Map of life expectancy at birth from Global Education Project.

Monday, July 22, 2013

The worst (corporate) persons on earth

If corporations are people, they're all psychopaths, but drug companies seem to be more psychopathic than others. Graduate student Jeppe Schroll, in BMJ, finds numerous instances in which Novo Nordisk, in published results of clinical trials, completely omitted important adverse events including deaths. I won't get too deep into the weeds here, which would just confuse the issues. I'll make it simple.

For background, a commonly used marker for diabetes control is called glycated hemoglobin, often called hemoglobin A1c and written as HbA1c. Basically, if you have high levels of glucose in your blood, higher levels of this variation of hemoglobin form. So doctors can use it to estimate what your average blood sugar level has been recently. Keeping it low is therefore a goal of diabetes management.

Lately there has been recognition, accompanied by considerable controversy and false balance in both the public reporting and the FDA response, that some drugs which have been found to reduce HbA1c in clinical trials are nevertheless associated with a higher rate of cardiovascular disease and adverse events. This is one more indication that it's probably not a good idea to rely on surrogate endpoints in approving new drugs. After all, the most important complication of diabetes is death from heart disease. We also want to prevent other adverse outcomes but it doesn't matter if you're dead.

So, investigations sponsored by the company found that some of their products lowered HbA1c, and on this basis the drugs were approved and widely prescribed. What they didn't bother to tell us in the published reports was that some of the people in the studies died, and that they couldn't rule out that this was linked to the drug. They failed to report other adverse outcomes as well.

Now, there are all sorts of lies, and for some reason we don't generally view omission of important facts as negatively as we do affirmative false assertions. But in this case we should, because clinical trials investigators are under a prior obligation to report on adverse events. These are lies of omission which can kill people, and the motive is greed. That's evil.

1 comment:

Christie said...

This is awesome!