Last summer, the American Society of Transplantation sponsored a “Best Practices in Living Kidney Donation” Consensus Conference. In January, OPTN distributed an Executive Summary of the conference’s recommendations (Best-Practices-in-LKD-Consensus-Conference-June-2014). Shortly thereafter, the American Journal of Transplantation (owned and operated by the American Society of Transplantation) published an article about the conference.
I received the Executive Summary in January, days prior an ACOT meeting. I was so incensed, I composed and read (it was a teleconference) my response to this conference and its conclusions, which is now part of the public record here (last page). Another living kidney donor, Jane Zill, also submitted public comment, which wasn’t included in the meeting notes for some reason, but I will include here.
In summary: this conference was nothing but another excuse for those who profit from living donor transplantation to sit around and devise means of increasing and promoting living kidney donation.
- Out of 67 conference attendees, only 3 were living donors, and all are employed by transplant centers
- 90% of the conference attendees profit from living kidney donor transplantation.
“It is our goal”, the Executive Summary reads, “to eliminate living donation and LDKT [living donor kidney transplantation] barriers”.
Not to ensure living donor risk is minimized, or that accurate and long-term living donor data is collected, or that living donor’s psychological well-being is protected; No, this “best practices” conference was primarily (and I would say solely) about promoting and increasing living kidney donation.
Since my thoughts are available online, I won’t repeat them here (but please read them yourself). Since Ms. Zill’s have been excluded from ACOT’s notes, I have copied/pasted them below:
The “Best Practices in Living Kidney Donation Conference” (2014) is not the first professional meeting to address the role of living kidney donors in transplantation. Prior meetings and reports have resulted in the articulation of “best practice” principles to guide living kidney donor transplantation. Key meetings and reports include:
1.) The “Consensus Statement of the Live Donor” (Kansas City, 2002) states:
The person who gives consent to be a live organ donor should be …free from coercion… The benefits to both donor and recipient must outweigh the risks associated with the donation and transplantation of the living donor organ.
2.) The Amsterdam Forum on the Care of the Live Donor (2004) emphasized the importance of establishing donor autonomy in decision-making by:
• Quantifying future renal function in living kidney donors;
• Providing information about alternative forms of therapy for potential recipients;
• Creating a meaningful role for independent donor advocacy;
• And, establishing mechanisms for long-term medical follow-up, data collection, and the creation of living kidney donor registries
3.) The Institute of Medicine (2006) reported:
• the need for independent donor advocacy;
• the need for inadequate data to ensure informed consent;
• the importance of a risk-benefit assessment when using living organ donors; and,
• the need for prospective donor registries.
(“Organ Donation: Opportunities for Action”, National Academy of Sciences)
4.) In 2007, Dr. Sue Mc Diarmid, then President of the OPTN, surveyed OPTN member centers for their protocols on living donation. Two protocols were selected to represent “best practice” by the UNOS/OPTN Living Donor Committee, one from North Carolina and another from New York. In both states there had been a death of a living
liver donor, which prompted each state legislature to enact laws regarding living organ donation due to an absence of regulation at the national level. It was recognized that:
A.) Advocacy for a potential donor cannot occur separate from the medical evaluation and informed consent;
B.) The primary relationship in the donation experience should be between the donor and his/her multidisciplinary Independent Donor Advocacy Team;
C.) Independent Donor Advocacy must occur free from institutional and administrative pressure fueled by financial motivation to perform transplants;
D.) An advocate’s recommendation to veto a donation could be compromised by negative reactions from those invested in a transplant going forward. For this reason team support is required to deflect this burden from any one individual.
5.) “The International Summit on Transplant Tourism and Organ Trafficking” (2008) recommend strategies to “minimize the burden on living donors.” It emphasized, “A positive outcome for a recipient can never justify harm to a live donor, on the contrary, for a transplant to be regarded as a success means that both the recipient and the donor have done well.”
