New Law to Prevent Kidney Deaths
Finally, something substantial is being done to provide more kidneys for transplantation
Short Summary
The long-awaited End Kidney Deaths Act has been submitted to Congress, and is on track to becoming law.
Companies and individuals who benefit from dialysis make a LOT of money, won’t be happy to lose dialysis patients to transplantation, and if history is an indicator, will spend millions to billions to kill this bill.
BUT, YOU and your friends can help a lot if you contact your Congressman and Senators, and write OP-ED’s for your local newspaper. You can also join the group advocating for the End Kidney Deaths Act here.
See more below…
End Kidney Deaths Act is Introduced
In the previous substack, I mentioned that a bill was being prepared to allow the US government to purchase kidneys from willing volunteers, and redistribute them to End Stage Kidney Disease patients—those people who, without dialysis1 or a kidney transplant, will die shortly from kidney failure. Currently there are about 130 thousand new ESKD patients per year. Most currently cannot get a new kidney, because there aren’t enough available from either deceased donors or living donors. Today only about 20 thousand new kidneys are available, meaning the remainder, 110 thousand, will die much earlier than would have been the case than if they had obtained a kidney, since the average life on dialysis is about 6 years—and much less if the person is over 65.
The bill has now been introduced to Congress, sponsored by Representatives Malliotakis (NY-11), Bacon (NE-02), Harder (CA-09) and Neguse (CO-02), with bipartisan support, which will provide either $10,000 each year for 5 years tax credit, or or $10,000 direct payment per year to citizens who don’t have tax liabilities for 5 years, for those individuals who make a “non-directed” kidney donation.2 The bill is called the End Kidney Deaths Act, H.R. 9275—118th Congress3.
The bill promises to make available at least 10,000 additional kidneys per year, probably prolonging 10,000 lives per year each an additional 15 to 20 years. It will also save the US government something in the range of $35B dollars, because the cost of maintaining someone on dialysis is far more than that related to transplanting a kidney. Of course, kidney transplants will greatly improve the quality of life for what would have been 10,000 per year dialysis patients, and their families.
The program is a pilot program, lasting 10 years, but it is clear that if it comes anywhere close to living up to expectations, it would be expanded and many more of the remaining 100 thousand per year would likely be able obtain kidneys, and dramatically shorten waiting lists.
Biggest contribution to saving lives of End Stage Kidney Disease Patients since the passage of the National Organ Transplantation Act (NOTA) 40 years ago
Little progress has been made in increasing the number of available kidneys ‘til now, but it hasn’t been for lack of trying. Huge efforts have been undertaken to:
increase the distribution efficiency, and decrease the waste of available kidneys
use kidneys previously thought to be too diseased (with hepatitis, AIDS, etc), or too old, or obtained with long ischemic times (times without blood flow)
increase the number of potential deceased donors by, in many states, having drivers deliberately select whether to allow donation upon death
publicity campaigns encouraging people to, while living, to donate a kidney
But these efforts over many years have been shown not to yield substantial improvements.
This single bill will increase the number available kidneys more than all the above efforts combined have done over the past 40 years.
Help Needed!
Despite the obvious benefits, getting any bill through Congress recently has been difficult. This bill will only get through if:
Congress prioritizes this bill high enough to get through the clutter and
Nay-sayer’s arguments are debunked, and special interests objections are discounted
You, and your friends can help get the bill through Congress by texting your representatives (using this tool find your representative) and senator (by going to this website contact senators, and following links there to the senator’s contact page), and by sending your opinions to local newspapers for their Op Ed page. Tell them this bill will save a huge number of lives, and billions of Medicare dollars—and how important it is to you, and your extended families. Use the link below to forward this post to friends and kidney patients.
Most bills have opponents as well as proponents. This bill will help current kidney disease sufferers, their families, and future kidney patients, as well as the taxpayer through saving many billions of dialysis dollars. Every day of every year, about 60 transplant candidates die because not enough kidneys were available.4
Still, there will be those who will oppose this bill for malign reasons, and will use smokescreens to hide their opposition. They may succeed in influencing others to follow their lead, because the influenced are financially dependent.
Every organization that derives significant revenues from dialysis patients (dialysis centers — DaVita, Fresenius Medical North America; dialysis consumables suppliers—Baxter; manufacturers of dialysis equipment; hospitals; drug suppliers;5 and individual (principally nephrologists) has a strong incentive to keep people on dialysis as long as possible—keeping them alive, but not getting them off dialysis via transplant. In the US there are about 550K people on dialysis, with the average annual per person expenditure over $100K67 , which results in an annual Medicare expenditure of about $55B, which is paid out to dialysis centers, associated medical staff including nephrologists, and for specialized medicines.
