FDA Asks Transplant Patients, “What’s it like?”

FDA slideOn September 27, 2016 I joined one of four panel discussions on living with an organ transplant—held at the Federal Drug Administration’s sprawling campus just outside of Washington, DC. Our organ transplant meeting was the last of 20 public meetings this year on different medical conditions explored in the FDA’s Patient-Focused Drug Development initiative. A panel of distinguished FDA doctors (MDs, PhDs) presided over the agenda:

Patient Panel 1: Life immediately post-transplant, including changes, symptoms, daily impacts.

Patient Panel 2 (my panel): Ongoing challenges in maintaining an organ transplant.

Scientific Panels 3 & 4: Medication adherence and interventions to mitigate non-adherence.

***JUNE 2017 UPDATE:
For the FDA’s excellent summary of various organ transplant patients’ experience, as well as insights from scientific panelists, click on this link:


If you are considering or waiting for a heart transplant, you will gain an invaluable preview of a variety of challenges you may face post-transplantation—in addition to how great you will feel. These patients’ remarks, based on a range of organ transplant experiences, make concrete what transplanting clinicians mean when they counsel, “Transplantation is not a cure. It is a treatment. You are trading one set of challenges for another. BUT you are ALIVE.” If you are an organ recipient, you might take comfort in knowing that others are experiencing your side-effects and have found ways to lead good, engaged, and rewarding lives despite restrictions and complications.***

Speaking of post-transplant challenges, I nearly missed the meeting altogether because I was not quite recovered from a GI infection that had plagued me for six months. My situation illustrated what turned out to be a big topic of discussion that day: illnesses caused by immunosuppressants—the very drugs that prevent organ rejection and keep us alive.

Having finally received last-minute medical permission to travel, I was fragile but I was there, with Jack as my guardian. After months of virtual isolation and living on broth, I walked into a room of at least 300 people mingling sociably—a typical conference scene until you considered that almost everyone was powered by organs that were not their own. (Another 150 or so participated by webcast.) There was so much awe and gratitude in that room that meeting organizers announced that joy would be accepted as a given in our remarks, and we were to focus on the challenges of life post-transplant. The FDA wanted to hear our complaints.

Every participant had a moving story of pain and suffering, everyone was fighting for her life, and everyone was on a mission to save lives. It was an intense day. For private levity, Jack and I found ourselves referring to my fellow committed patient-activists by organ. The kidneys, for example, were out in force. They  comprised the majority of patients, families, and experts in attendance, and my new heart bled for them. Of course, I have shared hospital rooms with kidney transplant patients several times and personally endured kidney failure, as well as three days of dialysis. But now I was surrounded by an army of long-suffering, courageous kidneys, who had received one, two or even three transplants. And then there were the determined lungs—one of whom had cystic fibrosis and had endured two double-lung transplants—and the livers and the pancreases. And then the children, represented by one extraordinary 15-year-old girl who was utterly cool and smart and funny and sweet, despite kidney disasters her whole young life. I only found one other heart in the crowd and he was positively jolly, celebrating 23 years alive. But we didn’t have to talk about what that took. We both knew intimately.

It was a tough morning for an open heart, just escaped from her sick-bed, but my challenge that day was small potatoes (as we say in Maine) compared to the overwhelming issues in that room. In fact, I listened so intently to so many compelling tales of pain and suffering, that by the time it was my turn on Panel 2, I could barely speak and almost forgot to turn on the mic! But I’ll get to that later.

Here is my take on meeting issues that seemed most important to the cardiac transplant community:

  1. The biggest culprit in our complicated post-transplant lives—across organs—is our drugs, especially immunosuppressants. Everyone had stories of infections, cancers, toxic responses, GI issues, anxiety and depression struggles, and everything else that is listed as a side-effect of our medications and procedures. We, my fellow sweet hearts, are not alone.
  2. There is no “magic pill” known to the FDA that is under development to improve on immunosuppressants. While other medical conditions may have several treatment and drug options, organ transplantation does not. Immunosuppression is the primary life-saving therapy for our generation of organ recipients.
  3. The front line of research on organ/patient-specific immunosuppression therapy seems to be right in the doctor’s office: between individual physicians and their patients. Other patients and I emphasized the need for more research on transplantation’s “precision medicine,” as an improvement over the broad blast of immunosuppressants that is the current practice. A physician-panelist explained that most doctors are loathe to experiment with our immunosuppression out of “insecurity.” His self-deprecation was not lost on us. Any organ transplant clinician understands only too well that tweaks in drug load can put our lives at risk for rejection. Why mess with what’s working?
  4. Sadly, non-adherence to drug protocols is a big deterrent to a good and lasting life post-transplant. This discussion was particularly illuminating because I cannot imagine going through all this and then refusing to take my core transplant medications, no matter how disgusting the process and side-effects. But people do stop and for many understandable reasons, including economic, psychological, educational, sociological, and physical. Many patient-advocates expressed eagerness to be more fully engaged as capable people by their physicians. They asked for more in-depth explanations for exactly how our meds work and called for new, creative ways to educate patients about transplant drugs, especially resistant or at-risk patients. How much is misunderstanding at fault when patients skip a dose or two or three or all (!) and slide into rejection?

