TACT

From March 13 to 15, 2013, the International College of Integrative Medicine (ICIM) held a summit meeting about what should be accomplished next, now that EDTA chelation therapy has been supported as a useful treatment for vascular disease by the Trial to Assess Chelation Therapy (TACT).  Experts from around the world were invited.  This paper is a summary of the conclusions and recommendations of this gathering.  Key presentations were given by Drs. John Trowbridge, Efrain Olzsewer, and Eleonore Blaurock-Busch.  Representatives from the U.S., Canada, Indonesia, Brazil, Denmark, the Netherlands, Germany, Ecuador, and New Zealand participated, as well as the attendees for the Advanced Metals Workshop that was part of the spring meeting of ICIM.  Recordings of the lectures are available from icimed.com. This paper was prepared prior to articles on TACT published in the Journal of the American Medical Association in the March 27, 2013 issue.

Background

EDTA has been used as a treatment for vascular disease since Norman Clarke, Jr.’s work in 1952.  For a timeline of the many studies that have supported its effectiveness, see chelation.me.  In 1981, the AMA challenged the proponents of chelation therapy to produce a large-scale, randomized, controlled, clinical trial to prove its safety and effectiveness.  The members of the American College of Advancement in Medicine (ACAM) led by president Ross Gordon collaborated with Walter Reed Hospital to begin such a study for treatment of peripheral vascular disease in 1987.  Unfortunately, the first Gulf War took the investigators away from the study, and it was not completed.  In 1999, Congressman Dan Burton, Chair of the Committee on Oversight, held a hearing bringing together the head of the Heart, Lung, and Blood section of the National Institutes of Health and several physicians who testified about their experiences with chelation.  NIH subsequently called for proposals, and eventually TACT was funded, with Gervasio Lamas as chief investigator.

TACT was unique in that it combined university research cardiologists and experienced chelation specialists with private offices.  134 sites from the U.S. and Canada participated in the randomized, placebo-controlled, double-blind, clinical trial.  TACT continued for 7 years, and included 1708 patients with documented previous heart attacks who continued to receive evidence-based therapy.  The primary end point was a composite of new cardiac events to include death, heart attack, stroke, hospitalization for unstable angina, and need for revascularization surgery.  TACT showed that the therapy was unquestionably safe, and the group treated with chelation therapy had fewer cardiac events, which was statistically significant.  The results were announced by Lamas at the American Heart Association meeting on November 4, 2012 in Los Angeles.  Publication of the results is pending.  The authors called for further studies to confirm the results and explore the mechanisms of action.

Where we stand now, according to the Summit

1. TACT conclusively showed that chelation therapy used according to the recommended protocol is safe.
2. TACT and the many other studies that proceeded it support the use of chelation therapy as an option for patients with vascular disease, especially for those who also have diabetes and those with a history of anterior wall myocardial infarction.
3. There is not yet enough evidence to state that chelation therapy should be given to all cardiac patients.  More studies need to be done.  A duplication of TACT would be ideal, as long as it included heavy metal testing.  However, another $30 million to repeat the study might be difficult to find.
4. Strong consideration should be given to doing a challenge test for heavy metals (especially lead) for all patients with vascular disease.  If high levels are found, the patients should be treated with chelating agents.
5. Regulatory agencies, such as medical boards, should immediately stop harassing physicians who offer chelation therapy to their patients who give appropriate informed consent.  Physicians who offer chelation therapy have accomplished exactly what the AMA asked them to do in 1981 to justify its use.
6. Most physicians who offer chelation therapy are happy to serve as consultants for placebo-controlled RCT’s, but are uncomfortable with the ethics of giving placebos to patients who have come to them for help.  Certainly, patients should not be asked to pay to receive placebos, especially for a potentially life-threatening illness.  Physicians who provide chelation are almost always convinced that in their experience the therapy is very effective.
7. Many chelation doctors feel that their primary goals of showing efficacy and safety with a RCT have been accomplished with TACT.  Gaining FDA approval of EDTA for use in vascular disease is secondary, and they encourage qualified investigators to move in that direction.

