BUILDING A BETTER (artificial) HEART
Seventeen years after Barney Clark’s death, scientists are ready to try again.
By Richard A. Knox - Boston Globe Staff
Designing and artificial heart seems like a straightforward engineering problem. The heart, after all is not a space shuttle. It has just one job to do: Pump blood.
But the agonizing early-1980s experiences of the first few people to have their failing hearts replaced by machines showed that it was anything but straightforward. The first artificial heart recipient, Utah dentist Barney Clark, died after 112 miserable days on a heart pump powered by a bedside box the size of a washing machine.
“If it was simple, we would have done it a long time ago, “said John Watson, who heads the federal government’s 36-year-old artificial heart program.
But researchers have quietly tackled the challenges over the 17 years since Clark died, and now they say they’re set to try to again.
The everyday work of the human heart is extraordinarily difficult to duplicate. A healthy heart beats without fail 100,000 times a day, nearly 40 million times a year. It withstands an environment more corrosive than seawater, due to the hundreds of molecule-splitting enzymes in blood. It moves a tremendous volume of blood without touching off a shower of clots that can plug an artery in the brain. It responds instantly when the body demands more blood flow in order to rise from a chair or climb a flight of stairs. It even has its own self-contained, fail-safe power supply.
Developers of the next generation artificial heart say they have a device that comes close enough to the real thing that most ordinary activities will be possible — although recipients of the implant will have to be ever mindful of the two hour battery life in the external batteries that keep the device beatings.
Watson and scientists in Massachusetts and Pennsylvania who are developing these heart substitutes expect recipients will be able to run “a slow mile” as Watson puts it, or even sprint for a bus, as well as engage in most occupations, and in sports such as golf or bowling.
Before the end of the year, according to current plans, the first of these next- generation hearts, made by Abiomed Inc. in Danvers, Mass., will be implanted in one or more humans. Surgeons in Boston, Louisville, Philadelphia, Houston and Los Angeles are training for the experiment. But there’s no telling where the first implant will be or who will get it, since that depends on where the first suitable and willing patient pops up, once federal officials have given the heart the green light.
But everyone agrees on two things: The experiment will be conducted in a fishbowl, and the stakes are do-or-die — quite possibly for the artificial heart program itself, as well as for the subjects who bravely volunteer.
“This is the most visible clinical experiment” in the world, said David M. Lederman, Abiomed’s chief executive. “It was in the ‘80s, and it will be again.”
The risks are worth taking, Lederman and others insist, because of the number of natural hearts donated for transplants have leveled off at about 2000 per year, due in par to widespread use of seatbelts and motorcycle helmets that reduce traffic fatalities among relatively young people.
Meanwhile, the number of Americans with failing hearts is mounting steadily. Partly this is because doctors are more successful these days in pulling heart attack victims back from the brink of death, but they can’t always prevent associated cardiac damage that often leads to later heart failure.
Moreover, few expect animal-to- human heart transplants, such as from genetically engineered pigs, to fill the demand for natural hearts anytime soon, due to formidable obstacles, such as the body’s ferocious rejection response to cross-species transplants and the risk of introducing animal viruses into humans.
The new generation of artificial hearts faces very high expectations. The field will
be doomed, many say, by anything resembling the death-watch experience of Barney Clark, who suffered strokes and severe depression while he was tethered to the control unit of the Jarvik-7, the first generation artificial heart.
The first patient, and Indiana man named William Schroeder, survived 620 days on the Jarvik-7, but most in the field agree with Boston ethicist George Annas that Schroeder’s psychological and physical pain proved “there are fates worse than death.” Even artificial heart pioneer Robert Jarvik has abandoned the idea of a totally implantable heart substitute in favor of tiny pumps that merely assist failing natural hearts.
“We sort of laid low for 10 years, quite frankly, because Barney Clark and the others in the l980s created a public perception of failure,” said Abiomed’s Lederman, who is clearly worried that expectations of the new artificial hearts will be unrealistic.
But Boston cardiac surgeon Gregory Couper of Brigham and Woman’s Hospital, one of five centers recruited for the next round of human trials, said he thinks the researchers must set high standards if the artificial heart program is to survive in the court of public opinion.
If the first five patients in the next experiments have severe complications, Couper warned, “both the public’s and the profession’s enthusiasm will be dampened very quickly.”
“We really need to ensure that we do not repeat the early history of the Jarvik-7 heart,” Couper added. “We ought to have 80-plus percent of the first 15 patients surviving at 6 months, free of any severe complications.”
