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Thanks for taking this question on, Derek. Re: the QT prolongation issue I’m right with you (which is one reason I’m on the board of ECG biomarker company iCardiac Technologies.)

It’s too bad when drugs get knocked out because they have the potential to hurt a “small susceptible population.” It won’t be easy but I’m hopeful that the pharma and diagnostics industries will find ways to identify those populations and keep them away from the drugs rather than keeping the drugs off the market for everyone or slapping on black box warning labels that limit access.

I do think there are areas where pharma could be more innovative, especially in clinical trial design. For example, as a neuropsychologist told me, “Anxiety trials use the Hamilton Anxiety Scale, which has been around for forty years. At best this is a weak indicator and companies need to be defining markers of disease against which results can be better measured .” Protocol writers tend to use whatever’s been accepted in the past rather than pushing ahead. Yes, they have to engage with FDA as they try new things, but too often there’s an overemphasis on not rocking the boat.

Agreed on clinical trial design - I’m a fan of Bayesian designs myself, but they’re still rare outside of the medical devices area. I think that no one wants to have a drug trial fail where the new neat-o trial design (or the person who championed it!) could be seen as the culprit. As you say, it’s safer to use what’s been done in the past.

In the past the pharma business model has been based on developing blockbusters. The basic idea is that substantial up-front R&D can be recouped through many years of back end patent protection. This model is fading….

How does pharmacogenetics (the study of inherited differences (variation) in drug metabolism and response) affect the trends you raise?

I like the idea that drugs of the future theoretically will be designed with my specific genes and body chemistry in mind. However, this seemingly also would tremendously further complicate and increase drug development costs?

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