Health Breaking News 336

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Health Breaking News 336

 

World Health Assembly Approves Milestone Resolution On Price Transparency 

WHO Resolution 28 May 2019: Improving the transparency of markets for medicines, vaccines, and other health products 

Negotiators Agree On Game-Changing WHA Resolution For Medicine Price Disclosure 

The growing gap between what the public had been told R&D costs are, and the actual costs 

Does the political will exist to bring quality assured and affordable drugs to low- and middle income countries? 

‘You disappointed us’: Why is Canada opposing more transparency in drug prices? 

MPP Statement at the 72nd session of the World Health Assembly 

Reporting a clinical trial result on the European registry: My nightmare journey 

AMR incentives could be next big EU opportunity, pharma boss says 

Linking Vaccines And Quality: A Public Health Imperative In A Value-Based Era 

Major cholera vaccination campaign begins in North Kivu in the Democratic Republic of the Congo 

Following 110 years of neglect, an official day for Chagas disease is declared 

New Plan For Ebola Outbreak Response To Ensure Safety Of Respondents 

Aid group: Most new Ebola cases were not known contacts 

DRC Ebola: latest numbers as of 27 May 2019 

Big tobacco, global health, and the limits of shared value 

WHO: World No Tobacco Day 31 May 2019 

Poor people struggle to access cancer medicines in India 

India: extreme inequality in numbers 

As the World Health Assembly Convenes, Let’s Elevate Use of Economic Evidence on the UHC Agenda 

Budget Cuts May Undercut the U.N.’s Human Rights Committees 

Human Rights Reader 483 

The Time is Now: End Sexual and Gender-Based Violence 

For Lack of Will: Child Hunger in Africa 

‘Pick the Odd One Out: Sugar, Salt, Animal Fat, Climate Change: What Are We Teaching?’ by David Patterson 

Nobel Laureate: UN Reform Needed to Stop Climate Rule Fights 

European cities target net-zero carbon buildings by 2050 

Fossil fuel subsidies are wrecking the world, says U.N. chief 

Four energy storage projects that could transform Europe 

Water Research & Education Needs to Flow Towards Developing World 

Pick the Odd One Out: Sugar, Salt, Animal Fat, Climate Change

We can and must tackle global health and environmental challenges holistically, thus benefiting from double and triple duty actions.

Food and beverage corporations are unlikely to adopt environmentally sustainable approaches without strong government regulation. (In fact, they may vigorously oppose them.)

In democratic societies at least, governments will most likely require broad civil society support to legislate to sustainably transform the food and beverage sector. (In undemocratic countries and in countries transitioning to democracy, there is an even greater risk that corruption will weaken government resolve.)

By David Patterson

Health, Law and Development Consultants

 dpatterson@healthlawdc.com

Disclosure: From 2009 – 2018 David Patterson was senior legal expert, health, for the International Development Law Organization (IDLO). He is now a consultant with IDLO and other health, law and development organizations

 

 Pick the Odd One Out: Sugar, Salt, Animal Fat, Climate Change

 What Are We Teaching?

 

 At a recent dinner party in The Hague, my friends’ 14-year-old son told us how at school the kids mapped how much of the Netherlands will be flooded if there is inadequate action on climate change over the next few years.[1] The adult conversation faltered… and moved on. But the child’s implicit plea haunts me. In fifty years, much of this country may well not be habitable.

This year two reports from The Lancet linked food, health and climate change and offered part of the solution. The reports ‘Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems’ (‘EAT Commission report’) and ‘The Global Syndemic of Obesity, Undernutrition and Climate Change: The Lancet Commission report’ (‘Global Syndemic report’) between them recommend a fully or largely plant-based diet for most of us to improve global health and also reduce the green-house gas emissions associated with the meat industry. Importantly, the reports address the impact of current, unsustainable food systems and climate change on low- and middle-income countries. Droughts, floods and desertification caused by climate change drive up food prices and increase both under-nutrition and obesity as people shift to less nutritious, often calorie-dense foods.

The reports also identify some culprits and systemic barriers, and hence some opportunities. Crucially, the Global Syndemic report notes that many countries have failed to include environmental sustainability principles within their dietary guidelines due to pressure from strong food industry lobbies, especially the beef, dairy, sugar, and ultra-processed food and beverage industry sectors.

Yet these lobbies are corporations. Corporations are, by definition, created by law. They can be controlled, taxed, and dissolved by law. But governments won’t adequately regulate these industries without strong civil society support for tight legislative control.

