COVID-19  has, moreover, spurred increased use of antibiotics – ostensibly to suppress or prevent secondary bacterial infections that people sick with the virus could also get.

This week is World Antimicrobial Awareness Week, marking the fight against the silent and rising global threat of antimicrobial-resistant superbugs. Can patients be part of the solution?

This week is the World Antimicrobial Awareness Week (WAAW) when we turn the world’s attention to the growing problem of drug resistant diseases – caused by bacteria, viruses and other pathogens that have developed resistance to the lifesaving drugs that we use every day.

Why Is This Important?

Antimicrobial resistance (AMR) is a natural process of pathogens’ adaptation to the drugs we use to kill them, which should normally have a slow evolution-like pace. Our inappropriate use of common antibiotics, antiviral agents and other drugs on all fronts of human and animal health speedwarps this process.

The often imperceptible tidal wave of AMR already kills some 700,000 people each year. But it threatens to become a “tsunami”, as World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus recently said. A report last year by a special ad hoc UN group, “No Time To Wait” projected that the world could see up to 10 million deaths annually by 2050. This looming crisis thus has the potential to be as large or even larger than COVID-19 in terms of the death toll and economic costs.

The Problem is Not New

Alarm bells started ringing as early as 2008, when the European Centre for Disease Prevention and Control issued warnings about the trends. In 2015, WHO adopted its first Global Action plan on AMR – and the world observed the first Antimicrobial Awareness Week.

However, so far the warnings have failed to turn around embedded practices and habits. Although awareness in some health systems is growing, there is widespread overuse of antibiotics and other antimicrobial agents in countries with weak regulatory systems – where people can buy antibiotics and other drugs over the counter without a prescription.

In addition, drugs that need to be reserved for human use are still wantonly used in industrial livestock production as growth promoters or disease prevention –  further increasing risks that drug-resistant bacteria will emerge. In many countries it is difficult or impossible to even assess how much antibiotics and other antimicrobials are used, where, and on what populations.

COVID-19  has, moreover, spurred increased use of antibiotics – ostensibly to suppress or prevent secondary bacterial infections that people sick with the virus could also get. And this, according to WHO, is exacerbating AMR trends. In the United States, some 70-80% of hospitalised COVID-19 patients received antibiotic treatment, according to one report, even though less than 10% actually had secondary bacterial infections.

Pandemic as an Opportunity: the World is Waking Up

Against this grim reality, however, the current pandemic may also be serving as something of a wake-up call fostering more action on AMR, among both health care providers – as well as the patients that my organization, the International Alliance of Patients’ Organizations (IAPO), represents. Having confronted the harsh reality of a deadly virus for which there is no vaccine, medicine or treatment – can we act more assertively to stave off future threats like this that could emerge if more bacteria and viruses become resistant to the existing drugs that we do have?

This July, an AMR Action Fund of nearly $1bn was established by more than 20 leading biopharmaceutical companies, with a mission to bring 2-4 new antibiotics to patients by 2030, and replenish the collapsing antibiotic R&D pipeline. This fund complements other initiatives, like the WHO’s Global Antibiotic Research and Development Partnership, and its added value is in creating market conditions that enable sustainable investment in the antibiotic pipeline.

In August, the Tripartite Coalition of the WHO, the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE) initiated a “One Health” Global Leaders Group on Antimicrobial Resistance, to advocate for urgent action among heads of state, government ministers, private sector and civil society. The  Group, co-chaired by the prime ministers of Bangladesh and of Barbados, will be formally launched at a WHO press conference on Friday.

On Wednesday, Wellcome Trust launched their report “The Global response to AMR: Momentum, successes and critical gaps”, underlining that AMR is not only reversing recent progress in controlling infectious diseases, but is also undermining improvements in healthcare provision in general, threatening to disproportionately more affect the low- and middle-income countries.

This AMR week will also see a flurry of activities across WHO regions, under the theme “Unite to prevent antimicrobial resistance”. And in the spirit of “One Health, stakeholders across diverse sectors are linking together on this common interest.

This is reflected in a joint call for more action issued Wednesday by IAPO along with the International Hospital Federation, the International Society for Quality in Health Care, and the International Federation of Pharmaceutical Manufacturers and Associations.

The statement calls for the development of more innovative partnerships of healthcare providers, patients and the business sector to tackle the growing AMR threat while improving healthcare safety and quality worldwide.  It aims to raise awareness of AMR, promote antibiotic stewardship and call upon policymakers to create the appropriate conditions to attract investments in R&D to ensure that a sufficient pipeline of antibiotics will remain available to treat both common and rare infections.

Empowering Patients to Fight AMR in A Global AMR Patient Alliance

Paternalistic approaches to healthcare have largely left patients on the sidelines in the battle against AMR. This, despite the abundant evidence showing that patients bear a big part of the responsibility for what is happening right now.

Driven by Einstein’s postulate that we cannot do the same thing, and expect a different result, IAPO along with patient organisations from different regions and countries has developed A Global Patient Consensus Statement and a Call to Action, that aims to convene civil society groups representing patients, carers and advocates in a global AMR Patient Alliance, to be launched in the first week of December. The AMR Patient Alliance will be a place where patients can exchange views, be educated, and acquire knowledge and resources that we need to raise awareness about the importance of sustaining the efficacy of antibiotics – for as long as possible, for as many patients as possible.

Among patients today, there are widespread practices of self-treatment with antibiotics. Patients also put pressures on providers to prescribe such medications – even when their health care provider may not think they are needed. And, there remains a widespread public perception of antibiotics as ‘a wonder drug’; evidence shows that if patients can get access to antibiotics without a prescription, they will do so. Oftentimes, patients may only follow a partial antibiotic course or use antibiotic leftovers inappropriately – if no direct harm is perceived.  But these behaviours also stimulate drug resistance. All of this needs to change.

It is always politically sensitive to mention that patients have some responsibility. But, no amounts of funding to develop new drugs or curb AMR now will work, if people at the grassroots continue to abuse their life-saving potential. The magnitude of people’s power is so great…and it can be destructive or productive.

That is why, at IAPO we have joined the AMR fight in order to convert this challenge into an opportunity, by building awareness and empowering patients to take responsibility – so as to preserve their right to use antibiotics and antimicrobials over the long term.

We All Have a Role to Play

The problem of antibiotic overuse or misuse is not restricted to certain countries or regions, although the drivers may vary by country.  According to Professor Hanan Balkhy, assistant director general for antimicrobial resistance at the WHO, categories of antibiotics that are only used very selectively when all else has failed, on hospitalized patients in intensive care – can often be obtained by outpatients or over-the-counter in low- and middle-income countries.

And even when drugs to people are being rationed more carefully, an out-sized footprint for antibiotic use in livestock exists in countries ranging from the USA to Spain, Italy and Chile. This exacerbates risks that these drugs may one day soon, become ineffective in human populations.

Finally, only about one third of all countries are actually tracking their antibiotic use systematically, according to WHO, with significant discrepancy across regions – from 85% of European countries to none in South East Asia. In some countries, notably  the USA, animal use is systematically reported at the national level – but not so for human use.

The problem is not a simple one – solutions are complex and interrelated. We knew that progress would be slow and the current pandemic has set up new challenges. The ‘infodemic” of fake news and unconfirmed facts has also seen conflicting messages about the effectiveness of antibiotics on viruses – undermining one of the key principles of rational and appropriate antibiotic use.