The FDA had asked me to focus my three minutes of panel time not on the heart transplant patient’s allopathic medical program, but specifically on the complementary or integrative therapies that I am also using to maintain my transplanted heart—for example, massage, osteopathy, yoga, reflexology, proper nutrition, exercise, the mind/body connection, scar tissue release and structural integration therapies.

While impressed with the serious interest on the part of the FDA, this request put me in a bit of a pickle. With only two hearts on the panels, how could we express the full experience of heart transplant graduates if my three minutes were dedicated to a slightly atypical approach? Furthermore, I feared being misunderstood. As a disciplined and collaborative heart transplant grad, I know my life depends on allopathic medicine. Anything extra that I do to support my heart transplant is fully approved by my beloved clinicians at Mass General Hospital in Boston, and you can be sure it does not interfere with my life-saving meds.

But the FDA had its reasons. Apparently, I was the only panelist to list counter-balancing therapies and daily disciplines in addition to the heart transplant graduate’s normal regimen of allopathic medications, procedures, and treatments. I was being asked to add something new to the FDA record.

Still, as I heard myself speak as a member of Panel 2, my assigned contribution felt lightweight in the context of all the pain and suffering expressed in that room. When our discussion facilitator asked how many in the room incorporated complementary or integrative therapies into their post-transplant routines, only a few of us raised our hands. So, feeling like a bit of a dud, I refrained from pressing the point. All that mattered, it seemed to me as the day went on, was that one clear, essential message seemed to be coming from all of us to the FDA: While immeasurably grateful to receive our organ transplants, we are being poisoned by the very drugs that save our lives.

Later, a physician followed me into the ladies’ room and thanked me for raising what she called “the difficult issue of patient responsibility” in organ transplantation, which she explained as leading clean lives and doing everything one can to bring the strongest and healthiest body possible to the medical situation. In the corridor, a few fellow transplant grads stopped to ask exactly what I was doing to manage daily side-effects and the long-range impact of toxic drugs and invasive procedures. One grad even asked for my delicious recipes for a prune lassi (one part organic, plain yogurt, one part divided between water and prune juice) and an Ayurvedic tea (equal parts fennel, coriander, and cumin seeds) to help with GI issues. It was a very funny bonding moment.

But on the flight home to Maine, dearest hearts, I got to thinking: How much of the pain and suffering that hung like a thick cloud in that conference room could be eased if more transplant graduates incorporated a holistic approach to healing and coping?

We had just learned that there is neither a “magic pill” nor medical research data to alter our current treatment by immunosuppressants. Other solutions—for example, avoiding a transplant altogether through regenerative cell biology and gene therapy—are even further in the future for most organs. As organ recipients today, we must live with the paradox of transplantation: The meds and procedures that save our lives also make us sick and often kill us.

So, could patient self-care actually be the frontier of cardiac transplantation today? With no magic coming to rescue us, what can we do to improve our own lives in the here and NOW? How can we—today, this very morning, tonight—better manage the toxicity of our medications through and out of our bodies? What behaviors do we need to continually assess and be prepared to release if they do not support the health of our precious organs and the body that houses them? If as advocates we are asking allopathic medicine to continuously improve, how willing are we to try new things, to change and grow?

It is not easy. But the way I see it is this: We owe the extra effort entailed to the 120,000 desperate people on the national wait-list and to the more than 8,000 people every year who die waiting for an organ transplant—22 people a day. Above all we owe extra effort to our donors, clinicians, and loved ones, who have made huge efforts and sacrifices for us.

While my supporting strategies may appear lightweight compared with the cath lab and kidney dialysis, I know they are giving me a decent life. I also suspect that my extra effort contributed to no rejection episodes in the 10 years I have lived with my lovely new heart.

So, here’s a thought: If more transplant graduates—in full partnership with their physicians—committed to plain old healthful living while sensibly combining allopathic and complementary therapies, maybe we patients would expand today’s frontier of transplantation just by living well.

Thank you, people of the FDA, for hosting this fascinating meeting and listening to us. I deeply respect your having asked me to raise the issue of non-allopathic supporting therapies and disciplines in organ transplantation. It took curiosity, creativity, and courage to invite discussion about strategies that are outside of the FDA’s jurisdiction—the same qualities, by the way, that it takes to live with a transplanted organ.

(Note: This fledging website will continue to share tips and tools that have worked for me—but only little by little because I, too, am leading my life as best I can with my perfectly lovely transplanted heart.)