IDSA steps up commitment to 10 new antibiotics by 2020

The Infectious Diseases Society of America formally outlined a challenge for global leaders to develop 10 new antimicrobial drugs by 2020 in a statement published online in Clinical Infectious Diseases.

The aim is to discover new drug classes, explore possible new drugs from existing classes and develop diagnostic tests specific to multidrug-resistant infections.

The comprehensive plan will call on a global core of economic, industry, intellectual, medical, philanthropic, political, regulatory and scientific leaders to meet research and development challenges.

IDSA researchers wrote that there are few candidate medications in the pipeline that offer benefits over existing drugs and few drugs moving forward that will treat the following infections: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species.

“The lack of new antibiotics in the pipeline threatens to leave physicians around the world without the tools they need to effectively treat patients, which could change the practice of medicine as we know it,” IDSA President Richard Whitley, MD, said in a press release. “Advances that we now take for granted, such as surgery, cancer treatment, transplants and the care of premature babies, could become impossible as our antibiotic options dwindle. If we can initiate a global commitment to achieve this 10 X ’20 goal, we will take a giant step toward protecting and ensuring the health of patients worldwide.”

The project is a collaboration involving the American Academy of Pediatrics, American Gastroenterological Association, Trust for America’s Health, the Society for Healthcare Epidemiology of America, the Pediatric Infectious Disease Society, the Michigan Antibiotic Resistance Reduction Coalition, the National Foundation for Infectious Diseases and the European Society of Clinical Microbiology and Infectious Diseases.

The European Union is also committed to the effort. The IDSA supports the creation of the transatlantic task force by President Barack Obama and Swedish Prime Minister Fredrik Reinfeldt. The task force will focus on increasing the antibiotic pipeline and promoting antimicrobial stewardship in human and veterinary settings.

The IDSA said collaborative efforts among global stakeholders will incentivize sustainable research and development infrastructure. This infrastructure will, in turn, replenish a skilled scientific workforce that has steadily declined over the past two decades as a result of industry abandonment of antimicrobial development projects. – by Rob Volansky

Gilbert DN et al. Clin Infect Dis. 2010;50:1081–1083.

It is useful to evaluate the 10 x ’20 initiative by whether the goals are specific, measurable, achievable, realistic and timely. The initiative seems both too specific in that it concentrates on small-molecule drugs rather than interventions that may prevent or treat infectious diseases, and not specific enough in that it focuses primarily on organisms instead of specific serious and life-threatening diseases caused by those organisms.

The initiative lacks specificity on issues of advances in diagnostics, vaccines, infection control and antimicrobial stewardship that are necessary to appropriate use and preserve the effectiveness of new drugs. Saving 10 drugs by 2010 should be advocated as an equally important goal. Releasing 10 new drugs into a system with much injudicious use would shorten the lifespan of any newly developed drugs, so we will need 20 by ’30.

The measurement goals seem to be based on quantity of drugs approved rather than the quality of the drugs that are studied. Are the drugs superior to available interventions, particularly for serious infections? It is not clear why we need 10 more drugs that are non-inferior to available interventions in sinusitis, bronchitis, otitis or skin abscesses.

The measurement aspect also does not take into account the quality of data for approval. Non-inferiority trials often ask the wrong questions and fail to address unmet medical needs.

Regarding cost, I am not convinced that spending $1 billion to $12 billion for 10 new drugs is achievable or realistic. It is not merely a lack of will or money that has made it challenging to develop new antimicrobials. What is clear it is that a comprehensive approach to prevention, diagnosis, and judicious use of antimicrobials in the treatment of infectious diseases and aiming for better interventions going forward is timely and something on which we can all agree.

– John Powers, MD
Assistant Clinical Professor of Medicine, George Washington University School of Medicine
Washington, D.C.