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COMPREHENSIVE MEDICAL CARE FOR BIOTERRORISM EXPOSURE—ARE WE MAKING EVIDENCEDBASED 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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

BOB BARR, Georgia

DAN MILLER, Florida

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, Tennessee

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

———

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

(III)

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

(1)

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.

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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 advoVerDate 11-MAY-2000 10:47 Mar 20, 2002 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\DOCS\77497.TXT HGOVREF1 PsN: HGOVREF1
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cate 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.

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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

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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,

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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

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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. Agentspecific 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 laboratoryacquired 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.

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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.

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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

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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

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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 highthreat 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,

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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 AdminisVerDate 11-MAY-2000 10:47 Mar 20, 2002 Jkt 000000 PO 00000 Frm 00060 Fmt 6633 Sfmt 6633 C:\DOCS\77497.TXT HGOVREF1 PsN: HGOVREF1
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tration, 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.

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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.

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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.

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Mrs. Morella.

Mrs. MORELLA. Thank you. Thank you, Mr. Chairman. I ask

unanimous consent that my opening statement be included in the

record.

Mr. BURTON. Without objection.

Mrs. MORELLA. I appreciate your calling this hearing and the series of hearings that you’ve been very interested in, and that has

helped us all. It has become clear to us all that while the threat

of bioterrorism is significant, it can be overcome with knowledge,

good planning. We need a coordinated civil defense, a robust, prepared public health system and further development and research

into current and future therapies. We need to integrate our hospital, our response system, increase our stockpiles of medicines and

vaccines and recruit and train more first responders.

So today’s hearing is pointing out to us medicinal treatments

that are most effective and what new ones should be developed.

[The prepared statement of Hon. Constance A. Morella follows:]

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Mrs. MORELLA. My first question is to Dr. Meyerhoff. Two weeks

ago, Dr. Frank Young, remember him, he was an FDA Administrator? He testified in front of the Science Committee, of which I

am also a member, and he mentioned some so-called ‘‘urgent recommendations.’’ One of these recommendations was for Congress to

finalize the proposed FDA regulations whereby new drug and biological products used to reduce or prevent toxicity from chemical,

biological and nuclear substances could be approved, even though

the traditional efficacy studies in humans are not feasible and cannot be ethically conducted under FDA’s regulations for adequate

and well-controlled studies in humans.

I would agree with the agency that this is necessary to protect,

or treat individuals that are exposed to lethal or permanently disabling toxic substances, even when human studies have not and

cannot be performed. But presently, are there treatments available

that would help someone affected by a chemical or biological agent

that could not be used because of the present regulations? Is this

regulation familiar to you?

Dr. MEYERHOFF. Yes, it is. If I understand your question, you are

asking if there are current remedies available that are not permissible to use because—— Mrs. MORELLA. In other words, is that recommendation valid in

its premise, as well as then I’m going to ask you if you think that

Congress should be moving on this.

Dr. MEYERHOFF. OK. That regulation is designed to facilitate the

development of the products that you describe, for rare diseases

and diseases that can’t ethically be studied in humans. There are

a number of products available for use in humans who have been

exposed to a biological or a chemical or a nuclear agent. Some of

them are proved. Some of them would be available under the IND,

or Investigational New Drug, regulations. Right now I can’t think

off the top of my head of anything that is not usable because the

animal efficacy rule is not finalized.

Mrs. MORELLA. If Congress did not finalize these regulations,

would it seriously hamper our ability to provide treatment to those

who suffer from a chemical or biological or nuclear agent?

Dr. MEYERHOFF. Well, the use of an animal model to demonstrate drug or vaccine efficacy is certainly a critical piece of the

development of these types of products that can’t be studied in humans for the efficacy piece of their development.

Mrs. MORELLA. Would any of the other members of the panel like

to comment on that? Do you have any problems with that idea,

General?

General PARKER. Yes, I would. The support and the passage of

a good surrogate model rule for the FDA is critical in these weapons of mass destruction, because it would be unethical to expose

human beings to any of these agents that we call the threats, because of the severe effects they have on a human being. Bioethics

wouldn’t even allow us to approach an individual and ask them for

informed consent because of the voracity of these diseases and the

potential to kill.

So I support the FDA in exploring a way to license drugs through

a surrogate model, and I think they’re trying to do that very carefully and in a correct way, but we all want it yesterday.

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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,

64

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

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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.

66

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

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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 DeVerDate 11-MAY-2000 10:47 Mar 20, 2002 Jkt 000000 PO 00000 Frm 00071 Fmt 6633 Sfmt 6633 C:\DOCS\77497.TXT HGOVREF1 PsN: HGOVREF1
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partment 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 cumVerDate 11-MAY-2000 10:47 Mar 20, 2002 Jkt 000000 PO 00000 Frm 00072 Fmt 6633 Sfmt 6633 C:\DOCS\77497.TXT HGOVREF1 PsN: HGOVREF1
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bersome 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

70

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

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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

72

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.

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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.

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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 nutriVerDate 11-MAY-2000 10:47 Mar 20, 2002 Jkt 000000 PO 00000 Frm 00083 Fmt 6633 Sfmt 6633 C:\DOCS\77497.TXT HGOVREF1 PsN: HGOVREF1
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tion 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 deVerDate 11-MAY-2000 10:47 Mar 20, 2002 Jkt 000000 PO 00000 Frm 00094 Fmt 6633 Sfmt 6633 C:\DOCS\77497.TXT HGOVREF1 PsN: HGOVREF1
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sign, 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 lifethreatening 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

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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-thespot 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?

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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 21⁄2 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

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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

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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

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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.

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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-thebox 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

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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.

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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

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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.

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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

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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 molVerDate 11-MAY-2000 10:47 Mar 20, 2002 Jkt 000000 PO 00000 Frm 00114 Fmt 6633 Sfmt 6633 C:\DOCS\77497.TXT HGOVREF1 PsN: HGOVREF1
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ecules 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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