The “terrible crisis of organ availability” is actually a public health crisis with origins in diet, lifestyle, obesity and diabetes — combined with an aging population that increasingly refuses to let go when the time comes. It’s all in how you look at it, and the transplant industry has been very successful in getting us to see the situation from their perspective. It’s time to reconsider live donation when a leading transplant surgeon tells colleagues that data on donor safety is “bullshit.”
Bullshit: Skewed Literature and Useless Safety Data
In addition to the determined lack of curiosity from transplant surgeons regarding the long-term effects of their profession on American organ donors, problems with safety data arise from the laws that govern live donation.
There aren’t any.
The nation’s official purveyor of transplantation, the Organ Procurement and Transplantation Network (OPTN) was created in 1984 by an act of Congress in an effort to gain some control over the procurement and distribution of cadaver organs.
Then, as now, “the crisis” of organ availability was the rallying cry for action — and the claim was as suspect then as it is today. In 1983, Congressman Henry Waxman, Chairman of the House Subcommittee on Health and the Environment, opened hearings on The National Organ Transplant Act (NOTA) by stating that “Although the major problem has been perceived to be a shortage of willing donors, this is, in fact, not the case.” Dr. Jeffrey Prottas, a researcher at Brandeis University, agreed in his testimony. “This shortage of transplantable organs is not the result of a shortage of potential donors nor of an unwillingness on the part of the population to donate.”
“Harvesting” eyeballs, kidneys, livers, and many other body parts from dead people had become routine by the 1980s. There were more than 100 organ procurement organizations operating across the country. The patchwork system was not very effective when it came to matching donors with recipients, and perfectly usable body parts were being tossed in the trash every day. Rather than a shortage of organs, the problem was a disorganized, inefficient and wasteful system. NOTA, championed by Waxman and Rep. Al Gore, was supposed to streamline the process. OPTN became the umbrella group for procurement organizations. UNOS, formed as a private nonprofit corporation, was the sole bidder for the government contract to operate the new system — in perpetuity for all practical purposes since an alternate management organization has never surfaced.
One feature of NOTA that guaranteed its easy passage was Section 103 (a), which outlawed the sale of human body parts.
Legislators had been plodding along all summer, crafting a national matchmaking system. Then one morning in September everyone snapped open their Washington Posts to find a story announcing the grand opening of The International Kidney Exchange. Dr. Barry Jacobs of Virginia had set up shop intending to broker the purchase and sale of human kidneys. He had brochures printed and sent to hospitals. The third-world impoverished were supposedly lining up at the prospect of easy money.
Doctors and politicians were appalled. To the bemusement of all, it turned out there was no law against operating a kidney emporium in Virginia or anywhere else in America. They hauled Jacobs up before Waxman’s committee. His proposal was denounced in an orgy of righteous indignation. The New York Times minced no words:
“Buying of Kidneys of Poor Attacked”
It was duly reported that in the 1970’s Jacobs had been convicted of mail fraud for overbilling Medicare and Medicaid. He’d lost his medical license. He’d gone to prison for ten months. Basically, Jacobs was run out of town on a rail — and Section 103 (a) was born. Selling body parts was henceforth and forever prohibited in the USA.
The uproar over the prospect of selling kidneys reveals the attitude toward the whole concept of living donation at the time, and the contrast to its portrayal today is striking.
“It is immoral to offer incentives to undergo permanent physical damage,” Dr. Robert Ettenger, President of the American Society of Transplant Physicians, told the committee regarding Jacobs’ dollars for donors scheme. “Many centers have grappled with the ethical considerations implicit in living-related donation, and have come to accept it only because of the high motivation of the donor and the improved success of the recipient… It is impossible for physicians to ethically justify removal of kidneys from living, unrelated human beings when we are utilizing only a small fraction of the available cadaveric organs.”
Live donation — paid or pro bono — was such an unpalatable idea that, aside from the prohibition on selling organs, it was not even addressed in the new legislation. The whole thing was basically a scheme to match people who needed organs with those who didn’t. The laws that oversee transplantation in America were enacted for the dead, not the quick. Once the deal is done, scant attention is paid to the health and safety of living donors.
