By Brigid McMenamin
The following article published in the March 11, 1996 issue of Forbes Magazine is extremely controversial, at best. The editor of UpBeat does not feel he is knowledgeable enough to critique what are seemingly distortions, omissions of fact, and obvious errors - as in the case of it taking "0" days median wait for a heart in Hawaii. As of this writing UNOS has not offered an official comment, however, such is expected and UpBeat will attempt to publish same next month. DM
In January 1994 doctors at New York's Mount Sinai Hospital told Electra Tsucalas that her liver was failing. Her only hope was a transplant. Across the river in New Jersey, Tsucalas could have had a new liver in less than 3 months. In New York, she had to wait 15 months. By a miracle she survived. Others aren't that lucky. Last year 3,104 patients died waiting for transplants of all types. (For tips on how to make sure you aren't one of the unlucky ones, see box, p.148.)
How lucky you are depends almost entirely on where you are. About 44,000 patients in the U.S. are waiting and hoping for transplants of all kinds; in Fort Worth, Tex., the wait for a kidney is only a few weeks; in nearby Dallas, however, the wait is more like a year.
Why don't the transplant hospitals simply harvest more organs? Or import them from other cities? Because they aren't allowed to under a 1984 law that took organ donation and allocation out of the hands of doctors, hospitals and patients and put it in the hands of a federal bureaucracy.
The bureaucracy rules over a series of organ banks. The banks, with rare exceptions for kidneys, aren't allowed to export organs if anyone in the local territory can use them. Thus a critically ill patient in one city might die while organs go to less desperate patients nearby. The system was supposed to insure the supply and fair allocation of organs. It doesn't work that easily.
Until about a decade ago federal government involvement was limited to Medicare reimbursement for kidney replacements. Doctors did relatively few transplants because patients' immune systems usually rejected the foreign organs. All that changed in 1983, when Sandoz Pharmaceuticals Corp. introduced cyclosporine, a drug that suppresses the immune system, thereby reducing the chances of rejection. Along with the sudden boom in transplants came fears that an unregulated market would benefit only wealthy patient s. In 1984 AI Gore, then a U.S. congressman and a strong advocate of federal interventionism, demanded that the federal government step in to regulate transplants.
As often happens in such cases, policies intended to promote egalitarianism simply ended up making everyone worse off. Congress took the bait, and the National Organ Transplant Act of 1984 was passed. The act banned commerce in organs and put the Department of Health and Human Services in charge of donations and transplantation.
Faster than you could say "bureaucracy," the feds set up a network of 69 local organ banks to harvest and distribute organs. The allocation guidelines sound logical: A Richmond, Va. contractor called the United Network for Organ Sharing keeps a list of all transplant candidates. That list has all kinds of information, including how sick the patient is, his blood type, height, weight and what size organ the candidate needs.
Say a liver turns up in San Francisco. The Richmond organ network ranks suitable liver seekers in northern and central California based on how sick they are and how long they've been waiting. The local organ bank selects the sickest patient within the local territory who has waited the longest. The organ bank sells the liver to the hospital where the patient is waiting. No organ can
be sent out of that territory, however, until every liver candidate has been considered, even if, say, a patient in southern California has a more urgent need.
These arbitrary territorial limits are killers. Ask Dr. John Fung, a liver transplant specialist at the University of Pittsburgh Medical Center. Fung has more than 530 patients waiting for livers. Many come from other states, draining the local organ supply and making it harder for locals to get organs. In 1995 some 18% of Fung's liver patients died waiting, including many Pittsburgh area patients who couldn't afford to go elsewhere.
"This system is so grossly unfair," fumes Fung, who says he went into medicine to avoid politics and now finds that the only way he can help his patients is to lobby for change.
Quite clearly the national demand for organs exceeds the supply. The chief source is patients who become brain-dead through accidents or other causes but have otherwise healthy systems. There are more than enough brain deaths each year--some 15,000, according to the Harvard University School of Public Health--to take care of the 44,000 people on the transplant waiting list. In cases of brain death, the organs can be kept alive with a respirator that keeps the heart pumping. One donor can provide several or gans, a couple of kidneys, say, and a heart, lung or liver. In 1994, the latest year for which figures are available, the federal system produced 5,100 dead donors, enough for 15,200 transplants. (The organs become available when the hospital calls the local organ bank to report a potential donor and the family consents.) So why the interminable waits? In large part because of the bureaucratic centralization dreamed up by Gore and passed by Congress. A doctor cannot make a deal on his own to get an organ fo r a patient. The doctor must list his patient with the Richmond, Va. organ network, even if there is a potential donor in the doctor's own hospital. The donor's family simply turns the organs over to the local organ bank.