Appropriate antibiotic use is everybody’s business – not only of governments and healthcare providers, but of patients and industry as well. The old ones we have to preserve, as the new antibiotics discovery pipeline has run dry in the past decade. Our generations have enjoyed the 20th century discovery of antibiotics; yet, we need to treat them not as an inheritance from the past, but as borrowed from the future generations. If we want to live in and leave a better, safer world.

Image Credits: NIAID.

Vials of remdesivir
The study published in The BMJ found that remdesivir had no meaningful effect on mortality or other significant outcomes, like the need for mechanical ventilation.

WHO on Friday issued formal guidelines recommending against the use of remdesivir for COVID-19 patients, based on a  lack of evidence that the antiviral drug, developed by Gilead, significantly improves patient outcomes.

The recommendation followed publication of trial results on the drug in the The BMJ  involving more than 7,000 patients who had been hospitalized with COVID-19.

Reviewing data obtained from 4 international randomised-controlled  trials, the WHO Guideline Development Group (GDG) concluded that remdesivir had no meaningful effect on mortality or other significant outcomes, like the need for mechanical ventilation.

Four patients who have had COVID-19 were among the panel of leading experts to review the data.

WHO previously advised against the use of remdesivir in October, based on insufficient evidence of its benefits.

WHO did clarify, however, that further evidence would be needed to write-off the treatment completely, and encouraged continued enrolment into ongoing remdesivir trials, to provide higher certainty of evidence for specific groups of patients.

The authors of the paper wrote: “Considering the low or very low certainty of evidence for all outcomes, the panel interpreted the evidence as not proving that remdesivir is ineffective; rather, there is no evidence based on currently available data.”

The authors also said: “The unprecedented volume of planned and on-going studies for COVID-19 interventions … implies that more reliable and relevant evidence will emerge to inform policy and practice.”

“The solidarity results are available in preprint and those are publicly available. And that provided some of the largest evidence source for the guideline that we publish and the recommendation we made today that is currently under peer review in a journal and from what I know, will be available shortly,” said Janet Diaz, WHO Head of Clinical Care in Health Emergencies, in a WHO press conference Friday just after the negative WHO recommendation was announced.

Due to the negative results, WHO’s plans to “pre-qualify” remdesivir for bulk procurement and sale to developing countries have also been put on hold, said WHO’s Mariangela Simao, who oversees the prequalification process.

Gilead Sciences Ignored WHO Evidence In US FDA Submission For Drug’s Approval

The formal recommendation against remdesivir’s use followed upon statements made in October by WHO’s chief scientist to the effect that WHO’s evidence, drawn from WHO co-sponsored “Solidarity” trials of the drug, had not shown significant benefits for the drug.

The WHO Chief Scientist, Soumya Swaminathan, spoke just after the United States Food and Drug Administration had approved the drug, in a review that failed to consider the results of WHO trial findings.

At the time, Swaminathan, noted that Gilead had not included the WHO data that had provided to them in their FDA submission for drug approval. Speaking at a press conference, Swaminathan said that results had been provided for its Solidarity Trial weeks before the submission, “but it appears that the Solidarity results were not considered, were not provided to the FDA”.

She also said: “What we understand from the FDA decision yesterday was that it was based on data submitted to them from Gilead, which did not include the Solidarity Trial results.”

In a press conference on Friday, Swaminathan said that despite the negative recommendation for remdesivir, to date, the results released are still interim. And the remdesivir arm of the Solidarity Trial would continue until the sample size that had been planned originally is reached.

“The results of the solidarity trial that were released on October 15th were interim results. So the trial is continuing with the Remdesivir arm until the sample size is reached,” said Swaminathan. “We had an agreement with Gilead for a certain number of doses, and we will continue to enroll until we complete that.”

Once the trial is completed, she said that the data base would also be shared with Gilead, Swaminathan added.  But already,  a peer reviewed publication on the findings so far will be published.  Said Swaminathan: “What will be available very soon is the peer reviewed publication that should be out in the next couple of days. But it’s almost the same as what had been released in the pre-print. So most of the data is already out there.”

Image Credits: Gilead, Gilead.

Tobacco protests
The tobacco industry is responsible for more than 8 million deaths annually worldwide, but has now framed itself as being “part of the solution” to the COVID-19 pandemic.

The tobacco industry has been exploiting the COVID-19 pandemic and resulting health sector resource shortages to gain a stronger foothold in the policy corridors of many national governments – making huge donations of PPE and other desperately needed goods, new research has shown.

The Global Tobacco Industry Interference Index 2020, released by STOP (Stopping Tobacco Organizations and Products) on Tuesday, a global tobacco industry watchdog, scores some 57 countries around the world for their policy performance vis a vis the tobacco industry.

Key findings reveal that the tobacco industry used endorsement of charitable contributions to capitalize on the vulnerability of governments facing a shortage of resources during the COVID-19 pandemic, including donations of free PPE in Bangladesh, artificial respirators in Costa Rica, sanitizer in Kenya and Indonesia.

But those donations often came at a price – for instance in Indonesia the company also asked the local government of Bali to roll back restrictions on outdoor tobacco advertising.

All in all, the report found that the worst performing countries were: Japan, Indonesia, and Zambia, with  high levels of industry interference in government policies. The South-East Asian country of Brunei Darussalam, as well as France, and Uganda ranked the best.

Japan, Indonesia, and Zambia rank worst overall due to deep ties between the government and the tobacco industry.

“The coronavirus pandemic has given the industry an opportunity to knock on doors and offer immediate donations in exchange for favors down the road. Ultimately, citizens pay a price for their governments accepting tobacco industry donations: more harm, death and disease from tobacco products,” said Jorge Alday, director at the New York City-based global health non-profit Vital Strategies, and a partner in STOP, an initiative supported by Bloomberg Philanthropies.

 Big Tobacco Working To Hook New Users In Pandemic Times

The new index covers countries in Africa, the Eastern Mediterranean region, Latin and North America, Europe, South and Southeast Asia, and the Western Pacific region. This is compared to just 33 countries reviewed in the first index, published in 2019.

Countries were ranked on a scale of 0 to 100, with a lower score indicating a lower overall level of interference from the tobacco industry. The Index found that lack of transparency in interactions with the tobacco industry, government endorsement of tobacco-related charity, industry targeting of non-health sectors to derail tobacco control measures and conflict of interests are the main problems globally.

“Even as more countries adopt comprehensive tobacco control, the tobacco industry is working to undermine government efforts in order to hook new users and push new products,” says Kelly Henning, director of public health programs at Bloomberg Philanthropies. “They have even gone so far as to try and take advantage of the COVID-19 pandemic, when countries are desperate for resources.”

Brunei Darussalam, France, and Uganda ranked best. The 2019 report’s best-ranked country, the United Kingdom, slipped to fourth place as a result of connections between industry and current government ministers and industry participation in government consultations in 2019.

Though the tobacco industry is responsible for more than 8 million deaths annually worldwide, it has never taken responsibility for the disease and deaths its products cause, and has even framed itself as being “part of the solution” to the COVID-19 pandemic, the report states.

Although Big Tobacco aggressively targets low- and middle-income countries (LMICs) with larger populations and weaker regulations, high-income countries are also susceptible to industry interference. For instance, the UK, which scored the highest ranking in 2019, slipped to fourth place as a result of connections between industry and government ministers that have since taken office, as well as increased industry participation in government consultations.

