- Controversy in the New Zealand Medical Journal, 2010
- Professor Ron Jones asks ‘Why Did So Many Women Develop Cancer’ in the New Zealand Medical Journal, 2010
- Professor Charlotte Paul crtiques Professor Bryder’s book, 2010
- Phillida Bunkle points out the consequences of Professor Bryder’s lack of familiarity with the patient case histories in the New Zealand Medical Journal, letters, 2010
- Phillida Bunkle analyses the weakness of professor Bryder’s argument in the Women’s Studies Journal, 2010
CONTROVERSY IN THE NEW ZEALAND MEDICAL JOURNAL
The publication of Professor Linda Bryder’s revisionist volumes denying the occurrence of the Unfortunate Experiment, or harm to patients aroused controversy in the New Zealand Medical Journal in 2010.
Professor Ron Jones, a gynaecologist at National Women’s Hospital who had been a consistent critic of the ‘unfortunate experiment’, asked why, if there was no experiment, there were marked increases in the development of invasive cancer during the period of the research, especially among the women with minimal or no initial curative treatment.
Professor Bryder responded in the same edition of the Journal. Jones and Bryder are here divided by two key issues; the ability to distinguish clearly adequate from inadequate treatment and the implications of the fraudulent nature of Green’s methodology.
Firstly Jones assumes that whatever management has been employed, if a patient continues to have tests which show that she has continuing abnormalities then she has, by definition, not been fully treated. Thus two groups of patients can be distinguished on the basis of whether they continued to have evidence of continuing disease. This is the basis of the both the published analyses of 1984 and 2008, which show elevated rates of invasion in the group of patients with persistent abnormalities.
Bryder’s rejoinder assumes that no such distinction between adequately and inadequately treated patients can be made, therefore there are no ‘groups’ of patients, and therefore comparison of the rate of invasion is invalid. Bryder continues to accept Green’s evidence in part because she does not accept that it is possible to distinguish adequate and inadequately treated patients.
Jones raises a related secondary point about the meaning of ‘independent’. Jones asserts that the 2008 review of the pathological evidence which established increased rates of invasion was ‘independent’ because it was conducted at an Australian laboratory separate from National Women’s Hospital.
Bryder argues that ‘independence’ is only established if the people authoring the review are not ‘related to’ the Hospital. This would seem to discredit any debate originating from people working within that institution.
Secondly, Jones raises the issue of the crucial claim in Green’s 1974 paper ‘The Progression of Pre-invasive Lesions of the Cervix to Invasion’, New Zealand Medical Journal (vol. 80 1974) in which Green stated that only 6 out of 96 cases had developed invasion in women managed with limited diagnostic procedures. Green had arrived at this figure by removing the other cases of invasion from his series.
Jones is concerned that evidence that the results were distorted by Green’s fraudulent removal of cases of invasion from his study series had not been reported in the medical media at the time. Had they been, Jones believes that the professional response, especially by the internal committee established to investigate, would have been more effective in dealing with the seriousness of the issues.
Bryder’s response to this critical issue is that the overall rate of invasion was not in fact high compared to other countries.
The article and response can be found in this pdf below:
PROFESSOR CHARLOTTE PAUL EXAMINES PROFESSOR BRYDER’S BOOK 2010
Introduction to Professor Charlotte Paul, ‘A critique of Linda Bryder’s history of the ‘Unfortunate Experiment’ at National Women’s Hospital’
Professor Charlotte Paul submitted this comprehensive examination of the medical misunderstandings underlying Professor Bryder’s history to the New Zealand Medical Journal where it was accepted for publication. The article provides detailed accounts of how accepting Associate Professor Green’s erroneous propositions led Professor Bryder to misrepresent the medical situation. In particular Professor Paul drew attention to the implications of Green’s scientific misconduct in withdrawing cases of invasive cancer from his reported findings. Paul shows how this led both the authorities at the time and Professor Bryder to underestimate the real risk to the women patients.
Prior to publication of this article Professor Paul found, however, that although she had not been informed, the Journal had invited Professor Bryder to write an editorial to accompany the paper. The attribution of the authoritative editorial voice to one protagonist gave them a privileged position. Such authorial inequality is incompatible with effective and open debate. Disrespect for Professor Paul’s medical expertise and comprehensive knowledge of the medical issues involved was particularly surprising in a professional medical journal. Professor Paul withdrew her article from publication in the New Zealand Medical Journal in May 2010. It is published for the first time on this site.
A critique of Linda Bryder’s history of the ‘Unfortunate Experiment’ at National Women’s Hospital
Department of Preventive and Social Medicine, University of Otago
Historian Linda Bryder has published an account of the ‘unfortunate experiment’ at National Women’s Hospital that paints a different picture of Dr Herbert Green’s study of carcinoma in situ of the cervix than the findings of the Cartwright Inquiry and of the Medical Council of New Zealand. A detailed examination of Bryder’s case shows both medical and scientific errors: (a) conflicting descriptions of the nature of Green’s research proposal; (b) illogical portrayal of the aim of Green’s study; (c) drawing conclusions about the safety of the study from Green’s published papers when the true outcomes were not presented in these papers; (d) accepting that Green removed cases from his study but not recognizing the implications for scientific integrity; (e) incorrect descriptions of independent publications showing results of Green’s study; and (f) incorrect reasons given for rejecting the findings of the Medical Council of New Zealand.
The profession should be careful before accepting claims that purport to overturn the findings of properly constituted inquiries. If this mis-portrayal is accepted it will set back the profession’s task of acknowledging and dealing with error.
The recently published history of the ‘unfortunate experiment’ at National Women’s Hospital by Professor Linda Bryder1 paints a very different picture of Dr Herbert Green’s management of patients with carcinoma in situ (CIS) of the cervix in the 1960s and 1970s, and the outcome of that management, than the established story told in the Cartwright Report.2 Bryder’s history has been welcomed in the pages of the Journal,3 so it deserves serious attention. It also deserves serious attention because Bryder claims that Cartwright’s medical experts and advisors were wrong and that the Medical Council was mistaken in upholding the Cartwright Inquiry findings. Does Bryder really have a convincing story to tell? In what follows I explain in outline the established story and Bryder’s new story, then give a detailed analysis of the flaws in Bryder’s account. I was one of the three medical advisors to Judge Cartwright and have written previously on the Inquiry and its aftermath.4,5,6
The established story, as told in the Cartwright Report,2 is that Dr Green gained approval in 1966 for a trial of withholding treatment from a selected group of women with a new diagnosis (by punch biopsy) of CIS of the cervix. Further treatment was also withheld from some women with persistent or recurrent CIS after cone biopsy; women with a histological diagnosis of microinvasion; women with CIS of the vaginal vault following hysterectomy; and women with CIS of the vulva. Green wrote that his aim was to follow adequately diagnosed but untreated lesions indefinitely.7 Women were followed closely and repeat biopsies, often incomplete, were performed to exclude invasive cancer. For a minority of these women the outcome was the development of invasive cancer, and in some cases death. He published his results in a series of papers, the last one in 1974.8 At that time he recorded that six out of 96 women who had been followed for at least two years with positive smears after a diagnosis of CIS had developed invasive cancer (Stage 1B or worse). But this figure under-represented the true number with cancer because Dr Green had removed cases from his series after reviewing the histology and deciding that they were already invasive at the outset.
Some of Green’s colleagues were concerned about the dangers to patients evident from the outcomes for women in the trial and complained to him, then to the hospital superintendent. This led eventually to an internal inquiry, which was later called a whitewash because the committee called on Green and his colleagues to continue the ‘clinical trial’ and to subjugate their personality differences in the interests of scientific enquiry. Nevertheless, following the internal inquiry, new patients did start to receive conventional treatment, though Green continued to follow some existing patients without treatment. In the early 1980s, the doctors who were most concerned about the trial, colposcopist Dr Bill McIndoe and gynaecological pathologist Dr Jock McLean, joined at that time by gynaecologist Dr Ron Jones, reviewed the patients’ notes and wrote the outcome up for publication. This paper, ‘The invasive potential of carcinoma in situ of the cervix’ was published in 1984.9 Among the 131 patients who were followed with positive smears for around two years (following a punch biopsy or a cone biopsy or a hysterectomy), 29 developed cancer. The incidence was 25 times higher than for women who had negative smears. Cartwright concluded that criticisms of this paper did not stand up to examination. There were a few minor uncertainties in interpretation but they did not detract seriously from the general findings.
The outline of Bryder’s new story is that Green did not do an experiment but was first and foremost a clinician and his research was secondary data gathering. His aim in his 1966 proposal was to prove that CIS was not invariably a pre-malignant disease. If he followed women with CIS without treatment, this was similar to what many other gynaecologists worldwide advocated at that time. Moreover, it spared women the morbidity related to cone biopsy. In fact she wrote that the 1966 proposal was for ‘current best practice’. She claimed it was not clear that there were any bad outcomes; if there were, they couldn’t have been known at the time. The paper by McIndoe and colleagues didn’t show what other people thought it showed. She said the groupings had nothing to do with whether the patients were under Green’s care and the group who had positive smears at two years could not be differentiated by treatment from women in the negative smear group. She claimed that the McIndoe paper formed the basis of Cartwright’s erroneous findings.
Deciding whether Bryder is right is primarily a matter of determining whether her medical and scientific case stands up to scrutiny. In what follows I examine her evidence for these arguments and conclusions. A detailed examination of Bryder’s handling of the ethical issues can be found in The Cartwright Papers.10 Also included there are essays on her historical method and her handling of arguments about the role of the women’s health movement and feminism.
The portrayal of Green’s study
Bryder portrays Green’s study in a variety of contradictory ways. One view she puts forward is that he was treating some women and not others based on clinical indications, and that his study was a retrospective collection of statistics about the outcomes for these women. She quotes Green’s evidence to the Inquiry to the effect that his management of CIS was fortunate because many patients avoided unnecessary surgery, and clinical decisions always came first. Yet sometimes she describes his as a follow-up study of a group of untreated women, akin to earlier studies of untreated women with CIS, or to more recent ones among women with lesser cervical abnormalities. Sometimes she compares Green’s study to retrospective follow-up studies of the outcome after treatment; and sometimes the same thing is called conservative treatment as if it were the same as other gynaecologists were doing at the time. Elsewhere she calls it a clinical trial. These different views are explored in more detail below.
