Time To Move The Goalposts

Provenge is neither a drug nor a vaccine. Given that, why should it be under the aegis of the FDA? All good negotiators know enough to begin the bargaining process from an unattainable position so that in the process of negotiated compromise they arrive at or near the desired result. Rather than coming to the FDA as a supplicant which postulates that theirs is the right to approve, why not begin by questioning their legitimacy to approve? This Agency no longer has the moral highground. It allows carcinogenic cigarettes to be sold. It never approved fluoride which is a poisonous by-product of the aluminum industry in our drinking water, yet while the rest of the world eschews its use, the FDA stands idly by. Its mandate is to opine on the safety of what we ingest and it has failed. Its mandate is not to play a costly game of Simon Sez with our right to try to save our own lives. Rather than risk stirring demands for a sea change, the FDA could see that a change of heart on approval is more conducive to their own safety and efficacy.