CEOs Beware: More on New US FDA Commissioner Califf’s Insightful Risk Management Ideas Affecting Health and Healthcare in the US and the World

CEOs and Their Employers Beware: More on New FDA?Commissioner Robert Califf’s Insightful Risk Management Ideas

Having roughly 18,000 employees and a $6B budget, the US FDA is the world’s largest and most respected risk management agency of any kind. So, it is essential news worldwide when the FDA’s new Commissioner makes profound public statements on health and healthcare risk management.?

FDA is an agency where I was once principal deputy commissioner and COO. So, accordingly, when the Commissioner speaks, I, too, listen. Very carefully!

This article is the next of my roughly 50 Articles and Posts regarding how to vastly improve infectious disease spread risk management. It is a national embarrassment for the US and many other countries that using old ideas, strategies, and models led to the avoidable deaths of many of the millions of people who died from COVID-19, both in the US and worldwide. Their lives might have been spared.?

New FDA Commissioner Califf has some ideas that will add value to this national and international debate. Immediate assessment and execution of his thoughts, some of which might soon become more than public policy statements, is warranted during his term in office. He is leading an enormously influential agency in the right direction.

Of great importance, Commissioner Robert Califf said, “the US health care system could be improved by harnessing technology [I assume he includes here IT, AI, and ML health and healthcare risk management technology, which is my area of expertise]:?

(1) To improve the quality of evidence used for [creating and satisfying] clinical guidelines, and?

(2) To restructure the public health information system [of which my young company, Safely2Prosperity LLC, is a prominent risk management member; I assume he intends to improve provider, individual, enterprise, expert, political, and governmental responses, as well].?

Commissioner Califf also recommended:?

(1) Closing the gap between FDA approval of products and payment for them [I assume he includes here payment for non-FDA-approved but ancillary devices, such as S2P’s Software-as-a-Service (SaaS) infectious disease risk management software platform, that help approved products “be all they can be”],?

(2) Aggregating health information for all stakeholders [I assume he includes here both micro (enterprise-level, and as well as macro (government-level) information],?

(3) Improving health outcomes for smaller populations [I assume he includes here better risk-managed health outcomes for our most highly at-risk low-paid front-line workers], and?

(4) Fighting against misinformation [I assume here he means not just public health and healthcare misstatements of health status, health risk, and the power (or lack thereof) of vaccines, tests, and therapeutics related facts, but also private ones used by employers in making important public-private health statements and decisions regarding the intra-enterprise protections the enterprise provides (or partially or entirely fails to provide based on internal and external misinformation, which today is rampant) to employees.”

Commissioner Califf, and therefore the FDA, could not have been more right.

It is time (in fact, way past time) that America and the world charge forward in these long-neglected directions. It is just as important to observe the safety and effectiveness of products as they are actually deployed in the marketplace as it is to assess their same attributes in highly controlled clinical trials.?

(Before scaremongers of all types become hysterical on this point, let me say that much more thought must go into HOW one might properly achieve this goal. “Properly” means achieving a high level of goal satisfaction without being counter-productive and/or unreasonably expensive in every way and for every concerned party, from payers, to regulators, to patients, to product developers, to employees, to employers.)

Right now, we have the technology to do all these things in spades—not just here but worldwide. But this technology is either not being employed and deployed, or it is being poorly formed, employed, or deployed. What a shame!

My focus is on risk managing the spread of infectious diseases, the scourge of humankind since the beginning of time, within enterprise workspaces and inside employees’ homes, the two closed facilities that are easiest to control. So, my company and I represent a small but critical slice of the academic and business support Commissioner Califf needs.?

If you might want to get behind Commissioner Califf’s initiatives, and help him to make them become realities, sooner, let me know. I am assembling a broad-spectrum volunteer army of experts and non-experts to do so. I want him to know that the cavalry is mounting, and help is coming soon.

To smartly, which means most effectively and only then most efficiently as is reasonable, “save lives,” in the broadest sense of that phrase, from death, to long-term disability, to loss of mental capacity from overwhelming fear for self or family, to loss of job, we must raise fulfilling this requirement to a higher level of commitment in our nation and in the countries in which we might be capable of inspiring their government and their people to “do the right thing.”

Here are just two significant examples of my concerns:?

(1) 50M people worldwide died from the 1918 Flu, many avoidably. I say avoidably because those in charge used the wrong models (but also to a far lesser yet still significant extent the improper methods) of infectious disease spread risk management.?

Let me put that number into perspective. Today, because of:?

(a) the immense growth in the world population since then, from 1.8 billion people in 1918 to 7.9 billion in 2022, a 4x increase,?

(b) the far greater concentration of those people in large cities where jobseekers have flocked, and?

(c) the more significant commingling of people between countries and cities because of increased levels of public demand for more and broader trade and the ability to take advanced, relatively low-cost, and high-speed planes and trains to fill that demand for national and international commerce

—the deaths alone might have been as high as 200M. Might a variant of that virus become just as dangerous again? Who knows? But it is worth thinking about and taking reasonable steps to prepare for, right?

(2) 6M people worldwide died from 2019’s COVID-19, many avoidably. But, again, I say avoidably because the persons in charge used the wrong spread risk-management models. And they did this even though companies quickly invented, and governments immediately and widely deployed, miraculous risk management methods. So, again, I ask, might a variant of that virus become just as dangerous or even more dangerous in months or years? Who knows? But it is also worth thinking about and taking reasonable steps to prepare for, right?

And what about other currently dangerous infectious diseases and the subsequent pandemic-sized infectious disease right around the corner—or the bioterrorist attack or nation-sponsored biological warfare attack being almost daily threatened (or implied)??

Regarding the last comment, I have long predicted publicly that the next world war (yes, another world war is possible, if not likely) will, with a high degree of certainty, be fought first electronically and then biologically. (Why destroy buildings or supplies of later use or kill or irreparably harm people whom the winner can later enslave.)?

In historic times wars were sometimes fought by throwing “smallpox-infected blankets,” for example, over the walls of besieged castles. Or by infecting their water supplies.?

In more recent times, the combatants shared the infected blankets with prisoners of war who were then released to return to their countries.?

While combatants might use the same evil tricks today, there are more insidious and far more efficient and effective means of conducting biological warfare that can be added: from planted bombs to dropped bombs, to rocket-propelled charges, to landmines, to grenades, to machine air blowers, to other methods that are virtually undetectable.

If you asked the average employer, or worse, the average union or its workers, if they know all these things or any of them, they almost certainly would give you a blank stare.?

FDA Commissioner Califf is right.?

We must invent technological responses (and strategic methods for their deployment and use) to reasonably prevent, mitigate, control, or at least dampen avoidable health or healthcare risks.?

And then honestly (the truth, the whole truth, and nothing but the truth) and clearly inform enterprises and then educate them on reasonable steps they might take to prepare themselves, their employees, and their families for an uncertain future, whether it be better or worse.?

Please let me know if you agree. And if you might want to explore joining a national and international effort to execute FDA Commissioner Califf’s ideas.

Best,?

John

John A. Norris, JD, MBA

Founder and Executive Chairman

Safely2Prosperity LLC

Email:?john.norris@safely2prosperity

LinkedIn:?/company/safely2prosperity

Website:?safely2prosperity.com

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? 2022 Safely2Prosperity LLC and John Norris, JD, MBA

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Hon. John Norris JD, MBA

FDA Former #2; 20x Board Member; Executive Chair Safely2Prosperity; formerly managed ~14,000 EEs and ~$6B budget; ~30,000 LinkedIn followers; Former Harvard Life Sci and Mgt Faculty Member; facilitated raising $Billions