When Mitchell Schubert learned last winter that he had won a $710,000 Veterans Affairs grant to study gastric acid secretions, he hired his lab staff, rearranged his teaching calendar, and scheduled his vacation days around his research at the VA Medical Center in Richmond, Va.
So Schubert was more than a little surprised this past spring to get another call from the VA's Office of Research and Development, this one saying he wouldn't be getting money after all. "I wasted most of this year," says Schubert, who has worked two decades at the center. "Without the grant ... the [staff] found work elsewhere. It was very disruptive to my laboratory, this fiasco."
Schubert had become one of many casualties in an ongoing battle over the future of VA-funded research, one that has led to the resignation of a top VA official, the departures of talented VA researchers, and questions about...
The department's Office of Research and Development distributes $400 million a year in research grants to 1,000 laboratories across the country. Historically, half that money has gone to bench or laboratory research. The remainder was divided among research projects that focused on rehabilitation, health services, and cooperative studies. VA-funded bench research has led to the discovery of cancer-fighting drugs, as well as the identification of genes that cause alcoholism and cardiovascular problems.
The balance between clinical and bench research began to change, however, under the leadership of Nelda Wray, a healthcare-outcomes researcher appointed to lead the Office of Research in January 2003. Wray, a highly regarded physician at the Houston VA Medical Center in Texas, argued that bench research did not serve veterans well. She began putting more emphasis on clinical workloads at VA hospitals, and she proposed changing the office's research portfolio so that more money went to the clinical and health-services research with which she was familiar, and which she says better served the veteran population.
Wray proposed putting 25% of research money into a new category that she called "laboratory science," a classification that worried bench researchers who were unsure of Wray's meaning of the term. She wanted to split the remaining 75% of the money equally among research that focused on clinical applications, rehabilitation, and health services.
Even some of Wray's strongest critics applauded her efforts to ensure that VA research translated into treatments and medications for patients. They acknowledged that many bench scientists aren't trained to think beyond the laboratory. Many in the VA research community were upset, however, by what they called the rapid and heavy-handed way Wray went about instituting her changes.
"The strategy to change the landscape of the VA research portfolio is, in many respects, a very reasonable thing to do," says John Cowdery, acting chief of staff at the Iowa City VA Medical Center. "The concern that I and other folks in the field have had is the tactical implementation ... that a rapid implementation may destabilize the personnel infrastructure and the clinical mission."
Convinced that VA researchers were unproductive, Wray introduced a new measure of productivity for evaluating grant applications. She put less emphasis on peer review, and she assigned numerical values to productivity, using factors such as the numbers and eminence of journals in which the researchers published. Using this method, she notified 15 researchers in April 2003 that they would not be getting grants that her office had already told them they'd won.
"These grants had been reviewed by peers," says Debra Aronson, senior science policy analyst with the Federation of American Societies for Experimental Biology. "To have someone come in afterward and say, 'I'm going to apply some new standards here and I don't think all of these should be funded' – there was a lot of distress."
Critics warned that taking money from laboratories would drain VA hospitals of talented physicians who are drawn to the government-funded system because of the opportunity to conduct bench research. Their predictions came true soon enough. "I was just disgusted with the way things were being done," says Fred Finkelman, a researcher at the Cincinnati VA Medical Center; he has moved most of his lab operations elsewhere. "Were the VA to decide to change the type of research it supports, it would have to find a way to replace all of the sub-specialty clinicians who are there because they're doing laboratory work. I am one of them. I came to the VA because it afforded some opportunities that were not really available elsewhere."
Schubert says some of his colleagues at the Richmond center have found work elsewhere. "If you don't have the academic research to attract the best and brightest, the medical care is not going to be the quality that patients are getting today," he notes.
On Dec. 5, VA staffers learned that Wray would be leaving "indefinitely" because of a "pressing family health concern," according to a memo. Perlin and Wray's deputy, Mindy Aisen, would not discuss the circumstances leading to Wray's departure. The department's inspector general is investigating allegations that Wray's office approved $750,000 in grants for two of her former Houston colleagues without going through proper peer-review channels. The VA also is investigating allegations that her office may have used funds intended for clinical studies on such inappropriate items as an office "image consultant."
In early December, Perlin and Aisen told the 15 researchers who had lost funding under Wray's tenure that they would get money after all. While that is good news for the researchers, most pointed out that they had lost time, momentum and staff. "If you stop funding on any research program, you do have a set-back, and to try to gear up again is a problem," says Dean Yamaguchi, associate chief of staff for research and development at the Greater Los Angeles VA Medical Center, which lost and then regained a $456,000 grant to study how kidneys handle changes in acidity.
Wray, who could not be reached, has her defenders; even many who disagree with her proposals say they understand the rationale behind them. "I believe the American public ... does want to see that this investment in biomedical research has an impact on human health," says Carolyn Kelly, associate chief of staff for research and development at the San Diego VA Medical Center in La Jolla, which lost and then regained a $500,000 grant to study esophageal pain.
"We want the people who get our funds to ... be thinking translationally about how they intend to bridge that gap between lab work and veterans' care," says Aisen.
Perlin and Aisen offered few specifics when asked if they would pursue Wray's initiatives. It is unclear, for instance, how heavily the office will rely on Wray's productivity measures, particularly her reliance on journal publishing. As for Wray's plans for the VA research portfolio, Perlin and Aisen say they have asked the National Research Advisory Council, which will include newly appointed members from the academic and science communities, to evaluate Wray's proposal.
"In my bench research, I really was not thinking about how that research could ... improve care," says Perlin, who trained as a molecular biologist. "We'd like to encourage our bench researchers [to think] about how their research can contribute to the ... veterans we serve." He says that any changes in distributing grant money would be done slowly, so as not to upset the pace of research already underway. Observers expect the office to continue to shift its focus toward clinical research, however, and away from the lab science that has been the cornerstone of the VA medical system.
"What was damaged was the credibility of the program and the sense of security that [researchers] had," says one observer close to the situation, who requested anonymity. "People ... started looking elsewhere, and that's where we might see the long-term consequences." 6