US compensates subjects of radiation experiments

The United States federal government has announced that it will pay $4.8m (£3.2m) in compensation to survivors of secret cold war experiments sponsored by the government in which patients were injected with radioactive isotopes without their consent.

The experiments were an offshoot of the Manhattan Project and were developed to gain an understanding of the biological consequences of nuclear warfare. They violated the Nuremberg code, as in most cases patients were unaware that they were experimental subjects and were not only unlikely to derive any therapeutic benefit from their participation but were also subjected to potential harm.

According to the energy secretary, Hazel O'Leary, the compensation is part of an ongoing effort by the government to rectify its past behaviour, but she said: "It in no way compensates families for what they have suffered or what they haven't known about their suffering."

The recent settlement follows the recommendations of the Presidential Advisory Committee on Human Radiation Experiments established by US President Bill Clinton in 1994. The advisory committee found that between 1944 and 1974 the US conducted or sponsored about 4000 experiments involving up to 20000 people.

The experiments varied widely, from direct injections of uranium, polonium, and plutonium into unsuspecting patients to the testicular irradiation of prisoners and the intentional release of radiation into the atmosphere. Other experiments investigated by the committee included studies performed on army personnel stationed near atomic test sites and uranium miners, as well as the far reaching 1953 "Project Sunshine," in which human tissues and bones from areas of radioactive fallout worldwide were collected and tested for residual radioactivity.

The experiments were performed under the auspices of the Department of Defense, the Department of Energy, and the Atomic Energy Commission. They were conducted by both military officials and civilian physicians and scientists.

The experiments were intended to study the short and long term effects of radiation exposure, establish "safe" exposure limits, and develop accurate radioactivity monitoring assays. The monitoring assays developed are still standard today. Although much of the research advanced biomedical science, many studies were performed in the pursuit of national defence and in the interests of space exploration.

Isotope injections were given to 18 patients between 1945 and 1947 who had been admitted with various disorders including hepatitis, dermatitis, scleroderma, ulcers, heart attacks, and Addison's disease. Initially, researchers claimed that only those patients deemed "terminal" who were expected to die within a decade were chosen. This was believed to obviate the problem of cancers induced by radiation in the experimental subjects.

Some of the patients survived more than the 10 years predicted, and one is still alive. It is unclear whether the experiments themselves contributed to the subjects' death. However, excess morbidity, such as radiation induced osteopenia and uranium induced urinary tract disorders, have been directly attributed to the experiments and confirmed with postmortem examinations. As late as 1973, follow up studies on the radioactive injections were performed without patient consent.

The presidential advisory committee also discovered that under current federal regulations, human research can still be performed in secret, and that in some circumstances informed consent can be waived. Moreover, governmental policies still allow the intentional atmospheric release of biological and radioactive contaminants.

These findings highlight the ongoing conflict of preserving individual rights in the face of national security interests. Furthermore, the panel found that many of the existing informed consent forms used in conventional biomedical research intentionally mislead prospective experimental subjects with overly optimistic portrayals of the potential benefits of participating in investigational studies. In the next two months, President Clinton is expected to respond to the panel's report by announcing farther measures to prevent recurrence of governmental abuses and to compensate more survivors.

Deborah Josefson,

Norwalk, Connecticut

Patients do not read consent forms

Doctors have an enormous influence over whether a patient consents to take part in a clinical research trial, according to a study of patients' attitudes to research.

Patients tend to assume that any research that they enter into is safe. They often do not read consent forms carefully because they assume that someone else has scrutinised the risks and benefits on their behalf

Interviews with 103 patients showed that many factors influence a decision to take part in medical research (Hastings Center Report 1996;26(5):25-9). The main motivation for subjects enrolled in therapeutic research was that the experimental intervention was better than any existing alternative and offered some personal benefit. Many patients thought that they had tried everything else and had little choice.

Doctors' recommendations were also powerful factors influencing the decision to participate in trials. Many of the respondents believed simply that the doctor knows best. Respondents were also trusting of the hospitals where they received their medical care, as well of the research system, believing adequate checks and balances were in place. Many of the patients interviewed said that they had decided to take part in a trial before they had been given the consent form to sign and that they did not pay attention to the details on the form.

