A Review of Epidemiologic Evidence

Regarding Impact of Presumed Consent Legislation on Organ Donation

Wendy J. Manuel

Introduction to Epidemiology (PH2610)

Dr. Melissa H. Stigler

December 1, 2008

Since the increased efficacy of transplant immunization drugs there has been increased demand worldwide for donation of human organs.  In response to this demand governments have explored various legislative policies to improve organ donation rates.  Potential remedies vary from legislative policy, enticing donors with financial compensation, transplanting organs from nonhuman hosts, methods of hierarchically organizing recipient lists, and educating the general public (Abadie & Gay, 2006).

Within a presumed consent legal system, it is assumed that all individuals would want to donate organs upon death.  Under presumed consent a deceased individual is classified as a potential donor.  Specifically, unless a person has affirmatively “opted out” of the system, the community may claim the right to remove much-needed organs (Liddy, 2001).  A presumed consent public health policy attempts to target those individuals who support organ donation but have not actively consented to donating their organs.  In this way, the policy hopes to increase the supply of organs.  One’s actions regarding organ donation do not always accurately reflect the individual’s actual attitude. Health researchers Mossialos, Costa-Font, and Rudisill (2008) illustrate with the example ofGermany, where only 7–10 percent of individuals who are in favor of organ donation carry a donor card.  Presumed consent countries include Australia, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Greece, Hungary, Israel, Italy, Latvia, Luxemburg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and Turkey (Abadie & Gay, 2006). Belgium, for example, has had presumed consent since before 1991.

Having defined the public health policy of presumed consent, it is also useful to examine the need for such a policy.  This need is demonstrated through examining the number of patients waiting for organ donation versus the number of organ donors and adverse outcomes due to the organ shortage crisis.

Number of organ transplant candidates

In an ecological study of 22 countries, Abadie and Gay (2006) illustrate the growth of cases waiting for organs from just under 30,000 in 1992 to more than 70,000 in 2002.  More recently, Abouna (2008) establishes a higher number of new cases in the United Statesas a new patient was added to the waiting list every 15 minutes and in the year 2007 more than 95,000 patients were waiting for transplants.  In 2007, as many as 96,559 individuals in the United Stateswere waiting for transplant as of May 31^st (Mocan and Tekin, 2007).

Not only is the crude count of individuals waiting for transplantation high, but the rate of new candidates being added to the waiting list (or incident rate) is also incredibly high.  Childress and Liverman (2006) document rate increases over two different decades.  The rate of increase in individuals in theU.S.on the organ waiting list for the seven year period between 1988 and 1995 was an astonishing 275%.  Dolan (2008) discusses the tremendous growth in the transplant waiting list as doubling in the past 10 years from 46,961 to 99,040.  A primary driver in this growth is an increasing need for kidney transplants.  Point prevalence for kidney transplant candidates alone (as a proportion of all organ candidates) onMarch 24, 2006was 71% (Childress & Liverman, 2006).  Even more specifically, Abouna (2008) documented the incident rate for renal failure in theU.S.andCanadaas 140 to 160 million per year.

Number of organ donors

Barnieh, Baxter, Boiteau, Manns, and Doig (2006) explain that organ donation rates are generally measured by number of donors per million population (DPMP) or the simple proportion of number of donors divided by the potential donor population.  Marti Manyalich, the Chief Transplant Coordinator at theUniversityofBarcelonahas documented that despite increases in cadaveric organ donation, organ shortages remain.  The rates vary by country, but Manyalich (1999) lists theU.S.with a rate of 22 donors pmp versus a need of around 50 donors pmp.

Interestingly, the PMP (or DPMP) measurement as a standard of success is questioned in the work of Barnieh et al. (2006) due to assumptions inherently imbedded in this measurement.  Specifically, Barnieh et al. document three issues:  assuming age and gender distribution is similar for all populations, assuming age and gender death rates from brain injury are similar for all populations and assuming all programs use the same case definition of organ donor.  Nonetheless, the need for donors is commonly accepted as dire.  U.S. Representative James C. Greenwood aptly described this need in a 2003 congressional hearing, “only 40 percent of individuals who died and had organs eligible for donation actually became donors.  When you consider that as many as eight lives can be saved from the gifts of one donor and that there are more than 81,000 people needing a lifesaving organ, 40 percent is just not good enough.” (House Committee on Energy and Commerce, 2003, p. 1).

