[By Reuters]

NEW YORK (Reuters) – Merck & Co Chief Executive Ken Frazier said on Thursday a rule to base the price the U.S. government pays for some prescription drugs in it[s] Medicare program on lower prices in other countries would face legal challenges if adopted.

U.S. President Donald Trump said last year that one way his administration would seek to lower drug costs to consumers could be through an international pricing index (IPI) that would determine what Medicare pays for certain medicines based on the prices set in a handful of other countries. A proposed version of the rule is expected in August.

Ken Frazier, Chairman and CEO, Merck & Co., speaks during a meeting of the Economic Club of New York in New York City, U.S., October 3, 2018. REUTERS/Brendan McDermid

Other developed nations with single payer systems typically pay far less for drugs than the United States, which Trump called “global freeloading.”

“I think there will be challenges to the rule,” Frazier told reporters following the drugmaker’s investor day in New York. “A lot of people have objections to that rule. It’s not just pharmaceutical companies.”

Frazier, a lawyer by trade, did not say whether Merck would launch its own legal challenge to the proposed rule.

The company was one of three U.S. drugmakers that sued the U.S. Department of Health and Human Services this week over a new government regulation requiring them to disclose the list price of prescription drugs in direct-to-consumer television advertisements.

Of the Trump administration proposals to lower drug costs, the IPI option is the one Frazier said most concerns him, due to the effect importing price controls from other countries might have on innovation and patient access in the United States.

“We tell incomplete stories about those markets,” Frazier said, noting that some countries ration treatments available to patients. He pointed to lower survival rates for lung cancer in Britain, which has an agency that can bar the use of approved new medicines based on their cost.

Earlier on Thursday, Merck executives touted the company’s pipeline of experimental drugs beyond its blockbuster cancer treatment Keytruda.

The investor event was also an opportunity for Merck to showcase executives other than Frazier, who turns 65 in December. Last year, the company scrapped its mandatory retirement age of 65 for its CEO, saying it gave the board flexibility around finding his successor.

“I’m extremely pleased by the breadth of the leadership talent at the company,” Frazier said in response to a question about succession. “I know that the board feels the same way. And they will continue to look at when the right opportunity is … to make a selection.”

(Reporting by Michael Erman; Editing by Bill Berkrot)

Image Credits: REUTERS/Brendan McDermid.

The proportion of the world’s population using safely managed sanitation services increased from 28-45% between 2000 and 2017, according to the latest joint report of the World Health Organization and UNICEF on Progress in Household Drinking Water, Sanitation and Hygiene.

However, huge service gaps still remain, with 4.2 billion people worldwide still lacking access to what WHO defines as hygienic toilets or latrines — where wastes are treated and disposed of safely. And while numbers have declined by one-half since the year 2000, some 673 million people still practiced open defecation in 2017.

In terms of drinking-water, the proportion of people with a “safe” drinking water sources, increased from 61% to 71% between 2000-2017, notes the WHO report, released Tuesday. However, some 2.2 billion people  still lack access to a safe drinking-water source, which WHO defines as water located on the household premises, free from contamination and available when needed. Finally, some 3 billion people also lack  basic-hand washing facilities of soap and water at home; these are critical in preventing transmission of many bacterial and parasitic diseases.

The report, Progress on drinking water, sanitation and hygiene: 2000-2017: Special focus on inequalities finds that large gaps also remain in the quality of services that can be accessed by rich and poor, as well as by urban and rural populations.

Of the 2 billion people that still lack access to even the most basic toilet or latrine, 7 out of 10 live in rural areas and one third live in least  developed countries, the report notes.  Nearly three quarters of people in least developed countries still do not have basic hand washing facilities  at home.

And in countries where service levels were assessed by socio-economic group, coverage of basic services among the richest sectors of the population was far higher than among the poor.

