Acceptable Risk

Charles Krauthammer has a hard-edged op-ed over at RealClearPolitics in which he attempts to tackle an extremely thorny subject: when does something become an acceptable risk?

The question is: How do you distinguish the idiosyncratic failure from the systemic — for example, the single lemon that came off the auto assembly line versus an intrinsic problem inherent in that model’s engineering? How do you separate one patient’s physiology producing a drug side effect versus an intrinsic problem with a drug that makes it unacceptably dangerous?

Consider the oddity of those drug commercials on television. Fifteen seconds of the purported therapeutic effort, followed by about 45 seconds of a rapidly muttered list of horrific possible side effects. When the ad is over, I can’t remember a thing about what the pill is supposed to do, except perhaps cause nausea, liver damage, projectile vomiting, a nasty rash, a four-hour erection and sudden death. Sudden death is my favorite because there is something comical about it being a side effect. What exactly is the main effect in that case? Relief from abdominal bloating?

And how many sudden deaths does it take until we say: “Enough,” and pull the drug off the market?

The sudden unintended acceleration that prompted the chairman of Toyota’s unprecedented apology to Congress served as Dr. Krauthammer’s stepping-off point for his op-ed but I’m not sure that it’s a clear example of the sort of risk that he’s talking about in the op-ed. I suppose it depends on what you think the nature of the problem is.

If you believe that the Toyota case is one in which a problem can occur more or less randomly and rarely, it’s one thing and something which might fall under the category of acceptable risk. However, if the problem is one that occurs 100% of the time under conditions which are at present unknown, it’s a failure of workmanship and even occurring once is unacceptable.

The crux of the problem is that neither we nor, apparently, Toyota knows what the source of the problem is. In carefully parsing the statements from company executives I’ve reached the tentative conclusion that Toyota’s engineers are completely convinced that the problem isn’t a design problem and that the recall of millions of automobiles by Toyota is not intended to remedy a technical or manufacturing problem but to solve a marketing problem and, possibly, counter potential legal problems.

In turning to the medical examples that Charles Krauthammer poses as supporting evidence, I can’t help but wonder if we’ve reached a point where we’ve discarded the mandate primum non nocere, “first, do no harm”, or even primum succurrere, “first, make haste to help”, in favor of “first, weigh the risks”. It’s not a black and white decision and I’m not even sure whose decision it should be.