Research Slowly Resuming at L.A. VA Center

The $45-million research program at the Veterans Administration Greater Los Angeles Healthcare System (VAGLAHS) is slowly recovering after being abruptly shut down in March in an unprecedented sanction over regulations safeguarding patients in studies.1 "This might be the thing that wakes everybody up."--Stephen Pandol All 322 laboratory and animal studies, and more than 300 of the original 352 human clinical studies have been authorized to resume, leaving about 50 human studies in various stages of review. In addition, 29 new human studies have been approved since the shutdown. "It's quite a laborious process putting them through this review," says acting research director Marguerite Hays, who is on leave from the Palo Alto, Calif. VA medical center. "The difficulty has been that it takes an awful lot of work to re-review all the protocols as though they have never been reviewed before," says John R. Feussner, VA chief of research and development, Washington, D.C. In addition to the reviews conducted by the newly constituted committees internally, he explains, "We have been re-reviewing their work externally, and that has placed a significant burden on them, and I think it's slowed them down somewhat." The mood and morale of researchers continue to run the gamut. Though a few investigators are still bemoaning that the shutdown was too drastic, others are viewing the new ethics measures and comprehensive consent forms now being instituted as a necessary process that may well lead to improvement in human research oversight in the United States. Among the new ethics measures: the creation of a special safety panel to closely monitor studies involving patients with mental illnesses, one of the few of its kind at a public hospital; reducing the use of placebos in research on patients who are ill and need treatment; and cutting back on research sponsored by pharmaceutical companies, which on occasion have rules that conflict with the hospital's proposed protections of research subjects. On the human-use research front, paperwork has increased dramatically by all accounts, and how the investigators are reacting to this depends on whom you ask. "It's worse than ever, and the paperwork is driving us crazy," said one physician-researcher who requested anonymity. "There's tons and tons of paperwork now for human-use research. The consent form has been greatly revised for all projects, and multiple copies have to be sent out. In addition, all the subjects have to be recontacted to sign the new consent forms, and there's a tier of committees and offices and numbers that have to be assigned on all the revisions. 'Back on track' is a euphemism and doesn't really say anything. It means you've got a green light, but that doesn't mean you can go until you get all the revisions and new requirements completed. In other words, in order to step on the gas, you've got to get all kinds of ignition keys and there are a lot of them." Kenneth Rosenfeld, a University of California at Los Angeles (UCLA) physician-investigator, views it differently: "At this time, the most important thing is that everyone work together to try and improve things, and I don't think articles about low morale and people complaining is a productive way of doing that. You're hearing both sides of the same coin. We're trying to improve things, and that often requires pain in the initial phases. Hopefully, in the long term, things will be much better." The increase in paperwork is necessary, maintains Hays: "We're trying to meet all of the regulations and to be absolutely pure in what we're doing and to make sure that all of the requirements are being met. We're bending over backward, and after all, the paperwork was part of the reason we got into trouble. I believe most of the investigators understand that." It's been a "bootstrap" operation, she adds, "but we finally now have the forms easily accessible on computer and in standardized language that is acceptable, so I think the process is going to get easier for the investigators." Nevertheless, Hays surmises, the paperwork is going to continue. "We're looking over our own shoulders very carefully, and other people are going to be looking over our shoulders." As for those investigators who are still unhappy, Hays acknowledges, "I think people have justified reasons for being unhappy." However, she adds, "They undoubtedly don't see that they are personally at fault for the shutdown. When an institution has problems, everyone in the institution has problems to some extent, but I think they really feel that they're being punished for problems that they were not personally responsible for." "Basically there has not been much of a change with regard to the animal studies, although a new biosafety committee has been established to thoroughly review the animal studies, meaning researchers are having to fill out more biosafety paperwork," says Scott Krahl, chair of the animal research committee for the West Los Angeles center. "Overall, I feel the morale looks good and things are back to where they were before--at least from my perspective," says Anna N. Taylor, VA research career scientist and UCLA professor, who sits on the R&D committee. However, George Sachs, director of the membrane biology laboratory at West Los Angeles, has a different opinion: "There's much more paperwork, and the ordering procedure has become labyrinthine, ... so that things are not timely at all. We still have no budget reports for 1999, let alone 1998, so we don't know how much money we have or don't have to spend." Sachs has put more than $6,000 on his Visa card to keep his research going. The budget has taken a lot longer to figure out than had originally been planned, Krahl admits, "but nobody should be having to take money out of their own pocket if they have research funding here on station, because the budget issues have pretty much been worked out." So when will this all be over? "It's tricky," says Hays, reluctantly predicting November as the month when things will finally be back to normal. "I think it's going to be an asymptotic process. I think we've gotten over the biggest hump already in that none of the projects that were ongoing before the shutdown are just waiting. They're all in the review process at the present time. I think within the next couple of months, we'll be through with that process. Then it's going to be a matter of regrouping and making sure that the ongoing process we have is going to be viable in the long run." Meanwhile, Stephen Pandol, the former head of research for VAGLAHS, and three managers in his division who were also temporarily reassigned, have recently been informed that the whistle-blower case they filed last spring with Special Counsel will be investigated. Special Counsel, the independent agency within the federal government that takes allegations or complaints from employees who have had personnel actions taken against them after reporting wrongdoing, has the authority to reinstate people, as well as prosecute the wrongdoers. Interestingly, Pandol, who has been reassigned as a staff physician and on his own research in gastroenterology, is optimistic about the changes. "In the long run, this particular episode, even though it may have had a negative impact on me and others, has the potential of having a very positive effect on human research in the United States. It brought forward the issues we all face in trying to manage this activity in our various environments," he says. "If you look at the human research enterprise, it's only going to get bigger. We have these biotech companies potentially spinning out an enormous number of potentially important advanced products, and if we don't have a system that works, it's going to fall apart. In the end this may be one of the [events] ... that may change how we think about human research oversight ... [and] could set the new model. This might be the thing that wakes everybody up." A.J.S. Rayl (ajsrayl@loop.com) is a freelance writer in Malibu, Calif. A.J.S. Rayl, "Research suspended at Los Angeles VA center," The Scientist, 13[8]:11, April 12, 1999; and A.J.S. Rayl, "Researchers, officials dealing with VA problems in L.A.," The Scientist, 13[10]:6, May 10, 1999.

Research Slowly Resuming at L.A. VA Center

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