The Process of FDA ApprovalThe process of vetting a smoking cessation drug for approval by the Food and Drug Administration is thorough enough that any increase in suicide risk, in addition to an increase in suicidal thoughts, should be caught by the company which is doing the testing. The standards that have to be followed along every step of the way need to account for all the possible side effects, and the drugs in question have to pass muster in front of the federal agency. If they don’t, then it’s back to the drawing board.
Studies and StatisticsStatistics can be twisted to say almost anything. Whenever someone sees the phrase “studies have said”, it’s important to take a closer look at what those studies actually say. Since not everyone is a statistician though, there are some key things to look for. Is this study being discredited by legitimate members of the scientific community? Do the results have a potential agenda? Was the study funded by a notably biased organization? Only when readers have answered those questions can they get a real view as to what the information may or may not be saying. The key phrases that readers need to look for are things like “statistically significant”, which means that the study did in fact find that a given result fell outside the realm of pure chance. A thorough understanding of what statistics are truly saying, either in favor or against a given product, is important for forming one’s opinions about that research.
Correlation Does Not Prove CausationThis phrase is perhaps one of the most famous in statistics. Say for instance that a number of people who committed suicide were all taking a smoking cessation drug. It might seem logical to conclude that the drug was responsible. That’s is a false conclusion though. It’s like how the increase of ice cream sales in the summer could be responsible for violent offenses rising; both of them are commonly attributed to heat, rather than to sweet treats causing assault and battery.This is extremely important when talking about smoking cessation drugs. Even if there appears to be a correlation between suicide risk and taking the drugs in question, the cause has to be scientifically proven. If it isn’t, then the suicide risk could come from outside sources, rather than from the drugs in question. Only once causation has been proved and confirmed should the product go off the market. Even then, some companies may be allowed to keep the drug on the market, as long as they list suicidal thoughts and risk as potentially dangerous side effects of use.
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