[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
COMPREHENSIVE MEDICAL CARE FOR BIOTERRORISM EXPOSURE--ARE WE MAKING
EVIDENCED-BASED DECISIONS? WHAT ARE THE RESEARCH NEEDS?
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
NOVEMBER 14, 2001
__________
Serial No. 107-45
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
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_____________________________________________________________________________
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COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California PATSY T. MINK, Hawaii
JOHN L. MICA, Florida CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
BOB BARR, Georgia DENNIS J. KUCINICH, Ohio
DAN MILLER, Florida ROD R. BLAGOJEVICH, Illinois
DOUG OSE, California DANNY K. DAVIS, Illinois
RON LEWIS, Kentucky JOHN F. TIERNEY, Massachusetts
JO ANN DAVIS, Virginia JIM TURNER, Texas
TODD RUSSELL PLATTS, Pennsylvania THOMAS H. ALLEN, Maine
DAVE WELDON, Florida JANICE D. SCHAKOWSKY, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida DIANE E. WATSON, California
C.L. ``BUTCH'' OTTER, Idaho STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia ------
JOHN J. DUNCAN, Tennessee BERNARD SANDERS, Vermont
------ ------ (Independent)
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Robert A. Briggs, Chief Clerk
Phil Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on November 14, 2001................................ 1
Statement of:
Jonas, Wayne B., M.D., director, Samueli Institute for
Information Biology, Alexandria, VA, and associate
professor, department of family medicine, Uniformed
Services University of the Health Sciences, F. Edward
Hebert School of Medicine; H. Reg McDaniel, M.D., director
of research, Fisher Institute of Medical Research, medical
director, Mannatech, Inc., Grand Prairie, TX; Sherwood
Gorbach, M.D., Tufts University, Boston, MA; and Richard S.
Klasco, M.D., medical director, Micromedex, Inc., Greenwood
Village, CO................................................ 72
Parker, Major General John S., U.S. Army Medical Research
Institute for Infectious Diseases, Department of Defense;
Stephen Straus, M.D., Director, National Center for
Complementary and Alternative Medicine; Carole Heilman,
Ph.D., Director, Division of Microbiology and Infectious
Diseases, National Institute of Allergy and Infectious
Diseases; Andrea Meyerhoff, M.D., Director of Anti-
Terrorism Programs, Center for Biologics Research and
Review, Food and Drug Administration; and William Egan,
Ph.D., Director, Office of Vaccine Research and Review,
Food and Drug Administration............................... 12
Letters, statements, etc., submitted for the record by:
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 5
Clay, Hon. Wm. Lacy, a Representative in Congress from the
State of Missouri, prepared statement of................... 112
Gorbach, Sherwood, M.D., Tufts University, Boston, MA,
prepared statement of...................................... 92
Heilman, Carole, Ph.D., Director, Division of Microbiology
and Infectious Diseases, National Institute of Allergy and
Infectious Diseases, prepared statement of................. 45
Jonas, Wayne B., M.D., director, Samueli Institute for
Information Biology, Alexandria, VA, and associate
professor, department of family medicine, Uniformed
Services University of the Health Sciences, F. Edward
Hebert School of Medicine, prepared statement of........... 75
Klasco, Richard S., M.D., medical director, Micromedex, Inc.,
Greenwood Village, CO, prepared statement of............... 97
McDaniel, H. Reg, M.D., director of research, Fisher
Institute of Medical Research, medical director, Mannatech,
Inc., Grand Prairie, TX, prepared statement of............. 81
Morella, Hon. Constance A., a Representative in Congress from
the State of Maryland, prepared statement of............... 61
Parker, Major General John S., U.S. Army Medical Research
Institute for Infectious Diseases, Department of Defense,
prepared statement of...................................... 16
Straus, Stephen, M.D., Director, National Center for
Complementary and Alternative Medicine, prepared statement
of......................................................... 35
COMPREHENSIVE MEDICAL CARE FOR BIOTERRORISM EXPOSURE--ARE WE MAKING
EVIDENCED-BASED DECISIONS? WHAT ARE THE RESEARCH NEEDS?
----------
WEDNESDAY, NOVEMBER 14, 2001
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 1:10 p.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Gilman, Morella, Shays,
Lewis, Otter, LaTourette, Waxman, Owens, Sanders, Norton,
Cummings, Kucinich, Clay, Watson, and Lynch.
Staff present: Kevin Binger, staff director; David A. Kass,
deputy chief counsel; Mark Corallo, director of communications;
S. Elizabeth Clay and John Rowe, professional staff members;
Robert A. Briggs, chief clerk; Michael Bloomrose and Michael
Layman, staff assistants; Robin Butler, office manager;
Elizabeth Crane, legislative assistant; Joshua Gillespie,
deputy chief clerk; Leneal Scott, computer systems manager;
Corinne Zaccagnini, systems administrator; Sarah Despres,
minority counsel; Ellen Rayner, minority chief clerk; and Jean
Gosa and Earley Green, minority assistant clerks.
Mr. Burton. Good afternoon. The quorum being present, the
Committee on Government Reform will come to order. I ask
unanimous consent that all Members' and witnesses' written and
opening statements be included in the record. And without
objection, so ordered. I ask unanimous consent that all
articles, exhibits and extraneous or tabular material being
referred to be included in the record. Without objection, so
ordered.
We are here today to look at comprehensive medical care for
bioterrorism exposure. There are several treatments suggested
to protect individuals who have been exposed to biological
agents such as anthrax and smallpox. We have vaccines. We have
antibiotics and other drugs. We also have complementary and
alternative treatments and nutritional approaches that can
supplement conventional treatments. This area has not been
discussed very much.
The medical community is now expected to be on the lookout
for anthrax, smallpox and other possible biological terrorism
agents. The public is looking for answers on what they can do
to protect themselves. People want more information than they
are getting. Many are turning to the Internet for answers about
what to do to protect themselves and their families.
There is a lot of very good information on the Internet.
There's also some very bad information on the Internet. It's
hard for the layman to tell the good from the bad. And that's
why it's so important for people to get advice from their
doctors and other qualified health experts. Some unscrupulous
people have been advertising alternative products on the
Internet as a cure for anthrax. We have found no evidence to
support any of these claims. The leading dietary supplement
association has issued a statement to make it very clear that
there is no dietary supplement known to cure anthrax and it is
illegal to make such a claim. I applaud them for doing that.
The vast majority of the supplement manufacturers have always
behaved very responsibly and this is another example of that.
We want to clear up some of these issues today. We will be
looking at how much we know about the safety and efficacy of
all treatments of potential use in a bioterrorist attack.
At the same time, there are complementary and nutritional
approaches that may help minimize some of the side effects of
conventional treatments like antibiotics. There are also some
nutritional approaches that may improve the outcome of the
conventional treatments. There is research evidence in both of
these areas.
This fall anthrax spores were mailed to several media
outlets and congressional offices. As a result, four people
have died and several individuals are ill from either
inhalation or cutaneous anthrax. We are fortunate that we have
some very good antibiotics available and that doctors were able
to save the lives of several anthrax victims. Today as a
precautionary measure thousands of individuals are now on
antibiotics, and it's very important for those at risk to
continue their antibiotics under their doctor's care.
All antibiotics can leave patients vulnerable for other
infections, and some antibiotics have more severe side effects
than others. In fact, Cipro has serious side effects associated
with it. According to the information provided on the Bayer Web
site, that is the producer of the product, expected side
effects include nausea, diarrhea, vomiting, abdominal pain,
discomfort, headache, rash and restlessness. In rare cases,
Cipro may cause more serious side effects than these.
Let me repeat, it's important for patients who have been
prescribed this antibiotic to follow their doctor's advice.
While these side effects are usually rare, patients need to be
fully informed of what they can expect when taking this or
other products and what they can do to maximize the benefit
while reducing the risks. We will be hearing today from Dr. Reg
McDaniel and Dr. Sherwood Gorbach, both experts in the area of
nutrition and immunology.
Vaccines are another area where the public needs more
information. For instance, the Government Reform Committee has
done extensive oversight investigations about the Department of
Defense's anthrax vaccine immunization program. And I'd like to
thank Congressman Shays, who I think will be with us in a
little bit, for his diligence in this area.
We have all heard in the media the DOD talking about giving
everyone in the country the anthrax vaccination. People who
advocate but don't have all of the facts. In the military, the
rate of adverse events from the vaccines has been very high. A
few people have been very seriously injured. The company that
makes this vaccine has a deplorable track record. There's also
many, many questions about the effectiveness of this vaccine.
There are many different strains of anthrax, and whether this
vaccine would protect people from all of those strains is an
open question. So I don't want people to have a false sense of
security thinking that the vaccine would protect every one of
them against these various strains.
As we learned during vaccine investigations, there's not
always a lot of definitive science in vaccine development. Even
the Institute of Medicine agrees on this point. Every time the
Institute of Medicine has reviewed the body of research
evidence on specific vaccines, their experts have pointed out
significant shortcomings in the evidence.
Some of the information on the Internet recommends using
homeopathic remedies to protect against biological terrorism.
We will hear today from Dr. Wayne Jonas about the research he
conducted at Walter Reed Army Research Center on homeopathic
solutions and biological agents. He has published several
studies in this area. Because of his expertise in complementary
and alternative medicine and research methodology, Dr. Jonas
was loaned by the Army to the National Institutes of Health for
3 years to serve as the Director of the Office of Alternative
Medicine. While he is retired from the Army, Dr. Jonas is
continuing his research as the Director of the Samueli
Institute for Information Biology. Dr. Jonas is also a member
of the White House Commission on Complementary and Alternative
Medicine Policy.
We have a lot of questions that need to be answered today.
No. 1, what is the evidence base for safety and efficacy for
various preventative and post-exposure treatment options? What
is the evidence base about nutritional support for the immune
system and for patients on antibiotics? What is the role of
homeopathy, essential oils, dietary supplements and other
complementary and other alternative therapies in biological
terrorist prevention and recovery? Has our government embraced
existing science and historical case studies and looked to
maximize low cost, low harm immune supportive theories? Has our
government looked at other systems of medicine for promising
therapies? And where does the public go to find reliable
information on these therapies?
Three themes are crucial as we move forward from September
11. First, we must think outside the box. Second, we must work
together. And third, information is power.
First, let's think outside the box. Solutions to protecting
the public from biological warfare cannot be found in any
existing ``how to'' manual. We are not going to be able to
develop vaccines to protect the public against every possible
biological threat. We need to know how to take care of those
who have not been vaccinated.
Second, we must put aside our differences and work
together. We as a nation, as a world, must set aside our
political differences. We must set aside biases against those
whose ideas are different from our own and work together to
find safe, effective and available solutions to the challenges
we face as a result of the evils of terrorism.
And the government and the research community must move
away from attacking those who would use nutritional approaches
and complementary therapies in healing and keep an open mind
about theories that we may be unfamiliar with. We must work
together to determine the existing level of evidence on both
safety and efficacy on all therapies and then move quickly to
fill in the research gaps.
And third, information is power. It is important to put
good information in the hands of the medical community and the
public. How can we get answers quickly and with some measure of
confidence?
Dr. Richard Klasco is here today to talk about one possible
solution. As an emergency room physician, Dr. Klasco knows how
crucial it is to have accurate information at your fingertips
in unusual circumstances. Micromedex is a company that markets
the electronic Physician's Desk Reference [PDR], and numerous
drug, toxicology and alternative medicine data bases. They have
recently developed a data base on bioterrorism. BioDex provides
the full array of information needed by first responders and
medical personnel for biological terrorism agents. The data
base will be Web accessible. It can be purchased on CD or
loaded into hand-held ``palm'' computers as well.
From the government, we are going to receive testimony from
Major General Parker on behalf of the Department of Defense;
also Dr. Straus, the Director of the National Center on
Complementary and Alternative Medicine; and Carole Heilman from
the National Institute of Allergy and Infectious Diseases will
be testifying. We also have Dr. Andrea Meyerhoff and Dr.
William Egan from the FDA to answer questions.
I look forward to hearing from all of our witnesses today,
and the record will remain open until November 28.
And with that Mr. Waxman, I will recognize you.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Waxman. Thank you very much, Mr. Chairman. Thank you
for holding this hearing today. It is critical that we take
seriously the threat of biological terrorism. The list of
biological agents that could be used as weapons is terrifying.
Smallpox, a disease that was eradicated just over 2 decades
ago, is highly contagious and fatal in about 30 percent of the
cases. Anthrax, as we have recently seen, can cause fatal
illnesses. Other potential biological weapons include botulism
toxoid, Q fever, plague and tularemia.
We now know that threats are no longer theoretical. The
possibility that there may be more cases of anthrax in the
future or that there may be new attacks with different agents
must be taken seriously and we must be prepared. These
preparations involve making sure we have adequate stockpiles of
safe and effective treatments and vaccines as well as systems
for distributing the drugs and vaccines. Preparations also
involve making sure that State and local health departments are
well staffed and fully equipped to handle a chemical or
biological weapons attack, and we have to ensure that we have
sufficient hospital capacity.
We also need to make sure that people are informed about
what to do in case of an attack and where they can go to get
reliable information. This includes, for example, an
understanding of whether someone needs to take antibiotics or
other drugs in the absence of symptoms without confirmed
exposure to an agent. People also need to understand what the
side effects of these treatments could be.
We do not have treatments or vaccines for every possible
biological agent. It is clear that we need to continue to do
research in this area to make sure that Americans will be
protected against these potential threats. All possible
treatments or preventions, including pharmaceuticals, vaccines
or dietary supplements, need to meet strict scientific
standards for both safety and efficacy. Americans deserve the
most effective, safest treatments science can produce.
And I thank the witnesses for appearing today. I look
forward to their testimony, and I do want to point out that we
will be reviewing all the testimony that is submitted.
Unfortunately my schedule is in conflict because I have
meetings going on at the same time, so I may not be here to
hear your testimony. But rest assured that my staff is here and
I will have an opportunity to review what was said as well as
the written statements that will be put into the record.
Thank you, Mr. Chairman.
Mr. Burton. Do other Members have opening statements?
Mr. Sanders. Thank you, Mr. Chairman. This is an important
hearing. It seems to me that on one hand we certainly don't
want to frighten the American people, but on the other hand, we
would be irresponsible if we did not go through the dreadful
exercise of looking at worst case scenarios and seeing how can
we best protect the American people in the event of some
terrible, terrible outrage against this country.
Some of the concerns that I have, Mr. Chairman, and Mr.
Waxman I think touched on it, is if we ran through some worst
case scenarios where many millions of people might be made ill
on a given day, do we as a nation have the public health
infrastructure to deal with that? Now, can one just imagine the
kind of panic and concern that would take place all over this
country? People wanting information, people wanting medicine,
perhaps vaccines. Where do we get those? Do we as a nation have
adequate stockpiles of that?
We have heard, for example--and this is not a criticism
because I think, as the chairman indicated, we are into new
territory. We've never been there before. We are all trying to
learn and do the best thing, and I applaud the efforts of
everyone who is trying to do the right thing. But I think even
in terms of anthrax, I heard within a period of a couple of
days several different analyses and descriptions of what is the
proper thing to do. Some people say take Cipro for 60 days.
Some people say, well, take Cipro for 5 days and doxycycline
for the rest of the period. Some people say, well, take
doxyclcyline all throughout.
So I think we have an obligation as a government to make
clear to the American people what is the best course of
treatment. There were some people that think, oh, I guess Cipro
is good for the wealthy people. But if I'm poor, we just get
the lower-cost drug. I don't think that's the case, but what is
the case? What is the best and effective form of treatment for
all people?
Getting back to the issue of public health infrastructure,
the truth is that in many ways our country is very advanced
medically, but in other ways we are fairly primitive medically.
