Research Suspended at Los Angeles VA Center

Anger, uncertainty, and confusion followed in the wake of the unprecedented suspension of research March 26 at the Veterans Administration Greater Los Angeles Health Care System (VAGLAHS), the largest center of its kind in the country. "Everything has come to a screeching halt," said VAGLAHS spokeswoman Marianne Davis, who estimated some 1,200 protocols and hundreds of researchers were stopped in their tracks. The order--which applies to the five Los Angeles-area facilities and seven outpatient clinics that had recently been merged to create VAGLAHS--came by way of a two-page letter signed by Kenneth W. Kizer, Veterans Administration (VA) undersecretary for health. The letter did not mention any specific incidents, nor offer any evidence that research practices had harmed any people or animals. Rather, it cited "management's unresponsiveness," as well as an overall failure to meet federal guidelines as the reasons for the suspension, dubbing the action a "preemptive" measure to prevent injuries and to ensure protection of human and animal research subjects. It is the first time such a far-reaching order to halt research has been issued. In a statement released the day before the suspensions took effect, Smith Jenkins, acting CEO of VAGLAHS, stated: "We want to assure the public we are not recklessly experimenting on patients. There is no evidence whatsoever that human and animal subjects have been harmed." That same day, however, the Los Angeles Times ran a story1 detailing a series of alleged improprieties and alleged patients' rights abuses in 1995 involving cardiology patients under the care and research of Philip Sager, chief of cardiac electrophysiology at the West Los Angeles Center. In one case, the patient died. In a related action, the National Institutes of Health's Office for Protection from Research Risks (OPRR), which had placed the facility on probation in 1995, terminated its umbrella contract to conduct clinical studies funded by the U.S. Department of Health and Human Services. The termination marked another unprecedented step "to ensure adequate protections for human subjects," according to a letter obtained by the Los Angeles Times. In its letter of suspension, which comes after six years of inquiries, notices, and citations, the OPRR cited 10 procedural violations. "We are faced with two suspensions--one is from the OPRR and the other is from the VA headquarters," explained Peter Eggena, the interim acting associate chief of staff for R&D at the West Los Angeles facility. "The VA suspension ... includes everything, and the OPRR only affects human studies." Since the merger of the facilities into VAGLAHS took place recently, there is no one central database from which to determine exactly how many studies or researchers are affected, Eggena explained. He did confirm Davis's estimate of 1,200 protocols and said, "It is safe to say the researchers number in the hundreds." Meanwhile, all investigators have been asked to submit memos explaining why their studies should continue. "We are currently going through those and logging them into a central database," Eggena said. While that process is under way, he added, "those studies where the patient's life or health is at risk are continuing." Although the suspensions do block recruitment of new subjects and delay decisions on all proposed research, according to Eggena, "if you have, for compassion reasons, a need to enroll somebody--for instance, if you have a study with a drug that might be the last resort for a certain type of cancer patient--then it would be unethical to withhold that, and the same is true for the animals." Neither Eggena nor spokeswoman Davis was able to cite specific studies that were still under way, but Eggena said that data is being collected on those that are continuing. For now, every researcher The Scientist spoke with requested anonymity. Said one: "We were issued an executive order not to speak about this." Both Eggena and Davis denied any such order was issued. "They are not allowed to speak as representatives of the hospital, but no one is going to stop them from speaking as individuals," said Davis. One researcher said: "We were told that it would be 90 to 120 days before things will be back up and running--that is, the research that will be reinstated. We were also told not everything would be reinstated." Although all VA tenured medical professionals at the West Los Angeles hospital have an appointment at the University of California, Los Angeles (UCLA) School of Medicine, and some UCLA faculty members conducting research will be affected by the suspension, the sanction does not apply to research done on the UCLA campus, according to university spokesperson Warren Robak. John R. Feussner, the Veterans Affairs chief of research and development in Washington, D.C., repeated that the suspension was ordered because of procedural and administrative deficiencies, and not because of any inappropriate actions on the part of investigators. However, he said that the Washington office had not been aware of the 1995 Sager investigation and reprimand at the time the decision was made. Feussner said he had just reviewed the West Los Angeles VA Hospital internal report on Sager. "The issues about the cardiology situation involve human research, and we have stopped all human research at the Greater Los Angeles Health Care System, much like OPRR has done. In the process ... we made the judgment that we would first, as with OPRR, look at human studies where if they were stopped abruptly they do the patient harm, and in those circumstances they would have stopped the enrollment of new study subjects. Other studies where there is no concern about patient safety have been stopped, period. Essentially, we have suspended all human research until we look at the safety issue and then go in and review all of the human studies to determine which ones could continue or not." A full review of the informed consent procedures will be launched, Feussner said. "We will look to see that research proposals have a solid scientific base, that the informed consent procedures recommended in the research project pass human studies review ...." The first order of business, Feussner asserted, are the safety issues. "It is my understanding that there are 500 human studies involved, and we will review these first," he said, adding that they may consider some studies to be reinitiated for new-subject accrual. "That we would have to do and want to do in concert with OPRR." Feussner said that the 200 human studies will be submitted to other sites across the country within the VA system to look at the issue of patient safety. However, he maintained that initially, "We don't have any reason to believe that any patients have been harmed or that the informed consent process has been abused." There is growing concern among investigators about the broader implications of this unprecedented action on their own careers. Said one AIDS researcher: "Tomorrow I'm supposed to go into a meeting because we just got two new grants for two new labs and I don't want to lose $10 million." Another physician, who is currently in the midst of a research protocol there with human patients, confirmed that they had been told to stop all research. "It's changing day to day," she said. " ...We assume there will be a blanket exemption for basic science research that doesn't involve humans or animals. But all human and animal research has been suspended for now. Things are in a maintenance ... state where we can treat patients who would be harmed if we stopped. People can still take care of the animals, but not continue or begin any new experiments unless it would cause harm. We're filing for exemptions but things are kind of up in the air." So where from here? "We're looking for space outside the VA," sighed one researcher, echoing the reaction of most of the others. "It's a horrible situation and it's going to get worse before it gets better," said another. A.J.S. Rayl (ajsrayl@loop.net) is a freelance writer in Malibu, Calif. T. Monmaney, "VA Hospital's ethical nightmare," Los Angeles Times, page 1, 24-25, March 25, 1999.

Research Suspended at Los Angeles VA Center

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