Researchers, Officials Dealing with VA Problems in L.A.

Studies are slowly restarting at the Veterans Administration Greater Los Angeles Healthcare System (VAGLAHS) after an unprecedented suspension of research last March 26.1 Investigators, meanwhile, are dealing with the fallout, and many are waiting to learn the fates of their protocols. They're also struggling still to understand why such drastic action was taken because of administrative failures. "We're all ... amazed this could happen, and I think all of us feel we're being blamed for what is probably an administrative oversight ...," says George Sachs, who heads the membrane biology laboratory at the West LA Healthcare Center. The story emerging is one of missing memos, a lack of communication, lack of follow-up, and lack of resources and support. VAGLAHS was hit with two suspensions last March--one from the VA headquarters and another from the National Institutes of Health's Office for Protection from Research Risks (OPRR), which terminated its umbrella contract to conduct clinical studies funded by the U.S. Department of Health and Human Services--as a result of "management's unresponsiveness" and an overall failure to meet federal guidelines. The situation heated up when on the eve of the suspension announcement the Los Angeles Times ran a story detailing alleged improprieties and alleged patients' rights abuses in 1995 involving four cardiology patients under the care and research of Philip Sager, chief of cardiac electrophysiology at the West LA Healthcare Center. Within a week, the members of two U.S. House of Representatives subcommittees overseeing veterans issues called for an investigation and held a hearing in April. Prior to the House hearing and just after the shutdown, John R. Feussner, the VA chief of research and development in Washington, D.C., traveled with other officials to Los Angeles for a meeting with the faculty and investigators on site. "The Washington people were hostile at first, saying 'You didn't fix this or this,'" says a physician-cancer researcher who requested anonymity. "Apparently we were on probation for two years, but they never let the investigators know ...," she adds. While VA headquarters claims that memos announcing the probation and ordering changes were sent to management, "We were surprised to find out about the probation," confirms Sachs. "Were [the memos] sent? Were they discarded when they came? I think we have a situation where our bureaucracy and [the] central office's bureaucracy were not acting together." "I thought everybody knew," responds Feussner, who added that memos went to the three major communication areas--research leadership, hospital leadership, and [Veterans Integrated Service Network] leadership--and that he had received a returned letter of acknowledgement. "It's plausible to me that the investigators might not be aware of that. That would determine how close a relationship the leadership had with the investigators." Stephen Pandol, who was reassigned in March from his post as director of research and development at the VA center, insists that no such memos were sent. "I've heard that Dr. Feussner indicated the medical center was getting memos frequently indicating we were on probation as an extension of a six-month probation back in 1997, but neither [I] nor ... the acting chief of staff ... has ever seen any such memos," Pandol, who initiated the investigation into the Sager situation, told The Scientist. At the House hearing, VA Undersecretary of Health Kenneth W. Kizer announced plans for two new organizations to oversee clinical research at its facilities: the Office of Research Compliance and Assurance, which would monitor researchers' adherence to federal regulations protecting patients and, according to Kizer, could be up and running within six weeks; and another organization of outside experts who would inspect and accredit VA research facilities every three years. That system, Kizer added, will probably take until the end of the year to be set up. In other testimony, Pandol charged: "There have been innumerable erroneous allegations made toward the research administration of the VAGLAS." Pandol went on to detail specific problems and incidents, citing a lack of resource commitments to complete required changes, and a lack of timely communication with the VA as well as OPRR. Pandol later told The Scientist: "For example, we had a report in to OPRR last November, and in February when we called to check on the status, they said, 'we haven't gotten to it.'" "We stand by our findings," says J. Thomas Puglisi, director of human subject protections, OPRR. "Indeed, the VA responded to some of our required actions and did make some improvements; however, it was our judgment after six years that they hadn't acted broadly enough or specifically enough." Meanwhile, VA headquarters has appointed Marguerite Hays of the Palo Alto VA medical center as the interim acting associate chief of staff for research and development at the West LA Healthcare Center to help rebuild the research program. "We have obtained a formal multiple-project agreement with VA headquarters .... Our newly reconstituted institutional review boards are ... reviewing all human subject protocols except those funded by Health and Human Services," says Hays, adding that it will take a minimum three weeks to get through all of them. "Approval is being given on a protocol-by-protocol basis." News of the shutdown is reverberating through the research community, and many investigators are worried about their reputations. "Researchers from here have been asked not to take part in some of the combined human project studies that are carried out in many hospitals across the