One way that Bryder portrays Green’s 1966 study proposal was that it was for ‘conservative treatment’. In the published literature at that time, conservative treatment meant treatment aimed at removing the lesion while conserving the uterus. It entailed cone biopsy and regular follow-up.11,12 By 1981, lesser procedures such as cryosurgery, electrocautery and carbon dioxide laser therapy were described.13 The aim in all these cases was to remove or destroy the abnormal tissue.
Bryder claims that this was what Green was proposing to do. She wrote:
The Hospital Medical Committee agreed to a protocol for treatment of CIS in 1966… collectively adopting what they believed was current best practice.
A careful reading of Green’s actual proposal would show this was not the case. Bryder presents Green’s proposal in her book, but omits the crucial section which shows he was intending to follow without treatment. The relevant paragraph from the full proposal as set out in the Cartwright Report is shown below, with the section Bryder omitted in italics.
It is considered that the time has come to diagnose and treat by lesser procedures than hitherto, a selected group of patients with positive (A3-A5) smears. Including the four 1965 cases, there are at present under clinical, colposcopic, and cytological observation, 8 patients who have not had a cone or ring biopsy. All these continue to have positive smears at intervals. It is suggested that this should be extended to include all cases in women under the age of 35 with positive smears in which there is no clinical or colposcopic evidence of invasive cancer, ie (a) The cervix shows nothing more than eversion (erosion) on clinical inspection; (b) There is no undue bleeding on probing the cervical canal; (c) Colposcopic findings are consistent with carcinoma in situ only.
Without the missing words, it might appear to be a proposal for conservative treatment by cone biopsy. The omission must be deliberate (there is an ellipsis where the words are omitted) and made in order to suggest that Green was presenting a treatment protocol; what Bryder calls ‘current best practice’.
This impression is strengthened by the misleading comparisons Bryder makes between Green’s proposal and the reports of other gynaecologists’ conservative treatment around that time. For instance, on page 24, after Green’s proposal is set out (with the section omitted), Bryder writes:
‘This protocol would have met with the approval of Professor Per Kolstad….’ She then quotes from a 1970 article by Kolstad: ‘By the complementary use of cytology, colposcopy and histopathology, the risk of overlooking invasive carcinoma of the cervix are minimal.’13
This sounds as if he were advocating following women without treatment, as Green was proposing. This is incorrect. What Bryder omits to quote from the article is: ‘…we agree that it is not justified to allow a patient to go without treatment when a diagnosis of carcinoma in situ is made, we would like to plead for a conservative approach…’. That approach, Kolstad explained, was conization.14
Is Bryder intending us to believe that Kolstad was also following without treatment – which he was not? Or is she wanting us to believe that Green was treating as Kolstad was? In either case, she is misleading us. The paper by Kolstad14 is describing follow-up after conservative treatment with cone biopsy. The reason for such follow-up was to detect persistent or recurrent CIS and to offer further treatment. Green was proposing to follow without treatment and to check periodically for invasive cancer. On the evidence of Kolstad’s full paper, Green’s full proposal would not have met with his approval.
Diagnostic punch biopsy only
There are a number of places in the book where Bryder seems to acknowledge that Green was, in fact, taking only a small diagnostic biopsy and then following without treatment.
(i) Immediately after describing Green’s 1966 proposal and her expectation that Kolstad would approve it, Bryder writes: ‘Coppleson also later referred to a number of studies (citing a 1971 article, for example), “confirming the safety of this approach” which was “colposcopically directed punch biopsy” ’. This time she seems to be arguing that Green did only punch biopsies (which is what the proposal actually said) and that Coppleson was doing so too. But again, the reference tells a different story. Coppleson refers to colposcopically directed punch biopsies and a number of studies ‘confirming the safety of this approach’ for diagnosis (instead of a ‘randomly directed procedure’, ie blind cone biopsy for diagnosis). He then describes how this allowed women to proceed to definitive therapy with ‘excisional biopsy, cryocautery, therapeutic conization, hysterectomy, or irradiation’.13 Coppleson says nothing about the safety of colposcopically directed punch biopsy as the only procedure, as Bryder implies. Obviously by 1981 lesser procedures than cone biopsy were coming to be used but Coppleson never advocates not removing the lesion.
(ii) Bryder describes Green’s study as a follow-up study involving observation and not treatment. This section starts with quotations from pathologist Dr Ralph Richart and gynaecologist Dr Joe Jordan who gave expert evidence at the Inquiry. She quotes Richart: ‘I have known of no one except Dr Green who would recommend prospectively following patients with persistent CIS of the cervix, vulva or vagina rather than treating them and eradicating the lesions’. Then Jordan: ‘From 1966 onwards, I know of no unit other than Professor Green’s which was prepared to allow patients with carcinoma in situ to continue without treatment’.
These statements by Richart and Jordan, in the context of their knowledge and expertise and their reviews of the patients’ files, provided important evidence for the Inquiry. Here Bryder appears to accept the experts’ evidence about what Green was doing, but she rejects the assertion that he was alone in doing so. She writes: ‘Yet Professor Jeffcoate’s advice in his 1975 textbook (and 1980 reprint) that in some cases it was preferable to ‘observe’ patients rather than treat them has already been noted’. Here is Bryder, in this case, accepting the expert witnesses’ evidence that Green was not treating, but justifying it on the basis that other units at this time were also not treating. What does Jeffcoate actually say? Does she quote correctly in the context? Once again the reference tells a different story. In the 1975 edition Jeffcoate advises that the woman who has a positive smear during pregnancy ‘should generally merely be kept under observation’ and a cone biopsy should be performed after delivery if the smear remains positive.15
Bryder then proceeds to describe other follow-up studies that reported on the outcome for women with CIS without treatment. She mentions Petersen’s retrospective pre-cytology study of CIS in Copenhagen from 1930 to 1950, and Richart’s prospective study of women with cervical dysplasia, as if they were also the same.16,17 Bryder makes no distinction between following CIS and following dysplasia without treatment.
At the Inquiry, Professor Graham Liggins also likened Green’s study to that of Richart. Thus Liggins clearly acknowledged that Green was doing a prospective study entailing withholding treatment. Nevertheless there were important differences relevant to the ethics of the two studies which Bryder does not mention. Richart and Barron designed their study so that when women were found to have progressed to CIS (though in three cases invasive cancer was diagnosed at that stage) follow-up stopped and treatment was undertaken. Green’s study was designed to stop only at frankly invasive cancer. Importantly, Richart and Barron also informed their patients of the research project, and gave them a choice as to whether to take part.17 Thus their patients also knew they remained at potential risk while they were being monitored, and understood why they needed to continue follow-up. This was not the case with Green’s patients, who were also at much greater risk, because they already had CIS.
(iii) When Bryder reports on Green’s own publications, she starts with a quotation from Green, acknowledging that he was doing something unusual: lesions were ‘almost disdainfully undertreated’. Then she questions Green’s own statement. She says: ‘Yet how disdainful was his treatment in reality?’
This time she implies that it might have been under-treatment but at least it was harmless. She uses Green’s 1969 paper to conclude that only one woman had developed invasive cancer, and this was a woman who had been conventionally treated.7 Now, here she is acknowledging that he was not treating (or was at least ‘disdainfully under-treating’), but concluding that it was safe not to treat, because only one case had gone on to develop invasive cancer. She doesn’t say it, but this was by June 1968 only two years after the proposal was approved – many more cases would emerge in later years. Moreover, at the Inquiry, Green was criticised for reclassifying cases from his special series when they developed invasive cancer and removing them from the series. Bryder discusses this reclassification and accepts that it was done. But she doesn’t see that because Green was removing cases, she can’t rely on the outcomes presented in his papers to show that the study was safe for the women. Green records no cases in his special series developing invasive cancer; this is simply incorrect.
(iv) Bryder goes on to quote from one of Green’s 1970 publications and to compare his management with two descriptions from papers by Kolstad. She quotes Green:
The 27 [women] treated by punch biopsy form part of a special series, … in whom invasive cancer has been excluded as far as possible by clinical, colposcopic, and cytological examinations; the histological diagnosis rests on punch biopsy alone, and no further therapy is being undertaken.18
Once more she makes a comparison with another contemporary publication apparently to show that Green was not alone in following without treatment. First, she says that this is ‘like Kolstad’s “observed” patients in his 1976 study’. Are they alike really? No. Kolstad’s 25 patients had had cone biopsies, not punch biopsies, though with evidence of incomplete excision. The clear implication in Kolstad’s paper was that he was observing them for evidence of recurrent CIS (that occurred in six cases) which was an indication for further treatment.19 Then Bryder claims that Green’s approach is ‘very similar to many overseas studies and was considered according to Kolstad’s 1970 statement a “safe” approach’. Wrong again. Once again, Kolstad’s safe approach was careful follow up after treatment by cone biopsy to look for and treat persistent or recurrent CIS.14
The paper by Green, above, that Bryder quotes from, sets out in the most unambiguous way Green’s views and aims at that time:
Provided invasive cancer is adequately excluded at the outset the patient with diagnosed in situ cancer has only the normal chance of developing invasive cancer in the future. This conclusion will be completely unacceptable to many for it signifies in effect that carcinoma in situ is a benign disease.
He also gives his aim: ‘to follow indefinitely patients with diagnosed but untreated lesions.’18 Bryder does not use these quotes.
The last paper Green published on his study, in 1974, outlined the outcomes for patients who were being followed with treated and untreated CIS.8 Bryder describes the paper as showing that 10 out of 750 patients developed invasive cancer, and she says: ‘As with similar studies elsewhere, he found a small minority of cases [she says 1.3 percent] slipping through the net.’