One consequence is that few hospitals have any incentive to encourage donors. Why bother when they won't be able to keep them for their own patients? Five thousand of the nation' s 6,300 hospitals don't produce even one donor per year. Even the huge transplant hospitals aren't very good at it. In 1994 New York's Mount Sinai did 262 transplants of all kinds. But Mount Sinai (1994 revenues, $736 million) produced only two donors. Today 230 patients are waiting for livers at Mount Sinai. Last year some 30 Moun t Sinai liver candidates died waiting. Many would have lived had Congress not wrapped the whole transplant system in so much red tape.
The basic problem is this: The government monopoly that runs the transplant market is terribly bad at creating supply to satisfy the demand. Each organ bank has a staff of "procurement coordinators" trained to sell grieving families on the idea of donating a loved one's organs to help strangers. It's a tough sell. And the coordinators are forbidden to offer compensation, not even to help with burial expenses. So the families of potential donors have no financial incentive to give.
In a recent survey by the Boston-based Partnership for Organ Donation, 52% of the families that refused said they didn't realize that their brain-dead relative was in fact dead. No wonder the yields are low.
"Our organ bank does not do a good job," says Dr. Byers Shaw, head of the transplant program at the University of Nebraska Medical Center in Omaha. Shaw, who received only 95 livers last year, says he could have used 200 more.
If Shaw is disturbed by conditions in Nebraska, he would be outraged by what happened in New York City. The New York Regional Transplant Program (1994 revenues, $10.5 million) is the organ bank that handles procurement at hospitals in New York City and its northern and eastern suburbs. Last year the board hired a lawyer to investigate the spending practices of Executive Director Bruce McFadden. Among the findings: In 1994 the organ bank staff spent $721,476 on travel, $353,449 on consultants, $153,182 for & quot;conferences," $121,000 on public relations and nearly $1 million to renovate the offices, including a custom made standup desk for McFadden. More than half the organ bank's revenues come from Medicare and Medicaid. But what really worried the board wasn't the extravagances so much as one outlay that did a lot of good for patients: $30,000 to reward families who donated by picking up the cost of shipping the donor's remains home for burial. Under the federal law, payments for donations are a no-no. McFadden was allowed to resign. The New York situation may not have been typical, but it demonstrates how little the politically appointed bureaucracy is concerned with increasing the supply of organs.
Transplants have long been lucrative procedures, according to Burlington, Mass. based Putnam Associates. Liver transplants typically run about $200,000. The federal government has found a way to keep a lid on demand. To get Medicare transplant patients, hospitals must promise to shun candidates with certain conditions. To get Medicare liver transplant patients, for example, they are expected to avoid liver seekers with diseases like cancer. Medicare recently came out against paying for lung transplants at c enters accepting patients who have had chest surgery, are seriously overweight, smoke or have recently quit smoking. It's Medicare's way of rationing transplants for everyone.
In at least one sense the artificial shortage of organs caused by federal policy encourages high prices: What's scarce becomes more valuable, and price resistance vanishes. Given a better supply of hearts, livers, lungs and kidneys, more such operations would take place and the price might well drop.
An obvious solution would be for the government to get out of the way and let the market take over. Once doctors and hospitals could harvest organs for their own patients, there would be added incentive for doctors and hospitals to solicit for them. If they could offer money and other economic incentives, more families might agree to donate. Of course, this would inevitably lead to charges that the rich were buying organs from the poor. So if that totally free market solution is unacceptable, there are less drastic changes that could increase the supply of organs and reduce the waiting time and the regional disparities.
At minimum, local organ banks should compete with one another so that there is more incentive to find donors. Also, the arbitrary territorial boundaries should be eliminated to let the organs go to the neediest patients. And the government should reward donors. Here's a good way:
If you sign "donor" on your driver's license at age 18, you get to the top of the list when you need a heart at age 53. (My goodness, the UpBeat system!)
The earlier you get on a waiting list, the more likely you are to get an organ before it's too late. So get the process going, even if your doctor says you do not need the transplant right away. Call the United Network for Organ Sharing (UNOS) at 1-800-24DONOR. Ask for a copy of the 1994 Report of Center Specific Graft and Patient Survival Rates (price: $115) or just the liver volume ($30).
This book tells how many liver transplants each hospital did between 1987 and 1991, what percentage of the grafts took and what percentage of the patients survived. The results vary considerably.
