SOCIOPATHY AND STANDARD OPERATING PROCEDURE IN PHARMA

A Note on Pharmaporn

Every few days, it seems we get a new one-liner from the annals of trial materials. “We may need to seek them out and destroy them where they live,” said a Merck insider about Vioxx critics. “"Thus far, we have buried Trials 15, 31, 56…”, writes John at AstraZeneca. Trial 15, as it turns out, showed the diabetic risks of Seroquel. This is the same study about which we also read company players congratulating each other for their “smoke and mirrors” success in downplaying its significance.

The examples go on. Endlessly. But what I am always left with is the question of what we do with such “material.” All the defense arguments have a degree of truth. It would be a rare company (or individual) who didn’t write a bad-looking email at some point. Materials of this sort sometimes reveal what is a widely shared marketing plan. At other times, they may represent the views of a lone sociopath.

Perhaps the most recurring theme—when the issue of fraud or cover-up is broached in these communications—is that other companies are doing it “so why shouldn’t we.” All of us learned from our mothers about what “just because others are doing it” means. The relevance here is the question of whether these assertions are rationalizations (and, inevitably, self-fulfilling) and/or whether they represent an accurate snapshot of standard industry practice, at least in the marketing-of-blockbusters arena.

Understandably, people from within industry almost never comment on this question. That was true on Pharmalot when there was plenty of opportunity. Again, this makes sense for all the relevant reasons—the great majority of people in a company have no involvement with such goings-on; there is the anticipation of vicious push-back by critics; there is probably also the anticipation of sanctions from within the company if one’s identity is uncovered.

The rest of us are left with the question of what to make of these bits and pieces. Like porn of other kinds, there is undeniably a certain titillation in the face other people’s corruption. Many of us carry an “inner church lady.”

But lives are, indeed, on the line. My guess is that nothing good will happen to change these aspects of industry short of revulsion within companies robust enough to clean up their scuz. Strongly as I oppose preemption, I think that it will take whistleblowers, not private plaintiffs, to do the job. Only insiders can distinguish, and document, what represents the views of lone cowpokes versus the orchestrated strategy of a significant coterie of senior management.

Unfortunately, the latter appears to be the most common.