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Top stories In this issue
- Featured: DRIVE-AB an exclusive report from Amsterdam
- Wilton Park on AMR: building national responses in middle and low income countries
- Antibiotic Resistant Gonorrhoea: A Looming Threat
- U.S. and UK form global partnership to speed new antibiotics
DRIVE-AB- brings all stakeholders together
On Thursday 2 June, 2016, the IMI DRIVE-AB, a public-private consortium (www.drive-ab.eu) held the “Stimulating innovation, sustainable use and global access to antibiotics” conference in Amsterdam.
From WAAAR, the presidentDr Jean Carlet was unable to attend, G. Upham participated with Jean-Jacques Monot, from the Geneva desk. Overall the organizers must be congratulated with the format which involved extremely lively debates on the podium, as a chosen moderator (Dr Ramanan Laxminarayan who directs the Center for Disease Dynamics, Economics & Policy, CDDEP, or Dr David Heymann, head of The Centre on Global Health Security at Chatham House, or John-Arne Røttingen from the Norwegian Institute of Public Health), asked questions to the personalities on the podium followed by dialogue with the 180 participants in the room, with a wide array of public agencies represented, and, in addition the large pharmaceutical industry (with Julie Gerberding CEO, Merck, G. Lynn Marks of GSK, John Rex, CEO Astra Zeneca and others), and a significant number of SMEs (like Florence Séjourné, CEO, Da Volterra).
The Departments of Health or ministerial level AMR representatives were in attendance from many European countries, including, of course, Dame Sally Davies CMO of England, or Shiva Dustdar from the European Investment Bank, as well as the WHO, with Assistant Director General,Dr Marie-Paule Kieny. In terms of country representatives, we noted Pr Christian Brun-Buisson, France's Inter-ministerial delegate on AMR; USA's Joe Larsen PhD, US DHHS, Deputy Dir., Division of CBRN Countermeasures, Biomedical Advanced Research & Development Authority (BARDA) which is now investing in antibiotic resistance, as well as Thailand's frequent country representative at the UN, Pr Suwit Wibulpolprasert, Deputy Permanent Secretary, MoH.
From civil society, besides WAAAR, the star NGO was DNDi ( Drugs for Neglected Diseases initiative), which was there in force with Dr Manica Balasegaram, former Executive Director MSF Access Campaign, and now director of the DNDi's Global Antibiotic Research and Development Partnership (GARD), as well as Jean-Pierre Pacaud, PhD, Business Dev. Director at DNDi.Dr Suwit Wilbulpolprasert, as Dr Marie-Paule Kieny, did not hide their preference for public funding of public research and for the type of collaboration with the private sector put forth by the DNDi's GARD initiative.
Most of the June 2nd event was spent discussing stewardship, and it was only mid-afternoon that the issue of R&D was discussed. We regretted that not-for-profit civil society was not invited to participate in the following day discussion on R&D, leaving 17 public institutions and seven pharmaceutical industries alone to debate on R&D. The debate format was extremely refreshing and a framework to follow in place of the stiff, and often enough quite boring string of presenters talking full speed and no questions asked in the typical format of the seminars during the WHA, even on the 'hot' topics like AMR.
May the DRIVE-AB organizers inspire others to adopt these modern form of interactions.
DRIVE-AB discussion on Stewardship
The first day was mostly spent on the issue of proper use of antibiotics by all stakeholders. All participants agreed that access to medicines could not be left aside as the need to restrain the excess use of AB is high on the global agenda, especially as 'stimulus' for new products to come to the market is discussed. The participants agreed that: "stimulating AB innovation alone will not solve the problem (of resistance). Promoting sustainable use and greater access are also key".
The lead organizers emphasized that the issue of excessive use of AB could not be tackled independently from the issue of 'access' as many developing countries populations still lack access to basic AB medications.
AMR-Times editor noted recently that the UN Task Force report on the Millenium Development Goals noted the lack of access to even basic generic drugs. " (...) 15 years after the Millennium Declaration, there has been very limited progress in providing access to aﬀordable essential medicines." (...) "Essential medicines were available in only 57 percent of public and 65 percent of private health facilities in 2012. Prices of medicines are about 3.3 to 5.7 times the international reference prices and many treatment regimens are priced far above the WHO affordability benchmark.” In that situation, we noted that Member States meeting in the WHO on AMR are stormy due to developing countries reluctance to agree to global management of AB, and tend to balk to top down endeavours to manage AB.
