[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
ANTIBIOTIC RESISTANCE AND THE USE OF
ANTIBIOTICS IN ANIMAL AGRICULTURE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
----------
JULY 14, 2010
----------
Serial No. 111-144
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
ANTIBIOTIC RESISTANCE AND THE USE OF ANTIBIOTICS IN ANIMAL AGRICULTURE
ANTIBIOTIC RESISTANCE AND THE USE OF ANTIBIOTICS IN ANIMAL AGRICULTURE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
JULY 14, 2010
__________
Serial No. 111-144
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
----------
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Washington, DC 20402-0001
COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah JOHN SULLIVAN, Oklahoma
JANE HARMAN, California TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
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Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Prepared statement........................................... 3
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 7
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 8
Prepared statement........................................... 10
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 16
Hon. Janice D. Schakowsky, a Representative in Congress from the
State of Illinois, opening statement........................... 17
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 18
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 19
Hon. Donna M. Christensen, a Representative in Congress from the
Virgin Islands, opening statement.............................. 20
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 21
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 22
Hon. Zachary T. Space, a Representative in Congress from the
State of Ohio, opening statement............................... 23
Hon. Bruce L. Braley, a Representative in Congress from the State
of Iowa, opening statement..................................... 24
Prepared statement........................................... 26
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, prepared statement.................................... 230
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 232
Hon. Roy Blunt, a Representative in Congress from the State of
Missouri, prepared statement................................... 237
Hon. John Sullivan, a Representative in Congress from the State
of Oklahoma, prepared statement................................ 239
Witnesses
Joshua Sharfstein, M.D., Principal Deputy Commissioner, Food and
Drug Administration, U.S. Department of Health and Human
Services....................................................... 28
Prepared statement........................................... 31
Answers to submitted questions............................... 316
John Clifford, D.V.M., Deputy Administrator, Veterinary Services,
Animal and Plant Health Inspection Service, U.S. Department of
Agriculture.................................................... 42
Prepared statement........................................... 44
Answers to submitted questions............................... 322
Rear Admiral Ali S. Khan, M.D., M.P.H., Assistant Surgeon
General, Acting Deputy Director, National Center for Emerging
and Zoonotic Infectious Diseases, Centers for Disease Control
and Prevention, U.S. Department of Health and Human Services... 49
Prepared statement........................................... 51
Answers to submitted questions............................... 324
Per Henriksen, D.V.M., Ph.D., Head of Division, Division for
Chemical Food Safety, Animal Welfare and Veterinary Medicinal
Products, Danish Veterinary and Food Administration............ 77
Prepared statement........................................... 80
Answers to submitted questions............................... 327
James R. Johnson, M.D., F.I.D.S.A., F.A.C.P., Professor of
Medicine, University of Minnesota, and Fellow, Infectious
Diseases Society of America.................................... 104
Prepared statement........................................... 107
Answers to submitted questions............................... 332
Gail R. Hansen, D.V.M., M.P.H., Senior Officer, Human Health and
Industrial Farming Group, Pew Charitable Trusts................ 123
Prepared statement........................................... 125
Christine Hoang, D.V.M., M.P.H., C.P.H., Assistant Director,
Scientific Activities Division, American Veterinary Medical
Association.................................................... 163
Prepared statement........................................... 165
Answers to submitted questions............................... 334
Randall Singer, D.V.M., M.P.V.M., Ph.D., Associate Professor of
Epidemiology, Department of Veterinary and Biomedical Sciences,
College of Veterinary Medicine, Division of Epidemiology,
School of Public Health, University of Minnesota............... 183
Prepared statement........................................... 185
Richard Carnevale, D.V.M., Vice President, Regulatory, Scientific
and International Affairs, Animal Health Institute............. 204
Prepared statement........................................... 206
Answers to submitted questions............................... 341
Stuart Levy, M.D., Professor of Molecular and Biology, Professor
of Medicine, Tufts University.................................. 216
Prepared statement........................................... 218
Submitted Material
Letter of July 13, 2010, from Centers for Disease Control to Mr.
Pallone, submitted by Mr. Waxman............................... 241
Statement of San Francisco Medical Society, submitted by Mr.
Waxman......................................................... 257
Statement of Physicians for Social Responsibility in Los Angeles,
submitted by Mr. Waxman........................................ 258
Documents for the record submitted by Ms. Schakowsky............. 259
Statement of Hon. Leonard L. Boswell, submitted by Mr. Waxman.... 313
ANTIBIOTIC RESISTANCE AND THE USE OF ANTIBIOTICS IN ANIMAL AGRICULTURE
----------
WEDNESDAY, JULY 14, 2010
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 2:12 p.m., in
Room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone, Jr. [Chairman of the Subcommittee] presiding.
Members present: Representatives Pallone, Dingell,
Schakowsky, Baldwin, Barrow, Christensen, Murphy of
Connecticut, Space, Braley, Waxman (ex officio), Shimkus,
Buyer, Pitts, Sullivan, Murphy of Pennsylvania, Blackburn and
Gingrey.
Staff present: Ruth Katz, Chief Public Health Counsel;
Sarah Despres, Counsel; Rachel Sher, Counsel; Stephen Cha,
Professional Staff Member; Emily Gibbons, Professional Staff
Member; Virgil Miler, Professional Staff Member; Alvin Banks,
Special Assistant; Allison Corr, Special Assistant; Eric Flamm,
FDA Detailee; Karen Lightfoot, Communications Director, Senior
Policy Advisor; Elizabeth Letter, Special Assistant; Lindsay
Vidal, Special Assistant; Mitchell Smiley, Special Assistant;
Clay Alspach, Minority Counsel, Health; and Ryan Long, Minority
Chief Counsel, Health.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. The meeting of the Health Subcommittee is
called to order, and the subcommittee is convening today for
its third hearing to discuss antibiotic resistance and its
threat to public health. Today we will examine the use of
antibiotics in food-producing animals and the impact of this
use on human health.
Antibiotics, as you all know, are among the most
significant medical innovations of the 20th century. The CDC
lists control over infectious disease as one of its top 10
great public health achievements of the last century, and
antimicrobials are crucial to that accomplishment. And yet we
must collectively be alarmed that we are undermining the power
of antibiotics by failing to use them judiciously. In past
hearings, we have heard testimony about physicians that are
prescribed antibiotics just in case their patients have
bacterial infections, and we all know patients that have
stopped taking their antibiotics once they felt better, even if
they didn't finish the treatment. It is clear that the
consequences of such actions are severe. Manmade antimicrobial
resistance weakens our options to treat pneumonia, food-related
diseases including E. coli and Salmonella, and hospital-
acquired infections, commonly known as MRSA.
Our examination of antibiotic resistance would not be
complete without a discussion of the use of antimicrobials in
animals. It is very timely that we are having this hearing
today. Last month the FDA issued draft guidance detailing its
position that using medically important antimicrobial drugs for
food production purposes threatens the protection and promotion
of the public health. FDA will state today that antibiotics
should only be given to animals under supervision of a
veterinarian and should only be used to assure animal health
and not to promote growth. We will have the opportunity today
to hear from the major experts and stakeholders in the field
about reactions to FDA's draft guidance and the overall debate
on how animal use of antibiotics impacts human health.
As we consider future action to limit antibiotic
resistance, it would be helpful to hear about the Danish
experience. Starting in 1995, the Danish government implemented
aggressive steps to limit the use of antibiotics in food-
producing animals and collected extensive data that they and
the World Health Organization used to evaluate the effects of
these actions. Clearly, any future action to limit antibiotic
resistance must be carefully considered and guided by science.
We have two great panels today of government and private
witnesses with 10 people total testifying who will contribute
to this discussion, and I know that many of the witnesses
rearranged their schedules today to be here including Dr. Josh
Sharfstein at the FDA. We greatly appreciate your ability.
However, I am going to have to say one thing you are not going
to like, and that is that unfortunately as too many times has
been the case here, we did not get the testimony within 48
hours before the hearing. I know that the hearing was changed,
I guess, from tomorrow to today but we notified everybody 3
weeks ago of that, and the FDA testimony arrived at about 6
p.m. Tuesday, which was last night, and the CDC testimony also
arrived late in the day on Tuesday, which obviously doesn't
make the 48 hours, so please in the future, it is really
important that we get the testimony 48 hours before the
hearing. Otherwise we really can't adequately prepare for the
hearing, so I just want to mention that, and I don't want to be
difficult but it really is important.
[The prepared statement of Mr. Pallone follows:]
[GRAPHIC(S) NOT AVAILALBE IN TIFF FORMAT]
Mr. Pallone. With that, I will yield to our ranking member,
the gentleman from Illinois, Mr. Shimkus.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman, and thank you for
obviously the admonition about getting testimony in, and I
appreciate that. I know it is not easy.
Thank you all for coming. The debate centers around whether
antibiotic use in animals presents a safety risk for humans.
Rather than focus on theory, we must really rely on the science
behind the issue. So far there is nothing that links use in
animals to a build-up of human resistance, and so I will be
focusing on, I know it sounds crazy, but real science, real
peer-reviewed science and testing, which in previous testimony,
and I have the record from the previous hearings that we have
done none in this country. There has been no testing in this
country on this connection. So the challenge will be to not
move in public policy until we have verifiable peer-reviewed
science to address this issue.
We do know through the hearings that people are overusing
and misusing antibiotics and that leads to faster development
of resistance of drugs in the body, and when it comes to people
getting sick from foodborne antibiotic-resistant strains,
evidence shows it is again from humans through handling food,
not animals. Even then because of our rigorous oversight,
foodborne illnesses in the United States have continued to
decline over the past decade. Nevertheless, as science develops
and we learn more, we can always work to improve risk-based
approach to making people and the foot they eat safer. We
should explore ways to strengthen our hazardous analysis and
critical control points, plans across the spectrum from farm to
fork.
At the same time, FDA should continue its strict approval
path of antibiotics for animal use. The FDA process is
resulting in increasing amounts of approved antibiotics that
are not used in human medicine at all. As a result, those
classes of antibiotics have no potential impact on human
resistance while yielding benefits on the farm. Still, there
are some who would ban use of antibiotics in animals similar to
what occurred in Denmark in the late 1990s, and I know the
chairman mentioned that, and I will be talking about that
research too. Since the ban, Danish animals' death and diseases
have increased. To control these increases, therapeutic use of
antibiotics to treat sick animals more than doubled to a level
greater than all antibiotic use combined prior to the year of
the ban. So they banned it and we use more. Animals are not
healthier; they are sicker. So that is why we do appreciate
this hearing, and this question, we did make humans safer? No.
Only did humans not become any less resistant, they became more
resistant to antibiotics in Denmark. Resistance increased in
Salmonella, penicillin, tetracycline. At the same time those
resistances in the United States have decreased to about half
the level of Denmark. Before we go down a path that will have a
devastating economic impact on our agriculture industry, we
must ensure science drives this debate.
So again, I want to thank you, Mr. Chairman, for holding
this hearing.
The last thing I do want to mention is that we have 10
witnesses today. This is our third or fourth hearing on
antibiotics. We have not had a single hearing on the new health
care law passed. We have asked for the CMS actuary. We have
asked for Secretary Sebelius. Now we have a recess appointment,
Dr. Berwick, who we like to see, who said some interesting
things about rationing care and that we would do it with our
eyes open, but I guess what is as telling as anything else why
we need to have a hearing is, it seems that in the $160 million
that we provided to Pennsylvania for the high-risk pool,
abortion and abortion services are being expanded at taxpayers'
expense. I thought this was a promise made to the pro-life
Democrats in voting for the bill through the Executive Order.
Obviously that was not the case and that is why we should have
a hearing, and I yield back my time.
Mr. Pallone. Thank you, Mr. Shimkus.
The chairman of our full committee, the gentleman from
California, Mr. Waxman.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman. I am pleased
you are holding this third of a series of hearings on
antibiotic resistance. This is a serious public health problem.
Our first hearing provided the context for understanding
the nature of the problem, the scope, the statistics and the
science that make up this emerging public health crisis. The
focus of today's hearing, the use of antibiotics in animals, is
an issue that has been raised by numerous members of this
subcommittee as well many of our previous witnesses,
representing both the public and private sectors, and I think
we would all agree that the topic is complicated and
controversial.
I believe we would also all agree on this point: By
definition, antibiotic resistance is bred by the very use of
antibiotics, be it by humans or by animals. To remain
effective, then, antibiotics need to be used judiciously.
As we learned at our last hearing, antibiotics are being
overprescribed in humans. That is a very real and difficult
problem and one that requires our full and immediate attention.
But the issue with animals is something else. For animals,
we use antibiotics for purposes other than treating illnesses
in the animal. As we will hear today, animals raised for food
production are routinely provided antibiotics to prevent
infections. In stark contrast to animals, we would be shocked
if a pediatrician ever ordered antibiotics for an entire
nursery school class to keep the children from being infected
with strep throat. But in this country, that is standard
practice for a barnyard full of pigs or cows or chickens. In
addition, animals regularly are fed these drugs not to treat
any illness at all but simply to promote growth. In both
situations, this is an overprescribing of a very different
sort.
There appears to be universal agreement on yet another
point: The key to reducing antibiotic resistance is to reduce
the use of antibiotics. The Food and Drug Administration
recently announced one approach for achieving this goal with
respect to animals. In June, the agency issued draft guidance
which recommends that antibiotics not be given to animals to
promote growth and that when these drugs are used, they should
be administered only under the supervision of a veterinarian.
This sounds to me like a very good first step.
But we must do more to tackle this piece of the antibiotic
resistance puzzle and we must do so as part of a comprehensive
strategy designed to safeguard the vitally important public
health tool that is our antibiotics. I would like to put into
the record a letter from Dr. Frieden, the director of the
Centers for Disease Control to Chairman Pallone, and according
to Dr. Frieden, ``The Centers for Disease Control and
Prevention finds there is a compelling body of evidence to
demonstrate this link between antibiotic use in animals and the
resistance from the antibiotics.''
[The information appears at the conclusion of the hearing.]
Mr. Pallone. Without objection, so ordered.
Mr. Waxman. It is critical we encourage the development of
new drugs. It's also essential to preserve the antibiotics we
already have. That means we must move expeditiously to slow the
advancement of antibiotic resistance in both humans and
animals. In each instance, our strategy must be based on
science. I agree with that statement. But science, not just the
science that may fit our constituency but real science and the
scientific evidence is now strong enough to create a consensus
among major public health groups and experts around the world
that the time has come to reduce the use of antibiotics in
animals. Organizations as diverse as the American Medical
Association, the Institute of Medicine, the World Health
Organization, and as we will hear from both CDC and the FDA,
they all agree: We must take action now.
This brings us to today's hearing. It is an important
hearing. Mr. Chairman, I want to thank Dr. Sharfstein. He has
been very accommodating to be here today. He accommodated us by
rearranging his schedule. I happen to know that by watching
television he has been very busy. I didn't see him out in Los
Angeles at any of the beaches, so I think he has been working
pretty hard and I have noticed he has been involved in Avandia.
We would like those statements in earlier, but I think they
ought to cut you a little slack. At least I am going to make
that comment. And the same is true for others but we do need
these statements as early as possible.
I thank all the witnesses who are here. I particularly
thank you, Mr. Chairman, for this hearing. I think this is
going to be an interesting one. Let us follow the science.
Thank you. Yield back.
[The prepared statement of Mr. Waxman follows:]
[GRAPHIC(S) NOT AVAILALBE IN TIFF FORMAT]
Mr. Waxman. Can I ask, Mr. Chairman, two statements by
unanimous consent be added to the record, one from two
California-based groups, the San Francisco Medical Society and
Physicians for Social Responsibility in L.A. regarding the use
of antibiotics for animals?
Mr. Pallone. Mr. Chairman, the----
Mr. Waxman. I ask unanimous consent their statements be
added to the record.
Mr. Pallone. The Republicans just want to look at it.
Mr. Waxman. I certainly want them to look at it. Whether
they agree with the statements or not, I think that the
groups----
Mr. Shimkus. Reserving the right to object. We don't want
to get into----
Mr. Waxman. I will pull back and have you look at it, and
then we will ask unanimous consent at a later time.
Mr. Shimkus. Thank you, Mr. Chairman.
Mr. Pallone. OK. So we are going to proceed without at this
point. I don't know, you took me back when you talked about
seeing him on the beaches. I didn't realize you traveled from
beach to beach.
Mr. Waxman. I was in L.A. My district has a lot of beaches
and I didn't see him at any of them.
Mr. Pallone. Next is the gentleman from Indiana. Oh you
want to reserve your time. OK.
Then we go to the gentleman from Pennsylvania, Mr. Pitts.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. Thank you, Mr. Chairman.
This is now the third hearing this subcommittee has held on
antibiotic resistance. First was on April 28th of this year and
second was held on June 9th. There is no doubt that over the
last 50 years antibiotics have saved countless lives worldwide.
There is also no doubt that we are experiencing a growing
amount of bacterial resistance to antibiotics, and many
infectious diseases are becoming increasingly difficult to
treat as a result.