Two dialysis companies, DaVita and Fresenius Medical Care North America have, as of 2019, about 80% US market share8—de facto monoply power—and thus get a large share of the $55B. They have had numerous run-ins with the law for such things as doctors illegally steering customers to centers jointly owned with the dialysis company, over charging CMS, antitrust violations, and bribery, with total fines of more than $1.5B9—and just recently Fresenius has been charged (by over 15 states so far) with defrauding Medicare and performing unnecessary surgeries on dialysis patients10. Fresenius’ corporate communications to shareholders make the point that dialysis is a growing market (from an aging population) and valuable segment. They are not likely to give up any of their revenue without a fight.
Most of the 11,000 US nephrologists are financially dependent on dialysis companies. The nephrologists have one or more of the following relationships11 12 with dialysis companies: joint ventures in dialysis centers; their dialysis centers possible acquisition targets, where the purchase price is way over market; benefit from management agreements or dialysis agreements; medical directorships, fellowships/research grants; consultancies and honorariums) which suggest their long and short term financial interests may be served by following the dialysis company’s lead, and not aggressively encourage patients to become transplant candidates, nor supporting legislation that would encourage conversion of dialysis patients to transplantees. [even though it is common knowledge and statistically proven, that transplants provide 2 -3x13 longer post diagnosis life, and far better quality of life]. In one example, DaVita paid $400M+ fines for conspiring with nephrologists to restrain trade, while rewarding participating nephrologists with artificially high returns in joint ventures.
Kidney “charities” are not immune from influence by dialysis providers and dialysis medical suppliers. Financials and PR from the National Kidney Foundation14 show that it accepts substantial contributions and sponsorships from both. Similarly, the American Association of Kidney Patients web site acknowledges many drug company sponsorships.
All of these (companies, individuals, charities) entities profess to encourage kidney transplantation, but have done very little to actually “move the needle”15 16. For example, the National Kidney Foundation has solicited, and then spent, over $500M since 2011, with less than $1M directed at increasing kidney availability—and virtually no effect as measured by changes in non-directed donation.
Fresenius’ corporate PR, on a one page message from the president, mentions two programs: One is to simplify applications to transplant hospitals (which I know from my own experience, isn’t used); and one (initiated in 2019 with partners NKF and DaVita) to publicize the need for non-directed donors called “The Big Ask; the Big Give”(which also has no visible results). Given the tens of billions per year available to DaVita, Fresenius, and NKF it is surprising that they couldn’t get something significant done—if they wanted to.
NKF’s inaction re in obtaining more kidneys for transplantation is especially disappointing since it has on its 30+ person board people you’d expect would be enthusiastic cheer leaders including:
Tracy McKibben—the chair(woman) of the board, a Harvard JD with time on the National Security Council, and most importantly, the donor of a kidney to her mother
Anthony Tuggle—former President of Customer Operations, Afiniti and past kidney recipient
Anne Barr-CIO of Sutter Health (SFBay Area Hospital Chain) who supported a kidney transplant center
Matthew Cooper, MD—kidney transplant surgeon who professes to be working with NKF for “demonstrable, real investment in actions beyond words and a leadership committed to the mission” to “increase kidney transplant opportunities”
Renee Gosline—Harvard PhD who was diagnosed with kidney disease early in life
With all their shady, and sometimes criminal activities in the past, and with vast amounts of money to spend, it wouldn’t be surprising if dialysis and drug companies spent many millions trying to retain control over “their” dialysis patients. It is unlikely that the companies would directly take a position against providing more kidneys to increase transplantation. More likely they would, through lobbyist and other surrogates, try to delay or water down the EKDA legislation, or confuse legislators by offering competing bills/amendments17 or criticizing EKDA with irrelevant arguments from the past that were only appropriate when discussing organ trafficking18 19.
This bill avoids the significant legitimate concerns that people had in the past, such as:
preying on the poor. It actually helps the poor most because it gives much greater access to kidneys to disadvantaged groups. It is a voluntary program which many find useful to pay for housing, education, or transportation. Already there are careful screening procedures to make sure that the donor is psychologically capable to make informed decisions
Paying for non-directed kidney donations may lower the number of voluntary directed donors, or voluntary (“altruistic”) non-directed donors. Studies have shown this is not true. Certainly voluntary altruistic non-directed donors could only increase if, in addition to their altruistic motives, they were eligible for this program.
Kidneys obtained through this program may not be good. Kidney donors will be rigorously screened by the same organizations that currently screen voluntary donors. Likely the kidneys from this program will be much better than the deceased donor kidneys, and, because there is more time to match with recipients, will last much longer.
The existence of a kidney replacement program will lower the incentives for people to avoid poor diets that cause diabetes and high blood pressure, and which are known to lead to kidney disease. But this is like saying that requiring the use of seat belts has encouraged reckless driving.