DRIVE-AB's Academic manager, University Hospital of Geneva, Dr Stephan Harbarth gave a preview on stewardship in the forthcoming book AMR Control 2016: "Successful initiatives to promote best practices and innovative solutions should always be achieved through an interdisciplinary process involving different stakeholders taking the issue of resistance outside of expert conference rooms and putting the issue on the agenda of global institutions and policymakers. The DRIVE-AB project follows this trend bringing academics and colleagues from the pharmaceutical industry to work together to find new solutions to the problem of resistance. The task is not an easy one since the point of views of each participant will be most certainly different and inﬂuenced by their professional background and experience, their local context of action and the outcomes they will take into account in order to make their evaluations." (AMR Control 2016, forthcoming, this edition of AMR Control also includes an article by Pr Inge Gyssens, of the Netherlands and in the DRIVE-AB Stewardship group, on the issue of stewardship for patients.)
In this discussion, it was concluded that:
- Hospital stewardship programmes and antibiotic regulation are either lacking or insufficient in many parts of the world.
- Reward models for antibiotics should align with sustainable use policies to delink the volume of sales from return on investment.
- New reward models should be piloted in appropriate settings as soon as possible, with support from pharmaceutical companies. - Innovation and sustainable use are only part of the equation for addressing antibiotic resistance. Infection prevention and control, vaccine use and proper sanitation are necessary as well.
- There is a need for coordinated global public investment, which should direct antibiotic research and development to meet public health needs that are defined by a global body.
- The conference was followed on June 3rd by an invitation-only workshop designed to explore the feasibility of DRIVE-AB’s five preliminary reward models. The consortium is now re-evaluating these models in the context of the feedback received."
DRIVE-AB meeting’s discussion on R&D
While all agree that the AB pipeline is empty, the ways and means to stimulate innovation was subject to debate. WHO ADG M-P Kieny emphasized the role of public investments and public entities for research and innovation to occur, and the importance of public R&D, with the example of DNDi's new initiative. The latter was highlighted, and Pr Pacaud spoke from the podium; the US representative said that the National US administration endeavor BARDA enjoys public and private funding, and mainstream opinion insisted on public funding of private pharmaceutical companies, and also sought ways and means to attract private investors into the bargain. We noted that Doctors without Borders lost its 'access to medicines' manager, as Dr Manica Balasegaram has now been recruited to head the DNDi initiative on AMR. There was a strong group of public and private sector representatives who stressed the need for (high) rewards to the pharmaceutical industry in the name of "economic models" to stimulate innovation.
How can public financing spur private research and manufacturing?
AMR-Times Editor’s note: Clearly, if all the AB combined still under patent, have the same level of profitability as one cancer drug, the issue becomes – from mainstream market economics: how can the profitability of an AB be raised to the level of a cancer drug? And obviously, in today's framework, noted a participant to us privately, the reverse question is not raised: is it possible that the new cancer drug be somewhat overpriced?
The DRIVE-AB group tried to come down to the nitty gritty of the ways and means of 'incentives' which they separate into 'pull' and 'push' mechanisms. The conference document is on their website
Regarding ‘PUSH’: 2 mechanisms which were put forth for discussion:
The 'grants' can, of course, represent public investment for public research or public investments for private research, or diverse PPP formats. It seemed to us (AMR-Times editor) that the issue there is that the focus seems rather narrow: as with any real scientific research (example of AZT, discarded cancer drug found active on HIV – ) it is mind stifling when a bureaucracy, even well intended, puts forth objectives in a tunnel, ie 'WE WANT SOMETHING FOR SYPHILIS' for example. Ironically this might be the best way to waste time and efforts. Most productive science is free.
