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Ethical Considerations Living Donor Misinformation Living Donor Research Living Donor Risks Living Kidney Donor

If Every Transplant Center Says It, It Must Be True

Subtitle: Or it isn’t, but they say it anyway…

 

Recently, Google Alerts dropped the University of Wisconsin Medical Center’s “10 Reasons Why You Should Be a Living Kidney Donor” in my lap (or inbox). The exaggerations and misleading statements on the page are worthy of multiple blog posts, but right now I want to focus on the most egregious:

You can be assured, living donor outcomes are strong. Living donors go through the donation experience without experiencing any decrease in lifespan and they do not have a higher rate of kidney failure.

 

Here’s the problem: the U.S. has no valid comprehensive data on living donors. Since 2000, OPTN, the membership organization that manages the U.S. transplant system, has required transplant centers to report one year of follow-up on all their living donors. But nine years later, their Consensus Report of the Living Donor Data Task Force  called the resultant database ‘woefully incomplete’ and ‘useless for research or making conclusions about living donor safety’. In late 2011, they again admitted, the LDF [living donor followup] forms were too incomplete for analysis

So if we don’t have one year of decent data, how can transplant centers make assurances about a living donor’s lifetime? Well, we have the press barrages for two different studies to blame for that.

 

The first is John Hopkins’ promotion of Segev’s “landmark study”. The press release claimed that living kidney donors “are likely to live just as long as” non-donors. The study, however, only looked at kidney donors up to 15 years post-donation (median 6.3 years). If the average living kidney donor was 65 years old at the time of donation, the press release might have some credence. But they’re much younger: from 35 years of age in 1988 to 41 in 2008. From that perspective, discovering the “risk of death [at 56 years old] was no higher for live donors” isn’t terribly comforting. Taking that same measure when the kidney donors are 78 years old, the average U.S. life expectancy, would be much more significant.

Our second author, Ibrahim, from the University of Minnesota Medical Center, seemingly forgot “how healthy” living kidney donors were and compared their expected death rate to that of the general population. His conclusion, that kidney donors have a death rate “similar” to a group “with coexisting medical conditions (e.g., heart and kidney disease) that would make them ineligible for kidney donation”, is far different than saying living kidney donation doesn’t decrease a person’s lifespan.

Ibrahim’s “ground breaking report” is also responsible for the statements regarding living donors’ future kidney health. The kidney donors at the single transplant center he examined underwent dialysis at a lower rate than the general population. The media attention failed to mention that during the evaluation process, prospective living kidney donors are screened for diabetes and hypertension, the two biggest causes of end-stage renal disease (44% and 30%, respectively). A lower rate of kidney failure than the general population is expected.

 

 

Unfortunately the University of Wisconsin Medical Center isn’t alone in spreading these “Living kidney donation doesn’t affect your life expectancy and/or kidney disease risk” mischaracterizations (the following are only a sample):

 

The transplant industry has gone out of its way to tout living donors as healthier than the general population. If removing a kidney from a healthy person produces an individual with risk comparable to the general population (as Ibrahim and Segev imply) then living kidney donation does the opposite of what the above transplant centers claim. It actually increases a donor’s risks of kidney disease and shortens their life spans.

Because living kidney donors are NOT the general population, at least not before they take our kidney.

 

 

ETA July 2014: Two recent studies have indicated that living kidney donors experience 8-11x increased risk for end-stage renal disease as compared to a well-matched cohort.

Categories
Advocacy Living Donor Misinformation Living Donor Risks Living Kidney Donor

Bring On the Living Kidney Donation Propaganda Machine

Anyone who’s paid even a little attention to the transplant industry understands there’s a lot of questionable vocabulary around the whole thing (Donate Life, Be the Match, Give the Gift of Life, Be a Hero, etc), and those of us who live in a post-Mad Men era know that marketing is often less than truthful.

But then there’s this, which descends right into lying territory.

 

 1. Will donating a kidney affect my life span?

No. After one kidney is removed, the remaining kidney will adjust to filter as much as two kidneys would normally. The one functioning kidney is enough to remove all the metabolic wastes from body completely.

