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Archives | (March 2003)
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FEDERAL FRANKENSTEINS: PART ONE
ARE CLINICAL TRIALS BREEDING FEDERAL FRANKENSTEINS? (cont.)
------------------------------------------------------------------ Page 7 of 9 A CRITICAL OMISSION By the third year of the experiment, it was clear that there was a major problem: fully 40% of the patients were experiencing graft failure – a rate 40 times normal! Despite this fact, the researchers continued their experiment. But there was something else as well. Dr. Storb had been working on another treatment for GVHD and was having considerable success. He had cut the rate of acute GVHD from 54% to 33% and increased the 18-month survival rate from 55% to 80%. Most important, his patients were not experiencing graft failure. His treatment clearly gave patients a much higher chance of survival than Protocol 126. They only trouble was they were never told about Strob’s alternative. As the graft failures mounted, the IRB demanded that the Protocol 126 researchers change their consent form to reflect the risks patients were facing – especially the risk of graft failure. A change was made, but it hardly met the requirement. Where the original form indicated that Protocol 126 would not damage “cells necessary for engraftment,” the new form said that it “may damage the cells necessary for engraftment.” The form went on to say that if that happened, a second transplant might be required. What the form did not say was that second transplants failed 95% of the time and the patients died. It still made no mention of Dr. Storb’s alternative or any alternative for that matter. It also failed to mention the financial interest of the investigators. In short, it was tailored to conceal some of the most vital information concerning the experiment. At this point seven people had died from graft failure. The IRB laid down an ultimatum: if two more people died, the experiment would be terminated. Within months, there had been two more deaths. Dr. John Draheim, a U.S. Navy physician, and Seci Cay, a Turkish businessman both died as a result of graft failure. Again the experiment was suspended. Protocol 126 had now claimed 9 victims. |
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