Innovative Practice Interview: Mission Personalized Medicine
October 23, 2017
Health Innovations in Our Community
WCMS’ Cutting Edge highlights WNC physicians, practices and programs that are on the cutting edge of healthcare transformation, both big and small. WCMS supports local physician members who are change agents by recognizing them and sharing among other WCMS members and the general community information about these local innovations. If you know of such a physician or practice, please contact Miriam Schwarz
Mission’s Personalized Medicine Program
At Mission Health, personalized medicine focuses on trying to predict how an individual will respond to certain medications through genetic testing. The Personalized Medicine Program offers a wide range of services, including an individualized consultation that examines a patient’s genetic variations to discover how a patient may respond to a drug, including the risk of a severe side effect or the likelihood the drug will work for a patient’s condition. The Personalized Medicine Program staff are here to serve as a resource to the region, committed to staying abreast of the genetic literature in order to ensure providers and patients have the most up-to-date clinically vetted information available.
Personalized Medicine offers a scientific, individually guided approach to improve the health of patients. Although an emerging field, it has the potential to replace the trial-and-error approach to drug treatment commonly used to manage cancer and other chronic diseases. Building on the advances in genomic medicine, personalized medicine provides patients and their healthcare providers with information that could help minimize toxic side effects from drug treatments and maximize drug effectiveness.
WCMS interviewed the Director of the Personalized Medicine Program, Dr. Lynn Dressler to learn more.
Dr. Dressler joined Mission Health, in February 2013, to develop and direct the Personalized Medicine and Pharmacogenomics Program (PMP). Formerly a faculty member in the Schools of Medicine and Pharmacy at the University of North Carolina at Chapel Hill, and a founding member of the UNC Institute for Pharmacogenomics and Individualized Therapy, Dressler’s 30 year career spans translational laboratory research in cancer, health policy research and the ethical, legal, and social implications (ELSI) of genomic medicine At UNC, her laboratory conducted the research study that directly led to the FDA approval of the HER2 FISH assay (PathVYsion ™), one of the first pharmacogenomic tests in solid tumors. At Mission, Dressler has implemented a clinical and research program in Personalized Medicine for cancer and non-cancer patients.
- What is personalized medicine and how is it innovative?
Dr. Dressler: Personalized medicine (also known as precision medicine or targeted medicine) focuses on understanding a person’s genetic or genomic makeup to try to minimize negative drug responses and optimize positive drug responses. Personalized medicine began in the field of cancer but the approach is applicable for drugs used in non-cancer patients as well. In cancer patients, personalized medicine testing identifies mutations in the tumor tissue that may be driving the growth of a patient’s tumor and matching those mutations with a drug that specifically targets (kills) cells with those mutations. In non-cancer patients, personalized medicine testing looks at a person’s genetic makeup (inherited variations in DNA) to predict what the individual’s response will be to certain drugs.
I have 35 years of experience in translational research in academic medical centers - evaluating promising new molecular markers to predict response to therapy and then implementing those tests in the clinic. With my recruitment to Mission Health, I have been given the opportunity to bring that research to life, here in Western North Carolina. For example, during my tenure at UNC-Chapel Hill, we and others observed in breast cancer patients that 30% had the same gene abnormality. In collaboration with one of the large pharmaceutical companies, a drug was developed to target cells with that mutation. This was the start of what we now call “targeted therapy” for cancer. The mutation is HER2 and the drug is called HERCEPTIN. The therapy is now used not only for breast cancer but also for gastric and prostate cancer. The idea behind targeted medicine is that it brings genomic guided research data to clinical practice, changing the approach to a more science based one and less trial and error.
Personalized Medicine has revolutionized the way we treat cancer patients. Now, with the knowledge and technology learned from the Human Genome Project, we can apply that same approach to treating non-cancer patients with other chronic conditions. The idea is that if we test for certain gene variations, especially those known to influence drug metabolism, BEFORE you begin treatment, we may be in a better position to predict response to the drug and avoid or minimize side effects.
At Mission, the Personalized Medicine Program focuses on predicting response to drugs in cancer and non-cancer patients. The schematic below illustrates the intent of personalized medicine testing. Clinicians have known for decades that patients with the same diagnosis do not respond to the same drugs the same way. For some patients, the medication may lead to a side effect that may cause the patient to stop taking the drug or require hospitalization. For other patients, the drug, at the usual dose, may not work well to treat the patients’ conditions. And for the majority of patients, the drug at the usual dose works fine. The idea behind personalized medicine testing is to try to distinguish those three groups of patients (responders, side effects, non-responders) BEFORE the patient gets the drug. If genetic testing predicts a bad side effect, the clinician may decide on an alternate drug. If no alternate is available, then the clinician may monitor the patient more carefully to anticipate and treat a side effect. Genetic testing may predict that a higher or lower dose of drug is needed or it may simply confirm that the treatment regimen the clinician prescribed has no known genetic reasons for not working.
Ideally, the direction personalized medicine is heading is to help prevent or minimize the severity of chronic diseases by understanding the genetic and environmental causes of disease development and intervene to prevent the disease, or by optimizing treatment so that disease management is enhanced.
- What were the reasons that you launched the personalized medicine program?
