Getting the drugs we need  pg. 2

Just to pick Alzheimer’s, we don’t have terrific data on the fundamental biology right now, so developing drugs to prevent Alzheimer’s rather than to treat patients’ symptoms is in some ways a leap in the dark, at least in terms of an investment. If we’re going to make these leaps and we should—God, I hope we do—then we need to develop some means of reducing the risk to the people who make that investment ...

I think we need to fundamentally change the drug approval process ...

PAUL—I disagree with Dr. Wood on this one. I believe that Alzheimer’s disease is a great example of how understanding the fundamental biology of a disease will likely, in my opinion, lead to effective treatments. Over the past decade or so, there have been several genes identified which have been shown to unequivocally cause the disease in certain families or in one case to dramatically increase one’s risk for developing the disease.

By understanding how these genes influence disease pathogenesis, several novel approaches to treatment have emerged. We now have three or four different types of “anti-amyloid” drugs that are in early clinical development—that I believe for the first time gives us a reasonably good chance of modifying the disease process itself…

Unfortunately, most of us believe that the best way to treat Alzheimer’s disease is to prevent it from occurring in the first place (but) the current drug development process—including the current limits on intellectual property protection—provides such incredible disincentives for discovering “preventative” agents that very few companies would even approach this at the present time.

Photo by Dana Johnson
WOOD—We’re talking about Alzheimer’s, but you could talk in the same way about other diseases of aging like osteoarthritis, for example, which is going to be a huge problem for my generation. We need to be prepared to develop drugs that lower amyloid deposition (in the brain) or that slow the deterioration of the loss of your cartilage in your hip joints, without the confidence, other than a hope, that that will affect the ultimate endpoint.

I don’t think at this stage… that we know with any degree of certainty that lowering amyloid deposition pharmacologically in the brains of humans will necessarily prevent Alzheimer’s ... but I think that we need to be prepared to approve drugs based on imaging techniques or whatever… that show a reduction in some surrogates ...

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