[House Hearing, 106 Congress]
[From the U.S. Government Printing Office]




  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

                                 ______

                    U.S. GOVERNMENT PRINTING OFFICE
59-973 CC                   WASHINGTON : 1999




                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
JOHN T. DOOLITTLE, California            (Independent)
HELEN CHENOWETH, Idaho


                      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




                            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

 
 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 manmade 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 FDA-approved 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 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 non-profit 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 
open-heart 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.
    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 debates 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:]
[GRAPHIC] [TIFF OMITTED] T6973.014

[GRAPHIC] [TIFF OMITTED] T6973.015

    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:]
    [GRAPHIC] [TIFF OMITTED] T6973.016
    
    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 
board-certified 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.
    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.
    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.
    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.
    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 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.
    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 so-called 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 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 
hard-pressed 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 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 3\1/2\ 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.
    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.
    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.
    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 
alternative-medicine 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 3\1/2\ 
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----
    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.
    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 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.
    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 psycho-
neuro-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 
government 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 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 publish 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?
    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 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 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.
    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.
    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.
    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 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? 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 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 response 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.
    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.
    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 well-controlled 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.
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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.
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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.
    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 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 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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