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Monday, August 06, 2007Breaches of clinical research standards and a federal oversight system that allowed key decisions to be made behind closed doors may have helped draw Mohr into an experiment that was not, her husband says, what she thought it was. "It was presented to her like this is going to make her knee better," said Robb Mohr, an agronomist who lived with his wife of nine years in a modest vinyl-sided ranch home near Springfield, Ill. "It was supposed to be just a simple thing." ....A two-sentence paragraph halfway through a 15-page consent document that Jolee Mohr signed warns of the possibility of "unknown side effects," including, "in rare circumstances, death." Further in, after long descriptions of how the product may help, a single sentence states: "We do not expect you to receive any direct medical benefits from participation in this study." Mohr was in an early-phase study, the prime goal of which was to see whether the treatment was safe, not to provide a therapeutic benefit. If the drug passed muster, other studies would determine whether it was an effective treatment. Her rheumatologist, Robert Trapp, whose Springfield clinic got payments from Targeted Genetics for each subject he recruited, also defended the study. "The theory behind it seemed good, and the science seemed good," he said. "There's nothing I knew of that could have predicted this." posted by Sydney on 8/06/2007 08:40:00 PM 0 comments 0 Comments: |
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