COVID-19 Exploitation by Tobacco Industry to Gain Favor for Policy Changes

The report provides numerous examples of such exploitation, including:

  • Bangladesh. British American Tobacco (BAT) Bangladesh provided PPE to public hospitals, and the Ministry of Industries wrote to various agencies asking them to cooperate with both BAT and Japan Tobacco International during the COVID-19 shutdown.
  • Costa Rica. Philip Morris International donated artificial respirators to hospitals. The company launched its heated tobacco product (HTP) IQOS product in the country this year.
  • Kenya. BAT Kenya contributed 300,000 liters of sanitizer to government agencies. Tobacco was then listed as an “essential product” during the pandemic.
  • Indonesia. PMI’s local subsidiary, PT HM Sampoerna Tbk, used donations of sanitizer, PPE, and other goods for marketing and media coverage. The company also requested policy changes, such as asking the local government of Bali to roll back restrictions on outdoor tobacco advertising.

The tobacco industry has also intensified lobbying to enable government acceptance and industry promotion of new e-cigarettes and other “heated” tobacco products. Philip Morris International lobbied for the promotion and sale of its HTP, IQOS, in at least 12 countries which resulted in the government reversing a previous ban on HTPs. The government also allowed the sale of HTPs after Philip Morris International threatened to withdraw operations, and lowered levels of taxation on HTPs compared to cigarettes.

Countries are ranked on a scale of 0 to 100, with information provided by civil society groups in participating countries – the lower the score, the lower the overall level of tobacco industry interference.
India and South Africa Banned Some Tobacco Sales in Pandemic

On the plus side, governments such as India banned the sale of smokeless tobacco products, like chewing tobacco which is often spat onto the street. South Africa went a step further and banned the sale of cigarettes entirely between March and August, as did three municipalities in the Philippines. Mexico prohibited the sale of e-cigarettes, while the USA listed vape, smoking, and cigar shops as non-essential businesses that must close.

Civil society can expose and counter industry interference, but it is in the hands of governments to halt it altogether. They need to implement the recommendations in the report.

In its report, STOP advised the following measures governments can take to identify and prevent tobacco industry interference, including: preventing tobacco industry participation in policymaking, avoiding unnecessary interactions with the industry and ensuring transparency of meetings that do occur, and removing benefits and incentives for the industry.

“The message to governments is do not take the bait when it comes to industry offers,” said Mary Assunta, a partner in STOP and Head of Global Research and Advocacy at the Global Centre for Good Governance in Tobacco Control (GGTC). “With tobacco, there are always strings attached and ultimately the cost is paid in human lives.”

She added: “Governments can hold tobacco companies liable for the harm they cause instead, offering a win-win for the economy and health that is especially important during the coronavirus pandemic.”

Image Credits: STOP , STOP.

Frontline healthcare workers screening an individual for cardiovascular disease in Karnataka, India.

COVID-19 and non-communicable diseases (NCDs) are combining as a “syndemic” that reinforce each other and disproportionately impact the most vulnerable communities in every country during the pandemic period, said experts at a NCD Alliance panel on Thursday. 

However, primary health care workers, particularly nurses, who are the backbone of routine NCD responses have been particularly stretched during the pandemic, challenging NCD progammes. The panellists were speaking at a session on “COVID-19 and Noncommunicable Diseases: a healthcare workforce perspective.” The session focused on shared experiences and challenges of continuing care for those with NCDs in the midst of the COVID-19 pandemic in Rwanda, the United Kingdom, and India. 

Overall, people with NCDs are at an increased risk of serious COVID-19 disease and death. Approximately one fourth of the global population is estimated to have an underlying condition that increases their vulnerability to COVID-19, mostly due to NCDs. 

“In many disadvantaged communities, COVID and NCDs are experienced as what is increasingly being termed as a syndemic, a co-occurring synergistic pandemic that is interacting with and increasing socioeconomic inequalities,” said Katie Dain, CEO of the NCD Alliance. 

Noncommunicable diseases, including cardiovascular disease, hypertension and diabetes, are the world’s leading source of premature death, disease and disability, killing 15 million people annually. 

The pandemic has caused widespread disruptions in routine health services, screening, diagnosis, treatment, and palliative care for those with NCDs. Delays in diagnosis could lead to more advanced diseases and interruptions in therapies risk the wellbeing, recovery and survival of NCD patients. 

NCD diagnosis and treatment was the most frequently disrupted health service during the COVID-19 pandemic, according to a WHO survey released in June. Of the 122 countries surveyed, 39% reported that NCD-related clinical staff were deployed to provide COVID-19 relief, 46% reported a closure of population level screening programmes, and 32% reported insufficient staff to provide NCD services. 

Katie Dain, CEO of the NCD Alliance, at the media briefing on Thursday.

Said Dain: “What we can see is that COVID-19 has exposed the real damage that neglecting NCDs and cutting public health spending on health, including the health workforce, has done over many years in many countries.” 

Half of countries worldwide lack national guidelines for the prevention, early diagnosis, and treatment of the four major NCDs, cardiovascular disease, diabetes, cancer, and chronic respiratory disease. And only a third of countries can provide drug therapies and counselling services to their populations to prevent heart attacks and strokes, she said. 

“A joint approach is needed across education, training, employment, and investment in the workforce to provide integrated, people-centered care for NCDs,” said Elisabeth Iro, WHO Chief Nursing Officer. “Nurses…have a crucial role in health promotion, literacy and management of NCDs. They are key for connecting people to appropriate, timely information, services, referrals, follow-ups, and continuity of care.”

Prior to the pandemic, NCD services were already suffering from serious under-investment. The deployment of NCD healthcare workers to support the response to COVID-19 further exacerbated resource shortages.  However, there are bright spots. Examples of how health systems in Rwanda, the United Kingdom and India met those challenges creatively were showcased at the session. 

Rwanda
Gedeon Ngoga, a NCD nurse and educator in Rwanda.

Partnerships between hospitals and the government in Rwanda enabled a decentralized system of providing care and treatment to NCD patients during COVID-19. Private cars and ambulances were used to transport patients to the hospital for essential treatments and food was delivered to housebound people living with NCDs. 

“The integration and decentralization is one of the approaches and mechanisms to accelerate the achievement of the SDGs [Sustainable Development Goals] for universal access for all, especially for noncommunicable diseases,” said Gedeon Ngoga, NCD nurse and educator. 

United Kingdom

The disruption of NCD services and deployment of NCD clinical staff was exacerbated by a shortage of 40,000 nurses in the UK in the National Health Services at the start of the pandemic. The need for palliative and end of life care for cancer and other NCDs in community health services has doubled during COVID-19, taking a toll on an overstretched workforce.

However, one community that has benefited from increased support and care during the pandemic is homeless individuals. A programme was developed to provide hotel accommodations and health screenings, diagnosis and treatment for homeless communities, improving their NCD health profiles.

India

The overburdened health system in India is struggling to handle COVID-19, as the country approaches 9 million total cases. The strict lockdown enforced from March to July had far reaching consequences for people living with NCDs and their livelihoods. Many could not access essential medicines and others had to choose between buying food or insulin. This led to the rationing of insulin, which is extremely dangerous and can cause diabetic ketoacidosis. 

“Many countries today are facing the double burden…the countries are not just battling the virus, but also the overburden of NCD-related challenges,” said Apoorva Gomber, a doctor working in Delhi. “The COVID-19 crisis has opened up a window of opportunity and it is up to us to acknowledge the overburdened health system in each country and raise the urgency of ensuring equitable access to health care.”

Mobile medical service set up in Karnataka state, India to assist vulnerable populations.

