Brave New Visions  pg. 3

When we move into evaluating disease and finding imaging endpoints that chart progression, the story is somewhat different. Here the imaging endpoints are valuable to everybody trying to treat that disease—independent of the mechanism they are using to do so.

In this case there is a very good case for a consortia approach, which combines the efforts of interested pharmaceutical companies with academia and perhaps also diagnostic companies. The goal: defining new surrogates that speed drug assessment and approval, particularly in areas where medical need is poorly met.

I think the ADNI has the potential to be a wonderful example of this approach. We’re going to set the “goal posts” for imaging biomarkers and the evaluation of therapies in Alzheimer’s disease.

Will imaging increase the emphasis on using drugs to treat disease, or will it help validate behavioral/cognitive approaches as well?

I think the two go together.

The industry spends its time making highly selective pharmacological agents. But if you combine those together with the amazing imaging of brain function, then you can understand the functional/chemical neuroanatomy of health and disease as well.

Functional brain imaging should help you design better therapies—be they pharmacological or non-pharmacological. Indeed, it’s already begun to help us understand what the placebo component of responses really is, and to segregate responders from non-responders in the field of pain research.

If brain scans become a practical, reproducible method of predicting risk for disease, what kind of ethical issues will it raise?

Clinically, brain structural imaging is used to assess disease and to make treatment decisions based on prediction of long-term sequelae. I think functional brain imaging has a way to go before it reaches this point.

One concern that has been raised about functional brain imaging in the past is that we may find things that are unexpected, or image things that may be predictive of events or behaviors for which we have no solution or control. This is clearly an ethical issue, and we need to think how to respond in advance.

Do you want to bury your head in the sand and not know, or do you want to develop a strategy or set of rules that can help you deal ethically with the issues that could be raised as you strive, through imaging, to understand brain disease and provide a platform for discovery of better therapies?

The bottom line for me is that many new prognostic and diagnostic medical technologies raise these types of issues. You need to think about them and plan how to respond in advance, or reconsider what you are doing. It’s not just science for science’s sake.

Is there concern that the field is over-hyped?

It’s very visual and so it’s very powerful. It tends to get jazzed up. Scientists need to be central in communicating what the functional MRI technique is.

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