Antimicrobials, including antibiotics, are one of the greatest discoveries in modern medicine and have been key to increasing life expectancy. The spread of drug-resistant pathogens, known as antimicrobial resistance (AMR), is a growing public health concern. Overuse of antibiotics, or not using them as prescribed, contributes to growth of resistant bacteria, which renders antibiotics less effective or ineffective. It is estimated that by 2050, AMR infections could cause 10 million deaths annually, more than those caused by cancer or diabetes today.18
A comprehensive multi-partner approach is needed to address the complex challenges of AMR. As one of the original signatories of the Davos Declaration, in 2016, Johnson & Johnson joined the industry-wide call to curb development of AMR, also endorsing the Roadmap on Progress for Combating AMR in the same year. We have also been active members of the AMR Industry Alliance (AMRIA), one of the largest private sector coalitions addressing antimicrobial resistance. Through AMRIA, we have contributed to multiple position papers and presentations, and have participated in working groups.
We recognize that there is no one-size-fits-all approach to addressing AMR. We welcome and support legislative changes that will streamline regulatory pathways. Additionally, we believe new incentive mechanisms are needed to remove economic barriers to support investment in AMR, such as orphan or breakthrough designations and continued use of priority review vouchers.
We are working on multiple fronts to fulfill our AMR Roadmap commitments. We currently provide 22 antimicrobial medicines (including antiviral medicines) in 114 countries, of which seven are listed on the WHO's Model List of Essential Medicines. Much of our work is focused on tackling multidrug-resistant tuberculosis (MDR-TB), given our long legacy of fighting TB. Moreover, MDR-TB alone accounts for approximately one-third of AMR-related deaths.
In 2018, the Antimicrobial Resistance Benchmark was published, providing the first independent assessment of how 30 of the largest pharmaceutical companies are responding to AMR. Johnson & Johnson was highlighted as one of the two pharmaceutical companies leading efforts to combat AMR with the highest number of activities; specifically, the contribution of our work on TB was called out as a best practice.
Five ways we are supporting global AMR efforts
1. Supporting work on ensuring antibiotics are being used only in patients who need them
- Our education efforts for healthcare professionals include topics such as appropriate use, diagnosis, pharmacovigilance, and adverse event reporting and monitoring of side effects. For example, through unrestricted educational grants, we have engaged the International Union against TB and Lung Disease since 2014 to impart medical education programs on MDR-TB in Peru and South Africa. We also supported USAID training on the implementation of a Pharmacovigilance Program for TB drugs for staff from national TB programs and health authorities in several countries.
- To support the rollout and appropriate use of bedaquiline, Johnson & Johnson provides healthcare provider training and maintains pharmacovigilance and surveillance activities to monitor resistance to bedaquiline and companion treatments within the same regimen. To date, we have provided more than 82,500 courses of bedaquiline for patients in 114 countries since first approval, including nearly 39,000 in 2018 alone.
2. Improving access to existing and future antibiotics
- We use mechanisms such as tiered pricing, partnerships with public health organizations, and donation programs and other mechanisms as appropriate on a country-by-country basis to help achieve broad and timely access to our medicines in a way that is locally affordable. Examples of our initiatives are the program to broaden access to MDR-TB therapy with bedaquiline and our HIV medicines access program.
- One of the major drivers of AMR-related infections in the United States and Europe is hospital-acquired infections.19 Across Johnson & Johnson Medical Devices, we seek to prevent these infections through a variety of antimicrobial and sterilization technologies, including antibiotic-containing bone cements, chlorhexidine protective disks and more.
3. Monitoring AMR through surveillance as part of Johnson & Johnson R&D efforts
- Bedaquiline is a relatively new antimicrobial agent but, with widespread use, resistance may emerge. The bedaquiline Drug Resistance Emergence Assessment in MDR-TB (DREAM) is a global drug resistance surveillance study implemented by Johnson & Johnson to assess the emergence of resistance to bedaquiline. By mid-2018, thousands of bacteria recovered from TB patients from 10 countries were tested; preliminary results indicate that the prevalence of resistance to bedaquiline has remained very low.
4. Reducing the environmental impact from the production of antibiotics
- In 2018, we continued to assess the performance of our own manufacturing sites and those of key external manufacturers in controlling releases of antibiotics into the environment. We also worked with our industry partners and the Pharmaceutical Supply Chain Initiative (PSCI) to integrate a common framework for assessing antibiotic manufacturing operations into standard auditing protocols. In addition, we worked with our industry partners and independent technical experts to establish science-driven, risk-based targets for discharge concentrations for antibiotics.
For more details, see the AMR Alliance website.
5. Supporting new ways for open collaboration between industry and the public sector
- We maintain several partnerships to advance AMR research, such as our initiative with the Institute of Microbial Technology in India to help accelerate the discovery of innovative new treatments for TB, and our agreement with the Indian Council for Medical Research to bolster clinical trial capacity in India to support faster development and approval of TB medicines for India.