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Issue #1658      October 1, 2014

Call for global action on antimicrobial resistance

Civil society organisations (CSOs) and other stakeholders across six continents, grouped under the newly established Antibiotic Resistance Coalition, have called for international leadership and concerted global action to address the escalating crisis surrounding antimicrobial resistance.

In this regard, they urged the member states of the World Health Organisation (WHO) to pass a critical resolution on “Combating antimicrobial resistance, including antibiotic resistance” at the 67th session of the World Health Assembly.

The resolution, which, amongst others, requests the WHO Director-General to develop a draft global action plan to combat antimicrobial resistance, including antibiotic resistance, was eventually approved at the WHA.

“Antimicrobial resistance – and particularly antibiotic resistance – is the most pressing public health issue facing the global community,” said Otto Cars, founder of ReAct (Action on Antibiotic Resistance), in a Coalition press release. “If the resolution is not passed, and the WHO and its Member States do not act quickly, there will be disastrous global health consequences.”

According to the Antibiotic Resistance Coalition, public health researchers estimate that, each year, millions of people around the world are infected with antibiotic-resistant bacteria, and hundreds of thousands of them die, and that without immediate action, that toll is expected to worsen.

“We are on the precipice of a post-antibiotic era,” said Tim Reed, executive director of Health Action International. “Without a radical shift in the way antibiotics are marketed and used – and unless we overcome the gap in antibiotics discovery – antibiotic resistance will continue to become one of the greatest threats to humankind.”

In releasing a Declaration on Antibiotic Resistance on May 22, the Antibiotic Resistance Coalition underscored that consumer protection and public health must trump the pursuit of profit, and that effective antibiotics are global public goods.

Overuse and misuse

Various research studies trace accelerating trends in growth of antimicrobial and antibiotic resistance for disease treatments to the overuse and misuse of antibiotics in human medicine, industrial food animal production and the food-processing sectors, in commercial animal husbandry for routine disease prevention in livestock, and their use for growth promotion.

Among the original signatories to the Coalition’s Declaration are the Alliance to Save Our Antibiotics, the Centre for Science and Environment, Consumers International, Food and Animal Concerns Trust, Health Action International, Healthy Food Action, Institute for Agriculture and Trade Policy, People’s Health Movement, Public Citizen, ReAct – Action on Antibiotic Resistance, South Centre, Sustainable Food Trust, Third World Network, Universities Allied for Essential Medicines and What Next Forum.

“Member States must deliver a strong mandate to WHO to not only develop a pressing action plan on antimicrobial resistance, but also to ensure that public health is prioritised over commercial interests,” said Chee Yoke Ling, program director with the Third World Network. “Access to affordable and effective antibiotics is of particular importance for developing countries.”

The Coalition called for international leadership and action to, in part: prohibit the promotion and advertising of antibiotics; promote new, needs-driven and open research and development models based on the principle of de-linkage (divorcing price from research and development costs and sales volumes); phase out the use of antimicrobials for routine disease prevention in livestock, and end their use, altogether, for growth promotion; build robust systems, in all countries, to monitor and report antibiotic use and resistance trends in humans and animals; and improve public awareness to support an ecological understanding of human-bacteria interaction and behaviour change around antibiotic use.

Undermining medicine

In its Declaration on Antibiotic Resistance, the Coalition said that antibiotic resistance threatens to undermine the effectiveness of modern medicine.

“More and more strains of bacteria are resistant to an ever-rising number of antibiotics, with no new antibiotics on the horizon to treat some of the most serious infections. The change is global and accelerating. Millions of people are infected with antibiotic-resistant bacteria each year; hundreds of thousands lose their lives. The toll will increase,” it said.

Antibiotic use causes resistance to emerge, and their misuse and overuse accelerates its spread. Without a radical change in antibiotic usage, antibiotic resistance will become one of the greatest threats to humankind, to security and to the global economy, the Coalition warned, further noting that efforts to slow the march towards this dire future have largely failed.

In its Declaration, the Coalition affirmed, amongst others, that clinically useful antibiotics are a finite resource and a global, essential public good, and that consumer protection and public health must not be subordinated by governments or international institutions to the pursuit of profit.

“Public leadership is needed to enact new, needs-driven research and development models, with open research and transparent data, which support rational use and equitable access to antibiotics,” it said. “National-level action is paramount, international cooperation is essential, and the collective responsibility of all stakeholders is crucial in order to bring about a solution to the escalating healthcare crisis caused by antibiotic resistance.”

