A good drug changes some conditions from specialty conditions to mass-market conditions—the way Prozac helped move treatment
of depression to the primary-care doctor's office. Presumably, a good agent for Alzheimer's, a condition that Wyeth and you
personally are very interested in, would do a similar thing.
It's been my personal passion, this Alzheimer's disease. I'm 60. If you really look with a cold eye at what Alzheimer's alone
will cost to deal with when my generation reaches 80 ... No country in the world has any plan that will allow them to deal
with this issue alone and not either break the bank or have to put in place significant rationing of healthcare. This issue
is huge, but it's still far enough in the distance that the governments and politicians don't want to deal with it today.
But it's clearly coming.
But you have both a treatment and a vaccine in the works, is that correct?
We actually have more than ten projects in clinical development. We're trying to, in the words of our researchers, surround
this disease and use every pathway we can think of to get at it. One of our candidates is a vaccine in the sense that it utilizes
the body's immune system to attack the beta amyloid plaque that seems to be a cause of Alzheimer's disease. But we have other
approaches, such as a monoclonal antibody, to get at that same target. We have other approaches aimed at other points we think
are the basic biological causes of Alzheimer's disease.
If it works, it's going to be real proof that your new approach to research is working. What stage are you at in the transition
to that newer approach to R&D?
The learn and confirm model? We're there. We are now doing all of our development work using this model, and it's going extremely
well. Our whole development machine now uses this method of first developing the hypothesis you want to test in the "learn"
mode, and then testing it in the "confirm" mode.
In the last year you've had a couple drugs fail in Phase III. How many projects do you have in Phase III that came out of
learn and confirm?
I don't know the exact number; it's a large number of compounds in Phase III. But the things that failed—the things that have
been delayed at the level of regulatory authorities—those were developed using the older model. I don't think the failure
rate has anything to do with the model that we're embarked on now. We had a success with Pristiq [desvenlafaxine] in depression,
and we're hopeful that we'll have Relistor [methylnaltraxone, for opoid-induced constipation] approved. It was approved in
Canada I think last week, and we're hopeful we'll have that approved here in the near future. [It was in fact approved by
FDA on April 24.]