Medical Breakthrough - White Paper on Transplantation

The Gift Of Life
by Sandy Krawitz

In a world of staggering medical advances, the technology exists to save thousands who would otherwise die. Yet, many are left to perish anyway due to the lack of transplantable organs or the lack of means to pay for transplant surgery. This paper covers the numerous ways Americans are working to make life-saving organ transplants possible -- and the obstacles that block the way. At the same time, we'll take a glimpse at new technologies that may provide alternatives to traditional transplants, while spelling an end to anti-rejection medication. We'll also look at life after transplant, from the U.S. Transplant Games to the very personal effects it has on a patient's family and we'll realize that for every negative story, there is an equally positive one in the quest for a gift of life.

The Donation Conundrum
Driver's License Registration
Miscommunication
Presumed Consent
New Federal Rules On Organ Distribution
Some Donor Families Would Change Their Minds If Asked Again
Leaving the Country
The High Costs Of Organ Transplantation
An End To Meds
The Organ Trade
After the Transplant
Conclusion: The Unresolved Issues
Links To Relevant Web Pages

The Donation Conundrum

In 1996 alone, there were 5,416 cadaveric donors; 20,360 lifesaving transplantsl; 50,047 registrations on the UNOS waiting list; and 3,916 people who died while waiting.

As of now, about 58,673 people are on the list. 11 will die each day

and the need for donated organs is growing. Recently, AIDS patients were added to the list of eligible organ recipients. Substance abusers and the growing elderly population are also eligible for transplant.

As this need grows, the pool of donors and potential donors is not able to keep up despite the fact that eight out of 10 Americans support organ donation, and 78 percent of Americans say they are willing to donate their organs. Of those Americans that don't wish to donate their organs, the primary reasons are:

Religious or moral (37 percent)
Concern for relatives (17 percent)
Unwillingness to make plans about death (13 percent)
Concern organ donation will change a body's appearance (nine percent)
Fear that doctors won't try as hard to save registered organ donors (seven percent)

Nearly every religion, from Christianity and Hinduism to Buddhism and Islam, believes organ donation is acceptable, if not a means of finding grace. The Christian Scientists and Jehovah's Witnesses allow the procedure. Yet, religion remains the main reason cited for refusal to donate. The problem is that many are not aware of their religion's stand. According to a recent Gallup Poll, 29 percent of Americans do not know whether their religion has laws or doctrines governing organ donation.

The Gypsies are one religious group whose beliefs do not allow them to donate organs right away. They believe that for one year after a person dies, the soul retraces its steps. All of the body parts must be intact because the soul maintains a physical shape. The Gypsies are not a majority. So why is religion such a major reason behind the decisions not to donate? According to Melissa DeVenney of the Coalition For Donation, it may be because most people are uncertain about their religion's stand. To help clear the confusion, the Coalition has implemented a national Clergy Council, which helps to develop sermons and presentations for religious institutions nationwide.

Driver's License Registration

Every state allows its citizens to register as donors on their driver's licenses. Some even provide electronic registration on behalf of local donor databanks. This isn't effective everywhere, though. Texas just recently eliminated its electronic registration program because only three percent of its drivers signed up. The Southwest Transplant Alliance attributes the failure to uninformed driver's bureau employees and the widespread myth that physicians won't try as hard to save a registered donor's life.

Conversely, Illinois has the most successful electronic registration program in the country, boasting four million registered donors with an additional 50,000 registering every month. A major reason for the state's success is a popular advertising campaign that couples educational initiatives with compelling radio, print and television ads. Since this campaign's 1994 debut, the number of registered donors has jumped by 52 percent.

Some consider approaches like the one used in Illinois flawed. Explicit agreement from the donor is required, and that person usually must be a registered driver. At the time of death, the family must also approve, but fear prevents many from sharing their decision with their relatives, who are often left to deal with serious questions.

Arkansas has also been successful in their campaign for more organ donors. Their year-old Department of Motor Vehicles registry already claims 600,000 registered donors. Citizens' licenses or identification cards are issued with "ORGAN DONOR" in bold, red letters. Families are then informed that the donor is registered to donate. Ninety-nine percent of families give consent in agreement with their loved one's predetermined choice.

Pennsylvania has gone a step further. In a law passed late last year, physicians have the right to harvest organs without family consent as long as the deceased is a registered donor. So far, there is little controversy and no known lawsuits.

The Coalition for Organ Donation hopes to educate potential donors about sharing their decisions through a national media campaign called, "Share Your Life, Share Your Decisions." Featuring Michael Jordan, the campaign has run since 1996 and will be followed later this year with another campaign entitled, "Are you an Organ and Tissue Donor?"

Questions from recent UNOS survey to Organ Procurement Orginizations (OPOs):
"Will you recover organs or tissues on a signed donor card?"

	OPOs Responding	Yes	No
1. In all situations?	39	3	36
2. In the absence of family?	38	18	20
3. Against family wishes?	36	1	35
4. Only after obtaining family approval?	39	34	5

Miscommunication

According to a recently released UNOS survey, miscommunication between hospitals and organ procurement organizations (OPOs) may be contributing to the organ shortage. Only 21 percent of OPOs have more than half of their region's hospital death reports. So many organs are going unharvested. The U.S. Department of Health and Human Services has proposed legislation to solve this problem.

Presumed Consent

According to some European countries, such as Austria, France, Greece and Italy, perhaps the best way to solve the donor deficit is through presumed consent. Under this policy, physicians assume the recently deceased would wish to donate their organs. Harvesting takes place immediately without consulting with the family, unless the deceased signed a form explicitly stating he or she did not wish to donate. The most celebrated success of these experiences is a case from Belgium, where organ recovery more than doubled following implementation of its policy of presumed consent, but there are still waiting lists.

Although there are limited talks about enacting similar policies within the United States, the overriding question is whether it's possible in our political climate. According to a 1991 poll of 801 citizens, the answer is "probably not." When asked "whether physicians should be able to act on implied consent," 38 percent said "yes," 55 percent said "no," and seven percent were undecided.

According to the ad hoc committee that sponsored the poll, "As many (33 percent) of the respondents may not have fully understood the concept of presumed consent by objecting to presumed consent on the grounds that "a person should make the choice/give consent." In the view of the ad hoc committee, "The individual has made a choice by not objecting to donation, and therefore respondents should not object to presumed consent on the basis that it precludes personal choice."

Some states, including Texas, have very limited presumed consent rules on their books. In a John or Jane Doe situation, organs can be harvested if the family cannot be located. Even then, however, the medical examiner may be wary of giving the nod. In the event of a murder, the organs might be needed as evidence. In other cases, the medical examiner may be concerned about potential lawsuits or unknown risk factors, such as the deceased's potential for HIV.

According to the Southwest Transplant Alliance, these situations are very rare, occurring only a few times a year and not contributing much to the waiting list.

Interestingly enough, about 24 states, including Texas and California, do have presumed consent laws that apply to cornea removal. UNOS and the Southwest Transplant Alliance believe most of these laws will soon be revoked due to a surge of recent controversy and lawsuits.

Phil Berry, M.D., head of the Texas Medical Association, hopes there will be more presumed consent laws in the future. A liver transplant recipient himself, Berry recently said, "What we're doing right now isn't working. The number of people added to the list who need organs goes up and up, while levels of donation remain stable. We have to be willing to look at alternatives." So far, no legislators have agreed to carry a presumed consent bill.

New Federal Rules on Organ Distribution

While the debate over presumed consent plods along, the Federal Government moved recently to ensure the right patients are allocated organs at the right time.

Currently, patients on waiting lists have to play a guessing game over which medical center they should register with, as organs are allocated to the center within the closest proximity to the donor. The result is that some rural patients have to move to urban areas, and certain less critically ill, but better located patients are apt to receive their organs in a timely manner.

On March 26, 1998 Health and Human Services (HHS) Secretary Donna Shalala announced a new rule which calls for organ allocation based on medical criteria rather than geography. Shalala says, "Patients who need an organ transplant should not have to gamble that an organ will become available in their local area, nor should they have to travel to transplant centers far from home simply to improve their chances of getting an organ. Instead, patients everywhere in the country should have an equal chance to receive an organ based on their medical condition and the judgement of their physicians."

The rule, for which congressional hearings ended this August, is not without criticism, particularly from Tennessee heart surgeon and U.S. Senator Bill Frist, as well as UNOS, the private system that administers all U.S. organ allocation. UNOS argues that "the government lacks the legal authority to dictate the rules of organ allocation, which the group says should remain in the hands of the transplant community, including the centers that UNOS represents." Frist agrees, fearing federal micromanagement of the system.