- Grants "non-repayable research funds / for Early phase research
An independent organization that manages and finances a portfolio of AB discovery and development projects through to commercialization. Incremental innovation and development with a high risk profile. This seems to be the DNDi model favored by the WHO. It can be viewed by clicking here
- "Non-Profit Antibiotic Developer"
Regarding ‘PULL’ : 3 mechanisms were stated:
A dual pricing model where a premium price is charged if the AB is used for the entire course or a lesser price if the AB is used first empirically and then promptly de-escalated." Greater diversity of broad and narrow-spectrum AB with significant improvements. We (AMR-Times) thought it a bit difficult to implement. The desire to incentivize diagnostic tools is really worthwhile, even crucial, but this 'dual' approach does not seem very doable, as it doesn't fit well with restricting prescribing, and represent somewhat the approach of doctors today. : a) prescribe AB 'just in case', we will see about more precise diagnosis later, sometimes even when diagnostic tests are reimbursed by national health insurance system, and b) increasingly, prescribe AB 'just in case' it's a bacteria, and newest AB 'just in case' the bacteria is resistant to old drugs (see the Review on AMR of O’Neill on Gonorrhea in the EU, for example), an occurrence also widespread among clinicians treating the middle class throughout the LMIC and emerging economies sector, i.e. affecting 2/3 of the world population. The case of hospitals making money from drug sales is one problem there. On the other hand, some, including Pr Jacques Acar (one of the first world pioneer in antibiotics research, founder of AGISAR and Member of the OIE experts rooster) expressed to us his concern that too much top down restricting of prescriptions for AB could mean lost lives of patients! (exclusive interview in AMR Times September edition).
- Diagnosis Confirmation Model
An annual license paid to a manufacturer to have access to a specific AB, up to a specified volume.
- Insurance Licenses / (a sort of stockpiling mechanism)
Rarely used, emergency AB situation.
A series of pre-defined lump-sum payments awarded to the developer after regulatory approval of an antibiotic meeting predefined characteristics. - 'Most pressing public health threats', this entails de-linkage where revenues are not linked to consumption.
Market Entry Rewards (heavily featured in the Review on AMR) could reach in the one billion USD, to be as 'rewarding' as new cancer or anti-HIV drugs. If the Prize were to compensate for the R&D effort itself, it would certainly become more 'affordable', so it seems, i.e. a prize established independently of the other income an industry could make in another more profitable market, such as latest cancer or HIV drugs.
It is noted in the DRIVE-AB tables that this model strongly promotes sustainable use and strongly promotes equitable availability. However, it is here 'restricted' it appears. And the issue of managing public use is not quite settled yet.
WAAAR in Action
Wilton Park on AMR: building national responses in middle and low income countries (June 29– July 1rst, 2016)
The three-day meeting in June featured many speakers from LIC’S and LMIC’s presenting their national antimicrobial resistance (AMR) action plans. The meeting also featured talks and interventions from leading international experts in the area of AMR, including Dr Jean Carlet, the President of WAAAR, and chair of the recent French ministerial task force for antibiotic preservation. Dr Jean Carlet shared the French experience and as he presented French national programme against AMR. He presented the history of France’s successive plans against antibiotic resistance French program 2002-2016, the first and second one put great emphasis on awareness among the public with the slogan “Antibiotic are not automatic”. The 2015 Plan aims at a 25% reduction in AB consumption. True enough, France is among the highest in the EU in terms of AB consumption. Some figures comparing the EU average with the US and the situation in France. 25000 deaths in Europe per year ( ECDC); 23.000 deaths in the USA (CDC); MRSA USA: 90000 infections. 19000 deaths; France in 2015: 12500 deaths, 158 000 cases. And an estimated 700 000 deaths per year worldwide (WHO).
Dr Carlet then explained how he build the French Task Force last year with many experts. The report can be consulted in English version on line.The Wilton Park report noted that “differences sometimes exist between HICs and LMICs with regard to the access agenda. Furthermore, donor agencies tend to emphasise interventions that strengthen surveillance and laboratory infrastructure, and prioritise the human health sector over activities in the agricultural sector. Many LMICs are keen to ensure that AMR is built into broader agendas, such as health systems strengthening and universal access, and require particular assistance for surveillance and interventions in the agricultural sector. In order to ensure the sustainability of NAP implementation, donors and recipient countries need to work towards greater alignment of their agendas. The final report issued after the meeting focuses on a One Health approach, which involves the health of humans, animals and the environment.