For the purposes of this hearing, however, the key question
is this: Does the use of antibiotics in feed-producing animals
cause antibiotic resistance in humans? An exchange between
Chairman Emeritus Dingell and Dr. Thomas Frieden, director of
the Centers for Disease Control and Prevention, during the
April 28th subcommittee hearing is instructive, and I will
briefly quote. Mr. Dingell asked, ``There appears to be much
debate over whether the practice of adding antibiotics to
agricultural feed is thought to promote drug resistance. What
does current science and surveillance tell us on this point?''
Dr. Frieden answered, ``I am not aware of evidence in this
country that has documented the spread from animals to humans,
feed animals to humans.'' Mr. Dingell then replied, ``I am
getting the impression from what you are telling us here is
that we really don't know what the nexus between the feed with
antibiotics is and when there is a point of danger and what is
the level of danger and what research is going on.'' Mr.
Dingell was right. There is much that we don't know about how
the use of antibiotics in animals causes or does not cause
antibiotic resistance in humans.
Clearly, more study must be done. However, until we have
definitive scientific evidence, it seems to me that legislation
like H.R. 1549, the Preservation of Antibiotics for Medical
Treatment Act, or PAMTA, as they are calling it, which seeks to
eliminate the use of antibiotics in animals except for
treatment purposes, is premature and potentially dangerous. I
am pleased that it appears that the FDA is working with the
scientific and medical community in its new guidance, and I am
interested to see what the comment period produces. As I have
said before, we should study and explore every possible cause
of antibiotic resistance but we should let the scientific
evidence guide us.
I look forward to hearing from our distinguished panel of
witnesses today. Thank you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you.
The gentlewoman from Illinois, Ms. Schakowsky.
OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS
Ms. Schakowsky. Thank you, Mr. Chairman, for your
leadership on this issue.
The CDC has described antibiotic resistance as one of the
world's most pressing health problems and overwhelming data
proves that antibiotic resistance is increasing in this
country. This is a safety issue, a public health issue and
quite frankly an issue of national security.
Mr. Chairman, I would like to submit for the record
statements regarding the need for legislative action to protect
the effectiveness of antibiotics, legislation like the
Preservation of Antibiotics for Medical Treatment Act. These
letters are from organizations including the American Medical
Association, the American Academy of Pediatrics, Consumers
Union, Union of Concerned Scientists, and over 1,000 individual
physicians from across the country who have concluded that the
non-judicious use of antibiotics in livestock is a problem of
public health. So if I could submit these for the record?
Mr. Shimkus. Reserving the right to object, Mr. Chairman,
just so we get a chance to look at them.
Ms. Schakowsky. On June 28th, the FDA released draft
guidance on this issue. The report states that ``The overall
weight of evidence supports the conclusion that using medically
important antimicrobial drugs for production or growth-
enhancing purposes in food-producing animals is not in the
interests of protecting and promoting the public health.'' In
other words, pumping animals full of non-medically necessary
antibiotics is not good for public safety. I want to point out
that this guidance carries no enforcement mechanism but rather
asks the industry to voluntarily follow these suggestions.
It is obvious to me that legislation is needed. Eighty
percent of the meet randomly tested by the National
Antimicrobial Resistance Monitoring System shows traces of
antibiotic-resistant bacteria. Antibiotic resistance is not a
victimless phenomenon. Seventy percent of the 98,000 people a
year who die from hospital-related infections had a microbe
resistance to one or more antibiotics.
Mr. Chairman, I have looked forward to this hearing for
quite some time because it provides an opportunity to get the
facts straight. I want to leave today knowing who has clear
jurisdiction over the use of antibiotics in feed. If it is more
than one agency, I want to know what the agencies are doing to
work together and who is in the lead, and I want to feel
confident that the agencies do not forget about this issue once
this hearing is gaveled to a close, and I yield back.
Mr. Pallone. Thank you.
Next is the gentlewoman from Tennessee, Ms. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman, and thank you to
those of you who prepared testimony and are here before us
today. Certainly this is a topic that all of us are concerned
about. Whether or not it should be the topic that is taking the
time that we have today and the taxpayers' money, I will add,
is a subject of another debate.
And Mr. Chairman, I will have to tell you, as we look at
what is rolling out with this new health care law, I think it
is very evident to us that that is where our time needs to be
spent. When my children were little, and there was an issue in
front of them that needed to be addressed, I would always
remind them that avoiding the issue did not make it easier to
handle the issue in the long term. If you want to address the
problem, it is important that you hit it head on, and we are
hearing from people of the numerous problems that exist with
this health care bill that has been passed by this Congress and
signed into law. There is a lot of concern over there over the
expansion of agencies. There is tremendous confusion over the
implementation or the expected implementation of that bill.
There is surprise by taxpayers that benefits are going to be W-
2'd back to them on their health insurance. We are hearing from
employers all during the July 4th break as we talked about
freedom and the imperative of preserving freedom. We heard from
employers who were saying we are so concerned about the cost.
Look at what it is going to cost us to provide insurance under
this new list of mandates with all of these new agencies, with
all of these new directives. That, believe it or not,
translates into jobs lost, and the employers are concerned
about that. Now, maybe my colleagues across the aisle are not
that concerned but I can tell you losing the number of jobs
that have been lost in the past 15 months is a tremendous
concern. There is talk about rationing. There was a recess
appointment. Talk about national security. How about securing
the border? That is something that needs attention from this
Congress. Definitely that is an issue that is of great
importance to the American people.
Now, while the use of antibiotics in animals and the
transference of that to humans is important and we are
concerned, we know that there is a lack of large amounts of
data on this issue. Does it need our attention? Yes. Do we need
to keep a focus on this as we go forward? Yes. But what is an
imperative right now is that we look at what the people of this
country are saying they want us to address, an ill-conceived
health care bill that was passed that is a government takeover
of health care and they want to make certain that we tend to
getting that off the books. I yield back.
Mr. Pallone. Next is the gentleman from Connecticut, Mr.
Murphy.
Mr. Murphy of Connecticut. Thank you, Mr. Chairman. I am
eager to hear more about the subject that we are convened to
learn about today, so I will waive my opening statement.
Mr. Pallone. The gentleman from Georgia, Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Gingrey. Mr. Chairman, thank you.
As past hearings have highlighted, we have a potential
antibiotic crisis on the horizon. Simply put, we do not have
enough new antibiotics in the development pipeline to meet the
health care needs of the 21st century. Therefore, I believe it
is important for this committee to review the current
regulatory structure and promote incentives that will encourage
greater antibiotic production. To that end, I look forward to
working with my colleagues on both sides of the aisle to
achieve this worthy goal and to look forward to the testimony,
of course, from our witnesses today.
Mr. Chairman, on another note, following up a little bit
from the opening statement of Ms. Blackburn, I am appalled that
President Obama used the July 4th recess to appoint Dr. Donald
Berwick as the new CMS administrator without allowing a single
public hearing. During the health reform debate, this
Administration promised the American people that reform would
not ration health care. In fact, the White House's own Web site
under the heading ``health insurance reform reality check''
claims to debunk, and I quote, ``the myth that reform will mean
a government takeover of health care or lead to rationing.''
According to Dr. Berwick, however, the question, and this is
his quote, ``is not whether or not we will ration care but
whether we will do so with our eyes open.'' To be frank, Dr.
Berwick's outspoken support of health care rationing is
completely at odds with the Obama Administration's statements
on whether rationing is good for our country.
In his inaugural address, President Obama said that, and I
quote, ``On this day, we gather because we have chosen hope
over fear, unity of purpose over conflict and discord.'' In the
July 26, 2008, edition of the British Medical Journal, Dr.
Berwick chose hope when describing his support for the British
health care rationing system and this is another quote from Dr.
Berwick: ``The only sentiment I feel for the NHS [National
Health Service] that exceeds my admiration is my hope. I hope
you will never, ever give up on what you have begun.'' Mr.
Chairman, my hope is that we have some clarity on this issue.
Either the President and his Administration support or they are
opposed to health care rationing. The American people deserve
answers, and unfortunately, this recess appointment has stolen
those answers from them.
Mr. Chairman, I urge this committee to schedule a public
hearing on Dr. Berwick and his plans for our seniors' health
care program. Further, given past statements and opposition to
rationing, I believe that the Administration owes us answers to
very, very simple questions. Number one: Does President Obama
support Dr. Berwick's philosophy on health care rationing, and
number two, does President Obama agree with Dr. Berwick's
statement that any humane civilization must, again, Dr. Berwick
``redistribute wealth from the richer among us to the poor and
the less fortunate.'' Given that Dr. Berwick now runs our
seniors' health care program, I sincerely believe the American
people deserve a public hearing so we can get answers to these
questions, and with that, Mr. Chairman, I will yield back.
Mr. Pallone. The gentlewoman from the Virgin Islands, Ms.
Christensen.
OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS
Mrs. Christensen. Thank you, Mr. Chairman.
For decades, the scientific literature worldwide has shown
that non-therapeutic low-dose antibiotic use in farm animals
has caused increased resistance in humans yet I understand that
in 1977 when FDA attempted to take steps to curtail such use,
Congress ignored the research and the effort was lost. So thank
you, Chairman Pallone and Ranking Member Shimkus for your
attention to this important issue. Under your leadership, I am
sure that we are not going to repeat that unfortunate
interception, which is resulting in what is now termed a crisis
in antibiotic resistance.
I commend the FDA for the draft guidance they have issued
this year, and while I think it is a good first step, I think
it is up to the Congress to go further and pass H.R. 1449, the
Preservation of Antibiotics for Medical Treatment Act. Led by
Denmark and Europe, it has been proven that good animal
husbandry and judicious use of antibiotics has successfully
reduced resistance without adversely affecting industry or
profits. This is yet another area where our country is
threatening to fall behind, and this is unacceptable, not only
in terms of our leadership but because it places Americans at
undue and unnecessary risk. It also has the potential to put
our meat and poultry industry at risk. There can be no denying
that swift and definitive action must be taken to protect the
health of current and future generations as well as to protect
the health of our future economy.
I welcome the witnesses and look forward to their
testimony.
Mr. Pallone. Thank you, Ms. Christensen.
I have two statements that Mr. Waxman put forward for the
record, one from the San Francisco Medical Society and
Physicians for Social Responsibility in--well, one from the San
Francisco Medical Society, the other from the Physicians for
Social Responsibility in Los Angeles regarding the use of
antibiotics, and I would ask unanimous consent that these
statements be entered into the record. Without objection, so
ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pallone. And then we had another statement from Ms.
Schakowsky. There were one or two letters from Ms. Schakowsky
that she asked to be entered into the record, and I would ask
unanimous consent that those also be entered into the record.
Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pallone. And next is the gentleman from Michigan, our
chairman emeritus, Mr. Dingell.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, I thank you for your courtesy
and I commend you for the hearing.
Today's hearing is the third in a series of hearings on the
emerging public health threat posed by antibiotic resistance.
The specific focus of this hearing has proven to be the more
controversial aspect of the concern raised by public health
experts. Its controversy spends decades and very frankly some
very serious and important answers are required.
I introduced legislation on this topic in 1980, the
Antibiotics Preservation Act. That bill would have directed the
Secretary to designate antibiotic drugs which may or may not be
used in subtherapeutic doses in animal feed or ingredients of
animal feed unless such use is required to meet a compelling
need. Interested parties expressed very passionate opinion on
the legislation during hearings that year. I remember being
troubled by the efforts of FDA Commissioner von Eschenbach in
2007 to approve use of certain antibiotics of last resort in
food-producing animals. While there is substantial disagreement
between major parties on the magnitude of the problem and the
proper approach, I believe all sides would generally agree on
two things. One, antibiotic resistance is a growing public
health threat. According to the Infectious Diseases Society of
America, about 2 million people across bacterial infections in
U.S. hospitals each year. Ninety thousand people die as a
result. About 70 percent of these infections are resistant to
at least one drug.
It appears the injudicious use of medically important
antimicrobial drugs in animal agriculture increases the level
of antimicrobial resistance in animals and humans. A variety of
scientific committees, task forces and organizations including
a number of government organizations have studied the issue.
The general conclusion drawn from these studies is that the
injudicious use of antimicrobial drugs is not in the interest
of protecting and promoting human health, and while that
includes many different things, it is a warning to us.
While we can agree on these two points, there is a great
deal of uncertainty as to how to address this critical issue
and getting proper information on this matter is necessary to
properly address it. We must not take for granted the current
authority that rests in the Food and Drug Administration to
responsively address this matter. I was encouraged by recent
actions in that agency, specifically the issuance of a draft
guidance, and look forward to updated programs in their work in
other areas including the development of new antimicrobials.
I hope today's hearing will provide some interest on a few
critical questions that come to my mind. First, is the problem
best solved by a one-size-fits-all approach or should the
impact of each drug be separately considered? Two, are
additional authorities and resources justifiably needed to
fully address the problem? I might just observe, I think so.
Three, do the benefits of curbing the use of antimicrobial
drugs outweigh the risk of doing so? Four, what data should be
reasonably required of regulators to justify future action on
the use of antimicrobials in animal feed? And lastly, how do we
define judicious use in a way that removes all ambiguity and
helps us attain our public health goals while not impairing our
other concerns about animal health and about the business of
agriculture? I believe the answers to these questions will
guide us as we seek ways to address the problem we have before
us. Our attempt to address the problem should not be rushed. It
must be based on sound science and good information. It must be
done in a way that protects both human and animal health, and
it should not unnecessarily disrupt the animal agricultural
community.
I look forward to hearing the views and thoughts of our
witnesses this afternoon. I am especially interested in hearing
the views of our agency experts on this matter.
Again, Mr. Chairman, I thank you for this and I commend you
for your leadership. I yield back the balance of my time.
Mr. Pallone. Thank you, Chairman Dingell.
Next for an opening statement, the gentleman from
Pennsylvania, Mr. Murphy.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman, for
holding this hearing.
For decades, doctors have known that the widespread use of
antibiotics is going to speed the development of bacterial
mutation in antimicrobial resistance but what we don't do is
give antibiotics to every schoolchild just to prevent
infection.
Today, 70 percent of all health care-associated infections
in the United States are resistant to at least one antibiotic.
These infections cost some $50 billion a year. One antibiotic-
resistant infection, MRSA, kills more people in the United
States every year than HIV/AIDS. But what would happen if it
finally becomes resistant to the few remaining effective
antibiotics?
Of course, this resistance is not limited to human health.
The vast majority of evidence for the last three decades points
to linkage between routine low-level antibiotic use in food
animals and the transfer of antibiotic-resistant bacteria to
people, often through the food supply. The American Medical
Association, the American Academy of Pediatrics, the American
Public Health Association and the American College of
Preventive Medicine have all called for a significant reduction
in the amount of antibiotics we use in food animal production.
Antibiotics have four purposes: to treat disease, control the
spread of disease once an infection has occurred, prevent
disease from occurring and promote the growth in animals.
Last month, the FDA issued guidance to drug makers, animal
farmers, veterinarians that represents a step toward ending
antibiotic use for growth promotion and increasing veterinary
oversight of animal antimicrobial drugs that are available over
the counter at feed mills. Some drug makers are already moving
in this direction, and I encourage pharmaceutical companies,
farmers and the FDA to keep working together to limit any
unnecessary use of antibiotics.
I look forward to hearing from the FDA and other witnesses
of how they intend to ensure that disease prevention does not
become growth promotion by another name. There are other
solutions out there that will keep our food supply safe, our
society healthy and our antibiotics effective, and I hope this
hearing today will awaken our colleagues to the very real
threat to public health posed by the declining effectiveness of
antibiotics. Any use of antibiotics anywhere can cause bacteria
to select for resistance but overuse and misuse of antibiotics
simply gives bacteria an environment-rich situation to develop
resistance and multiply.
To really cut health care costs, save lives and preserve
the effectiveness of these vital drugs, we have to eliminate
unnecessary antibiotic use everywhere we find it, in hospitals,
nursing homes, the general community and sometimes even on the
farm.
With that, I yield back.
Mr. Pallone. Thank you, Mr. Murphy.
The gentleman from Ohio, Mr. Space.
OPENING STATEMENT OF HON. ZACHARY T. SPACE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO
Mr. Space. Thank you, Mr. Chairman.
We have before us a public health issue of significant
importance. Studies have indicated the antibiotics upon which
our doctors and hospitals relied are losing their effectiveness
in treating very serious illnesses. This resistance is a very
real problem and indeed a very scary one. Our committee is
right to investigate it and right to consider potential
solutions.
I am, however, worried about some of the discussions
relating to limiting the use of antibiotics in the agricultural
setting. My Congressional district is home to a significant
agricultural industry which directly employs over 17,000 people
and countless more indirectly. It is the linchpin of our
economy and an industry easily affected by regulation here in
Washington, D.C. Many of the farmers in my district rely on the
use of antibiotics to keep animal populations healthy and run
productive businesses. And while we must be mindful of the
importance of equipping farmers and veterinarians with the
tools they need to treat animals when they are sick, obviously
we all have to be mindful of the strategic necessary of
preventing illnesses from spreading.
Today's witnesses offer a variety of opinions on this
issue, many of which take different approaches to the same
issue. I look forward to the testimony and to learning more
about their perspectives. I believe it is critical that we
study the evidence further and take into account all options
and all sides of the issue before deciding whether to move
forward. If the committee does decide to move forward on this
issue, it is my hope we will move in a moderate and bipartisan
fashion while working with stakeholders in the agricultural
industry. This issue is an important one and worthy of careful
consideration, and we must be vigilant in ensuring that the
policies we create are carefully thought out.
