6-Month Wait
Liver transplantation was declared a clinical service at a consensus conference organized by the U.S. Surgeon General in 1983. By 1988, liver transplant pioneer surgeon Dr. Thomas Starzl said "...the imposition of an arbitrary period of abstinence before going forward with transplantation would seem medically unsound or even inhumane." In the same article, he confirmed the survival and long-term prognosis of patients transplanted for alcohol-associated liver disease was as good as, or better than, patients transplanted for other diseases.
Despite the fame and available expertise of Dr. Starzl, the University of Alberta, along with the rest of Canada's liver
transplant centres, chose to ignore his published research in the area of transplantation in patients with alcohol use
disorder. Yet 25% of the references of their waitlist criteria, (at left) written around 1989, used Starzl's work as reference
for other types of liver disease. The treatment of alcohol patients was backed by a phone call to a professor at the
University of Alberta with no published research on transplantation patients.
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Although subsequent research papers continued to echo Dr. Starzl’s position, international liver transplant centers refused to accept ALD patients who were not alcohol-free for 6 months. In 2008, the University of Pittsburgh published a meta data analysis, summarizing the results of 52 studies over a 22-year period in 3,600 patients. The research team observed that rates of return to heavy drinking in any given year was 2.2%.
The policy, based primarily on moral judgment of patients with alcohol use disorder, is also supported by an acute fear that poor public perception of alcohol use disorder will negatively impact donation rates.
But neither return to drinking or public reticence to donate have ever been supported by medical research or data. Patients rarely return to heavy drinking and waste the organ.
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In recent years, individual transplant centres in Europe and the U.S. have slowly started to conduct trials and transition to a more modern and compassionate approach to liver transplantation in patients whose liver disease is caused by alcohol use disorder.
You can find the status of the 6-month wait in Canada, and its application at U.S. liver transplant centres here.
The Reasons Given for the 6-Month Wait
Research papers and transplant centres’ responses to media queries include many explanations of why the 6-month wait exists. If carefully analyzed, all comments on its validity are variations of these five standard reasons:
[ Reason #1: International Standard ]
The phrase “international standard” is a common response from the medical community. It was the first reason the hospital cited in their response to the Selkirk case at the HRTO. The same words can also be found in doctors’ responses to the media.
In the context of human rights, this reason would have to be the poorest of all. In its simplest form, “We apply this rule because that is what other transplant centres do.”
Historically, Canada has chosen to go beyond the common practices of other countries, placing itself at the forefront of individual rights. Slavery too was an “international standard”. But, in 1819, Canada's Attorney General John Robinson declared that all African American slaves were free and would be protected in Canadian courts. Meanwhile in the United States, for example, slaves were not legally free until December 6, 1865.
More recently, in July 2005, Canada became the fourth country in the world to accept people’s right to love and to marry whoever they choose. Yet, same sex marriage remains illegal in many countries or creates controversy and public disapproval in others. In short, physicians should not and cannot follow an unjust, life-ending policy just because it exists in other jurisdictions. Before government agencies decide to adopt an international standard, they must first ensure it meets the law in their own country.
[ Reason #2: Liver Regeneration ]
Liver transplant physicians argue that the six-month wait is imposed because at times, the liver responds to treatment, negating the need for a transplant. If this reason were valid, every family who has lost someone to the 6-month wait should wonder if the severity of the person’s illness was vastly underestimated.
Sometimes, patients suffering from liver failure caused by any disease may be able to wait six months. Others cannot wait at all. Every patient’s prognosis and progression through liver failure is unique. Waitlists are managed on the premise that the sickest patient gets the organ. Liver transplant centres list patients when their MELD score is 12. If a patient’s condition worsens, they are moved up the list. If it improves, they are moved down the list or taken off altogether. Most centres perform transplant surgery when the MELD score is between 15 and 20.
Persons suffering from liver failure caused by alcohol use disorder should be assessed and listed like everyone else, based on their MELD score. If their MELD score and clinical condition do improve, they would not reach the top of the list.
It is also not credible to believe that every single alcoholic’s medical condition is so identical to the next, that a standard six- month wait is the magical threshold for regeneration. If this were true, why in the United States, does the wait may vary between six months and two years, depending on transplant centre’s policy, the state where that centre is located, and the policy of the health insurance provider paying for the surgery?
