Jim,
You're most certainly right. I believe the FDA should allow, even encourage the type of experimentation that's now being tried in England where patients who aren't excepted into trials can go to something like 20 hospitals where experimental drugs can be utilized. The beauty of this is patients there aren't restricted to FDA approved protocols, so Drs. can try combinations and doses never tried in trials.
Now it may only be anecdotal, but if Experimental drug X, is used in combination with Experimental drug Y, and perhaps approved drug Z and the result is far better than anyone's ever seen, even if with only one patient, wouldn't that encourage more similar experimentation. Finally couldn't this anecdotal evidence lead to trials where they may have never been tried, and where results may be far more successful than ever would have been found without such experimentation.
It's the FDA who largely drives up costs with their insistance that clinical trials not utilize the experience of the Dr. to gain the best results. The FDA has no qualms about spending millions to run an additional trial because MTD was called because of headaches which couldn't be treated. It's fine with the FDA if the drugmakers run another trial, spend tens of millions more to try the drug in combination with headache meds. The FDA wastes time and money insisting things be done their way.
The Big Pharmas are bloated with executives earning salaries that aren't justified, but they can get the money, the perks, etc. Top scientists never get paid nearly what top executives make, generally the best and brightest scientist won't be moved up to management as you can't afford to lose their expertise, but mediocre scientists can make it to CEO.
In countries like Japan the highest paid executives make perhaps ten times what the higher paid workers make, here it's thousands of times when all the perks, options etc are considered. Eventually this has got to change.
JMHO.
Gary |
