An HHS Official’s 'Real-World Evidence': Infection Detection, Sepsis Measures Needed


An HHS official says his seemingly minor gardening mishap shows why the government should learn who out there has technology to identify infections early and fight off sepsis, a life-threatening reaction to infection.

Rick Bright, head of HHS’ Biomedical Advances Research and Development Authority (BARDA), cut the side of his thumb while tending to his garden. The area began to swell, but he didn’t think much about it at first. After it festered for a few days, he sought treatment and discovered the situation was more serious that it first seemed.

“It sent me to the hospital,” Bright told me at the Biotechnology Innovation Organization’s annual conference in Boston. “This was in many layers of tissues and spreading up my arm. [Doctors] scheduled surgery to slice my thumb open or off because it took five days to the culture the bacteria and two more days to understand which drug worked.”

He says he was hours away from becoming septic. Sepsis, an inflammatory response to an infection that can lead to organ failure, kills 250,000 people each year and is responsible for a third of all hospital deaths.

Bright’s episode happened three weeks ago. This week he and his boss, HHS Assistant Secretary for Preparedness and Response Robert Kadlec, announced a new BARDA division that will scour the startup world to find solutions to health security risks. The first two risks on the agenda are now very familiar to Bright: identifying infectious diseases before symptoms arise and fighting off sepsis.

“[W]e don’t have systems to tell me I was infected,” he said, “and infected with something bad.”

It was an eerie coincidence for Bright, who will oversee the new office, the Division of Research, Innovation, and Venture (DRIVe). HHS says DRIVe will work with business accelerators around the country that can identify startups working on technologies BARDA can use. BARDA works with the private sector to develop and acquire medical countermeasures, such as vaccines, that typically don’t have a large commercial market.

Read my story on the DRIVe announcement here.

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