Image Credits: Flickr – Trinity Care Foundation, NCD Alliance, Flickr – Trinity Care Foundation.

Shoppers in Geneva on 6 June, following nearly two months of lockdown. Many European countries, including Geneva, are now re-implementing partial lockdowns. Some, like the UK, have re-introduced full, national lockdowns.

A tier system to assess transmission and public health responses may be able to avoid the economic fallout from long term COVID-19 lockdowns, while combatting transmission of the disease, WHO has said.

The European region has recorded over 15.7 million total COVID-19 cases, over 4 million of which occurred in November alone. Europe now accounts for 28% of global cases and 26% of global deaths, joining the US as an epicentre of the pandemic. Several countries are resorting to lockdowns, with significant economic collateral damage.

Hans Kluge, WHO Regional Director for Europe.

A tier-based system that ranks regions based on the rate of community transmission is hoped to help stem the spread of the virus, and Hans Kluge, WHO Regional Director for Europe, has now encouraged governments to implement similar systems.

He said: “A set of proportionate measures that could be considered under each tier can better situate government actions along a gradient of severity that can go both ways without ever stalling.”

The tier system is included in the interim guidance updated by the WHO European Regional Office on 4 November. The document provides indicators and thresholds to gauge the intensity of transmission and the capacity of the health system to respond. This information is then used to guide decisions to introduce, adapt or lift public health and social measures.

On-going situational assessments at national and sub-national levels based on epidemiological indicators will provide policy coherence and predictability to decision-making on COVID-19.

It is hoped that this methodological approach would ensure “people do not think that policymakers are flip-flopping,” said Kluge. The evidence-based guidelines divide community transmission into seven categories, ranging from no active cases to very high case incidence, and assess the response capacity of health systems as limited, moderate or adequate.

“The transmission scenario, the coping capacity and the response is really the important thing to keep in mind,” said Catherine Smallwood, Senior Emergency Officer at WHO Europe.

“The ultimate aim is to prevent countries from going into a worse situation where stricter measures would be implemented. It’s really relying on an increased knowledge that we have around what works and an increased ability within the public health agencies … to calibrate those public health responses to the specific situations.”

80% of countries in Europe have reported an increase in cases over the past two weeks, overwhelming their health systems and leading to national lockdowns.

The proposed tier system would take time to impact new cases and deaths and will need to be adapted and improved based on the situation.

Kluge’s statement comes two weeks into the UK’s nationwide lockdown, which followed what is now largely considered to be a failed tier system.

Introduced in early October, the UK’s three-tier system was criticised for its ‘confusing’ restrictions, and disproportionate enforcement across the country.

New Vaccine Results Too Late for Wide Winter Distribution

Two vaccines for COVID-19 recorded an efficacy rate of more than 90% in phase 3 clinical trial, conducted by Pfizer and Moderna, but WHO has warned against public complacency.

Pfizer and BioNTech’s COVID-19 vaccine candidate exceeded expectations, showing a 90% efficacy rate.

“Technologies and pharmaceutical developments are offering us a new horizon. While vaccines won’t stop COVID-19 entirely and don’t answer all our questions, they do represent a great hope in the war against this virus,” said Kluge.

As the vaccine will be too late to be widely distributed and administered to the public this winter, low technology public health measures – including hand washing, cough hygiene, physical distancing, and mask wearing – need to be prioritized.

Masks are a particularly important measure. Although they are not a panacea for COVID-19, if mask use reached 95%, instead of the current 60% or lower, it is expected that national lockdowns would not be needed.

In addition, vaccinating against the seasonal influenza and mitigating COVID-19 transmission, through contact tracing, isolating cases, and monitoring high risk situations, are essential strategies.

“The vaccine is very important, but it’s not the silver bullet,” said Kluge.

Up to 75% COVID-19 Patients Could Be Taking Antibiotics Unnecessarily

Meanwhile, the coinciding of COVID-19 and drug-resistant bacteria is a growing concern. Antimicrobial resistance (AMR) poses a serious threat to health systems globally and could place patients with COVID-19 on antibiotics at a greater risk.

“We have a pandemic of COVID-19 that should not turn into an antimicrobial resistance pandemic, because we know from evidence that about 15% of the COVID-19 patients, in fact, need antibiotics because of bacterial infections,” Kluge said.

But studies WHO conducted in 9 European countries revealed that up to 90% of COVID-19 patients are taking antibiotics.

This week, the Wellcome Trust released a new update on “The Global Response to AMR” that said concrete progress on attacking the root causes of AMR had been too slow and key priorities like water, sanitation, and hygiene (WASH) and infection prevention and control (IPC) have not been addressed.

Image Credits: S. Lustig Vijay/HP-Watch, Pfizer.

Meeting of the WTO TRIPS Council on Thursday October 15.

 

Nearly 100 World Trade Organization member countries and entities could potentially swing behind a proposal by India and South Africa to enact a wide-ranging waiver of complex World Trade Organization requirements on the use of patented products, trade secrets and copyrights on health products during the pandemic, asserted the Médecins Sans Frontières (MSF) Access Campaign on Thursday.

MSF on Thursday called upon governments to support what it called “this game-changing step” that would allow countries worldwide to opt out of the granting and enforcement of patents and other IP related to COVID-19 drugs, vaccines, diagnostics and other health technologies for the duration of the pandemic.

The proposal for a “TRIPS Waiver” of the WTO’s requirements by India and South Africa, along with co-sponsors Eswatini and Kenya, is due to be discussed informally tomororw by WTO members, after a formal discussion last month at the WTO TRIPS Council.

The Council administers the complex rules around adherence to patent laws in international trade – Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as so-called TRIPS flexibilities that allow countries to disregard some patent rules, under certain conditions, during health emergencies.

But proponents say that the rules don’t go far enough in loosening the reins of IP control – so that low- and middle-income countries could rapidly gear up, produce and export generic or biosimilar versions of new up-and-coming drugs, such as monoclonal antibodies. Ditto for the barriers to producing COVID-19 vaccines using cutting-edge technologies like mRNA, which seem to have proved themselves in the results of Phase 3 clinical trials unveiled this week by both Moderna and Pfizer. 

Both sets of trials, involving tens of thousands of people found that the mRNA vaccines were about 95% effective in protecting people against COVID-19.  Almost as important was news that the Pfizer vaccine, developed jointly with BioNTech was 94 % effective in preventing COVID infections among older people, who are much more vulnerable to the disease.  

Race For Vaccine Distribution Set To Begin – Where, How & When ?
Most vaccine campaigns, like polio, have been aimed at children. COVID would target adults.

Pfizer is now poised to submit its vaccine for emergency use approval to the United States Food and Drug Administration by Friday, with Moderna to follow soon afterward.  With the prospects the vaccines may be approved by the FDA as early as December, the race will be on to roll out production and distribution – and the questions of who gets what vaccines first – will become all the more acute.  

But due to the huge logistics and financial challenges involved, vaccine distribution could very well prove to be even more challenging than the research itself. And low- and middle-income countries with long experience in getting the shorter end of the stick, when it comes to quickly getting access to new drug treatments, are becoming more and more anxious. 

According to an MSF background brief, based on informal polling and statements made at the 15-16 October TRIPS Council meeting, a majority of WTO members, some 99 countries, already support the waiver proposal either fully or in principle.  Those expressing full support, include: Argentina, Bangladesh, Egypt, Indonesia, Mali, Mauritius, Mozambique, Nepal, Nicaragua, Pakistan, Sri Lanka, Tunisia, and Venezuela. 