At Duke University Medical Center, for instance, fewer than 40% of the liver recipients lived one year. By contrast, at the University of Wisconsin Hospital nearly 85% of the liver recipients survived at least one year. And at New York University Medical Center nearly 90% lived at least one year.
Be sure to ask transplant hospitals for current survival rates, in writing. Once you've picked a hospital with good numbers, ask how long its patients usually wait. Insist on getting the overall average waiting time, then check it with UNOS. Demand a copy of the Analysis of Waiting List Registrations and Median Waiting Times.
If the hospital or UNOS puts you off, contact Judith Braslow at the Department of Health & Human Services Division of Transplantation (301-443-8036, or E-mail her at firstname.lastname@example.org).
Some of the differences in waiting times are astonishing: In New York, for instance, the median wait for a liver is 308 days, while in Wisconsin, it's only 61 days. So, as good as NYU is, if you need a liver fast, you're better off in Wisconsin.
But before you go flying off to the Midwest, make sure the hospital doesn't rule you out because of your age or medical problems such as cancer, or alcohol or drug abuse. If you don't make the cut because of some arbitrary rule, use the UNOS book to check if they've ever transplanted anyone in your condition. Your doctor may be able to convince them to make an exception for you, too.
Next step: Figure out how your transplant will be paid for. Medicare pays for kidney replacements, with no age limits. But if you're under 65 you are not eligible for a Medicare heart, lung or liver, unless you have been disabled at least two years. So ask each center to estimate the price for your evaluation, transplantation, follow-up care and medicine. Then check your health plan to see if there are any coverage limits. Even with limits, there is some room for bargaining.
Next, have your doctor refer you to your first-choice center for evaluation. If they accept you, they'll send UNOS information on your age, sex, condition, blood type and a $325 computer registration fee. You can improve your chances of getting an organ quickly by listing at more than one transplant center. Few doctors will tell you about this option. Only 5% of all patients multiple list. But if you can afford it, you should.
Transplant candidates waiting in the hospital usually take precedence over those well enough to go home. So another way to speed things up is to get your doctor to put you in the hospital until an organ turns up.
Improve your chances even more by getting the transplant center you've chosen to import an organ from a foreign organ bank. U.S. transplant centers are allowed to use foreign sources as long as the donor is dead and the family receives no compensation. UNOS can provide you with a list of foreign organ banks if asked.
Finally, be available. A third of transplanted organs don' t go to the first person on the list--often because when the organ turned up, the doctor couldn't get the patient on the phone in time. Carry a beeper all the time so when your turn comes, you'll be ready.
From UNOS, request copies of three brochures: "What Every Patient Needs to Know," "Questions Patients Should Ask" and "Financing Transplantation.--B. MCM.
Where do you find the longest waits?
Where do you find the longest waits?
Where are you least likely to get a kidney'?
|D. of Columbia||**||18.5|
* Of patients listed in 1994.
**So few of the kidney patients listed in 1994 have been transplanted that UNOS can't compute median waiting times for 26 of the 42 states, Washington, D.C. and Puerto Rico, where kidney transplants are done.
Source: United Network for Organ Sharing. Forbes Inc. 1996 Issue Date March 11, 1996
It was amusing to see, therefore, an article in the latest UNOS Update discussing the '96 blizzard in Richmond, VA, the home of UNOS. With the article was a picture showing "neighbors helping each other shovel out their cars." Now the caption didn't say they were UNOS employees, but it did identify them by name, and very significantly to this reader the car they were extricating was most definitely a Mercedes Benz. Doesn't seem to be a great PR month for UNOS !
Remember Claire Silvia? She's the '88 heart/lung recipient who has been on national TV indicating that she feels strong characteristics of her donor since her transplantation. Well she has now signed a book contract for a "goodly sum of money" to describe her experiences.
The book will be ghost written and called "A Change of Heart." It's from Little Brown and due out next year. Some of us apparently just don't realize what's going on - if Ms. Silvia is to be believed my donor was obviously a portly, yet sloppily dignified person, always hungry, who napped a lot with heavy snoring, but write a book about such experiences? I don't think so.
LOS ANGELES -- It was a suh-PRISE, suh-PRISE, suh-PRISE for a young transplant patient when Jim Nabors strolled into her hospital room.
Priya Singh let out a holler when the star of "Gomer Pyle, U.S.M.C." visited her and other patients Thursday at the University of California, Los Angeles, Medical Center.
"Well golllly!" Nabors said in his trademark hayseed fashion. "She's obviously seen Gomer' s work."
Touching the 14-month-old girl's cheek, Nabors said: "Well, bless your heart. I felt like that when I was in the hospital, too."