The study authors from the United States advisory committee on human radiation experiments said: "Clinicians should be mindful of the tremendous influence they have over their patients, given that the mere suggestion of enrolment in research by a patient's personal physician was interpreted by many patients to be an endorsement."

They suggest that research should not be presented simply as a new intervention with possibilities for beneficial effects but as an intervention with little evidence suggesting whether effects will be beneficial or harmful. They also say that research committees should ensure that any benefits are not overemphasised and strike out any comments on consent forms for phase I trials which suggest the likelihood of personal benefit to participants.

Jacqui Wise, BMJ

Lessons still need to be learned from Nuremberg

Fascist comparisons should not be used when discussing social issues such as abortion or euthanasia as this only tends to trivialise the enormity and atrocity of what Nazi doctors did, according to a leading medical ethicist.

Dr Michael Grodin, professor of medical ethics at Boston University said that he regrets that human experimentation issues, although central to the Nuremberg trials, tended to overshadow the broader issues of sterilisation, euthanasia, and eugenics that played a major part in German doctors' complicity in state ideology.

A speaker at a conference on the Nuremberg code and human rights at the Holocaust Memorial Museum in Washington, DC, this week, Dr Grodin said that doctors were indispensable to the Nazi ideology and there remains a legacy of concern surrounding the medical profession. Part of the problem is the tendency to this day to medicalise social issues and to treat the public as an amorphous entity with a resultant debasing of the value of the individual. That debasement, he said, may occur when doctors fail to take the matter of informed consent seriously, when they "buy into" the notion that elderly people are a burden on society, or when they make far reaching and potentially dangerous connections between social pathology and genetics.

And while many people believe today that ethical issues can be resolved in law, this is not morally defensible, said Dr Edmund Pellegrino, founding director of the Center for Bioethics at Georgetown University. The Nazi doctors distorted medical ethics, subverting them to the will of the state, which made their actions legal and mandatory. This led during the Nuremberg trials to rationalisations about how human experiments at Auschwitz were justified for the greater good-the wellbeing of the military and victory. What we can learn from that, he said, is that the integrity of medical ethics must be preserved if patients and experimental subjects are not to become mere objects of political purpose. We cannot intentionally sacrifice individual lives even for the good of the whole, he said.

The US Food and Drug Administration recently issued new regulations allowing medical researchers to perform experiments on some patients without their permission, arguing that ultimately other patients will benefit from the new regulations. This is seen in some quarters as setting a dangerous precedent (16 November, p 1223).

Dr Arthur Caplan, head of the Center for Bioethics at the University of Pennsylvania, said that it was ironic that 50 years after Nuremberg we are seeing a serious pulling away from the old concept of mandatory informed consent. While there is a case to be made for waiving consent in some emergency situations, he said, there is a need for more explicit guidelines for research committees and for "the involvement of a community voice in reviewing each case.

DAVID WOODS,
medical journalist,
Philadelphia

Public supports euthanasia for most desperate cases

Almost nine out of 10 people favour euthanasia in the most desperate cases, according to the recent British social attitudes survey.

But the survey, carried out by Social and Community Planning Research, highlights the fact that people's responses vary according to the individual circumstances of the case. Complex judgments tend to be made about a patient's chance of recovery, pain levels, and quality of life. Very few people, for example, agreed with euthanasia if the person is simply lonely and tired of life

The survey was based on interviews with 3500 people in England, Scotland, and Wales. When the question "Should doctors be permitted to end a life when someone requests it?" was asked, 82% said yes and 1504 said no. When the same question was asked 10 years earlier 75% had said yes and 24% no. The researchers then presented seven scenarios where decisions about euthanasia might be made:

A patient has an incurable illness and is too ill to make a life or death decision (for example, in a coma on a life support machine with no hope of regaining consciousness) . The relatives agreed to euthanasia -percentage of respondents agreeing that euthanasia would be justified - 86%

The patient has an incurable and painful illness and is bound to die (for example, dying of cancer) - 80%

The patient is in a coma, not expected to regain consciousness but is not on a life support machine - 58%

The patient is not in pain or in danger of death but becomes permanently and completely dependent on relatives - 5 1%

The patient has an incurable illness from which he or she will die but which is not very painful (for example, leukaemia) - 44%

The patient has an incurable, painful, but not fatal, illness (for example) severe arthritis - 42%

Someone is not ill or close to death but is simply tired of life and wishes to die (for example, extremely lonely) - 12%.

