Is It Safe?
D.A. Jim Trotter : Now, uh, Ms. Vito, being an expert on general automotive knowledge, can you tell me... what would the correct ignition timing be on a 1955 Bel Air Chevrolet, with a 327 cubic-inch engine and a four-barrel carburetor?
Let’s start with a new question.
D.A. Jim Trotter: Is It Safe?
Mona Lisa Vito : It's a bullsh*t question.
D.A. Jim Trotter : Does that mean that you can't answer it?
Mona Lisa Vito : It's a bullsh*t question, it's impossible to answer.
D.A. Jim Trotter : Impossible because you don't know the answer!
Mona Lisa Vito : Nobody could answer that question!
“Is it safe?” is a ridiculous question that no one can answer. Let’s start with one of the questions that seems to be floating around the internet, “Is the COVID vaccine safe?” Does that mean that no one will be harmed by the vaccine? If they will, does that mean it’s not safe? Does it mean that, for most people, it makes sense to take it because the vaccine won’t make them sick? It also depends on what you think of the data about the likely outcomes of taking the vaccine versus the possibility of getting COVID. You may not, at this point, trust FDA and CDC, or you may, correctly, think that you are a different case from most people.
In fact, the question depends on what the context is for the decision. There are three decisions that are related to “safety”:
A medical/personal decision
A legal decision
A regulatory decision
Each one is partially based on the probability that risk will be increased or decreased based on the decision.
In fact, whether some is safe is a subjective judgment, that may or may not reflect actual risk or risk changes. I used this example in FDA to talk to the staff who approve food and color additives.
Suppose I am a driver, and you are a passenger, and we are on a two-lane road with trees on both sides on a dark rainy night and there is a large truck in front of us. I am driving and want to get to our destination quickly (maybe to go to the bathroom). On the other hand, you, the passenger, are in no hurry. I slide the car to the left to see around the truck and I don’t see any oncoming lights, but visibility is bad. I say, “I’m going for it, I’m gonna pass this guy.” You may be terrified. I am not. To me, it’s safe but to you, there is no way this is safe.
I told the regulators that, just like their “safety analysis,” where they find levels of food additives in foods that are hundreds or thousands of times less than the amount fed to rats, that they are making subjective judgments on the safety of the additives.
Is it safe to go swimming in the ocean or fly in an airplane? You have a one in 3.7 millionchance of being killed by a shark and a 1 in 11 million chance of dying in a plane crash. Bad things can happen and whether you think it’s safe depends in part on your fears.
Actually, rather than ask “Is it Safe?” we should think about the context of the decision.
Medical/Personal – This is a before-you-do-it question. Should I expose myself, e.g., eat a particular food, go swimming in the ocean, or buy a motorcycle? It may depend on a lot of personal factors, health status, individual fears, genes, microbiome, etc. It also depends on the benefit to you of the chemical or activity.
Legal – This is an after-you-have-done-it question. Did an exposure to this chemical or activity cause an individual to become ill, have an accident, or die. What is the probability of that and how much of that probability is related to the individual’s actions versus someone else (such as a firm)? A lot of factors, such as confounders (i.e., other possible causes), must be taken into account to make this judgment.
Regulatory – This can be prior to a product being introduced into the market or post-market introduction of an activity or a chemical. Initially, the question is whether the risk is big enough and/or should be addressed by a regulatory agency. If it is both, the decision should also be based on the benefits of the activity or chemical to the population or to a specific subpopulation compared to the costs of regulating it. The decision must also take into account the probability that a replacement activity or chemical is riskier (risk/risk trade-offs).
The question “Is it safe?” or the declaration “It’s not safe” are bullsh*t. Decision makers need to put the decision in context.