ONE OF the most urgent global public health problems is the increasing capability of bacteria to resist antibiotic drugs. The crisis of antimicrobial resistance is particularly acute in hospitals, where superbugs able to resist multiple drugs have spawned. More than 70 percent of the bacteria that cause hospital-related infections are already resistant to at least one type of antibacterial drug.
The specter of a world without effective antibiotics has been looming for years, but recent evidence suggests that the superbugs are evolving ever faster. Meanwhile, the pipeline of new antibiotics is running dry, leaving some patients with no effective treatment for life-threatening disease.
The Food and Drug Administration (FDA) announced last month that it is establishing a 19-member task force aimed at boosting the development of antibacterial drugs. Congress recently approved new incentives for industry innovation as well. This is only one aspect of the problem; overuse of antibiotics is another. But it is significant. Not every government task force gets results, but this one combines specialists from different disciplines to deal with a serious health risk for billions. Success could bring a big payoff.
The dearth of new antibiotics is due, in part, to economics. Antibiotics are usually taken for a short period and thus are not as lucrative as drugs for chronic disease; pharmaceutical companies have turned away from expensive research and development in the field. But the problem is also regulatory and scientific. The FDA task force has pledged to take a look at “new approaches for weighing the risks, benefits and uncertainties of potential new antibacterial drugs.” Before they can be sold to the public, drugs must be checked for safety and efficacy in a lengthy process involving large test groups. The Infectious Diseases Society of America has proposed, with support from other medical groups, approval mechanisms with smaller groups of people for serious bacterial infections where there is no existing therapeutic. According to the FDA, “innovative clinical trial designs” are on the task force’s agenda.
Without a doubt, innovation is needed. The President’s Council of Advisors on Science and Technology has just published a valuable report on drug development that underscores the point. It calls for doubling the output of “innovative, new medicines for patients with unmet medical needs,” while increasing safety and efficacy, over the next 10 to 15 years. The panel found that remarkable advances in basic biomedical research — including leaps in understanding genomics — “have not yet led to significant increase in the flow of new medicines to the American public.” The FDA’s task force, working with industry, government, clinicians and academia, may produce better results.