Excellent Article about Kidney Transplantation

Our Deeply Unethical National Organ Policy
By Harold Gershowitz and Amy Gershowitz Lask
Wednesday, July 7, 2010

Filed under: Health & Medicine, Government & Politics, Public Square

In our zeal to protect the poor from exploitation by the moneyed classes, the organ donor—alone among all the participants in the world of transplantation—receives no benefit.

In America it is a felony to provide a financial incentive for someone to donate a bodily organ. Each year, this misguided and wrongheaded public policy takes the lives of nearly 5,000 Americans with end-stage renal disease and, ironically, costs taxpayers billions of dollars.

The math is simple. In a country the size of the United States, a payment, either direct (cash, vouchers, or tax credits) or indirect (tuition, charitable donations, etc.) of, say, $20,000 to kidney donors would probably produce enough donated kidneys each year to eliminate or drastically reduce the backlog of approximately 83,000 people waiting for their turn to receive a donated kidney. This financial inducement would cost about $1.7 billion. The federal government currently pays 100 percent of the cost for treating most people with end-stage renal disease. With the average annual cost estimated at about $30,000 to maintain one person on dialysis, the taxpayers are paying about $8 billion a year to dialyze fellow citizens in kidney failure. Furthermore, people usually wait about five years to receive a donated kidney unless they are fortunate enough to have a living donor offer one of their two healthy kidneys. Thus, the actual total cost to the taxpayers of maintaining fellow citizens on dialysis for five years is approximately $40 billion.

Each year, nearly 5,000 men, women, and children die in this country while waiting for a kidney to become available.So in our zeal to protect the poor from exploitation by the moneyed classes, the organ donor, alone among all the participants in the world of transplantation, receives no benefit save the pleasure of performing a noble deed.

At first blush, the policy seems to make perfect sense. After all, few people would condone letting the wealthy use money to induce others, who may be in financial extremis, to provide vital organs for transplantation. Such a practice, the argument goes, would turn the altruistic concept of organ donation into little more than a mercantile opportunity for buying and selling body parts. This is an emotionally compelling argument. It is also seriously flawed, and has produced extremely questionable public policy.

In the case of kidney transplantation, the donor is subject to relatively little post-surgical risk. Statistically, a kidney donor fares no worse throughout his or her life than a person with both kidneys. Life insurance companies impose no rating on premiums for kidney donors because, actuarially, they represent no greater risk to the insurer.

At an average annual cost estimated at about $30,000 to maintain one person on dialysis, the taxpayers are paying about $8 billion a year to dialyze fellow citizens in kidney failure.Everyone involved in the organ transplantation process benefits handsomely, except the donor. Organ transplantation provides a wonderful example of life-saving science and technology deployed in serving mankind. It is also a thriving industry. The entire transplant team, including the surgeons, nurses, technicians, pharmacists, nephrologists, and other specialists are well-paid for their respective roles in providing organ transplant service. The medical centers at which transplants are performed are also handsomely compensated. The procedure feeds revenue into virtually every facet of the hospital. It occupies rooms, keeps labs busy, requires numerous expensive tests, and staff at all levels benefit. The pharmaceutical industry certainly benefits, as transplant patients remain on various expensive drugs to protect their new organ for the rest of their lives. Then, of course, there is the recipient who is, perhaps, compensated best of all. He or she gets his or her life back. Only the donor, who gives the most and without whom the entire process would grind to an abrupt halt, is required to forego any material recompense for his or her service.

A more serious consequence of this flawed policy is that it costs thousands of lives annually, and consigns thousands of other people to years of expensive dialysis, the bill for which goes to taxpayers.

Each year, nearly 5,000 men, women, and children die in this country while waiting for a kidney to become available. We suggest that most of these individuals would, more than likely, have received a life-saving transplant but for the seriously flawed policy of denying compensation to those who might otherwise donate a kidney to a friend, a loved one, or even a stranger. A sensible, well-regulated program of organ donor compensation could convert most of these patients to transplant recipients. Their lives would improve drastically, the national cost of maintaining them on dialysis would be slashed, and donors would, in many cases, receive life-changing compensation for their generosity. Every time someone dies waiting for an organ in this country, the ethical case against providing compensation for organ donors is turned upside down. Unquestionably, the prohibition against compensating organ donors costs lives.

