A Big Question

16 Dec 2005|Davis Masten

I heard the Presidents of the National Academies talk about their most challenging issues recently. While all of questions and concerns were provocative and, in most cases things I had not considered much or even at all, one thought has come back to me again and again. This was raised by Harvey Fineberg MD, PhD, President of the Institute of Medicine . Harvey challenged the group to help him think about the role of the double-blind testing in a future world of personalized medicines.

Double blind is considered by many the gold standard and successful results of phase three clinicals conducted as double-blind tests, paves the way for FDA approval of drugs. A double-blind test is a control group test where neither the evaluator nor the subject knows which items are controls. But in a world of designer prescription drugs, how is doing double-blind even possible?

I do not have an answer. While it intrigues the researcher in me, mostly it challenges me to think through the types of juxtapositions much closer to the domains in which I operate. For instance, how can food manufacturers address the consumer needs for personalization of products while they mass produce at ever higher efficiency? My hunch is that this type of personalization will be controlled by food retailers who will customize at store level. Many food manufacturers will need to change their business models to support the retailers or die.

The answer that Harvey needs is one that may effect whether millions live or die. What is the question you need to ask your business about personalization to know if in the future your company will be dead or alive?

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