Oriented to Thoracic Transplant Recipients -- March 1997

The UPBEAT! Archive


Outcomes of Patients Undergoing Transplantation with Older Donor Heads

By Davis C. Drinkwater, MD, et al UCLA, Cardiothoracic Surgery & Cardiology

Background: The limited number of donor hearts relative to the number of waiting recipients is the major determinate of a growing inequity. Although a number of potential options are being vigorously pursued, the most effective immediate solution is to expand acceptance criteria for donor age and medical condition. This report is a review of our early and late results with the use of older donors, including simultaneously "bypassed" donor hearts.

Methods: Between April 1987 and September 1994, 52 patients received older donor hearts (older than 45 years) with a mean donor age of 51 years. Ten patients in this group received hearts simultaneously bypassed with from 1 to 4 grafts per patient. Donor and recipient age, diagnosis, and HLA match were compared between the older donor group and a contemporaneous younger (younger than 45) donor group (N = 324). Also compared was actuarial survival at up to 5 years of follow-up in addition to graft function, bypass graft patency, infection and rejection incidence at 1 year, and the prevalence of transplant-associated coronary artery disease in the two groups. Echocardiography, coronary angiography, and intravascular coronary ultrasonography were used for this assessment.

Results: One-year actuarial survival was 84'W for the older donor group, which included 19 status 1 patients (survival 76%) and 23 status II patients (survival 90%). In the bypassed donor subgroup there was a 60% @-year actuarial survival with 5 status 1 patients (survival 80%) and 5 status II patients (survival 40%). At 1 year, left ventricular function and the incidence of infection and rejection were equal between these two donor groups.

Five-year actuarial survivals were the same between the overall older and younger donor groups. Finally, the development of transplant-associated coronary disease was similar in both groups up to 5 years after transplantation.

Conclusions: This initial review of heart transplantation with older donor hearts, including bypassed hearts, demonstrates similar early and late survival outcomes as compared with those of a contemporaneous younger donor group. Significantly, there appears to be no difference in the development of transplant-associated coronary artery disease during the follow-up period. The older donor represents a potential immediate increase in the number of suitable hearts for transplantation. Bypassed donor hearts represent a small but potentially significant subgroup that may be safely and effectively used when appropriately matched to the recipient by age and medical condition.

Greater experience, particularly with this bypassed group, will help determine optimal donor-to-recipient matching in the future.

J Heart Lung Transplant 1996;15:684-91


By Marilyn Elias, USA Today

George Balding, owner of a thriving electronics firm in Salt Lake City and inventor of 27 products, refused to accept the verdict at his local hospital: Go home and die because you are too old for a heart transplant.

Balding had just turned 65, the cutoff age at the Utah Cardiac Transplant Program. Doctors gave him six months to live. But a later marriage had left him with five children at home, "and there was no way I'd just roll over and die. I was healthy in every way except for my heart."

So Balding sent a 40-page "resume" of his medical records to 10 hospitals. The news back was mostly bad until he got a unique offer from the University of California, Los Angeles. Wait on an alternate list for older patients willing to take hearts from donors over 50, which usually are not transplanted, or in need of repairs such as coronary bypass.

He jumped at the chance for a "retread." "It sure beat the alternative," says Balding, a healthy 68-year-old with a different heart. He works, parents and, he says, "appreciates every day I have."

UCLA's pioneering program, launched five years ago, is gathering impressive survival data on patients over 65 given hearts consigned to the "reject' bin elsewhere. Critics doubt the bold gamble taken by program director Hillel Laks will pay off in enough added survival time to justify the cost of a heart transplant $150,000 to $250,000. But a handful of other centers are beginning or expanding similar alternate programs. They're betting on a worsening shortage of hearts as baby boomers swarm into the age bracket when the transplant need is greatest but the fewest donor hears are accepted.

