Superbug Bulletin

June 2, 2021

Superbug Bulletin #11: It's time to combat the silent pandemic

Covid-19 has taken more than 3 million lives since last year, including more than half a million right here in the United States. Thankfully, the extraordinary efforts of the world's medical researchers, private companies, non-profits, and governments are helping to end this global health emergency. It’s time to apply the same intensity to combatting the "silent pandemic" of antimicrobial-resistant bacteria and fungi.
In the years ahead, the crisis of antimicrobial resistance (AMR) could prove deadlier than the Covid-19 pandemic. Yet, even though the dangers of AMR have been well-understood for years and the threat is already present, the response to this catastrophic threat has been hampered by a lack of urgency, a shortage of innovation, and major structural failures in the antibiotics market.
None of these challenges are insurmountable. But in order to contain -- and ultimately defeat -- the threat of AMR, the world will need to attack the problem with the same determination we have seen in the Covid-19 response.

A Tale of Two Pandemics

Each of the three million-plus lives lost to Covid-19 is a tragedy. And that figure would be far larger today were it not for the lightning-fast global response to the crisis.
In the weeks after the new coronavirus was first identified, governments around the world implemented unprecedented policy responses. The biopharmaceutical sector went to work developing multiple new vaccines and therapies. The United States government alone committed nearly $20 billion to accelerating these medical breakthroughs through Operation Warp Speed. And new global norms of mask-wearing, social distancing, and regular hand-washing took hold.
Compare this to the AMR crisis, which scientists have warned about for decades, and which was with us long before Covid-19 emerged. By one estimate, antibiotic-resistant infections kill as many as 162,000 Americans each year. Global deaths now total at least 700,000 a year. And if current trends continue, annual AMR fatalities could reach 10 million by 2050 -- a death toll that significantly exceeds Covid-19.
Just like Covid-19, AMR has a dramatic impact on our daily lives and it will only get worse over time. Without effective antibiotics, everything from routine surgeries like cesarean sections and hip replacements to life-saving treatments and procedures like chemotherapy, organ transplants, and open-heart surgery would become extremely risky due to the prevalence of deadly, untreatable infections. In this scenario, even minor, superficial injuries could lead to life-threatening infections.
And while one could drastically minimize the chance of contracting Covid-19 by staying inside and avoiding contact with others, in a world without antibiotics, the threat of acquiring a deadly bacterial or fungal infection would be near-impossible to avoid. No person, no matter how cautious or healthy, would be safe.
Given these risks, one would expect the response to the AMR crisis to be at least as serious as the reaction to Covid-19. But unlike the coronavirus pandemic, the threat of AMR has grown slowly over the course of years. As a result, it has yet to inspire the same sense of urgency as Covid-19. And the problems preventing us from overcoming this challenge have yet to be solved.
That needs to change. Fortunately, there are a number of promising strategies for addressing the threat posed by drug-resistant superbugs. What's lacking are the resources and policy solutions to put these strategies into action.

Time to Take Action

Back in 2015, the Obama administration released its National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). That document contained a five-year framework for advancing five essential goals.
The first was to slow the emergence and prevent the spread of resistant bacteria. The second was to strengthen national surveillance efforts to combat resistance. The plan also committed the nation to advancing the development and use of rapid and innovative diagnostic tests for identifying resistant bacteria. It aimed to accelerate basic research and applied R&D into new antibiotics and therapeutics. Finally, the CARB plan sought improved international collaboration in the effort to combat AMR.
Since then, the federal government has made some modest progress on these goals. The Trump administration released an updated plan last year. Known as the National Action Plan for Combating Antibiotic-Resistant Bacteria 2020-2025, the plan keeps the original goals, while creating new objectives and targets for achieving those goals.
But unless the Biden administration takes up this project and provides its own update to the plan this year, the effort could soon lose momentum.
One valuable way that the Biden administration can strengthen the CARB plan is to include more aggressive pull incentives for the development of new antibiotics. Pull incentives help address one of the biggest barriers to antibiotic innovation: The fact that the traditional market mechanisms that spur the creation of new medicines simply don't work for antibiotics.
It costs between $568-$700 million to create just one new antimicrobial medicine. And that process can take anywhere from 10 to 20 years. For most kinds of drugs, such massive upfront investments of time and money are justifiable because biopharmaceutical companies can earn back these costs once their medicine is available for use in the market. But antibiotics are intended to be used as infrequently as possible. This makes it incredibly difficult for companies to recoup their investment, which means they can't justify staying in the antibiotic market.
In recent years, several companies have tried to defy this harsh economic logic, often with disastrous results. For instance, Melinta Therapeutics, one the nation's largest firms specializing in antibiotics, filed for bankruptcy in 2019 after failing to turn a profit on four of its antibiotics. Another major antibiotic maker, Achaogen, declared bankruptcy that same year.
Such stories are tragically common. In fact, a third of companies responsible for the 15 new antimicrobials released over the past ten years have since left the market or filed for bankruptcy.
In short, the current biopharmaceutical market is far too inhospitable to the medicines we need to beat back the AMR crisis. Pull incentives are a way to overcome these economic limitations. With this approach, the federal government could provide a monetary incentive to any company that successfully launched a new antimicrobial drug that targets an important unmet need. Such an initiative would not only attract more firms to the antibiotics market -- it would also remove some of the downside risk of pursuing these much-needed medicines.
Similarly, the Biden administration could advance reforms to how antibiotics are reimbursed through Medicare as part of a revamped CARB action plan. Currently, Medicare's reimbursement formula rewards providers for avoiding newer, more sophisticated antibiotics in favor of older medicines. By changing this arrangement, the administration could strengthen demand for new antibiotics, further boosting the incentive for companies to invest in the next generation of these medicines.

The International Community Commits to AMR

The United Nations had originally planned an international meeting on the AMR threat for April 2020 -- the first such gathering in five years. That much-anticipated event was put on hold due to the Covid-19 pandemic. But in late April the gathering finally took place.
During the event, a consensus emerged that the coronavirus pandemic has made it more important than ever to attack the AMR crisis. But it also became clear that Covid-19 had diverted energy away from efforts to combat drug-resistant bacteria and fungi.
The meeting concluded with a call to action, in which participants committed to 19 separate strategies for combating AMR. These included the goal of keeping AMR high on each nation's policy agenda, strengthening antibiotic stewardship efforts, and working towards more generous funding for AMR efforts.

Despite Major Barriers, Innovation Continues

The impediments to developing new antibiotics might be daunting, yet, as a new report makes clear, the nation's biopharmaceutical sector remains committed to the cause. According to that study, Medicines in Development for Antimicrobial Resistance (AMR) 2021, there are close to 90 medicines in development aimed at treating drug-resistant infections. These include not only antibiotics, but also innovative technologies such as live therapeutic products, monoclonal antibodies, and bacteriophage products.
Now is the time to act. The coronavirus pandemic has shown what is possible when the global community brings its expertise, determination, and ingenuity to bear on a seemingly intractable health crisis. To prevail against the threat of AMR, we'll need to summon these same resources. Otherwise, we may soon confront another pandemic that could be more deadly and disruptive.

Learn More at Working to Fight AMR
Working to Fight AMR
Copyright © 2019 Biotechnology Innovation Organization, All rights reserved.

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