Dark Age medicine
Taking organs without permission is a practice worthy of medieval times, says Sabine Louët. But creating a consent system that works is far from simple.
A scandal of organ retention that has unravelled over the past few weeks in Ireland highlights medical practices that should have disappeared long ago.
Two pharmaceutical companies, Pharmacia Ireland (now merged with Pfizer) and Novo Nordisk in Denmark, have recently admitted paying hospital pathologists in the 1970s to harvest the pituitary glands of dead people, primarily infants, to extract human growth hormone. And Dublin-based 'Parents for Justice', a group representing the families of the deceased, is threatening to expose four more companies.
Among the 7,500 pituitary glands that Novo Nordisk admitted receiving from Ireland at the time, none was extracted with the family's knowledge. And there are many other organs, glands and tissues that have not yet been accounted for.
It seems that those involved in gland removal considered that informed consent was not needed or was not applicable to hormones. Such a small gland, removed from the brain to harvest growth hormone, seemed too insignificant to warrant consent.
But many of the families affected by the scandal categorize this behaviour as the worst kind of theft.
In their defence, incriminated hospital staff in Ireland have claimed that organ and gland removal and retention was common practice, at least from the 1960s until 2000, when guidelines on informed consent for donating organs were first established in the country.
Little could those pathologists have guessed that informed consent would soon be required for an apparently even more insignificant part of a human being, one that cannot be seen with the naked eye: DNA.
But are we doing any better today? Pharmaceutical companies targeting hospitals in Ireland at the time presumed a tacit agreement before helping themselves.
Today, this type of presumption still exists as a model of consent, for example in population genomics research in Iceland (see below). An 'opt-out' system requires people who do not wish to take part in research to say so explicitly. Understandably, the model does not apply well to dead patients, or to their uninformed relatives.
Iceland recently had to acknowledge the limitations of their system. An Icelandic court recognized the right of Ragnhildur Gudmundsdottir to protect her privacy by preventing the health records of her dead father from being included in the research database that genomics company DeCode Genetics is planning to build.
The court said that including the records in the database could identify her as being susceptible to a heritable disease that her father might have passed on to her. Even though the personal data accompanying a DNA sample would be rendered anonymous and then encrypted, there is nothing less anonymous than someone's DNA, as two related individuals can easily be matched.
Other countries, such as Britain, have a voluntary 'opt-in' system, where people who are willing to donate their organs actively notify this to the health authorities. Although preferable, this is still fraught with difficulties.
A similar scandal to that in Ireland, involving the retention of organs from dead babies, hit Alder Hey children's hospital in Liverpool in 1998, prompting the government to introduce the Human Tissue Bill to replace previous acts.
Although informed-consent legislation had been in place in Britain since the 1960s, it was not specific enough. The new bill makes the removal and storage of organs and tissue samples illegal unless written consent is obtained from the patient or a relative.
Seen as too restrictive by the research community, the bill was later amended to allow researchers to use tissue samples from living donors without consent, but only for research approved by an ethics committee and provided the samples carry no identifying information about the patient.
So opt-in consent is not always perceived as the best option. But it has clear advantages over the opt-out alternative. In particular, it is more likely to build trust between patients and both the medical community and the life-science industry.
Failing to secure consent, and therefore trust, will ultimately have an impact on research. Without enough consents from the Icelandic population to allow DeCode to peer into their DNA, the company's long-term plans to find disease treatments could be in jeopardy.
Violation of trust
Recent news stories have publicized abuse of children by priests in the Catholic church. Of course, child abuse and the use of organs without consent are not necessarily in the same league. But in both cases the central issue is the violation of the unquestioning trust the public put in what are sometimes seen as society's most respected institutions: the church and the medical profession.
Drawing the parallel helps make clear what is at stake for the medical community. The mistrust of the church following child-abuse scandals is not unrelated to the growing disaffection with this institution. In the same way, if mistrust of doctors and researchers grows, people are less likely to agree to donate, whether whole organs, tissue or DNA samples.
The pharmaceutical companies who sourced growth hormone inappropriately could easily have gained consent. They had a strong case to convince parents that they needed the hormones to benefit other children, who required growth hormone to help their development.
They must not make the same mistake again.
Updated 15 October 2004: We would like to clarify that the opt-out consent system described in paragraph 9 refers to the proposed Icelandic Health Database, which DeCode Genetics plans to create in partnership with Iceland’s Ministry of Health. This description does not apply to DeCode’s ongoing population genetics research, which is carried out only with informed written consent.