U.S. GOVERNMENT PRINTING OFFICE

59–973 CC WASHINGTON : 1999

CARDIOVASCULAR DISEASE: IS THE GOVERNMENT

DOING MORE HARM THAN GOOD?

EDTA CHELATION THERAPY

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

MARCH 10, 1999

Serial No. 106–33

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: 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

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

JOHN T. DOOLITTLE, California

HELEN CHENOWETH, Idaho

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

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

CHAKA FATTAH, Pennsylvania

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

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian

CARLA J. MARTIN, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on March 10, 1999 ............................................................................ 1

Statement of:

Chappell, L. Terry, M.D., immediate past president, American College

for the Advancement of Medicine, accompanied by Theodore Rozema,

M.D., president-elect, American College for the Advancement of Medicine; Norman Levin, M.D., board certified, internal medicine and

rheumatology; and Victor Marcial-Vega, M.D., board certified

oncologist ....................................................................................................... 25

Lenfant, Claude, M.D., Director, National Heart, Lung, and Blood Institute; Donald A.B. Lindberg, M.D., Director, National Library of Medicine; Joan Z. Bernstein, J.D., Director, Bureau of Consumer Protection,

Federal Trade Commission, accompanied by Deborah Valentine, General Counsel, Federal Trade Commission ................................................... 113

Letters, statements, etc., submitted for the record by:

Bernstein, Joan Z., J.D., Director, Bureau of Consumer Protection, Federal Trade Commission:

Followup questions and responses ........................................................... 155

Information concerning ACAM ................................................................. 148

Prepared statement of ............................................................................... 130

Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of .......................................................................... 5

Chappell, L. Terry, M.D., immediate past president, American College

for the Advancement of Medicine:

Information concerning chelation therapy .............................................. 35

Information concerning the Danish chelation study .............................. 99

Prepared statement of ............................................................................... 29

Davis, Hon. Danny K., a Representative in Congress from the State

of Illinois, prepared statement of ................................................................ 24

Kucinich, Hon. Dennis J., a Representative in Congress from the State

of Ohio, prepared statement of .................................................................... 21

Lenfant, Claude, M.D., Director, National Heart, Lung, and Blood Institute, prepared statement of .......................................................................... 115

Levin, Norman, M.D., board certified, internal medicine and

rheumatology, prepared statement of ......................................................... 84

Lindberg, Donald A.B., M.D., Director, National Library of Medicine,

prepared statement of ................................................................................... 124

Marcial-Vega, Victor, M.D., board certified oncologist, prepared statement

of ..................................................................................................................... 95

Rozema, Theodore, M.D., president-elect, American College for the Advancement of Medicine, prepared statement of .......................................... 44

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, information concerning formal positions .............................. 13

(1)

CARDIOVASCULAR DISEASE: IS THE GOVERNMENT DOING MORE HARM THAN GOOD?

EDTA CHELATION THERAPY

WEDNESDAY, MARCH 10, 1999

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 11:22 a.m., in room

2154, Rayburn House Office Building, Hon. Dan Burton (chairman

of the committee) presiding.

Present: Representatives Burton, Morella, Horn, Ose, Waxman,

Norton, and Kucinich.

Staff present: Kevin Binger, staff director; Dan Moll, deputy staff

director; Beth Clay, professional staff member; Mark Corallo, director of communications; John Williams, deputy director of communications; Carla Martin, chief clerk; Lisa Arafune, deputy chief

clerk; Maria Tamburri, staff assistant; Phil Schiliro, minority staff

director; Phil Barnett, minority chief counsel; Kristin Amerling,

Sarah Depres, and Michael Yang, minority counsels; David

McMillen, minority professional staff member; Ellen Rayner, minority chief clerk; and Earley Green, minority staff assistant.

Mr. BURTON. The committee will come to order.

I apologize for us being just a little bit tardy. We had a vote on

the floor. But I do appreciate your patience.

I ask unanimous consent that all Members’ and witnesses’ written and opening statements be included in the record. And without

objection, so ordered.

Today we continue our inquiry into Americans access to complementary and alternative medicine. We began this year’s hearings with a look at the level of integration of complementary and

alternative medicine into government-funded healthcare. During

that hearing, we heard testimony from Dr. Dean Ornish about the

importance of other options to treat cardiovascular disease. We are

continuing to work with the Department of Health and Human

Services on increasing access to alternative therapies that have received positive results.

Today’s hearing expands our inquiry into alternative treatments

for the leading cause of death in America, cardiovascular disease.

One alternative treatment that is widely used for cardiovascular

disease is EDTA chelation therapy. Chelation therapy is the intravenous injection into the bloodstream of a substance which bonds

with heavy metals and then is expelled from the body. It is a manVerDate 11-MAY-2000 08:25 May 03, 2001 Jkt 010199 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 E:\HEARINGS\59973 pfrm04 PsN: 59973
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made amino acid. EDTA chelation is used by some physicians to

treat circulatory problems as well.

Off-label use means that a drug is used for purposes other than

those for which the FDA originally approved it, and for which the

indications are provided on the label. This off-label use of an FDAapproved drug has been shown to be safe and, according to some,

effective.

The off-label use of chelation therapy is an excellent example of

an alternative therapy with tremendous bias against it within the

medical establishment and within the government.

The National Heart, Lung, and Blood Institute has never funded

any research into chelation therapy. The National Library of Medicine has refused to index the Journal for the Advancement of Medicine in MEDLINE. The Federal Trade Commission has launched

an attack on the free flow of information from a non-profit professional medical association. The Federal Trade Commission has

been working with the Federation of State Medical Boards and individual State medical boards to identify physicians who offer

EDTA chelation for off-label use and to remove their licenses. They

want to drive them out of business.

Dr. Joseph Jacobs, former Director of the Office of Alternative

Medicine at the National Institutes of Health, stated, ‘‘I came to

the conclusion that EDTA chelation merited study because of the

possible truth of the claims made in favor of the therapy, and because of the exceedingly large numbers of Americans who seek out

and submit to this therapy.’’

In 1978, a U.S. District Court rejected the actions of the Food

and Drug Administration when they sought an injunction against

a physician that administered chelation. The court characterized

the FDA’s actions as, ‘‘an attempt to compel physicians to practice

according to State-sanctioned protocols.’’

Furthermore, the court determined that the weight of the evidence submitted to it supports the practice of chelation.

We will hear testimony today from the National Heart, Lung,

and Blood Institute. Last year, this institute had a total budget of

over $1.5 billion. They spent only $5.6 million on alternative medical research. That is not even one-half of 1 percent. The National

Heart, Lung, and Blood Institute has never funded any research in

the off-label use of chelation therapy and vascular disease.

The committee has learned that researchers from several leading

U.S. medical schools have approached the Institute with the desire

to conduct studies in this area, but they were discouraged from

doing so.

And I want to know why.

While the new National Center for Complementary and Alternative Medicine now has the ability to conduct research without

clearing it through the various institutes and centers of the National Institutes of Health, the center leadership has stated that

they will continue to utilize the expertise of these Institutes.

If there continues to be a bias, will it stand in the way of research? For a rigorous, scientific study, such as a large, multi-site

clinical trial to be conducted on EDTA chelation, and for the results

to be acceptable to the medical and regulatory communities, the

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National Heart, Lung, and Blood Institute will have to be a major

player.

We will also hear from the National Library of Medicine.

MEDLINE is the most well-known of the library’s data bases. It allows anyone to query the library’s computerized store of journal article references on specific topics. Several of the broader, ‘‘alternative journals’’ have been indexed for MEDLINE; however, several of the specialty journals have not.

The committee has concerns that doctors and the public, who

refer to MEDLINE for access for medical information, are not gaining access to novel treatments that have not been accepted in

mainstream publications. It is widely known that there is a publication bias against alternative medicine in conventional journals.

And I would like to know why that is the case as well.

One special issue of the Journal of the American Medical Association does not cure that. I guess there was one special issue on

this subject, and that doesn’t cure the problem.

Therefore, specialty journals play an important role in providing

information about treatments that do not get published in mainstream journals. Also, the bibliographic data base of alternative

medicine research clinical trials at the NIH is drawn from

MEDLINE.

The Federal Trade Commission enforces a variety of Federal

antitrust and consumer-protection laws. With respect to regulatory

activities, this hearing will seek to determine whether the Federal

Trade Commission exceeded its statutory authority by opening an

investigation of and extracting a settlement agreement from the

American College for Advancement in Medicine [ACAM], a nonprofit medical society.

The committee is concerned that Federal agency actions like this

can adversely affect patient access to complementary and alternative medical therapies. This association entered into a consent

agreement in December with the Federal Trade Commission because they were afraid to challenge a government bureaucracy.

And that fear is something we want to see end.

With the permission of the author, I have attached one patient

letter submitted to the Commission during the comment period for

this action. This retired Navy captain did his own research when

facing open-heart surgery and opted for chelation as a first choice.

Within 6 months, his Navy doctor told him he no longer needed

open-heart surgery.

This is pretty astounding. They told him he had to have openheart surgery. He went ahead and had chelation therapy; went

back to his Navy doctor 6 months later, and he said you don’t need

open-heart surgery anymore, but whatever you are doing, keep on

doing it.

An additional concern with the Commission is the actions in determining the scientific validity of medical therapies. Is this an appropriate action for the Commission to undertake?

The Commission claims that there is not enough evidence to

show that chelation therapy was an effective treatment for cardiovascular disease. Apparently, the standard of evidence that the

medical society relied upon in making their statements did not

meet the standard of evidence the Commission expected.

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However, it has not been made clear in the consent order or in

conversations with the Commission what the level of evidence

would need to be. Chelation has remained one of the most controversial topics in alternative medicine. It is important to remove

longstanding bias from our government agencies, to conduct research in areas where there is a need, and to preserve the free flow

of information in this country, including that of differing medical

opinions.

We will hear today from four conventionally trained doctors who,

in order to better care for their patients, began including alternative therapies for their patients, including EDTA chelation.

We look forward to hearing from today’s witnesses. There has

been a great desire by many patients, healthcare providers, associations, and researchers to speak to the committee about this

topic. We were not able to bring them all in today, but we will hold

the record open until March 25th to allow for written submissions

to be included in the hearing record.

I now recognize my colleague from California, Mr. Waxman.

[The prepared statement of Hon. Dan Burton follows:]

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Mr. WAXMAN. Thank you, Mr. Chairman. At the outset, I would

like to express my concern with the title of this hearing, ‘‘Cardiovascular Disease: Is the Federal Government Doing More Harm

Than Good?’’ The answer is obvious. The Federal Government has,

in fact, made huge investments into medical research, preventive

health, epidemiology, and primary care to combat cardiovascular

disease.

There can be no doubt that the work of the public health service

and the Federal health programs has dramatically improved the

quality of life and survival of Americans suffering from cardiovascular disease.

I also want to point out the role that the FTC, one of today’s witnesses, has played in the fight against heart disease. The FTC ensures that the public has access to accurate information by monitoring claims made by advertisers.

One recent example of FTC’s work involves cigarettes, a major

risk factor of heart disease. Earlier this month, R.J. Reynolds

agreed to settle FTC charges that ads for Winston cigarettes, which

claim that those cigarettes are additive free, make an implied claim

that they are somehow safer.

But as we all know, there is no such thing as a safe cigarette.

Under the agreement, Reynolds has to make a disclosure on future

Winston ads that reads, ‘‘No additive in our tobacco, does not mean

a safer cigarette.’’

This is a fine example of how the FTC has contributed to the

fight against cardiovascular disease.

I understand that today we are focusing on EDTA chelation therapy as a way to treat heart and blood-vessel disease. Clearly there

are a diversity of views on whether such views of chelation therapy

is safe and effective. Hearings such as these give us a good opportunity to learn about new therapies. It is important to keep an

open mind about new, safe, and effective treatments for diseases

that can be so crippling and affect so many people.

However, as we keep an open mind, we should also be humble

enough to know that no member of this committee, at least as far

as I know, is a medical scientist. And if we hear competing claims

on medical issues, we have to recognize the fact that we are not

in a position to adjudicate these claims, that there are proper agencies to do that within the Food and Drug Administration, if it is

a matter before them, within the American Medical Association

and within the medical societies generally, through the scientific

method, to adjudicate whether claims and hypotheses really are effective.

Having said that, we must take into consideration the reservations about chelation therapy raised by many doctors who have devoted their lives to treating heart disease. The American Medical

Association, the American College of Cardiology, and the American

Heart Association have all found that the evidence of chelation

therapy’s efficacy in treating heart disease is inconclusive at best.

At this point, Mr. Chairman, I ask that the formal positions of

these groups be entered into the hearing record.

Mr. BURTON. Without objection.

[The information referred to follows:]

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Mr. WAXMAN. I also want to point out that we want to be sure

that the National Library of Medicine and other institutions that

are funded by the taxpayers of this country are operating on good

science and that they are not operating from a position of bias.

That’s a question that is a legitimate one. As I understand the National Library of Medicine has a periodic consultation with experts

from different fields to evaluate the library’s collection of periodicals in that field. The board of the National Library of Medicine

will use the experts’ recommendations when reviewing journals in

that field.

In fall of 1997, the board asked 14 organizations involved with

complementary and alternative medicine to advise it on the NLM’s

collection, these experts review 695 titles, 79 percent of which the

NLM already held, the reviewers determined that 6 titles not held

should be added to the collection and recommended that 7 titles be

added to MEDLINE. And these titles have been added to

MEDLINE.

I would be disturbed if the National Library of Medicine were

open to consulting with those in this area of alternative medicine,

but it appears that they have tried to sort out those issues for

which various titles would be appropriate to be added to

MEDLINE.

I welcome our witnesses. I look forward to their testimony. I

thank the chairman for holding this hearing, and I yield back the

balance of my time.

Mr. Chairman, we have a unanimous consent request that some

of our members want to insert opening statements. I presume that

your unanimous consent request was all Members have that opportunity.

