Blog Series: Defining Innovation
04.01.13 | By Randy Burkholder
We talk a lot about innovation in health care. This week on the Catalyst we’d like to take a step back and look at the big picture. What is innovation? How does it come about? How is biomedical innovation contributing to progress against serious and life-threatening diseases and conditions?
Most people recognize we’ve made great strides against many serious diseases and conditions over the past several decades, and most would agree that innovative medicines have made important contributions to this progress. Ellen Sigal, PhD, the head of Friends of Cancer Research, summed it up well in a paper last year when she said “There has been enormous impact in recent years, but you don’t get there overnight…we have to sustain innovation.”
While most people would agree with the idea of sustaining biomedical innovation, I think there is far less agreement about how we define it and support it. My own view is that the traditional policy tools for assessing the value of innovation (comparative effectiveness research and health technology assessment) are not sufficiently aligned with the push for patient-centered care, the emerging science of personalized medicine, or the fundamental dynamics of medical innovation itself.
I outlined some of the reasons for this in a recent presentation to an Avalere webinar conference, which you can access here. One important reason is that our understanding of a new treatment’s clinical value emerges over time as further research is conducted and additional treatment options are introduced. For example, one of the first major advances against chronic myeloid leukemia (imatinib) was approved by FDA based on surrogate endpoints showing patient response at the cellular level. Six years later, longer-term trial results demonstrated its dramatic effect on patient survival of CML. This evolutionary, incremental process is fundamental to biopharmaceutical innovation, but it is not well understood. Several recent papers from Boston Health Associates have described how it occurs in the treatment of several cancers, rheumatoid arthritis and HIV/AIDS.
Whatever one’s view about how to sustain continued innovation in an increasingly cost-constrained health care system, an important first step is to examine and understand how the process works and how we can best assess the value of new medicines.
Throughout the week we will feature guest bloggers who will look at innovation from various angles. They will examine the research process, how we assess clinical value, and the policy implications, among other topics. I hope you will stay tuned as we dig deeper into this important topic.