CIPRO—MILLIONS OF PRESCRIPTIONS, SPARSE DATA. Cipro has been widely used for a long time. One would think that there would be a lot of data about what happens after a patient takes Cipro. The numbers are missing because the data is not collected.
I mad a mistake yesterday when I said that the FDA announcement made “no mention of what studies lead to the FDA’s conclusion”. In fact there is a link to the briefing information materials on the subject which the FDA considered in a meeting in November, 2015. Here is a link. Page 31 indicates that there were an estimated 33 million oral fluoroquinolone prescriptions in the United States in 2014. The data on success and side effects of taking the drugs seem to be in the thousands. (The adverse side effects which are described are serious and scary.)
I think that the emphasis on the “gold standard “of controlled studies with a placebo has discouraged the collection of large volumes of information of the kind that we are accustomed to see on other policy issues.