsible for design, layout, and distribution of the Francophone version. Finally, we wish to express heartfelt admiration to the entire LAC Leadership team, LAC educators, clergy and community members for their courageous and inspiring efforts to defy EVD in Liberia by living their faith and bridging sectoral, denominational, agency, and international boundaries. You emboldened us to walk humbly alongside you and together we left a roadmap for all those who answer the call to serve.

Authors'information

All contact information for each author is on the title page.  Also below as follows:

Richard A. Nisbett, UL-PIRE Africa Center, The University of Liberia Capitol Hill 1000 Monrovia 10, Liberia  West Africa

E Julu Swen, United Methodist Church 12th & 13th Streets, Sinkor P.O. Box 10-1010 1000 Monrovia 10, Liberia

M. Scott Gilpin Wesley College P.O. Box 7756, Mwanza, Tanzania Banda St, Mwanza, Tanzania

Funding

This work was supported by private donations. No external funding supported this publication. Donations were raised for supplies, food and printing of the booklet.

Competing Interests

The authors have no competing interests or conflicts-of-interest.

Ethical Approval

The humanitarian effort was approved by the Bishop and Executive Board of the Liberian Annual Conference of the United Methodist Church. The booklet was distributed along with food and hygiene supplies. There were no human or animal research subjects.

 

References

  1. Kennedy SB and RA Nisbett, The Ebola Epidemic: A transformative moment for global health, Bulletin World Health Organ 2015;93:2; M Fallah et al. (2018), Preventing rural to urban spread of Ebola: Lessons from Liberia, The Lancet 2018 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31435-1/fulltext?dgcid=raven_jbs_etoc_email, retrieved 25 July 2018; and P Piot and J Spencer,  From 1976 to 2018: reflections on early investigations into the Ebola virus, Transactions of The Royal Society of Tropical Medicine and Hygiene, 2018, https://doi.org/10.1093/trstmh/try088
  2. Ebola update Promed 2018:15, Case update, quarantine breaches, border controls, vaccine http://promedmail.org/post/20180524.5816349; Ebola update Promed 2018:16, Cases, DRC cultural factors, vaccine implications, case terminology http://promedmail.org/post/20180525.5817907; Ebola update Promed 2018:17, Case update, public fears, government responses http://promedmail.org/post/20180526.5820606
  3. Patheos 2014, Catholic Archbishop, https://www.patheos.com/blogs/progressivesecularhumanist/2014/10/catholic-archbishop-ebola-is-punishment-from-god-for-homosexuality/, retrieved June 8, 2018; and Daily Observer 2014, God is Angry with Liberia, https://www.liberianobserver.com/news/god-is-angry-with-liberia/ , retrieved June 8, 2018.
  4. Nisbett, RA, “Ebola Disease Facts for Community and Household Health,” Discipleship Resources International 2014 (digital copies in English and French are available from the corresponding author upon request).
  5. Madon T, KJ Hofman, L Kupfer, RI Glass (2007). Implementation Science, Science 2007 (318): 1728.
  6. Kalenga OL. We’ve halted the spread of deadly Ebola in Congo – so what went right? The Guardian 2018, https://www.theguardian.com/global-development/2018/jul/25/halted-spread-deadly-ebola-drc-oly-ilunga-kalenga?utm_source=esp&utm_medium=Email&utm_campaign=Global+Dispatch+collection&utm_term=282054&subid=12289974&CMP=poverty_matters_collection, retrieved 25 July 2018.
  7. Farmer, P, Pathologies of Power: Health, human rights and the new war on the poor. Berkeley: University of California Press, 2004; and H Saussy (ed.), Partner to the Poor: A Paul Farmer reader. Berkeley: University of California Press, 2010.

Health Breaking News 310

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Equity in Investments – a Need to Map the Research Landscape for Health

More information should be made available in equity terms to the global health community about how money invested in research for health is collectively spent and how much benefit emerges from the research itself

By  Michael Head 

Senior Research Fellow

Clinical Informatics Research Unit and Global Health Research Institute

Faculty of Medicine, University of Southampton, UK

Equity in Investments – a Need to Map the Research Landscape for Health

 

Billions of dollars are invested in health research every year, but we (the global health community) have very little idea in how that money is collectively spent and how much benefit emerges from the research.

It is, of course, important to have that data and a viewpoint on the research landscape. Knowledge of what has been funded will show the strengths within a portfolio, show where the skillsets and infrastructure lie, and where the collaborations are taking place. A description of the research landscape will also, importantly, show what hasn’t been funded. Where are the evidence gaps, and why? Is research not feasible in that setting? Does the technology not quite come up to scratch yet, but might do in five years’ time? Has no one really considered that question before and thus a key burden of disease been forgotten somewhat?

To provide some examples – in 2018 and via the Research Investments in Global Health study (ResIn), I co-authored a report covering $3 billion of pneumonia research funding across 2000-2015, awarded by funders in the G20 and EU nations.1 We showed how in sub-Saharan Africa, The Gambia was the country receiving the greatest focus for research related to pneumonia, whilst countries such as Chad and Central African Republic were involved in virtually no pneumonia research over the 16 year time-period of our dataset. However, there is certainly plenty of pneumonia in both countries.

Similarly, in 2017, we published an article in The Lancet Global Health that looked at malaria funding for both research, and for malaria control, across sub-Saharan Africa.2 Here, for both types of financing, countries across west and east Africa were clearly global health hubs and recipient of greater amounts of investment (for example, Tanzania, Uganda and Kenya), but Chad and Central African Republic were again lacking in being the focus of funding, despite these nations having a large burden of malaria-related disease.

Clearly, these two countries are very difficult to invest in. They have significant political and socio-economic difficulties, and little infrastructure or experience to do large-scale research. The answer cannot be to simply throw money at the problem. Investments must be smart, targeted, carefully thought out. I often finish my presentations with the phrase “We must invest wisely”. Our data can provide some answers in terms of quantifying the landscape and highlighting research strengths, and evidence and investment gaps. This data can then lead to conversations across a range of global health stakeholders about findings solutions (for example, small-scale in-country capacity building, or encouraging partnerships between universities in resource-poor settings with institutions in the global north). When considering the distribution of limited resources, in this case focusing on money, equity is important and we need better data to more fully consider the problem and apply solutions.

Through ResIn, we are currently working through an analysis of all infectious disease research 2000-2017. This will cover around 80 000 separate awards covering approximately $100 billion of research funding. We are likely to publish our findings in 2019, and believe that the dataset and results will be a useful resource for funders, policymakers and researchers across the globe.

 

Author

Dr Michael Head is a Senior Research Fellow based in the Clinical Informatics Research Unit and Global Health Research Institute at the Faculty of Medicine, University of Southampton, UK. He co-founded the ResIn (Research Investments in Global Health) study and has led the development of research investment analyses, presenting the study findings at WHO headquarters in Geneva, Wellcome Trust in London, and to European Commission colleagues in Brussels. He also has an interest in scabies research, and vaccines and the activity of anti-vaccination activists.

Funders

The pneumonia study was funded by the Bill & Melinda Gates Foundation, and the malaria project was funded by the Royal Society for Tropical Medicine and Hygiene.

 

References

1            Rebecca J Brown, Michael G Head. Sizing Up Pneumonia Investment. Southampton, 2018 DOI:https://doi.org/10.6084/m9.figshare.6143060.v1.

2            Head MG, Goss S, Gelister Y, et al. Global funding trends for malaria research in sub-Saharan Africa: a systematic analysis. Lancet Glob Heal 2017; published online June. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5567191/.