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Donation after Cardiac Death: Conceptual Ambiguity and Public Trust

October 23rd, 2008

Donation After Cardiac Death Click here for full commentary

Sandra Woien, PhD

The pediatric heart transplant team at the Children’s Hospital in
Denver, Colorado recently published an article describing cases
in which the hearts of three infants who were declared dead using
the cardiac death criteria were transplanted into three different
infant recipients (Boucek et al, 2008).  In spite of the ethical issues
raised by such a novel procedure, the authors of the article deserve
accolades in bringing these cases to the public’s attention, and
the recent flurry of debate regarding the novel donation after cardiac
death (DCD) procedure offers a unique opportunity to make the
 practice of controlled DCD more transparency.

Mission Impossible

September 21st, 2008

Tom Hooyman, PhD

Several years ago, Jesuit theologian Richard McCormick argued that the mission of Catholic health care was no longer possible because of the inherent contradiction between running a business and being a ministry.  Last week’s events of the Federal Reserve and Treasury Department rescuing Wall Street from a financial meltdown are akin to the unresolved debate started by Father McCormick.  The Fed cannot serve two masters—Wall Street and Taxpayers. 

Of course, the argument will be made that by stabilizing the financial system the Fed is minimizing losses to taxpayers.  But is that the case?  Over the past 7 months the Fed has either loaned or flat out spent $314 Billion to failing businesses:

• 3/16/08–$29 Billion for JP Morgan buyout of Bear Sterns
• 9/8/08–$100 Billion for Freddie Mac bailout
• 9/8/08–$100 Billion for Fannie Mae bailout
• 9/16/08–$85 Billion for AIG bailout

This is not counting the fees the Fed is paying BlackRock, Inc. to manage the $29 Billion securities pool of the Bear Sterns deal; or the fees to the lucky company for managing the $85 Billion AIG pool; or the tens of billions that analysts are reporting that the Fed is loaning to bankrupt Lehman Brothers–that’s right, Lehman Brothers.

Just because the Fed didn’t officially bail out Lehman Brothers doesn’t mean it didn’t happen.  Reports in the NY Times state that Lehman “is borrowing tens of billions of dollars through the Fed’s six-month-old emergency loan program for big investment banks.” (Andrews, 2008)  What could a bankrupt company put up for collateral for such vast amounts of money?  None other than all of the risky investments that got them into such trouble in the first place—stocks, junk bonds and mortgage-backed securities rated BBB.

Who is next in line?  The auto industry is not foolish when they see the government opening its coffers to bailout failing companies, so another $25 Billion loan guarantee for ailing car manufacturers.  It’s an election year and Michigan is a swing state.  Why not airlines—their having a bad year and what about housing—new housing starts haven’t been this low since 1991?

What could prevent the Fed from carrying out this impossible mission?  Run out of money—but that’s not possible because all it needs to do is print more money or for the Treasury to sell more of its own securities.  One year ago all of the Fed’s $800 billion reserves were in Treasury securities and last week that had dwindled to $300 billion in part because of the bailouts.  No problem, just auction more T-bills.

Amidst all of the debate, rhetoric and punditry of the U.S. financial crisis is the fundamental question of the purpose of government, which is based upon an understanding of the common good.  Some will argue that the role of government should be kept to a bare minimum—“let the market sort itself out.”  This position is typically identified with the Republican Party, which holds that “the government should tax only to raise money for essential functions.” (Republican Platform, 2008)  Of course, what is understood as “essential functions” is the essence of the debate. 

During the tumultuous Clinton administration when health care reform was getting a lot of attention, there was a popular bumper sticker which read, “If you like our postal system you will love national health care.”  This sticker’s intent was to connect what was thought to be horrible service by the post office with the possibility of a national health care system.  “God forbid!” was the desired response.  42 cents still seems to be a pretty good deal to send a letter 3000 miles.  Is a national postal system an essential function of government?  Is the common good better served by the federal government operating and managing a national postal system or should this be left to the private sector? 

These same questions should be asked of the systems that have been developed to provide education, health care, transportation, prisons, defense, communications and yes even commerce, to name a few essential functions of society.  With the Fed’s bailout of Fannie Mae and Freddie Mac, the federal government has essentially become the mortgage holder of most American homes.  “If you like our postal system you will love a national mortgage system.”  The irony is so thick it is beyond laughable. 

References

Andrews, Edmund L. (2008). A New Role for the Fed: Investor of Last Resort. NY Times, September 18, 2008: A1, A28.

Republican Platform (2008). Available at: http://www.gop.com/2008Platform/Economy.htm

When is Dead Dead? Ethics of Organ Donation and Cardiac Death

August 7th, 2008

When Dr. Hootan Roozrokh walked into the operating room to harvest the organs of Ruben Navarro, a 25 year old young man with a long history of neurological disease and who was very near death, he didn’t expect to be charged with a felony count of dependent adult abuse. Dr. Roozrokh, who had completed a transplant fellowship at Stanford, was attempting to keep Mr. Navarro comfortable during his dying process and maximize the chances of successfully harvesting as many organs and tissues as possible, once the young man was dead. But there’s the rub. Mr. Navarro didn’t die right away. It took another 8 hours and organs were never harvested.[i]

Mr. Navarro’s case is rather unusual but does illustrate the ongoing controversy and confusion with organ donation after cardiac death (DCD). While medical science and technology have made remarkable developments for keeping people alive despite devastating neurologic onslaught, determining when someone is dead has become more complicated and DCD is the most recent iteration.

