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The Ins and Outs of Organ Donation

A policy trend has picked up in Europe that has yet to take off this side of the Atlantic.

Over the last year and a half, three more countries have shifted or plan to shift from an “opt-in” organ donation system to an “opt-out” (or “presumed consent”). That makes 27 European nations where citizens no longer have to register to be organ donors. Rather, it’s assumed they are until they take themselves off the list.

Wales started its “soft opt-out” policy (in which a family member must consent to donation if a deceased person didn’t opt out) in December 2015. This past January, France switched to an opt-out approach (no consent required by family). And Scotland voted in July to move forward with a soft opt-out.

On paper, the opt-out system may seem like a good way for the United States to help drive up its poor numbers. With over 117,000 people in need of an organ, but few usable ones available, the country needs more solutions. Every day, 22 people die waiting for a kidney, lung, heart or other organ.

For one, the data is enticing. Last year, Wales reported a 10 percent increase in donations a year after its policy went into effect, and some studies have put rates at 90 percent in opt-out countries versus just 15 percent in opt-in countries. The approach also falls in line with the so-called “default options” health care systems continue to lean into to improve care and cut costs.

But, in reality, what works in one country – or countries – may not work in another, especially when talking about a place like the United States. Nor is it the silver bullet to solve the organ supply problem – which is bigger than most think.

We spoke with Scott D. Halpern, MD, PhD, a physician and bioethicist at Penn Medicine,

to hear his perspective on the possibility of switching to an opt-out system, that promising (but often flawed) data, the caveats and ethics to consider here, and what else we could be doing to help address the problem.

Q: There are different ways to help increase the availability of organs, but the opt-out approach appears to really drive up the numbers, based on studies out there. Broadly speaking, what are your thoughts on an opt-out system to increase organ supply? 

A: Across a range of behaviors and choices, opt-out systems tend to drive desired behaviors far more so than opt-in systems. This is particularly true for things that people may not have deep-seated, or heavily-contemplated, preferences about. And I’d posit that organ donation is one of those things. So, for these reasons, opt-out organ donation should work. But there are important caveats.

First, the quality of the data supporting the idea that opt-out systems drive higher donation rates, is low. Studies that compare country A (with an opt-out system) with country B (with an opt-in system) are flawed because there may be lots of things that differ between countries A and B that have nothing to do with organ donation rates – such as how easy it is to become a donor regardless of the opt-in or opt-out policy, or the cultural norms around donation.

The second problem is that the enthusiasm about opt-out donation is predicated on the assumption that there are tons of organs out there that could be used if only they would be donated.

Most of the available evidence suggests that this unmet opportunity is rather small. Most unused organs are not actually usable, and most usable organs are already being used. That’s not to say that we can’t do better – we undoubtedly can. But even a perfect “fix” to organ donation consent rates wouldn’t meaningfully change the fact that organs are a very scarce resource.

Q. Why do you think this type of system has taken off in Europe and not in the United States?

A. In contrast to other nations that have adopted opt-out systems, the U.S. has a large and highly variegated population. The ethical key to the opt-out approach is that everyone is at least aware that there’s a decision to be made, such that an opt-out choice becomes viable.

That’s a much harder standard to achieve in a diverse population, like this country, than a homogenous one.

Q. Speaking of ethics, what other concerns or factors would need to be considered if America did adopt such a system? For instance, some have argued we may lose living donors.

A. I don’t think that an opt-out system for deceased organ donation would adversely impact living donation of kidneys. Those who wish to donate organs while alive will be driven, as they are now, by the sense that the current approach is insufficient. And as I said, even if opt-out became the new “current approach,” we wouldn’t have nearly enough organs to meet the demand. So, I don’t see how living donation could be affected.

That said, for an opt-out system to be ethically viable, there needs to be a way to ensure that everyone is aware that there’s a decision actually being made, and that there’s a specific, easy path to follow to choose against the default option.

Q. Given that doctors and legislators have pushed for opt-out here in the United States, and there’s a strong argument for default options in health care, do you think that’s where we’re eventually headed?

A. Defaults are unambiguously here to stay. Defaulting to generic medicines in electronic health records is a perfect example because it’s clear from the evidence that this helps constrain costs without worsening outcomes.

But I don’t necessarily think that’s what will help improve organ donation, because we’re already getting a “yes” from most medically eligible donors.

So, the best interventions would work even further upstream, increasing the true supply of eligible donors without regard to whether they consent. Improvements in how we manage brain-dead patients in the intensive care unit are one example of how we could increase the supply of eligible donors.

Spain, which has an opt-out system and the highest rate of donations globally, has been successful because of a number of other factors, like expanded criteria for organ suitability and putting donor coordinators in each hospital to build relationships with potential donor’s families.

Q. Last question. Why would moving to an opt-out approach not solve the organ shortage here?

A. People wildly underestimate just how big the shortage is, because they look at the waitlist numbers without accounting for the fact that most “rationing” occurs in choosing who even gets on the waitlist to begin with.

The shortage is much, much larger than most people think, and the opt-in vs. opt-out choice won’t impact the true shortage one bit.

That said, there’s also the elephant in the room, which is whether everyone who could potentially benefit from a transplant ought to get one – for almost all those patients, the procedure would not meet conventional criteria for cost-effectiveness, but for one reason or another, we’re not currently at a place – as a society – where anyone is eager to say that more transplantation is a bad thing.

We remain beholden by the very human instincts to try to save a potentially savable life – regardless of what it costs to do so. In this regard, transplantation is not so unique.


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