One of the ironies in organ supply is the gap between donor registration and expressed support for organ donation. Abadie and Gay (2006) cite a 1993Gallupsurvey that quantifies Americans favoring organ donation at an 85% rate and willingness to donate organs after death at a 69% rate.  However, only 28% have indicated their permission for donation on their driver’s license or a donor card.  This anomaly is also found in other countries such as theU.K.where 90% of the population favors organ donation yet only 24% signed the Organ Donation Register (Hammand Tizzard, 2008).

In 2007, Siminoff, Mercer, Graham, and Burant conducted a cross-sectional study where they identified 420 cases of potential donors from hospital records inOhioandPennsylvania.  They interviewed the family members of these cases to identify determinants of the decision to donate or not.   The study found significant differences between those who donated and those who did not.  Variables showing differences included family race; patient gender and age; family income and attitudes toward organ donation. Specifically, the study found that organs donated were more likely to be from white, male and younger patients. More family decision makers who refused to donate had incomes of less than $25,000 and also scored lower on the attitude toward organ donation scale (Siminoff et al., 2007).

Despite the anomaly of support versus active registrations and demographic determinants of actual donation, donor numbers are actually increasing.  In the U.S., “total organ donation (deceased plus living) has steadily increased over the past 10 years, from 9208 organ donors in 1996 to 14488 donors in 2005” (Punch, Hayes, LaPorte, McBride and Seely, 2007, p. 1328).  However this increase falls short of keeping pace with the demand.  “Between 1995 and 2000, the number of patients who wait for organ transplantation increased by 80%, while the number of cadaveric donors increased only by less than 12% in the United States” (Mocan & Tekin, 2007, p. 2527).

Adverse outcomes

Adverse outcomes due to organ shortage crisis include both loss of life and economic costs.  “As a consequence of this organ shortage crisis the majority of patients with vital organ failure are deprived of a new life, many patients with nonvital organ failure are deprived of life extension, and the cost/benefit ratio of medical care to society is markedly increased. In theU.S., the cost of dialysis is three times the cost of a kidney transplant over a 4-year period. In a recent European study, kidney transplantation for 1000 patients saved 2 million euros” (Abouna, 2008, p.34).

While not one of the top 10 leading causes of death, the chronic shortage of organs does contribute to loss of life.  Just as numbers of patients waiting for transplants is climbing, so are deaths on the waiting list.  As of 2002, approximately 18 patients died per day (Abadie and Gay, 2006) and in 2006, 6120 patients died a waiting a transplant (Abouna, 2008).  According to Mocan and Tekin (2007), the 2006 count is higher at 6828 individuals.

In addition to the pure loss of life, one can consider the waste of valuable organs.  “From an economist’s point of view, the shortage of cadaveric organs for transplantation is an intriguing phenomenon. First, from a purely utilitarian perspective, it represents the routine disposal of a highly valuable commodity, with the potential to save lives” (Abadie and Gay, 2006, p. 600).

An example of this waste is illustrated by Etzioni (2003) in describing how a single organ, tissue and eye donor can save up to 7 lives and help up to 50 people.

Finally, there is an economic cost as well.  As transplantation costs decline, it becomes more cost-effective.   Etzioni (2003) reviews one study showing the cost recovery for kidney dialysis at about 2.7 years after transplant.  Besides cost savings, the transplant recipient no longer has to endure pain or inconvenience of dialysis.

Effectiveness of presumed consent policy

Since there is a clear need for organs for transplant based on the number of patients waiting for organs, the large shortage of organ donors, as well as the loss of life and economic costs, there is much discussion as to how to improve donation rates.  Epidemiological research indicates that organ donation is influenced by a variety of determinants.  Hammand Tizzard (2008) deem the relationship between presumed consent and donation rate as difficult to fully comprehend.  A 2006 quantitative study by Abadie and Gay study is one of apparently few empirical studies on organ donation rates.  Abadie and Gay analyzed data for 22 countries over a ten-year period.  They sought to control for potential confounding factors in measuring the impact of presumed consent on organ donation.  Specifically, they “obtained information on a number of factors that are thought to affect donation rates and legislative defaults on organ donation, such as per capita GDP, health expenditures per capita, religious beliefs, the legislative system and the number of deaths caused by motor vehicle accidents and cerebro-vascular diseases” (Abadie and Gay, 2006, p. 607).  The researchers then utilized regression analysis to understand the relation of consent legislation to organ donation rates after controlling for the above determinants. They concluded when other determinants are accounted for, presumed consent countries on average experience approximately 25–30% higher donation rates than informed consent countries. 

