By Kevin Longino, CEO and Leilah Sampson, Kidney Advocacy Committee Patient Liaison
As kidney transplant recipients and advocates we were enthusiastic and hopeful to learn that the Food and Drug Administration (FDA) had scheduled a public meeting for organ transplant recipients to share their experiences with scientists and decisions makers in new drug development as part of the Patient Focused Drug Development Initiative. For the past few years the National Kidney Foundation (NKF) has advocated for FDA to include organ recipients as part of this initiative, so we were pleased that our advocacy efforts were successful. However, we also know following the meeting much more advocacy will be needed to advance solutions to the issues that organ recipients raised during the meeting and the National Kidney Foundation is committed to this effort. First and foremost, if you are reading this and have not submitted your own comments on the questions raised during the meeting you can do so here. Additionally, since we were selected as panelists we wanted to share our thoughts and experiences at the meeting.
Prior to the event, we were asked to respond to ten questions divided into two topics on life post organ transplant. The first topic was titled, “Disease Symptoms and Daily Impacts That Matter Most to Patients”. This topic focused mainly on how your symptoms (post transplant) affected you emotionally and physically in completing daily tasks. The second topic titled, “Patients’ Perspectives on Transplant and Treatment Options” focused more on how you are managing your post transplant treatment regimen. As we mentioned, you can submit your own responses to these questions as well and we encourage you to do so.
Leilah participated in the panel on topic one, as one of five panelists and the only adult kidney transplant recipient alongside of the Pediatric kidney representative and lung, liver, and heart recipients. In preparation for the meeting, Leilah met with FDA staff in charge of the meeting who expressed appreciation for her honesty about her post transplant experience not being “rainbows and sunshine”, but more so trial and error. They also felt because she was a transplant newbie; she could represent a fresh perspective that would help balance the other seasoned panelists perspectives. FDA briefed Leilah on what to expect when she arrived and to prepare a narrative style version of her comments (as patients get nervous on the panel). Leilah set the intention for her speech to reflect her life of self compassion and honoring her transplant process.
When we arrived at the campus we were appreciative to see so many patients, caregivers, researchers and FDA staff all committed to hearing the voices of organ transplant recipients. The first half of the day was all patient discussion on comorbidities, daily challenges, medications and side-effects post-transplant. Many recipients, like Leilah, shared their experiences having depression and anxiety post transplant. Many also highlighted social stigma as the public expecting them to be “cured” from disease with their new organ, when in reality the need to take multiple medications at specific times of the day, and that had various side-effects reminded them they were still not “normal”. Some participants indicated hesitancy to discuss symptoms post transplant with their healthcare professionals as they had received comments back that they should learn to adapt and instead focus on the fact they were still alive and no longer on dialysis.
Polling questions were asked of the audience and multiple choice responses given as options, but throughout the polling there were a significant number of patients who experienced challenges not captured by the multiple choice responses and instead indicated “other” experiences during the polling. Some of the comments raised in those “other” categories included: fear of rejection, but also fear of infection, skin cancer, and other cancers due to immunosuppression therapies – many participants had also experienced these complications.
The addition of the afternoon sessions was different than past PFDD meetings for other conditions. The afternoon included scientific presentations and panels on non-adherence to transplant regimens and interventions to improve adherence. Most of the patients participating in person indicated that while they faced challenges with taking multiple medications, overall they were adherent. Although they also recognized they were perhaps not reflective of all organ transplant recipients. Webinar participants indicated through polling a greater difficulty with adherence than those participating in person. We and other participants discussed how we were active in working with our care team to modify dosing of medications to reduce side effects. Kevin specifically indicated a need to have personalized immunosuppressive regimens, which could improve both adherence and reduce side effects. We and other participants also acknowledged a need for greater psychosocial support from our care team post-transplant. Of course, we were all supportive of one organ recipient’s comment on the need to have one magic combination pill that we only have to take once a day – oh and it could come with no side effects too.
We were surprised to see so little interaction from the FDA staff. They fulfilled their duty of hearing the voices of the patients. After a long day of discussions, presentations, and polling about symptoms and the impact of organ transplant regimens on patients; we left better educated but even more motivated. More importantly, we left with the obligation to spread what we learned from the research and opinions of other seasoned organ transplant patients to the pre-transplant community. I think we all agreed that laying the foundation for post-transplant life begins with implementing support and coping skills long before transplantation occurs. Although we have only scratched the surface of trying to understand how to better support organ transplant patients; we are pleased to know that the FDA, among many other organizations, are opening their ears to hear from us – the patients. If you are an organ recipient please do take the time to send your responses to the FDA by November 27, 2017, they are listening and comments will be included in the final report. You can also view the presentations and listen to the recorded meeting here.