The Coalition further affirmed that effective action on antibiotic resistance requires that the social and economic determinants of infectious diseases be addressed. In many parts of the world, these are manifested through poverty, exploitation, international power relations and local inequities, as well as through poor access to nutrition, safe drinking water and sanitation.

The Coalition said it commits itself, according to the principles and actions laid out in its Declaration, “to urgently work to avert the looming post-antibiotic catastrophe”.

According to the Declaration, lack of effective antibiotics is a global concern with the potential to affect all humans and domesticated animals. It threatens to undermine the effectiveness of modern healthcare. An ever-widening range of bacteria, causing a spectrum of diseases in humans and animals, is becoming resistant to most available antibiotics.

“Unchecked, escalating antibiotic resistance will lead to the global spread of untreatable infections and massive deterioration in health and loss of life. It will also make most surgery impossible and end organ transplantation and cancer chemotherapy.’

Unrestrained marketing

While antibiotic resistance is a natural phenomenon, it has greatly accelerated with decades of unrestrained marketing by the pharmaceutical industry, which promotes overuse and misuse of antibiotics in human medicine, industrial food animal production and the food-processing sectors. For some infections resistance has already reached critical levels, said the Coalition.

“Inadequate regulation and control of the sale and use of antibiotics in animals and humans, including financial incentives for prescribers and dispensers, has been a major factor leading to this crisis.”

According to the Coalition, international organisations, such as WHO, the Food and Agriculture Organisation (FAO) and the World Organisation for Animal Health (OIE), “have so far failed to exercise effective leadership in the stewardship and responsible use of antibiotics”.

National bodies that set food standards and regulate pharmaceuticals have largely failed to control human and animal antibiotic use. Data systems for monitoring antibiotic resistance and use remain very fragmented.

“New trade and investment regimes threaten to place commercial interests above public health and consumer protection, thereby undercutting effective control of antibiotic use and resistance,’” said the Declaration.

The policy frameworks for research and development are further fuelling resistance without advancing innovation. They are failing to build on available scientific research in developing new antibiotics and diagnostics, and there is a severe antibiotic discovery gap. They are also failing to ensure access for people who need treatment and are ineffective in limiting excessive and irrational use of antibiotics.

The Declaration asserted that antibiotic treatments and diagnostics should be considered global public goods – common resources requiring common stewardship.

Public health systems

“Effective regulation and control of antibiotics must be exercised to ensure that existing and new antibiotics are made available and are affordable to those in need in all countries, while not being overused or misused. This calls for further strengthening of public health systems everywhere.”

All countries should adopt a national policy on rational use of antibiotics, as well as taking necessary action to prevent excessive antibiotic use. Regulatory controls must address prescription and marketing practices, it said.

Activities to curb excessive use must include better training of health professionals through non-commercial, evidence-based programs and sustained and targeted public education. Standard treatment guidelines should inform antibiotic administration.

“Antibiotic stewardship, involving optimal antibiotic drug regimens and appropriate duration of therapy and route of administration, as well as future effectiveness, should be incentivised, and unnecessary use should be dis-incentivised.”

The Coalition stressed that the public sector in every country needs to build a robust national system for monitoring antibiotic use and resistance trends in humans and animals, as well as contributing to the development of an effective global monitoring system.

Diagnostic uncertainty must be minimised through development and availability of rapid diagnostic tools and techniques. This is instrumental for timely determination of the nature of infection and to prevent irrational use of antibiotics. Promotion and advertising of antibiotics, including marketing for inappropriate uses or incentivising medical and veterinary personnel to overuse or inappropriately prescribe antibiotics, is harmful to health and should be prohibited.

“We should avoid seeing ourselves as being at war with bacteria and learn to live more harmoniously with them, except on the rare occasions when infectious strains threaten our health. Treatment of infections must be balanced with the importance of maintaining healthy populations of bacteria for humans and animals,’ said the Coalition.

Antibiotics in food production

The preservation of effective antibiotics for human health should take priority over their use for commercial gain in food production. A disproportionately high amount of antibiotics is used in animals, particularly in the industrial production of food animals. Antibiotics should only be used for treating animals when indicated by a genuine therapeutic need and based on antibiotic therapeutic guidelines.

“Antibiotic use for mass disease prevention must not substitute for good animal husbandry and welfare. Farm practices such as overcrowding, unhygienic conditions, inappropriate diets, and early weaning requiring routine antibiotic administration, must be prohibited. Similarly, antibiotic use for growth promotion must be banned,” said the Declaration.

Antibiotics considered critically important for humans must not be used for animals, except in specific circumstances in order to save life or prevent serious suffering, it added, recommending that regulations be instituted and enforced to ensure antibiotics are marked with appropriate warnings and clear distinctions between human and animal use, so as to help control and monitor antibiotic consumption.

