|
Archives | (March 2003)
Printer Friendly
FEDERAL FRANKENSTEINS: PART ONE
ARE CLINICAL TRIALS BREEDING FEDERAL FRANKENSTEINS? (cont.)
------------------------------------------------------------------ Page 6 of 9 A NEW BOARD RAISES OLD QUESTIONS In 1983, The Hutch, like many other institutions, reorganized its Human Subjects Review Committee as an Institutional Review Board. With this change came a new chairman, Dr. Henry Kaplan of Seattle’s Swedish Medical Center. He was appalled at what he discovered at The Hutch. Another board member, Dr. John Pesando summed up the situation for the Seattle Times. He said the IRB “found problems everywhere we looked.” Among the most serious problems were those associated with Protocol 126. One of the Board’s greatest concerns were rumors of financial conflicts of interest, but when Kaplan tried to raise the issue with officials at The Hutch he was strongly chastised and accused of trying to impede research. In a strongly worded reply, Kaplan pointedly stated that the IRB had only one purpose “To protect the rights of the human subjects.” Kaplan sought help from NIH but got nowhere. It was all too clear that no one outside the IRB was interested in assuring patient safety. Every time Kaplan came up with a new suggestion to curb what was beginning to appear as an out of control experiment he was rebuffed. Sadly, clinical evidence of just how out of control Protocol 126 was would soon surface – in the form of fatalities. A DEADLY EXPERIMENT IS ALLOWED TO CONTINUEIn January of 1984, the first reports of deaths from graft failure (the rejection of donor marrow by the recipient’s immune system) came to the Board. This should have been the signal to end the experiment. Normally grafts among siblings like those being performed for Protocol 126 only failed 1% of the time. Ultimately, the failure rate in the experiment at the Center would be 35%! Worse, many of those who died would have had a good prognosis for survival. For example: Ruth Agnes Fisher, a computer programmer with a perfect match from a sibling and a relatively mild form of leukemia stood a 60% likelihood of being cured by a transplant. Her transplant failed to take and she died. Jacqueline Couch, a New York attorney also had a good prognosis. She, too, died. The same was true for Lourdes Caridad Llera of Tampa, Florida and Carol Sue Obermeyer of Oldenberg, Indiana. Lawrence Haspel, a New York orthodontist, Bina Bidsaria, a housewife from India and Paul Mahler, Chairman of the Anthropology Department at CUNY’s Queens College all died following second transplant attempts when their first transplant failed to take. Although federal rules did not require that the deaths be reported to the FDA, they did require that they be reported to the IRB – they were not. Also, state law required that they be reported to local officials. Again, they were not. |
|
