Friday, May 16, 2008

The NIH Trial to Assess Chelation Therapy (TACT): an unethical study sponsored by taxpayers

Two occasional HCR bloggers are co-authors of an article published this week:

Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned

Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; Wallace I. Sampson, MD
Medscape J Med. 2008;10(5):115. ©2008 Medscape
Posted 05/13/2008
The National Institutes of Health (NIH) Trial to Assess Chelation Therapy (TACT) was begun in 2003 and is expected to be completed in 2009. It is a trial of office-based, intravenous disodium ethylene-diamine-tetra-acetic acid (Na2EDTA) as a treatment for coronary artery disease (CAD). A few case series in the 1950s and early 1960s had found Na2EDTA to be ineffective for CAD or peripheral vascular disease (PVD). Nevertheless, a
few hundred physicians, almost all of whom advocate other dubious treatments, continued to peddle chelation as an office treatment. They claim that chelation dramatically improves symptoms and prolongs life in 80% to 90% of patients. In
response, academics performed 4 controlled trials during the 1990s. None favored chelation, but chelationists repudiated those findings.
We have investigated the method and the trial. We present our findings in 4 parts: history, origin and nature of the TACT, state of the evidence, and risks. We present evidence that chelationists and their organization, the American College for Advancement in Medicine, used political connections to pressure the NIH to fund the TACT. The TACT protocols justified the trial by misrepresenting case series and by ignoring evidence of risks. The trial employs nearly 100 unfit co-investigators. It conflates disodium EDTA and another, somewhat safer drug. It lacks precautions necessary to minimize risks. The consent form reflects those shortcomings and fails to disclose apparent proprietary interests. The trial's outcome will be unreliable and almost certainly equivocal, thus defeating its stated purpose.
We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned.
The entire article is available at:
You may be asked to "register"; don't worry, it's free. The article is very long, but the Introduction, Executive Summary, Discussion, and Conclusion are reasonably succinct and make the important points. Readers who want to learn more details, who want to see more evidence for our assertions, or who are compelled by an odd fascination with crackpotism (my own weakness) will want to read more.
I've posted a similar announcement on Science-Based Medicine.


Anonymous said...

You may wish to check out today's BBC. They highlight this finding from the Lancet: "Chemotherapy treatments which aim to prolong patients' lives and reduce suffering from asbestos-related cancer do not work, UK researchers suggest."

The results from this study were immediately refuted with the statement that there are now newer treatments. There always seem to be newer treatments or some other variable to allow the continuation of questionable medical practices.

The common denominator in both of these situations is money. As long as treatment continues profits can continue and more potential patients can be persuaded this is a viable option for their medical condition. Now we have reached the point where we have institutionalized this type of questionable science at the expense of taxpayers and patients.

Steve Lucas

Anonymous said...

I suspect snake oil has been around since our hunter gatherer beginnings. From the shaman who, to preserve her power position in the tribe, employs some fear-based ritual; or the pharmaceutical corporation who, driven by profit-seeking, pollutes the scientific process by way of its own machinations.

At least pharma usually has one foot (or at least a toe) in the realm of reality. This chelation garbage is not driven by a scientific mindset at all. It is driven by either charlatanism or cult-like adherence to wacky ideas. The idea of "studying", let alone funding, these quack ideas is ludicrous. The NIH is meant to spend public money on science NOT BS.