UNOS is also concerned about the following:

The HHS regulations will require a national list with a "sickest first" criteria. This means that patients will become sicker before they receive their life-saving transplant. Statistics show that patients who are extremely ill when given a liver transplant have a higher rate of transplant failure and may need a second or third transplant to survive.
Local centers will close; organ donation will be affected. By centralizing the system into a national waiting list, the new regulations will reallocate donated livers away from the vast majority of the country's 120 transplant centers and shift them to about a half-dozen regional surgical centers. This would force many smaller transplant programs to close their doors, depriving their communities of life-saving medical technology and highly-skilled doctors.
Transplantation access for poor will decrease. Almost one of every five transplant patients is on Medicaid. If, as a result of this new policy, a large percentage of the country's smaller transplant centers close, many transplant patients and their families will be forced to travel far from home during an already traumatic time.
Preemption of State Law. The new HHS regulations would preempt many state laws governing organ procurement and distribution. For example, Louisiana law states that organs donated or acquired in the state shall not leave the state for transplantation.

Another camp pushing for HHS intervention includes Senators Rick Santorum and Arlen Specter (who chairs the subcommittee that funds HHS). Both are Republicans from Pennsylvania, home to the University of Pittsburgh, a large transplant center that stands to gain millions of dollars in business from a change to broaden sharing of organs.

Practically speaking, a rule such as this might work well for liver and kidney transplants, as livers can remain transplantable for up to 24 hours and kidneys for up to 72. It becomes more difficult in terms of hearts, which can be preserved only up to six hours and impossible for lungs, which cannot be preserved outside the body for an extended period of time.

UNOS has until December to vote on new liver allocation policies and until 1999 to decide on the rest. Its committee of 30, headed by University of Michigan transplant surgeon Jeremiah Turcotte, is trying to strike a balance between allocating to the most critically ill, and those less so, so that survivability is increased. They are actively using computer modeling to find the best solution.

The next committee meeting will be held on September 14, 1998 at the Dallas/Fort Worth Airport Marriott. It will be open to the public.

Some Donor Families Would Change Their Minds If Asked Again

According to a Washington University School of Medicine study, there is a significant portion of donor families who would not donate their loved one's organs if asked to do so again. In their survey of 225 family members who were approached to donate their relatives' organs, 178 were satisfied with their decisions, while 47 reported they were not. Of this group, 22 said they would not donate again. Dr. Barry Hong, associate professor of psychiatry and medicine, says, "I'm concerned that 20 percent of these people think they should have done something else. That's a sizable proportion, and I think it's one that should be worrisome to the transplant community."

Interestingly enough, the researchers found that those who chose to donate but were later dissatisfied tended to go to church more and be more religious. The research also found that those more comfortable with their decisions tended to be more highly educated and had previously discussed the issue with their families. Donation was less likely to occur if the decision was up to a large number of family members.

Leaving the Country

Some patients are leaving for foreign countries in order to improve their chances of receiving an organ. Case in point is 71-year-old Orlando Magic owner, Richard DeVos, who traveled to England because his uncommon blood type and age were decreasing chances of receiving a heart here.

DeVos waited five months for his heart, which he said he received only after it was determined that no one in the United Kingdom could use the AB blood-type organ. "All that we know is that we followed the procedure," DeVos said. "We went to London because of our age and because no one else in this country would do it."

The High Costs of Organ Transplantation

Donor Families Pay, Too -- According to University of Pennsylvania researchers, government should provide financial reimbursement to donor families, who are, as of today, forced to pay all medical expenses until their loved ones are declared brain dead. (My note: Most of these hospital charges would be billed to the donor family if there were no donation. These charges are not directly associated with the donation process. Most hospitals will discharge a patient and then re-admit to determine the charges related to donation. Anyone who feels they were unfairly charged any expense related to the donation should contact the O.P.O. involved to get this taken care of. Unfortunately, hospitals have been known to double-bill patients.)It should be noted that once the family agrees to donate, all expenses are incurred by the government.

Standard Acquisition and Total Recipient Charges

Organ	Charges To Donor Family	Recipient Charges
Kidney	$12,749	$92,700
Liver	$15,403	$280,200
Heart	$13,651	$222,700
Lung	$13,528	$265,100

Association of Organ Procurement Organizations. 1994 Annual AOPO survey results.
Falls Church,VA: Association of Organ Procurement Organizations;1995.

The Cost To Recipients -- While the costs to donor families are much more than we'd expect, the recipients' bills are astronomical. In today's free market economy, if a patient can't show that insurance or some other source will pay the minimum required by a transplant program, he or she probably won't be accepted for surgery. "A hospital is not obligated to go broke," says Dr. Frank Stuart, head of transplants at Northwestern Memorial Hospital in Chicago, which works with patients' financial problems. "There's no free lunch."

Fortunately, most private insurance policies cover transplants, and Medicare covers most transplants for low income patients. A patient can even bargain with his/her hospital and insurance company to ensure the entire bill is covered.