[ Reason #3: Best Use of a Scarce Resource ]
Doctors’ responsibility to make the best use of a scarce resource is a principled reason. Nevertheless, there is no connection between best use of a scarce resource and denial of liver transplantation for persons with alcohol use disorder.
Survivability graphs of liver transplant recipients consistently show that their survival rates are as good as, or better that those transplanted for cancer, Hepatitis A and Hepatitis C as late as five to seven years post-transplant.
Persons suffering from liver failure caused by alcohol use disorder should be assessed and listed like everyone else, based on survivability of the surgery and long-term prognosis The TGLN waitlist criteria sets out a minimum survivability requirement of 50% at five years. In 2015, the list of medical research papers used by TGLN set the survival rate of persons with alcohol use disorder from 78-90% at five years. This rate was unrelated to any alcohol-free period and well above the minimum 50% requirement. It is discriminatory to apply a secondary qualifying condition – 6 months’ alcohol free – that has no bearing on the success of the surgery.
It is also not ethical to improve access to a resource for some groups of patients by eliminating an entire demographic from the list. The 6-month rule creates a life and death scenario that not only temporarily removes patients in that group from the transplant list, it eliminates many of them permanently.
[ Reason #4: Likely Return to Drinking ]
“…because he will only drink again and waste the organ.” is one explanation given in hospitals, leaving people ashamed of the disease of alcohol use disorder.
A 2008 meta data analysis from the University of Pittsburgh contradicts this argument. The research team analyzed 54 studies carried out done over a 22-year period that tracked the outcome of 3,651 patients who received a transplant due to substance misuse. It is the largest analysis ever done on liver transplant data.
The Pittsburgh study stated that 1.2 persons per year in North America and 3.5 persons per year in Europe - a weighted average of 2.5 overall - relapsed in any given year to heavy drinking after liver transplant surgery. The same analysis observed that not all patients were subjected to the 6-month wait, and concluded that regardless, the wait was not effective in predicting which patients might return to any amount of drinking.
The mainstream research sources used in this analysis, as well as others released since 2008 all report similar findings in most cases. The most interesting statistic in almost every study is that relapse rarely occurs in the first six months after surgery, which further weakens the argument that a 6-month wait proves the patient is able to control their disease.
Regardless of the relapse rate cited in studies, virtually all of them concede that alcohol consumption is rarely a factor in the health of the transplanted organ.
[ Reason #5: Public Perception ]
Liver transplant networks carefully safeguard the trust of the public, whose consent for donation largely governs the number of lives they can save.
Justification for the 6-month rule originated in part from negative public perception of persons suffering from alcohol addiction and fear that perception would have an impact on organ donation rates. Celebrities such as Dallas actor Larry Hagman, U.K. soccer star George Best, musician David Crosby and New York Yankees baseball star Mickey Mantle all received transplants for liver failure caused by alcohol. In each case, there were media reports of public outcry that a celebrity who was an alcoholic received waitlist priority over other "more deserving" patients with other types of liver disease.
But, the research paper Public and Professional Attitudes to Transplanting Alcoholic Patients, discusses how purported comments in the press after the death of George Best showed opposition to transplantation in ALD patients. However, the director of UK Transplant was not able to establish significant public negativity nationally in response to his transplant.
The notion of negative public perception is only a presumed one. Patient privacy laws ensure the public does not know who received a donated liver; the patient and the public do not know from whom they received their liver. Stigma could be lessened with public campaigns to raise awareness of alcohol use disorder as a disease and patient rights to equal access to health care and transplants. This type of campaign would have limited effect, however, because the 6-month rule is often the result of stigma in the medical community.
TGLN does little to address the issue of poor public perception. If anything, their educational materials perpetuate it. The high school curriculum, One Gift, Many Lives, calls liver failure caused by alcohol use disorder 'self-inflicted' and their liver failure is the result of lifestyle choices. The teacher's guide provides this definition: Self-induced organ failure A term to describe an injury to an organ caused by the personal lifestyle behaviour of an individual, e.g., liver failure from excessive alcohol consumption. The same guide identifies the 6-month wait as a condition and acknowledges very few patients complete the wait, without clarifying whether it is because they die first, or because they cannot remain alcohol free that long.
The content of those materials is concerning, because they teach teenagers to judge people with alcohol use disorder.