Mr. BURTON. That is correct. Do any of the Members have a brief

opening statement they would like to make? Mrs. Morella.

Mrs. MORELLA. I simply want to tell you that I look forward to

this hearing. I think we are going to learn a great deal, and I want

to thank the panelists for being here. I particularly wanted to extend my appreciation and give recognition to the Director of the

National Heart, Lung, and Blood Institute, Dr. Lenfant, since the

National Institutes of Health is in my district, as well as Dr. Donald Lindberg, the Director of the National Library of Medicine,

since the National Library of Medicine is also in my district.

Bethesda is well-named for the healing powers of the pool of Bethesda in the Bible.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Mrs. Morella. Mr. Kucinich.

Mr. KUCINICH. Thank you very much, Mr. Chairman. I want to

thank the chair for holding these hearings. I have a statement,

which I would like included in the record.

And at the outset, I would like to say that I think these hearings

on alternative and complementary medicine are important because,

as much respect as we all have for allopathic practice in this country, which is second to none in the world, it is important that we

keep our minds open with the new frontiers because the allopathic

practice, which we recognize today as being the best, was advanced

through many years of having to push the barriers and create deVerDate 11-MAY-2000 08:25 May 03, 2001 Jkt 010199 PO 00000 Frm 00023 Fmt 6633 Sfmt 6602 E:\HEARINGS\59973 pfrm04 PsN: 59973
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bates over their practice. And things that were years ago considered at the fringe are now at the heart of allopathic practice.

So we have to consider that our understanding of human health

and the ways in which we treat disease keep changing. And it

keeps changing because we learn of newer and sometimes alternatively effective ways of doing things.

So I appreciate the spirit in which Mr. Burton has proceeded on

this. I am very grateful for the leadership which you have shown.

And I look forward to the testimony.

[The prepared statement of Hon. Dennis J. Kucinich follows:]

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Mr. BURTON. Thank you, Mr. Kucinich. Any further discussion?

Mr. Horn.

Mr. HORN. I would just like to concur in Mr. Kucinich’s and Mrs.

Morella’s remarks that we commend you, Mr. Chairman, for holding these hearings. I am going to have to move in and out with a

few commitments, but I shall return.

Mr. BURTON. Thank you, thank you.

We are pleased to open our hearing today with four physicians

who use chelation therapy. Dr. Terry Chappell of Ohio is the immediate past president of the American College for the Advancement

of Medicine.

You know, those who don’t agree with us, I wish they would stick

around to hear some of the testimony.

Mr. KUCINICH. If I may, my leaving—— Mr. BURTON. It kind of bothers me that, you know, no disrespect

to Mr. Waxman, but he reads the information that comes in from

the agencies, i.e., the National Heart, Lung, and Blood Institute,

and makes a statement about that, and then leaves before we even

have a chance to have the chelation experts testify. That is disappointing. But we are pleased—— Mr. KUCINICH. Mr. Chairman, if I may, on behalf of Mr. Waxman. He presents a point of view, which is challenging to us to

keep advancing our point of view, but he did have a conflict which

he had to sadly fulfill.

Mr. BURTON. Since you are on his side of the aisle, Mr. Kucinich,

I hope that you will convey to him all the relevant facts that we

get from this hearing.

Mr. KUCINICH. I will do that, Mr. Chairman. Thank you.

[The prepared statement of Hon. Danny K. Davis follows:]

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Mr. BURTON. Thank you very much.

We are pleased to open our hearing today with four physicians

who use chelation therapy. Dr. Terry Chappell of Ohio is the immediate past president of the American College for the Advancement

of Medicine. He is board-certified in family practice, pain management, and geriatrics.

Dr. Ted Rozema of North Carolina is the president-elect of the

American College for the Advancement of Medicine. He is boardcertified in family medicine and is considered one of the world’s

leading experts in chelation therapy.

Dr. Norman Levin is board-certified in internal medicine and

rheuminology, rheumatology, pardon me, and has a private practice

just outside of Middleburg, VA.

Dr. Marcial-Vega, a friend of mine of Coral Gables, FL, is a

board-certified oncologist who received his oncology training at the

Johns Hopkins University Hospitals. And he has held academic appointments at the Washington University and the University of

Miami.

Gentlemen, we sometimes have people sworn in because we want

to make sure that the testimony is accurate and documented. So

if you would rise and raise your right hands, I would like to swear

you in as well as the other witnesses.

[Witnesses sworn.]

Mr. BURTON. Let the record reflect that the witnesses responded

in the affirmative.

On behalf of the committee, I want to thank you for being here

today. And we would like to have you give your opening statements. If your opening statement is beyond 5 minutes, if you could

condense, we would appreciate it, and we will put the rest of your

statement in the record.

So why don’t we start with you, Dr. Chappell.

STATEMENTS OF L. TERRY CHAPPELL, M.D., IMMEDIATE PAST

PRESIDENT, AMERICAN COLLEGE FOR THE ADVANCEMENT

OF MEDICINE, ACCOMPANIED BY THEODORE ROZEMA, M.D.,

PRESIDENT-ELECT, AMERICAN COLLEGE FOR THE ADVANCEMENT OF MEDICINE; NORMAN LEVIN, M.D., BOARD

CERTIFIED, INTERNAL MEDICINE AND RHEUMATOLOGY;

AND VICTOR MARCIAL-VEGA, M.D., BOARD CERTIFIED

ONCOLOGIST

Dr. CHAPPELL. Thank you, Mr. Chairman, members of the committee. My name is Dr. Terry Chappell, and I am from Bluffton,

OH. As was stated in the introduction, I practice integrative medicine, which I would define as using the best from conventional

medicine, and the safest treatments from conventional medicine,

and combining that with the best and most scientific treatments

from alternative medicine.

Chelation therapy is one of the treatments that I use in my practice. I have used this for about 19 years. I find that 85 to 95 percent of the patients that I treat show measurable improvement

with objective tests that we do before and after the treatment.

Many of the patients have been able to avoid cardiac surgery. Others have come after they have had cardiac surgery that has not

worked very well for them, and still they might do quite well.

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Personally, I have had coronary disease with a positive stress

test and I took chelation treatments alongside my patients. Eighteen months after that I was able to run a 26-mile marathon without stopping. I take no medications and have no further cardiac

symptoms.

Next month, I will have the opportunity to present at the Ohio

Academy of Family Physicians Research Day two projects that I

have been working on. The first was looking at the 10 leading

causes of death and how alternative medicine might improve those

causes of death.

When I looked at those carefully, I found that the fourth leading

cause of death, which is often not listed, is prescription medications, medications prescribed by physicians. And even more shocking to me, when we added up the statistics, we found that the

ninth leading cause of death is cardiac surgery.

So 2 out of the top 10 leading causes of death are actually caused

by the well-meaning efforts by physicians to treat their patients.

There is a significant risk in the medicine that we do practice

today.

Very interestingly too, 5 out of the top 10 leading causes of death

are related to vascular disease, and that is obviously the biggest

challenge we face.

The second project was a survey. And I wrote to 230 of the leaders of alternative medicine that I identified mostly in this country,

and I asked them what were the five alternative therapies that

they found most effective in their practice and experience.

Interestingly enough, chelation therapy was the No. 1 therapy

most commonly mentioned. Of the five therapies that were most

commonly mentioned, four of those have had very little, if any, research funded by the U.S. Government.

So the question is: Are we doing research on the wrong therapies?

I think we are in a situation where we have the majority of

deaths in this country due to vascular disease. One of the most

promising therapies we have is chelation therapy, and yet those responsible for doing research in this country, and the government is

included, and the medical schools, too, have refused to do research

on chelation therapy.

Something is wrong. Something is drastically wrong with this situation.

And there are a number of factors that Chairman Burton mentioned in his opening statement. I’ll just touch on a few.

One is publication bias. Journals for years have had bias against

various alternative therapies, and research projects on those therapies. And they have not been accepted for publication. Chelation

therapy is a good example of that.

The Journal for the Advancement of Medicine, which has a number of studies on chelation therapy published, has not been indexed

in the Index Medicus. And the excuse given is that there hasn’t

been enough high-quality scientific studies submitted to the journals.

Well, those journals will not receive submissions from authors

who have high-quality scientific studies if the journal isn’t indexed.

So it is a catch-22 situation.

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Many universities have been approached to do studies on chelation therapy, including Harvard and Emory University. At Washington University, we worked for 2 years to try to get a study on

chelation therapy done, and it got down to the very last day of submission of NIH of this proposal, and all a sudden the dean of the

medical school withdrew the application with no explanation to

anybody as to why he withdrew it.

Then we worked with the University of Missouri. For another

year and a half we worked with the University of Missouri and officials at NIH and tried to get the best protocol we could. Spent a

lot of our resources in doing that. It was finally submitted to NIH,

and this last fall it was turned down flatly.

I have to say that, to me, the review comments that were made

were—seemed to be much more political than they were scientific.

For years, governmental agencies have made negative comments

about chelation therapy when asked by the public, and they have

referred to editorial comments that have appeared in journals, and

they have not fairly represented the research that has been done

on chelation therapy.

This has been another obstacle.

I would like to say just a few words about the FTC action against

ACAM. First of all, I never dreamed that the FTC would get into

these issues. ACAM is a research and educational medical society.

And the FTC asked for 3 years of activity—everything that ACAM

had done over a 3-year period. And they found a couple of statements in two educational brochures that were meant—the purpose

of those brochures were to enhance the doctor-patient communication. And the main brochure in question contained a waiver saying

that other physicians have different opinions about what was expressed in the brochure.

Somehow the FTC called this advertising. I don’t believe it was

advertising. I believe also that all the statements did have a scientific basis, although they did not have the two double-blind studies that the FTC requires. That is what ACAM has been trying to

get accomplished over the last 25 years.

ACAM did sign a consent order. They had no choice because if

they tried to fight it, they would have had to submit to bankruptcy.

The legal fees were astronomical to fight it.

This consent order has the potential of having a huge impact on

ACAM. It was very costly, and it puts ACAM under FTC supervision for 20 years.

On the positive side, there is a major textbook on cardiovascular

drug therapies, edited by Messerli, which came out with its latest

edition and it devoted an entire chapter to chelation therapy. It

was very positive in its effects and its descriptions.

Stephen Olmstead, who is a professor at University of Washington, published a monograph that was an exhaustive look at the

research, the pharmacology, the chemistry, the history of chelation

therapy. It is 140 pages, and has many, many references. This is

significant because he was an independent observer. He was not in

favor, he was not against chelation therapy. His conclusions in this

monograph were, first of all, that more research had to be done.

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But second, that the preponderance of the evidence on chelation

therapy was in favor of the therapy for cardiovascular disease, for

coronary-artery disease, for peripheral vascular disease.

There are many other studies that have come out recently. One

of the most significant ones was by Hancke in Denmark. They took

65 people that were on the waiting list for bypass surgery and they

chelated them; 58 out of those 65 were able to cancel their surgery.

Even more significant, they took 27 patients who were waiting

to have their limbs amputated, and 24 out of the 27 were able to

save their limbs by giving chelation therapy. They did not require

surgery.

My hope is that the government will encourage research on all

aspects of chelation therapy. The potential benefit is staggering,

both for reducing death and improving quality of life, especially for

certain conditions, such as critical limb ischemia, macular degeneration, and vascular dementia, for which there is no conventional

treatment that is effective. And yet we see improvements on patients that have been chelated that have these conditions.

I think it would be greatly beneficial if this monograph could be

distributed widely to every physician in the country. Right now, it

has just gone to medical libraries. And, further, I would hope that

the FTC could be asked to stay out of the doctor-patient relationship and the practice of medicine, areas where they do not belong.

[The prepared statement of Dr. Chappell follows:]

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Mr. BURTON. Dr. Chappell, we let you go on a little bit longer

than normal because—— Dr. CHAPPELL. I am sorry.

Mr. BURTON. No. That is OK because I think the information

that you are giving us is very important. In fact, a lot of the studies and results that you have just cited there, I would like to have

those.

Dr. CHAPPELL. I would be happy to provide them.

Mr. BURTON. And if you could give that information to Beth, she

is our righthand person on this issue, I really would appreciate it

because what we are going to do is we are going to make sure the

Food and Drug Administration, Health and Human Services are

given this statistical information so that they can’t say they don’t

have it.

We want to make sure it is stuck right on their desk so they can

look at it. Then we will ask them why we are not responding on

that issue.

[NOTE.—The monograph prepared by Stephen F. Olmstead, M.D.,

is held in the committee files.]

[The information referred to follows:]

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Dr. CHAPPELL. Thank you.

Mr. BURTON. Dr. Rozema, you are recognized.

Dr. ROZEMA. Mr. Chairman, members of the committee, I thank

you very much for the privilege of presenting information about the

facts surrounding the administration of EDTA for both vascular

and degenerative diseases by qualified medical practitioners.

I have been actively involved in the care of my patients using

EDTA chelation therapy for the past 16 years. And over that time,

I have probably treated over 2,000 patients and have administered

over 80,000 infusions of EDTA.

Now, I was asked to give a brief summary about EDTA. EDTA

is, as you mentioned, a manmade synthetic amino acid created in

Nazi Germany back in the mid-thirties because Hitler was going to

war and needed a substitute for citric acid to take minerals out of

water. If you don’t take minerals out of water and you dye clothing,

you get dye tie-dyed, you don’t get evenness in the dye. So they invented EDTA. In this country, Fredrick Bersworth invented EDTA

about the same time and had it patented around 1941.

EDTA is a compound when introduced into the body has very

specific method of operation. It is like a Pac-man, it goes in, it

grabs a mineral ion, takes it to the kidney, and you excrete it.

When the scientists and chemists figured out what this molecule

was doing, they began using it for lead toxicity. Of course, in those

days, the lead industry knew that there was no problem with lead,

and the 1923 issue of National Geographic had a wonderful advertisement in there about how lead was so good to run the water

from the city pipes into your house.

