Possible Directions For Further Research
The committee was hampered by lack of evidence in several areas, including not only medical questions pertaining to transplantation but also factors affecting patient compliance with medical advice and the comparison of the costs of alternative treatments that receive substantial public funding. Given the cost and risks associated with long-term use of immunosuppressive drugs, the prospect of alternatives that are safer, less expensive, or both is obviously attractive.
For the present, a better understanding of the factors that support or obstruct compliance with therapeutic regimens would be helpful. Compliance is clearly a complex phenomenon that is difficult to study. However, because noncompliance puts pressure on an already scarce lifesaving resource, it is important to try to identify barriers to compliance that are amenable to mitigation through dose alteration, financial, educational, or other strategies. Research indicating that patients are more compliant just before contact with health care professionals suggests that research on practical, affordable ways of increasing such contacts might be productive.
The committee also encourages the National Kidney Foundation and George Mason University in their survey of kidney transplant patients. The survey may improve understanding of the impact of coverage on both patient compliance and other social and economic activities such as employment.
The Next 50 Years: Hope And Promise
The next 50 yr are sure to deliver advances that will again revolutionize the way we think about transplantation and, more globally, about the health-disease continuum. Already the experience with autoimmune disease, immunosuppressive states such as HIV and AIDS, and transplantation has influenced the way we conceptualize the immune system and circumstances in which it malfunctions. The immune system is now understood to be a complicated overlap of multiple systems that can both fight and promote states of disease depending on the circumstances. The simple notion of a binary process of on and off, for example, were necessarily abandoned upon the discovery that immunosuppressed AIDS patients often demonstrated augmented types of allergic immune reactions and that immune activated autoimmune patients had suppressed reactions to normal pathogens. These patients did not have suppression so much as a dysregulation of their immune systems. Accordingly, we have now moved toward specific modulation of the immune system to achieve more precisely what is desired and are thus able to avoid many of the deleterious consequences of having simply too little or too much immune activation.
Statements Of Others On Coverage For Immunosuppressants
More policy attention has been devoted to renal transplantation than to the transplantation of other organs, reflecting the greater number of these operations and the longer experience with transplantation as a successful treatment modality in the case of ESRD. The disparity in the number of transplants of different types of organs may decrease as continuing developments in the technology of transplantation are reflected in the increased success rate of other types of transplants. At this time, policy statements by other groups tend to focus on renal transplantation.
The committee noted that a previous report included coverage policy recommendations at the request of the Congress. In Kidney Failure and the Federal Government, the IOM committee then in place recommended that all ESRD patients who are citizens or resident aliens of the United States be eligible for Medicare coverage, that the time limit on coverage for immunosuppressive drugs be eliminated, and that other Medicare benefits also be extended to these patients without time limits. The earlier report did not address transplants of organs other than the kidney.
The National Kidney Foundation also advocates the elimination of the time limits on Medicare coverage. It too argues that this would save Medicare money.
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First Successful Transplant Of A Pig Kidney Into A Human Performed
The first successful transplant of a pig kidney into a human was performed on Saturday, September 25, 2021, at the New York Universitys Langone Transplant Institute.
The kidney was obtained from a pig that had undergone gene editing to knock out a sugar molecule that elicits a devastating immune response in humans and has been responsible for the failure of previous attempts at cross-species transplantation, so called xenotransplantation, said lead investigator Dr. Robert Montgomery who led a surgical team in a two-hour operation. Biopsies taken every 12 hours and viewed under the microscope showed no evidence of rejection.
The transplant was performed on a patient who was already brain dead. According to a press release by NYUs Lagone Transplant Institute the family graciously approved donation of their loved ones body for this procedure.
The kidney was obtained from a genetically engineered pig hundreds of miles away and transplanted into a deceased donor. The donor was maintained on a ventilator, with the consent of the family, for 54 hours while doctors studied the kidneys function and watched for signs of rejection, said NYU.
What was profound about these findings is that the pig kidney functions just like a human kidney transplant, said Dr. Mongomery. Individuals who receive a kidney transplant on average live twice as long and with a better quality of life as patients who remain on dialysis. However, human organs for transplantation are scarce.
In 1997 India Had Seen A Similar Operation When A Transplant Surgeon From Assam Had Conducted A Pig
New Delhi: For the first time in history, a medical team in the US was able to successfully transplant a pigs kidney to a human patient.
The breakthrough procedure was performed by surgeons at NYU Langone Health, using a kidney that had been grown in a genetically altered pig. The patient who received the kidney was brain-dead and was being kept on a ventilator, according to a report by The New York Times.
The kidney was attached to blood vessels in the patients upper leg outside the abdomen. The NYT report quoted Dr Robert Montgomery, the director of the NYU Langone Transplant Institute, as saying that the organ had started functioning normally, making urine almost immediately.
Xenotransplantation, i.e. the transplantation of organs from one species to another, is not a new phenomenon.
