NO GUARANTEE WITH THIS ORGAN

Any donated human organ or tissue may harbor an unwanted, undiscovered or unrecognized infection, malignancy or other disease. With the transplant, irregardless of the best intentions and most up to date testing, that disease is donated too and may cause serious illness(even death) in a recipient. To minimize this risk, to allow assessment of the risk, and to facilitate informed judgement about whether or not to proceed……in advance of the transplant….. are the objectives. But risk cannot be completely eliminated.

The U.S. Centers for Disease Control and Prevention (CDC) has just issued long awaited guidelines for use in preventing the transmission of Hepatitis B (hep B),  Hepatitis C (hep C) and HIV through organ transplantation. They are based on currently available evidence and expert opinions, and formally update guidelines last published in 1994. An essential difference between organ donation and blood or tissue donation led to the restriction of these new guidelines only to the former field. In organ donation transplantation must proceed within hours of the procurement of the donated material that might bear infection. In contrast, both blood and tissue are typically recovered, processed and stored for a longer period of time varying from multiple days to even months or longer. During that interval definitive testing and further risk reduction can clearly be performed.

This rapid time frame within which results of any laboratory testing must be available so that organ procurement and transplantation are not unduly delayed defines different ground rules than in most medical scenarios. For example, only a few labs throughout the country perform the most specialized testing (nucleic acid testing -NAT) for Hep B, Hep C and HIV with 24/7/365 availability and rapid turn around. Blood samples are typically sent by courier to one of these labs when testing of a deceased donor is required. Of course, these steps do increase the cost of transplantation.

A practical approach was, by necessity, taken by the U.S. Public Health Service in developing the guidelines. For example, if one of the test results indicates the presence of  Hep B, Hep C or HIV when the virus is really not present (a false positive result), the inappropriate exclusion of the organ donor would be a serious consequence costing one or more lives. The need to balance the potential benefit to be gained from a successful transplant, with the statistical risk of using the possibly infected organ is acknowledged in the guidelines. Thus, it might be reasonable to use a liver from a donor who is suspected of having a false positive test if the liver candidate is at death’s door and no other organs are available. But, it would not be reasonable to use the same donor’s tissue without clarification of the possible infection.

Wisely, these guidelines also delve deeply into the important issue of involving the patient or family (if the patient is unable) through education when transplantation is only a concept, and through full informed consent when the detailed risks and benefits are known. This is a codification of the timing and content of informed consent similar to other approaches in this tightly regulated field.

Behavioral factors that increase the donor’s risk of infection with Hep B, Hep C or HIV include sex with an infected person in the preceding 12 months, male-male sex within the preceding 12 months, people who have had sex with a person in exchange for money or drugs in the preceding 12 months, people who have had sex with a person who injected drugs in the preceding 12 months, a child < 18 months born to an infected or at risk mother, a child who has been breastfed within the preceding 12 months by an infected or at risk mother, people who injected drugs in the preceding 12 months, people in lockup, jail, prison or a juvenile correctional facility > 72 hours in the preceding 12 months, and people newly diagnosed with a sexually transmitted disease in the preceding 12 months.

For any transplant that involved an increased risk of transmission of Hep B, Hep C or HIV, surveillance testing of the recipient for the first year is recommended. If infection does occur, treatment can be initiated as early as possible with the intent of staving off serious illness. 

Today, these are the most common severe viral infections that concern transplant recipients. But previously, similar donor transmitted infection with the cytomegalovirus (CMV) and the Epstein Barr virus (EBV) were also highly problematic, at times even causing fatalities. Now these infections are much more manageable because of the anti-viral medications available for use.

If all of these details seem frightening, the real statistic that new (de novo) Hep B, Hep C or HIV infection through transplantation is very rare should be reassuring. The newly available document has simply formalized screening practices that have already become routine at many transplant programs for the protection of patients. Patients are entitled to be familiar with any unusual risks posed by the specific donor whose organ they are being offered (if they are so fortunate). Patients should feel empowered to ask about unusual issues with their donor (if they have not already been informed, which should happen). 

