When new medications come on the market, they have to have shown proven efficacy and a reasonable side effect profile in studies. Most of these studies compare the medication with placebo in a highly selected group of individuals that have a disorder and compare them to a group of control individuals that do not have the disorder but are of more or less the same age, same intellectual level. etc. Those with the disorder are excluded from the study if they have various other disorders.
We have learned through the years that once medications go on the market, they often do not work as well as we would like and may have more side effects than were reported in the studies. We have also learned that drug companies are not enthusiastic about publicizing studies that do not show that their products are efficacious. Moreover, it seems that often a new product is released when the patent of an older drug expires. Drug companies make most of their money selling newer, patented drugs than those that are available in generic form.
Effectiveness studies, under “real world” conditions, generally are done after a drug is in pharmacies. People who take the medication in the real world and are included in effectiveness studies often differ from those in the efficacy studies by having more complicated psychiatric problems than those selected to be in the initial efficacy studies. With rare exceptions, once drugs are made available to the public, one learns that they do not work as well as hoped and advertised, and they have more side effects. The take home message is that psychiatrists should be circumspect about prescribing new medications and the public should not be overly enthusiastic when requesting the newest medications.