Adults over 50 already are the majority of patients awaiting hearts and the number on waiting lists surged from 1,722 to 3,693 between 1988 and 1994. Only 9% of donor hearts are from people over 50. "In the long term, death is simply more cost effective (than transplant) in the older age groups," Laks wryly observes "because they may come back with longer-term complications."

But are boomers apt to "go gentle into that good night'"?

The generation isn't famous for stoic acceptance of aging and decline. After setting records for facelifts rummy tucks, hair transplants and hip replacements why would bionic boomers draw the line at a heart'?

"Thirty years ago you'd reach 70 and the prevailing philosophy was 'now you're old and you can expect to die. Now people at 70 are saying 'I want to travel I want to play golf, I want to get married again,' says Laks.

Regardless of what they want not everyone with terminal heart disease should get a new heart Laks says. The UCLA program only transplants in older patients who have no other serious organ damage or diseases.

"You have to pick candidates carefully or you'll have high mortality," says transplant surgeon Robert Kormos whose University of Pittsburgh alternate program started six months ago. It was prompted by UCLA's success rate.

In five years UCLA has transplanted 27 .... retread'" hearts in older patients 11 in 1996 alone. Doctors only have three-year survival data so far. At 78%, it's equal to survival of younger patients given prime hearts Laks says. Excellent survival also is reported for older patients of the Northern Indiana Heart Institute at Lutheran Hospital, Fort Wayne.

Critics say that too many usable hearts are being discarded from donors older than 50. Some people over 50 hike in the Alps, play tennis stay sexually active and keep their cholesterol low. If they die in an accident why discard their adequately ' functioning hearts they ask.

"Our clinical experience is that 20% to 40% of hearts traditionally considered unusable can be used or fixed to be functional, says cardiologist Gregg Fonarow of UCLA's center. On the national level this means more than 1,000 additional hearts would be available per year he says.

But some experts think this is a dangerous route to take particularly at a fast pace. "Using older or repaired hearts is still experimental. We have to do it slowly carefully. Only a few questionable deaths could bring the whole thing to a screeching halt, says Arthur Caplan director of University of Pennsylvania's Center for Bioethics.

Older people are more apt to have many health problems says surgeon David Taylor of the Utah Cardiac Transplant Program. Patients over 65 aren't transplanted there, and even 60-year-olds are scrutinized carefully.

Despite UCLA's short-term high success rate, heart recipients over 65 in international registries have lower long-term survival says Taylor. The American Heart Association (AHA), in a 1995 scientific consensus paper even questions transplants in patients over 55. Though these surgeries can work medically they're ethically debatable AHA says.

But right now older heart patients are far more likely to never make it onto a transplant list than to take a heart from a younger person says Caplan. He favors potential quality of life "not any age cutoff written in stone,' as the key criterion. And that sounds fine to UCLA's Laks whose book-lined office displays photos of transplanted patients playing baseball at "reunion" picnics. His older patients aren't sloths.

James Shirley 67, fits right in. He rides horses and ropes steers as a hobby. Heart disease forced his retirement from contracting work. Since the transplant last June, "my energy is coming back, says Shirley "and I'm getting just as ornery as I used to be ..... I plan to start working again soon I can't sit around. This sitting around drives me crazy."

James Taylor, 73 the program's oldest alumnus is five years post-transplant. A retired engineer he's lay pastor at a nearby Hispanic church. Taylor is designing and marketing a camper/trailer that folds electrically.

Despite good news so far UCLA's program is still "an experiment in progress,' says cardiologist Jon Kobashigawa, who treats the post-transplant patients for the rest of their lives.

Meaningful five-year survival rates will be out in two years he says, "and we'll know a lot more then ."

The jury is definitely in, though for many touched by UCLA's program. Virginia Balding, 52, works beside her husband George in the family business. She doesn't have any illusions about George.

"George's problem," she coilfides, "is he thinks he's 40 years old. He can't figure out why he can't do 14-hour days, even with his new heart. He can only work 9 hours. He thinks, "What's the problem? But you know, that's the reason he deserved to get a heart. My Lord, he had so much life left in him."