“Mere access is not enough. If the water isn’t clean, isn’t safe to drink or is far away, and if toilet access is unsafe or limited, then we’re not delivering for the world’s children,” said Kelly Ann Naylor, Associate Director of Water, Sanitation and Hygiene, UNICEF, in a WHO press release. “Children and their families in poor and rural communities are most at risk of being left behind. Governments must invest in their communities if we are going to bridge these economic and geographic divides and deliver this essential human right.”

Without stepped-up action, the world will fail to meet the 2030 Sustainable Development Goal 6 for universal access to safe water and sanitation services, WHO officials warned.  That translates into higher rates of transmissible diseases, which are both deadly as well as costly to treat for budget-strapped health systems.

“If countries fail to step up efforts on sanitation, safe water and hygiene, we will continue to live with diseases that should have been long ago consigned to the history books: diseases like diarrhoea, cholera, typhoid, hepatitis A and neglected tropical diseases including trachoma, intestinal worms and schistosomiasis,” said Maria Neira, Director of WHO’s Department of Public Health, Environmental and Social Determinants of Health in the WHO press release.

WHO estimates that some 297 000 children under the age of 5 die every year as a result of diarrhoeal diseases linked to unsafe drinking water, inadequate sanitation or hygiene. Poor sanitation and contaminated water are also linked to transmission of deadly water-borne diseases such as cholera, dysentery, hepatitis A, and typhoid.

Although some 2.1 billion people have gained access to basic sanitation services since 2000, in many parts of the world the wastes produced by toilets and latrines leach untreated into ground and water sources – meaning that they are not really adequate sanitation solutions.

And despite the global decline in open defecation, in 39 countries the practice has actually increased over the past 17 years, the report notes. The majority of these countries are in sub-Saharan Africa, which has experienced strong population growth over the same period.

“Closing inequality gaps in the accessibility, quality and availability of water, sanitation and hygiene should be at the heart of government funding and planning strategies. To relent on investment plans for universal coverage is to undermine decades worth of progress at the expense of coming generations,” said Naylor.

The report is the latest in the series of reports that are issued by the WHO/UNICEF Joint Monitoring Programme (JMP) for Water Supply, Sanitation and Hygiene, which is the official United Nations mechanism for tracking global progress on safe drinking water, sanitation and hygiene, in relation to the Sustainable Development Goals (SDG).

 

Image Credits: UN Water, WHO.

The World Health Organization (WHO) today launched a global AWaRe campaign, which aims to support national health systems to make more judicious use of lifesaving drugs so as to combat a worldwide trend of antimicrobial resistance (AMR) – including increased pathogen resistance to common antibiotics, antivirals and anti-fungal medications.

However, WHO’s own 2018 Report on Surveillance of Antibiotic Consumption shows that some of the biggest countries worldwide, including the US, China and India, have not submitted even the most basic data on total amounts of antibiotics consumed nationally every year by their countries’ health systems.

Ironically, the US Food and Drug Administration (FDA) does report on animal antibiotic use; that data shows the US to be the largest net consumer, by far, of antibiotics in animal agriculture in comparison to most European countries combined.

In light of the growing urgency of the AMR threat – which a major new UN report in April said could lead to as many as 10 million deaths by 2050 – some leading AMR researchers and advocates from the United Kingdom, Thailand, Australia and the US, are saying that a simple global metric is needed to track the quantities of drugs that countries are actually using.

Their work, available at Antibioticfootprint.net, and supported by a grant from the Wellcome Trust, compares aggregate use of antibiotics by country, for human and animal sectors, relying upon publicly available, official data. (See also In Focus).

Papers published out of the project in the Journal of Antimicrobial Chemotherapy as well as by the Center for Disease Dynamics, Economics, and Policy (CDDEP) make the argument that a simplified “antibiotic footprint” is needed to communicate to the wider public the magnitude of antibiotic use in humans, animals and industry.

The antibiotic footprint project builds upon a concept originally developed by a Thai researcher,  Direk Limmathurotsakul at Mahidol University, Bangkok, and then adopted by other leaders in the AMR field, including:  Ramanan Laxminarayan of CDDEP, New Delhi,  Marc Mendelson, of the University of Cape Town, and Philip Howard, President of the British Society for Antimicrobial Chemotherapy (BSAC).