And with that, Mr. Chairman, I yield back.
Mr. Pallone. Thank you, Mr. Space.
The gentleman from Iowa, Mr. Braley.
OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF IOWA
Mr. Braley. Thank you, Chairman, for holding this important
hearing on the use of antibiotics in animal agriculture, and I
also want to thank all the witnesses who came here today, and I
hope that we can have a meaningful conversation on this issue.
Most Americans when they go into a supermarket and buy some
pork or chicken or beef have no idea where that food came from
how or how it wound up in the supermarket or in their kitchen.
A lot of public health officials have never been to a farm and
seen with their own eyes and talked to production people
involved in agriculture about how that food is taken care of
and how it is grown and how it is processed and how it is
shipped off to the packing house where it is ultimately dealt
with and sent to their table.
A lot of parents take their kids into doctors' offices and
demand the use of antibiotics for something that won't even
respond because it is a viral infection. We are a culture that
looks for simple, easy answers when oftentimes we are talking
about complex tradeoffs, and it is no different here talking
about the very real public health concerns about antibiotic
resistance and very real production concerns about food safety
and food supply.
When I was a student at Iowa State University, it was a
well-known accepted fact that it was more difficult to get into
the Iowa State Veterinary Medicine College than the University
of Iowa College of Medicine, and yet we seem to think that
public health research is somehow in some way more superior
than animal veterinary research even though oftentimes they
come from the same raw data.
So my hope for this hearing is that we can all agree on
some fundamental things: A, that antibiotics are essential for
fighting bacterial infections in humans, and yet there is still
significant disagreement in some sectors about the specific
relationship between the use of antibiotics in feed products as
they relate to consumption of food and how that affects
antibiotic resistance in humans. I have always been an advocate
for science-based approach and I think this is an issue that
demands careful, thoughtful consideration of all scientific
points of view. Rather than come to conclusions based upon
ideology, I think we need to look through the entire body of
research available. There many well-intentioned people on both
sides of this debate, and my hope is, we can continue to have
meaningful discussions around tables like this, talk about the
best forward to move forward to make sure we continue to have a
safe, reliable food supply and are doing everything we can to
protect human health. We need to continue to assess how
antibiotics are being used in animals but also across the
spectrum in ways that they are being abused and creating the
type of antimicrobial resistance we are seeing today, and we
also need to make sure that as we listen and learn from the
witnesses who have come here today, we continue to fund the
necessary research to get to the bottom of how these problems
relate to one another and how we make the best informed
decisions to protect the public health interest.
So I want to thank you all for being here today. I look
forward to your input, and I yield back.
[The prepared statement of Mr. Braley follows:]
[GRAPHIC(S) NOT AVAILALBE IN TIFF FORMAT]
Mr. Pallone. Thank you.
And we also have the gentleman from Georgia, Mr. Barrow.
Mr. Barrow. I thank the chairman.
I can add nothing to the comprehensive statement of my
colleague, Mr. Braley, so I will waive an opening.
Mr. Pallone. I thank the gentlewoman.
That concludes our opening statements so we will now turn
to our first panel. I want to welcome you. Let me introduce
each of you. First on my left is Dr. Joshua Sharfstein, who is
the Principal Deputy Commissioner for the Food and Drug
Administration. And then we have Dr. John Clifford, who is
Deputy Administrator for Veterinary Services, Animal and Plant
Health Inspection Service for the Department of Agriculture,
and finally is Rear Admiral Ali Khan, who is Assistant Surgeon
General, Acting Deputy Director of the National Center for
Emerging and Zoonotic Infectious Disease with the Centers for
Disease Control.
I think you know the drill, 5-minute opening statements.
And I should mention, I guess we are expecting votes, but I am
going to proceed and then we will see. We may have to--well, we
will have to interrupt at some point but I think we might as
well start with Dr. Sharfstein.
STATEMENTS OF JOSHUA SHARFSTEIN, M.D., PRINCIPAL DEPUTY
COMMISSIONER, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES; JOHN CLIFFORD, D.V.M., DEPUTY
ADMINISTRATOR, VETERINARY SERVICES, ANIMAL AND PLANT HEALTH
INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE; AND REAR
ADMIRAL ALI S. KHAN, M.D., M.P.H., ASSISTANT SURGEON GENERAL,
ACTING DEPUTY DIRECTOR, NATIONAL CENTER FOR EMERGING AND
ZOONOTIC INFECTIOUS DISEASE, CENTERS FOR DISEASE CONTROL AND
PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
STATEMENT OF JOSHUA SHARFSTEIN
Dr. Sharfstein. Good afternoon, Chairman Pallone and
Ranking Member Shimkus and members of the subcommittee. I am
Dr. Joshua Sharfstein, Principal Deputy Commissioner of the
Food and Drug Administration, an agency of the Department of
Health and Human Services. Thank you for holding this hearing.
Thank you for the opportunity to discuss FDA's role and work
with respect to antimicrobial resistance, and we appreciate
your leadership.
In my testimony, I will describe FDA's actions to combat
resistance and discuss the newly released draft guidance
entitled ``The Judicious use of medically important
antimicrobial drugs in food-producing animals.''
As I will discuss in more detail later, in the draft
guidance FDA concludes that the overall weight of evidence to
date supports the conclusion that using medically important
antimicrobial drugs for production purposes is not in the
interest of protecting and promoting the public health.
Developing strategies for reducing antimicrobial resistance is
critically important for protecting both human and animal
health, both of which are very important to scientists and
regulators at the FDA.
Antimicrobial resistance is being addressed on a number of
fronts. Dr. Khan from CDC will talk about the data associated
with human resistance as it relates to antimicrobial use, and
his agency's leadership in efforts to fight resistance in human
medicine, but I do want to make a comment as a pediatrician.
I remember vividly in 1998 when I was a pediatric resident
and the Centers for Disease Control and the American Academy of
Pediatrics published principles for the judicious use of
antibiotics in common pediatric infections including the common
cold, ear infections, sinusitis and sore throat. I remember
giving conferences on the basis of that and I remember the
format of the papers and how they printed off the computer.
Children have many infections, and as Congressman Braley
mentioned, there was a big issue of parents coming and
expecting antibiotics, and these were very strict guidelines
for pediatrics on when to use antibiotics and when not to.
There was a major effort in pediatrics starting around that
time to reduce prescribing, to reduce antimicrobial resistance,
and it had an impact. A recent study in the Journal of the
American Medical Association showed that antibiotic
prescription rates for children under 5 with respiratory
infections decreased by 41 percent between 1995 and 2005. That
study was published last year.
Many centers at FDA are addressing the public health
concern about antimicrobial resistance including the Device
Center, which works on diagnostics, the Biologic Center, which
works on vaccines, the Drug Center, which works on Drugs.
Because today's hearing focuses on antimicrobials in
agriculture, I want to talk about the efforts at the Center for
Veterinary Medicine.
Our efforts start with surveillance through the National
Antimicrobial Resistance Monitoring System. CVM works with CDC
and USDA in overseeing surveillance of resistance in multiple
areas. In addition, CVM has an approach for assessing
resistance associated with the use of drugs intended for food-
producing animals. There was a guidance issued, Guidance 152,
which explains an approach when there is a new product coming
onto the market, how we assess whether there is a risk from
antimicrobial resistance and how that translates into our
regulatory pathway.
However, many antimicrobial drug products that were
approved prior to the implementation of this guidance have not
been evaluated, and a particular concern are those
antimicrobials that are considered medically important drugs,
meaning those that are important in human medicine and are
approved in food-producing animals for production or growth-
enhancing purposes.
To address this concern, the Center for Veterinary Medicine
released a guidance, as you have heard, on June 28. This is
intended to inform the public of FDA's thinking on this issue
and to minimize resistance by outlining broad principles for
assuring that medically important antimicrobial drugs are used
judiciously in animal agriculture. The draft guidance reviews
major public health reports on this topic including reports by
the Institute of Medicine, the Government Accountability
Office, the World Health Organization and its affiliated
agencies. Those reports include multiple peer-reviewed studies
conducted around the world including in the United States.
Based on this evidence, in this draft guidance FDA
recommends phasing-in measures that would, one, limit medically
important antimicrobial drugs to uses in food-producing animals
that are considered necessary for assuring animal health, and
two, include veterinary oversight or consultation. These steps
would help reduce overall use of medically important
antimicrobial drugs and reduce the selection pressure that
generates antimicrobial resistance.
Prior to issuing the draft guidance, FDA consulted with a
wide variety of stakeholders. We spoke with CDC and USDA and
got their input on the recommendations. I visited a farm in
southern Illinois, which was a very interesting experience, and
we are committed to working with all stakeholders across the
spectrum, our sister agencies as we get comments from the
public on the right way to implement this policy. We are
seeking comment through August 30, 2010, and we look forward to
a very productive dialog to figure out a very sensible path
through this issue that promotes both human and animal health.
Thank you.
[The prepared statement of Dr. Sharfstein follows:]
[GRAPHIC(S) NOT AVAILALBE IN TIFF FORMAT]
Mr. Pallone. Thank you, Dr. Sharfstein.
Dr. Clifford.
STATEMENT OF JOHN CLIFFORD
Dr. Clifford. Good afternoon, Chairman Pallone and Ranking
Member Shimkus and other members of the subcommittee. My name
is Dr. John Clifford and I am the Deputy Administrator for
Veterinary Services with the Department of Agriculture's Animal
and Plant Health Inspection Service. In this position, I also
serve as the U.S. Chief Veterinary Officer for animal health.
Today the subcommittee is looking at an important issue
that has far-reaching consequences for human and animal health.
USDA believes that it is likely that the use of antimicrobials
in animal agriculture does lead to some cases of antimicrobial
resistance among humans and in animals themselves, and we
believe that we must use medically important antimicrobials
judiciously. USDA is committed to playing an active role in
preserving the effectiveness of medically important
antimicrobials.
USDA believes that policy decisions must be science-based
and will provide research to inform the debate. To do this,
USDA will work with our federal partners including those at
this table.
What constitutes judicious use and how it applies is a
central question to this debate. This must be answered with a
sound scientific evaluation and with data-based decision-
making. USDA is working to conduct surveillance and research
and a number of agencies within the Department are actively
engaged on projects to better understand the issue. My written
statement details many of these efforts.
Beyond my department, FDA has an existing process for
completing risk assessments concerning the use of
antimicrobials. USDA believes that this process provides a
rational, science- and data-based approach to making decisions
about specific antimicrobial use. This is preferable to the
approach that broadly eliminates antimicrobials for specific
uses.
As we move forward, we must carefully address what current
research says and identify gaps in our scientific knowledge. We
are committed to working with our federal partners as we have
been on these important issues. We need more data so that the
policy can properly balance risk between animal and human
health needs.
USDA is also looking to expand its existing partnership.
For instance, USDA is interested in expanding our work with HHS
to improve outreach with veterinarians in the animal
agriculture community. We need to work together to conduct
research and develop new therapies that protect and preserve
animal health without increasing the risk of resistance to
medically important antimicrobials.
USDA is also interested in making our veterinary experts
available to provide guidance and share information with
veterinarians and producers. This Nation's farmers and ranchers
want to do the right thing. If we provide them with the
resources and information so they can make informed decisions,
they will do the right thing.
Mr. Chairman, I can assure you that USDA recognizes the
challenges of antimicrobial resistance and that the entire
Department is taking these challenges very seriously. We are
committing to ensuring that medically important antimicrobials
are used judiciously, which will preserve both human and animal
health.
I will be happy to answer any questions that you or your
members of the committee may have. Thank you.
[The prepared statement of Dr. Clifford follows:]
[GRAPHIC(S) NOT AVAILALBE IN TIFF FORMAT]
Mr. Pallone. Thank you, Dr. Clifford.
Dr. Khan, or Admiral Khan, I guess.
STATEMENT OF ALI KHAN
Admiral Khan. Good afternoon, Chairman Pallone, Ranking
Member Shimkus and other members of the subcommittee. I am Ali
Khan from CDC, and thank you for the invitation to address the
subcommittee today.
Antimicrobial agents are used to treat infection by
different disease-causing microorganisms. Resistance occurs
whenever and wherever antibiotics are used, in the community,
on the farm or in health care settings. Antibiotics are a
subset of antimicrobials used specifically to fight bacterial
infections. Many of the bacteria in our food that cause human
disease are also in food animals. These healthy food-producing
animals commonly carry bacteria in their intestinal tract and
they can cause disease in humans including Salmonella and
Campylobacter are two examples. Today I will focus on the human
health impact of antibiotic-resistance bacteria as they relate
to food animals.
There is unequivocal and compelling evidence that the use
of antibiotics in animals leads to the development of drug-
resistant bacteria that have adverse impacts on human public
health. This has been demonstrated for numerous production
animals--pigs, cattle, poultry--for numerous pathogens--
Salmonella, E. coli, Campylobacter enterococcus--and in
numerous countries--Denmark, England, Spain, Canada, and right
here in the United States. Antibiotic-resistant pathogens move
through the food supply, so use of antibiotics in animals
results in resistant bacteria in food animals. These resistant
bacteria then can be present in the food supply and be
transmitted to humans. And finally, these resistant bacterial
infections can result in adverse human health consequences such
as increased hospitalizations or potentially death.
Please allow me to describe some specific examples. Let us
see if slide one works here. Can somebody bring up the first
slide potentially?
Mr. Pallone. Do we have technicians here? Oh, there you go.
Admiral Khan. Let us go to the next one. Perfect.
[Slide shown.]
So Campylobacter is one of the leading causes of foodborne
bacterial disease in the United States. It causes approximately
2 million cases per year. And studies have unequivocally
demonstrated movement of resistant pathogens through the food
supply linked to antibiotic use in animals. So what you can see
nicely in this slide to the far left is antibiotic--well, that
depends on what side of the screen you are looking at, to the
far left of the slide. There is probably less than 1 percent
resistance in those bacteria, and then following the use of
fluoroquinolones and the licensing for fluoroquinolones in
poultry, what you can see is a dramatic increase starting 2 to
3 years later that has persisted despite a decision by FDA a
couple of years ago to stop the use of fluoroquinolones.
Now, this failure to see a subsequent decline in resistance
really is a cautionary tale for us and it suggests that the
movement of resistance from animals to humans should be
considered a sentinel event and demonstrates that resistance
once it occurs may not be easily reversed and that prevention
is a much better strategy that a control strategy.
[Slide shown.]
The next slide shows similar data in the United Kingdom.
Again what you can see is introduction in the yellow box of a
type of quinolone antibiotic in animals and then the increase
shows, the increase in resistance, not just in a number of
different animal species but in humans also.
And then finally, the Canadian data, which is really quite
dramatic, published this year from Quebec, and what this shows
is changes in cephalosporins. This is a common antibiotic that
we use, changes in cephalosporin resistance in chicken and
human Salmonella and chicken E. coli strains that appear to be
related to changes in the use of a type of similar antibiotic
in animals, and what you see is a marked decline in those
resistance in the E. coli and the Salmonella following a
decision for voluntary reduction of the antibiotic in animals,
and what is not on this slide is, if you follow out to 2, 3
years, there was a limited reintroduction of that antibiotic
for animals, and you see a little spike again as the antibiotic
is reintroduced. So very nice, clean evidence of what happens.
You introduce the animal. You reduce the antibiotic into the
animal population and increase in resistance, and then some
examples of a decrease in resistance associated with
discontinuing the antibiotic in animals.
Now, studies in Europe have also demonstrated the most
compelling and direct links between non-therapeutic use, often
referred as subtherapeutic use or use for growth promotion, et
cetera, in food-producing animals and subsequent antimicrobial
resistance in humans. So the ban of growth promoters in Denmark
has prevented spread of vancomycin-resistant enterococcus in
humans, reduced resistance in pathogens like Campylobacter and
reduced serious human infections, for example, due to specific
types of resistant Campylobacter, and this conclusion has been
independently verified by the World Health Organization.
Finally, antibiotics are a critical in our Nation's defense
against infectious diseases and we need to take strong measures
to make sure that we maintain their effectiveness. This
subcommittee and my colleagues at HHS and USDA have focused on
elements of a comprehensive strategy to protect public health
by avoiding resistance that stems from the overuse of
antibiotics in animals. Consistent with this one health
approach to the prevention of infectious diseases, CDC supports
these efforts to minimize non-judicious use of antibiotics in
both animals and humans for better human health, animal health
and environmental stewardship.
Thank you again for the invitation to testify today and I
will be happy to answer any questions.
[The prepared statement of Admiral Khan follows:]
[GRAPHIC(S) NOT AVAILALBE IN TIFF FORMAT]
Mr. Pallone. Thank you very much. I thank all of you.
We have three votes, the last votes of the day, about half
an hour or so, and so we are going to stand in recess.
Mr. Shimkus. Mr. Chairman, will you yield for a minute?
During the break, could we ask the majority since those slides
weren't provided as far as I know in the testimony, that we get
copies of those slides?
Mr. Pallone. Yes, we will get copies for you.
Mr. Shimkus. Thank you.
Mr. Pallone. So we will stand in recess.
Mr. Waxman. Mr. Chairman, before we break, may we renew our
unanimous consent request to put the----
Mr. Pallone. I am sorry, Mr. Chairman.
