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Newsletter Vol. 29 No. 2




APUA presents study findings to country and global decision makers in Uganda and Zambia

APUA renews advocacy to eliminate antibiotics in animal feed in the U.S.
Expert evaluation of the GAIN Act finds it lacking


APUA presents study findings to country and global decision makers in Uganda and Zambia

The APUA staff continues to increase dissemination of the findings of the Gates Foundation-supported AR-SANA project in its two target countries. From May 29 to June 11, 2011, Dr. Susan Foster (APUA Director of Public Policy and Education) and Dr. Aníbal Sosa (APUA Director of International Chapter Programs) conducted two country-level workshops and made a series of presentations in Uganda and Zambia. Initial meetings presented findings to the Country Advisory Team (CAT) members, who made many helpful comments and suggestions. Broader workshops involved health authorities, representatives of health NGOs, and funding organizations. Findings were also presented to Ministry of Health staff, at medical school Grand Rounds, and to medical staff from university teaching hospitals in both countries. Several CAT members and workshop attendees requested access to the outpatient register database, which will be made available.

Special sessions were held at the Centre for Infectious Disease Research in Zambia (CIDRZ; http://www.cidrz.org/), affiliated with the University of Alabama, and the Zambia Center for Applied Health Research and Development (ZCAHRD; http://www.bu.edu/cghd/), affiliated with Boston University. Both research groups found the project findings to be extremely valuable to their ongoing research efforts.

In another venue, an APUA panel on antibiotic resistance was presented at the Global Health Conference held in Washington D.C. on June 14, 2011. Hellen Gelband from the Center for Disease Dynamics, Economics & Policy (CDDEP) spoke on the Global Antibiotic Resistance Partnership (GARP) project activities and Marisabel Sánchez, President of LinksMedia, served as symposium chair. Further dissemination activities are being planned.
 



APUA renews advocacy to eliminate antibiotics in animal feed in the U.S.

APUA is seeking more scientists to participate in its expanded activities to eliminate misuse of antibiotics in food animal production in the US. In the last decade, APUA has published and disseminated a large body of scientific, clinical, and public health evidence to promote more prudent use of antibiotics in food animal production. In the coming year, it plans further activities to impact public policy by bringing the full weight of science to ensure government accountability in eliminating antibiotic misuse in agriculture. To join APUA’s advocacy campaign, please contact Carol Cogliani (APUA Program Manager) at carol.cogliani@tufts.edu or 617-636-4021.

Recently, two Congressional bills have started to gain traction – the Preservation of Antibiotics for Medical Treatment Act (PAMTA) and the Strategies to Address Antimicrobial Resistance (STAAR) Act. Passage of PAMTA would forbid the use of seven classes of medically important antibiotics for growth promotion purposes, while still allowing their use for treatment of sick animals. The STAAR Act would strengthen the Federal Interagency Task Force on Antimicrobial Resistance (FITFAR) and establish surveillance of antibiotic sales and usage data.

In June 2010, the U.S. Food and Drug Administration also issued a draft guidance, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” concluding that the use of medically important antimicrobials as growth promoters in food animal production is not beneficial to public health. The FDA recommended that antimicrobial drugs in agriculture should be limited to therapeutic uses with veterinary oversight, and that antibiotics should not be used for enhancing production (i.e. for feed efficiency and growth promotion).

Although this guidance constitutes a step forward in terms of laying the ground work to build consensus, it falls short. According to Dr. Stuart Levy (APUA Chairman and President), “The fact that the FDA considers mass administration of antibiotics to herds and flocks through feed and water as a viable prevention strategy is cause for concern.” Given the long duration and low dosage of antibiotics given to food animals, heightened antibiotic resistance and other negative impacts on microbial environments are very likely to result. This opinion came from EU experts who observed the effect of the EU ban on antibiotic growth promoters and testified at the APUA coordinated roundtable in May 2010. Since many animal diseases may be averted by alternative management strategies (e.g. improved animal hygiene, reduced crowding, and “all-in/all-out” housing), public health organizations such as APUA are advocating stronger U.S. regulatory policies to mandate more responsible use of antibiotics by relevant stakeholders (veterinarians, farmers, industry) and to establish a system to monitor and ensure compliance.
 


  


  
 



Expert evaluation of the GAIN Act finds it lacking

In a recent opinion article in Nature Medicine, Dr. Paul Ambrose (President of the Institute for Clinical Pharmacodynamics) applauded the initiative taken by supporters of the Generating Antibiotic Incentives Now (GAIN) Act but was of the opinion that “the legislation as written is not likely to have the intended consequences.”

Hospital-acquired infections (HAIs) from antibiotic resistant bacteria have reached an all-time high mortality rate of up to 70,000 deaths per year, and antibiotic resistance has been called the number one threat to global public health by both the WHO and the IDSA. Both organizations have proposed increased surveillance of resistant bacteria, more responsible use of existing antibiotics, and increased incentives to develop new antibiotics. These initiatives were also recently reintroduced to Congress (after failing to pass in September 2010) by Georgia representative and physician Phil Gingrey in the form of the GAIN Act. The legislation would grant faster application reviews from the FDA for newly developed drugs, and if licensed, would extend marketing exclusivity of those drugs to ten years (from the current five).

However, Dr. Ambrose points out why the GAIN Act may not be enough to revitalize the antibiotic pipeline. First, the legislation only provides for hastening the FDA response to a request for approval, rather than increasing the likelihood of approval for an experimental drug. More importantly, the GAIN Act alone simply does not provide sufficient medical reimbursement for the research and development of a new drug. The current price for antibiotic drugs, compared to lifestyle drugs or treatments against chronic illness, is simply too low to provide incentive to invest in this very expensive process. As proof of both these allegations, Dr. Ambrose notes that many pharmaceutical companies in the U.S. and in Europe (including the world’s two largest – Pfizer and Johnson & Johnson), have already dropped antibiotic development from their research roster within 2011 despite impending reintroduction of the GAIN Act. There is even less incentive for the smaller, usually venture capital-funded, biotech companies.

In addition to the GAIN Act, Dr. Ambrose urges legislators and the healthcare industry to simplify the path to regulatory approval for experimental drugs and to provide more investment incentives to pharmaceutical companies, such as greater protection for intellectual property, R&D tax credits, research subsidies, and tax relief for educational programs that promote prudent antibiotic use. APUA is following this legislation with the objectives of increasing incentives for development of novel agents while promoting more prudent use of antibiotics once they are on the market. “We need to work on both ends of the equation to be able to have access to cost-effective antibiotics,” says Kathleen Young (APUA Executive Director).


References
1. Ambrose, P.G. (2011) Antibiotic bill doesn’t GAIN enough ground. Nature Medicine 17:772.
 




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