Gridlock: The Inability to do Research in Deceased Donors to Improve Transplant Organ Quality and Quantity

As a practicing organ transplant surgeon, I am struck every day by how many people I could help, if only...

That's both the hardest and most important thought to finish. I've tried to take it in so many different directions, but there's only one that I'm sure is actually right: ... if only we had enough organs to transplant. Transplantation is unlike any other area of U.S. medicine in that, among patients who gain access to a therapy (i.e. they are placed on the transplant wait list), the majority wait a (very) long time and may never even be treated. The imbalance of the increasing demand for transplantation and decreasing supply of organs is worsening: the current waiting list for transplants exceeds 120,000 Americans, and 22 of them die each day.

If only we had enough organs to transplant.

The obvious next question is: how might we do that? While great efforts exist to increase organ donation rates, parallel efforts should be undertaken to increase the donor potential; that is, only a fraction of deaths even medically qualify for donation, but there is a significant opportunity to increase this number through scientific research. Recently, there was an example of how incredibly effective a very simple research intervention in deceased donors -- cooling by 2-3°C -- can be to improve the function of kidneys after transplantation. Kidneys from "cool" donors were 60 percent more likely to work right away such that the recipients never required dialysis after transplantation. A treatment such as cooling the donor that clearly improves transplant organ function might enable us to accept organs for transplantation that we are currently turning down.

Simple, right?

Not exactly. For the most part, as illustrated above, the research needed involves new methods to treat deceased donors, intervening as early as possible in the process (i.e. closer to the actual time of death) to minimize organ injury. The problem is that there is no clear ethical or regulatory pathway to enable this; laws and guidelines that govern clinical trials and human subjects' protection are difficult to apply to organ donation because the research intervention happens in the deceased (the deceased, by definition, are not considered "human subjects"), yet affects the living. Further, the unique logistical constraints that are part and parcel of transplantation, including the distribution of organs over geographically broad areas, the identification of recipients late in the donation process, and the pressure to transplant organs as quickly as possible, render it difficult, if not impossible, to meet the standards of informed consent. The devil is in the details, I guess.

So, what do we do? Recently, the Institute of Medicine and the U.S. Division of Transplantation have set out to create exactly this ethical and regulatory framework, with the goal of facilitating clinical trials involving donor interventions. This is a tremendous start, but we need to see it over the finish line.

It is up to the transplant community to affirm, loud and clear, that the lack of organs for transplant is a desperate and unmet need, and that innovative research is necessary to bridge the gap. We must mandate an all-hands-on-deck approach to navigating the complexities of clinical trials and, finally, advocate for public and private funding for research with the goal of improving organ quality and increasing organ quantity.

This problem is complex, but the outcome would be simple; enabling scientific research for transplantation will save lives.

This post is part of a series produced by The Huffington Post and ORGANIZE, a non-profit looking to end the organ donation crisis by identifying and building on opportunities for improvement through technology, advocacy, and policy. Learn more at ORGANIZE.org.