Among other suggestions, the Global Syndemic report proposes an approach based on international human rights law. This move reflects the increasingly multi-disciplinary nature of the teams convened to tackle global health challenges. Similarly, a recent WHO Bulletin special issue on noncommunicable diseases (NCDs) included an article on legal capacities required in NCDs prevention and control. In April 2019 The Lancet published the report of the Lancet–O’Neill Institute Commission on Global Health and Law titled ‘The legal determinants of health: harnessing the power of law for global health and sustainable development’ (‘Global health and law report’).  Most importantly, the report is replete with observations about the essential role of civil society in advocating for government action on law reform for global health.

Drawing together the threads of these four reports from these two authoritative journals, it emerges that

  • We can and must tackle global health and environmental challenges holistically, thus benefiting from double and triple duty actions.
  • Food and beverage corporations are unlikely to adopt environmentally sustainable approaches without strong government regulation. (In fact, they may vigorously oppose them.)
  • In democratic societies at least, governments will most likely require broad civil society support to legislate to sustainably transform the food and beverage sector. (In undemocratic countries and in countries transitioning to democracy, there is an even greater risk that corruption will weaken government resolve.)

Hence we need national and global civil society movements that are informed, resourced, courageous and free to advocate for sustainable food policies, including access to accurate, accessible information to inform food choices. (For example, in many countries, industries lobby hard against ‘traffic-light labelling’ that helps people identify healthier processed food.)

The internet provides a powerful platform for social organization and advocacy, but also an almost unregulated medium to market junk food, and trace and censor dissent more effectively.

So what do we say to a 14-year-old who is questioning why he should study Latin if, in 30 years’ time, he may be a climate refugee? In November 1969, the educator Neil Postman delivered a lecture in Washington D.C. at the National Convention for the Teachers of English. He called it ‘Bullshit and the Art of  Crap-Detection.’ Postman reckoned that ‘…the best things schools can do for kids is to help them learn how to distinguish useful talk from bullshit.’

Fair advice. So, let’s stop pretending we can address climate change without transforming our diets. Let’s be straight about the profit motives of corporations, and the need for government capacity and political will to regulate them for the common good. And let’s use the common language of human rights to draw together all the civil society movements implicated in the struggle for global health, including the women’s, children’s, labour, faith, disability, indigenous, people of colour, LGBT and other groups. Above all, let’s share our vision of human and planetary health with young people over the dinner table – keeping in mind Postman’s advice!

 

——————————-

[1] For example, Delta Programme 2019, measures to adapt the Netherlands to climate change in time available at https://english.deltacommissaris.nl/news/news/2018/09/18/delta-programme-2019-measures-to-adapt-the-netherlands-to-climate-change-in-time [accessed 27 May 2019]

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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

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WHA72: Watch Live 

WHA72: Documents 

G7 Countries Prioritise Primary Health Care At Health Ministers’ Meeting In Paris 

WHO Launches Health Product Profile Directory To Stimulate New Drug Research 

Future Of Drug Pricing Resolution Hangs In Balance At World Health Assembly 

MSF response to World Health Assembly Medicine Price Transparency Resolution negotiations 

Dimitri Eynikel: Transparency Matters 

How transparency of the costs of clinical trials will improve policy making 

House Passes Legislation To Strengthen the ACA 

We Asked, You Answered: Reflections on the First Round of MVAC Feedback 

What’s in a…‘Debossed Code’? 

Allergopharma-Nexter’s transparency case in Poland deserves infographic. Who else is not afraid of transparency?

Regulatory barriers to life-saving and affordable HCV medicines can be overcome 

DRC Ebola: latest numbers as of 22 May 2019 

DRC Ebola: Still a Horrifically High Level of Nosocomial Infections by Garance Upham  

United Nations strengthens Ebola response in Democratic Republic of the Congo 

Three Big Lessons for The Next Pandemic Response 

Tackling malaria hotspots in the Amazon jungle 

Argentina and Algeria stamp out malaria in ‘historic achievement’ 

‘Unprecedented’ HIV outbreak infects hundreds of young children in Pakistan 

Schoolchildren in Cambodia fight dengue using guppy fish 

Venezuela struggles to halt measles epidemic 

Meet the champions who are moving the needle on patient and Health Care Worker Safety 

Why we are troubled by elitist inequality review 

Human Rights Reader 482 

UNAIDS Calls On Countries To Change Laws That Hinder Access To Health For LGBTI People 

Chasing Financial Health: A Top Bank’s Latest Investment in Underserved Communities 

Why Don’t Venture Capital Firms and Government Funders Co-Invest in Healthcare Technology More Often? by Dhevi Kumar 

Green Light For First-Ever WHO Strategy On Health, Environment And Climate Change 

Climate change efforts set for disappointing EU summit in June 

Microplastic pollution adds to oceans’ problems 

Why Don’t Venture Capital Firms and Government Funders Co-Invest in Healthcare Technology More Often?