Perhaps more significant, however, is the growing list of countries that have “welcomed” the proposal and said it should be discussed further. Those include: global giant China, Turkey; Pacific influencers like the Philippines and Thailand; Latin America’s Chile, Colombia, Costa Rica, Ecuador, El Salvador, and Jamaica; and African powerhouses like Nigeria, Senegal and Tanzania. 

In addition, according to the MSF count, seen by Health Policy Watch, support has been expressed in principle by dozens of other countries as members of various WTO trade alliances, including: 

  • The “African Group”, including Botswana, Cabo Verde, Congo, Cote d’Ivoire, Democratic Republic of Congo, Ghana, Morocco, Namibia, Seychelles, Togo and Tunisia;  
  • Organization of African, Carribean and Pacific countries, specifically Antigua and Barbuda, Barbados, Belize, Cuba, Dominica, the Dominican Republic; Fiji, Ghana, Grenada, Guyana, Papua New Guinea, Saint Kits and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Solomon Islands, Suriname, Tonga, Trinidad and Tobago, Vanuatu, the Bahamas, Comoros; Equatorial Guinea, Ethiopia, Sao Tomé and Principe, and Somalia.
  • Chad on behalf of most other members of the WTO’s “Least Developed Countries group not already supporting the proposal individually.  The group includes some 45 other African and Asian countries, as well as small island states; 

Against that growing wall of low- and middle-income country opinion,  most of the world’s developed countries have lined up against the waiver proposal, led by the United States, the United Kingdom, Australia, Japan and the European Union – but also including Switzerland, Brazil, Norway and Canada. 

Developed countries have largely grouped behind the WHO co-sponsored ACT Accelerator, including its COVAX facility – a procurement network that now includes 186 countries. COVAX aims to secure and distribute sufficient vaccinedoses to immunize health workers and at-risk populations globally by pooling large vaccine purchase orders to pharma, without upending patent rules. Similar schemes are underway, under the broader ACT umbrella, to pool and procure orders for the large-scale purchase of COVID medicines and diganostics.

European Union, South Africa, Norway and WHO Issue Call to G20 for Billions in Funding 
European Commission head Ursula von der Leyen, Melinda Gates, Norway’s Erna Solberg and (upper right) WHO’s Dr Tedros Adhanom Ghebreyesus speak at the Paris Peace Forum.

But that scheme still requires some US$ 28 billion in funds to ensure that some 92 countries that cannot afford to buy pricey new COVID vaccines, medicines and tests will obtain the products that they need. At the Paris Peace Forum last week, European leaders along with WHO issued an urgent appeal for money. On Thursday, WHO issued yet another high-level appeal ahead of this weekend’s planned G-20 Summit, being hosted  by Saudia Arabia, asking the Group of 20 most industrialized countries to “fully fund” the initiative, including an immediate $US 4.5 billion allocation of funds.

The letter, jointly authored by Norway’s Prime Minister, Erna Solberg, South African President Cyril Ramaphosa, President Ursula Von der Leyen of the European Commission and WHO’s Director General, Dr Tedros Adhanom Ghebreyesus, underlined that funds are now needed immediately to “lay the groundwork for mass procurement and delivery of COVID-19 tools around the world.

“A commitment by G20 leaders at the G20 Summit in Riyadh to invest substantially in the ACT-Accelerator’s immediate funding gap of US$ 4.5 billion will immediately save lives, lay the groundwork for mass procurement and delivery of COVID-19 tools around the world and provide an exit strategy out of this global economic and human crisis,” the letter states.

“With this funding, and a joint commitment to spend a proportion of future stimulus on the COVID-19 tools needed globally, the G20 will build a foundation to end the pandemic. This year’s G20 Summit takes place during the most serious global crisis in memory and could mark on the most important moments in multilateral cooperation.

The letter, co-signed by South Africa, which is also leading the WTO waiver initiative, as well as by the EU’s Von der Leyen, whose countries oppose the same, also hints at how the G-20 leaders’ response could impact the future course of debate on the trade and IP front, stating:

“We need the G20 to continue to lead, not only in securing the necessary resources to end the COVID-19 pandemic, but also in addressing the crisis from a strategic macroeconomic perspective that transcends national and sectoral interests and demonstrates joint global action.”

In other words, if  rich countries step up to the bat with massive funding – and big pharma actively joins the ACT initiative with massive offers of voluntary licenses to expand needed vaccines and medicines production – then a polarizing debate at the WTO might be avoided. But if funds fall short, and low and middle income countries can’t access new, lifesaving technologies – then the WTO option may become much more attractive. And its sponsors have already suggested that they might even take the measure to a vote at the WTO – shattering the tradition of decision by consensus.

The Hurdle of Fair Distribution Of Patented Vaccine Supplies

Even if funds become available to purchase brand-name vaccines produced by Moderna, Pfizer and others through the ACT Accelerator, the next problem will be the rapid scale-up of vaccine manufacturing and thus supplies. 

Rich countries have already snapped up huge quantities, if not the lions share, of all of the vaccines that Moderna and Pfizer are planning to manufacture next year. And to hedge their bets further, those same countries have also made pre-orders of vaccine doses from other pharma companies which have other front-running candidates in final stage trials.

Moderna’s vaccine is particularly relevant to low and middle income countries because the vaccine can be stored at 2 ° to 8 ° C (36 ° to 46 ° F) for up to 30 days, for longer at around -20 C ° (-4 F °). In comparison, Pfizer’s vaccine needs ultra-cold storage temperatures of -70 C ° or below. 

The Boston-based Moderna has said that it is on track to manufacture 1 billion vaccine doses in 2021 in collaboration with the Swiss-based manfacturing firm Lonza, at sites in the USA and Visp, Switzerland.

But with pre-orders for some 300.5 million doses, and options to purchase another 480 million more doses – high income countries already have a corner on the market for 780.5 milion out of the 1 billion doses to be produced by Moderna in 2021. Countries with the largest pre-orders and options include the United States, the European Union, Canada, Switzerland and Japan.

Vaccine research at the US National Institutes of Health – the US government has poured billions into pharma R&D

That would mean up to 78% of Moderna’s available vaccine supply would go to countries representing just 12% of the world’s population, as a coalition of NGOs recently pointed out.

Another issue being raised by access groups is the potential price tag companies will put on their vaccines, versus the public subsidies that the same vaccine R&D has already received.  Leading pharma firms developing COVID vaccines have so far received some US$ 12 billion in public funds, according to MSF. That includes Moderna’s receipt of some US$ 2.48 billion in United States government public funds. And yet Moderna’s reported price tag for the two-dose vaccine at $US 50-60 per course is the reported to be the “highest cited for a potential vaccine so far.”

Moderna’s ‘No Patents Enforcement’ – MSF Says Its Not Enough 

Against the background of the pandemic, Moderna, as well as other pharma companies have already made gestures indicating that they would not try to do business as usual.

AstraZeneca, another firm with a vaccine in Phase 3 trials, has pledged to sell its vaccine, if approved,  on a not-for-profit basis for as long as the pandemic continues. The company, which co-developed its vaccine with researchers at the UK’s Oxford University, also recently signed a licensing agreement with Brazil’s world-class public research institution, Fundação Oswaldo Cruz (Fiocruz) to produce 100 million vaccine doses. But critics point out that, despite these moves, the no-profit clause may only be good until July, 2021.