Without being specific as to what studies were reviewed, the researchers claim “most previous studies have pointed out that, on average, presumed consent countries do not produce significantly higher organ donation rates” (Abadie and Gay, 2006, p. 613).  While an exhaustive literature search is beyond the scope of this paper, there is indeed at least one study found that concluded no positive correlation between presumed consent and donor rates.  For example, an examination of new presumed consent legislation in Singapore enacted in 2004 concluded that legislation alone was insufficient to significantly increase donation rates and must be accompanied by public education and family support (Low et al., 2006).  The methodology of this study was to compare numbers of referrals, potential donors, liver recovery surgery, and liver transplant for 24 months before and after the legislative change.  There was no effort to control for determinants as in the Abadie and Gay study.

The mere fact that donation and transplant rates vary widely between presumed consent countries seems to indicate potential confounders.  Transplant rates vary by up to seven times among these countries and in some cases have lower rates than opt in countries such as theU.S.and theU.K., which have transplant rates of 24.1 and 13.8 pmp, respectively (Low et al., 2006).  However another study in 2003 made similar conclusions to Abadie and Gay.  Examining cadaveric donations made per million (DPMP) in 17 European countries over a nine year period, Johnson and Daniel (2003) concluded that presumed consent has a strong effect on donation rates.  “When donation is the default, there is a 16.3% (P < 0.02) increase in donation, increasing the donor rate from 14.1 to 16.4 million” (Johnson and Daniel, 2003, p. 1338).  The study utilized a multiple regression analysis and also controlled for other determinants (similarly to Abadie and Gay) such as transplant infrastructure, education, and religion.

English and Sommerville compared donation rates between the twoBelgiumcitiesAntwerpandLeuvensince they are from the same culture and were equally exposed to presumed consent publicity when it first came out in 1986.  Antwerpdid not enact presumed consent and had flat donation rates. Leuvenimmediately adopted presumed consent and experienced a 37% increase in donors over three years. Belgiumoverall experienced a 55% increase in organ donation over a five-year period, even though traffic fatalities decreased during the same period.  Only two percent of Belgian people have opted out of the presumed consent system (Liddy, 2001).  Similarly, the inverse correlation is noted inDenmark, which experienced donation declines by 50% when it reverted back to express consent from a presumed consent model (English and Sommerville, 2003).

Family influence as a determinant

One of the main determinants of the success of any policy to increase organ donation is deferring the decision to donate to the family, whether or not there is consent from the deceased.  The fact that families refuse to consent to donation is a frequently cited reason for shortage of available organs. “Approximately half of the families that are approached to request donation refuse it in the U.S. and Great Britain, compared to around 20% in Spain and around 30% in France” (Abadie and Gay, 2006, p. 600).  Interesting assumptions made by the families of potential organ donors were noted by Abadie and Gay.  Families in informed consent countries assume that if the deceased was not registered the deceased therefore had weak preference for donation.  In presumed consent countries, the families made the opposite inference, assuming that non-registered individuals had strong preferences for donation.  The end result being that family donor consent rates were equal to or higher in presumed consent countries (Abadie and Gay, 2006).

Clearly, family preferences are a key determinant in donor rates.  When an individual dies, the family assumes responsibility for not only providing information on what the patient may have preferred, but also to make decisions on behalf of the deceased.  It can be argued that presumed consent (with consideration to the family) creates a better balance in public policy between duties to the deceased and to patients waiting for an organ transplant (English and Sommerville, 2003).  It is often difficult for bereaving relatives to move beyond the abstract support of organ donation as a societal benefit and think about how they feel for donation for a family member (Mossialos, Costa-Font and Rudisill, 2008).   A cross-sectional study by Mossialos, Costa-Font and Rudisill (2008) found that relatives in presumed consent countries expressed a higher willingness to donate both their own and relative’s organs.  It is possible though that presumed consent legislation may merely be the reflection of a society already pre-dispositioned towards donation (endogenous) as reflected in the survey results that  “awareness of regulation increases the odds of being willing to donate one’s own organs by 91 percent and those of a relative by 74 percent” (Mossialos, Costa-Font and Rudisill, 2008, p. 6)

