Enrollment stopped in dubious chelation therapy study

[Guest guest]

This only shows Dr. Goldberg's concerns, he was against the principle

of EDTA since the mid 90's. Nobody is protecting our children for

what is safe!

Elyse

Enrollment stopped in dubious chelation therapy study

Enrollment into the $30 million NIH-sponsored Trial to Assess

Chelation Therapy (TACT) has been suspended. The 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. In May, Medscape General Medicine

published a lengthy report calling for the study's immediate

termination because:

**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 treatment

to patients.

** Many of the doctors administering the chelation therapy have been

in regulatory trouble and are untrustworthy.

**The trial's outcome would be unreliable and almost certainly

equivocal, thus defeating the study's stated purpose.

NIH has made no public announcement about the suspension, but an

astute reporter learned that the federal Office for Human Research

Protections had opened an 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

School of Medicine, told the reporter that doctors who had been

disciplined by state boards or have criminal records were asked to

drop out. [Marchione M. Government probes chelation-heart disease

study. Associated Press, Sept 25, 2008]

http://ap.google.com/article/ALeqM5jI1k5Hrp22Ind9eS3jbWYHfJh_BQD93E17L

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Earlier this year, after the FDA expressed safety concerns, the two

companies that sold disodium EDTA in the United States stopped

selling it, which means that it is no longer legally available in the

United States. [barrett S. FDA issues chelation therapy warning.

Chelation Watch, Sept 26, 2008]

http://www.chelationwatch.org/reg/fda_warning.shtml For additional

details plus links to key documents, see

http://www.chelationwatch.org/research/tact.shtml

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