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“ANTIBIOTICS FOR HUMAN TREATMENT ACT OF 2005” mentioning the U.S. Dept of Agriculture was published in the Senate section on pages S3407-S3408 on April 11, 2005.
The publication is reproduced in full below:
ANTIBIOTICS FOR HUMAN TREATMENT ACT OF 2005
Mr. KENNEDY. Mr. President, it is a privilege to join my distinguished colleagues, in proposing The Preservation of Antibiotics for Human Treatment Act of 2005. Our goal in this important initiative is to take needed action to preserve the effectiveness of antibiotics in treating diseases.
These drugs are truly a modem medical miracle. During World War II, the newly developed ``wonder drug'' penicillin revolutionized the care for our soldiers wounded in battle. Since then, they have become indispensable in modem medicine, protecting all of us from deadly infections. They are even more valuable today, safeguarding the nation from the threat of bioterrorism. Unfortunately, over the past years, we have done too little to prevent the emergence of antibiotic-resistant strains of bacteria and other germs, and many of our most powerful drugs are no longer effective.
Partly, the resistance is the result of the overprescribing of such drugs in routine medical care. But, mounting evidence also shows at the indiscriminate use of critical drugs in animal feed is also a major factor in the development of antibiotic resistant germs.
Obviously, if animals are sick, whether as pets or livestock, they should be treated with the best veterinary medications available. That is not a problem. The problem is the widespread practice of using antibiotics to promote growth and fatten healthy livestock. This nontherapeutic use clearly undermines the effectiveness of these important drugs because it leads to greater development of antibiotic-
resistant bacteria that can make infections in humans difficult or impossible to treat.
In 1998--7 years ago--a report prepared at the request of the Department of Agriculture and the Food and Drug Administration, by the National Academy of Sciences, concluded ``there is a link between the use of antibiotics in food animals, the development of bacterial resistance to these drugs, and human disease.'' The World Health Organization has specifically recommended that antibiotics used to treat humans should not be used to promote animal growth, although they could still be used to treat sick animals.
In 2001, Federal interagency task force on antibiotic resistance concluded that ``drug-resistant pathogens are a growing menace to all people, regardless of age, gender, or socio-economic background. If we do not act to address the problem . . . [d]rug choices for the treatment of common infections will become increasingly limited and expensive-and, in some cases, nonexistent.''
The Union of Concerned Scientists estimates that 70 percent of all U.S. antibiotics are used nontherapeutically in animal agriculture--
eight times more than in are used in all of human medicine. This indiscriminate use clearly reduces their potency.
Major medical associations have been increasingly concerned and taken strong stands against antibiotic use in animal agriculture. In June 2001, the American Medical Association adopted a resolution opposing nontherapeutic use of antibiotics in animals. Other professional medical organizations that have taken a similar stands include the American College of Preventive Medicine, the American Public Health Association, and the Council of State and Territorial Epidemiologists. The legislation we are offering has been strongly endorsed by the American Public Health Association and numerous other groups and independent experts in the field.
Ending this detrimental practice is feasible and cost-effective. In fact, most of the developed countries in the world, except for the United States and Canada, already restrict the use of antibiotics to promote growth in raising livestock. In 1999, the European Union banned such use and money saved on drugs has been invested in improving hygiene and animal husbandry practices. Researchers in Denmark found a dramatic decline in the number of drug-resistant organisms in animals--
and no significant increase in animal diseases or in consumer prices.
These results have encouraged clinicians and researchers to call for a similar ban in the United States. The title of an editorial in the New England Journal of Medicine 4 years ago said it all:
``Antimicrobial Use in Animal Feed--Time to Stop.''
On Thursday, the American Academy of Pediatrics, the American Public Health Association, Environmental Defense, the Food Animal Concerns Trust, and the Union of Concerned Scientists joined together in filing a formal petition with FDA calling for the withdrawal of certain classes of drugs from animal feed.
Earlier last week, Acting FDA Commissioner Lester Crawford emphasized his own concern that the use of such drugs in food-producing animals has an adverse health impact on humans. He stated that the FDA agrees with the GAO recommendation to review approved animal drugs that are critical to human health, and described FDA's progress in doing so. He stated, however, that the review process is extremely slow and labor intensive, and that even when safety issues are identified, the FDA can do little more than hope that the animal pharmaceutical companies will cooperate in addressing the issue.
There is no question that the Nation stands at risk of an epidemic outbreak of food poisoning caused by drug-resistant bacteria or other germs. It is time to put public safety first and stop the abuse of drugs critical to human health.
The bill we propose will phase out the nontherapeutic use in livestock of medically important antibiotics, unless manufacturers can show such use is no danger to public health. The act requires applying this same strict standard to applications for approval of new animal antibiotics. Treatment is not restricted if the animals are sick or are pets or other animals not used for food. In addition, FDA is given the authority to restrict the use of important drugs in animals, if the risk to humans is in question.
