Why the NIH Study of Chelation Therapy
Should Be Stopped
Stephen Barrett, M.D.
In May 2008, Medscape General Medicine has published a book-length report calling for immediate termination of the National Institutes of Health's Trial to Assess Chelation Therapy (TACT). The $30 million clinical trial, which began in 2003 and was scheduled for completion in 2009, is intended to test whether intravenous disodium EDTA is effective against coronary artery disease. The report concludes:- There is no reliable preliminary evidence or logical reason to believe that the treatment will work.
- Chelation proponents used political connections to pressure the NIH to fund the study.
- The application for the trial misrepresented previous data and concealed evidence of risks.
- The study lacks precautions necessary to minimize risks.
- The consent form reflects these shortcomings and fails to disclose apparent proprietary interests, including the fact that more than half of the investigators make money by selling chelation treatmnent to patients.
- Many of the doctors administering the chelation therapy have been in regulatory trouble and are untrustworthy.
- The trial's outcome will be unreliable and almost certainly equivocal, thus defeating the study's stated purpose.
Shortly after the Medscape article was published, the NIH removed the password protection from its TACT “Portal” Web site, which originally was available only to investigators and others associated with the trial. Kimball Atwood, M.D. lead author of the Medscape article, quickly examined the site and found further evidence of impropriety [2]. To ensure that the documents would continue to be available for criticism, I uploaded the Portal site to Chelation Watch [3].
In September 2008, the American College for Advancement in Medicine (ACAM), which had spearheaded development of the study, announced that it has been suspended because the Office for Human Research Protections (OHRP) is investigating "allegations of impropriety." [4]. NIH made no public announcement, but an astute reporter learned that the OHRP had opened the investigation after concluding that a complaint by the Medscape article authors had merit. TACT's principal investigator, Gervasio Lamas, M.D., of the University of Miami Miller School of Medicine, told the reporter that doctors who had been disciplined by state boards or have criminal records were asked to drop out [5].
Earlier this year, after the FDA issued a safety warning, both U.S. companies that marketed the disodium EDTA that chelationists use stopped distributing it, which means that disodium EDTA is no longer legally available in the United States [6]. Lamas told the reporter that the EDTA used in the TACT study comes from a European source [5].
References
- Atwood KA and others. Why the NIH Trial to Assess Chelation Therapy (TACT) should be abandoned. Medscape Journal of Medicine 10(5):115, 2008.
- Atwood KA. The TACT is at least as bad as we predicted. Science-Based Medicine Web site, May 30, 2008.
- TACT Portal Web site, downloaded May 29, 2008.
- ACAM supports NIH decision to suspend TACT trial. ACAM Newswire, Sept 3, 2008.
- Marchione M. Government probes chelation-heart disease study. Associated Press, Sept 25, 2008.
- Barrett S. FDA issues chelation therapy warning. Chelation Watch, Sept 26, 2008.
This article was revised on September 26, 2008.