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Stanford University School of Medicine

FDA Commissioner urges universities to help unlock access to biomedical data

At a discussion Wednesday at Stanford's medical school, Food and Drug Administration Commissioner Robert Califf, MD, didn't address political changes in Washington, mentioning only that he has submitted his resignation as is customary for presidential appointees following elections.

Instead, he wanted to discuss the issue that has taken him on a nationwide "college tour," with Stanford as its last stop: what to do with the so-called "knowledge reservoir" of data held by the FDA as well as by health-care organizations and universities.

"Rob is looking for ways the FDA can harness the tremendous amount of information embedded in the data the FDA collects and that today oftentimes sits in repositories and isn't really being mined," said Dean Lloyd Minor, MD. "That's very consistent with what we're trying to do here today at Stanford Medicine, which is defining the future of precision health."

The FDA's own knowledge reservoir is big, Califf said, addressing a crowd of several hundred physicians, researchers and students packed into a portion of Berg Hall. Moderated by Bob Harrington, MD, chair of the Department of Medicine, Califf fielded questions from a number of well-known Stanford researchers -- including, among others, Harry Greenberg, MD, senior associate dean of research, and Paul Auerbach, MD, professor of emergency medicine.

And the data?

"We have mountains of data - it's disaggregated, not highly organized," Califf said. "There are still stacks of paper. We also have a huge amount of computerized data from clinical trials."

Currently, the FDA is blocked by privacy laws and by internal and legal precedent from sharing much of that information, even with other federal agencies, Califf said. But assume, he said, that laws can change.

"A major role for universities is to help society figure out what the rules should be about data sharing," Califf said. A related question is who owns data from an experiment involving human volunteers. Traditionally, companies or other trial organizers have considered that data among their valuable assets, he said. "Universities need to be thinking about these things because there is a lot at stake."

Outside the federal government, health-care systems are increasingly "the biggest hoarders of data," Califf said. Sharing that data -- millions of images, samples and electronic health records from patients of all ages and races -- is a social good and could lead to major advances, Califf said.

Califf also addressed the discrepancies in attention given to certain conditions versus others and talked about the growing link between economic inequality and health disparities.

Much progress has been made on cancer and cystic fibrosis, for example, in part because they have active, organized advocacy groups, Califf said. In the future, patient advocacy may become even more important, and federal agencies and universities need to consider how to stand up for those who are underrepresented, he said.

Califf said he is also deeply concerned about the relationship between economic status and access to health care and healthy behaviors.

"How much money you make is a huge determinant of life expectancy," Califf said. The gap stands in stark contrast compared with the scientific progress being made in many areas, he added.

"The key to unlocking things is in the hands of young people," he said. "There's a great imperative that you think about access and societal equality."

And perhaps consider a stint at the FDA, he said:

You can tell I'm pretty fired up. I may not be at the FDA after January 20, but I've sure learned a lot.

Previously: How the FDA is promoting data sharing and transparency to support innovations in public health,  Researchers call for the "democratization" of clinical trials data and Video explains why doctors don't always know best
Photo by Paul Keitz

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