Do We Need to Realign Evidence-Based Versus Precision Medicine?

Debra Madden is a 2-time cancer survivor who was diagnosed with Hodgkin’s lymphoma as a young adult and breast cancer nearly 20 years later, which was thought to be secondary to the radiation she had received for her original cancer treatment. Debra became an active Cancer Research Advocate following her second cancer diagnosis at the age of 42 years. She is currently a member of the ECOG/ACRIN Cancer Research Group and the Patient-Centered Outcomes Research Institute’s Advisory Panel on the Assessment of Prevention, Diagnosis, and Treatment Options. She also serves on multiple grant review panels, including the Congressionally Directed Medical Research Program Breast Cancer Research Program. Debra blogs at “Musings of a Cancer Research Advocate,” (https://draemadden.wordpress.com/) and you can follow her on Twitter at @AdvocateDebM.
An interview with geneticist and pathologist Gabriel Bien-Willner, MD, PhD, FCAP, on why we need to change our outlook toward precision medicine in oncology.
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During this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, I decided to attend a pre-meeting session on a critical timely topic. The half-day session, Genetics and Genomics for the Practicing Clinician, included multiple panelists, each of whom presented real-world cases to form the basis of discussions on both tumor and inherited genetic variations, the molecular testing that is now available to clinicians, and when such tests should be administered.

The entire session was insightful, but what remains with me most was when a gentleman in the audience stood up and posed a question to the panelists concerning precision medicine, during which he made the following provocative statement: “I would argue that evidence-based medicine is incompatible with precision medicine and, as currently practiced, is not effective for cancer care.”

As one whose blog uses the tag line “It’s all about the evidence,” I was immediately intrigued. Following the session, I walked over and asked whether he would be willing to be interviewed for my blog to discuss his thoughts concerning precision-based versus evidence-based medicine in this genomic era—he agreed.

An Introduction
Gabriel Bien-Willner, MD, PhD, FCAP, is board certified in Anatomic Pathology and Molecular Genetic Pathology. Gabe, a classically trained human geneticist and molecular pathologist with deep expertise in next-generation sequencing (NGS), has a long history of providing knowledgeable, critical insight into the molecular basis of disease in cancer patients. 

Currently the executive director for medical affairs at Molecular Health, Gabe began his role with the company as medical director, when he was responsible for the daily clinical activities of Molecular Health’s CLIA-certified NGS laboratory following the launch of the company’s cancer genome panel.

Today, the company is focused on developing innovative software solutions for precision medicine for both clinicians and laboratories. Molecular Health has centered its products around the “Dataome” (MH Dataome) technology platform, and its current products are based on analysis of data from a tumor’s genetic composition in addition to numerous types of biomedical data, enabling physicians to create a report including qualified and individualized treatment recommendations for the patient and allowing oncologists to make more fully informed treatment and medication decisions. Per Molecular Health’s website, based on genomic and molecular evidence, the Dataome provides clinical and molecular data interpretation that can anticipate patient-cohort drug response, predict drug side effects and toxicity, and identify personalized treatment options for patients.

As we began our interview, Gabe stressed that he was speaking as an individual who was expressing his personal opinions and views and was not representing those of Molecular Health in any way.

Challenges for Oncologists in the Genomic Era
We began our discussion by reflecting on how unprepared many clinicians feel when it comes to explaining genomic test results to their patients. “We’re in a kind of precarious position,” Gabe explained, “where they are given a very complex genetic test result, and now, the way our medical system is today, they’re expected to be able to explain the results to the patient, but they themselves don’t understand it.” He shared an example from last year’s ASCO Annual Meeting: a breast cancer oncologist was the moderator for a precision-based medicine biomarker session, and she opened the session by saying, “I’m a breast oncologist; I don’t really understand any of this. But, here we go.” Gabe’s reaction? “I just thought ‘Wow! Okay, this is where we are today!’ Everyone knows the value of this, but how could we possibly be using these data correctly? There’s this missing link between the information and making use of that information: the interpretation of that data is left to people who don’t really understand it.”

To address this serious disconnect, Gabe would like to see practice changed, where there is a “learned intermediary.” As he explained, “Just like the doctor is between the treatment and you, I think there needs to be this other, new type of molecular physician who should stand between the genetic data and the oncologist, so that what they receive is something that they are capable of digesting. Computational tools to simplify the workflow and knowledge gaps will be a big part of this process, but I personally feel today that you cannot expect all oncologists to now be experts in genomics. I think that if that is the expectation, we’re setting ourselves up to fail with this endeavor into precision medicine.”



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