Opinion | Drug-resistant bacteria are proliferating. We need new antibiotics.

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Antibiotics, drugs that kill bacteria or slow their growth, have been a mainstay of medicine since the 1940s. However, bacteria can evolve to fight back. They can stop antibiotics from getting into your cells, for example, or pump out the drugs. The resulting antibiotic resistance has become a global public health crisis, a grim pandemic, threatening the effectiveness of human medicine in areas such as joint replacements, C-sections, organ transplants, chemotherapy, dialysis, and more.

The relentless pace of antibiotic resistance is well known. What to do about it is less clear. The inadequate pipeline of potential new drugs has been a matter of concern for years, sparking frequent debates about whether and how the government should help. With recent studies showing that antibiotic-resistant infections are on the rise and more lethal than previously thought, the new Congress must address the issue, learning from the shortcomings of past attempts to spur antibiotic development.

Antibiotics are used for a short, defined course and are ideally prescribed in moderation to avoid overuse. The return on investment is often insufficient to cover research costs or satisfy shareholders. By the late 1990s and through the 2000s, the pipeline of new antibiotics under development had dwindled. methicillin resistant Staphylococcus aureus and drug-resistant tuberculosis raised alarms; moreover, so-called gram-negative bacteria were proving increasingly resistant to antibiotics.

A period of renewed action followed. In 2012, Congress passed the Generating Antibiotic Incentives Now Act, which offered antibiotic developers an accelerated regulatory pathway for new antibiotics, as well as five years of additional market exclusivity to sell their new drugs. Both “push” incentives, such as direct grants for research and development, and “pull” incentives, to reward those who succeed, were also offered. In 2016, CARB-X, a not-for-profit public-private partnership at Boston University, was launched to help advance the development of new antibiotics that address the most pressing threats to public health. Following passage of the 21st Century Cures Act in 2016, the Food and Drug Administration eased clinical trial requirements for some antibiotics and antifungals. The result of these incentives was modest: there was an increase in the number of new antibiotics, but they often duplicated existing ones and few met unmet needs.

This has led to a renewed search for policy models that might work. The traditional biotech route – backed by investors – is complicated. Small companies are still scrambling to create new antibiotics, but the field was rocked by the bankruptcy of Achaogen in 2019, a biotech company that benefited from government incentives and support, developed an antibiotic against resistant pathogens that gained FDA approval. – and still failed to make a sufficient profit to stay afloat.

A major new proposal that followed was the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance or Pasteur Act, first introduced by Senators Michael F. Bennet (D-Colo.) and Todd C. Young (R-Ind.) in 2020. The legislation would create a “subscription model” in which the government would provide developers with payments of $750 million to $3 billion each for antibiotics that target unmet needs. The government would only pay once, dissociated from the volume of medicine used, after the antibiotics were developed and approved. The proposal had bipartisan support in both houses, but failed to pass the 117th Congress; it will be reintroduced this year.

The Pasteur Act is supported by Pharmaceutical Research and Manufacturers of America (PhRMA), the biopharmaceutical lobby, although it has never before supported such a large government contract purchase scheme. Jocelyn Ulrich, associate vice president of policy and research at PhRMA, explained the reasoning: “Over a decade ago, I think 18 to 20 major pharmaceutical companies were still in this space, and now we’re down to just a handful. The market dynamics are simply not there. It is not viable. Everyone kind of agrees now that we have a market failure in that particular area.”

The Pasteur Act can help drug developers achieve a predictable return on investment, but the $11 billion price tag has been criticized for being excessive. Some see a parallel with the roughly $10 billion Operation Warp Speed ​​coronavirus vaccine effort during the pandemic. But antibiotic resistance is not a one-time “moonshot” problem. Rather, it requires years of commitment to research, ultimately creating a steady stream of effective new antibiotics.

Another interesting model would be to create a non-profit organization that is being tested with tuberculosis and malaria. Brad Spellberg, medical director of the Los Angeles County and University of Southern California Medical Center, was one of the biggest advocates of the incentives approach a decade ago, but now he has proposed creating a nonprofit organization to encourage the discovery of antibiotics. Spellberg and others wrote in the New England Journal of Medicine in 2019: “A drug with annual sales of tens of millions of dollars is a catastrophic failure for many for-profit companies, but would be a lifeline for non-profit organizations…” One The nonprofit wouldn’t have to worry about quarterly results or nagging shareholders, and it could use the profits from the sale of its new antibiotics to fuel additional research. It may still need to rely on for-profits in later stages of drug development to license or sell the products. It could also require some upfront money from the government, but that “may be a better long-term investment than perpetually offering multibillion-dollar prizes or other lure incentives for every new antibiotic,” argued Dr. Spelberg.

Congress should explore both approaches, and quickly. The end of the antibiotic era – when a doctor has nothing left to treat an infection – is too horrible to contemplate. Waiting is not a reasonable option.

Post View | About the Editorial Board

Editorials represent the views of The Post as an institution, as determined through discussion among members of the Editorial Board, based on the Opinions section and separate from the newsroom.

Members of the Editorial Board and areas of expertise: Opinion Editor David Shipley; Associate Opinion Editor Karen Tumulty; Associate Opinion Editor Stephen Stromberg (politics and national politics, legal affairs, energy, environment, health care); Lee Hockstader (European affairs, based in Paris); David E. Hoffman (Global Public Health); James Hohmann (domestic policy and electoral politics, including White House, Congress and governors); Charles Lane (foreign affairs, national security, international economics); Heather Long (economics); Associate Editor Ruth Marcus; and Molly Roberts (technology and society).

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