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UCSD Asks Court to Restore Custody and Control of Alzheimer’s Data

Xconomy San Diego — 

If there’s anything that’s clear in the recent donnybrook between UC San Diego and the University of Southern California, it’s that a 24-year study known as the Alzheimer’s Disease Cooperative Study (ADCS) is suddenly not very cooperative anymore.

UC San Diego filed a civil lawsuit last week against USC and former UCSD scientist Paul Aisen, alleging they conspired to “misappropriate” the ADCS by moving the work to USC. The private university has been leading a campaign to create a major life sciences innovation hub in Los Angeles, and hired Aisen last month to serve as director of USC’s new San Diego-based Alzheimer’s Therapeutic Research Institute.

In its lawsuit, UC San Diego alleges that Aisen and at least eight colleagues who also jumped ship to join USC’s new Alzheimer’s institute have continued to exert their “dominion and control” over the ADCS data after leaving UCSD, and they have refused to provide UCSD with “account data, passwords, and access credentials to enable UCSD to maintain administrative control of ADCS data.”

As part of the suit, UC San Diego has asked San Diego Superior Court Judge Judith Hayes to issue a temporary restraining order against USC, Aisen, and other defendants “to refrain from making any changes or alterations to ADCS data” that would interfere with restoring the custody and control of ADCS data to the Regents of the University of California.

Lawyers for UC San Diego also have asked the judge to take the preliminary legal steps required to restore “dominion, custody, and control” of the ADCS data to UC San Diego, and to appoint a special master to supervise the process and ensure that UC San Diego regains control in a complete and timely manner.

In a response submitted with the court late today, lawyers for USC asked the judge to deny UCSD’s request in its entirety, saying, the “entire lawsuit is designed to stifle academic freedom and intimidate researchers from leaving.” They added that UCSD’s request for a court order is “a blatant effort to usurp the traditional judicial process.”

The judge has scheduled a hearing Wednesday morning to consider the request.

Aisen could not initially be reached for comment for several days after UC San Diego filed its suit. But in a recent statement provided by USC spokesman Carl Marzioli, Aisen outlined his position, writing that the ADCS, “in essence operates independently of UCSD.

“I left UCSD, not the ADCS. I strongly believe that USC offers the best environment for this research program to prosper and grow, regardless of what it may be called in the end. This lawsuit is more about affiliation with an institution than about the protection and support of Alzheimer’s research.”

In a related legal declaration that USC lawyers submitted to Judge Hayes, Aisen argues that the ADCS operated without adequate contracting support from UC San Diego, and was plagued by UC-related funding delays and shortfalls. He also maintains that sponsors, such as pharmaceutical companies, make their funding decisions for ADCS grants because of Aisen’s role as a principal investigator or clinical investigator, and that funding has tripled since he took over as ADCS director.

But that’s not the way UC San Diego sees it.

In a filing related to its lawsuit, lawyers for UC San Diego describe the ADCS as a “set of contractual relationships between the regents of the University of California, the National Institute of Aging [which provided federal funding for the Alzheimer’s study] and private companies (or sponsors) [such as Eli Lilly and Toyoma Chemical] that provide funding for clinical research studies.”

According to UC San Diego’s lawyers, UC San Diego is responsible for overseeing ADCS studies conducted under sub-contracts with about 70 academic medical centers and research clinics throughout the United States and Canada. Under the terms of funding contracts, the lawyers contend that UCSD is the designated custodian of ADCS data, and co-owns the data with the sponsors funding the studies.

In Aisen’s statement to Xconomy and other news organizations, Aisen writes, “ADCS has been migrating to the cloud for several years as a matter of convenience and data protection. Both UCSD and USC have access to all of the data. UCSD has always had access to the cloud data as well as a mirror database on its own supercomputer.”

In his legal declaration, however, Aisen concedes, “Personnel from UCSD do not, however, have administrative access or the passcodes necessary to administer and manage the [ADCS database] on Amazon cloud. I also do not personally have such passcodes needed for management of the [database.]”

In his legal declaration, Aisen suggests that only his informatics team has the specialized knowledge needed to properly maintain ADCS data and maintain its integrity. He contends that at least 30 ADCS employees have resigned from UC San Diego, and says, “It is not a stretch to say that the entire work of the clinical trials relies on the data in the [database] maintaining its integrity, having a clear chain of custody, and being maintained securely and accurately by those with knowledge of the [database] and its software platform.”

Elsewhere, Aisen says, “UCSD no longer has the personnel with the specialized knowledge needed to properly maintain the [database] so as to protect the data and maintain its integrity.”

A spokesman for UC San Diego Health rejected Aisen’s view, saying, “This is all about the administration of the data. UCSD was the administrator, and at the simplest level, we don’t have the passwords we asked for.”