Comment on FDA Approvals

Development of a new drug or FDA approved devices to market stage involves studies to show they areeffective and safe enough to release to the general population. Research ethics decide who can be in the study. People in these studies are generally fairly healthy. The studies go through different stages with increasing numbers of people. They find out some of the side effects and precautions that have to be taken and then have to decide to release it for a specific use. Then the drug may be given to huge numbers of people by care providers of varying skill and diligence in monitoring for side effects. Other side effects now occur because not everybody is as healthy as the study participants were. They take more medications. Some use large amounts of alcohol. Some have kidney disease and heart disease. If the prescriber is watchful the effect may be caught and the drug discontinued. Some people suffer lasting problems. All these side effects are supposed to be reported back to the FDA to be followed. Like vioxx if a drug had a great many or dangerous side effects they look at it again and may decide to pull it off the market. It also assumes no one has concealed, suppressed, or manipulated data. The FDA does look at the quality of the research and can determine if statistics were misapplied. Also, statistics apply to groups of people not individuals.
Note there is a situation when doctors/patients "halfway through death's door" can apply for compassionate use of a promising drug for their condition. If they improve researchers may comment on that but they are not included the statistics for the study because they did not meet the criteria for the study. There are occasionally enough of they people in an advance disease that they can form a small study group-HIV/AIDS comes to mind.
The point is that the FDA does not say the drug is safe-give it to the masses. They do the first couple passes at determining if a drug's benefits may outweigh the risks. Then the FDA watches to see what happens when the drug is taken by many. It is why I prefer not to take a new drug if a well established drug or treatment is available.