President Reagan signed the NOTA bill without mentioning the Section 103(a) assault on laissez-faire capitalism. He was happy enough that — in the spirit of the times — the new legislation was virtually free of regulations and mandates. UNOS and OPTN are private corporations partly funded with federal dollars, run by people from the transplantation business with exclusive rights to manage national transplantation policy. And now, 30 years and hundreds of millions of dollars later, perfectly usable body parts are being tossed in the trash every day, and there is a crisis in organ donation.
The officially stated number one goal of UNOS and OPTN is to “increase the number of transplants.” Goals two through four are variations of goal number one.
The last goal, number five, is the welfare of the living kidney donor.
“In the push to increase living kidney donation there has been a shocking lapse in collecting data about its effect on donors,” says nephrologist Miriam Weiss.
A review of UNOS data gathering in 2003 found that nearly half of living donors to that point had been “lost to follow up.” Social Security numbers, the UPC code for the citizenry, were not even collected from living donors until 1994, and even when they were, it was found that half of that data was probably wrong.
The Institute of Medicine issued a report in 2006 saying “It is difficult for transplantation teams, independent donor advocate teams, and prospective donors themselves to perform their analyses and assessments of risks, benefits, and risk-benefit ratios because of incomplete data about the health outcomes of living donation.”
The report called living kidney donation “a surgical procedure with a range of substantial risks, including death.”
Hopkins transplant surgeon Robert Montgomery knew all that while he was cheering on the donors during the taping of the Oz show. When the episode aired, he was back in Baltimore putting the finishing touches on a journal article about live kidney donation which begins with the observation that “safety remains in question.”
UNOS, however, finally decided that something had to be done. The Professional Standards Committee passed a resolution declaring that as of February 15, 2015, information supplied to UNOS from transplant centers has to be “accurate.” Apparently, there’s been some confusion on that point for the past thirty years.
In November 2009, when Ronda Peterson made her initial call to the transplant center to offer up her kidney, a task force looking into record-keeping at UNOS reported that the information upon which Ronda based her decision to undergo major surgery was “useless for research or for making conclusions about living donor safety.”
The reason that Dr. Oz — with Robert Montgomery smiling and nodding in the front row — could tell Ronda and two million other people that anyone could safely donate a kidney with “no change in long-term life expectancy, no change in kidney function,” and that the operation would leave you “just as good as you ever were,” was because that’s what had been coming out of medical journals for years, despite the fact that there was and is no solid evidence for such claims. Along with the make-believe data that comes out of UNOS, transplant physicians have been publishing articles proclaiming the safety of live donation based on unsound research methods.
According to Hopkins transplant surgeon Dorry Segev, what the transplant industry has been telling donors thus far about safety “is bullshit.”
Segev, a Montgomery protégé, let that slip last year while down in Miami for the American Transplant Society’s Annual Winter Symposium at the Loews Miami Beach Hotel. The theme was Transplant: The Ultimate Team Sport. All the presentations had sports motifs. Segev’s presentation on the long-term risk of kidney donation featured wakeboarding, a punishing exercise in which athletic young daredevils on miniature surfboards attempt somersaults while being whipped around behind speedboats, the idea being to highlight the fact that people take all kinds of risks every day.
Segev himself is a wakeboarder, but he is not a kidney donor.
If you were down there in Miami and you came in off the beach just to hear Segev expound on the long-term risks of kidney donation, you would have been really disappointed. It turns out he doesn’t know. Nobody knows. Segev opened his talk about the consequences of donor nephrectomy by saying “well, we do about 6,000 of these a year and we still have actually very little understanding of the medical risks.”
One of the reasons that they have very little understanding of the risks is because they like to bury their mistakes.
