Nature asks a disturbing question about how we create and distribute what are arguably the most important scientific projects of all – the antibiotics and other drugs that save human lives. Why has it become so difficult for a researcher to do this research, and for a chemical firm to bring these medicines to the people who need them most?:
In a bitter paradox, antibiotics fuelled the growth of the twentieth century’s most profitable pharmaceutical companies, and are one of society’s most desperately needed classes of drug. Yet the market for them is broken. For almost two decades, the large corporations that once dominated antibiotic discovery have been fleeing the business, saying that the prices they can charge for these life-saving medicines are too low to support the cost of developing them. Most of the companies now working on antibiotics are small biotechnology firms, many of them running on credit, and many are failing.
In just the past two years, four such companies declared bankruptcy or put themselves up for sale, despite having survived the perilous, decade-long process of development and testing to get a new drug approved. When they collapsed, Achaogen, Aradigm, Melinta Therapeutics and Tetraphase Pharmaceuticals took out of circulation — or sharply reduced the availability of — 5 of the 15 antibiotics approved by the US Food and Drug Administration (FDA) since 2010….
A team of economists estimated in 2016 that the cost of getting from first recognition of an active drug molecule to FDA approval in the United States was US$1.4 billion, with millions more required for marketing and surveillance after approval. When companies such as Eli Lilly or Merck made antibiotics in the mid-twentieth century, those costs could be spread across their many divisions. And when, as used to happen, big companies bought smaller ones whose new drugs showed preclinical promise, the purchase price covered any debt the small companies had incurred.
Those business models no longer exist.
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The reasons are complex. Start with the obvious: antibiotics kill bacteria, living things that are constantly adapting to threats against their survival. As soon as a new compound is used, pathogens start evolving strategies to foil the attack. That means an antibiotic’s useful life, and thus its earning potential, can be limited — a situation that doesn’t occur for most other drugs.
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By one estimate, a new antibiotic needs to make at least $300 million in annual revenue to be sustainable. Other researchers estimate that the entire US market for new antibiotics that work against carbapenem-resistant Enterobacteriaceae — one of the most resistant and most stubborn classes of infection — is $289 million per year.
In other words, “there’s room in this marketplace for maybe one drug”, [antibiotic consultant and former pharma exec David] Shlaes says. “There’s not room for more than one drug if people want a return on their investment.”