- Home
- Transplant Links
- News
- News Archives
- My Life
- Search Engines
-
- Designed By
- Copyright 1998-2007
Sunday, January 30, 2005
By John Richardson
Portland Press Herald Writer
 |
Staff photo by Herb Swanson Cathleen and Donald Macrelli of Boston campaigned for new regulations requiring informed consent for harvesting organs and tissues after learning that their 18-month-old son's organs were removed without their permission. |
In Arizona, a woman's complaint that her father's bones and other tissues were taken from his body without the family's permission led to a new state law.
In Massachusetts, a couple who held a second funeral for their 18-month-old son after learning his organs had been taken pushed for new consent rules adopted by that state.
And in the United Kingdom, the discovery of huge stores of body parts in a Liverpool children's hospital fueled national legal reforms that guarantee families the right to informed consent.
Now, allegations that brains were collected in Maine without the permission of families have led the state attorney general to adopt a new policy that, starting Monday, requires full and informed consent. The policy will first apply to bodies examined by the state Medical Examiner's Office but may eventually lead to rules covering all organ and tissue donation in Maine, Attorney General Steven Rowe announced on Friday.
While the complaints in Maine are still being investigated, the disputes are part of a clear trend in the United States and beyond as the growing demand for organs and tissues collides with new attitudes toward medicine and the rights and sensitivities of families who lose loved ones.
The use of organs for research and transplants is an old practice. For centuries, it has advanced medical knowledge while challenging cultural taboos and personal emotions surrounding death.
Advances in tissue research and organ transplantation have now thrust what once were fringe practices into mainstream medical specialties, some of which save lives and provide hopes of curing terrible diseases.
And while the use of body parts has gained respect - and more families are asked to donate a loved one's eyes, bones or other parts - there also are more opportunities for misunderstanding or deception, experts say.
"The reason this is a prevalent issue is that we are kind of in the dawn of a new age, and research has proliferated and people are desperate for new drugs and therapies, and they want cures," said Cathleen Macrelli of Boston.
As a nurse and an advocate of research and organ transplantation, Macrelli says she wants those things too. But, she said, she and her husband, Donald, have learned through a lot of personal pain that the system is not set up to protect families' wishes.
Macrelli's 18-month-old son, David, died in 1996 from a rare reaction to a vaccination. After an autopsy was conducted for the Office of the Medical Examiner, Children's Hospital retained his brain, heart, liver, kidneys and other organs without asking, or telling, his parents, Macrelli said.
They learned later that they buried their son without his internal organs. In 2003, after the organs were returned to them in a plastic bag, the Macrellis held a second funeral.
"My husband and I have not been the same since," she said. "It's difficult enough to lose a child. But when you bury that child and you have a feeling about the way that you have put him to rest, that brings you a certain amount of comfort. We put him to bed with his favorite book. We thought we had buried him in the way he came into this world."
When the Macrellis complained and filed a lawsuit, they discovered another reason that disputes had become common.
"Everyone pointed their finger at everyone else," she said. "The reason that nobody could do anything was because no laws were broken - because there were no laws."
Massachusetts, like Maine and most other states, had few regulations and little oversight to make sure families get information and give permission before organs and tissue are taken.
"In some ways, we're chasing our tails because biotechnology has outpaced law," said Michele Bratcher Goodwin, director of the Health Law Institute at the DePaul University College of Law in Chicago. "The laws are very much behind the times."
Goodwin and others said the disputes about consent are a trend that in some ways feeds itself. As more families come forward to tell their stories, the experts say, others ask questions about what happened to the bodies of their loved ones.
A major shift in attitudes toward the medical profession also plays a role, the experts say.
"I think the medical culture historically has been one that says, 'We don't have to tell patients everything that we're doing. We're doing things to benefit parents and families, and they don't need to know everything,' " said Karen Maschke of Hastings Center, a bioethics think tank in Garrison, N.Y.
Patients and families today are demanding more information from doctors and a bigger role in health care decisions. That desire for transparency has spilled into the area of organ and tissue donation.
Old-fashioned secrecy was partly a paternalistic gesture to spare families the details and partly an effort of maintain control and a supply of organs, Maschke said. "The (new) notion is really informed decision-making, and people may decide to say 'no.' "
The issue of informed consent is still a source of tension among advocates for organ and tissue donation.