Here are a few thoughts  on why venture capital firms and government funders could co-invest (and why they don't) in healthcare technology more often   

By Dhevi Kumar,  MA, MHS

Dhevi Kumar is interested in private and public sector investment in the global health space. She’s worked on public private partnerships throughout Eastern African and Haiti. She’s currently based in Seattle, Washington USA. The views expressed below are solely those of the Author

Why Don’t Venture Capital Firms and Government Funders Co-Invest in Healthcare Technology More Often?

 

Health tech has seen significant investment from the venture capital (VC) space as well as multi-million dollar government sponsored cooperative agreements. In 2018, VCs invested nearly $10.6 billion in healthcare startups. Government funded Cooperative Agreements typically issue five year awards of almost $100 million to support a host of treatment and preventive care services. Investors and funders both appear aligned in their support of emerging technologies that have the potential to make money and save lives.

And yet, venture capital firms and government funders tend not to collaborate on their investments in the healthcare technology space. In my own experience in the public-private intersection of digital health and data initiatives, I’ve often wondered why this is the case. The push towards standing up sustainable investments (products that will actually make their own money beyond their initial seed funding) aligns with both VC and philanthropic interests.

Given the shared goal of getting the most bang for the buck, it seems like entities on opposite ends of the funding spectrum would try to meet each other half way more often. Whether combined investments from public agencies and industry, or a philanthropic grant with matched investments from companies, start-ups, or even private individuals (different variations of public-private partnerships, or PPPs), the motivation to stretch a dollar/euro to get to a result faster seems like a no-brainer.

The pros of such collaborations revolve primarily around shared opportunities:

1) Mutual interest in leveraging data to improve health outcomes. Government entities hold critical access to vast datasets that startups can leverage for breakthroughs in the machine learning and artificial intelligence space.

2) Shared vision of fueling cutting edge research with an agile approach via an influx of capital; including rapid design, testing, iteration and refinement.

3) Shared investment also equals shared risk so no one entity shoulders the burden of success or failure – especially in a space where the consequences of failure could mean lives lost or threatened.

However there are also potential blockers that can threaten the success of these initiatives:

1) Government funding agencies and VC firms often have opposing timelines and metrics of success. VCs look for rapid ROI, while Government contracts look for alignment with complex policy mandates that are sometimes decades in the making.

2) Regulatory environment for healthcare technology doesn’t coincide with VC’s expectations to see ROI (return on investment) yesterday. Government grants are not typically focused on moving incubation stage ideas into go to market/commercialization phase, thus their lack of concern about sitting in stage gate approval purgatory.

3) Cultural clash. Allbirds sporting Silicon Valley players are typically not hanging out in the same circles as badge-wearing government policy wonks.  Staying in separate sandboxes leads to missed opportunities to align on goals, share resources, and just play together!

Based on my experience in the health care PPP space, my conclusion is that as a collective industry we need more venues to bring together disparate groups of investors to deliberate meaningfully on co-investment. There may be a fleeting moment where say, an MD from an established VC finds herself on the same panel as the PPP lead from USAID. It’s very likely that some shared, good intentions will be thoughtfully discussed. They may even have some overlapping examples of investments in similar geographies or technologies. But those good intentions of actually figuring out a plan to get past the known blockers to make both private and public dollars go farther fizzles out by the time each panelist is on their respective flights back to San Jose and Washington DC.

We need both VCs and federal agencies to align their funding priorities and strategies prior to fund distribution. A coordinated funding approach could lead to some great ideas getting a longer runway to try, fail, improve and actually get it right. The outcomes could mean dollars saved and increased money earned for investors in both public and private arenas.

Who’s up for talking about these potential collaborations further? I’m proposing a working group with VCs in the healthcare tech space and public sector funders to have some targeted, coordinated conversations to strategize next steps. Please reach out to me at Dhevi.Kumar@gmail.com if interested.

DRC EBOLA: Still a Horrifically High Level of Nosocomial Infections

Nosocomial transmission of Ebola still unacceptably high in the Democratic Republic of Congo, says WHO Emergency Health DG Dr Michael Ryan. 

Aware of the importance of infection prevention and control, (IPC), the WHO has decided to place IPC as a tripartite AMR - UHC - EH priority, said Ryan at a public event in Geneva.

Ryan stressed that armed attacks come from outside terror groups and that the population welcomed the international teams as shown by the high rate of vaccine acceptance 70%!

