Basic rules that guide the ethical treatment of all patients cannot be waived for the most vulnerable, the terminally ill. Clearly in the case of Terri Bradley a University of California, Davis, brain cancer patient those basic rules were ignored. That's the message and the warning underlying the story of Bradley's life and painful death, as reported by The Bee's Marjie Lundstrom.
In November 2010, UC Davis neurosurgeons J. Paul Muizelaar and Rudolph J. Schrot implanted live bacteria in an open wound in Bradley's brain.
The doctors had a theory that the bacteria would trigger an immune reaction that would attack the cancer cells in her brain and prolong her life.
But it was an untested theory. Two years earlier, the U.S. Food and Drug Administration had rejected the doctors' request to test their theory on a child with life-threatening brain cancer, ordering them to conduct animal studies first.
The university's Institutional Review Board an independent panel of physicians and public members that reviews and monitors all research at the university involving human subjects did not sign off on the Bradley procedure, either. In fact, the IRB had told the physicians to stop performing the procedure.
Despite the absence of any FDA approval or IRB review, the neurosurgeons proposed their treatment, to Terri Bradley. The consent form she and her daughter signed appears straightforward. It made clear that the infection the surgeons were deliberately introducing into Bradley's brain "may be totally ineffective." It then laid out the many serious risks, including "further neurological deterioration paralysis, coma or death." The women were told the procedure did not have FDA approval.
Faced with the alternatives presented and the near certainty of death, not surprisingly, the Bradleys signed.
Here's what the Bradleys weren't told. They were not told that the FDA hadn't just failed to approve the procedure their physicians were pushing, federal officials had told the doctors specifically not to perform the procedure until they had conducted animal studies. The Bradleys were not told that the doctors had bypassed the university's IRB process or that the IRB had previously told the doctors not to perform their "experimental" procedures on human patients.
These safeguards the physicians ignored exist for very good reasons.
Faced with imminent death or other serious maladies blindness, paralysis, amputations medical professionals know that desperate people will agree to almost anything. That is why the FDA exists and why panels of experts are established at hospitals to vet experimental treatments, to prevent patients from becoming human guinea pigs.
Dr. Michael Carome, a physician and one of the nation's leading experts on human research protections, characterized Bradley's brain operation as a serious ethical breach.
"To do something that has not been tested at all for which you've been told you need to do vigorous animal studies first is extraordinarily serious and unethical," Carome told Lundstrom.
Terri Bradley died Nov. 28, 2011, one year after her surgery, but the controversy surrounding her treatment swirls on.