During a 30-minute presentation, Dr. Califf read from prepared remarks, but also went off-script and answered a few questions from an audience featuring other event speakers, healthcare policy leaders and patient advocates.
The FDA is “hyperaware of digital health changes,” he said. “But I think we are behind and it’s going to be really hard to catch up.”
Increasing patient engagement has changed research standards, Dr. Califf said, but not enough. He cited type 2 diabetes as an example, saying researchers should be able to someday survey 50 million people about their experiences with, and risk for, the disease. But they still cannot do so.
Do the Right Thing
The healthcare environment is a large part of the overarching problem, Dr. Califf concluded, with much of the U.S. system geared primarily toward generating revenues and pleasing shareholders instead of caring for patients. “Ninety-nine percent of people really want to do the right thing, but they exist in an environment where the outcomes of interest are financial profit-loss statements—even in not-for-profit health systems,” he said. “So box-checking becomes a fine art just like it does in any bureaucracy.”
“You just have to have the courage to seek out and identify lip service where it exists. The problem is lip service is in great abundance right now, not because people don’t want to do the right thing,” he added. Instead, this trend is largely due to job conditions preventing employees from doing so.
Although the agency is often lambasted and Dr. Califf himself has been called “crooked,” he noted that “we can take it at the FDA; we are used to being criticized, so keep us on our toes.” But he also urged the audience to hold health systems to the same ethical standards as such public agencies as the FDA. When a system sets up and touts a new clinic, for example, he encouraged viewers to question if its leaders are launching it primarily for money or to help patients. “Obviously [these leaders] have got to account for both,” he noted, “but have the courage to speak up.”
New technologies already allow researchers to collect more data more efficiently, including remote monitoring devices that improve patient access to and participation in clinical trials, he added. “Technological advances allow us to envision, explore and realize unprecedented new approaches for preventing and treating a wider range of previously untreatable diseases.”
