Superbugs and the Flawed Antibiotic Development Model, Alert to a Growing Global Health Risk

Contributed Commentary by Thierry Mauvernay

August 27, 2021 | After over a year of the coronavirus pandemic, it’s hard to picture another global health crisis emerging, but data indicates bacterial infections could cause the next pandemic, as several known “superbugs” have adapted to resist all available antibiotics. The effects could be highly detrimental if today’s antibiotic development model doesn’t evolve and take priority. Antibiotics typically take an average of 10-15 years to develop and at high costs, roughly 1-2 billion dollars. This is due in part to the long, risky drug development process that has become the standard.

Finding substances that kill bacteria is relatively easy, but it’s difficult to discover substances that are both effective and non-toxic in humans. But even if the process were to be accelerated as it was for COVID-19, three to four-year period would be the minimum time required. To complicate matters, the purchase price of the antibiotics is so low that major pharmaceutical companies have steered away from developing new antibiotic therapies because it’s not profitable. A new business model that is not dependent on the profitability of sales volume is essential to preserve new antibiotic development. With what we know today about current superbugs and the lengthy antibiotic development process, if we don’t act now, we will all be guilty. We must act now so that, globally, we are prepared.

Antimicrobial Resistance and Its Global Impact

The World Health Organization (WHO), declared antimicrobial resistance (AMR) as one of the top 10 global public health threats facing humanity. It’s anticipated that drug-resistant infections could kill more people than cancer by 2050. One reason for this threat is the overuse of antibiotics that are oftentimes prescribed unnecessarily and at larger doses than needed.

The global antibiotic consumption has increased by 65% between 2000 and 2015 alone.  One in three antibiotic prescriptions in the United States are unwarranted. Antibiotics should be prescribed only when needed and with the proper guidance on usage. New antibiotics should be used extremely sparingly to prevent bacteria from evolving and becoming resistant.

New antibiotics should be used sparingly

The clinical pipeline for new antimicrobials is limited. If an antibiotic does make it to market, ideally, it should serve as a weapon of last resort. Antibiotics should be in the same bucket as fire extinguishers—they are available, but only used when needed. When new antibiotics are available, hospitals should have just a few doses for emergency use only. Unfortunately, this means the potential market return is too low to justify the necessary investment in research and development.

How we can learn from COVID-19

Similar to the pandemic we’ve endured, drug-resistant bacteria (often referred to as the silent pandemic) can infect anyone. There are differences between AMR and fast-moving viral pandemics. COVID-19, while presenting huge challenges, could be mitigated through infection prevention and control, improved clinical management in hospitals, testing, vaccines, and most importantly, the collaboration among key industry players. AMR, however, requires a long-term, sustained response, including resources, political will, and coordination across multiple sectors and countries. Bacteria does not respect boundaries and can travel around the world quickly. Health and food systems, infection prevention organizations, and long-term research and development teams must be aligned.

We’ve learned how a pathogen can block the entire world economy. While we cannot discover therapies to treat new, unknown viruses in advance, we can focus on developing treatments against the most dangerous pathogenic bacteria. If we ignore this need, a bacterial pandemic is inevitable.

More than 700 possibilities for COVID-19 treatments and vaccines were investigated, despite being introduced to a pathogen just over a year ago. In contrast, for antimicrobial resistant infections, only one new class has made it to the market since 1984, even though AMR has been a known and growing problem for decades. Of note, only a few new classes have advanced into clinical development since the 2000s.

Looking Ahead

If a bacterial pandemic occurred, it could take over ten years to find a solution. Timely access to appropriate antibiotics will be an essential component of preparedness and responsiveness to future microbial pandemics. We, as a society, have made promising strides in combating AMR, including the addition of government funding for The Global Antibiotic Research and Development Partnership (GARDP), which mobilizes resources and partners to develop lifesaving treatments for drug-resistant infections. However, the current initiatives don’t help profitability, as the economic potential of this market is low. We have to imagine an insurance-type business model that does not pay for antibiotics based on volumes sold, but rather in the same vein as airbags in cars, or military technology that is paid for regardless of usage. A solution could be provided by the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, that would establish an innovative way to pay for critically needed new antibiotics, with a subscription model that provides federal payment to companies that develop them. 

Change is possible. Since we can predict what’s to come in terms of viruses, why not get started on a bacterial solution now before it’s too late?

Mr. Mauvernay is the President and Delegate of the Board of Debiopharm. He joined Debiopharm International SA as Executive Vice President in July 2001. In 2006, Mr. Mauvernay handed over his operational activities within Debiopharm International SA and has since been focusing on the administration, finance and strategy of Debiopharm Group. He became Delegate of the Board in 2012. He can be reached at thierry.mauvernay@debiopharm.com