citation

"Winning the Fight Against Antimicrobial Drug Resistance." CSIS Commission on Strengthening America's Health Security, Center for Strategic and International Studies, September 13, 2018. Accessed December 04, 2018. https://healthsecurity.csis.org/articles/winning-the-fight-against-antimicrobial-drug-resistance/

Antimicrobial drug resistance is a complex, long-range global crisis threatening the foundations on which modern medicine is built.

Photo Credit: Yawar Nazir/Getty Images

A Kashmiri Tuberculosis patient shows his anti-TB medicines which he takes daily at Kashmir's lone chest diseases hospital.
A Kashmiri Tuberculosis patient shows his anti-TB medicines which he takes daily at Kashmir's lone chest diseases hospital. Yawar Nazir/Getty Images

Key Challenges

Increasing Problems of Drug Resistance

Antimicrobial resistance (AMR) is the ability of microbes to resist drugs that were once effective against them (aka superbugs). Antibiotic resistance (ABR) describes resistance in one type of microbe, bacteria. It is difficult to treat infections with resistant organisms, as they require costly and sometimes toxic alternatives to the usual treatment choices.

Antimicrobial drugs have been used for over 70 years to treat infection and since the 1940s have significantly reduced infectious disease illnesses and deaths. However, as noted by the U.S. Centers for Disease Control and Prevention (CDC), “these drugs have been used so widely and for so long that the infectious organisms the antibiotics are designed to kill have adapted to them, making the drugs less effective.”1 Drug resistance is now impacting global efforts against malaria, tuberculosis, and HIV.

Key driving factors behind drug resistance are the overuse and misuse of antibiotics in both animals and humans. In the United States, livestock producers use approximately 80 percent of all antibiotics (by volume) sold in the country. Such widespread antibiotic use, intended to promote faster growth and prevent disease in otherwise generally healthy animals, occurs in parts of Europe and is projected to spread to middle-income and developing countries.2 On the human side, access to antibiotic drugs varies widely around the world. Some countries rely on physician or pharmacist orders for antibiotics, while in other countries antibiotics are freely available over the counter or access is lacking. Initial endeavors to improve antibiotic drug access and use have centered on doctor and patient education.3 Additional strategies include efforts to better measure antibiotic use, to use vaccines to prevent infections that can encourage antibiotic use, and to improve diagnostics to quickly determine whether antibiotic use is warranted.4

Barriers to New Antibiotic Development

There is urgent need for both new diagnostic tools and new antimicrobials to replace those rendered ineffective by widespread resistance, yet the current pipeline of antibiotics is insufficient to meet future demands. There are significant economic, scientific, and regulatory challenges to antibiotic development. Historically, clinical drug development has a low success rate, with only about 20 percent of drugs that enter human testing being approved for patients.5

Antibiotic development is no longer considered an economically wise investment for the pharmaceutical industry. Given their short-term use, antibiotics are not as profitable as drugs that treat chronic conditions.6 Experts have also begun to advise restricting antibiotic use, further decreasing the profitability of antibiotic development.7 Industrial innovation is discouraged by weak market conditions and awareness of the potential for evolving resistance to quickly render new drugs obsolete.

Key scientific barriers have impeded attempts to discover new types of antibiotics. One of those barriers is a major gap in the understanding of how to defeat some of the toughest and most complex pathogens out there: drug-resistant Gram-negative bacteria, which cause many of the most serious and deadly bacterial infections.8 A better understanding of Gram-negative bacteria will be necessary to make significant progress in antibiotic development.

