Informed Consent Living Donor Misinformation Living Donor Protections Living Donor Research Living Donor Risks Living Kidney Donor Registry

Kidney Donors’ Risk of End-stage Renal Disease – AGAIN

Recently, a media blitz heralded the arrival of an end-stage renal disease prediction calculator for potential living kidney donors, backed up by a prestigious publication in the New England Journal of Medicine. I glanced at the study, noticed that it used the “woefully incomplete” and “useless” OPTN database, and it only pulled living kidney donors from 2005 onward. Which is not good.

You see, OPTN has been collecting (inefficiently) identifying information (aka social security number) on living donors since 1993. The Secretary of Health mandated one year of follow-up on all living donors in 2000. In addition, prior studies indicate that living kidney donors who progress to kidney failure will do so 17-20 years post-donation. These facts led me to believe that the researchers were more interested in minimizing the risk of ESRD for LKDs rather than warning us of our true probability.

And since I have written about this very topic many, MANY times in the past 7 years, I have no inclination to rehash myself. Fortunately, Steiner did much of the work for me in his editorial commentary on the published paper.

However, a recent 7.6-year study in the United States showed that the incidence of ESRD was 8 times as high among donors as among well-selected nondonor controls.2 A similar 15.2-year study in Norway showed that the risk was 11 times as high.3 The magnitude of these relative risks has been debated, but when predonation risks of ESRD are multiplied by the relative risk of donation, significantly greater absolute postdonation risks are predicted. However, the absolute rates of ESRD were low in both studies, which reinforced the prevailing “low risk” characterization of donation..

To translate a smidge: Two prior studies (which I’ve written about here) have found that living kidney donors have an 8-11x increased risk of kidney failure as compared to their healthy, matched, two-kidneyed cohort. But the pro-living donation advocates don’t like using those numbers because they’re – well – scary. Instead, they squawk about “absolute” risk, meaning that even if donating raises the chance of an individual LKD progressing to kidney failure, the incidence of ESRD in living kidney donors is low so – you  know – don’t worry too much about it.
For example (and I’m pulling these numbers out of the air here), say there’s a 4 in 100 chance of developing a type of cancer, but that eating garbanzo beans increases that risk 50%. Yikes, right? In ‘absolute’ terms, that’s still only a 6 in 100 risk, which is like ‘meh’, bring on the garbanzos!

But if we were talking about smoking? If the same numbers applied, would you pick up the habit? Hmmm…

[Note: see this nice explanation of these statistical maneuvers here]
He goes on to say that the low estimates in the prior studies “may well have been underestimated” (In other words, the true risk is higher). Why?

…approximately 90% of cases occur after 44 years of age, and half the cases occur after 64 years of age.5,6 Many diseases that will cause ESRD in later life will not be present in young candidates, and screening will not detect them.

He uses diabetes, which accounts for nearly half the kidney failure currently seen in the US, as an example:

Currently, postdonation diabetes is poorly predicted in donor candidates, even with the use of focused, traditional criteria8 rather than the nonspecific risk factors used in the current study. Furthermore, ESRD would not have developed in any patient with classically progressing diabetic nephropathy during the study interval.

  1. The researchers included generic risk factors which have limited applicability. When I was being evaluated as a living kidney donor, I asked the nephrologist about my recipient’s expected graft survival. He stammered and said “the average graft survival is…”. Well, I didn’t want to know the “average” of every recipient under all circumstances, I wanted to know specifically about my sister. Potential living kidney donors feel the same way about their own kidney health too.
  2. The six-plus years this study captured is simply NOT ENOUGH TIME to know the true incidence, prevalence and risk of end-stage renal disease for kidney donors. Following them for such a short period results in a gross underestimation of disease progression.

It also allows the transplant industry to keep reassuring the public about living donation’s safety, all while emphasizing the need for living donor organs. They appear to actually care about living donor safety and well-being,when recent and distant history shows they clearly do not.

