Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al
Filing
33
DECLARATION of Jennifer A. Sorenson in Support re: 19 MOTION for Summary Judgment.. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P, # 17 Exhibit Q, # 18 Exhibit R, # 19 Exhibit S, # 20 Exhibit T, # 21 Exhibit U, # 22 Exhibit V, # 23 Exhibit W, # 24 Exhibit X, # 25 Exhibit Y, # 26 Exhibit Z, # 27 Exhibit AA, # 28 Exhibit BB, # 29 Exhibit CC, # 30 Exhibit DD)(Sorenson, Jennifer)
EXHIBIT X
TO DECLARATION OF
JENNIFER A. SORENSON
CDC Q&A on Antibiotic Resistance (2009)
CDC - Get Smart: Antibiotic Resistance Questions and Answers
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http://www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html
What are bacteria and viruses? (#a)
What kinds of infections are caused by viruses and should not be treated with antibiotics? (#b)
What is an antibiotic? (#c)
What is antibiotic resistance? (#d)
Why should I be concerned about antibiotic resistance? (#e)
Why are bacteria becoming resistant to antibiotics? (#f)
How do bacteria become resistant to antibiotics? (#g)
How can I prevent antibiotic-resistant infections? (#h)
How can healthcare providers help prevent the spread of antibiotic resistance? (#i)
Are antibacterial-containing products better for preventing the spread of infection? Does their
use add to the problem of resistance? (#j)
Can antibiotic resistance develop from acne medication? (#k)
Do probiotics have a role in preventing or treating drug resistance or drug-resistant infections?
(#l)
Q:
What are bacteria and viruses?
A: Bacteria are single-celled organisms usually found all over the inside and outside of our
bodies, except in the blood and spinal fluid. Many bacteria are not harmful. In fact, some are
actually beneficial. However, disease-causing bacteria trigger illnesses, such as strep throat and
some ear infections. Viruses are even smaller than bacteria. A virus cannot survive outside the
body's cells. It causes illnesses by invading healthy cells and reproducing.
What kinds of infections are caused by viruses and should not be
treated with antibiotics?
Q:
A: Viral infections that should not be treated with antibiotics include:
Colds
Flu
Most coughs and bronchitis
Sore throats (except for those resulting from strep throat)
Some ear infections
Q:
What is an antibiotic?
A: Antibiotics, also known as antimicrobial drugs, are drugs that fight infections caused by
bacteria. Alexander Fleming discovered the first antibiotic, penicillin, in 1927. After the first use
of antibiotics in the 1940s, they transformed medical care and dramatically reduced illness and
death from infectious diseases.
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CDC - Get Smart: Antibiotic Resistance Questions and Answers
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http://www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html
The term "antibiotic" originally referred to a natural compound produced by a fungus or another
microorganism that kills bacteria which cause disease in humans or animals. Some antibiotics
may be synthetic compounds (not produced by microorganisms) that can also kill or inhibit the
growth of microbes. Technically, the term "antimicrobial agent" refers to both natural and
synthetic compounds; however, many people use the word "antibiotic" to refer to both. Although
antibiotics have many beneficial effects, their use has contributed to the problem of antibiotic
resistance.
(#top)
Q:
What is antibiotic resistance?
A: Antibiotic resistance is the ability of bacteria or other microbes to resist the effects of an
antibiotic. Antibiotic resistance occurs when bacteria change in some way that reduces or
eliminates the effectiveness of drugs, chemicals, or other agents designed to cure or prevent
infections. The bacteria survive and continue to multiply causing more harm.
Q:
Why should I be concerned about antibiotic resistance?
A: Antibiotic resistance has been called one of the world's most pressing public health problems.
Almost every type of bacteria has become stronger and less responsive to antibiotic treatment
when it is really needed. These antibiotic-resistant bacteria can quickly spread to family
members, schoolmates, and co-workers - threatening the community with a new strain of
infectious disease that is more difficult to cure and more expensive to treat. For this reason,
antibiotic resistance is among CDC's top concerns.
Antibiotic resistance can cause significant danger and suffering for children and adults who have
common infections, once easily treatable with antibiotics. Microbes can develop resistance to
specific medicines. A common misconception is that a person's body becomes resistant to specific
drugs. However, it is microbes, not people, that become resistant to the drugs.
If a microbe is resistant to many drugs, treating the infections it causes can become difficult or
even impossible. Someone with an infection that is resistant to a certain medicine can pass that
resistant infection to another person. In this way, a hard-to-treat illness can be spread from
person to person. In some cases, the illness can lead to serious disability or even death.
(#top)
Q:
Why are bacteria becoming resistant to antibiotics?
A: Antibiotic use promotes development of antibiotic-resistant bacteria. Every time a person
takes antibiotics, sensitive bacteria are killed, but resistant germs may be left to grow and
multiply. Repeated and improper uses of antibiotics are primary causes of the increase in
drug-resistant bacteria.
While antibiotics should be used to treat bacterial infections, they are not effective against viral
infections like the common cold, most sore throats, and the flu. Widespread use of antibiotics
promotes the spread of antibiotic resistance. Smart use of antibiotics is the key to controlling the
spread of resistance.
Antibiotics kill bacteria, not viruses
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CDC - Get Smart: Antibiotic Resistance Questions and Answers
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Q:
http://www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html
How do bacteria become resistant to antibiotics?
A: Antibiotic resistance occurs when bacteria change in some way that reduces or eliminates the
effectiveness of drugs, chemicals, or other agents designed to cure or prevent infections. The
bacteria survive and continue to multiply causing more harm. Bacteria can do this through
several mechanisms. Some bacteria develop the ability to neutralize the antibiotic before it can do
harm, others can rapidly pump the antibiotic out, and still others can change the antibiotic attack
site so it cannot affect the function of the bacteria.
