By: Deborah Miller, Ph.D., M.P.H., R.N.
It’s October and the pink ribbons representing breast cancer awareness month are again a common sighting. These ribbons are reminders that breast cancer is still to be overcome. Breast cancer remains the most common cancer among American women, except for skin cancers. Just about everyone knows someone affected by cancer in general, and many have been touched by breast cancer in some way.
For many years, I worked at the Government Accountability Office (GAO), where I became familiar with FDA. I joined FDA’s Office of Special Health Issues (OSHI) in September 2008 because I wanted to be involved more directly with patients again after working for years during my earlier career with seriously ill patients and their families as a neonatal nurse, research nurse, and hospice volunteer.
Like a lot of people, I have experience with cancer – personal, family members, and friends. As the manager of OSHI’s Cancer Liaison Program, I’ve had many experiences that have enhanced my compassion, respect, and patience as I strive to explain FDA’s role in medical product development and regulation to patients with breast and other cancers.
FDA’s Cancer Liaison Program interacts with many cancer patients and family members asking for help. The program seeks to meet the needs of patients and their families in three basic ways. Listening, educating, and assisting.
First and foremost, we listen to patients and caregivers. They tell us their story – when they were diagnosed, treatments they have tried, providers they have seen, and tests they have been through. Often, they tell us they’re scared.
Some of these patients have been dealing with cancer for a number of years, and they tell us that the approved therapies have not worked or have stopped working. Some have considered or joined a clinical trial of an investigational therapy. Some call with the hope of obtaining a “promising” new investigational product that they have heard about in the news and are convinced may be their last hope.
Secondly, we educate. We spend a significant amount of time explaining to patients and family members how cancer drug development, clinical trials, and expanded access, (known in the community as compassionate use) work. We explain FDA’s role, and what we can and cannot do for patients, and try to guide patients toward practical and appropriate options.
We help bridge the gap between patients, their treating physicians, and FDA scientists who are working to review and approve new treatment options for patients. We strive to provide a human touch for each patient or family member with whom we interact.
Finally, we assist the patients. For example, we try to find potential clinical trials for them, guide them through the expanded access process when it’s appropriate, and work with their healthcare providers throughout the expanded access application process. We give patients, family members, and healthcare providers our contact information so they can reach us to work through regulatory issues at any time, including evenings and weekends. We periodically call them to see how they’re doing.
And if access to investigational drugs is not practical, we go back to listening. We listen to patients’ expressions of their disappointment, anger, frustration, and fears.
This month, I am thinking about the many breast cancer patients I worked with during this past year who benefited from FDA’s approval of Perjecta in June. But I am equally mindful of the many other patients who did not benefit from the drug and will be calling me, desperately searching for something more.
Deborah Miller, Ph.D., M.P.H., R.N., is the manager of the Cancer Liaison Program in FDA’s Office of Special Health Issues