And

5. Does donating a kidney have risks for kidney donor?

Generally speaking, donating a kidney will not affect the life span or lifestyle. However, the surgery itself may have risks just like other surgeries.

6. Can donating a kidney affect having children?

Women after kidney donation still can get pregnant successfully because the surgery does not affect their reproductive organs.

7. What are the long-term effects for kidney donors?

The current research has shown that there are few long-term effects on the kidney donors. Mortality rates is the same or better than the general population.

 

Below was a “Have questions?” form, so I submitted the following:

 

This article is full of falsehoods. We have no comprehensive short or long-term data on LDs health and well-being so we have no idea if donating a kidney affects one’s lifespan. The Ibrahim and/or Segev studies do not proclaim any such thing, despite what their press releases declare. Segev was based on a ‘woefully inadequate’ database while Ibrahim was single-center and overwhelmingly white. Neither study actually followed LDs long-term.

As for pregnancy post-donation, both Reister and Ibrahim in 2009 found that LKD women were at higher risk of gestational diabetes, gestational hypertension, proteinuria and preclampsia. They also found that post-donation pregnancies had a higher likelihood of fetal loss and lower chance of full-term delivery.

There’s marketing and then there’s propaganda. This article is most-assuredly the latter. You should be ashamed of your deception.

 

 

A relevant side note: I perused the About Us page which says very little about exactly who the organization or people are who run the page. In other words, the whole thing looks more than a little sketchy. Unfortunately, most people looking for information will probably be drawn in by the official, medical appearance and tone, not realizing they have no idea if the source is credible. When it comes to one’s health, suspicion and curiosity are far better than blind trust.

Categories
CMS - Medicare Living Donor Misinformation Living Donor Research Living Donor Risks Living Kidney Donor

Living Kidney Donors Still Can’t Obtain Health Insurance

The NY Times blog took some time to present yet another way we living living donors are being screwed by our own generosity: some of us can’t get health insurance.

(Read the article here)

 

What’s sad is that this problem isn’t new. NATCO (the self-proclaimed ‘organization for transplant offiicials’) issued a statement in May 2006, and the fact they felt compelled to do says the issue was pretty significant then.

And OPTN’s own Informed Consent guidance document recommends prospective living donors be informed they may have difficulty obtaining health or life insurance post-donation.

 

A provision in the Affordable Care Act, when it is implemented, will prohibit insurers from denying coverage based on pre-existing conditions. However, this will not stop insurance companies from pushing living kidney donors into the high-risk pool, forcing them to pay more for less coverage.

 

Some observations on the article itself (you know I had to):

– the writer uses the inflated wait list numbers instead of the ‘active’.

 

In Mr. Royer’s case, tests found a high creatinine level in his blood, which was interpreted to mean that Mr. Royer had kidney damage. Dr. Connaire told the Blue Cross panel that heard Mr. Royer’s second appeal that creatinine levels are high in most, if not all, kidney donors.

 

How many prospective living kidney donors are told their post-donation creatinine will be considered ‘high’? Conduct a random search on transplant centers’ website and tell me if it’s ever mentioned. I’ve spoken to quite a few LKDs (not to mention the survey takers) and it’s never come up. We’re all lead to believe we can lose 50% of nephrons and we’ll continue to be just as healthy as before.

 

“The literature says that if you have kidney problems you’ll have more heart disease, but taking a kidney out in a situation where everything is fine is a very different story,” said Dr. Connie L. Davis, who is chairwoman of the living donor committee of the Organ Procurement and Transplantation Network. “It does not have the same implications.”

 

Really? I’d like to see her proof of that, considering we have NO long-term comprehensive data on living donors at all.

Let’s see:

Garg’s study was Canadian where they have universal health care and different lifestyle than the US. And it only covered a decade as opposed to twenty years or more.

– Two published letters retorting Garg are less than flattering about his conclusions.

 

New research, not yet published, suggests the risk of developing kidney failure is even smaller for living kidney donors than for the general population, Ibrahim said.

This is the same Ibrahim that used an incorrect comparison cohort in single-center study which didn’t follow living kidney donors long-term, whose subjects were overwhelmingly white, and who sort of hid that only a tiny percentage of the entire sample underwent actual physicals?

