Word: tulsa
(lookup in dictionary)
(lookup stats)
Dates: all
Sort By: most recent first
(reverse)
ANDREW GOLDSTEIN, a staff writer, went to Tulsa, Okla., for this week's cover story and interviewed terminally ill patients taking an experimental melanoma vaccine found to have been manufactured, stored and tested improperly...
...lesson would have been a lot less shocking if McGee's vaccine trial had been run out of a back-alley clinic or a storefront in Tijuana. In fact, the study was conducted at the St. John Medical Center in Tulsa, Okla., and co-sponsored by the respected University of Oklahoma Health Sciences Center. It had been approved by the university's institutional review board, or IRB, a body set up to ensure that such trials meet federal standards for experimental design--including the obligation to inform participants of any safety issues. And it had been given the green light...
Mathias reported substantial protocol violations to Plunket and told Dr. Harold Brooks, dean of the university's College of Medicine in Tulsa, as well. They finally agreed to hire an outside consulting firm to audit the experiment. The finding: deficiencies "so severe that it is beyond the scope of this report to advise corrective actions." This finally persuaded Brooks to put the trial on hold. But according to the investigation, Brooks and Plunket decided not to share the report with the IRB; instead, Plunket filed an annual report that stated, "There are no significant safety issues related to the vaccine...
That's when Mathias wrote her whistle-blowing letter. On the basis of its investigation, the OHRP shut down all federally funded human research at the university. The university, meanwhile, did its own digging and came to the same conclusions. It disbanded the Tulsa IRB, suspended and later fired McGee, and terminated Plunket and Brooks as well. And on July 7, 2000, it sent a new letter to McGee's subjects. This one admitted that "in fact, the trial was closed because of possible safety concerns...
...patients in Dr. Michael McGee's vaccine trial, Cherlynn Mathias already had that attitude--though she has paid a price for her action. Facing nasty criticism from many of her colleagues at the University of Oklahoma and worried she would not be able to get decent medical treatment in Tulsa, she finally moved to Texas last August. Sometimes she wonders whether she did the right thing by sending that letter to the OHRP, but she is proud of the way the university responded...