We found out differently. I recently attended a meeting, the largest international meeting ever held on lead toxicity in Bangalore,

India. The purpose of the meeting was specifically to get the Indian

government to remove lead from gasoline. And at that meeting,

they announced that as of April next year they will be doing that.

Lead is a terrible scourge. The government has spent a lot of

money on research on lead with EDTA and compounds that are

chelating agents as well. Doctors in the early 1950’s who began

using EDTA figured that it might have an effect on removing calcium from soft tissue, including arterial walls. And Dr. Norman

Clark and others found that it was effective in removing calcium

from arterial walls and also from aortic valves. This was all published, I believe, in the Journal of Cardiology way back when, when

they were studying this.

Now, as Dr. Chappell has said, Dr. Olmstead has done a tremendous review in his monograph, but I wanted to add something else

to that. And this is a list of 489 references from the medical literature dealing with chelation, some of them EDTA and vascular

disease, some of them with EDTA for other purposes, as EDTA is

sold by the carload for use in industry, for use in agriculture, and

for use in food as a food additive.

Now, we were talking before about the Federal Trade Commission and their involvement with ACAM. I was not party to that.

I am the president-elect. So a lot of things have gone on that I have

not been particularly privy to, but I want to give you a personal

happening.

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I started doing chelation in 1983. In 1984, the North Carolina

Medical Board said that if I was doing chelation therapy and accepting money for that, they were going to revoke or suspend my

license to practice medicine.

Now, I have always tried understanding what I do in medicine.

So when I started using EDTA, I wanted to know more about it.

So it has been a 16-year study: what this compound does and how

it works. Created the International Chelation Research Foundation, which was one of the two foundations responsible for the

study at Walter Reed Army Hospital. That started in the late

1980’s, having to do with EDTA and peripheral vascular disease.

However, for a number of reasons, primarily the unwillingness of

Army vascular surgeons to refer eligible patients into the study

and transfer of personnel active in the study to the Persian Gulf

during Desert Storm, the trial was discontinued before useful data

was obtained.

We wanted to get something going there. But because the study

got going, the North Carolina Medical Board put my license on

hold. There was a cloud over it. They removed the cloud a number

of years later, and a month later jumped on the physicians who in

North Carolina were doing chelation therapy. Again, to take their

licenses.

What happened was the public got involved. The public went to

their legislators, and now North Carolina is one of eight States

that have legislation protecting the physician doing alternative

medicine, including chelation therapy.

Now, over the years, 13 States have tried without success to

eliminate or reduce the practice of chelation therapy. Now we find

that the Federal Trade Commission, a Federal agency with no authority to regulate the practice of medicine, has been working with

the Federation of State Medical Boards to assist the States in their

failed regulatory efforts.

Who stirred up the FTC action? What is the basis for the aggressive anti-chelation action? From whom did the FTC receive complaints? Where are the unhappy customers? Where are the patients

seeking redress against their chelation doctors? Where are the injured? Where are the people saying they wish they had had surgery

instead of chelation?

Is this a genuine issue or a trumped-up charge by powerful special interests with a self-rewarding hidden agenda?

People are not stupid. It costs money to take these treatments.

And usually it costs money out of pocket because the insurance industry has seen fit not to pay for these treatments.

I can solidly attest that people will not continue to pay for something that is not working. You wouldn’t. I wouldn’t. And our patients don’t.

A physician doing chelation therapy would not stay in business

if he weren’t delivering positive results because patients talk to

friends, relatives, neighbors, and as a result, referrals come from

satisfied patients, not from advertising.

We have a great deal to gain from ending this ongoing controversy. Heart disease is the leading cause of death and disability

in this country. So far, there has not been 1 penny for a therapy

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which has been documented as life-saving for over 40 years by hundreds of thousands of patients.

The Center for Alternative Medicine should be working diligently

with the NIH to free up dollars for the benefit of our citizens. Let’s

put tax dollars to work where they will do a great deal of good in

research to establish the effectiveness of EDTA chelation therapy

for both peripheral vascular and coronary disease.

And let’s not wait while many patients that could be alive with

this therapy will never have the opportunity to better health with

it.

Thank you.

[The prepared statement of Dr. Rozema follows:]

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Mr. BURTON. Thank you, Doctor. And as I said to Dr. Chappell,

any statistical data you have regarding the people you have treated

or any other information, we would sure like to have that because

those documented figures that you have will be helpful in us presenting the case to the appropriate health agencies.

Dr. Levin.

Dr. LEVIN. Mr. Chairman, members, thank you. I’m Dr. Norman

Levin. I am 53 years old and I have been married for 22 years. My

wife and I have three children and two grandchildren. My medical

training was all academic and university-based in Philadelphia and

Denver, and I have been practicing clinical medicine for 21 years.

I am board-certified in internal medicine and rheumatology.

Two years ago, I completed my board certification in chelation

therapy, which is a 2-year process that consists of written and oral

examinations as well as supervising a certain number of chelations.

I am a member of the American Association of Physicians and Surgeons, the American College of Rheumatology, the American College for Advancement in Medicine, and I am on the board of directors of the Great Lake College of Clinical Medicine.

Up until today, I have never been involved in the politics of

healthcare. I am one of those rare birds, actually, an increasingly

endangered species, I am a private-practice physician in solo practice. My practice is in my home in the Virginia countryside, west

of here, near Middleburg, in a small town called Aldie, which is a

very tight little community where everybody knows everybody else.

My clinic is housed in the main part of my home. I, my wife,

Kate, and our youngest child, Sarah, who are both with me here

today, live upstairs.

So how did I become involved in something as controversial as

chelation therapy? That’s a good question.

Actually, I was recruited to do chelation therapy by a journalist

and medical writer who had the ulterior motive of wanting a doctor

trained in chelation near her home so that she and her husband

would be able to get chelation therapy regularly.

This was something that I greatly resisted for many, many

months. Why would I go out and intentionally look for trouble, especially with the current climate in healthcare and the related regulatory agencies?

However, after reading about chelation therapy, both the clinical

and the basic science aspects, talking to patients who had chelation

therapy, and attending conferences related to chelation therapy, I

could no longer avoid proceeding with my own training because I

thought of so many of my patients who might benefit greatly by

chelation therapy. And that was approximately 7 years ago.

Over these years, I have supervised many thousands of chelation

therapies on hundreds and hundreds of people. My experience,

which is backed up detailed medical records, support two conclusions. First, chelation therapy is extremely safe when administered

by properly trained physicians. We have not ever had a patient

have a side effect that required any kind of remedial treatment as

a result of receiving chelation. Second, the therapy is so very, very

effective. And I can think of only a handful, maybe 10 at the most

out of hundreds and hundreds of people doing chelation, who did

not have any appreciable benefit as a result of this therapy.

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The vast majority are so significantly improved that they are

textbook examples of successful patient outcomes. However, as

with any single approach, chelation therapy is not a panacea by

itself. A successful program includes lifestyle changes, nutrients,

and oftentimes emotional work. The patients who have cardiovascular problems either already have a cardiologist or are strongly

advised to get one by me because balance is important. It doesn’t

have to be all one way, all conventional therapy or all alternative

therapy. An integrative approach is often the approach that works

best.

Occasionally, an individual who starts chelation therapy will deteriorate clinically and need some kind of acute intervention, such

as angioplasty. This is a rare occurrence, but certainly can happen.

Then, when the patient returns to complete the course of chelation

therapy, we find that they don’t require any further invasive therapies.

It’s a sad comment on the times that most patients choose not

to tell their other doctors that they are taking chelation therapy because they are afraid of the response that they will get from their

other doctors.

Why do people come to me for chelation therapy? I don’t advertise or market my practice in any way, nor do I give public talks

to recruit patients. We don’t even have a brochure to hand out or

fliers or any kind of promotional material. Nevertheless, I see two

to four new patients a day.

Most of the patients that I see have already been through the socalled system and have either not responded satisfactorily or have

had such bad experiences one way or the other that they refuse to

continue on the conventional or, ‘‘acceptable’’ medical path.

Most of the people who come to me are there because of word of

mouth. They have come because a patient recommended the treatment based on their own experience or they know of someone who

has responded well to the treatment. Or they have read about chelation and want to try a non-invasive therapy before undergoing

surgery. Some may have read an article that I wrote that was published in an alternative medical journal or gotten my name from

a list of doctors who are qualified and certified in chelation therapy.

I think that there has been a deliberate campaign to produce the

misconception that physicians doing chelation are akin to gypsies

in the business of selling driveway repair jobs to little old ladies

who don’t know any better. Nothing could be further from reality.

Most of the chelating physicians I have met at conferences were

trained at the finest medical universities in the country. Many are

board-certified cardiologists. And a surprising number used to do

cardiovascular surgery.

I always make it a point to talk to the new physicians coming

to a conference for the first time. And one of the questions I ask

is why are you here. Almost all report getting interested in chelation therapy because patients requested that they look into it. Then

they become further involved for the same reason that I did, because it works.

As for the patients, many of the people being chelated in my office are professionals and very well educated. Our patients include

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doctors, lawyers—and I was nervous the first time I chelated a lawyer—CEO’s of very large companies, accountants, a famous national announcer, a former major league baseball player, Harvard

graduates, one of whom wrote the definitive biography on George

Washington, et cetera.

We also have a small number of patients who don’t want it

known that they are being chelated. These are airline pilots, who

need to maintain drug-free optimal health to stay flight-status

qualified. Because of our location, I also see many country people

and farmers, who may not have advanced degrees but are very

wise in the ways of the world and nature.

I don’t have to sell people on chelation. Most of the people I

chelate come to me for that purpose. It is my responsibility to

evaluate their condition, to make sure that chelation is an appropriate treatment. Then I set up a program, and we proceed one

treatment at a time, paying very close attention to the feedback

that the person is getting. That is: How are they doing? Better,

worse, or no change?

Most of the patients being chelated for cardiovascular disease are

on pharmaceutical treatment when they come to me. They are

maintained on these treatments until we start seeing evidence of

improvement, and then, hopefully, medications can be slowly and

carefully tapered, ideally under the supervision of a cardiologist.

I think it is important to point out that you would be hardpressed to find a doctor who administers chelation who doesn’t

chelate themselves and their family. To me, that says something

significant about the nature of the treatment and the physicians

who are offering it to their patients.

And not uncommonly, the results are so dramatic and life-changing in people that their gratitude brings tears to your eyes because

it is such a wonderfully fulfilling feeling to be treating people this

way and to so consistently be getting this kind of feedback.

In the past 5 or 6 years, I have been investigated by the Virginia

Board of Medicine on two occasions. The second time the investigators just showed up at the office unannounced. As I later found out,

both cases were instigated by other physicians who heard about the

treatments I was doing, didn’t like the sounds of the treatments,

and then reported me to the medical board. The, ‘‘concerned’’ doctors didn’t call me to ask about what I was doing, nor did they consider the fact that the patients were being helped by the treatments that they reported me for.

Also, the accusers went unidentified. Both cases were investigated by the board, which can be a harrowing experience and can

really distract you from your purpose. In both instances I was acquitted of the charges and no action was taken or recorded on the

record by the board.

In my 21 years of practice, I have never had a complaint filed

by a patient, and I have never had a suit filed against me. When

people come to me in my office, I would like to be able to recommend to them what I feel will best serve them based on my academic knowledge and, most importantly, on my clinical experience.

I don’t want to be concerned that these therapeutic decisions will

be judged by someone who might have a vested interest but most

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assuredly has no practical knowledge with the therapies that he

will be judging.

Thank you very much.

[The prepared statement of Dr. Levin follows:]

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Mr. BURTON. Thank you, Doctor. You said you treated how many

patients?

Dr. LEVIN. With chelation therapy? Probably 400 or 500.

Mr. BURTON. Do you have any records that we could see?

Dr. LEVIN. With me?

Mr. BURTON. No. Not with you.

Dr. LEVIN. Yes, certainly.

Mr. BURTON. And you are welcome to black out their names. We

don’t want to intrude on anybody’s privacy.

Dr. LEVIN. Certainly.

Mr. BURTON. But we would like to get that——

Dr. LEVIN. Actually, one of my patients has probably received

more chelations than anybody else is here, who is a government retiree.

Mr. BURTON. Maybe we can talk to him after the hearing is over.

Dr. LEVIN. Sure.

Mr. BURTON. My good friend, Dr. Vega.

Dr. MARCIAL-VEGA. How are you doing? Thank you, Mr. Chairman, and one member of the committee that I see.

Mr. BURTON. Rest assured that the other Members will get the

information. I promise.

Dr. MARCIAL-VEGA. I hope so. They will do great with chelation,

too. [Laughter.]

Thank you for the opportunity to speak to you today, and I thank

God for this opportunity and ask for illumination to better serve

humanity. I am a board-certified radiation oncologist, and I trained

at the Johns Hopkins Hospital. Subsequently to that, I have taught

at Washington University in St. Louis and the University of

Miami. And I am presently researching ways to assist individuals

to reach optimal states of health and rejuvenation through the use

of tools that strengthen the whole person.

And this is the essence of holistic medicine. This new type of

medicine can heal any condition, and the public needs to know this.

And to give you two examples that will better illustrate this, I

would like to talk about two patients of mine.

One of my patients was operated on at the Mayo Clinic. And he

was evaluated there. He was also evaluated at the Baptist Hospital

of Miami. And both institutions recommended to him chemotherapy

and radiation for his condition. He had a stage 4 non-Hodgkins

lymphoma. But in addition to this, they told him that they could

not cure him. So they recommended this with that prognosis.

The patient evaluated the situation and he denied any conventional treatment from both institutions, and his surgeon at the

time referred him immediately to me. At that time I evaluated the

patient and as part of his therapy, I recommended chelation therapy and other things that I have in a complete rejuvenation and

holistic program.

He followed the program diligently and, to make the long story

short, it has been 31⁄2 years, and this patient has no evidence of

cancer. He is 80 years old, and he is living a completely fulfilling

and healthy life. Some of you may know this person, as I’m sure

he is a very well-respected and trusted friend of yours. His name

is Luis Cerna.