Dr. Dressler: Mission Health President and CEO Dr. Ronald A. Paulus, offered me the opportunity to develop and direct a personalized medicine program at Mission. Before Mission, I had been a researcher in academic medical centers my whole career. Personalized medical centers are almost always housed in academic centers, so it is incredibly uncommon to find a personalized medicine program in a community health system such as Mission. Dr. Paulus wanted to start this program at Mission so that patients in western North Carolina could have access to genomic-based personalized medicine services locally. The program offers clinicians and patients throughout the region access to education, training, testing and results interpretation. This type of resource typically does not exist in a rural setting and especially a tertiary care health system that serves an underserved community. The potential for clinical impact is great. This is especially true because our community is very stable and therefore individuals, young and old, can benefit from personalized medicine testing throughout their lifetime, not just a one point in time.
- What key lessons have you learned along the way? What has worked? What hasn’t?
Dr. Dressler: Physicians, physicians, physicians. Making doctors aware of the benefits as well as limitations of genomic testing for drug response. Providing clinicians with education and training so they have a comfort level with that knowledge base and how to interpret test results is imperative. Important is the ability for a physician to “try out” testing in the context of a pilot research study or to have personalized medicine testing solve an existing clinical problem that the physician faces. Physicians becoming knowledgeable about precision or personalized medicine and understanding how to apply genomic test results for an individual patient can also provide opportunity to strengthen the physician-patient relationship. The reality is that many physicians I speak to about our services are already so busy with their day-to-day work load that the thought of learning about a patient’s genetic response to drugs isn’t feasible. That’s why we have a program where physicians can call us for consultation about whether a patient may benefit from testing and if they want, they can refer their patients to our personalized medicine clinic for a consultative visit. Testing results and interpretation of genetic variations are shared with the patient and the physicians.
Another challenge we’ve faced is simply getting the word out that this program exists. Mission is the only community health system in the state that offers this program and I want to demonstrate that we can make personalized medicine work in a rural, largely underserved area. Personalized Medicine is not a magic bullet, but it may help explain why a patient did or did not respond well to a drug and it can prevent certain serious side effects - that’s powerful information.
One example of the success of the program that didn’t involve testing is a policy change in the drugs used to treat pain and cough in children. Due to the potential for lethal side effects in children, Mission removed codeine from its pediatric formulary and developed alerts that are part of our electronic medical record system. If a clinician orders codeine (and soon also tramadol) for a patient under 18 years of age, an alert will fire reminding the physician that, for safety reasons, the drug is off formulary and gives drug alternatives. We also have education programs to disseminate this information to nursing moms whose infants could be at risk for severe side effects.
- What are the impacts/outcomes of personalized medicine?
Dr. Dressler: Ultimately, personalized medicine should result in more individualized care, improved outcomes and lower costs. If a patient takes a drug that does not give them a bad side effect and actually helps to treat their condition, they are more likely to take that drug and adhere to the treatment plan. If more patients are taking drugs with a low side effect profile, then this should lead to less hospitalizations and emergency room visits due to serious drug effects. And if we can minimize the trial and error approach by guiding drug selection or drug dose by genetic testing, then that should also save costs to the patient. The bottom line is if we can predict and prevent bad side effects, we should. However, we also need to consider that genetics is only a piece of the puzzle of why some patients respond well to a drug and others don’t.
- Who were your primary influencers and mentors in creating this program?
Dr. Dressler: Mission Health President and CEO Dr. Ronald A. Paulus recruited me to help start this program; so much of this is thanks to him and his foresight. The former system CMO for Mission Health, Dr. Dale Fell, was a great mentor and advocate for the program. A team of clinician leaders, including Dr. Bill Hathaway, Senior Vice President and CMO for Mission Hospital, Mission’s Chief Program Development Officer, Jonathan Bailey, Dr. Chris DiRienzo, Mission’s Chief Quality Officer, and Dr. Michael Messino, Service line leader for oncology, among others, have been outstanding supporters of this program.
- In what ways does personalized medicine affect the physician-patient relationship?
Dr. Dressler: Well, I hope in a positive way. I think it adds another layer of communication that allows the physician to explain to a patient why they’re prescribing a certain drug. It may aid the physician-patient relationship in that it allows for a more intimate interaction and more individualized care. We recently interviewed patients and their doctors before and after genetic testing for drug response, and they were in agreement that they appreciated being able to have a focused conversation about drug treatment.
- In what ways does this innovation influence the joy and meaning you find in medicine?
Dr. Dressler: To be part of an era where we are using a science-based approach, rather than a trial and error approach makes my heart sing. Being able to implement this approach in a community health system is rewarding as it demonstrates that this can be done outside an academic setting and be accessible to more people. I am all for equitable access to innovative healthcare programs.
- What advice would you give to others interested in implementing a personalized medicine program?
Dr. Dressler: Patience and perseverance. Physician support is very important. Focus on understanding what motivates physicians and practice behavior in your region so that you can minimize disruption to the work flow and maximize outcomes. I suggest researching solutions to existing clinical problems so that the work you perform is relevant and of interest to physicians.
I’ve learned through this process that people are very supportive of this type of work. We’re all trying to figure out how to do this and do it well and responsibly, so finding ways to make personalized medicine both clinically and financially responsible is essential.
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