Veterans Agency Orders Reforms to Protect Patients After Rights Abuses

After revelations that patients’ rights were abused in research at the Veterans Affairs hospital in West Los Angeles, the U.S. Department of Veterans Affairs is creating sweeping measures to better protect veterans in clinical studies nationwide.

At a House of Representatives hearing Wednesday into the hospital’s crisis, the VA announced plans for two new organizations to oversee clinical research at all its facilities.

A new VA entity, dubbed the Office of Research Compliance and Assurance, will monitor researchers’ adherence to federal regulations protecting patients. The office may be running within six weeks, said Undersecretary for Health Dr. Kenneth W. Kizer.

Also in the works is a novel organization of outside experts to inspect and accredit VA research facilities every three years, he said, though that system could take the rest of the year to develop.

The hearing occurred less than a month after the VA and the U.S. Office for Protection from Research Risks took the unprecedented step of shutting down research activities at the VA West Los Angeles Healthcare Center, the nation’s largest VA medical facility. The risk office began investigating the hospital in 1993 and put it on probation a year later, citing multiple shortcomings in procedures for evaluating study proposals and obtaining patients’ informed consent to take part in studies.

The persistent research problems at the now embattled West L.A. facility included The Times’ revelations of four cardiology patients subjected to clinical research in 1995 without legally required informed consent.

Such cases were a trigger for the increased safeguards, Kizer said. “The unfortunate situation,” he said, “will be an event that turns around research in a broad framework across the country.”

Representatives from two Veterans Affairs subcommittees heavily criticized medical officials from the West Los Angeles hospital. They lambasted the hospital for lax oversight of research overall and inaction regarding the patients’ rights abuses in cardiology, which were documented in a 1996 internal report obtained by The Times.

“The VA has failed to protect our veterans at the West Los Angeles medical research facility. . . . This is the most serious trouble in VA medical research in many, many years,” said Rep. Terry Everett (R.-Ala.), chairman of the Oversight and Investigations Subcommittee.

He repeatedly suggested that violations of informed consent regulations by prominent cardiology researcher Dr. Philip T. Sager may have constituted assault or battery or a crime under a unique California patients’ rights law.

Also, Everett and other representatives expressed puzzlement at the tentative response of acting Chief of Staff Dr. Dean C. Norman in reprimanding Sager, who was ordered suspended without pay for 10 days but retained his position as chief of cardiac electrophysiology.

Saying his past action was appropriate, given Sager’s reputation as a respected physician, Norman prompted further dismay when he said he had just found out that Sager served only seven days of the suspension.

“The most troubling concerns about research at the VA in West Los Angeles involved . . . abuses of the requirements for informed consent and patient protection,” Dr. Paul Appelbaum, chairman of the American Psychiatric Assn.’s ethics appeal board, said at the hearing.

Dr. Stephen Pandol, who was forced to step down as acting chief of research at the West LA hospital, lashed out at the risk office during the hearing, saying that its action was “based on misinterpreted and out-of-date information. . . . There are many instances where [the risk office] failed to recognize improved procedures at the facility,” he said.

However, a risk official said the hospital was still out of line. A safety monitoring board that the hospital was supposed to set up several years ago was still not in place, said Thomas Puglisi, director of the division of human subject protections.

A major purpose of the House probe is to find out to what extent the problems at the West L.A. hospital reflect systematic shortcomings in the VA network of 173 hospitals. Puglisi said the risk office had no systematic data on the question, though it is investigating allegations of ethics violations involving research patients at VA facilities in Philadelphia, Cincinnati and Tampa, Fla.