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APUA Suggests Priority Activities for Transatlantic Task Force on Antimicrobial Resistance (TATFAR) for Office of Global Health Affairs Meeting: Oct.1, 2010

Thank you for the opportunity to suggest priorities for the Transatlantic Task Force on Antimicrobial Resistance on behalf of The Alliance for the Prudent Use of Antibiotics (APUA). APUA is a global scientific and public health organization, which promotes evidence -based policies to improve antimicrobial access, while containing antibiotic resistance. APUA conducts a multidisciplinary research, education and policy advocacy program in conjunction with chapters in 60 countries, 30 in the developing world. We welcome the partnership of this Task Force and view it as a uniquely powerful vehicle with the regulatory leverage and funding sources to enable concrete action.

The convergence of increasing antibiotic resistance, continuing antibiotic misuse, and a dwindling antibiotic pipeline has created a global public health crisis. A recent APUA sponsored study at Cook County Hospital estimated the cost of antibiotic resistance in US hospitals at greater than $20 billion annually, adding 6.4 – 12.7 hospital days per patient stay. In addition to economic and health costs, resistant bacteria represent a national security risk as a potential source for biological weapons.

We consider the task force work to be an emergency agenda related to global health and biosecurity and focused on two main goals: 1. Reduce unnecessary selective pressure on existing antimicrobial agents and 2. Promote novel infectious disease products, including diagnostics, innovative antibiotics and alternatives. We offer the below suggestions for achievable priority activities over the next 12-15 months.

Develop and publicize a concrete “ emergency action plan”
This plan should in no way emulate other antibiotic resistance plans but concretely identify all available funding and regulatory levers that can be focused on the resistance problem. This “emergency action plan” could be tied to World Health Day and become part of a publicity campaign to raise awareness among policy makers, funders, providers and consumers. Agency representatives on the task force should go back to their agencies and ensure resistance becomes a funding priority within existing budgets. RFP’s could be sent out to spur priority research, action and surveillance. Educational materials should be sent to potential funding groups to expand funding possibilities for future work.

Ensure Surveillance Systems to Monitor Antibiotic Use and Resistance
The first activity for the Task Force should be establishing compatible surveillance systems capable of documenting both antibiotic use and resistance trends in both human medicine and food animal production. In addition to pathogen surveillance, APUA’s ongoing international surveillance of commensal resistance should be used to provide complementary data and serve as an early warning of resistance emergence. (Surveillance needs are more fully discussed in the APUA 2005 GAARD report in CID.)

Reduce Antibiotic Misuse on the Farm
Food animal production sites are a major contributor to the selection and transfer of dangerous resistance genetic elements, which promote resistance in human pathogens. The animals far outnumber humans; the volume of antibiotics used there is high; massive low dose levels are routinely applied; and infection control is inadequate. At a recent APUA scientific roundtable, top scientists from European countries evaluated the impact of the ten- year EU ban of antibiotic use for growth promotion in food animal production. The group noted the many lessons learned from the surveillance and pilot interventions there. There is little sense in requiring responsible stewardship and data from the human medicine sector and not requiring the same from the food animal production sector where sludge and downstream waterways make for massive resistant gene pools. In the next year demonstration projects for infection control and antibiotic alternatives in food animal production should be funded, surveillance instituted and incentives identified to discontinue growth promotion antibiotics.

Promote Infection Control Programs and Antibiotic Stewardship Programs
The Task Force should identify regulatory and financial incentives to promote antibiotic stewardship programs in EU and US healthcare facilities and community medicine clinics. Also integration of environmental hygiene, infection control and antibiotic stewardship efforts should be encouraged to simultaneously address resistance drug resistance emergence and spread. To address drug resistance in the developing world, more funding should be allotted in the EU and US aide programs, with the goal of improving antimicrobial access and use.

Research Funding and Incentives to Promote Novel Products
The task force should agree on a few key incentives to encourage drug companies to develop antibiotics for priority resistant infections as well as targeted treatments or novel modes of action. Subsidies, patent extensions, and wild card incentives should be considered for companies, which meet priority infection needs and actively develop strong post-marketing surveillance and stewardship programs. Government agencies should ensure development and dissemination of objective and current treatment guidelines. Currently WHO guidelines and professional society work in this area tends to lag. At the same time, basic research on antibiotic resistance should be funded at much higher levels and a coordinated Transatlantic research agenda developed to accelerate answers.

Antibiotics as a Special Class of Drugs
Finally, one broad-brush strategy for the Task Force to consider would be designation of antibiotics as a special regulatory class (similar to orphan drugs or narcotics). Semantics is so important in any public policy and education campaign. Reclassification of antibiotics into a protected class would give these life saving agents the respect they deserve, allow special regulations and incentives to encourage pharmaceutical company investments and promote responsible stewardship and marketing. Finally we would ask government and private sector experts to work together to fully employ existing resources and expertise. As an independent global health organization with a dedicated network of laboratories and professionals in over 60 countries, APUA looks forward to partnering with you to address our mutual security interest in “preserving the power of antibiotics.” Thank you.

Kathleen T. Young, Executive Director, APUA
Stuart B. Levy, M. D. President, APUA















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