I have spent much of my life writing about the benefits of exercise. And as with any benefit there is always a tradeoff. Any action or inaction involves risk(s). And risk can be in different forms: time, money, physical harm, other missed opportunities.
I am told that the same Chinese pictogram for opportunity is also for danger.
What is danger?
What is safety?
What is the relationship between danger and safety?
Are these concepts absolutes or relativities?
I see both of these concepts as residing on the same continuum. At the left end is safety and as we slide to the right, safety is diminished as danger is increased.
My convenient continuum breaks down; however, because while safety can never be absolute, danger can be. And this reality pretty much parallels life and death as biological death is absolute and final while life is fleeting.
Nothing can be absolutely safe.
For example, one might assert that a salt and pepper shaker is safe, but it can be used, as many utensils can be, to kill a person. G. Gordon Liddy used to brag about how he could kill people with a No. 2 pencil.
Note that—excluding modern warfare—many more people have been killed throughout human history with hammers than with guns and much of this killing was done before the invention of the nail.
So… is the common hammer… or pencil… or salt shaker safe? Of course, they are safe, relatively, but not absolutely.
And if I drop you from a helicopter into the molten lava flow of a live volcano, is it absolutely dangerous? Yes. The risk of death is 100%.
Is an exercise that I recommend safe? Sure, but only relatively safe. And that relativity depends on its opportunity for benefit. If an exercise provides no benefit, then its relative safety decreases precipitously.
The medical community has long tried to align itself with exercise just as the exercise enthusiasts have tried to cozy up to the doctors. And I have consistently chastised the doctors for their ignorance about the subject. Some of my harangues have centered on their lack of balance between exercise risk and benefit. As I explain ad nausea and in great technical detail (The Renaissance of Exercise Volumes 1 and 2 from baye.com), the doctors cannot define exercise, have never witnessed exercise, have never experienced exercise, do not know its potential benefits, and are, hence, unable to balance the risks of exercise to its benefits.
Null Reckoning
Sorta like the null hypothesis test used in statistics, I used what I called null reckoning in the design of my exercise machines.
Example: If I was concerned that a joint weld would safely hold, I, at first, would pose the questions, “Is it secure?” or “Will it hold?”
Eventually, I learned to approach the risk from the opposite direction. I posed the question, “Can I deliberately break the weld?”
The null reckoning had some application in my shop and might serve in other assessments of risk. For instance, if I design a guard rail to protect tourists at the edge of the Grand Canyon, I might pose: “How might I defeat the barrier?”
Probability
Another way to assess safety and danger is probability. And to do this, I propose that safety is omitted as a separate probability. Only the probability of harm is required.
So when compared to benefit, we should ask for probability of harm versus the probability of benefit.
The Infinite Derivatives of Harm
Harm can be expressed in many ways. The easiest one is death. There’s nothing inobvious or indefinite about death.
But other than death, the possibilities for harm are endless. And harm can be with many degrees of the psychological, physical, financial, temporary, and permanent realms.
Risk Management
The general, overriding concept regarding both danger and safety is risk. Hence, the overlying discipline of risk management emerges. And as I’ve already alluded, there is risk in everything under the sun. My father asserted that merely living was a risk to one’s life.
Questions
I warn you that this posting merely reflects my musings, some of which I have stated before in other writings. And although I have friends who have serious careers in risk management, I have not consulted them on this subject.
As many readers already know, I sometimes enjoy the risk of writing blind. In other words, I like to free think my way into dark corners to see what emerges. Sometimes, this lone exploration is productive, and sometimes it is truly embarrassing, but it is always a path to learnng. I suppose you could say that this approach is my intellectual risk-benefit.
But I do have some remaining questions on the subject of risk:
How does the United States Food and Drug Administration (FDA) determine risk?
How does the FDA balance risk with benefit?
How can the FDA balance risk and benefit (safety and efficacy) when it grants an Emergency Use Authorization (EUA) (not an approval*) for a product, thus denoting that the product was not completely tested for either.
*I might have used the phases “full approval” or “fully approved” in some of my earlier posts. I am certain that I have seen these phrases used by other authors. These are truly unacceptable phases as a product is either “approved” or it is not. There are no degrees of approval as far as I know. Please advise.
Usage of “FDA Approval”: one of my pet peeves. Yes for the FDA, “approval” is binary. A product is either FDA-approved for a particular use or it is not. There are no levels of approval. Emergency Use Authorization is not approval. In order for a product to receive approval the FDA needs to determine that it provides an overall benefit, that its benefits outweigh its risks. For Authorization the FDA need only determine that the benefit *might* outweigh the risk, which is generally an exercise in willful ignorance.
For vaccines, or the more general category of blood biologics (injectables), as opposed to drugs (generally taken orally), officially speaking these products do not get approved by the FDA at all. What gets approved is their manufacturer’s “license application.” So it may be more correct to say “authorized” vs “licensed” products in this case.