Mr. Waxman. Oh, we did it already?
Mr. Pallone. They have all been entered including Ms.
Schakowsky's. They have all been entered.
Mr. Shimkus. I was all over it for you.
Mr. Pallone. The subcommittee stands in recess.
[Recess.]
Mr. Pallone. The subcommittee hearing will reconvene. We
are going to have questions now, and I will start with myself
for 5 minutes.
This is sort of--I am going to cover all three of you with
this. I will start with Dr. Sharfstein.
At the end of last month, as you mentioned, the FDA
released a draft guidance on the judicious use of medically
important antimicrobial drugs in food-producing animals, and as
I understand it, the guidance essentially says that antibiotics
that are important for treating human disease should not be
used in animals except as needed to assure their health, and it
also says that veterinarians should be involved when the
antibiotics are used for that purpose. So I guess my point is
to note that today medically important antibiotics, whether
important for treating people or treating animals, are used for
non-therapeutic purposes, and so many of the people who use
them for those purposes, Dr. Sharfstein, haven't necessarily
reacted to your guidance in a positive way.
So my questions are about the scientific basis for the
guidance. What led you to develop the guidance? Did you meet
with stakeholders such as industry that would be affected by
the policies? What has been the general reaction to the
guidance? Who supported it? Who has opposed it? I mean, we know
that the producers aren't happy about it. On the day your
guidance was released, the president of the National Pork
Producers Council said FDA didn't present any science on which
to base this. So that is my question, really, is it
scientifically based? What is your response to the naysayers?
Dr. Sharfstein. Well, we look forward to the comment period
and we will review everything that we get from different groups
officially. I actually have been impressed at the interest
across many different areas of the animal agriculture in
working with FDA and I will note that the Animal Health
Institute, that they welcome the guidance, and the AVMA said
that they were pleased that we are committed to working with
the veterinary profession to address antimicrobial resistance
concerns.
So I think it may be--you know, I wouldn't necessarily buy
into us versus them on this. I think that is a very sensible
path. It really rests on a mountain of strong science, and one
of the documents we cite, I think is really excellent. It is
the WHO 2003 report which walks through six lines of evidence
that exists, citing multiple studies including a number done in
the United States, and the six are outbreak investigations
which trace Salmonella infections to farms, epidemiological
investigations which demonstrate that people are more likely to
have visited or lived on a farm prior to illness, that they
have antimicrobial-resistant infections, field studies
including some I think you will hear about on the next panel
where they actually prospectively demonstrate how antimicrobial
use in food animals selects for the emergence of resistance,
case reports including children who have been sick, spatial and
temporal associations where countries where they use less
antimicrobial agents you see less antimicrobial resistance in
bacteria, and finally, molecular subtyping, so this is the
sixth type of evidence, and I will be happy to submit this to
the record--it is cited in our report--where you actually can
trace the specific bacteria around, and they find--and one of
the studies I found most interesting, I think it was from
Minnesota, is that the resistant strains of the bugs in humans
match the resistant strains in the animals and those match the
sensitive strains in the animals except for the resistance
genes, but the sensitive strains in humans don't match those.
So you think it basically looks like the resistance is coming
from the animals and the animal resistance is developing in the
animals, and they do that by molecular analysis of the actual
bacteria.
So I really do think there is a very strong foundation of
evidence. I think Dr. Khan----
Mr. Pallone. Well, let me ask the other two guys.
Dr. Khan, do you agree with Dr. Sharfstein on this, and Dr.
Clifford, do you believe that growth promotion is an
injudicious use of antibiotics? Basically if you would comment.
Admiral Khan. CDC supports the FDA position. The position
is consistent with the one health approach and essentially how
we use antibiotics for human use, and a number of members of
the committee have pointed that tout. So we use antibiotics in
humans specifically for treatment, for prophylaxis when it is a
specific targeted individual or targeted drug for targeted
indication, and those are the three uses in antibiotics. So,
you know, I have kids in daycare, and lots of them are infected
with all sorts of things. Nobody would ever propose that all
children in daycare, for example, should be on antibiotics
through that whole time frame. So this is very consistent with
the one health approach and how we deal with antibiotics in
humans.
Mr. Pallone. Dr. Clifford?
Dr. Clifford. We work very closely with FDA in consultation
with this document and provided feedback to them. We think this
is a good first step, and we welcome seeing the comments as
well that FDA receives on this particular document.
As far as whether growth promotion or judicious use of
antibiotics, our position is that with regards to judicious use
of medically important antibiotics, we are talking about
treatment, control and prevention of animal health issues and
disease. So there are antibiotics, though, that are used, or
antimicrobials that are used in animals that have no analog
being used in human medicine and should not be of concern
unless there is proven evidence to the human side.
Mr. Pallone. OK. Thank you all.
Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman.
Dr. Clifford, is there science to support the removal of
antibiotic use for growth promotion?
Dr. Clifford. I am sorry?
Mr. Shimkus. Is there science to support the removal of
antibiotic use for growth promotion?
Dr. Clifford. You mean as far as the cause and effect?
Mr. Shimkus. Right.
Dr. Clifford. There is some cases.
Mr. Shimkus. Well, can you cite them?
Dr. Clifford. Well, obviously you can cite the Danish
experience.
Mr. Shimkus. No, I am talking about United States.
Dr. Clifford. Not right offhand, no, I cannot.
Mr. Shimkus. Do you know of any U.S.-supported research
peer review?
Dr. Clifford. I cannot cite any.
Mr. Shimkus. You are similar to other testimony we received
in April where Dr. Fauci and also quoted Dr. Frieden, and this
is the hearing record. ``To my knowledge and to Dr. Frieden's
knowledge, I don't think any of those studies have been done in
the United States.''
I mean, I saw Dr. Sharfstein give you a note. The question
is for you, not for Dr. Sharfstein. Dr. Sharfstein, I will ask
you questions if you have--with my time available.
Equating animals to people is like equating an apple to an
orange. I am just--that is why we have vets and that is why we
have doctors. That is why vets are not qualified to work on
human beings or medical doctors qualified for animals unless I
am sure in parts of southern Illinois years ago but--let me ask
Dr. Sharfstein. What decreases in the level of human antibiotic
resistance will we see if FDA proceeds with this Guidance 209
document as currently proposed?
Dr. Sharfstein. I expect that if we go forward with
Guidance 209 as currently proposed that this will reduce
antibiotic resistance pressure. We will have less antibiotic
resistance in animals and less antibiotic resistance in humans,
and it will promote both human and animal health.
Mr. Shimkus. And by what percent?
Dr. Sharfstein. I don't think I can answer the exact
percentage.
Mr. Shimkus. And can you cite me a study, a U.S. study that
verifies that analysis and that answer?
Dr. Sharfstein. Yes, I can. The Institute of Medicine's
2003 report was very clear that this would be the right
approach to take for this reason.
Mr. Shimkus. Is that a study and is it peer-reviewed
science?
Dr. Sharfstein. It is a study, and they do have a peer-
review process at the Institute of Medicine. The Institute of
Medicine is considered our Nation's leading scientific expert,
you know, group. They looked at this issue. They said to do
nothing is in effect to allow the continued evolution of
antimicrobial-resistant microbes which poses serious and long-
term----
Mr. Shimkus. And let me--and what do we see as a national
government? Have we done any additional research to verify
their findings?
Dr. Sharfstein. There has also been research in King County
related to Campylobacter that is very compelling. There is a
New England Journal study from Minnesota that is very
compelling. I would be happy to submit all these studies for
the record.
Mr. Shimkus. We would like them all, please.
Dr. Sharfstein. Dr. Frieden mentioned in his letter to the
committee that there is extensive data from the United States.
Mr. Shimkus. Yes, correcting the record by which he was
quoted in April, and we find that curious and also timely that
that occurred.
Dr. Khan, I want to go to your slides that you had
presented to us, and if the staff could pull up slide number 1
for me from Dr. Khan's. I am sorry. We should have given you a
heads-up, but if we didn't, we apologize. That is the right
one.
The antibiotics on chart 1 are mostly used for therapeutic
use, not subtherapeutic use. Is that correct?
Admiral Khan. Yes.
Mr. Shimkus. I see that there was no reduction in the
little arrow there for those who have it. That is when it has
been removed. There was no--in fact, there is an increase after
it was removed. What does that say?
Admiral Khan. That says prevention is really a lot more
important than control, so these may represent sentinel events.
The moment you get a resistant bacteria from animals that makes
it way into the human population, there is a different set of
drivers for maintaining it in humans that makes it impossible
to shut it down.
Mr. Shimkus. Could it be that there is another cause for
the resistance other than for which we are speaking of today?
Admiral Khan. I think the data is pretty unequivocal.
Before the use of fluoroquinolone----
Mr. Shimkus. Well, let us go to the second slide. Let us
talk about this unequivocal data here. This is the, I can't
pronounce it, quinolone resistance, Salmonella and typhimurium.
First question. I was elected to Congress in November of 1996,
took office in 1997. This chart ends in 1997, 14 years ago. Is
there no data after that?
Admiral Khan. There is data after that.
Mr. Shimkus. And what does that data show?
Admiral Khan. The data shows continued resistance. The
purpose of this specific slide was to show that the
introduction of this antibiotic into animals led to an increase
in resistant bacteria in not just----
Mr. Shimkus. I think if you would add data, I think what we
can find, and maybe this is why it was not submitted is that
you are going to see a decrease, and if that is the case, I
find it very perplexing and very troubling that we use data
from 1997 and we don't go to 14 years later to show the path.
Mr. Chairman, I know my time is expired, but the last
thing, I also have problems with the third slide. That is the
importance of getting data and information here in a timely
manner so we can check sources, and to use World Health
Organization data, to have dumbed down from the Danish study
which will make the Danish products competitive because it is
going to make us more difficult to compete. We are dumbing down
our ability, is very problematic and I would agree with some of
my colleagues, even on the other side, we better go very, very
carefully and use real science in this antibiotics use of
animals, and I yield back my time.
Mr. Pallone. Chairman Waxman.
Mr. Waxman. Dr. Khan, just on that last question you were
asked, if you had more data, you say it would show the same
results as what you saw in 1997?
Admiral Khan. It depends on the country, sir. So in the
U.K. there is continued persistence. In the United States,
using National Antibiotic Resistance Monitoring System, NARMS,
which is a system we use with FDA, that FDA, USDA and CDC
sponsors, there is variable data for different pathogens that
shows either continued increase or for some select Salmonellas
decreases in resistance. The reason I used--so the first slide
is actually U.S. data, fluoroquinolones in the United States,
unequivocal that the moment you use the fluoroquinolones,
within 2 to 3 years from less than 1 percent you went up to 20
percent resistance. That has remained----
Mr. Shimkus. Mr. Chairman, I don't want to be
disrespectful, but the point is, that is for therapeutic----
Mr. Waxman. Just a minute. You are disrespectful.
Mr. Pallone. Chairman Waxman has the time.
Mr. Shimkus. Well, I was hoping you yield, but I apologize.
Mr. Pallone. No, he is not yielding at this time.
Mr. Waxman. Go ahead. He doesn't like the answer you are
giving but let us hear what it is.
Admiral Khan. So that initial data, sir, the
fluoroquinolone data is U.S. data. We also have abundant
additional U.S. studies showing this. So if we look at
Salmonella typhimurium DT-104, multi-resistant outbreak amongst
people, that was due to ground beef. If we look at Salmonella
Newport, this is a multi-resistant strain----
Mr. Waxman. Well, let me ask you this because in USA Today
on Monday, the director of the National Pork Producers Council
said that, ``According to top scientists with the Centers for
Disease Control and Prevention and the National Institutes of
Health, there are no scientific studies linking antibiotic use
in livestock production with antibiotic resistance in people.''
Is this an accurate reflection of CDC's views?
Admiral Khan. Sir, Director Frieden has submitted a letter
to the committee that specifically states that there is a
compelling body of evidence to demonstrate this link that is
summarized above, so there is multiple North American studies
that describe how use of antibiotics in animals results in
resistant bacteria in food animals. These resistant bacteria
then are present in the food supply and transmitted to humans.
And finally, these resistant bacteria can result in adverse
human health consequences such as increased hospitalization,
and there is good scientific evidence for each one of those
three assertions.
Mr. Waxman. Well, a large part of the confusion seemed to
stem from the question about the adequacy of the peer-reviewed
literature showing a link between antibiotics use in animals
and resistant infections in humans. Do you think there is
substantial scientific evidence demonstrating a link between
antibiotic use in animals and infections in humans, and can you
discuss the implications of European versus USA data?
Admiral Khan. So there is an unequivocal evidence and
relationship between use of antibiotics in animals and
transmission of antibiotic-resistant bacteria causing adverse
effects in humans following that pathway that I have outlined.
The Danish data is also very clear on the use of subtherapeutic
use of antibiotics for animals and what the consequences on
resistance in humans.
Mr. Waxman. Dr. Sharfstein, do you think there is
substantial scientific evidence demonstrating a link between
antibiotic use in animals and infections in humans?
Dr. Sharfstein. Yes, I do think that.
Mr. Waxman. And is this scientifically controversial?
Dr. Sharfstein. I don't believe so, no.
Mr. Waxman. I wanted to ask a different line of questions,
and that is regarding, as we consider antibiotic use in
animals, we have heard concerns from some of the producers that
reducing the routine use of antibiotics in animals could result
in increased risk of foodborne illnesses. Since we have
representatives of two of the country's leading public health
agencies, I would like to ask you about your assessment of the
risks and benefits of reducing the use of antibiotic use in
animals. I think it is important to understand that no one here
is proposing to ban the use of antibiotics for animals. The
goal here is to reduce the use of antibiotics that are
important to human health and animals, particularly when that
use provides little or no benefit to those animals.
Dr. Sharfstein, as you know, it is the mandate of the Food
and Drug Administration to ensure that the food supply is as
safe as it can be, so would you be concerned if you believed
that reducing the use of important human antibiotics in animals
could result in increased risk to the food supply?
Dr. Sharfstein. Let me make sure I understand your
question. Am I concerned or would it be concerned?
Mr. Waxman. Are you concerned if you reduce the use of
antibiotics in animals that affect humans that this could
result in increased risk to the food supply?
Dr. Sharfstein. I think with our guidance, we are talking
about the use for not-health purposes, so we don't believe if
we are eliminating the use for not-health purposes we are going
to have adverse health consequences.
Mr. Waxman. Is there evidence to support the claim that
phasing out certain uses of antibiotics could increase risks to
the food supply?
Dr. Sharfstein. I think if by certain uses you mean the
uses we are proposing phasing out, you know, for growth
promotion, feed efficiency, I would say no, there is not
evidence.
Mr. Waxman. Dr. Khan, you are the Nation's leading
epidemiologist at CDC as well as the agency tasked with
conducting outbreak investigations foodborne illness. Would CDC
be concerned if it believed that phasing out certain use of
antibiotics in animals would increase the risk of illness in
humans?
Admiral Khan. No, sir, there is no scientific evidence
suggesting a negative impact on human health for limiting the
non-judicious use of antibiotics in animals.
Mr. Waxman. Thank you.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you.
Next is the gentleman from Indiana, who has 8 minutes. Mr.
Buyer.
Mr. Buyer. Thank you very much.
Dr. Clifford, I have a question that deals with
adulterated, counterfeit, knockoff drugs. We have a problem in
our country, and countries around the world are challenged by
this. Do you see any escalation or any evidence of adulterated
counterfeit drugs in animal health?
Dr. Clifford. Congressman, since this really falls under
FDA's jurisdiction, I would have to turn to them to answer that
question.
Dr. Sharfstein. In the United States----
Mr. Buyer. Hold on a second.
Dr. Sharfstein. Oh, I am sorry.
Mr. Buyer. Hold on. Go ahead. Thanks. For animal health.
Dr. Sharfstein. For animal health, I think we are going to
have to get back to you. I am not prepared to answer that. I
have not heard of a significant counterfeit problem in the
United States but I want to make sure and get back to you.
Mr. Buyer. You know, as our problem is growing, it is only
time before it migrates. It is going to follow the money,
right? Bad guys follow the money. And that is why I asked the
question.
I want to thank the FDA for continuing the blitzes that you
are doing at international mail facilities, so thank you for
doing that. You are trying to ``get the word out'' to Americans
that if you go on the Internet and you think that that is an
approved Web site to order your pharmaceutical products, that
you are really playing Russian roulette with your life, and so
thank you for keeping these blitzes going and trying to get the
word out. I noted in your testimony when you were with us in
March, you had in your testimony, ``Protecting Americans from
unsafe or contaminated drugs is not just an important
responsibility of the FDA, it is our core charge.'' Do you
agree with that today?
Dr. Sharfstein. I do believe that. I think it is one of the
reasons that FDA----
Mr. Buyer. So----
Dr. Sharfstein [continuing]. Was established.
Mr. Buyer. I am sorry?
Dr. Sharfstein. I was saying, it is one of the reasons FDA
was established.
Mr. Buyer. You also then in your testimony talked about FDA
must adopt a new approach. Now, I think when you talked about
your new approach, also you were concerned about the
production, i.e., raw ingredients, that are used within our
supply chain for which people are buying at retail outlets
within the gold standard of our own country. So ensuring that
we maintain that gold standard, you are putting your eyes on
that supply chain and production. I don't have any problems
with that. I think that is wonderful. I think the
Administration is doing what it is supposed to do. I applaud
you with regard to your striking the agreements with other
countries, putting more inspections on other soils. That is
awesome.
