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VA Hospital's Ethical Nightmare

COLUMN ONE

Morality and medicine collide at West L.A. facility, where probe about informed consent clouds research.

March 25, 1999|TERENCE MONMANEY | TIMES MEDICAL WRITER

For the last few years of his life, the ailing septuagenarian slept in a listing trailer parked in the patchy yard behind his daughter's rented North Hollywood house.

He had a history of coronary artery disease as well as ventricular arrhythmia, a disorder in which the heart's largest pumping chamber beats chaotically, leading to dizziness, fainting spells or death. In the 1980s, his daughter said, doctors outfitted him with a defibrillator, an electronic device implanted in the body that shocks the heart when it beats out of control.

In the spring of 1995, he went to the West Los Angeles VA facility seeking treatment for dizzy spells. Sager and other physicians attributed his dizziness to an anti-arrhythmia medication he was then taking, sotalol, the investigation report shows.

So he was asked to be in a study of dofetilide. The Food and Drug Administration and the hospital's ethics committee endorsed the design of the dofetilide study. It carried the FDA designation of Phase Two, meaning the drug was in an intermediate stage of development.

The drug, made by Pfizer, recently received preliminary FDA approval for a heart disorder other than the one tested in the research Hanson was subjected to.

Over several days at the hospital in June, Hanson underwent extensive cardiac testing before he received the experimental drug. After being released from the hospital, he crossed the parking lot to his car and was found on the pavement.

There is debate over the drug's role in Hanson's death. The hospital autopsy concluded that the most plausible cause of death was "cardiac arrhythmia," but said nothing about whether the drug was involved. Sager said he doubted it.

But one VA physician said: "He died of a drug reaction." The tragedy prompted another VA physician to begin referring to dofetilide as "the death drug," sources say.

Following Hanson's death, VA health care providers challenged the medical decisions that led him into the research program and said it was "inhumane" to put a sick old man in a study where he had a 50% chance of receiving a placebo, or no medication.

Finally, some questioned whether Hanson realized he was in an experiment. Two VA health care providers who saw him during his hospitalization said in interviews that Hanson did not know what was going on.

But Sager and another caregiver disputed that version of events, saying Hanson understood what he was getting into. Hanson's medical record, Sager said, contains "multiple documentations" that "the patient understands and is aware. . . . I feel really comfortable in my heart that this patient did understand."

As for Alvarado, she said her father never mentioned being a research subject before or during his five-day hospital stay. And it would have been out of character for him to keep that news from her, she said. "My dad did not know he was in a clinical study program," she said. "No, he did not."

He must have mistaken the consent form for routine hospital paperwork, she said, adding that he needed reading glasses that he did not have with him during his hospital stay.

The panel declined to pursue the charge that Hanson was inadequately informed about the study, presumably because he signed the study consent form, which said dofetilide "has been associated with sudden death in patients with arrhythmias and heart disease."

Independence of Panel Doubted

Despite the investigation's many harsh findings, a number of current and former VA caregivers argue that the panel was a "kangaroo court" and that the hospital's response to it was "an obstruction of justice."

Fueling skepticism of the panel's independence was a potential conflict of interest: At the time of the probe, the panel's highest-ranking member, and the only one with cardiology expertise, was collaborating with Sager on a research project.

Dr. Pamela Steele was then chief of cardiovascular diseases and acting chief of medicine at the VA central office in Washington. Along with five other VA researchers, Steele and Sager co-authored a defibrillator study presented at a 1996 American Heart Assn. meeting.

Norman, who created the panel, disputed that the collaboration tainted the panel's work. Steele "claimed no conflict and in fact if I remember correctly . . . she was very upset with Dr. Sager," he said.

In a brief interview, Steele said emphatically that there was no conflict of interest. Sager agreed, adding that he had minimal or no personal contact with Steele while the study they co-authored was being prepared.

But Ellis, director of the Office for Protection from Research Risks, said it is not good practice for a collaborator to be among those probing a researcher's alleged wrongdoing. "Co-authors are not as independent of one another as they need to be to have one credibly investigate the other," Ellis said.

In addition to Steele, the VA panel consisted of the West Los Angeles hospital's associate chief of psychiatry, who chaired the proceeding; a hospital administrator; a physician specializing in geriatrics; a clinical nurse; and a pharmacoeconomics specialist.

Summarizing its findings, the internal hospital panel noted that Sager "has had an illustrious career thus far as an academic cardiologist" and "responded rapidly and responsibly to feedback regarding lapses in research procedures." It recommended that the hospital take a "measured" response in reprimanding him.

Sager said the ordeal has made him a better doctor and researcher. The investigation "really improved the research environment at this medical institution," he said last week.

"I think it's been a very positive thing. It's been painful for me emotionally, personally and professionally. But I think it's been appropriate."

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