Moderna, for its part, has pledged “not to enforce our patents” on its novel mRNA vaccine technology for the duration of the pandemic. In theory, this could mean that other vaccine manufacturers with capacity to make biosimilar versions  (the biological equivalent of generics) could theoretically step into the vacuum, as soon as the Moderna vaccine wins FDA approval, to scale up production much more. 

But access advocates say that Moderna’s pledge so far has not included any commitment to actually license its novel mRNA technology to other manufacturers, so that they could acquire the know-how to produce the novel vaccine.  

While pharma voices point out that many low- and middle-income countries don’t even have the capacity to handle sensitive vaccine technologies, some do. They include India, which is the other key co-sponsor of the WTO initaitive. 

And for countries like India, with significant pharma export potential, a WTO waiver could be far easier to manage, sources say, than the current IP “flexbilities” offered by the TRIPS system in cases of public health emergencies.

Those TRIPS flexibilities largely revolve around Article 31 and 31bis of the TRIPS agreement, which stipulate that countries may issue “compulsory licenses” for patented products.  But, they must do so on a case-by-case basis, and for use primarily in domestic markets.  MSF sums up the rules, and their limitations, like this: 

  • Article 31 requires that compulsory licenses are issued on a case-by-case basis and used predominantly to supply domestic markets, thereby limiting the ability of manufacturing countries to export to countries in need.
  • Article 31bis requires that any product produced and exported under a compulsory license be identified with specific packaging and quantities, which can lead to unnecessary delays in the context of COVID-19 where countries need urgent access to medical tools.

Concludes the MSF brief, despite the “no enforcement” pledge, Moderna, Pfizer and other large pharma firms engaged in promising vaccine trials would need to go much further with voluntary steps to really make a difference in the yawning demand that will open up as soon as new vaccines and drugs are approved: 

“Moderna must share all IP, including the necessary technology, data and know-how, so that other manufacturers can scale up production of these potentially lifesaving vaccines. Many COVID-19 vaccine developers, including Pfizer/BioNTech, have taken no steps towards licensing or transferring IP-protected technologies to enable increased global manufacturing capacity and supply.” 

-Menaka Rao contributed to this story. 

 

Image Credits: WTO, Moderna TX, United Nations Photo, National Institutes of Health (NIH) .

Global health is acting out of a legacy of colonial influences, where rich countries dominate policies that determine how key health investments are made, and where distribution of health products may take place.

The current power dynamics in global health are a barrier to achieving health equity, partly because too many high-profile politicians are simply reluctant to listen to, or act upon, scientific evidence, and partly because of countries and institutions that wield disproportionate influence in today’s global health architecture aren’t willing to relinquish their power: a left-over of colonial influences.

Sarah Hawkes, director at the Centre of Gender and Global Health.

At the Geneva Health Forum session on Wednesday, ‘How do We Decolonialise Global Health?’, Sarah Hawkes, director at the Centre of Gender and Global Health, asked: “Why don’t people, particularly in political circles, use the evidence that’s in front of them?”

Hawkes urged that people in the global health sector need to evaluate “how we’ve ended up in a situation where very powerful political stakeholders are seen as anti-evidence and anti-science”.

Further confounding matters, she added: “We have ended up in a position in 2020 where those people with political power are not necessarily the same or equal to those with financial power.”

Health Equity – A Fragile Concept

Tammam Aloudat, Senior Strategic Advisor Access Campaign at Médecins Sans Frontières (MSF), noted that populist politics also have made health equity a fragile concept.

Tammam Aloudat, Senior Strategic Advisor Access Campaign at Médecins Sans Frontières (MSF).

And since financing and funding still determine many aspects of delivering health, he added: “What stands now is a set of norms that allocates resources, and that is controlled by power hierarchies, that can aim as much towards perpetuating their own power as towards improving health and prosperity.”

Global health is also acting out of a legacy of colonial influences, where rich countries dominate policies that determine how key health investments are made, and where distribution of health products may take place.

“Rarely has any colonial power, in classic colonialism, given up its position of power willingly by the kindness of their hearts,” Aloudat said.

Historically, those holding power relinquished control “because [they were] incentivized” one way or another. Without proper incentives, he argued, it may be difficult to convince countries and institutions that wield outsized power in the present day global health arena to commit to real health equity.

This is evident in the burgeoning debate over the fair distribution of COVID-19 vaccines. Two vaccines have now been reported to have an efficacy of greater than 90%, but how and when these will be administered in low- and middle-income countries (LMICs) remains unclear.

Stakeholders Must Acknowledge Global Health’s Colonial Legacy

In any case, it is important for stakeholders to acknowledge that global health’s legacy “isn’t all good and fuzzy”, keynote speaker Dr Mishal Khan said.

Dr Mishal Khan, Associate Professor at the London School of Hygiene and Tropical Medicine (LSHTM).

Khan, an Associate Professor at the London School of Hygiene and Tropical Medicine (LSHTM), said that global health players need to start thinking about how decolonisation could be framed, she added. Currently, it is proffered in a way that is so “naive” as to assume that everybody is on board and everybody cares.

In early November, when Khan spoke to Health Policy Watch, she noted that while colonialist influences in global health are ubiquitous, the issue still hasn’t attracted sufficient attention.

At the GHF session, she clarified that stakeholders in the health sector need to be “very clear on imagining what sort of new global health we want to see, and then looking into organizations and asking them what they are going to do.

“What steps are you going to take as an organization to become closer to that?”

Open Dialogue Needed On Decolonisation

Open dialogue and a commitment towards decentralisation are key to tackling colonialist influences, the panelists also stressed.

Seye Abimbola, Editor of BMJ Global Health.

Seye Abimbola, Editor of BMJ Global Health noted that an ‘open dialogue’ process would provide clarity on what changes stakeholders want to see, first of all.

“Getting clarity on what the change looks like is an incentive because it can help galvanise energy behind goals. Imagine what that world looks like, and start taking concrete steps,” Abimbola said.

COVID-19, moreover, has presented an opportunity for global health actors to realise that decentralizing power is feasible. For instance, Geneva’s global health organisations have been forced to shift more staff and responsibilities from headquarters to national and regional offices, as a result of travel restrictions that have dramatically curbed international travel.

More Acknowledgement of ‘Shared Burden’ of Universal Health Coverage Goal

The panellists also noted that the pandemic has strengthened awareness about the importance of universal health coverage (UHC) – among both rich and poor countries – in order to stave off future health threats.

Emanuele Capobianco, Director for Health and Care at the International Federation Of Red Cross And Red Crescent Societies.

Whereas “global health” used to be seen largely as a system to enable developing countries’ health systems, the pandemic has revealed – to many for the first time – that there are big gaps in UHC in developed countries as well, said Emanuele Capobianco, Director for Health and Care at the International Federation Of Red Cross And Red Crescent Societies.

“We are very passionate about UHC breaking away from an oppressive way of thinking. UHC breaks away from that, bringing issues of access to healthcare. From Malawi to Switzerland, health access predominates in the COVID pandemic,” Emanuele said.

Image Credits: Geneva Health Forum.

The COVID-19 pandemic did not so much create cracks in healthcare systems around the world, as it exposed weaknesses in them, participants at the Geneva Health Forum said Wednesday at a session on how health systems have fared during the COVID-19 pandemic.

Edward Kelley, Director of Integrated Health Services Universal Health Coverage and Life Course, WHO.

“We have found fragility everywhere,” said Edward Kelley, Director of Integrated Health Services Universal Health Coverage and Life Course, WHO, during the session entitled Health Systems Resilience in a Pandemic Crisis, co-sponsored by the World Economic Forum.