With regard to your--it is twofold. Not only do you have
that to do but we also have the mail facilities. Now, as we are
doing this, we have got both of these going on at the same
time, is we are trying to then do our electronic pedigree, and
Mr. Dingell has a bill, and we are going to do work and do this
electronic pedigree, but let me tell you what I was bothered
about what I read in the Miami Dade about your last blitz. I
think it is great. Like I said, you are doing the blitz. You
did a 3-day blitz. You did everything you were supposed to do,
your coordination with Customs, Border Protection, thousands of
pieces of foreign mail. You X-rayed them. You separated them.
You identified them, the suspicious pharmaceutical products.
You ID'd them. You showed how many of them were counterfeit and
knocked off, and then you sent them back. America has to be
shocked, and the counterfeiters have to be excited that America
is a place where you can counterfeit your drugs, send them to
America, steal people's money, and the American government will
send the counterfeit drugs back to you so you can then send
them to someone else that you can steal more money from. This
is like one of the dumbest policies I think we have in this
country.
Now, last year I sent questions on this, and the answer
from FDA is that FDA currently has authority to seek through
the judicial process the destruction of any drug and other FDA-
related products that relates to the Federal Food, Drug and
Cosmetic Act. Now, the person right next to your inspectors,
Customs, I mean, there is no wall. You have been there, right?
There is no wall between these guys. That customs person, when
they see it identified prima facie as knockoff, they destroy
it. But if they hand off and give to the FDA person, the FDA
says we can't destroy it, put a label on it and they send it
back. I know you have got to be uncomfortable with that as a
policy. Are you?
Dr. Sharfstein. Yes. I mean, I have spoken to some of the
inspectors who are, you know, as frustrated as you are.
Mr. Buyer. All right. Now, if you are willing to step into
a new--and that was your testimony that you gave to us in
March, that you embrace and wanted to adopt a new approach with
regard to the raw ingredients, through production and
distribution always to U.S. consumers, I think I have an
opportunity. I think, Mr. Dingell, we have an opportunity to
help protect America, and that is embrace what the FDA is
saying here, Mr. Dingell, and let us figure out how we can
destroy these when they are identified, when your inspectors
identify them. Let us not send them back to the counterfeiters
so they can continue to rip off people. You know, Doc, come on,
they are preying upon the most vulnerable of our population,
which is awful. Would you be willing to work with Mr. Dingell
and I to come up with a policy here that can give your
inspectors the ability to destroy these counterfeit, knockoff,
adulterated drugs?
Dr. Sharfstein. Yes, and I believe we have been already
starting that process by working with your staff and
Congressman Dingell's staff on this issue.
Mr. Buyer. All right. Well, I want to be as proactive as we
possibly can. John Dingell, to his credit, started this a long
time ago with his paper pedigree, and he has always had a great
interest. It goes all the way back many years into the 1970s,
and I applaud what he has done. I think he has got to be pretty
shocked on where America is today compared to where we were in
the 1970s, and as a policy and I know you adopted this, I was
just as frustrated with the last Administration but I am
embracing your spirit, and if we are able to move ahead, Mr.
Dingell, I want to join with you today and I want to work with
the FDA and I want to resolve this matter.
I want to yield to the chairman for a second.
Mr. Dingell. I thank the gentleman. He is most kind to me,
and I want to thank him for the kind comments he has made about
me. I want to assure him that my assurances of the last
Congress, I would be happy to work with him, and I happen to
agree with the gentleman about the problem of imports, about
tracing pharmaceuticals and other drugs, and I am pleased to
report to the gentleman that very shortly we will be
circulating a draft for comments about pharmaceutical safety,
and I hope that the gentleman when that occurrence happens that
he will look at it with sympathy and I look forward to working
with him because he is a valuable member of the committee, and
I thank him.
Mr. Buyer. I thank the gentleman.
The last, can I do this piece of math? Thirteen----
Mr. Pallone. The gentleman's time has expired, but all the
love----
Mr. Buyer. I ask unanimous consent for 30 seconds.
Mr. Pallone. Yes, with all the love and bipartisan here----
Mr. Buyer. God bless you.
Mr. Pallone. I certainly don't want to stop the gentleman.
Mr. Buyer. Thirteen international mail facilities, on
average 35,000 are pharmaceutical packages, times 365 days,
that is 1,666,075 packages a year. If 80 percent are
counterfeit, adulterated or knocked off, that means there are
132,860 pharmaceutical packages that are coming into the
country that are either adulterated, counterfeit or knockoff,
and people are taking these and they are not metabolizing in
the body in ways in which as doctors you intend.
With that, I yield back. Thank you.
Mr. Pallone. Thank you.
The gentlewoman from--I am sorry. Chairman Dingell is next.
Mr. Dingell. I thank you, Mr. Chairman.
These questions are for all three witnesses. The first is
yes or no. Is there a definitive link between antimicrobial use
in animal feed and antibiotic resistance in humans? Starting
with Dr. Sharfstein.
Dr. Sharfstein. Yes.
Mr. Dingell. Our next witness, Doctor.
Dr. Clifford. Yes, some.
Mr. Dingell. Some?
And you, Dr. Khan.
Admiral Khan. Yes, sir.
Mr. Dingell. Now, Dr. Sharfstein, please tell us what
scientific studies support your claim.
Dr. Sharfstein. I think the best document that begins to
summarize those is this 2003 study from the World Health
Organization and it goes through outbreak investigations,
epidemiological investigations, field studies, case reports,
spatial and temporal associations and molecular subtyping. In
each of those areas of research there are studies that support
that statement.
Mr. Dingell. Now, Doctor, if you would like, I would be
pleased to have you make other submissions supporting the
statement which you just made.
So next question to all three of our panel members. Are
these studies based--rather is to Dr. Sharfstein. Are these
studies based entirely on the European experience or do we have
some that reflect experience in the United States?
Dr. Sharfstein. They are both based on European experience
and some that are in the United States including one by someone
I went to medical school with.
Mr. Dingell. Now, again, Dr. Sharfstein, it is my
understanding that FDA currently has authority to withhold
approval for certain animal drugs if they are use poses a risk
to the public health. Is that correct?
Dr. Sharfstein. That is correct.
Mr. Dingell. OK. Now, does the likelihood that an
antimicrobial drug used to treat a food-producing animal may
cause antibiotic resistance to a problem in humans to pose a
risk, and I put the risk to public health in quotes. What is
the answer to that? Do you want me to repeat the question?
Dr. Sharfstein. Yes.
Mr. Dingell. Does the likelihood that an antimicrobial drug
used to treat a food-producing animal may cause an antibiotic
resistance problem in humans pose a ``risk to public health''?
Dr. Sharfstein. I think that the likelihood that that would
happen does factor into the regulatory process as we approve
new antimicrobials, so yes.
Mr. Dingell. And our other two witnesses, Dr. Clifford and
Dr. Khan, what is you view on that question?
Dr. Clifford. Could you repeat that question again, please?
Mr. Dingell. It is a difficult question. All right. Does
the likelihood that an antimicrobial drug used to treat a food-
producing animal may cause an antibiotic resistance problem in
humans pose a ``risk to the public health''?
Dr. Clifford. I still--yes, I mean, it is possible for
sure.
Mr. Dingell. Dr. Khan.
Admiral Khan. Yes, sir, and there is currently ample
evidence that use of antibiotics in animals results in
resistant bacteria in food animals, resistance is present in
the food supply and transmitted to humans and that resistant
bacteria result in adverse human health effects. So that data
already exists and is summarized in various documents.
Mr. Dingell. Now, gentlemen, again, based on this
interpretation, and this is to Dr. Sharfstein, based on this
interpretation, since 2003 FDA has considered the likelihood
for antimicrobial resistance in the drug approval process. Is
that correct?
Dr. Sharfstein. Yes.
Mr. Dingell. Now, has the interpretation been applied to
all drugs currently on the market as well as new applications
for drugs where the manufacturer is seeking access to the
market?
Dr. Sharfstein. No, it has just been applied to new drugs
coming on, and that is the reasons we would like to do this
guidance is addresses some of the issues with the drugs that
were already on the market.
Mr. Dingell. But you are not dealing with those which are
already on the market. All right.
Now, why has this interpretation not been used more widely
for those drugs that were on the market prior to 2003? Is it
for want of authority by Food and Drug?
Dr. Sharfstein. I don't believe it is for want of
authority, no.
Mr. Dingell. Now, Doctor, what are some of the barriers to
new antibacterial drug development and what is FDA doing to
help spur innovation in this area?
Dr. Sharfstein. I think there are two main barriers to
antimicrobial drug development. One of them is the need for
clear approval pathways so that companies can design studies
that can reach the right endpoints and be approved, and FDA is
working very hard to get the science right so we can have those
clear approval pathways. There is a meeting by the end of July
that will be the next step in that process.
The second major issue is the issue of incentives for
antibiotic development because it is expensive to bring drugs
to market, and for antibiotics we don't want them to be used
that much when they are there so the market isn't that great,
so we believe there is a market issue as well as a pathway
issue. FDA is supportive of discussions around the market
incentive issue but it is a little bit outside of our sphere to
really solve that problem.
Mr. Dingell. Thank you.
Mr. Chairman, I have used more than my time. Thank you.
Mr. Pallone. Thank you, Mr. Chairman.
Next is the gentlewoman from Illinois, Ms. Schakowsky.
Ms. Schakowsky. Dr. Sharfstein, I am trying to understand
then what the guidance says. Does it say it will only apply to
new drugs?
Dr. Sharfstein. No, no. I am sorry. I must have been
confused.
Ms. Schakowsky. Oh, OK.
Dr. Sharfstein. There is a Guidance 152 that only applies
to new drugs. I was referring to a guidance that was issued in
2003. I think that was what Chairman Dingell was referring to.
This new guidance--one of the reasons that we are issuing this
new draft guidance is because the old one doesn't apply to
existing drugs. This deals with some of the issues with
existing drugs.
Ms. Schakowsky. This would apply to all antibiotics?
Dr. Sharfstein. All medically important antibiotics.
Ms. Schakowsky. Right. OK. So we have the FDA, the USDA,
the CDC here today. Which agency has lead jurisdiction to
ensure then that the public is not at risk from overuse of
antibiotics in livestock feed?
Dr. Sharfstein. I think FDA has regulatory authority over
the use of antimicrobials in animals, but we work very closely
with our----
Ms. Schakowsky. That was my next question. So how do you
coordinate? Is there some sort of a----
Dr. Sharfstein. Yes, the President's Food Safety Working
Group is one of the places that we have had very good
discussions. This issue has been presented in a lot of
discussions, and then separate from the big group, we have also
worked individually. I think Dr. Clifford and the team at FDA
were on the phone multiple times, and certainly CDC was within
HHS, we are constantly talking to CDC at FDA.
Ms. Schakowsky. The FDA voluntary guidelines address non-
therapeutic use, right?
Dr. Sharfstein. It addresses what we call production uses,
growth promotion, feed efficiency.
Ms. Schakowsky. But I heard that poultry farmers have
recently stated that from egg to slaughter, chickens and
turkeys always need antibiotics to prevent disease. Now, here
is my concern. If you are only talking about non-therapeutic
use, what is to prevent farms from re-categorizing the purpose
of the antibiotics they give to animals instead of actually
ending the overuse?
Dr. Sharfstein. Well, I think you are getting to the
concept of prevention, how we would approach preventive uses,
and what the guidance, the draft guidance states is that it is
not enough for someone to say I think this prevents disease,
that is not enough, that our approach to prevention has to be
based on evidence, and factors to consider include the evidence
of effectiveness, the evidence that such a preventive use is
consistent with accepted veterinary practice, evidence that the
use is linked to a specific microbial agent, evidence that the
use if appropriately targeted and evidence that no reasonable
alternatives for intervention exist. So if we were going to
look at prevention uses, which we do believe are important, can
be important for animal health, we would apply kind of a
scientific evidence-based set of criteria to that scenario.
Ms. Schakowsky. Dr. Khan, are you comfortable with that as
well? Because you talked about prevention being the best thing.
Admiral Khan. Very much, ma'am, and this is also consistent
with how we use antibiotics in humans for prevention purposes,
so a good example is meningococcus. It is a meningitis,
inflammation of the brain. We do use it for prevention, a
specific drug for prevention purposes, but it is specific to
targeted people who get it. You get the drug twice a day for
two days for targeted infection. You don't get it forever, and
everybody in the emergency room, for example, doesn't get it.
Ms. Schakowsky. Let me ask you this. To what extent would
it be true to say that the use of antibiotics can be effective
in masking unsanitary conditions where livestock is raised? In
other words, if you use antibiotics, then you don't have to be
quite as precise about the level of cleanliness at places. Is
this ever an issue?
Dr. Clifford. Production management with regards to farms
and location of animals, that type of thing could be possible
but that is not a good management use of animals and it is not
going to lead to their bottom line economically. If they run
poor sanitation on a farm and have to use antibiotics to offset
that, they are taking away cost and dollars from their
operation, and the bottom line with production agriculture, it
is economics. I mean, they are raising food and----
Ms. Schakowsky. But let me--can I ask one quick question?
Dr. Sharfstein, the guidance has no enforcement component.
How can we be sure that it will have any effectiveness at all?
Dr. Sharfstein. Well, the way we think of this is not much
as a guidance or regulatory document, this we kind of put out
as a white paper. This is sort of the foundation for how FDA
intends to move in this area, and then it is basically like a
foundation for us to build on. We have had some productive
discussions with the various components of the animal
agriculture industry and we expect that we will be seeing
movement in this direction by their good efforts and I think
their comments in response to the guidance indicate that, but I
also think that as we move forward under this kind of
framework, we will be open to the idea that we will then have
to, you know, consider regulatory options. So this was not
intended as a regulatory document. It was really intended as a
here is what the science says, here is the right direction to
move in, and really let us get comments on how to do this as
well as possible with the minimal impact on agriculture and let
us do it effectively, but we are going to see what we can get
from setting this vision and then we are going to consider
other things.
Ms. Schakowsky. This is really a health hazard. It all
sounds real slow but I hope that we will have a progress report
that will show some movement before too long. Thank you.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you.
The gentlewoman from the Virgin Islands, Ms. Christensen.
Mrs. Christensen. Thank you, Mr. Chairman, and thank the
panelists. I really thought I had missed this first round of
questioning with the panel but I am glad I didn't.
Just maybe three questions. Dr. Sharfstein, welcome back.
Dr. Sharfstein. Thank you.
Mrs. Christensen. The FDA should now be implementing and
receiving--I apologize if this question was asked--and
receiving more detailed animal drug sales data under the Animal
Drug User Fee Act Amendments that was signed into law in 2008.
Has any data started coming in?
Dr. Sharfstein. Yes, we have started to get data.
Mrs. Christensen. I am concerned that we don't seem to have
a method in this country to track actual usage of these drugs
in animals that become food. Is that concern warranted, and if
so, when would be able to review an analysis of this new data
to see whether additional reporting requirements might be
necessary?
Dr. Sharfstein. Well, first, we are starting to pull
together the data. We are just getting--I don't think we have a
complete set yet. I am not 100 percent sure about that, but I
know that we are just sort of pulling it together, and I don't
think it will be too long before we will be able to share some
of that information. But I think to your point, I think you are
exactly right. The data under ADUFA is just part of it. It is
overall sales and a little bit by particular use, but it
doesn't really tell you how the antimicrobials are being used.
It is not the kind of data, for example, that we might get
about pediatric practice and pediatricians' use of
antimicrobials, and so I think that one of the things that we
have been talking about, and there is a meeting very shortly in
NARMS coming up is that there is a need for a better
surveillance system and that is something where we hope to work
very closely with USDA on.
Mrs. Christensen. Thank you.
Dr. Khan, we talked a lot about the antibiotic resistance
in animals and the fact that it creates resistance in humans
but how do people become exposed to antibiotic-resistant
bacteria through the food supply? Is it by eating contaminated
meat and poultry or can cross-contamination become a problem?
And does cooking resolve the problem? Could you just clarify
for us how that happens?
Admiral Khan. Yes, ma'am, I would be glad to. There are
multiple mechanisms by which resistant bacteria in animals can
make their way into humans. The first is the most obvious. That
would be the direct transmission or the direct route, and that
would be directly from animals to humans, and we see that----
Mrs. Christensen. Just from contact working with animals?
Admiral Khan. Direct contact, and we see that reported all
the time. The second mechanism within that direct route is from
food, so contamination of food that subsequently you are
handling and you become infected. So we see that route as the
direct route. There is also the indirect route of transmission,
and this is where specific genetic material within a bacteria
of animals can move into bacteria of humans and that
resistance, so although the bacteria in animals doesn't move to
humans, the resistant pattern moves into humans and then can
cause human resistant bacteria.
Mrs. Christensen. Thank you for that clarification.
And Dr. Clifford, if funds were available, would the USDA
be willing to initiate a pilot program where producers could
receive assistance for transitioning to antibiotic-free methods
and where results could be collected and reported?
