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Cassandra Books Monthly Newsletter
Archives | (March 2003)
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FEDERAL FRANKENSTEINS: PART ONE
ARE CLINICAL TRIALS BREEDING FEDERAL FRANKENSTEINS? (cont.)
------------------------------------------------------------------ Page 5 of 9 HIDING THE DEADLY FACTS Dr. E. Donnell Thomas, one of the Center’s founders wanted the proposal to be approved. Another HRSC was empanelled, and a revised experimental protocol with minor changes was submitted. A key change was that the ability of the antibodies to kill T-cells was reduced. As with the initial HSRC, the reconvened panel was not told of the researchers’ financial interest in the experiment. This time it was approved. The first results from the experiment, however, did not match the researcher’s high hopes. The antibodies did not perform as expected and kill the marrow’s T-cells. Worse, the patients still developed GVHD in the same proportions that they would have without the treatment. Going back to the drawing board, the researchers postulated that if they added certain enzymes to the antibodies, they would become more lethal and kill the T-cells as intended. They took their modified proposal to the HSRC. As had happened twice before, the HSRC was not told of the researcher’s financial interest. But there was something else as well. The panel was not told that The Hutch itself had acquired a financial stake in the antibodies being used in the experiment. They also did not tell the new committee that the original HSRC had raised concerns that killing all of a patient’s T-cells could cause the marrow to be rejected. That is why the initial experiment had used a weakened form of the antibodies. Adding the new enzymes effectively reversed this modification. But even without this information there were concerns. One of the committee members immediately raised a red flag. The enzymes the researchers wanted to use were associated with the emergence of new cancers. He wanted to require that the experiment be stopped if such a problem arose. He also wanted the informed consent document to include a clear statement that some adverse events had occurred using the enzyme in question. Again the researchers were given the go-ahead, but behind the scenes the ethical issues surrounding Protocol 126 were about to come to a head. |
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