Government Hearings On IV Chelation Therapy

    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:]
    INSERT OFFSET FOLIOS 1 TO 7 HERE
    [The official committee record contains additional material here.]
 

    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:]
    INSERT OFFSET FOLIOS 8 TO 13 HERE
    [The official committee record contains additional material here.]

    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:]
    INSERT OFFSET FOLIOS 14 TO 15 HERE
    [The official committee record contains additional material here.]

    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:]
    INSERT OFFSET FOLIOS 16 HERE
    [The official committee record contains additional material here.]

    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:]
    INSERT OFFSET FOLIOS 17 TO 21 HERE
    [The official committee record contains additional material here.]

    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:]
    INSERT OFFSET FOLIOS 22 TO 27 HERE
 

    [The official committee record contains additional material here.]

    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:]
    INSERT OFFSET FOLIOS 28 TO 63 HERE
    [The official committee record contains additional material here.]

    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:]
    INSERT OFFSET FOLIOS 64 TO 70 HERE
    [The official committee record contains additional material here.]

    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:]
    INSERT OFFSET FOLIOS 71 TO 73 HERE
    [The official committee record contains additional material here.]

    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:]
    INSERT OFFSET FOLIOS 74 TO 78 HERE
    [The official committee record contains additional material here.]

    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, Chair