Patients make appeal for cancer vaccine
Monday, July 31st 2000, 12:00 am
By: News On 6
TULSA, Okla. (AP) -- The University of Oklahoma will aid patients who are seeking federal approval to continue receiving a cancer vaccine from a now-disbanded study, the head of the university's Tulsa campus said Monday. Three patients who participated in the study at OU's College of Medicine in Tulsa are petitioning the U.S. Food and Drug Administration for emergency relief. They want to resume receiving the vaccine they consider crucial to their survival. "We're going to assist them in that filing," said Ken Lackey, OU-Tulsa president. "Basically, our focus is on the patient. We're trying to assist the patients in obtaining treatment they think is beneficial to them."
The university halted the skin cancer vaccine trial in March after an independent audit found regulatory and safety problems. Twenty-eight seriously ill melanoma patients were receiving the vaccine when the study was stopped. "You feel like there goes your lifeboat," said Karla Wright of Depew, who was given just months to live two years ago when she underwent surgery for a cancerous tumor. She joined the OU study after being told that traditional chemotherapy and radiation could not help her. She is cancer-free after receiving the vaccine. "To me, that says the vaccine helped me," Wright said. Lackey said FDA approval would apply only to patients who were among the 28 receiving the vaccine at the time the study was canceled. The study itself would not be resumed. A doctor approved by OU and the patients would administer the vaccine if FDA permission is granted, Lackey said.
Attorneys representing Wright and fellow patients Rosie Whisman and Bill VanMeter met with OU officials Friday to seek help in getting the experimental vaccine restored on the basis of "humanitarian exceptions." Attorneys Steve Holden and Michael Ashworth said they told OU officials that they wanted a cooperative approach, not an antagonistic one. "A lawsuit will not help these 28 people," Holden said. Holden said other patients involved in the study may be to afraid to join in the effort because of worries about legal fees. The Holden, Glendening & McKenna law firm will represent all 28 patients, if they're interested, at no charge, he said.
The FDA is investigating the research project, which prompted federal health officials to temporarily suspend government research at the Tulsa campus in June. Although other projects were allowed to resume, the FDA placed the cancer project on hold, Lackey said. Even with FDA approval, Holden said the potentially "ticklishâ€ issue of intellectual property rights remains. Dr. J. Michael McGee, the study's prime researcher, was dismissed by OU following the research scandal. He may have rights to the vaccine, along with the university, officials said. "There's so many unknowns," Holden said. He expects to know more about the results of the emergency request within the next 10days.
Despite the troubles that brought an end to the study, the three patients said they have no concerns about resuming the vaccine. Whisman said she has been free of cancer since last year, but a test recently showed a spot on her liver. Further testing is needed to determine if the spot is cancer, she said. She said she is praying the FDA will grant approval needed for her to resume receiving vaccine booster shots. "If I don't get it, I won't be here very long," Whisman said.