Gw, 6 hour was also the delay for placebo. Same conditions operating for drug/placebo is the aim of the RTC (ramdomized trial with placebo control and blindness, the universally recognized higher standard of proof in epidemiology investigational clinical medicine).
It is mock cry from whoever talk about that, real trial conditions determined the results, not anyone ideal conditions.
The moral reasons for informed consent, IRBs committes, ethical protocols is based on long history of abuse, nazi, imperialjapanese experiments, the Tuskeggee men syphilis, thalidomide, breast implants, torture with clinicians directing, canada/australia misplacement of aborigines, the church, mental illness treatment, orphans,....
Bpi is very safe, but there is no way around the above, too bad.
Surprinsingly, the best science has come while respecting ethical protocols, unrestrained experimentations in humans (and animals, enviroment,plants) is the cause of huge damage.
Approval of a drug just for safety and let the market decide is just plain unworkable, you in the comfort of your orange juice bedroom can not comprehend the difficulties in such scenario.
Look at the clinicians who decide to turn into women the boys born with some anomaly or accidents in the genitalia (like cutting the penis during circumcision)30 to 40 years after it was a disaster, a tragedy, when almost everyone the big mistake, 40 YEARS LATER!
In many poor countries informed consent is taken over by institutions and some oral formality with the subjects, but it is clearly not financially appetizing for a xoma like enterprise. |
