Life science without ethics

One of the things that has struck me about life science researchers, entrepreneurs, teachers and students is the sense of mission — compared to other technology entrepreneurs, it’s not just about the money.

The story of John Crowley (as immortalized by the movie “Extraordinary Measures”) and others fighting to solve rare childhood diseases are particularly good examples of this. (Some of their pricing decisions are controversial, but that’s another issue).

But no industry or line of work is full of saints (not even, alas, the Catholic church). Every industry has its bad apples.

This week Fortune tells the story of four executives of Synthes who plead (in effect) no contest over deaths due to an untested medical implant called Norian. The short version is that Norian is a calcium glue that works well for (and was approved for) arm and skull breaks — because gradually over time it transforms itself into bone.

However, Synthes wanted to go after the larger spine fracture market. The execs used a variety of marketing techniques to try it on humans while bypassing GRAS or FDA qualification procedures (as an off-label treatment).

The problem is that when used with spines, in some cases the glue got into the bloodstream, caused blood clots and killed people almost immediately. And, in fact, this showed up pretty quickly in animal tests. Several employees raised alarms, but top management went ahead anyway.

As intended by the magazine, the story is chilling. We expect this sort of behavior out of tobacco companies (or, once upon a time, out of polluting factories) but not out of FDA-regulated companies selling life-saving products.

I don’t get how this happened, but then I’ve never worked in an organization with a culture as toxic as this one appears to have been. It can’t just be about the money. At some point, perhaps there was the escalation of commitment — the cover-up or fear of getting caught — but surely someone early on thought “we can’t do this” or “it’s not worth the risk” (whether to the patients, companies or the individual employees).

Perhaps it’s just mirroring a broader decline in society’s moral compass (or maybe just a more effective process of rooting out fraud that has always existed at some level). Even so, as an educator we all wonder what we can or should do to prevent, inoculate against or early identify such attitudes and behaviors.