Eli Lilly has been in trouble for some time now regarding off-label promotion of their antipsychotic Zyprexa – specifically, their sales reps seem to have gone around saying that it was useful in treating the dementia of Alzheimer’s patients, although there was no FDA approval for that indication. (Whether it actually is any good for that, or whether much of anything is, I don’t know).
Word is this morning that the company will pay a total of about 1.4 billion dollars to settle the regulatory and civil complaints. That appears to be the new record. The idea is to send a strong message to other companies about aggressive off-label promotion, and a billion dollars should certainly get attention. Lilly will also be operating under a special monitor for five years, which is no joke, either.
But still. . .this is going to happen again, at some point. As we run things in the US, physicians are free to prescribe medications as they see fit (and I have to say, I agree with that principle). Insurance companies can pay for these or not as they wish, but the doctors can write for what they like. Drug companies, on the other hand, can only market for the indications that they’ve been approved for, and in this gap you can lose 1.4 billion dollars.
Despite these problems, I think the lines need to stay about where they are, although this is always going to cause problems. There’s a temptation to try to broaden your market when you have only preliminary data – worse, there’s a temptation to broaden it when you have no data at all. That’s got to be kept in check somehow. If you want to mark the limits of my libertarian leanings, there’s one of them. I worry that if every company were free to market every drug for everything, the resulting free-for-all would drag us all back down to the level of the late-night infomercial hucksters. The potential profits are just too great; they’re a moral hazard, and they’re not commensurate with the benefits for society at large.
The only middle ground I can think of at the moment would be a category of “Some evidence exists for. . .”, which would be in between an approved and unapproved indication. Perhaps then the sales reps could mention it? Maybe not, though, because where would you draw the line for how much promotion you could do? How would we keep this from turning into a battle zone? And there are too many ways that it could be abused: running a few sloppy studies to try to get some arrows pointing the right way, for example, and then turning the marketing department loose. (You know, the sort of thing that critics of the industry figure that we do already). No, again, I think that the temptation would be too great.
So here’s a general principle: we need enough regulation in the industry to keep ourselves from turning into what our worst critics think we are already. Not the most stirring call to arms, but there it is.