Melanoma sufferer wants vaccine quarantined after cancer study was Halted
Monday, July 24th 2000, 12:00 am
By: News On 6
TULSA, Okla. (AP) -- A woman suffering from melanoma wants to be allowed to continue treatments with an experimental vaccine used during trials that were shut down by the federal government at the University of Oklahoma School of Medicine. "I'm not going to give up until I get my vaccine back," Rosemarie Whisman said while at the office of her Tulsa lawyers on Sunday. The vaccine was quarantined in a locked location and labeled "not for human use," OU officials have said.
Whisman said doctors have given her only three to six months to live, but she was getting healthier while she was being treated with the vaccine. She believes the vaccine has helped her stay alive."We know what we're asking is a monumental task," attorney Steven Holden said. "We've got 28 people here who need help." There were 28 active participants in the study when it was shutdown, and Holden believes they should be allowed to continue being treated with it.
The study was conducted in Tulsa, and at sites in Newport Beach, Calif.; Knoxville, Tenn.; Nashville, Tenn.; Bloomington, Ind.; and Springfield, Mo. It was not known how many of the 28 are from Oklahoma, and how many were treated at the remote sites.
The Tulsa World reported that principal researcher, Dr. J. Michael McGee, apparently was trying to treat patients with the vaccine, not do controlled clinical trials in a regulated environment. "The word `treat' is used in the above findings to underscore a primary finding in this matter," an audit obtained by the Tulsa World stated. "It is apparent that Dr. McGee was conducting what would in decades past been described as `therapeutic research,' in that his objective appears to have been to treat patients with a potentially promising new product, rather than to conduct controlled clinical trials in a regulated environment," the audit report state.
The report was prepared by Quintiles Inc., one of at least two outside firms that found widespread problems with medical research at OU's Tulsa campus. The other audit, done by Haussman and Wynne Associates, also found numerous safety and ethical concerns. Whisman and others have defended McGee in spite of the criticisms, calling him a compassionate and dedicated doctor. McGee "looks you straight in the eye and tells you the truth that he is going to do everything he can for you," Whisman said.
The U.S. Food and Drug Administration began an investigation into reported problems at the OU-Tulsa campus last week, and the report by Quintiles Inc. indicates that FDA rules were broken. The findings also indicate that problems with research at OU-Tulsa were not isolated to the melanoma vaccine study. "The allegations related to the McGee protocols were not isolated events but instead reflected the ordinary course of business by the Tulsa IRB (Institutional Review Board)," the report stated.
The Quintiles report also said drafts of correspondence intended for patients conveyed the impression "of an intent to deceive at the very time that full disclosure is most needed." In the end, patients may not have been told the truth about the study being shut down over safety concerns, government officials have said. OU later sent patients a letter explaining that the study was shut down over safety concerns -- not a shortage of vaccine as the patients had originally been told.
Tuesday is the tentative date for Whisman's meeting with OU officials. "We don't want to sue OU. Rosie just wants to live, and OU holds those strings right now -- OU and the FDA," Holden said.