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Every healthcare company should be striving to identify better ways to ensure patients and consumers inspire every decision they make, writes Joanne Waldstreicher.
Today’s patients and consumers are much more educated and engaged in their health and wellness than any previous generation. This shift to a more informed public has brought a welcome change to medical practice and drug development, putting emphasis on patients and consumers at the center of decision-making.
When I started my career as a physician, I worked directly with patients every day. I heard their stories firsthand, listened to their concerns, asked about their priorities and participated in their decision-making. In industry, we have traditionally been a step removed from the patients who use our medicines and the participants in our clinical trials. And while we always strive to make decisions in their best interest, in the past, we often made decisions for them, not with them.
As science, medicine and technology has continued to advance, there is also a tremendous increase in access to information and engagement of people in their care. Just as healthcare professionals incorporate patient perspectives into care decisions, so many organizations – especially healthcare companies – bring the patient voice into everything we do.
As I moved from academia to industry, looking for new ways to prioritize people in how decisions are made grew into a real passion. Ultimately, this inspired the development of the Office of the Chief Medical Officer (OCMO) within Johnson & Johnson, where I lead as Chief Medical Officer.
The OCMO was designed to be a people-centric organization within Johnson & Johnson that is functionally independent from commercial interests and guides best practices around patient and consumer safety. The organization is composed of medical and scientific professionals, including safety experts, from all three sectors of Johnson & Johnson: pharmaceutical, medical device and consumer. We are focused on the safety of our products through people-driven processes, initiatives and policies. We look at every decision with a bioethical lens – asking ourselves what is best for patients and consumers rather than what is best for our products – and work to shape bioethical policies inside and outside our walls.
To ensure the work of the OCMO reflected a strong sense of ethics and echoed Johnson & Johnson’s mission and credo,I established a set of core values to guide us – integrity, tenacity, compassionand inquisitiveness. I empower my team within the OCMO to use these values to shape our culture and guide our decision-making to ensure people are our first priority, always.
Our partnership with the Yale School of Medicine Open Data Access (YODA) Project is one example of how the OCMO is applying these core values. Our team recognized sharing clinical trial data with other researchers in a responsible way can advance the science that is the foundation of medical care. That’s why Johnson & Johnson now shares its clinical trial data with researchers around the world through the YODA Project, led by researchers at the Yale School of Medicine, which conducts a fair and unbiased assessment of outside research proposals that require the use of clinical trial data. The YODA Project staff has full decision rights regarding granting access to clinical trial data from Johnson & Johnson’s studies. By ensuring that data continue to be used to generate new knowledge rather than sitting on a shelf, we honor the participants in our clinical trials who want their data to help future patients. We also diligently protect privacy by de-identifying the data and allowing access through a secure server, rather than downloaded.
Another example is Johnson & Johnson’s partnership with the Division of Medical Ethics at the New York University School of Medicine to create the Compassionate Use Advisory Committee (CompAC) – an external, independent group of medical experts, bioethicists and patient representatives that review compassionate use requests. Johnson & Johnson receives many urgent requests for investigational medicines from patients when clinical trials aren’t available or when there are no remaining treatment options. Inspired by our commitment to patients and this very sensitive bioethical challenge, we worked with NYU to develop an approach for reviewing requests for Janssen’s investigational medicines in a consistent, transparent and equitable manner that includes the patient voice.
As healthcare professionals, it is our responsibility to prioritize people above all else. Every healthcare company should be striving to identify new and better ways to ensure the patients and consumers they serve are the inspiration and guidepost for every decision they make.
Joanne Waldstreicher, M.D., is Chief Medical Officer, Johnson & Johnson.