Funny thing. When we hear the term “placebo-controlled study,” the methodological purists amongst us generally think that is a good thing. After all, without a placebo control arm, how would we know whether benefits apparently produced by a therapy were, in fact, actually placebo effects. But check this out. What you will see is a situation in which the circumstances of “placebo control” raise significant ethical questions. Why? Several reasons. Most tellingly, because the study participants were disproportionately “disadvantaged” inner city children of color. AND. Because the placebo control involved withholding a standard treatment for patients with Vitamin D deficiency. AND. Because the study lasted almost a whole year, with standard therapy being withheld for this entire time for the control group.
Bottom Line. Think about this one for a couple of minutes. The real kicker here is that this research could have been done without the placebo control arm. The reason it wasn’t? It would have taken longer and been more expensive.
The right question, as posed at the end of this piece, deals with how the heck institutional review boards at several major institutions signed off on this research. Exactly the kind of unethical research such boards are intended to prevent.