The constant pace of antibiotic resistance is well known. It’s not very clear what to do about it. An inadequate pipeline of promising new drugs has been a concern for years, with frequent debates about whether and how governments should help. As recent studies show that antibiotic-resistant infections are on the rise and more deadly than previously thought, the new Congress is ditching previous attempts to revitalize antibiotic development. We should learn from our shortcomings and work on this issue.
Antibiotics should ideally be used in short, well-defined courses and prescribed sparingly to avoid overuse. It is not enough to let In the late 1990s and 2000s, the pipeline of new antibiotics in development dwindled.methicillin resistance Staphylococcus aureus and drug-resistant tuberculosis sounded the alarmIn addition, so-called Gram-negative bacteria were proving increasingly resistant to antibiotics.
A period of renewed action followed. In 2012, Congress ordered antibiotic developers to Rapid regulatory pathway A new antibiotic and an additional 5 years of market exclusivity to market a new drug. Both “push” incentives, such as direct grants to R&D, and “pull” incentives that rewarded success were also offered. came in 2016 release CARB-X is Boston University’s nonprofit public-private partnership to accelerate the development of new antibiotics to address the most pressing public health threats. After the 21st Century Cure Act was passed in 2016, the Food and Drug Administration eased Clinical trial requirements for some antibiotics and antifungals. The result of these incentives is moderate: New antibiotics proliferated, but they often overlapped with existing antibiotics and few addressed unmet needs.
This will Search again for policy models that might workThe traditional investor-backed biotech route is problematic. Small businesses are still working to develop new antibiotics, but the field was rocked by his Achaogen bankruptcy in 2019. Achaogen, a biotech company that benefited from incentives and government support, has developed an FDA-approved antibiotic drug against resistant pathogens, but has yet to do so. Make enough profit to survive.
A major new proposition that followed was a pioneering antimicrobial subscription to end burgeoning resistance. pasteur methodfirst introduced by Sens. Michael F. Bennett The law would create a “subscription model” in which the government would offer developers $750 million to $3 billion in payments each for antibiotics targeting unmet needs. Governments pay only once after antibiotics are developed and approved, decoupled from the amount of drugs used. The proposal received bipartisan support in both houses, but failed to pass the 117th Congress. It will be reintroduced this year.
The Pasteur Act, which is endorsed by the biopharmaceutical lobby group the Pharmaceutical Research and Manufacturers of America (PhRMA), has never before endorsed a government purchase contract scheme on such a large scale. Jocelyn Ulrich, PhRMA’s vice president of policy and research, explains why: Market dynamics are not there. it is not viable. Everyone agrees that the market is failing in this particular area. “
of pasteur method It may help drug developers get a predictable return on investment, but $11 billion price tag He was criticized for going too far.Some are approximate $10 Billion Operation Warp Speedcrash coronavirus Vaccine Efforts During a Pandemic. But antibiotic resistance is not a one-time ‘moonshot’ problem. Rather, it takes years of research effort to eventually create a steady pipeline of effective new antibiotics.
Another interesting model is the formation of non-profit organizations. tuberculosis When malariaBrad Spelberg, chief medical officer of the County of Los Angeles and the University of Southern California Medical Center, who was one of the most vocal proponents of incentive approaches a decade ago, now wants to accelerate antibiotic discovery. I am proposing the establishment of a non-profit organization for Dr. Spelberg and others New England Journal of Medicine In 2019, “Drugs with tens of millions of dollars in annual sales are a catastrophic failure for many commercial companies, but will be a lifeline for nonprofits…” Nonprofits Quarterly You don’t have to worry about per-secution results or pesky shareholders. Proceeds from the sale of new antibiotics can be used for further research. In the later stages of drug development, it may be necessary to license or sell the product commercially. It may also require seed funding from the government, but “is a better long-term investment than perpetually providing billions of dollars in bounties and other pull incentives for each new antibiotic.” There could be,” Dr. Spelberg argued.
Congress needs to quickly consider both approaches. The end of the antibiotic era — when doctors have nothing left to treat infections — is too scary to think about. Waiting is not a reasonable option.