We have 44 million Americans who do not have health insurance.
Others are underinsured. Where are they going to get their
medicine? Do they have to line up at a local drugstore? I was
talking to somebody in Vermont. We are a very rural State. And
they said, the drugstores will be open. Sure, we have a town of
1,000 people and some elderly gentleman owns a drugstore. Do
you really think that he is going to be able to deal with
people besieging the drugstore? Does he have adequate supplies?
Should we be dependent on pharmacies to be distributing drugs
or do we need a public health approach? Do we have adequate
numbers of clinics?
I don't agree with President Bush on many things, but the
President has indicated his support for federally qualified
health clinics, FQHCs. In fact, these are cost effective ways
of providing health care to lower income people all over this
country. I think we can agree that in the event of a national
emergency, when millions and millions of people need health
care, you are not going to ask somebody, well, where is your
Blue Cross/Blue Shield card? I'm sorry, we can't treat you.
Every American has got to know that they equally, whether
you are rich or poor, will get the same type of treatment. Are
we prepared to do that today? Frankly, I don't think we are. So
I think we have to look at the health infrastructure, the
public health infrastructure, so that we can dispense the kinds
of drugs and vaccines that we need, give people the
information, give people the treatment. The difficulty here is,
and it is a nightmarish issue scenario that we have got to look
at, is that on a given day millions and millions and millions
of people may need medical treatment. Are we prepared to do
that? I suspect we are not.
Mr. Chairman, you and I disagree on many issues but I do
applaud you raising the issue of complementary health care and
alternative health care. I think there is a lot to be learned
from that, but at the same time I think we have got to make
sure that we have available drugs. For example, I think the
Secretary had come up with--what was it, Dustin--12 million
people in terms of an anthrax attack. Why 12 million and not 30
million? Who made that determination? So I think what's
important today is to take a hard look at some very ugly,
frightening circumstances and do our best to make sure that the
American people are as prepared as they can be, and I thank you
for calling this meeting, Mr. Chairman.
Mr. Burton. Thank you, Mr. Sanders. Further discussion? If
not, I would like to invite to the witness table Major General
Parker, Dr. Stephen Straus, Dr. Carole Heilman and Dr. Andrea
Meyerhoff. Would you please come to the witness table, please.
And Dr. Egan, I guess you need to be sworn as well. Would you
stand as well?
[Witnesses sworn.]
Mr. Burton. I think we will go right down the table. Major
General Parker, is there an opening statement you would like to
make, sir?
STATEMENTS OF MAJOR GENERAL JOHN S. PARKER, U.S. ARMY MEDICAL
RESEARCH INSTITUTE FOR INFECTIOUS DISEASES, DEPARTMENT OF
DEFENSE; STEPHEN STRAUS, M.D., DIRECTOR, NATIONAL CENTER FOR
COMPLEMENTARY AND ALTERNATIVE MEDICINE; CAROLE HEILMAN, PH.D.,
DIRECTOR, DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES,
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; ANDREA
MEYERHOFF, M.D., DIRECTOR OF ANTI-TERRORISM PROGRAMS, CENTER
FOR BIOLOGICS RESEARCH AND REVIEW, FOOD AND DRUG
ADMINISTRATION; AND WILLIAM EGAN, PH.D., DIRECTOR, OFFICE OF
VACCINE RESEARCH AND REVIEW, FOOD AND DRUG ADMINISTRATION
General Parker. Good afternoon, Mr. Chairman and members of
this committee. I am Major General John Parker and today I
represent the Department of Defense at this hearing. Sir, we
submitted testimony to you for this hearing and I am concerned
that it did not address your questions of the committee. I
received those questions yesterday morning, and I would
appreciate the chairman's indulgence and allow me to resubmit
within the next 96 hours testimony that addresses your
questions in a very specific manner. Meanwhile, I will address
your questions orally from my personal perspective as the
Commander of the U.S. Army Medical Research and Materiel
Command and Fort Detrick.
The September 11th and the multiple anthrax attacks that
occurred since then are only a small indication of the
potential destruction and harm that a biological agent can
produce. Terrorism, specifically biological terrorism, is an
immediate threat to our security both at home and abroad. As
our Nation addresses this terrifying threat that has invaded
our homeland, the Department of Defense is prepared to assist
and to support other Federal and civilian agencies as our
capability permits.
We can do this because we have already developed the force
health protection program that includes not only acknowledgment
of the threat, but also development and implementation of a
planned multi-faceted approach to the medical management of
biological warfare casualties.
I would now like to turn to the specific questions that
were identified in your invitation to this testimony. The
question: Current recommendations for medical care for
individuals both at risk for exposure and those suspected or
known to have been exposed to the most common biological
agents. Several military publications provide information on
the medical management of biological warfare casualties. These
serve as guidelines and references for health care providers in
handling biological warfare casualties.
In addition, the Centers for Disease Control and Prevention
issues medical guidance in their weekly publication, Morbidity
and Mortality Weekly Report, and in special publications for
various events. Pocket-sized handbooks designed to fit in the
battle dress uniform pockets are routinely published and
provided to military health care personnel as field expedient
references in the management of nuclear, biological and
chemical casualties. Some of these include Medical Management
of Biological Casualties Handbook and Defense Against Toxin
Weapons.
In my testimony, I hope to send two tables to be included,
one entitled Biological Warfare Agent Characteristics and the
other entitled Biological Warfare Agent Treatment. These are,
in fact, appendices from the Medical Management of Biological
Casualties Handbook and address many of the questions
identified.
A field manual has been developed to provide detailed
guidance to health care providers. The most recent addition of
Field Manual 8-284, titled Treatment of Biological Warfare
Agent Casualties, was published in July 2000. This field manual
provides in-depth information for the management of these types
of casualties. The manual focuses on medical response to
biological warfare weapons used against military personnel
during military operations. Agent-specific medical preventive
and treatment regimens are offered for health care providers.
On your second question, an analysis of research evidence
on known treatments, including vaccines, antibiotics and other
approaches, the existing evidence on effectiveness of vaccines
and antibiotics for prevention or treatment of disease caused
by biological threat agents comes from two sources. The first
is in the prevention or treatment of human disease in
occupational or natural disease settings. As noted by the
Centers of Disease Control and Prevention in their publication
Biosafety and Microbiological and Microbiomedical Laboratories,
that publication has a number 93A395, the use of vaccines has
reduced the number of laboratory-acquired infections for a
number of agents. They particularly note that no laboratory-
associated cases of anthrax have been reported in the United
States since the late 1950's, when human anthrax vaccine was
introduced.
In the case of the anthrax vaccine, actual clinical field
studies were conducted in which the efficacy of the vaccine in
reducing cutaneous anthrax in woolen mill workers was
demonstrated. The vaccine also appeared to reduce the number of
pulmonary anthrax cases, but the numbers were insufficient to
achieve good statistical significance.
With respect to the antibiotic treatment, much experience
has been gained over the years in treating natural occurrences
of the disease caused by various threat agents. For example,
bubonic plague, tularemia and cutaneous anthrax occur routinely
in humans in the Midwest and western United States.
Similarly the use of Ribavirin, an antiviral drug, has been
tested clinically around the world with several viral
hemorrhagic fevers, including Lassa fever and Congo Crimean
hemorrhagic fever. The medical community has experience in
antibiotic and antiviral therapy of these disease
presentations. In addition, the sensitivity of biological
threat bacteria to various antibiotics can be tested in vitro
in the laboratory. Such testing can provide a good indication
of which drugs are likely to be effective in treating human
disease.
The second source of evidence of the effectiveness of
vaccines and therapies comes from studies in animal models. In
the laboratory, animals can be immunized with vaccines and then
exposed to the biological agent either by injection or by
aerosol. Because the battlefield threat is believed to be from
an aerosol, large scale delivery of a biological warfare agent,
this is the critical route by which testing may be performed.
It is almost the most difficult route, and very few
organizations have the facilities or trained personnel to
accomplish this type of research.
Obviously, there are inherent limitations in what can be
achieved in the laboratory, but in general we are able to
challenge animals with many hundreds or even thousands of
lethal doses of biological threat agent and assess the
protection afforded by a vaccine. Protection against an aerosol
challenge is one of the critical requirements of our vaccine
candidates.
In order to translate the results obtained in animal
studies to the effectiveness in humans, we identify and develop
surrogate markers of protection that we can measure in humans
and use as a basis for inference of protection. Animal models
are also used to verify the effectiveness of antibiotics and
antivirals that are identified in vitro screening. This is the
same standard practice that is used by the pharmaceutical
industry.
Sir, I have a long paragraph about our comprehensive list
of DOD-funded research addressing vaccines, and I would like to
submit that testimony rather than read that.
Mr. Burton. That will be fine. Do you have quite a bit more
in our opening statement, General?
General Parker. I just would like to read our
recommendations on research needed to fill the gaps, if that's
possible. Thank you for allowing me to do this.
Recent events have certainly eliminated gaps in our
knowledge of medical countermeasures for biological threat
agents. In the context of chemical and biological terrorism,
the Institute of Medicine in 1999 provided recommendations in
their study, Research and Development to Improve Civilian
Medical Response, which are as relevant today as they were
then. The study identified needs for vaccines, effective drugs,
diagnostic technologies, patient management paradigms and many
other facets of the response to bioterrorism. Many of these
recommendations are being acted upon nationally, but progress
takes time.
One need has become strikingly apparent as a result of the
current situation, and that is for a national capability to
test and evaluate emerging products, existing products, and new
technologies for their effectiveness in the prevention,
treatment, detection, diagnosis and decontamination of
biological threat agents or the diseases caused by them.
As I mentioned earlier, a critical element in evaluation of
any of the medical countermeasures is testing and evaluation in
animal models, and in particular, the capacity to expose
animals to the disease-causing agent in the form of an aerosol.
Our national capability to perform these studies and others
that necessitate the use of containment laboratories and
handling of hazardous biological agents is extremely
constrained. Rather than enumerate specific studies that need
to be performed sooner rather than later, I would like to
identify this shortfall in capability containment laboratories,
certain species of animals, trained personnel and the funds
required to support them. This is a critical gap.
Thank you very much, sir, for allowing me to read in the
testimony.
[The prepared statement of General Parker follows:]
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Mr. Burton. Thank you, General. We have three votes pending
on the floor, and I really apologize because it is going to
take us probably 25 to 30 minutes before we get back. We will
stand in recess until the fall of the gavel and we should be
back here a little after 2 o'clock. So if any of you want to do
something for about 30 minutes, make yourselves at home. We
will be right back. Thank you.
[Recess.]
Mr. Burton. The committee will reconvene. Other Members are
on their way back from the floor, so we'll get to them as soon
as they arrive.
Dr. Straus, would you like to make your opening statement?
Dr. Straus. Yes. Thank you, Mr. Chairman, members of the
committee. I submitted fuller testimony. I'll make some brief
opening remarks and await your questions.
As a physician who for the past 25 years I have specialized
in the care of patients with severe and life-threatening
infections and as a public health official, I fully support the
current CDC recommendations for managing potential exposure to
and infection by anthrax. The success of current efforts to
locate and disinfect contaminated sites and dispense effective
antibiotics to those exposed is evidenced by the small numbers
of infected persons and the even smaller numbers, fortunately,
of serious illnesses or deaths that have resulted from such
exposures.
The specific question you asked me to address today, Mr.
Chairman, in my capacity as director of the National Center for
Complementary and Alternative Medicine [NCCAM] is whether there
are additional health tools and practices that could
effectively serve as alternatives or as complements to those
ones already implemented to prevent or treat diseases from
biological weapons.
Many of these alternative approaches were displaced by the
emergence of evidenced-based medicine. Before the articulation
of the germ theory of disease in the late 19th century and the
subsequent development of vaccines and antibiotics, people
believed that specific rituals and selected herbal extracts and
tonics would, in current parlance, eliminate the offending
pathogens or boost one's resistance to them. In fact, a
characteristic shared by many of the traditional healing
systems of indigenous peoples, such as Ayurvedic medicine,
various forms of oriental medicine and the more recently
developed systems, like Naturopathy, is an emphasis on
maximizing the body's inherent capacity to heal itself.
While augmenting one's own natural healing powers may prove
beneficial for some diseases and is the focus of much of the
work funded today by the NCCAM, there is no scientific basis to
believe that this approach would be of value in the context of
virulent diseases incited by biological weapons.
From the perspective of contemporary immunology, diseases
like anthrax, smallpox and tularemia exceed one's innate
immunity to control them and progress too rapidly for specific
and protective antibody and lymphocyte responses to evolve.
Simply stated, Mr. Chairman, they can kill us before we can arm
ourselves fully to defend against them.
Had the traditional healing rituals and natural products
available to pre-20th century man been truly effective, our
history would have been rather different. Through the
availability of cleaner water, uncontaminated foodstuffs and
vaccines and antibiotics, human life span has increased by a
greater proportion in the past century than through all
recorded history up to that time.
Despite these impressive public health achievements, people
still turn today to natural products, hoping for them to help
mitigate infections. While these may be justifiable decisions
as regards milder and more self-limiting conditions, we must
discourage any assumption that these products can serve in lieu
of proven drugs like ciprofloxacin or doxycycline for people
exposed to anthrax bacilli. It may even not be prudent to
combine such natural products with antibiotics because of the
possibility that they would interfere with the proper
metabolism and action of drugs.
For example, calcium supplements have been shown to reduce
the body's content of ciprofloxacin by over 40 percent. Even
though there is some doubt that certain approaches involving
herbs, homeopathic medicines, essential oils or colloidal
silver could be effective for diseases like anthrax or
smallpox, we cannot prove the claims to be entirely specious.
It would be unethical and dangerous to withhold drug and
vaccines in order to see whether the alternative remedies
protect people who become exposed. Exploration of such
exposures should first involve careful studies in animals using
contemporary methodologies to discern whether they hold any
promise against diseases associated with biological weapons. In
the interim, however, lacking any competent evidence that they
work, the claims about these products are dangerous both to the
individual who uses them and to the population in general who
might become infected if some others refuse standard
treatments.
In conclusion, Mr. Chairman, in the instance of
bioterrorism, the best approach is to manifest, as I do, an
unwavering trust in the currently approved drugs and vaccines
and not to dissipate our energies or to distract the public by
pursuing unproven remedies. The stakes are simply too high at
this time of national emergency to do otherwise.
I would be happy to take any questions you may have about
NCCAM's responses to bioterrorism. Thank you.
Mr. Burton. Thank you, Dr. Straus.
[The prepared statement of Dr. Straus follows:]
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Mr. Burton. Dr. Heilman.
Ms. Heilman. Mr. Chairman and members of the committee,
thank you for inviting me here today to discuss the medical
response to bioterrorism as well as current efforts by the NIH
to facilitate basic and clinical research related to the
prevention and treatment of bioterrorism agents. In just the
past 2 months we have witnessed the deliberate mailing of
spores of anthrax, including the exposure of members of this
esteemed body to this deadly bacterium. Federal health agencies
have responded by evaluating and accelerating measures to
protect the public from the health consequences of such an
attack.
Today I will describe one component of the national effort.
As part of the NIH, the National Institute of Allergy and
Infectious Diseases supports research on the diagnosis,
prevention and treatment of infections caused by a wide variety
of pathogens, including organisms of bioterrorism such as
anthrax, smallpox, plague, tularemia, viral hemorrhagic fevers,
and botulism.
