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Researchers Feel the Crunch From VA Shutdown

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TIMES MEDICAL WRITER

For the first time in his 15 years of scientific work at the veterans medical center, Dr. George Sachs used plastic to keep his lab running: He charged $935 of chemicals and supplies to his personal Visa card this week after the Department of Veterans Affairs cut off his funds as part of its abrupt suspension of research activities at the VA West Los Angeles Healthcare Center.

The unprecedented research shutdown stems from concerns over the safety of patients taking part in studies at the facility. And that is what bothers Sachs, who had more than $240,000 in VA research funds frozen, virtually paralyzing his 15-member staff. They do not work with patients.

“Such a sweeping research ban is punitive and unjustified,” said Sachs, director of the membrane biology laboratory and a UCLA professor of medicine. “There should have been something done for people in research who do not conduct human studies.”

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On the sprawling West L.A. campus, home to the VA’s largest medical facility, researchers like Sachs who do experiments with test-tube cells and lab animals are frustrated and angry that their work is being held up because of management’s problems overseeing clinical studies.

The mood is no better among physician-researchers who say that their efforts are thwarted by overly broad government edicts aimed at administrative problems far from the front lines of treating patients.

“We feel handcuffed and a tremendous sense of loss,” said Dr. Kenneth Rosenfeld, who has a private foundation grant to monitor the care of people at the end of life. But central VA authorities clamped down on research funded by outside sources too. “It’s demoralizing to come into work every day and not be able to do what we’re passionate about doing.”

Several physicians said in interviews that the research suspension, while painful, may strengthen the medical center in the long run. It was dispiriting, said Dr. Seymour Levin, director of the hospital’s clinical research center and diabetes program, “but I guess it had to be done.”

In spite of the funding freeze, researchers have been told to maintain their projects, keeping research animals and test-tube cells alive. The medical center has created an especially elaborate new process for submitting orders to purchase supplies, but Sachs and other basic researchers say they worry that the added layers of bureaucracy dangerously prolong simple transactions.

Scientists have described other indignities, small and large. Disheartening internal memos suggest that some salaries are in jeopardy, with some research personnel on a “pay period to pay period basis.”

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Looming deadlines for filing grant applications may be missed because tests cannot be finished, thus threatening future projects. Disapproved FedEx packages remain unsent. The institution’s fresh black eye discourages top recruits from signing on to work there.

At first, Veterans Affairs officials in Washington said the research suspension would cover about 500 studies. But they later broadened the ban to all research activities regardless of the funding source and upped the total to more than 1,000. Since then, hospital officials have been working long hours, poring over study summaries to determine which should continue, lest patients or animals be harmed.

As of last week, they had decided to suspend 47 studies sponsored by the Department of Health and Human Services and allow 25 others to continue, according to a letter from the medical center’s acting chief executive, Smith Jenkins Jr. Veterans Affairs officials said all clinical studies that would cause harm to people or animals if discontinued will be kept going.

The unusual research ban came from VA officials in Washington and the U.S. Office for Protection from Research Risks. In separate investigations, VA officials and the risk office--which regulates human and animal studies funded by the Department of Health and Human Services--uncovered persistent problems in the medical center’s procedures for overseeing the ethics and safety of studies involving people. Officials at both agencies said they were not aware that patients had been physically harmed by the failings.

The risk office sanction is limited to clinical studies because it found no problems with animal research at the West Los Angeles facility, said Director Gary Ellis. VA officials have also said they found no problems with animal research, but they justified the all-encompassing sanction by explaining that if problems existed in human studies--which should be scrupulously safeguarded--there might well be shortcomings in the oversight of animal studies.

Some researchers at the medical center have said that decision was unreasonable because the West Los Angeles facility’s animal care programs have received high marks from outside inspection teams.

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Also upset are clinical researchers and basic scientists at the Sepulveda VA Medical Center in North Hills, which is linked to the West Los Angeles facility and therefore subject to the research suspension.

VA officials have said they have not identified problems with human or animal research at the San Fernando Valley facility.

“It’s appalling,” said one researcher who spoke on condition of anonymity. “This feels like an extended siege.” When the ban was announced last week, he thought it would be lifted quickly, but it lingers. His lab costs $20,000 a week to run, and his funding has been cut off, he said. “How am I going to pay for that?”

Among the scientists in Sachs’ lab, perhaps none is feeling the suspension as acutely as Dr. Christoph Athmann, whose visa expires in seven weeks, when he must return home to Germany. But now he is not sure he will be able to finish his experiment, and he said he is afraid that in the publish or perish world of international academic medicine, he may not have enough to publish.

“Basic research is hard enough because of the complexity of biology,” said Sachs, whose work has contributed to the development of modern antacid drugs such as Prilosec, one of the world’s top sellers. “But this is making it far more difficult.”

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