A large number of anthropologists have studied the approach of the authorities (such as the Army death camps in Sierra Leone) and question the top down approach, pointing out that better outcome in Ebola control are achieved when people are equipped with home care: bleach, boots and gloves 

By Garance Fannie Upham

Vice-President, ACdeBMR / WAAAR World Alliance Against Antibiotic Resistance
co-Editor in Chief, AMR Control 2015, 2016 and 2017
AMR Control 2018 or full book 2018
Chief Editor AMR-Times E-journal and subscription E_newsletter 

EBOLA in the Congo: Still a Horrifically High Level of Nosocomial Infections, Reports WHO HE Director

Infection Prevention and Control: Top for AMR-UHC-Health Emergencies Agenda!

The views expressed below are those of the Author and do not engage her Board or the WAAAR

 

The World Health Organization has now placed Infection Prevention and Control (IPC) as a tripartite priority which brings together the Departments of Antimicrobial Resistance (AMR), that of Universal Health Coverage (UHC) and of Health Emergencies (HE), stated Dr Mike Ryan, WHO Director for Health Emergencies, in a public event on Ebola, at the Graduate Institute on May 13th.

WHO needs be congratulated on an initiative which could save millions of babies and women every year!

We had anticipated this move by the WHO, with the choice in the creation of an ADG (Assistant Director General) for Antimicrobial Resistance, and the nomination of the fierce Dr Hanan Balkhy, a world authority on IPC and leader in her country’s fight against MERS cov, this Middle East Respiratory Syndrom coronavirus, being a major nosocomial threat, not just in Saudi Arabia but also in South Korea, the later having spent several hundred million dollars in IPC to stop the MERS outbreaks.

We could only wish international donors had spent a few millions on IPC in West Africa after the Ebola outbreak, instead of leaving the three Western States Health systems even more desolate after the 2014-15 Ebola than they were before!

Dr Ryan had shaken the WHO Executive Board (EB) with his revelations last January 28 that “86 % of Ebola cases in the town of Beni, DR Congo, were acquired nosocomially”.

Last fall, Dr Peter Salama, previous ADG HE and now moved to the UHC Department, had first spoken from Congo’s Ebola centers on the fact that poorly kept health centers were “spreading” that hemorrhagic fever disease.

We also noted with interest the coming of ECDC (European Centre for Disease Prevention and Control)’s Dr Alessandro Cassini to the WHO IPC group (under Dr Allegranzi), as Dr Cassini had been lead author of the Lancet ID article last fall pointing out that even in the EU/ Euro zone, 426 000 AMR infections were Hospital Acquired Infections.

At the Graduate Institute

The Graduate Global Health Center event, organized and chaired by the Director Michaela Told, was remarkably thought provoking.

Basically the event addressed all the right questions: what is the best way to approach a population affected with a dangerous pathogen outbreak? What are the dangers of a militarized approach? How not to play electoral politics in an epidemic situation (preventing Ebola region populations from voting, for example), if you don’t want a dangerous disease to spread further? How to engage with local populations and start from their capacities instead of sweeping down on them? Can home care work?

What can be the role of Imams and local chiefs? How the terror striking health care workers is commanded from the outside (by whom? Who provides the weapons and why?): an unanswered question.

The event started with the London School of Hygiene and Tropical Disease, Pr Susannah Mayhew, Dept for Global Health and Development; Principal Investigator, ‘Ebola Gbalo Research Project’ (conducted on the lessons to be drawn from the 2014-15 Sierra Leone Ebola outbreak). And she was accompanied with Mrs Esther Mukowa, researcher, from the Njala University of Sierra Leone and the Wageningen University (in the Netherlands).

Pr Mayhew explained how her team had mapped two districts and sought to learn from frontline responders. It was pointed out in the conversation that the first to respond are local folks, and that is also true for the RCRC, the Red Cross and Red Crescent Organisation, represented on the podium by Emanuele Capobianco, Dir. Health and Care, IFRCRCS.

Speaking of bad actions to avoid at all costs in future outbreaks, Pr Mayhew spoke of the reaction in Sierra Leone in June when, faced with a large outbreak of Ebola then, the army was sent in, set up a quarantine militarized camp and rounded up any and all person suspected of having Ebola into that death camp without any form of care, while relatives and families could deposit food and drink at the door! This made people very afraid of interventions, and made people hide the sick! While the local Chief had OKed the military move, it was clearly counter to proper behavior…”You don’t treat disease with guns!”

A rapid mobilization elsewhere with chlorine and gloves, as occurred in some places, would have been much more productive!

