Our Plan for Reinventing Alzheimer’s Disease R&D at UC San Diego

Opinion

Xconomy San Diego — 

When the late Dr. Leon Thal, renowned neurologist and chairman of the Neurosciences Department at the UC San Diego School of Medicine, first imagined a research network able to conduct clinical trials of new therapies for Alzheimer’s disease, it was an idea ahead of its time.

The degenerative condition was poorly understood, with no existing infrastructure for developing new therapies, let alone preventive measures or a cure. The Alzheimer’s Disease Cooperative Study (ADCS), co-founded by Dr. Thal and the National Institutes of Health in 1991, changed the course of Alzheimer’s research.

It has not been an easy road. Over the past quarter-century, ADCS at UC San Diego has conducted scores of trials, with thousands of participants testing dozens of promising therapeutics. Alzheimer’s is better understood, but effective therapies and a cure remain elusive. But this is why the ADCS exists. Success was never expected to come quick or simply. There have been and will be many setbacks along the way. Only a public research university like UC San Diego can invest the necessary time, expertise and commitment.

UC San Diego now seeks to reinvent ADCS in a time when the graying of the postwar baby boom means Alzheimer’s is even more pressing upon our minds.  Today, someone in the United States develops Alzheimer’s every 67 seconds. One in three seniors in the U.S. will die with it or another dementia. In every conceivable way, the reality of Alzheimer’s is growing.

ADCS is growing to meet the challenge too, adding more staff and resources, and gearing up for four new trials, funded by the National Institute on Aging, which are slated to begin over the next year. This is happening with the resolute support of UC San Diego Chancellor Pradeep Khosla and the university, and it is happening in very distinct ways.

First, a national search has begun for the next permanent ADCS director, who will be a global thought leader in neurosciences and specifically in Alzheimer’s disease, an unquestioned expert in both the latest research and the design and operations of clinical trials. I have already received unofficial job inquiries from some of the country’s finest Alzheimer’s researchers. ADCS deserves no less than the best.

Second, UC San Diego will innovate more, and more often. With advances in knowledge and technologies, there are new and better ways to conduct trials. They can be smaller, for example, more focused upon a single question, or upon a targeted cohort of patients. They can leverage tools that didn’t exist even a few years ago, including advances in imaging and biomarkers.  ADCS will be on that leading edge.

Third, ADCS will more thoroughly tap the extraordinary resources of UC San Diego, the University of California and its research partners. One of UC San Diego’s great strengths, a factor that distinguishes us from other academic institutions, is our unabashed and abiding enthusiasm to work with others toward a common goal for the common good. Our physicians and scientists have a long history of successful collaborations with renowned peers at the Salk Institute for Biological Sciences, The Scripps Research Institute, and Sanford Burnham Prebys Medical Discovery Institute. We recently signed a major affiliation agreement with the La Jolla Institute of Allergy and Immunology.

We share academic appointments, grants, students, and insights. We work with international pharmaceutical companies and local biotech startups. ADCS will be a greater part of this mix. It can happen in many ways:  through the involvement of students who provide limitless vigor and fresh ideas; through unprecedented affiliations with foundations, advocacy groups, technology and insurance companies and others who share our mission; and through bold, equitable collaborations with similar academic institutions, such as our sister UC campuses, San Diego State University and beyond. Each school brings its own set of strengths and resources.

Over the last few months the University of California has been locked in an unfortunate legal proceeding. We have alleged in our lawsuit that former ADCS director Paul Aisen and members of his team, along with his new employer, the University of Southern California (USC), took custody and control over ADCS data and computer systems that belong to UC San Diego. Aisen and USC continue to control these data and systems and to deny custody and control to UC San Diego that we need to manage Alzheimer’s research and clinical trials under the ADCS program.

In a preliminary injunction issued Aug. 5, a Superior Court judge ordered Aisen and USC to restore the ADCS data and systems to the custody and control of UC San Diego. We look forward to their compliance with the court’s instructions.

The court case continues, with what we believe are serious ethical and legal breaches by Aisen and USC still to be resolved. We did not want to go to court, and would have preferred to follow the customary procedures for departing faculty. Litigation was a last resort, part of our obligation to protect not just the integrity of the ADCS, its trials and visionary work, but the role and responsibilities of public research universities.

USC should follow the example of UC San Diego in creating the ADCS: Do the work. Despite recent legal issues, UC San Diego faculty and staff—the heart of ADCS—continue to quietly and expertly administer daily needs in such core clinical areas as biomarkers, imaging, and statistics, which are elemental to assuring the safe conduct of trials at more than 100 test sites across the country and world. The ADCS work is done only at UC San Diego.

This is not big science. It is good science and ethical science. Recent events are upsetting. The process of righting what we believe are serious wrongs will likely be neither easy nor pleasant. But we must persevere because our ultimate goal is too important, not just for the millions of Americans who suffer from Alzheimer’s disease, but for everyone touched by it and whose struggles motivate the hard work and contributions of enterprises like ADCS.