The list of recommendations was very comprehensive, while recognizing that implementations of national programs in countries can be seriously challenged when laboratories and health staff are crucially lacking, and that new technologies would need to be introduced to make surveillance of AMR both feasible and effective. Kenya seems to be ahead having a national prevention program integrating AMR. The main LIC group was from the CDDEP GARP, the initiative on AMR.
Web=links: contact with Dr Carlet : jeancarlet AT gmail.com
English version of France’s WG Report on AB Preservation : http://esgap.escmid.org/?p=1288
Climate Change and Health / French Foreign Ministry and WHO
July 7-8 2016, French Foreign Ministry Conference on "Climate Change and Health", organized with the WHO, in Paris, France, in preparation for the COP22. The “Conference Conclusions and Agenda Action” was published by the WHO Department on Health and Climate Change headed by Dr Maria Neira. WHO says : “This is the living document that WHO and the Government of France will deliver to COP22 on behalf of the Conference’s participants, and that will also be used to inform the discussions with Member States at the 70th World Health Assembly, and to guide the work of the global health community as a whole.” More than 300 government ministers, health practitioners and experts in climate change and sustainable development were invited to attend. Garance Upham and Jean-Jacques Monot, representing the WAAAR Alliance and SOI participated as NGO guests.
The final document of the conference is very comprehensive and dwells with hot issues such as clean air in cities, a better health promoting environment, water and sanitation, and resilience of health systems.
We thought that among the key messages, the statement by Indian – US Professor Veerabhadran Ramanathan, representative of the Vatican in the 2015 COP21 was noteworthy: “recommendations on good diet and exercise … should not make us shove the slums under the carpet!” French and Moroccan Ministers of the Environment, H.E.Mrs Ségolène Royal and Dr. Hakima El Haite (who presides over COP 22 in Morocco) both gave excellent passionate speeches on the crucial sector of health in the effort to slow ‘the rate of change in climate change’ as Ségolène put it. After noting all the effects that extreme weather events could have on the health of populations, particularly in developing countries, the concluding document states:
“There are two main areas of engagement. The first is to adapt to climate change, by strengthening the resilience of health systems, and those which supply essential services, such as water and sanitation, and food and nutrition. The second is to ensure that global emissions of climate pollutants are reduced to a sufficient extent to protect the environmental and social determinants of health, and in such a way as to gain health “co-benefits”, through reductions in air pollution and other environmental risks. “
During the Q&A, Upham asked how come there were not more discussions on the environmental causes of health problems such as antibiotic resistance, since untreated waste poured into rivers and soil in emerging countries from both meat / fish industrial producers and pharmaceuticals (most of th global production is in India and China) had been identified as one of the major sources for the emergence of genes of antibiotic resistance in bacteria? Both regulations of waste and new technologies to clean waste were needed and would contribute to more responsible agricultural and drug productions.
A draft proposal for a session on AMR at the COP22 in Marrakesh, Morocco, (to focus on waste management and resilience in health care systems) is available from the author (garance AT waaar.ch). More information will be available in the September edition of AMR-Times.
AMR in the News
A Blood Test to Determine When Antibiotics Are Warranted
Researchers found they could differentiate between viral and bacterial infection through certain gene testing. This test would help in reducing the use of antibiotics and restrict it to rational practice when infection is confirmed not to be viral. This test could be useful in the early stages of infection.
Gonorrhoea is the second most frequently transmitted sexual disease. it is usually treated with a combination of antibiotics: azithromycin and ceftriaxone. Unfortunately, experts confirm the rise of Gonorrhoea superbugs resistant to the last line of antibiotics. The solution would be by first preventing STD infections, controlling antibiotics use in animal and look for potential antibacterial innovations.
Antibiotic Resistant Gonorrhoea: A Looming Threat
The article talks about a new soil compound discovered recently that could fight bacteria like Clostridium difficile, Mycobacterium tuberculosis and Staphylococcus aureus. The new drug discovered is teixobactin. Usually, bacteria growing antibiotics in soil do not grow the same compounds in laboratory conditions thus making antibacterial innovations difficult to researchers. That wasn’t the case of teixobactin since bacteria ignored the presence of agar and continued the compound synthesis even when not in soil.
