Clinical trial enrollment suspended

---amidst concerns about ethics breeches, conflicts of interest, safety, and investigator qualifications. The latest Pharma funded study, you’re thinking. No, it’s funded by a branch of the NIH. It’s none other than the Trial to Asses Chelation Therapy (TACT). The NIH is keeping mum about this---no announcement has been issued. In fact, the guvment’s official web site says the study is still recruiting participants!

Although I smelled the rat and started agitating about this over two years ago I’ve been a little remiss in keeping up with recent developments and missed this Science Based Medicine post last fall concerning the suspended enrollment. What finally tipped me off was an article from the International Journal of Clinical Practice posted January 22 in Medscape. It reads, in part:

A comprehensive review of the TACT trial by Atwood et al.[2] calls into question the safety of the study and highlights deficiencies in the NIH application process, economy with detailing the adverse effect potential, inappropriate political pressure to undertake the study and failure to provide complete data on conflicts of interest, especially investigator financial gain. The authors concluded in May 2008:

"... TACT is unethical, dangerous, pointless and wasteful. It should be abandoned."

That review, a powerful expose of the corruption associated with the trial, was published in the Medscape Journal of Medicine and may have had something to do with the suspension of enrollment.

Among the allegations swirling around TACT is that it violates provisions of the Declaration of Helsinki. I can think of a number principles being violated, one of which is that:

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

That principle, that research be based on “generally accepted scientific principles,” proscribes (or ought to) many forms of woo based research currently being supported by NCCAM, the Consortium of Academic Health Centers for Integrative Medicine and the Bravewell Collaborative.