To meet the challenges posed by bioterrorism, especially to
civilians, NIH supports research in the basic biology and
disease-causing mechanisms of pathogens, the development of
rapid and sensitive diagnostic tools, the creation of new
vaccines using both traditional and novel technologies and the
design of new therapeutic agents. To address the specific
interest of this committee, I have provided you a compendium of
NIH-funded research and a bibliography of published research
articles related to vaccines and treatments of potential agents
of bioterrorism in appendices A and B, respectively, of the
written testimony. The current recommendations for medical care
of a wide variety of potential agents of bioterrorism can be
found in appendix C. Appendix D is a copy of the Health and
Human Services' action plan on antimicrobial resistance.
I would like to spend the remainder of my time providing
examples of the research efforts that have been initiated and
accelerated for two bioterrorist threats of particular concern,
smallpox and anthrax. Smallpox is considered one of the most
dangerous potential biological weapons, because it is easily
transmitted from person to person and because few people carry
full immunity to the virus. Smallpox vaccine has proven to be
highly effective in preventing infection and was an essential
factor in the global eradication of smallpox in 1977.
Vaccinations to prevent smallpox have not been required in
the United States since 1972. In the near term, a bioterrorist
attack involving smallpox would require the utilization of
stores of the existing smallpox vaccine to protect those at
immediate risk. The current stock of Dryvax vaccine,
approximately 15 million doses, clearly would not be enough to
respond to a national smallpox epidemic.
Last year, NIAID conducted a study to determine whether
this vaccine had maintained its potency over the years. As a
next step, we wanted to determine if a diluted vaccine,
combined with an alternative vaccination schedule, could
protect a greater number of people than does the standard dose
and regimen. Earlier this month, we initiated a new smallpox
vaccine study that is designed to compare the use of a 1-to-5
dilution or 1-to-10 dilution in undiluted vaccine with the
revaccination schedule. This study should yield information by
January, which may help guide us on how to use the remaining
stockpile of smallpox vaccine if needed, to protect the general
population.
NIAID is also designing other protocols for clinical
testing of Dryvax and the newer cell-cultured smallpox vaccines
for use in other segments of the population. At the same time,
we are looking into alternative vaccine strategies with the
goal of designing safer and more effective vaccines.
NIAID is also accelerating efforts to identify antiviral
drugs that will be effective in treating smallpox and related
viruses. One of these agents is an antiviral called cidofovir,
which has shown potential activity against smallpox and related
viruses in test tube studies and in animal models. NIH has
taken the lead in developing a protocol that would allow the
use of cidofovir in emergency situations.
As we have seen in recent weeks, anthrax is another agent
that deserves our attention as a bioterrorist threat. Human
anthrax has three major clinical forms--cutaneous, inhalation
and gastrointestinal. If left untreated, anthrax in all of
these forms can lead to septicemia and death. Anthrax vaccine
adsorbed [AVA], is the only currently licensed anthrax vaccine
and is used solely by the Department of Defense to protect U.S.
military personnel in high-threat areas. NIAID has been working
with DOD to support the development of the next generation of
anthrax vaccines that may be more appropriate than AVA for use
in a civilian population.
In collaboration with other government agencies, NIH is
working to prioritize and accelerate testing of promising
candidates for use as antimicrobial therapies for anthrax in
order to increase the pool of available treatments. Novel
antitoxins approaches are also under development. An example of
this work has just recently been published in the scientific
journal, Nature. Much remains to be accomplished, however, and
the challenges posed by bioterrorism will require a protracted
and sustained commitment.
The NIH will announce in the next few weeks several new
initiatives to provide the academic and industrial research
community with an opportunity to propose studies targeting new
approaches concerning bioterrorism research. The submission,
review, and funding of these proposals will be expedited in
order to facilitate the rapid advance of these important
research endeavors.
With a strong research base, talented investigators
throughout the country, and the availability of powerful new
research tools, we fully expect that our basic and applied
research programs will provide the essential elements that will
help enhance our defense against those who attempt to harm us
with bioterrorism. Thank you.
Mr. Burton. Thank you, Dr. Heilman--Heilman.
Ms. Heilman. Heilman.
Mr. Burton. I had it right the first time.
[The prepared statement of Ms. Heilman follows:]
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Mr. Burton. Before we go to Dr. Meyerhoff, Ben Gilman, the
chairman emeritus of the International Realtions Committee, has
a brief statement he'd like to make.
Mr. Gilman. Well, thank you very much, Mr. Chairman. I
regret I'm being pulled away to another hearing, but I want to
thank you and the committee for conducting these extensive
hearings on bioterrorism; and our committee has been one of the
leading committees in doing the oversight on what our Nation is
prepared to do to take care of the problem. The September 11th
attacks in New York, Pennsylvania and Virginia and the
subsequent breakouts of anthrax around the country raised the
issue of bioterrorism to a high level.
With regards to vaccines and remedies against various
biological agents such as smallpox and cholera, there's a
tremendous amount of medical information that we already know,
but there's still a great deal more that we should know and
that we should be doing. The American public has been inundated
with information about anthrax and smallpox, some of it
accurate, some not so accurate. Doctors and pharmacists are
having to learn about these illnesses as they present
themselves, as the margin for error or a misdiagnosis is so
great.
The American public needs to know that their health
professionals are prepared to handle a biological crisis, and I
want to thank you for bringing these expert witnesses before
us, and we're eager to learn how the defense and medical
communities are prepared for any attack of this nature, what
we've learned from the most recent attacks and what still needs
to be done to further prepare us accordingly.
Mr. Chairman, again I thank you for arranging these
hearings. I regret I'm going to have to run to another hearing,
and I'll try to return as quickly as possible. Thank you, Mr.
Chairman.
Mr. Burton. Thank you, Mr. Gilman.
And now we'll hear from Dr. Meyerhoff.
Dr. Meyerhoff. Thank you. I am here to answer questions,
and I am joined by Dr. William Eagan, also from FDA.
Mr. Burton. OK. So you're prepared to answer questions, but
you don't have a statement?
Dr. Meyerhoff. That's right.
Mr. Burton. OK. Fine. Let me start off with General Parker.
In your written testimony, you reference that the
Department uses passive and active countermeasures to protect
our troops, and you mentioned pretreatments, therapies, timely
detectors and effective protective equipment. During our
previous committee hearings we had last year, we learned that
DOD had to recall most of their protective gear and masks. Has
all this gear been replaced?
General Parker. Mr. Chairman, respectfully, I'd asked to
come back to the answer with that question.
Mr. Burton. OK.
General Parker. I am not in that part of the world to
acquire garments and masks, but I will answer that question off
the record.
Mr. Burton. OK. If you could have somebody get that back.
General Parker. I will.
Mr. Burton. OK. We know there are numerous potential
biological terrorist agents--anthrax, smallpox, Q-fever,
tularemia, Ricin, cholera and plague. In your written
testimony, you mention that we only have licensed vaccines for
one biological agent, that being anthrax. However, the medical
NBC battle book, which we have here, which is given to medical
personnel states that 14 possible biological agents have
vaccines, including anthrax, cholera, plague, tularemia,
typhoid fever, Q-fever, botulism, toxin and smallpox. It also
states that seven other agents have vaccines in development.
Are all these vaccines that are mentioned in the battle
book licensed vaccines; and if not, what specific measures are
taken to advise members of the military about their
participation in human subject research?
General Parker. Sir, the vaccines mentioned other than the
anthrax vaccine have not been licensed. They fall into the
category of investigational new drugs, which means that if you
take that vaccine, it has to be under a protocol with a
principal investigator leading that protocol and informed
consent is used, of the individual.
Now, we use a lot of those vaccines in our research program
because our researchers and scientists who are dealing with
those pathogens like tularemia, plague, Rift Valley fever, a
lot of the things that you mentioned, have to be protected in
their laboratory from the agent. And we give them the
investigational new drug vaccine and follow them in our special
immunization program, but they are not fully licensed with the
FDA for use on the public.
Mr. Burton. Well, these vaccines are mentioned in this
book. If they're not ready for use by the military, why are
they mentioned?
General Parker. They're mentioned, sir, because in a
contingency or a crisis, we could invoke the protocol for those
who were infected or threatened to be infected by those agents
and make them part of the research group of the investigational
new drug. And in that particular case, we would have to go to
each individual and explain what their situation was and that
this drug was available and here's all the things that we know
about that drug or vaccine, but it is not licensed; and you
would have to be essentially a subject to a research
experiment.
Mr. Burton. In a few minutes, you're going to hear from Dr.
Wayne Jonas, a retired Army doctor who conducted research in an
Army laboratory and published and peer reviewed a scientific
journal showing that homeopathy could be utilized with
tularemia.
What have you done at Fort Detrick to capitalize on this
research?
General Parker. Mr. Chairman, I would say that we probably
have done nothing to capitalize on that research, except to
know about it.
Mr. Burton. Well, if there is a disease that the military
might be faced with and there was a published journal or paper
showing that some product was helpful or had a cure rate, why
wouldn't they check into that?
General Parker. Mr. Chairman, we pursue the use of fully
licensed or fully approved drugs under the Food and Drug
Administration for the use of our forces, to use on our forces.
And so for that particular reason, I would say to you that we
use the Food and Drug Administration as our regulating and
licensing agency, and if a product isn't in some queue with the
Food and Drug Administration, either under an investigational
new drug protocol or licensed, we don't anticipate using that
on the service members in the Department of Defense.
Mr. Burton. Homeopathy is fully licensed and regulated by
the FDA, and I guess I'm a little at a loss here. If this paper
has been published in peer-reviewed scientific journals and it
shows that this could be helpful in this particular situation,
I don't understand why the military hasn't looked at that.
You have to wait till the FDA gives its approval on that;
is that correct?
General Parker. That's correct, Mr. Chairman.
Mr. Burton. Dr. Meyerhoff, could you respond to that?
Dr. Meyerhoff. Generally, the sponsor of a product would
come to us and ask us to review the safety and efficacy data of
a particular product. We're not currently aware of any
particular homeopathic remedy for tularemia, but we would
certainly be willing to review that information if it were
brought to our attention.
Mr. Burton. Well, when something is published in a peer-
reviewed journal, scientific journal, you don't review that and
then take action on it? You wait until somebody submits it to
you?
Dr. Meyerhoff. Generally that's the way that proceeds.
Mr. Burton. That's surprising. I just don't understand why,
if it looks like there's something that's very promising and
has some very beneficial effect, why wouldn't the FDA go ahead
and take the initiative to check that out, especially if it's
published in a scientific journal?
Dr. Meyerhoff. Generally, a product is brought to our
attention by a sponsor--an individual or an organization or a
business--that is intending to manufacture or use the product;
and it's at that point that those data are presented to us, and
that's when we review them.
Mr. Burton. Do you have many homeopathic, or remedies like
that, that are brought to you, other than, say, it's things
that are brought to you by pharmaceutical companies?
Dr. Meyerhoff. I'm not aware of any.
Mr. Burton. So unless it's brought to you by a
pharmaceutical company, you normally don't take action on it?
Dr. Meyerhoff. No. A product could be sponsored by any
number of potential organizations or individuals, academic
investigators, other government agencies or a pharmaceutical
company.
Mr. Burton. But, in fact, you don't know of any that have
been sponsored, other than by pharmaceutical companies?
Dr. Meyerhoff. Perhaps I misunderstood your question. I'm
not aware of any homeopathic remedies for that----
Mr. Burton. That have been licensed by you?
Dr. Meyerhoff. That's correct.
Mr. Burton. So unless it was submitted by a pharmaceutical
company, you probably wouldn't have taken any action on it?
Dr. Meyerhoff. A pharmaceutical company or an academic
investigator or----
Mr. Burton. Well, has there been any academic
investigations on homeopathic remedies that have been brought
to you?
Dr. Meyerhoff. No. I'm not aware of any.
Mr. Burton. Oh, OK.
Do you have any questions? Mr. Kucinich.
Mr. Kucinich. First of all, I want to thank the Chair for
his ongoing interest in trying to advance the cause of humanity
by making sure that people are aware of emerging practices in
health care and making people aware of broader choices in
health care and offering the possibility of increasing public
awareness of other than allopathic practices.
I think the chairman did you a service, and I want to
congratulate him for that. I'd also like to continue to pursue
the line of questioning, perhaps with Dr. Meyerhoff.
Is it of interest to the FDA or to you that there may be
alternative or complementary approaches to medicine that may
provide relief under certain circumstances to people who are
affected by a wide range of diseases, some of which might be
connected to a biological event?
Dr. Meyerhoff. Yes, it is, and we would be very willing to
look at those data.
Mr. Kucinich. You just haven't done it yet, because the
question hasn't really arisen. Is that----
Dr. Meyerhoff. That's correct.
Mr. Kucinich. But you're not averse to considering the
possibilities of alternative medicine to deal with any
particular health crisis that would confront the American
people?
Dr. Meyerhoff. That's true. We would be happy to review any
data that's presented to us for either safety or efficacy.
Mr. Kucinich. Now, your role is just--you've mentioned it
several times--happy to review any data. Do you ever initiate
any study or initiate any action in a search for alternatives,
or are you pretty much bound by medicine as it's described by
allopathic practitioners and pharmaceutical companies?
Dr. Meyerhoff. As a regulatory agency, there is a limit to
how much we can get involved in the actual development of a
product, and generally the process is that the developer comes
to us and presents the data so that we can review it. There is
a potential for conflict of interest if we go out and
participate in the development.
Mr. Kucinich. I understand that, but aside--you know, if
we're talking product, we're talking pharmaceuticals. What
about a practice as opposed to a product? What about an
approach to medicine itself that--apart from a particular
product, I'm asking you. I mean, what's your view of that?
Dr. Meyerhoff. I'm sorry. Could you repeat the question?
I'm having a little trouble hearing you.
Mr. Kucinich. What I'm asking is, when you speak of a
product, you're speaking, I suppose, of pharmaceuticals. And I
understand that the FDA has to, through the procedure of
clinical trials, keep a distance from something until it proves
itself.
Now, as the chairman pointed out, there are many peer-
reviewed articles which derive from complementary and
alternative practices. Does the FDA do anything to publicize,
encourage, bring forward, let the public know or anything like
that to let people know they have other choices; or are you
pretty much bound by what we would know as conventional
medicine?
I'm trying to find out about your scope here.
Dr. Meyerhoff. OK. We're focused on the approval of
products, whatever those products might be. Certainly when
we're looking at some of these more unusual diseases that are
presented to us by bioterrorism threats, we maintain an open-
minded stance about what might be appropriate remedies for
them.
Mr. Kucinich. Thank you, Doctor.
If I could ask, before I'm finished here--Dr. Straus, I
looked at your testimony carefully, which takes in a way a
common-sense approach saying, look, if we're in a bioterrorism
incident, we certainly want to use time-tested measures to
treat the general public; and I think most of us would agree
with that.
As the Director of the National Center for Complementary
and Alternative Medicine, are you prepared to bring forward
alternatives which may provide for efficient treatment of some
of the bioterrorist episodes we may have that may even be less
expensive, let's say, than the pharmaceuticals which are
currently being prescribed? Do such, to your knowledge,
products exist, or are you--is it simply your position that
there really are no other alternatives than what we have
conventionally?
Dr. Straus. Mr. Kucinich, NCCAM solicits and funds
meritorious research applications in a very wide range of
areas. We are specifically looking for complementary and
alternative approaches to neurological disorders, to cancer, to
arthritis, mental health conditions and infectious diseases. We
are funding studies related to HIV/AIDS, respiratory
infections, influenza, hepatitis and several others. And we
would be happy to receive and consider applications that come
through the new initiatives that Dr. Heilman indicated from the
NIH or through any other mechanism as a priority.
We have had no such applications, and in the absence of
what I would consider to be fairly good evidence that something
is safe and effective and does not interfere with other safe
and effective therapies, I would be loathe to deploy them.