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Mr. Cerna’s son is here today representing his dad. He is right

behind me. And he has been through that ordeal with his father.

So he knows what those physicians were telling him throughout

the ordeal: ‘‘There is nothing we can do, but do radiation, do chemotherapy.’’ And on the other hand, what the reality of what happened was.

Another patient of mine was preparing to die. Just as simple as

that, he was preparing to die. There was nothing else that could

be offered to him. He had full-blown AIDS. And this patient had

a cancer spread throughout his abdominal cavity. It was so spread

out that he had a scar where I could put my hand into the abdomen. It could not close because the tumor was so large—just to

give you an idea of what was going on with this individual.

He again was told that there was nothing else that could be

done. This was 3 months ago.

In the meantime, he has done, among other things, chelation

therapy. Of course, there are other things that go together. What

we are talking about here today not only applies for chelation, but

other things that have been not looked at or persecuted or not evaluated properly or disseminated to the public.

This patient did the treatment and, today, basically all his symptoms have gone away. I did an x ray about a week ago, and the

x ray showed no cancer, totally gone from the whole abdominal cavity. This was a tumor that was about a foot in diameter, 1 foot.

And the scar has closed; there is no more pain; he has gained about

20 pounds. And also 95 percent of the virus has disappeared from

his blood. Today he is leading a totally normal and healthy lifestyle. This is 3 months later.

Also, I would like to tell you about my story. It is not in the testimony here because I just decided to tell you. I was very sick 4

years ago and that is one of the reasons why I went into alternative medicine. I had full-blown AIDS, which means I had 40

pounds less than what you see here today. I was very sick, with

fevers, and fatigue. Sixty to 70 percent of the time I was in disability. I had partial blindness of my left eye. I was having seizures. But I was even more scared that I knew what medicine

could do for this disease. And I didn’t do any medicine. None.

All I did was natural, and part of that was chelation therapy

also. To make the long story short, my T–4 count became normal.

It has been normal for 3 years. My viral load, which means how

much virus I have in my blood, is zero, has been undetectable for

3 years. In addition, if you take my blood today, it is HIV negative.

And it has been HIV negative for 3 years.

So no one can tell me anything. No agency can tell me that these

things work or don’t work because I am living proof of what the

reality of this is.

So what do these things mean? Just to give you the other side

of the story. If you can remember the losses of King Hussein and

Jacqueline Kennedy Onassis with all the money in the world and

all the available information from the best medical—supposedly

medical, but I would say conventional medical care—and they still

died. And they didn’t die from the cancers; they died from treatment-related complications.

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Why? Why should this happen? Basically, because what we call

conventional medicine, the medicine that I was trained, that I was

given as a trainee, an oncologist at Johns Hopkins Hospital, that

type of training does not include things that actually cause the

benefits that we have heard about here today. None of the training

includes that today.

And in addition to that, I recognized the fact that I needed to go

outside of my medical training in order to get this information.

There is no school that teaches this. We needed to learn this, most

of us, in the trenches, which makes things harder.

And, not only that, but the importance of this is that Americans

are dying today. It’s as simple as that. Our country is dying because the information is not available. We need to inform the public.

There are three things that I propose in order to stop this ignorance. No. 1, I propose that a study is instituted that recruits physicians already achieving these similar results, like the gentlemen,

people, here. And so we can discuss the outcomes and study them

in a right fashion, phase one, two, three, and four studies. And

those are the studies that we need to do.

Second, let new programs be designed to implement this knowledge into medical schools. This is non-existent at the present time.

Third, that we expand on the general consensus of the way disease is treated in the United States, cancer, AIDS, what have you,

that does not look at the cause of why the disease is there. So that

is why they don’t look into ways to improve the body, ways of

strengthening the individual.

Chelation therapy is an integral part of the care that I give my

patients. And as an NIH-funded research researcher—I have done

from NIH-funded programs—I know the importance of this to be

integrated into the regular or conventional medicine at the present

point. The Federal agencies have not conducted research in this

field, and they have done a disservice because the information is

not being disseminated to the public.

Another thing I want to say is that I have here a letter from the

editor-in-chief of the New England Journal of Medicine. This is the

medical journal in the world; I would consider it that. This is Dr.

Kassirer. And I sent him a study of 205 patients—and I’ll give you

copies, of course—205 patients treated with an eye preparation.

Mr. BURTON. Doctor, could I interrupt you? We have to run and

vote. And what I would like to do is come back and let you finish

your testimony and read that letter. Then I would like to go into

questions of the four of you. I have a number of questions.

Dr. MARCIAL-VEGA. Thank you very much. OK.

Mr. BURTON. And the other panel from the health agencies, we

will get to you just as soon as we get through with this panel. But

we are going to be gone about 10 minutes for the vote, and I will

be back just as quickly as possible.

We stand in recess at the fall of the gavel.

[Recess.]

Mr. BURTON. If we could have our panelists back at the table, I

would sure appreciate it. We will reconvene the hearing.

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Dr. Vega, you were about to read a letter from one of your patients. So won’t you proceed? As soon as you complete that, we will

get to the questions.

Dr. MARCIAL-VEGA. Thank you. Mr. Chairman. This letter was

sent to me after I sent an abstract. An abstract is a compilation

of information. I had 205 patients that I treated with certain processes. And I sent the article to the New England Journal of Medicine to be considered for publication. And this is the usual process

that decisions follow.

Mr. BURTON. This is on the gentleman that you were talking

about that had the AIDS problem?

Dr. MARCIAL-VEGA. No. This is a letter from the editor of the

New England Journal of Medicine, just to show the point of how

regular doctors look at alternative medicines.

Because sometimes they make the accusations that alternativemedicine practitioners are not doing research and are not doing

double-blind—that is not true. And I will show you how they deal

with this.

So he sent me a letter back. This is the editor-in-chief of the

most prestigious medical journal in the world, Dr. Kassirer. And he

says, directed to me, ‘‘I cannot encourage you to submit the manuscript to us because I doubt it is something we would be interested

in reviewing.’’ And to give you my conclusions, the eye preparation that I saw

had helped cataracts in 80 percent of the patients within 1

month—helped means that their vision was getting clearer, that

they were seeing colors better, and some of them the prescription

got better. Those were my conclusions.

So if he was not interested in that, I don’t know what he would

be interested in. I think that this was fascinating.

So that was the rest of what I wanted to say.

[The prepared statement of Dr. Marcial-Vega follows:]

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Mr. BURTON. Well, thank you Dr. Vega.

Let me start off by asking Dr. Chappell—you mentioned that 58

out of 65 patients avoided surgery. Now these were patients that

had closed arteries into the heart?

Dr. CHAPPELL. These were patients in Denmark. And with socialized medicine, they have a waiting list for surgery. And all of

them—— Mr. BURTON. Excuse me, just 1 second.

OK, I am sorry, go ahead.

Dr. CHAPPELL. All of them had documented coronary artery disease, and were actually on the waiting list to have bypass surgery.

There is a waiting list of 6 to 8 months.

Mr. BURTON. And this was in Denmark?

Dr. CHAPPELL. Yes.

Mr. BURTON. And it showed that 58 out of the 65 avoided surgery?

Dr. CHAPPELL. Yes.

Mr. BURTON. Does it go into detail in that study as to how occluded their arteries were? I mean, did they completely clear up?

What does it say?

Dr. CHAPPELL. The printed study did not go into detail on that.

But I could ask for further details from the author if you would

like.

Mr. BURTON. I would like to have as much information as possible.

Dr. CHAPPELL. OK.

[The information referred to follows:]

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Mr. BURTON. And, if you could get that for us. Also, how many

patients did you say you have treated?

Dr. CHAPPELL. I have treated probably at least 2,500 to 3,000 patients with chelation therapy.

Mr. BURTON. And what kind of results have you had?

Dr. CHAPPELL. In the ones that I have kept a running account

on, the results have shown measurable improvement in 85 to 90

percent. That is using objective testing before and after treatment.

Mr. BURTON. And what kind of testing did you do before and

after?

Dr. CHAPPELL. Mostly Doppler ultrasound to measure the blood

flow through the peripheral artery.

Mr. BURTON. And it showed the arteries did open up somewhat?

Dr. CHAPPELL. Yes. There is increased blood flow to the extremities.

Mr. BURTON. Was it pretty substantial in some cases? Or was it

just moderate?

Dr. CHAPPELL. Sometimes it is very substantial; sometimes it is

not. It is not a perfect treatment. It is not a cure-all. But it shows

a significant improvement in the vast majority of people that are

treated.

Mr. BURTON. Over time, if you continue the chelation treatments,

does it continually get better or do you reach a point where it does

not get any better?

Dr. CHAPPELL. With any treatment, you might see a plateau. But

it is interesting with chelation that, after the basic course of treatment, there have been some studies that show even 3 months after

you stop treatment there is a continued improvement 3 months

later.

Mr. BURTON. I have talked to some doctors who do chelation

therapy, and they have told me that the chelation that they conduct goes on for an indefinite period of time and it does show continual results, positive results, after what would be a normal period

of time.

Dr. CHAPPELL. A lot of times that is the case. The other thing

is, one of the effects of chelation is that it has a very positive effect

on the platelets, so that the blood doesn’t clot as easily. And the

platelets’ life span is about 31⁄2 weeks. So to get the continued effect, many times we will give monthly treatments and maintenance.

Mr. BURTON. How long do your treatments usually last?

Dr. CHAPPELL. About 3 hours.

Mr. BURTON. But over what period of time?

Dr. CHAPPELL. The basic course is about 30 treatments. Most of

my patients take them once a week, sometimes twice a week.

Mr. BURTON. OK. Do you have any cost figure on that?

Dr. CHAPPELL. The cost in our office is $101 per treatment.

Mr. BURTON. $101. So it is not extraordinarily expensive?

Dr. CHAPPELL. No. We priced that in the home health agency and

the outpatient department of the hospital, and we found that the

cost for just a routine IV was two or three times that much.

Mr. BURTON. Do you ever put anything, in addition to the conventional chelation fluids, into the fluid? I mean, I have heard that

some doctors add vitamin C and other things into the——

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Dr. CHAPPELL. Well, in the conventional bottle, there is some vitamin C, but many times we will add additional vitamin C or other

minerals or other ingredients to try to improve the effects. It is all

individualized based on the patient’s condition.

Mr. BURTON. And what kind of side effects do you have?

Dr. CHAPPELL. From chelation therapy?

Mr. BURTON. Do you have many side effects of any problems?

Dr. CHAPPELL. Well, it is very, very important that you monitor

the kidney function. And as long as you monitor that and give a

dose based on the normal kidney function and don’t overload the

kidneys, the side effects are very minimal, very minimal.

Mr. BURTON. So you haven’t had any serious problems.

Dr. CHAPPELL. I have had no serious problems with it. Once in

a while we get somebody who gets washed out or tired after a

treatment because you are removing some of the minerals, normal

minerals. And then you have to replenish those more aggressively.

But the side effects are not significant.

Mr. BURTON. But the mercury that you remove, and things like

that that are causing problems in people, it is more than offset by

the minerals you replace? I mean, you are able to replace the minerals that cause problems?

Dr. CHAPPELL. We can replace those just fine.

Mr. BURTON. I mean the ones that are taken out.

Dr. CHAPPELL. Yes.

Mr. BURTON. Dr. Rozema, can you tell us how many patients you

have treated?

Dr. ROZEMA. Well over 2,000.

Mr. BURTON. And, have you had any problems with the side effects from those people?

Dr. ROZEMA. As Dr. Chappell mentioned, the most prevalent, not

complaint, but observation we have, when we give a patient a

treatment, they are a little washed out for a few hours after the

treatment. Medicare Blue Cross and Blue Shield in my Carolinas

area and I got into a little argument once about, well, if a patient

comes into your office and he has intermittent claudication or pain

on walking a short distance because of circulation problems, the insurance company will pay for the first study because that is good

medicine. But they won’t pay for a second study unless you have

had surgery.

Well, why not?

We all know that there is no medical treatment that is going to

improve this patient without surgery. So we won’t pay for the second study.

Mr. BURTON. So there is a bias.

Dr. ROZEMA. I would believe so. So I sent this gentleman 12

cases, went to my records, just pulled out 12 cases, befores and

afters, that demonstrated clear reversal or clear opening of the vessels, reversal of atherosclerosis, and asked him for his comments,

asked him to please share this with any of his experts.

It took 5 months. I got a letter back, ‘‘Thank you for your interesting information, but you know according to Medicare regulation

XYZ, we do not pay for chelation therapy or any of the testing associated with it.’’ That is the response I had.

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Mr. BURTON. When the arteries were reopened, was it a dramatic

change or just marginal, or did it vary from patient to patient?

Dr. ROZEMA. No. Most of the patients had quite a marked improvement. And I can agree with the published studies done in the

office of Dr. McDonough, that if you do 30 chelation treatments on

a patient, say for carotid artery disease, that you have about a 30

percent reduction in the size of that plaque in 30 treatments.

Mr. BURTON. Well, how close does that come to putting him back

to completely normal? What would be the normal, 100 percent?

Dr. ROZEMA. I like the 100 percent, yes. But I think if you gave

enough treatments over long enough time, you could get back to

that point.

Mr. BURTON. In other words, you think that beyond the 30 treatments, if you continue to have chelation, it would eliminate most

of the plaque in the artery?

Dr. ROZEMA. It does continue to improve the situation, yes.

Mr. BURTON. How many patients have you treated?

Dr. LEVIN. Probably about 500.

Mr. BURTON. Have you had pretty much the same results as the

other doctors have?

Dr. LEVIN. Yes. I have.

Mr. BURTON. Have the arteries that have been reopened, been reopened substantially?

Dr. LEVIN. Substantially enough to make a significant clinical

difference.

Dr. LEVIN. To eliminate the need for surgery and eliminate possible heart attacks or strokes?