This program will encourage kidney trafficking (getting kidneys from out of the country). This won’t happen because kidneys must come from US citizens. Furthermore, the existence of more kidneys from this program will lower the pressure to try “organ tourism”—where someone leaves the country to obtain a kidney elsewhere.
We’re constantly improving kidney availability and therefore stronger measures that are currently prohibited by law aren’t necessary. These arguments have been made for at least the last 20 years, and so far, very little progress has been made. The part of the NOTA law that prohibited sale of organs was in reaction to a trafficking case where a doctor imported organs, took a large finder’s fee, and resold the kidneys without significant safeguards. The proposed program is a government monitored program where everyone’s interests are safeguarded.
NOTA specifically prohibited purchase of organs. That law has been copied by many countries. As already stated, the NOTA law, originally sponsored by Al Gore, prohibited organ purchases as a last minute addition, in response to an organ trafficking case. Al Gore himself said at the time that he would favor providing tax credit for donors.
Pig kidneys will eventually be able to replace human kidneys. We all hope so, BUT we won’t know whether pig kidneys are good enough for humans until after a successful human trial, and then only after approximately 15 years to see if they last. Some doctors feel that even if pig kidney rejection problem is solved, pig kidneys may not last because of differences in blood pressure and anatomy. Even if pig kidneys can be shown to last, we will have to wait to scale up farms of pigs, and scale pig surgery to in the range of 10,000 per year to get close to what we could get today with a healthy live donor human kidneys selected for good HLA matches (typically 15 to 20 years). The best human trial kidney has only lasted a few months, so far. Thus substantially changing the time on the waiting list will take at least 15 years.
This program “commodifies organs”, and therefore is unethical.
There is no consensus about the validity and generality of the term “commodification”. Some ethicist (following Kant) feel that there is something divine about certain body parts, which should not be allowed to be separated from the body—and certain religions emphasize this, even after death [which would cease any form of transplant, even deceased donors]. Other ethicists (following Locke) feel that individuals own their own bodies, and can do what they want with their body parts. Medical ethicists have turned themselves inside out justifying, for example why plasma sales are ethical, and blood sale is not; why it is ethical for someone to donate his cadaver to medicine, but not his kidney to someone whose life would be extended20.
Should ethicists decide what individual freedoms someone else has—if they aren’t directly or indirectly harming another? And, would ethicists reject a live or deceased donor kidney if they or their relative needed one? Can ethicists distinguish, credibly, between a donor who gives a body part to a first degree relative (which some support) and a second degree relative (which they don’t support) and one who gives that same body part to help a stranger? Should the indecision of a group of ethicists over a panoply of subtle issues delay what the vast majority of Americans want?
There is an agreed upon principle in the kidney transplant world of “the greatest good for the greatest number” (John Stuart Mill)—already used by UNOS in their kidney allocation process—which tends to give better kidneys to younger people, since the younger people are likely to live longer, and older people are more likely to die of other diseases before their shorter lived kidneys fail. Kidney donors aren’t harmed; kidney donors live as long as non-donors.
Kidney donors receive a significant benefit (and they’re fully aware of any benefit/harm tradeoffs); they’re guaranteed to go to the head of the line in the very unlikely circumstance that they needed a kidney. So, really, the volunteer, paid donor, the recipient, and the American taxpayer all benefit. Win/win/win21.
In the end, though, ethicists (self-stiled, or even graduates of some accredited, recognized program) do not make policy. Voters, based on many possible tradeoffs, do.
All the above arguments have been hashed and rehashed over decades, while hundreds of thousands needlessly die while nothing has changed.
It is time to make a difference.
What can you do to fight “malign” forces?
The malign forces have literally billions of dollars to spend, and history of devious tactics to preserve and improve their “bottom line” (profits). BUT, those forces can be countered if your representatives are put on notice that arguments by any of the organizations above are suspect. Write to your representatives. Support ModifyNota. Any acceptance of money or favors from these organizations will be made visible in future elections, and an unsupportive vote will endanger the lives of kidney patients, and cost the taxpayer billions of dollars. Tell your representative so.
Write “charitable” organizations such as the National Kidney Foundation at this link, the American Kidney Fund, and the American Association of Kidney Patients (at info@aakp.org or on this form).
Please, help!
Your influence can make a difference by increasing interest in this legislation, and fending off special interests with deep pockets.
Dialysis is a very poor substitute for a working kidney. Dialysis only simulates one function of kidneys—removing waste. Other functions, including controlling blood iron are not solved by dialysis. Because of lack of these other functions, dialysis patients are progressively more miserable because of tiredness, itching, and opportunistic infections (100 times more than a normal person), and, knowing that their lives are being significantly shortened, depressed. Dialysis patients have poor quality of life because they spend, typically, 4 hours, 3 days per week in the process, and are too exhausted after dialysis to do anything.
