Congress needs to fix the antibiotic market
The market for new antibiotics is broken, and that’s a problem because our current ones are failing.
Almost any antibiotic you or I take is an older generic drug discovered decades ago. Society relies on older, generic medicines because they are affordable, easy to manufacture, and widely accessible across the globe. But unlike most generic drugs that maintain their efficacy over time, our antibiotic arsenal has grown weaker thanks to a phenomenon known as resistance.
Antibiotic resistance occurs when bacteria are exposed to antibiotics and then evolve to become impervious to those drugs. It can get to a point where bacterial infections, called superbugs, no longer respond to individual, or even all, antibiotics. Soon, the generic antibiotics we rely on after we get scratched on a hike or break an arm on the playground will not work.
When antibiotics fail, people pay the price with their lives.
We are at a tipping point now where antibiotic resistant infections are so common, the World Health Organization declared antibiotic resistance as one of the top ten global health threats.
The COVID-19 pandemic has accelerated this issue, but it’s a problem I have known my entire life. I live with cystic fibrosis, a rare genetic condition that leads to a buildup of thick, sticky mucus in my airways. That thick, sticky mucus is the perfect environment for harmful bacteria to thrive, and several species of bacteria have called my lungs home since I was a kid. Decades of antibiotic exposure have led the bacteria living in my lungs to become resistant to all but a limited number of last-resort options.
My health is stable because drug makers have historically been incentivized to tackle rare diseases like cystic fibrosis, so I have medication that alleviates the protein dysfunction at the heart of my condition. But I am still reliant on antibiotics to maintain the fight against infectious disease in my lungs.
One of my best friends with cystic fibrosis died suddenly in 2018 when every antibiotic failed her. It was scary how fast it happened.
Her end is one that is already playing out across the globe for people without cystic fibrosis. Millions of Americans already suffer from antibiotic resistant infections each year, and tens of thousands die annually because a disincentive stands in front of new antibiotic development.
In the absence of new drugs, the only way to curb the spread of resistance is limiting antibiotic use. This essential policy that governs antibiotic prescriptions is called stewardship, and it minimizes evolutionary growth of superbugs because it leads to less antibiotic exposure.
The result, though, is a negative feedback loop. Since fewer antibiotics get prescribed, an entire suite of drug makers has run out of money, and because so many ventures have failed, investors are putting their resources into other therapeutic areas. Now, only a handful of drug makers are working to develop desperately needed antibiotics.
Without capital, many small life sciences companies do not have the necessary resources to invest in research, development, clinical trials, and more to bring new antibiotics to market.
If this market failure isn’t solved, more people living with bacterial infections will pay the ultimate price.
Congress needs to give the industry an incentive.
Our legislators can with the bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. The law encourages the development of novel antibiotics with upfront payments after regulatory approval. In effect, the law proposes a subscription that will allow antibiotic stewards to keep new drugs on the shelf until medical necessity beckons, while enabling drug makers to keep the lights on. The United Kingdom recently instituted a similar payment.
For investors who have poured their capital into other indications, the law will provide certainty for revenue forecasts, and hopefully drive future funding for antibiotic makers.
For society, PASTEUR greatly reduces the risk of economic calamity. New antibiotics will chip away at the excess cost of antibiotic resistance, which is already at $55 billion annually in the US.
And most importantly for patients, the law will give us desperately needed options to treat our stubborn infections. The PASTEUR Act is a no-nonsense bipartisan proposal that needs to be signed into law.
Gunnar Esiason is a patient advocate living with cystic fibrosis. His family’s non-profit organization, the Boomer Esiason Foundation, has raised more than $160 million in the fight against CF. He leads patient-facing strategy at Florence Healthcare. Follow him on Twitter @G17Esiason.
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