What net? Amongst the 750 women with CIS, Green reported on the group of 96 followed for at least 2 years with positive smears.8 There was no safety net of treatment and post-treatment follow up for these women. Green reported that six of them had developed invasive cancer, and we know (and Bryder accepts elsewhere) that this actual number was wrong because some cases had been removed. Using the correct denominator, 6.3 percent, not 1.3 percent, developed invasive cancer, and we know this is an underestimate. Even 6.3 percent is at least an order of magnitude higher than treatment outcomes after 10 years published elsewhere. A recent review of studies showed annual rates of invasive cancer after conservative treatment of 56 per 100,000 – hence 0.56 percent after 10 years.20
The study aim
Bryder makes an illogical claim about the aim of Green’s study. She says that the aim of his 1966 proposal was to prove that CIS was not invariably a pre-malignant disease. She quotes Green telling the Inquiry that the word ‘invariably’ had been omitted from the recorded aim, and that ‘I was not setting out to prove anything, but I did question the view that CIS invariably progressed to invasive cancer’. Bryder omits to mention that the Cartwright Report contains a long discussion on whether ‘invariably’ was in the stated aim, and concluded, on the evidence of Professor David Skegg, that such inclusion would have made not treating much more dangerous: in fact to test that it does not invariably progress, ‘one would have to go on until every single women developed invasive cancer’. (Testing such an aim entails attempting to disprove it.)
Bryder has continued to support the contention that ‘invariably’ should have been in the stated aim. In the Listener21 she said that had Green ‘proposed that CIS was harmless, he was sure the committee would never have agreed to the proposal’. What does this mean? If he had told the committee that CIS was harmless, they wouldn’t have agreed to a trial of no treatment? Surely they would have agreed more willingly to no treatment for a benign condition (if they accepted his assurance that CIS indeed was) than for one that went on to cancer in some cases, but not invariably! An unbiased examination of the evidence would also have led her to consider other writings by Green on this subject. For instance, in the paper quoted above, Green implied he could only countenance following women with untreated CIS indefinitely because he believed the condition was benign.18 The disturbing statement in the Minutes of the Hospital Medical Committee meeting, that Dr Green’s conscience was clear and that he could therefore ‘accept complete responsibility for whatever happens’, seems to confirm that Green was convinced in his own mind that what he was doing was safe; that is, that CIS was benign – but that the other members of the committee were less convinced and didn’t want to share the responsibility. (Bryder gives another interpretation of this statement, that ‘the committee confirmed their trust in Green to keep the welfare of his patients paramount’).
There is further evidence in the Cartwright Report that Green believed CIS was harmless. Cartwright notes how, time and again, Green reassures anxious general practitioners that he considered CIS to be harmless. She quotes Kolstad at the Inquiry: ‘Dr Green has certainly proved that his fanatic belief that CIS is a harmless disease is a severe mistake’. This was presumably why Cartwright concluded that it was wrong to say that Green had no intention to cure his patients. She wrote:
During the course of this Inquiry there was no serious suggestion that he had anything other than a benevolent attitude towards his patients… There is however, a difference between the overall intention to cure the patient and a decision not to treat a particular condition. It was, and I still believe is, Dr Green’s view that CIS is essentially a benign condition. If a gynaecologist holds that view, then there is no purpose in treating the lesion.
Such a position clearly put Green out on a limb. Bryder cannot accept that. But she cannot have it both ways. Either he believed CIS was essentially a benign condition and hence following without treatment was, in his view, caring for his patients. Or he believed CIS progressed to invasive cancer in a proportion but not 100 percent of cases (i.e. not invariably), in which case he was knowingly endangering his patients.
To get out of this bind, Bryder wants to claim that Green was treating his patients ‘conservatively’, but as we have seen, she cannot sustain that claim and does not always even try to do so. And of course, it would have been impossible to test either aim if patients were receiving treatment.
The expressions of concern about Green’s study
The Cartwright Report devotes a whole chapter to the expressions of concern from McIndoe and McLean that culminated in their written complaints to the hospital superintendent, Dr Algar Warren, who in turn consulted the hospital superintendent in chief, Dr Fred Moody. Dr Moody wrote back to Dr Warren setting out a course of action to follow to investigate these complaints. Cartwright describes how this led eventually to an internal committee of inquiry. In Bryder’s account Dr Moody is not mentioned at all and the internal inquiry is portrayed as a response to ongoing disputes.
More gravely, Bryder’s account of the report of the internal inquiry shows a lack of judgement about the serious issues for patients that were at stake. First, she misrepresents the findings of the committee (set out in full in the Cartwright Report). It was charged with reviewing the case notes of 29 patients, though in the end it reviewed only 14 and commented on 13. These 29 cases had been given to Warren by McIndoe and McLean as part of their complaint. The internal inquiry concluded that in all 13 cases ‘managed by the agreed  conservative policy, invasive carcinoma was subsequently diagnosed’. One of these patients died of her cancer. About this finding, Bryder says: ‘[The committee’s] report noted that all except one had been successfully treated’. This is seriously misleading: none had successful treatment for CIS; all had developed invasive cancer, from which one woman had died. Treatment for invasive cancer generally entailed radiotherapy and radical hysterectomy.13 Surely all 13 developing invasive cancer and one dying was a cause for concern? Secondly, she makes a strange assertion about the committee’s recommendation for what it called the ‘clinical trial’. The committee did not recommend that the 1966 policy be reviewed and noted that it was outside its own (self-made) terms of reference to comment on ‘the outcome of the clinical trial to which the agreed policy applies’. It went further and noted that continuation of the trial depended on ‘the staff members concerned subjugating personality differences in the interests of scientific enquiry’. Far from agreeing with Judge Cartwright that the committee report did not put patient safety first and threatened to compromise it for the sake of scientific enquiry, Bryder rejects this conclusion by quoting from another source. She quotes the celebrated advocate of clinical trials, Archie Cochrane: “‘in a situation where there is so much honest doubt”, even a randomised trial would be ethically justifiable if technically possible’. It is very hard to know what Bryder means by this. The full quotation from Cochrane helps us to understand:
The classical approach – the randomised controlled trial – has never been attempted, for the good reason that it is technically very difficult – the diagnostic biopsy necessary to establish the diagnosis of carcinoma-in-situ may have considerable therapeutic effect – and the poor reason that it would be unethical. (In a situation where there is so much honest doubt…)22
This shows that Bryder is supporting the continuation of the (non-randomised) trial of no treatment (which she has previously asserted did not exist) despite 13 or more women having already developed invasive cancer. I am certain that Cochrane would have been more worried than Bryder about the harms and would have recommended stopping. Once again Bryder shows no concern at all for the adverse effects on the women.
Scientific misconduct in Green’s study
It is a telling fact that in Green’s publications up to 1970, he reported that none of the women in his ‘special series’ had gone on to be diagnosed with invasive cancer. However, Judge Cartwright concluded that some cases originally included in his special series had progressed to invasion in that time. Several lines of evidence supported this conclusion: a memorandum from McIndoe in 1969, Richart’s review of Green’s evidence to the Inquiry, Green’s 1974 publication, the evidence of Dr John Donovan, a mathematician and co-author of a 1970 publication with Green23, and the medical review in the Cartwright Report.
The implication of reclassifying cases in Green’s study was spelt out by Richart in his evidence:
Dr Green has stated in his brief, that it was obviously impossible to exclude invasion in some patients. This is given as a reason for retrospectively excluding them from the study. This creates three problems. It introduces an unacceptable bias that militates against ever having a valid study; it allows the investigator to influence the outcome of the study by introducing his preconceptions (even if unconsciously); and, most importantly, it indicates that the entry criteria are such that a significant number of women will be followed prospectively as carcinoma in situ patients who already have invasive cancer – a potentially fatal disease. That discovery once made, requires in my opinion that the study be terminated.
This statement was included in my account of the Inquiry published in 1988.4
Indeed, Bryder acknowledges that Green removed cases, but she completely fails to recognise the significance of this, not alluding at all to the statement above. She says: ‘Green was not alone, however, in conducting retrospective reviews of the histology of invasive cancer’. She goes on to quote again from Kolstad’s retrospective review of treatment outcomes for 1121 women with CIS,19 noting that Kolstad re-examined the operative specimens in two cases and confirmed that ‘there must have been a microcarcinoma which was overlooked during the initial histopathological examination’. It is a serious misunderstanding to equate Kolstad’s review of histology with what Green was doing. In fact the cases he mentions were not removed from the analysis; the review of histology was used to explain why these cases might have developed metastatic cancer. Moreover, Kolstad’s study was a retrospective observational study, not a prospective trial. To be clear, removing cases in the way that Green did meant his published results could not be relied on. Yet, Bryder actually relies on these falsely reassuring results to tell her readers that Green was doing no harm, as described above.
Paul Gerber with Malcolm Coppleson, the gynaecologist who pioneered colposcopy in Australia, wrote about this in 1989 in the Medical Journal of Australia.24 They commented on Green’s ‘highly unscientific approach’, in which he justified removing cases from his series by going back and changing the diagnosis. They also wrote:
Green should have concluded that if cases of invasion were capable of being missed at the outset, his protocol not only was unsafe in that some women would, without treatment, proceed to develop invasive cancer, but also was incapable of testing his hypothesis.
It is a signal failing, amounting to scientific misconduct, that Green did not report his study accurately, and hence did not stop it when evidence of harm emerged.
Incorrect descriptions of the papers of McIndoe (1984) and McCredie (2008)
Bryder incorrectly represented the McIndoe paper as underpinning the Cartwright Report, but Judge Cartwright’s conclusion that women had had inadequate treatment did not rely on any information in this paper by McIndoe and colleagues. Instead it relied on review of the case notes of patients. Bryder is also confused about the question of ‘two groups’ of patients described in the 1984 paper. It needs to be stated clearly that similar groupings of patients were also made by Green in his research publications.