6.) The Third WHO Global Consultation on Organ Donation and Transplantation (Madrid, March 23–25, 2010 asserted that deceased donor organs should be the dominant form of transplantation in every country, “In all countries in which deceased organ donation has been initiated, the therapeutic potential of deceased organ donation and transplantation should be maximized. “
The “best practice” recommendations from the 2014 “Best Practices in Living Kidney Donation Conference” are astounding because instead of bringing forth the messages of caution and the reduction in the use of the living kidney donors, the current consensus is to increase the use of living kidney donors.
Fundamentally, the 2014 recommendations are to establish a philosophical approach that LDKT is the best option for transplant candidates and to “educate” nearly every medical professional in the recipient’s and donor’s life to promote and pursue living kidney donor transplantation.
The new recommendations are diametrically opposed to the consensus that has emerged over the past decade and amount to strategies that are 1) coercive, and, 2) will lead to the continued exploitation of the living for their vital organs. Already, because independent donor advocates are employees of transplant centers intent on increasing the number of LDKT, the well-being of living kidney donors is not prioritized. Standards for the medical evaluation and informed consent of living donors and for data collection are so weak that they are useless.
Even more egregious, many of participants of the 2014 meeting also participated in the consensus meetings in Kansas City and Amsterdam. And, the 2014 recommendations have been made in the ongoing context of inadequate data to support the conclusion that living organ donation is safe.
In 2009 a UNOS task force found its data to be “woefully incomplete” and “useless for research or for making conclusions about living donor safety.” Unbelievably, in 2010 and 2014 the Journal of the American Medical Association published articles that used this same data to conclude that living kidney donation has little risk now widely cited as evidence of the safety of living kidney donation. The algorithm used to verify SSNs for the JAMA research has never been described.
But, in 2013 researchers in Norway reported in Kidney International an increase in rates in mortality from all causes after kidney donation – over many years. In 2007 the Bulletin of the World Health Organization reported that in Iran, Egypt, and India, where donors are paid, donors report deteriorated health, worsened financial status, and regret for their paid donation.
Transplant medicine in the U.S. is a highly commercial industry and is dependent upon a supply of human body parts to be viable. BizAcumen in 2009 reported, “The global organ and tissue transplantation market stands to gain from the increasing living donor organs…” BCC Research Market has forecasted in “Organ and Tissue Transplantation and Alternatives” (2011), “The global market for transplantation products, devices, and pharmaceuticals was valued at nearly $54 billion in 2010 and is projected to grow at an 8.3% compound annual growth rate (CAGR) to reach $80 billion in 2015.“ This is nearly a 50% increase in the market in four years.
Although donors are not paid, there is profit and profiteering from the donated body parts of living and nearly deceased human beings, ranging from the creation of private contracts to treat foreign nationals seeking placement on the U.S. deceased donor wait list (from, “UNOS/OPTN Revisions to and Reorganization of Policy 6.0
Transplantation of Non-Resident Aliens,” 2012), to the development and promotion of products, devices, and pharmaceutics employed in the practice of human organ transplantation.
The most recent product developments are organ transport pumps, which are set to revolutionize the exchange (trade) in human body parts. Powerful principals are promoting the commercial use of products related to human organ transplantation, and thus exerting industry influence on U.S. policy related to human organ transplantation.
One example of links between industry and government is the appointment of former Secretary of DHHS, Tommy Thompson, to the Board of Directors of Organ Transport System. He has long ties to industry as the initial leader of the Donor Organ Breakthrough Collaborative.
Despite the well-articulated “best practice” principles that have occurred from 2002-2010, in transplant centers around the United States, the donor’s well-being is a low to non-existent priority compared to encouraging LDKT. The meaning of the combined lack of quality data on recipient and donor outcomes and weak standards for the
evaluation and informed consent of living kidney donor is that U.S. living donors will continue to be a vulnerable, exploited by the transplant community and its commercial interests.
The practice of LKDT will someday be compared to the unethical treatment of research subjects in the Tuskegee syphilis experiments, but will be judged more harshly due to the collusion between industry and government that has resulted in policy creation that prioritizes profit for a callous and ruthless industry that is dependent upon a
continuous supply of human body parts.