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by Jon Airheart
It was reported on the front page of Wednesday’s Wall Street Journal that despite doctor pleas and 2 fatalities, Northfield Laboratories Inc. has been given the okay by the FDA to continue clinical trials of a blood substitute called PolyHeme. What’s worse is the manner in which the FDA is allowing it.
“The FDA is allowing Northfield to test its blood substitute without the consent of the trauma patients, who often are unconscious.”
With this appalling fact, it would appear that the FDA is in blatant violation of 3 out of the 10 principles of The Nuremberg Code’s Permissible Medical Experiments (http://www.ushmm.org/research/doctors/Nuremberg_Code.htm).
1. The voluntary consent of the human subject is absolutely essential.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
The number 1 principle is self-explanatory and is the basis for which the studies are not in compliance with number 9. How can someone be at liberty to end an experiment if he/she is not made aware of said experiment?
In addition to 2 fatalities several years ago, 8 of 81 patients who received the fake blood suffered a heart attack within 7 days.
Northfield to this day has never publicly disclosed these results and fails to mention them in newly printed materials. This raises serious questions as to compliance with the number 5 principle.
The FDA has lost all credibility with this recent incident. Are they a part of our servant government or not? Are they accountable to us or not? You can give them a piece of your mind at 1-888-INFO-FDA. Lester Crawford has been the acting commissioner of the FDA since March 2004 and was confirmed the permanent head of the organization on July 17, 2005.
asked me to publish this guest article for him. The photo (most embarrassing one I could find of him) is of Jon, Jessica Caplan and me and was taken in NYC in 2004.