Dr. LEVIN. Yes.

Mr. BURTON. How about you, Dr. Vega?

Dr. MARCIAL-VEGA. I have treated about 200 patients, and I have

similar results. I checked on seven patients that had particularly

the problem of impotence. And 100 percent, seven of those seven

patients, had marked improvement in their erections and in their

sexual function. I did a study on that.

Mr. BURTON. So what you are saying is, when the arteries started opening, it started cleaning out other capillaries and other

smaller blood veins as well?

Dr. MARCIAL-VEGA. Yes. And I am assuming at this point, at

least in the patients I see, that most of the causes of impotence are

related to a reduced blood flow to the area.

Mr. BURTON. You guys are going to put Viagra out of business.

[Laughter.]

Dr. MARCIAL-VEGA. Hopefully.

Mr. BURTON. Anyhow, that was a joke, folks.

Dr. MARCIAL-VEGA. That was a joke, too.

Mr. BURTON. None of the other doctors have said anything about

this, but you mentioned you dealt with an AIDS patient that had

substantial tumors. That is kind of unusual. I have never heard

anybody other than you talk about how chelation really helped

somebody who had the AIDS virus. Can you elaborate a little bit

more on that? Was it just the chelation therapy? Or was it what

else that you did?

Dr. MARCIAL-VEGA. It wasn’t just the chelation therapy. I also

used ozone baths. It is a machine that I have designed that gives

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ozone. In addition, I have used herbal therapy. In addition, massage therapy, stress-reduction techniques, meditation. It is a complete program that takes about 3 weeks to be completed.

But chelation has another effect, in addition to opening up arteries and veins. It is a very powerful anti-oxidant. And it can repair

cells in the body that have been damaged. And the whole mechanism of how chelation works is not fully understood. Some of it is

by increasing circulation. Some of it is by repairing free-radical

damage that has been done for whatever reason: viruses or chemicals in the body.

Mr. BURTON. Do you put large infusions of various kinds of vitamins into the chelating material?

Dr. MARCIAL-VEGA. Yes, I do. Sometimes I combine it, especially

in patients with cancer or immuno-suppressed states, with high

doses of vitamin C. Sometimes as high as a 100,000 milligrams.

Most people take 1,000 milligrams a day as a supplement. So this

is 100 times that. Intravenously.

Mr. BURTON. Does that have an adverse impact on their kidneys

and other vital organs?

Dr. MARCIAL-VEGA. Not if it is given properly. Again, kidney

function, like the doctor here was mentioning, is very important.

And as long as that is done, there are no side effects.

Mr. BURTON. OK. I have a pretty hard question, and then I will

accede to my colleague here. I suspect from your testimony, and the

testimony of other doctors with whom I have talked about the chelation therapy and alternative therapies, that there is not only a

bias by the conventional medical system, the AMA, the IMA, Indiana Medical Association, and all the medical associations, but that

there might be some kind of a—I don’t like to use word ‘‘conspiracy’’—but an organized opposition to these alternative therapies because it might cut into the profits that they might be making from pharmaceutical companies or other specialties. Do you

have that kind of suspicion? Or is there any indication that you

have seen that that is the case?

Dr. Chappell.

Dr. CHAPPELL. Well. I don’t have any firsthand knowledge of any

conspiracy as such. But I think that it has evolved. There certainly

are some financial interests. There certainly are some people that

crop up all over the place with the same type of message that has

been very obstructionist. And we certainly have some suspicions

that at least there is a lot of talk among people that are opposed

to chelation therapy, and they seem to coordinate their efforts to

a certain degree.

Mr. BURTON. Dr. Rozema.

Dr. ROZEMA. I think it is interesting, as long as I have been involved with chelation now, 16 years, to go to the meetings and listen to the stories of the doctors who have had charges brought

against them for doing medicine which is outside that which is ordinarily practiced within their State. That is usually how it is

worded.

They are doing something different. There is activity going on

now in many States to bring legislation to allow practitioners to

use what they know works.

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I know that if you go to your doctor, the first thing he is going

to say was, ‘‘How do you feel?’’ It is a marker; it is a measure.

Can you measure that? No. But do you know it? Yes.

The comment was made earlier about evidenced-based medicine.

We all do that in our practice—evidenced-based. You were in this

condition to begin with. This was an intervention during this other

condition after the intervention. And we can measure that. Outcomes-type research.

I think there is a bias in the fact that, if you want to call it

standard medicine or the establishment medicine, AMA-based medicine likes to use scientific studies, scientific research as words to

hide behind. All of us in medicine practice evidence-based medicine.

Only 20 percent of everything we do in medicine has been shown

to stand up to double-blind, placebo-controlled studies. So 80 percent of what we do in medicine is because we have learned it in

school; we have practiced on our patients; we all do this, and we

use what we know works best.

I was concerned, as I mentioned in my testimony, about the FTC

hosting a Dallas meeting with the States attorney generals and the

Federation of State Medical Boards. And there has been some talk

about getting rid of chelation therapy and using the States to do

that, and the FTC to help do this.

And this concerns me because it is not the patients that are

bringing this up to any authority. If you go to the States and find

out who has made a complaint against a physician, it is usually another physician. It is not a patient. Patients are satisfied.

Mr. BURTON. I think I get the gist of what you are saying. We

have some people from the FTC here today. We are going to talk

to them about that.

Dr. LEVIN. I don’t have any firsthand experience with a conspiracy type of scenario. I agree with what Drs. Chappell and

Rozema were saying. There appear to be certain people, or names,

that crop up a lot of times around different trials for individuals

and against chelation therapy, in general.

I think to pick up on what Dr. Rozema was saying about the double-blind, placebo-controlled studies being the gold standard by

which a treatment is judged, a factor that is not considered is that

there are some very significant, inherent limitations in those types

of studies, because there are certain factors that are extremely important that don’t get thrown into the equation, at all: emotional

states, dietary factors. There is a lot of basic and cutting-edge scientific information. There is a whole field of what is called psychoneuro-immunology, which basically shows, beyond any shadow of a

doubt, that every thought we have, especially those with a lot of

feeling behind them, has significant effects on our physiology and

on our biochemistry.

When these studies are being done, that just doesn’t come into

the equation at all, nor does dietary factors. Is someone eating a

lot of margarine which is very, very toxic, or processed oils? What

is being used as the gold standard really isn’t so gold.

Mr. BURTON. Dr. Vega.

Dr. MARCIAL-VEGA. In my experience there are three major reasons why there is some bias. No. 1, physicians are afraid—conventional physicians. One of the reasons is persecution from governVerDate 11-MAY-2000 08:25 May 03, 2001 Jkt 010199 PO 00000 Frm 00112 Fmt 6633 Sfmt 6602 E:\HEARINGS\59973 pfrm04 PsN: 59973
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ment agencies. But most importantly, they are afraid that other

physicians will stop referring patients to them, if the referring physicians find out. ‘‘Why is he giving these herbs to this patient of

mine?’’ They may be seen as practicing medicine that is not considered ‘‘the norm.’’ My practice is not based on referral from other

physicians. So that is not a factor for me to decide what is best for

my patients.

But in most physician practices, they depend on other physicians

and their opinions, in terms if these physicians think they are

doing something too forward. That can stop their referral. That can

stop their income. That is one of the things that I have seen.

No. 2, grant money. I have been involved with grants, directly

and indirectly, for most of my medical life. The two things that

most of my professors taught me were, ‘‘Get a grant for as long as

you can,’’ and ‘‘Get as much money as you can.’’ Then, ‘‘Try to do

something good about it for humanity.’’ That was No. 3.

There is a propensity toward stretching a grant, getting money

for a long time, and giving the results not very quickly, but taking

as long as you can to give a result. I have lived it and I know this

is a fact.

No. 3 will be insurance companies. Insurance companies do not

control so-called ‘‘alternative medicine,’’ which includes herbs, massage, and other things. Because insurance companies do not control

that and that is a lot of the momentum and drive of medicine in

the United States, obviously, that is another bias against it.

Mr. BURTON. Well, I think I have exhausted my questions. I

would just like to make a couple of real quick comments. I would

like to have any statistical data you can give us, any patient

records you can give us, as many as possible. Like I said, you can

mark out their names or anything that would be sensitive materials, but we would like to have that so we could use that in further testimony.

Did you have any questions you would like to ask really quickly?

Mr. Kucinich.

Mr. KUCINICH. Thank you, Mr. Chairman. I just have a few questions to any of the panelists.

Are there any, that you know of, health insurance policies that

cover chelation therapy, Dr. Rozema?

Dr. ROZEMA. In our area, in the northern end of the western portion of South Carolina, there is a company called the Michelin

Corp. Most of us, I think, ride on tires made by Michelin. They

have their U.S. headquarters. I was very surprised, a short time

ago, when a patient came in and brought his benefits and his covered medical services book to the office. In that book, EDTA chelation therapy was a covered service for atherosclerosis, degenerative

disease, and, by the way, lead poisoning, which is one of the only

accepted reasons to use EDTA.

Mr. KUCINICH. Dr. Chappell.

Dr. CHAPPELL. We did a survey of that in our chelation office

about 2 years ago. We found that there were 13 or 14 insurance

companies that had covered it for individual cases. It is probably

most likely if you present that: This patient is scheduled for a

$40,000 bypass procedure; would you be willing to spend $3,000 to

see if we can avoid the procedure? Sometimes they will approve

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that on a person-to-person basis. But very few have a policy of covering chelation therapy.

Dr. LEVIN. That is my experience also. If you have a policy that

covers it. Although we have had patients over the years submit

their bills to insurance companies and have been reimbursed to

varying degrees—maybe from 30 to 80 percent of the charge, which is about $100 a treatment.

Mr. KUCINICH. So would all of you agree that, when the issue of

cost-effectiveness comes up, chelation therapy has certain advantages which are then recognized by a few insurance companies?

Dr. CHAPPELL. Yes.

Mr. KUCINICH. Would you say, Dr. Chappell, is that how you pronounce your name?

Dr. CHAPPELL. Yes.

Mr. KUCINICH. Would you say that the difference in cost between

the more conventional therapy for dealing with cardiovascular disease and chelation therapy is pretty consistently the ratio that you

have talked about, almost 10 to 1?

Dr. CHAPPELL. Sometimes it is much more than that. I have one

patient that came to me after spending 350 days in the hospital for

a 3-year period. He had had one bypass, but multiple angioplasties

and five heart attacks. He totaled it up. He had spent $640,000 and

his insurance covered every penny of it. He had spent one-third of

his life in the hospital for the previous 3 years. After chelation, for

the next 3 years, he spent 1 day in the hospital for observation. It

turned out to be a muscle spasm. With me he spent, maybe $5,000,

and his insurance refused to pay a penny of that, even though we

demonstrated that we had just saved them $600,000-and-something. It can be very dramatic at times.

Mr. KUCINICH. When you do your reports, which in effect summarize the treatment for any given patient, is it much the same

kind of dictation that takes place where an allopathic practitioner

might give a comprehensive medical report, if you are using chelation?

Dr. CHAPPELL. Yes.

Mr. KUCINICH. That having been said, wouldn’t it be helpful,

without divulging, of course, names and confidential information

about individuals, to make those reports available in a way that

could indicate the value of chelation therapy to a wider community?

Dr. CHAPPELL. Perhaps.

Mr. KUCINICH. So, one of the things that the chairman and I

have been talking about is if the medical library that puts things

online here would consider some of the publications which summarize cases which you speak of, anecdotally, but do it in a scientific

way, that could help advance the public awareness of, and also the

appreciation for, chelation therapy.

Mr. BURTON. If the gentleman would yield real quickly. We

talked about this a little bit earlier. If we could get a compilation

of cases, like all of you are talking about, and go through and put

those in some kind of a report-type form, the two of us would be

happy to co-sponsor a letter—and maybe get a lot of other Members to be involved, too—to these journals that publish statistical

data and information for the medical community; get them to pubVerDate 11-MAY-2000 08:25 May 03, 2001 Jkt 010199 PO 00000 Frm 00114 Fmt 6633 Sfmt 6602 E:\HEARINGS\59973 pfrm04 PsN: 59973
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lish the report that we come up with and ask them to get that out

for doctors across the country.

Dr. CHAPPELL. We could sure try that. When we have tried similar-type things in the past, it has been dismissed as anecdotal.

Mr. BURTON. Well, you are talking to some Congressmen, now.

[Laughter.]

Mr. KUCINICH. You know, what’s anecdotal is one thing. I can

well understand the concern of the not-alternative medical community to having folklore be the basis of scientific decisions. However,

in your presentations here, and you are all M.D.’s, there is a structure of communication of systematized gathering of knowledge on

individual patients, which I suppose could be presented in a way

that would present itself as fairly analytical—not just fairly, but

strictly analytical—where you can actually see the differences. You

present the differences between the physical condition that was

presented at the beginning of therapy and what was presented

after therapy. That, then, would seem to be to me, if you have parallel structure for the presentation of your cases, it seems to me

you have a stronger argument.

The chairman has come up with a suggestion which, I think, is

a great suggestion. I share his willingness to pursue to this. If we

can include the entire body of testimony from these hearings and

make that available in bound form—it’s a publication. We issue

these as publications from the House. Get that as something that

would be available to the people in the science that is behind what

you do, because there is a science behind it. It may not be the

science that some would pick for their approach, but there is a

science behind it.

Thank you, Chairman.

Mr. BURTON. Yes, let me conclude with this panel by saying that

we can send copies of this kind of information to the Agency for

Health Care Policy Research—Beth just told us about that—and to

some of these other agencies and really try to force the issue; make

them look at it and ask them to write back to us and give us their

analysis of it.

Sometimes, like you said, it takes 5 or 6 months for you to get

a response and then it is just some kind of a pacifying letter that

really doesn’t say anything. They usually respond to us with a little

more detail. So, we probably could get a little better result from

that. We need to have the statistical data, the case work that you

have done, and the results that you have accomplished, so that we

can really make a case for that. We will try to get other doctors,

as well.

Let me end up by, first of all, thanking for you for being here.

Second, you told me, one case that I was really interested in was

a guy that ran a marathon—which one of you did that?

Dr. CHAPPELL. That was myself.

Mr. BURTON. Was it you that ran the marathon?

Dr. CHAPPELL. Yes, it was.

Mr. BURTON. It was you?

Dr. CHAPPELL. I was the patient there.

Mr. BURTON. And you had occluded arteries?

Dr. CHAPPELL. Yes.

Mr. BURTON. And you ran a marathon?

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Dr. CHAPPELL. Yes.

Mr. BURTON. Well, I admire you and I think you are crazy, too.

[Laughter.]

Dr. CHAPPELL. So did my wife.

Mr. BURTON. The second thing that I’d like to say is that I have

had some personal experience, on another subject, with stomach

problems. I incurred a very severe stomach problem in Africa.

When I was senior Republican on the Africa Subcommittee, I traveled all over Africa. I went to stomach doctors all over the place.

They took little samples of my stomach tissue and everything else.

They told me it was nerves and all kinds of things and gave me

Zantac and Prilosec and everything else.

I read an article by a fellow named Dr. Barry Marshall. He said

that it was caused by a H-pylori bacteria. I went to see him down

at the University of Virginia. He tested me. Within 2 weeks I was

normal and haven’t had a stomach problem since.

He went before a medical group gathering in Belgium and gave

a speech on his theory. They laughed him off the stage. He went

home and drank the bacteria, then cured himself. Now, I think he

ought to get the Nobel Prize for scientific research because he is

going to cure, probably, ultimately, billions of people from severe

stomach problems. Even some people who had cancer of the stomach were cured.

But the point I am trying to make is that many times people like

you fellows, who actually lay your reputations on the line by trying

new therapies, are not unlike Louis Pasteur and Dr. Marshall, who

ultimately are proven to be accurate. I admire you for doing that,

because you are not only helping people, you are also paving the

way for new and innovative procedures that are going to help people.

I was watching television last night, just as a coincidence, and

I watched a movie called ‘‘Lorenzo’s Oil.’’ I don’t know if you have

ever seen that movie. I wish everybody at the Health and Human

Services and FDA would watch that movie, because they had some

people from the FDA that actually tried to block and obstruct people from getting Lorenzo’s Oil, even though their children were getting progressively worse, to the point where they just died.

To me, when somebody is adjudged ill and there is no cure, for

us or anybody—FDA, Health and Human Services, anybody—to

say, ‘‘Hey, we can’t do anything more for you. Go home and die,’’

I think that is criminal. There ought to always be hope. You folks

are helping to perpetuate hope in a lot of people and doing more

than that. You may be curing a lot of people. I really appreciate

it.

This committee, one of its primary goals is to look into every single area where Health and Human Services, the Food and Drug

Administration, and the Federal Trade Commission are blocking

new research. We are going to be hauling them before this committee on a regular basis—they will get sick of seeing my face before this is over—to make sure that we are not blocking something

that is going to save lives.

I don’t know if you fellows have to leave right away. If you would

like to stick around while we talk to the people from the other

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agencies, you are welcome to do so. Maybe afterwards, we can talk

a little more informally about some things.

With that, thank you very much. I really appreciate your testimony.

The next panel is Dr. Lenfant, Dr. Lindberg, and Ms. Bernstein.

Would you come forward, please? Would you stand so that I can

swear you in, please?

[Witnesses sworn.]

Mr. BURTON. Let the record reflect that the witnesses responded

in the affirmative and then we will hear your testimony.

I’ll tell you, we don’t have a lot of cameras here today like we

sometimes do when we have hearings. The information that you

are going to give to us will be widely disseminated. And my colleagues, I can assure you, will be privy to your testimony.

So, Dr. Lenfant, do you want to start?

STATEMENTS OF CLAUDE LENFANT, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD INSTITUTE; DONALD A.B.

LINDBERG, M.D., DIRECTOR, NATIONAL LIBRARY OF MEDICINE; JOAN Z. BERNSTEIN, J.D., DIRECTOR, BUREAU OF CONSUMER PROTECTION, FEDERAL TRADE COMMISSION, ACCOMPANIED BY DEBORAH VALENTINE, GENERAL COUNSEL,

FEDERAL TRADE COMMISSION

Dr. LENFANT. Thank you, Mr. Chairman. As you heard from the

previous panel, the first observation that chelation may improve

some symptoms of a disease was made in 1950. The interest for

this procedure remained somewhat insignificant until the early

1980’s.

But then, the interest grew markedly, I suppose because this occurred at the time that we began to recognize the potential for alternative medicine. We at the National Heart, Lung, and Blood Institute began to receive many inquiries about chelation. They came

from the public and some practicing physicians as well. Our response, at that time, was that we had no evidence in support of or

against chelation to treat atherosclerosis.

At the same time, we were encouraging investigators to initiate

studies, but no applications were ever submitted to the Institute.

In the early 1990’s, two well-designed studies were completed, one

from Denmark and the other one from New Zealand. Both showed

no beneficial effect of chelation therapies. And these, I have to say,

were the bases for the public fact sheets that we have distributed

ever since.

We are well aware of the work done by Dr. Chappell and, in particular, the meta-analyses that he conducted some time back. He

came out with a very provocative conclusion, but it is not and cannot be a substitute for the gold standard and that is a blinded, randomized clinical trial.

Eventually, we had some discussions with one investigator who

approached the Institute about starting an application that he

wanted to submit. However, as was pointed out earlier, this application was not submitted and actually was not submitted at nearly

the 26th hour. The same application finally appeared last year, but

under a different name, different investigators and from a different

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institution. Unfortunately, it did not do well when reviewed by scientific peers.

Since, we have had many contacts with the investigator, and I

personally spoke to him on the phone last week. He indicated to

me two things. First, he was satisfied with the help he has received

from the staff of the Institute. But then, at the same time, he had

not decided yet whether he would resubmit the application. So, Mr.

Chairman, I should mention to you that I am aware of a study

which is now on-going in Canada at the University of Calgary.

From the information that I have received, it is very well designed.

If completed as it is expected in the next couple of years, I think

it will bring about some very, very valuable information.

Meanwhile, our position remains the same. We would welcome

receiving applications from American investigators. So far, we have

not received any except the one that I just mentioned earlier,

which unfortunately, did not do well during the review process.

These, Mr. Chairman, are the comments that I wanted to make

before answering questions, which I will be glad to do.

[The prepared statement of Dr. Lenfant follows:]

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Mr. BURTON. Thank you.

Dr. Lindberg.

Dr. LINDBERG. Mr. Chairman, I am happy to describe to you the

operation of the National Library of Medicine. This collects journals, books and scientific literature from about the world. It has

done so since 1836. It has produced an electronic compilation of

those publications since 1969. The Index Medicus, actually, was

produced in 1879. It is an institution that has committed itself to

acquire, organize and disseminate the biomedical knowledge of the

world for the benefit of the public health.

I have been there only since 1984. In the last testimony you

heard an interesting comment about Lorenzo’s Oil and the movie.

There is a real person behind Lorenzo’s Oil and that is the Odone

family. I want to point out to you that it was at the National Library of Medicine that the Odones found the information that they

then were able to apply to curing and saving the life of their child.

They did not find people who were hiding information. They found

medical librarians who welcomed their inquiry and helped them to

get what they needed. So, we consider them to be very much a success.

Mr. BURTON. Well, I hope you will go back and watch that movie

again. Although they did get that information from that source,

there were some obstacles that were thrown up in front of them by

people of that Institute during the course of their investigations

into getting into a final position.

Dr. LINDBERG. I have been on the platform many times with Mrs.

Odone and she is full of praise and gratitude.

Mr. BURTON. Well, we’ll bring her up here and we’ll just see, OK?

Dr. LINDBERG. That would be a good idea.

Today, just fast-forwarding, the Library of Medicine receives

22,247 periodicals. Of these, we index approximately 4,000 for

MEDLINE, which is our primary data base of journal article references and abstracts. The printed version is called Index Medicus.

It now runs 18 volumes and 35,000 pages. This is basically a pretty

comprehensive compilation of the world’s literature.

The electronic MEDLINE data base contains 11 million references. Now I should say that all journals, whether they are in

the printed or the electronic form, or just collected by the Library,

are available to be read at the Library as the Odone’s did or to be

sent on inter-library loan to readers anywhere in the United

States. We are supported by a national network of libraries of medicine, which is something for the country to be proud of.

I should comment to you on the manner in which journals are

selected by NLM, to be either purchased or indexed or both. In

this, the Library depends upon a committee of outside experts, duly

appointed through the NIH process and compliant with the Federal

Advisory Committee Act. We call this the Literature Selection

Technical Review Committee. The committee meets three times a

year. It is composed of medical scientists, administrators, health

practitioners and librarians. At each of the meetings they review

120 to 150 new titles. It is surprising to us that 300 to 400 new

journals arrive every year. These journals are nominated by publishers, health professionals, and librarians. In other words, we

take their advice about which to look at.

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The committee looks to see that a journal’s contents are predominantly core biomedical subjects. If so, then the entire journal is indexed from cover to cover. More importantly, they assess the scientific merit of a journal’s contents and consider its contribution to

the field and also the quality of the editorial processes. These are

features like evidence of objectivity, credibility, the quality of the

contents, external peer review of articles, adherence to ethical

guidelines, publication of retractions, correction of errors and publication of dissenting opinions, of course.

Of the titles reviewed at such a meeting, generally, around 20

percent are recommended strongly for indexing. That is about what

we can manage to get on the data base. Since I came to NLM, incidentally, we have added 1,000 journals to the MEDLINE.

Often the committee, which is a finite number—10 to 12—feel a

need for advice by additional experts in special areas. They, of

course, can’t know everything. So I want to move on to how they

acted in the area of complementary and alternative medicine.

In September 1997, Dr. Wayne Jonas, who was then head of the

NIH National Center for Alternative and Complementary Medicine,

was invited to speak to the NLM Board of Regents. He did and he

presented a talk on the subject and his organization. After that, his

center gave us a list of 695 journals that published most of the articles in his field. We took his advice and NLM then sent that to 14

organizations that specialize in complementary and alternative

medicine, a number of these nominated, and in some cases funded

by Dr. Jonas. I have appended a list for you.

Of those 695 journals, we found that we already owned 79 percent. We already collected them and identified them. They were organized and in the Library. Based on the review we collected, we

added six more. We added a certain number to the MEDLINE electronic file, as well.

The fact that a journal is or isn’t on that list is of some importance, but following that up, there are 74 journals from the list

that we do index in MEDLINE that are considered by that center

to be fundamental to complementary and alternative medicine. I

can give you that list, also.

[NOTE.—The information referred to is retained in committee

files.]

Dr. LINDBERG. I understand that the committee is specifically interested today, amongst all the complementary and alternative

medicine, in modalities in chelation therapy. Let us take a look at

what MEDLINE has to say about that.

The term ‘‘chelating agents’’ has existed in our controlled indexing vocabulary since 1966. Many specific agents are included under

that. The term ‘‘chelation therapy’’ was introduced in 1990. If we

search MEDLINE under chelation therapy we get 59,600 references. If we narrow the search in the therapeutic use of chelating

agents and cardiovascular disease, there are 762 references. There

is big literature out there. We do our best to choose, fairly and consistently, in the journals that we add. We are definitely in the business of providing information not only to healthcare professionals,

but the public, as well. There is a MEDLINEPlus designed for the

patients’ families and the public.

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We are completely open to all of these new areas, and include

chelation therapy for cardiovascular or any other purpose. Thank

you for the chance to be with you.

[The prepared statement of Dr. Lindberg follows:]

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Mr. BURTON. Thank you.

Dr. Bernstein.

Ms. BERNSTEIN. Thank you very much, Mr. Chairman. I am

Joanie Bernstein. I am the Director of the Bureau of Consumer

Protection at the FTC. With me this morning is the agency’s general counsel, Deborah Valentine who, if it is appropriate, may wish

to join me at the table.

Thank you for the opportunity to be with you today and to provide this information, particularly about the settlement of the

American College for the Advancement of Medicine with the Commission.

First, a brief word about the Commission’s mission. It really is

to prevent unfair competition and protect consumers from unfair or

deceptive acts or practices in commerce. As part of it, the Commission has long sought to encourage the dissemination of truthful advertising. We have approached it two ways. The first is, where it

is appropriate, we have challenged private restraints on truthful

advertising. And second, we have a longstanding program of challenging misleading claims in advertising. It is particularly important, the Commission believes, in healthcare advertising.

Each year, consumers spend billions of dollars on products and

services in this field. Advertising plays an important, we think,

often vital role in informing consumers about the availability, the

cost and other features of these products and services. If the advertising is misleading or deceptive, the consequences for consumers

can be especially serious, causing not only economic injury, but creating risks to consumer health and safety. For this reason, the

Commission has paid close attention to deceptive advertising

claims for a wide variety of healthcare-related products and services.

I want to address some of the questions you raised in your correspondence with the Commission, Mr. Chairman. First, you focus

specifically on the settlement with the American College for the

Advancement of Medicine. In that case, the Commission has alleged that ACAM, if we may call it by its briefer name, promoted

chelation therapy directly to the public as an effective treatment

for atherosclerosis, through an Internet website and through brochures that it distributed directly to consumers who contacted

ACAM.

Our inquiry focused on two claims that ACAM allegedly made to

consumers. The first claim, which is alleged to be false, is that scientific studies show that EDTA chelation therapy is an effective

treatment for atherosclerosis. Second claim, which is alleged to be

unsupported by reliable scientific evidence, is that EDTA chelation

therapy is effective in treating atherosclerosis.

The staff then investigated, in order to formulate those complaints; conducted an extensive review of information concerning

this therapy; reviewed information, principally from ACAM, and

also from other sources. They conducted a literature search and

consulted with experts in the treatment of atherosclerosis and with

other Government agencies. In the settlement process which then

followed, staff met with ACAM attorneys on numerous occasions

and advised them that staff believed that the existing scientific evidence did not support ACAM’s claims.