A tall order, but researchers and their sponsors can point to growing reasons for confidence, much of it unknown to the public, or even many physicians. Over the last 15 years, University of Arizona researchers have tinkered with the Jarvik heart, overcoming its tendency to generate
blood clots and other failings so that it can be used as a “bridge” to carry patients until they can get a natural heart transplant. One hundred fifty-five patients have used it, for periods as long as 320 days.
At the same time, other researchers have developed successful temporary pumps that take over the work of one or both of the hearts ventricles, the main pumping chambers. Use of these temporary “assist devices,” which require external power sources like the jarvik-7 heart, is virtually routine in many major medical centers throughout the world. They have saved the lives of thousands of patients, either by keeping them alive while they await transplants, or by giving virus-d4maged hearts the chance to rest In fact, surgeons sometimes delay transplant surgery for patients on these assist devices so that they are in better physical shape for the rigors of a transplant.
One of those patients is Danalyn Adams Schart who this week became the first heart transplant recipient to run in (and complete) the Boston marathon. Prior to her transplant, the 28-year-old New Hampshire woman was sustained by a temporary assist device after a virus had devastated her own heart.
Use of assist devices as “bridges to transplant” is controversial because, with a finite number of donor hearts, the temporary pumps merely rearrange the order of transplant queues. That’s why, Lederman said, Abiomed has not requested federal approval of its temporary bi-ventricular assist device as a “bridge,” and will not seek an OK to use its totally implantable artificial heart that way.
Despite the controversy, the wide spread use of temporary artificial heart assist devices has buoyed researchers’ confidence that they have “engineered out” many of the clotting, infection, and reliability problems of the Jarvik-7.
“The bridge-to-transplant experience has done nothing but reinforce our feelings about how well patients can do on these devices,” said Alan J. Snyder of the Pennsylvania State University, which is developing a totally implantable artificial heart that will be ready for human tests in 2001 or 2002.
While heart surgeons have been accumulating this clinical experience, engineers have been exploiting new technologies in biomaterials, batteries, and miniaturization. Together, these advances make possible a device that is totally implantable, with an internal battery that puts out enough power — about the same needed by a 15-watt light bulb to run the artificial heart for an hour before needing to be recharged.
The internal battery is recharged by 4- pound, lithion-ion batteries with a two-hour charge that are worn on a belt. Their charge is transmitted by radio-frequency waves from an external transmitter to an internal receiver disc the size of a large cookie implanted in the abdomen. This eliminates the need for any tubes or wires protruding through the skin — a source of infection in the early artificial heart and temporary assist devices.
Computer technology enables researchers to give the latest artificial heart a “brain,” also implanted in the abdomen, that senses increased demand for blood output and automatically steps up heart rate. The control unit also will transmit readings on the artificial heart’s performance it’s rate, internal pressures, and output by radio to doctors at the bedside, across town, or across the country to a “mission control” in Danvers.
So far, the Abiomed heart has been implanted in about 45 calves in Louisville, and Penn State researchers have tried their unit on about as many calves. The devices have not been trouble-free, but researchers say the have gradually “designed out” the bugs and improved reliability to a point that justifies human tests. While the calves do well, even trotting on treadmills, they outgrow the heart’s pumping capacity within three months.
But which humans should be the first to receive the new artificial heart? Lederman said the company is planning to otter it to three groups of patients:
- The roughly 750 patients a year whose immune systems are chronically rejecting the heart transplants and have no other disqualifying complications. Because the artificial heart is experimental, researchers would face ethical problems if they implanted one in a person who otherwise could have received a heart transplant;
- Patients who couldn’t be “weaned” from heart-lung bypass machines after undergoing cardiac surgery, or from temporary assist devices, a group that may total 6000 annually.
- Victims of massive heart attacks who have only days to live, and are unlikely to get a heart transplant in time, a group that may number 50,000 a year.
Others differ about some of these candidates. Surgeon Couper, for instance, said he thinks heart attack patients will present logistical problems as well as difficulties in obtaining informed consent, since these patients, by definition, will be deathly ill.
Annas, the Boston University ethicist, agreed that patients in shock following a major heart attack “can’t possibly give consent.” He also questions the quality of life among artificial heart recipients who must be ever-vigilant about the life left in their two-hour batteries, or about big down stream issues about how many would get artificial hearts if the upcoming trials are successful, and who would pay.
“But that doesn’t mean I don’t think we shouldn’t be doing artificial heart research,” said Annas, one of the leading critics of the earlier round of artificial heart trials. “If we had a totally implantable artificial heart that the recipient could really forget about, I think it would be a good thing.”