“A review of the existing literature showed that the subject of live donor nephrectomy is a seat of underreporting and underestimation of complications,” according to a 2007 article in The Journal of Urology. Before laparoscopic surgery, there was just a surgeon and a scalpel. It’s called “open flank” surgery:
“Ten deaths were reported by 1991. What happened in the [previous] 15 years? There are generally known deaths from open donor nephrectomy that have gone unreported… why have there been no death reports? Possibly programs do not want the publicity of bad results. Possibly journal editors do not deem the reports worthy of publication. There are a lot of factors that go into a skewed literature.”
The “minimally invasive” live laparoscopic donor nephrectomy (LLDN) technique that makes it easier to entice donors has its problems — which practitioners are not eager to publicize. The idealized portrayal of a nearly risk-free endeavor for donors was (and is) somewhat misleading. “A thorough search of the literature showed that some reports were overlooked… In terms of donor safety at least 8 perioperative deaths were recorded after laparoscopic live donor nephrectomy.” One surgeon recorded 5 donor deaths which were not published as case reports in transplant journals. Two donors died from blood clots, another bled to death and a fourth died of respiratory failure during the procedure. Nobody knows why the fifth donor died.
At the University of Minnesota Medical Center, as of 2007, two donors died and one was left in a persistent vegetative state. The Urology journal noted that these deaths somehow didn’t make it into previous review articles because “during the introduction of a new and exciting technique such as LLDN there may be a tendency toward reporting nice data while retrenching unsuitable data.”
As far as anyone can tell, at least 81 people have died from donor-related causes since 1988, most likely within 90 days of surgery. Two kidney donors died during the research and writing of this story.
One bit of routinely retrenched not-so-nice data is the learning curve. It’s not easy for surgeons to get the hang of laparoscopic surgery. “The learning curve for LLDN is associated with a remarkable number of major complications,” says a 2010 review in The Archives of Surgery, remarkable meaning anywhere from 5 to 26%, with an average of 18%. And there too, it’s likely worse than they’re letting on. Readmissions to the hospital are not reported, “therefore, complication rates are likely underestimated… complications range from urinary tract infections to bowel injury and renal failure.” Other complications within the range include collapsed lungs, spleen injury, blood clots and nerve damage. One in four donors was injured at the University of Maryland as the docs tried to learn the ropes.
An interesting observation was that “there may be discrepancies between the admitting physician on record and the actual surgeon performing the donor nephrectomy.” This is a reference to the common practice of having the well-known, highly experienced surgeon lead you to believe he or she will be performing your surgery, and then handing the job to some rookie whom you’ve never met, because everyone’s got to start somewhere, and it might as well be you — with you none the wiser. Since “a minimum of 50 difficult cases is needed to acquire adequate laparoscopic skills,” you’d better hope that you’re not the first one — although you, of course, would have no way of knowing.
End Stage Renal Disease (ESRD) is kidney failure.
“The old school was, we just told people, your risk of ESRD after donation is no higher than that of the general population,” Segev said to the transplant docs in Miami. “I mean that’s completely stupid. That’s like basically saying, compared to, you know, obese, hypertensive, poor health behavior America, you won’t be that bad. We don’t know how bad you’ll be, but, don’t worry, it’s no higher than the general population. But we use this as sort of like this reassurance to donors, I mean it’s completely scientifically stupid.”
He was referring to widely cited studies that declare that not only is there no real risk to kidney donation, but that kidney donors actually live longer, healthier lives than regular people. Chief among the many problems with these studies is that you really can’t compare healthy donors with regular people for the reasons cited above by Segev.
In the more ethically conservative era from which these studies draw their data, “obese, hypertensive, poor health behavior” Americans were not allowed to become organ donors. The subject donors were generally young, healthy people who are naturally going to have fewer health problems and live longer — even with one kidney — than those afflicted with obesity, high blood pressure, and bad habits.
You could argue that these fit and healthy people might have lived even longer if they had not donated.
