Drugs and Their Effects
SOOOO…THE DRUG MY DOCTOR WANTS TO GIVE ME WORKED IN A CLINICAL TRIAL..BUT COMPARED TO WHAT? This is, arguably, one of the more important questions we can ask. In randomized, placebo controlled trials we compare a pill with the active “drug” ingredient to an inert pill with nothing in it (a “sugar pill”). Or so we thought. I just found out last night that in the early studies approving Prozac for use here in the US, that when participants in the trials experienced side effects like agitation, they used benzodiazepines (like Valium) to control the side effects!! This was not disclosed in the study. We could easily argue that we NEED to know what the active pill is being compared to. What if there are other components in the placebo that also have clinical effects, like the benzodiazepines used in the Prozac studies (I’m not saying that this was in the placebo, but you get the idea)? Than how accurate is the comparison? If the placebo contains some harmful tableting chemicals that will make 20% of the patients who take it ill, and 21% of the patients got ill from the active drug, the study will say that there was no difference in side effects between the placebo and the active drug! Makes it sound safe, huh? This particular study looked at how often drugs trials described what was in the “sugar” pill. In only a meager 8.6% of the studies looked at did they disclose what the “placebo” was. You cannot get a good idea of whether a drug is effective or has too many side effects without knowing what the placebo fully is. Period. What was YOUR drug compared to? Read More…