Dr Green’s 1966 research proposal described selecting groups of patients with CIS to be given no further treatment after a small diagnostic biopsy (he also records giving no further treatment to patients with positive smear test results following cone biopsy and hysterectomy). In his subsequent papers these patients were referred to as one or more ‘special series’ of cases and as ‘untreated’ or ‘under treated’.18,7 In his last paper, in 1974, he described ‘following of 96 of them with positive cytology for at least two years….’8
In the 1984 paper, McIndoe and his co-authors reported on their review of the files of patients with CIS first diagnosed at the Hospital between 1955 and 1976.9 In order to investigate the natural history of CIS they compared patients with no evidence of persisting disease (negative smears) to those with evidence of persisting disease (positive smears), and identified two groups. ‘Group 1’ had negative smears at two years after diagnosis. ‘Group 2’ were those with positive smears at two years after diagnosis. Group 2 is basically a retrospective reconstruction of Dr Green’s group described above: ‘96 of them with positive cytology for at least two years’. The 96 were those diagnosed up to 1971. The McIndoe paper included women diagnosed up to 1976 and included 131 women. This extension of the period by five years explains the difference in number of cases.
Bryder also claims that the paper ‘provided no suggestion that there were two groups differentiated by treatment’. This is incorrect: first, the timing of surgical treatments differed, 78 percent of Group 1 but only 49 percent of Group 2 had a cone biopsy or hysterectomy as their primary management; second, incomplete removal of the abnormality as shown by disease at the margin of cone biopsy specimens was reported for only 15 percent of Group 1 but 75 percent of Group 2; and third, the presence or not of abnormal smears obviously differed. Bryder’s claim that there was no difference in treatment between groups 1 and 2 also leaves her with no explanation for the fact that the rate at which cancer appeared in Group 2 was 25 times higher than in Group 1. Again, she has made an illogical and incoherent claim.
Bryder also misrepresents the results of the re-examination of the natural history of CIS, drawing on material from National Women’s Hospital during 1955 to 1976. This was undertaken by Margaret McCredie and colleagues (including myself), and published in 2008 in Lancet Oncology.25 Table 2 in the Lancet Oncology paper shows the direct effect of Green’s clinical study on the 143 women who received only a small diagnostic biopsy (as opposed to treatment by a cone biopsy) within six months of diagnosis. Over the next 30 years, 31 per cent of these women went on to develop invasive cancer. Even within five years, 11 percent had developed cancer, compared to one percent among women who had received a cone biopsy initially. The implication of these figures should be obvious.
The conclusion of the Lancet Oncology paper was that among women who received only a small diagnostic biopsy and no subsequent adequate treatment, 31 percent developed cancer after 30 years, as did 50 percent among the subset of women who had positive smears subsequently. Bryder says about this finding: ‘[w]hile an aggressive approach to CIS could be shown after 30 years to be a better approach than the more conservative one, this knowledge was not available at the time’.
This statement cuts to the heart of the difficulties that Bryder has in her interpretation of scientific material. First, the women in this group received no treatment, not conservative treatment. Second, there was already evidence in 1966 that a substantial proportion of cases would progress to invasion if untreated. For instance the Cartwright Report includes a table compiled in 1961 by Kolstad showing the development of invasive carcinoma in untreated cases of CIS; the average proportion of cases progressing was 28 percent over a range of 1-23 years of observation. Third, Bryder assumes that the outcomes of Green’s study did not become available for 30 years. As the data given in the Lancet Oncology paper show, the differences between the initially untreated and the treated women should have been obvious to Green well within five years of the beginning of his study in 1965. The harms were clear by 1970; there was no need to wait until 2008.
Incorrect conclusions about the medical experience of the women
The Cartwright Report concluded that some women had not received adequate treatment during the period they were in the care of Dr Green. This judgment was based on evidence from expert gynaecologists from around the world who reviewed the patients’ files. As noted above, all the gynaecologists concluded that the treatment was inadequate; not even Dr Ellis Pixley, called by counsel for Green, agreed with his management of patients. Cartwright commented on the ‘remarkable degree of unanimity’ among the overseas authorities in their conclusions from reviewing patients’ files. Professor Per Kolstad, the same eminent Norwegian gynaecologist that Bryder tried to recruit as approving of Green’s original proposal, concluded that some women suffered ‘severe’ and ‘terrifying mismanagement’.
In one specific instance, Bryder claims that the patient, Clare Matheson, was discharged from National Women’s following ‘five negative smears’; later in the book this becomes five negative smears plus ‘one equivocal report of probably carcinoma in situ in the four years preceding her discharge’. This is wrong. At the time of Clare Matheson’s discharge from the hospital, she had an unequivocal histological report of ‘fragments of carcinoma devoid of underlying stroma, probably carcinoma in situ’. The pathologist was certain about the presence of carcinoma; he was equivocating between CIS and invasive cervical cancer; it was not possible to tell, because there was no underlying stroma. Histology obviously over-rides the negative cytology finding. What is more, multiple biopsies had left her cervix stenosed, making a false negative finding more likely. In line with his own beliefs, Dr Green wrote in the discharge letter to her general practitioner: ‘she has no more chance than the next person of now developing any carcinoma of the cervix’. Unsurprisingly, given she still had CIS, she went on to develop invasive cancer of the cervix and required even more extensive treatment. It is another grave error to portray Matheson’s treatment as conventional when she was followed with intermittent positive smears for 13 years, had a diagnosis of CIS with microinvasion which was left untreated, had five wedge or cone biopsies under anaesthetic over this time, was discharged with untreated CIS, and was subsequently diagnosed with stage 1B invasive cancer.
The nature of empirical evidence
Ron Paterson noted in the New Zealand Medical Journal in 200826 that the revisionists had not provided any empirical evidence for their position, referencing a presentation of mine. Bryder replied in the Journal, rejecting this claim on the basis that the empirical evidence was contained in her paper on a history of cervical screening published in 2008.27
This is to mistake the nature of the relevant empirical evidence. For Bryder’s case to have been credible she would have needed to demonstrate that women who were part of Green’s study had similar or better outcomes compared to those who received conventional treatment. The relevant outcomes are the occurrence of invasive cancer of the cervix or vaginal vault, deaths from cancer, and any harms from the treatment of CIS itself. But Bryder provides no information on relevant outcomes at all. Nothing. Not a scrap. She doesn’t believe that the McIndoe analysis provides this information because she misunderstands it and similarly with the McCredie re-examination. There was another source available to her in the Cartwright Report itself which she does not refer to at all. A review of all the case notes undertaken by Professor Eric McKay and Dr Linda Holloway, medical advisors, allowed the recording of patient outcomes. This formed the basis of the analysis of the outcomes for women by time period. This showed that over the time that Green was recruiting patients into his study (1965 to 1974), the overall rate of invasive cancer within 10 years of diagnosis was 7.7 percent. This was compared to the earlier period, 1955 to 1964, where it was 1.6 percent and the later period, 1975 to 1976, when it fell again to 1.7 percent. This difference underestimates the effect of Green’s study because it is limited to ten years follow up and because some women in the earlier and later time periods were also not treated conventionally.
Bryder correctly notes that treating CIS by cone biopsy was not in itself without harm. This is a point worth making and in the advocacy of cervical screening it has sometimes been ignored. Cartwright notes the risk of haemorrhage from repeat cone biopsies and Bryder notes the potential for haemorrhage and effects on fertility, but gives no direct evidence. In fact there is direct evidence in a paper by Grace and Pattison on outcomes after cone biopsy at National Women’s from 1970 to 1981, where secondary haemorrhage was recorded in 8.7 percent of cases.28 In terms of potential adverse effects on fertility, it is worth noting that the vast majority of women diagnosed from 1965 to 74 had already had children,25 so these would have been less of a concern than today. But there were potential harms of cone biopsy and Bryder suggests that women under Green’s care were avoiding these. This was not the case; most women in Green’s study were subjected to repeated biopsies to check for invasive cancer. The biopsies were intended to leave some of the abnormal area so that the disease process could continue to be observed. The consequence of this approach was that many women had more biopsies than if they had had conventional treatment. The Report states: ‘A review of the patients’ notes demonstrates that many women with continuing positive cytology have had more than one cone or ring biopsy and in some cases up to six…’ And ‘[i]n some patients the practice of multiple cone biopsies or conizations resulted in unpleasant and painful side effects.’
This means the women suffered in two ways from having conventional treatment withheld. They had multiple biopsies with the attendant repeat general anaesthetics and painful side effects. Many also developed invasive cancer; this required even more extensive surgery plus radiation, and put them at risk of death. No contrary evidence at all is provided by Bryder.
Medical Council findings
Bryder calls into question the Medical Council of New Zealand’s finding of disgraceful conduct with respect to Professor Denis Bonham,29 head of the Postgraduate School of Obstetrics and Gynaecology at National Women’s. She does this on the basis of three observations. First, she disputes the Council’s finding that Green’s 1966 proposal was dangerous, though the Council claimed its opinion was based on the standards of the 1960s. Bryder says about this: ‘They appeared to be unaware of the major international controversies that had raged in the 1960s’. But as we have seen, Bryder provides no evidence that there was any controversy (apart from Green’s controversial position) about whether to treat CIS in the 1960s. Secondly, she rejects the Council’s conclusion that colposcopy was in its infancy in New Zealand then and should not have been relied on as a safeguard. Byder says: ‘This ignored the facts that Dr Malcolm Coppleson’s 1968 book in which he advocated the use of colposcopy in the diagnosis of CIS had been highly commended by Oxford University’s professor….’. And that McIndoe had trained under Coppleson. So, she is claiming that Coppleson was an expert and McIndoe trained under him. Why then does she not tell us that Coppleson himself wrote, in a paper she quotes, that ‘there was no experienced colposcopist at the National Women’s Hospital who was able to take into account important features of the colposcopic image…’ .24 Coppleson also said that McIndoe had only briefly attended his colposcopic clinic in Sydney and was keenly aware of his own lack of expertise. Coppleson even said that he told the Inquiry that Green himself seemed unaware of how the new colposcopy could have assisted.24 On this evidence, Coppleson would have agreed with the Medical Council. Thirdly, she questions the Council’s conclusion that ‘[t]he belief that patients with positive smears could be followed without risk was unjustified’. She quotes Kolstad’s advocacy of conservative treatment and follow-up, again omitting to note that Kolstad was advocating follow-up after treatment by cone biopsy not without treatment.14 None of these criticisms provide any basis for rejecting the Medical Council findings.
A detailed examination of Bryder’s case shows both medical and scientific errors: (a) conflicting descriptions of the nature of Green’s research proposal; (b) illogical portrayal of the aim of Green’s study; (c) drawing conclusions about the safety of the study from Green’s published papers when the true outcomes were not presented in these papers; (d) accepting that Green removed cases from his study but not recognizing the implications for scientific integrity; (e) incorrect descriptions of independent publications showing results of Green’s study; and (f) incorrect reasons given for rejecting the findings of the Medical Council of New Zealand.
This mis-portrayal of the medical context should be of serious concern to the profession in New Zealand. The medical profession aspires to put patients first, to serve their needs and to preserve their agency. It also aspires to high standards of scientific conduct. Research such as Green’s which questions received wisdom should be welcomed, but only if it is scientifically sound and safe for patients. If this distorted story of blameless doctors, grateful patients, and normal scientific conduct is accepted it will set back the profession’s difficult task of acknowledging and trying to learn from error.
Acknowledgements: This paper is a reduced version of a chapter ‘Medicine in context: A response to Linda Bryder’s arguments’, The Cartwright Papers, Bridget Williams Books, 2009.
1. Bryder L. A history of the unfortunate experiment at National Women’s Hospital. Auckland: Auckland University Press, 2009.
2. Cartwright SR. The report of the Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at National Women’s Hospital and into other Related Matters. Auckland: Government Printing Office, 1988.
3. Baird MAH. A history of the ‘Unfortunate Experiment at National Women’s Hospital, NZMedJ 2009 (9 October); 122: 1 of 1 URL: HYPERLINK “http://www.nzma.org.nz/journal/122-1304/3847/” http://www.nzma.org.nz/journal/122-1304/3847/
4. Paul C. The New Zealand cervical cancer study: Could it happen again? BMJ 1988;297:533-9.
5. Paul C, Holloway L. No new evidence on the cervical cancer study. NZMedJ 1990;103:581-3.
6. Paul C. ‘Internal and external morality of medicine: Lessons from New Zealand’, BMJ 2000;320:499-503.
7. Green GH. Invasive potential of cervical carcinoma in situ. Int J Gynaecol Obstet 1969;7:157-71.
8. Green GH. The progression of pre-invasive lesions of the cervix to invasion. NZMedJ 1974;80:279-87.
9. McIndoe WA, McLean MR, Jones RW, Mullins PR. The invasive potential of carcinoma in situ of the cervix. Obstet Gynaecol 1984;64:451-8.
10. Manning J (editor). The Cartwright Papers, Wellington: Bridget Williams Books, 2009.
11. Graham JB, Sotto LSH, Paloucek FP. Carcinoma of the cervix. Philadelphia: WB Saunders Company, 1962. pp95-7.
12. Coppleson M, Reid B, Pixley E. Preclinical carcinoma of the cervix uteri. Oxford: Pergamon Press, 1967 pp190-9.
13. Coppleson M [ed] Gynaecologic Oncology. Fundamental Principles and Clinical Practice Vol 1 New York: Churchill Livingstone, 1981. pp416-29.
14. Kolstad P. Diagnosis and management of precancerous lesions of the cervix uteri. Int J Gynaecol Obstet 1970;8:551-60.
15. Jeffcoate N. Principles of Gynaecology 4th edition. London: Butterworths, 1975, p492.
16. Petersen O. Precancerous changes of cervical epithelium in relation to manifest cervical carcinoma; clinical and histological aspects. Acta Radiol 1955 suppl 127:1-168.
17. Richart RM, Barron BA. A follow-up study of patients with cervical dysphasia. Am J Obstet Gynecol 1969;105:386-92.
18. Green GH. Cervical carcinoma in situ: an atypical view point. Aust NZ J Obstet Gynaecol 1970;10:41-8.
19. Kolstad P, Klem V. Long-term follow up of 1121 cases of carcinoma in situ. Obstet Gynecol 1976;48:125-9.
20. Soutter WP, Sasieni P, Panoskaltsis T. Long-term risk of invasive cervical cancer after treatment of squamous cervical intraepithelial neoplasia. Int J Cancer 2006;118:2048-55.
21. Bryder L Unfortunate Criticism. New Zealand Listener Sept 12, 2009: pp34-5.
22. Cochrane AL, Holland WW. Validation of screening procedures. Br Med Bulletin 1971;27:3-8.
23. Green GH, Donovan JW. The natural history of cervical carcinoma in situ. J Obstet Gynaecol Br Commonw 1970;77:1-9.
24. Gerber P, Coppleson M. Clinical research after Auckland. Med J Aust 1989;150:230-3.
25. McCredie MRE, Sharples KJ, Paul C, Baranyai J, Medley G, Jones RW, Skegg DCG. Natural history of the cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: a retrospective cohort study. Lancet Oncol 2008;9:425-34.
26. Paterson R. Inquiries into health care: learning or lynching? NZMedJ 2008;121. HYPERLINK “http://nzma.org.nz/journal/121-1286/3376/” http://nzma.org.nz/journal/121-1286/3376/
27. Bryder L. Research into the Cartwright Inquiry. NZMedJ 2009;122 HYPERLINK “http://nzma.org.nz/journal/122-1288/3444/” http://nzma.org.nz/journal/122-1288/3444/
28. Grace HF, Pattison NS. Cone biopsy of the cervix: Does surgical technique influence cytological follow-up? Aus NZ J Obstet Gynaecol 1987;27:216-9.
29. Medicolegal. Medical Council charges Professor Bonham. NZMedJ 1990;103:548-9.
PHILLIDA BUNKLE’S LETTER TO THE NEW ZEALAND MEDICAL JOURNAL
The controversy stimulated a vigorous correspondence in the New Zealand Medical Journal. In the document below Phillida Bunkle points out that the Cartwright Report was not based on the 1984 McIndoe article but on the evidence contained in the patients case notes. She argues that Professor Bryder’s lack of familiarity with these key sources leads her to seriously misinterpret the evidence from experts and testimony from patients
August 10th 2010
New Zealand Medical Journal,
I hope that my delayed entry into the public controversy concerning the Cartwright Inquiry may help clarify some of the many points raised in the July 30th issue of the New Zealand Medical Journal.
1.0 The nature and role of the ‘1984 paper’.
A number of assumptions and assertions concerning this paper and its role demand elucidation.
1.1 A retrospective study
Professor Linda Bryder stated in her book and at a seminar at the University of London on 16th June 2010 that Sandra Coney has ‘admitted’ that the authors of the 1987 original Metro articlei, Sandra Coney and I, had not understood the retrospective nature of the 1984 analysis.ii
This is a misrepresentation. Coney explained that, on first reading the 1984 paper in 1985, it was not clear who was responsible for the clinical management of the patients whose cases were reported there. However, her book went on to describe how, having undertaken extensive research, including interviewing all the authors of that paper, and having seen the internal hospital memoranda concerned, we were quite clear, well before writing the Metro article in 1987, that it was a retrospective analysis. Coney was describing our research process not making an ‘admission’ of error.iii
1.2 The validity of the Cartwright Findings is independent of the 1984 paper.
It has been asserted by both Professor Bryderiv and Helen Overtonv that the Cartwright Inquiry made the same alleged error. Close reading of the Cartwright Report shows that this is incorrect.
The 1984 paper was not central to the Inquiry process or its findings. The Inquiry had access to thousands of original clinical case notes of women treated at National Women’s Hospital during the relevant period. These case histories provided the critical evidential base of the Inquiry and showed a most significant gap between what various Parties said, especially Dr. Green, and what had actually been performed on patients.
2.0 The important role of the patient case notes
Parties to the Inquiry had full access to this case evidence on condition of preserving the anonymity of individual patients. These cases were the subject of intensive cross examination of expert witnesses. Case material also provided much of the content presented in the three submissions by Phillida Bunkle, Sandra Coney and Dr. Forbes Williamsvi as well of many other Parties.
I believe it was because this case evidence was so compelling that none of the Parties appealed the Inquiry findings.
Unfortunately, researchers who were not involved in the judicial process do not have access to this crucial evidence. This places severe limitations on attempts to reassess the evidential base of the Inquiry.
Professor Bryder seeks to overcome these limitations, by (i) reference to the 2 case histories published in the appendix to the Cartwright Reportvii, (ii) analysis of the crucial cross examination of international expert witnesses about these cases, and (iii) use of evidence from patients either in letters or presented to the Inquiryviii.
In the absence of access to the case notes this procedure is, however, weak. The Inquiry identified 131 cases similar to the two contained in the Appendices and it is only by considering the detailed facts of those notes that the crucial issue of treatment of curative intent can be illuminated. Moreover, it is difficult to decipher the import of the cross examination without access to the clinical records the witnesses referred to.
Finally many of the letters from women were solicited by counsel for Dr. Green, Professor Bonham and the University of Auckland. They were often from women who did not yet know what had happened to them; most were not subject to cross examination and, hence, rate as inferior to evidence based on case histories or expert testimony that was subject to cross-examination by Parties of all persuasions.
Professor Bryder also quotes from the cross examination of two patients who gave evidence publicly. For example, she quotes from one woman who was very satisfied with her treatment and appreciative of Dr Green’s careix. This case, however, demonstrates the difficulties of evaluating such evidence without access to the patient’s case notes. What the judge, counsel and Parties were aware of, but the patient and Professor Bryder were not, is that the patient had been repeatedly observed as a research subject without treatment for many years while CIS spread throughout her vagina. Rather than support the view that Dr. Green provided excellent care, this patient’s statements demonstrated how uninformed she was and how seriously her trust in National Women’s Hospital was misplaced.