USA Today, February 10, 1997


UpBeat is delighted to report that recent contact with Cal Miller at his vacation golfing retreat in Florida reveals that his condition is very stable and he is in "full operating condition." As will be remembered two years ago Cal was the first heart transplant recipient to undergo the laser cardiac revascularization procedure called TMR for transmyocardial revascularization. This is the promising procedure where a grid of small holes are fired into the heart muscle by a highly technical laser. The heart muscle there after is able to become oxygenated via direct contact with blood, very similar to the heart of a frog. Cal says his ejection fraction is holding steady at about 45% and he has no symptoms of any heart problems. He still feels it is a very worthy treatment for consideration by heart transplant recipients with TCAD, but not in a position for retransplant or other treatment. See below:

PLC Sys Sees FDA Approval Of Heart Laser This Summer

By Louis Hau

NEW YORK (Dow Jones 3/4/97)-PLC Systems Inc. (PLC) expects the Food and Drug Administration to approve its Heart Laser this summer for use in the treatment of late-stage coronary artery disease, Chairman Robert Rudko said. "We really think we're in the final stages," he told Dow Jones.

PLC's carbon-dioxide laser zaps channels into the heart to enable blood tO reach tissue that has been deprived of sufficient oxygen because of coronary artery blockages. The procedure is known as transmyocardial revascularization, or TMR. Other TMR laser manufacturers include CardioGenesis Corp. (CGCP) and Eclipse Surgical Technologies Inc. (ESTI), both of which are conducting U.S. clinical trials on their respective laser systems.

PLC's application to the FDA asks for approval of the Heart Laser for use in patients for whom angioplasty or bypass surgery is not an option. Market observers expect TMR to be used eventually in conjunction with a bypass to move blood more effectively into oxygen-starved heart muscle.

Somehow right after my heart transplant, I came into ownership of a paper poster with the heading, "Look at Cyndi! Thanks to Heart and Blood Donors." It showed a pretty young lady happily dancing and said at the bottom that Cyndi Jeikmann received a heart transplant at Stanford University in 1977. It was sponsored in those very early days by the American Red Cross and the Anatomical Transplant Association of California. It made me feel good just looking at it from time to time.

A couple of weeks ago I stumbled across the same poster, now not in very good shape, jammed behind a cabinet. Just about the same day I read about the death of Cyndi Jelkmann Bock at age 40. She had undergone a 2nd transplant and married both about 5 years ago. As Peter Rauch of the Los Angeles area TRIO put it: "She was a pioneer who lighted the way for all of us to follow. It was my privilege to know her. She will be missed by all who knew her and by the "world of transplantation "for her courage and her dedication to the cause which gave her another 20 years." I think I'll still keep the poster around for those days when I need a little boost.

Gosh, I'm just plain tired of hearing about the organ donation non-stamp! The late Ed Heyn of Michigan worked hard on that campaign and gathering supporting signatures and requesting letters be written for several long years before his death. Then it was taken over by the Southwestern Michigan Transplant Association and they are still very much at it with still more of the same. After all this action, nothing has happened at all. The Stamp Selection Committee has met and literally done no more than chosen not to put out an organ donor stamp in 1998. Obviously we're doing something wrong, or at best we're not doing anything that works. Maybe we should suggest a stamp portraying the agony of a family who lost a loved one because organs weren't available. No, not a good idea. Well, how about a stamp that just says "Thanks" and has the portrait of one of the better know recipients on it - Mantle, Hagman, Casey, Coleman, Lewis? The weakness seems to be the approach we're taking and the stamp concept being put forth, not really the idea of organ donation. We've got the donor cards now with the tax refunds and astronauts signing their cards in space, so Uncle isn't against donation. We just haven't sold the idea for a good stamp.

