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Opposition
to antibiotic use in animal feed has been mounting.
US
FDA's Center
for Veterinary Medicine's website
contains the proposed framework document along with comments and
testimony transcripts.
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Antibiotic
Abuse
The Boston Globe | August 8, 2005 | A10 Editorial
THE GREAT, life-saving
medical advance of the 20th century was the discovery of antibiotics.
Now, in the 21st century, the effectiveness of these miracle drugs
is being undercut by their misuse in both people and animals.
The fight to end
overuse of the drugs in animals had two recent victories: a decision
last month by the Food and Drug Administration to ban the use
of two antibiotics in poultry and an announcement Tuesday by a
major food services company, Compass Group, that its pork suppliers
would no longer use antibiotics to promote growth. As welcome
as these steps are, the best route to stop agricultural misuse
of these drugs is legislation pending in Congress.
According to the
Union of Concerned Scientists, 70 percent of all antibiotics used
in the United States are put in the feed of poultry and livestock.
This is done not to treat infections but to speed growth or prevent
disease in the unhygienic quarters of the animals. One effect
of this indiscriminate use of the drugs is to breed strains of
bacteria that are resistant to them, eroding their ability to
cure infections in humans. The risk is greatest with germs that
pass from animals to humans, such as salmonella.
In 2000, the FDA
started the process of banning two antibiotics in poultry farming
after a study showed that 17.6 percent of humans who were treated
with these drugs in 1999 had resistant bacteria strains. In 1995,
when the drugs were first approved for use in poultry, just 1
percent of humans had resistant strains. One maker of poultry
antibiotics, Abbott Laboratories, quickly agreed to withdraw its
drug from the market, but the Bayer Corp. chose to contest the
ban. Because of the FDA's cumbersome procedures, it has taken
five years to get a final ruling against Bayer.
That timeline is
an argument in favor of a Senate bill, whose sponsors include
Senators Olympia Snowe of Maine and Edward Kennedy, that would
ban the nontherapeutic uses of antibiotics in animals. The ban
would go into effect two years after enactment of the law, with
provisions for financial aid to farmers. The National Academy
of Sciences estimates that the ban would raise a person's annual
meat bill by $5 to $10. The American Medical Association, the
American Academy of Pediatrics, and the American Public Health
Association all favor an end to this use of antibiotics.
Resistant bacteria
are also the result of doctors prescribing the drugs for conditions
not caused by bacteria and of patients prematurely breaking off
a course of antibiotic doses. Efforts to curb resistance have
to address these as well. But banning the nontherapeutic use of
antibiotics in animals is a sensible step to make sure medicine
doesn't lose these potent weapons against infection.
Copyright 2005
Globe Newspaper Company
This material is distributed in accordance with Title 17 U.S.C.
Section 107.
APUA's
position on the FDA's proposed framework for antimicrobial drug
use in food-producing animals
APUA.
April 5, 1999.
There is growing recognition and concern that the use of antibiotics
in food-producing animals contributes to the development of resistance
in bacteria that find their way into food and humans. To protect
public health by preserving the long-term effectiveness of antimicrobial
drugs for treating human diseases, the Alliance for the Prudent
Use of Antibiotics supports the FDA's efforts in developing rigorous
guidelines for approving and evaluating animal antimicrobial drugs
used in food-producing animals. APUA, an international nonprofit
organization dedicated exclusively to the proper use of antibiotics
and containment of drug resistance, strives to preserve the effectiveness
of antibiotics in both human and veterinary medicine. To this
end, APUA recommends that the proposed framework be applied to
both current and new animal-use antimicrobial drugs along with
the following changes:
The FDA
should eliminate the non-therapeutic use of antimicrobial drugs
in food-producing animals.
Chronic
subtherapeutic antibiotic usage, such as in growth promotion,
poses a major ecological problem that impacts public health. Domestic
food-producing animals outnumber humans in the United States by
more than five to one, and the majority of these animals are routinely
given subtherapeutic doses of antibiotics to promote growth. Repeated
low-level exposure to antibiotics (i.e., subtherapeutic doses)
disrupts the normal bacterial flora of the animals and promotes
the growth of antibiotic resistant bacteria. Chronic use (a week
or more) of antibiotics, at either sub-therapeutic or therapeutic
levels, leads to multi-drug resistance in both humans and animals.
Antibiotic-resistant bacteria selected in animals can reach humans,
where they are propagated by the use of the same antibiotic in
humans.
Antimicrobial drugs, regardless of drug "category,"
should not be used for non-therapeutic purposes in food-producing
animals. While it is clear what antimicrobial drugs are currently
used in human therapeutics, it may not be clear what new antimicrobial
drugs, or derivatives, may someday be used in human medicine.
As pharmaceutical companies continue discovery efforts, active
analogs of animal-use drugs have been found useful in human medicine.
Today derivatives of animal-use drugs have been developed as important
classes of valued human therapeutics.
However, because of years of chronic use as growth promoters,
resistant bacteria are already present in the environment which
thwart the efficacy of these new antibiotics and transfer resistance
traits, in some cases even before the new human therapeutics have
been introduced.
The FDA
must prohibit the use of any human-use antimicrobial drugs in
food-producing animals if there is evidence of an increase in
antimicrobial resistance within the animal population.
