[House Hearing, 106 Congress]
[From the U.S. Government Publishing 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
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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:]
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Mr. Burton. Thank you, Mr. Kucinich. Any further
discussion? Mr. Horn.
Mr. Horn. I would just like to concur in Mr. Kucinich's and
Mrs. Morella's remarks that we commend you, Mr. Chairman, for
holding these hearings. I am going to have to move in and out
with a few commitments, but I shall return.
Mr. Burton. Thank you, thank you.
We are pleased to open our hearing today with four
physicians who use chelation therapy. Dr. Terry Chappell of
Ohio is the immediate past president of the American College
for the Advancement of Medicine.
You know, those who don't agree with us, I wish they would
stick around to hear some of the testimony.
Mr. Kucinich. If I may, my leaving----
Mr. Burton. It kind of bothers me that, you know, no
disrespect to Mr. Waxman, but he reads the information that
comes in from the agencies, i.e., the National Heart, Lung, and
Blood Institute, and makes a statement about that, and then
leaves before we even have a chance to have the chelation
experts testify. That is disappointing. But we are pleased----
Mr. Kucinich. Mr. Chairman, if I may, on behalf of Mr.
Waxman. He presents a point of view, which is challenging to us
to keep advancing our point of view, but he did have a conflict
which he had to sadly fulfill.
Mr. Burton. Since you are on his side of the aisle, Mr.
Kucinich, I hope that you will convey to him all the relevant
facts that we get from this hearing.
Mr. Kucinich. I will do that, Mr. Chairman. Thank you.
[The prepared statement of Hon. Danny K. Davis follows:]
[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.]
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