Hm. I think we can see why I’m more than a little skeptical. After all, U of Minnesota makes big bucks from their living kidney donor transplant program.

 

And here’s my favorite:

…long-term studies have found donors live as long as other healthy people. One study reported that donors live even longer.

 

First off, the writer is referring to the Segev study, which is based on a ‘woefully inadequate’ and ‘useless’ database (that would be OPTN’s and the quoted terms are from OPTN’s own data task force in 2009). Secondly, NOT LONG-TERM. Thirdly, the abstract linked in the article has a small sample size, in a country where they have universal health care and a different lifestyle than the US. Not to mention, we have no idea how those LDs were evaluated and selected.

 

Meanwhile, Mjoen in 2011, who did follow his kidney donors into old-age, and used the correct comparison cohort, found that once living kidney donors hit their 60s and 70s, we started dying off at a faster rate than our two-kidneyed cohorts.

 

Do I think we should be discriminated against by insurance companies? Of course not. But do I think health insurance companies should operate on a for-profit paradigm? NO.

 

The ironic part of this entire discussion is that in the 1972 Social Security Act, Section 1881, wherein Congress created a Medicare benefit for those diagnosed with end-stage renal disease, they also granted benefits to their living donors. Of course, Congress (nor CMS) ever thought living donors would eventually compose nearly half the kidneys transplants every year. Consequently, they’ve kept that little gem under their proverbial hats.

So maybe what Mr. Royer needs to do, instead of talking to the NY Times, is contact a Medicare lawyer and fight not just for his benefit, but for the one owed to all living kidney donors.

 

 

 

 

 

 

 

Categories
Living Donor Research Living Donor Risks Living Kidney Donor

Living Kidney Donors, Cardiovascular Mortality, & Lifespan

From 1963-2007, there were a total of 2269 living kidney donors in Norway with a mean age of 47.6 +/- 12.6 years at the time of donation (41.3% male). Median observation time: 14.3 years.

324 LDs died during study period, but the cause of death was only available for the first 274 because the database was updated only to Jan 1, 2008.

 

The practice [of living kidney donation] is based on the assumption that carefully selected donors, being offered qualified medical follow-up*, are not exposed to future medical risks. 

*In Norway, LKDs are given lifelong medical care, unlike the US where uninsured people are accepted as living donors and left to fend for themselves (See more here)

And then they admit:

However, data supporting this view is rather scarce and hampered with methodological problems. 

 

It’s well-established that a modest drop in renal function results in an increase in proteinuria and blood pressure, causing a greater risk of cardiovascular disease and death in the general population. So, this study (and others like it) are attempting to discern if the same phenomenon exists in living kidney donors when we know LKDs also experience an increase in proteinuria and blood pressure after nephrectomy.

 

However, life expectancy following kidney donation has been described as similar or superior to that of the general background population. Such studies do not take into account that kidney donors are extremely health and clearly supposed to have a substantially longer life with less medical complications than the general population. (emphasis mine)

The Ibrahim study from 2009 still continues to cause great furor because it claimed (or rather, the media coverage claimed) that LKDs live just as long, if not longer than, the general population. The study is rife with flaws, the least of which is that it was single center, mostly white, and only covered six-plus years, but our authors here tackled the major problem with all the versus-gen-pop papers that have appeared as of late:

The control group is not accurately matched to the living kidney donor population.

 

While the national media ran wild with the Ibrahim press release, no one followed up with the equally important, but more far pendantic and less glamorous, criticism levied by Lin et al:

For a comparison group, the investigators used rates of death in the general population, which included adults with coexisting medical conditions (e.g., heart and kidney disease) that would make them ineligible for kidney donation.

 

Lin et al. carved out a cohort that much more closely resembles that of living kidney donors, which Mjoen used in his comparison. The mortality rate between the two was fairly even from age 20-59, but at age 60, living kidney donors began dying in larger numbers, a rate that increased even more for folks over the age of 70.

LKDs 60-69:

22.07 +/- 2.45 deaths per 1000

vs. Gen Pop:

17.02 +/- 3.72

 

LKDs 70-79:

44.32 +/- 6.53

vs. Gen Pop:

27.83 +/- 5.01

 

Now refer back to that ‘substantially longer life’ thing.

