Comments from Jane Zill:
I oppose the “Proposal to Establish Requirements for the Informed Consent of Living Organ Donors.”
It is unlikely that the Joint Societies Work Group (JSWG) will ever support efforts to standardize informed consent, which would require much greater specificity than is provided in this proposal, due to their fear of litigation, resentment over limiting “medical judgment,” and awareness that more specific information may discourage living organ donation. The JSWG is primarily comprised of individuals and organizations with professional and commercial interest in promoting living donor transplantation. Their conflict of interest regarding living donors could not be more apparent.
Specific mention of death, hernia, pulmonary embolism, adrenal dysfunction, nerve impingement, testicular injury, to name only a few known surgical complications, are not specified in this proposal. Long-term, poorly understood consequences of nephrectomy such as hyper filtration, insulin resistance, Vit A malabsorption, elevated homocysteine levels, protein in urine, microalbuminaria, or the many complications associated with CKD, such as anemia, fractures, increased risk of injury from dye contrast, hyperparathyroidism, CVD, dementia, and depression are neglected altogether.
Likewise, regional disparities that are foreseeable now that will impact former donors in need of a transplant are not described, such as the trends in deceased donor allocation that will disadvantage older transplant candidates. There is not disclosure about the absence of a national plan for former donors who progress to ESRD, nor are the disparities in access to high quality dialysis disclosed. Daily home dialysis confers the same survival advantage as deceased donor transplantation, but this treatment modality may not be available to former donors who progress to ESRD. And certainly, progression to CKD or ESRD will create serious psychosocial problems occurring long after the post-surgical period, but this document does not specifically disclose these risks.
This proposal would require substantial modifications to be meaningful. It will not lead to standardization of a comprehensive informed consent document for living organ donors.
Also, the use of the word “recovery” of living donor organs reveals a fundamental lack of empathy and appreciation for living organ donors. Organs from the living are not “recovered,” they are donated. Living organ donors return to their home communities as medically vulnerable individuals. The surgical transplant community is not necessarily expert in internal medicine, nephrology, endocrinology, cardiology, oncology, pharmacy, or psychosocial evaluation and treatment. Not only is this professional group unprepared with data and expertise, they are emotionally and psychologically ill equipped to make recommendations regarding the care of living organ donors. As a living kidney donor, I am not comfortable with this community of professionals addressing informed consent for living donors beyond the donor surgery.
Regarding the provisions made for monitoring compliance, I object to blind, internal review of programs by peers and colleagues. Additionally, centers routinely ask for and receive variances to excuse them from UNOS/OPTN policy compliance.
Regarding the provisions made for independent donor advocacy (IDA), the OPTN and CMS, have separated the medical and psychosocial evaluation of living organ donors from the role of independent donor advocates. How will they gain their information about a donor?
IDAs come from a range of disciplines, including clergy, medicine, nursing, psychology, social work, and education. Their professional skills, knowledge, and perspectives are not uniform. This means that many IDAs are subject to the same vulnerabilities as living organ donors regarding lack of knowledge about living organ donation.
Within this proposal, IDAs are to be employed or contracted by centers with powerful institutional motivation to perform living donor transplants. Due to the hierarchical nature of most medical institutions, with surgeons enjoying the most prestige, those who come from other disciplines or professions lack institutional prestige and authority compared to their surgical colleagues.
Whether from lack of skill, knowledge, position, or a limited role, IDAs may lack an in-depth understanding of the donor and of living donor kidney transplantation, and cannot, therefore, be expected to be effective advocates for informed consent
Although it is true that the Secretary gave the OPTN authority regarding matters of living donation in 2006, “What the Secretary giveth, the Secretary can taketh away.” Taxpayers should stop spending money on UNOS/OPTN activities that serve the interests of this industry at the expense public safety.
Jane Zill, L.I.C.S.W.
Living Donor Committee, OPTN 2007-2009
Living Donor Data Task Force, OPTN 2008
Living Kidney Donor, 1991