Alert: World Health Organization Director- General Has a Dire Warning

BOSTON: I am a former FDA COO and Harvard faculty member, and a decades-long infectious disease spread risk management expert. (It’s the rate, depth, and breadth of “spread” that most counts.) At the FDA, I co-led its last major internal reform. At Harvard, I taught policy, law, and management, including risk management.

A few days ago, at the World Economic Forum in Davos, Switzerland, the top executive of the World Health Organization called for immediate preparation—through the creation of nation[1]state-level and enterprise-level “systems of systems” to promote, require, and begin to regulate “preparedness”— for worldwide risk management of infectious “Disease X” spread. Disease X is the next far more significant outbreak than the COVID-19 Pandemic waiting just around the corner.

Government agencies and businesses (for-profit and not-for-profit) worldwide were caught off guard when COVID-19 struck full force in 2020. WHO demands proper preplanning for the hypothetical more dangerous Disease X—a pathogen projected to be responsible for creating a next-generation pandemic that is much larger than the COVID-19 Pandemic, perhaps one that kills as many as 50 million people (or more) worldwide, many of the avoidably, if we are not prepared, and directly wastes many 10s of trillions of dollars worldwide.

Most government agencies and businesses were totally or substantially unprepared in 2020 for a pandemic-sized attack by a dangerous pathogen—one that was both very dangerous and harmful in terms of being deadly or seriously and sometimes permanently debilitating.

And one that was highly spreadable because, given our “shrunken globe,” a person can travel by jetliner to the world's farthest reaches in 24 hours. Compare that to the spread of the deadly bubonic plague (the “Black Death”) when it took years by camel or boat in the Middle Ages to kill an estimated half the population of the world.

The Director-General of WHO announced his critical concern about the almost instantaneous worldwide spread of “Disease X,” a far more dangerous pathogen, whether nature-made or human[1]manufactured, than COVID-19. He emphasized that, in his opinion, it is “when, not if,” the nation-states and enterprises of the world will be confronted with the spread of this far more dangerous pathogen.

He calls for both public and private oversight. For now, I prefer and recommend primarily private oversight. I take this position once again to prevent the destruction of innovation in this category and the slowing of the pace of innovation. Intuitively, in the late 80s, then FDA Commissioner Dr. Frank Young, with the strong support of his staff and FDA’s career employees, created a decades-long path for developing most of the miracle healthcare IT “devices” we rely so heavily on today.

Without that insight and leadership by Dr. Young, this, at the time, fledgling industry would have been significantly stifled for decades, and, likely, many of these life-saving innovations we depend on today would not yet exist. This differs from saying that public agencies like the FDA don’t need proper oversight roles. But the oversight should continue to be milder and far less financially expensive, both to the agency and to the device developer, than the oversight now applied to drugs.

This is possible since embedded enterprise-based patient and staff safety programs, such as those at the Massachusetts General Hospital, enterprise-oversight-based voluntary private organization programs, such as those at The Joint Commission, and dedicated robust digital tools, such as those invented and developed by Safely2Prosperity, now exist. Together, they provide a significant level of private oversight and highly functional and configurable support when providing oversight and preparation at the enterprise level.

 Plus, appropriately, the FDA does not regulate health and healthcare “delivery systems,” such as hospital-led or other groups, hospitals, clinics, nursing homes, and assisted living facilities, or their “application” (use) of drugs or medical devices, including their healthcare IT or derivative products.