Just last night a living donor cheerleader (she donated to a stranger and is involved with a group run by a kidney recipient whose sole purpose is to convince other people to donate kidneys to strangers) poo-poo-ed the fact that Ron Herrick died in his 70s, on dialysis and after cardiac surgery.

“He lived fifty-some odd years” she said.

 

Right. But everything in his demographics indicate he should’ve lived a helluva lot longer. And if you subscribe to the notion forwarded by Heeman, that one of the goals of the ethical acceptability of living kidney donation is to ensure that both the kidney donor and the recipient live a life free of dialysis, then Ron Herrick is not a success story**.

These details are important because (well, obviously) people die at the end of their lives. Studying living kidney donors when they’re 45 or 60 says nothing about life expectancy if their deaths don’t occur until they’re 75. We can’t know if living kidney donation reduces one’s lifespan if we don’t compare how long an ‘extremely healthy’ person should should live with how long they actually do.

Admittedly, even if we had this data, some people would be willing to trade (insert number here) years of their own life to keep their loved one around. And that’s okay, if someone is making a personal and informed choice. But right now, we’re not even making educated guesses. Some transplant centers, meanwhile, are handing prospective LKDs copies of Ibrahim (or Segev) and insisting that donating a kidney has no affect on longevity at all. This sort of manipulation disguised as education is making the decision for the donor, and that’s not ethically acceptable at all.

 

 

 

**Mjoen found six previous kidney donors with kidney disease as the primary diagnosis on the death certificate (five chronic renal failure, one glomerulonephritis) and nine of the controls (six chronic renal failure, one glomerulonephritis and two hypertensive kidney disease). They acknowledged this was statistically “slightly more frequent among kidney donors”.

 

Mjoen, G., Reisaeter, A., Hallan, S., Line, P., Hartmann, A., Midtvedt, K., Foss, A., Dahle, D., & Holdaas, H. (2011). Overall and cardiovascular mortality in Norwegian kidney donors compared to the background population Nephrology Dialysis Transplantation, 27 (1), 443-447 DOI: 10.1093/ndt/gfr303

Categories
Living Donor Misinformation Living Donor Research Living Donor Risks Living Kidney Donor

Reading Between the Lines

It seems that every time a ‘significant’ research study is released, the media goes all hob-nob in reporting how great the results are. Too often the miss the finer points, issues that academics and scientists know are important and often lead to additional studies, but the average layperson (including the journalist reporting it) gloss over entirely.

 

Today it’s the latest from the New England Journal of Medicine regarding the long-term consequences of kidney donation.

Associated Press article

The average reader will walk away from this article thinking “See, you can be a living donor and lead a perfectly normal life with no repercussions”.

 

However, let’s break this down. Excerpts from the article, but the bolding is mine for emphasis:

The good outcomes likely reflect the strict criteria used to pick the donors, the researchers said. The donors had to be healthy with no kidney problems, and be free of high blood pressure and diabetes — two main causes of kidney disease.

“We think these donors do extremely well because they were screened very well,” said Ibrahim.

 

Drs. Jane Tan and Glenn Chertow, of Stanford University School of Medicine, who wrote an accompanying editorial in the journal, noted that the study donors were mostly white and were likely younger than donors today. The results may not apply to older, nonwhite donors, they said.

 

Also, of the living donors who were asked to return for lab tests and a questionaire, only 14% did so. Is this really a large enough sample? And is it a skewed sample? Are the 14% who replied more healthy and well-adjusted than the 86% who didn’t?

The subjects were 99% white and had a median age of 41 years. These facts alone maks the results quite limited in their application. When you begin to add in all the other factors… Well, let’s just say no one should go running to their nearest transplant center any time soon.

 

Ibrahim, H., Foley, R., Tan, L., Rogers, T., Bailey, R., Guo, H., Gross, C., & Matas, A. (2009). Long-Term Consequences of Kidney Donation New England Journal of Medicine, 360 (5), 459-469 DOI: 10.1056/NEJMoa0804883