Analysis: NIH Guidelines Appear to Support UCSD in Alzheimer’s Study

Xconomy San Diego — 

[Updated 7/13/15 5:15 pm. See below.]  It’s a little hard to score the fight after the first court hearing adjourned last week in a lawsuit between UC San Diego and the University of Southern California over a nationwide study of Alzheimer’s disease.

The UC Regents filed the civil lawsuit against USC and former UCSD scientist Paul Aisen on July 2, alleging that USC conspired to hijack the Alzheimer’s Disease Cooperative Study (ADCS) while it was recruiting Aisen to lead its new Alzheimer’s institute. Aisen had been overseeing the study for UCSD since 2007.

By hiring Aisen from UC San Diego, USC gained an early advantage because Aisen has retained his authority over the computer system and database where ADCS clinical trial data has been stored for the past 24 years, according to filings by both sides in the case.

UC San Diego wants to regain control over the Alzheimer’s data and resume its management of the study. In its lawsuit, UC San Diego alleges that Aisen and at least eight colleagues (who have joined Aisen at USC) changed computer passwords to retain their custody and root control of the ADCS system, essentially locking out UCSD from administrative control of the Alzheimer’s study.

But as Aisen put it in a statement last week, “I left UCSD, not the ADCS.”

The scientist maintains that he’s done nothing wrong—and his continued management of the program is necessary to ensure the integrity of the research and its data. According to The San Diego Union-Tribune, Aisen said, “I believe what I did was obviously in the interest of science and public health. I am very comfortable with the decision I made.”

USC likewise expressed its disappointment that UC San Diego sued Aisen and his team, as well as USC, “rather than manage this transition collaboratively, as is the well-accepted custom and practice in academia.”

But what, exactly, is the standard procedure for handling a federally funded research program after the principal investigator moves from one academic institution to another?

In response to a query from Xconomy, the office of extramural research at the National Institutes of Health provided a link that describes NIH policy in detail, and summarized the process:

“Principal investigators (PIs) on an NIH grant must contact NIH through their institution to seek prior approval for a change of institution. NIH grants are made to institutions, not to individuals. When a PI moves to another institution, the original grantee institution frequently agrees to relinquish the grant to the PIs new institution but NIH must approve this transfer. If the original grantee institution does not wish to relinquish the grant, they must seek NIH approval to appoint a new PI to the grant. NIH must assess whether the project can continue under the new scientific leadership at the original institution, and if so will approve a change in PI. If not, the grant is terminated.”

A spokesman for UC San Diego, when shown the NIH statement, wrote in an e-mail: “UC San Diego immediately notified NIH upon receiving Aisen’s resignation. At the suggestion of NIH, we appointed [William] Mobley and [Michael] Rafii as co-interim directors of ADCS. We are in the process of working with the NIH to confirm their appointment.”

[Updated with comment from Aisen.] In a statement released this afternoon by USC, Aisen said, “Our research program receives grants from several private and public sources. It would be premature to discuss the status of any specific award. We will have a large and vigorous research program regardless of which grants transfer to USC.”

The NIH statement appears to support UC San Diego’s contention that the contracts that control funding from the National Institute of Aging and pharmaceutical sponsors like Eli Lilly were awarded to UC San Diego—not Aisen. Moreover, a statement released by UC San Diego after the court hearing asserted that UCSD—not Aisen— “is contractually obligated by its agreements with the NIH and research partners to maintain and safeguard data from clinical studies conducted by ADCS. ”

According to the UCSD statement, Aisen and USC have prevented UC San Diego from carrying out those contractual obligations. What Aisen has done, UCSD says in the statement, is  “akin to taking another’s keys and car without permission because you believe you’re a better driver.”

Undeterred, Aisen has rallied support for his cause. USC submitted letters to the court supporting Aisen from four prominent ADCS-funded scientists—Harvard’s Reisa Sperling, Yale’s Christopher van Dyck and Stephan Strittmater, and Wake Forest’s Suzanne Craft. They all emphasize that in the short term, Aisen and his team are best equipped to manage day-to-day operations of the Alzheimer’s study until the dispute can be resolved.

Another letter from Eli Lilly & Co., which is funding a landmark ADCS study intended to test whether an experimental drug can slow the memory loss associated with Alzheimer’s, warns that 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.”

However, the letter from Lilly also states, “Regarding the A4 study data, the current contract states that it is jointly owned by Lilly and UCSD.”

Whether this means the Alzheimer’s study will move to USC, stay with UC San Diego, or result in some kind of shared oversight will likely depend on negotiations that haven’t yet begun between two research universities that are still snarling at each other.

Paul Aisen

Paul Aisen

So what’s at stake in this fight?

UC San Diego and the National Institute on Aging (NIA) founded the ADCS in 1991 as a kind of joint venture to facilitate the discovery, development, and testing of new drugs for the treatment of Alzheimer’s disease. The program coordinates Alzheimer’s research among 35 primary and 50 affiliate research sites throughout the United States and Canada. Total funding for the program from both federal and private sources amounts to about $100 million.

But the fight for control of the program clearly comes at the expense of collaborative research efforts, and might even affect progress on potential Alzheimer’s therapies.

In response to a query from Xconomy, an NIA spokeswoman wrote in an e-mail that the NIH agency overseeing Alzheimer’s study wants to assure “participants, the ADCS network of sites, and the research community that we are aware of this situation and are doing everything we can to support the ADCS and keep it moving forward.”

In an official statement, the NIA concluded: “The NIA’s goal is to ensure that operations of the ADCS network continue as seamlessly as possible, with a focus on the safety of study participants and the integrity and utility of data from ongoing ADCS studies.”

In Southern California, the stakes include a broad effort—led largely by USC—to build a new hub for life sciences innovation in Los Angeles. Fueled by a fund-raising campaign that has raised $4.3 billion since 2011, USC has been aggressively recruiting elite scientists in a quest to boost its prestige.

If successful, a proliferation of biotech, pharmaceutical, and medical device companies in Los Angeles would presumably strengthen the industry throughout Southern California—unless of course a schism opens between life sciences leaders in Los Angeles and San Diego.

The San Diego Superior Court judge handling the dispute issued no rulings last week, and continued the hearing in the matter until July 24.