This letter to the editor of Clinical Infectious Diseases explores the "10 x ′20 initiative" — a global commitment to develop 10 new antimicrobials by 2020. The authors question the development costs, the current clinical trial system, and the neglection of current antimicrobials. They also examine issue of quality versus quantity and conclude that "... we need to set priorities to achieve a balance between antibiotic conservation and new drug development, focusing on policies that will best serve public health.
The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. This paper reviews a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics.
Sanford School of Public Policy; Duke Global Health Institute
Neha Gupta •
Sanford School of Public Policy; Duke Global Health Institute
Samir K. Brahmachari, PhD •
Open Source Drug Discovery; Council of Scientific and Industrial Research, New Delhi, India
Ian Chopra, PhD •
Institute of Molecular and Cellular Biology, University of Leeds
Bernard H. Munos, MS •
InnoThink
Carl F. Nathan, MD •
Weill Cornell Medical College, Department of Microbiology and Immunology
Kevin Outterson, LLM, JD •
Boston University School of Law
Jean Pierre Paccaud, PhD •
Drugs for Neglected Diseases Initiative (DNDi)
David J. Payne, PhD •
GlaxoSmithKline, Infectious Diseases Therapeutic Area Unit
Rosanna Peeling, PhD •
London School of Hygiene & Tropical Medicine
Melvin K. Spigelman, MD •
Global Alliance for TB Drug Development, New York
Johan Weigelt •
Karolinska Institutet Department of Medicine
In the face of a growing global burden of resistance to existing antibiotics, a combination of scientific and economic challenges has posed significant barriers to the development of novel antibacterials over the past few decades. Yet the bottlenecks at each stage of the pharmaceutical value chain—from discovery to post-marketing—present opportunities to reengineer an innovation pipeline that has fallen short.
Concerns about a dearth of antibiotic innovation have spurred calls for incentives to speed the development of new antibiotics. The data from this study suggest that policymakers should be focused on the clinical quality of the new drugs, not just the raw number of new drugs introduced to the market each year. In other words, quality over quantity should be the focus.
University of Washington, Office of Sponsored Programs
Tanya Karwaki, JD and Patricia Kuszler, MD, JD, from the University of Washington School of Law propose that enacting laws that make vaccine exemptions more difficult to obtain could improve public health outcomes.
The Problem: Vaccine coverage for preventable disease is an essential public health goal. Low vaccine coverage rates enable otherwise avoidable outbreaks of harmful diseases. CDC: Vaccines and Immunizations.
The Problem: Tuberculosis is a classic public health scourge. TB is one of the top 10 causes of death globally. World Health Organization: Tuberculosis Fact Sheet. The risks associated with TB have increased with the emergence of more virulent and drug-resistant strains of the disease. In the United States, the rate of TB incidence and associated mortality declined precipitously for most of the 20th century.
The Problem: Vaccine coverage for vaccine preventable disease is an essential public health goal. Vaccination against specific diseases is particularly important for high risk populations, which may include individuals of a certain age (e.g., greater than 68 years for Pneumococcal Polysaccharide) or with specified medical conditions (e.g., HIV/AIDS for influenza). CDC: General Recommendations on Immunization.
