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Cancer trial report issued

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TULSA, Okla. (AP) -- Forty-one of the 92 people who were injected with an experimental drug during a skin cancer study at the University of Oklahoma had died as of June, most due to progression of their disease, according to a report by the consultant who recommended halting the study.

The Tulsa World reported that the Sept. 1 report by AQUAL Clinical Research Services Inc. states that 37 patients died due to progression of their melanoma, one due to stroke and three due to an unknown cause. The report says the number of deaths was not unusual.

"The survival of melanoma patients in this study is well within the known survival range for this disease," the report states.

It concludes that "no notable pattern of adverse experiences was observed. The study drug appears to be well tolerated."

The study involved treating cancer patients with an experimental melanoma vaccine and a second drug known as GM-CSF. A report released in March by AQUAL, a Massachusetts-based firm then known as Hausmann & Wynne Associates Inc., recommended shutting down the study.

"The recommendation that the auditors propose is to immediately terminate study treatment...since adequate precautions to protect the safety of patients have not been taken," it said.

The report was highly critical of methods used in the study, which was conducted in Tulsa and at sites in Newport Beach, Calif.; Springfield, Mo.; Knoxville, Tenn.; Nashville, Tenn.; and Bloomington, Ind.

The cancer trial was closed by OU after research nurse Cherlynn Mathias went public with safety concerns.

AQUAL President Nadene Hausmann said comprehensive safety data were not available in March when AQUAL recommended closing the study. She said AQUAL staff, aided by principal researcher J.

Michael McGee, brought together all the records for a more accurate picture of what was going on when the melanoma study was closed.

"Although safety was not an issue, other problems with the study were outside the boundaries of what is acceptable," Hausmann said. "No study is perfect but this study had problems and our first report reflected that."

The Sept. 1 report details the experience of a 62-year-old Tennessee cancer patient who was treated in Knoxville.

He began itching and "knots" developed over his entire body about 12 hours after receiving the vaccine and GM-CSF, the report stated.

The man's eyes "reportedly felt like they were on fire, the right arm where the injection occurred swelled tight and had red streaks on it," the report stated. "The patient's throat felt like it was swelling shut."

After the man took some Benadryl, most of his symptoms subsided, the report stated.

The man's doctor in Tennessee considered the event to be life-threatening, but it was not considered to have been life-threatening by McGee, according to the report.

"Serious adverse experiences" were reported by 45 cancer trial participants but were not attributed to the experimental vaccine, the report said. Meanwhile, 44 patients reported at least one adverse experience considered possibly related to the study vaccine. Adverse events included fever, nausea, headache and skin nodules.

The Sept. 1 report also said three women reportedly became pregnant while participating in the skin cancer study.

The report does not include information on the health of any babies born to the women. But one of the three women, Dawanna Robertson of Okmulgee, has expressed concerns about the health of her baby.

Robertson became pregnant after beginning her vaccine shots.

Although she gave birth to an apparently healthy child, Robertson has said she is uncertain whether the drugs she was given are safe for pregnant women.

Pregnancy was among the issues mentioned by the U.S. Food and Drug Administration in an Aug. 4 inspection report. The FDA found nearly 60 possible deficiencies connected to the study.

Among the agency's observations: "Failure to perform all study protocol procedures as required. For example: Pregnancy tests as appropriate."

However, an attorney for McGee disputes the FDA's findings.

"The FDA missed it," attorney Lynn Mattson said. "The exclusion criteria is clear. It says women who are of child-bearing age must practice some form of contraception or get a waiver if they get pregnant. There was no requirement for a pregnancy test."


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