Yes, some donors might be poor, but what is wrong with a poor person receiving compensation for performing a noble deed?Too many assume that this would motivate only the poor to donate an organ such as a kidney. Unquestionably, not only the poor, but many people who have considered such a donation would find reasonable compensation a legitimate factor in their decision-making process. Yes, some might be poor, but what is wrong with a poor person receiving compensation for performing a noble deed?

In the case of the authors, a daughter’s love for her father was all the motivation needed to produce a successful and happy outcome for both the recipient and donor. We were, however, both haunted by the reality that a system relying on pure, uncompensated altruism in thousands of other cases results in the unnecessary deaths of men, women, and children in end-stage renal failure.

All first-year medical students have drummed into their heads an old adage, “Above all, do no harm.” Perhaps members of Congress and public health officials should consider the same when considering organ transplant policy.

Harold Gershowitz is a businessman and recipient of a transplanted kidney. Amy Gershowitz Lask is an uncompensated kidney donor.

Thanks, Mark. The author got a few facts wrong in this article:
1). The government does not “pay 100 percent of the cost for treating most people with end-stage renal disease.” The Medicare ESRD Program pays 80% of the allowable costs.
2). The annual cost of dialysis is not $30,000–it’s $69,239, per the 2009 USRDS Annual Data Report (all dialysis–though PD is considerably cheaper than standard in-center HD), which ends up being quite a bit more.
3). While in the U.S., under the current (non-paid) system, donor odds of poor outcomes tend to be minimized, there are no large scale, long-term follow-up studies of living donors. Most studies are small or go out only about 7 years. We don’t really know what happens to a 25 year old donor 40 or 50 or 60 years later. And we don’t know what would happen to people who are poor, have less access to healthcare, and donate a kidney for cash. In other countries where “medical tourism” occurs, the paid donors have had some very poor outcomes.
4). Some donors HAVE had problems getting life insurance.

Kidney transplants don’t cure kidney failure–they are just another treatment. Providing better dialysis–minimally every other day to eliminate the 2-day treatment gap–would save an estimated 10,000 lives per year (according to Dr. Carl Kjellstrand). Increasing treatment time to a minimum of 4 hours for everyone would save more lives. And at least three studies now show that short daily and nocturnal HD have survival that is comparable to deceased donor transplant. IMHO, it makes more sense to devote $1.7 billion to ensuring that people on dialysis get good treatment than on paying donors to have a potentially dangerous surgery.

Yes, I realize that Medicare pays 80 percent and the cost per year is close to $70,000. The real point of my posting the article is the hypocrisy of the people in the medical system who cry about the idea of donors making money, while they are making money hand over fist. They “boohoo” over the poor, when they are doing little or nothing to help the poor, while we suffer day and night. So, you would rather have us suffering on dialysis than to have the freedom of a transplant? It may make more sense to you, but, not to the people suffering on dialysis. People who donate kidneys DO NOT have any difference in life span than someone who does not. So, because someone in a life insurance company is a bozo, we should have to suffer? The excuses of these people are amazing. I wonder if they are willing to live under their own rules, NOT! It is amazing how these people use the poor to shield them from their moral smugness and arrogance. Individuals who receive kidneys and kidney donors are adults who can and do make rational cost/benefit decisions, not subject to the oversight of people who think they always know what is best for us.

No question there’s some paternalism built in. And I disagree that “People who donate kidneys DO NOT have any difference in lifespan” – IMHO, the jury’s still out on that one. But, interestingly, while donors can’t get cash directly in the U.S. for kidneys, a number of states (more than I thought) do allow things like paid time off and $10,000 tax credits and/or deductions for donation costs. Here’s a site that lays out what those benefits to donors are: http://www.transplantliving.org/livingdonation/financialaspects/statetax.aspx. Maybe getting the word out about that in states that have it (and increasing the numbers that do) would help.

My Nephrologist said that individuals who donate kidneys live as long as those who do not. Some paternalism, try like alot! My Nephrologist is considered to the best in Greater Cincinnati. I think the hypocrisy of these people is unreal. The attitude of them caring about us is like the rich who live in a mansion, while proclaiming to care about the poor, as they are stuffing their faces. Would you be willing to live under this system? How much of a house or car do you believe you will obtain for the price of zero??? “As you have done to the very least of my brothers, you have done unto me.” It is amazing how many of these people are, “Do as I say, not as I do.” In the future, these people will have alot to answer for, in the treatment of kidney patients. It is easy to talk about these things in theory when you are not living this life. This field is filled with arrogance, hypocrisy, and smugness. In other words, other people with kidney failure should suffer so we can feel morally superior, what a goofy system. I have to laugh when I hear these people crying about a donor making money. I am glad when I go to my Nephrologist’s office, I do not have to listen to these silly attitudes. In fact, my Nephrologist’s office feels like a family, not a bunch morally superior fools.

