Project to get transplant organs from ER patients raises ethics questions
Monday, March 15, 2010
In the hope of expanding a controversial form of organ donation into emergency rooms around the United States, a federally funded project has begun trying to obtain kidneys, livers and possibly other body parts from car-accident victims, heart-attack fatalities and other urgent-care patients.
Using a $321,000 grant from the Department of Health and Human Services, the emergency departments at the University of Pittsburgh Medical Center-Presbyterian Hospital and Allegheny General Hospital in Pittsburgh have started rapidly identifying donors among patients whom doctors are unable to save and taking steps to preserve their organs so a transplant team can rush to try to retrieve them.
Obtaining organs from emergency room patients has long been considered off-limits in the United States because of ethical and logistical concerns. This pilot project aims to investigate whether it is feasible and, if so, to encourage other hospitals nationwide to follow. So far, neither hospital has yet gotten any usable organs.
"This is about helping people who have declared themselves to be donors, but die in a place where donation is currently not possible," said Clifton W. Callaway, an associate professor of emergency medicine at the University of Pittsburgh who is leading the project. "It's also about helping the large number of people awaiting transplants who could die waiting because of the shortage of organs."
Critics say the program represents a troubling attempt to bring a questionable form of organ procurement into an even more ethically dicey situation: the tumultuous environment of an ER, where more than ever it raises the specter of doctors preying on dying patients for their organs.
"There's a fine line between methods that are pioneering and methods that are predatory," said Leslie M. Whetstine, a bioethicist at Walsh University in Ohio. "This seems to me to be in the latter category. It's ghoulish."
For decades, most hearts, lungs, kidneys, livers and other organs obtained for transplants in the United States have come from patients who have been pronounced dead in a hospital after a complete cessation of brain activity, known as brain death, was carefully determined.
But because thousands of people die each year waiting for organ transplants, the federal government has begun promoting an alternative that involves surgeons taking organs, within minutes, from patients whose hearts have stopped beating but who have not been declared brain-dead. The faster organs are retrieved, the better the chances they will be useable.
Although increasingly common, the practice remains controversial because of questions about whether organ preservation and removal might begin before patients are technically dead, and because of fears that doctors might not do everything possible to save patients and may even hasten their deaths, to increase the chance of obtaining organs.
In the United States, the practice, known as "donation after cardiac death," or DCD, is being done only on patients in the intensive-care unit or other parts of the hospital for whom the possibility of death has been long anticipated, and there has been time to methodically assess their condition and make sure family members are comfortable with the decision. Each hospital can decide whether and how to perform the procedure.
In 2008, the Children's Hospital in Colorado sparked intense debate with a federally funded DCD pilot project that involved taking hearts from babies 75 seconds after they were removed from life support. After an intensive review, the hospital restarted the program about two months ago but required that surgeons wait two minutes.
The Washington Hospital Center launched a DCD program in its emergency room in the late 1990s but discontinued the effort when it proved too difficult logistically. The Washington Regional Transplant Community, which coordinates organ procurement for the region, "is always evaluating best practices across the nation to see if they are replicable in our service area and can meet the ultimate test of offering more donation options to families and saving more lives," said Cindy Speas, director of community affairs for the group. "So we will, of course, look at the results of the program" in Pittsburgh.
The University of Pittsburgh started screening patients last year, and Allegheny started within the past month.
Many ethicists and transplant experts and advocates say the Pittsburgh emergency room experiment is worth pursuing as long as it is designed to include protections, especially for patient care.
"There are strict firewalls in place," said Jim Bowman, the medical director for the transplantation division at the Health Resources and Services Administration, which is funding the project. "This is potentially a new source of organs that up until now have been neglected."
Others remain wary. One concern is that under the program, doctors will take organs from people who have agreed to become donors by checking off a box on their driver's license or by signing up on a state registry, and will not seek a family member's consent if one is not present.
"The problem is there's no real informed consent in driver's license designations," said David Crippen, an associate professor of critical-care medicine at the University of Pittsburgh. "The computer asks, 'Would you like to be a donor -- yes or no.' . . . Many people may be consenting to something that they really don't understand."
Some experts worry that the practice could send subtle signals to doctors and nurses that could influence how hard they work to save patients.
"When you do this stuff in such close proximity to treating the patient, the people in the emergency room will quickly start to think, 'This is a potential organ donor,' even when they are treating the patient," said Michael A. Grodin, a medical ethicist at Boston University. "People are going to wonder, if they are being treated in the ER, 'Are the transplant people going to swoop down to get my organs?' "
The practice could backfire by making an already skeptical public less likely to designate themselves as organ donors, several experts said.
"Imagine you have a 20-year-old inner-city kid who gets shot. Twenty minutes later, a family member comes in and says, 'What happened?' They're told, 'We tried to save him but couldn't, and he had an organ donor card so we took an organ,' " said University of Pennsylvania bioethicist Arthur Caplan. "You can imagine they're going to think, 'Did you really do everything you could to save him?' "
Trying to allay concerns
The project's organizers have taken several steps to address the concerns, Callaway said. No one will check whether a patient is an organ donor until after the patient has been declared dead, he said. The medical personnel involved in trying to save patients will be completely separate from those involved in obtaining their organs.
"If I were simultaneously given the task for being part of the transplant team, and that was in the back of my head, I might have some conflicting priority that your death may benefit someone else," Callaway said.
Some critics question whether patients pronounced dead in the emergency room meet the official criteria for organ donation, or whether there are enough safeguards in place in case someone pronounced dead unexpectedly revives -- which can happen, though very rarely. The Pittsburgh protocol requires only that doctors wait two minutes after death is pronounced before taking steps to preserve organs.
"There's no consensus regarding how long CPR must be performed before death is determined as irreversible. In other words, when in the resuscitation process does the patient transition from being treated as a patient to a donor?" Whetstine asked. "Are such patients really dead after resuscitation efforts end and after a time interval of two minutes of cessation of circulation elapses?"
But Callaway dismissed any suggestion that the patients technically may not be dead. Only patients for whom everything has been done, and who it is clear cannot be revived, will be considered, he said.
"This is donation after cardiac death. No heartbeat. No breathing. Dead. Clinically dead. There is an unambiguous death," he said.
And, although the protocol officially calls for waiting two minutes, he said, in reality it would take at least 15 minutes before the special team could arrive and start preparing the body for organ donation.
"Right now, every single person who dies in the emergency department, even if they designated themselves as an organ donor, their organs go to the morgue," Callaway said. "That's not what their wishes were, and certainly there's someone waiting for an organ who could have benefited."