In order to strengthen healthcare systems so they can withstand the brunt of health emergencies, more private-public cooperation is critical, said Kelley and other participants, which also included a representative of India’s health ministry and the pharma sector.

For a long time, universal health coverage (UHC) has been seen as a primarily public sector function. This, however, should not be the case, according to Kelley: “There is no way we will get to where we need to be by making this anything but a public and private partnership.”

Shri Rajesh Bhushan, India’s Secretary of Health & Family Welfare, cited India’s experience in the pandemic, which saw unprecedented public-private health sector cooperation, while also keeping death rates low.

“For the first time ever, various state governments and the Union [central] Government closely coordinated with the private sector healthcare providers to repurpose their ICU, oxygen and isolation beds, to suit the needs of COVID,” said India’s Secretary of Health & Family Welfare, Shri Rajesh Bhushan.

Shri Rajesh Bhushan, Secretary of Health & Family Welfare, India.

In fact, while India has seen 8.8 million reported COVID cases, that is still only about 25% as many, per capita, as the US. And, per capita, India has recorded half as many deaths.

Whereas the global mortality rate from people with confirmed cases of COVID hovers around 2.46%, the mortality rate in India is 1.48%. This translates to 2.5 deaths per million population, which is about 10 times less than the US, “and quite a bit less than other countries in Europe like Belgium,” added Bhushan.

Digital Care Allowed for Better Resource Prioritization

The partnership space should not only cater for physical modes of healthcare provision. Rather, it needs to extend to the digital or virtual approaches of dispensing care. AstraZeneca executive vice president, Iskra Reic, described how the multinational pharmaceutical company partnered with the UK’s NHS during the COVID pandemic to create what is dubbed a ‘virtual ward’ for COVID patients.

This digital solution allowed vulnerable and at-risk patients to get care without physical interaction with a physician.

Reic, who oversees operations in Europe and Canada, said that the digital solution has eased the workload for physicians, in addition to easing pressure on the healthcare system and patient traffic, something which in and of itself can be a risk factor for COVID-19 transmission.

“It has helped physicians prioritize, and really focus their time and effort on those who are at the highest risk.”

Image Credits: Geneva Health Forum.

Healthcare workers wear protective gear at a community-based testing site for COVID-19 in Madagascar, OCtober 2020.

Experts met at the Geneva Health Forum (GHF) this week to discuss the successes and challenges met in expanding social health protection to achieve Universal Health Coverage (UHC).

Every year, around 100 million people are pushed into “extreme poverty” because they have to pay for health care, and over 800 million people – almost 12% of the world’s population – spend at least 10% of their household budget on health care costs, according to WHO figures.

With half of the world’s population still not having access to the health services they need because of financial constraints, social health protection – meaning any kind of financial system that assures access to health care, including both free national health insurance or affordable health insurance plans – is vital to bridge this gap and reach the goal of UHC set by the 2030 Sustainable Development Agenda.

“A number of countries are trying to strengthen their efforts and expand social health protection as a right – a right to be enjoyed by everybody,” said Claude Meyer from P4H Social Health Protection Network, speaking at a GHF event on Tuesday to discuss global efforts to extend social health protection systems to achieve UHC. “But they are often confronted with what we call fragmented systems of coverage, and these fragmented systems of coverage affect equity.”

The GHF invited three experts to reflect on the ways this fragmentation of health care can be reduced while extending coverage, and offer examples of methods in practice across different countries.

Merging Social Health Protection Systems

Valeria Schmitt, deputy director of the social protection department at the International Labor Organization (ILO), discussed how merging different systems could serve to reduce admin costs and ensure healthcare services are more widely available.

“Regarding fragmentation of institutions, it’s very clear that instead of having two or even three institutions in charge of access to health care, as it is the case in Thailand for instance, merging the operations would reduce admin costs,” said Schmitt.

But such a move is by no means easy. Thailand has been attempting to merge the three systems into one for many years to level up inequalities between the care available for the three different social groups that are protected by each scheme – civil servants, workers in the so-called formal sector, and informal workers .

Aungsumalee Pholpark, lecturer at the department of society and health at Mahidol University in Thailand, explained that, if achieved, combining the three schemes into one would hopefully solve problems that exist in the current systems, where informal workers often receive lower standards of care.

Difficulty Reaching the Most Vulnerable Populations

There are also specific challenges within certain populations, the panelists noted, especially hard to reach communities that may be remote from central administrations and institutions. Matthew MacGregor from the Global Fund discussed how, as countries make changes and transition between systems to achieve UHC, the most vulnerable populations are at risk of being left behind.

“At the Global Fund, enhancing equity and making sure that services reach the most vulnerable and are sustained even beyond our financing is a critical and major piece of our work,” said MacGregor. He emphasised the importance of external funding to strengthen public health systems and outreach programmes to make sure health care services, when available, can actually reach the most vulnerable populations.

A New Recognition for UHC After COVID-19

The experts also discussed the key lessons of COVID-19 in terms of UHC – primarily the importance of investing in social protection systems for health coverage.

“Countries that already had relatively strong social protection institutions in place were able to react to COVID-19 much more rapidly and efficiently,” said Schmitt, citing the example of Indonesia, which has invested heavily in its national health insurance system for many years and was able to rapidly distribute testing and treatment widely among the population.

Schmitt also noted how COVID-19 had highlighted the need to ensure people at all levels of society had equitable access to a high standard of health care, and the ability of governments to make this happen.

“I think COVID-19 has shown that when you have the political will, you can implement social health protection and social protection in general, and that there is solidarity at the level of the international community,” she said. “So this gives a message of hope that if all the countries want to achieve universal health coverage and universal social protection, they can make this happen.”

Health Policy Watch Watch is collaborating with Geneva Solutions, a new non-profit Geneva platform for constructive journalism covering International Geneva

Image Credits: Flickr – World Bank.

antimicrobial resistance test on bacteria in petri dish
Recent AMR successes include increased prominence in global discussion and a robustly funded discovery-stage and translational research but momentum and public communication have been long-standing issues.

The COVID-19 pandemic has underlined the need to dramatically step up the combat against drug-resistant bacteria, viruses and other pathogens. The world can’t afford to be caught again by surprise with the spread of a dangerous infectious disease for which there is no cure, a growing chorus of global health leaders are warning as the world observes World Antimicrobial Awareness Week (18 – 24 November).

“The antimicrobial resistance (AMR) agenda must move forward with renewed vigor and momentum in the global health space, one that can fit into a post COVID-19 narrative,” says Timothy Jinks, Head of the Drug Resistance Infections Program at Wellcome Trust.

Timothy Jinks, Head of Wellcome Trust’s Drug Resistant Infections Priority Program, speaking on Wellcome Trust’s “The Global Response to AMR” Report

He spoke as the Wellcome Trust released a new update on “The Global Response to AMR” that said concrete progress on attacking the root causes of AMR had been too slow and key priorities like water, sanitation, and hygiene (WASH) and infection prevention and control (IPC) have not been addressed.

To up the political ante, WHO will be launching Friday a new “One Health Global Leaders Group on Antimicrobial Resistance” (AMR) – led by Sheikh Hasina, Prime Minister of Bangladesh and Mia Mottley, Prime Minister of Barbados – whose mission will be to give the issue more visibility among other world leaders. The “One Health Global Leaders” initiative was first announced in August by the  WHO, the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE)- which are trying to work together more closely to curb both human and animal use of precious drugs – which is one of the key drivers of AMR.