My private insurance pays 100% of mine - not the government. AND my insurance is paying way more than $70,000/year - more like over $300,000/year now. While in-center they were paying 100% of the billed amount for a whopping total of $600,000/year!

This is what is soooo laughable about these people crying about a donor making money. I would not send my dog to these people. I feel their pain.

The National Organ Transplant Act was amended in 2008 to exclude paired donation from the definition of “valuable consideration.” Here’s the section of the law that relates to what is allowed and what isn’t.

[I]Sec. 274e. - Prohibition of organ purchases

(a) Prohibition
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects
interstate commerce. The preceding sentence does not apply with respect to human organ paired donation.

(b) Penalties
Any person who violates subsection (a) of this section shall be fined not more than $50,000 or imprisoned not more than five years, or both.

© Definitions
For purposes of subsection (a) of this section:

(1) The term ‘‘human organ’’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.

(2) The term ‘‘valuable consideration’’ does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.

(3) The term ‘‘interstate commerce’’ has the meaning prescribed for it by section 321(b) of title 21

(4) The term “human organ paired donation” means the donation and receipt of human organs under the following circumstances:

(A) An individual (referred to in this paragraph as the “first donor”) desires to make a living donation of a human organ specifically to a particular patient (referred to in this paragraph as
the ‘first patient’), but such donor is biologically incompatible as a donor for such patient.

(B) A second individual (referred to in this paragraph as the “second donor”) desires to make a living donation of a human organ specifically to a second particular patient (referred to in
this paragraph as the “second patient”), but such donor is biologically incompatible as a donor for such patient.

© Subject to subparagraph (D), the first donor is biologically compatible as a donor of a human organ for the second patient, and the second donor is biologically compatible as a donor of a human organ for the first patient.

(D) If there is any additional donor-patient pair as described in subparagraph (A) or (B), each donor in the group of donor-patient pairs is biologically compatible as a donor of a human
organ for a patient in such group.

(E) All donors and patients in the group of donor-patient pairs (whether 2 pairs or more than 2 pairs) enter into a single agreement to donate and receive such human organs, respectively,
according to such biological compatibility in the group.

(F) Other than as described in subparagraph (E), no valuable consideration is knowingly acquired, received, or otherwise transferred with respect to the human organs referred to in such subparagraph.[/I]

http://www.unos.org/SharedContentDocuments/NOTA_as_amended_-_Jan_2008.pdf

The National Living Donor Assistance Center can provide assistance to living donors with unreimbursed transportation costs and subsistence.

http://www.livingdonorassistance.org/

The law needs to be changed.

[QUOTE=Dori Schatell;19849]Thanks, Mark. The author got a few facts wrong in this article:
1). The government does not “pay 100 percent of the cost for treating most people with end-stage renal disease.” The Medicare ESRD Program pays 80% of the allowable costs.
2). The annual cost of dialysis is not $30,000–it’s $69,239, per the 2009 USRDS Annual Data Report (all dialysis–though PD is considerably cheaper than standard in-center HD), which ends up being quite a bit more.
3). While in the U.S., under the current (non-paid) system, donor odds of poor outcomes tend to be minimized, there are no large scale, long-term follow-up studies of living donors. Most studies are small or go out only about 7 years. We don’t really know what happens to a 25 year old donor 40 or 50 or 60 years later. And we don’t know what would happen to people who are poor, have less access to healthcare, and donate a kidney for cash. In other countries where “medical tourism” occurs, the paid donors have had some very poor outcomes.
4). Some donors HAVE had problems getting life insurance.