Nabors received a liver transplant at the medical center two years ago. He, the center and Baylor University Medical Center in Dallas recently started an organ donor awareness and fundraising program called "Friends & Nabors." The campaign is designed to stress the importance of organ donations and raise $1 million for transplant research and education.
ROME -- A man who had six organs transplanted at a Miami hospital returned Sunday to his native Italy nearly sere n months after the 36-hour operation.
Leonardo Cioce, 29, was near death from Gardner's Syndrome, a rare congenital disease in which tumors slowly invade and strangle organs.
He received a new kidney, pancreas, stomach, large intestines, small intestines and liver in the operation that began July 15 at Jackson Memorial Hospital.
The operation, which cost $600,000, was directed by Dr. Andreas Tzakis, one of the leading transplant specialists in the United States.
"I can't wait to get home and hug my entire family," said Cioce, who stopped in Rome while en route to his hometown of Bari in southeastern Italy.
He urged Italians to overcome the "psychological barrier" of organ donation, which is very rare in Italy.
SAN FRANCISCO - Doctors in San Francisco said on Saturday they successfully removed the donor liver from a young girl who underwent a partial liver transplant after eating poisonous mushrooms, adding that the girl is recovering.
In a rare procedure, doctors last week removed the transplanted liver after finding that 13-year-old Jennifer Chang's injured liver was quickly regenerating itself.
Chang left the hospital on Thursday following the procedure and is recovering at home. Her doctors said she was in good condition on Saturday and was no longer taking anti-rejection drugs, which could have increased her susceptibility to infection and other problems.
"She probably will have perfect health from this," said Jean Emond, director of pediatric liver transplantation at the University of California at San Francisco Medical Centre. "This operation succeeded beyond our wildest expectations."
Chang returned to her home to recover with about 70 percent of her own liver intact. Doctors said a healthy patient can live with as little 30 percent of her own liver.
"She proved to us that she had sufficient liver function," said Emond, adding that Chang's liver would quickly add cells and would be functioning normally within three to 10 weeks.
Wild mushrooms grew around the San Francisco Bay area after recent heavy rains. The 13-year-old girl, two brothers and her mother fell seriously ill earlier this month after mistakenly picking and eating the highly toxic "death cap" variety, which can cause liver damage and sometimes death.
WARSAW, -- A 26-year-old Polish woman with a transplanted heart Monday gave birth naturally to a 7.2-pound baby boy, the first such event in Poland, the Polish news agency PAP said.
The woman had her heart transplant three and-a-half years ago and has been under the care of the Cardiological Academy of the Jagiellonian University of Krakow, southern Poland.
The birth took two hours and mother and child are said to be in good condition.
There have been only 30 such cases worldwide so far.
Date: Sat, 2 Mar 1996 13:26:03 EST
Don Marshall <email@example.com> reported:
I just had a call from a fellow heart recipient, Cathy McGill, in Silvis, Illinois. She was in a mild state of shock because on going to pick up her monthly drug supply today at her local pharmacy (name withheld), she was told that "Sandoz is no longer making cyclosporine capsules and that she would have to see her doctor about switching to Neoral" ... has someone at her local pharmacy really dropped the ball. or is there truth to this potential bad situation ?
I apologize in advance for using brand names in this message, but using cyclosporine (Sandimmune) and cyclosporine-for-microemulsion (Neoral) gets a little cumbersome. I can't speak for her pharmacy, but I can tell you:
1) Cyclosporine (in this case, I guess, Sandimmune-type) is not manufactured in this country at all - it is made in Germany and shipped here for packaging. As far as I know, cyclosporine is being made both as Sandimmune and Neoral at the German plant, because there are places where Neoral is not approved for use - and even in those places where Neoral is approved, not everyone is on it; so there is still demand for the older formulation, and that demand will continue to be met for as long as it exists.
2) Whoever is responsible for ordering stock for the pharmacy in question should get in touch with the wholesaler and order some Sandimmune; if there is any problem with the wholesaler filling the order, that responsible person should call Sandoz customer service (201-503-7500) and get the name of a wholesaler that has the drug in stock.
3) Projections of prescribing habits, based on experience in other countries, indicate that we can expect a virtually complete switch to Neoral (which is, in my professional opinion, a better formulation - but I may be biased, because I have been watching all the effort put into making the formulation better) by the end of 1996; ordering of drugs is based on projections of this sort, so there is the possibility that someone may over-order Neoral and under-order Sandimmune at some time during the transition period - but there should be plenty of Sandimmune in the warehouses, so I would not expect that anyone who is prescribed Sandimmune will be unable to get it - it just might take a few more phone calls, and I regret that inconvenience to anyone.
