Synopsis of The Controlled Clinical Trial by Harris Coulter, PhD.
The essence of Harris Coulter’s argument is that a so-called Controlled Clinical trial can’t really be controlled. For example, if you choose a population that is very homogeneous then the results of the study says nothing about individuals who are not similar to this population (e.g. women and children, who have been left out of most studies, or people who are sicker or healthier or have different symptom patterns or health histories than the study population).
If you choose a population that is very heterogeneous (dissimilar) then it is very difficult to get consistent results. So the drug companies do their studies with very narrowly defined groups so they can get good results. Then they pick doctors who have given them good results in the past and don’t use doctors who don’t give them the results they want.
So you can see how the Vioxx fiasco occurred. And with billions of dollars at stake these disasters will continue to happen. So, you can see it’s not as simple as saying “lets just do some double blind studies and be done with it.”