Antibiotics kill or inhibit the growth of susceptible bacteria. Sometimes one of the bacteria
survives because it has the ability to neutralize or escape the effect of the antibiotic; that one
bacterium can then multiply and replace all the bacteria that were killed off. Exposure to
antibiotics therefore provides selective pressure, which makes the surviving bacteria more likely
to be resistant. In addition, bacteria that were at one time susceptible to an antibiotic can acquire
resistance through mutation of their genetic material or by acquiring pieces of DNA that code for
the resistance properties from other bacteria. The DNA that codes for resistance can be grouped
in a single easily transferable package. This means that bacteria can become resistant to many
antimicrobial agents because of the transfer of one piece of DNA.
The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) produced a
nine-minute animation (http://www.fda.gov/AnimalVeterinary/SafetyHealth
/AntimicrobialResistance/ucm134359.htm) explaining how antimicrobial resistance both emerges
and proliferates among bacteria. Over time, the use of antimicrobial drugs will result in the
development of resistant strains of bacteria, complicating clinicians' efforts to select the
appropriate antimicrobial for treatment.
(#top)
Q:
How can I prevent antibiotic-resistant infections?
Only use antibiotics when they are likely to be beneficial
A: By visiting this website, you are taking the first step to reducing your risk of getting antibioticresistant infections. It is important to understand that, although they are very useful drugs,
antibiotics designed for bacterial infections are not useful for viral infections such as a cold,
cough, or the flu. Some useful tips to remember are:
1. Talk with your healthcare provider about antibiotic resistance:
Ask whether an antibiotic is likely to be beneficial for your illness
Ask what else you can do to feel better sooner
2. Do not take an antibiotic for a viral infection like a cold or the flu.
3. Do not save some of your antibiotic for the next time you get sick. Discard any leftover
medication once you have completed your prescribed course of treatment.
4. Take an antibiotic exactly as the healthcare provider tells you. Do not skip doses. Complete
the prescribed course of treatment even if you are feeling better. If treatment stops too
soon, some bacteria may survive and re-infect.
5. Do not take antibiotics prescribed for someone else. The antibiotic may not be appropriate
for your illness. Taking the wrong medicine may delay correct treatment and allow bacteria
to multiply.
6. If your healthcare provider determines that you do not have a bacterial infection, ask about
ways to help relieve your symptoms. Do not pressure your provider to prescribe an
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CDC - Get Smart: Antibiotic Resistance Questions and Answers
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http://www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html
antibiotic.
How can healthcare providers help prevent the spread of antibiotic
resistance?
Q:
A: Prevent the spread of antibiotic resistance by
Only prescribe antibiotic therapy when likely to be beneficial to the patient
Use an agent targeting the likely pathogens
Use the antibiotic for the appropriate dose and duration
View CDC's Adult (../campaign-materials/adult-treatment.html) and Pediatric (../campaign-materials
/pediatric-treatment.html) Academic Detailing Sheets for providers
(#top)
Are antibacterial-containing products (soaps, household cleaners,
etc.) better for preventing the spread of infection? Does their use add to
the problem of resistance?
Q:
A: An essential part of preventing the spread of infection in the community and at home is
proper hygiene. This includes hand-washing and cleaning shared items and surfaces.
Antibacterial-containing products have not been proven to prevent the spread of infection better
than products that do not contain antibacterial chemicals. Although a link between antibacterial
chemicals used in personal cleaning products and bacterial resistance has been shown in vitro
studies (in a controlled environment), no human health consequence has been demonstrated.
More studies examining resistance issues related to these products are needed.
The Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee voted
unanimously on October 20, 2005 that there was a lack of evidence supporting the benefit of
consumer products including handwashes, bodywashes, etc., containing antibacterial additives
over similar products not containing antibacterial additives.
Suggested readings:
Weber JT, Hughes JM. Beyond Semmelweis: Moving Infection Control into the
Community. Ann Intern Med. 2004;140:397-398.
Larson EL, Lin SX, Gomez-Pichardo C, Della-Latta P. Effect of antibacterial home
cleaning and handwashing products on infectious disease symptoms: a randomized,
double-blind trial. Ann Intern Med. 2004 Mar 2;140(5):321-9.
Q:
Can antibiotic resistance develop from acne medication?
A: Antibiotic use, appropriate or otherwise, contributes to the development of antibiotic
resistance. This is true for acne medications that contain antibiotics. Short and long-term use of
antibiotics for treatment or prevention of bacterial infections should be under the direction of a
physician to ensure appropriate use and detection of resistance.
Q:
Do probiotics have a role in preventing or treating drug resistance or
9/22/2011 3:55 PM
CDC - Get Smart: Antibiotic Resistance Questions and Answers
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http://www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html
drug-resistant infections?
A: Probiotics are defined as microorganisms that when administered in sufficient quantities may
improve health. There are a variety of probiotics that have been studied for various health
benefits. Their role in preventing drug-resistant infections in humans has not been established.
CDC is currently monitoring research on probiotic use, but cannot make any recommendations at
this time.
Related Materials
Questions and Answers on Over-the-counter Medicines (symptom-relief.html#c)
Facts About Antibiotic Resistance (fast-facts.html)
Antibiotic Resistance: An Ecological Perspective on an Old Problem (2009)
(http://academy.asm.org/images/stories/documents/antibioticresistance.pdf) PDF [2 MB, 38 pages]
(#top)
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Page last updated: June 30, 2009
Content source: National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases
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9/22/2011 3:55 PM
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