1200 Patients Project Offers Glimpse of Future of Genomic Medicine

Peter O’Donnell, MD

As an oncologist, Peter H. O’Donnell, MD, assistant professor of medicine, has seen first-hand how the response to chemotherapy can vary dramatically from patient to patient – both in terms of tumor killing and side effects, such as neurotoxicity.

In an initiative within the Center for Personalized Therapeutics called “The 1200 Patients Project,” his research team is looking at implementing pharmacogenomic testing into routine clinical practice. They have created a customized pharmacogenomics panel to test patients for specific gene variants associated with predicted responses to dozens of commonly prescribed medications.

Through the development of an electronic “Genomic Prescribing System”, they are analyzing how physicians use this information to guide prescribing decisions. He is now a couple of years into the ambitious project and gives us an update.

Q: What is the “1200 Patients Project” and why it is important?

A: We are testing whether providing pharmacogenomic information on patients to their providers will improve outcomes. Currently, physicians typically practice and prescribe drugs out of habit or experience, but not necessarily using genetic data. We think genetics might inform those decisions to prevent adverse outcomes and improve response rates. Therefore, we preemptively genotype across a panel of variants that we think are important in determining drug response and then provide that information to physicians to see whether and how they utilize it in medical care.

Q: A key aspect of the project is that both physicians and patients are the study subjects. Why was that an important element of the design, and how will the information be used?

A: We thought it was important to have both patients and physicians involved in this project because there are many things that go into the individualized, personalized medicine approach that are outside of genetics. And these elements depend on that doctor-patient relationship.

We see pharmacogenomics as one of the elements that go into high quality patient care. This information will not be used in a vacuum; it is critical to know your patients in every aspect. That is why it was so important to us to incorporate patients and physicians – the decision-making pair – into this study, to understand how both parties use and assimilate genetic information.

From a practical aspect, the prescription has to be written by a provider, but providers should be involved because the genetics are just one piece in a larger context of what you know about that patient. There are many avenues of direct-to-patient delivery of this kind of information. We chose a different model – direct to provider with patient involvement – because patients do not always have the tools necessary to put that information into context.

Q: How has the response been from the physicians to implement pharmacogenomics in their clinical practice and be involved in the study?

A: They have been much more enthusiastic than I ever expected. Certainly, this is a biased group in that they are physicians that put themselves out there and said they are willing to do this, being among the first wave of users of this type of information. We currently have 16 physicians from the University of Chicago participating in the study.

But importantly, physicians keep coming back to the GPS system to access their patients’ results. They are reporting information to us, and they want to enroll other patients in the study to get this information on other patients. They are telling us that it is helping them make more informed prescribing decisions and improves patient safety and their general health.

I have had several providers tell me that they feel lucky to participate because they see this as something they are all going to be doing commonly in the coming years. They enjoy being at the leading edge of this research area and using pharmacogenomics in their clinical care ahead of everyone else.

Q: How do you expect pharmacogenomics to change the way physicians practice and how long is that going to take?

A: I think pharmacogenomics is already changing the way we practice medicine. However, it is not widespread because there are so many barriers to making it happen.

The bigger question is – how quickly we can dissolve those barriers? One barrier is who pays for the test. In our project, we pay for the test; the patient and physician gets it for free.

Another barrier is actually having the most useful gene panel available. We designed our own panel to run all of our patients’ samples that includes everything at once so that it is a bundled test and provides lifetime value. However, most people are still using a one-off approach where you test a specific drug that you know there is a test for. This strategy is a barrier to repeat use and wider dissemination, and not-forward thinking enough.

These are the types of barriers that have to be solved before pharmacogenomics is widely implemented. We do not know when that is going to happen, but we are trying to push it forward. If and when we can demonstrate that this type of preemptive approach is feasible, then it would be worth studying in a bigger context.

Q: How do you envision disseminating pharmacogenomic information to patients? What do you think they will do with it?

A: This is an important aspect of the project and involves who is really going to be the ultimate owner of this type of information when it becomes widespread. Here is an example of how I think the information will be used. Most patients I know will carry around with them a list of their medications in their pocket. They know what medications they are on and want to convey that to their doctors because they are often interacting with more than one provider.

As I envision it, patients will include their genetic data on the list of information that they carry to multiple providers. Perhaps they will have a card or electronic information and can ask “Dr. X, did you check my pharmacogenomic information?” The next phase of the study, then, will involve the patient more.

Q: What is the current status of the project? Do you have any updates to report?

A: We have enrolled more than 800 patients across the Department of Medicine at the University of Chicago. Our adoption rate has been very high; 90% of patients approached about the study have enrolled. Patients seem really eager to be a part of this, just as the physicians are.

Of course, to make the data as meaningful as possible, we really need to increase the number of physicians and patients. Our goal is to expand the reach from the current goal of 1,200 patients and 16 physicians to a future, larger population and context. Ultimately, we would really like every physician and patient at the University of Chicago to be benefitting from this type of information.

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