The investigators and institutions that have been participating in the National Institutes of Health Trial to Assess Chelation Therapy (TACT) have temporarily and voluntarily suspended enrollment of new participants in the study. The lead TACT investigator, Gervasio Lamas, M.D., of the University of Miami’s Miller School of Medicine, received a complaint from an outside party about the consent form. The consent process is currently under review with the institutional review board.
The American College for Advancement in Medicine (ACAM) has announced its support for the NIH decision to suspend patient accrual until allegations of impropriety can be proven false. Jeanne Drisko, M.D., president of ACAM, said in a statement, “We believe that the Office of Human Research Protection will find the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial.” Click here to read the ACAM news about the study’s temporary suspension.
While two of the study’s participants have died, the lead investigator says their deaths were completely unrelated to the chelation therapy treatment they received. The study’s participants are all older patients with heart disease, and death is an acknowledged risk—as it is in many, if not most, medical procedures. In fact, the risk of death has been acknowledged as an acceptable side effect of many FDA-approved prescription medications, a position that many are now actively questioning. The risk-to-benefit ratio first became part of the public dialogue during the New York Times coverage of the Vioxx recall.
Many patients cite the lower risk in using remedies such as homeopathic medications as a reason they seek out complementary and alternative medicine. Most healthcare consumers understand that in order to make an informed decision, they must assess the benefits of a treatment or remedy and weigh them against the potential risks. Heart disease treatment in this country has already engendered a vigorous risk-to-benefit ratio discussion. Since the 1980s, coronary artery bypass grafting (or CABG) surgery has become the standard of care to relieve angina in individuals who have failed medical therapy and are not good candidates for angioplasty. Yet its risks, as outlined on the Medicare website, include:
- Risks associated with anesthesia;
- Death;
- Heart attack;
- Stroke;
- Excessive bleeding;
- Infection;
- Subtle problems in long-term memory, comprehension, calculation skills, and concentration; and
- Blockage (occlusion) or narrowing of the artery or vein graft.
This has resulted in a spirited debate about alternative treatments for heart disease in periodicals such as Business Week.
In fact, as discussed in a recent New York Times article, the whole approach to the treatment of heart disease has changed dramatically since the Framingham study. While genetic factors are important, the emerging picture is that lifestyle choices are key to who develops heart disease. The treatment of heart disease using medicines and surgical procedures has provided benefit, but more and more medical professionals now believe that heart disease is not merely a plumbing issue.
Physicians who use chelation therapy along with lifestyle changes to manage heart disease are growing in number, but the politics of medicine has put the licenses of these practitioners on the line. Many of the physicians involved in the TACT have been disciplined by their boards of medicine for advocating chelation therapy, even though a 1978 Florida Supreme Court ruling affirmed the right of the physician to provide this therapy to an informed patient. The practice of chelation therapy dates back to the 1950s, and has helped many people overcome heart disease.