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Thursday, October 05, 2023

New, lifesaving antibiotics don't make it to patients. Researchers say a different business model is needed.

Antibiotics have played a major role in helping to extend the average life expectancy across the world by fighting infectious diseases. But the companies that develop and produce antibiotics are struggling to make profits on the antibiotics they produce, causing severe problems in efforts to fight newer disease strains and keep patients alive. "The Treasure Called Antibiotics" explains the drugs' impact: "Prior to the beginning of the 20th Century, infectious diseases accounted for high morbidity and mortality worldwide. The average life expectancy at birth was 47 years. . . . The antibiotic era revolutionized the treatment of infectious diseases worldwide, although with much success in developed countries. . . . In the U.S., the average life expectancy at birth rose to 78.8 years."

Stock prices slide on new antibiotic companies.
(Graph by Josh Ulick,WSJ, from Dow Jones data)
But those once powerful drugs are no longer always effective. Antibiotic-resistant bacteria require new antibiotics; however, the companies that create new strains don't make money, reports Dominique Mosbergen of The Wall Street Journal. "The push for antibiotics to fight fast-evolving superbugs is snagging on a broken business model. Six startups have won Food and Drug Administration approval for new antibiotics since 2017. All have filed for bankruptcy, been acquired or are shutting down. About 80% of the 300 scientists who worked at the companies have abandoned antibiotic development, according to Kevin Outterson, executive director of CARB-X, a government-funded group promoting research in the field."


The crux of the problem is the current model for drug company profits, "which counts on companies selling enough of a new treatment or charging a high enough price to reward investors and make a profit — isn't working for antibiotics," Mosbergen explains. "New antibiotics are meant to be used rarely and briefly to defeat the most pernicious infections so bacteria don't develop resistance to them too quickly. Companies have priced them at 100 times as much as the generic antibiotics doctors have prescribed for decades, costing a few dollars per dose. Most have sold poorly."

Infectious disease specialist Dr. John. H. Rex told Mosbergen, "Antibiotics are like fire extinguishers. You really want these drugs available, but you mostly don't want to use them. That's the paradox." Mosbergen reports, "New antibiotics should get support similar to treatments for rare diseases, said Ryan Cirz, a co-founder of Achaogen, which filed for bankruptcy in 2019 less than a year after the FDA approved its drug Zemdri for complicated urinary tract infections. . . . The Orphan Drug Act of 1983 provides subsidies, tax breaks and additional years of market exclusivity to drugmakers that develop treatments for diseases affecting fewer than 200,000 people in the U.S."

"About 13,000 people in the U.S. each year develop a severe type of drug-resistant infection that Achaogen's drug Zemdri was developed to defeat," Mosenberg reports. "Up to half of people hospitalized with such infections die. They are among the more than 35,000 people in the U.S. who die annually from drug-resistant bacterial or fungal infections, a toll that has risen in recent years."

In 2019, the United Kingdom started a "subscription-style model to pay drugmakers for new antibiotics based on their potential public-health value," Mosbergen adds. "U.S. lawmakers have considered similar legislation. Bipartisan bills reintroduced in the House and Senate in April committed $6 billion to purchase new antibiotics to treat drug-resistant infections. They haven't received a vote." Dr. David Hyun, director of the Antibiotic Resistance Project at Pew Charitable Trusts, told Mosbergen: "It sounds like the intent is to save companies, but we're really talking about trying to fix the antibiotic pipeline itself."

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