Change, even change for the better, is often met with resistance, and that is probably a good thing, else we might all run headlong into a situation before it has been fully explored. As I stated above, I am convinced that Neoral is a better formulation of an almost miraculous drug - and I have commented elsewhere in this newsgroup on my perspective on the idea of "if it isn't broken, why fix it?" so I won't take up bandwidth here. As I comment in another note in close proximity to this one, Neora l is simultaneously the same drug and a very different one, which will probably have to be given in a different fashion: I have theories about how it will be given, but that isn't mine to say - it is up to the practitioners of medicine (and the patients, as well) to determine how this new formulation will best serve the needs of those who need it in order to lead healthy new lives...
WASHINGTON (AP 2/9/96) -Lloyd Cohen says he's found a way to end the severe shortage of vital organs needed for medical transplants: Let people sell their hearts, livers and kidneys when they die.
"There are those who like to pontificate about the desecration of the human spirit and such, but meanwhile people are dying for the lack of vital organs," says Cohen, a law professor at George Mason University.
It may sound like a ghoulish proposition, but Cohen says giving people an economic incentive to let their organs be used in transplant operations would end a scarcity that prevents many Americans from having lifesaving operations.
"If you pay people for something that's valueless to them, you'll probably get more of them to provide it to you. Why let usable organs be burned or become food for worms?"
Cohen wants people to have the same property right in their body parts as they have in homes, cars, boats or other worldly possessions. In other words, an estate could earn money through the sale of the vital organs of the deceased.
Such a right does not exist today. "Why shouldn't someone own his heart or his liver in the same way he owns his wristwatch?" Cohen asks.
Here's how Cohen's organ-transplant market would work:
--A government or quasi-government procurement agency would spread information about how valuable their organs have become, perhaps $5,000 per heart, liver and kidney.
--Potential donors would sign cards agreeing to provide organs if the circumstances of their deaths make harvesting possible and would specify to whom payment should be made.
--The procurement agency would maintain a national registry, and hospitals would have a legal duty to notify the agency and preserve the organs until transportation could be arranged.
He estimates that as many as 80,000 organs would become available each year, at a cost to the government of $560 million -$5,000 per organ plus shipping and handling costs. Cohen does not say whether recipients or their insurance companies would have to pay for the organs.
Cohen isn't too concerned with those questions, although alternatives are discussed in his book, Increasing the Supply of Transplant Organs: The Virtues of an Options Market.
Cohen says the new market would not add more incentive for murder or suicide than already exists because of lite insurance. "If we can, let' s induce people who are going to commit suicide anyway to do it in a way that may save someone else's life," he said.
The problem is, Cohen has failed to get anyone in Congress excited about his proposal. And federal law -- the National Organ Transplant Act of 1984 -- currently makes it a crime to buy and sell human organs and tissue, with the exception of blood.
The National Conference of Commissioners on Uniform State Laws drafted a model anatomical gifts law in 1968, and all 50 states adopted it or something close to it. The model was amended in 1987 to conform to the federal law and make organ selling illegal. To date, 21 states have adopted that version.
"We are revisiting the model act periodically but so far nobody has raised the sale issue," says the conference's John McCabe. "I don't hear anyone in the organ procurement area talking about this. There' s no hue and cry."
McCabe believes some other form of economic incentive might be more attractive. "Allowing deductions on health insurance in return for donor cards is one alternative," he suggests.
"Cohen's idea, which is really a market in organ futures, has value," McCabe says, "because it causes us to rethink."
Richard Catelli covers legal affairs for The Associated Press.
BALTIMORE,(UPI 2/10/96) -- The doctors who transplanted baboon bone marrow into a San Francisco AIDS patient want to try again this year and already have "hundreds of volunteers" to be the next human guinea pig, they said Saturday.
These volunteers have come forward even though doctors do not yet know whether the first transplanted cells took, said transplant surgeon Dr. Suzanne Ildstad from the University of Pittsburgh.
The AIDS work may be grabbing all the headlines, but Ildstad said the transplant techniques might eventually treat diabetes, sickle cell disease, leukemia and other diseases.
As part of her overall transplant research, she and colleagues worked with doctors at San Francisco General Hospital to give AIDS activist Jeff Getty baboon bone marrow cells on Dec. 14.
Baboons, like most other primates do not get AIDS, and doctors hoped that the baboon cells would make themselves at home in Getty's body and boost his failing immune system.
