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[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

                        U.S. GOVERNMENT PRINTING OFFICE
77-497                          WASHINGTON : 2002
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512-1800  
Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001

                     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:]
[GRAPHIC] [TIFF OMITTED] T7497.060

    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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