DTE Call For Action: The growing antibiotic resistance and antibiotic pipeline crisis

For over eight decades, antibiotics have not only saved lives but also helped transform them. From preventing pre-mature deaths to successful cancer chemotherapy, it is difficult to imagine modern healthcare without them. But sadly, there is a growing antibiotic resistance and antibiotic pipeline crisis.

Worldwide, antibacterial treatment options are reducing, becoming expensive and less accessible. Known to be a silent pandemic, it can take humanity back to the pre-antibiotic era, when even a minor scratch or a common infection could kill.

‘Penicillin’, the first antibiotic, was a chance discovery in 1928 by a Scottish bacteriologist Alexander Fleming in London. In 1941, with the help of pharmaceutical companies in the US, it was mass produced to save countless lives of soldiers in World War II. Hence known as a ‘Miracle Drug’.

Then followed the ‘Golden era’, when many pharmaceutical companies became keen and developed antibiotics of several novel types / classes.

But since the 1980s, the antibiotic revolution had begun to fade. Antibiotics developed since then are not novel enough. They have less power to kill bacteria, which has become smarter.

All this while, the world desperately needed novel antibiotics. More so, against the Gram-negative bacteria that can cause severe infections like pneumonia and a pose a big threat in hospitals and intensive care units.

Gram-negative bacteria are a major part of the World Health Organization’s list of ‘priority pathogens’ against which existing antibiotics are becoming ineffective and new antibiotics must be developed.

With only 77 antibacterial candidates in the clinical development, the global antibiotic pipeline is weak and miniscule compared to drugs in development for cancer and other chronic conditions. The clinical pipeline of traditional small-molecule antibiotics to target ‘priority pathogens’ is also stagnant since 2017.

The short-term scenario is bleak. Only nine such molecules are in phase three of clinical development and none are for tuberculosis, which can cause deaths.

Major pharmaceutical companies have left this space of antibiotic development. Some exited decades ago. Our analysis of the clinical pipeline of 15 high-earning pharmaceutical companies revealed that of the total 1,007 candidates as on June 2023, only 13 are antibacterials, which are being developed by four companies.

Eight by GlaxoSmithKline and remaining by Roche, Pfizer and AbbVie. Most companies are focusing on one or more of other disease areas. Collectively, 2022 revenue of these 15 companies was about $711 billion. A considerable 17.5 per cent of this ($124 billion) was invested in research and development.

This ‘big exodus’ is not only because of the high-risk, low-return of antibiotics. It is also because of humongous profits that drugs for other diseases can make.

The often cited ‘market failure’ is typical for antibiotics due to resistance. Antibiotics have to be used less to remain effective. New antibiotics are to be kept as ‘reserves’ and developers can’t push for their sales.

On the contrary, if a cancer drug is used more, it earns more profits as it continues to remain effective. Shorter duration of bacterial infections is also linked with lower sales volume.

Antibiotics are also kept inexpensive for them to be affordable and accessible. This means profits from selling antibiotics would not be enough. This also means that traditional market-based models will not work.

Recovery of R&D costs will have to be de-linked from revenues from sales. Two approaches talked about to support antibiotic R&D are ‘Push incentives’, which include grants and technical support for early and late-stage research for primarily small-and medium-scale companies. They are working but considered insufficient.

‘Pull incentives’, being worked upon by a few high-income countries to help a researched product enter into the market. These include the UK’s piloted ‘subscription model’, which is completely de-linked and involves fixed payment per drug, per year to a company; Sweden’s pilot of a partially de-linked reimbursement model to ensure access in hospitals; and PASTEUR Act (Pioneering Antimicrobial Subscriptions To End Upsurging Resistance) of the US which is yet to pass.

It is clear that much more needs to be done to address the triple crises — the crisis of antibiotics becoming ineffective, the development crisis, and the access crisis. The Global Leaders Group on Antimicrobial Resistance is also discussing, if antibiotics could be considered as a ‘global public good’.

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