In India too, in 1997, a transplant surgeon from Assam, Dr Dhani Ram Baruah, along with Hong Kong surgeon Dr Jonathan Go Kei-Shing hadconducted a pig-to-human heart and lung transplant in Guwahati. The surgery, however, landed him in hot waters following the patients death.
Heres a look at the history of xenotransplantation, the challenges, and how the particular procedure in the US was conducted.
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Immunosuppressive Drugs For Transplant Patients
Successful transplantation of human organs is one of the most dramatic achievements of modern medicine. The first successful kidney transplant was performed in 1954 between identical twins, and the first transplants of other organs such as pancreas, liver, and heart followed in the 1960s. Organ transplantation was, however, restricted by the limited effectiveness of the treatment then available to control the body’s rejection of grafted organs. With the development of more effective immunosuppressive drugs in the 1980s, transplants have become an accepted treatment for an increasing number of deadly diseases . More than 20,000 transplants were performed in 1998. With the increasing survival of recipients with functioning grafts, estimates of the number of people now living with a graft range up to 125,000, but a precise figure is not available.
Today, a major limit on transplantation is the shortage of organs available. Nearly 65,000 people were registered on waiting lists for organ transplantation in 1998, and more than 4,500 were removed from waiting lists due to death . Maintaining the health of transplanted organs not only protects the recipients of transplants from death, retransplantation, or other trauma it also protects a scarce resource. Immunosuppressive drugs are essential for these dual protections, but their high cost means that most transplant recipients need financial assistance to pay for them.
How The Docs Did This Miracle
Allow us to inform you that theres a sugar within the cells of the pig, which the human physique doesnt settle for. Thats the reason all the sooner makes an attempt have been unsuccessful. Retaining this in thoughts, docs this time used pig kidney with particular modified gene. That sugar current within the pigs cell with the modified gene had already been eradicated. Aside from this, some genetic modifications have been made to keep away from the assault of the immune system within the pig.
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In The Us Health System
Transplant recipients must take immunosuppressive anti-rejection drugs for as long as the transplanted kidney functions. The routine immunosuppressives are tacrolimus , mycophenolate , and prednisolone these drugs cost US$1,500 per month. In 1999 the United States Congress passed a law that restricts Medicare from paying for more than three years for these drugs unless the patient is otherwise Medicare-eligible. Transplant programs may not transplant a patient unless the patient has a reasonable plan to pay for medication after Medicare coverage expires however, patients are almost never turned down for financial reasons alone. Half of end-stage renal disease patients only have Medicare coverage. This provision was repealed in December 2020 the repeal will come into effect on January 1st 2023. People who were on Medicare, or who had applied for Medicare at the time of their procedure, will have lifetime coverage of post-transplant drugs.
The United Network for Organ Sharing, which oversees the organ transplants in the United States, allows transplant candidates to register at two or more transplant centers, a practice known as ‘multiple listing’. The practice has been shown to be effective in mitigating the dramatic geographic disparity in the waiting time for organ transplants, particularly for patients residing in high-demand regions such as Boston. The practice of multiple-listing has also been endorsed by medical practitioners.
Unos Is Committed To Increasing Transplants
Today, the U.S. system for organ donation and recovery is among the best in the world. As a result of innovation and continuous improvement, more patients in need of organ transplant than ever have received the gift of life. But there is more that we can and must do to serve the patients still waiting for a lifesaving organ.
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When Was The First Successful Kidney Transplant Performed
Experimental allotransplants and xenotransplants of the kidney in animals were begun in the latter half of the 19th century. By the opening decades of the 20th century, unsuccessful attempts at xenotransplantation in humans were undertaken in Vienna by Emerich Ullman , who transplanted a pig kidney in the elbow of a young woman with uremia, and in Lyon by Mathieu Jaboulay , who transplanted a sheep kidney in one patient and a pig kidney in another. The first cadaveric kidney transplant was performed on April 3, 1933 in Kiev by Yuri Voronoy , who transplanted the kidney from a 60-year-old woman who had died from head injury to a 26-year-old woman with acute kidney injury from mercury poisoning, a common cause of kidney injury at the time. The patient died 48 hours later.
Richard Herrick recovered kidney function, married the recovery room nurse who had cared for him after the transplant, had two children, and enjoyed good health until his death in March 1963. In 1990 Joseph Murray received the Nobel Prize in Physiology or Medicine, shared with another American physician E. Donnall Thomas , for their contribution to organ and cell transplantation in the treatment of human disease, the third Nobel prize to be granted for work on transplantation.
A Controversial Case In India
India had also seen a case of xenotransplantation 24 years ago, although that story had a tragic ending.
In January 1997, news emerged of a cardiac surgeon in Assam, Dr Dhani Ram Baruah, transplanting pig organs into a 32-year-old man with end-stage heart disease. Baruah is said to have carried out the procedure on the patient as a last resort with consent from their family.
A week after the transplant procedure, the patient died of multiple infections, which led to Baruah being detained for 40 days forviolating the human organ transplant laws in India.