Unfortunately, I think that’s the point.
Grams ME, Sang Y, Levey AS, Matsushita K, Ballew S, Chang AR, Chow EK, Kasiske BL, Kovesdy CP, Nadkarni GN, Shalev V, Segev DL, Coresh J, Lentine KL, Garg AX, & Chronic Kidney Disease Prognosis Consortium (2015). Kidney-Failure Risk Projection for the Living Kidney-Donor Candidate. The New England journal of medicine PMID: 26544982


Steiner, R. (2015). The Risks of Living Kidney Donation New England Journal of Medicine DOI: 10.1056/NEJMe1513891


Follow-Up Living Donor Research Living Kidney Donor OPTN Registry

Why Transplant Centers Have Incomplete Living Donor Follow-up


The authors examined the follow-up data on living donors who donated in 2008-2012 using the 2013 (or new/current) standards.


“Complete follow-up at 6, 12, and 24 months was 67%, 60%, and 50% for clinical and 51%, 40%, and 30% for laboratory data, respectively, but have improved over time.”

“Donor risk factors for missing laboratory data included younger age 18–34, black race, lack of insurance, lower educational attainment, >500 miles to center, and centers performing >40 living donor transplants/year.”


Some intersectionality happening here:

Younger living donors are more likely to be uninsured

Folks with less education are more likely to be in lower paying jobs and therefore, more likely to be uninsured


The fact that folks who travel to donate are less likely to return for follow-up is yet *another* reason why we should find ways to allow people to donate near their home.


Since I can only see the abstract, I’m not sure how they calculated the incomplete follow-up with transplant volume. I’m assuming they’re using percentages versus raw numbers, because it makes more sense that way. Point being, if high volume centers are prone to more incomplete follow-up,  it’s reasonable to say they’re less attentive to their living donors in general, which doesn’t bode well for the evaluation or informed consent processes, not to mention, the long-term health and well-being of the donors.


The Secretary of Health mandated one year of follow-up on all living donors in 2000. Yet data submission is still abysmal. Yes, OPTN paid lip service to the importance of living donor data with the new/rehashed policy in 2013, but we have no way of knowing if the situation will improve. After all, there’s still no indication that any center will be penalized for not complying, and there’s no way for living donors to know what data is being submitted on their behalf. Without such teeth, what’s to stop a center from carrying on as usual and/or submitting false data? If history is any indication, it’s not as if they have anything to fear if they do.

Schold JD, Buccini LD, Rodrigue JR, Mandelbrot D, Goldfarb DA, Flechner SM, Kayler LK, & Poggio ED (2015). Critical Factors Associated With Missing Follow-Up Data for Living Kidney Donors in the United States. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons PMID: 25902877

Advocacy Follow-Up Living Donor Risks Living Kidney Donor OPTN Registry

Letter to Editor: Where’s the Care for Living Donors?

[note: is it sad that I’m more impressed/surprised/pleased a newspaper actually published this than I am about what was said?]

Letter to the editor: ‘Heroic’ organ donors need aftercare

It is gratifying that Gary Rutter received a long-awaited kidney and that Hallie Twomey has found solace in donating one of hers (“Six linked patients, three saved lives in series of kidney transplants,” Jan. 17). The marvels of modern medicine and the generosity of the human heart are breathtaking.

However, while the article cited possible outcomes for recipients, there was no reference to outcomes for donors.

In fact, the United Network for Organ Sharing/Organ Procurement Transplant Network – a private corporation that has managed the nation’s transplantation system since 1986 and collects a fee for every recipient and living donor – has fiercely resisted the establishment of an independent registry of living organ donors through which long-term outcomes could be tracked.

According to figures cited in your article – 16,812 kidney transplants last year at an average cost of $262,900 – kidney transplantation is a multibillion-dollar industry. Surely that staggering sum can finance long-term monitoring and health care for living donors, who will experience reduced kidney function.

Hallie Twomey deserves no less for her heroic act. Your reporter wrote that “being tired all the time” a month after surgery is “a lasting effect of the anesthesia.”

Actually, her fatigue might be caused by her remaining kidney hyperfiltering to compensate for the loss of its partner. I hope Ms. Twomey has had an independent donor advocate to guide and support her through this process.

Nora Irvine

South Berwick

Advocacy Living Donor Risks Living Kidney Donor Registry Transplant Wait List

Living Kidney Donors Wait Listed for Kidney Transplants Keeps Growing

In my last post, I promised I’d get you some updated wait listed living kidney donor numbers and here they are:

As of December 31, 2012, 324 living kidney donors have been wait listed in need of their own kidney transplant.*


I wrote three in-depth posts regarding this very subject back in July 2011, using multiple data sets. They, in conjunction with the new total above, show very clearly that the number is growing.