I do think that bioterror-weapon infections are a special
case because of their rapidity of action, their virulence and
their spread; and I think we must be more cautious with issues
of public health in this setting than for many other disorders
in which complementary and alternative medicines may have far
more to offer--disorders of a more chronic nature, where the
capacity to retain people's dignity and comfort, to reduce
pain, to improve their nutritional status, to fight off
opportunistic infections and things like that--all make a great
deal of sense.
Mr. Kucinich. Well, Mr. Chairman, I want to thank you, and
I just want to address the Chair in saying that, you know, we
hear reports that if we were to be subject, God forbid, to one
kind of biological terrorism or another, that perhaps the
vaccines may not be available, you know, in quantity, all
right; and I would think that it might be helpful for the
National Center for Complementary and Alternative Medicine to
have plan B ready, plan A being unwavering trust, ``in the
currently approved drugs and vaccines;'' plan B, alternative
and complementary medical approaches that in an emergency might
help save lives. And I think that's the spirit in which the
Chair proceeds here.
And I thank you, Mr. Chairman. I thank the gentleman.
Mr. Burton. Thank you, Mr. Kucinich.
Mrs. Morella.
Mrs. Morella. Thank you. Thank you, Mr. Chairman. I ask
unanimous consent that my opening statement be included in the
record.
Mr. Burton. Without objection.
Mrs. Morella. I appreciate your calling this hearing and
the series of hearings that you've been very interested in, and
that has helped us all. It has become clear to us all that
while the threat of bioterrorism is significant, it can be
overcome with knowledge, good planning. We need a coordinated
civil defense, a robust, prepared public health system and
further development and research into current and future
therapies. We need to integrate our hospital, our response
system, increase our stockpiles of medicines and vaccines and
recruit and train more first responders.
So today's hearing is pointing out to us medicinal
treatments that are most effective and what new ones should be
developed.
[The prepared statement of Hon. Constance A. Morella
follows:]
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Mrs. Morella. My first question is to Dr. Meyerhoff. Two
weeks ago, Dr. Frank Young, remember him, he was an FDA
Administrator? He testified in front of the Science Committee,
of which I am also a member, and he mentioned some so-called
``urgent recommendations.'' One of these recommendations was
for Congress to finalize the proposed FDA regulations whereby
new drug and biological products used to reduce or prevent
toxicity from chemical, biological and nuclear substances could
be approved, even though the traditional efficacy studies in
humans are not feasible and cannot be ethically conducted under
FDA's regulations for adequate and well-controlled studies in
humans.
I would agree with the agency that this is necessary to
protect, or treat individuals that are exposed to lethal or
permanently disabling toxic substances, even when human studies
have not and cannot be performed. But presently, are there
treatments available that would help someone affected by a
chemical or biological agent that could not be used because of
the present regulations? Is this regulation familiar to you?
Dr. Meyerhoff. Yes, it is. If I understand your question,
you are asking if there are current remedies available that are
not permissible to use because----
Mrs. Morella. In other words, is that recommendation valid
in its premise, as well as then I'm going to ask you if you
think that Congress should be moving on this.
Dr. Meyerhoff. OK. That regulation is designed to
facilitate the development of the products that you describe,
for rare diseases and diseases that can't ethically be studied
in humans. There are a number of products available for use in
humans who have been exposed to a biological or a chemical or a
nuclear agent. Some of them are proved. Some of them would be
available under the IND, or Investigational New Drug,
regulations. Right now I can't think off the top of my head of
anything that is not usable because the animal efficacy rule is
not finalized.
Mrs. Morella. If Congress did not finalize these
regulations, would it seriously hamper our ability to provide
treatment to those who suffer from a chemical or biological or
nuclear agent?
Dr. Meyerhoff. Well, the use of an animal model to
demonstrate drug or vaccine efficacy is certainly a critical
piece of the development of these types of products that can't
be studied in humans for the efficacy piece of their
development.
Mrs. Morella. Would any of the other members of the panel
like to comment on that? Do you have any problems with that
idea, General?
General Parker. Yes, I would. The support and the passage
of a good surrogate model rule for the FDA is critical in these
weapons of mass destruction, because it would be unethical to
expose human beings to any of these agents that we call the
threats, because of the severe effects they have on a human
being. Bioethics wouldn't even allow us to approach an
individual and ask them for informed consent because of the
voracity of these diseases and the potential to kill.
So I support the FDA in exploring a way to license drugs
through a surrogate model, and I think they're trying to do
that very carefully and in a correct way, but we all want it
yesterday.
Mrs. Morella. Right. Did anyone else want to comment on it?
I guess not.
Dr. Young also discussed the need for just-in-time immune
therapies to treat potential threat agents. Does anyone have
any comments on that? Dr. Meyerhoff.
Dr. Meyerhoff. I'm not sure I'm familiar with the type of
agent you're referring to. Could you give a little bit more
information on it?
Mrs. Morella. Well, it would be the--I guess those
therapies that you would just--as you see the incident occur,
that you would be using it at that time so it hasn't gone
through the whole approval process. I will get you more
information on that. I can get you part of the testimony that
he presented. It might be very helpful for us to have you look
at some of his recommendations.
Dr. Meyerhoff. OK.
Mrs. Morella. From your experience point of view. He hasn't
called me on time yet.
General Parker, it's my understanding that there aren't
nearly enough field hospitals that can be used in the case of
mass casualty management within the DOD. DOD, I understand, has
only five such units, and the equipment is lacking to meet the
civilian need. Are you aware of anything that's being done to
address this situation, sir?
General Parker. You spoke to a field hospital? I think you
said field hospital.
Mrs. Morella. Yes.
General Parker. The Secretary of Defense has quite a bit of
capability from the standpoint of hospitals that are built by
the Services, Army, Navy and Air Force and the Marine Corps,
and he has stated publicly that the Department of Defense
stands by to support the homeland security and homeland defense
with all of the Defense Department's capabilities. I would say
that the capability to field combat support hospitals, field
surgical teams, ambulatory medical units is quite robust, and
stands by to support local government and State government and
Federal Government in the event of need.
Mrs. Morella. So your answer is that you don't have any
concern that these needs would be addressed?
General Parker. I don't have any concern. If the Federal
Government or an agency turned to the Secretary of Defense and
said we need help, I'm sure he would leverage his capability.
Considering we have a campaign going on right now----
Mrs. Morella. Yes.
General Parker [continuing]. I'd think he'd want to hold a
little in reserves so we wouldn't have any service members in
jeopardy as they fight the Nation's wars and work on this
campaign, but he would also have residual capability to help
the Nation.
Mrs. Morella. I think your trust is probably well founded.
Thank you.
Thank you, Mr. Chairman.
Mr. Burton. Thank you, Mrs. Morella.
You know, General, in previous hearings that we've had, DOD
experts have testified that we had to vaccinate with the
current anthrax vaccine because if there was an exposure to
anthrax spores, the military wouldn't be able to or shouldn't
be giving all of the troops battlefield antibiotics, because it
will leave them unable to fight. What would be the side effects
of battlefield antibiotics in lieu of giving them preventative
anthrax vaccines?
General Parker. Well, sir, if they were immunized via
vaccine, we wouldn't have to have a daily regimen of giving an
antibiotic----
Mr. Burton. Well, right now the Bioport Co. is not
delivering the vaccine, because there's been a number of
problems, as you know, and the complete regimen of vaccines has
not been given to all the military. Some of them have received
it and some of them have not. Let's say we had a battlefield
situation where anthrax was sprayed by an airplane over a whole
battlefield contingency and they had not been vaccinated, or if
they had been vaccinated they hadn't received the complete
regimen of the vaccinations. What would be the problem with
giving them the antibiotics to fight that?
General Parker. None, sir, and we would do that, because
they were threatened, and we'd have credible evidence that they
were exposed. We would in fact treat them as exposed at this
present time.
Mr. Burton. What would that do to the fighting force? What
kind of incapacity would be involved?
General Parker. Well, sir, you eloquently stated the side
effects in your opening statement of a drug like Ciprofloxacin.
Mr. Burton. Right.
General Parker. I don't know how many people in this room
have taken an antibiotic for any length of time, but just the
compliance of taking something every day is one aspect of that.
The second thing is, it doesn't make you feel good on a day-to-
day basis. You're taking an antibiotic, and it has an effect on
the system. Now, all the people don't respond the same way. I
mean, maybe 80 percent of the people could probably take this
and they wouldn't have a problem at all, but 20 percent would
probably have a problem, and it would be serious enough that it
would worry them and they wouldn't be at full capacity to fight
our Nation's wars.
Mr. Burton. Now, the side effects of the anthrax vaccine
that have been pretty severe in a number of cases, you think
that's a fair tradeoff, though, rather than going with the
antibiotics in the event of exposure?
General Parker. Mr. Chairman, I personally feel that that's
a good tradeoff, compared to the risk of contracting anthrax or
the pulmonary anthrax----
Mr. Burton. No. I understand that, but I mean the
vaccination of--you think would be preferable to giving
battlefield antibiotics in the event of an exposure?
General Parker. Mr. Chairman, I do.
Mr. Burton. Dr. Straus, do you think there are
complementary therapies that can improve a person's immune
response and if so, can you give us examples of those?
Dr. Straus. There are complementary therapies that are said
to improve people's immune responses and there have been
laboratory assays showing changes in lymphocyte and other kinds
of white cell responses to animals or people who have been
placed on some of those. Echinacea is a common herb in which
that is stated to be the case. What we don't know is whether
the changes that had been measured in the clinical studies or
in the laboratory models are of such a nature as to be
clinically meaningful, and for that reason we are currently
funding large prospective studies of echinacea for volunteers
being challenged with respiratory virus infections and people
who casually acquire these infections to see whether it would
make a difference in the course of the illness. An important
belief, among those who use complementary medicine, is that
echinacea boosts immunity. Our responsibility, one that we're
taking seriously, is to find out whether that's true and
whether it's to a meaningful extent.
Mr. Burton. And how long does a study like that take?
Dr. Straus. It depends on the studies. Most of them take at
least 2 years.
Mr. Burton. Now, is that the only one that you know of
that's being studied right now, or are there others?
Dr. Straus. There are other approaches that are said to
affect the immune system, various mind and body techniques,
relaxation and meditation techniques.
Mr. Burton. I know, but other things that you can--dietary
supplements that can be taken that might help, like zinc or
Vitamin C or those sort of things? Have there been studies on
those?
Dr. Straus. There have been studies of zinc and Vitamin C.
There have been conflicting studies of outcomes in colds, as
well as studies of immunologic effects of zinc. Some have been
positive. Some have been negative. There have been many more
studies of Vitamin C in the aggregate. There's no good evidence
that Vitamin C boosts one's measurable immune response, and its
effect on colds themselves is in the aggregate a very small
one. Of all the studies combined, Vitamin C is said to have
perhaps a 9 or 10 percent difference in rate of resolution of a
cold, though we don't know whether that's because of a
biochemical effect or whether it's working through the immune
system, per se.
Mr. Burton. You know, I talked to Dr. Linus Pauling before
he died, who won two Nobel prizes, one for scientific research,
and he was convinced that Vitamin C had tremendous positive
effects on a whole host of things, and his research he said had
shown that. Have you ever looked at any of his documents?
Dr. Straus. Of course. When I was a medical student, I read
his book, Vitamin C and the Common Cold. I've read many of the
papers that he's published in the field. I've reviewed the
literature on Vitamin C and the cold. There have been many----
Mr. Burton. I'm not just talking about the----
Dr. Straus [continuing]. Large studies. In addition, there
are studies suggesting that Vitamin C and other antioxidants,
nutritional supplements, might be beneficial in cancer. Small
studies with oral Vitamin C have not been successful. There are
some data suggesting that if it is given intravenously one may
be able to achieve cellular levels that cannot be achieved with
oral supplements. For that reason, we're working with the
National Cancer Institute to plan a workshop at this time on
antioxidants, including Vitamin C, as adjunctive approaches to
the treatment of cancer.
Mr. Burton. Now, when would that start? I'm just curious,
because cancer is pretty prevalent in our society, you know.
Dr. Straus. Yes, of course. There was a preliminary
planning workshop. Authorities came together this past summer.
I believe the workshop is planned for later this fiscal year.
Mr. Burton. What is NCCAM doing to look at homeopathic
remedies and natural substances for infectious diseases?
Dr. Straus. Mr. Chairman, as I mentioned earlier, we are
funding several studies related to dietary approaches, mind/
body approaches and the like for HIV/AIDS, for influenza,
respiratory infections of various kinds and for various forms
of chronic hepatitis B and C infections.
Mr. Burton. In your written testimony, you appear to
discount that any complementary therapy would prove useful for
bioterrorism agents. In the cases of things like dengue fever
and tularemia, don't they offer viable options that should be
considered?
Dr. Straus. Well, there are differences between dengue
fever, which is a fatal disease in unusual circumstances when
people have been reinfected by other dengue types. There is an
epidemic in Hawaii right now.
Mr. Burton. Right.
Dr. Straus. And most people really recover quite well from
dengue. Tularemia is a more virulent and explosive infection
for which there are very good antibiotics that are quite
effective. I fully support the notion of exploring any option
from any background, doing so in the context of good science,
and I would argue that before I would wish to displace an
antibiotic treatment for tularemia, I would like to see serial
animal model studies suggesting that the therapy is active.
Mr. Burton. Well, we understand the antibiotics are
effective, but one of the concerns that we have in some of
these other diseases is that you might have a huge run on
antibiotics in a given area and they may not be ready
available. Now, hopefully they would be, and in that particular
case, is it not logical to look at alternatives in the event
that should occur?
Dr. Straus. I think it would be logical to determine
whether alternative medicines would provide adequate clinical
preventative and therapeutic effect. If our national response
was such that we could not deliver enough antibiotics, it would
be problematic to give some of our populace therapies which are
untested and unproven and let others have the tested and proven
therapies.
Mr. Burton. No. I understand, but if there are therapies,
homeopathic remedies and so forth, that have had success or
there's alleged successes, why are those not being looked into
as an adjunct to antibiotics in the event that that would
occur?
Dr. Straus. Right. I would have no problem funding studies
of homeopathic regimens. Dr. Jonas is here and is far more an
expert in homeopathy than I am, but if he or someone else
wished to investigate the small studies suggesting a 20 percent
overall improvement with homeopathy as compared with 100
percent improvement with the tularemia vaccine, that certainly
could be addressed. NCCAM has no reluctance to receive or fund
studies that are well-designed and can answer the question in a
way that will benefit American public health.
Mr. Burton. You know, in a number of other countries, there
have been therapies that have been used in the past for
centuries that have been believed to have been very, very
effective in dealing with a number of diseases and problems, in
China and India in particular. Has your organization done much
to collect the existing data from countries like India and
China and conduct trials on some of those things that they have
used these remedies for?
Dr. Straus. Yes, Mr. Chairman. This is a small planet
today, and the American melting pot has brought experts in
these therapies to our shores. We have many investigators who
are exploring Ayurvedic and traditional Chinese approaches to
many diseases. In addition, we've reached out abroad. This very
day we are holding a workshop with the National University in
Singapore in which we've invited investigators throughout Asia
to come together and talk about opportunities for research
funding through the NIH. In addition, I have met personally
with the Minister of Traditional Medicine of India, and we have
been planning with them a workshop in India to bring American
investigators to India to meet with investigators and
practitioners of Ayurvedic medicine to discuss research
opportunities.
We have had some such investigators here, and we have
discussed, in collaboration with the National Cancer Institute,
funding a study of a homeopathic approach to cancer in
Calcutta.
Mr. Burton. Mrs. Morella, do you have more questions?