"The more information you have to give families, such as how are you going to use (the organs) and how are you going to take them out...A lot of people don't want to hear that, and they lose donors that way," said Debbie Newman of the American Association of Tissue Banks in McLean, Va.
Newman, however, said it's clear that Americans do not want to be kept in the dark and that the organizations collecting and using organs and tissues need to be forthright.
"I don't think we have a choice," she said.
There is support among many in the medical field today for what is known as "presumed consent," which means organs or tissues that might save or improve the lives of others can be removed unless there is a known objection. A number of countries in Europe and other parts of the world follow the presumed consent principle.
The 86 U.S. organ and tissue banks that belong to the national association are committed to "informed consent," Newman said. That means they agree to follow guidelines for informing families ahead of time and documenting their permission. There always needs to be a witness to telephone conversations, for example.
Strict procedures may protect families from pain later on, but they also protect the person asking for permission in cases when there is simply an honest misunderstanding, she said.
"Under that most stressful of times, people (who are grieving) do forget what they have given consent for, so it's important to have documentation," she said.
Lawsuits that have been filed around the country are clearly unwanted publicity for the organ and tissue banks, though they have generally not yielded large payouts. The Macrellis, for example, lost their case in Superior Court in 2003 and are appealing.
A Gorham couple who sued those involved in the Maine brain collection program settled out of court this month for $52,500.
Many fear that disputes over consent have the potential to undermine trust in the organ-donation system and worsen donor shortages. It's not clear how great that risk is, however, and some evidence indicates that donations have actually increased after reports about complaints had the spinoff effect of increasing awareness about donor programs.
While the industry is policing itself, some states also are tightening the rules for consent.
The Arizona Legislature, inspired by a woman who said her father's bones and tissues were removed without consent, passed a law last year requiring that families be given copies of detailed consent forms, among other changes. Lawmakers have since called for more oversight by the state government and for making it easier to penalize violators of the consent law.
In Massachusetts, the Macrellis' efforts helped create new regulations that require permission for any tissue and organ to be retained after an autopsy and spell out what information must be on new detailed consent forms given to families.
On Friday, Maine joined the growing number of states creating new rules.
The attorney general's new policy directly addresses many problems identified by two lawsuits and an investigation by the Portland Press Herald/Maine Sunday Telegram. All telephone conversation seeking family permission will be tape recorded, for example, and consent forms must provide detailed information and be filed with the state Medical Examiner's Office.
The policy will cover a relatively small number of deaths - about 1,200 a year - that are reviewed by the medical examiner, usually because they are suspicious or unattended. Rowe said in a written statement Friday that he wants the internal policy to become the basis of new rules covering all organ and tissue donation in Maine.
The trend that is now changing rules in Maine spreads beyond the United States.
In Great Britain, scandals over "organ stripping" were so massive that they led to sweeping changes in national law.
The body parts of thousands of people, many of them children, had been collected, stored and used for research at hospitals in England and Scotland for decades without the knowledge of families. The scandal erupted in 1999 at the Royal Liverpool Children's Hospital, known as Alder Hey Hospital.
Thousands of families held second funerals, and sometimes third and fourth funerals, as organs of their children were found in various collections and returned. There were mass graves for the body parts of people who could not be identified.
Parliament adopted the Human Tissue Act of 2004, which primarily set nationwide standards for obtaining the consent of families before organs and tissue could be removed. The law set up an oversight authority and punishments for those who violate it.
Disputes scattered around the United States have not led to a similar outcry here or to any public legislative efforts in Congress, according to the experts.
Cathleen Macrelli said she has been pushing for a congressional inquiry, but that changing the rules has proven difficult because of resistance in the medical community and because the issues are "huge and complex."
Goodwin, director of the Health Law Institute at DePaul, is working with other experts to update national organ- and tissue-donation guidelines that will be recommended to each state in 2007. Those guidelines - known as the Uniform Anatomical Gift Act - are modified and adopted on a state-by-state basis.
"Consent issues are actually at the top" of the group's agenda, she said. Among the proposed changes will be more communication and increased transparency in the process, she said.
In the meantime, given the widespread disputes over consent around the country, Congress also should begin a thorough debate, Goodwin said.
"I think there is a need for a national dialogue here," she said.
Staff Writer Kevin Wack contributed to this report.
Staff Writer John Richardson can be contacted at 791 - 6324 or at:
Copyright © 2005 Blethen Maine Newspapers Inc.
This article posted February 27, 2005.