Kidney transplants don’t cure kidney failure–they are just another treatment. Providing better dialysis–minimally every other day to eliminate the 2-day treatment gap–would save an estimated 10,000 lives per year (according to Dr. Carl Kjellstrand). Increasing treatment time to a minimum of 4 hours for everyone would save more lives. And at least three studies now show that short daily and nocturnal HD have survival that is comparable to deceased donor transplant. IMHO, it makes more sense to devote $1.7 billion to ensuring that people on dialysis get good treatment than on paying donors to have a potentially dangerous surgery.[/QUOTE]

Dori, thank you as always for your grasp of the details and the facts. I just had an “interesting” exchange over on IHD about the cancer risks of renal transplant. A 44 yo female with young kids wanted to know how “real” the cancer risk is for renal transplant. I spoke up after several people tried to “encourage” her to proceed and in effect really minimized the real cancer risks. I had more than one participant criticize me for simply pointing out that the cancer risks as well as the infection risks are very real and were a large part of my decision to choose daily dialysis at this point in time. It is quite sad that we not only have a greed filled dialysis industry that shortchanges US dialysis patients to a death rate 2.5 times that of many other industrialized nations while at the same time the renal transplant propaganda mill makes renal transplant look like a slam dunk cure when it is instead a good treatment option for many, but it is not a cure.

As far as payed donation, or more correctly, payed vending of organs is concerned, it is not an issue of not wanting the donor to be payed, but instead not wanting to use people as a simple commodity that can be bought and sold. That is the correct ethical choice in my opinion on several fronts not the least of which is the unknown long term effects on the general population of live organ donors. We have several small and retrospective studies of a fraction of the people who have donated over the years while the qualifications for donation were quite stringent. There is no organ donor registry to track ALL donors at this time to answer the very simple question of what happens to these people. We do know that their renal function declines faster than the general population in the limited studies to date but compared to the general population, the mortality has not declined. The problem is with the stringent selection, there very well may be a decline that is not measurable since we have no concurrent control group and the fact that the selected individuals were healthier than the general population to start with. To say that there is no long term effect on mortality or other wise is terribly premature as you noted.

In addition, the people such as Dr. Sally Satel who advocates strongly for a payed donor pool, perhaps in time to replace her current graft when it statistically will fail after 10 years, she paradoxically strongly advocates against cash payment and opts for in kind rewards instead. She understands intuitively that cash incentives for kidneys will be a coercion to the poor to donate and studies support this concern. On the other hand, the in kind rewards would likewise only appeal to an underprivileged class of people in desperate financial straights. This could easily lead to exploitation of the poor and is the main reason that ethicists and medical practitioners as well as politicians have avoided payed organ donation in America.

The fact that almost no one that sites the deaths on the transplant lists ever equates that with how many lives we could likewise save with optimal dialysis strategies in America lends the argument that we are dealing with renal transplant propaganda instead of a true open discussion on the best strategy for renal replacement therapies.

I believe that there is a greater harm to society in general if we simply open up the human body as a parts factory for the highest bidder. The fact that we have already stepped off into the ethical deep slope with fetal human body parts as a commodity as well as payed donors for sperm and eggs and bone marrow among other things is not in the end going to be a sustainable pursuit when taken to the full extreme When the “right” to sell becomes a “duty” to sell, the game will be over. The discourses I have read on payed renal vending directly suggests it is an implicit duty for healthy people to give organs that “they don’t need” to people who need them. It is a very slippery slope in my opinion and I strongly oppose this as a viable system in America. At present, the movement for implementing this system in America does not have the political clout to bring it to pass even though it looked like it might a couple of years ago. Many people are stepping back and looking ahead to what the real implications could mean down the road which is rightfully so.

Thank you Dori once again for speaking plainly on a very polarizing issue, but which issues today are not polarizing?

Coercion for the poor, how so? You mean to state that that they are not free actors who are not free to make rational decisions? Basically, that is a stereotype. Being poor is not a crime and many times, poverty is caused by government policies, such as the minimum wage or regulation, etc. In other words, this policy is based on stereotypes, in other words, “We know what is good for you.” In fact, the high cost of our medical system is because of excessive government regulation, especially in prescriptions. I applaud the fact that you point out the health risks of a kidney transplant. Many times, the medical profession downplays the risks of certain treatments and pushes treatments that do not improve health or all cause morality, for example, cholesterol medication which is a fraud. You do not have to give money for a kidney transplant, you can reward them with paid health insurance, a condo, an education, it does not have to be a cash payment. If you want to perform daily dialysis, that is great for you, wonderful. However, you are imposing your viewpoint on people who disagree with your standard of morality. As for me, I would not get a kidney transplant because of the harsh medication required after surgery. A Stanford Nephrologist told me that the average living donor kidney will last around 20 years. Yet, if someone wants to pay for a kidney transplant and the costs and benefits are worth it to them, I say why not? The ultimate form of bigotry is demanding rights for yourself, while denying those same rights for other individuals.

