News-Newsletter Vol. 29 No. 1

To Save Antibiotics, Make Them a Separate Class of Drugs
New FDA Guidance Expected to Protect Medically Important Antimicrobials
APUA and U.S. Regulators Consider Foodborne Hazards

Preservation of Antibiotics for Medical Treatment Act (PAMTA) reintroduced to US Congress

  On March 9, 2011, Representative Louise Slaughter (D-NY) reintroduced the Preservation of Antibiotics for Medical Treatment Act (PAMTA) targeting the non-therapeutic use of antibiotics in farm animals. Representative Slaughter first introduced this legislation in 2009. PAMTA would call for the FDA to re-examine its approvals of veterinary antibiotics. If enacted, it would remove from food animal production the non-therapeutic use of seven classes of antibiotics that are important to human health, unless animals are diseased or drug companies can prove that their use does not harm human health. Statistics from the Center for a Livable Future, an organization at Johns Hopkins Bloomberg School of Public Health, reveal that almost 29 million pounds of antibiotics are used in animals in the United States — 80 percent of the total antibiotics used in the country.

  The Alliance for the Prudent Use of Antibiotics, Pew, and over 300 other health, agricultural, environmental, humane, and consumer organizations are in support of enactment of legislation to remove the non-therapeutic use of medically important antibiotics in farm animals. These groups warn that the overuse and misuse use of antibiotics in food animal production is an immense threat to humans because it produces drug resistant bacteria that our current antibiotics will be ineffective against. The Bill currently has 19 co-sponsors and has been referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules.

The list of cosponsors can be found at

To Save Antibiotics, Make them a Separate Class of Drugs

  Stuart B. Levy, M.D., President of the Alliance for the Prudent Use of Antibiotics (APUA) and Tufts University School of Medicine Professor, suggests that the U.S. Food and Drug Administration (FDA) develop a separate class of antibiotics as “societal drugs” to bring increased awareness of their unique societal effects and to provide stronger incentives for industry to develop new drugs to combat resistant infections.

   “Antibiotics are different from all other drugs,” Levy explains. “Unlike, for example, drugs administered for heart disease, which affect the treated person and have no impact on anyone else, antibiotics affect the treated individuals and those sharing their health facility, home, and other environments.” One British study found that if one person was taking an antibiotic for acne, others residing in the same home had 1000 times more multi-drug resistant bacteria on their skin than did members of a household without antibiotic use.

  This proposal was made in conjunction with World Health Day (April 7th), which focused on antimicrobial resistance and was sponsored by the World Health Organization and collaborators including APUA. Continuing antibiotic misuse and a dwindling antibiotic pipeline has created a global public health crisis.
Antibiotics affect society at large by giving a survival advantage to the drug resistant organisms, which then spread resistance to other bacteria. Superbugs which emerge in one patient, animal, or hospital, proliferate quickly and spread easily from one patient to another. The recent outbreaks of the dangerous NDM-1 resistance gene and the CRKP “superbug” in California are the latest warnings about the increasing danger of antibiotic resistance. More than 350 cases of CRKP were reported at healthcare facilities in Los Angeles County, mostly among elderly patients in long-term care facilities.

  “Over the past 30 years there have been scores of expert reports calling for voluntary changes in use of antibiotics by physicians and food animal producers but unnecessary antibiotic use is still prevalent. Educational programs are helpful, but as in other areas of healthcare, it is the monetary and regulatory incentives that will get people’s attention and drive change," says Kathleen Young, Executive Director of APUA. According to a recently completed study sponsored by APUA, the estimated annual cost of antibiotic resistance in U.S. hospitals is greater than $20 billion and adds 6.4 – 12.7 hospital days per patient stay.


New FDA Guidance Expected to Protect Medically Important Antimicrobials

  FDA’s revised Draft Guidance #209, on “The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals,” is expected to be released for a 90-day public comment period this June. The agency’s most recent version of this guidance concluded that “using medically important antimicrobial drugs for production purposes is not in the interest of protecting and promoting the public health.” In anticipation for the release, The Pew Charitable Trusts, the American Academy of Pediatrics, and Keep Antibiotics Working held a meeting to prepare for FDA’s findings and coordinate an effective response to ensure the agency maintains its commitment to reducing injudicious antimicrobial use in farm animals. APUA was among 35 groups invited to participate at the meeting this May in Washington, DC.

APUA and U.S. Regulators Consider Foodborne Hazards

  The Pew Charitable Trust, together with Center for Science in the Public Interest, convened a day-long meeting on January 25, 2011 on “Managing the Risk of Foodborne Hazards: STECs (shiga toxigenic E. coli) and Antibiotic-Resistant Pathogens.” Presenters hailed from the food and pharmaceutical industries, governmental agencies – USDA, FDA, CDC, universities, and global agencies –WHO. The purpose of the conference was to collect expert recommendations to respond to emerging foodborne pathogens and related public policy.

  Dr. Elisabeth Hagen, Under Secretary for Food Safety in the U.S. Department of Agriculture, delivered the opening keynote. She highlighted the uniqueness of both the challenge and opportunity posed by the problem of foodborne illness in that it is one of the few public health problems that are preventable. It is important to anticipate emerging threats. The current challenge that remains unaddressed is that posed by non-O157 STECS, which cause about 36,700 illnesses, 1,100 hospitalizations and 30 deaths annually.

  She noted that a new challenge to managing foodborne pathogens is how to preserve antibiotic effectiveness. Collaboration among groups and good science are essential to the development of prevention-based policies and are at the core of all decision-making in food safety.

  The focus of the morning session was antibiotic-resistant pathogens. Dr. Stuart Levy delivered a talk on “Environmental and Societal Impacts of Antibiotics.” He related that every dose of antibiotic given has a consequence. Antibiotics are powerful drugs and powerful selectors of resistance. Between 30-50% of antibiotics used is unnecessary. He cited his prospective farm study in 1975-76 which demonstrated the transfer of tetracycline -resistance genes from chickens fed tetracycline-supplemented feed to farm dwellers: one-third of human fecal samples contained more than 80% of tetracycline-resistant bacteria (N Engl J Med 295: 583-588, 1976). Dr. Levy emphasized that antibiotics are societal drugs and that giving them to one person affects others and the environment. Selection density influences antibiotic resistance frequency. APUA’s Reservoirs of Antibiotic Resistance (ROAR) Scientific Network has investigated the role of commensal bacteria in resistant pathogens and its ISRAR project focused on surveillance among commensal flora in the environment in a search for new resistance determinants, with the participation of APUA Chapters in India, South Korea, South Vietnam, South Africa, Turkey, Georgia, Uganda, and Bangladesh.

  The afternoon session included presentations on the State of Science, Public Health Impact, Strategies for Risk Management, and Enhancing the Collaborative Response to Foodborne Hazards. Michael Taylor, of the US Food and Drug Administration, delivered the keynote summary.

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