Recommendations of the Summit

1. More research should indeed be done on metal toxicity, free radical pathology, and on various diseases that have been linked to free radical pathology, especially vascular disease.
2. Chelation doctors do not have the resources to fund or carry out clinical trials, but they do have the expertise to help plan them.
3. The conditions that are most likely to show benefit with chelation treatment and thus should have the greatest research priority are as follows:
   1. Patients waiting to have limbs amputated due to non-infected vascular disease.  For end points, all that is needed is to count the remaining limbs.  Claus Hancke’s work is most impressive in this regard.

b. Walking distance and A/B index in patients with peripheral vascular disease.  In our experience, a very high percentage of patients improve.  Ffrain Olzsewer and Jim Carter documented this.  There have been a couple of negative studies published on this subject in prominent journals, but they have been seriously flawed. Stephen  Olmstead has written a good research protocol to evaluate chelation treatment for peripheral artery disease that is almost ready to go.  He is willing to share his work with others. Attendees to the summit expressed significant concern that opponents of the therapy might proceed with new studies that are designed to fail, which has happened in the past.

1. Brachial artery stiffness and other measurements of vulnerable plaque.  Peter van der Schaar is beginning a study on arterial stiffness.
2. Diabetic patients who have evidence of vascular disease.
3. Patients who have suffered an anterior wall MI.
4. Patients who have angina that is difficult to control with drugs.
5. Macular degeneration.
6. Patients who have been told that revascularization surgery is an option
7. Quality of Life measurements should be included in all research projects.  Chelating physicians insist that their patients feel considerably better with long-term treatment, even though the relatively short follow-up in TACT detect significant improvement.
8. Other areas that are important to study and are likely to show successful outcomes:
   1. Patients with hypertension and elevated lead levels
   2. Arterial intimal thickness and high resolution ultrasound of the carotid arteries (see the work of Robert Bard)
   3. Osteoporosis
   4. Mild to moderate Alzheimer’s disease associated with heavy metal toxicity
   5. Autoimmune diseases, especially scleroderma
   6. Fibromyalgia with high levels of toxic metals detected with a challenge test
   7. Diseases that are familiar to the public should be studied in order to raise awareness and support for chelation.
9. There are many biomarkers in the laboratory that can help examine the mechanisms of action of chelation therapy.  Expert biochemists (Blaurock-Busch, Jaffe, Quig) are happy to consult with investigators as to which ones are most appropriate to utilize in this assessment.
10. Various combinations of chelating agents, and different doses of such entities as EDTA and vitamin C are important to study.
11. Chelation therapy is useful to study at all stages, to include

a.     Preventive

b.     Pre-emptive (early signs of disease)

c.     Treatment of established disease

d.     Treatment following revascularization  procedures

e.     Maintenance treatments are very important

1. Such international lecturers as van der Schaar, Olzsewer, Rozema, Hancke, Dooley, and Godfrey continue to teach physicians on how to use chelation therapy safely and effectively.  Organizations such as ACAM, ICIM, and A4M hold workshops in the United States.  Excellent recent textbooks have been published by van der Schaar and Blaurock-Busch (both are available through the International Board of Clinical Metal Toxicology).  There is a need to move toward consistent protocols and best practices.
2. Studies must be well-designed and conducted so that clear outcomes can be readily understood and will resonate with a large portion of the population, as well as stimulate Congressional action.
3. Use of NBMI—a compound being studied by Boyd Haley might turn out

to be a powerful therapeutic modality.

Conclusion

Raising public, political, and media awareness is now essential.  Experienced chelating physicians can help provide solid data to support general understanding of efficacy, mechanisms, and positive outcomes in the treatment of vascular diseases. Registries might be the best way for clinicians to collect data without the constraints of a RCT.  Self-insured corporations, such as Parker-Hannifin are now paying for chelation therapy.  Cooperation among organizations with similar interests, such as ICIM, ACAM, AAEM A4M, ABCMT, IBCMT, and specialized laboratories is strongly encouraged to standardize protocols and set up registries.  This can be done quickly and with minimal expense.  Physicians from around the world should be included.  Experienced chelating physicians can serve as consultants for researchers who are qualified to perform RCTs.  NIH and various foundations are encouraged to fund projects discussed in this paper.  Pollution with heavy metals continues to get worse, and evidence is mounting that their toxicity is an important factor in the development of chronic degenerative diseases.