In an interview with Health Policy Watch, Howard called the footprint a “One Health” Approach to antimicrobial resistance.  “At the moment every country you look at through official data sources considers human and animal [antibiotic] consumption separately. We wanted to show everything in a single place,” he said.

He noted that this holistic approach is important because recent evidence indicates that if you can “reduce the amount of antibiotic use in animals, then you can reduce resistance in humans by as much as 24% — with the strongest correlation among people working in food production.”

He said that the footprint’s data, all peer reviewed, is based solely upon official data submitted to WHO, other international agencies or published by national governments, but often buried in the fine print of highly technical sources.

“What the antibiotic footprint tries to do is to pull together freely available information, ideally information that has been submitted to WHO about antibiotic consumption, World Organization for Animal Health, or published by national governments,”  said Howard.

Currently there are very wide regional discrepancies in countries that report on antibiotic consumption to WHO or others, said Howard. “If you look at the countries who are submitting data on human use of antibiotics, you will see Europe is very good –  85% of countries submit data, whereas in the Western Pacific Region it is only 22%; in the Americas it’s only 17% percent of countries, and then Africa has 9%; and there is no data submitted from South East Asia.”

Limmathurotsakul says that in developing the site he was inspired by similar efforts to create carbon footprints for awareness-raising about climate change. The simple formulation of the website allows the public to visually grasp trends, such as the very high use of antibiotics for animals in some countries; very consistent levels of reporting in Europe and Japan; and key gaps in data elsewhere. “If you don’t know the amount you are using, you can never reduce,” he pointed out.

The site also provides a snapshot of available per capita data on antibiotic use by country – to put comparisons on a more equal playing field.  Those countries ranking very high in per capital human consumption, such as Mongolia, tend to be middle or upper middle income nations Limmathurotsakul observed. In such countries people  can afford to purchase drugs, but products may also be poorly controlled by regulatory authorities, leading to overuse.  The footprint data also reflects the fact that in lower middle income countries, little data on animal consumption exists. “I think that many lower middle income countries are doing a good job, but the data from the animal sectors is still lacking from most lower middle income countries; they need to do more,” said Limmathurotsakul.

WHO AWaRe campaign

In contrast to the antibiotic footprint, the WHO AWaRe tool is aimed more squarely at the health sector – and at shifting from the use of drugs that should be held in reserve for the most serious health conditions, to drugs that are effective in combating most common pathogens, but less likely to stimulate trends of antimicrobial resistance.

The WHO tool can also be used to rationally expand access to antibiotics among groups that don’t currently get such drugs at all, said Assistant Director General for Access to Medicines, Mariângela Simão, speaking today at a WHO press briefing.

“It is a tool that countries can use to reduce antimicrobial resistance, but also a tool [for supporting] use of antibiotics where access is low,” said Simão, noting that an estimated 1 million children die every year from treatable bacterial disease linked to the lack of antibiotic treatment.

“On one side we have an imbalance in [human] access to antibiotics,” she said. “In other countries there is an imbalance in antibiotic use, where animals and agriculture have an excess use.

The tool helps hospitals and health systems assess and classify their drug use in terms of categories defined by WHO as Access, Watch and Reserve, said Hanan Balkhy, WHO’s new Assistant Director General of Antimicrobial resistance. The 19 medicines in the  “Access” category can be made widely available without high risks of stimulating antimicrobial resistance.  Amoxycilin is an example of such a drug, used for many common infections, she said. Another 11 drugs in the “Watch” category should be used only as a second resort, and not at all in animal health; another class of antibiotics, Fluoroquinolones belong in that category. Finally, there is a list of 7 “Reserve” drugs should only be used as a last resort, Balkhy explained.