Mrs. Morella. Oh, thank you. I do. This could be directed
to any of you on the panel. I know that developing medical
countermeasures to disease historically has been a very long
process. The estimate is it's taken anywhere from 12 to 14
years. Today recombinant DNA techniques and other
biotechnologies are reducing the total development time and
allowing improvement of existing vaccines, treatments and
diagnostic methods. My question is how significantly has the
development time been reduced, and are there any more
biotechnologies on the horizon that would further reduce the
time needed to produce these countermeasures? Are there any
vaccines or treatments that might be available soon?
Ms. Heilman. I'd like to answer that. You are correct in
that there are a number of approaches that are new that would
allow for, for example, insertion of genes into a platform, and
so the possibility of having a compendium of genes that you can
simply insert in when you do have a problem is a reality.
The problem that we do face is getting from that stage into
the next stage, and that's getting products that have been
approved for use in humans and then getting the information
about how these products actually work in humans. Those steps
are still long steps that one needs to take in order to assure,
before you can even use the product under an investigational
new drug status, that it actually has some potential value. So
although the time on basic research is cut short, there is a
long road that needs to be taken in order to be able to use the
products in humans.
Mrs. Morella. I might jump into a followup question and
allow anyone else who wants to comment. The development process
is guided, as you are suggesting, by a whole series of reviews,
scientific, clinical, regulatory, to assure the product's
safety and efficacy, and all of the research at USAMRIID is
performed in full compliance with Federal guidelines and
regulations, including FDA, NIH, the Centers for Disease
Control and Prevention, the Department of Agriculture, the
Nuclear Regulatory Commission, the Environmental Protection
Agency, the Occupational Health and Safety Administration.
Does this process significantly slow product development?
And it sounds like it probably would. And if you agree, is
there anything that we can do to further coordinate compliance?
For instance, has the Office of Homeland Security looked into
the process at this point?
Anyone want to comment about the process and what could be
done for better coordination if you feel it's necessary? Dr.
Meyerhoff.
Dr. Meyerhoff. There are certain points in the product
development process where as a regulatory agency FDA seeks to
streamline or make more efficient that process, and some of the
points I would cite would include very early dialog with
developers at the period that we would call the pre-IND phase;
that is, as the developers, thinking about moving into human
trials, we encourage them to come to us for regulatory guidance
that often can streamline the process.
As the development process goes on, there are points later
on where products can be made available under what we would
call a treatment IND or an emergency IND. That is prior to the
formal approval, but if there is a certain amount of data or a
certain body of data that has been developed that suggests
safety and some efficacy, products can be made available that
way.
Later on when a formal application is made for marketing
approval and comes to us for review, there are a number of ways
that can be expedited, such as the accelerated approval
process. There are ways that developers can present their work
to us in what we call a rolling fashion, where as it's ready,
it goes to FDA and we review it as a rolling submission. When a
product is demonstrated to have a particular public health
need, we can commit to an expedited review clock, where we will
perform the review and render a decision more quickly than we
normally would on the standard review clock.
So there are a number of points in the development process,
where as the regulatory agency, FDA would seek to streamline
that process and make it more efficient.
Mrs. Morella. Anyone else want to comment on it? Dr.
Straus?
Dr. Straus. Mrs. Morella, I'm not a regulator, but I've
been a clinical investigator for 22 years. We have an
extraordinary series of tensions that play upon us. We have not
only the usual high responsibility of not harming our patients
that we have as physicians in general, but we have the added
burden of not imposing additional harm to people who are not
sick in the conduct of research. This august body has held
hearings in recent years about potential risks of doing
research, and here we are challenged at a time of a great
national emergency to respond, but yet our responsibilities to
each individual person who would be a research subject remains
the same. It's hard to overlook that responsibility.
Mrs. Morella. That was a very good answer. So it sounds
like you're trying to say, you can expedite when necessary, but
you haven't really approached the fact that there may still be
a cumbersome process that could well be coordinated. At least
I've always felt that way.
Thank you very much. Thank you, Mr. Chairman.
Mr. Burton. Thank you, Mrs. Morella.
Ms. Watson, do you have any questions?
Thank you.
Let me just say that Tommy Thompson, the head of HHS, has
indicated that we would have something like 12 million
vaccinations for smallpox. Is that correct? I think that's
correct, isn't it, 12 million?
Ms. Heilman. It's actually 15 million.
Mr. Burton. 15 million. We have 240 some million people in
America right now. If we had a massive outbreak of smallpox
through a terrorist attack of some kind and it was spreading,
that might not be sufficient.
Have we looked at any other approaches for the population
that would not be vaccinated to deal with that tragedy so they
would not come down with smallpox other than to get it and just
die?
Ms. Heilman. I think the only other approach that we have
taken seriously is to look at potential antivirals. We have
screened about 500 potential candidates in an animal model
system to try to identify classes of compounds that may be very
valuable in actually treating smallpox even after you have just
gotten it. One of them is cidofovir, which I mentioned before,
and although it is delivered by the IV route, and so it is a
very cumbersome as well as toxic drug, that we have actually
put in a treatment IND to the FDA so that if we were in that
horrible situation, we would have at least another option to
consider, and that is treating people with cidofovir.
Mr. Burton. But you don't know of any alternative or
homeopathic therapy that would be helpful in dealing with that?
Dr. Straus. There is a homeopathic regimen that has been
marketed on the Internet recently that's of uncertain initial
origin that has such claims, but the experts in homeopathy and
the American Association of Homeopathic Pharmacists and the
National Center of Homeopathy have declared recently in their
own literature and Web sites that they don't believe there is
any cogent data to suggest that the material works. I do
believe it is possible that there are materials out there in
our natural kingdom that may have activity inhibiting the
replication of the variola virus. They haven't been found, and
such compounds have been screened.
It is true that many products that are drugs that we use
today originated in plants, and people identify those
activities, purify their substance and prove them to be
effective. One of the recent examples is that of artemisinin,
which has been extracted from and synthesized and chemically
modified as a treatment for malaria. It was used for many
centuries in Southeast Asia for treatment of chronic and
recurring fevers without knowing of malaria as a specific
disease.
I am not aware in the literature whether there are natural
products that people have felt to be very effective against
smallpox. History is writ large with the scourge that it
represents having dessimated populations in regions in the
world that have developed some of the most robust empirical
approaches to health care, such as India and China I would say
that we as a Nation would be challenged by a mass epidemic of
smallpox, and it's not yet clear whether there are products to
meet it other than through the existing vaccines and kinds of
new drugs that NIAID-funded investigators and industry are
looking at. I would have no difficulty taking leads from
practitioners of nominating products to put into the screens to
see whether some of these were effective in mouse models of
smallpox. There would be no problem doing that in the priority
list of products that need to be screened that make the most
sense.
Mr. Burton. I appreciate that, and I think that's an open-
minded approach to it. The problem is, we are facing a
terrorist threat now, and it could happen at any time. We don't
know. We know that the threat exists, and we know how lethal it
can be. So I guess the question is there have been some claims
made, I think, by homeopathic entities. None of those that have
been claimed are being checked by our health agencies right now
as to the veracity of those claims.
Dr. Straus. I am not aware of any such activities.
Mr. Burton. So the bottom line is if we had a smallpox
epidemic right now, we would be able to take care of
approximately 15 million people. And maybe some of the people
who are vaccinated previously might have some residual immunity
because--like me, I had one when I was a child, so I probably
would have some immunity possibly. But by and large, we would
have a terrible loss of life.
Ms. Heilman. Could I just clarify, because we are indeed
doing a dilution study, and our first attempt at looking at the
dilution study at the current vaccine showed that if we diluted
it 1 to 10, we got a 70 percent take rate of the general
population. These are people who actually have not been
immunized before. So the possibility of at least making the
vaccine more broadly available and then going back and
revaccinating people within a week, for example, who did not
get a take rate, may indeed stretch the vaccine. And that is
something we are seriously looking at and considering.
Mr. Burton. I have one more question for this panel, and if
my colleagues have any, that's fine.
Dr. Ken Alibek has talked about the need to develop
vaccines or other treatments to provide nonspecific immunity.
Dr. Heilman, can you please explain his theory and what NIAID
and others are doing in this field?
Ms. Heilman. The concept of being able to in some way prime
the general immune system such that when you had an assault
such as a bioterrorist agent or some other pathogen, the immune
system would already be primed is indeed an area of a lot of
investigation. This area is much more in the basic arena at
this point in time, and the ability to translate anything into
a clinical trial to validate it is still kind of early, but
there are a number of people that are looking at ways to tweak
the immune system to keep it primed enough, but not overprimed,
to be able to be responsive quickly.
Mr. Burton. So you are looking at something that may be a
panacea for number of diseases. I would like to get one shot
instead of tons. I am sure our children would, too. Children
receive as many as 25 or 26 vaccinations before they start
school, and there has been some severe side effects with some
of those.
Ms. Watson. Just one question before the panel concludes.
Thank you so much for being here. I am just now coming in to
hear you, but I harken back to the recent death that have
occurred because of anthrax, and it seems like even describing
the classical symptoms, the healthcare providers did not or
were not able to diagnose. Are we doing a better job of trying
to train the personnel out in the hospital emergency rooms to
be able to identify these communicable diseases and
bioterrorism kinds of agents? How are we doing along that line?
I am very disturbed that they misdiagnosed and death occurred.
Ms. Heilman. I would like to respond on behalf of the
Department. This is an area that is primarily the
responsibility of the Centers for Disease Control. But I do
know there has been a lot of effort both within the Centers for
Disease Control and Prevention as well as within medical
societies, for example the Infectious Diseases Society of
America, to better train all of our physicians on how best to
diagnose. A lot of the activities within the Society have
resulted in Web pages and information that's immediately
accessible to the infectious disease community.
So I do agree with you that although we are at a point
where it is unfortunate that we weren't able to do things
immediately, the community has really rallied around the need
to be able to better inform. So I think we are in better shape
than we were.
Ms. Watson. Just this last weekend there was a panel on
which I served that went on for about 4 hours, and the main
questions coming from community-based people is how do we
recognize and how do you respond, where do we go? And so the
more information that can be given out publicly that is
accurate, that everybody is aware of--because they are calling
my office as I am sure other Members' offices when they see
baby powder on the floor of the restroom. And I had asked the
experts, how do you identify anthrax spores--well, probably
don't see them at all--and what does the powder look like? And
there was a little hesitancy to give a description. They said,
you know, call this number. Well, calling the number doesn't
give you the answers you want.
So we have a challenge there. I understand you are
developing as you go along, but please keep us well informed.
And certainly we are talking to CDC everyday, but we want to be
able to give answers out there to the general public. Thank
you.
Mr. Burton. I have a whole host of questions we would like
to submit to you for the record, and that way we won't keep you
here all day, but if you would answer those, we'd appreciate
that. Thank you very much.
If you have the opportunity to stick around, we may have
some more questions, but we understand that you have demands on
your schedule. But if you could make it, we'd appreciate it.
We'd now like to have Wayne B. Jonas, Dr. H. Reg McDaniel,
Dr. Sherwood Gorbach and Dr. Richard Klasco come to the table,
please. Would you stand, please, so we can have you sworn,
please.
[Witnesses sworn.]
Mr. Burton. Well, you have heard the testimony from the
previous panel. I hope that you will incorporate that thinking
into your opening statements, and if you choose to take issue
with some of those things, then feel free to do so. We would
like to try to get the questions as quickly as possible, so if
you have a long opening statement, if you could submit for the
record, we'd appreciate it.
Dr. Jonas.
STATEMENTS OF WAYNE B. JONAS, M.D., DIRECTOR, SAMUELI INSTITUTE
FOR INFORMATION BIOLOGY, ALEXANDRIA, VA, AND ASSOCIATE
PROFESSOR, DEPARTMENT OF FAMILY MEDICINE, UNIFORMED SERVICES
UNIVERSITY OF THE HEALTH SCIENCES, F. EDWARD HEBERT SCHOOL OF
MEDICINE; H. REG McDANIEL, M.D., DIRECTOR OF RESEARCH, FISHER
INSTITUTE OF MEDICAL RESEARCH, MEDICAL DIRECTOR, MANNATECH,
INC., GRAND PRAIRIE, TX; SHERWOOD GORBACH, M.D., TUFTS
UNIVERSITY, BOSTON, MA; AND RICHARD S. KLASCO, M.D., MEDICAL
DIRECTOR, MICROMEDEX, INC., GREENWOOD VILLAGE, CO
Dr. Jonas. Thank you very much. Mr. Chairman, before I
begin, I'd like to point out that some of the research that I
will be describing that I conduct has been supported by the
Department of Defense and the NIH, and currently is also.
Mr. Chairman and members of the committee, I want to thank
you for inviting me to testify on the potential for
nonconventional approaches to medicine and health care to the
fight against terrorism. I am a medical doctor and basic and
clinical researcher who has retired recently after more than 20
years in the military. I was Director of the Medical Research
Fellowship at Walter Reed Army Institute of Research where I
did research on bioterrorism, and I was also Director of the
Office of Alternative Medicine at the NIH where I did work on
complementary and alternative medicine. I currently direct the
Samueli Institute for Information Biology, which is a
nonprofit, freestanding research organization investigating the
biology of healing with informational and nonmolecular signals.
Those are things like homeopathy, consciousness, the placebo
effect, bioenergy, digital biology and bioelectromagnetics.
Much of what I will describe in this testimony is
controversial. Some of it has solid data to support it. Some of
it is more speculative and can only suggest directions for
research. Thus my comments will be focused mostly on practices
of potential, but not proven, use. And as we have heard
already, I agree that none should be used to substitute for
effective treatments and preventive tactics that we have
against bioterrorism.
To sort out what works from what does not, it will be
necessary to make a focused, concerted investment in research
on complementary medicine approaches to terrorism. I have been
asked by committee staff and others to comment on homeopathy,
digital biology, phototherapy, colloidal silver, essential
oils, protobiotics, herbal preparations, dietary supplements
and other complementary therapies.
Mrs. Morella. Is that all you asked him to do?
Dr. Jonas. As you can imagine, time precludes a discussion
of these; however, I have provided some information on most of
these in my written testimony.
I will focus on homeopathy, which seems to be the topic of
the day because it is a medical system that illustrates both
the potential and the scientific neglect of that potential in
bioterrorism. First let me give you some historical background
on homeopathy and low-dose effects.
The German physician Samuel Hahnemann developed homeopathy
about 200 years ago. It is based on the concept that small
doses of medicines or toxins or infectious agents for that
matter can stimulate a heating response which, when carefully
selected to match the symptoms of the disease or the illness of
the patient, then is beneficial.
It is of historical interest that the first use of a
homeopathic preparation of an infectious agent, which are
called nosodes, was done in 1830 by the German veterinarian
Gustav Louks, who reported using anthracinum, which is derived
from anthrax for the prevention of anthrax in animals. Data
collected from conventional compared to homeopathic hospitals
in the last century when it was prominent about 100 years ago
reported much lower mortality rates in homeopathic hospitals
during epidemics of smallpox, scarlet fever, yellow fever,
diphtheria, cholera and influenza.
I refer you to the testimony of Joyce Frye for a more
complete discussion of this literature, but an example of this
is a comparison done in Ohio in the 1920's of 24,000 cases of
influenza treated with conventional therapy compared to 26,000
approximately treated with homeopathy. The mortality in the
conventional was 28 percent, and the homeopathy was about 1
percent. Let me point out that these mortality differences in
epidemics historically may not be due to homeopathy because the
conventional treatments used at that time, such as bloodletting
and mercury toxicity, likely increased the mortality in
conventional hospitals. However, we should not simply discount
this information.
