Stories from the sharp end
Human expectations and experiences of cancer research – by Catriona Gilmour Hamilton
A letter to British Empire Cancer Campaign in June 1967 contained the following bold offer:
I have, after much careful thought and deliberation, arrived at a resolution which, it is hoped, will provide a certain amount of real assistance to your organisation while enabling me to do something worthwhile with my existence…
I propose to offer my body to medical science for use in its battle against cancer.
It may be that experimentation on a living human organism might provide medicine with a useful step forward such as could not be achieved so rapidly otherwise. …it seems obvious to me that a living human body used for such a purpose could help tremendously in bringing forward the date when the disease will be conquered.
In the past, as this poignant letter illustrates, the offering of a body for cancer research did not always imply that the donor had to be deceased. The author in this case was a healthy middle-aged man inviting medical science to use his living body in the fight against cancer, suggesting that doctors cultivate cancers in his healthy flesh for the purpose of testing treatments and understanding how specific cancers develop. Surely, he believed, a human body would offer greater potential than that of a laboratory rodent. And he was not alone. The British Empire Cancer Campaign received many similar letters from people in the postwar period who were eager to offer themselves as ‘human guinea-pigs’ – a phrase that many correspondents used at the time when talking about themselves.
The histories we write furnish us with assumptions about the immediate past, even about the period many of us have lived through. I am a PhD student now researching the culture of my earlier working life as an oncology nurse. In my investigation of experiences of cancer research in postwar Britain, I have found that the archives of voluntary organisations – those, like the British Empire Cancer Campaign, explicitly charged with public engagement – offer valuable and balanced perspectives on questions of public expectations, motivations to participate in research and personal experiences of clinical trials. The voices of those at the receiving end of cancer research can often challenge our assumptions about the recent past and our ethical standards in cancer studies.
Historians of medicine have argued that, by the 1950s, high-tech biomedicine had become something of a secular religion, the cure of cancer its ultimate goal. The British public, in thrall to a feverish cancer phobia, was acutely vulnerable to promises of hope and progress. Cancer was a diagnosis associated with imminent death, and in the days before sophisticated palliative care, such deaths could be acutely distressing. Public anxiety, inflamed by everyday metaphors about the ‘cancer-battle’ and sometimes reinforced by bitter, painful experience, generated great enthusiasm for the cancer research enterprise.
For a generation recently emerging from World War II, participation in cancer research was often framed in terms of moral and civic responsibility. Offering one’s body for the greater good of medical science was seen as an act of altruism. For some, it was a form of penance for a life lived to excess (not those that smoked or drank heavily but instead people who had lived life in the fast lane and been lucky enough to escape bad health); for others, it was an offering in lieu of a financial donation. Generally, it was a way of making oneself useful to society or a means to alleviate feelings of guilt at the suffering of others.
Today, historical research explores assumptions about all participants in research: not just the exploited, but the willing volunteers too. This is because recent histories of medical research have tended to concentrate on the ethically questionable use of the vulnerable, those – like children, the poor, prisoners and military personnel – who were often marginalised or disempowered. It is fitting that the history of medicine investigates the most unscrupulous types of medical research; however, we also need to be aware of the methodological issue of examining a relatively narrow cross-section of people, portrayed as passive research subjects. There is another, more general history of the research volunteer to be written too: one that examines individual agency and choice for those that wanted to be research subjects. It is possible to overlook or misunderstand the enthusiasm with which some people volunteered themselves, the attractions of partnerships with medical practitioners, and the personal satisfaction of offering one’s body for instruction and scrutiny.
Of course, this is not to suggest that in the 1960s the British Empire Cancer Campaign took up the offers of healthy living bodies. It responded with a standard letter pointing out that it would be “entirely contrary to the ethics of the medical profession to conduct experiments of the nature you propose”. Besides, cancer research was increasingly geared towards the production of evidence about new therapies and technologies. The ‘war against cancer’ applied an industrial principle to medical science, and it needed the participation of people with cancer to form cohorts for randomised controlled trials.
The demands of robust scientific methodology – empiricism, objectivity and the avoidance of bias – were, it was believed, impossible to explain to vulnerable patients, so enrolment in a trial was seldom explained in advance. It is one of the ironies of the history of cancer that the ethics of the medical profession, which held eager volunteers at arm’s length, were invoked to keep actual research participants in the dark about their role in a clinical trial.
Histories of medical ethics might lead us to assume that informed consent became enshrined in research practice with the Declaration of Helsinki in 1964. In fact, new research shows that until very recently people taking part in cancer clinical trials often did so unknowingly. Against a backdrop of social anxieties about cancer, British doctors generally maintained an acute ambivalence about disclosing a cancer diagnosis. Many health professionals believed it was their ethical duty to protect an individual’s psychological wellbeing, even if this meant deception. It was feared that to reveal the truth about cancer would rob the individual patient of hope, causing irreversible psychological distress. Consequently, until well into the 1980s, people diagnosed with cancer were often kept ignorant of the true nature of their illness in the interests of preserving their wellbeing.