Remember that the only way to have no risk at all is to have no transplant. If a transplant does happen, the human donor’s organ has been assessed with a risk/benefit ratio tailored to the specific recipient who should have been informed and should have intentionally opted to proceed. Of course, the transplant team would not typically offer an organ that they did not consider acceptable for that patient. But, in the end, it must be the patient (and/or the family) who agrees to go ahead.

HOPE – A LEGISLATIVE ACT NEEDED IN TRANSPLANTATION

U.S. federal law currently prohibits the transplantation of organs from HIV positive donors – a hold over from an early stage in the HIV era. But today many believe that cautious exploration of the safety of using HIV +ve donor organs for HIV +ve recipients may be a reasonable strategy to expansion of the critically limited organ donor pool. Similar approachs are used (with informed consent from the recipients) for patients and donors infected with the hepatitis B and C viruses, with favorable outcomes.  There was therefore substantial cause for preliminary celebration on June 17, 2013 when the U.S. Senate unanimously approved the HIV Organ Policy Act (HOPE Act; S. 330).

This legislation directs the Department of Health and Human Services (DHHS) and the Organ Procurement and Transplantation Network (OPTN) to develop and institute standards for the use of HIV positive organs in HIV positive recipients if ongoing research warrants. The Secretary of DHHS is also directed to : (1) review annually the results of scientific research in conjunction with the Network to determine whether they warrant revision of quality standards relating to donated HIV-infected organs and to the safety of cross-strain transplantation; and the Network, if the review so warrants, is directed to revise its standards in a way that ensures the changes will not reduce the safety of organ transplantation.

This legislation has been referred back to the House of Representatives and is now in the House Committee on 1) the Judiciary and 2) Energy and Commerce.  It was initially introduced by Representative Lois Capps (California) as H.R. 698 and now has 30 co-sponsors. Why not check to see whether your Representative has yet joined as a co-sponsor? If not, call or e-mail his/her office or website to indicate your support. This bill does have bipartisan and bicameral (both houses of Congress) support. Let’s help stimulate our politicians to take a logical step forward to solve the organ shortage, even if it is a small one. Every bit helps.

FUNDAMENTALS OF ORGAN DONATION

Pathways through which people may become organ and tissue donors can be confusing. Pathways to consent for donation (for yourself) while still alive thereby authorizing action upon your own wishes should no longer be confusing.

A live donor may give a kidney, partial liver, partial lung, partial intestine, or partial pancreas.

A deceased donor may give one or both lungs, a heart, a liver (or 2 pieces of a liver for 2 different recipients), a pancreas, a small intestine, two kidneys, a face, two hands, tissue for up to 50 different recipients.

Organs will not be recovered (procured) for donation unless death has been declared by a physician who has no connection to the organ donation team.

Death may be legally declared on the basis of two different criteria. In the first pathway to organ donation, brain death has occurred and has been formally declared. Very specific criteria must be met including: a body temperature of  >96.8 degrees, exclusion of drug intoxication or poisoning, absence of spontaneous breathing, absence of movement or responsiveness (except for reflexes), absence of brainstem activity.

Not all individuals with severe neurologic injury will end up with death of the brain. Today, many of us have advised our families or healthcare proxies that we would not like to be maintained in vegetative or moribund states. Families are legally and socially supported in decisions to withdraw supportive care in these circumstances. Following such a decision, a family may be approached about organ donation with the following question: “If your loved one dies within one hour of the withdrawal of support (for example, after the breathing tube has been removed) and a physician who is separate from the organ donation team declares that death has occurred because circulation has stopped, can the organs be rapidly removed for the purpose of organ donation? This is donation after circulatory death (DCD).

When support has been withdrawn from a person with consent for DCD but death does not happen within 60 minutes, organ donation does not occur. The individual will still be expected to die but the focus remains comfort care. No organ recovery takes place because death has not occurred within the timeframe necessary for the organs to remain transplantable.

Brain death is not a natural state. Since a brain dead person does not breathe spontaneously, the heart and other organs (except for the brain whose cells are dead) are kept functional because the person is kept on a ventilator that artificially delivers oxygen into the lungs. However, this is NOT life support because the human being has already died. Thus, 2 references to “life support” in USA TODAY’s 6/15/13 should have been edited. They can still be amended.

The pathway to consenting for organ donation is no longer ambiguous. Each state has its own donor registry. Enrollment now represents legal consent for donation and removes a potentially difficult decision from being your family’s responsibility in the case of your death (at a very difficult and vulnerable time). If you really want to be a donor, please take this step. Only 45% of eligible donors in this country have done so thus far even though 90% of people say they believe organ donation is the right thing to do. Let’s do better.

NO POLITICS, ONLY GOOD THOUGHTS FOR A RECIPIENT + GRATITUDE TO A DONOR

If an ABCnews report is accurate, Sarah, the young protagonist  in the lung allocation controversy is about to have her chance. Apparently, someone has died and given the gift of life with the lungs being allocated to Sarah.

This no time for politics. Best wishes to Sarah and her surgical team. Deep gratitude to the donor and his/her family. Their generosity cannot be described in words.

PROFESSIONAL RESPONSE TO PLEAS + DIRECTIVES FOR LUNG TRANSPLANT ACCESS

Challenged by the public, the legal system, and by recognition of the validity of concerns about possible unfairness to pediatric patients in need of lung transplants, the transplant community has responded rapidly. On Monday, June 10, 2013 the 16 member Executive Committee (and invited guests) of the  United Network for Organ Sharing/ Organ Procurement and Transplantation Network (OPTN) convened a meeting by conference call to review data, policies, and input from various sources pertaining to the allocation of organs for lung candidates age 11 or younger. The meeting agenda included:
  • Statement from the American Society of Transplant Surgeons + American Society of Transplantation
  • Letter from the House of Representatives’ Doctors’ Caucus
  • Letter from Senator Robert Casey 
  • Statement from Stephen Harvey, Esquire (attorney for the family of a critically ill pediatric lung candidate) 
  • Comments from 3 other Committees (Ethics, Thoracic and Pediatrics) 
  • Correspondence with Secretary Sebelius of HHS
  • UNOS data about lung transplantation
  • Current lung allocation policy

The outcome was a unanimous vote to effect an immediate change to policy  Policy 3.7.6.4 (Lung Candidates with Exceptional Cases) to permit transplant centers to request prospective review and additional listing (for adult lungs) of pediatric cases age 11 or younger from the Lung Review Board. This policy change will expire on July 1, 2014 pending reconsideration by the entire UNOS/OPTN Board of Directors and additional study and recommendations of the Policy from relevant Committees.

This is an example of the system and the transplant community at its finest. A data driven, comprehensive review with input from all stakeholders. Transparency in the processes defined and executed as outlined, and fully shared with the public (follow the links above). Making the best possible judgement while simultaneously acknowledging the tragedies to befall those receiving the short ends of allocation straws.

But, it would be so wrong to celebrate a process when the lives of dying patients are at stake. This system does not serve them all. It cannot unless we become more successful in addressing the organ shortage. Register now to be an organ and tissue donor. Become an effective ambassador for this cause and these patients. Join our team.

JUDICIAL INTRUSION INTO ORGAN TRANSPLANTATION?

Desperate transplant candidates and families caught in the vast organ shortage in the U.S. should not be criticized for turning over every rock in search of a life-saving organ. But they can not all be winners who receive an organ within the allocation system. The discrepancy between supply and demand is simply too great. (register now to donate) This system of distribution has been devised over years, by multi-disciplinary teams of highly knowledgeable stakeholders (including patients and families) through transparent and democratic processes (Organ Procurement and Transplantation Network Policies). It is imperfect but iterative. Improvements are made. When a gap is identified within this incredibly complex set of policies, a process is followed to fix it. When an unfairness is perceived, a similar process of debate is initiated. Action – or not – is taken. Unilateral decisions that effect multiple patients are not made by individuals, any of whom has an intrinsic bias of one sort or another.