The survey says that the issue has become more prominent because more people are living into old age; there is greater geographical mobility, so fewer relatives are likely to live close by and family size is declining.

Greater numbers of people now assume that the burden of care in such cases belongs to the state not to them. Young people are more likely to approve of euthanasia than old people, mainly because fewer younger people are church goers. Religious beliefs and ethic background are much more powerful determinants of attitudes than age.

There are also regional variations with people from Scotland less accepting of euthanasia than those in England and Wales. Younger, but not older, disabled people are also more likely to endorse euthanasia.

Jacqui Wise, BMJ

Euthanasia reporting is increasing but is still low

Most Dutch doctors do not fulfil the legal obligations to report cases of euthanasia, according to a unique confidential study. But the researchers found that reporting has reached 41%, and the Royal Dutch Medical Association believes every act of euthanasia could be performed openly by the end of the century.

The four part study ordered by the Dutch government to evaluate the euthanasia reporting procedure entailed interviewing 1250 doctors, as well as coroners and magistrates. The response rate from doctors was between 8404 and 9804. The study shows that reporting increased from 1804 to 41% over five years, which, it argues, has strengthened social control and shows that decisions about the end of life are taken with increasing care.

The 59% of doctors still not notifying the authorities fear conviction, are concerned that families and next of kin should not face a criminal investigation, or do not regard the death as unnatural.

The study will now form the basis for new legislation that could allow doctors' actions to be judged in the first instance by their professional peers, rather than according to criminal law. Though euthanasia remains a criminal act, Dutch doctors are not prosecuted provided that they follow strict guidelines, including providing a detailed report to the local coroner.

The study, led by Paul van der Maas, professor of social health care at Erasmus University, Rotterdam, and Gerrit van der Wal, professor of social medicine at the Free University of Amsterdam, shows significant changes since the last major study five years ago. The number of initial requests by patients asking for euthanasia, if required in the future, increased by 37%, to 34500, last year. Explicit requests rose less rapidly by 9%, to 9700 a year. Of these, 3200, or 2.4% of all deaths, were granted, an increase from 30% to 37%.

In 1995 there were 900 more cases of euthanasia than in 1990, which the researchers argue is due to a comparative rise in deaths from cancer, increased medical possibilities for prolonging life, and an increase in the overall death rate.

Assisted suicides have remained the same, at 400 a year. Cases in which doctors reported ending a patient's life without an explicit request have declined from 1000 to 900 cases. Researchers argue that there is a grey area between these cases and palliative care as they often concerned patients with cancer within days of death. It is estimated that 15 such cases concerned severely handicapped newborn babies.

Professor van de Maas said that in five years the public had become more aware, discussions about euthanasia had started earlier, and decisions were taken more professionally. But there was much to be done with more formal consultation, such as with specialists in palliative care. We are in the process of a very difficult social change. We have to find a way to deal with extreme suffering at the end of life including all the nuances, he said. Some kind of reporting and review must be mandatory, society demands that, but at the moment it is too legalistic, he added.

Secretary of medical affairs at the Royal Dutch Medical Association, Robert Dillmann, called for three adjustments to improve reporting: expert advice should be available to doctors before a decision on euthanasia is taken; doctors actions should first be considered by an independent committee of experts such as doctors, ethicists, and lawyers, with the public prosecutor involved only if guidelines are not met; and new regulations should be introduced in which euthanasia performed according to the guidelines is not a criminal act.

If you combine these elements the chances of 10,004 reporting by the end of the century increases tremendously. We have always argued that physicians performing euthanasia should be willing to be open and to be judged, he said.

Tony Sheldon, medical journalist, Utrecht

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