I was at a shocking dinner for Boniva the other night. Obviously the dinner was meant to coincide with the study in NEJM about Zometa (don’t forgot about your old friend Boniva). The talk was given by a reproductive endocrinologist who sounded very smart. I was accidentally learning all kinds of things that night. She forgot that we went there to eat a free steak, NOT listen to a lecture.
But I guess the biggest eye opener came near the end of the talk when she talked about the non-inferiority study (I want to write about those soon) that gave Roche and GSK the bonanza they so desperately wanted. Apparently she was one of the principle investigators for the study (gee, what a surprise) and she was describing a funny thing that happened during enrollment.
But first I should probably remind everyone (in case you forgot, and how could you with news being on EVERY FREAKIN RADIO AND TV SHOW) that bisphosphonates might cause osteonecrosis of the jaw, and that part of the reason stopping it before dental procedures does no good is that it hangs out in your bones for freakin TEN YEARS!!!
OK, so back to the story. The lecturer states that the women being enrolled were excluded if they had previously taken other bisphosphonates (for the reason cited above). So one patient is enrolled, she swears up and down she has never taken a bisphosphonate. And so everything seems hunky dory. Now part of the process involves routine review of any prior lab tests, for instance bloodwork, bone mineral density tests, etc. etc.
So our hero is flipping through these old results and finds an old BMD result. Everything looks cool, except… WAIT! As she scans the result, she sees the clinical history that was given “Elderly female, rule out osteoporosis, on Fosamax…” HUH?
Did she just read that right? “ON FOSAMAX”!!!
OK. So even though this enrollee swore up and down she never took a bisphosphoante before, and even though she’s already passed the screening process, we discover she should have been excluded… and COMPLETELY BY ACCIDENT! And obviously, the next question is… how many MORE of these forgetful women made it into the study???
Well, I asked the lecturer this very question, with what most likely was a very shocked look on my face. She just nodded and accepted that “yeah, it’s a problem.” Audible laughter went up from those assembled.
So, to summarize, you can’t believe any studies from drug companies. I know, it goes without saying. Just more evidence. And this Boniva study is more tainted than the scallions at Taco Bell.