By Marjie Lundstrom, The Sacramento Bee –
SACRAMENTO, Calif.—A federal watchdog agency has initiated an investigation into the care of three University of California, Davis patients who died after undergoing experimental treatments for brain cancer.
The university confirmed this week that the federal Centers for Medicare and Medicaid Services has asked the state to “review the care” provided to the patients by two neurosurgeons, Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot.
Findings from the probe, being led by the California Department of Public Health, are expected in about a month, said Bonnie Hyatt, spokeswoman for UC Davis Health System.
Representatives of the state and federal agencies said they could not comment on an open case.
The investigation is the third to be conducted into the activities of Muizelaar and Schrot, who introduced bacteria into the open head wounds of three patients suffering from deadly glioblastomas. The doctors, who obtained the patients’ consent, theorized that postoperative infections might stimulate the patients’ immune systems to attack the cancer and prolong their lives.
Two of the three patients developed sepsis and died several weeks after their procedures in 2010 and 2011, according to university documents. A third patient lived for some months but also has since died, Muizelaar told The Sacramento Bee in July.
Neither Muizelaar nor Schrot responded Wednesday to a request for comment.
UC Davis officials contend that the doctors stepped out of regulatory and ethical bounds by failing to get proper university and federal government approval for their novel approach.
Research involving human subjects is tightly controlled in the United States and, according to federal regulations and university policy, must undergo a rigorous approval process to ensure that subjects are protected.
In a highly unusual move last year, the university banned both doctors from all research activities and reported their findings directly to the U.S. Food and Drug Administration. Alleged violations involving experimental drugs or devices can trigger a “for-cause audit” by the FDA, although the agency has not notified UC Davis what, if any, action might be taken.
“The most important thing here is, you cannot treat people with a completely unapproved drug,” said R. Alto Charo, a law and bioethics professor at the University of Wisconsin.
Another nationally known medical ethicist, Arthur Caplan, said the federal government’s interest in the case is “significant” for UC Davis and its medical center. Caplan said the Centers for Medicare and Medicaid Services, or CMS, are known for being “financial auditors” who frequently step in where there are questions about billing.
“They’re really there to protect against public money being spent on things that aren’t proven,” said Caplan, director of medical ethics at New York University’s Langone Medical Center.
UC Davis has not released the names or ages of the patients who underwent the procedures, so it is unclear if the experimental treatments were billed to a government program.
Their care, however, appears to have been extremely costly. University documents show that Patient No. 1 died after being hospitalized for six weeks following treatment. Patient No. 3 survived for about two weeks in the hospital before the family “elected to withdraw support,” according to the university’s letter to the FDA.
Hyatt, the university’s spokeswoman, said the government’s inquiry appears to be focused on patient care, not billing or insurance payouts. Hyatt said it is “routinely the case” that hospital investigations are opened when “stories appear in the news media.”
A July 22 Bee story was the first published report about the controversial treatments and the research ban. At that time, Muizelaar was chairman of the department of neurological surgery but “temporarily relinquished” that position a week later, pending the outcome of an investigation by the university’s provost.
That internal investigation continues. A six-month internal investigation in 2011 resulted in the research ban, and the letter to the FDA.
Jack Cheevers, a San Francisco-based spokesman for CMS, would not comment on any aspect of the UC Davis investigation.
However, he explained that CMS has far-reaching responsibilities, ranging from rooting out Medicare fraud to inspecting hospitals, nursing homes and clinical labs. The agency frequently asks state agencies to handle the “on-the-ground inspections,” but the entities work together to determine if there are violations of federal or state rules, he said.
Cheevers said the agency can threaten to pull federal funding for noncompliance — a potentially severe penalty for hospitals, whose federal funding ranges from 30 percent to 70 percent.
“It really gets their attention when we say, “We found all these problems and you’d better clean them up,’” he said. “… We’re kind of the 800-pound gorilla in health care financing.”
In 2007, Martin Luther King Jr./Drew Medical Center in Los Angeles was forced to close after CMS revoked its federal funding following a series of failed inspections. The agency cited a host of problems at the hospital that had harmed patients or contributed to deaths.