Recently an MSF “Rethink”, to which people referred to on the podium, also proposed a shift to more home care today in the DRC. Mrs Mukowa elaborated on that point: “Involve families, otherwise people will suspect a hidden agenda”.

Pr Michela Told, as Chair & Moderator, underlined the need to combat misinformation and violence and how the second follows the former.

The panel also referred to the sensation press, more inclined to make headlines on violence than help build information.

Pr Capobianco, as for him, focussed on the needed emphasis on “preparedness”, and outlined how different initiatives had arisen since the West Africa outbreak of 2014-15, citing the WHO World Bank Global Monitoring, headed by former WHO DG Gro H Bruntland.

He noted (and later Dr Ryan reiterated the fact) that the proof the populations are welcoming the intervening teams and not fighting them, was the high rate of Ebola vaccine acceptance, around 70%. So far 150 000 people have been vaccinated, the response has been quick, even if the number of Ebola cases is going up still.

The Red Cross, he said , intervenes mostly through the local branches and tries to include families. However, the number of Ebola cases continues to climb with the spilling into neighboring countries a near certainty, he said.
As the Ebola Gbalo group before him, Capobianco stressed that one had to move “from Community Acceptance to Community Ownership”.

Knowledge in the community is critical, and the nosocomial Ebola cases among children is an important issue, he said. Alarm bells are ringing, he added as there is a dramatic shortage of cash.

Dr Mike Ryan, just back from the airport, stressed the importance of holding the State, the government accountable. As a former director of Global Alerts for many years, he said, he had come back from the Middle East to face Ebola, and he could testify how there were no investments made (from donors or there) in the aftermath of the West African Ebola outbreak, which meant the area was as vulnerable as before. Ryan mentioned the Mozambique disaster, stressing that the majority of lives saved are achieved by first line local folks not by international teams, and it is the same whether it’s an earthquake, a hurricane or an epidemic. Which doesn’t mean we should forget that 80% of infectious diseases affects the poor of the world, which comprises 60% of child mortality. UHC is about facing that.

The need is to serve vulnerable communities.

North Kivu has the rain forest on three sides, and an enormous level of natural and forced migrations, and a really high density population.

The key word, he said, is “resilience”. “I would hate to see Geneva with 8 centers for Ebola!!  We could learn a lesson from African community resilience they could teach us.”

“In some of these places, Kinshasa, the capital appears as far as New York City!! We stopped in Beni …”

“Armed insurgents, not communities, are authors of violence. Last week, we lost 4 days. Yet the acceptance of the Ebola vaccine is higher than that of measles in the US”. Meanwhile, “election gaming needs to stop (The Kinshasa gov’t pretexted the Ebola epidemics for forbidding the affected regions from going to vote while the later are in the opposition – Author’s note), while reporting the important – he said – Prime Minister’s initiative to create a committee with all the religious entities”.

“Soon, a new vaccine will also be introduced. While there has been some cases of Ebola with the first vaccine, the clinical cases were less severe. We have piloted home care as well…We have 900 people in the field, and we do better than NGOs because of preparedness”.

During the Q&A, I asked Ryan a question: at the EB, you shook people with the very high rates of Ebola contracted in health care, what of your plan , as you  had told me then in January, to re-institute IPC into the HE cluster?

Then Ryan said: “There is still a horrifically high level of nosocomial infections, people get infected by Ebola in Health care centers.”

He spoke of the tripartite plan (AMR+UHC+HE) on IPC, and went on to say that “nosocomial Ebola is still unacceptably high in the DRC. Among pregnant women, Ebola is 70% nosocomial ! So health centers are part of the problem.”

Both Ryan and the Red Cross director stressed that there remained a big problem of preparedness, not very appealing to donors. There was a little pick on the anthropology studies, saying that if there were many an anthropologist on sites, the interpretations would be systematically further away.

The announcement of this WHO  tripartite priority initiative on IPC is especially timely and comes amidst several signs and campaigns including on the part of NGOs.

In The Economist AMR event this past month, Dr Marc Sprenger, insisted on IPC as a key answer to AMR spread, perhaps even more than in the interview we had conducted last year for AMR Control.

In an outstanding policy document, REACT and the Dag Hammarskjöld Foundation started outright:

“• Antibiotics have become a substitute for good quality health care. We must raise standards in basic infection prevention. (…) • Health insurance companies frequently fund activities related to better exercise and diet because these investments save money over time. The same should apply to AMR: insurance companies should demand high standards of drug stewardship and infection prevention and control.”