Out of WHO’s 194 member states, some 65 countries worldwide are reporting to WHO on their antibiotic use through use of the AWaRe tool, Balkhy said.  Of those, only 29 countries meet the goal recommended by WHO for 60% overall use of drugs in the lowest-risk “Access” category.

While national monitoring of aggregate drug consumption would still be required to use the WHO tools, pulling together such data globally is difficult, Balkhy asserted, since “there is not one single tool that all countries are using.”

The AWaRe tool will be formally launched Wednesday at the Second Ministerial Conference on Antimicrobial Resistance, which is taking place 19-20 June in Noordwijk, The Netherlands, in collaboration with WHO, the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE).

The conference will look at ways to advance the Global Action Plan on Antimicrobial Resistance, approved by the World Health Assembly 2015.  The Global Action Plan takes a multi-pronged approach to combating AMR, with more rational and optimal use of existing drugs in humans and animals; development of new drug therapies; more effective management of sanitation and hygiene in health facilities, livestock production and communities, where sewage and waste may provide a fertile breeding ground for resistant microbes; as well as improved surveillance, research and awareness-raising.

Balkhy acknowledged that the AWaRe tool addresses just one of the “big pieces of this big mosaic, of antimicrobial resistance that we all need to tackle.  The other pieces are just as critical, and they all have to be put into place to slow down and mitigate AMR. But if we don’t do this, it will probably lead to a halt in modern medicine as we know it today.”

 

 

 

Image Credits: WHO .

In the lead-up to the United Nations High-Level Meeting on Universal Health Coverage (UHC) in September, the latest draft of a planned political declaration calls on member states to increase transparency of the cost of research and development (R&D) – in addition to drug prices – but falls short in the area of R&D incentive reform, with no mention of delinking R&D incentives from medicines prices.Continue reading ->

Image Credits: WHO.

A new Knowledge Portal that aims to ease policymakers’ access to reliable information about themes in medicines access, pricing and pharma innovation was launched today by the Global Health Centre of Geneva’s Graduate Institute of International and Development Studies.

The Portal currently covers some 17 topics grouped under three broad themes – Pricing, Intellectual Property and Innovation. But there are plans to double that number, through a hybrid approach of Wiki-style crowd-sourcing and academic curation of suggested content, says Suerie Moon, research director at the Global Health Centre and project lead.

Moon said that the project, supported by the Open Society Foundations, aims to demystify often complex topics and put existing knowledge at the fingertips of policymakers and their advisors – who need vital background on issues that are increasingly hot topics of debate in UN fora, as well as in national health systems.

Each theme (Pricing, Intellectual Property, Innovation) is covered by four main resources including: brief research syntheses, directories of data sources, listing of research gaps and webinars on related issues.

“The real added value is the research syntheses, which is hard to get anywhere else,” Moon observed. “Sometimes these are buried in a Masters’ thesis, or an academic article, but they are generally not produced for the policy practitioner community. “We have synthesized this research to provide concise, up-to-date summaries on the state of knowledge on each policy topic.”

For instance, under the “Pricing” tab, a user can find can find easy-to-read descriptions and assessments of the often highly technical tools and tactics used to make drugs more affordable in low- and middle-income countries, such as Tiered Pricing and Voluntary Licensing.

Under “Innovation,” initiatives such as Patent Pools, Priority Review Vouchers and Advanced Market Commitments, are described. These are often used to stimulate new drug development, while promoting broader medicines access.

The portal also seeks to present the oft-divided perspectives of different private sector, civil society and research stakeholders in an evidenced-based way, Moon said:

“For instance, with regards to accessible pricing, different stakeholders will say ‘why don’t we solve the issue with tiered pricing, or using donations, or we can solve it using bulk procurement?’ But when I engage in these debates, people don’t have easily at their fingertips the evidence that they need to assess whether any particular solution will work to solve the pricing challenge.”

“The issue area is quite sensitive and sometimes quite polarized. You have a lot of sides producing documents that might support one or another perspective, but not a lot of groups that have taken a step back to say what do we know about this issue?”