Dr. Clifford. I think one of the issues that is out there
is the lack of evidence of cause and effect when you remove
these things, so I think it would be important to look at some
of these types of things from the standpoint of a pilot project
but also from the standpoint of the development of other
methods and working with industry and such as vaccine
development and other technologies to be able to better address
this issue.
Mrs. Christensen. So do you have other priorities such as
vaccines? New vaccines would be a higher priority than----
Dr. Clifford. I am not saying which one would be the
highest priority but I think all those things need to be looked
at, and I think we as a body within the federal agencies need
to be identifying, sitting down and working with the industry
and others to identify the highest priorities and identify the
way that we can best use our resources to address those.
Mrs. Christensen. In your testimony, you say that animal
impacts must be considered in the context of the decision-
making process. Does that mean that there is some tension
between USDA and FDA over the approach or are you all on the
same page?
Dr. Clifford. Well, I think in general concept, we are on
the same page. I mean, it is not that FDA and USDA are going to
agree on every particular issue. I think it is important to
note that as we all know, this is an extremely complex issue.
My role as chief veterinary officer is the protection of animal
health. Obviously I care very much about public health as well.
So I think we have got to look at all of these things and
balance these things, and this is a very complex issue and we
don't believe that one size fits all.
Mrs. Christensen. Thank you for your answers.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you, Ms. Christensen.
Thanks a lot. Unfortunately, we are interrupted with two
sets of votes today but I appreciate your bearing with us and
also changing the date which we did on you a few weeks ago, so
this is very helpful. Now, we will likely send additional
questions in writing within the next 10 days or so, but I
appreciate your being here today. Thanks so much.
Marathon panel coming up here. Let me welcome the second
panel. I hope you have enough room there kind of squeezed in.
Let me introduce each of you. Starting on my left is Dr. Per
Henriksen, who is Head of the Division for Chemical Food
Safety, Animal Welfare and Veterinary Medicinal Products from
the Danish Veterinary and Food Administration. And then we have
Dr. James R. Johnson, Director of Infectious Disease Fellowship
Program and Professor of Medicine at the University of
Minnesota; Dr. Gail R. Hansen, who is Senior Officer for the
Human Health and Industrial Farming Group of the Pew Charitable
Trust; Dr. Christine Hoang, who is Assistant Director,
Scientific Activities Division for the American Veterinary
Medical Association; Dr. Randall Singer, Associate Professor of
Epidemiology, Department of Veterinary and Biomedical Sciences,
also from the University of Minnesota; Dr. Richard Carnevale,
Vice President, Regulatory, Scientific and International
Affairs from the Animal Health Institute; and Dr. Stuart Levy,
who is Professor of Molecular and Microbiology and Professor of
Medicine at Tufts University.
As you know, we ask each of you to limit your comments to 5
minutes, and then of course you can submit additional written
comments as well, and we will start with Dr. Henriksen.
STATEMENTS OF PER HENRIKSEN, D.V.M., PH.D., HEAD OF DIVISION,
DIVISION FOR CHEMICAL FOOD SAFETY, ANIMAL WELFARE AND
VETERINARY MEDICINAL PRODUCTS, DANISH VETERINARY AND FOOD
ADMINISTRATION; JAMES R. JOHNSON, M.D., F.I.D.S.A., F.A.C.P.,
PROFESSOR OF MEDICINE, UNIVERSITY OF MINNESOTA, AND FELLOW,
INFECTIOUS DISEASES SOCIETY OF AMERICA; GAIL R. HANSEN, D.V.M.,
M.P.H., SENIOR OFFICER, HUMAN HEALTH AND INDUSTRIAL FARMING
GROUP, PEW CHARITABLE TRUSTS; CHRISTINE HOANG, D.V.M., M.P.H.,
C.P.H., ASSISTANT DIRECTOR, SCIENTIFIC ACTIVITIES DIVISION,
AMERICAN VETERINARY MEDICAL ASSOCIATION; RANDALL SINGER,
D.V.M., M.P.V.M., PH.D., ASSOCIATE PROFESSOR OF EPIDEMIOLOGY,
DEPARTMENT OF VETERINARY AND BIOMEDICAL SCIENCES, COLLEGE OF
VETERINARY MEDICINE, DIVISION OF EPIDEMIOLOGY, SCHOOL OF PUBLIC
HEALTH, UNIVERSITY OF MINNESOTA; RICHARD CARNEVALE, D.V.M.,
VICE PRESIDENT, REGULATORY, SCIENTIFIC AND INTERNATIONAL
AFFAIRS, ANIMAL HEALTH INSTITUTE; AND STUART LEVY, M.D.,
PROFESSOR OF MOLECULAR AND BIOLOGY, PROFESSOR OF MEDICINE,
TUFTS UNIVERSITY
STATEMENT OF PER HENRIKSEN
Dr. Henriksen. Thank you, Mr. Chairman, Mr. Ranking Member
and members of the subcommittee for inviting me to testify.
First I can say I am a veterinarian by training, got my degrees
from Royal Veterinary and Agriculture University of Copenhagen,
Denmark. I have been working as a scientist for more than 10
years. I have been working in the farmers' organization as a
health consultant for more than 5 years and working for the
Danish government for more than 10 years.
As a representative of the Danish government, I am aware
that the use of antibiotic growth promoters is a contentious
issue in the United States and that Denmark is often mentioned
in the debate. Against this background, I wish to emphasize
that the Danish government is not represented here today to
advocate for or against any specific legislative proposals.
However, we are a nation willing to share our experiences when
requested and therefore we have accepted your kind invitation.
I submitted five fact sheets for the record, and with the
subcommittee's indulgence, I will therefore shorten my remarks
to allow for your questions.
Mr. Pallone. I want to interrupt and say that I understand
you obviously came from Denmark here today to participate in
this hearing, and we really appreciate your coming so far to be
with us today. Thank you.
Dr. Henriksen. Thank you.
Denmark is a major livestock producer in Europe and the
world's largest exporter of pork. Danish livestock production
is highly industrialized, intensive and supplies modern
management principles. Due to the significance for the Danish
economy, the Danish government takes the competitiveness of the
Danish farmers seriously.
Treatment with antibiotics is in many cases essential for
human and animal health and an uncritical use of antibiotics
can lead to several antibiotics becoming ineffective. Because
antimicrobial resistance can be transferred between bacteria,
regardless of whether the bacteria are pathogenic or not, the
development of antimicrobial resistance in any kind of bacteria
can constitute a problem.
It is a fact that antimicrobial resistance can be
transferred from animals to humans by consumption of meat, and
every year also Denmark experience human outbreaks caused by
consumption of meat contaminated with resistant bacteria.
A ban on antimicrobial growth promoters was considered
necessary for several reasons in Denmark. There was science-
based evidence that the use of antibiotics in animal feed could
create resistance in pathogenic bacteria to medically important
antibiotics, and there was a real concern that doctors would
run out of options for treating life-threatening infections in
humans. Given the fact that very recently, a Danish Ph.D.
project concluded that production animals and meat might be a
source of human E. coli urinary tract infections, the Danish
ban seemed to be an example of due diligence.
Among the initiatives that are all mandated by the Danish
government, I would like to mention the following: No
prophylactic use of antimicrobials and mandatory low fixation
of the veterinarians' profit from sales of medicine. This
fixation of low profit was an initiative of the Danish
Veterinary Medical Association. The critically important
antibiotics call fluoroquinolones can only be used in Denmark
if a laboratory test shows that no other antibiotics can be
used. Treatment guidelines for swine and cattle veterinary
practitioners have been issued by the government. Continuous
monitoring and research in antimicrobial resistance in animals,
humans and food. Monitoring of foodborne pathogens in Danish as
well as imported meat. Antimicrobial resistance is one of the
parameters used to determine whether a shipment of imported
food is dangerous or not. Control and action plans to combat
Salmonella bacteria in poultry and pork and Campylobacter in
poultry are implemented. And the most recent development
includes mandatory action plans in swineherds above a certain
threshold value for antibiotic use, the so called ``yellow
card.''
It is important to note that, according to our experience,
a ban on antibiotic growth promoters can immediately and
dramatically reduce the amount of antibiotics used. In Denmark
the decrease was 40 percent. Such a ban should not stand alone
in the long run. This explains the fact that we have
implemented this range of follow-up measures and we can expect
also to have to take additional steps in the future.
The ban of growth promoters has resulted in a marked
reduction in antimicrobial resistance as measured among several
different bacterial species in food animals. The percentage of
macrolide resistance in porcine Campylobacter has decreased
from 80 percent before the ban to less than 20 percent in 2006.
A similar reduction from more than 75 percent vancomycin
resistance in enterococci isolated from broilers before the ban
to less than 5 percent.
Additionally, Denmark has a markedly lower level of
resistant bacteria in meat compared to meat imported from other
EU member states. I can mention as an example, that the
percentage of cephalosporin resistance in E. coli isolated from
Danish broilers' meat is less than 5 percent, while more than
35 percent of E. coli isolated from broiler meat from other EU
member states reveals cephalosporin resistance. This marked
difference in resistance can be ascribed to our ban of growth
promoters and low usage of antimicrobials compared to other EU
countries.
The Danish swine industry has been producing pigs without
the use of growth promoters for many years now and has
increased both the production and the productivity. The same
picture applies in the broiler chicken and cattle industries.
In the last few years, and particularly in 2009, we have noted
an increase of usage of antimicrobials above the concurrent
increase in pig production. However, as this increase appears
more than 10 years after the ban, we do not relate this to the
ban. Nevertheless, we take this recent increase in usage
seriously and have imposed several initiatives.
When presenting the Danish experience here in the United
States, it is important to stress that Denmark is favored by a
range of institutional characteristics which helped
implementing the ban and the following steps. In Denmark, we
can identify every herd, farmer and veterinarian and we are
able to pinpoint the antimicrobial usage right down to the
individual cow and to an age group of swine. This is due to our
many databases on husbandry and medicine usage. And we have
also monitored and researched in resistance for the past 15
years in a program called DANMAP. Our farming industry is
highly organized in a cooperative structure with one common
organization for farmers and food companies. We have a
longstanding tradition for working towards a consensus between
government, industry and the Danish Veterinary Medical
Association. I would like to mention that the Danish Veterinary
Medical Association along with the Danish Medical Association
has supported a ban from the beginning.
Working as an entity, the Danish swine industry has
therefore played an important role and voluntarily stopped all
non-therapeutic use of antibiotics starting in 1998, with a
total state ban in place by January 2000. Only 2 weeks ago the
Danish swine industry again issued a voluntary ban, this time
against therapeutic treatment with the critically important
antibiotic cephalosporin. Danish farmers are well educated and
have easily learned to produce pigs without growth promoters.
Instead, they use good management, weaning at 28 days instead
of 21 days, initiatives concerning food and proper care of sick
animals. These institutional advantages have enabled Denmark to
take ambitious risk-mitigating strategies in order to combat
antimicrobial uses and resistance and without endangering the
economic sustainability of the swine industry.
If you have any questions, I will gladly answer them, and I
will also your attention to the fact sheet handed out. Thank
you for your attention.
[The prepared statement of Dr. Henriksen follows:]
[GRAPHIC(S) NOT AVAILALBE IN TIFF FORMAT]
Mr. Pallone. Thank you, Dr. Henriksen.
Dr. Johnson.
STATEMENT OF JAMES R. JOHNSON
Dr. Johnson. Chairman Pallone----
Mr. Pallone. Could you maybe bring that mic a little
closer? I always gave Dr. Henriksen a lot of leeway, since he
came from Denmark. The rest of you should try to stick to the 5
minutes. I think you have to either turn it on or move it
closer.
Dr. Johnson. It was the turning it on. Thank you.
Chairman Pallone, Ranking Member Shimkus and members of the
subcommittee, on behalf of the 9,000-plus members of the
Infectious Diseases Society of America, or IDSA, I appreciate
this opportunity to speak in support of the Health
Subcommittee's efforts to promote judicious use of medically
important antibiotics in animal agriculture. I am James
Johnson, an infectious diseases physician, a Professor of
Medicine at the University of Member, and a member of IDSA's
antimicrobial resistance work group.
I applaud the emphasis that Ranking Member Shimkus and
Congressman Pitts as well as other speakers today have put on
science as a foundation and guide for decision-making in this
area. I would point out that IDSA is made up of research
scientists, infectious disease commissions and public health
epidemiologists who value and rely on the scientific method.
IDSA supports rigorous science and critical impartial
evaluation of the scientific evidence base. IDSA also publishes
two of the premier peer-reviewed scientific medical journals in
infectious diseases, Journal of Infectious Disease and Clinical
Infectious Disease. These two journals have published dozens,
if not hundreds, of peer-reviewed scientific studies on this
topic.
IDSA supports efforts to eliminate all non-judicious uses
of antibiotics in human medicine and agriculture such as the
Preservation of Antibiotics for Medical Treatment Act, or
PAMTA, and the FDA's recently announced public health approach
toward antibiotic use in food animals. The elimination of non-
judicious will mean the end of antibiotics for growth
promotion, feed and efficiency and routine disease prevention
in food animals. The United States also must strengthen efforts
to ensure that all other food animal antibiotic use is
supervised by a veterinarian within the boundaries of a valid
veterinarian-client-patient relationship.
Now, IDSA regards the development of antibiotics to treat
life-threatening infections as one of the most notable medical
achievements of the past century. Unfortunately, these wonder
drugs' ability to cure is being increasingly compromised by
emerging antibiotic-resistant pathogen, and there are few new
antibiotics in development that will come to our rescue any
time soon. As a result, infectious disease physicians and
public health experts believe that we must do everything in our
power to preserve existing antibiotics to protect both human
and animal health.
As noted in opening statements by several committee member
including Congressman Murphy and the Administration witnesses,
an extensive body of scientific evidence demonstrates that
antibiotic use in food animals does contribute to the spread of
resistant bacteria to humans, leading to drug-resistant
infections with their many adverse consequences. Our written
testimony cites science-based studies and reports from
authoritative panels over the past 40 years that support this
position including studies supported by USDA and CDC.
Eliminating non-judicious antibiotic uses in food animals would
help protect the American people against drug-resistant
infections and extend the utility of existing antibiotics. This
concludes reflects a broad consensus within the medical,
scientific and public health communities. Such measures have
been advocated repeatedly by the World Health Organization and
the National Academy of Sciences, and as you have heard here
today, have already been implemented across Europe.
IDSA is very encouraged by FDA's new draft guidance to
industry which establishes a policy framework for judicious
food animal antibiotic use. We view this new guidance as an
important first step. Both FDA's guidance and PAMTA provide
elements of the overall policy framework that Congress should
consider as it moves forward to develop and enact legislation.
We are concerned, however, by FDA's apparent decision to
rely on drug companies to voluntarily remove growth promotion
and feed efficiency claims from their drugs' labels. Past
experience suggests that this will take years or decades and
many companies will not comply. Therefore, we urge Congress to
expedite the process through legislation.
We also are concerned that FDA does not specify its plans
for eliminating those uses of antibiotic in food animals for
prevention, control and treatment that likewise may be non-
judicious. These also must be addressed.
U.S. experts also require access to reliable and
standardized data regarding the scope of antibiotic consumption
in humans and animals. The lack of data in both the human
health and agricultural settings impedes our ability to respond
effectively to the antibiotic resistance problem. Although the
U.S. Animal Drug User Fee Amendments, or ADUFA, legislation of
2008, as mentioned earlier, strengthened FDA's ability to
collect animal antibiotic sales and distribution data. This was
only for national-level data. What we need are local-level data
reported by animal species. Of importance, also pharmacists do
not control antibiotic distribution in the agricultural sector.
Instead, feed mill operators are responsible for mixing animals
into antibiotic feed and they control antibiotic distribution
from the drug manufacturers to our Nation's farmers. Given feed
mills' key role in distributing these lifesaving drugs, they
must become better integrated into the infrastructure for
protecting antibiotic by tracing and regularly reporting to the
FDA the amount of antibiotics being consumed by each animal
species.
In conclusion, the Subcommittee on Health has a long
history of leadership in addressing our Nation's most pressing
public health issues. Today, IDSA calls upon you to help
protect our patients and the health of every American by
adopting strong measures including PAMTA to end non-judicious
antibiotic use in food animals and to require that other food
animal uses of these precious drugs be supervised by a
veterinarian within a valid veterinarian-client-patient
relationship. We also urge the committee to move with haste to
enact the Strategies to Address Antimicrobial Resistance, or
STAR Act, which will significantly strengthen U.S. antibiotic
resistance efforts. Finally, we urge you to enact statutory
incentives to spur new antibiotic development.
Thank you, and I will be happy to answer questions.
[The prepared statement of Dr. Johnson follows:]
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Mr. Pallone. Thank you, Dr. Johnson.
Dr. Hansen.
STATEMENT OF GAIL R. HANSEN
Dr. Hansen. Chairman Pallone and Ranking Member Shimkus and
members of the subcommittee, good afternoon, late afternoon,
and thank you for inviting me. I am Gail Hansen. I am a
veterinarian. I am a member of the AVMA, the American
Veterinary Medical Association, and I also a Senior Officer
with the Pew Charitable Trust.