3.0 The significance of the Cartwright Inquiry as a judicial inquiry.
It is important to clarify that the Cartwright inquiry was a judicial inquiry with status, process and rules of evidence equivalent to those of the High Court. It examined the second-hand evidence of the 1984 paper but only accepted its findings in so far as they were corroborated by its own evidence base as interrogated by international experts.
The appropriate appeal of findings of such an inquiry is via an application to the High Court for a Judicial Review by participating Parties. Presumably, had counsel for aggrieved Parties judged that there had been weaknesses in the evidence or the process of its evaluation, they would have recommended an appeal. None did so.
An attempted application for Judicial Review by a member of the public friendly with Dr. Green was struck out, in part on the grounds that the applicant had no standing with the Inquiry, was not familiar with the issues, and because it was considered that it was wrong for an unconnected person to launch an appeal when the Parties themselves had not chosen to do sox.
3.1 Evidence in a judicial process
It is important to understand that the Inquiry independently examined this body of original evidence. The team of medical advisors , which consisted in Professor Eric McKay, a gynaecologist from Australia, Dr., later Professor Dame Linda Holloway, a pathologist, and Dr., later Professor, Charlotte Paul an epidemiologist.
The team of medical advisors were officers of the inquiry not witnesses. They did not give evidence. They advised the judge.
It also follows from the judicial status of the Inquiry that when its findings are contested in the media the judge cannot defend herself. (Imagine the consequences if every court decision was publicly contested by the judge.) It has, therefore, been appropriate that members of the medical advisory team, Professors Holloway and Paul , who are familiar with the evidence, have played a role explaining the findings of the Inquiry.
4.0 Definitions of ‘conventional treatment’
Professor Sir Iain Chalmers criticises Professor Paul for not providing the Inquiry with a definition of ‘conventional treatment’xi. It is not the role of the medical advisory team to give evidence; they are not witnesses and are not cross examined. A judge relies on the advice of experts who can be cross-examined. These expert witnesses are responsible for reviewing the published evidence (of much of which they were the authors) in giving their opinions. The judge noted that the experts’ advice was ‘derived from an examination of medical literature, a review of research projects and personal experience in practice’.xiiCounsel representing Parties of all interests participated in cross examining these experts.
The judge concluded that: ‘the appropriate treatment of CIS, if invasive cancer is to be avoided, is to remove the lesion. The patient must then be monitored so that further treatment can be offered if there is persisting disease or a recurrence…’.xiii
The judge also found that: ‘All overseas authorities were agreed that since the mid-1950’s the aim in treating a patient with a diagnosed cancer precursor, including CIS, has been to eradicate the disease. The method of treatment has always depended on the available skills and equipment, but the aim remains unchanged…..’ xiv
The definition of ‘treatment’ is eradication of the lesion rather than a protocol of specific interventions. None of the experts thought, however, that diagnostic wedge or punch biopsies were ‘treatment’ even though such biopsies very occasionally have the effect of eradicating lesions. ‘Treatment’, thus, implies curative intent not just a particular procedure.xv A series of propositions flows logically from this definition.
Whatever eradication procedure was used, whether the more usual cone biopsies or the less common hysterectomy or other forms of excision, follow-up was necessary to ensure complete eradication, with more extensive removal if abnormal cells continued to be detected.
Those patients who continued to have positive smears, sometimes for years, without attempts to remove the abnormality can be considered to have been inadequately treated.
Procedures that were not directed at removing abnormal tissue were not ‘treatments of curative intent’.
‘Treatments of curative intent’ can be distinguished from those procedures which are not, according to whether their purpose was to remove abnormal tissue or not.
Counting the number of surgical procedures each patient eventually had does not show that no women with CIS was untreatedxvi. In some cases, intention changed. Long periods of interventions with no curative intent, were followed by drastic procedures to eradicate malignancy.xvii
Case notes and the original research proposalxviii and his many publications showed that Dr. Green, was following some women who had had only diagnostic biopsies. For instance, in 1970, he described following ’75 patients with untreated or incompletely treated CIS’xix.
Further, these were not the only form of non- or inadequate treatment; patients with cervical micro-invasion, vaginal and or vulval CIS, and other abnormalities of the genital tract were also involvedxx. Professor Joe Jordan, an expert witness, for example, noted that there was ‘another group where a definitive diagnosis of microinvasive carcinoma was made and ignored’.xxi The judge subsequently found evidence of ‘cases where mircoinvasive carcinoma has not been treated with even the least radical procedure’.xxii
Finally the definition of treatment identifies that for many women their CIS was not treated. It is true that they may eventually have had extensive surgical procedures, after diagnoses of microinvasive or invasive cancer had developed. But even then there were frequently delays of years.
Thus, it is not the case, as Professor Bryder claims, that there is no evidence of non-treatment or that it is impossible to distinguish groups which differ by treatment.
5.0 The support of Professor A. Cochrane
Professor Chalmers is concerned that there is inadequate recognition of Professor Cochrane’s support for randomised trials to settle the issues involved.xxiii
The Inquiry found evidence that such trials were considered unethical even at the time. Evidence to the Inquiry showed that Dr. Green cited Professor Cochrane’s support in his internal memorandum of 1973 justifying his researchxxiv. In his own evidence to the Inquiry, Dr. Green also testified, in two places, that Professor Cochrane supported the ethics of his researchxxv. He neglected to say, however, that when he and Professor Cochrane had applied to the Medical Research Council in the UK for support for a randomisation of Green’s practice, it was rejected as unethical. Under cross examination Dr. Green eventually conceded that he was aware of thisxxvi.
The judge concluded that ‘This is one occasion when I cannot accept that there was an oversight or memory loss on Dr. Green’s part’xxvii. The judge also concluded that the issue should have been followed up by the hospital since the MRC’s refusal would have prompted them to reconsider the ethical legitimacy of Dr. Green’s activities because ‘the validity of the 1966 trial would have appeared far more questionable’xxviii.
6.0 The construction of Professor Bryder’s evidence
Professor Chalmers concludes his article by citing, with approval, the conclusion of Professor Bryder’s third chapter. This passage reads:
‘What then was the conventional treatment’ that the patients at National Women’s were apparently denied by Herb Green? According to Cartwright it was not hysterectomy which had already been rejected throughout the world as a routine response to CIS in favour of cone biopsy or local excision by the 1960’s. Yet many gynaecologists still believed that hysterectomy was the appropriate response to the problem, including star witness to the Inquiry Ralph Richart. A significant minority of gynaecologists was questioning the appropriateness of hysterectomy and cone biopsy, both of which were far from benign procedures. Kolstad might have queried Green’s clinical decisions, but he was the first to admit that there were no clear cut answers. Jordan might also have been critical of Green’s approach, but he did acknowledge the ‘dilemmas’ in deciding appropriate treatment for asymptomatic women when the treatment options themselves carried a ‘high morbidity’. Jeffcoate recommended cone biopsy only when smears repeatedly continued indicative of malignancy’xxix.
It is quite understandable that without access to the case history evidence Professor Chalmers could accept this summary at face value especially as he is not familiar with the archival record. However, this passage encapsulates a number of problems with Professor Bryder’s study. Professor Jordan, for example, is quite clear. He said of some of the patients whose clinical notes he reviewed ‘the patients, in fact, were not treated. I think that’s the point, not even inadequately. They weren’t treated’xxx.
One of the most serious concerns is that Professor Bryder sometimes misconstructs critical passages. For example, she uses the quotation concerning Jordan’s ‘dilemma’ five times to suggest that other clinicians sympathized with Dr. Green’s positionxxxi. In fact, Jordan made two references to clinical dilemmas during his cross examination concerning the terrible fate of women whose CIS had been merely observed while it spread throughout the vagina and in some cases other areas of the genital trackxxxii. These women had the highest mortality. By the time of the Inquiry, 7 of the women who developed vaginal invasion had died of the disease.xxxiii At least 15 of the 19 women identified as having CIS of the vagina, had a previous history of cervical abnormalities. 13 of these 19 developed invasionxxxiv and it was the difficulty in treating these women that posed the dilemma to which Jordan referredxxxv.
The ‘dilemma’ Jordan referred to in the passage quoted by Professor Bryder, was a discussion about the decision to be made about patient 60/64 in 1981. The decision was difficult because treatment at this late stage entailed the excision of the vagina and possibly other genital organs with a very high risk of damage to bladder and colonxxxvi.
The sentence in Jordan’s statement which occurs immediately before that quoted by Professor Bryderxxxvii, but which she omits, could not be more explicit. He said, ‘I think that some definitive treatment to the vaginal vault lesion should have been instituted in the early 1960’s, and at the latest in October 1965, when the vaginal vault biopsy confirmed the presence of severe dysplasia.’xxxviii The full text of Jordan’s evidence to the Inquiry, thus, makes clear his view, that the ‘dilemma’ was created by the more than twenty years of prevarication about diagnosis and delays in treatment. Jordan was extensively cross examined concerning these cases and he is quite clear that the predicament was created by non treatment and delay.xxxix This is forthright professional criticism not sympathy, as Professor Bryder would have us believe.
In conclusion, I would like to emphasise that in contributing to this discussion I do not want to leave the impression that I consider any reconsideration of the Cartwright Report to be undesirable. On the contrary, we should always be prepared to objectively reassess its conclusions and recommendations in the light of new knowledge. An objective reassessment would be of far more value to New Zealand women than the current dispute.
PHILLIDA BUNKLE RESPONDS IN THE WOMEN’S STUDIES JOURNAL 2010
Phillida Bunkle’s paper ‘Patient-centred ethics, the Cartwright inquiry and feminism: indentifying the central fallacy in Linda Bryder, A history of the ‘Unfortunate Experiment’ at National Women’s Hospital (2009, 2010)’ was published in the Women’s Studies Journal, (vol. 2, Nov 2010: 8-24). It is a contribution to the history of the Cartwright Inquiry and the reforms which followed. The paper seeks to explore the origins of the patient-centred ethic that formed the basis of those reforms, and to locate that in the feminist vision shared by Sandra Coney and Phillida Bunkle.