As multi-drug
resistance can emerge in as little as 7 days of chronic use of
an antimicrobial drug, any rise in resistance levels that is related
to antimicrobial drug use in food-producing animals could constitute
a public health threat. Thus, the FDA must monitor resistance
levels associated with animal-use antimicrobial drugs.
Many pharmaceutical companies monitor animal flora before, during
and after the administration of new antimicrobial drugs. These
longitudinal data would be invaluable in determining resistance
trends and should be available for decision-making purposes. The
FDA should require pharmaceutical companies to submit resistance
data on a regular basis. These data will be used to determine
a conservative threshold of resistance and monitor resistance
trends. If antibiotic resistance levels rise above a predetermined
point, the use of any human-use drug must immediately be discontinued
while further studies are conducted.
In conclusion, the FDA framework must identify and eliminate non-essential
antimicrobial drug use and reserve as many of these drugs as possible
for proper use in human and veterinary medicine. To accomplish
these goals, the FDA must curtail non-therapeutic use of all antimicrobial
drugs and closely monitor antimicrobial drug resistance in food-producing
animals. Again, APUA applauds the FDA for developing a framework
for evaluating new animal-use antimicrobial drugs to protect human
safety. APUA would be pleased to work with the FDA to help evaluate
and monitor antimicrobial drug resistance patterns.
Mounting opposition to antibiotic use in animal feed
APUA. 1999. APUA
Newsletter 17(1): 6.
Concerned scientific and public advocacy groups are calling for a long overdue ban on antibiotic use in animal
feed. On March 6,1999, the Center for the Science in the Public Interest held a press conference to present its
public petition and included the following APUA position concerning antibiotic use for growth promotion in animals:
"...To preserve antimicrobial drugs for human use, antibiotics used in human medicine should not be used for
non-therapeutic purposes in food-producing animals. While it is clear what antimicrobial drugs are currently used
in human therapeutics, it may not be clear what new antimicrobial drugs, or their derivatives, may someday be used
in human medicine. As pharmaceutical companies continue discovery efforts, active analogs of animal-used drugs
have been found useful in human medicine. For example, virginiamycin and avoparcin were classified as animal-use
drugs when first introduced. Today animal drug derivatives have been developed as important classes of valued human
therapeutics. Because of years of chronic use as growth promoters, resistant bacteria are already present in the
environment which thwart the efficacy of these new antibiotics and transfer resistance traits, in some cases even
before the new human therapeutics have been introduced.
Chronic subtherapeutic antibiotic usage, such as in growth promotion, poses a major ecological problem that impacts
public health. APUA endorses the World Health Organization's 1997 recommendation to progressively eliminate antibiotics
for growth promotion.
To protect public health by preserving the long-term effectiveness of antimicrobial drugs for treating diseases
in humans, APUA supports the efforts of the FDA in developing rigorous guidelines for approving and evaluating
new animal antimicrobial drugs used in food-producing animals."
EU bans antibiotics from animal feed to protect
public health--Will the US follow suit?
APUA. December 1998.
There is growing recognition and concern that the use of antibiotics in food-producing animals contributes to the
development of resistance in bacteria which find their way into food and people. Some bacteria are reservoirs of
resistant genes that can cause food-borne diseases. This link between antibiotic use and resistant bacteria in
agricultural products led to the recent European Union ban of four growth promoters.
The possibility of antibiotic resistance being transferred from animals to humans is no longer disputed, nor are
the phenomena of resistance and cross-resistance to these substances due to additive use, the European Commission
reported, "...it is imperative to preserve the effectiveness of those human medicinal products, all the more
so as medicinal products belonging to new classes of antibiotics are not ready for authorization in the immediate
future."
Currently, the US Food and Drug Administration is developing guidelines to evaluate the impact on human health
of new animal drugs intended for use in food-producing animals.
FDA approves antibiotic for treatment
of cattle with respiratory diseases
US Food and Drug Administration's Center for Veterinary
Medicine. July 24, 1998.
The US FDA's Center for Veterinary Medicine of the FDA has approved enrofloxacin, a fluoroquinolone, for treatment
of respiratory disease in cattle. APUA, the Center for Science in the Public Interest, even the FDA, have raised
considerable concern about introducing fluoroquinolones into animal use because of the potential effect on selection
of resistant bacteria of consequence to human health. Already, fluoroquinolone resistant Salmonella
and Campylobacter have appeared subsequent to the introduction of the fluoroquinolones to
poultry.
The difference, we can hope, is that this new approval is restricted to veterinary prescription and as an injectable,
and is not for water use, which is the way the poultry have been receiving their therapy. The implication is, of
course, that as fluoroquinolones are used in food animals, the selection of resistant strains can emerge which
will travel to the people through the food product itself. This new approval raises important questions about how
well the guidelines for use will be adhered to and who will regulate this use so that the fluoroquinolones do not
affect the larger ecology. According to the prospective approval, if resistance emerges, there is envisioned a
voluntary removal of the product. Still, no details are provided as to how this process can occur. APUA will continue
to watch this situation and report on how this new application for fluoroquinolones into animal husbandry will
affect the resistance problem which impacts human health. |