Legal considerations on policy effectiveness

Legal considerations may also mitigate the effectiveness of presumed consent policies.  An extensive discussion of why preferences of families are allowed to override the express consent of the deceased donor was published by Downie, Shea, and Rajotte in 2008.  Primary reasons given for this behavior by healthcare practitioners were lack of understanding of the law, concern for the feelings of the family, fear of lawsuits by the family, and public perception (Downie, Shea, and Rajotte, 2008).  Control of one’s body is considered a fundamental right in western law and generally regarded as part of the principle of self determination.  So regarded is this right that law provides for competent adults to be allowed to die versus prolonging life by medical technology when this has been expressly consented (English and Sommerville, 2003).  In theory, this same right would extend to the consent of organ donation, if consent was clearly expressed.  There have been few legal cases regarding organ donation and none yet reviewed by the U.S. Supreme Court.  An objection to presumed consent (if strictly enforced) is that it would be a violation of personal liberties to presume the decision.  The current Supreme Court has been reluctant to continue expanding the meanings of personal liberty and the personal autonomy argument challenge would therefore likely fail (Powhida, 1999).  A property rights challenge however, may impact the success of legislated default presumptions for organ donation.  The Supreme Court could look to state laws regarding property and may find the surviving family has the property interest in a cadaver (Powhida, 1999).  The less conscriptive the presumed consent law, the less likely this challenge might arise as without state enforcement, there is less offense to our sense of control over what happens to one’s remains (Powhida, 1999).

Several state cases have occurred regarding property rights and organ donation.  Examples include a 1972 case in Ohio, where a court of appeals did recognize the family’s right to the property of the dead body citing the Uniform Anatomical Gift Act.  In 1985, the Supreme Court of Georgia did not recognize a property interest in the dead body where parents were not notified of corneal tissue removal of an infant during autopsy (Liddy, 2001[WJM1] ).  This paper is not meant to be an exhaustive review of legal cases, but to point out that case law is a consideration in how legislated defaults may or may not be implemented or be successful.

Conclusion

Presumed consent may not be sufficient to drive organ donation. Nonetheless, it is a policy that is capable of contributing to improved donation rates.  In the U.S.over the last decade there has been a gradual increase in deceased organ donors, accelerating from two percent of eligible donors per year to eight percent per year during 2003-2005.  Total deceased donors have increased almost 40% since 1996 (Punch et al., 2007).  Despite this progress, the number of U.S.patients awaiting a solid organ increased 70% from 1996 to 2001 (Siminoff, Gordon, Hewlett, & Arnold, 2001).  The Organ Procurement and Transplant Network (UNOS) website (http://www.optn.org/) publishes data regarding organ transplant and as ofNovember 29, 2008,1:18 p.m., showed 100,712 individuals waiting for all organ types.  The threshold of more than 100,000 people waiting for an organ transplant was exceeded for the first time in October 2008.

The gap between candidates and donors is in no small part the result of the inability of current policy to address the ubiquitous need for organ donations, primarily with the problematic nature of initiating donor consent. When implemented, presumed consent programs can address personal autonomy, property rights, family considerations and awareness of legislation issues.  There is empirical research to suggest that presumed consent laws may greatly increase the supply of cadaveric organs for transplantation. While a presumed consent policy may not be a panacea for resolving organ shortage (Abadie and Gay, 2006), neither should its potential to contribute to prevention of loss of life and economic costs to society be underestimated.

The total value of life lost due to death because of waiting for an organ transplant is estimated at greater than $4 billion annually in theUnited States(Mocan and Tekin, 2005).  This loss of life is tragic on many levels but particularly so when (like so many public health issues) it can be prevented.    Where there is no clear impact to the deceased (harm or benefit), it is odd that our culture assumes citizens would be more likely to not help others (presuming do not want to donate organs) versus we would want to help others (flipping presumption).

“If we are to presume anything, we should presume that people would wish to do the morally right thing in the particular situation. In the case of cadaver organs this is certainly to make them available for life saving or life enhancing use” (English and Sommerville, 2003, p. 150).

References

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Mossialos, E., Costa-Font, J., & Rudisill, C. (2008). Does organ donation legislation affect individuals’ willingness to donate their own or their relative’s organs? Evidence from European Union survey data. BMC Health Services Research, 8, 48.

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Siminoff, L.A, Gordon, N., Hewlett, J., Arnold, R.M. (2001).  Factors Influencing Families’ Consent for Donation of Solid Organs for Transplantation.  JAMA, 286(1), 71-77.

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