There are two sets of recent high-quality, double-blind
studies of relevance to biological terrorism. Three double-
blind, placebo-controlled trials have been done showing that
homeopathic remedy is safe and effective in the treatment of
influenza. And Jennifer Jacobs, an epidemiologist at the
University of Washington, has done three double-blind, placebo-
controlled trials finding homeopathy safe and effective for the
treatment of infectious diarrhea. All these data must be
considered preliminary. They are not ready for public use.
Chemical warfare might also be approached with low-dose
exposures in homeopathy. In 1994, Klaus Linde from the
University of Munich and I did an overview of all homeopathic
laboratory studies investigating prevention and treatment of
toxin exposures. Most of these studies were of poor quality,
unfortunately. However, there were two sets of good quality
studies that reported an average percent protection with high
dilutions of 19.7 percent more than controls.
It is also of historical interest in the 1940's in what was
probably the first multicenter double-blind placebo-control
study done ever, some British investigators who were fearful of
mustard gas exposure in London did a study in two sites looking
at the homeopathic preparation of mustard and whether it could
protect against mustard gas. They reported it as effective.
I spent part of my military career in Walter Reed Army
Institute of Research investigating whether homeopathic
preparations might be of use for prevention and treatment in
biological attack. One biowarfare agent I studied which has
been mentioned today is tularemia, and it is still considered a
threat. In a series of 15 laboratory experiments conducted over
2 years, my coinvestigators and I found that homeopathic
preparations of tularemia reduced the mortality of lethal
exposure to tularemia by 22 percent in mice. Now, this is less
than the 100 percent protection that is afforded by a vaccine;
however, it might offer a potentially harmless approach for
partial protection when vaccines are not available or not yet
developed.
At this point it would be irresponsible to recommend that
we use homeopathic prophylaxis in place of vaccine therapies or
say that they have been proven as a cure; however, certainly
this is an area that warrants further discussion.
More recently, our laboratory, again funded with two NIH
grants, has shown that the chemical agents may be useful for
the prevention and treatment of low-dose--of high-dose toxic
agents using homeopathy. For example, we found that low-dose
and homeopathic preparations of glutamate, diphtheria and
cyclohexamide will protect against exposure to higher doses of
these agents. We have repeatedly found that homeopathic
preparations of glutamate reduce brain injury by 40 to 50
percent, and this is published the peer review literature.
Not all toxins afford protection in low-dose or homeopathic
form. We have screened about a dozen. Some of them do not
produce this effect. There is, however, an extensive data base
in the low-dose nonhomeopathic literature called hormesis
showing that low doses stimulate autoregulatory and healing
responses in many models and in many toxins, and these should
be looked at as potential protective agents.
Mr. Chairman, members of the committee, it is a fact that
the United States has the greatest biomedical scientific
research expertise and infrastructure in the world, much of it
funded with Federal dollars. It's my opinion that it's time for
us to acknowledge that business as usual in biomedical research
is no longer adequate. Rather it is essential that we broaden
our investment into other potential avenues in the defense of
and the healing of terror.
Mr. Burton. Thank you, Dr. Jonas.
[The prepared statement of Dr. Jonas follows:]
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Mr. Burton. Dr. McDaniel.
Dr. McDaniel. Mr. Chairman and members of the House
Committee on Government Reform, it is a privilege to be asked
to appear before this panel of Members of the House, invited to
testify with the professionals and scientists chosen to address
the problems of bioterrorism.
If it were not for the passage of the Dietary Supplement
Health and Education Act of 1994 [DSHEA], my comments and
written information given to you would not exist. I as a
physician, who I might say was initially quite skeptical, now
commend the Congress for its unanimous vote that passed this
legislation.
My comments and written submission are focused on the
impact of glyconutrients, dietary sugars, not herbs or oriental
preparations, have with the human body that support and enhance
natural defense mechanisms against infectious disease. They
also are taken in support of standard therapy. Slide 1 that is
included in the packet identifies 30 scientists and 11
institutions in the United States that performed experiments on
our dietary ingredients and reported their results for peer
review. Slide 2 identifies researchers outside the United
States that have contributed to the development of clinical
applications of glyconutrition. Over 200 scientific
presentations have been made by these scientists on the
glycoscience of these micronutrients.
When research was initiated in the early 1980's, it was a
scientific heresy to represent that sugars have significant
biological roles to play in the biochemistry of life processes.
It had been incorrectly accepted that glyconutrients, known as
dietary sugars, monosaccharides, carbohydrates were simply
burned for energy to support life. Slide 3 is a collection of
journals that validate the very major role sugars play in the
structure and especially the function of the human body.
Glycobiology and glyconutrition are now recognized as cutting-
edge technology. Dietary sugars are critical components in the
molecular structure of compounds synthesized in cells that
conduct the complex and marvelous processes we call life, and
this includes protection and defense against infectious agents.
Multiple bacteria and viruses have been shown to be killed
and inactivated in cell cultures and in animals by
glyconutrients. This was done because humans claimed benefit
from this before we did the laboratory examinations. With our
limited funds, we have shown five viruses are inactivated.
Independently, Lancet in 1996 contains a review article citing
similar saccharides induced action against 37 infectious agents
classified as pathologic bacteria, viruses, fungi and
protozoans.
Evidence is expanding that supplying concentrated
micronutrients of which glyconutrients are a major category
will support relief for chronic and acute diseases in a manner
unmatched for a lack of toxicity with unparalleled low cost.
This is accomplished by nutritional support of intracellular
molecular synthesis under the control of the genetic code that,
much like a computer program, contains the instructions for the
biochemistry of life; that is, normal structure and function.
Such instructions enable appropriate recognition and response
to invading microorganisms.
How is this possible with nontoxic dietary supplements?
There is a common belief promulgated by authorities in medicine
and nutrition that all one needs for good health and healing is
a good general diet with variety. The statement may be correct
for those who are healthy. We have found it is not sufficient
for those with chronic and recurrent diseases, especially
infections. In instances of unusual, epidemic and virulent
infectious agent exposure, glyconutrient supplementation has
been found effective for enhancing general immune function and
defense. When supplied at a higher level and available in
nature, sugars needed for cellular synthesis can take innate
defense mechanisms to a much higher level that are effective
against infectious agents. The biochemical principles
responsible for this phenomenon and mechanisms of action are in
your written material.
Body defense, such as the mechanisms that act naturally
when we recover from a common cold or influenza, can now be up-
regulated to destroy virulent organisms associated with more
virulent disease. Such benefit is the result of increased
synthesis of slide 4 cell-to-cell communication molecules that
act like tiny IBM cards sent between cells to provide
instructions for destroying bacteria, viruses and other
infectious organisms. Slide 5 increasing the levels of
glyconutrients in the diet increases the synthesis of these
anti-infection molecules.
The bar graph provided is evidence of the functional
antiviral activity described. It is an example of the increase
in general defense against infectious organisms that results
when glyconutrients are progressively added to the diet.
There is a current concern for not only preventing and
destroying anthrax bacteria, but neutralizing toxins that
attack host cell membranes. Physicians have reported apparent
neutralization of bacterial toxins produced by various species
of bacteria and full recovery of patients near death. In
addition, there have been a few reports in major trauma and
postsurgical infections complicated with multiple-drug-
resistant organisms that dietary glyconutrients rendered the
patients afebrile within hours of use and shortened hospital
expected stays. Minimal morbidity occurred in patients expected
to die, based on abundant prior medical experience.
Under the provisions of DSHEA, glyconutrient formulations,
of which I am listed as a coinventor, have been marketed for
nearly 8 years. Over 750,000 people have consumed them.
Currently we estimate over 200,000 people consume our
glyconutrients daily. Several thousand have taken the
supplements continuously for 8 years. There have been no
significant toxic reactions or fatalities, and complications
have been limited to rare food allergies. This attests to the
safety of this concentrated dietary nutrient approach.
A research partnership of industry and academia, Texas A&M
University School of Veterinary Medicine and Mannatech, Inc.,
stand ready to move this research forward. If supported by the
action of Congress, experimentation on bioterrorist infectious
agents will be conducted. There is a real potential through
nutritional fortification to neutralize decades of what I would
call dark side research on the use of disease-causing agents
designed to destroy or incapacitate millions of innocent
people. Thank you.
Mr. Burton. Thank you, Dr. McDaniel.
[The prepared statement of Dr. McDaniel follows:]
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Mr. Burton. Dr. Gorbach.
Dr. Gorbach. Thank you, Mr. Chairman and members of the
committee, for your kind invitation. I am an infectious disease
physician. I am going to be talking about the use of
probiotics, which is a dietary supplement for prevention of
side effects associated with antibiotic use for prevention of
anthrax.
It's estimated that 32,000 persons are currently taking
prophylactic antibiotics for periods of 60 days for potential
exposure to anthrax in the workplace. The most commonly
prescribed drug is Cipro, which is in a class of
fluoroquinolones.
Cipro is a drug that has been used for the past 14 years in
treating over 300 million persons as out-patients and within
the hospitals. It has one of the best safety records of any
antibiotic that is used to treat serious infections.
Nevertheless, the package insert reports an incidence of 16
percent of adverse effects possibly or probably related to
taking Cipro. Extrapolating to the 32,000 taking the drug
currently, this could mean between 2,000 and 5,000 of these
people could experience side effects, and this relates to the
usual duration of treatment, 7 to 14 days. The number could be
considerably higher during a 60-day exposure.
The most common side effects of all oral antibiotics
relates to the intestinal tract, as you had stated. Nausea,
abdominal cramps, diarrhea and loose bowels are the major
complaints. It appears that antibiotics upset the normal
balance of healthy bacteria that inhabit our intestine.
Restoring these healthy bacteria and normalizing our balance is
the way to recovery from the ill effects of antibiotics.
One approach to reestablishing the normal balance is to
implant healthy bacteria by using probiotics. Many of you will
recognize these products as consisting of Lactobacilli, the
bacteria that have been used since Biblical times to make
fermented dairy products such as yogurt, sour cream and cottage
cheese. These Lactobacilli are considered dietary supplements
and are recognized by the Food and Drug Administration as
generally regarded as safe. In our country, various probiotics
are sold in the supermarkets as dairy products and over the
counter as capsules and tablets.
I developed a probiotic in 1983 which is known as
Lactobacillus GG or LGG. This product was patented in 1985 and
is sold in this country as a capsule by ConAgra by the name of
Culturelle. LGG is 1 of a family of about 15 probiotics that
are sold under various trade names in various countries. What
distinguishes LGG from other antibiotics is the record of
scientific research that has confirmed its safety and efficacy.
Over 100 publications in medical and scientific journals has
documented the beneficial effects of LGG.
In relation to this hearing, I would like to recount the
results of two published studies published in the journals
Pediatrics and the Journal of Pediatrics of preventing
antibiotics side effects with LGG. In 1999, Dr. Jon Vanderhoof
and colleagues in Omaha reported on a trial of LGG in
preventing side effects in 188 children who received
antibiotics for common respiratory infections. At the end of 10
days, 26 percent of the children who received placebo developed
diarrhea compared to only 8 percent of the LGG-treated
children, a threefold difference in diarrhea rate. Using a
similar design, a group from Tampere, Finland, also found a
threefold reduction in antibiotic-associated diarrhea.
While these reports are encouraging for using probiotics to
prevent side effects relating to antibiotics, important caveats
need to be issued with regard to the current situation of
antibiotic prescriptions for anthrax prevention. These
probiotic studies relate to antibiotics that are used in
children, generally ampicillin, amoxicillin and erythromycin,
not to Cipro, a drug that is not prescribed for children.
Indeed, we have no information about using probiotics to
prevent intestinal side effects due to Cipro. If the mechanism
of disturbing the intestinal flora holds for all antibiotics,
then probiotics, which restore normal healthy bacteria to the
intestine, might work as well with Cipro, but this remains to
be proven.
Another issue relates to the long course of Cipro usage now
recommended for 60 days. In the studies reported above, the
antibiotics were used in children for an average of 7 to 10
days. Whether the salutary benefits of LGG would persist for a
treatment period of 60 days remains to be proven.
The final point is that these reported benefits relate to
LGG, not to probiotics in general or to yogurts in general.
Each type of probiotic is somewhat different, and each one must
be compared in a clinical trial to show that it is beneficial.
In summary, Mr. Chairman, a probiotic such as LGG could
provide protection from the expected intestinal side effects
associated with antibiotic prophylaxis for anthrax exposure.
Based on published research, LGG could reduce these side
effects by two-thirds. Probiotics offer a safe, reasonably
inexpensive means to lower the rate of such adverse effects
with antibiotic usage; however, more research is needed before
these products can be recommended for wide usage.
Thank you for your attention.
Mr. Burton. Thank you, Dr. Gorbach.
[The prepared statement of Dr. Gorbach follows:]
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Mr. Burton. Dr. Klasco.
Dr. Klasco. Mr. Chairman and distinguished members of the
committee, I appreciate the opportunity to testify before you
today. I am an emergency physician and vice president of
medical affairs at Micromedex.
September 11 taught us several valuable lessons. One thing
that we learned is that America's police, firefighters and
healthcare workers deserve our very special praise. Together
with the brave men and women in the Armed Forces, they are on
the front line of this new war against terrorism.
We also learned that these agencies, and indeed every
potential American victim of biological terrorism, have an
urgent need for quick access to comprehensive and accurate
information to guide effective triage and treatment.
Mr. Chairman, I know the importance of this from my own
personal experiences as an emergency physician. In an emergency
rapid access to reliable information can in a very real sense
mean the very difference between life and death. I was on duty
in the ER during the Columbine High School shootings.
Critically wounded students arrived who had suffered gunshot
wounds to both their spinal cords and bowels. The problem that
this situation poses is that the recommended treatment for
spinal cord injury, a drug that might offer these children the
chance to walk again, seriously increases the risk of
infection, and such an infection can be a life-threatening
complication of bowel injury. To decide whether to administer
this drug, I consulted a computerized medical information data
base in the ER and was able to quickly retrieve the information
needed to provide the best possible care.
The information that I used on the day of the Columbine
shootings and many times before and since, and the computer
system that provided me access to that information is what is
known in the medical field as decision support technology. It
allows a caregiver real-time access to information that can
establish a diagnosis, suggest a treatment and in the process
improve medical outcomes.
Mr. Chairman, in the wake of recent events, it is clear
that our Nation's emergency responders could strongly benefit
from access to similar decision support technology. To meet
this need, Micromedex has been working day and night over the
past several weeks to develop BioDex, an electronic information
product delivered on a CD Rom for use in a personal computer,
and mobile BioDex, an electronic product that can be accessed
by an emergency responder at the response site via a hand-held
device.
BioDex contains comprehensive, easy-to-access information
on all of the agents likely to be used in a bioterrorist event,
including information on all of the treatable CDC category A
critical biological agents, their appropriate medical
treatments, including antidotes and drugs, and appropriate
protective clothing to ensure the safety of our healthcare
workers and first responders.
While this type of information might sound dry or academic,
anyone who has watched the recent difficulties experienced by a
myriad of public health, law enforcement and other government
officials in attempting to respond to the introduction of
anthrax into the U.S. mails knows otherwise. The importance of
quick access to information to protect public safety and to
treat victims cannot be overstated. Quite simply, BioDex can
save lives.
Mr. Chairman, Micromedex would like to partner with the
Federal Government to immediately get this crucial information
into the hands of the more than 22,000 law enforcement
agencies, 29,000 fire departments and 6,000 hospitals in the
United States. Within days and with your help, we can provide
all of those on the front lines of bioterror response with
BioDex.
