Cancer patients eager for FDA approval

Thursday, August 24th 2000, 12:00 am
By: News On 6

TULSA, Okla. (AP) -- The U.S. Food and Drug Administration has agreed to allow seven patients to begin taking a melanoma cancer vaccine again as early as next week.

The FDA notified attorneys by phone Wednesday that the vaccine could continue, according to a statement from the Tulsa law office of Holden, Glendening & McKenna.

"I didn't figure we'd ever get it," said Rosie Whisman of Claremore. "But I sure am glad to hear it. I just hope this hasn't come too late for any of us."

Whisman was among 28 who received the vaccine during a study at the University of Oklahoma's medical school in Tulsa. The university halted the study in March after an independent audit found numerous regulatory and safety problems.

Because of those problems, federal regulators in June suspended five government-sponsored research studies. Regulators gave the university permission to reopen those studies, but the skin cancer study remained closed.

The patients said they owe their cancer-free status to the vaccine and want to complete their treatment plans.

Suffering from an advanced stage of melanoma, Whisman wasn't expected to live more than six months when she started the experimental treatments in September 1999.

Last week, doctors declared her cancer-free, but Whisman wants to continue taking the vaccine to keep the cancer from returning.

The treatment's only negative side effect, she said, is that three nails on each hand and foot turned black.

"Boy, can I ever live with that," Whisman said. "I very much believe that this is life-saving medicine, and I can't tell you what it means to me to have it again."

Landon Jefferson, 64, of Dewar had said he received the vaccine after undergoing surgery for recurring skin cancer and had been free of cancer since.

The university had sent its own proposal to the FDA and the Office of Human Research Protections asking that the patients be allowed to take the vaccine.

Whisman's attorney, Steven Holden, said he was surprised at how quickly the FDA gave its approval.

He said Gary Raskob, associate vice president for clinical research through the OU Health Sciences Center, OU-Tulsa President Ken Lackey and others at the university deserve much of the credit.

He said they helped cut red tape at two large bureaucracies -- OU and the FDA.

"OU is a very large organization, and that was the easy part, but the FDA is the almost immovable object, and to have this occur in approximately 30 days is nothing short of a miracle," Holden said.

"To see it done here in about 30 days, I'd have bet my law license it wasn't going to happen," he said.

Raskob said OU is "thankful for the constructive help and prompt response by the FDA and pleased with their permission to treat these seven patients with the melanoma vaccine according to the treatment plan we submitted to them on Aug. 12, 2000."

Holden's law firm has been seeking all 28 patients who were participating in the study when it was stopped. Privacy concerns have prevented OU from identifying the patients, but word-of-mouth and media accounts helped the firm get in touch with the seven.