 

With G2H2 and the World Alliance Against Antibiotic Resistance, last year’s pre World Health Assembly event had focused on the need for IPC with a round table featuring AMR WHO leaders, Dr Marc Sprenger, and Dr Awa Aidara Kane, along with REACT Africa leader and Ecumenical Pharmaceutical lead Dr Mirfin Purdue and WAAAR President Dr Jean Carlet, with economist Mireille Martini (Finance Watch and Stiglitz Commission). 

And three years earlier, in 2015, “From Ebola to AMR: The need for IPC” was the title of a 2015 WHA UN event organized by the WAAAR Geneva group with EB member and AFRO group leader the Republic of South Africa, the DG of Health Services, Mrs Precious Matsoso, head of delegation, and the USA WHA’s delegate representative, Dr Mitchell Wolfe (now at CDC Washington and then Deputy Assistant Secretary for Global Health).

 

References & Background

From Ebola to Antimicrobial Resistance, by Garance F Upham

http://www.peah.it/2019/02/6374/

WHO Places Emphasis on IPC, AMR and UHC, by Garance F Upham

http://www.peah.it/2019/03/6479/

Ebola Experts Say It’s Time For A Radical Rethink Of Strategies In Congo: Goats and Soda https://www.npr.org/sections/goatsandsoda/2019/05/10/721020887/threats-by-text-a-mob-outside-the-door-what-health-workers-face-in-the-ebola-zon

For coverage of last year’s G2H2 AMR Round Table: http://amr-times.info/

For Past and Current AMR Control (and Dr Sprenger’s interview in 2018 edition) see www.amrcontrol.info

The Economist (we could not find a report back on the web, the information on Dr Sprenger’s talk came to me from one of the attendees).

https://www.youtube.com/watch?v=9IXa7FujV5E

 

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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

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New Analysis Finds that Modicare, One Year In, Lives Up to Its Promise 

Modicare Post-Election: Recommendations to Enhance the Impact of Public Health Insurance on UHC Goals in India 

Fair Pricing – Striking The Balance 

Access to affordable medicines is a growing global challenge: Europe is no exception 

Warning over global failure to act on deaths from drug-resistant TB 

The Medicines Patent Pool responds to call for feedback on the WHO draft Global Strategy for TB Research and Innovation 

24 May 2019 – KEI panel discussion – Assessing the implications of the development of new cell and gene-based therapies (including CAR T and CRISPR): What role should WHO play? 

The Medicines Patent Pool publishes framework for prioritising target medicines for in-licensing under its newly expanded mandate 

Here’s how people in Nigeria are avoiding vaccination 

‘A Closer Look at The Toronto Star’s Stats on Vaccine Coverage in Ontario’ by Lawrence C. Loh 

DRC Ebola: latest numbers as of 14 May 2019 

Struggling with Scale: Ebola’s Lessons for the Next Pandemic 

Fights to end polio, contain Ebola made tougher by rising violence, research finds 

Political Games Hinder Efforts to End Ebola in Congo: WHO 

Progress Against Child Mortality Lags in Many Indian States 

Pediatric tropical medicine: The neglected diseases of children 

Trachoma in Australia: environmental improvement needed for long-term elimination 

‘The Evil of Unregistered Clinical Trials in Europe’ by Daniele Dionisio 

Increasing access to health care for people in areas of return in Ninewa 

Reframing the Blame for the War on Drugs 

EU countries put pressure on refugee sea rescue missions 

Rohingya crisis update – May 2019 

To Reach 2025 Target On Reducing Low Birthweight, Current Progress Must Double 

South Asia bears half of global low birthweight burden 

WHO Releases Draft Guidance On Labelling For Healthy Foods 

Limiting global warming to 1.5 to 2.0°C—A unique and necessary role for health professionals 

EU national climate plans well below par, study reveals 

Over 180 countries — not including the US — agree to restrict global plastic waste trade 

UN kicks off major climate change effort 

Climate Change, Wildfires, And How Public Health Leaders Can Rise To The Challenge 

As risks rise, too little is spent to avert disasters, say U.N. and Red Cross 

The Evil of Unregistered Clinical Trials in Europe

This article adds to debate on the heavy lack all over the European Union of the required diligence and transparency regarding the registration in publicly available databases of research clinical trials and their results. This gap undermines patients’ right to an equitable access to health while jeopardizing financial resources for research

By  Daniele Dionisio

PEAH – Policies for Equitable Access to Health

The Evil of Unregistered Clinical Trials in Europe

 

On April 30th, 2019, Transparimed, BUKO Pharma-Kampagne, Test-Aankoop and Health Action International-HAI released the joint report  Clinical Trial Transparency at European Universities: Mapping Unreported Drug Trials.

