NO, Dr. Siskin. Now is not the time to lower your scientific standards. If you say, it's OK, it's time to retire from this, you are giving up, and the Forces of Ignorance have won. The only way to win is to play, on a level field. The rules are strict, but you are setting yourself up to fail if you just pack up and go home when you have a setback. That is what the Fool and Dunce Admiseration are handing you, and you must fend off these minor blows. Sham procedures, randomization etc., are why you get the big bucks to do research. They are not rocket science either. The trial is ready to go. It just needs a few brave American women and men to step up. I know they will. Let them. I am willing to put some of my few dollars into it, and I bet there are plenty of others of the same mind.
I gave $100 or $200, once only, to McMaster for Dr. Haake's research, and I expect to receive begging letters and phone calls for the rest of my life. If they can do it, so can you. Appeal to existing patients and previous ones. Appeal to the caregivers of MS/CCSVI patients, too.
The more people that get put down without any response, the harder it will be for the next one to carry the torch when you do want to pass it. CCSVI is winning this race, except where interference from drug vendors and lobbyists is allowed to prevail.
Listening to the Saskatoon papers (or the FDA) about heavy scientific or ethical matters is like listening to your cat tell you what you should have for dinner, or how to drive your car.
If you do revisit the design of your trial, you might want to include the use of IVUS.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience