Money's increasing role in attracting more donors, new transplant legislation lead stories in 2003.

The year 2003 in transplantation will be best remembered for two issues that are joined at the hip - the increasing disparity between people on the waiting list for a life-saving organ and the number of people willing to donate, and the increasing role money is going to play in the donor process.

The year began with a recommendation from a small transplant ethics meeting held in December in Germany that under certain circumstances commerce in organ donation is acceptable. It ended in December with the uncovering of an international organ trafficking scheme involving paid donors from Brazil, transplants performed in at least one South African hospital, and recipients including at least one Israeli, paying for organs.

In any other year the most significant event would have been the surprise passage of national transplant legislation in the US Senate. Under the guidance of Senate Majority Leader and transplant surgeon Bill Frist (R-TN), The Donation and Recovery Improvement Act (S. 573) easily passed the Senate in November. The centerpiece of the legislation is $5 million in funding for reimbursing expenses of living organ donors.

In March the Organ Procurement and Transplantation Network (OPTN) released data showing that for the 3rd straight year the number of organ donors, deceased and living, increased by a miniscule1.3% over 2001. Once again, like 2001, living donors outnumbered deceased donors.

The tiny increase underscored what has been known for the past several years--public and professional education programs designed to increase donors simply do not work. The lack of new donors fueled interest in offering financial incentives to donor families to see if it will increase donation. In June, a House subcommittee chaired by Rep. James Greenwood (R-PA) held a hearing on the donor shortage which included testimony by groups and individuals who were for and against offering incentives. Greenwood introduced legislation last year that would authorize a financial incentives trial.

In September the federal government released the results of a comprehensive study-the "Organ Donation Breakthrough Collaborative: Best Practices Final Report" which recommends that others emulate the success of the nation's most successful organ procurement organizations and transplant centers' success in increasing organ donation. The report led to the launch of a nationwide effort in 200 of the largest hospitals in the US to increase the conversion rate of eligible donors from the current 43% to 75% in the next year.

Here's a look at the major news developments in transplantation in 2003.

JANUARY

*Participants attending a small transplant ethics meeting in Germany challenge mainstream transplant organizations' mantra that commerce in organ donation is unacceptable by declaring that under certain circumstances it is indeed acceptable for a variety of ethical, moral, medical and practical reasons. The interdisciplinary group of transplant professionals, ethicists, theologians, legal experts and philosophers attended the International Congress on Ethics in Organ Transplantation December 10-13 in Munich, Germany.

*Nearly a year after the tragic death of a live liver donor at Mount Sinai Medical Center, New York becomes the first in the US to endorse strict guidelines governing live donor liver transplants. The comprehensive guidelines were developed by a panel of experts following the death of Michael Hurewitz on January 15, 2002.

*Following the death of the California inmate in December, legislation is introduced lthat would allow people who sign a donor card or driver's license to exclude prisoners from receiving their organs.

*Bipartisan legislation introduced in the House and Senate which could ease financial strains on transplant recipients and living organ donors alike. Under bills organ transplant recipients would receive lifetime Medicare coverage for their lifesaving immunosuppressive drugs and health insurers would be prohibited from raising premiums or imposing preexisting condition exclusions on living organ donors.

FEBRUARY

*Department of Health and Human Services (HHS) Secretary Tommy Thompson's Advisory Committee on Transplantation (ACOT) calls on HHS to develop and maintain a live organ donor registry.

*The prospect of the world's first face transplant triggeres fierce debate in Britain over the ethical and medical implications of the procedure.

*Italian surgeons successfully perform the world's first jawbone transplant using a cadaveric mandible.

*A Mexican teenager brought to the US by her parents in search of a life-saving heart-lung transplant dies on February 22 because of a tragic mistake that results in her receiving organs with the wrong blood type. Despite heroic attempts to rectify the mistake with a second transplant, 17-year-Jesica Santillan dies at the Duke University Medical School in Durham, NC.

*Dolly the sheep, the world's first cloned mammal, is put to death on February 21 by her creators at the Roslin Institute in Scotland. Dolly's premature death age 6-about half the life expectancy of her breed-fuels speculation that cloning had affected her aging process.

MARCH

*Senate Majority Leader Bill Frist (R-TN) introduces a comprehensive transplant bill - The Organ Donation and Recovery Act (S.573) -- which contains a provision to reimburse travel and other expenses incurred by living donors and their families. Senator Richard Durbin (D-IL) introduced a less comprehensive bill - The DONATE Act-- in February, which also addresses removing financial disincentives for live donors, developing a national organ and tissue donor registry center, and grants to hospital organ procurement coordinators.

*The number of Americans who consented to be organ and eye donors in 2002 remained virtually the same as 2001, according to preliminary data compiled by the Organ Procurement and Transplantation (OPTN)/United Network for Organ Sharing (UNOS).

The number of organ donors-deceased and living-increased by only 164 (1.3%) in 2002 over 2001. The Eye Bank Association of America (EBAA) reported similar results in eye banking with corneal donation increasing only 0.2% (93) over 2001.

*Austrian man gets world's first double forearm-hand transplant.

APRIL 

* In a legal opinion that carries implications for those in need of a kidney, an analyst rules it is legal and proper to give waiting-list priority to a recipient whose loved one or relative has donated a kidney anonymously to someone else. Such an arrangement is not in violation of the 1984 National Organ Transplant Act's (NOTA) Section 301, which prohibits buying and selling of human organs, according to the legal analysis.

*In Memoriam: Jeanne Mowe, the longtime executive director of the American Association of Tissue Banks (AATB), dies in her home on Thursday, March 27. The cause of death was cancer. Mowe served as the Executive Director of AATB for nearly 20 years until her death.

*The National Donor Family Council (NDFC) of the National Kidney Foundation, and the Association of Organ Procurement Organizations (AOPO), and other national organizations, ask media and transplant professionals to cease using the terms "cadaver" or "cadaveric" when referring to a organs procured from a deceased donor, and the word "harvest" when refering to the actual "procurement" of the organ.

*The Center for Medicare and Medicaid's (CMS) enforcement of a 12-year-old rule covering organ acquisition fees could cost US taxpayers millions of dollars and ultimately force some transplant programs and organ procurement agencies to shut down, a transplant reimbursement and health policy expert charges. The issue involves the amount of money Medicare will reimburse OPOs and transplant centers for recovering kidneys and, indirectly, other solid organs, such as hearts, livers and pancreas.

*New research shows that tumor cells from a type of cancer known as Kaposi's sarcoma (KS) can be passed from an organ donor to the recipient.

MAY

*Deceased liver donor transplants found to have increased 9% while patient deaths on the waiting for a liver have decreased 23% since the inception of a new liver allocation policy in the US. The new policy - known as MELD-for Model for End-Stage Liver Disease and PELD-for Pediatric End-Stage Liver Disease, which was implemented in February of 2002, directs that for all but the most severe and acute cases of liver failure, patients' priority for a transplant is based primarily on a formula that calculates their short-term risk of death without transplantation.

*The first program in the US to offer a graduate certificate in organ donation science is unveiled at the Medical College of Ohio in Toledo.

JUNE

*An obscure government subcommittee meets on June 3 to address the growing donor shortage and discuss whether financial compensation might be a solution to the growing donor shortage. House Energy and Commerce Subcommittee on Oversight and Investigation Chair James Greenwood (R-PA) states, "Many in the medical community have begun to question whether it might be possible to provide some sort of ethically acceptable financial incentive to the beneficiaries of a decedent that may motivate an individual to formally express his intentions about donation prior to his or her death."

*Tommy Thompson confirms he will not serve a second term as Secretary of Health and Human Services (HHS) if President Bush is reelected.

*The American Medical Association says the use of cloning for biomedical research is consistent with present-day medical ethics.

*In Memoriam - The transplant community loses 2 pioneers in June: Belding Scribner, MD, the inventor of the shunt that allowed physicians to administer dialysis without having to tap into a new blood vessel for each treatment and Robert Good, MD, a pioneer in modern immunology who is credited with performing the world's first successful human bone marrow transplant.

JULY

*Investigators clear Duke University Hospital (DUH) and the involved OPOs of any wrongdoing in the death of heart-lung transplant recipient Jesica Santillan last February. A United Network for Organ Sharing (UNOS) investigative panel concludes that neither Duke nor the OPOs involved-The New England Organ Bank and Carolina Donor Services-- violated any policies that led to the death of the17-year-old Mexican girl on February 22.