The report points the finger at documented non-fulfilment all over the European Union (EU), including Italy, of due diligence and transparency regarding the registration in publicly available databases of research clinical trials and their results. Non-fulfilment here runs contrary to the human right to equitable access to health and puts financial resources for research at risk.

Admittedly, trials results are instrumental to allow doctors, patients and policy leaders to make informed choices including relevant to the safety and appropriateness of therapeutic interventions. As such, sharing methods and results of all clinical investigations does represent a scientific and moral duty.

How to contextualize the reported gap inside the EU regulatory system? In a landscape characterized by various and complex local/national situations, the European Medicines Agency – EMA runs the EU Clinical Trials Register–EUCTR  where clinical trials, once notified by the sponsors as completed, are put in following input by national (AIFA in Italy) regulatory agencies.

As an integral part of – and parallel with – EUCTR, EMA also runs the EudraCT database open to insertion, by the sponsors and national regulatory agencies, of updated data relevant to in progress clinical trials. Once ratified by the sponsors and completed, trials enter inclusion route in EUCTR.

Unfortunately, these rules suffer from disregard in Europe, as the just released joint report tells us. For example, as regards Italy’s low ranking in the report, we know that once a trial is approved, notification to AIFA is required for insertion in AIFA’s national register of clinical studies. As such, and consistently with the EU system, it should be incumbent to AIFA register and sponsors  to pour registration and results of Italian clinical trials directly into EudraCT. With how much completeness and sense of timing has this being happened so far? This is a well-grounded question in the light of the joint report results.

In any case, the gap of trials registration in EUCTR, far from being circumscribed to the present time or a few countries, actually strikes transversely with the majority of accountable national bodies in Europe being defaulting.

In spite of non-stop blaming by several studies in recent years (including the one by Christine Schmucker et al. published on PLoS One in 2014), the problem has long been overlooked by the media, nor has it raised enough attention by the European Commission and national governments as well.

Last year, finally, an exhaustive analysis by Ben Goldacre et al. on the British Medical Journal achieved (also thanks to a tireless pressure on the media by Till Bruckner, TranspariMED Director) widespread international success, and paved the way for a seemingly just in motion reawakening of policy makers’ consciences from inaction.

In a wider perspective, and now that a silver lining looks like it would emerge in Europe, can long-term forecasts be possible? Unfortunately, no happy ending can be counted on at a time when governments must keep on being strictly pro-active and alert so that all involved parties comply with their duty to make trials data fully accessible to citizens, health professionals and researchers.

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WHO: Public health round-up 

Exclusive: Questions arise over Tedros’ new deputy director-general 

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Comparison between April 29 and May 7 version of WHA 72 resolution on transparency 

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A Closer Look at The Toronto Star’s Stats on Vaccine Coverage in Ontario

...despite decades of underfunding and a “motley of surveillance systems” (as characterized by The Star), public health units and healthcare providers have still managed, by and large, to protect Ontarians against vaccine preventable diseases through promoting and tracking high rates of compliance and coverage...

By Dr. Lawrence C. Loh

 Adjunct Professor, Dalla Lana School of Public Health, University of Toronto

 The opinions he expresses here are his own and do not represent any other institution with which he is presently or has previously affiliated

Stats, Data and the Popular Media: a Closer Look at The Toronto Star’s Stats on Vaccine Coverage in Ontario

 

There is a part of the world where measles outbreaks are incredibly common, owing to a relatively lower measles-vaccine coverage rate of 65%. Between 2017 and the middle of 2018 there were nearly 1000 cases of measles reported, with just under a hundred cases being reported monthly and a major outbreak to kick off 2017 with nearly 500 cases seen between January and February.

A recent article in the Toronto Star, Canada’s largest daily circulating newspaper, has reported a similarly low “coverage rate” in Toronto and other health units in Ontario, which might have you imagining that this is the case right here at home.

But it’s not. In fact, the jurisdiction in question (with the mid-sixties measles coverage rate) is actually Guinea, in West Africa – also infamous for being the epicenter of the 2014 Ebola outbreak.

The flawed statistics and analyses are presented in the Toronto Star article, along with a suggestion by an academic at the University of California, Berkley that the “coverage rates” presented are “nowhere near the level required for herd immunity.”

If true, however, why isn’t Ontario and the Greater Toronto Area seeing endemic transmission, perennial outbreaks, and hundreds of cases being reported every single month?

The answer lies in in echoes of a similar misstep by the newspaper around a since-retracted article on the safety of the quadrivalent-HPV vaccine.

How vaccine records and coverage rates are determined in Ontario

It’s important to understand a few basics: firstly, how vaccine coverage data is collected in Ontario, and secondly, how coverage rates are calculated.

