OU officials won't ask for permission to make more cancer vaccine
TULSA (AP) -- Patients who are trying to resume use of a cancer vaccine they took in a now-defunct study at the University of Oklahoma-Tulsa have been dealt some bad news: there isn't enough of the medicine to treat all the study's former patients and OU isn't planning to ask to make more.
There were 28 cancer patients in the study and eight of them have contacted a Tulsa law firm in hopes of continuing their treatments for the deadly cancer melanoma.
The study was shut down in March after numerous regulatory and safety problems were found in an independent audit.
OU is working on a proposal seeking continued use of the drug from the U.S. Food and Drug Administration, but that proposal will apparently not include a request to make more of the drug.
In an Aug. 1 letter, obtained by the Tulsa World, the university's legal counsel tells the patients' attorneys ''there is not sufficient vaccine for all 28 patients who were participating in the trial at the time it was closed to receive treatment, and the University does not intend to seek permission to manufacture more.''
The letter also says the school won't let the former patients in on the proposal it is making to the FDA, saying the school ''will make a proposal to the FDA which, in part, sets out your client's requests. It will not be a joint proposal.''
An attorney for the patients, Steven Holden, said his clients feel like they're on the outside looking in.
''I have patients who need to know what is happening. If OU has decided to be noncooperative, then we need to start working directly with the FDA ourselves and see what is needed, because our patients' lives are at stake. We can't afford to wait,'' Holden said.
Attorney Michael Ashworth said the impact of the school's decision will depend on how far along the patients requesting the medicine were in their treatment.
Those in the early phases of their treatment required more intensive treatment, compared to those who had been in the study longer.
OU officials offered no timeline on when they might submit the proposal, saying the patients requesting to use the drug must first have a medical evaluation before the proposal can go forward.
The study was conducted in Tulsa and at sites in Missouri, Tennessee, Indiana and California.