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The Global AMR Crisis, Lack of New Antibiotics and A Way Forward
The world is facing a large and growing problem due to infections caused by bacterial pathogens that are becoming increasingly resistant to existing antibiotics. The World Health Organization (WHO) recently published their priority list of pathogens which urgently need new antibiotics and critical to this are multi-drug resistant gram negative pathogens.1 (See Figure 1)
Figure 1: WHO priority pathogens list, adapted from WHO Press Release 20171
Antimicrobial-resistant infections claim at least 50,000 lives each year across Europe and the US alone2 with many hundreds of thousands more dying in other areas of the world.2 According to the Review on Antimicrobial Resistance (AMR) by Jim O’Neil, 10 million deaths per year are projected by 2050 if current rates of AMR increases.2 The World Bank also quantifies the crisis by indicating that drug resistant infections could cause Global increases in healthcare costs ranging from $300 billion to more than $1 trillion per year by 2050.3
There are now several high profile efforts ongoing to address AMR globally. In the U.S., the Presidential Advisory Council on Combating Antibiotic – Resistant Bacteria (PACCARB)4 was established in March 2015. The role of PAC-CARB is to help develop and implement the National Strategy for Combating Antibiotic Resistant Bacteria.
In May 2017, Health Ministers of the G205 convened a meeting to tackle the global health risks associated with AMR. Similarly, in 2015, the G76 countries released a Declaration on addressing AMR at the G7 Health Ministers meeting in Berlin voicing strong support for the World Health Organization’s (WHO) first Global Action Plan on Antimicrobial Resistance (AMR).
As one of the original signatory companies of the Davos Declaration, Pfizer has joined other pharmaceutical companies in endorsing the Roadmap for Progress on Combating Antimicrobial Resistance in 4 key areas7:
Flagging Interest In Antibiotics Development by Pharma
According to the Association of the British Pharmaceutical Industry (ABPI), it can take over 12 years to discover and develop a new medicine and typically costs more than £1.15 billion to undertake the research required for a medicine to be approved.8
Furthermore, only one-third of medicines developed recoup their research and development (R&D) costs.8As of March 2016, an estimated 37 new antibiotics with the potential to treat serious bacterial infections are in clinical development in the U.S.9 The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be approved for patients.9
There is also According to a recent WHO report, As of May, a total of 51 antibiotics and 11 biologicals -- medical products are being developed The report confirmed the potential for biologicals to replace use of antibiotics.10 Peter Beyer, the author of the report and senior adviser to the WHO's Department of Essential Medicines and Health Products stated that "The idea is that biologicals could replace use of antibiotics, which could help in overcoming the resistance problem."10 Thus, whilst AMR is increasing in seismic proportions, the WHO states that it is likely that “the speed of increasing resistance will outpace the slow drug development process.”10.
Furthermore, the diminishing interest in the development of antibiotics by the pharmaceutical industry due in part to a reimbursement system that does not reward the initial investment for their R&D (research and development) continues to be a hurdle that renders continued development in antibiotics commercially unattractive.
Pfizer’s Position and Activities in Tackling AMR
Despite the diminishing interest in antibiotic research, Pfizer continues to make significant and substantial investments in antibiotics and vaccine R&D.
Pfizer endorses a six–part strategy to help address AMR, stewardship, manufacturing, surveillance, vaccination, a supportive regulatory framework, as well as incentives and new business models to support Research and Development (R&D) and a sustainable marketplace.
Pfizer partnered with the British Society for Antimicrobial Chemotherapy (BSAC) and the University of Dundee to launch the Massive Open Online Course (MOOC)11 on antimicrobial stewardship. This course helps health care professionals understand and address the global threat of antimicrobial resistance, focusing on how to responsibly use high-quality antibiotics appropriately in everyday practice.
Pfizer and other pharmaceutical companies have developed and endorsed antibiotic stewardship strategies through the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Pfizer believes that regional and global surveillance of antibiotic resistance patterns are an important tool and Pfizer aims to support surveillance programs to monitor global changes in bacterial resistance patterns via its Global Antimicrobial Surveillance Programs.12
Through Antimicrobial Innovative Vaccines13 program, Pfizer aims to prevent initial infection by developing new vaccines. This will consequently reduce antibiotic use and the spread of AMR.
Pfizer believes that there is need to address strategies that not only reverse the effects of AMR but also those that curtail the shrinking pipeline of new antibiotics. This can potentially be realised with a mix of economic incentives and an attractive reimbursement model, regulatory reforms that focuses on antibiotics and vaccines for drug-resistance strains and emerging diseases.
- WHO Priority Pathogens list of bacteria for which new antibiotics are urgently needed, accessed from: http://www.who.int/mediacentre/news/releases/2017/bacteria-antibiotics-needed/en/ on 23/10/17
- O’Neil, J., Review on Antimicrobial Resistance, 2014 accessed from: https://amr-review.org/sites/default/files/AMR%20Review%20Paper%20-%20Tackling%20a%20crisis%20for%20the%20health%20and%20wealth%20of%20nations_1.pdf on 23/10/17
- World Bank Research on AMR, Press Release 2016 accessed from: http://www.worldbank.org/en/news/press-release/2016/09/18/by-2050-drug-resistant-infections-could-cause-global-economic-damage-on-par-with-2008-financial-crisis on 19/10/17
- Centre of Disease Control, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) accessed from: https://www.cdc.gov/drugresistance/paccarb.html on 19/10/17
- Berlin Declaration of G20 Health Ministers Report 2017, accessed from: https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/G/G20-Gesundheitsministertreffen/G20_Health_Ministers_Declaration_engl.pdf on 19/10/17
- G7 On Tackling AMR, accessed from: http://www.jpiamr.eu/g7-makes-commitments-on-tackling-rising-resistance-to-antibiotics/ on 19/10/17
- Davos Declaration, Roadmap to Combatting AMR, September 2016, accessed from: https://www.ifpma.org/wp-content/uploads/2016/09/Roadmap-for-Progress-on-AMR-FINAL.pdf on 19/10/17
- ABPI Press Release, The Price of Medicines, 2014, accessed from: http://www.abpi.org.uk/media-centre/newsreleases/2014/Pages/300714.aspx on 19/10/17
- PEW Charitable Trust, Antibiotics Currently in Clinical Development, 2016, accessed from: http://www.pewtrusts.org/~/media/assets/2016/05/antibiotics-currently-in-clinical-development.pdf on 19/10/17
- BSAC, Antimicrobial Stewardship Massive Online Course, accessed from: https://www.pfizerpro.co.uk/sites/default/files/as_mooc_flyer_revise.pdf on 19/10/17
- Pfizer Global Antimicrobial Surveillance Programs, IFPMA website, accessed from: http://partnerships.ifpma.org/partnership/pfizer-global-antimicrobial-surveillance-programs on 19/10/17
- Pfizer Antimicrobial Innovative Vaccines IFPMA website, accessed from: http://partnerships.ifpma.org/partnership/pfizer-antimicrobial-innovative-vaccines on 23/10/17