She argues that the focus of Bunkle and Coney’s work was a vision of patient-centred ethics which was derived from the women’s rights perspective which had informed their work in the Women’s Health Movement. Bunkle argues that as feminists these authors placed the experiences of the patients at the centre of their work. The case histories of the women provided the foundation of their analysis and of their prescriptions for change, in particular their advocacy for a broad human rights approach to patient’s rights.
Bunkle argues that Professor Bryder has been mislead into believing the claim that the 1984 McIndoe et al. paper provided the foundation evidence on which the inquiry was based. Whereas, the critical evidence was the examination of the case notes and testimony of the women themselves. It was Bunkle argues, the placing of patient evidence and testimony at the centre of Cartwright’s assessment which was the key innovation in the Cartwright Report; it led directly to Cartwright’s assertion that the health system should be run primarily for the benefit of patients.
The women’s case histories formed the core evidence on which the Cartwright Report was based. Bunkle argues that Professor Linda Bryder’s limited access to and use of this material leads to her to marginalise the experience or patients and misrepresent the inquiry process.
This marginalisation of the women’s voice, Bunkle argues, arises in part from Professor Bryder’s antipathy to feminism and leads her to misunderstand the meaning of her sources.
Phillida Bunkle, ‘Patient-centred ethics, the Cartwright inquiry and feminism: indentifying the central fallacy in Linda Bryder, A history of the ‘Unfortunate experiment at national Women’s Hospital (2009, 2010)’
Women’s Studies Journal, volume 2, November 2010: 8-24.
Key words: feminism; Unfortunate Experiment; patient-centred ethics; Professor Linda Bryder
The Cartwright Report was published by the New Zealand government in 1988. It presented the findings and recommendations of a judicial inquiry into allegations that women with cervical carcinoma in situ had been untreated or under-treated in the course of medical research at national Women’s Hospital. The allegations arose in an article called ‘An Unfortunate Experiment at National Women’s Hospital’ authored by Phillida Bunkle and Sandra Coney. The recommendations included through reform of medical and research ethics. These popular reforms are usually regarded as feminist achievements and significant ethical millstones.
A book by Professor Linda Bryder published internationally in 2009 and 2010 questions the reality of the ‘experiment’, the findings of the Cartwright inquiry and argues that the recommendations made little contribution to changes already underway within medicine.
This article draws on the records of the inquiry, particularly the case histories of the women involved to refute Linda Bryder’s arguments.
Patient centred ethics, the Cartwright Inquiry and feminism:
Identifying the central fallacy in Linda Bryder, A History of the ‘Unfortunate Experiment at National Women’s Hospital (2009, 2010)
This article calls upon my personal recollections and documentary evidence to argue that Professor Linda Bryder’s anti-feminist bias means that her book A History of the ‘Unfortunate Experiment at National Women’s Hospital (2009, 2010)’, is built upon a series of errors and so misrepresents the history of the Unfortunate Experiment.
Academic discussion of this book has presented the key issues as an intra-medical debate (Manning ,2009 )between those who believe like Bryder that Green purveyed standard treatment and those who regarded Green as an incompetent doctor who had to be exposed. Concluding this debate in this way reinforces the idea that medical reform concerns the internal morality of the medical profession rather than external accountability of the medical system to patients (Paul, 2000). Such a perspective has minimised the feminist voice and obscured the extent to which the Inquiry and subsequent reforms grew from the analysis developed by the Women’s Health Movement which was focused on systematically safeguarding physical safety premised upon respect for the ethical autonomy of patients.
Bryder suggests that Cartwright’s recommendations came about from the personal influence of Sandra Coney and myself upon the judge, sometimes implying a semi clandestine connection (Bryder 2009, 2010; 2010, June). In fact the only time I meet the judge was at a function one year after the Report was published, and do not recall ever speaking to her except within the formal legal constraints of the Inquiry room.
Patient experiences and case notes provided much of the evidence which premised the original Metro article written by Sandra Coney and I, and the three submissions to the Cartwright Inquiry, from Fertility Action, written by Sandra Coney, Dr. Forbes Williams and myself. An analysis of case histories by the Inquiry’s medical advisors was fundamental to the evidence upon which the Judge made her findings, reached her conclusions, and based her recommendations.
Our process and that of the Inquiry put the experiences of the women patients first. Sandra and I built our case upon a patient-centred vision of medical ethics which arose directly from our experience in developing the Women’s Health Movement in New Zealand. The recommendations of the Inquiry embodied a patient-centred perspective; a singular achievement for feminism.
Bryder, by contrast, marginalizes the experience of women patients and fails to examine the evidence presented in their case histories. The reality described in these case notes contradicts the claims made by Associate Professor Green and his colleagues at the Auckland University Post Graduate School of Obstetrics and Gynaecology. In summary Green claimed that from the early 1960’s and particularly in their ‘special series’ formally instituted in 1966, the hospital was providing conservative treatment of in situ carcinoma of the cervix (CIS) in the interests of saving women from more invasive treatment. Bryder’s bias means that she invariably takes Green’s part in this conflict.
The publication of Professor Linda Bryder’s book A History of the ‘Unfortunate Experiment at National Women’s Hospital (2009, 2010) both in New Zealand and internationally has prompted a reconsideration of both the events around the Unfortunate Experiment and the changes which followed from it, in which I was intimately involved.
In 1987, in an article entitled ‘An Unfortunate Experiment at National Women’s Hospital’, Sandra Coney and I presented evidence that for many years some women presenting with (CIS) at National Women’s Hospital (NWH) had not been treated or had been under-treated. We showed that Associate Professor Herbert Green and his colleagues at the Auckland University Post Graduate School of Obstetrics and Gynaecology had systematically followed this course so that Green could test his theory that CIS was a harmless condition. We reported that a significant number of these women had gone on to develop invasive cancer of the cervix and some had died (Bunkle & Coney, 1987). We provided evidence that in 1966 this regime had been formalised into a prospective research programme, which had never been formally ended. Even when, in the early 1970’s, deaths occurred and the dangers had become apparent, the institution, including its Board, senior clinicians and particularly its head, Professor Bonham, did not act to save the remaining patients, and marginalised critics of the programme within the hospital.
Sandra and I had since 1970’s been women’s rights activists and had increasingly focused on women’s health. We worked together on a variety of issues concerned with documenting and giving credence to women’s experiences in the health system. We were alerted to the issue at NWH in 1986 when a retrospective study of the results of the research was drawn to our attention by a colleague. This study, by McIndoe, McLean, Jones and Mullins (McIndoe, McLean, Jones, & Mullins, 1984) reviewed the case notes of women diagnosed with CIS at the hospital between 1955-1976. Most were treated at the hospital ‘CC’ or Consultation Clinic under Green. Results were presented by arranging the cases into two contrasting groups performed retrospectively by McIndoe and his co-authors to assist analysis of the results. The largest group of 817 women had returned to negative (normal) cytological cervical smears following biopsy diagnosis and differing degrees of treatment. If, as is usual, a return to normal smears is the measure of successful treatment these women had been successfully treated. Of this group, 1.5% developed invasive cancer. The contrasting, smaller group of 131 women, continued to have positive smears. Their outcome was starkly different. 22% of these women had developed invasive cancer by 1983.1
Our article was based around the experiences and case notes of one of Green’s patients Clare Matheson (known at the time as patient Ruth) and extensive, mostly tape recorded interviews with doctors and other professionals associated with Auckland University and NWH (Bunkle & Coney, 1987).
The allegations in the Unfortunate Experiment article were examined in a Judicial Inquiry chaired by Judge (later Dame) Silvia Cartwright. Sandra Coney and I, with the help of Dr. Forbes Williams and our Counsel Rodney Harrison, made three submissions of evidence to this Inquiry. The first (Bunkle, Coney, & Williams, 1987b) provided substantiation of our claims and an analysis of a large number of women’s case histories. These showed that Clare’s experience was shared by many other patients. The second submission (Bunkle, Coney, & Williams, 1987a) argued that the problems were systemic and advocated innovative changes to the regulation of medicine; and the third summarised these arguments, put forward draft legislation for change and provided evidence concerning 26 deaths which had resulted from the regime (Harrison, 1987).
Judge Cartwright’s Report of the Inquiry, presented to government in July, and made public on 8th August 1988, found that the allegations we had made were largely correct. She made a series of recommendations for comprehensive change in medical ethics which would place the patient and his/her interests at the centre of the medical system (Cartwright, 1988). These changes included the scrutiny of patients’ complaints by a Health Commissioner external to the medical professions, a legislated Code of Patients’ rights, the establishment of independent ethics committees with half lay membership including a lay chair, and a population based national cervical screening programme free to users. These changes were a decisive move towards patient centred medicine and are usually regarded as milestones in the recognition and protection of patients’ rights and medical ethics.
In 1990, journalist Jan Corbett (1990b) made a series of unfounded allegations of bias and misrepresentation in our article and subsequently by the Inquiry. Corbett alleged that we had misunderstood the nature of the 1984 retrospective study. She further asserted that we had based our claim that there had been an experiment on the mistaken belief that it was Green and his colleagues who had established two groups of patients. Furthermore, she argued that we had, as feminists, recruited Judge Cartwright to our point of view and the judge had colluded by ignoring, or failing to hear, contrary evidence.
The appropriate arena for these allegations would have been a judicial review of the inquiry by one of the parties to the proceedings. An unsuccessful attempt to bring a judicial review was made by Mrs. Smith, a neighbour of Green’s, and, Dr. Bruce Farris (Bryder, 2009, p.158) who, Bryder neglects to mention had been charged with professional misconduct over his contribution to events as a senior hospital board manager and member of the internal committee which had failed to stop the experiment. Bryder claims that the application for review was withdrawn and reiterates Corbett’s view (Corbett, 1990a) that the outcome endorsed the view that we and the Inquiry had misunderstood the structure and significance of the 1984 McIndoe paper (Bryder, 2009, p.158). She claims that the Solicitor–General found that we were wrong (Bryder, 2009, p.160).