Is it really time and does it make good policy sense to make organ donation a capitalistic endeavor. What if people could sell their kidneys to the highest bidder on eBay or other Internet sites? Would that provide more “rights” to organs for those with more cash and deny those “rights” (discriminate) to organs for those who are too poor? Would there be a day when only the disadvantaged would be on dialysis? In some ways that’s happening now but the difference is that those who have jobs and good health insurance are more likely to get transplants than those who are unemployed and have what transplant programs view as insufficient insurance.

[QUOTE=NDXUFan12;19882]Coercion for the poor, how so? You mean to state that that they are not free actors who are not free to make rational decisions? Basically, that is a stereotype. Being poor is not a crime and many times, poverty is caused by government policies, such as the minimum wage or regulation, etc. In other words, this policy is based on stereotypes, in other words, “We know what is good for you.” In fact, the high cost of our medical system is because of excessive government regulation, especially in prescriptions. I applaud the fact that you point out the health risks of a kidney transplant. Many times, the medical profession downplays the risks of certain treatments and pushes treatments that do not improve health or all cause morality, for example, cholesterol medication which is a fraud. You do not have to give money for a kidney transplant, you can reward them with paid health insurance, a condo, an education, it does not have to be a cash payment. If you want to perform daily dialysis, that is great for you, wonderful. However, you are imposing your viewpoint on people who disagree with your standard of morality. As for me, I would not get a kidney transplant because of the harsh medication required after surgery. A Stanford Nephrologist told me that the average living donor kidney will last around 20 years. Yet, if someone wants to pay for a kidney transplant and the costs and benefits are worth it to them, I say why not? The ultimate form of bigotry is demanding rights for yourself, while denying those same rights for other individuals.[/QUOTE

Let me first take issue with the alleged example of cholesterol meds which you incorrectly call useless. Millions of lives have been prolonged by aggressive lipid lowering especially in the post MI population. There are many regression studies showing not only improved survival but plaque reduction in affected arteries as well. As in all things, risk stratification improves the efficiency of the involved med. It puzzles me how medicine has made such great strides in the last 50 years, but many people don’t appreciate how much more we have now compared to that 50 year mark.

Exploitation of the poor is a real issue that many ethicists continue to stand on as a contraindication to an organ market. I agree with that view and believe they are correct. This is most vividly shown in the documented exploitation in the illicit organ market and even in the only legalized market in Iran. Much can be said in detail on this issue. The same type of exploitation is already a known factor for a US market as well. we have many other alternatives that are ethically acceptable that should be explored.

I finally got around to reading the AEI article - this is cross posted from DSEN.

AEI publishes another kidney-centric call for an organ market
By Bill Peckham

The American Enterprise Institute is out with another call for an organ market. Our Deeply Unethical National Organ Policy by Harold Gershowitz (recipient) and Amy Gershowitz Lask (donor) is a full throated call for kidney donor reimbursement. They even suggest a figure, $20,000.

The piece is aggravating for a number of reasons but the most aggravating part is that the authors view the issue as exclusively a kidney issue.

Kidney transplantation is not walled off from the rest of medicine. Change the structure of the kidney acquisition/transplant process, and you change the structure of medicine. Most particularly by paying for kidneys you change the system that has developed for the acquisition/transplant of other organs and tissues.

If a kidney from a living donor is worth $20,000, what’s a postmortem kidney worth? How much for a postmortem liver? Postmortem donation of hearts, livers, lungs and all manner of other useful tissues rely on altruistic donation. If body parts become commodities what will it mean for all the people waiting for postmortem donations? I think the needs of people waiting for irreplaceable body parts (e.g. hearts, lungs, liver (mostly)) should be considered before the needs of those waiting for a kidney.

Have the authors spoken to the relatives of postmortem donors, the ones who had to make the decision to donate, and asked how compensation would have effected their decision? I have. The ones I’ve spoken to were repulsed by the idea. An altruistic donor system can’t coexist with a paid donor system, it’s one or the other. We will lose more than we’ll gain if we allow kidneys to be sold.

Here’s an abstract with a new finding related to kidney donation in men–something I hadn’t thought of before, but there are other conditions (such as BPH) where the urinary system and sexual function can both be compromised at the same time. So, it’s not always about survival…

Urology. 2010 Jun 23. [Epub ahead of print]

[b[Prevalence of Erectile Dysfunction in Living Donors Before and After Nephrectomy in China.[/b]
Guo P, Xie Z, Wang Y, Wang J.

West China School of Medicine, Sichuan University, Chengdu, China.

