Should chronically ill patients be treated with untested drugs?
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SACRAMENTO, Calif. -- The consent form allowing University of California, Davis, doctors to open Terri Bradley's skull and infect her with bowel bacteria was hand-delivered on a single page with a 300-word warning.
"There is no proof that such treatment (for brain cancer) might be beneficial," the form read, "nor are there animal data to support it."
The ensuing infection might cause further harm to the patient, the form stated, including "paralysis, inability to speak or understand speech, inability to swallow, vegetative state, coma or death."
Terri and her daughter Janet signed the form that day in November 2010 in what the family now describes as a desperate Hail Mary attempt to save the woman's life.
But at what cost? family members now ask.
"I felt really pressured to sign it," said Janet, 26, who believes the experimental procedure only prolonged her mother's misery. "There was no quality of life. None."
Terri Bradley was one of three patients who consented to the untested treatments for their life-threatening brain tumors, or glioblastomas, in 2010 and 2011.
The first two patients developed sepsis and died within weeks of their procedures. Terri lived nearly a year, though "chronic meningitis" was found at autopsy, according to the pathology report.
Two neurosurgeons, Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot, have been accused by the university and by federal investigators of violating numerous hospital policies and government regulations.
But questions about the cases go beyond the realm of hospital manuals and federal codes. In letters to the editor, in blogs, on message boards and radio talk shows, the doctors' actions and the decisions by the three patients and their families have stirred emotional debate.
Why, some ask, is the government so restrictive? Why shouldn't dying patients have easy access to untested drugs and procedures? If things go wrong, how can anyone at death's door legitimately complain? Why punish the doctors?
Others, including some of the nation's foremost bioethicists, contend that vulnerable patients desperate for a cure must be protected from experiments that offer little hope and may cause harm.
Without strict oversight, they ask, who will protect society's most fragile and desperate patients?
Today, more than a year after their mother's death, the Bradley daughters find their own questions spinning into focus.
"When you're dying, you'll pretty much do anything," said Regina Bradley, 28. "I don't want any other family to deal with what we had to go through."
Amid the controversy, no one seems to dispute that all three patients and their families agreed to the experimental treatments. All of them signed consent forms, according to the university.
"I think it's important indeed that all the patients themselves, plus their families, gave their consent," Muizelaar told The Sacramento Bee. "We made it totally clear to them that this had never happened before."
All were "of sound mind," he said, and their disease did not affect their judgment.
Rabecca Rich, the widow of Patient No. 1, could not be reached for this story. But in a letter published in The Bee, she said that she is grateful to the doctors.
"There were no choices left except hospice and a slow deplorable end of life," she wrote.
Terri Bradley was destined to become the surgeons' so-called success story -- the one patient who lived nearly a full year after having her brain infected with bowel bacteria.
In university documents and medical records, she is held up as the one patient who had a "positive response" and "improved," showing signs before her death of tumor regression. A report on her autopsy, conducted at the university, noted that she "had improved with regards to daily functioning" after the wound-infection surgery, but still required skilled-nursing care.
Muizelaar took note of his patient's decline but seemed pleased overall with the wound-infection results.
"Her life expectancy was basically only two months when we started treating her," Muizelaar said. "For a good part of the 1½ years, she was in pretty good condition.
"But later she started to deteriorate, and unfortunately also, her wound started to smell bad, so that was one of the reasons we started to treat her infection."
But federal regulators, who recently examined all three cases, put much of the responsibility for Terri's deteriorating condition on the doctors and their novel treatment.
"Patient 2 (Bradley) experienced worsening of her abilities to move and speak, which required placement in a nursing home," according to the report released in November by the Centers for Medicare and Medicaid Services. "Over the coming year, increased pressure in the brain and chronic drainage from a wound infection of the original surgical site required additional surgical interventions.
"Patient 2 did not experience significant functional benefit," investigators concluded, "and upon her death ... recurrences of the tumors and chronic infection of the brain were identified.
The university initially concluded in October 2011 that all three procedures were improper, and that the treatments of Terri Bradley and Patient No. 3 "constituted human subjects research without Institutional Review Board review and approval."
The university since has revised its findings, saying that none of the surgical cases constituted "research," but that the second and third surgeries still lacked appropriate approvals. University officials recently adopted a new care policy "to prevent similar unusual occurrences in the future."
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