Ildstad told the annual meeting of the American Association for the Advancement of Science on Saturday that she "felt really badly" about a flurry of news stories last week, many of which reported that Getty' s treatment failed.
"I was disappointed that the f-word (failure) was used," she said.
So far, researchers have found no signs that the transplant is taking and that baboon cells are grafting onto Getty's own immune system.
Those results are just "inconclusive" at this point, said Ildstad. The baboon cells may indeed be blending with the human ones, but doing so in very small numbers.
"If there is a take, it' s at a very low level," said Ildstad.
Several labs are continuing to look for evidence of grafting.
Even if grafting does not seem to be reaching the hoped-for level of 10 percent baboon cells, Ildstad is intrigued by how well Getty seems to be doing. After the transplant, his T-cell count, a measure of the immune-system strength, jumped from the 10-to-30 range to 75.
"He's out sailing; he's fixing his car -sometimes we can't find him he's doing so well," said Ildstad.
She and other researchers want to know where this jolt of energy came from, whether the baboon cells held some mysterious factor or whether the pre-transplant treatments had an unexpected bonus.
"People have been faxing me theories, even people from the general public," she said.
After about a month more of monitoring Getty's health, she hopes to be ready to ask the Food and Drug Administration for permission to try transplanting baboon bone marrow into another AIDS patient.
For the next transplant, she said, the research team will try a different system of radiation and drugs to prepare the patient and "make room" for the transplanted cells.
Ildstad has already tried a similar kind of bone marrow transplant for leukemia patients whose best donor is still a bad match -- not as mismatched as a man and a baboon but offset enough to require new techniques.
She said her lab did not want to report the results formally until they had reached 20 patients, but said that, so far, she has seen very little of the dreaded Graff Versus Host Disease, the immune system's version of race wars that ruins many transplant attempts.
The techniques may also be useful in transplanting whole organs, she said, because a successful bone marrow transplant can take the place of the expensive, tricky drugs used to prevent people's bodies from rejecting transplants.
A bone marrow transplant acts an ambassadorial mission to another body. If bone marrow settles in successfully, the recipient's body will accept later organs from the same donor without complaint.
Ildstad said that health plans often pay for only the first five years of the expensive transplant-protection drugs.
One of her new patients lost his first transplanted organ when he had run out of money for the drugs.
"One of the things that' s most dear to my heart is to try to find a way to make the quality of life better" for transplant patients, she said.
By Kevin Drawbaugh
CHICAGO (Reuter 2/29/96) - Transplanting animal organs and tissues into humans looks like a coming surgical lifesaver, but the fast-emerging science is setting off alarm bells among U.S. disease researchers.
Epidemiologists fear animal-to-human transplants -- or xenotransplants -- could allow poorly understood, perhaps dangerous animal diseases to cross species and spread through human populations. They cite the origin of the AIDS virus in African monkeys as an example.
National guidelines are expected to be issued within a month or so by federal public health agencies hoping to make xenotransplants safe, without curtailing their possibilities.
"There is potential promise and potential danger. Neither is fully materialized. We're feeling our way along," said Dr. Louisa Chapman of the U.S. Centers for Disease Control and Prevention in Atlanta.
Public attention focused on xenotransplants in December when surgeons at San Francisco General Hospital transplanted bone marrow from a baboon into Jeff Getty, an AIDS patient.
The experiment, intended to shore up Getty's immune system, did not work as hoped. But researchers said it showed such procedures are safe. They are seeking permission to try the bone marrow transplant again on another patient.
Physicians and surgeons are excited by xenotransplants because they offer the chance to save thousands of lives now lost due to a chronic shortage of human organs by substituting animal organs and tissues, most likely from pigs.
Xenotransplants "will be a reality ... I just don't know how soon," said Dr. David Sachs, director of the transplantation biology research center at Massachusetts General Hospital and a professor at Harvard's Medical School.
"I've seen nothing at all in the work I'm doing -- and I've been working in this area for 20 years-- that would indicate this won' t work," said Dr. Sachs, whose work is supported by a Massachusetts-based company called Biotransplant.
Other companies pursuing xenotransplants include Deerfield, Illinois-based Baxter International Inc through its Nextran subsidiary and Britain's Imutran.
"Some people are very optimistic that breakthroughs have occurred and new breakthroughs are right around the corner'," said Dr. Chapman.
She cautioned, however, "Other people are pessimistic in that, to date, attempts to use animal tissues in humans have not provided any lasting cures, and there is no immediate promise that that's suddenly going to happen."
About 18,200 human-to-human organ transplants were done in 1994 in the United States. Sixty percent were kidney transplants, with liver, heart, pancreas and lung procedures making most of the balance.
