I pestered the PR rep until she couldn't stand it anymore, and finally admitted that they'd originally expected a competitor to announce contradictory results at ADA, and therefore all that "study design" language was prepared to deposition that other study. In other words (my words), "the other guys don't do their studies right, so their results are bogus, and our drug is still on top."
We are not talking about small cut-throat startup companies here. We're talking about major medical players whose research results impact the lives of millions of diabetics. So all the while, I am thinking: WtF?
This sort of thing was extremely common when I used to work in the high-tech industry. Loads of dollars were at stake, but in many ways, it still seemed like it was all in fun: which tech geeks could out-study and out-position which other tech geeks? Whose GPS or cellphone LBS or Infrared wireless solution would prevail? So maybe I'm naive, but I was just kind of shocked to realize how heavy-handed these games are in the world of medicine, where people's lives hang in the balance between "good results" and "manipulated results."
I too learned in college not to trust statistics. It's just that when it comes to diabetes, I want and need to trust the intent behind them.