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ACAM representatives then met with me and each of the commissioners to present their arguments against the staff’s recommendations. Following these meetings, ACAM again met with

staff and decided to enter into a settlement of the allegations. On

December 8, 1990, the Commission accepted, subject to public, an

agreement containing a consent order. This order would ensure

that advertising and promotional claims relating to chelation therapy, distributed by ACAM to consumers, was both truthful and

supported by competent, reliable scientific evidence. These are the

same standards as would be and, indeed, are applied to all

healthcare advertisers promoting products and services as treatments for serious diseases.

It is important, I think, critically important to focus on, as we

have tried to do, what the order does not do. The proposed order

does not restrict patient access to medical treatment. It does not

restrict a physician’s use of chelation therapy. It does not regulate

how individual doctors use or prescribe drugs in the course of treating or advising their patients, or other choice of therapy issues. In

other words, Mr. Chairman, members of the committee, each of the

doctors whom you heard at the first panel could continue to practice medicine in the exact same way as they are doing now, based

upon their experience in their practices and their views and opinions, based upon the administration of that therapy. The proposed

order—the Commission’s proposed order—only applies to representations made in advertising and promotional material by ACAM.

Consistent with that policy, the Commission’s analysis to aid

public comment which was issued in conjunction with the proposed

settlement states, ‘‘The Commission’s actions should not be construed to regulate how doctors use or prescribe drugs in the course

of treating their patients or other choice of therapy issues.’’ Your letter also raised additional questions concerning the staff’s

interaction with other Federal and State agencies concerning chelation therapy. As explained in our fuller, written testimony, at various times in the proceeding Commission staff consulted with the

Federation of State Medical Boards, individual State medical

boards and other Federal regulatory enforcement agencies in regard to chelation therapy.

In general, the primary purpose of these contacts has been to collect information regarding the therapy. Such contacts are a routine

part of the Commissions efforts to maintain an active and coordinated program in the healthcare field. The proposed order in this

case, as I indicated earlier, is now on the public record. Commission received a substantial number of comments on the proposed

settlement. When the comment period is closed, the staff reviews

the comments, makes a recommendation to the Commission. The

Commission will review all that information, including all of the

comments, and decide what action to take. Thank you.

[The prepared statement of Ms. Bernstein follows:]

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Mr. BURTON. Dr. Bernstein.

Ms. BERNSTEIN. Yes.

Mr. BURTON. Does this order that you entered into with them,

does that prohibit a doctor from talking to their patients about alternative therapies such as chelation therapy?

Ms. BERNSTEIN. No, it does not.

Mr. BURTON. It is only advertising?

Ms. BERNSTEIN. Only advertising.

Mr. BURTON. As I understand it, you said that you had public

comment about this before a decision was reached?

Ms. BERNSTEIN. What I said was that once the Commission provisionally accepted, that is conditionally accepted, the settlement— which is a routine way in the Commission operates—it is placed on

the public record and a request for public comment is made. We

are in that comment period now, which ends the end of March. We

are receiving comments from the public at this time.

Mr. BURTON. I have here, I think, all the comments that you

have received so far?

Ms. BERNSTEIN. Yes.

Mr. BURTON. And as I understand it from my staff, it is about

97 percent positive that chelation therapy has been beneficial. Are

you aware of that?

Ms. BERNSTEIN. We have not completed our review of the comments. My information is that there are almost 800 comments.

Many comments are positive about, particularly, alternative medicine in general. They are in support for alternative medicine, some

specifically to chelation therapy. But you are quite correct that a

large majority appear to be in support of chelation therapy.

Mr. BURTON. As I understand it, the reason that the ACAM settled was because they were concerned about the long-term, high

legal costs that they would incur if they had to fight this thing.

They thought discretion was the better part of valor because they

didn’t have the money. Are you aware of that?

Ms. BERNSTEIN. I think that is frequently a concern of any organization that makes a decision about whether to litigate a matter

such as this.

Mr. BURTON. So the Government comes with a sledge hammer

and makes an accusation and the organization either has to acquiesce or go bankrupt.

Ms. BERNSTEIN. Well, it often doesn’t cost that much.

Mr. BURTON. That is not what ACAM told us. They just simply

didn’t have the resources so they had to acquiesce. I think that is

kind of unfortunate, especially if they have a valid argument they

want to make. It really is.

Ms. BERNSTEIN. I believe they had every opportunity to make all

of their arguments to the Commission that were heard. I would not

like to think that we proceed in this organization, or any other,

with a sledge hammer. I don’t believe we have in this instance. I

don’t believe it is the intention of the Commission to have us proceed in that fashion.

Mr. BURTON. This folder I have here has all the responses you

received. Well over 90 percent support the theory that chelation

therapy has helped these people—over 90 percent—and yet they

had to pay a penalty. Doctors around the country are in jeopardy

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of losing their medical license if they don’t stop, cease and desist

using chelation therapy.

Ms. BERNSTEIN. I think that is not correct, Mr. Chairman.

Mr. BURTON. We don’t have doctors being threatened in individual States with losing their medical licenses?

Ms. BERNSTEIN. Not by the Federal Trade Commission.

Mr. BURTON. No, I understand. But you are working with those

States, I believe, aren’t you?

Ms. BERNSTEIN. We are not working with the States in regard to

licensing. We have worked with the States, as we do with States’ Attorneys General and other organizations where there is a law enforcement matter, where we coordinate or share information.

Mr. BURTON. Dr. Lenfant, you get $1.5 billion in your budget, is

that correct?

Dr. LENFANT. Yes.

Mr. BURTON. How much of that do you spend on alternative

therapies, such as chelation?

Dr. LENFANT. On chelation, nothing. Well, chelation for atherosclerosis, nothing. We do support a great deal of work for other chelation therapies, such as for Cooley’s Anemia, for example. But that

is no longer considered alternative medicine. To answer your question, we support approximately $5 or $6 million in alternative medicine. I should say, so that you understand

the context within which we provide that amount of support, we

have solicited applications in alternative medicine and we receive

very few—very, very few.

Mr. BURTON. For chelation therapy?

Dr. LENFANT. No, not on chelation. Just alternative medicine.

Mr. BURTON. I wonder why that is? There are a lot of people interested in Chelation therapy.

Dr. LENFANT. Well, yes. Yes, from what I understand here from

the previous presentations made to you, it would appear that chelation therapy and alternative medicine are in the practice of the private physician, rather than the academic setting. Of course, all the

National Institutes of Health is primarily researchers from academic institutions.

As I am sure you know, Mr. Chairman, the previously named Office of Alternative Medicine, has become a stand-alone at the National Institutes of Health. I think that is going to increase the visibility of that program tremendously. We are beginning to receive

some applications from academic institutions.

Mr. BURTON. So it should be directed to them first?

Dr. LENFANT. Many programs at NIH are shared between various centers of the Institute. My belief is that, for example, would

an application come on chelation therapy for the treatment of atherosclerosis, it would be dually assigned to the Center for Alternative Medicine and to the Institute. The one application that I

mentioned earlier, the one from the University of Missouri, was exclusively and solely assigned to the National Heart, Lung, and

Blood Institute. I want to say it one more time. We would have

supported that application if it had passed peer review.

Mr. BURTON. What would you say if we had the doctors who are

here assembled today, if they sent in a couple of thousand cases

where there had been positive results from the chelation therapy?

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We put that in a binder with a report and sent it to you. Would

you review that? Or is that not the way you do things over there?

Dr. LENFANT. Well, if we would get this data, most likely I think

it would probably go to the Agency for Health Care Policy and Research. Should that come to us, we would certainly look at it and

hand out an opinion on it. That is not quite the same thing as submitting a proposal to undertake a research project. I was discussing with one of your previous witnesses this issue during the

recess and said to him, ‘‘Why don’t you send an application?’’ The

fact, Mr. Chairman, is that we do not receive applications.

It is true that today our budget is, in fact, $1.8 billion for 1999.

During the last 20 or 25 years we have received over 50,000 applications for research grants.

Mr. BURTON. Excuse me for interrupting. I didn’t want to lose

this thought. My staff said that several leading medical research

institutes contacted your office and were discouraged from submitting applications. Is that not correct?

Dr. LENFANT. Mr. Chairman, I heard you say that when you introduced this hearing. All I can say is that I don’t know about it.

I am the Director of the Institute, none of these interested investigators came to me to mention that to me. If they had done it, I

would have acted upon it.

Mr. BURTON. Well, why don’t we do this in order to eliminate any

misunderstanding. Why don’t we contact those institutes and have

them submit their applications through us. We will give them to

you directly. We will take them right to your office and lay them

on your desk.

Dr. LENFANT. That would be fine to me. They will be reviewed

and fairly reviewed. And then we will see what peer review comes

up with.

Mr. BURTON. We will get to work on that right away.

Dr. LENFANT. Again, Mr. Chairman, I really would like to say

that we support approximately 25 percent of the applications that

we receive. The 75 percent that are not supported always say that

the system is flawed. I cannot blame them for it. I guess if I would

be in that position, I would do that as well. But the fact of the matter is if an investigator feels that he or she has not been treated

appropriately by the Institute, again, they should come to the Director of the Institute and say what is going on there. I can tell

you in my case, I would have addressed that.

Mr. BURTON. All I can tell you is that we will contact those institutions. We will get their submissions, which they have already

sent to you and haven’t received any response. Or they have been

discouraged, I guess. And we will be sure to put those right in your

hand. In fact, I will be happy to come over and give them to you,

personally. How is that?

Dr. LENFANT. I’ll come down and get them.

Mr. BURTON. Well that’s good. We’ll have lunch. [Laughter.]

Mr. WAXMAN. Mr. Chairman, I have a conflict.

Mr. BURTON. Well, you know, Mr. Waxman, you have been gone

all day. We have been sitting here hearing testimony. We had doctors, prominent, eminent doctors here, testify about the efficacy of

chelation therapy. You weren’t here to hear their testimony, which

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was disconcerting. If you need to have 5 minutes now, we will give

you 5 minutes.

Mr. WAXMAN. Mr. Chairman, I don’t need a lecture from you on

how to do my job. I have conflicts in my schedule. I am sorry that

I was not here to listen to all the witnesses. I would have regretted

not being here and not listening to other people in other meetings

that I have at the same time. But I am entitled under the rules

to be able to ask questions, and the Chair went 5 minutes beyond

when his time had expired. After I leave, He can continue on in

another round. Those are the rules; so let’s follow the rules. Under

the rules, I want to ask some questions.

Dr. Lenfant, when you get a request for a grant proposal do you

have uniform standards by which you evaluate proposed grants?

Dr. LENFANT. That is correct. At the first place, it is not reviewed

by the Institute. In fact, for a very simple reason: in order to eliminate biases for or against the application. It is reviewed by an independent unit of the National Institutes of Health.

Mr. WAXMAN. You don’t have a different standard for proposals

regarding complementary and alternative treatment than you do

for any other proposal?

Dr. LENFANT. Not me.

Mr. WAXMAN. Not you or your Institute?

Dr. LENFANT. Not me or my Institute. I must admit that I am

very troubled by what was said by the chairman that some people

or investigators came and said they were told not to submit an application, because that should not have been done. There is only

one person in our Institute who has the authority to say that. And

that person does it, always, when that needs to be done, after

checking with me.

Mr. WAXMAN. I believe that you testified that, of the tens of thousands of grant proposals the NHLBI has received in the past 30

years, only three have addressed chelation therapy as a treatment

for heart disease?

Dr. LENFANT. That is correct. Only one was on clinical studies,

and the two other ones were some more basic aspects of it.

Mr. WAXMAN. Were these proposals evaluated with the same criteria that other proposals are evaluated?

Dr. LENFANT. My answer to that would be ‘‘yes.’’ Mr. WAXMAN. Dr. Bernstein, if an association of doctors ran advertisements making unsubstantiated efficacy claims regarding coronary artery bypass surgery, would the FTC take action against

the association?

Ms. BERNSTEIN. Yes, we would if we had evidence that they were

not substantiated or were false.

Mr. WAXMAN. Are such claims being made now?

Ms. BERNSTEIN. Not to our knowledge, Mr. Waxman.

Mr. WAXMAN. How has the advertising community reacted to the

FTC’s policy of requiring that advertisers substantiate their substantive ad claims?

Ms. BERNSTEIN. Extremely well. After the Commission adopted

its substantiation for certain kinds of claims in the 1970’s, in the

1980’s in order to review that policy—that is, requiring substantiation for objective claims, particularly for drugs and medical devices—it was put out for public comment and the overwhelming reVerDate 11-MAY-2000 08:25 May 03, 2001 Jkt 010199 PO 00000 Frm 00148 Fmt 6633 Sfmt 6602 E:\HEARINGS\59973 pfrm04 PsN: 59973
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sponse of the advertising community was that it had served a very

valuable purpose for the credibility of advertising which, of course,

advertisers are critically concerned about as well as the general

public.

Mr. WAXMAN. I know the FTC has a policy prohibiting you from

talking too much about the specifics of your investigation into

ACAM’s claims. However, I have a few general questions about

how you determined that the evidence ACAM offered was not

enough to substantiate the claims they were making.

When the FTC evaluated the evidence provided by ACAM to substantiate its claims about chelation therapy, did the FTC use objective criteria to determine if the evidence was sufficient to substantiate the claims?

Ms. BERNSTEIN. Yes, we did. Yes, we did.

Mr. WAXMAN. Were these criteria the same criteria used to

evaluate all medical claims?

Ms. BERNSTEIN. Correct. Absolutely, correct.

Mr. WAXMAN. Are claims regarding alternative medicine or treatments held to higher standards for substantiation than other medical claims?