Teixobactin and the hope it represents for fighting antibiotic resistance
A group of researchers in Germany discovered a new source of antibiotic that could be lifesaving. According to the article, people who did not have Staphylococcus Aureus in their nose had another competing bacterium that is Staphylococcus lugdunensis. This bacterium could form a compound proved to have antibacterial characteristics. However, more researches and studies are needed until it can be prescribed.
The Superbug-Beating Antibiotics May Come From Your Nose
U.S. and UK form global partnership to speed new antibiotics
US and UK health leaders agreed to form a global partnership in order to speed up the innovations and research in antibiotics. The urge to find new antibiotics pushed the two health leading countries to invest hundreds of millions of dollars to face to ongoing bacterial resistance. The new group is Carb-X, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, and is based in Boston. Kevin Outterson, an outstanding researcher on intellectual property rights and pharmaceuticals, has been selected to lead Carb-X.
AMR-related studies and scientific articles
Assessment of the safety of injection practices and injection-related procedures in family health units and centres in Alexandria
The Safe Injection Global Network (SIGN) developed an intervention strategy for reducing overuse of injections and promoting the administration of safe injections. Tool C–Revised is designed to assess the safety of the most common procedures that puncture the skin within health services. The aim of the study was to assess injection safety within the primary healthcare facilities in Alexandria using Tool C–Revised. The results highlighted the possible deficiency of alcohol- based hand rub tools, non adherence to hand hygiene before preparing an injection, and inadequate adherence to using a clean barrier during preparations means risks in procedures such as phlebotomy, infusions, injections, all skin piercing procedures.
AMR-Times notes that: Those results also may also reflect on the potential of easily contracting AMR related infections within the primary healthcare facilities. Egypt was one of the few selected countries to initiate the Smart Syringe drive launched by the WHO Director General in February 2015 at the WHO SIGN meeting. Lack of funding restricted the WHO ‘global’ ambitions in this regard, to a few countries in the world.
This study by the J Egypt Public Health Assoc. 2014 Aug;89(2):66-73, Elhoseeny TA1, Mourad JK. Entitled : Assessment of the safety of injection practices and injection-related procedures in family health units and centers in Alexandria, is thus very important in light of the United Nations emphasis on strict infection control as a priority for countries to face AMR in the Plan of action adopted in May 2016. See also the dossier on IPC to face AMR in the forthcoming AMR Control 2016
Subcutaneously administered antibiotics: a national survey of current practice from the French Infectious Diseases (SPILF) and Geriatric Medicine (SFGG) society networks
A national survey was performed to explore antibiotic prescription by the subcutaneous (SC) route among French infectious diseases and geriatric practitioners. Among the participating physicians, 367 (96.1%) declared administering SC antibiotics at some point. Ceftriaxone was prescribed SC by all but one, and Ertapenem, Teicoplanin, aminoglycosides and amoxicillin by 33.2%, 39.2%, 35.1% and 15.3%, respectively. The SC route was resorted to mainly in case of unavailable oral, intravenous or intramuscular routes, especially during palliative care. Pain, skin necrosis and lack of efficacy were the main adverse effects, reported by 70.8%, 12.8% and 19.9% of practitioners, respectively. Further studies are needed to precise the indications, modalities and tolerance of SC antibiotic use.
Chloramphenicol Derivatives as Antibacterial and Anticancer Agents: Historic Problems and Current Solutions
Chloremphenicol or CAM is a cheap broad spectrum antibiotic with mainly a bacteriostatic activity. The article states the concerns about CAM are rising because of increasing bacterial resistance and potential harmful side effects such as neurotoxicity and hematological disorders. It acts by inhibiting bacterial protein synthesis. CAM is currently studied and developed in new formulations to overcome resistance and fatal side effects. According to the research study, such changes include the synthesis of forfenicol by replacing an OH group with a fluoride atom, CAM dimers synthesis and other structural modifications. The various synthetic approaches for CAM show improved pharmacological profile however inefficacy when it comes to antibacterial properties; the newly discovered molecule cannot cross the bacterial wall or vulnerable to drug efflux pumps. Facing antimicrobial resistance and undesirable effects is challenging but focus goes now towards CAM-ribosomes interactions to find new alternatives.