Micromedex is a Colorado-based division of the Thomson
Corp. and is uniquely qualified to help these new American
heroes in carrying out their mission. We are the premier
manufacturer of medical information data bases for decision
support. For almost 30 years, Micromedex has been the reference
standard for every U.S. poison center. U.S. Military health
professionals used us for on-the-spot decision support during
Operations Desert Storm and Desert Shield. Our information
guided military healthcare workers in the diagnosis and
treatment of a variety of unusual and exotic health risks, from
the special chemicals used regularly by the military to the
poisonous snakes and plants indigenous to the area, and
prepared them for biological and chemical threats. Micromedex's
knowledge also helped the World Health Organization to diagnose
and treat the victims of the Wakayama, Japan, arsenic
poisonings.
Over 500 physicians, pharmacists and healthcare experts
from leading universities such as Harvard and Stanford make up
the Micromedex editorial board that reviews this content. With
a staff of 400, Micromedex reviews the world's literature every
day.
Mr. Chairman, accurate comprehensive medical information in
the hands of our Nation's emergency responders can strongly
improve the safety and effectiveness of any response to
biological or chemical terror. I hope that the members of this
committee can support our efforts to put this knowledge into
the hands of these individuals and entities.
Finally, Mr. Chairman, Micromedex is proud of its corporate
good citizenship. Our parent organization, the Thomson Corp.,
has already pledged $5 million to World Trade Center relief
efforts and to assist the families and loved ones of victims.
I appreciate the opportunity to testify before the
committee and will be pleased to answer any questions that you
may have.
Mr. Burton. Thank you, Dr. Klasco.
[The prepared statement of Dr. Klasco follows:]
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Mr. Burton. You know, this isn't the first time that we
have held hearings where our health agencies testify and then
we have another panel testify, and it's like you are talking to
two different worlds. The health agencies indicate that there's
one train of thought, one line of reasoning as far as dealing
with epidemics or terrorist attacks like the anthrax scare, and
then you talk to people like yourselves and you get a different
perspective, that there are other possible approaches or
complementary therapies that can be used in conjunction with
those to save lives.
So I would like to start off with a general question, and
that is, start with you, Dr. Jonas, why is there this attitude
at our health agencies that there is only one approach to use
the antibiotics, and when you are talking about complementary
or homeopathic or alternative therapies, that they are untried,
untrue and unproven, and they really don't have any desire to
go ahead and research those?
Dr. Jonas. Well, sir, I have sat on both sides prior and
this is the first time I sat on as a nongovernmental
representative, and I think there are a couple of reasons. No.
1, when you are tagged as being someone whose primary duty is
to protect the public health, then you take an
ultraconservative approach and require--or I think a more
extensive data base before one would make a public announcement
that something is useful for fear that your remarks might be
taken out of context and that they generate things that others
would criticize.
I think there is a deeper reason, however and that has to
do with belief. Montaigne said 500 years ago that there's
nothing so firmly believed as that which is least known. And I
think in these areas, a lot of the information is not known,
even by our public health officials. So we get individuals who
believe in complementary medicines and believe so strongly that
they are willing to promote them without evidence, and then we
get individuals who believe so much against them that they are
not willing to look at the evidence in an open-minded way.
Unfortunately, most of the support comes from the more
conservative, the latter side, and so the investment then in
research to try to get that information isn't forthcoming.
But I think faith and belief supplanting science and
rationale is the underlying cause, and that is not a judgment,
sir, that is an observation.
Mr. Burton. How do you bridge that kind of gap, because,
you know, there are things that have been accomplished and
proven over time that the conventional belief wouldn't listen
to. And I guess maybe this is an age-old question. I think
Pasteur faced the same thing in his day and age when he talked
about vaccinations and cleanliness and surgery and so forth.
And it gets very frustrating here especially when you are
looking at a possible terrorist threat against the United
States and limited resources to deal with some of those
terrorist threats should they occur. If we had a smallpox
epidemic right now, we would be limited to 12 to 15 million
vaccinations. What would we do with the other 230 some million
people in this country? I mean, if there are complementary and
alternative therapies that could be used to save a lot of those
lives--maybe not a large percentage of those--how do we get
that message across?
And I know this is a general question, and it's not really
scientific-related, but I am frustrated, quite frankly, because
we have had these hearings time and time and time again, and it
seems there is a narrow approach by our health agencies, and
when you talk to others in the alternative and complementary
therapies and homeopathic therapies, they have a different
view. And to get them together so we can all work together to
make sure that we have the best approach to solving these
problems is just like breaking down a wall with your fist.
Dr. Jonas. Right. I think that the government can play a
large role in this. I think an example is the Office of
Alternative Medicine and now the National Center for
Complementary and Alternative Medicine.
Mr. Burton. Let me interrupt. The gentleman who is here
from the Office of Alternative and Complementary Medicine--I
don't know if you listened to him or not, but his attitude is
very much like the rest of the attitudes at CDC and FDA. I
mean, he's got a very conservative view on complementary and
alternative therapies. And when you talk about testing some of
these things, they don't do it.
Dr. Jonas. Wouldn't you agree, Mr. Chairman, that they are
doing more than they would have without such an office? I think
that certainly is advancing the field.
I agree with you that we need a more open attitude. I
experienced a number of the pressures that he's going through
right now and how to deal with them, but I tried to maintain an
open attitude to a variety of possibilities and not simply cut
things off because I didn't think they were plausible, but to
actually look at the evidence. I think one way to do that is to
make sure that practitioners who had experiences in these areas
are an integral part of guiding those types of offices and
actually work in those types of offices. I think that is one
thing that could help.
Mr. Burton. In other words, having some people on the
advisory boards and so forth who are having input into the
leadership of those agencies so that they will look at those
alternatives.
Dr. Jonas. I think that is one approach, and also having
individuals in those offices who have those types of attitudes
who are interested in that. You wouldn't ask an orthopedic
surgeon to run an office who was doing pediatric research. You
need to have individuals that are widely supportive and widely
knowledgeable about the areas actually in charge of those
places.
Mr. Burton. I will try to get ahold of Secretary Thompson
and ask that that be done. Remind me to do that.
Comment?
Dr. McDaniel. I think Dr. Jonas hit the nail on the head
and pretty well summarized it. In some ways I think of myself
as almost an anarchist about freedom until I was elected to be
an official down in Austin for 2\1/2\ years, and all of a
sudden fiduciary responsibility for people that I don't even
know, and the all the variations that may be in the formula,
you get more personally involved when you see them and you know
what they are and you are in a situation and you feel the
pressure of it.
Even when I was hearing the officials speak during the
early phases of the AIDS epidemic, I was amazed at how bending
and yielding the FDA could be under crises and panic, and even
found out and told me, ``You could have an individual
physician--I indeed attest this--and you can start next week.''
So I was really amazed because FDA gets nothing but hell and
criticism, and some of it is well founded because human beings
like power and protection, but they are also responsible for
the regulation of poisons that get elevated to the status of
drugs. If you and I were responsible for that, we would be very
conservative, too. And if anybody doubts that, look at how many
drugs have been pulled off the market in the last 10 years
after years and millions of dollars of development, and they
had to be pulled off. They are responsible to the public to
have something safe and effective.
Another thing is about--as Dr. Jonas hit about belief, I
have found that people are very religious in terms of
developing the idea and it is right, and everybody else is
wrong, and we all got together, this is canonized and
acceptable and we followed that. And I call that the dark side
of this equation. But on the other light side, human beings can
be very spiritual and understanding and forgiving and will take
actions and break the laws and all the regulations when it
calls for it, but they usually want really good substantiation
even as an administrator in the government, but they don't like
to do it because they are held responsible for it.
I was thinking about the vaccine. If they turned something
loose, like a drug, and it works before they've done all the
regulatory tasks, they are heroes, but if it doesn't, who gets
drawn and quartered?
Mr. Burton. I understand.
That was a great defense for the FDA that you just made. It
doesn't alter the fact that there are alternative and
complementary therapies out there that are not being thoroughly
investigated, and you wonder why, because not only are they
having a different viewpoint, but there's not a lot of
investigation or clinical studies being done on alternatives
that ought to be done.
Dr. McDaniel. It takes a lot of money to do studies. I have
been trying to move up the ladder. Dr. Straus gave an excellent
interview in the JAMA--two pages. He called this pioneer
medicine, and you start with anecdotals, and you get case
series, and you work your way up. Once you get past case
series, you start getting into $500,000 to $1.2 million just
like that. And this is very demanding and difficult. And I was
taught, and the scientists that have been here, ``Where is your
double-blind placebo random-assigned crossover?'' But on the
other hand, just in the last year, the number of physicians and
even faculty members that all of a sudden wanted to know more
about this, and I couldn't imagine some of the hell I have been
through for pursuing this path off the beaten path, why they
were showing such interest, and their statement was, ``Helped
my little boy.'' ``My daughter's surgery was canceled.'' ``My
wife is alive.'' One patient was all it took to change their
attitude when they saw it themselves.
Mr. Burton. Well, therein, as Shakespeare said, lies the
rub. Do any of the other gentlemen have a comment on that?
Dr. Gorbach. I am a NIH success story. I have been funded
continuously for 35 years, and most of my salary is paid by the
NIH, so I work for the government. I have five NIH grants, but
when I put in grants--I put in three now for probiotics--they
always get turned down. So I get well-funded for my other
research, which is on nutrition and HIV, but the review panels
just don't believe in anything that isn't straight party-line
conventional therapy. Even if you present a study which is very
well designed in order to prove efficiency, they don't
acknowledge the first step that there may be some worth to
exploring the question. So I think it is a problem with the
study sessions of the NIH.
Tomorrow, I am going to a study session at the NIH. I serve
on a study session, but my colleagues just don't believe in
this type of medicine. I have to put a different hat on when I
go to the NIH, because I can't talk about probiotics. They
won't accept it.
I think the way to deal with this, Mr. Chairman, is that if
the NIH puts out what they call an RFA, if they have a request
for an application, in which that is the program that they want
to study, whether it is probiotics, homeopathy or the
carbohydrate, then the study session has to deal with the
applications, and they must give out the money that is
allocated. But if you put it into the general study sections,
these applications, I find, they just get cut up and
slaughtered.
Mr. Burton. Well, if you have suggestions, because you are
on the side that's looking at new approaches to dealing with
major problems in our health area--if you have suggestions, I'd
wish you submit those to me in writing, and we will pursue them
with the agencies and with the Secretary of HHS. This is a time
that we've never experienced before where we have terrorist
attacks and terrorist threats on the United States of America,
and while we want to make sure that we have the best science
and the best medicine, we want to make sure that we get to the
bottom of it as quickly as possible so we can protect the
largest number of people. And if there is a cemented mental
attitude about research in any of the agencies, we got to break
through that so we get as much bang for the buck and as many
results as we possibly can.
So if you have suggestions--and I hope I am making myself
clear the way I am expressing myself--if you have some
suggestions on how we can get that done, I would like to know
what they are, and I will talk to the Secretary about that.
Dr. Klasco. Mr. Chairman, much of our discussion today
focused on the use of complementary or alternative therapies as
an adjunct to stretch otherwise constrained resources to meet
the needs of 240 million people. We talked about diluting
vaccines in order to make a limited supply meet the needs of
our country, and we have talked about many other agents.
I think one of the most important ways that we can stretch
our limited resources to meet our needs is to take the
information that we already possess, put it in the hands of
those people who are going to be on the front lines, and
empower them to use our resources wisely, empower them to use
our resources for people who are actually exposed or actually
infected, and to spare the use of precious resources for those
people who turn out not to be infected.
Mr. Burton. Your comment in your opening statement was not
lost upon me, and I understand that you would like to have this
information that you produce given to the various agencies
around the country so that there is real quick access to it in
the event of an emergency, and we will see if we can figure out
a way to make sure that is done. So I want to make sure we
followup on that.
I know you have been here a long time, and I don't want to
prolong this, but there are a few questions I would like to
ask. Let me start with Dr. Jonas.
Homeopathy has been used around the world for some time.
Can you explain how it's used and the success rate in a generic
sense?
Dr. Jonas. We have looked at this in quite detail. It's
used, as you say, all around the world for a variety of
conditions. We published a med-analysis of all the clinical
research that was done in homeopathy in 1997 in the Lancet, and
the amount of research, unfortunately, wasn't large enough to
say that we can identify a specific condition in which it has
been proven safe and effective.
Subsequent to that there has been additional research that
I mentioned in my testimony that has demonstrated that, but the
overall effects did show that it was effective, about twice as
effective as placebo on average in the clinical studies.
Mr. Burton. Well, if it's twice as effective as placebo on
average, then it would have a positive impact on those who did
not benefit from other forms of prevention.
Dr. Jonas. Yes. There were two other similar summaries of
the studies that came to similar conclusions, one did not, and
there has been criticism about the statistics and the
statistical approaches on that from the conventional community
saying that it is not adequate evidence.
Mr. Burton. So there is inconsistencies, and so they are
not going to pursue any studies on that?
Dr. Jonas. Well, they are pursuing some studies of it. I
have a couple of NIH grants, and actually there are two or
three other NIH grants that I know of specifically on
homeopathy, and there is currently an RFA out in which they did
put experts in the area of homeopathy on the review panel, and
it's currently under review. That potentially could fund a
center in these areas as well as other frontier areas. So there
is some money being put into it.
Mr. Burton. You talked about digital biology. Can you
explain a little bit more about that and its potential
applications?
Dr. Jonas. Digital biology is a concept that has been
really developed by a French researcher by the name of Jacques
Benveniste who claims he has been able to digitize biological
signals and record them on a computer and then deliver them
through an electromagnetic frequency off of a wave file and
reproduce those digital effects. If this is true, and if this
is something that could be developed, then it is a technology
that possibly would allow us to detect agents as well as
possibly deliver medical treatments in an electronic format. So
it is an exciting procedure.
The Department of Defense actually is supporting some
research in one of my labs to see if we can replicate some of
those claims.
Mr. Burton. How about our health agencies, are they doing
anything on this?
Dr. Jonas. The only support of this that I know of is from
DARPA, the Defense Advanced Research Products Agency, which
funds what they consider out-of-the-box types of things. This
is one of those things that I wouldn't dare submit to a NIH
review group. It wouldn't even get the time of day.
Mr. Burton. It sounds like it is an exciting research
project.
Dr. Jonas. It's what's called a high impact, high risk.
That's the terminology that's used. I mean high risk in the
sense that if you find nothing, you have wasted your money. But
high impact, if you find something, it will revolutionize
medicine.
Mr. Burton. Do you think the White House needs a senior
domestic policy advisory on complementary medicine to
coordinate the OAM issues worldwide and governmentwide?
Dr. Jonas. Yes, I do, sir, and we are actually discussing
this on the White House commission.
Mr. Burton. You are on the commission?
Dr. Jonas. I am on the White House Commission for
Complementary Medicine, yes, and I do believe something like
this is needed. You only have to look to the success of the OAM
and the National Center for Complementary Medicine in terms of
the stimulus that they have provided in the research area.
There are many things that need to be done if we are going
to properly integrate complementary medicine into our
healthcare system, including education, licensing, technology
transfer, business issues, and a senior-level effort in those
areas I think could go a long way toward moving that forward.
Mr. Burton. Is your advisory panel going to make that
recommendation to the----
Dr. Jonas. I can't speak for them right now. It is under
discussion, but it is one of the considerations, one of the
things they are strongly considering, yes, sir.
Mr. Burton. How many people are on that advisory panel?
Dr. Jonas. There are I think 16. Has it increased--16 or
17.
Mr. Burton. Well, if you need assistance in making that
recommendation to the President and the White House, I'll be
glad to work with you on that. So if you'll let me know, we
could send a note over there to the----
Dr. Jonas. Thank you very much. As we get closer, I'll let
you know that.
Mr. Burton. OK. Dr. McDaniel, how does the public find good
information about micronutrients, and is the government
providing this information?