The Coalition further said that food produced without routine use of antibiotics and without antibiotic residues should be labelled through reliable, certified schemes to facilitate consumer choice. Likewise, it added that food produced with routine use of antibiotics must be clearly labelled, until effective prohibition of such antibiotic use can be introduced.

“Civil society and consumer movements should target the supply chain by exposing and boycotting corporations that produce or provide food with routine use of antibiotics.

“Short of radical changes in our innovation system, we stand at the precipice of a post-antibiotic era. We call for public leadership promoting new, needs-driven research and development models based on the principle of de-linkage: divorcing price from research and development costs, as well as from sales volumes,” said the Coalition.

It underlined that public funding is essential, and benefits of these investments should accrue to the public. In addition, incentives should target new antibiotics with novel mechanisms of action or with significant public health value.

“We must couple these incentives with measures conserving antibiotics use,” said the Coalition.

Further noting that innovation requires access to the building blocks of knowledge, the Coalition called for public leadership to establish pooled efforts and support open research. These might include enriching compound libraries with potential new drug candidates, providing specimen banks to aid developers of new diagnostics, building clinical trial networks to ease recruitment of patients, sharing pre-clinical and clinical data, and publishing findings in open access journals.

“We call for public leadership to establish a network of bio-repositories that can harness biodiversity for natural products that might be tomorrow’s antibiotics. This will require committing public funding, enlisting the informed participation of low- and middle-income countries, where much of this biodiversity exists, in the process of innovation, and ensuring returns through fair and equitable benefit-sharing arrangements with those countries.”

Complete trial data and other information concerning the safety, efficacy and resistance profiles of antibiotics and diagnostics should be made publicly available, to advance scientific progress and rational use, with privacy protections in place.

“We reject additional intellectual property measures. These are likely to compromise patient access and reward high sales volumes without altering the current failing incentives structure. The needs of one patient group should not be sacrificed to another, for example, via proposals for an Intellectual Property (IP) voucher that would transfer the cost of antibiotic development to other patient groups,” said the Coalition in its Declaration.

The paramount concern of regulatory review of new antibiotics must be the improved health outcomes and safety of patients facing multi-drug-resistant infections. In recent years, drug regulatory agencies have amended regulations for antibiotics to approve them based on clinical trials with small sample sizes and surrogate endpoints.

However, the Coalition stressed, lowering standards of clinical trials only to incentivise drug companies to bring drugs to market without significant public health benefit is not acceptable.

“A broad, holistic approach, based on an ecological understanding of bacteria, should be encouraged so as to spur innovative ways of discovering new antibiotics as well as finding solutions and approaches to infections other than through the use of antibiotics,” said the civil society groups.

International action

With respect to international action and cooperation, the Coalition said that a global framework for action must be developed by governments through the United Nations system, in close collaboration with all stakeholders, and that such a framework must include targets and ways of tracking their achievement that can be applied according to national circumstances.

“National governments should formulate specific, measurable, achievable, realistic and time-bound targets for controlling antibiotic resistance.”

International cooperation should support low- and middle-income countries financially and technically, including through capacity-building, to enable them to implement the set targets effectively, said the Coalition, adding that international action should ensure that the terms of any global, regional and bilateral trade, investment or intellectual property rules do not undermine laws and policies that aim to implement effective controls over antibiotics.

International organisations, including both the United Nations system and other institutions, should scale up their actions and coordination to match the urgency of the crisis posed by antibiotic resistance, said the Coalition.

In this regard, it called on WHO to enhance its efforts to take a genuine leadership role by significantly expanding its in-house capacity, making a strong case for member states to provide the necessary funds, providing enhanced training and policy guidance to developing countries for strengthened national regulatory structures, establishing closer collaboration with organisations and movements with non-profit, public health interests at the core, and effectively challenging institutions and interests working against the containment of antibiotic resistance.

“The Codex Alimentarius, the joint WHO and FAO international food standards, should develop new sets of standards for antibiotic use in food animals which takes into account not only residues in food, but also antibiotic resistance.”

In addition, the Coalition said that FAO and OIE should prioritise efforts to ensure radical reductions of antibiotics use in food production and processing, and not shy away from the far-reaching implications this may have on the industrial agriculture model of food production.

It also called on international organisations to work together with national governments to develop a robust system of surveillance of antibiotics usage and resistance.

The Coalition’s Declaration on Antibiotic Resistance can be found at www.reactgroup.org.

Third World Resurgence

Next article – Germany: The votes are in

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