The Boston Globe 4/18/2000
A very timely contribution by long time reader and supporter, TX Mary E. Robinson, Roxbury, MA
Comparison Of Three Hearts
- Size — about the size of a small grapefruit, weighing 1 pound
- Life expectancy — 76.4 years, for an American born in 2000
- Maxiumum output — 5.3 gallons of blood per minute, enough to run a marathon
- Biggest drawback — heart disease is leading U.S. killer
Jarvik-7 artificial heart
- Size - under 1 pound plus 375 pound console attached by tubes
- Cost - $250,000 for the care of Barney Clark, the first recipient
- Life expectancy— Patients lived 10 days to two years.
- Maximum output —2.1 gallons of blood per minute, hypothetically enough to climb stairs.
- Biggest drawback — patient tethered to refrigerator-size console except for short periods when a portable pack was used.
Abiomed artificial heart
- Size — about the size of a small grapefruit, plus external battery pack. Pump weighs 2 pounds, total unit is 3.5 pounds.
- Cost — currently $75,000 per unit, not counting medical care and surgery.
- Life expectancy —Abiomed’s goal is for patient to live one to five years.
- Maximum output — 1.8 gallons per minute, enough to run after a bus.
- Biggest drawback — battery holds one-hour charge, needs recharging from external battery.
N.H. Heart Transplant
Patient’s Journey Ends At Boston Marathon
By Jay Lindsay
BOSTON (AP 4/17/00) Doctors who performed heart transplant surgery on Danalyn Adams Scharf gave her this incentive when she awoke after her operation unable to move her legs: Climb 16 stairs and you can go home.
It was a month before Scharf made the climb. But her progress in the three years since has been astounding.
Scharf completed the Boston Marathon in 5 hours, 53 minutes Monday, and is believed to be the first female heart transplant recipient to complete a marathon. A male marathoner with a heart transplant completed the Boston Marathon in 1985.
Schart 28, who gave interviews along the Marathon route, finished next to her husband, Matt. The pair hugged as her family and friends crowded around to congratulate her.
“I feel really good,” said Scharf of Dover, N.H. “I made a difference today.”
At the finish line, Scharf met Kim Koza-Harris, sister of her heart donor Jane Koza, for the first time. “I feel proud,” Koza-Harris said. “I really feel like my sister is part of this race, too.”
Running the marathon had been a goal of Scharf’s, but it was also about saying “Thank You” to the doctors who saved her, and the family of the donor whose heart now beats inside her. “I’m so grateful,” she said. “These words don’t mean much. They did so much. They gave me life.”
“I’m going to take good care of this heart the rest of my life,” she said. Scharf, a high school track star, had never been sick enough to merit a hospital visit before the nearly fatal virus hit in February 1997. At first Scharf thought she’d caught the flu, but doctors at Lahey Clinic in Burlington later diagnosed a condition called viral myocarditis, an inflammation of heart muscle tissue.
During the next month, doctors would open her chest five times, first to massage her heart to life during cardiac arrest, then to install and maintain a device that pumped blood for her, and finally for the transplant at Brigham and Women’s Hospital.
“She was seconds away from dying” after the cardiac arrest, said Dr. David Adams, associate chief of cardiac surgery at Brigham and Women’s Hospital. “She was walking through a minefield for several weeks.”
The month between her visit to the hospital and her transplant are a haze for Scharf. When she woke up after the surgery at Brigham and Women’s Hospital, she’d lost 25 pounds and couldn’t move her legs, which were little more than skin and bones.
After Scharf passed the doctors’ stair test, she’s focused on returning to her former good health. Scharf said she now feels like her old self, though she thinks occasionally that someone else’s heart is beating inside her. The 39-year-old donor, Jane Koza, had suffered a brain hemorrhage. The first time Scharf met Koza’s mother, Elnore, she touched Koza’s sternum to feel her daughter’s heart beating.
“It’s a tough relationship because they’re strangers but there’s something intimate about it,” Scharf said.
Scharf hopes her example running the marathon can show that transplant patients can return to active lives, and also encourage organ donation. “Without the donation I would just be dead,” she said. “I want to get the word out to anyone.”
The Boston Globe Contributed by Tx Dave Cannavo
Footnote: Danalyn sent a thank you note for our donation to her sponsorship —"I really appreciate the gift. My husband and I crossed the finish line in 5:53:40, under our goal of 6 hours. Not only was the race incredible, but the media coverage was thorough and cer tainly delivered the message of organ donation. We’re already signed up for Boston 2001 — our goal time for next year is 5 hours or less. On with the training...