Other Key Features – Data Sources, Research Gaps and Webinars

Along with synthesis of each major topic, the Portal’s other key features include:

  • Compilation of open-access data sources where users can find further information related to medicines prices, pharmaceutical company policies, patent information, R&D funding and costs, among other topics;
  • A curated list of “Research Gaps” developed during the literature reviews that underpin the website construction; and
  • Announcements and recordings of webinars organized by the Knowledge Network and presented by leading medicines policy researchers.

Moon said that the research syntheses and other documentation are “living” instruments that will undergo open peer review and be periodically updated to incorporate feedback and new research.

In that respect, she hopes to harness some of the approaches used by open-source libraries such as Wikipedia, where the crowdsourced feedback will constantly improve the site.

“I’m a huge fan of the Wiki philosophy,” says Moon. “We want other people to send us their feedback and ‘what did we miss’,” noting that comments and suggestions for the online materials, as well as the webinar series, are welcome at globalhealthresearch@graduateinstitute.ch.

Building the Portal – Curation and Interpretation

At the same time, she draws a clear line between the Portal’s development by an academic sponsor such as the Graduate Institute, and the Wikipedia approach that relies almost entirely on crowdsourcing.

“The difference is in the expert curation and interpretation,” she said. “You know who wrote it, and that there is an academic reputation behind it. While we are not claiming that it is perfect, and we do want to spur a Wiki-type reaction, we also hope the resource will have a different level of credibility and value.”

She says that the focus themes and topics were originally chosen from a series of interviews and expert meetings. While it was impossible to do systematic literature reviews, the syntheses are the product of comprehensive literature reviews, supplemented by in-person meetings and peer review. Each topic synthesis is accompanied by referenced sources, which users can further explore.

Charting what is missing is as important as what exists, Moon added. In some areas the team found an abundance of recent research, whereas in others, a dearth.

For instance, with regards to medicines shortages – the subject of a World Health Assembly resolution in 2016 – the team found little recent published analysis of drivers and causes.

“Researchers follow trends like everyone else,” Moon observed. “So you have certain topics that are trendy and there may be multiple reviews in a single year. And then there are other areas where there are lots of gaps and we haven’t had a significant new review in 5-10 years.”

“We were constantly filtering through the most important pieces of research and policy analysis to put it together in a coherent story line,” she said, noting that the project is managed by a small team at the Graduate Institute. “Now, we will wait to hear back from the broader policy and practice community on our Version 1.0, and as we get input from different readers, we will be updating and posting the improved versions – although we will keep the older versions online.”

Image Credits: Marco Verch.

Following the adoption of the World Health Assembly resolution on the transparency of medicines markets last month, a new civil society group has formed in France to monitor the French government’s implementation of the resolution.

L’Observatoire Transparence Médicaments (Drug Transparency Observatory), was launched today in a statement calling on the French government and all countries to implement not only the adopted resolution on the transparency of medicines markets, but also the transparency measures included in the initial resolution draft, which go beyond just medicines pricing.

The French government “showed its support to this initial text proposed for the resolution going further than prices, and we now want full transparency to be implemented in France,” said Pauline Londeix, Co-founder of the Observatory, in the statement.

“Besides monitoring the advancement on the implementation of the transparency resolution in pricing, clinical trials, research and development, marketing and patenting,” the statement said, “the Observatory will also monitor the position of France within the international institutions (WIPO, WTO, WHO, etc), as well as at the European level, in particular as part of the European Commission (EC) negotiating Free Trade agreements such as MERCOSUR, Tunisia and Morocco. These agreements currently in negotiation include, on the request of the EC, provisions such as data exclusivity and trade secrets, that go in the opposite direction to transparency.”

“Transparency is critical for countries like France to face the unstoppable increases in medicines prices and to sustain their health systems,” Londeix said.

The Observatory “will work hand in hand with local and international NGO partners,” according to the statement, and can be followed on Twitter at @OTMeds.