Over two decades on, the doctor told ThePrint that his career was totally disturbed due to the number of restrictions put by the court and he eventually had to divert his focus from xenotransplantation to genetic engineering. He now runs the runs the Dr Dhaniram Heart Institute and Research Centre in Sonapur, about 20 km from Guwahati.
Comparing the procedure he had performed and the one that was done by the US doctors, Baruah said his procedure was quite different.
I did not do any genetic alteration in the pigs organ and instead came up with an anti-hyperacute rejection therapy, which was given to that pig organ so that it can be accepted by the human body easily, he said. I did not use any immunosuppression and additionally removed preformed antibodies from human blood so that it had given extra protection for acceptance.
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Organ Transplantation: Halfway Through The First Century
The ancient dream of successful organ transplantation was finally realized 50 yr ago, on December 23, 1954, at the Peter Bent Brigham Hospital in Boston. Over the subsequent half century, the separate disciplines of clinical transplantation and transplant immunology have made remarkable progress. The story of the convergent evolution of these two fields represents one of modern medicines most important advances. This path of discovery has uncovered both the practical and the fantastic, and along the way, it has been marked by the awarding of more Nobel Prizes than any other field of medicine. The movement of functional organs from one individual to another and the clinical manipulation of the immune system necessary to make this movement successful have gone from being a tour de force to part of everyday clinical practice in just 50 yr. Perhaps most striking, however, is the enduring effect of these advances on the way we think and dream about medicine itself.
Did You Know This Doctor Performed The First Successful Kidney Transplant Between Humans Who Were Not Identical Twins
Theodora Aidoo | Staff Writer
Theodora Aidoo is a young woman who is passionate about women-related issues. Her Love: To bring to fore the activities of women making a global impact. This stems from her journalism background from the Nigerian Institute of Journalism and Ghana Institute of Journalism.
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Committee Findings And Conclusions
In developing its findings and conclusions, the committee benefited from the review of the literature presented in and the discussion during a public workshop that included clinicians, researchers, and members of the public . Unfortunately, little systematic research is available to assess the health and cost consequences of the current coverage limit on immunosuppressive drugs. The committee’s findings, as discussed in this chapter, are summarized briefly below. Its conclusions about Medicare coverage follow:
Waiting Lists For Transplantation
The increased transplant success rate has meant that renal transplantation became a better treatment for ESRD than dialysis. For kidneys and other organs as well, increased success has made the supply of donated organs a critical concern.
The relative scarcity of organs is evident in the growing number of patients on the waiting lists for transplantation . This growth is due in part to the increasing number of people with organ failure and in part to the improved safety and effectiveness of the procedure that allows it to be offered to a wider population of patients including some who have survived the failure of a first grafted organ. Long waits for a transplantâwaits that may end in death before an organ becomes availableâare a significant part of the burden of the diseases treated by transplantation. The main âtreatmentâ for these waits would be an increase in organ donation or the development of effective, acceptable alternatives to human organs. For the present, however, every transplanted organ that is successfully maintained also helps prevent further increases in the waiting list and waiting times.
Number of Patients on Waiting Lists at Year’s End, Selected Years.
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The Disparity Between Organ Supply And Demand
The largest and most pernicious problem affecting transplant programs today is the shortage of suitable organs to transplant. Despite a sizable public awareness campaign, the number of cadaveric donors has remained fairly steady over the last decade. The numbers of patients on the waiting list, however, has skyrocketed, leading to burgeoning waiting times and increased death rates for those on the waiting list. Some of this shortfall, at least in kidney transplantation, has been met with the use of living donor transplantation. Living donation also has been utilized with patients who need liver allografts, because a part of the donor liver can be taken, which will subsequently grow in to an entire organ. High rates of morbidity and some mortality has limited the widespread acceptance of living donation of livers, and for obvious reasons, this approach is not generally possible for the intrathoracic organs.
Availability Of Effective Treatment
Questions that the committee had to grapple with in the previous chaptersâwhether evidence showed that the clinical intervention proposed for coverage improves outcomesâhave largely been settled in the case of immunosuppression after organ transplantation. As shown in , more than 75 percent of kidneys, livers, hearts, and even lungs are now functioning one year after transplantation, and in all categories except lung grafts, more than 60 percent of the grafts are still functioning five years after transplantation. Patients are surviving at somewhat higher rates than grafts. More than two-thirds of transplant recipients now survive at least five years.
Graft and Patient Survival Rates at One and Five Years.
Of the four classes of drugs that have contributed to the major improvements in graft and patient survival in recent years, products in one class are used on a short-term basis and, thus, are not a Medicare coverage issue. Products in the other three classes are used on a long-term basis. Physicians generally prescribe a combination regimen for long-term use because the different classes of drugs work in different ways and have different side effects. The combination approach helps achieve high levels of immunosuppression without letting any particular type of side effect become as bad as it might otherwise be.
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