Dr. McDaniel. Well, it's available on various search
engines. In fact, Acta Anatomica, Volume 161-1998, out of
Switzerland, points out that with a MEDLAR search--I think that
comes out of the national library--that in that year alone,
there were over 20,000 journal articles published worldwide on
glycobiology, glyconutrition, glycoscience with a MEDLAR
search, and it doesn't require the government to disseminate
everything or do everything. I think this is a private company
that is doing the technology that we talked about. But where
the problem is in some of these out-of-the-box things is being
able to get the funds to do the research to get the type of
evidence base, because the funds are limited even for all of
the drug studies. We've got 20,000 journals in the world, and
we still haven't got all the drug studies done in a century.
And here you come up with something else outside the box. It
just doesn't get funded, as Dr. Gorbach said about, and I was
sitting here feeling--I got into all of this. I was taught all
the same things that--of the men that preceded us and the
ladies then, and I found out that prebiotics or probiotics were
very important, and I think after nutrition and the role it
plays in health and disease, that the flora in our bowel and
what it contributes to health and disease is going to be
another very common economical approach. As an addition to
energy, I would call what you were talking about, which is as
old as Oriental medicine, and we're just applying it in a more
technical, modern----
Mr. Burton. I see Dr. Jonas grabbing for the mic there.
Dr. Jonas. Sir, I just want to say that we shouldn't be
thinking that the government should be funding all of this
research. It is very expensive----
Mr. Burton. No, no. I don't think anybody has indicated
that the government should be funding it, but it seems like
there's roadblocks to some of this research.
Dr. Jonas. There are roadblocks, and one of the major
roadblocks is that there are currently few incentives for the
private sector to move into this area. The current patent
structure, the current tax incentives and these types of things
result in a very large amount of money going into standard
medical technologies and drugs and this type of thing.
Mr. Burton. Do you have recommendations on how that could
be changed?
Dr. Jonas. Well, I think that should be looked at. I think
we should look at patent laws in terms of the relation to
natural products, and how can we incentivize the private sector
to begin to invest in this. I think we should look at the FDA
regulations to create a category that will allow for approval
of products so that they don't have to spend $250 million for a
drug classification that they may not recover or tax incentives
that then would incentivize the private sector to move into
these areas.
Mr. Burton. Let me just tell you that Members of Congress--
we have 40 some members on this committee. Do you see how many
is here right now? My colleague from Ohio and I. But the thing
is we have so many things on our plate, that we can't
concentrate--there are few people who have concentrated on what
we're talking about here today, and what we need from you folks
is recommendations on how we can cut through the logjam and
solve the problem. So if you have suggestions, I implore you to
give those to us. If it's a change in our patent laws or a
suggested change or a suggested change in how research is done
on nutrients so that it's more cost effective and could be done
in the private sector or if it's a tax incentive for people to
invest in new technologies and new methodologies, we'd like to
have those, and we can make those suggestions.
Dr. Jonas. In March 2002, the White House Commission will
be providing you with a number of specific suggestions in
those----
Mr. Burton. Well, I'll look forward to that. Yes, sir?
Dr. McDaniel. I wanted to also mention another thing that I
do think is an area of government that--in response to your
first question. It is the hesitancy of people to get outside
the box or out of standard practice of medicine because of
exposure to litigation. If it works--but if it doesn't work--
and nothing works 100 percent of the time--the exposure ends
in----
Mr. Burton. Malpractice.
Dr. McDaniel [continuing]. Malpractice insurance, and they
won't even cover you if you're doing it. I know a practitioner
in Texas that got involved with some of this energy flow-type
thing, and he had to appear before the State Board of Medical
Examiners. We've had a number of incidences that I've been
involved in after DSHEA was passed that physicians, very
frustrated with patients with chronic unresponsive conditions,
found out through their patients and their own self-
administration, ``Hey, this works.'' And they tried it and
another--the next thing they knew, they were turned in by their
peers and are appearing before the State Board of Medical
Examiners. I happen to be one of those, turned in by no less
than the dean of my own medical school to defend my license for
doing this work. They found out, surprise, that I had an FDA
individual exemption to do research on it, and I had never
charged a patient a dime, which kind of tilted the machine. But
if I hadn't have had those, I would be in deep you know what.
Mr. Burton. Well, I think I understand that. These
glyconutrients that you're talking about, you know, you can't
make a medical claim on those, because if you do, then of
course there's another avenue that has to be pursued and you
could be held responsible. So you don't make those claims. But
I know in your opinion, you think they really help with a lot
of medical problems.
Dr. McDaniel. I will put it this way. The glyconutrients do
not treat, cure or mitigate any disease. They give the body,
under the control of genes, what the cells need----
Mr. Burton. I understand.
Dr. McDaniel [continuing]. To do normal structured and
function. It is not normal to be sick.
Mr. Burton. I understand.
Mr. LaTourette, do you have any questions?
Mr. LaTourette. I do, but I can wait until you're done.
Mr. Burton. I'll be through here in just 1 second. I only
have two more questions and then I'll yield to my colleague.
Mr. LaTourette. Patience is a virtue.
Mr. Burton. OK.
How much training do doctors get in medical school about
biological warfare and terrorism?
Dr. Klasco. Very little. At least during my time in medical
school, anthrax was an esoteric disease of slaughterhouse
workers. So there's a real gap. There's a knowledge gap. But
the knowledge fortunately exists. We just need to get it out
into the hands of the responders.
Mr. Burton. The gentleman from Ohio.
Mr. LaTourette. Thank you, Mr. Chairman, and I won't take
long. I appreciate all you gentlemen coming here today, and I
appreciate the fact that the chairman has these hearings on
alternative methods of looking at things. We hear from the CDC
and a lot of other people that do wonderful work, but I can
remember a hearing that the chairman had last year on autism
and some research relative to whether or not the early
childhood vaccinations may be contributing to things in a way
that people--that everybody to be vaccinated as early as
possible didn't want to hear, and I find it to be elucidating.
And I don't know whether it was you, Dr. McDaniel, or you, Dr.
Gorbach, that said that sometimes one of these cures, it's my
child--I can remember when Dr. Gorbach was going over the
antibiotics, our--my first child had horrible ear infections,
and we went through ampicillin, amoxycillin, Ceclor, and the
ear kept oozing. And finally some wonderful pediatrician came
out with a couple needles that looked like you would give it to
a horse and said, we're going to fill this with gamma globulin,
and I didn't think that this was going to be--and apparently it
was that--the introduction of gamma globulin--and I think as
I'm hearing you, Dr. McDaniel, talking about glyconutrients--
gave the body the ability to not be sick, and then she's been
fine ever since.
Dr. Jonas, I am not as smart or well versed as the chairman
is on many subjects, and if you don't believe me, you can just
ask him later, but I read your testimony about homeopathy, and
I guess I'm a little unclear. I read your observations about
influenza breakouts and other things from previous centuries.
Can you just describe for me in general--I understood taking a
small amount of medicine and inserting it--is it similar to an
inoculation where you take a portion of the disease and
reinsert it back into the person to buildup an immunity, or is
it something else?
Dr. Jonas. I guess you could say it is similar to that,
yes. However, instead of focusing on a particular peptide, as
you would in an inoculation where you're trying to get the
immune system to produce a specific antibody, what you're
trying to do is match the stimulus, the homeopathic remedy, in
a global fashion, with the entire person's response so that
they get an overall healing response. So it's the level of
focus in which you have it. You can use it, apparently, at the
level, like you might for a particular infectious agent, and
that's done in a number of countries. But the classical
homeopathic approach is really an attempt to give the body a
particular signal, a particular energetic stimuli, that it
responds completely, so it responds both mentally and
physically. And there's a very special matching process that
goes on for those that practice that type of classical
homeopathy.
But the analogy is very similar to a vaccine or very
similar to a toxin, in which if you take a little bit of the
toxin, you develop a tolerance for it, so that if you then get
a higher level of that toxin as a stressor, you'll be able to
respond to it.
Mr. LaTourette. Can you give me an example of what was used
for influenza, for instance, what was the homeopathic remedy?
Dr. Jonas. Yes. For example, there's usually about four or
five remedies that are used for influenza, depending upon the
symptoms. If someone had a type of headache in which they were
not able to move, they just had to lay on the bed but they were
very thirsty, then that matched the symptoms of a particular
remedy called baptisia, which when they had given it to healthy
people produced those kinds of symptoms. So that type of an
influenza would respond to baptisia.
If someone had a completely different type, if they were
not thirsty, for example, but were crying all the time for some
reason--sometimes that happens--had aches down a part of their
spine, that corresponds to tests that have been done with
pulsatilla in healthy people, which is another plant product,
and they would get that remedy.
Mr. LaTourette. Got you. Thank you very much.
Dr. Gorbach, you were talking about probiotics and
particularly the LGG that you were most familiar with. You
indicated that the news is encouraging on probiotics, but the
studies I think you indicated were as a result of pediatric
studies and they were 7 to 10-day courses for Cecor or
amoxycillin and those matters. And I think I heard you say that
there's a need for a clinical trial to determine whether or not
probiotics can be effective in fighting off some of the--or
diminishing the side effects from Cipro. Are any clinical
studies underway that you're aware of?
Dr. Gorbach. No. No clinical studies underway.
Mr. LaTourette. And is that because of the reluctance of
NIH and others to--I mean, have you submitted such a thing
saying that, hey, I've got this great stuff?
Dr. Gorbach. Well, I'll have to say we've only been in this
current crisis for a matter of weeks. It takes a few months
even to put together an NIH application. But besides that, I
personally am not doing research on this. It's a conflict of
interest for me, because I am an investigator, but in this case
I own the patent on it, so I rather encourage other people from
universities to do the research where I don't have a conflict
of interest, and I would hope that this issue of antibiotic
side effects with Cipro would become important enough for
others to submit applications and do research.
I help a lot of investigators, about 30 around the world,
who are doing research in various aspects, by giving advice,
but I don't feel it proper to do research of my own product
itself.
Mr. LaTourette. Got you.
Dr. Gorbach. So I hope someone else does it.
Mr. LaTourette. Well, I do, too, to tell you the truth.
And then, Dr. Klasco, you made observations about the
preservation of scarce resources, and anthrax is a pretty big
deal around Capitol Hill because of what happened at the Ford
Building and the Hart Building and other places. And there's
been sort of--even though Bayer has been, you know, kind
enough--I don't know if that's the right word, but they've
slashed their prices and others have indicated you can take
these antibiotics, there's a great deal of concern, and so you
have a lot of people taking 60-day courses of Cipro that
probably shouldn't be taking 60-day courses of Cipro.
The advice that has been generated by the Bush
administration and also by the Attending Physician here at the
Capitol is that unless you've been exposed don't run out to the
drugstore and hog up everybody's Cipro, one, because it's a
scarce resource, and, two, it may do you harm through some of
the side effects that Dr. Gorbach has been talking about.
Does everyone agree with that prudent approach by both the
administration and our Attending Physician?
Dr. Gorbach. Everyone agrees, except if you're exposed.
Mr. LaTourette. Right.
Dr. Gorbach. And then it's very difficult to persuade a
postal worker that he or she shouldn't take Cipro. So it's a
very difficult position for the physicians, the health
authorities to make that call, but the general view--I think
it's been rather conservative--do not give Cipro unless there's
an indication. I know as a physician I'm getting a lot of phone
calls from my patients to stock up on Cipro, and I have refused
to write any scripts. And the recommendations now that we're
giving and teaching to the community of physicians is if you
have someone with a potential exposure, do not write a script
yourself, but consult with the authorities to see if that
person in fact has a legitimate exposure, because otherwise--I
mean, we're already giving 32,000 courses of Cipro. But it
could get even worse.
Mr. LaTourette. Right. Dr. Klasco, is there something you
wanted to say relative to that?
Dr. Klasco. I agree with the way Dr. Gorbach just phrased
things. I would differ in one slight regard, in that health
care providers shouldn't have to look to a central authority to
guide their patient care decisions. They should be armed with
the tools that they need so that their knowledge, expertise and
training can make an informed decision in the setting of a
patient care experience.
Mr. LaTourette. Thank you. And Dr. McDaniel, last to you,
like homeopathy, I'm not real familiar with glyconutrients and,
as I understand it, they are sugar-based nutrients and I think
in your testimony you said it was heresy to suggest such things
would be beneficial in the past. And, I mean, is that rooted in
the fact that your mom said you shouldn't be eating a lot of
candy, I suppose, but I don't know that's an
oversimplification. But is the basic tenet of your research on
glyconutrients is if you increase the body's levels, it brings
you to a point where you don't have to--not that you don't have
to worry about it, but your body is better able to deal with
infection and you don't get sick. Is that where you are?
Dr. McDaniel. Except that you don't eat more candy.
Mr. LaTourette. I understand that.
Dr. McDaniel. They are sugars that aren't sweet. And
actually the business end of antibodies, the variable-end that
matches up are written in sugars. Who we are and the reason we
can't take a transplant from anyone other than an identical
twin is written on the surface of our cells in sugars. But in
the packet, you see there that the head of immunology and
allergy at the University of Health Science Center in Houston
showed in mixed culture, followed by--that showed the cytokines
which are, as I referred to them, little IBM cards, that the
various cytokines that are made to be able to identify
bacteria, yeast, tumor cells, viruses, go up on a dose-response
basis. And then it follows through, there with the 4-hour
cytolytic assay, that the natural killer cells that come out of
this will punch holes in the virus-infected cells. And I
presented a conference here in Washington that it will do the
same to tumor cells. It puts holes in them. So these are used.
But they're not complex--you know more about this problem than
you think you do. I do a lot of lecturing. Everyone knows the
difference in taste of vine-ripened tomatoes versus those
picked green, shipped across the country, allowed to turn red;
you take them home in great anticipation and they're tasteless
red mush. We've plowed up our gardens, chopped down our
orchards, insulted many of the things that have come to our
table.
Our work started with aloe vera. Why have human beings been
using aloe vera for over 5,000 years? And we found out with
cooperation of work and a review done at Washington University
in St. Louis that in the endoplasmic reticulum, you need nine
molecules of the sugar that is in the aloe gel to start the
synthesis of these cytokines, or the little IBM cards.
Why that is so important? We raise it by the tons in the
rice patties of Louisiana and Texas, through the grain fields
up to Canada, but on the way to our table, what do we get?
White flour and white rice, and you strip that sugar out,
making white flour and white rice, creating a deficiency such
that when you add it back from the aloe plant, people say,
``It's a miracle; look what happened.'' It is not a miracle. It
is correcting the supply of sugars that are missing from our
diet that we have to have, and that happens to be a very
critical one in the endoplasmic reticulum.
Mr. LaTourette. Well, I thank you very much for that
explanation, and, again, I thank you all for your work. I thank
you for your testimony before the committee. And I guess I was
more hopeful that I could leave here, Dr. McDaniel, and
indicate to people that said that Dr. McDaniel has indicated I
had to eat that extra Kitkat or whatever, but I appreciate your
research very much. And thank you, Mr. Chairman.
Mr. Burton. And I want you to know that there are very few
areas where I have more knowledge than the gentleman from Ohio,
except possibly in postal reform. We have a big difference of
opinion on postal reform, which I'm sure would be of little
interest to any of you.
Let me just end up by saying I really appreciate your being
here, and I meant sincerely what I said, that if you have input
that you'd like to give to us on--or suggestions on how to make
things better for research in these homeopathic and alternative
and complementary therapies, we would like to do it.
I would like to talk to you about getting this information
to Mr. Thompson, and then I appreciate very much you being
here. We stand adjourned.
[Whereupon, at 4:37 p.m., the committee was adjourned.]
[The prepared statement of Hon. Wm. Lacy Clay and
additional information submitted for the hearing record
follows:]
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