Nonetheless, Montgomery in 2009 presented a webinar in which he reassures donors by comparing the risk of nephrectomy to “having your wisdom teeth removed.” He says “we now have very good data including a very recent paper in the New England Journal of Medicine that donors don’t have any increased rate of renal failure, and on average have normal blood pressures…”
The recent paper Montgomery cites as providing “very good data” is in fact an example of what Segev calls “complete bullshit.” It’s a widely touted article called Long-term consequences of kidney donation by Drs. Hassan Ibrahim and Arthur Matas at the University of Minnesota Medical Center that generated headlines across the country proclaiming safety and longevity regarding kidney donation. Among the problems of the study, in addition to the questionable population comparisons, is that of the 3698 donors studied, only 38 had their kidney function analyzed. These are the studies referenced on the Johns Hopkins website to attract and reassure potential donors.
Segev himself presented two papers that, according to his own definition, qualify as bullshit. They too made headlines across the country, mostly variations on the one Hopkins used in a 2010 press release:
Kidney donors suffer few ill effects “We have shown that live kidney donation is safe and free from significant long-term excess mortality,” Segev said. “With this study we’re able to say that whatever happens to people physiologically after kidney donation — it doesn’t cause a premature death. After donating a kidney a person can live exactly the way they lived before donating — a long, healthy, active life with virtually no restrictions at all.”
A press release/news story posted on a website in 2014 for journalists to rewrite or reuse as they see fit went even further:
Newswise — The risk of a kidney donor developing kidney failure in the remaining organ is much lower than in the population at large, even when compared with people who have two kidneys, according to results of new Johns Hopkins research… The same researchers reporting in the same journal also showed in 2010 that the risk of death from any cause for kidney donors is extremely low. (Citation: Journal of the American Medical Association; R01DK096008)
So you would actually be doing yourself a big favor by getting rid of that extra kidney.
Segev based this landmark study on the UNOS data which had been officially declared “useless for research or for making conclusions about living donor safety.” Using all manner of statistical contortions, it compared 80,000 live kidney donors from the corrupt UNOS database with 9,000 people from a general health study conducted from 1988 to 1994, with a mean follow-up of about six years.
But this particular flaw in old-school research methods is slowly being corrected.
Given the critical kidney shortage, transplant centers are putting out the welcome sign for “expanded criteria donors” i.e. “obese, hypertensive, poor health behavior” Americans. Also currently under construction is the “medical, ethical, and legal framework” for Complex Living Kidney Donors, people who are already on track to require kidney transplants themselves down the road.
If the trend keeps up, there will be no problem with comparing kidney donors with the general population — because we’ll all be in the donor pool.
“We can’t keep telling that thing that we were telling people before which is, ‘Oh, your risk of ESRD is going to be no higher than the general population’ because that’s actually meaningless,” Dorry Segev told his peers. “We actually have to tell them, ‘Your risk of ESRD is going to be higher than if you hadn’t done it’, but so is your risk of, you know, jumping into a swimming pool and saving a drowning kid, and you would do that any day.”
Well, yes. Most people would jump into a pool to save a drowning kid.
But they wouldn’t have to pay thousands of dollars in expenses to do it or take up to two months off of work afterward. They’d get some dry clothes and then maybe drink a few martinis and they’d be able to take a couple of extra aspirin or Advil the next morning. And they could go wakeboarding again, or get a CT scan, MRI, colonoscopy or angiogram without worrying about damage to their remaining kidney from the contrast agent.
They wouldn’t have a harder time getting life insurance.
They wouldn’t risk adrenal problems.
They wouldn’t have to worry about decreased metabolism and absorption of vitamins.
They wouldn’t have put themselves at increased risk for kidney stones, gout, high blood pressure, thyroid problems, cardiovascular disease, and diabetes.
They wouldn’t have to worry that future pregnancies might be more difficult.
They wouldn’t face an increased risk of kidney failure. They wouldn’t have to worry about not living so long as they might have. They wouldn’t have increased their chances of sliding into depression, anxiety and regret.
And yes, if those risks did apply to saving a drowning kid, and you knew all those risks and more, you’d probably do it anyway — especially if it was your kid.
People are like that, and it’s a virtue that’s vulnerable to exploitation.
Next: A Thorough Evaluation