Tuesday, June 4, 2019

V.A. Hospital Is Told to Halt All Research
Published: March 25, 1999

The Department of Veterans Affairs has for the first time suspended all research in one of its health care centers, saying the center has failed to meet ethical guidelines in human experiments.

After six years of investigations and temporary suspensions, the hospitals and clinics of the Veterans Affairs of Greater Los Angeles Health Care System -- including the West Los Angeles Veterans Affairs Medical Center, one of the nation's largest research hospitals -- were ordered on Monday to halt all of their animal and human experiments. The order will go into effect on Friday.

About 100 researchers are conducting 500 experiments there, officials said.

Dr. Dean C. Norman, acting chief of staff at the Los Angeles veterans hospitals, said in a telephone interview that several managers of research projects would be removed from their jobs and an interim team would be put in place to correct the problems.

Dr. Norman added that ''no patients or animals have been harmed'' and that the failures were breakdowns of administration, not of patient care.

The shutdown was ordered by Dr. Kenneth W. Kizer, Under Secretary for Health at the Department of Veterans Affairs, who noted that the hospitals had already been put on probation and that the management had repeatedly failed to correct the problems.

At the same time, the Department of Health and Human Services office in charge of overseeing human experiments officially cut off all Federal funds to the Los Angeles hospitals. Dr. Kizer's order also halted all private funds for the hospitals.

The problems mainly involve experiments carried out on veterans who are mental patients. In some experiments, advocates for the patients say, subjects in the experiments were deliberately taken off their medicines and allowed to suffer relapses so that researchers could study the course of their symptoms.

In other experiments, the subjects were given drugs that intentionally made the symptoms worse so that doctors could observe them as they occurred.

The investigation of the Los Angeles hospitals began in 1993 when Federal officials found, among other violations, that proper informed consent was not obtained from patients in the experiments.

To protect against such problems, hospitals are charged with establishing review boards that monitor proposed experiments for abuses, said Dr. John F. Feussner, the chief research and development officer at the Department of Veterans Affairs in Washington.

It is the failure of the Los Angeles hospitals to properly monitor and report on the sensitive experiments, he said, rather than any specific abuses of patients, that led to the Government's order to suspend the research this week.

Dr. Adil Shamoo of the University of Maryland, an expert on ethical issues in psychiatric experiments, said yesterday that the action against the Los Angeles hospitals showed that ''levels of concern on these kinds of experiments have been rising.''

''People are now seeing some potential harm to patients if these issues are not taken seriously,'' Dr. Shamoo added.

Dr. Feussner, describing the research system as ''an honor system,'' said: ''It requires that responsible officials assure us that their human and animal studies meet Federal policies and my expectations. In this case, the processes in place do not provide us with that assurance. I don't have any evidence that harm is taking place, but I don't have the proper assurance that it isn't, either.''

He continued, ''I am unwilling to assume things are fine, because the costs of being wrong are too high for the patients.''

In a six-page letter on Monday, the Department of Health and Human Services' Office for the Protection from Research Risks charged the hospitals with multiple violations, including these:

*Failure to include at least one representative to speak for the experimental subjects on the board that gives ethical approval for the experiments.

*Failure over five years to establish a ''data safety monitoring board'' to oversee events during experimental treatments as they were going on to assure the safety of particularly sensitive subjects like those with severe psychiatric disorders.

*The hospital ethical review board's continuing, despite warnings, to approve human experiments when few board members were present and even though insufficient information to decide on the ethics of the experiments was given to the board members.

Dr. Feussner said that it would take 30 to 90 days to correct the problems initially, but that the Department of Veterans Affairs expects to monitor the Los Angeles hospitals for at least a year after new rules and new managers are put in place.

No comments:

Post a Comment