Word: mcgee
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...lesson would have been a lot less shocking if McGee's vaccine trial had been run out of a back-alley clinic or a storefront in Tijuana. In fact, the study was conducted at the St. John Medical Center in Tulsa, Okla., and co-sponsored by the respected University of Oklahoma Health Sciences Center. It had been approved by the university's institutional review board, or IRB, a body set up to ensure that such trials meet federal standards for experimental design--including the obligation to inform participants of any safety issues. And it had been given the green light...
Still, something is clearly wrong with the system as it now operates. Over the past three years, more than 60 institutions, including several of the world's most prestigious research centers, have been criticized by the U.S. government for failing to protect human subjects adequately. McGee's patients were very sick, so in a sense they couldn't be made much worse by his treatments. But federal records show that since 1999 at least four people who entered clinical trials in reasonably good health wound up dead--including two infamous cases, at Johns Hopkins Medical Center and the University...
...Oklahoma case, it may have been a nobler motive that tripped up McGee. "McGee is a good surgeon and a decent man," maintains his whistle-blowing research nurse, Mathias. "But he became a biased investigator. He thought he had found the cure for cancer. He really wasn't interested in running a clinical trial; he wanted to administer his drug"--even if that meant breaking the rules to get there. Although McGee said he had tested his drug properly on animals, he had not; the data he submitted in his original protocol came from animal studies of a different drug...
Then the university review board dropped the ball. Despite federal rules requiring it to conduct "continuing review" of ongoing studies, the board met just once a month, typically for an hour, and then went out to dinner. Among other things, the board approved McGee's consent form, which contained numerous errors. McGee later got permission to add more subjects than the original 25 he had applied for. According to the OHRP investigation, 11 of McGee's first 18 subjects didn't meet eligibility criteria. Like most of the key oversight decisions, this one actually came directly from the IRB chair...
...This finally persuaded Brooks to put the trial on hold. But according to the investigation, Brooks and Plunket decided not to share the report with the IRB; instead, Plunket filed an annual report that stated, "There are no significant safety issues related to the vaccine." That gave cover to McGee's letter lying to patients about why the trial was being halted...