My editorial corpus got a deserved going over last month from my brother, who also plays a role in UpBeat’s cyberworid existence. I received the following e-mail from his hideaway in the northern Michigan woods:
“Gee, when I started to read about how ‘cosmopolitan’ Upbeat is with all of your demographics, you left out the best parts.... You could have doubled your story by adding: 1) It is then shipped back to Mathews for mailing. 2)It is received in Michigan by brother via snail mail. 3) It is painstakingly re-scanned into machine form and then re-formatted and placed on the web at www.bmarsh.com/upbeat"
He is absolutely correct. The thing I can’t figure out is why don’t I also e-mail the contents to him. Oh yeah, now I remember, all the better to keep him busy scanning on those dark nights by the woodstove.
This here issue will be the last UpBeat you will have the pleasure of reading... until the July issue. Or stated another way, in the year 2000 the Library of Congress has been notified that there will be no June issue of UpBeat. Now if you can handle further detailed information: Contrary to past practice there will be a December 2000 issue of UpBeat containing the best of the transplant and medically related cartoons received between now and then. So please keep your eyes open and help contribute to this fun issue.
Why no July issue? Oh, well I can’t create UpBeat and drive the UpBeatmobile at the same time, and the latter is going on a trip to Nova Scotia, if they will accept this medical massacre at the border. I also heard our west coast office staff intends some heavy kayaking next month.
The Heart Transplant Expert
The famous surgeon, a bit surprised, walked over to where Morris the mechanic was working on the car. Morris straightened up, wiped his hands on a rag and asked argumentatively, “So Mr. Fancy Doctor, look at dis here work. I also open hearts, take valves out, grind ‘em, put in new parts, and when I finish, dis baby will purr like a kitten. So how come you get da big bucks, when you an’ me is doing basically da same work?”
Dr. DeBakey leaned over and whispered to Morris the loudmouth mechanic.
“Try doing it with the engine running.”
Contributed by Tx David Campbell, Cinnaminson, NJ
A Beep for Your Thoughts
By Lisa Singhania - Associated Press Writer
GRAND RAPIDS, Mich. (AP) — Merle Den Bleyker’s pager went off hundreds of times during the months he spent recuperating from a stem-cell transplant to fight cancer.
But the buzzings were a blessing, not an annoyance. Den Bleyker’s friends used the pager to let him know they were praying for him around the clock.
“It really was an instrument in God’s hands,” says Den Bleyker, 52, who today is back at his job as a missionary director.
“It was simply a message ... that someone cared, that someone was praying for me.”
Across the country, groups are turning to pagers to provide 24-hour support to those they believe are in need of prayer. It’s the latest example of the ways technology and spirituality come together, says Brenda Brasher, a religion professor at Mount Union College in Alliance, Ohio.
People already use e-mail and Internet chat rooms to pray together, but pagers offer an added benefit. In a society where people frequently live far away from family, a pager’s beep or buzz can be a comforting reminder that a person is not alone.
“We live far apart from each other, so when you’re ill, to some extent you’re facing it alone,” Brasher says. “With a pager, there is this concrete evidence that people are praying for you.”
Most Pure Heart of Mary Church in Topeka, Kan., set up a prayer pager program after a member read about a similar Texas effort. Since then, the church has distributed more than 40 pagers to ailing parishioners and set up a Web page.
“Some of those people are very ill — they can’t necessarily get up to answer a telephone,” says Kathy Welch, who helps coordinate the program and herself calls more than three dozen pagers a day after praying.
“This way they don’t have to return any phone calls, and they know they are being prayed for,” she says.
Youth Specialties, a business dedicated to Christian education, suggests that youth pastors give their pagers to young congregants to call when they need a prayer.
“It could be, ‘Hey, I need to pass this test,’ or something more serious,” says Rene Howe, a manager with the El Cajon, Calif., company.
In Denver, high school students as well as the ailing carry pagers as part of Third Christian Reformed Church’s ministry.
“We’ve partnered every student with an adult leader. ... These kids get paged by their prayer leaders,” says Pastor Dave de Ridder, who came up with the idea four years ago as a way to let an ill friend in another state know she was in his prayers.
Some efforts are initiated by friends or worshippers just looking for a way to stay in touch. Others are started by youth ministries, church bulletins, Web sites or word-of-mouth.
The pagers also are used differently. In some cases, worshippers punch in a number code that stands for a specific message. Den Bleyker’s pager, for example, used the numbers “77,” which corresponds to “PP” on a phone dial and stands for the “peace prayer.”
Under other programs, people dial in a prearranged phone number connected to voice mail, where they’ve left a message of support.
Cathy Mies of Topeka says her 87-year- old mother received a prayer pager from the Most Pure Heart of Mary Church during the last months of her life. Again and again, the pager’s display would flash “888” the code the church chose to represent the words “Our Lord Jesus.”
