Case Study 4: A Balancing Act PHILIP REILLY I think first of all, we have to ask what uses can be made of the information. It's natural to think that the information will be used mostly in a clinical context, to help people at risk for disease, or to help them avoid a reproductive risk. But other groups in the society are surely going to be interested in this information. Insurance companies, employers, educators, and we really don't have a system of rules in place to help control the flow of information outside of the clinic. PHILIP REILLY Hi, I'm here to see Steve. We're going to do the seminar today. What I'd like to take on is as a topic today with you folks is in the broadest sense of the word, the future of genetic testing. PHILIP REILLY I am by training a physician, a clinical geneticist and an attorney. I've devoted more than 20 years of my professional life to looking at the impact of genetics on society. PHILIP REILLY The work that you do here everyday is generating more information about the human genome. That information is going to flow out of Millennium in one way or another and eventually make its way into clinical medicine and affect our lives. There are some very large social questions that we are in a position to help educate the public about and generate some answers about. PHILIP REILLY Over the last decade, investment in genetic technology has become a multi-billion dollar business. It is a hugely exciting time, but excitement doesn't always mean good. Exciting can mean it's also there are difficult issues. Who should have access to genetic information? What kinds of uses are permissible to make, to utilize genetic information? Are there any kind of limits? Millennium is one of a dozen or so genomic companies that have sprung up over the last three years. Millennium approached me and said, what about engaging a dialogue with our scientists asking them some tough questions. I said sure. JOANNE NARDONE Millennium is in almost every common disease area. I mean, whether it's atherosclerosis or obesity or diabetes or asthma, I mean, these are huge markets, too, when you think about it. Obesity's 34 million people, diabetes, 18 million people. Schizophrenia, I think and manic depression are 13 million people. I mean, these are huge diseases. JEFFREY THOMAS We could test these folks for that gene and they would be negative, but you know, there would, clue that would go on get diabetes. Millennium is a gene discovery company. By using a genetic approach, we expect to find the key genes in these various diseases, and then our plan is to develop drugs that target those genes. But there's a spin-off, of course, that having these genes in hand, you can think about genetic testing. We can do that as soon as we can get some blood. PHILIP REILLY What would you want to know before you decided to have the test? Would you all just run out and have the test? What do you want to know? Say that I am a diabetic or that I have breast cancer or whatever, how is that information going to be used through the insurance company? Well, I think that's a great question. Are, do we, what do you think happens now, if, let's just say that you took the test and you turned out to be positive for one of these mutations in one of these genes. It'll get in your medical record. How private are medical records? You think that your medical records are not private. Why do you think that? WOMAN IN SEMINAR There's articles all over the paper right now that say that you'd be able to ... that you know, there's questions about selling the medical information and how insurance companies are going to use it. And that's what the biggest dilemma for this company. We identify a mutation in a gene responsible for polycystic kidney disease that you don't develop until you're 45 years old. And yet you might be able to know that you carry the mutation at 5 years. Is my child that carries that disease not going to be able to get health insurance? That's a big dilemma that we're faced with. PHILIP REILLY OK, so what do you want to do to limit the down side of acquiring this information? JEFFREY THOMAS What we don't know is, what we have to communicate. I mean, we actually don't know what the real risk of having the mutation is, right? And we don't know what the best therapies are, and I think we really have to communicate how preliminary this really is. JEFFREY THOMAS I think the value of genetic testing is going to be gene dependent. For example, the test for cystic fibrosis. Those are great tests. There's clearly a benefit to society by having those tests available. For the disease that Millennium's working on, it's less clear. We were talking about an expansion of the genetics that we know into more complex genetics, but also less certain genetics. Genetics that tell us, well, you're at increased risk for this, but not necessarily that you're going to get diabetes or you're going to get heart disease. PHILIP REILLY Let's just imagine we leap a few years ahead. We have five to ten different genes, each of which contribute to a significant percentage of moderate to severe obesity in humans. Is that to enter the realm of testing? JOANNE NARDONE I think that's definitely important information, because in that instance, when you use that example, you can then hopefully influence someone's behavior or their lifestyle. You can make changes. JEFFREY THOMAS I don't necessarily agree, because for the obesity as we understand it right now, I don't think there's value for diagnostic test. JOANNE NARDONE But he was using the example that down the road, there may be new discoveries that we find at this company or other companies, and say that your child or whatever, and you find that you have a predisposition to obesity, right, and you're five years old. And your lifestyle, you're eating 50 Big Macs because that's the way you've been raised. You are going to educate the parents to say little Bobby shouldn't be eating Big Macs ... JOANNE NARDONE I don't think that the social, legal, ethical issues are reasons for us to stop what we're doing. I do think that diagnostics is one particular arena where you can make a difference and have a product in the short term, and that's definitely why I'm looking at this market, because you know, coming from a marketing background, I want a product. And so I think that there are so many opportunities, whichever way you play. JOANNE NARDONE So we're going to talk about first some key sort of themes in diagnostics, because as you know, we're sort of trying to figure out what we want to do in diagnostics, and then JOANNE NARDONE I think this company is positioned to make a huge difference in the health care industry. And what I mean from that is, we're going to be finding novel genes in all these major areas, and then we're going to be giving that information in terms of validated targets, after we find out the function, to our pharmaceutical company partners, and they're going to develop breakthrough drugs that are going to change the whole way that medicine is being practiced. This is a huge revolution. I really believe it. JEFFREY THOMAS I mean, I question whether this is the paradigm that we should be thinking about for the diseases that we're working on. JEFFREY THOMAS I'm hopeful that the application of gene tests will be thoughtful. I would hate to see the day where everyone got tested for mutations in every gene that we thought could be involved in diseases. There won't be much value in that, and I think there's going to be a lot of confusion. Continue to The Disenfranchised.