Abstract
OBJECTIVES: To investigate the prevalence of erectile dysfunction (ED) in living donors before and after nephrectomy in China. METHODS: From January 2006 to December 2008, erectile function of 94 living donors was evaluated before and after nephrectomy by International Index of Erectile Function, version 5 (IIEF-5). A subanalysis was performed by splitting the total cohort into 2 age groups: those <40 years of age (group 1, n = 21) and those >/=40 years of age (group 2, n = 73). RESULTS: Before and after nephrectomy, the prevalence of ED in group 1 was 9.5% and 19.0% respectively, and in group 2 was 38.4% and 56.2%. The difference between groups was statistically significant at the stage of preoperation (9.5% vs 38.4%, P = .012) and 12 months postoperation (19.0% vs 56.2% P = .003). Compared with the stage of preoperation, the prevalence of ED at the stage of postoperation was significantly increased at group 2 (38.4% vs 56.2%, P = .031), but not in group 1 (9.5% vs 19.0%, P = .663). CONCLUSIONS: The prevalence of ED increased in living donors aged more than 40 years after nephrectomy in China. The change in sexual function of these living donors after nephrectomy should cause clinicians’ attention. Copyright © 2010 Elsevier Inc. All rights reserved.

[QUOTE=Dori Schatell;19920]Here’s an abstract with a new finding related to kidney donation in men–something I hadn’t thought of before, but there are other conditions (such as BPH) where the urinary system and sexual function can both be compromised at the same time. So, it’s not always about survival…

Urology. 2010 Jun 23. [Epub ahead of print]

[b[Prevalence of Erectile Dysfunction in Living Donors Before and After Nephrectomy in China.[/b]
Guo P, Xie Z, Wang Y, Wang J.

West China School of Medicine, Sichuan University, Chengdu, China.

Abstract
OBJECTIVES: To investigate the prevalence of erectile dysfunction (ED) in living donors before and after nephrectomy in China. METHODS: From January 2006 to December 2008, erectile function of 94 living donors was evaluated before and after nephrectomy by International Index of Erectile Function, version 5 (IIEF-5). A subanalysis was performed by splitting the total cohort into 2 age groups: those <40 years of age (group 1, n = 21) and those >/=40 years of age (group 2, n = 73). RESULTS: Before and after nephrectomy, the prevalence of ED in group 1 was 9.5% and 19.0% respectively, and in group 2 was 38.4% and 56.2%. The difference between groups was statistically significant at the stage of preoperation (9.5% vs 38.4%, P = .012) and 12 months postoperation (19.0% vs 56.2% P = .003). Compared with the stage of preoperation, the prevalence of ED at the stage of postoperation was significantly increased at group 2 (38.4% vs 56.2%, P = .031), but not in group 1 (9.5% vs 19.0%, P = .663). CONCLUSIONS: The prevalence of ED increased in living donors aged more than 40 years after nephrectomy in China. The change in sexual function of these living donors after nephrectomy should cause clinicians’ attention. Copyright © 2010 Elsevier Inc. All rights reserved.[/QUOTE]

Dori, as you well know and have spoken for years, the donor transplant literature is almost void of any real follow up for these people, yet it is universally called safe, while there is a myriad of observational data and some RCTs for daily dialysis and it is not accepted. There is a terrible transplant bias in America and an anti-dialysis establishment. It is time for a fair and balanced look at both modalities.

Cholesterol medication is useless. Here is a video with Dr. Jerome Kassier, Former Head Editor, New England Journal of Medicine, Nephrologist. My primary care had him in med school, said, “He is awesome.”

Professor Emertius of Organic Chemistry Joel Kauffman, 80 peer reviewed publications, 11 drug patents, 14 years experience in drug development:

Misleading Recent Papers on Statin Drugs
in Peer-Reviewed Medical Journals

Journal of American Physicians and Surgeons Volume 9 Number 1 Spring 2004

Bias in Recent Papers on Diets and Drugs
in Peer-Reviewed Medical Journals
Professor Kauffman

Professor Uffe Ravnskov, Professor of Nephrology and Ph.D. Chemistry:

If heart attacks are caused by eating too much animal fat or saturated fat, a rising intake in a population should of course be followed by more heart attacks and a decreasing intake by fewer attacks. No consistent pattern has been found, however. In a few countries the changes have followed each other and the data from these countries have been used eagerly to support national diet counceling. But in many countries fat consumption has changed whereas heart mortality has not, or vice versa; in many countries they have even changed at opposite directions (54).