Dialysis is also tough on families who generally have to support the patient with travel, and if done at home, help disinfect, attach, and tear down dialysis paraphernalia, and provide moral support.
Not given to a friend or relative, but to a pool of kidneys to be allocated by the current government monitored UNOS process
The full text of the Bill can be found at HR-9275 Text
This includes people on the transplant list, who died, and people who were removed from the transplant list (and subsequently died) because, due to the long wait, their health failed as a result of complications of dialysis. This number doesn’t include probably an even greater number of ESKD patients who weren’t able to get on the transplant because their medical care didn’t encourage them to apply, or because their health didn’t meet the very high criteria to be on the transplant list. The people who weren’t able to get on the transplant list tend to include the working poor, minorities, and people who live where transplant wait times are very long.
A list of drug suppliers to nephrologists is typified by this list of partners for the American Society of Nephrologists “platinum level” AstraZenica, Baxter, Fresenius Medical care, Calliditas (therapeitics), Vera (therapeutics), and diamond level Novartis, novo nordisk, and Amgen. ASN has proposed policies to inhibit direct conflict of interests in their society and publications, but that proposed policy doesn’t extend to society members. Importantly, ASN acknowledges the substantial contribution the financial support makes, and hasn’t tried to wean itself off it—because, as they acknowledge—they can’t afford to. See this ASN Conflict of Interest Recommendation
A Comparison of US Medicare Expenditures for Hemodialysis and Peritoneal Dialysis, J Am Soc Nephrol 2022 Nov; 33(11):2059-2070. doi: 10.1681/ASN.2022020221. Other estimates of the dialysis market, including equipment, in the US in 2023 are as high $116B (https://market.us/report/dialysis-market/ , retrieved 8/23/2024). This last market analysis states: “The increasing number of patients choosing kidney transplants limits the market growth”
The average duration on dialysis til death is about 6 years, and the most recent number of adds to the dialysis base is about 110K per year, consistent with the current number of 550K patients on dialysis
See https://violationtracker.goodjobsfirst.org/parent/fresenius-medical-care for a list of Fresenius’ fines, totaling about $1B
See for example DaVita soliciting nephrologists for their financial gain; DaVita solicitation
NY Times: “Doctors reap millions for anemia drugs”
Younger patients live far longer with transplants than older patients whose life might be limited by other comorbidities. Still, a 70 year old patient on dialysis will have about a 28% per year mortality rate, whereas a transplant patient with similar other health problems will have about a 6% mortality rate—more than 4 times better. And the transplanted patient will have no debilitating symptoms and daily schedule freedom,
Not to be confused with the National Kidney Registry, which has a strong program to encourage and facilitate altruistic kidney donation
NKF publishes its goals in its IRS form 990—the return for 401 (C)(3) charitable organizations. Their goals, including “increasing the availability of all organs for transplant” is recorded at https://projects.propublica.org/nonprofits/organizations/131673104/202333549349300543/full , Part 1, line 1. That same IRS form shows no significant expenditures supporting this goal.
One such bill is the “Living Donor Protection Act of 2023”—which provides protection of living donors from discrimination by insurance companies. Most states already have such protections, and more—such as paying donation expenses, providing up to 30 day paid job leave. While not bad, this bill will do little to increase the number of donors.
Another act is the Living Donor Tax Credit Act of 2023, which proposes additional recoupment of donor expenses which would be applicable to low income donors. That act provides insufficient incentives (studies show that $50K or more are required to significantly increase donation), requires the donor to file a tax return .
One study that quantifies how much money it would take ($50K) just to provide adequate incentive to donate a kidney is here. Another study, Payment for Living Donor (Vendor) kidneys: A Cost Effectiveness Analysis, A.J. Matas and M Schnitzler, Am J Transplantation, 2003; 4: 216-221 or doi: 10.1046/j.1600-6143.2003.00290.x shows the government could afford to pay at least $90k just from savings, and about $250K more if the value of QALY’s (Quality Adjusted Life Years) is included in the calculation. This model is very conservative since it only assumes $50K per year to support dialysis (whereas other studies claim $100K)
Financial Incentives for Living Kidney Donors: Are The Necessary?, Dominique. E. Martin and Sarah L White, https://doi.org/10.1053/j.ajkd.2015.03.041
As a consortium of dialysis providers did in California to confuse voters in referendums in 2018 and 2022 where they spent record amounts ($100M in 2018; $75M in 2022) and essentially lied to voters about the impact the referendum would (supposedly) have—closing dialysis centers. They also proposed alternative legislation that sounded confusingly similar to the grass roots proposal. See: 2018 referendum and 2022 referendum.
The groups that don’t win are the organizations and people who benefit financially from dialysis. What the government saves from replacing expensive dialysis fees will be lost to the dialysis beneficiaries… many billion dollars.