IRJ, Will You send an innocent man to jail, just because there is not a culprit one during a justice trial?
The premise in clinical trials is the same as in a justice one: Innocent, until proven otherwise.
A drug is non-effective (innocent) until proven otherwise, guilty (effective).
In the legal system, guilty (effective in clinical trials) MUST be proven beyond reasonable doubt. In a clinical trial with the placebo control randomized prospective trial and multicenter is the equivalent of beyond a reasonable doubt.
Statistics are to further enhance that the evidence is good and reliable (kind of good police/detective work).
The market is to a drug in clinical trials as the tv followers of a famous trial in a justice one.
Anecdotes are hearsay, even if coming from experts, maybe good for a civil trial, but not for a criminal one.
In many trials, the previous conduct and even crimes of suspects are (sometimes, and very variably)kept from the jurors to keep bias from influencing outcomes.
Anecdotes are hearsay, and the FDA accept anecdotes in the big reports from companies, but the evaluators try to keep them a little to the side.
Erbitux is innocent (non-efective) until proven otherwise.
As deffendants are to declared "non-guilty", it is irrelevant to them to be "innocent" or not, cause their problem is when "guilty, beyond reasonable doubt".
It is irrelevant what many ask when their pet drugs are in trouble: "prove me it does not work" (innocent), the only valid relevant aspect is when "proven to work" (guilty).
Lots of misunderstandings when one need a drug to be proven "guilty" to be approved by the Fda!
And the first trial to go to the Fda just could not prove Erbitux guilty, only suspicious!
Of course, one would not make one cent in the market following the analogy above !!! |