In Switzerland, for instance, coronary mortality decreased after World War II. During the same period intake of animal fat increased by 20 per cent (55).

In England, the intake of animal fat has been relatively stable since at least 1910 while the number of heart attacks increased ten times between 1930 and 1970 (56).

In the US coronary mortality increased about ten times between 1930 and 1960, leveled off during the sixties and has since decreased. During the decline of mortality from coronary heart disease the consumption of animal fat declined, but so it did during the previous thirty years of sharply rising mortality (57). In Framingham the decline of coronary mortality was balanced by an increased number of non-fatal heart attacks (58) suggesting an effect of better treatment rather than an effect of dietary changes.

[QUOTE=NDXUFan12;19926]Cholesterol medication is useless. Here is a video with Dr. Jerome Kassier, Former Head Editor, New England Journal of Medicine, Nephrologist. My primary care had him in med school, said, “He is awesome.”

Professor Emertius of Organic Chemistry Joel Kauffman, 80 peer reviewed publications, 11 drug patents, 14 years experience in drug development:

Misleading Recent Papers on Statin Drugs
in Peer-Reviewed Medical Journals

www.jpands.org/vol12no1/kauffman.pdf[/QUOTE]

Well if he thought it was useless, you couldn’t tell by all of the regression studies he showed. Secondary prevention after a heart attack is well documented. Primary prevention has also been shown as well. MRFIT, Framingham and several other studies show that cholesterol is a definite risk factor for atherosclerotic disease. If you don’t believe the well established data, not much I can do about turning that around for you. In the mean time, I will keep taking my Pravachol.

Well, please explain to me, why when I started eating tons of cholesterol, my cholesterol went from 2,000 to 54. My primary care who has been practicing for 30 years, said that people on Atkins or some form of it, tend to have non-existent cholestrol levels. I had my dad read the paper, he said the math was correct, my dad is a chemist. My brother is a Ph.D. in Physics at Northwestern, he said that there is not enough evidence to back up that theory. In additon, was told by physicians at Ohio State University Hospital that cholesterol medicine is worthless. I know too many hard scientists, Ph.D. in Physical Chemistry and Lipid Biochemists who do not agree with that theory. Many hard math people have told me that the Framingham study is incorrect, mathematically.

Professor Ravnskov:

But a correlation has been found in a few studies. One of these was the famous study from Framingham, Massachusetts (32). The correlation found by the Framingham investigators was minimal, however. In statistical terms, the correlation coefficient there was only 0.36. Such a low coefficient indicates a desperately weak relationship between variables, in this case, of course, between cholesterol and atherosclerosis. Usually, scientists demand a much higher correlation coefficient before they conclude that there is a biologically important relationship between two variables.

The very low correlation coefficient was arrived at after much study. First, many of the townspeople of Framingham had their cholesterol tested several times over a period of several years. Then, Dr. Manning Feinleib of the National Heart, Lung, and Blood Institute, led a team of coworkers in studying the coronary vessels of those who had died. The researchers were eager to learn which of the many factors they had studied was most important in the development of atherosclerosis in these dead people from Framingham. Was it blood cholesterol or the number of cigarettes smoked, or something else?

After carefully describing the atherosclerosis in the coronary arteries of the dead people, Dr. Feinleib and his associates concluded that the cholesterol level of the blood best predicted the degree of atherosclerosis. Neither age nor weight nor blood pressure nor any other factor was as good as blood cholesterol. But again, the correlation coefficient between cholesterol and atherosclerosis was a mere 0.36.

The written report of the study offered no diagrams and no information about the cholesterol and atherosclerosis of each of the individuals whose bodies had been examined. And the report did not discuss the very low correlation coefficient; it didn’t even comment upon that matter.

When scientists reach a result contrary to all previous studies, it is routine–not merely usual but routine–to provide a detailed report about the result and also to discuss any possible ways in which the study may have been biased away from accuracy and truth. In the Framingham case, there was an especially great need for this routine scientific procedure to be followed. Not only was the correlation coefficient so trivial, but this study, funded with millions of taxpayers’ dollars by The National Institute of Health, could have a major impact on national health care and the American economy. If there was no connection between cholesterol and atherosclerosis, as the previous studies had shown, then there was no reason to bother about cholesterol or the diet. And billions of taxpayers’ dollars could have been spent more wisely than in lowering the cholesterol of healthy people.