UpBeat received the following note from author/writer Tx A.C. Green of Salado, Texas: "Want to thank you for the 10-year piece in the January UpBeat. It sure makes me, coming up on nine (June) feel a little better about things; not full of false hope or optimism, but just seeing statistics about people who have made it beyond five, which is where most of those stats. have ended. I've managed to fight off a nerve cancer, although not some of its after effects, and my case has fit most of the "good" profile for possibility: no smoke, no rejection episodes of any kind, no cardiomyopathy nor disease, and ability to continue working so my mind ain't wore out! May not make 10, but at least I now know it can be done."

Help may have arrived for those males who have had sexual performance problems since transplantation for many reasons, but mostly basically due to medications. There is a new drug system recently approved by the FDA called Muse, manufactured by Vivus. The drug is available in four dosage levels and is directly inserted into the end of the male organ with the goal of making it functional for a portion of an hour. Those who desire to pursue the matter further should discuss the situation with their transplant physician, who would then refer them to a urologist for examination and establishment of the proper dosage. Now, without overly dampening the optimism that this new drug may offer, it also must be reported that some very preliminary reports indicate a lack of success on certain individual transplant recipients, most likely due to unknown interactions of certain drug combinations. The only way to determine individual reaction is to have a urologist perform a trial dose.

In acknowledgment of the many comments made on the recent questionnaire about the problem of the seemingly constant need urinate during the night, here's a restatement of the best explanation yet put forth as to the reasons why, as first published in UpBeat October of 1996.

At long last, here's a rather neat theory to explain all the night-time trips to the "john" by heart transplant recipients. Accept as a given that cyclosporine is at minimum rough on kidney function. Thus during the active hours of the day when the body is attempting to regulate all its needs using a minimally fixed heart rate controlled only by catacholamines, kidney function is minimal, or even suppressed. However, at night when the body is in a supine position, the heart doesn't need to work as hard, yet it's resting beats per minute are still fixed at a significantly higher rate than that of a "normal." Thus with extra circulatory volume that is not really needed by other areas of the body, the kidneys are in a situation where they can function more efficiently, and we all know the result, clockwork trips to get rid of their successful efforts to clean up the blood.

Going one step further, if one checks the PDR it will show that two out of the three heavy hitter "standard transplant drugs", cyclosporine and prednisone, have listed as "less common" side effects "frequent urge to urinate" and "frequent urination" respectively.

I guess the best solution is don't be leaving your foot stool in the middle of your route to the facility.


By Elizabeth Manning - UPI Science

Seattle, (UPI 2/15/97)- Proposing a new view of how the immune system works, a National Institutes of Health researcher says her model may better explain a range of biological mysteries: why mothers do not reject their unborn babies, how tumors gain a foothold, and why the body continues to reject transplanted organs.

Contrary to traditional belief, NIH immunologist Polly Matzinger says, the immune system responds to danger -- not necessarily battling every foreign invaders.

In a presentation at the annual meeting of the American Association for the Advancement of Science in Seattle, she noted traditional thinking holds the immune system does not attack cells of its own body because it learns early in life to recognize what native tissues look like. So anything it does not recognize must be a new arrival -an invader to be destroyed.

But Matzinger says this thinking does not explain several common situations.

For example, a woman who was not breast-fed as a child would not be able to recognize human milk. Yet this same woman can breast-feed her own child, and her immune system will not attack her milkproducing cells.

Matzinger's theory explains this mystery simply: the milk cells pose no danger to the body, so the immune system leaves them alone.

The same is true for tumor cells, at least at first. Matzinger says, "After all, what's a tumor cell but a normal cell that has lost its growth control'?"

Transplanted organs would seem to benefit, not threaten, the body. But an organ can sense the stress of removal and transportation from donor to recipient. Its cells send out distress signals to warn its host of injury. Matzinger says it is these signals, not the organ itselK that triggers rejection.

Furthermore, Matzinger points out, current anti-rejection drugs also suppress the signal that would teach the body to accept its new organ. Thus transplant patients must take them for life, or risk rejection even years later. The new view could alter the way drugs for transplant patients are developed to more accurately target the immune system's rejection response.


