How did you end up at the FDA?
I went to the agency in 1972. I'd been at NIH for a few years, and I actually thought of myself as a consumer advocate, so I wanted to go where the decisions about medicines are made, and I've stayed ever since. No one in those days went to the FDA knowing what it was going to be like, but it turned out to be just unbelievably fascinating. And the particular areas that I have been interested in as a sort of discipline are how to design trials that give you the answer you want. There are a lot of issues. That's what I've mostly written about. Recently, there have been some ethical issues related to the use of placebos, which is intimately connected with what kind of study design gives you the answers you need, so that's become an area of particular interest.
Your specialty is pediatric AIDS. Talk about your successes.
The key development, the most significant development that I think that's happened in the last five years in my field, which is HIV, is the prevention of Perinatel transmission, of HIV Perinatel -- meaning around the time of birth or during pregnancy or at delivery of HIV, the human immunodeficiency virus, from the mother to baby. When I started in this field, about 28 percent of babies were infected. And through clinical trials we were able to as a group, a large group, a national group, able to demonstrate that we could prevent transmission from mother to baby. We are now hoping that this can be translated internationally, and there's already significant strides there. And hopefully, we'll be able to similarly effect transmission rates around the world.
Do you think the general public understands what's going on in HIV these days?
I think the general public is now beginning to understand the impact of research. I think the newspapers, television, have educated people, which if you go back 10 years, I don't think the information was that accessible. And education where they actually hear about research and how it's conducted has really benefited the public.
How'd you like to be remembered?
I have two kids and a husband. I'd like to be remembered both as a good mother and a good wife and a great scientist. At some point, I'd like to be remembered as a great scientist, and that I've contributed to benefiting patients locally in our community.
From the point of view of a bioethicist, where are we heading this century?
I haven't seen that many indications of major developments in the sense of the ethics side. There are obviously enormous developments on the science side. I mean, right now we're debating what happens in the stem cell field, adult stem cells and embryonic stem cells; I think they hold enormous promise. There are complex issues about the use of the somatic nuclear transfer technique -- cloning -- both to produce stem cells and, more radically, to produce people. That would have a totally transformative effect, I think. Probably not for the good, but potentially, [could] remake the relationship of generations in ways for which we really have no analogies.
Do you think humans need to be the subjects for drug tests?
I think anything that is going to end up reducing the use of living human beings as subjects offers the prospect of learning a lot more about drugs than we now can with a lot less risk. And that's advantageous. I think for quite a while, maybe forever, people in the end are going to say the only experimental animal for human beings is ultimately human beings, that you have to, in the end, test drugs or the biologics with human subjects. But with computational biology, the use of embryonic stem cells, and other tissue-culture methods -- as we learn more about these -- they offer great prospects for doing this with less risk to human beings.
