General Discussion
In reply to the discussion: Meet the medical student who wants to bring down Dr. Oz [View all]jeff47
(26,549 posts)Believe it or not, different departments of our government do different things.
Also, there is no requirement that a medication actually work before it is patented. You can patent the chemical or the process to extract/synthesize the chemical before you know if the chemical does anything.
The FDA puts forth the standards companies have to follow, and the studies they have to submit before they can market a medicine. Why? Because there is nowhere near enough resources for the FDA or other public entities to test every medication. Instead, companies are liable for fraudulent studies.
Part of the problem is the belief that studies can actually reveal all possible side effects of a medication. They can't.
An enormous study is 10,000 people. Those 10,000 people do not have every possible combination of genetics, medical conditions and other medications to detect every possible side effect.
So sometimes drugs get approved, and then it turns out there is a condition not in those 10,000 that makes the drug dangerous. And then approval either gets yanked, or the drug's label is updated telling doctors to not prescribe it if the patient has that condition.
That's why it takes a very long time for a drug to move from prescription to over-the-counter. We need to try the drug in a pool of millions before we've identified every possible combination of genetics, medical conditions and other medications to find adverse reactions, and your doctor is supposed to be monitoring for adverse reactions to prescription medications. Only after the drug has been used by many, many millions can a decision be made if it's safe enough for over-the-counter.