In that year, 3,154 people died while waiting for a new organ that never became available, according to the United Network for Organ Sharing. The network keeps a steadily growing national waiting list of people needing organs. At last count, 44,328 names were on the list.
"We really cannot satisfy the need for organs from the available cadaver population. That's really what's led to this great impetus to try to find another source of organs," Dr. Sachs said.
Experimental xenotransplants involving transgenically altered pig donors and human recipients may begin this year, says Salomon Brothers pharmaceuticals analyst Peter Laing.
He forecasts pig-to-human kidney transplants could begin on a commercial scale in the year 2000 and become more common than human-to-human procedures as early as 2002.
By 2010, he projects humans worldwide will receive transplants of thousands of pig kidneys, hearts and lungs.
Potential exists, as well, for pig-to-human transplants of brain tissue, although "there are likely to be issues of public acceptance with use of porcine tissues in the brain," Laing said in a recent report on xenotransplants.
Heart valves from pigs -- which are anatomically similar to humans -- have been used for years as replacements for worn-out or diseased human heart valves.
Four federal agencies are rushing to issue guidelines on xenotransplants that "will be standard operating procedures for hospitals," said U.S. Food and Drug Administration spokeswoman Lorene Gelb.
The guidelines are eagerly awaited by laboratories nationwide that are holding up projects until they know how federal regulators want them handled, said Dr. Chapman, one of six researchers who recently published a paper in the New England Journal of Medicine warning of infection dangers.
Although xenotransplants hold promise, they also pose "an unquantifiable but undeniable potential for harm to the wider community," Dr. Chapman wrote in the journal.
Viruses or bacteria that are harmless in one species can sometimes be deadly in another, researchers said.
For example, rodents can harmlessly carry certain strains of hantavirus that can kill humans. Similarly, macaque monkeys can carry a herpes virus that barely bothers them, but is usually fatal to other primates and humans.
The potential danger with xenotransplantation is that unpredictable animal microbes could hitchhike their way into humans via transplanted animal organs. Researchers hope to minimize that hazard by using donor animals bred to be free of dangerous microbes and by carefully monitoring recipients.
"There's always risk when you try to accomplish anything," Dr. Sachs said. "The question is, does the potential benefit outweigh that risk. And I think it does."
LONDON (Reuter 3/6/96) - A British ethical panel said Wednesday that it was acceptable to transplant pig organs into people, but doctors should think long and hard before doing so and should avoid using "higher" animals such as chimpanzees.
The Nuffield Council on Bioethics, set up by charities to debate medical morality, also said more research was needed to see if people risked infections from animal transplants.
"Proceed, but proceed with caution, always paying attention to the highest standards of patient care and animal welfare," said Albert Weale, a university professor of government who headed the panel. The committee recommended that no animal-to-human transplants go ahead until the government set up a national committee to analyze the risks to both people and animals.
"There is a huge unmet need for organs ... (but) in the absence of published information it may be too soon to say the time is yet right for putting animal organs into humans," Mark Walport, professor of medicine at the Royal Postgraduate Medical School in London, told a news conference.
Doctors fear that animal-to-human transplants -- or xenotransplants -- could allow dangerous animal diseases to cross species and spread through human populations. They cite the origin of the AIDS virus in African monkeys as an example.
But researchers note that heart valves from pigs have been used for years as replacements for worn-out or diseased human heart valves, and genetically altered pigs already produce insulin for use in treating human diabetics.
Drug companies are pushing ahead. Britain's Imutran, which specializes in the area, welcomed the report. "Imutran is confident that they will be able to comply with the guidelines proposed by the Nuffield's report, and that the necessary research is being carried out," it said in a statement.
The committee said pigs were the most appropriate candidate for xenotransplants. They are similar in size to humans but genetically distant enough to pose less of a risk of disease.
"Primates are more similar to humans ... the immunology is similar but also the risk of infection is higher," Walport said. He also noted that chimpanzees are endangered.
Pigs are more available, breed more easily, and are killed for food anyway. "We might as well use them to save lives rather than just for our gastronomic satisfaction," said David Morton, a veterinarian and professor of Biomedical Science and Ethics at the University of Birmingham.
They also recommended that an independent person -- either a doctor or counselor- advise a patient before such a transplant went ahead "because scientists involved in the transplant might be over enthusiastic."
"It's important to remember that sometimes death with dignity is the most desirable medical option," Weale added.
Celia Davies, a professor of health care at the Open University in Milton Keynes, said more than 100 individuals and organizations had been contacted by the committee. People had also been encouraged to write in with their thoughts.
