-Caveat Lector-

Lawmakers Probe VA Research

By EUN-KYUNG KIM
.c The Associated Press

WASHINGTON (AP) -- Lawmakers expressed concern Wednesday over ``sloppy''
management by officials at a Los Angeles veterans hospital that allowed
potentially harmful clinical research to be conducted on patients without
their proper consent.

``The concerns about informed consent go straight back to the awful things
that Nazis did to people during the Holocaust and called it medical
research,'' said Rep. Terry Everett, R-Ala., who chairs the House Veterans
Affairs Committee's oversight and investigations panel. ``The civilized world
vowed that it should not happen again.''

The research problems, along with an overall failure to meet federal
regulations, prompted federal regulators last month to suspend research at
the West Los Angeles VA Healthcare Center, the nation's largest veterans'
hospital. They also spurred an investigation into the issue by two House
panels -- including the one Everett heads -- into whether the problems are
widespread among VA facilities.

During a hearing on the issue Wednesday, lawmakers questioned witnesses about
other violations that have surfaced since the research suspension was
imposed. The most serious violations involve Dr. Philip Sager, a cardiologist
accused of collecting data on four patients during heart procedures without
obtaining their consent.

In 1995, Sager conducted ``moderate to high-risk'' catheterization research
procedures in which probes were inserted in the hearts of four patients. One
patient had twice refused to give his permission.

Sager was suspended without pay for 10 days. An investigation later
determined he only served seven days of his suspension, although hospital
officials told lawmakers Wednesday that Sager will finish serving out his
discipline.

Rep. Cliff Stearns, R-Fla., who chairs the VA subcommittee on health,
chastised officials for being slow to learn about Sager's behavior and for
failing to make sure he had been punished.

``All down the line, there's a tentative approach here,'' he said.

Everett questioned why Sager was not fired.

Dean Norman, the acting chief of staff at the West Los Angeles facility, said
a panel of doctors had determined that suspension was more appropriate than
termination for Sager because he had not violated practices before and he was
a well-known and respected cardiologist.

Kenneth W. Kizer, the VA Department's undersecretary for health, announced a
pair of initiatives that he said will toughen controls on medical research.
Kizer said the department will create the Office of Research Compliance and
Assurance, an independent agency that will review all VA research efforts. It
also will fund an outside program to accredit all department research
programs, particularly those involving human subjects.

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