The Value of the Patient Voice in Kidney Transplantation

By Kevin J Fowler

On September 27, 2016 the FDA conducted a Patient Focused Drug Development (PFDD) Meeting for “Patients Who Have Received an Organ Transplant.” This is one of only 20 PFDD meetings conducted to date.

Kevin J. Fowler, a recipient of a preemptive kidney transplant in 2004, attended this meeting and provides his insights below.

Like other transplant recipients, I was very grateful for this opportunity for patients to use their voices constructively. I want to thank the FDA for planning and executing a meeting that, I hope, provided them with deep insights into kidney transplant recipients.  This is significant for three reasons:

1. Building a patient engagement strategy.

The first and routinely over looked step in building a patient engagement strategy is understanding a patient population.  This meeting will produce an FDA Patient Voice Report which will be available not only to commercial industry but all stakeholders involved with kidney transplant patient care.

2. Sharing the patient experience beyond experience with transplant medications. 

Patients shared their insights into the emotional and psychological aspect of kidney transplantation.  It is my hope that this information can be used to improve the patient experience for a larger number of kidney transplant recipients.

3. Overcoming all types of adherence challenges. 

During the afternoon session physicians and patients shared insights and experiences centered on adherence challenges. Immunosuppressant medications, doctors’ appointments, and exercise: these and other factors present non-adherence challenges that may contribute to suboptimal long-term outcomes.  I hope this informative session leads to a Consensus Conference on Adherence that would advance understanding of the issues that propel non-adherence and affect outcomes.

KHI Patient and Family Partnership Council (PFPC) members contributed varied perspectives at this meeting.  Dave White received his transplant about a year ago and offered the perspective of a recent transplant recipient.  Bobbi Wager, who has had two kidney transplants and undergone dialysis, provided a longer-term perspective. One of the most powerful contributions came from Lindsey Duquette. Lindsey is the teenaged daughter of fellow PFPC member, Pam Duquette.  Her poised and mature testimony underscored the urgent need to improve long-term outcomes and quality of life for kidney transplant recipients.


For me, the meeting was a bittersweet experience.  I felt at home with fellow transplant recipients since they truly understand the transplant experience, that combination of extreme gratitude for your gift and uncertainty about your future.  I was so grateful to see such an engaged group of patients representing their patient voice in a professional manner. I applaud the FDA Office of Strategic Programs for hosting and moderating an excellent discussion and the Division of Transplant and Ophthalmology Products (DTOP) for their attendance and for being a strong supporter of the transplant community.  In particular, DTOP Director Renata Albrecht’s, MD, desire to improve the lives of transplant patient is palpable.

For sustainable solutions to be achieved, all stakeholders need to be involved and engaged.   I hope that industry will pay particular attention to the meeting transcripts and “Voice of the Patient” final report.   In addition, I hope they recognize this meeting as testament to the interest and commitment from patients to partner with all stakeholders so that an ideal environment for innovation can bloom.

The FDA meeting was a welcome first step in understanding kidney transplant recipients. This meeting provides a foundation for developing patient engagement strategies I welcome your feedback on my recommendations (see table above), and the opportunity for dialogue.

Kevin J Fowler

Kidney Health Initiative, PFPC

kevinjohnfowler@gmail.com

Follow on Twitter: @gratefull080504

 

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On September 27, 2016 the FDA conducted a Patient Focused Drug Development (PFDD) Meeting for “Patients Who Have Received an Organ Transplant.” This is one of only 20 PFDD meetings conducted to date.

Kevin J. Fowler, a recipient of a preemptive kidney transplant in 2004, attended this meeting and provides his insights below.

Like other transplant recipients, I was very grateful for this opportunity for patients to use their voices constructively. I want to thank the FDA for planning and executing a meeting that, I hope, provided them with deep insights into kidney transplant recipients.  This is significant for three reasons:

1. Building a patient engagement strategy.

The first and routinely over looked step in building a patient engagement strategy is understanding a patient population.  This meeting will produce an FDA Patient Voice Report which will be available not only to commercial industry but all stakeholders involved with kidney transplant patient care.

2. Sharing the patient experience beyond experience with transplant medications. 

Patients shared their insights into the emotional and psychological aspect of kidney transplantation.  It is my hope that this information can be used to improve the patient experience for a larger number of kidney transplant recipients.

3. Overcoming all types of adherence challenges. 

During the afternoon session physicians and patients shared insights and experiences centered on adherence challenges. Immunosuppressant medications, doctors’ appointments, and exercise: these and other factors present non-adherence challenges that may contribute to suboptimal long-term outcomes.  I hope this informative session leads to a Consensus Conference on Adherence that would advance understanding of the issues that propel non-adherence and affect outcomes.

KHI Patient and Family Partnership Council (PFPC) members contributed varied perspectives at this meeting.  Dave White received his transplant about a year ago and offered the perspective of a recent transplant recipient.  Bobbi Wager, who has had two kidney transplants and undergone dialysis, provided a longer-term perspective. One of the most powerful contributions came from Lindsey Duquette. Lindsey is the teenaged daughter of fellow PFPC member, Pam Duquette.  Her poised and mature testimony underscored the urgent need to improve long-term outcomes and quality of life for kidney transplant recipients.


For me, the meeting was a bittersweet experience.  I felt at home with fellow transplant recipients since they truly understand the transplant experience, that combination of extreme gratitude for your gift and uncertainty about your future.  I was so grateful to see such an engaged group of patients representing their patient voice in a professional manner. I applaud the FDA Office of Strategic Programs for hosting and moderating an excellent discussion and the Division of Transplant and Ophthalmology Products (DTOP) for their attendance and for being a strong supporter of the transplant community.  In particular, DTOP Director Renata Albrecht’s, MD, desire to improve the lives of transplant patient is palpable.

For sustainable solutions to be achieved, all stakeholders need to be involved and engaged.   I hope that industry will pay particular attention to the meeting transcripts and “Voice of the Patient” final report.   In addition, I hope they recognize this meeting as testament to the interest and commitment from patients to partner with all stakeholders so that an ideal environment for innovation can bloom.

The FDA meeting was a welcome first step in understanding kidney transplant recipients. This meeting provides a foundation for developing patient engagement strategies I welcome your feedback on my recommendations (see table above), and the opportunity for dialogue.

Kevin J Fowler

Kidney Health Initiative, PFPC

kevinjohnfowler@gmail.com

Follow on Twitter: @gratefull080504