“I think she was surprised that people would be praying for her, people whom she didn’t even know,” recalls Mies. “It was very emotional to know that people were praying not only for my mom, but for myself.”
She also liked the fact that, as other church members gave the prayer pager numbers to their friends or people read about the pagers online, her mother was paged by worshippers from all faiths.
“It’s very ecumenical. A prayer is a prayer, I don’t care who does it,” she says. “Prayer is one of the most unifying things for all of us.”
De Ridder, the Denver pastor, uses the church bulletin to share prayer pager numbers with the 700 members of his congregation. A few have been returned by people who were uncomfortable with the constant buzzing, he said, but most people like them.
Sometimes, family members of those who carried pagers and died make donations to the program in their honor. “The widow or widower will say that was very valuable, please keep this going,” he said.
Den Bleyker’s “77” pages came at all hours during his treatment for non-Hodgkins lymphoma at a hospital in Ann Arbor, about 120 miles away.
The constant buzzing took a little getting used to, admits Den Bleyker, who had never used a pager before and carried it on his belt or placed on the nightstand next to his bed.
“There was one time when I thought, ‘Why can’t they let me sleep?” he recalls, chuckling. “But then I realized what it was about and I thought, ‘That’s really super.”
Ed Note: Actually the matter of religion on this subject is truly discretiona!. The beeper concept alone is simply a fantastic morale building idea. It would be especially good if the beeper would simply show the nickname of the person beeping, such as “Fred” or “Dad” or “Crystalstar”. What a waytojust say “Thinking of you”, or “Hang in there” to a friend or relative in the hospital or abed at home without forcing them into awkward con versation. Think of the times when you were on the slippety down slope and feeling pretty much alone, four or five good beeps a day could keep all sorts of tears away. It is to be hoped that the social workers and/or chap lains at every hospital would work toward pro viding this service. DSM
How Medicare Altered Rules After A Desperate Plea
By Laurie McGinley - Staff Reporter of The Wall Street Journal
Edward Petraiuolo Jr., 69 years old, lay in an Alabama hospital last fall awaiting a lifesaving liver transplant, when a hospital admissions official stopped by his room with the news: Medicare wouldn’t cover his surgery.
Mr. Petraiuolo’s wife, Kay, nudged the official into the hail to talk out of her husband’s earshot. To her distress, she learned that Medicare excluded patients who, like Mr. Petraiuolo, had liver disease caused by the hepatitis B virus.
Frantic that her husband of 44 years might be denied a transplant, Mrs. Petraiuolo (peh-treeOH-low), a 66-year-old New Haven, Conn., homemaker, set out on an improbable mission to circumvent Medicare policy and secure coverage of the costly surgery.
The result: Not only did her husband get a new liver, paid for by Medicare, but Medicare changed its policy to start covering all hepatitis B victims needing liver transplants - a reversal that could save lives and millions of dollars for patients and their families.
Behind Mrs. Petraiuolo’s crusade lies a tangled tale of medical advances, fortuitous political connections and a bureaucrat who took the extraordinary step of ordering that Medicare pay for surgery when policy explicitly barred coverage.
Medicare, the federal health program for 39 million elderly and disabled people, has long taken a conservative approach to covering liver transplants. Pioneered in the early 1 980s, the operations weren’t covered by Medicare until 1991, and then just for a few diagnoses. Five years ago, Medicare expanded coverage to all beneficiaries with “end-stage liver disease,” with two exceptions: patients with liver cancer or with hepatitis B.
Those patients were excluded because they usually fared poorly after transplants. In many hepatitis B cases, the virus would infect the new liver, killing both organ and patient. The exclusion for hepatitis B sufferers affected about 50 people a year, says the American Liver Foundation of New York.
In recent years, Medicare began to reconsider the exceptions. In December 1998, Liver Foundation officials, including some top liver-transplant surgeons, met with officials at the Health Care Financing Administration, which runs Medicare. The foundation presented a summary of studies showing sharp improvements in survival rates of hepatitis B sufferers who had undergone liver transplants. The improvements were attributed to new medications that help protect the transplanted liver from the virus.
HCFA officials responded positively, but insisted on getting more data before making a policy change. The foundation provided more information a few months later, but HCFA still wasn’t satisfied. In October, the foundation sent the agency a survey showing that nearly 100 private insurers cover transplants for hepatitis B patients. The goal was to convince HCFA that it was out of step with the market. But foundation president Alan Brownstein was so pessimistic about succeeding that he began planning a lobbying campaign aimed at Congress.