Columbus, Ohio, (UPI 2/26/97) -State Rep. William Schuck, R- Columbus, has introduced legislation aimed at increasing organ donation by prohibiting families of organ donors from overriding a family member's donation wishes.

Transplant experts said such a law would be the first of its kind in the nation.

Schuck, who introduced his bill Wednesday, said, "A mentally competent person should have a right to make binding decisions about donating his or her organs. This bill ensures that a donor's wishes are respected and takes several steps to promote anatomical donations."

The bill, among other things, provides that a hospital need not consult with the family of a deceased person before removing tissue for an anatomical gift, as stipulated by the deceased person.

Schuck's legislation also would require Ohio high school health and driver education classes to include information on anatomical gifts. It also authorizes declarations of such gifts to be filed with county recorders for a maximum fee of $5.

Although courts have ruled that the organ donor cards that people sign when renewing their driver's license are legal documents, organ banks and hospitals always ask families to consent to a donation.


BOLIVAR, Tenn. (AP 3/3/97) -- A fatal bullet has kept 18-year-old Clay Burford from joining his high school buddies at graduation this spring -- but his heart will be there, donated to a classmate who needed a transplant.

Police said Bufford was shot in the head Feb. 23 while trying to protect a child from a teen who was flashing a handgun. The teen was arrested and charged with murder.

Bufford, of Bolivar Central High School, was placed on life support. Doctors later told his mother that he was brain-dead and that there was nothing they could do for him.

Ms. Bufford then remembered 17-year-old Ameanna Turner, who had been hospitalized since December after doctors discovered a leaking valve in her heart. The mother decided to donate her son's heart to the girl the next day.

Ms. Turner had been told that Bufford was shot and that a donor had been found for her, but she didn't know he had died. Alter the operation, she figured out it was Bufford's heart before doctors could talk to her.

"She named his name," said hospital psychologist Glenn Ann Martin. "She smiled. She's OK with it."

Doctors expect Turner to go home in a few weeks. By April, they believe she should be marching in her graduation line to get her diploma.

Ms. Bufford said the only thing that mattered to her son was graduation, which is why she wanted Ms. Turner to have his heart. The family of an organ donor can designate a recipient under certain conditions, said Gary Hall of the Mid-South Transplant Foundation. The recipient must already be accepted by a transplant program and be on the national list for patients awaiting donor organs. The donated organ must also be acceptable medically for the designated recipient. with matching blood types and other such factors, Hall said.


Cleveland (AP 2/3/97) -- Patients awaiting transplants should be told how often hospitals turn away potential donor organs for administrative rather than medical reasons, medical ethics leaders say.

Twenty-eight of the nation's 167 hearttransplant centers refused donor hearts for nonmedical reasons 20 percent of the time or more during a seven-month period in 1994, The Plain Dealer reported today. The period is the only one in which complete data are available.

Of those 806 hearts rejected for administrative reasons, 97 percent eventually were accepted and transplanted by other hospitals, the newspaper said in the second part of a series on the organ transplant industry.

Many of the nonmedical rejections were made by smaller programs which often had only one transplant team, the newspaper said. That means the team might be unable to accept a donor organ if doctors were out of town or involved in other surgeries. The newspaper did not give examples of other nonmedical reasons.

Patients should be given information about a hospital' s nonmedical rejection rate while they are deciding where to have a transplant, not after they are hospitalized, said Jeffrey M. Prottas, an ethics committee member of the government's organ allocation contractor, United Network for Organ Sharing.

"Whenever I have my say on this issue, I say that UNOS ought to be publishing all of this," said Prottas, who teaches health politics at Brandeis University in Waltham, Mass. "It's really unfair. Everybody should know these sorts of things."

"I'm surprised that the numbers are that high," said Thomas H. Murray, director of the Center of Biomedical Ethics at Case Western Reserve University and one of several ethicists and doctors who said they were unaware of the practice. "You'd like to know what the circumstances were ... but if they can' t give good reasons, it' s troubling."

