Bad alt-med study back on track, funded by tax money
So, the NCCAM (National Center for Complementary and Alternative Medicine) portion of NIH (the U.S.'s National Institute of Health) was funding a study on the use of chelation therapy
(injecting special chemical in order to remove metals from the body) to treat heart disease.
The whole thing has oodles of problems:
- NCCAM's scientific advisory board initially voted against funding the study, but then alt-med supporter Representative Dan Burton applied some pressure and NCCAM suddenly coughed up $30 million to fund the study.
- The study, a phase 3 clinical trial, was done even though no phase 1 or phase 2 trials had been done, or even an animal study, contrary to the usual rules for a phase 3 study.
- The IRBs (Institutional Review Boards) which approved the project weren't provided with accurate scientific information and risk estimates by those performing the project.
- Many of the clinics where the study was being conducted had a financial interest in promoting chelation therapy, and the blinding protocol used was flawed in a way which let the investigators know which injections were the drug and which were the placebo.
- "Several site co-investigators have been disciplined for substandard practices by state medical boards, several have been involved in insurance fraud, and at least three are convicted felons." [From the NIH's response to a complaint about the study]
- "Since the mid-1970's court documents and newspapers have reported at least 30 deaths associated with intravenous disodium EDTA." [Also quoted from the NIH's response]
- The informed consent forms given to the study volunteers left out important risks.
#3 to #7 (plus other things left out of this summary) were enough to get the study halted, and combined with #1 and #2 you'd think that it would stay
halted. But nope, the study is back on track. The NIH basically:
- Told the people performing the study to inform the volunteers of the risks they'd left off of the consent forms.
- Told the IRBs to clean up their acts so that they'd catch similar problems in the future.
- Gave those performing the study a slap on the wrist.
- Otherwise carry on as they had before.