The Petraiuolos knew none of this when Edward, a retired junior-high school principal, was admitted to the hospital at the University of Alabama at Birmingham on Oct. 30. He was jaundiced and bloated, and his gastroenterologist back home in New Haven had told him he would die in a matter of weeks if he didn’t get a new liver. So dire was Mr. Petraiuolo’s condition that his doctor sent him to the hospital in Birmingham, where waiting times for new livers tend to be shorter than in New England.
Mr. Petraiuolo’s health struggles began in the spring of 1988, when he developed a blood disorder known as ITP. ITP causes a dangerous shortage of platelets and heightens the risk of internal bleeding and stroke. Mr. Petraiuolo had frequent transfusions and, for reasons that aren’t entirely clear, the disease disappeared in 1989. Shortly afterward, though, he learned he had been infected with the hepatitis B virus, probably via contaminated blood.
Hepatitis B kills about 6,000 Americans a year. Many people recover, but Mr. Petraiuolo wasn’t so lucky. His disease was kept in check by an antiviral medication for years but, at some point, the virus apparently mutated and attacked his liver.
Mr. Petraiuolo began feeling ill during a vacation last fall to Egypt, Jordan, Israel and Italy. “I didn’t even want to eat in Italy,” he says. Soon after returning home, he was on his way to Alabama. Hospital physicians decided Mr. Petraiuolo was fit enough to undergo major surgery. “Hope seemed to be on the horizon,” his wife recalls.
But hope began to wane in a nerve- wracking week that culminated on Friday, Nov. 5, as Mrs. Petraiuolo and one of the couple’s three grown children kept vigil in Mr. Petraiuolo’s sixth-floor hospital room. Late that afternoon, a woman from the hospital admissions office told the Petraiuolos that Medicare wouldn’t cover a
transplant, nor would it pay for postsurgery hospital expenses, drugs and follow-up care. Liver transplants typically cost between $150,000 and $250,000, and costs over five years can easily reach $400,000.
The admissions-office representative also dropped off forms requesting information on the couple’s household income, assets and expenses. Hospital officials say the forms help determine whether uninsured patients can afford their medical bills or whether they’re poor enough to get Medicaid or other financial assistance.
Partly because of the financial inquiry, there was confusion as to whether Mr. Petraiuolo had been placed on the regional transplant waiting list, a crucial step toward getting a new liver. A spokesman for the hospital says Mr. Petraiuolo was put on the waiting list that very day. But the Petraiuolos say they weren’t told that at the time. Rather, they say, they were told that a liver- transplant committee would review his case the following Tuesday, and consider his health, psychological state and finances. The family says their strong impression was that the operation wouldn’t proceed until their finances were deemed in order.
Brendan McGuire, the hepatologist on the case, says he tried to reassure Mrs. Petraiuolo that her husband eventually would get a transplant. But he also told her that, because of the absence of Medicare coverage, the doctors wouldn’t perform a transplant that weekend even if a liver were to become available. Their concern, he says, wasn’t with the prospect of unpaid bills, but with Mr. Petraiuolo’s ability to pay for postsurgery drugs - the key to long-term survival.
Through many of these discussions, Mr. Petraiuolo was confused and disoriented, his doctors say. But his wife, worried that any delay would doom her husband, started questioning doctors, nurses and patients. She learned that the posttransplant prognosis for hepatitis B patients had improved, and that Medicare covers transplants for hepatitis C patients, even though many doctors believe those patients don’t fare as well as their counterparts with hepatitis B. She became increasingly outraged.
Wall Street Journal 4/26/00
Deal Reached on Transplant Proposal
By Laura Meckler - AP Writer
WASHINGTON (AP 4/12/00) — The Clinton administration and senators struck a deal Wednesday that would give a panel of medical experts final say over how the nation distributes scarce organs to thousands of waiting patients.
Backers hoped the compromise, set for quick Senate action, would settle a battle over who has power to set transplant policy. The Senate Health, Education, Labor and Pensions Committee unanimously approved the legislation Wednesday.
The deal’s fate was far from clear in the House, where last week lawmakers passed a bill giving the private company that runs the transplant system sole power over policy. And marrying the Senate version with that in the House would be like trying to “cross a Chihuahua with a Great Dane,” said Sen. Edward Kennedy, D-Mass.
“There has been conflict, there has been debate, there has been disagreement, there has been anger,” said Sen. Bill Frist, R Tenn., a former heart and lung transplant surgeon who fashioned the agreement.
Clinton said in a statement issued Wednesday that he was pleased by Frist and Kennedy’s announcement that a compromise had been reached.
“This compromise takes a first step towards ensuring that those Americans most in need of receiving these life-saving resources will be able to better access them,” Clinton said. “At the same time, we must redouble our efforts to encourage voluntary donation by all Americans.”