Every transplant center turns down some donor organs for nonmedical reasons, said Dr. John R. Wilson of Vanderbilt University.

"There is no program in this country that can guarantee that every organ that's acceptable is taken," Wilson said.

Medical reasons for rejecting an organ range from issues related to the quality of the organ or a donor's social history, such as drug or alcohol use, to the recipient' s immediate need for a multiple organ transplant. Sometimes a recipient was too ill to accept a transplant, or the donor's size or weight was incompatible with the recipient.

Judith B. Braslow, who heads the U.S. Department of Health and Human Services' Division of Organ Transplantation, said the number of hospitals that regularly refuse donor organs for nonmedical reasons is small.

"We do 19,000 to 20,000 transplants a year. We're talking about very small numbers," she said.

But when it comes to withholding such data from patients, "That's not to say patients should have been treated this way," she said.

The number of people nationwide awaiting an organ transplant has tripled to more than 50,000 since 1988, with more than 3,700 waiting for heart transplants. During 1994, a total of 2,361 received heart transplants and 770 people died waiting, the newspaper said.


Guwahati, India (Reuter 2/19/97) - Three doctors charged with homicide for transplanting a pig's heart into a man who later died were released from prison Wednesday and promptly faced protests from local residents.

Witnesses said a crowd of over 100 people gathered outside a jail in the northeastern state of Assam, shouting "killers," "butchers" and "murderers" at the three doctors as they stepped out of the prison.

There was no violence, the witnesses said.

Hong Kong-based surgeon Jonathan Ho and two Indian doctors were arrested in Assam Jan. 8, a day after a 30-year-old heart patient was declared dead.

The doctors had transplanted the pig's heart into Purna Saikia Dec. 15 in a private clinic 20-miles west of the state capital Guwahati. The transplant attracted international attention and widespread criticism on ethical grounds.

After Saikia died the three surgeons were charged with homicide and violation of a three-year-old law governing organ transplants. The maximum punishment under the law is five years in prison or a $280 fine, officials said.

Tuesday a two-judge bench of the Guwahati High Court ordered the three doctors released on bail, but impounded their passports and told them to report to police twice a week.

The judges also barred the doctors from performing any organ transplants without federal authorization. No trial date has been set.


By Maggie Fox

London, (Reuter 2/27/97)- Pigs will not be immediately cloned for organ transplants to people, and the technology for such transplants is some way off still, experts said on Thursday.

David White, a co-founder of Cambridge-based Imutran, said he was intrigued by news that Scottish scientists had cloned an adult sheep but would have no immediate use for the technology.

"We are not planning to clone our pigs at this stage," he told a London conference on transplants which ends on Thursday.

News about the cloning technique, developed by the Roslin Institute and biotechnology company PPL Therapeutics Plc, alarmed many and prompted a call for worldwide examination of the research and its implications.

There has been equal anxiety about the prospect of transplanting animal organs into humans. In January, a government-appointed committee of experts advised further studies before passing laws on xenotransplantation.
The government agreed.

White, whose company has been producing genetically engineered pigs for transplant experiments, said the possibility of trying out pig transplants in humans was a long way off.

They were currently testing the organs in monkeys, but the best survival was just over 40 days and that was not being achieved all the time.

It would not be possible to go to clinical trials until scientists were routinely getting 30-day survival in monkeys, he said.

Currently the problem was getting the balance of drugs right. For an organ transplant to work, the recipient's immune system must be suppressed so the body does not reject the organ.

"We're busy working our way through a list of immunosuppressive drugs," White told the Royal Society of Medicine conference.

Other obstacles also remained, White. whose company is owned by Novartis, said.

These included public acceptance of the idea of xenotransplantation.

Questions were still being raised as to whether it was ethical, what the psychological effects would be and whether there were concerns for animal welfare.

Imutran is creating transgenie pigs whose organs can trick the human immune system into accepting them. Pig cells are injected with genes instructing for human proteins to be produced on the surface of certain organs.

The immune system tends to see such organs as human.

