I am willing to accept the idea that highly trained physicians view certain situations differently than I, who is not a physician, however, there are some decisions that do not make sense to me.

Why is it that a particular drug with side effects that include DEATH is not cleared for marketing by the FDA, yet, a related compound with the same side effect profile, including DEATH, is allowed to be marketed? Is it because doctors have become inured to death so that calling it a side effect makes it OK to use? Does being a physician, who sees death on a regular basis, cause physicians to expect to see this in very few patients without feeling guilty, consequently it does not make a lasting impression in his/her thought process?

What percentage incidence of any serious side effect does a drug have to posess before a physician removes it from his/her personal formulary even though it is OK'd by FDA?  When does any drug become too dangerous to consider at all?  What is the percentage incidence of a serious side effect that is acceptable? Does it ever become unacceptable ?  Is DEATH acceptable if it is a "side effect" but not acceptable if it is called a "TOXIC REACTION"? Has the drug industry found a way to "tone down" a toxic effect by calling it an "uncommon side effect"? Is FDA approval the only criteria a doctor cares about?

The use of drugs "OFF LABEL" means the drug has NOT YET been PROVEN "SAFE AND EFFECTIVE" to help a particular indication. Does this also mean there is not enough data to prove it is "SAFE and EFFECTIVE" as labeled (which is a requirement of FDA) because it is NOT so labeled? Has the doctor become the "MAD SCIENTIST" of fiction from the, "lets try it and see what happens?" school? WOULD THE DOCTOR USE IT ON HIS WIFE OR HIMSELF OR DOES HE HAVE A DOUBLE STANDARD?

I BELIEVE FDA HAS ALTERED IT'S  STANDARDS TO PLAY INTO THE HANDS OF THE DRUG COMPANIES WHO HAVE SPENT SO MUCH INVESTIGATING A NEW COMPOUND. IF THE DRUG IS ALLOWED.... IT WILL TAKE A SHORT TIME TO RECOUP ITS INVESTMENT DEVELOPING A DRUG "THAT DID NOT MAKE THE CUT". THE DRUG COMPANIES WILL HAVE RECOUPED THEIR INITIAL EXPENSES ON THIS COMPOUND AND THE DRUG WILL BE RECALED AS WAS DONE RECENTLY WITH VITORIN. THIS SHOULD NOT BE TOO SHOCKING BECAUSE THAT IS THE NATURE OF THE BUSINESS THEY ARE IN. YOU WIN SOME AND YOU LOSE SOME. NOT ALL DRUGS UNDER INVESTIGATION EVER BECOME AVAILABLE FOR SALE, HOWEVER, THE RESEARCH EXPENSES KEEP INCREASING AND WITHOUT NEW DRUGS WHAT WILL THE COMPANIES AND FDA HAVE TO DO?