One thing about the ADA Conference last month that I haven't gotten around to reporting: You wouldn't believe the jockeying for position by these Big Pharma companies around all the research announcements. What from the outside looks like a bunch of meaningful academic pursuits is in truth pure gold data that fuels streams of business. So when results are announced, they've got to make the right impression the first time.
Allow me to explain a little. As a registered media attendee, I was contacted by a number of companies who were very anxious to brief me about their latest human trials results. Myself and the dozens of journalists populating the Press Room were also encouraged to attend the many formal, scheduled ADA press briefing sessions as well. Normally these things aren't my bailiwick: I don't follow oral diabetes drugs particularly closely, and I usually the skip the formal briefings in favor of the chance to peruse the expo floor and meet up with movers and shakers face-to-face.
But this year, with the spotlight on orals and study results, I did attend a few sessions. And here are some things that struck me:
* In one session, a reporter raised his hand and asked why representatives from a competing Big Pharma company (Let's call them X-Pharm) were stationed outside the door of the press event passing out abstracts with results and claims in direct contradiction to those being presented. The physicians on the panel were clearly incensed. "Well, they shouldn't have that reference data!" one expert nearly shouted. "We just released that today! There's no way they can have that accurate data!" WtF?
* The next morning, a very young and cute PR gal in a suit and heels was standing outside the Press Room (the one where journalists can access the internet and do their work) asking each passerby if they were "registered press"? Well yes, those oversized blue name tags around our necks gave it away, and besides she was stalking our door. Like some perfume bunny in a department store, she was shoving little cardboard cards for ... let's say... Y-Pharm Company into everyone's hands and explaining how they just couldn't miss the "research briefing" taking place in that company's booth later that day. She was not (or just barely) taking no for an answer. WtF?
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* Later that day, I had a lunch briefing with Z-Pharm Company. I had been informed the week prior that our topic would be "trial design and its effects on data." The pre-briefing materials stated that we would "look specifically at clinical trials in Type 2 diabetes to answer often overlooked questions," including:
• Why should we look to double-blind, randomized, controlled trials and the efficacy measure of "A1C" as standards for diabetes clinical research?
• Why do we need to consider baseline A1C levels and prior treatment when assessing a diabetes drug's effect on average reduction of blood sugar levels?
• Why do we need to know if trial results are based upon an all-patients-treated analysis, a completers' analysis, or an open label extension?
When I got there, however, the physician and PR folks in attendance didn't want to talk about study methodology at all. Instead, they launched into a detailed specification of why and how their drug is best-in-class. Not that this was uninteresting, mind you: I learned a great deal about different classes of oral drugs and how they effect Type 2 diabetes. But what about all that emphasis on "higher-quality A1c"? (which sounded so compelling, btw)
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.