According to the National Academy of Sciences, eliminating the use of antibiotics as feed additives in agriculture would cost each American consumer not more than five to ten dollars a year. The legislation recognizes, however, economic costs to farmers in making the transition to antibiotic-free practices may be substantial. In such cases, the Act provides for federal payments to defray the cost of shifting to antibiotic-free practices, with preference for family farms.
Antibiotics are among the greatest miracles of modern medicine, yet we are destroying them faster than the pharmaceutical industry can create replacements. If doctors lose these critical remedies, the most vulnerable among us will suffer the most--children, the elderly, persons with HIV/AIDS, who are most in danger of resistant infections. I urge my colleagues to support this clearly needed legislation to protect the health of all Americans from this reckless and unjustified use of antibiotics.
Ms. SNOWE. Mr. President, today we are facing a public health crisis which most of us certainly did not anticipate. Nearly a half century ago, following the development of modern antibiotics, Nobel Laureate Sir McFarland Burnet stated, ``One can think of the middle of the twentieth century as the end of one of the most important social revolutions in history, the virtual elimination of infectious diseases as a significant factor in social life.''
How things have changed. Today some of our most deadly health threats come from infectious diseases. When we consider the greatest killers--
HIV, tuberculosis, malaria--it is clear that infectious diseases have not abated. At the same time we have seen an alarming trend--
increasingly physicians are stymied as existing antibiotics are becoming less effective in treating infections. We know that resistance to drugs can be developed, and that the more we expose bacteria to antibiotics, the more resistance we will see. So it is crucial that we preserve antibiotics for use in treating disease.
Most Americans appreciate this fact, and now understand that colds and flu are caused by viruses. So we know that treating a cold with an antibiotic is inappropriate, and we understand that such use of antibiotics is unwise. Over 9 out of 10 Americans now know that resistance to antibiotics is growing. Our health care providers are getting the message too. Physicians know that when a patient who has been inappropriately prescribed an antibiotic actually develops a bacterial infection, it is more likely to be resistant to treatment.
When we overuse antibiotics, we risk eliminating the very cures which scientists fought so hard to develop. The threat of bioterrorism amplifies the danger. I have supported increased NIH research funding, as well as Bioshield legislation, in order to promote development of essential drugs. Yet as we work hard to develop lifesaving medications, their misuse will render them ineffective.
Every day in America antibiotics continue to be used in huge quantities for no treatment purpose whatsoever. I am speaking of the non-therapeutic use of antibiotics in agriculture. Simply put, the practice of feeding antibiotics to healthy animals jeopardizes the effectiveness of these medicines in treating ill people and animals.
Recognizing the public health threat caused by antibiotic resistance, Congress in 2000 amended the Public Health Threats and Emergencies Act to curb antibiotic overuse in human medicine. Yet today it is estimated that 70 percent of the antimicrobials used in the United States are fed to farm animals for non-therapeutic purposes including growth promotion, poor management practices and crowded, unsanitary conditions.
In March 2003, the National Academies of Sciences stated that a decrease in antimicrobial use in human medicine alone will not solve the problem of drug resistance. Substantial efforts must be made to decrease inappropriate overuse of antibiotics in animals and agriculture.
Last week five major medical and environmental groups--the American Academy of Pediatrics, the American Public Health Association, Environmental Defense, the Food Animal Concerns Trust and the Union of Concerned Scientists--jointly filed a formal regulatory petition with the U.S. Food and Drug Administration urging the agency to withdraw approvals for seven classes of antibiotics which are used as agricultural feed additives. They pointed out what we have known for years--that antibiotics which are crucial to treating human disease should never be used except for their intended purpose--to treat disease.
In a study just reported in the New England Journal of Medicine, researchers at the Centers for Disease Control and Prevention found 17 percent of drug-resistant staph infections had no apparent links to health-care settings. Nearly one in five of these resistant infections arose in the community--not in the health care setting. While must do more to address inappropriate antibiotic use in medicine, and use in our environment cannot be ignored.
This is why I have joined with Senator Kennedy to again introduce the
``Preservation of Antibiotics for Medical Treatment Act''. This bill phases out the non-therapeutic uses of critical medically important antibiotics in livestock and poultry production, unless their manufacturers can show that they pose no danger to public health. I am pleased that we have been joined in this effort by Senator Collins, Senator Landrieu, and Senator Reed in introducing this measure.
Our legislation requires the Food and Drug Administration to withdraw the approval for nontherapeutic agricultural use of antibiotics in food-producing animals if the antibiotic is used for treating human disease, unless the application is proven harmless within two years. The same tough standard of safety will apply to new applications for approval of animal antibiotics.
This legislation places no unreasonable burden on producers. It does not restrict the use of antibiotics to treat sick animals, or for that matter to treat pets and other animals not used for food. The act authorizes Federal payments to small family farms to defray their costs, and it also establishes research and demonstration programs that reduce the use of antibiotics in raising food-producing animals. The act also requires data collection from manufacturers so that the types and amounts of antibiotics used in animals can be monitored.
As we are constantly reminded, the discovery and development of a new drug can require great time and expense. It is simply common sense that we preserve the use of the drugs which we already have, and use them appropriately. I call on my colleagues to support us in this effort.
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