VA Hospital in L.A. Reassigns Research Chief

Officials at the troubled West Los Angeles VA Healthcare Center have removed the director of research from his post and started a new inquiry into allegations of possible patients’ rights abuses in cardiology research.

The reassignment of Dr. Stephen Pandol, director of research and development, follows the U.S. Department of Veterans Affairs’ unprecedented suspension of research at the facility to protect human and animal research subjects.

Pandol has been assigned other, unspecified duties at the hospital, said its acting chief of staff, Dr. Dean C. Norman. The shake-up came after VA authorities in Washington called for an interim management team to address long-standing deficiencies in procedures designed to safeguard research subjects.

Similar problems prompted the U.S. Office for Protection From Research Risks to cancel the hospital’s umbrella contract to do clinical research funded by the U.S. Department of Health and Human Services. That action was also virtually unprecedented, a risk office official said.

In a separate development, Norman said he was launching an inquiry into new allegations of possible unethical research practices by Dr. Philip T. Sager, chief of electrophysiology and an associate professor at the UCLA School of Medicine. The move was prompted by a Times investigation of alleged ethics violations in cardiology research, Norman said.

The Times reported Thursday that Sager conducted or oversaw research on four VA patients in 1995 without first obtaining legally required informed consent. Those violations and others were documented in a 1996 internal report by a special hospital-led panel.

In recent weeks, a health care provider at the medical center provided The Times with information on three patients suggesting that Sager may have inappropriately enrolled them in studies last year.

Sager has reviewed the cases in question and is satisfied he acted properly and the allegations are false, said hospital spokeswoman Marianne Davis. Nevertheless, Sager told his superiors of the new questions raised by The Times.

He is cooperating with a new panel--including a cardiologist from outside the VA--that is reviewing records of all patients in his studies, Davis said.

“We’ve removed Dr. Sager from doing research until this board of inquiry has finished investigating” those cases, Norman said.

The specific, past problems in cardiology research under Sager took federal officials by surprise. Dr. Michael A. Carome, the federal risk office’s compliance chief, said his office never received the internal report detailing the infractions, contrary to regulations. The office had put the hospital on probation in 1994.

“The incidents as described [in The Times] would reflect serious noncompliance with federal regulations for protections of human subjects,” he said. The hospital’s failure to notify the risk office of the cardiology problems “reaffirms the concerns about its protection of human subjects” that led the office to cancel the contract, he said.

The risk office has recently sanctioned other medical facilities, including Rush-Presbyterian Medical Center in Chicago, which got a five-day research suspension last year. But Carome said the action against the West Los Angeles facility was far more extensive, amounting to a termination of its umbrella contract to do Health and Human Services-funded clinical research.

In the future, he said, the hospital will have to arrange to do such research on a study-by-study basis.

In a statement Thursday, hospital chief executive Smith Jenkins Jr. said, “We want to assure the public we are not recklessly experimenting on patients. . . . This shutdown is preventive, not punitive.”

The VA and risk office sanctions also apply to other VA facilities affiliated with the West Los Angeles hospital. At the Sepulveda VA Medical Center in North Hills, researchers say they are upset because they feel they are being unfairly punished for others’ mistakes. Though the two facilities share some administration, they have separate ethics committees for reviewing research.

The Sepulveda suspension is “setting back important research and wasting public funds for nothing,” a scientist there said. “We had to cope with the earthquake damage, which was tremendous here, and that set us back in our research. But now this is like a man-made disaster that is completely . . . unjustified.”

Dr. John R. Feussner, VA director of research and development in Washington, said there was no evidence of research oversight problems at Sepulveda. But he said it is subject to the action because the two facilities share the same Health and Human Services research contract.

“Neither the [risk office] nor myself have the prerogative to release them from this sanction,” he said. “The information I do have has led me to find essentially no problems with these types of . . . deficiencies at the Sepulveda VA. . . . I can understand their anger.”