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Step up efforts to preserve antibiotics for posterity

Saransh Chaudhary
Wednesday, August 3, 2022, 08:00 Hrs  [IST]

The government should foster a sustainable antibiotic research ecosystem aimed at enhancing shelf life of existing drugs through innovative solutions and novel platform technologies.

Assessed by the WHO as one of the top 10 global health threats, antimicrobial resistance (AMR) is essentially a natural phenomenon that makes deadly pathogens resistant to antimicrobial drugs through genetic mutations. But the indiscriminate use of these drugs has quickened this process. Antibiotics, in particular, are fast losing their efficacy. When exposed to antibiotics, vulnerable bacteria are killed, but the resistant ones continue to multiply and sometimes, more often than we would like, do not even respond to even the most potent antibiotics. In due course, such bacteria may cause untreatable infections, eventually leading to death.

Until a few decades ago, antibiotics were considered "wonder drugs" because they worked like magic against deadly diseases. But today, we are on the brink of an era where bacterial infections might no longer be successfully treated with the currently available antibiotics. Owing to the overuse and misuse of antibiotics, bacteria are becoming increasingly resistant to these drugs. Drug-resistant bacterial strains, which are developing faster than the solutions to tackle them, are responsible for life-threatening diseases that claim hundreds of thousands of lives every year.

An increase in the rate of resistance has been observed for all major classes of antibiotics used to treat a wide variety of respiratory illnesses, skin disorders, sexually transmitted diseases and nosocomial (hospital-acquired) infections. The WHO has rightly warned that "many common infections will no longer have a cure and, once again, could kill as it used to in the pre-antibiotic era".

What if antibiotics do not work anymore?
A critical question hangs over the future: What if antibiotics do not work anymore? It is a grave global health threat which calls for urgent action. The best option before us is to contain the spread and growth of resistant bacteria through the appropriate use of existing antibiotics till a new antibiotic class comes our way, something which hasn't happened since 1987. Simultaneously, we need to redouble our efforts to develop innovative solutions through novel technologies so as to enhance the shelf life of existing antibiotics.

Acting on these lines, researchers have been working relentlessly on breakthrough technologies to develop novel and more effective formulations. These include platforms like Renal Guard Technology that works to expand the narrow therapeutic window of the lifesaving antibiotics that cause dose-limiting nephrotoxicity. Most of the last-resort antibiotics, such as polymyxin B and colistin, are essential for treating severe, life-threatening bacterial infections and combating drug-resistant bacterial strains. However, the dose-limiting nephrotoxicity associated with these compounds that limits its clinical utility is a significant challenge. Optimising antibacterial activity without increasing kidney injury risk is an arduous task due to the narrow therapeutic window of these drugs. Safer versions of these drugs are a dire need, and technologies like Renal Guard can prove incredibly useful in making this possible.

Pipeline of new antibiotics drying up
Developing a new class of antibiotics involves a lot of time, effort, scientific research and funds. Discovering antibiotics that treat highly drug-resistant bacterial infections is even more challenging. An assessment of the drug pipeline shows 43 new antibiotics under clinical development, out of which only two have been filed for approval. About one in every four drugs in the pipeline represents a novel drug class or mechanism of action, but none of them is potentially active against Gram-negative ESKAPE pathogens, the ones which the WHO has classified as a critical threat.

However, even if a company is able to develop a new ground-breaking antibiotic, its success cannot be taken for granted. Of the 38 pharmaceutical companies which have antibiotics under clinical development, only two are among the top 50 in terms of sale volumes. Over 95 per cent of the antibiotics undergoing research are being developed by small companies rather than big multinationals which once dominated the scene. These companies often lack the financial and marketing muscle required to launch their drugs globally.

Lack of availability, and therefore access to these drugs, is equally problematic and leads to the increased use of inappropriate treatments. More people still die from lack of access to antibiotics than antibiotic resistance. The University of Oslo conducted a study in 2018 where they analysed the introduction and geographic availability of new antibiotics approved between 1999 and 2014. They identified that geographic availability is highly variable for these drugs. The availability of these antibiotics is significantly delayed in low and middle income countries even after 10 years of drug launch in high-income countries. Therefore, it is crucial to ensure that working antibiotics are accessible according to public health needs.

Unlike therapies like cancer and diabetes, antibiotics treat acute infections that last a few days, as against the drugs for a chronic therapy that have to be taken for many years or even a lifetime. This presents a particular challenge as developing antibiotics costs no less than any other therapy, but the returns are not so lucrative. This is the main reason why big pharma has been abandoning antibiotic research. If we do not provide economic incentives to deal with this situation, new antibiotics would have to be priced at a point where patients would not be able to afford them, especially in countries like India, where healthcare costs are still primarily borne out-of-pocket.

Platform technologies like Renal Guard can provide real value here. They have the potential to redefine the economics of antibacterial drug development as they offer a viable proposition to bring innovations to patients while maintaining drug affordability. In the short term, they will serve as a conduit to a sustainable antibiotic research ecosystem and allow for critical progress in this area.

However, considering the enormous costs of developing antibiotics to counter increasingly drug-resistant bacteria, the Indian government must come up with market incentives for firms engaged in antibiotic R&D along the lines of countries like the US and UK. In 2019, the UK National Health Service (NHS) had launched a subscription payment plan for developing novel antimicrobials. As part of this plan, the NHS will pay up to £10 million for up to 10 years for antibiotics meeting specific criteria.

In the US, a bipartisan legislation - the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act, is being proposed (pending approval) to address the broken antibiotics market. The provisions of this measure have many parallels to the UK program. By changing the way by which the US government programs pay for urgently needed novel antibiotics, this legislation would give a fillip to the development of life-saving drugs and ensure that patients with drug-resistant infections have access to the newly available treatments.

On similar lines, the Indian government can play a vital role in fostering a sustainable antibiotic research ecosystem by introducing such models that are critical to our ability to respond to this life-threatening problem.

With research efforts picking up momentum again, it is imperative to encourage collaborations between the government, industry and academic stakeholders. Resources need to be generated to rigorously test novel compounds for safety and efficacy. This will require a strong policy thrust and an indomitable resolve involving all stakeholders. We need to remove all financial and regulatory hurdles impeding antibiotic research before it is too late. We must develop new economic models where the economic risks and profits for developing new antibiotics can be shared between different stakeholders. We owe it to ourselves and our future generations.

(Author is president, Global Critical Care Division, Venus Remedies, and CEO of Venus Medicine Research Centre)


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