That's great news, as long as the patient has health insurance. In reality, the number of completely uninsured people is growing. The population of uninsured children under 18 grew to 10.6 million (14.8 percent) in 1996; both the number and percentage were statistically higher than the 1995 figures of 9.8 million and 13.8 percent, respectively. Overall, an estimated 41.7 million, or 15.6 percent of Americans had no health insurance during 1996.

Furthermore, Medicaid, when it does pay for transplants, often pays much less than the required amount, throwing patients into a similar financial crisis as the completely uninsured.

However, there are organizations available to help the millions of uninsured or underinsured, including The National Transplant Assistance Fund, the Transplant Foundation, the American Liver Foundation and the American Kidney Fund. An organization called AirLifeLine will even help cover transportation costs. The patient can also work with his/her hospital's financial coordinator to learn about government programs, disability coverage, high-risk insurance pools and other aids. Community or church-sponsored fundraising drives are other proven means of scraping together the necessary funds.

Sadly, the recipient's financial strain does not end once surgery is over. Drugs, which the patient will need to take for the rest of his or her life, can cost upwards of $20,000 a year. It's a hefty expense that often exceeds insurance companies' drug benefit caps, which can be as low as $3,000 a year. Medicare covers 80 percent of the cost, but only for three years.

Drug companies do have their own assistance programs, which are not necessarily limited to the indigent. For example, Novartis provides patients with a supply of cyclosporin for up to a year at a time based on income, insurance coverage and medical and living expenses.

An End To Meds

If all goes as the University of Pittsburgh Medical Center hopes, someday there may not be a need for anti-rejection medication. Besides being costly, medication currently prescribed for transplant recipients has dangerous side effects, including hallucination, cancer and kidney damage, and an increased risk of infection.

Orlando Magic Owner and transplant recipient, Rick Devos, knows about these side effects first hand. "You feel like you are going into a slimy pit when you have those hallucinations. I would wake up and reach down and feel my body. Then I'd put the light on and look at my body to make sure it really was there."

Pittsburgh's research concentrates on using gene therapy to block the body's rejection response at the time of transplant, thereby eliminating the need for further medicines. Now in pre-clinical study, the procedure utilizes a genetically-engineered virus that delivers a gene which blocks the body's rejection response. The engineered virus is placed in a solution that surrounds and preserves livers before transplant. Within two hours, the liver effectively "soaks up" the virus and is primed to prevent rejection for the rest of the patient's life.

The Organ Trade

Here in America, as in most countries, the selling of organs is strictly illegal. That has not stopped individuals from trying.

Rick Devos feels for people who wish they could just buy a heart. "My experience says you cannot," he said, adding, "Otherwise, I wouldn't have waited five months."

India ranks among the top countries engaged in the organ trade. With the average worker making $11.00 a month, the kidney trade is booming. Over the past five years, 2,000 or more kidneys have been transplanted (the sale of organs has been banned within India since 1993, but the country has an aggressive black market).

According to the American University, "The biggest participants in the trade are unscrupulous Western pharmaceutical companies seeking to profit from marketing their latest products that have derived from the procurement of human body parts."

In a German autopsy controversy, human body parts were smuggled out of hospital basements by shady hospital workers and sold to drug companies for the extraction of growth hormones.

After the Transplant

Return to Work -- According to Roger Evans of the Mayo Clinic, only about 35 percent of all transplant patients return to work. Most of the rest are forced to live out their lives on disability and Medicare. However, it is possible to lead a healthy life after an organ transplant. Rick Devoss says, "I can climb four flights of stairs, and I can ride a bike four miles."

The U.S. Transplant Games -- To acknowledge successful organ transplants, the National Kidney Foundation is host to the annual U.S. Transplant games. Open to recipients of heart, liver, lung, kidney, pancreas and bone marrow transplants, athletes participate in a range of sporting events, ranging from a 5K road race to swimming to biking. The 1998 games were held at Ohio State University in Columbus from August 5-8, 1998.

Psychology -- According to studies, there are psychological effects after the transplant that are felt by both the patient and spouse. These include survivor's guilt and depression. Interestingly enough, according to a University of Pittsburgh School of Medicine study, a transplant patient's spouse's health may actually deteriorate after the operation. Of course, the donors are often very fondly remembered. To commemorate their life-saving gifts, the National Kidney foundation has sponsored the National Donor Family Quilt. Constructed from patches made by donor families, this quilt is currently on a national tour, visiting 40 cities between March 6th and November 19th.