By Robert J. Guidos, JD, Vice President, Public Policy and Government Relations
Infectious Diseases Society of America (IDSA)
Finally, there is some good news to report on the global antimicrobial resistance policy front. Earlier this month, at a United States (U.S.) and European Union (EU) summit held in Washington, D.C., President Barack Obama and Swedish Prime Minister Fredrik Reinfeldt, representing the EU Presidency, joined forces to establish a transatlantic task force (“Task Force”) to address antibiotic resistance. Under the U.S./EU agreement, the Task Force will focus on appropriate therapeutic use of antimicrobial drugs in the medical and veterinary communities, prevention of both healthcare- and community-associated drug-resistant infections, and strategies for improving the pipeline of new antimicrobial drugs. A concrete action plan is to be drawn up, and it is suggested that the Task Force report back at the 2011 U.S./EU summit. The inclusion of the Task Force within the summit’s agenda followed a concerted effort by EU and U.S. stakeholders, including the Infectious Diseases Society of America (IDSA), who sought greater international collaboration on these urgent and growing problems that threaten patient safety and public health worldwide.
Addressing the global antimicrobial resistance crisis requires multiple approaches, including the reduction of inappropriate drug use, data collection, research, and prevention and control strategies currently being explored and/or promoted by the Center for Global Development’s (CGD) Drug Resistance Working Group, IDSA, Resources for the Future (RFF), the Alliance for the Prudent Use of Antibiotics (APUA), Action on Antibiotic Resistance-ReAct, the Pew Charitable Trust, Keep Antibiotics Working (KAW), U.S. and EU health agencies, the World Health Organization, congressional sponsors of U.S. legislation titled “The Strategies to Address Antimicrobial Resistance Act” and the “Preservation of Antibiotics for Medical Treatment Act”, and many others.
From IDSA’s perspective, however, the Task Force’s highest priority must be to identify permanent solutions, both legislative and regulatory, to the crisis that exists in the antibacterial drug pipeline. This crisis, and its causes and effects on patient care and public health, were highlighted in IDSA’s 2004 report Bad Bugs, No Drugs. To IDSA’s more than 9,000 infectious disease physician members based in the United States and internationally (~12 percent of IDSA’s members), the lack of new antibacterial drugs in development represents one of the world’s greatest health threats. For this reason, last week, IDSA wrote to President Obama and Prime Minister Reinfeldt seeking the establishment of an Antibacterial Drug Pipeline Work Group as a component of the new Task Force. IDSA also seeks a Global Commitment to Develop New Antibacterial Drugs by U.S., EU and global leaders with the measurable goal of developing “10 novel antibacterial drugs by 2020”. The key to the success of the 10 X ’20 Initiative is the creation of a long-term, sustainable research and development (R&D) infrastructure model that provides incentives across the spectrum of the antibacterial drug and related diagnostics research enterprises.
Of gravest concern and of highest priority must be the development of drugs to treat serious and life-threatening infections caused by a group of drug-resistant bacteria that IDSA calls the “ESKAPE” pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species), because they effectively escape the effects of antibacterial drugs. Two recent reports—one report by IDSA and another report by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA)—demonstrate that there are few candidate drugs in the pipeline to address infections due to these highly-resistant bacteria. The ECDC/EMEA report, for example, found only 15 antibacterial drugs in development with the potential to offer a benefit over existing antibacterial drugs[1], and only five of these had progressed to clinical trials to confirm clinical efficacy (Phase III or later). Unfortunately, based on past experience, we know that few of these drugs are likely to make it to market.
IDSA is hopeful that we can count on groups like CGD, RFF, KAW, ReAct, and APUA, the Bill and Melinda Gates Foundation, Pew Health Group, and other philanthropic organizations, governmental and international health agencies, industry, and academia to support the 10 X ’20 Initiative and to advocate that the Task Force and, more importantly, political leaders in the U.S., EU, and around the globe commit to this goal. Immediate support from the advocacy and philanthropic communities for the creation of an Antibacterial Drug Pipeline Work Group as a component of the Task Force would be of tremendous help. IDSA welcomes your feedback and support and would appreciate it if recipients of this newsletter would consider sending a letter endorsing this proposal.