These complex situations often made informed consent for participation in a clinical trial difficult to obtain. Not only would it be necessary to disclose the diagnosis, but the doctor in question would have the unpalatable task of explaining that the best course of medical treatment was uncertain. This could compound potential anxiety and – perhaps more pertinently – risk a loss of faith in the medical profession. Often it was judged to be better to proceed without consent. Randomised trials thus took place under the guise of routine therapy, with patients ignorant of the fact that they were taking part in a research project. This situation persisted partly because the UK, unlike the USA, had no explicit legal requirement for informed consent to medical research, but it also persisted because of the contingencies of principle.
Research ethics committees (RECs) were established during the 1970s, in theory to protect NHS research subjects. In practice, they offered scant guarantee of informed consent for cancer trials. Geographically patchy, and typically without lay membership, RECs invariably placed doctors in the positions with the most influence. These were doctors working to an individual code of medical ethics that was occasionally at odds with broader bioethical principles. Committees would defer to individual doctors’ interpretations of good ethical practice, including in some cases accepting that obtaining informed consent was impossible and contrary to the interests of a patient’s psychological wellbeing. This allowed some types of cancer research to remain undisclosed and yet continue with REC approval.
There is strong evidence that this situation persisted until as recently as the 1980s. On the BBC’s South East at Six broadcast of 27 July 1982, for example, Hugh Scully introduced a report concerning the death of Mrs W, an otherwise sprightly 84-year- old woman who had died after the administration of a drug that was being tested for treating bowel cancer. She had been unknowingly enrolled in a clinical trial following surgery, and although she recovered from the operation, she died within three weeks. The post mortem established that her death was due to the effects of the experimental drug, which had been administered without her knowledge or consent. It was only thanks to the diligence of the hospital pathologist and the coroner that the story came to light. The BBC reported:
One of the more disturbing aspects of the affair is that when it became known that the coroner intended to proceed with the matter, he came under great pressure from some of the surgeons at the hospital, who tried to persuade him to quietly drop the whole thing. One of them is alleged to have warned that by holding a full public inquest, cancer research could be set back by 20 years.
It emerged that the two RECs reviewing the trial had recommended that it proceed without obtaining informed consent. According to Professor O L Wade, who chaired one of the committees in question, to obtain consent would necessitate an explanation of the potential for cancer to return beyond the area of surgical excision. Such information would, he believed, be too distressing. The cornerstone principle that research be informed – one mapped out in global research standards from Nuremberg in 1947 onwards – was entirely contingent. In fact, Wade saw it as “one of the duties of the Research Ethical Committee to protect patients from that sort of psychological trauma”. The utilitarian imperatives of research took priority over individual autonomy. Rather chillingly, Wade concluded: “Tackling cancer is a highly professional job. It’s really, you know, just like the Falklands. It’s the professionals who win.”
Oddly enough, in spite of all the hand-wringing over causing distress, the coroner’s inquest revealed that Mrs W already knew she had cancer. Her doctor had told her “very directly” before her hospital admission, and according to her daughter she “accepted it very well indeed”.
Lest the reader suspect this was an isolated example, the correspondence pages of the Lancet and the British Medical Journal reveal that uninformed consent in cancer research was common, although it was of mounting concern to doctors. A report published in 1986, looking at how best to inform cancer research participants, points to a situation in which informed consent had long been avoided for fear of causing distress. But could it also have been avoided for fear of jeopardising recruitment to randomised trials? It must have been daunting to have to explain that treatments would be allocated by the proverbial toss of a coin and that neither the individual nor their doctor had any control over the randomised allocation process. The issue remains a concern for research ethicists to this day.
Examining the experiences of individual cancer patients highlights shortcomings in standard historical accounts of research ethics. Histories that attribute change to 1960s iconoclasm – such as those that credit famous whistleblowers like Henry Beecher and Maurice Pappworth with changing the tide of opinion – only go so far. We cannot assume that from then onwards doctors were forced to change their minds about what was ethical and what was not. As we have seen, individual professional ethics clashed with global guidance on scientifically robust research methods in which key principles became contingent. Nor is it adequate to attribute change to the establishment of review frameworks. As the case of Mrs W reveals, the presence of ethics committees made scant difference in practice.
Maverick doctors and peer review are an important part of the cancer story, but if we are to understand historical change – and if we are to measure historical change more accurately – we must look to the experiences of all those who are largely absent from the historical record. The archives of patient organisations reveal the issues and experiences that mattered most to those at the sharp end, views that add complexity to historical generalisations. Voluntary organisations were (and remain) situated at a threshold. To patients, they provided trusted information about what cancer research meant and how to get involved, as well as providing a forum for seeking redress for bad practice. To doctors, they were a potentially powerful mediator between the interests of cancer research and those of putative research subjects. It remains to be seen how that tension has been navigated and how patients and their representatives have influenced the ethics and experiences of randomised controlled trials over time in the modern era.
Catriona Gilmour Hamilton is a PhD student at Oxford Brookes University. The Wellcome Trust-funded research that features in this article forms part of her thesis: ‘Experimental Selves: Experiences, expectations and discourses of cancer research in Britain, 1960–2010’. She welcomes enquiries from other scholars or cancer patient groups working in this area (firstname.lastname@example.org).