Obviously, I care very deeply about this issue and I have
worked on antimicrobial resistance from a lot of different
angles. I was a State public health veterinarian for the Kansas
Department of Health and Environment in Kansas, obviously, in
working with both human and animal diseases. I was also a
veterinarian in private practice for several years in
Washington, New York City, North Carolina, and before I even
got into veterinary school I was interested in this topic
because I worked for the Food and Drug Administration, what was
then the Bureau of Veterinary Medicine, in 1978. That was the
year that FDA first proposed eliminating some drugs as growth
promoters in animal feeds based on the science, and we are
still here today.
I want to pick out one experience with a bacteria called
Campylobacter that you have heard about to illustrate the real
problem of antibiotic resistance, and let me give you a quick
background on Campylobacter. It is a real common foodborne
disease similar to Salmonella and E. coli, which you may be
familiar with. You get the same sort of symptoms. You have
diarrhea, you have vomiting. It is pretty unpleasant. There can
be some nasty complications that can occur with Campylobacter.
I guess the good news about that is that we can treat it with
antibiotic. The bad news is that the bacteria is becoming
resistant to antibiotics. We also that this is a bacteria that
is found in poultry and cattle. People get it from eating
contaminated poultry or meat, as we have heard before.
So let me talk to you about the Campylobacter outbreak that
I dealt with in Kansas in 1998 in Salina, Kansas. We had a
middle school where we had over 100 people that got sick with
Campylobacter. The physicians were using Cipro and tetracycline
to treat people because those are the drugs that all the books
said you should use, but then we found out that Campylobacter,
that Campylobacter was resistant to both of those drugs so the
physicians couldn't use those drugs. There was unequivocal
evidence that the resistance came from antibiotic that were
given to animals. Tetracycline was used and still is used in
cattle and poultry, and at that time Cipro was used in poultry
and it is still used in cattle today.
So antibiotic resistance from feeding low levels of
antibiotics to animals is real. It is here. We have got 40
years of science-based evidence and it is very clear. I have a
book here which I have given you an annotated version of the
bibliography of this that has some of the peer-reviewed studies
that we have over the last 40 years, so there is plenty of
science.
Antibiotics are overused in farm animals, in industry
farming to the detriment of human health. Animals are fed low
levels of antibiotics for growth promotion in the absence of
disease, and especially when bacteria come in contact with low
levels of antibiotics, it makes it much easier for them to
become resistant to antibiotic. That whole thing of what
doesn't kill you makes you stronger works for the bacteria as
well. And then that resistance gets transferred to people and
ultimately the antibiotics that we use for people don't work
anymore for people and they don't work for animals either, and
that is pretty scary.
But there are some effective alternatives to low-level
antibiotic use available to farmers and ranchers. Just this
last Saturday, I got back from a trip to Denmark looking at
what Dr. Henriksen talked about, and how their industrial
farmers are able to efficiently raise pork without the use of
non-therapeutic antibiotics. Farmers only give antibiotics, as
he said, when they are prescribed by a veterinarian for a
specific disease. The farmers at that point worked with
veterinarians and with others to find effective management
strategies that work.
So the American public really needs Congress to pass PAMTA.
The FDA guidance document is not likely to fix the problem by
itself. We need your help, and that is what PAMTA does. PAMTA
disallows the use of seven classes of antibiotics that are
critically important for human health to be used for non-
therapeutic purposes unless it can be shown that the use
doesn't contribute to antibiotic resistance in people. It still
allows antibiotics to be used to treat sick animals. We
absolutely have to have that. But we want to make sure that we
protect antibiotics for people and animals. We can help the
farmers and ranchers get past this outdated and very dangerous
practice of feeding antibiotics to healthy animals.
Unfortunately, the American Veterinary Medical
Association's position on PAMTA is different from mine and from
many other veterinarians. I am disappointed, I guess is the
best word, that the AVMA has not yet come to the same
conclusions that the American Medical Association and the
American Nurses Association, the American Academy of Pediatrics
has come to on the importance of this bill.
Thank you for the opportunity to testify. I would be happy
to answer any questions.
[The prepared statement of Dr. Hansen follows:]
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Ms. Schakowsky. [Presiding] Thank you.
Dr. Hoang.
STATEMENT OF CHRISTINE HOANG
Dr. Hoang. Thank you for the opportunity to speak about
antimicrobial resistance and the use of antimicrobials in
animal agriculture. My name is Dr. Christine Hoang and I
represent the American Veterinary Medical Association.
As a veterinarian with a dual degree in veterinary medicine
and public health, and additionally certified in public health,
my work is largely focused on scientific evaluations to inform
the decision-making process both domestically and abroad
through the AVMA, the Codex Alimentarius Commission and prior
to that the Food and Agricultural Organization of the United
Nations.
The AVMA's 80,000 members are engaged in every aspect of
veterinary medicine and public health. As veterinarians, our
oath ethically charges us with promoting public health and
protecting animal health and welfare. With that also comes the
responsibility to be cognizant of the potential health impacts
in humans that may occur as a result of any decision that we
make. The veterinarian must always the consider individual
animal, other animals and humans in contact with that animal,
and if it is a food animal, we must ultimately consider the
people who consume the end product. The decisions of the
veterinarian go far beyond a single animal or person and an
entire herd or flock and potentially hundreds of thousands of
people that are affected by the many foods that are produced by
a single animal. Therefore, as veterinarians, we carry a heavy
burden but we do willingly with the knowledge, education and
ability to make the right decision and to use the tools that
are available to us appropriately and judiciously. Our members
share the same concerns as our human health counterparts but
yet we have additional concerns that must be considered:
impacts on animal health and welfare and even negative impacts
on human health that are often unrealized.
Two decades ago, a study concluded that human health
hazards from growth-promoting uses could not be proven nor
disproven. The debate continues today for that very same
reason. A direct epidemiologic investigation still cannot be
completed. Furthermore, there are divergent opinions due to
differing levels of acceptable risk. For example, a person
might find risk associate with food unacceptable, any risk
would be unacceptable, but risks associated with high-speed
driving perfectly permissible.
As veterinarians, we must consider many risks, risk to the
animal, risk to ourselves, risk to our clients, risk to public
health, risk of action and risk of inaction, and the accepting
of some of those risks in order to minimize others. Whenever
antibiotics are used, there is some risk of resistance
developing. That risk resistance can be transmitted to humans
yet systems are in place that can trigger further investigation
to determine the level of those associated risks. Risk analyses
that evaluate only risk report adverse effects ranging anywhere
from one in 32,000 to seven in 100 million. Risk analyses that
also consider benefits indicate an increase in thousands of
sensitive strained human cases for a reduction of a fraction of
a single resistant case. Therefore, the greater risk of
foodborne illness must be weighed against the many other
factors.
We caution against preemptive bans based on the following
observations in other countries: significant increases in
therapeutic use as a substitution for growth promoters. The
need for increased therapeutic uses are indicative of a decline
in animal health and welfare associated with disease and no
clear evidence of a significant human health benefit.
Veterinarians are trained medical professionals with the
ability to predict disease conditions and recommend appropriate
therapy. Those uses should not be considered injudicious nor
banned as routine use. If a disease is predictable and can be
prevented, it is incumbent upon the veterinarian to initiate
appropriate therapy to prevent animal pain and suffering.
Although over-the-counter antibiotic are available for such
therapies, they are not unregulated. If a drug is not used
according to the approved label indications for the dose,
duration, disease or species or within extra-label drug use
regulations, it is illegal.
The AVMA's antimicrobial use task force recently concluded
that veterinarians should be involved in the decision-making
process for the use of all antimicrobials in animals regardless
of the distribution channel through which it was obtained. This
would encompass prescription products, veterinary feed
directives and over-the-counter antibiotics. Without exception,
the AVMA is supportive of measures to mitigate risk to human
health. To avoid potential diversion of resources away from
more appropriate disease control measures, we encourage a
regulatory strategy that is based on science, risk and benefit
analysis, risk management that is commensurate with the level
of risk, and cooperation with all relevant stakeholders. The
AVMA is committed to providing consumers with the safest food
possible and to protect human health against the current risk
without compromising the health of food animals.
Thank you for the opportunity to appear before you today.
[The prepared statement of Dr. Hoang follows:]
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Ms. Schakowsky. Thank you, Dr. Hoang.
Dr. Singer.
STATEMENT OF RANDALL SINGER
Dr. Singer. Mr. Chairman and members of the subcommittee, I
would like to thank you for giving me the opportunity to
discuss the role of antibiotics in animal agriculture. My name
is Dr. Randall Singer. I am an Associate Professor or
epidemiology at the University of Minnesota, both in the
College of Veterinary Medicine and in the School of Public
Health.
Antibiotic resistance continues to be a critical issue that
affects human health, animal health and environmental health.
All uses of antibiotics have the potential to select for
resistant bacteria. What we are discussing here today, though,
is risk and specifically the potential that the use of
antibiotics in animal agriculture might result in more
antibiotic-resistant bacteria that then lead to increased human
health harm.
One of the antibiotic uses that is of particular concern is
the approved label claim of growth promotion. The fact is that
this label claim is almost 50 years old. It is an unfortunate
label whose name has never been changed. Unfortunate why?
Because we now know that the reason these antibiotics help
animals grow faster is because these antibiotics help animals
maintain their health status. They prevent disease as well. And
for evidence of this, we need to look no further than the
Danish experience. It is a fact that following the removal of
growth-promoting antibiotics in Denmark, the animals got
sicker. Animal diseases that had been kept under control now
appeared as a quote from their papers, epidemics, as stated by
the Danish themselves. The unfortunate truth is that more than
15,000 swine producers in Denmark, over 60 percent of the total
that existed before the ban, went out of business, most of
these being the small and mid-sized farms.
But let us not focus on productivity. When it comes to
antibiotics, we should be thinking about impacts on health. The
only documented health benefit of the ban in Denmark was a
decrease in some resistance in some bacteria on farms and in
the community. There was no real human health benefit related
to fewer resistant infections, at least that I have seen
reported from the Danish experience.
Regardless, perhaps it is time to retire the outdated label
claim of growth promotion. After all, its name implies a
strictly production use of antibiotic. But let me ask you this.
Since when it has become better to treat the sick than to
prevent the disease in the first place? If we can give a lower
dose of a second-tier antibiotic to animals to prevent a
disease from occurring by, for instance, improving the gut
health of that animal, isn't this better than having to treat
an entire population of sick animals with a high dose of a
critically important antibiotic? The growth promotion doses
give us that option.
We need to take a holistic view of health that seeks to
maintain the healthiest animal population possible. Healthier
animals lead directly to a safer food supply. Nobody in the
animal industry wants to continue, though, with the status quo.
Changes in production are happening. Companies are voluntary
reducing their uses of antibiotics. But we still need options
for preventing and treating disease and these are disappearing
as can be seen in the poultry industry. The only animal
agricultural antibiotic banned from use in the United States
remains the fluoroquinolones in poultry production. There is
another antibiotic. It has no human counterpart and it still
has not been approved for treating disease in poultry in the
United States. Both of these antibiotics are available as
treatment options in Europe. I will stress that again.
Fluoroquinolones are available in Europe as a treatment option.
In the absence of efficacious treatment options, the
poultry industry at least needs the option of using antibiotics
to prevent disease in the first place. What we should be doing
is determining what antibiotic uses minimize risks to human
health while maximizing animal health. How do we begin to
quantify those risks and determine the antibiotic uses that
pose the least risk? FDA's Center for Veterinary Medicine has
an approved risk assessment approach as described in Guidance
for Industry Document number 152. I was part of a team that
used this approach to examine a specific antibiotic class, and
we found that under the FDA's own definition, there was
reasonable certainty of no harm to human health associated with
this use. That is a peer-reviewed publication.
I am in full agreement with the many international reports
and FDA statements that we need to continue to assess these
risks but they need to be done a drug-by-drug basis in each
animal species. All antibiotics that fall under the same usage
category are not equal in terms of their impacts on resistance
or their impacts on human and animal health.
In conclusion, Mr. Chairman and members of the
subcommittee, I thank you for the opportunity to speak today.
Antibiotics are an integral component of animal health and
healthier animals lead to healthier people. I would hope that
decisions regarding antibiotics, their approval and removal
from use will continue to rest with the FDA's Center for
Veterinary Medicine, who has in place a system for assessing
the risks to human health associated with animal antibiotic
use. I hope that those who make the final decisions about
antibiotic use are truly interested in all health, human,
animal and environment, and agree that preventing disease is
always preferable to having to treat the sick. The best way to
manage antibiotic uses in animal agriculture is through sound,
rational, science-based policy that evaluates the risks and
benefits of all antibiotic uses. Thank you.
[The prepared statement of Dr. Singer follows:]
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Ms. Schakowsky. Thank you.
Dr. Carnevale.
STATEMENT OF RICHARD CARNEVALE
Dr. Carnevale. Chairman Pallone, Ms. Schakowsky and Ranking
Member Shimkus and members of the subcommittee, thank you for
the opportunity to appear before you today. I appeared before
this committee some time back during the Animal Drug User Fee
hearings, and I want to thank the committee for moving that
piece of legislation through. We greatly appreciate it.
My name is Dr. Richard Carnevale. I am a veterinarian and
Vice President at the Animal Health Institute. AHI is an
industry trade association representing companies that make
medicines for animals. Before AHI, I spent nearly 20 years at
the FDA and USDA working on animal drugs and food supply.
While I submitted more thorough comments for the record, I
would like to talk to you today about one simple truth: animals
need medicines including antimicrobials. Without safe and
effective medications to treat, control and prevent diseases,
animal welfare would suffer and deaths would increase.
Additionally, as Dr. Singer pointed out, healthy farm animals
are critical to safe food. Animal health companies invest in
the development of new medicines to provide veterinarians and
producers the tools to keep food animals healthy and must be
able to rely on a predictable science-based regulatory process.
There has been much debate, as we all know, over the
contribution of animal antimicrobial use to resistant bacterial
infections in humans. Antimicrobial resistance is a serious
public health threat but resistance is not a single problem. It
is a problem comprised of several different bacteria/drug
combinations that must be examined individually to ascertain
risks. For example, some of the most widely recognized
resistance problems in humans are in respiratory tract
infections and venereal diseases like gonorrhea. In neither of
these cases is there any evidence that antimicrobial use in
animals is associated with these problems.
Both antimicrobial-resistant and susceptible bacteria can
contaminate foods, our food safety system is comprised of
multiple layers of protection to reduce their presence. The
first layer of protection is a stringent regulatory review
process at FDA. Animal antimicrobials must meet all the same
requirements as antimicrobials used in humans with two
additional requirements. First, sponsors must show that drug
residues left in foods are safe for human consumption. Second,
the FDA Guidance for Industry 152, which Dr. Sharfstein spoke
of, outlines a qualitative risk assessment process for new
antimicrobials. This process is designed to estimate and manage
the risk of antimicrobial-resistant bacteria that could be
transferred from animals to humans.
Quantitative risk assessments have also been conducted and
published on key antimicrobials, particularly those used in
animal feed. A quantitative assessment is a more detailed
review of each step along the food production continuum from
farm to table that could contribute to or reduce the presence
of foodborne bacteria. These studies have routinely reported
extremely low levels of risk.
As Dr. Sharfstein discussed, FDA has announced two new
initiatives relative to antibiotics used in food animals. These
actions illustrate that the agency has broad authority to take
actions it deems necessary to protect public health. AHI
welcomes these initiatives and understands the reasons for
their concerns. We will, of course, comment in detail to both
publications.
A second layer of protection and one of the most important,
in my opinion, is reducing bacterial contamination in slaughter
and processing plants. Improved hygienic and pathogen-reduction
measure in meat and poultry plants under the USDA HACCP
pathogenic reduction regulation has significantly reduced
bacterial contamination and therefore antimicrobial-resistant
bacteria as well.
A third layer is in the multi-agency National Residue
Program and National Antimicrobial Resistance Monitoring System
to assure antimicrobials are being used properly and according
to labels. Judicious-use guidelines which the AVMA
representative has spoken about help to ensure that
antimicrobials are being used responsibly in food and companion
animals.
Finally, USDA has mandated safe food handling labels, and
there are extensive food safety education programs that
instruct consumers how to properly handle and cook foods to
avoid foodborne illness.
Before I close, I want to note that Congress in the last 2
years passed legislation dealing with the use of antimicrobials
in animals. The 2008 Farm Bill included a mandate for
additional research on antibiotic resistance in food animals
and the 2008 Animal Drug User Fee Amendments required FDA to
collect antibiotic use data from sponsors by March of 2010. We
expect the report from the agency later this year.
Mr. Chairman and members of the subcommittee, there are
clear benefits to using antimicrobials to keep animals healthy
including attending to animal welfare and assuring food safety.
FDA has a stringent review process to ensure that
antimicrobials are safe and effective. Monitoring data from the
NARMS program as well as public and private risk assessments
have shown the process is working. With that said, FDA has
recently articulated concerns with the way certain antibiotics
are currently labeled and used. The animal health industry is
committed to working collaboratively with the agency to address
those issues while assuring that important animal health
products continue to be available to prevent, control and treat
animal disease.
Thank you for the opportunity to appear today and I welcome
any questions.
[The prepared statement of Dr. Carnevale follows:]
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Ms. Schakowsky. Thank you.
Dr. Levy.