285 – April 1, 1994-March 31, 2011

169 – January 1996-December 2007

121 – January 1996-May 2006

115 – January 1995-June 2005


I could spend hours ruminating on the reasons why this is happening, but it would be conjecture. We have so little data on living donors in general, and these kidney donors specifically, that’s it’s nearly impossible to draw any conclusions. However, Steiner’s point that a ‘clean’ 25-year-old prospect living kidney donor is at greater risk for developing end-stage renal disease than a 55 year old is probably a good thinking point.


As are my prior posts:

Read: Living Kidney Donors Listed for Kidney Transplant, Part I

Read: Living Kidney Donors Wait Listed for Transplant, Part II

Read: Minority Living Kidney Donors With End-Stage Renal Disease or Wait Listed for Transplant


If we had a registry, none of this would be a mystery. We’d know all of the living kidney donors’ pre-donation demographics and we’d be able to track the progression of their kidney disease. We’d have a greater knowledge of the living kidney donors who have end-stage renal disease but haven’t been wait listed (yet) or who have decided to forego transplant and continue on dialysis. As it stands, the transplant industry’s historical disregard for living donor safety has resulted in a pebbles of information lacking any real context. And it’s impossible to keep any living kidney donor safe under those circumstances.


*Per OPTN data request.

Living Donor Risks Living Kidney Donor Registry

Ten Year Kidney Donor Data Causes a Scandal

Recently, I posted information from the Swiss Living Donor Registry on the health and well-being of kidney donors ten years post-donation. Well, it seems that the researchers at the registry, who owe their paychecks and employment to the Swiss government, are more than a little ticked off about their numbers being made public.

As I understand the situation, Dr. Thiel (of the Swiss LD Registry) gave a bunch of data to the german tv show REPORT MAINZ in April 2011 for a July 2011 broadcast focused on living kidney donor chronic fatigue (remember that?).

The Swiss Federal Office of Public Health (BAG) released their annual report in December 2011*, which contained data from the Swiss Living Donor Registry. Problem is: the data reported to BAG didn’t match the data given to REPORT MAINZ by Thiel some months earlier. BAG omitted the statistics on long-term fatigue, everything on cardiovascular events and disease, and minimized the incidence of hypertension.


I did mention the Swiss government commissioned the data collection on living donors, right? That the Swiss government is funding the registry and its subsequent product, yes?


Given the situation, the folks at REPORT MAINZ did what any good investigative reporters would do – they released the data in a July 2012 broadcast, specifically the information on hypertension, cardiovascular events, and chronic kidney disease stage 3/4.

The remaining Swiss living donor registry doctors, when confronted with this, reacted like any person caught in subterfuge would react – they protested, yelled, stomped their feet, and when they didn’t work, they sued.


First they claimed that releasing the data was a violation of their copyright. (WTF? It’s TAXPAYER FUNDED RESEARCH).

Then Nolte, one of the Swiss LD Registry researchers, said that publicizing the data jeopardized her future publications (even though she presented the fatigue data in 2009).

When that didn’t work, Steiger, who took the helm after Thiel’s death, demanded a correction, stating that the incidence of cardiovascular disease among living kidney donors wasn’t an issue because it was equal to that in the general population. (Except that living kidney donors are supposed to be HEALTHIER than the general population, so if they’re experiencing cardiovascular events and disease at the same rate, and reduced kidney function is associated with a higher risk of CV events and disease, removing a living donor’s kidney increased their incidence of cardiovascular disease!).


And now a lawyer has issued a Cease and Desist letter, and threats are flying at the journalists.


By all accounts, Thiel was a caring and respected doctor and researcher. It’s not likely he would knowingly give false information to a reporter, or participate in concealing truthful data from the Swiss govt or public. If the remaining researchers can prove the data Thiel gave to REPORT MAINZ in mid-2011 is false, or at least, way over-exaggerated, why don’t they just do it? Why all the weird, side-stepping threats?


I don’t have any answer for any of that, but I thought the controversy important enough for you to know. As more rolls in, I’ll keep you updated.



*Thiel died in January 2012, so it’s likely he had very little to do with the numbers given to BAG for publication.