The ‘Unfortunate Experiment’ at National Women’s Hospital has entered the national folklore as a notorious case of medical misconduct. But there is still disagreement about what actually happened.
It is 22 years since the Cartwright Inquiry published its findings. Arguments about the whole affair persist, with repeated public support from those who say it was a valuable and proper exposure of damaging improprieties by the medical profession, and from those who say that the inquiry and the events which led to it are based on an erroneous interpretation of a scientific paper, and selective evidence gathering at the Inquiry.
If indeed an error has been made, then the vilification of the medical people involved, which has occurred and which still goes on, must be redressed.
I want to consider two aspects of this affair, and if the evidence shows a miscarriage of justice, to offer reasons as to why this might have happened.
- consider the contention that an unethical experiment was performed at National Women’s Hospital (NWH) by Professor Green and his associates, and whether or not the Inquiry made a fair and just assessment of the current (1988) internationally accepted management of carcinoma-in-situ of the cervix (CIN3);
- discuss what factors in our scientific literary world might be contributing to error.
- describe unwelcome aspects of our human behaviour which allow an issue of this magnitude to survive in our society, unresolved for 22 years, and how writers have described these for many centuries. I have chosen as my title a quotation from Aulus Gellius in his Attic Nights, written in c.150 CE to emphasise the long-standing nature of the problem.
It is important to have a clear outline of the sequence of events over time at NWH and here is a timeline for reference:
1966: Green proposed to the NWH Medical Committee that CIN3 should be managed by cone biopsy if indicated and regular review. This was in response to considerable doubt worldwide about the natural history of the condition, for which many advocated hysterectomy. The committee agreed.
1973: Editorial in the British Medical Journal, “Uncertainties of Cervical Cytology.”1
1974: Article in New Zealand Medical Journal (NZMJ) by Green showing evidence that “The proportion progressing to invasion must be small.”2
1975: The NWH Medical Committee reviewed the management protocol and agreed it should continue.
1982: Professor Green retired.
1984: “The Invasive Potential of Carcinoma-in-situ of the cervix” was published.3 This was the paper on which Sandra Coney and Phillida Bunkle based their Metro article.
1985: A letter to the NZMJ by Skrabanek and Jamieson was critical of a national cervical screening programme for CIN3 as a detection and treatment method for carcinoma of the cervix (14 August).
1986: A letter from David Skegg was published in the NZMJ supporting a cervical screening programme. “The case for the effectiveness of screening does not rest on the unfortunate experiment at NWH in which women with abnormal smears were treated conservatively and a proportion have developed invasive cancer” (22 January).
1987: “An Unfortunate Experiment at National Women’s” appeared in the June issue of an Auckland magazine,Metro. Within 10 days the Minister of Health (Michael Bassett) has announced the inquiry, and that it was to be chaired by Sylvia Cartwright.
1987/1988: The inquiry sat, and published its report in 1988.
1988: A book, An Unfortunate Experiment, by Sandra Coney was published.
1990: Jan Corbett, a journalist, wrote an article in the July issue of Metro reviewing the errors in the Coney and Bunkle paper, and the way in which the data in the 1984 paper had been distorted.
2008: A conference was held to commemorate the Cartwright Inquiry. A number of papers including Charlotte Paul (a medical adviser to the inquiry), and Sandra Coney, were presented endorsing the inquiry findings.
2009: A book, A History of the ‘Unfortunate Experiment’ at National Women’s Hospital, by Linda Bryder, a professional historian, was published.
2009: A book, The Cartwright Papers, published by participants in the 2008 conference, and now including a vehement criticism of Linda Bryder and of her book.
2010: The NZMJ publishes a letter from Dr Helen Overton, “In defence of Linda Bryder’s Book.”4
The 1984 paper
“The Invasive Potential of Carcinoma-in-situ of the Cervix” was written by two gynaecologists from NWH (McIndoe and Jones), a pathologist from NWH (McLean) and a statistician (Mullins).
I have read this carefully, and made a summary of its contents. It described the follow-up data for 948 women with carcinoma-in-situ of the cervix. The women were followed for five-28 years by repeated smears and observation according to the 1966 proposal, unless they showed evidence for spreading cancer. The women were seen at three, six, and 12 months after presentation, and yearly after that. The women’s records showed that at 24 months after presentation, 131 continued to have an abnormal smear. (Of course, the other 817 had normal smears, or had had removal of the cervix by hysterectomy or other treatment.) There was no difference in age or parity between those in either group.