Achieving regulatory approval is another major obstacle to new antibiotic development. Difficulties in pursuing regulatory approval include: bureaucracy, absence of clarity, differences in clinical trial requirements among countries, changes in regulatory and licensing rules, and ineffective channels of communication. Yet in the face of few promising new antibiotics in the pipeline, governments increasingly recognize the imperative to incentivize industry to research and develop new antimicrobials. “Push” incentives lower the cost of R&D, typically through government subsidy, while “pull” incentives increase the odds that successful drugs will be profitable.9

International Initiatives

Recognizing a need for a cohesive, global strategy to combat AMR, the May 2015 World Health Assembly (WHA) put forth a global AMR action plan with five objectives: improve awareness and understanding of AMR; increase surveillance and research; prevent infection; optimize use of antimicrobial medicines in humans and animals; and strengthen incentives for increased investment in fighting AMR in all countries.10

Following on the global action plan, the G7 health ministers issued a joint declaration, declaring support of and collaboration on AMR objectives.11 At the 2016 United Nations (UN) General Assembly High Level Meeting on AMR, only the fourth such high-level meeting on a health issue, Heads of States acknowledged the potential for AMR to undermine many medical achievements in the 20th century, and they committed to national AMR action plans.12 Yet despite such commitments, only 15 of 125 drafted national action plans have been costed and even minimally financed.

U.S. Action on AMR

The United States has made progress in responding to AMR. At least 2 million people are infected with resistant bacteria in the United States annually, costing an estimated $20-35 billion and resulting in 23,000 deaths.13 Domestically, the United States has devoted significant attention and resources to AMR/ABR through a national strategy and the U.S. National Action Plan for Combating Antibiotic Resistant-Bacteria (CARB), released in March 2015.14 The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) provides advice, information, and recommendations to HHS on U.S. government activities to combat antibiotic resistance.15 Other U.S. government agencies including DoD and CDC are also actively involved in combatting AMR. The United States has also addressed AMR internationally as part of the Global Health Security Agenda (GHSA) and through USAID efforts to combat MDR-TB through prevention, control, and surveillance. Further, U.S. collaborations with European Union member states on AMR have advanced significantly.

  1. CDC, “Antibiotic/Antimicrobial Resistance,” last updated March 29, 2018, https://www.cdc.gov/drugresistance/index.html 

  2. Thomas P. Van Boeckel et al, “Global trends in antimicrobial use in food animals,” PNAS 112, no. 18 (2015): 5649-5654, https://doi.org/10.1073/pnas.1503141112 

  3. CDC, “International Activities to Combat AR,” last updated January 25, 2017, https://www.cdc.gov/drugresistance/intl-actvities.html 

  4. Ibid. 

  5. The Pew Charitable Trusts Antibiotic Resistance Project, “Antibiotics Currently in Global Clinical Development,” February 17, 2014, https://www.pewtrusts.org/es/research-and-analysis/data-visualizations/2014/antibiotics-currently-in-clinical-development 

  6. C. Lee Ventola, “The Antibiotic Resistance Crisis, Part 1: Causes and Threats,” Pharmacy & Therapeutics 40, no. 4 (2015): 277-283, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4378521/ 

  7. Ibid. 

  8. Alan Coukell and Tim Jinks, “Why Can’t We Find New Antibiotics?” The Pew Charitable Trusts Antibiotic Resistance Project, October 26, 2016, http://www.pewtrusts.org/en/research-and-analysis/articles/2016/10/26/why-cant-we-find-new-antibiotics 

  9. Joseph Larsen, “Drug Development Incentives,” CDC, June 27, 2017, https://www.cdc.gov/drugresistance/tatfar/news/drugdevelopment.html 

  10. World Health Assembly, “Global action plan on antimicrobial resistance,” May 2015, http://www.who.int/antimicrobial-resistance/global-action-plan/en/ 

  11. G7 Health Ministers, “Declaration of the G7 Health Ministers,” October 2015, http://www.g8.utoronto.ca/healthG8/2015-berlin.pdf 

  12. WHO, “United Nations high-level meeting on antimicrobial resistance,” September 21, 2016, http://www.who.int/antimicrobial-resistance/events/UNGA-meeting-amr-sept2016/en/ 

  13. CDC, “Antibiotic/Antimicrobial Resistance.” 

  14. The White House, “National Action Plan for Combating Antibiotic-Resistant Bacteria,” March 2015, https://www.cdc.gov/drugresistance/pdf/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf 

  15. Office of the Assistant Secretary for Health, “Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB),” last reviewed August 21, 2018, https://www.hhs.gov/ash/advisory-committees/paccarb/index.html 

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