"It's clear there is disquiet about the idea that everything that technologically can be done should be," she said. Many people were concerned about animal welfare.
She said there was also a question of "emotional rejection" or "the yuck factor." Another question was whether having readily available animal transplants would make people less likely to donate their organs." We do stress that human donors will be needed for the foreseeable future," Davies said.
WASHINGTON, (UPI 3/6/96)-- Using an innovative technique, scientists in Scotland have successfully cloned sheep, a step they said Wednesday may allow them to produce dozens of genetically identical animals for research purposes.
Although sheep and even cattle have been cloned before, researchers at the Roslyn Institute in Edinburgh said this is the first time anyone has used a method that involves taking cells from sheep embryos, multiplying them in laboratory dishes, and then transferring them into the wombs of ewes who serve as foster mothers.
"What is different about this method is that theoretically, you could use it to produce hundreds of animals that are identical, rather than just a relative few, which was the case in the past," said Ian Wilmut, co-author of a report in the British journal Nature.
Until now, most genetically engineered animals have been mice, although Wilmut said they have proven "surprisingly difficult to clone. But while cloned mice have been used extensively for research on a variety of human disorders, Wilmut said investigators recognized the need for animals with larger organs and blood supplies.
After transferring genetically engineered embryos into foster sheep mothers, the researchers said they detected seven pregnancies, including a set of twins, which ultimately resulted in the births of five identical female Welsh mountain lambs. Three of the lambs died shortly after birth, but two survived and appeared normal and healthy at the age of 9 months.
"Although we only obtained five lambs, and three died from congenital abnormalities, I would say this is a biological breakthrough," said Wilmut. He said the Scottish investigators are "very keen" to try to clone pigs, which are already used widely in biomedical research. Porcine heart valves are routinely used in humans and pigs have been seen as a potential source of transplant organs if they can be engineered to prevent rejection. Wilmut said it may also be possible to clone other mam mals, including primates such as monkeys and baboons, "although I'm not sure why you would want to do that. At that point, you are getting into questions of ethical and practical considerations."
Davor Solter, a German visiting scientist at the National Institutes of Health who wrote an accompanying commentary in Nature, said that while the technological aspects of the Roslyn cloning method "are certainly quite significant," the practical results are unclear.
"If the success rates as far as healthy births remain low, then there probably isn't much of an impact, at least for now," he said. "But anything that can be done once can usually be done better, so I expect the success rates to improve."
Solter suggested two potential reasons for cloning sheep and other agricultural animals such as cattle. "One would be to improve the breed. The other would be to produce medical components for humans, such as, let's say, a blood coagulation factor."
BALTIMORE (AP 2/10/96) -- Using chemical and biological wizardry, scientists are learning to grow tissues to substitute for faulty human skin, heart valves and insulin-producing cells.
"We believe someday we'll be able to grow an entire human heart," said Gall N. Naughton of Advanced Tissues Sciences Inc.
In reports at a national meeting of the American Association for the Advancement of Science, researchers said Saturday they are now able to seed human cells onto cloth-like molds and then nurture the cells until they grow into useful replacement parts.
Naughton said her company, based in La Jolla, Calif., is using the cell nurturing technique to grow new, healthy and living heart valves.
Naughton said the process begins with cardiac fibroblast cells that are placed into a culturing machine that imitates the environment of the heart. The cells are grown on a polymer scaffold that resembles cheese cloth. The cloth is molded into the leaf-like shape of a heart valve.
"The cells think they are developing valves in a fetal heart," Naughton said.
Because the fabricated valves are of natural tissue, there is no rejection when they are surgically implanted.
'In sheep, there is no difference between the engineered tissue and natural heart valve," she said. Experiments are underway to make natural heart muscle that could be used to patch cardiac muscle damaged by heart attack, Naughton said.
Similar technology has been used to produce artificial human skin that already is being used to close ulcer sores common in diabetic patients and to temporarily cover burn wounds.
Also in development are engineered cartilage that could be used to replace joint parts damaged by injury or disease. Dr. Anthony Atala of Harvard Medical School said clinical trials may begin this year on the use of laboratory-engineered replacement parts for failed tissue within the urinary system.
He said lab experiments in animals have shown it is possible to selectively transplant engineered cells that will grow into new tissue to replace damaged segments of the urethra, bladder and kidneys.
Other researchers report that laboratory animals have been cured of diabetes with the injection of tiny polymer spheres that contain insulin producing cells from pigs. Human experiments with the technology could start within months.
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