country," says Sachs. "It really doesn't make much sense, because when you have a multiple project carried out in different hospitals, each hospital reviews the human use component of everybody as well, so it's not even uniquely being reviewed at the [West LA Healthcare Center]." As a result of the uncertainty, some are trying to move their projects out of the VA. "We're sending copies of all our protocols to the UCLA Human Services Protection Committee to see if we can run our studies through UCLA, as a subsite of UCLA, as an alternative to reopening them at the VA," explains one physician-researcher. The prospects for that appear good. In an open letter to the faculty and researchers, Gerald S. Levey, provost for medical sciences and dean of the school of medicine at the University of California at Los Angeles, wrote, "My team and I stand behind you and will not rest until this crisis is properly and fairly resolved." Another team of researchers has opted to go offsite to launch a long-planned series of small animal studies. "It looks now like we're going to be running these experiments out of my garage," said one of the team members, who like most investigators requested anonymity. "We will be able to do that pretty easily there, but at some point when you publish, you've got to say where the experiments took place--and I still haven't figured out how to handle that." Some investigators are not only looking for a new location, says Kenneth Rosenfeld, a UCLA physician-investigator; they're looking for new appointments. "I know of many investigators who are so demoralized with the administration and the management here that they're looking for other jobs, not because they feel their job is in jeopardy but because they feel our research administration can't take care of them in terms of doing what needs to be done." The general perception is that most of the research protocols will eventually come back on. Others are not so sure. Another speculation is that this is all a smokescreen hiding an agenda. "It's unbelievable what's going on--they're attacking the VA at its strength, with a vengeance and vehemence that is kind of breathtaking," says David Moskowitz, a former physician at the VA center in St. Louis. "I think they're taking down the VA, trying to abolish it, and they're using incredibly oppressive tactics. They want to turn the thing into a stripped-down, dumbed-down primary-care-only, managed-care operation that essentially just keeps the cemeteries busy."2 "There is something crazy going on here, but what it is I'm not sure," Pandol agrees. "There is no national oversight by the VA, no training or teaching of our people as to how to do things, and some of this I think was to cover that deficit." Says Sachs, "I don't know that [the shutdown] had much more motivation than to punish. The psychology of investigators and innovative research is a very delicate balance between frustration, obsession, and inspiration, and an act that brutalizes this psychology has to be very carefully considered and well justified and I don't think [the] central office has [done this] .... The people now in charge of central office ..., don't in my view have much appreciation for the role of basic research in improving patient care within the United States. Their actions of the last two, three years have been more geared to fully applied research than fundamental research. I think they have forgotten [that] in order to have the treatment there in the first place you have to do research." Feussner responds: "The majority of the VA's research appropriations supports basic biomedical research, and that has been the case at least throughout the decades of the '90s, so that assertion is bewildering to me. I just wish some of these people would get the facts before making assertions that are incorrect. I find the assertion bordering on the ridiculous." He continues: "Much to my chagrin, paranoia seems to be running rampant. ... Here's a fact: The research appropriation has increased from $262 million to $316 million. The VA is now funding more career development awardees than it did in 1995, 1996, and 1997 ... the first time that slope has been positive in a long time. The payline for basic science research projects was 20.5 percent; now, it's between 37 and 40 percent. And, just last year we tripled our investment in basic science equipment from a baseline support level of about $15 million to $48 million--almost all of that basic science equipment. Those are hard numbers. Now, does that sound like an organization that is downsizing and eliminating research?" As for the research protocols that may or may not be reinstated, Feussner says: "There are 909 total protocols, with fewer than 10 eliminated because they were completed and came off the list. Our goal is to bring them all back up." The lowest-risk basic science and the majority of animal studies have been cleared and reinstated, he adds, and "impressive" progress is being made on the estimated 500 human studies, some of which have been running on maintenance mode. "I would be surprised if the overwhelming majority of studies weren't fully active and fully reinstated within 90 days of March 26--by June." For most researchers now, however, it's still a waiting game. "No one," sighed Rosenfeld, "should have to go through this." A.J.S. Rayl (ajsrayl@loop.com) is a freelance writer based in Malibu, Calif. A.J.S. Rayl, "Research suspended at Los Angeles VA center," The Scientist, 13[8]:11, April 12, 1999. D.W. Moskowitz, "Should suicide of the VA health care system be condoned?" The Scientist, 12[14]:11, July 6, 1998.

Researchers, Officials Dealing with VA Problems in L.A.

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