But the scientists conducting the Framingham study had no reservations. They were eager to stress their own excellence and to highlight the weaknesses of Dr. Paterson’s study of Canadian war veterans. In their report, they did not mention the studies of Drs. Landé and Sperry at all, nor the studes from India, Poland, Guatemala or the USA. When the Framingham study authors mentioned their opponents, it was only to criticize without putting their own cards on the table. Some of those hidden cards are fascinating to wonder about.

How were the dead of Framingham chosen for postmortem examination, for example? From 914 dead individuals, the researchers examined only 281. And from the 281, they selected 127 (14 per cent of all dead) who became the subjects of an autopsy program especially designed to investigate the heart and its vessels.

Thus, those chosen for autopsy in the Framingham study were not a random sampling of the population, as they had been in the previous studies. The report from Framingham said nothing about the selection criteria, although scientific studies routinely do. Usually the determining factor is age. A postmortem is seldom performed on people who have died peacefully in old age, as most of us will. Primarily, a postmortem is restricted to young and middle-aged people, who have died before their time, and so it was in the Framingham study. Almost half of those autopsied were younger than 65 years. For this reason, the autopsied subjects had to have included a relatively large number with familial hypercholesterolemia, the unusual genetic disease of cholesterol metabolism. Furthermore, people with this disease are of special interest to scientists studying the cholesterol problem and were probably chosen for autopsy in a program tailored to investigate coronary disease.

With only 14% of the Framingham dead chosen for autopsy, the risk of bias must have been great because there is one exception from the above rule: patients with the rare disease familial hypercholesterolemia have much atherosclerosis, and very high cholesterol levels in their blood. If many such patients are included in a study of cholesterol and atherosclerosis, a correlation will be found.

The question about blood cholesterol and atherosclerosis has been studied by coronary angiography also. It seems as if every specialist in coronary angiography in America has performed his own study, funded with federal tax money awarded by the National Heart, Lung and Blood Institute. In paper after paper published in various medical journals, using almost identical words, these medical specialists emphasize the importance of the blood cholesterol level for the development of atherosclerosis (33).

But the reports offer no individual figures, only correlation coefficients, and these are never above a minimal 0.36, usually even smaller. And they never mention any of the previous studies that found no association between degree of atherosclerosis and level of blood cholesterol.

Studies based on coronary angiography are fundamentally flawed if their findings are meant to be applied to the general population. Coronary angiographies are performed, mainly, on young and middle-aged patients with symptoms of heart disease, which means that a relatively large number of patients with familial hypercholesterolemia must have been included. Again, there is an obvious risk for the kind of bias that I described above. The fact that this objection is justified was demonstrated in a Swedish study performed by Dr. Kim Cramér and his group in Gothenburg, Sweden (34). As in most other angiographic studies the patients with the highest cholesterol values had on average the most arteriosclerotic coronary vessels.

But if those who were treated with cholesterol-lowering drugs were excluded, and almost certainly this group must have included all patients with familial hypercholesterolemia, the correlation between blood cholesterol and degree of atherosclerosis disappeared.

In Japan the food is meager, blood cholesterol is low and the risk of getting a heart attack is much smaller than in any other country. Given these facts you will most probably say that in Japan atherosclerosis must be rare.

The condition of the arteries of American and Japanese people was studied in the fifties by Professors Ira Gore and A. E. Hirst at Harvard Medical School (35) and Professor Yahei Koseki from Sapporo, Japan. At that time US people on average had a blood cholesterol of 220 whereas Japanese had about 170.

The aorta, the main artery of the body, from 659 American and 260 Japanese people were studied after death. Meticulously all signs of atherosclerosis were recorded and graded. As expected, atherosclerosis increased from age 40 and upwards, both in Americans and in Japanese. Now to the surprising fact.

When degree of atherosclerosis was compared in each age group there was hardly any difference between American and Japanese people. Between age forty and sixty Americans were a little more arteriosclerotic than Japanese; between sixty and eighty there was practically no difference, and above eighty Japanese were a little more arteriosclerotic than Americans.

A similar study was conducted by Dr J.A. Resch from Minneapolis and Dr.s N. Okabe and K. Kimoto from Kyushu, Japan (36). They studied the arteries of the brain in 1408 Japanese and in more than 5000 American people and found that in all age groups Japanese people were more arteriosclerotic than were Americans.

The conclusion from these studies is of course that the level of cholesterol in the blood has little importance for the development of atherosclerosis, if any at all.