Prior to the development of brain death criteria in 1968, by an ad hoc committee at Harvard Medical School, determining death was based upon cardio-respiratory cessation. The need for brain death criteria corresponded with the growing interest to increase the number of viable organs for transplant. The number of transplantations in the United States has more than doubled over the past 20 years.[ii] The United Network for Organ Sharing that operates the Organ Procurement and Transplantation Network, collectively known as OPTN/UNOS is committed to increasing the number of organ donors and there is a general assumption that continuing to build a national infrastructure for organ donation and transplantation is a moral good that should be pursued.

Even though there are clinicians and entire health systems that continue to question whether DCD is ethical[iii], and cases such as Dr. Roozrokh suggests that there is confusion about the appropriate role of transplant teams, the OPTN/UNOS required all 257 transplant hospitals and 58 organ procurement organizations in the United States to comply with its new rule “to develop and comply with protocols to facilitate the recovery of organs from donors after cardiac death.”[iv]

Even if a hospital is not a transplant hospital, it will still be required to have a policy in place that addresses DCD because in January 2007, the Joint Commission implemented a new accreditation standard for donation after cardiac death. Hospitals can choose not to allow DCD because of ethical concerns. Ethics committee have an ethical obligation to assist clinicians and administrators to develop the organization’s policy on DCD; and to advise decision makers in intensive care units, operating rooms and waiting rooms when they are faced with making such a decision. Ethics committees need to develop an ethical framework that will guide this work. The following are suggested as elements for such a framework.

Beneficence and Nonmaleficence

Basic to the relationship between patients and health care providers is the understanding that health care professionals at a minimum will not “do bad things” to patients and hopefully will “do some good things” for their patients. We basically trust that doctors, nurses and therapists intend to help us and not hurt us.

When analyzing the administration of Heparin to a patient expected to donate organs following cardiac death, these principles should be kept in mind. Organ procurement organizations have an incentive to push the limits of an acceptable amount of Heparin in order to maximize retrieval of viable organs. Since Heparin is not being administered in order to help this patient but rather a potential patient who will receive the organs, beneficence is not being honored. There is the potential that such massive doses of Heparin could exacerbate intracranial bleeding and possibly hasten death, which appears to violate the principle of nonmaleficence.

Justice and Charity

Besides expecting that health care professionals will help us and not hurt us, we also have the general expectation that we should be treated fairly or justly. However, justice is not limited to an individual focus but rather includes the relationship each of us has to our communities and society as a whole. Communal justice basically asks, “What does the individual owe to the community?” Distributive justice in turn asks, “What does the community owe to the individual?” A patient who is expected to meet the criteria for cardiac death and then donate his/her organs is one of our most vulnerable community members and as such should expect that the community will protect them and promote their best interests.

Does the soon-to-be- dead patient have a moral obligation to the community? We could argue that because of justice each of has a moral obligation to donate our organs once we no longer need them to sustain our own lives. However, this feels like it could become heavy handed and the individual’s choice could be circumvented by the community. Rather than focusing upon the principle of justice, the virtue of charity provides better support for this ethical framework.

A loved one who is making such a momentous decision for such a patient could consider all of the charitable acts the patient made over his/her life and consider this final act as just another example of a charitable life. Of course, on the other hand, if the patient lived a miserly life such as Scrooge before his epiphany, the loved one would decide that organ donation following cardiac death is inconsistent with the patient’s overall philosophy of life and personal values. Charity provides a robust resource for reflecting upon personal sacrifices that benefit others.

Precautionary principle

How should we assess an action when we do not know whether it will cause harm? Those who are advocating for the action will attempt to place the burden of proof on those opposing the action by requiring proof that the action does in fact cause harm. Without such proof, they will argue, the action may be performed. However, this contradicts the precautionary principle which states that the burden of proof is on those who are advocating for the action. They need to prove that the action does not cause harm rather than the opponent proving the action is harmful. This principle should be utilized when an organ procurement organization (OPO) advocates actions such as administering large doses of heparin. The burden of proof is on the OPO.

Transparency

The purpose of OPTN/UNOS is to procure organs and allocate those organs in an ethical manner. Organ procurement organizations are expected to continue to increase the number of organs procured. Their primary focus is not on the patient who is donating but on the patient who will be receiving. One regional health system has even described an “uneasiness with…and perceived lack of concern” for the donor patient during the initial engagement with their designated organ procurement organization.[v] Such an inherent conflict of interest on the part of the national organizations responsible for designing, coordinating and operating the U.S. organ donation and transplantation system should remain on the collective consciousness of ethics committees as they collaborate with their designated procurement organizations. Transparency is critical in order to build public trust.

It goes without saying that informed consent must be an integral element of the entire process for organ donation after cardiac death. These four elements can provide an ethical framework for ethics committees to work with families and health care providers as informed consent is obtained.

Even under ideal conditions mistakes can still be made. Dr. Roozrokh is a case in point. Ethics committees need to be familiar with the clinical literature and adept at ethical argument in order to provide the necessary balance to the unchallenged assumptions and corresponding actions of the OPTN/UNOS. An aging population coupled with further developments in medical science and technology will only fuel the expectations for a continual increase of organ donations and transplantations.