“The world is in an arms race against antimicrobial resistance and we hope the new group will consider solutions on all fronts against AMR, including encouraging sustainable production of antimicrobials,” said Alba Tiley, the Global Director of the Sustainable Antibiotics Program at Centrient Pharmaceuticals, regarding the WHO initiative. Centrient, a generic pharma firm based in Rotterdam, Netherlands, is one of the few remaining antibiotic manufacturers in Europe. Their portfolio covers many medicines on the WHO Essential Medicines list including amoxicillin, penicillin and cephalosporins. 

“We need to make sure the very process of making these life-saving medicines does not contribute to antibiotics losing their effectiveness.”

Three Critical Gaps – Wellcome Trust Report

AMR already causes some 700,000 deaths annually. But if current trends are not reversed, that number could rise to 10 million per year by 2050, a special UN task force has warned.

As antimicrobial drugs lose their efficacy due to AMR, risks of prolonged hospital stays or additional surgical interventions increase substantially. AMR burdens health systems already struggling with cost inflation, and damages national economies from increasing illness and death that further hit health budgets. These health and economic burdens disproportionately fall on low and middle-income countries (LMICs). The Wellcome Trust report zeroes in on what it describes as three key gaps in global AMR response, that drive the risk of irreparable loss of valuable drugs.

  • Ambition has not translated into action. Though there has been a prominent increase of global discussion on AMR over the past three to four years, this has not translated into a broader implementation of initiatives, especially in LMICs, where AMR typically competes for political attention and resources with other public health topics.
  • The most critical drivers of AMR need to be prioritized. The ‘big tent’ approach of the AMR response to date has increased awareness among a broad range of stakeholders. However, AMR experts are concerned that the multifaceted nature of the issue, the complexity of its narrative, and the multitude of possible interventions are paralysing the community, preventing impactful action.
  • The AMR agenda was losing momentum before SARS-CoV-2 emerged. And now? Already in late 2019, a growing circle of experts perceived the AMR agenda as losing momentum, due in part to the complexities of communicating about the issue to the broader public. The COVID-19 pandemic has exacerbated those concerns.
The report notes that the COVID-19 pandemic has demonstrated how vital it is to conduct R&D to combat novel and drug-resistant viruses

New Opportunities – and Solutions

At the same time, now that politicians and the broad public have seen what damage an invisible virus can wreak, when no drug treatment exists, the time may be more ripe for warnings that this could happen again – very soon – if AMR trends aren’t vigorously addressed.

Wellcome Trust’s key preventative measures for the next decade

The Wellcome Trust report etches out a way forward for the next decade. The plan of attack focuses not only on accelerating the pace of R&D for new drug therapies to replace those rendered impotent by drug resistant bugs, but also limiting abuse of drugs in use now. Among the key preventive measures, are:

Human consumption of antibiotics: Optimising human consumption of antimicrobials requires guaranteed access for those who need treatment – but adequate stewardship to limit overuse and abuse. This requires much stricter regulation of sales and use of classes of antibiotics and antiviral agents to which bacteria have developed, or are beginning to develop, resistance. In particular, greater restrictions on over-the-counter sales to the public – and more public awareness about the appropriate use of such drugs, is needed.

Antimicrobial use in animals: A response that is preventative that doesn’t focus purely on treatment requires a holistic perspective that includes other topics such as ensuring appropriate antimicrobial use in animals. There needs to be a more prudent use of drugs needed for humans in the livestock sector, which is one of the world’s largest consumers of antibiotics, particularly in the USA, Europe and other OECD countries.

Water, sanitation, and hygiene (WASH): Access to clean water and better management of sewage runoff both prevents infections, reducing the need for drugs in the first place,  as well as reducing untreated waste streams laced with antibiotics or other drug residues that act as reservoirs where drug resistant pathogens might breed.

Infection prevention and control (IPC): IPC measures in hospitals and communities reduce the need for antibiotics and their consumption.

Surveillance: Right now, only about one-third of countries gather data and report systematically on use of antimicrobial drugs.  Much more effective surveillance systems also are critical to understanding the problem, designing and implementing interventions, and assessing the effectiveness of the response, the report underlines.

Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint)

Scaling up Research and Development for New Drugs

Research and development also needs to be scaled up dramatically, the report emphasizes. This has already begun to happen, with the establishment of a new Global Antibiotic Research and Development Partnership (GARDP), created by the World Health Organization (WHO) and Drugs for Neglected Diseases initiative (DNDi), which aims to drive more private and public investment into R&D to replenish the antibiotic drug pipeline. In July an AMR Action Fund of nearly $1 billion was also established by more than 20 leading biopharmaceutical companies, with a mission to bring 2-4 new antibiotics to patients by 2030.

In addition to that, the Wellcome report also underlines that in light of the COVID-19 pandemic – the source of which is a virus, not a bacteria – that R&D to combat new and drug-resistant strains of viruses, and other pathogens must also occur continuously and sustainably.

In addition, by preventing infection in humans and animals, vaccines play an important role in reducing antimicrobial consumption.

Can COVID be an Opportunity?

Despite the complexity of the issue, this week is seeing a flurry of activity that suggests the ripples of a broader awakening about AMR.

During Wellcome Trust’s panel on Wednesday, global leaders brought up AMR’s unique role in the face of the COVID-19 pandemic. 

COVID-19’s impact on the AMR global response

“So while COVID-19 is taking over the public health dialogue, it simultaneously has opportunities through this pandemic that we should strategize around. This is prevention’s moment; prevention has never been sexier,” says Lindsey Denny, a health advisor at Global Water 2020, and a global health practitioner with experience across Africa, Asia, and Latin America. Denny spoke to how the pandemic has generated a better understanding of public health principles such as WASH and the importance of PPE. “We can and should capitalize on advocating both to decision makers and to the broader public for WASH and IPC strategies.” 

Jyoti Jyoshi, Head of the South Asia Center for Disease Dynamics, Economics, and Policy, discussed the need for the AMR community to integrate itself more so into the global health sphere. “The AMR community should tie in with the large global health preparedness and systemic response agenda. Because we don’t live in isolation. Infections don’t need visas. It’s a flat wall – people travel just as microbials and chemicals like antibiotics do.” 

There was also a joint statement on the AMR threat issued today by very diverse group of actors, including: the International Alliance of Patient Organizations, the International Hospital Federation, the International Society for Quality in Health Care, and the International Federation of Pharmaceutical Manufacturers and Associations.

The statement supports innovative partnerships of healthcare providers, patients and the business sector in tackling the growing AMR threat.

In an op-ed in Geneva Solutions, Neda Milevska, vice-chair of the International Alliance of Patients’ Organizations, says it is also the patient’s responsibility to become more aware about the need to prevent the abuse and overuse of antibiotics and other drugs.

She describes the approach as one that can also enhance patient empowerment, saying that so far, the power of patients has been ignored by policymakers in the battle against AMR, even though personal behaviour plays a major role: “Among patients today, there is widespread practice of self-treatment with antibiotics. This is stimulated even more so by the COVID-19 pandemic, as physicians have increasingly prescribed antibiotics to stave off increased illness, which feeds back into the loop of drug-resistance.

“It is always politically sensitive to mention that patients have some responsibility. But, no amounts of funding to develop new drugs or curb AMR now will work, if people at the grassroots continue to abuse their life-saving potential. The magnitude of people’s power is so great .. .and it can be destructive or productive.”

Image Credits: DFID – UK Department for International Development, Wellcome Trust, USAID Asia/Flickr, antibioticfootprint.net.