The division into the two groups was made retrospectively by the authors on the evidence for the presence or absence of an abnormal smear at 24 months.
They compared the outcomes in the two groups in terms of the development of invasive cancer (22.1 percent in the group with positive smears at 24 months, 1.5 percent in the larger group). They also compared the number of deaths in each group at the end of the observation period (June 1983). Four women who had had normal smears at 24 months had died (0.5 percent) and eight women had died who had had abnormal smears at 24 months (6 percent).
There was no withholding of treatment in that group with the persistently abnormal smears – see Table 1.
||Cone biopsy or amputation
||Cone biopsy or amputation
|Group 1 (n=817)
|Group 2 (n=131)
Table 1. Initial and eventual treatment of patients with normal smears, or who had cervixes removed by hysterectomy or other treatment (Group 1), and of patients with persistent abnormal smears (Group 2). Percentages exceeding 100 percent reflect the need for two cervical procedures in some women.
The authors said in the paper’s discussion, “the almost universal acceptance of the malign potential of this lesion has made prospective investigation into the natural progression of CIS ethically impossible”. That would require an experiment where women had no treatment. This is quite clearly not the case in this reported series.
It is clear that in this report of the management of CIS there is no evidence of withholding of treatment, nor of an experiment.
Three years after this paper was published, it was used by Sandra Coney and Phillida Bunkle as evidence for gross wrongdoing by the medical staff at NWH. Here is what they wrote:
“The study divided the women into two groups – 817 who had normal smears after treatment by conventional techniques, and a second group of 131 women who continued to produce persistently abnormal smears. This group is called in the study the conservative treatment group. Some had only biopsies to establish the presence of disease and no further treatment.”
Later in the article the authors refer to “group two women who had little or no treatment”.
This paper in a popular magazine was used by the Cartwright Inquiry as some of the evidence which led to its conclusions.
In 1990, Liggins said, “The famous 1984 article which emanated from the National Women’s Hospital and on which the Metro article which stimulated the cervical cancer inquiry was based, was misinterpreted by the authors of the Metro article and by the judge”.5
Was the management of cervical carcinoma-in-situ unethical?
This is the second aspect of the Cartwright affair that I wish to examine. In June 2010 the statement was made that “treatment with curative intent was withheld in an unethical study” at NWH from 1965 to 1974.6
It is important to make clear what we understand by ‘ethical’, ‘unethical’ and ‘conventional’, or we shall be reduced to the state of the Looking-Glass world: “‘When I use a word,’ Humpty Dumpty said in a rather scornful tone, ‘it means just what I choose it to mean – neither more nor less.'”7
Ethical: “In accordance with principles of conduct that are considered correct, especially those of a given profession or group”. (Collins Concise Dictionary, 1988.)
Unethical: Not in accordance with these principles.
Conventional: Relating to convention or general agreement. (OED)
Convention is a general agreement or consent. (OED)
Was the protocol for the management of CIN3 by Prof Green and his colleagues at NWH an unethical experiment? If he had proposed to divide the women as they presented into two groups, one of which was treated and the other not, then that would have been unethical. Although uncertainty existed as to what proportion of women with an abnormal cervical smear developed an invasive cancer, it was agreed that an abnormal smear meant that the woman was more likely to develop cancer than if she had a normal smear.
His protocol did not deny women treatment.
There was widespread international uncertainty as to the best form of management. If Prof Green had withheld an acknowledged proven treatment that was agreed to by the majority of workers in the field, and replaced it with an unproven treatment, then that would indeed have been unethical.
He didn’t do that.
During 1966-1984 there was no international agreed conventional treatment for this condition. As Iain Chalmers of the James Lind Library in Oxford points out, 8 Linda Bryder in her book has made a thorough review of the contemporary medical literature on this subject which makes it clear that there was no worldwide, generally accepted treatment of CIN3. The evidence called by the Cartwright Inquiry did not reflect the lack of an international consensus. It was indicative of only one aspect of the issue. It has all the attributes of ‘cherry-picking’.
The accusation that Green and his colleagues behaved unethically in these matters is not sustainable. Unless his detractors can show that there was a single international conventional treatment which he ignored, then repeated accusations of “unethical behaviour” are wrong. These accusations continue to be made, as recently as 1 June, 2010.6
Why do manifestly false beliefs persist over time?
There are features of our human behaviour which are conducive to the persistence of untruths, and they include a desire for uniformity in the interest of the maintenance of a coherent and more easily managed society.
Once a decision has been made, it is easier for all of us to go along with it, and not to ‘rock the boat’.