The issue of disease transmission had still not been dealt with, either. Experts had found satisfactory ways to eliminate bacteria such as salmonella, viruses such as influenza and parasites such as the one causing toxoplasmosis from the pigs and their organs.

But one known pig virus, porcine endogenous retrovirus, was proving stubborn and there was still no way of being certain that unidentified viruses were not going to be passed on.

"Clearly there are things we cannot give a clear guarantee on," White said. "The regulatory authorities will have to be reasonable."

Ian Kennedy, who chaired the committee reporting on xenotransplantation to the government, said the issue of passing on animal diseases to people was a major one.

"Things like viruses do not carry passports," he said. "The risks we are talking about are not risks to the patient only, but also to the community that might be coming in contact with that patient."

Many doctors believe AIDS originated in monkeys, and say once infected, a transplant patient could infect many others.


Washington, (UPI 2/27/97) -- A study appearing in the March issue of Nature Medicine found a certain strain of a pig virus could infect human cells in a laboratory and then replicate itself.

In recent years medical researchers have expressed optimism for using pig and other animal tissues to meet the growing need of humans awaiting organ transplants -- but the new study adds to other research suggesting animal transplants possibly could infect humans with other species' viruses.

San Antonio virologist Jon Allan, of Southwest Foundation for Biomedical Research, wrote an accompanying opinion article in the same issue. In the opinion piece, Allan says, "The real question is can you make this safe? Safe enough to not introduce a new infectious disease into the population'?"

British researchers found that after several rounds of replication, the virus was no longer susceptible to the immunities of the host cells.

Several animal-to-human transplants, or xenotransplants ("ZENO-transplants"), have already taken place in the United States. Perhaps the most famous was a baboon bone marrow transplant to a San Francisco HIV patient in 1995. A pig liver has also been transplanted, as have fetal pig cells for Parkinson's disease patients.

The Food and Drug Administration must approve all xenotransplants. An FDA spokeswoman told United Press International studies like the one conducted in Britain may lead to a series of medical workshops before the practice becomes more widespread.

Mandatory FDA xenotransplant guidelines were first set up in 1996 to protect the public from health risks while not impeding medical innovation, FDA officials say.

But Allan says now that several transplants have already been done, the FDA will likely continue to approve xenotransplant requests.

Allan says, "There needs to be more vigilance on the part of public health agencies."


Dallas, (UPI 2/25/97) -- A Dallas federal grand jury today (Wednesday) indicted a former Seagoville, Texas couple for mishandling funds intended to help children seeking organ transplants.

The 22-count indictment names Jack and Bettie B radberry, managers and controllers of Children's Transplant Association. The U.S. attorney's office says the Bradberry' s are expected to turn themselves in Friday.

Prosecutors say the Bradberry's, who now live iri Tulsa, Okla., are charged with conspiracy, wirefraud, interstate transportation of money taken by fraud, mail fraud and money laundering.

From July 1988 until May 1993, the indictment alleges the Bradberry's induced persons across the nation to place trust funds with the CTA and then diverted some of those funds to their own use and the use of others.

U.S. Attorney Paul Coggins says the mishandling of the funds "added to the burdens of families already stressed to the breaking point."

A spokeswoman for the U.S. attorney says the alleged wrongdoing never actually prevented a child from getting an organ.

FBI Agent Jim Adams-says, "We hope this case does not create a chilling effect on charitable contributions as most charities perform just as they say they will."

Disclaimer: The material in this document has been collected by Don Marshall and friends. If any of the views and opinions expressed here are taken the wrong way, we can be nothing m ore than sorry. New ideas and materials are welcome all the time. As a policy, UpBeat is sent upon request to heart and heart/lung transplant recipients and other interested parties. Donations of $15 per year, or more, from Tx recipients, if not a burden, are vital. From all others t he donation is specifically requested. The date shown after the name on the address label indicates the last time a donation was received. Please make checks payable to Don Marshall, as we cannot afford to become nonprofit. Send materials, letters, or checks to:

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