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to me it is ludicrous to prevent access to not-yet-approved therapies to patients who's only other option is to die quickly from their disease, in the interest of "protecting the patient". Certain death from cancer is a pretty serious "adverse event".
Or, worst of all, lets say that someone actually does invent a "magic bullet" - even a less than 100% one such as TDM1 which has an extraordinary clinical benefit rate considering the heavily treated population that has been studied so far. How many people died or had metastatic recurrence waiting for Herceptin??? How many is too many?
What does BCA or the FDA have to say to the families of all the people who die waiting for "proof"? Oops, sorry about the wait but your mom/sister/daughter/father died for the greater good of validating the data?
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Boom. Boom. Boom. outta da park. Someone post this at ASCO.