San Diego County Superior Court Judge Judith Hayes accepted USC's promise that it will not alter data and computer systems that are part of the Alzheimer's Disease Cooperative Study (ADCS), a $100-million nationwide project that has been based at, and managed by, UC San Diego since 1991.
The university last week sued the director of the study, Paul Aisen, eight of his campus colleagues and USC, accusing them of hijacking a study that involves dozens of research institutions across the country, some which are conducting clinical trials for Alzheimer's treatments. USC effectively took control of the study when Aisen resigned from UC San Diego last month.
In an interview Wednesday, Aisen said that he is responsible for the study data and that he's basically operated the study on an independent basis for years. Further, he said, "over 30" people have left UC San Diego and followed him to join the new Alzheimer's research institute he is founding with USC in San Diego.
Aisen denied any wrongdoing in his shift of schools and said that such moves are routine.
The two research institutions were told to return to court on July 24 to resume a showdown that involves millions of dollars, institutional reputations and the pace of progress in finding ways to treat dementia.
UC San Diego said that Aisen and his staff have changed the study's computer passwords, preventing the campus from handling unique, sensitive and personal data that's being collected with the use of public and private money.
"Currently — and contrary to Dr. Aisen's unsubstantiated claims — UC San Diego remains blocked from full access to ADCS, a reality that underscores our concern for the integrity and safety of the data," campus administrators said in a statement Wednesday.
"Specifically, administrative oversight of the data has been blocked by Dr. Aisen. Merely being able to 'see' data that are UC San Diego property does not allow us to ensure its protection or integrity as by our contracts and by law," the statement said. "We and our research partners do not want the ADCS data and systems commandeered by Dr. Aisen and others to be jeopardized in the process of restoring it to UC San Diego."
USC defended its actions.
"As the university previously stated, we are surprised and disappointed that the University of California, San Diego, elected to sue its departing faculty member and his team, as well as USC, rather than manage this transition collaboratively, as is the well-accepted custom and practice in academia," Randolph Hall, USC's vice president of research, said in a statement.
Aisen, 60, said his decision to leave UC San Diego was made "in the interest of science and public health." He said the move "was straightforward and entirely consistent with usual practices. What it boils down to is that loyalty to [UCSD] is paramount. From my perspective, I believe that the integrity of the science is paramount. And consistent with the integrity of the science, there is no question that the program should move with our group."
He said that many UC San Diego employees who had been working on the study quit and joined him at USC's newly created Alzheimer's Therapeutic Research Institute in Sorrento Valley.
Outside the courtroom on Wednesday, David Brenner, dean of the UC San Diego School of Medicine, said, "That figure's not right; they didn't hire 30 of our people. I don't believe they even have a physical presence here. They just want our data." The campus later said it had lost 23 employees.
The mass defection drew some support for USC. The campus shared legal documents showing that three scientists involved in ADCS studies — Reisa Sperling of Harvard, Christopher van Dyck of Yale and Suzanne Craft of Wake Forest University — believe Aisen should remain in control of the study.
USC also released a letter from executives at the pharmaceutical company Eli Lilly, which is sponsoring A4, a key study meant to prevent memory loss in older people.
The letter says, in part, "We believe any near term action to remove administrative control from the study leaders (Aisen and Sperling) could jeopardize patient safety, study quality and otherwise negatively impact our ability to fulfill our sponsor obligations."
The letter also says, "Regarding the A4 study data, the current contract states that it is jointly owned by Lilly and UCSD."
Brenner said: "All of these contracts belong to UCSD, not to Aisen."
Aisen said UC San Diego's position is "not in the interest of science. It's a business decision" partly tied to the $11 million a year the campus currently receives from the National Institute on Aging.