The legislation does not address the substance of the argument: whether organs should be offered first to patients who live near the donor, as in the current system, or go to the sickest patients first, even if they live elsewhere.
Rather, it sets up a mediation system to settle disputes between the Department of Health and Human Services and the private contractor that runs the system. An outside panel of experts would have the power to make final decisions on policy, based on legal principles.
In the compromise, Frist agreed to add a provision making it clear that the distribution system should work to reduce geographic disparities in the system.
HFIS complains that the current system, which relies heavily on geography, is unfair because patients in certain parts of the country have a better chance at getting a transplant.
HHS and the United Network for Organ Sharing, which runs the system, have been at odds for more than a decade, but their dispute erupted two years ago when HHS directed the network to rewrite its rules to get more organs to the sickest patients.
The network balked that HHS should get the final say over medical decisions and complained that smaller hospitals would lose organs to the larger centers under the HHS plan.
The Frist-Kennedy legislation allows the transplant network to write policy. But if the sides cannot agree, an expert committee would make the final policy decisions.
The 21-member committee will be comprised of seven people nominated by HHS, by the transplant network and by the independent Institute of Medicine. The network and the IOM will each nominate 12 people and the HHS secretary will choose from among their lists.
Some transplant centers were already upset by that provision.
“It would be rather easy for the secretary to achieve a majority for whatever opinion or policy she would put forward,” said Dr. Tony D’Alessandro, who directs the transplant program at the University of Wisconsin-Madison and leads a group opposed to the HHS regulations.
But administration officials said they have an understanding with Frist that they will not compromise further.
In the Senate, at least, all sides appeared ready to move ahead with the deal.
Sen. Jeff Sessions, R-Ala., has been one of HHS’s fiercest opponents, voted for the legislation, saying, “It’s time for the (transplant) community to get back to what they do best — medicine.”
Imatron’s EBT Coronary Artery Scan Shown to be Improvement Over Ultrasound
SOUTH SAN FRANCISCO, Calif., May 4, 2000 (BUSINESS WIRE 5/4/00) Imatron Inc. (Nasdaq:IMAT) today announced the publication in Circulation, the journal of the American Heart Association, of a Humboldt University study at the German Heart Institute in Berlin.
Friedrich Knollman, MD, reported remarkable results of “Electron Beam Computed Tomography in the Assessment of Coronary Artery Disease After Heart Transplantation” in 112 transplant recipients who received EBT scans to measure coronary artery calcification an average of 4 years after surgery.
The authors reported that only the EBT “calcium score” predicted the occurrence of narrowings greater than 50% in the arteries of the new heart. The patients’ gender, age and the time after transplantation were not significant predictors.
Using an optimized threshold for detection, which matches that determined in other studies of asymptomatic subjects, the investigators determined a sensitivity of 94% for detecting these stenoses, or
narrowings of the coronary arteries, and a 99% negative predictive value in ruling out their presence.
Dr. Knoliman and colleagues concluded that their data “confirmed the role of EBCT calcium screening as a method for coronary artery disease assessment and extended its role in conventional atherosclerotic heart disease to heart transplant recipients.”
Their comparison with intracoronary ultrasound, which is the standard of reference for assessing allograft vasculopathy, but is invasive and expensive, suggested that EBT could be used as a “surrogate marker for coronary artery disease after heart transplantation.”
The authors point out that more than 3.000 people receive heart transplants every year and many undergo annual coronary angiograms. According to the authors, many of these procedures might be avoided by the use of this “highly sensitive method” which is an “inexpensive, non-invasive test” and could result in substantial cost savings.
Report: Dead Harvested for Products
SANTA ANA, Calif. (AP 4/16/00) — Donated human remains are processed into medical products that generate hundreds of millions of dollars for U.S. companies despite laws barring profit from body parts, The Orange County Register reported Sunday.
Although grieving families are told that the donations are a gift of life, the newspaper found that material harvested from the dead fuels an industry that is expected to have $1 billion in revenues by 2003.
"I thought I was donating to a nonprofit. I didn’t know I was lining someone’s pocket,” said Sandra Shadwick, whose brother’s remains were given to a Los Angeles tissue bank. “It makes me angry. It makes me appalled. If it’s not illegal, it ought to be.”
The National Organ Transplant Act of 1984 banned profits from the sale of tissue, but companies and nonprofit tissue banks are allowed to charge reasonable fees to handle and process the parts. The law does not define a reasonable charge.
“The law has never been tested in court. Nobody has ever decided what is selling and what isn’t,” said Jeanne Mowe, executive director of the American Association of Tissue Banks.
