FDA Commissioner Calls for Increased Information Sharing in Healthcare

Researchers, healthcare providers and patients all must recognize that sharing information is key to the future of medicine, U.S. Food and Drug Administration Commissioner Dr. Robert M. Califf said Sunday.

Califf, speaking during the annual Lewis A. Conner Memorial Lecture during the American Heart Association’s Scientific Sessions, noted the importance of collaboration.

“When I entered practice, the limiting factor in progress was technology,” he said, emphasizing the importance of collecting, storing and using health information. “In 2016, the limiting factor of progress is us.”

Less than 15 percent of all clinical guidelines are based on strong evidence because the evidence simply isn’t there, Califf said. For example, recent guidelines on opioid prescribing for chronic pain from the Centers for Disease Control and Prevention contain 12 specific recommendations, but none of them are supported by high-quality evidence, Califf said.

“We need to do a better job generating evidence and a better job of translating evidence into clinical practice,” Califf said.

The basic problem is that healthcare has traditionally separated evidence-gathering research from routine practice, while sectors like commerce have long recognized the benefit of sharing information as widely as possible and embedding research in routine operations, Califf said.

The key to the success of Amazon, Google and other tech and data-management companies is the creation of a learning culture that values information sharing and implants research into everything they do. Doing that as part of clinical practice is starting to take hold in health care, he said.

Health systems nationally are already collecting and sharing data, Califf said. With virtually all Americans in the healthcare system on electronic health records, collecting, sharing and analyzing data is easier than ever before, and federal agencies are moving in similar directions.

The Veterans Administration already has created a database of more than 500,000 veterans who have agreed to share their medical data and specimens for research. PCORNet, the National Patient-Centered Clinical Research Network, has enlisted about 145 million people who have agreed to share information and results.

“If we had an efficient data collection and sharing system, we would see greater than the 50 percent improvement we have already seen in cardiac outcomes,” Califf said. “All we need is the cultural and ethical principle that promotes the sharing of information for the benefit of our patients and our clinical practices.”