STATEMENT OF STUART LEVY
Dr. Levy. Thank you. Mr. Chairman and members of the
subcommittee, thank you for inviting me to testify on this
crucial subject of antibiotic use in animal husbandry. I am
Stuart Levy, a physician, research scientist and Professor of
Molecular Biology, Microbiology and of Medicine at Tufts
University School of Medicine in Boston. I also serve as
President of the Alliance for Prudent Use of Antibiotics.
For more than 3 decades, I have been studying antibiotic
use in animal husbandry and its effect on bacteria associated
with animals, farm workers and their families and the
environment in general. Throughout my career, I have noted the
paradoxical nature of human engagement with antibiotics, hence
the title of my book, the Antibiotic Paradox. On one hand,
antibiotics cure disease, are miraculous. On the other hand,
they select among their targets those which are resistant and
make these drugs not effective.
My own research stretching back to the early 1970s has
confirmed the broad environmental impact of antibiotic use, and
I stress that. We performed the first and only prospective
study of the effect of introducing antibiotic-, in this case,
tetracycline-laced feed for chickens on a farm. By one week,
almost all E. coli bacteria in the intestinal tracts of
chickens were tetracycline resistant. By 3 months, the chickens
and most of the farm dwellers were excreting E. coli not only
resistant to tetracycline but to other antibiotics as well. We
also demonstrated that low-dose non-therapeutic amounts of
tetracyclines can in fact propagate bacteria resistant to the
drug and other antibiotics at high levels. Resistant bacteria
were found to move among animals and from animals to people.
Antibiotics are unique. They are societal and ecological
drugs. Each individual taking an antibiotic whether animal or
person becomes a factory producing antibiotic-resistant
bacteria. Thus, there is a difference in the environmental
impact when the same amount of antibiotic is given to one as
opposed to a number of animals sharing that particular
environment. In principle, fewer animals will be given
antibiotics and for less time when antibiotics are used
prophylactically as compared to growth promotion.
Mr. Chairman, we are not gaining ground in the struggle
against antibiotic resistance. Antibiotics are continually
misused and overused in both human medicine and animal medicine
at great cost to our society in terms of human health and cost
of health care. It is estimated that antibiotic resistance
leads to more than $20 billion in hospital costs and up to $35
billion when society costs are included. Some progress has been
made in encouraging more judicious use of antibiotics in human
medicine but there has been precious little progress with
respect to stemming the spigot of antibiotics flowing into
animal agriculture.
In contrast, other industrialized nations have come to the
same conclusion that many public health organizations around
the world have, and that is that the use of antibiotics for
growth promotion and feed efficiency must be curtailed. We can
take some encouragement in the FDA's recent release of a draft
guidance. We need to move with greater urgency to stem the use
of antibiotics in industrial animal production. Because most
antibiotics currently approved for growth promotion are also
approved for routine disease prevention, I have great concern
that feeding large quantities of antibiotics non-
therapeutically will continue, rendering meaningless any FDA
guidance on eliminating antibiotic use for growth promotion.
Mr. Chairman and committee members, in view of the
certainty in my opinion of the public health threat, the
history of regulatory inaction and unyielding nature of the
relevant industry, it is now clear that even a well-intentioned
FDA is unable to overcome the influence of agribusiness. We
have given moral persuasion, medical urgency, scientific study
and voluntary guidance a chance and the situation has not
changed. We can't wait any longer.
Legislation pending in this session of Congress, the
Preservation of Antibiotics for Medical Treatment Act, would
withdraw the use of seven classes of antibiotics vitally
important in human health from food production unless animals
are sick with disease or the use is needed for disease
prevention without threat to human health. I urge this
committee to move expeditiously to consider and approve this
important legislation.
Thank you for giving me the opportunity to testify, and I
will answer any questions.
[The prepared statement of Dr. Levy follows:]
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Ms. Schakowsky. I want to thank all of our witnesses. As is
obvious, I guess, Mr. Pallone had to go to yet another
committee that he is on where they are voting and so he won't
be able to return.
I have some questions that I want to ask but I also want to
let you know that we have a whole bunch of questions that I
fear will not be asked and therefore we will get them to all of
you and would appreciate very much your answers in writing
later.
Mr. Shimkus. Madam Chairman, can we also ask, it wasn't
done, I think, a UC that all members' statements can be
submitted for the record?
Ms. Schakowsky. That all members' statements can be
submitted for the record, without objection so ordered.
Mr. Shimkus. Thank you.
Ms. Schakowsky. I want to give a special thank you to Dr.
Henriksen for coming from Denmark, and I wanted to give him the
opportunity at this hearing to answer some questions, because
there has been a lot of discussion about the Danish experience.
We have seen articles and heard testimony claiming that even
though you eliminated the use of antibiotics for growth
promotion, you ended up using more antibiotic than you had
before because all the animals got sick. That is what we are
hearing. And in fact, in the testimony of the American
Veterinary Medicine Association, Dr. Hoang states and Dr.
Singer as well that antibiotic use went up between 1998 and
2008. So can you clarify for us exactly what the situation has
been with regard to antibiotic use in Denmark? And as part of
that, can you tell us what steps you took to reduce antibiotic
use and what impact each step has had on the use of
antibiotics?
Dr. Henriksen. Yes, I will try to answer your questions,
all your questions. It is correct that after the ban the
consumption of therapeutic antibiotics has been increased but
in the same period the pig production has been increased too,
and if you see my fact sheets on page 10, you can see figure 1
which both has the antibiotic usage in all types of animals and
the number of pigs produced, and in that period from 1998 to
2008, you can see an increase in the therapeutic use of
antibiotics but an almost similar increase in the number of
pigs produced in Denmark. You can put it another way, that is
to calculate how many milligrams per kilo pig produced in
Denmark, and you can have the data before the ban. Before the
ban in 1994, the total use of antibiotic growth promoters and
for therapeutics were 99 milligrams per kilogram of pig
produced, and even in 2008 the total consumption was 49
milligrams per kilogram pig produced. That is, we have reduced
the total usage of antibiotic per kilogram pig produced from 99
to 49 milligrams. That is a 50 percent reduction.
It is correct as stated by many U.S. observers that the
disease situation has changed in Denmark. Diseases come and go
in humans and animals, but if you look at the fact sheet on
page 14, you can see the mortality in weaners, the mortality
since 1993 to 2003, 2004 has been increasing from about 2
percent to almost 5 percent, but since 2004 the mortality in
weaners has decreased almost to the level from 1992-1993. So in
that respect to mortality in weaners, the more focus of disease
in Danish pig production cannot be released by the mortality
figures. If you compare to the mortality in finishers in figure
7 on page 14, you can see that the mortality has been varying
little during the 1992 to 1997, 1992 to 2007, but the mortality
is between 3 and 4 percent. So there has not been any
significant impacts on mortality neither in weaners nor in
finishers.
I would like to add on the previous page on the fact sheet,
page 13, figure 4, this is the productivity as we express it in
Denmark, number of pigs produced per sow per year, and you can
see from 1992 to 2006, 2007, the number of pigs per sow per
year has been increasing from 20 to more than 22 pigs per sow
per year. That means that during this phasing out of growth
promoters has been increasing production, but I would of course
admit in some farms you see severe disease problems, and this
is the task for a trained veterinarian to deal with the
specific problem in specific farms whether it should be a
vaccination schedule, prophylactic changes in the environment,
new ventilation system, better feed quality and so on, maybe
prolonged weaning age from 3 weeks to 4 weeks, or treatment
with antibiotic. So that I think most of the questions I
answered.
Ms. Schakowsky. Let me just then underscore and make sure
that this is correct, that the total antibiotic consumption in
food-producing animals has been reduced by about 40 percent
from the mid 1990s until today. So we are talking about total
consumption is just almost in half or about 40 percent. Is that
correct?
Dr. Henriksen. That is correct when you compare the total
use of antibiotic growth promoters and therapeutic use in the
end of 1997-98 to 2008, yes, that's correct.
Ms. Schakowsky. Thank you. I appreciate your being here and
I appreciate your testimony.
Mr. Shimkus.
Mr. Shimkus. Thank you, Madam Chairman.
But I will say from ban until now, therapeutic use has gone
up, and that--and you are shaking your head, which I think that
means yes. We do appreciate you coming a long way.
Madam Chairman, and this has been addressed with the staff
for submission to the record a statement from the pork
producer, if you would----
Ms. Schakowsky. Without objection, so ordered.
[The information was unavailable at the time of printing.]
Mr. Shimkus. Thank you, Madam Chairman.
The other thing I want to--I need to highlight some stuff
going back to the previous panel and the third chart I didn't
get a chance to talk about. I think the issue--I just want to
get it on the record that the United States and Canada had
pathogen reduction regulations during this time and the issues
of voluntary withdrawal too. So there is more to be said by
charts that unfortunately we didn't have time to pursue that
with the previous panel because of time.
Another thing I want to make sure to put on the record, and
this is from the D.C. area, that there is a huge price
discrepancy between food products that are antibiotic-free and
conventional price, and there is a list of 10 products here and
it goes from anything from 141 percent to 20 percent change in
retail prices. So another thing to place on the table is the
cost of basic food products from beef to eggs to you name some
of the issues.
Also, the reduction in Danish swine farms from the passage
of legislation from 12,500 to 3,500, and for my friend from
Denmark, the United States is the number 1 pork-producing
country in the world. He knows that. I think it is a percentage
of what is exported based upon what is consumed. But I would
say second is the EU followed by, I don't know if it is Canada
or Brazil, but this is a major industry in the United States.
It is a major industry in my Congressional district, and that
is why we want to make sure that science is addressed because
we are concerned about antibiotic issues. We have had hearings.
But we want to make sure that again that we don't do more harm
than good. And I appreciate the various opinions and the issues
on risk because healthy animals should grow bigger. I mean, if
you are sick, you are not going to grow. If you are healthy,
you do grow.
We just passed a health care bill that said preventative--
let us make sure we keep Americans healthy because of the high
cost in taking care of sick people, but here we are going to
flip the charts. We are going to turn it upside down. We are
going to say let us don't keep the animals healthy, let us do
therapeutic antibiotics when they are sick.
Dr. Carnevale, I have two questions, because we heard from
a lot of the panelists both here and then also on the first
panel that there is unequivocal evidence, and it reminds me of
the climate change debate, that the science is settled. Well, I
think the American public understands that the science is not
settled. Is there unequivocal evidence that there is a
connection between the use of antibiotics in animals and
connect them to human health?
Dr. Carnevale. Well, as many have said today, this is a
very complicated issue. I would say there is not unequivocal
evidence that the use of antibiotics in animals, particularly
those used in animal feed, are directly responsible for human
health impacts, and human health impacts has been kind of
loosely defined here, but I would certainly think that the most
key human health impact would be failure of the treatment of a
disease.
Mr. Shimkus. Yes, and let me--my time is very limited and I
want to be respectful of my colleagues. And the animal feed
issue is different than what the Danish experience was in the
use of antibiotics. I don't want you to elaborate.
I want to follow up. My second question is, the FDA role.
The FDA role is to make sure they approve drugs for animals and
for humans. Now, when they say this antibiotic is good for use
in animals, do they also look at its possible risk for human
consumption through the process? Do they have to consider the
effect on human health?
Dr. Carnevale. Yes.
Mr. Shimkus. So when the FDA says it is OK, it is not only
saying it for the animal, it is saying it for human health and
consumption?
Dr. Carnevale. Absolutely. They have a mandate to approve
drugs safe and effective, which means safe to the animal, safe
to humans and safe to the environment.
Mr. Shimkus. My time is expired. Thank you, Madam Chairman.
Ms. Schakowsky. Thank you.
I wonder if you would mind if I just follow up with Dr.
Henriksen, just find out what the Danish experience was on the
cost of production after the ban. I don't know if----
Mr. Shimkus. No, we talked and I will be happy as long as
our colleague down there is fine.
Ms. Schakowsky. Just a quick question. Was there any impact
on the cost of production after the ban or the cost to the
consumer after the ban?
Dr. Henriksen. The prices in the shops have not been
increased due to this ban. I don't have any data available with
me about the production costs for the farmer.
Ms. Schakowsky. Thank you.
Dr. Henriksen. I can present it to you if you want.
Ms. Schakowsky. Thank you.
Congresswoman Christensen.
Mrs. Christensen. Thank you, Madam Chair, just a few
questions.
Dr. Hoang, the AVMA, I understand, suggests that the
current FDA approval process for antibiotic use in food animals
is sufficiently strict to protect human health but the FDA
doesn't apply a standard regarding antibiotic resistance
retroactively to drugs that were approved maybe decades ago. So
what is the AVMA's position? Should we reevaluate the safety or
not of already approved drugs?
Dr. Hoang. The AVMA is supportive of reevaluation of the
drugs that have been previously approved, but I might also add
that the FDA does have the authority to withdraw a drug if they
find that there is an imminent human health hazard, which they
have not done so.
Mrs. Christensen. Thank you.
Dr. Levy, why do you think the United States has yet to
follow the example of other industrialized nations in limiting
antibiotic use in meat production? Is it because the scientific
basis for action is questionable? It seems to me there is a lot
of evidence. I don't think the bacteria behave much differently
here than in Europe, so what do you think the reason is?
Dr. Levy. That is exactly what I was thinking. It has
bothered me a lot as I go out to teach about how to use
antibiotics that Europe, I think, is ahead of us by eliminating
this major source of resistant emergence. Why? It is much more
difficult in this country to get this ban. I had preferred all
along in my career that it would be more voluntary and that you
wouldn't need a legislative ban, but I have been disappointed.
But anyway, all that being said, as we know, the Europeans
looked at the data and with one fell swoop they said
precautionary principle, we eliminate this use. I think the
scientific data is clear, and I am a scientist and I have
looked at the data, and the APUA has actually put out a few
years ago an evaluation of this whole prospect with
stakeholders and all agreed that this is no longer needed.
First of all, we don't even know if growth promotion is really
working. If it is prophylactic, let us call it prophylactic.
And as I said in my statement, there is a big difference in
terms of the selection of the numbers of animals that we get
for growth promotion, which is everyone, whether healthy or
not, versus prophylaxis, which in human medicine, look at what
we do with surgery. We eliminated all that extra antibiotic and
we gave a dose before and a dose or two after. Why aren't we
doing that with animals? Where are the studies? If we call it
prophylaxis, show me that it is prophylaxis. Show me what--I
mean, a spade a spade. What is it? And so I think it is a
different, should I say culture, but I don't think that
anyone--there are plenty of us in the United States that agree
with the European decision.
Mrs. Christensen. And I noted Dr. Hansen in her statement--
I don't have a question for you but I know that you said that
even in 1977, that is where I got the point I made in my
opening statement, that the evidence was significant but we did
not allow FDA to apply a ban. Is that correct?
Dr. Hansen. Yes, ma'am. I would certainly agree with that.
I think that we certainly don't lack the science at all. We
certainly have--this is just a representative portion of the
science that we have. We may lack or we may have at least up
until this point with all these hearings may have lacked some
of the political will.
Mrs. Christensen. Thank you.
Dr. Carnevale, how does AHI justify opposing significant
reductions in antibiotic use in food animals when such overuse
ultimately helps to contribute to the demise in your products'
ability to treat both human and animal disease? Aren't you
sacrificing long-term financial well-being, not to mention
public health, in favor of short-term profit in this case?
Dr. Carnevale. If I understand the question, you are saying
why do we oppose reducing antimicrobial use. I don't think AHI
has ever said that. I think what our position is is that these
products have been approved as safe and effective by the FDA
Mrs. Christensen. Safe and effective for treatment.
Dr. Carnevale. Safe and effective for all the claims on the
label.
Mrs. Christensen. From growth----
Dr. Carnevale. They have been approved as safe and
effective for growth promotion, disease prevention, disease
treatment and disease control, whatever is on the label.
Mrs. Christensen. Well, FDA has issued some guidelines now
regarding----
Dr. Carnevale. Yes.
Mrs. Christensen. Does AHI support the guidelines that
FDA----
Dr. Carnevale. We welcome the opportunity to work with the
agency on their concerns about it. We clearly understand that
they do have a concern about the way these products have been
marketed for many years over the counter. We do understand they
have a concern for the growth promotion claims. I don't want to
prejudge the situation. I simply want to say that our companies
are committed to working with the agency to try to address
those concerns, and if there are alternatives that we can come
up with for growth promotion claims, I am sure our companies
will be more than happy to pursue that track.
Mrs. Christensen. And are your companies----
Dr. Carnevale. Yes, we really want to work with the agency
on this.
Mrs. Christensen. Are your companies willing to report on
the sale of medicines, drugs for animal use?
Dr. Carnevale. In fact, they are required to now under the
Animal Drug User Fee Act. In fact, our companies have all
submitted those reports to the FDA as of the end of March 2010.
So yes.
Mrs. Christensen. Thank you, Madam Chair.
Ms. Schakowsky. Well, that concludes all the questioning. I
really thank you for your patience today, for staying with us
all afternoon. In closing, I want to remind members that you
may submit additional questions for the record to be answered
by the relevant witnesses. The questions should be submitted to
the committee clerk within the next 10 days. The clerk will
notify your offices of the procedures.
And without objection, this meeting of the Subcommittee is
adjourned. Thank you.
[Whereupon, at 5:55 p.m., the Subcommittee was adjourned.]
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