Alzheimer’s Disease Neuroimaging Initiative a Model of Industry-Academia-Government Collaboration

Critics of industry supported research, clinical studies and education are often skeptical of the significant role drug, device, and imaging companies play in discovering ways to fight and treat serious diseases and conditions. But as one recent success story shows, to achieve breakthroughs in diagnosis, prevention and treatment of diseases such as Alzheimer’s, collaboration and support from numerous stakeholders is often required.

As New York Times explains, one such group embarked on “a project in 2003 that experts say had no precedent: a collaborative effort to find the biological markers that show the progression of Alzheimer’s in the human brain.” This extraordinary group of individuals included scientists and executives from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the drug and medical-imaging industries, universities and nonprofit groups.  

The idea for this collaboration, known as ADNI, for Alzheimer’s Disease Neuroimaging Initiative, emerged about 10 years ago when Neil S. Buckholtz, chief of the Dementias of Aging Branch at the National Institute on Aging, had a conversation with Dr. William Potter, a neuroscientist at Eli Lilly and his longtime friend.

Dr. Potter, who had recently left NIH, “had been thinking about how to speed the glacial progress of Alzheimer’s drug research, and how to find some way of seeing what was happening in the brain as Alzheimer’s progressed and asking if experimental drugs could alter that progression.”

The difficulty however, was finding ways to organize all the data because as Dr. Michael W. Weiner of the San Francisco Department of Veterans Affairs pointed out, “many different scientists in many different universities were doing their own research with their own patients and with their own methods.” Dr. Weiner, who directs ADNI, added further that because different people, methods, and subjects were being used in different places, different results were being seen. So “what was needed was to get everyone together and to get a common data set.”

To do this however, “would require a huge effort” because no company could do it alone, and neither could individual researchers.” Additionally, “the project would require 800 subjects, some with normal memories, some with memory impairment, some with Alzheimer’s, who would be tested for possible biomarkers and followed for years to see whether these markers signaled the disease’s progression.”

That’s when Dr. Potter realized that Alzheimer’s was important “enough to get people to work together and coordinate in a way that hadn’t been possible before.” This included using NIH to serve “as an honest broker between the pharmaceutical industry and academia.”

Another piece of the puzzle involved Dr. Richard J. Hodes, the director of the National Institute on Aging, who spoke with Dr. Steven M. Paul, a former scientific director at the National Institute of Mental Health who had recently left to head central-nervous-system research at Eli Lilly. In their conversation, Dr. Paul offered to ask other drug companies to raise money, which he thought “turned out to be relatively easy.” In fact, companies were realizing that because finding good diagnostic tools was so huge and complex, they were better off worker together rather than individually.

What also helped Dr. Paul raise money was his participation as a board member on the Foundation for the National Institutes of Health, which was set up by Congress to raise private funds on behalf of the institutes. Eventually, his work led to the National Institute on Aging agreeing to pay $41 million, with other institutes contributing $2.4 million, and 20 companies and two nonprofit groups contributing an additional $27 million to get the project going and sustain it for the first six years.

In addition, late last year, the institute contributed an additional $24 million and the foundation was working on a renewal of the project for another five years that would involve federal and private contributions of the same magnitude as the initial ones. With such a diverse group of supporters, the funding of this project showed a proper balance of government and private funding, which lead to tremendous results. And while “many people look suspiciously at collaborations with drug companies,” as Dr. Jason Karlawish, an Alzheimer’s researcher at the University of Pennsylvania pointed out, industry involvement in ADNI is transparent, and critics should just “get over it.”

Dr. Karlawish further recognized that industry support and collaboration for Alzheimer’s made sense because “the development of reliable and valid measures of Alzheimer’s disease requires such large science with such limited returns on the investment that it was in no one company’s interest to pursue it.”

What has also made the Alzheimer’s project so substantial is the fact that the goal of the project was “not just to raise money, not just to do research on a vast scale, but also to share all the data, making every single finding public immediately, available to anyone with a computer anywhere in the world.” This meant that “no one would own the data. No one could submit patent applications, though private companies would ultimately profit from any drugs or imaging tests developed as a result of the effort.”

Consequently, based on the ability of the members of ADNI to interact with each other, and share their experiences, data, and ideas from different backgrounds, their efforts are “bearing fruit with a wealth of recent scientific papers on the early diagnosis of Alzheimer’s using methods like PET scans and tests of spinal fluid.” In fact, their collaboration between government, industry, non-profit and academia has led to “more than 100 studies currently under way, which are testing drugs that might slow or stop the disease.”

Moreover, this model of collaboration, which specifically recognizes the important role of industry, is also significant because it has created an example for other diseases to follow. For example, a $40 million project to look for biomarkers for “Parkinson’s disease was recently sponsored by the Michael J. Fox Foundation, and plans to enroll 600 study subjects in the United States and Europe.” And as Holly Barkhymer, a spokeswoman for the foundation pointed out, “the work on Alzheimer’s is the precedent.”

Several private companies have now licensed the information from NIH and tests for Alzheimer’s will be quickly becoming available.  Also, with a diagnostic target new compounds and biologics will soon be developed to treat this very tricky disease.

As a result, because the results of sharing data, which is generated by partnerships between industry, academia, non-profit organizations, and government has shown overwhelming progress thus far, it would be in the best interest of patients, physicians, scientists and researchers if Congress and policymakers strengthened the relationships between each stakeholder, instead of weakening them with more oversight and paperwork. It should also be noted that had it not been for the friendly conversation between a government scientist and an industry scientist—which many critics and policymakers seek to restrict and hinder—none of this would have been possible.

Accordingly, by using NIH and other federal health agencies to ensure the fair and proper hand-off of information, the work of ADNI shows that government working with industry and not against it, can truly bring ideas and innovations to help improve the lives and health of patients.