] Patients: Oklahomans used as human 'guinea pigs' (PLANETNEWS)

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@@@@@@@@@@@@@@@PLANETNEWS broadcast...BL Fisher Note:Unfortunately, the common myth that vaccines are harmless, that doctors are infallible and that medical researchers are seldom unethical contributed to the blind trust that caused this tragedy. The "sacred cow" status of vaccines must be replaced with a more realistic understanding that every experimental or licensed vaccine, like every experimental or licensed drug, can carry significant risks for individuals. The right to informed consent to taking a risk with a medical intervention, such as vaccination, should be considered a human right because each human being has the moral right to voluntarily choose what they are willing to die for.<A HREF="http://www.kfor.com/Global/story.asp?S=1539828">http://www.kfor.com/Global/story.asp?S=1539828</A>KFOR-TV, OKNovember 25, 2003Patients: Oklahomans used as human 'guinea pigs'A cancer research project may have used Oklahomans as human guinea pigs.ALI MEYER reportsIn late 1996 a Tulsa doctor concocted a vaccine designed to fight deadly skin cancer. Sources close to the doctor say he believed in his research. He tested it on about 100 people, mostly Oklahomans, some of whom now believe that research nearly killed them.Five years ago, Jeff Teel was diagnosed with deadly skin cancer. Doctorsgave him a 20 percent chance of survival."I mean, I was petrified," he said, "thinking I was going to die." Surgeons removed a portion of Jeff's arm, but the likelihood of a cancer comeback was high and Jeff thought his best chance was an investigational new drug.A public service announcement aired on local TV in Tulsa and starred Dr. Michael McGee, principal investigator for the melanoma cancer project at OU Health Sciences-Tulsa. McGee believes his research could help cure melanoma cancer."They're told that this is a vaccine designed with a purpose to fight tumors and keep tumors from coming back once they've been removed," said Attorney Robert Seacat, who is representing some of McGee's patients in a lawsuit. In 1998 Teel signed up for McGee's melanoma study. According to the consent form, Saint John Medical Center and OU Health Sciences are working together. McGee had an office in the basement of Saint John's, the factory for his experimental vaccine."He said he had a very high success rate," Teel said. "That there were minimal side effects. I was hooked right there."But, Jeff and Paige Teel soon realized minimal side-effects meant something very different."It was like the worst flu you've ever had in your life times 10 and it was guaranteed," he said."It was like he was being poisoned," Paige said. "Like his body was fighting the poison in his system."Despite being violently ill, Jeff endured the poison. At first, the treatments were weekly, then monthly for two years."He told me because of my illness, my body was fighting it off. That's what was supposed to happen," Teel said.But while Jeff and about 100 others continued on Dr. McGee's experimental injections, a whistle-blower inside the melanoma project was reporting allegations of faulty research to the federal government. Attorney Robert Seacat is representing some of McGee's former patients in an ongoing lawsuit."The rats and the monkeys in cages in laboratories have better, adhered to anyway, regulations and standards of care than what we have in some research projects," he said.According to a Food and Drug Administration inspection, a laundry-list of violations were found. They included: failure to report side effects, failure to properly store vaccine, failure to control how vaccine is administered."One of my clients, he [Dr. McGee] literally gave her a box of the vaccine. Told her to go home and put it in the refrigerator. So she could self-inject at home," Seacat said.Four years after it started, the FDA closed the doors on doctor mc-gee's melanoma research. Subsequent reports from the Office of Human Research Protection show the violations extend beyond Dr. McGee all the way up to senior officials."It's a shorter conversation to talk about what they did right than what they did wrong," Seacat said.Now, patients such as Jeff, are finally learning the real reason for Dr. McGee's research. Even though some of the researchers believed the vaccine had the potential to ward of cancer, McGee's study was not a test for the effectiveness of the melanoma vaccine."The reality is, his study was simply to study toxicity levels," Seacat said. "To see whether it made you sick and how sick it made you. These people all thought they were getting on a study that would give them some hope for living. When, in reality, he was just using them as human guinea pigs."Volunteers relying on a miracle were left wondering if an Oklahoma researcher put their lives on the line."He's a Dr. Frankenstein, as far as I'm concerned," Paige Teel said.The University of Oklahoma settled the lawsuit with the former patients and issued a statement about their human testing programs. They say they've completed all the corrective actions spelled out by the Office of Human Research Protections and fired the board of administrators supervising Dr. McGee. They now have mandatory certification for researchers, including education on the ethical principals for protecting patients.Lawyers for Dr. McGee said: "the safety of the study participants was never compromised." They say an independent audit showed, "no notable pattern of adverse experiences." They say "the vast majority of the problems were administrative in nature, and could've been remedied had the universityprovided adequate resources."Those lawyers also point out, several patients sued to continue taking the experimental vaccine. We're told they're still taking that vaccine, with FDA approval. As for Dr. McGee's supervisors, their attorneys said they were used as scapegoats to protect OU's reputation.Dr. McGee is still practicing. He's a general surgeon operating in Tulsa. The FDA suspended him from further research.