A Cornerstone of Modern Medicine on the Brink of Collapse
By Dr. Michelle McMurry-Heath
Roughly a century after the first antibiotics revolutionized medicine, the development pipeline for these critical drugs is on the brink of collapse.
Without policies to reinvigorate research into newer, more potent antibiotics, the world may soon face another global public health crisis as devastating as COVID-19.
According to an analysis in The Lancet, more than 1.2 million people died from drug-resistant bacteria in 2019. By 2050, these superbugs could kill as many as 10 million people each year.
Since the discovery of the first marketed antibacterials in the early 1900s, these wonder-drugs have become indispensable. By the end of the 20th century, the U.S. Food and Drug Administration had approved 135 new drugs that kill bacteria or inhibit their growth.
These included breakthroughs such as penicillin-like drugs and medicines like erythromycin. These drugs made it possible to treat many infections, like pneumonia and strep throat.
But in recent decades, new antibacterials have become alarmingly rare. In the past 35 years, the FDA has approved just one antibacterial drug with a novel way to kill target pathogens.
This slowdown in antibacterial innovation is in stark contrast to new superbugs that are increasingly resistant to today’s therapies. Absent a global effort to develop more new and novel antibiotics, antimicrobial resistance could undo much of modern medicine as we know it.
If today’s antibiotics stop working, routine medical procedures, such as cesarean sections and hip replacements — not to mention open-heart surgery — could become impossibly dangerous.
Yet the chief obstacles to antibiotic development are economic, not scientific. It costs on average $1.58 billion to develop a new antibiotic. And since antibiotics should be used judiciously to preserve their effectiveness, it’s exceedingly challenging for research firms to recoup costs through traditional sales models.
As a result, investors aren’t funding antibacterial research adequately. Over the last decade, venture capital funding for U.S. antibacterial development amounted to $1.6 billion, compared with $26.5 billion for oncology. Biotech startups drive the vast majority of antibacterial research and development. Small companies discovered more than 80% of antibacterial treatments in clinical trials. But so great are the market challenges that many of these businesses fail — even when their drugs succeed.
Take the biopharmaceutical firm Achaogen, which earned FDA approval for its antibiotic plazomicin in 2018. The next year, the company filed for bankruptcy.
From the scientific standpoint, the prospects for new antibacterials look distinctly promising. Between 2011 and 2020, antibacterial drugs starting early clinical trials had a 16.3% likelihood of reaching FDA approval. That’s more than double the 7.9% success rate across all diseases.
With the right financial incentives, the biopharmaceutical sector is more than capable of building a pipeline for antibacterial drugs that can meet the challenge of antimicrobial resistance.
Thankfully, there are policy reforms pending in Congress that could fix the broken antibiotics market. The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act would establish a subscription-like model for new antimicrobials that treat the most pressing resistant threats. It would ensure availability of new products, while providing a predictable return on investment for biopharmaceutical firms that is tied to the drug’s value to public health, not the volume sold.
Another proposal known as the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act would enable appropriate access to newer antibiotics by modernizing how Medicare reimburses these drugs.
These are the two most important steps policymakers can take to address a public health crisis that is threatening our very existence.
Dr. Michelle McMurry-Heath is a physician-scientist and the president and CEO of the Biotechnology Innovation Organization. This piece originally ran in The Mercury News and the East Bay Times.
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