This New York Times article about a disastrous set of circumstances that is now being faced by the Niaspan brand team really got my attention.

The set-up: NIH stopped a large study with Abbott Laboratories’ cholesterol-fighting drug 18 months early after results showed that taking Niaspan in conjunction with a statin failed to prevent heart attacks and may also have boosted stroke risk (despite raising HDL levels and lowering triglycerides).

The sum-up: The playing field is clearly changing and comparative effectiveness will raise the ante even higher. The onus will be upon drug manufacturers to demonstrate positive clinical outcomes early, not just changes in lab values or biomarkers.

The takeaway: Medical affairs and marketing typically work in separate silos. Communication between these two groups is critical when clinical trials are in the planning stage to ensure that clinical endpoints are properly aligned with future marketing goals.

At the end of the day, we may remember the Niaspan clinical trial more for its role in changing the way pharma marketers do business than for its disappointing results.