In a nearly ignored development, the president of the National Pharmaceutical Council, Karen Williams, is leaving her decade-long post as the result of a strategic shake-up at the trade group. In a statement Monday, Joe Mahady, a Wyeth exec who is also NPC’s chairman, says NPC will shift its focus to evidence-based medicine, or EBM, from an emphasis on generating research on the value of pharmaceuticals, clinical outcomes and gaining access to those golden formularies.

At first blush, this may seem wonkish, but the change portends a shift in how big pharma views the debate over the use of outcomes research. Over the years, NPC has used its research, often sponsored by universities, to produce objective data, while steering clear of lobbying efforts. Hounding politicians is something that’s done by PhRMA, the high-profile trade group, which has nearly identical membership, by the way.

A key question now, though, is whether the change signals a plan to pressure NPC to produce studies that favor the industry’s position on drug outcomes. As one well-informed wag told us: “The relationship between PhRMA and NPC has been rocky because the two associations have had entirely different missions - PhRMA lobbies; NPC conducts research and subtle advocacy. PhRMA puts out fires; NPC prevents them. Even leadership at the NPC board level has been ambivalent about NPC’s mission - some, in fact, have covertly attempted to shut NPC down and direct the membership dues into PhRMA’s lobbying.

Karen walked a precipitous tightrope……”

“….balancing the need to produce credible information with the members’ desire to deliver predetermined results that support the industry’s positions unequivocally…EBM is controversial - payers want it, as does Medicare, to guide reimbursement and coverage decisions. But the studies have research design flaws and biases, the data bases to do the work are “messy,” and the ultimate question of whether EBM is a quality-of-care issue or a cost-containment issue is unresolved.”

So will NPC become another industry prograpanda arm? Will it continue to work with universities to produce independent research into key policy issues or will it work with PR firms and simply tell them what answers they want to key questions? Has pharma decided that EMB is key to marketing success? Or will drugmakers denigrate the role EBM can play in determining Rx drug access and pay-for-performance?

Say it ain’t so, Joe.