Ms. BERNSTEIN. No, they are not. Indeed, Mr. Waxman, we recently published a guideline for substantiation for nutritional supplements—dietary supplements—that has been very well received

by the industry, as well as by consumer groups, to provide guidance. That same kind of guidance is available for any group that

would like to consult with us.

Mr. WAXMAN. The FTC’s actions against ACAM does not prohibit

ACAM from making substantiated claims about chelation therapy,

is that right?

Ms. BERNSTEIN. That is correct.

Mr. WAXMAN. And ACAM is being held to the same standard of

substantiation that anyone who makes a medical claim is held to,

is that right?

Ms. BERNSTEIN. Correct.

Mr. WAXMAN. I think that is important, because people feel like

maybe they are being treated differently. We want everybody to be

treated the same. We want them all held to the same standard. I

don’t care how many letters you get in your file from people who

say one thing as opposed to another. It should not be based on the

number of letters you get, or comments you get. Things should be

based on the substance, the arguments that are made. They ought

to be all held to the same standard, whether they engineer a bunch

of letters or whatever the comments. The comments ought to be

taken on their merits, not on their numbers. Dr. Lindberg are there

objective criteria for selecting journals for inclusion in medicine?

Dr. LINDBERG. Well, I think we try to make them objective. We

certainly have printed rules and guides to evaluation, which are

very similar really, to the same process that is used to evaluate applications for research grants.

Mr. WAXMAN. And are journals regarding complementary and alternative medicine treatment held to the same standards as other

journals?

Dr. LINDBERG. Oh, absolutely.

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Mr. WAXMAN. Can you explain the importance of holding journals

you are going to include on medicine to such exacting standards?

Dr. LINDBERG. I think the whole essence of the Library is that

it has to be open to ideas and it has to be open to users. We are

both. A particular case is of these computer data bases. Since they

can’t literally contain everything in the world worth knowing, they

have to be selected based on our best judgment of high-quality scientific information—high-quality scientific judgments and processes

in writing the journals. And that we try to do, to the best of our

ability, using all the help we can get.

Mr. WAXMAN. I said ‘‘medicine,’’ but I meant ‘‘MEDLINE.’’ You

understood what I meant?

Dr. LINDBERG. Yes.

Mr. WAXMAN. Now, if I must just conclude in another minute or

two—let me apologize to these witnesses and other witnesses, but

I did have your testimony. I have had a chance to review some of

the testimony. Some I am going to read over more carefully. I have

an open mind on this issue. It is sometimes better not to be here

all the time and still have an open mind than to be here all the

time and to keep your mind closed. So I appreciate the testimony

all the witnesses have given.

I also appreciate the courtesy of the chairman by allowing me to

question this panel, under the rules, to which I am entitled. I yield

back my time.

Mr. BURTON. Ms. Bernstein, if a physician uses a pamphlet about

a medical treatment as part of his or her consultation with a patient, not to solicit patients, is that advertising?

Ms. BERNSTEIN. Probably not. It would, of course, depend on the

context of it. Generally we would not consider information provided

directly to a patient by a physician to be advertising, providing

that patient with the appropriate advice that he has sought from

the doctor.

Mr. BURTON. Well, it is my understanding that doctors are being

prevented from printing a pamphlet to give to a patient who is

being treated with chelation therapy.

Ms. BERNSTEIN. That is certainly not because of the Commission’s provisional order. They are not prevented from printing brochures to provide to patients.

Mr. BURTON. Well, my staff says that part of the order says that

if they provide this kind of a pamphlet to a patient, they can be

prosecuted.

Ms. BERNSTEIN. I don’t believe that that is the case.

Mr. BURTON. Well, it is in the order. You have your attorney

there. Can she look that up?

Ms. BERNSTEIN. Yes, that would be fine.

Mr. BURTON. Evidently, ACAM sent a letter to all of their members to that effect; warning them that if they had pamphlets and

they gave it, even to a patient that was getting chelation therapy,

they could be prosecuted.

Ms. BERNSTEIN. ACAM sent the letter?

Mr. BURTON. Yes, but it was based upon your decision.

Ms. BERNSTEIN. You are asking about the letter that ACAM sent

to its members?

Mr. BURTON. We are asking about your decision.

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Ms. BERNSTEIN. Well, our decision, the order simply requires

that a claim that ACAM would make or the advertising.

Mr. BURTON. As I understand it, while you are looking that up,

ACAM was told that, as part of the order, that they should tell

their members that if they even gave a pamphlet to a patient who

was getting, or who might want to take, chelation, that would be

a violation of the agreement and they would be prosecuted.

Ms. BERNSTEIN. That is not in the order. I believe that that’s a

misinterpretation of what the order provides. The order is strictly

limited to advertising claims that would be made by ACAM. It does

not prohibit them from any advertising claim, but requires wellcontrolled clinical trials. If they make a claim, that it is supported

by such studies. They also must have substantiation or support for

any claim they make, if they make a truthful claim. Indeed, we

even gave them examples of claims that they could continue to

make in the course of our discussions with them. If they wanted

to say that it is a therapy that should be considered by a patient,

that would be perfectly all right. The order only goes to making

claims, as they did in the past, that it was scientifically proven

that this was an efficacious claim. And for which they say themselves, I believe today, that they did not have such proof because

the studies had not been conducted.

Mr. BURTON. Could you send me a detailed letter outlining the

limitations that have been put on ACAM so that we can make absolutely sure that is clear to them, what they can and cannot do?

We would like to have it in our records here in the Congress.

Ms. BERNSTEIN. I would be happy to do that. We have it with us.

It is a very short order provision which really goes to substantiating a claim that is made along the lines that I just described.

We would be happy to do that.

Mr. BURTON. We would like to have that.

[The information referred to follows:]

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Mr. BURTON. Now, if a bona fide non-profit medical society maintains a library of information for the benefit of its physician members and the public, and if the society sells to interested members

of the public, from its list of publications, booklets on a medical

treatment, is that advertising?

Ms. BERNSTEIN. No, it’s not.

Mr. BURTON. Is that spelled out in your order, as well?

Ms. BERNSTEIN. No, it isn’t. But we would be glad to provide an

interpretation to that effect.

Mr. BURTON. I would like to have that in writing, too, if we could

have that. That way, there would be some clarification so doctors

would know what they are doing.

[The information referred to follows:]

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Ms. BERNSTEIN. We have made every effort to provide ACAM

with as much interpretation as they would like to have in regard

to both the inquiry and the coverage of the order.

Mr. BURTON. I have a couple of questions for Dr. Lindberg. Does

the Government have a physical location where the 695 journals

that publish alternative medicine articles can be found, or a

website where they are indexed?

Dr. LINDBERG. Sir, we have both. The physical location is at the

National Library of Medicine in Bethesda. There is a Web site

home page, which one can search.

Mr. BURTON. There are 695 journals, I guess, that publish these

alternative medicine articles. You do stock them currently?

Dr. LINDBERG. We hold 80 percent—79 percent, I guess it is

probably 80 by now—of those journals. We don’t hold all the rest.

Many are foreign, of course.

Mr. BURTON. Is that because you just don’t have the room?

Dr. LINDBERG. We can already see the end of the storage capability, which will probably peak out in 2003. But that is not what

is preventing us from getting just a few extra journals. I think,

probably, the collection on alternative medicine and on chelation

really has to be seen as part of the collecting responsibility that we

have, overall. If I could give you just an example from, sort of,

NIH’s point of view of the expanding amount of knowledge and understanding and specialization and consequently the areas in which

we have to draw. I have been there in the Institution only since

1984. Since that time, the following new centers and institutes

have been created by the Congress and brought into effect by NIH:

The National Arthritis Institute, didn’t exist; the AIDS program,

which is over $1 billion a year, didn’t exist; Office of Women’s

Health, didn’t exist; Office of Minority Health; the National Institute for Human Gnome Research; the National Institute for Nursing Research; the National Institute of Aging. The National Center

for Complementary and Alternative Medicine is the latest.

So those all define and expand the universe in which the Library

has to do its best to collect. Of course, it tries to collect the most

important, the most valuable, in each of those fields. In the case

of ACAM, as I indicated, we went to the then director, got his

ideas, had those evaluated by 14 outside centers and ended up

choosing what we thought was the very most important of that new

area.

Mr. BURTON. If they requested to have some of these other journals put in that facility, you would have no objection to those,

would you?

Dr. LINDBERG. It is easier to say ‘‘yes’’ to collecting a journal than

it is to indexing it. Indexing is a costly proposition. You can’t, as

I said, put everything in the world worth knowing into that one

computer system.

Mr. BURTON. Well, we would like to have it indexed—some of

these documents. I guess we could get a list of those and possibly

send them to you. Could you let us know if that would be possible?

Dr. LINDBERG. I am not certain if I understand the question, but

we certainly would respond.

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Mr. BURTON. If we sent a list of journals that are not currently

indexed, and asked you to take a look at putting those in with the

others, you would take a look at that?

Dr. LINDBERG. We would certainly take a look at them. Sure. Of

course.

Mr. BURTON. All right. We will be contacting you regarding that.

Dr. Lenfant, in your testimony you made specific reference to a

Danish study as being high-quality research. It was found by the

Danish Committee on Scientific Dishonesty that the researchers

violated the blind in their trial and that they did not follow the

ACAM protocol, which is the generally accepted protocol used in

the United States. We often hear that conventional science does not

accept many alternative medicine studies because they are not of

high enough quality. Why is it that this study meets your standard

of quality when they violated the blind?

Dr. LENFANT. I have to admit that I am not aware of this problem that you are mentioning. Our statements and acknowledgements that this study was of high quality was one on the design

of the study, as we could see it. But more importantly, on the fact

that it was published in a peer review journal of high ethical and

scientific standards.

Mr. BURTON. Well, it was in the journal.

Dr. LINDBERG. It was probably after the fact.

Mr. BURTON. But the Danish Committee on Scientific Dishonesty

said that the researchers violated the blind in their trial and they

did not follow the ACAM protocol. So, you took a journal that had

that study in it, although it had been somewhat tainted by the

Danish Committee on Scientific Dishonesty, and took that as fact,

I guess.

Dr. LENFANT. I understand, Mr. Chairman. The point that I am

making is that the revelation of this breach in the conduct of the

study was probably published—well certainly, published—after the

study itself was published. So, my statement is what we are saying

is on the basis of the original publication. I have to admit, I know

nothing about the problem that you mention here. We will look into

it. I would like to know where that has been published.

Mr. BURTON. We will get that for you.

Dr. LENFANT. I would appreciate that.

Mr. BURTON. We will get that for you and we will send you a

number of these case histories of people who have been helped by

chelation therapy. I hope you will take a look at those, as well.

I think that just about covers the questions. I did have one little

problem that I had with Dr. Bernstein that I would like to try to

clear up before you leave.

Dr. Chappell is still here and I would like to have him, if he

could, come up real quickly to try to clarify the FTC order language. I guess there is still some misinterpretation. Is Dr. Chappell

still here? Can you come, Dr. Chappell, take one of the microphones and maybe explain that a little bit? Can you elaborate on

that?

Dr. CHAPPELL. Apparently, there was considerable confusion

here. We were definitely told by FTC staff in some of our deliberations that even communication between a patient and a doctor

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would be subject to FTC jurisdiction, if there were brochures handed back and forth. I am glad that this information was changed.

There is no doubt that having an FTC order against ACAM has

a direct impact on what doctors can and cannot say in their patient

consultations, because the pamphlet challenged by the Commission

was used, principally, by ACAM’s member physicians in that context. It was not used as advertising. It was just used as patient

education purposes, in the first place.

Mr. BURTON. Well, here is what we are going to do to clear that

up today. Dr. Bernstein has said that she would give us a letter

clarifying that. Her attorney said they will give us a letter clarifying that. We will submit that to you and the ACAM Board of Directors and that can be disseminated to all of your members. That

should eliminate the possibility of any prosecution as long as you

comply with the decision within that framework. OK?

Dr. CHAPPELL. Sure.

Mr. BURTON. We will try to have that for you very quickly. But

if there is that misunderstanding, we want to make sure it is clarified.

Dr. CHAPPELL. I appreciate that.

Mr. BURTON. And you will do that, right Doctor?

Ms. BERNSTEIN. We would be happy to do that, Mr. Chairman.

Mr. BURTON. What you are saying is that the brochure from doctor to patient did not constitute advertising or violating the agreement?

Ms. BERNSTEIN. That is correct.

Mr. BURTON. OK. Well, we will get that straightened out.

I want to thank you very much for being here today. I know that

the comments from my colleague, Mr. Waxman, might be somewhat accurate in that I do have a bias. My bias is toward people

who are ill or terminally ill and allowing them to have opportunity

that is possible to save their lives.

The reason I feel so strongly about that, so that you will understand my position a little bit better, is my mother and father both

died of cancer in October and November. My wife had breast cancer

and she went into an alternative therapy treatment in Highland

Park, IL. The health agencies in this country, the Food and Drug

Administration and the Health and Human Services, tried to close

that operation down. My wife was given a prognosis that she might

live 5 years if she was lucky. There were 70-some other women in

that program. The FDA did try to close it down. We were able to

keep it open. My wife just passed her 5th year without cancer coming back. In large part I think that it was due to the treatment she

is getting at that facility, which would not have been available had

FDA been able to close it down.

So I think there is an awful lot of people who are suffering from

various kinds of maladies, who are told just to go home and die

when there may be other therapies that might, at least, give them

some hope. I think hope is an extremely important part of science

and survival. For that reason, we want to make sure that this committee does everything we can to make sure that people who do

have debilitating diseases: Parkinson’s Disease and cancer, and so

forth, at least have an opportunity to survive, even though medical

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science may say they can’t take any further treatment that will do

them any good.

With that, Dr. Lenfant, we will be in touch with you very soon.

Dr. Lindberg, we will be in touch with you very soon. And you, as

well, Dr. Bernstein. Thank you very much.

We stand adjourned.

[Whereupon, at 2:15 p.m., the committee was adjourned.]

[Additional information submitted for the hearing record follows:]

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