There have been trenchant criticisms of the Cartwright affair and its outcomes, often met with strident objections and not much logic. To accuse the whistle blower of “intransigence and arrogance” rather than meet the questions fairly is shameful.
Another feature of the last 22 years is the increasing number of papers published in the medical literature which on close examination are of poor quality. An example of this is the paper published on 1 June, 2010.
This was published as an abstract online. The authors include a medical adviser to the Cartwright Inquiry, a medical witness at the inquiry, and one of the authors of the 1984 paper. There is the old accusation that “treatment with curative intent was withheld in an unethical clinical study of the natural history of CIS at NWH in the years 1965-1974.” But in the results it is stated that 51 percent of these women had treatment with curative intent! The group treated with the diagnosis made in 1975-1976 had curative intent treatment in 85 percent. Prof Green retired in 1982; his proposal for the management of carcinoma in situ was approved in 1966.
Treatment with curative intent was not defined in the abstract.
The results include P values of 0.0005 for the significance of differences between groups, for a difference which defines the grouping.
The number of new patients in the year 1975-1976 was half that in each of the two previous decades. There is no explanation for this in the abstract. This group was not included in the comparison of risk for cancer of the cervix or vaginal vault. There is no explanation for this.
The medical science literature shares with all scientific paper publishing a current deterioration in standards. This contributes to the persistence of error. This issue has been recently addressed in an editorial in The European Journal of Clinical Investigation.9
“Why would scientists publish junk? Apparently the current system does not penalise its publication. Conversely, it rewards productivity.
Nowadays, some authors have been co-authoring more than 100 papers annually. Some of these researchers only published three or four papers per year until their mid-forties and fifties. Then suddenly they developed this agonising writing incontinence.”
Another factor in our society which feeds our appetite for orthodoxy is the popular press. Truth is often submerged in the sensational. An example of this occurred in the NZ Herald on 1 June, when their health reporter wrote a report of the on-line article6 with the headline:
“Otago research backs cancer inquiry findings: Unfortunate experiment at National Women’s not imagined, says report”
There followed 40 column centimetres supporting the headline, including two which stated: “The cancer death rate differences between the periods and sub-groups are not significantly different”. This information is not included in the on-line published paper. The reporter’s statement is not correct in his summary of the report. In addition he cites information which suggests he has access to the complete (as yet unpublished on June 1st) paper.
The television ‘press’ included that morning an interview with Charlotte Paul, one of the authors, and that evening, an interview with Clare Matheson, the woman named as ‘Ruth’ in the original Metro article. There was no reference to the valid criticisms of the Cartwright affair which have been made over the years.
It is not my case that the medical profession to which I belong is without fault, and I accept that since 1988 more attention has been paid by doctors to issues such as informed consent. But the means, by this miscarriage of justice, do not justify the ends.
Our human desire not to alter our beliefs in the face of contrary evidence, the willingness of the popular press not to disturb established ‘truth’, the current deterioration in the standards of the world medical press, and an unquestioning respect for ‘authority’ are factors recognisably active in the persistence of the myths surrounding the Cartwright affair. These behaviours are not new, and their effects on the emergence of truth have been recognised for centuries. Francis Bacon (1561-1626) in his Axioms wrote, in number 46:
“The human understanding when it has once adopted an opinion (either as being the received opinion, or as being agreeable to itself) draws all things else to support and agree with it. And though here be a greater number and weight of instances to be found on the other side, yet these it either neglects and despises, or else by some distinction sets aside and rejects; in order that by this great and pernicious predetermination the authority of its former conclusions may remain inviolate.”
- Editorial. 1974: BMJ, 5891, 561-2.
- Green, GH. 1974: NZMJ 80, 279-287.
- McIndoe, WA; McLean, MA; Jones, RW; Mullins, PR. 1984: Obstetrics and Gynecology 64, 451-458.
- Overton, H. 2010: NZMJ 123, 95-96.
- Liggins, CC. 1991: Australia and New Zealand J. Surgery 61, 169-172.
- McCredie, MRE; Paul, C; Sharples KJ; Baranyai, J; Medley, G; Skegg, DCG; Jones, RW. 2010: Australia and New Zealand J Obstetrics and Gynaecology, ‘earlyview’ on-line 1 June.
- Carroll, L. 1871: Through the Looking-Glass. Chapter 6.
- Chalmers, I. 2010: NZMJ Letters to the Editor. 30 July.
- Editorial. 2010: European J Clinical Investigation 40(4), 285-7.