Cholera outbreak caused by drug resistant Vibrio cholerae serogroup O1 biotype ElTor serotype Ogawa in Nepal; a cross-sectional study
Cholera is a virulent infection that characterized by severe diarrhoea leading to death if left untreated. Nowadays, most Cholera cases are successfully treated however few cases of drug resistance lead to treatment failure. The study was done on 116 stool samples from outbreak areas all over Nepal during a rainy season in 2012, the vibrio Cholera organism was then separated and susceptibility tests were performed. The article results show 31 samples positive to Vibrio Cholera positive test; they were all resistant to ampicillin and cotrimoxazole but susceptible to tetracycline, doxycycline, levofloxacin and azithromycin. The article states that Cholera infections were due to unsanitary water use and bad alimentary habits as well increasing drug resistance. Multi drug resistance was documented in Pakistan, Bangladesh, India and Nepal. The study had few limitations such as unavailable modern laboratory tests to affirm the results. The study recommends the use of antimicrobial based on susceptibility tests: tetracycline, doxycycline, levofloxacin, azithromycin, chloramphenicol and ciprofloxacin in Nepal.
Sub-Optimal Treatment of Bacterial Biofilms
Bacterial biofilms are aggregations of microbes bordered by extracellular matrix. Biofilms emerge in response to many factors including the use of sub-lethal antimicrobial dose and increasing use of quality of life-improving artificial devices. This article showcases that infections with bacterial biofilms respond less to standard antibiotic therapy causing a prolonged infection period by assisting bacterial survival. Biofilms contribute to bacterial tolerance also by decreasing the drug concentration penetrating through the biofilms. Surfactants might be great candidates to fight this approach for bacterial resistance working as strong antimicrobial, anti-adhesive, and anti-biofilm. The study suggests also different mechanisms through which biofilms react to sub lethal MIC: DNA changes, cell morphology alteration, reduced bacterial growth, induction mechanisms, Starvation and oxidative stress response. All these mechanisms of tolerance and adaptations make infections more consistent and chronic such as P. aeruginosa infections in cystic fibrosis, E. coli in urinary tract infections and S. aureus in wound infections. There is an emerging need for new techniques to evaluate biofilms response and antimicrobial therapy.
Upcoming AMR-related events
September 20th, 2016, USA
CDDEP meeting on AMR, preparatory introduction to the United Nations GA on AMR the next day, September 21, featuring Lord Jim O’Neill, Review on AMR, WHO DG Margaret Chan, New York City, USA, by invitation only
September 21rst, 2016, USA, UN
United Nations GA on AMR, New York City
October 16-18, 2017, France
4th Euro-Global Conference On Infectious Diseases. Paris, France. For abstract submission or registration contact: euroinfectiousdisease AT insightconferences.com
October 17-20, 2016, USA
The 7th Meeting of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR), North Carolina State University College of Veterinary Medicine, in Raleigh, North Carolina, USA. (Organiser : Dane Johnston, email : dane_johnston AT ncsu.edu)
October 25-29, 2016, United Kingdom
47th World Conference on Lung Health, in Liverpool, organized by the IUATLD
November 4-7, 2016, Austria
International Meeting on Emerging Diseases and Surveillance, IMED, in Vienna, Austria
November 28-29, 2016, Spain
Infection Prevention and Control, IPC, Valencia, Spain
March 14, 2017, UK
BSAC: Spring Meeting 2017: The Global Challenge of Multi-drug Resistant Gram Negative Bacterial Infections. International Convention Centre, Birmingham UK. Abstracts and posters are welcome, to be sent to: edavies AT bsac.org.uk – Deadline 20 January 2017
EU PUBLIC CONSULTATION
Proposals for draft EU guidelines on the prudent use of antimicrobials in human medicine: public consultation opens - For more info click here. The deadline for the public consultation is 5 September 2016.
This newsletter is published by the not-for-profit NGOs ACdeBMR/WAAAR and SOI.
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