U.S. Suspends Research at VA Hospital in L.A.

To protect patients in clinical studies, the Department of Veterans Affairs is taking the unprecedented step of suspending research activities at the West Los Angeles veterans hospital, the nation’s largest VA health care facility.

The action, scheduled to take effect Friday, climaxes six years of government inquiries into the medical center’s failures to comply with regulations safeguarding patients in studies, according to documents obtained by The Times. It marks the first time the agency has issued such a sweeping order to curtail research at one of its 173 hospitals.

The suspension, which covers research on human and animal subjects, potentially affects 500 studies being conducted by more than 100 researchers at the recently renamed West Los Angeles VA Healthcare Center, Dr. John R. Feussner, the agency’s chief of research and development, said Tuesday. It blocks recruitment of new subjects into existing studies, delays decisions on proposed research and threatens the continuation of ongoing experiments.

Feussner did not know how many research patients might be affected. But any studies that would cause harm if they were stopped will be allowed to continue, and his office will consider sustaining other clinical studies on a case-by-case basis to avoid disrupting research subjects’ lives, he said.

The VA’s two-page order did not cite specific incidents that triggered the agency’s investigations or this week’s action. It referred instead to “management’s unresponsiveness” and a general failure to meet federal guidelines.

“The lack of adherence to research policy and operational requirements is a very grave matter,” said the letter, signed by Dr. Kenneth W. Kizer, VA undersecretary for health.

In a related action, the federal Office for Protection From Research Risks on Monday suspended the hospital’s contract, known as an assurance, to do clinical studies funded by the U.S. Department of Health and Human Services. The step was “to ensure adequate protections for human subjects,” according to a letter obtained through the Freedom of Information Act.

Risk Office’s Inquiry Began in 1993

The risk office, part of the National Institutes of Health, began investigating the West Los Angeles VA hospital in 1993. At that time, it cited the facility for errant informed-consent procedures, such as not disclosing to mentally ill patients all the possible hazards of participating in studies of anti-psychotic medications.

Since then, the risk office has sent the hospital at least five notices detailing shortcomings in its oversight of safety and ethics procedures, according to letters obtained by The Times. The office put the hospital on probation in 1995, requiring quarterly progress reports on protections for human research subjects. The latest action is said to be the most stringent measure the risk office has taken against a clinical facility in recent years.

The VA’s broad sanction takes the risk office’s findings into account, Feussner said, but also grows out of the agency’s own investigations, which began in 1997 with a probe of procedural troubles in drug addiction research at the hospital.

In a stinging letter to hospital officials Monday, Kizer ordered the suspension of research by Friday, saying efforts to improve subject protections after repeated warnings were “wholly unsatisfactory.”

The research sanction pertains not only to the flagship West Los Angeles hospital but also to affiliated clinics and research facilities in the VA Greater Los Angeles Healthcare System.

VA officials say they have no evidence that the hospital’s allegedly lax oversight of research practices has harmed people or animals. Instead, the suspension is a “preemptive” measure to prevent injuries, according to the order, which is dated March 22.

The medical center “will comply with these orders and cease all research activities except for studies explicitly approved by the VA headquarters office of research and development,” said hospital spokeswoman Marianne Davis. A call to the medical center’s acting chief of staff, Dr. Dean C. Norman, was not returned.

The orders are not expected to affect ordinary patient care at the 1,056-bed facility or the many affiliated clinics, all of which serve an area with about 1 million veterans. Los Angeles County has the nation’s highest concentration of veterans.

A Milestone in Bid to Make Studies Safer

The measures taken against the hospital represent a milestone in the decades-long struggle to make clinical research safer and more ethical for the many thousands of Americans who volunteer for clinical studies.

A web of federal and state regulations is supposed to be a safety net for research subjects, shielding them from exploitation and undue injury. But scholars, medical researchers and patient advocates have recently suggested that the growing number of studies, coupled with their skyrocketing complexity, has made it increasingly difficult for overburdened hospital ethics committees to comply with regulations.

The VA’s Feussner said the action reflected the agency’s aggressive approach to safeguarding patients and animals in research. He said he was “very optimistic” that research there could be reinstated after the deficiencies are corrected and new procedures put in place.

“The scientists and clinical researchers at the West L.A. site . . . are outstanding investigators,” he said. “The problem is with management, not science.”

All VA tenured medical professionals at the West Los Angeles hospital have an appointment at the UCLA School of Medicine. Although UCLA faculty doing research at the VA facility will be affected by the suspension, the sanction does not apply to research done on the UCLA campus, university spokesman David Langness said.

“People who have adjunct or teaching appointments here are free to do research at other places,” he said, “but we do not govern that research.”

Feussner declined to mention specific examples of wrongdoing and characterized the problems as “process violations” found on the various hospital review committees that oversee the scientific validity, safety and ethics of research in human and animal studies.

He said some hospital administrators may dismiss problems on such committees as mere bureaucratic snafus. “People sometimes argue that this is all just paperwork and not important,” he said. “But we obviously disagree with that.”

Problems Found in Review Board

The federal risk office’s several notices to the hospital--which Feussner said the VA agreed with--provide more detail about the complex issue. In its letter Monday, the office cited numerous problems with the hospital’s Institutional Review Board, which evaluates the scientific and ethical validity of research proposals.

The risk office found that vital research decisions made at seven meetings of the committee in May through July last year were invalid because too few members were present or the sessions failed to include a nonscientist, who attends as a sort of proxy for patients to represent their interests.

Similarly, review board meetings to evaluate research involving mentally ill people were supposed to have a special member representing the patients’ interests. But a check of meeting records turned up instances in which no such representative was present.

All told, the risk office lists 10 violations of such procedures in its letter suspending research funded by the NIH and other federal agencies.

“Research activities involving previously enrolled subjects may continue only where it is in the best interests of individual subjects,” the letter says.