Opinion: The Biden administration’s pandemic agenda must not ignore superbugs

What if another devastating pandemic came on the heels of Covid-19?

Unfortunately, that looks increasingly possible. For years, the antibiotics used to fight various bacterial infections have grown gradually less effective. If current trends continue, these antibiotics could stop working altogether in the near future, leaving humanity vulnerable to deadly, drug-resistant “superbugs.”

Preventing this public health threat will require an aggressive, federally backed effort to develop new and more potent antibiotics. As the Biden administration begins thinking about pandemic preparedness, it should focus on jump-starting innovation in developing new antimicrobial drugs.

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Unlike Covid-19, which caught the general public and even many medical professionals by surprise, the crisis of antimicrobial resistance — the phenomenon whereby microbes like bacteria and fungi don’t respond to treatments — has loomed large for years.

An analysis by researchers at the Washington University School of Medicine in St. Louis put deaths from antimicrobial resistance as high as 162,000 a year in the United States alone. The World Health Organization estimates the annual global death toll exceeds 700,000.

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More frightening is how quickly this crisis will compound if left unaddressed. The WHO projects that, as soon as 2050, deaths from drug-resistant infections will reach 10 million a year — roughly the same as the death toll from cancer.

That’s because microbes are growing more and more resistant to the drugs used to fight them. With every antimicrobial treatment, some microbes can survive. As these survivors grow and multiply, they can also share their resistance with other strains of bacteria, leading to more and more infections that no longer respond to our current arsenal of treatments.

Without new, effective antibiotics, common medical procedures ranging from hip replacements and chemotherapy to organ transplants and cesarean sections would become extremely dangerous, since patients would be open to superbug infections with no effective treatments. Injuries as minor as a skinned knee could become lethal, as they sometimes were in the days before antibiotics were widely available. And no person would be immune.

Drug-resistant superbugs don’t merely pose a deadly threat in and of themselves. They can make pandemics far worse. During this pandemic, many patients hospitalized with Covid-19 have contracted secondary infections, some of which are resistant to antibiotics.

Even in the face of such monumental threats, the private sector has struggled to invest in antimicrobial research. Since new ones are saved as a last line of defense, they are inevitably used sparingly. So companies have little hope of ever breaking even on their investments into developing new antimicrobials, let alone turning a profit. As a result, many companies have thrown in the towel, and some startups have gone out of business even after bringing new antibiotics through the FDA approval process.

The biopharmaceutical industry is well-aware of these market issues. In 2019, the organization I work for, the Biotechnology Innovation Organization, launched Working to Fight AMR, an effort designed to educate the public about superbugs and push for policies to catalyze and incentivize investment into new superbug treatments.

And in late 2020, more than 20 of the world’s leading drug makers created the AMR Action Fund, with an initial pledge of nearly $1 billion. This fund aims to help support the antibiotic pipeline in the short term and to bring two to four new antibiotics to market by 2030. In February 2021, the fund announced an additional $140 million in new nonpharmaceutical investments from the Boehringer Ingelheim Foundation, the European Investment Bank, and the Wellcome Trust.

These efforts will make a difference, but their success depends on policymakers taking action.

A number of promising reforms are in play. One, known as the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act (PASTEUR) would create a subscription model, in which the federal government would provide biopharma companies a fixed annual payment for access to antibiotics regardless of how many doses are actually sold. Delinking revenues from sales volumes would give these companies the financial certainty they need to invest in the next generations of antibiotics.

Another approach, included in the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act (DISARM), would address an in-hospital reimbursement barrier under Medicare that de-incentivizes hospitals to treat patients with newer antimicrobials, even when they are the most appropriate therapy. DISARM addresses this barrier with an add-on payment and ensures that patients will have access to appropriate medicines when they are needed.

Enacting PASTEUR- and DISARM-style provisions would be a critical step forward in pandemic preparedness. The Covid-19 pandemic has led to a surge of secondary infections, which has in turn caused an increase in antibiotic prescriptions and accelerated the pace of antibiotic resistance.

As a physician and molecular immunologist, I have long acknowledged the importance of science, its ability to change the course of history and save lives. So does President Biden.

It’s time to leverage science and policy to fight antimicrobial resistance. Otherwise, we’ll set the stage for another global health crisis.

Michelle McMurry-Heath is a physician-scientist and the president and CEO of the Biotechnology Innovation Organization.

Source: STAT