BioPharm: Another area of leadership and research for NIH is the Genome Project, which is supposed to provide the foundation for personalized
medicine. How close do you think we are to truly having personalized medicine, and what do you think needs to happen to make
it a reality?
Collins: I think we're there in some instances. It isn't one of those things where you don't have it one day and the next day you do.
It comes along in various applications bit by bit. If you consider, for instance, a woman who's diagnosed today with breast
cancer and has negative lymph nodes at the time of surgery, the question is, is the surgery she just had, the lumpectomy and
the radiation that will follow, is that sufficient? Is she cured or does she also need adjuvant chemotherapy?
Well, personalized medicine is here because about half of the women in the US who are in that situation this year will have
their breast-cancer cells analyzed to see whether there is a signature at the genetic level that would indicate that they
are at a higher likelihood of recurrence and, therefore, need the chemotherapy or whether they're at low risk and can be
spared the cost and the side effects of what can be a pretty unpleasant experience. That personalized medicine intervention
right now is saving our healthcare system this year about $100 million in terms of the women who won't end up needing chemotherapy
who otherwise would go through it. So it's a pretty good example.
Pharmacogenomics is another frontier. One example is abacavir for HIV, where it's now required on the label to do a genetic
test before prescribing the drug for hypersensitivity. Or Plavix, which is one of the most highly prescribed drugs and where
there's now an FDA label saying physicians should be aware that about one-third of the people given that drug will not benefit
from it because of their genetics and should be offered some other alternative.
So, in those instances, I would say personalized medicine isn't the future, it's the present! It's here.