Nov 4, 2010

The First Rule of Fight Club

I'm taking a class on ethics in science right now. I love the class, but it's making me hate my job. I work as a consultant (of sorts) and it's been interesting being on the "other" side of the phone. There haven't been too many surprises, except one. I knew that it was less expensive to outsource a clinical trial, rather than for the sponsor to hirer the monitors, deal with product, and jump through the regulatory hoops. But now I am beginning to think there is another reason: plausible deniability. The consultant does the "dirty" work. It's a little hard to explain. I know what I think needs to be done. The sponsor knows what they think needs to be done. But we're going to put forward Plan B, which is cheaper/quicker/easier and hope it works. It makes sense all around to try a cheaper/quicker/easier route if it will give the same result. But we're working with a human population and there's one thing I've learned in the 3+ years I've been doing this: you can't predict human behavior. And that's what zaps us.

I'm trying to think of a good metaphor to illustrate what I'm talking about. I guess it's a bit like wrapping street lamps in padding. Nobody is going to walk into them, right? We can agree it's a highly unlikely incidence and would be very expensive to implement a streetlamp wrapping initiative. But then, parkour takes off, or there's a street lamp stunt on Jackass, and all of a sudden 100s of people are colliding with street lamps. Now, imagine as a consultant, I'd seen something similar happen with park benches we installed, for example. I try to warn you, persuade you, help you to conceive of this possible scenario. And you, being a highly experienced MD, have never seen this kind of nonsense. But we both agree that people can act in strange and mysterious ways. I'm convinced of the necessity to prepare for the unexpected, but you can't justify the expense to your shareholders. You get a promotion, and I chew my nails to the quick. Calamity strikes. Now, you're on the hotseat and you point to the consultant who "didn't adequately advise you of the risks."

It makes me feel badly.


There's a story I heard about an opioid product made in Australia (this is years ago). It was manufactured as a tablet, but people crushed the pills into powder to snort it and they were ODing and dying. So, the company converted the medicine from a tablet format to a liquid gelcap. No pills to crush. Problem solved, right? Except now, people used syringes to extract the liquid center and inject it directly into their veins.

Crazy, no? A bit like Fight Club.

No comments:

Post a Comment