A recent bypass of this set of checks and balances was created when a Federal judge temporarily ordered the Secretary of Health and Human Services to alter the allocation scheme for an individual patient’s benefit (temporary restraining order).  This precedent has already generated legal action from at least one other patient seeking similar protection. One can only imagine the potential legal responses from the candidates who may be disadvantaged as a result of the relative advantage afforded to the original plaintiff/claimant. After all, this is a zero sum circumstance in which one patient’s benefit comes only at another patient’s loss.

Similar uninformed meddling in the transplant field on behalf of a patient came from a Mississipi judge who granted parole to one female prisoner with kidney failure on the condition that her similarly paroled sister donate a kidney to her. Unfortunately, neither had been accepted by a transplant program and both were declined because of obesity.

Legal intrusion into medical arenas as complex as the area of pre-transplant organ allocation +/or transplantation is not likely to facilitate better regulations, more transplants or a fairer system. The only actions that can effectively do so are successful efforts to diminish the organ shortage by individuals who register to donate and organizations that make broad efforts to support donation.

Caution is warranted to avoid generating chaos similar to a crowd surging to find a space on a lifeboat. While all involved are undoubtedly well intentioned, it may be most appropriate to consult knowledgeable persons in the transplant field prior to taking actions that may have far reaching consequences.

COMPELLING PATIENT WITH A POIGNANT STORY

The moving story describes a person desperately in need of an organ transplant(s) that may not happen in sufficient time to avert death. We learn that  (first name) (last name)  is ____ years old. He/she has failure of the (heart, intestine, kidneys, liver, lung, pancreas – circle all that apply) caused by ___________(fill in disease name).  He/she is a mother/father/daughter/son/sister/brother/husband/wife/other  (circle all that apply). When healthier, his/her time was spent in work/study/other for ____________. The primary reason that (first name) wants to be transplanted is to “_________________” (use patient’s own words). Others want him/her to receive an organ(s) so that ________________.  He/she has been waiting on the list since (fill in month or year, whichever sounds more compelling) but is losing hope. This bare boned, generic outline of a person dying from organ failure and hoping to benefit from a life saving organ transplant describes virtually all of the patients actually waiting for organs.

It may seem callous to distill a real person’s desperate hope for transplantation into such a brief, apparently generic story as simple as the one that was sketched out above. Indeed, each of the >118,000 people waiting for organ transplants in the U.S. and thousands of others around the world does have a unique lifestory to tell that is truly heart wrenching when fully appreciated. Each is a real human being with a life partially lived but also partly unfulfilled. Each wishes to live longer. Some will. Some won’t. When the details of that human being’s life are stripped away from the relevant story outline leaving the virtually naked transplant candidate waiting in line without accoutrements, it becomes more feasible to assess the legitimacy of that person’s claim to transplantation. But how to do that?

The only reasonable way to decide who will be winners is to have a transparent system of rules that applies to everyone and cannot be altered because one person’s story is related in an especially compelling manner.
This system will necessarily seem harsh and unfair to the losers. It will probably also seem harsh but fair to the winners. And this system is administered by computer, not human beings.

It should not be forgotten that this is a “zero sum” situation. When one  patient with a poignant story wins, another deserving, compelling patient loses – and dies. Each is represented by a transplant team fully invested in their survival. They may even be listed at the same transplant center. In that case the same transplant team (real people with real feelings) deals with both the joy of caring for a surviving patient and the sorrow of caring for a non-survivor.

The only reasonable outcome is for every reader, for everyone who cares about one or more of these patients, and for every person who understands that some day they too may be telling their own story in the hope of being a winner, to work earnestly addressing the organ shortage. Register to be an organ and tissue donor now……tell your family…….and ask others to do the same.