*The OPTN/UNOS board of directors moves aggressively to begin addressing areas of concern to transplant professionals and potential live donors. The board adopts a series of actions which will allow long term assessment of live donors, require certification of live donor programs, and create a national registry to follow live donors for at least 9 years.

AUGUST

*Rep. James Greenwood (R-PA) introduces a legislation authorizing the federal government to fund demonstration projects on offering incentives in return for donation. Greenwood is chair of the House Energy and Commerce Subcommittee on Oversight and Investigation. The bill calls for the HHS Secretary to carry out well-designed demonstration projects.

*The largest study of donor potential in the US ever conducted finds there will never be enough organs from deceased donors for all patients in need and recommends the transplant community focus on increasing live donation and developing future technologies, such as xenotransplantation and tissue engineering.

*A 42-year-old man who had a malignant tumor on his tongue and jaw becomes the world's first tongue transplant recipient. The 14-hour operation was performed July 22 at Vienna's General Hospital.

*Physicians in Kazakhstan perform the world's first ever operation to transplant a human embryo's nerve cells into a patient suffering from myelosyringosis (a disease of the spinal cord).

*Organ donor rates vary widely across the country, according to a federal audit, a finding that helps explain the disparity in transplant waiting times from one area to another and illustrates the potential to increase the number of donors. Nationally, an average of 51% of people who are medically eligible to donate organs did so, according to a study of 190 hospitals by the HHS Inspector General, but the rate of donation varies tremendously across the country, ranging from below 30% at some hospitals to above 70% at others.

SEPTEMBER

*A comprehensive government study calls for dramatic increases in donations, donor-conversion rates and transplants in the country's 200 largest hospitals. The government panel recommends that others emulate the nation's most successful OPOs and transplant centers that employ a common set of "best practices." The HHS' ambitious set of goals include: 1) Increase the average conversion rate of eligible donors from the current average of 43% to 75% in the nation's largest 200 hospitals; 2) Increase donations by up to 1,900 donors per year; and 3) Increase transplantations by 6,000 per year.

*James Burdick, MD, becomes the first physician to head the Division of Transplantation (DoT).

OCTOBER

*Tissue banks are legally immune to liability claims if one of their transplanted tissue products is tainted by disease, a California appeals court rules. Distribution of tissue transplantation is a "service," not a sale of goods, thus tissue banks are not strictly responsible for product liability, according to the California Court of Appeal for the Sixth Appellate District.

*Prior to his recall, California Governor Gray Davis signs legislation that would create the nation's first statewide registry for researchers to locate embryonic stem cells.

The new bill is the 2nd signed by Davis that permits embryonic stem cell research in the state.

*Bi-partisan legislation--The Cord Blood Stem Cell Act of 2003 (S. 1717), establishing a National Cord Blood Stem Cell Bank network is introduced in the Senate.

*Medicare patients who are suffering from chronic end-stage heart failure but are not candidates for a heart transplant will soon be eligible to receive part of the cost of a left ventricular assist device (LVAD), the Centers for Medicare and Medicaid (CMS) announces.

NOVEMBER

*Senate passes first significant organ transplant legislation since 1990. The Donation and Recovery Improvement Act (S. 573), sponsored by Senate Majority Leader Bill Frist (R-TN), provides $25 million in funding for a variety of provisions including reimbursement of expenses incurred by living donors, and hiring in-house organ procurement coordinators in hospitals. A provision that would have allowed a demonstration project on offering financial incentives to donors does not make it out of committee. The bill is expected to be passed by the House of Representatives in January and signed into law by President Bush.

*University of Illinois, Chicago, settles lawsuit over allegations of liver transplant waiting list improprieties. "Whistleblower" Raymond Pollack, MD, who brought the charges of improper wait listing to authorities, receives $500,000 of the more than $2 million settlement.

*Wisconsin Assembly approves bill that would give living donors up to a $10,000 tax deduction. Bill is expected to pass the Senate in January and signed into law.

*In Memoriam -- Brian Brozick, president and CEO of the Center for Organ Recovery and Education (CORE) in Pittsburgh passes away. He was 51.

*GAO report finds at least 15% of US ESRD facilities have "serious quality problems"

DECEMBER

*Diabetics receiving pancreas transplants have lower survival rates than those on conventional insulin therapy, observational study finds.

*UN General Assembly postpones debate on total human cloning ban for 1 year. Delay seen as setback for US.

*EU research ministers fail to reach compromise on funding stem cell research