Audit of program turned up many problems

Thursday, July 13th 2000, 12:00 am
By: News On 6

TULSA, Okla. (AP) -- A study by an independent consulting firm cited many problems in a report about the procedures used in a cancer trial that now is suspected of endangering patients' safety. The audit of the manufacture and control of the melanoma vaccine was conducted by Hausmann & Wynne Associates, a clinical research consulting firm, at the request of Dr. J. Michael McGee, principal researcher of the vaccine study. "It was evident that the sponsor's manufacturing facilities were inadequate (including staffing, supervision and facilities)and that personnel responsible for the manufacture and control of the melanoma vaccine were not prepared by qualifications, training or experience to produce material suitable for experimental use in humans," the audit states.

The March 16 report found "an egregious lack of control," the Tulsa World reported in a story Thursday. Federal health officials on June 29 notified the University of Oklahoma College of Medicine in Tulsa that they had suspended five government-funded projects because of safety concerns involving the melanoma study, which was sponsored by the university. The university then suspended new enrollment in 70 other research trials during an internal investigation to ensure all federal safety regulations are being met.

The audit notes that the facilities at the OU-Tulsa campus are adequate for the responsibilities of conducting a clinical study as an investigative site. But they are not adequate for the managemen of clinical studies as the sponsor of an investigational new drug at this site or remote sites, the report says.

According to the audit, "there is not adequate space and personnel dedicated to controlling the management of remote clinical investigational sites."

A woman who first alerted officials to possible problems with the skin cancer study says participants sometimes were allowed to store vaccine in their refrigerator freezers. Cherlynn Mathias, a nurse who is on medical leave from her duties at the Office of Surgery Research with the OU College o fMedicine, first became concerned last July about improper monitoring of the melanoma vaccine at remote sites. "They had shipped drugs across state lines without keeping the mat proper temperatures," she said. A few patients were allowed to give themselves injections without proper monitoring for reactions to the shot, Mathias said. Others would arrive in Tulsa for their initial shots but then would be sent home with other vaccine doses packaged in ice coolers, she said. "Some of the other patients arrived and picked up the drug and took it home and stored it in their refrigerator freezer," Mathias said. The problem is that home refrigerator systems can have a thaw and freeze cycle, she said. Storing the vaccine that way, she said, is "one of the worst things you can do to a biological agent."

Mathias last month filed a complaint with the Office for Human Research Protections, a recently created division of the federal Department of Health and Human Services.