In Ontario, vaccinations are delivered by a variety of providers, most typically physicians, and students are typically screened annually throughout the school year for compliance with the Immunization for School Pupils Act, which requires up to date records of vaccination or a filed exemption for school entry.

This data is constantly evolving as the school year goes on, and can’t necessarily be calculated in real-time, since it relies on the health unit obtaining records from parents that they themselves have obtained from their provider.

To that end, parents are typically sent several requests, followed by warnings, before being issued with a notice of suspension, all with the goal of obtaining either up to date records, or a filed exemption (either medical or philosophic.)

Once that data is obtained, it can be used to calculate coverage rates, which are specific to disease, not to “vaccines given”. Someone up to date for ‘pentacel’, for example, is up to date for five diseases and shores up overall coverage rates for diphtheria, pertussis, polio, tetanus and haemophilus influenzae B.

So does The Star’s metric actually represent “coverage rates?”

Where did it go wrong with the statistic used by the Star? In its investigative article, presented as “coverage rates” is the summary measure: “all seven-year olds who are up to date for all antigens (diseases) required by law for school entry as of September 2018.”

While one can agree that being up-to-date with vaccines is a great individual health asset for anyone, there are several reasons why using this statistic is a significant misinterpretation:

Coverage rates are disease specific

The Star’s metric does not represent a coverage rate; coverage rates are calculated specific to disease. There is no disease called “up to date for all vaccines.”

Take, for example, a student who received every vaccine except their Men-C. They would in fact be covered for every disease save for Men-C but would still show up as “not covered” in the Toronto Star’s summary measure.

Coverage rates should answer the question: “How well protected are we against (disease x)?” That means digging into the disease specific coverage rates for the population in question.

On this, incidentally, appropriate coverage data do exist and are released annually by Public Health Ontario at the close of the enforcement year. Using measles as an example, coverage rates in 2016-17 among 7-year old students are closer to the 85-90% level across the province and much closer to required levels for community immunity. This is why Ontario’s measles picture does not look like Guinea, despite cases of measles passing through our communities with remarkable regularity.

The metric is drawn at the wrong point in time

Hockey fans know that a winning percentage at the start of the season changes dramatically as the season goes on. Similarly, the data reported by the Star was pulled at the beginning of the school year, before enforcement activities began. As work progresses over the school year, more data on the vaccination status of children (reflected as well in higher coverage rates!) becomes available, meaning The Star’s numbers largely reflect a reporting delay rather than a doomsday scenario.

Compliance rates matter more and 7-year olds are only part of the population

While 7-year olds are the age used for provincial coverage reporting, public health units also enforce legislative compliance for all students of all ages; “compliance” means having either updated records or an exemption filed. This is most useful in outbreaks, and where The Star’s metric falls short yet again – because a summary measure says nothing about which students have filed records or exemptions for a specific disease. When pertussis comes to call, 98-99% compliance rates in most health units allow determination around which students are vaccinated and which students should be excluded until the outbreak is over.

Different health units, different realities

Given thirty-five different health units in Ontario with vastly different socioeconomic and demographic realities, one can imagine that some health units will have not that many students, while others contend with a large, diverse, and growing number. Despite some things being easier in rural areas than in the metropolis, though, health units still manage to get the data they need over the course of a year – to ensure that coverage rates don’t resemble that of Guinea.

What does it really mean?

The simplest test of whether The Star’s numbers hold muster is thus in the overall infectious disease reality observed in Ontario. Our picture is not the picture of Guinea, or many other settings worldwide, where many vaccine-preventable diseases remain an ever-present threat.

While they did get the metric wrong, The Star in an accompanying editorial used their findings to helpfully highlight the potential perils posed by vaccine hesitancy. Certainly, more could be done to reassure parents that vaccinations remain one of the best ways to protect the health of their children.

More likely, however, the numbers reflected in their summary measure from the start of the school year simply reflect how data moves in a system where vaccines are delivered by one stakeholder, held by another, and tracked by a third; they also do not reflect what is commonly understood as “coverage rates.”

While real-time coverage rate tracking would be the holy-grail, such work would require providers to be on board with the mandatory reporting of the vaccines they give and significant additional investment in electronic data capture, which looms heavy against a backdrop of significant proposed funding cuts to public health in Ontario.

Perhaps the real story here is thus a foreshadowing: despite decades of underfunding and a “motley of surveillance systems” (as characterized by The Star), public health units and healthcare providers have still managed, by and large, to protect Ontarians against vaccine preventable diseases through promoting and tracking high rates of compliance and coverage. Where might further cuts lead?

Health Breaking News 332

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 332

 

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