Nonprofit tissue banks may obtain body parts useful for up to 100 patients from a single cadaver. The parts are then sold to companies that make products used by doctors and dentists, and the banks and businesses share revenues.
Survivors urged to donate usually are told about vital organs, such as hearts or kidneys, but most of the products derived from th,e dead are far from lifesaving:
Cadaver skin may be used to puff up the lips of models, enlarge penises or smooth out wrinkles, the newspaper said.
A single body can provide material that is worth up to $34,000 for nonprofit tissue banks, including skin, tendons, heart valves, veins and corneas that are then made available to doctors and hospitals for up to $110,000.
With bone taken from the same body, a cadaver can be worth $220,000.
“People who donate have no idea tissue is being processed into products that per gram or per ounce are in the price range of diamonds,” said Arthur Caplan, a professor at the University of Pennsylvania’s Center for Bioethics.
Lives are enhanced by donations: Tendons help athletes, cadaver skin helps solve bladder, problems and corneas help the blind to see, said Michael Jeifries, chief financial officer for Osteotech Inc., a leader in the bone business.
“There is a profit,” he said. “It’s not an evil thing because the profit is put to good use.
The two largest for-profit tissue companies had $142.3 million in sales last year and each pays its chief executive more than $460,000 annually, the newspaper said. The four largest nonprofit tissue banks will make $261 million in sales this year, it said.
The number of organ and tissue donors increased 172 percent nationwide over the past five years, according to the American Association of Tissue Banks.
Last fall, Vice President Al Gore announced $5 million in grants to organ and tissue agencies.
“I did not know that the amount of money involved was as large as you have pointed out,” Gore told the Register in a recent telephone interview.
Contributed by Tx Mary Robinson, Boston Ed note: Isn’t it something? Good honest people like Danalyn Scharf literally bust their phradattles to encourage organ donation, then not only is this ugly business "discovered" but also publicized.
Transplant Docs Face Murder Charges
By Busaba Sivasomboon - Associated Press Writer
BANGKOK, Thailand (AP4/5/00)— Three doctors and a former hospital executive already penalized for ethical breaches involving a series of kidney transplants now face murder charges, Thai police said Wednesday.
Police issued subpoenas for the four Wednesday on two charges of conspiracy to commit murder after a commission found that they had not followed proper procedures in declaring organ donors brain dead. Conspiracy to commit murder carries the death penalty. In February, Thailand’s Medical Council revoked the license of one doctor and suspended those of four others at the hospital after finding that they had illegally traded in human organs.
The council said it had sufficient evidence to show that surgeon Sirot Kanchanapanchaphol and his colleagues improperly harvested kidneys. The council also found the team violated brain-death analysis standards. Sirot was one of those charged by police.
The suspects, from Vachiraprakarn Hospital on the outskirts of Bangkok, are also charged with falsifying documents.
The suspects have previously denied all allegations.
The police acted on a complaint by the Law Society of Thailand, acting on behalf of the relatives of two people from whom kidneys were harvested after they were declared brain-dead.
They alleged that the kidneys were obtained by malpractice, trickery and payment. The cases came to light about a year ago, after one of the relatives took his story to the media.
Trading in organs is prohibited in Thailand. Organ donation is done by agreement between donors and recipients without any payments.
Sirot, former chairman of the hospital, and his colleagues allegedly used false documents which claimed relatives of brain-dead patients permitted them to remove kidneys.
They were also accused giving money to the relatives of the organ donors and then charging organ recipients.
Man May Lose Transplanted Hand
PERTH, Australia (AP 5/1/00) — Doctors were treating a New Zealand man Monday who was in danger of losing a hand grafted onto his arm 18 months ago in the world’s first hand transplant.
Clint Hallam, 49, was being given drugs to combat rejection of the hand transplant, Peter Cogan, a spokesman at Perth’s Sir Charles Gairdner Hospital said.
Hallam made international headlines in September 1998 when a team of surgeons in Lyon, France, grafted the hand of a 41- year-old motorcyclist on to his forearm in a 13-hour operation.
In France, Dr. Jean-Michel Dubernard, co-head of the transplant team, told RTLand France-Info radio that Hallam had suffered similar rejection problems before but that they had been successfully treated.
Dubemard said he was awaiting more information to decide whether the rejection was reversible.
“In the worst case scenario ... if the arm is rejected or becomes useless, it must be amputated, which would put him in exactly the same state he was in before the surgery.”
Hallam was serving a two-year sentence for fraud in New Zealand when he lost his hand in a chain saw accident in prison.
Last year, he said he hoped one day to learn to play the piano and told the Sunday Times newspaper he already was performing simple tasks with the hand such as holding a cup of coffee and swimming.
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