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"Protecting the health and informed consent rights of children since 1982." 

AVN list / 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.

http://www.kfor.com/Global/story.asp?S=1539828
KFOR-TV, OK

November 25, 2003
 

Patients: Oklahomans used as human 'guinea pigs'
A cancer research project may have used Oklahomans as human guinea pigs.

ALI MEYER reports
 

In 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. Doctors
gave 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 university
provided 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.
 

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