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In the wake of the trial's cancellation, 11 families have sued McGee, Plunket, Brooks, the IRB and the university. Says Phyllis Friesner, whose husband died in McGee's trial: "I want the universities and the hospitals to take notice. I want to change the way they do business." Dawanna Robertson, who discovered she was pregnant while on the vaccine, has a more personal reason to be angry. "For the rest of my life," she says, "I will wake up every day and think, 'Is there something wrong with my daughter?'" Robertson says she blames everyone involved, "but I blame myself the most. How could I have been so dumb? I didn't ask enough questions. I heard only what I wanted to hear."
Yet 12 of the 94 patients, even after reading about all the problems with the vaccine, fought to be put back on it after the trial was shut down. Rosie Whisman, now 60, joined McGee's trial in 1999 after finding a knot in the side of her groin. She had Stage IV melanoma, and doctors gave her three to six months to live. She found out about McGee after her daughter saw his ad on television. McGee did the surgery to remove the knot and put her on his vaccine. She has been cancer free ever since.
"I thank God every day for Dr. McGee," she says. She doesn't care, she says, that the drug wasn't properly tested on animals before being given to her. "When you're given three to six months to live and someone offers you something that will allow you to spend more time with your kids and grandkids, you do it. Who cares if they've tested it on animals? It was my only chance to live."
A federal judge has ruled that he has no jurisdiction in the lawsuits against McGee, but attorneys are pursuing the matter in state court. Michael Atkinson, McGee's lawyer, is trying to get the case dismissed there as well. "None of the participants in this trial suffered any real injury," he says. "And any technical issues, they were the University of Oklahoma's fault. They failed to give McGee adequate resources and staffing."
In contrast to the blatant lapses in Tulsa, those at Johns Hopkins, in Baltimore, Md., were subtler and in a way more forgivable. Dr. Alkis Togias wasn't testing a drug or pushing a treatment; he simply wanted to get at the mystery of why some people respond to airway irritation with asthma and some don't. His idea was to have healthy volunteers breathe a chemical irritant called hexamethonium, then to monitor their reactions. His proposal went before the Bayview Medical Center IRB, one of two set up by Johns Hopkins to supervise research at its hospitals. As is usual at Bayview, the heavy lifting was done by a subcommittee, which pored through the study and asked Togias some pointed questions about the source and purity of the chemical. His answers satisfied the board, and the study was approved.
Nine months later, Ellen Roche, a Bayview employee who had volunteered for Togias' study, was dead of respiratory failure--a direct result of having breathed hexamethonium. As in Oklahoma, the government shut down federally funded trials, and the OHRP and the hospital began their investigations. And as in Oklahoma, there were violations on several levels. For one thing, using subcommittees to pre-review applications is a violation of federal policy: minority views on a study's safety expressed at the subcommittee level might have a harder time being heard by the full committee.