Twice, the patient told doctors at the West Los Angeles Veterans Affairs Medical Center that he did not want to be a guinea pig. But they went ahead anyway, keeping him on an operating table with an electrophysiology probe inserted in his heart for an extra 45 minutes to collect research data.
Another patient, a veteran so disturbed by mental illness that he was hiding bullets in his hospital room, also had his heart catheterization treatment prolonged for research purposes, though he did not give his legally required permission either.
Then there was Robert Hanson, a stocky World War II veteran who dropped dead of a heart attack in the hospital parking lot after taking an experimental heart drug. Hanson signed consent forms agreeing to be in a study of the drug, but some caregivers and his daughter insist the 71-year-old did not realize he was forgoing standard therapy to be in an experiment, with all the uncertainty and risk that implies.
These cases, involving a top cardiologist at the hospital, are among the most dramatic informed consent problems documented in recent years. Even now, nearly four years later, this conflict of morality and medicine continues to plague cardiology researchers at the nation's largest VA health care facility.
Ironically, the incidents were apparently unknown to Veterans Affairs officials who this week suspended research activities at the medical center to protect patients in clinical studies.
The suspension order, the first time the VA has taken such drastic action against one of its 173 hospitals, was based on dissatisfaction with hospital administrative procedures for ensuring the safety of human and animal research subjects. The agency began reviewing the medical center's research practices in 1997.
In a related move, the federal Office for Protection from Research Risks on Monday canceled the medical center's contract to do clinical research funded by the U.S. Department of Health and Human Services for similar reasons. The risk office first notified the hospital of possible research violations in 1993 and put the facility on probation in 1994.
But the hospital itself found much more specific and apparently more serious problems in an extraordinary investigation of cardiology research in 1995, according to an internal report obtained by The Times. The report cites several cases in which research regulations were violated and patients were put at risk in cardiology research.
Officials at the hospital, recently renamed the West Los Angeles VA Healthcare Center, said the report was placed in proper agency channels. But Dr. John R. Feussner, the Veterans Affairs chief of research and development in Washington, said Wednesday that he was not aware of the research ethics violations in cardiology. He suggested that agency investigators should have been informed of the findings. "I will now get this report and make my own determination and see if it has any implications for our subsequent actions," he said.
High Principle at Stake
At the core of the controversy is informed consent, the preeminent moral principle of human experimentation. With few exceptions, U.S. law mandates that researchers obtain prior written informed consent from people to protect them from exploitation and undue injury. And a state law makes it a crime to do risky research on people against their will.
The hospital's internal investigation focused on research by Dr. Philip T. Sager, an internationally known clinical scientist who remains chief of cardiac electrophysiology at the medical center. Over several months of 1995, he conducted or oversaw potentially harmful catheterization research procedures on four patients without first obtaining proper consent, including one who refused his permission, the hospital's internal report states. Those patients were not physically harmed.
Overall, "quality assurance monitoring of human research with respect to informed consent appeared . . . to be basically nonexistent," says the 40-page report, which was procured through the Freedom of Information Act.
Sager said in an interview he accepted the panel's findings: "I have made mistakes. . . . I take them extremely seriously, greatly regret them, and have made major efforts to be certain these things don't happen again."
Though the report by a panel of five medical center employees and one VA medical official was sometimes scathing, several physicians and nurses close to the events were not appeased. They say the panel whitewashed serious incidents to protect the hospital and physicians involved.
"There is a loss of faith in the institution," one VA caregiver said of the probe and its aftermath. "There is a feeling it has failed in monitoring the problem and getting justice for the violations."