The history of phentermine
The history of phentermine shows the strengths and weaknesses of the regulatory system for medication. When this drug was first submitted to the FDA for approval in the late 1950s, medical science was still adjusting to the development of technology. Clinical trials were conducted but, by modern standards, they were relatively crude. Thus, the standards of “safety” and “effectiveness” applied were lower than those in force today. Once approved, the FDA does not require the manufacturer to conduct new efficacy trials. It is left to the monitoring system to judge whether there are safety issues.
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One of the ways in which the FDA protects the public is to invite all hospitals and medical professionals to submit reports of adverse side-effects for all drugs on the market. It would be better if this was a mandatory system but, as it stands, it does give the FDA some evidence of trends in the safety of classes of drugs. It tends to be only the more serious side-effects that are reported. Although there are some question marks over the use of the class of amphetamines, the FDA has never had sufficient evidence of adverse side-effects in the use of phentermine to justify instructing the manufacturer to withdraw it. Because it is significantly cheaper than the other appetite suppressants, it dominates the market. |