Bryder’s account accepts as accurate secondary sources from newspaper and magazine accounts derived from highly partisan views (Smith, 1990; Auckland Star August 1 and 8 1990) without checking their veracity against the primary documents (Bryder, 2009, p. 160). There are, as a result, multiple errors in her account.
She misunderstands the role of the Solicitor-General. New Zealand has an independent judiciary. The Solicitor –General is an officer of government, who acts on instruction from Cabinet. Applications for a judicial review are heard before a judge of the High Court.
In the High Court hearing, the Solicitor-General acted on behalf of The Attorney-General in arguing that the application from Smith be dismissed (Coney, 1993, p. 43). The Solicitor-General, as his document ‘Application to Strike Out’ makes clear (McGrath & Scholtens, 1990), was arguing for dismissal against Smith’s application. The application was ‘struck out’ and ‘dismissed’ by a judge of the High Court, not by the Solicitor-General.
The views Bryder quotes as part of the judgement were in fact part of the presentation by the Solicitor-General while arguing for the strike out.
Bryder writes that the Solicitor–General ‘while agreeing that Coney, Bunkle and Cartwright had misinterpreted the McIndoe paper, explained that he was disallowing it because of…’ other reasons (Bryder, 2009, p. 158). Bryder continues, ‘At least, Mrs. Smith observed, the Solicitor-General did acknowledge that the McIndoe paper, which was central to the Inquiry, did not describe a prospective division of patients into two differently treated groups, as the original Metro article had claimed’ (2009, p. 158). This claim was made by Mrs. Smith not the Solicitor-General
Bryder does not mention that Mrs. Smith acknowledged through her counsel that she had misunderstood Judge Cartwright’s findings about the McIndoe study. Mrs. Smith, in fact consented to her application being struck out, ‘agreeing the grounds on which she had sought the review had no substance’ (Coney, 1993, p. 15).Bryder’s assertion that the Inquiry findings turned on this paper is wrong, as is the assertion that Sandra and I had misinterpreted it in our original article. A check of primary documents would have shown how unreliable Bryder’s sources were.
Yet to those resistant to the findings of the Inquiry, the High Court’s dismissal of the application became further evidence of bias in the judiciary (Bryder, 2009, p. 160)
Professor Linda Bryder’s Revisionist History
Corbett’s challenges in 1990 slowed but did not stop the progress of reform of patients’ rights. In 1994, New Zealand became the only jurisdiction with a legislated Code of Patients Rights and an independent external enforcement system in the Office of the Health and Disability Commissioner (as legislated in the Health and Disability Commissioner Act, 1994). A system of ethics committees with half lay membership was established, which included supervision of clinical observational studies. A successful population based cervical screening programme based on cytological smears began (Skegg, 2009).
Bryder’s argument sometimes relies on Corbett’s evidence, rather than on primary sources. For example, Bryder makes a series of errors in recounting Clare Matheson’s experiences (2009, pp 63-65). These errors could have been avoided if she had used Clare’s own published accounts (Coney, 2009b, p.146; Matheson, 1989, 2010).
The Cartwright Report accepted the international experts’ agreed definition of conventional treatment for CIS or invasive cancer as the removal of the abnormal cells, followed up to ensure that eradication has been complete (Cartwright, 1988 pp. 106, 107). If cytological smears remain positive on follow up it shows that abnormal cells are still present. Further action will then be triggered to identify and remove those cells and ensure a return to negative, that is normal smears.
Bryder argues that the women were being appropriately followed because they had a great many treatments. Bryder uses the word ‘treatment’ ambiguously. The patients had many clinical procedures, but contrary to accepted international practice many of these procedures, which Bryder classes as ‘treatments’ were not intended to remove, but only to observe the development of abnormalities. This has recently been reconfirmed in an empirical study based on an independent blind examination of the original cytological specimens which found that ‘women underwent numerous interventions that were aimed to observe rather than treat their condition’ (McCredie et al., 2010, p.107). One of Green’s ‘special series’ made explicit that his punch biopsies were intended to disturb lesions as little as possible.
In summary the propositions of Bryder’s argument are:
- Medical literature shows that debate about the nature and invasive potential of CIS was legitimate in the 1960’s and has remained so.
- Green’s ‘conservative treatment’ was the similar to that of leading experts around the world, particularly Joe Jordan of Birmingham, Per Kolstad of Norway, and Malcolm Coppleson of Sydney.
- Green’s conservative management regime was motivated by a legitimate intention to, and actually did, save women from unnecessarily invasive treatment, especially surgery.
- Green’s management was not about studying the disease but closely monitoring patients individually and treating them as appropriate. This was international best practice at the time; and shows that patients were neither under treated nor denied treatment.
- Since he was providing best practice and did not divide patients into groups, distinguished by different treatment regimes, Green was not conducting an experiment.
- Since there was no experiment the issue of non-consent to research does not arise. Green provided information to patients which was in line and possibly better than with normal medical treatment at the time, and the information provided in fact satisfied many patients.
- Green’s view of CIS as rarely if ever invasive was reasonable, as therefore was his and his colleague’s resistance to a population cervical cytology screening programme.
- Judge Cartwright accepted Bunkle and Coney’s erroneous analysis, particularly she believed that Green had established two contrasting treatment groups, and wrongly based her assertion that there had been an unethical experiment on this error.
- Judge Cartwright demonstrated bias in failing to acknowledge that many patients were very satisfied with their treatment by Green and felt sufficiently informed.
- Judge Cartwright got it wrong because she was unduly influenced by Sandra Coney’s personal feminist agenda.
- The outcome was not a milestone in medical ethics, but based on erroneous conclusions occasioned by bias.
- Feminists were powerful enough to sway the Judge and bias the Inquiry but they were not powerful enough to effect medical reform, which already had significant momentum.
- The association between feminism and major ethical reform of medicine and human research is not therefore valid.
Each of these propositions has been subject to criticism in a thorough rebuttal (Manning, 2009) and publicly refuted by some of the senior doctors most centrally involved, particularly Professor, now Sir, David Skegg (2009), Dr. (now Dame) Linda Holloway, Dr. (now Professor) Charlotte Paul (2009a, 2009b) and Dr (now Professor) Ronald Jones (Jones, 2009a, 2009b, 2009c).
Propositions 1-4 provide the foundation of Bryder’s argument. If any one cannot be sustained in the face of available evidence then her thesis stands refuted. Together these propositions seek to argue that Green ‘was part of an international community of medical researchers who were questioning the significance and status of a diagnosis of CIS’ (Bryder, 2009, p.31). In a detailed critique of the errors in this claim, Paul (2009b) includes documentation of Green’s ‘scientific misconduct’ (p.129) in a post facto reclassification of his research subjects.
The centrality of patient case notes
Judge Cartwright did not base her judgements on a belief that Green had divided patients into clinically contrasted management groups. The Inquiry heard evidence from 84 patients and their relatives (Cartwright, 1988, p. 115). Most importantly the Inquiry went back to the original sources and carefully studied thousands of case notes. These were stored in a large walk-in safe at the inquiry and parties to the Inquiry, such as Sandra and I, had access to them on condition of anonymization of cases used in evidence. The Inquiry’s team of medical advisors prepared a thorough Medical Review based on analysis of cases. The results are available in the Cartwright Report (pp. 228-238).
Judge Cartwright weighed Green’s words against the evidence contained in patient accounts and medical case histories that showed what he was actually doing. She found that often a gulf existed between his claims and what actually was done for patients. By complete contrast, Bryder accepts Green’s words at face value. Bryder did not have access to the case notes on which the Inquiry findings were based. Unlike the Judge, she neither interviewed patients, nor made extensive use of the publicly available case notes. Crucially, without the information contained in the case notes, Bryder has little evidence against which to assess the reality or otherwise of Green’s practice.
The clinical notes showed a huge gap between what Green and his medical colleagues said they were doing and their actual practice, revealing not conservative management, but delays in definitive treatment of months, years, or altogether. Green, and Bryder, claimed that he was practicing ‘conservative management’ of CIS. At the time, this meant treatment by cone biopsy which conserved the uterus, followed up to ensure it had been effective in removing the entire lesion. Invasive cancer was treated at least by hysterectomy. In the notes, Sandra and I found that it was not uncommon for smear or even biopsy results classed as ‘suggestive’, ‘strongly suggestive’ or even ‘conclusive’ for malignancy not to be acted on. Some women were ‘followed’ for years as lesions grew more extensive and serious.
Indeed sometimes Green did not treat CIS at all, but only acted once the women had unequivocal invasive cervical or vaginal cancer. Even this was allowed to spread, sometimes for years, until it was grossly symptomatic and clearly visible on examination. At this stage, intervention was either terribly mutilating or impossible, giving the lie to Green’s claim to be saving women from invasive interventions.
As Counsel Assisting the Inquiry, Lowell (now Judge) Goddard said in her summing up, that expert witnesses were unanimous in their condemnation of the reality they found recorded there (Goddard, 1987, p.24)(Goddard, 1987a: 24). They were shocked to discover the extent of Green’s non-treatment and the length of delay in removing even the most serious lesions. According to those experts, Green failed to treat patients in a timely manner.
Bryder had access to the transcripts of the cross examination of international experts who consistently condemned Green’s lack of treatment. Bryder, nevertheless, suggests that when these experts gave evidence they were resiling from their former support for similar treatment. She explained the abhorrence these experts expressed about the treatment recorded in the case notes as in a hypocritical attempt to absolve themselves from a record of similar management (2009, pp. 191-192).
Bryder’s central premise is that Green’s treatment was not experimental but rather, international best practice. Bryder denies the Judge’s conclusion that by, 1966, there was a consensus on the treatment of CIS and that only Green was outside it. ‘There was’ she Bryder argues ‘no consensus about the invasive potential of carcinoma in situ, either in 1952 or in 1976’ (Bryder, 2009, p.28). (Bryder, 2009: 28),
Her argument depends heavily on her interpretation of the international expert witnesses to the Inquiry, especially Per Kolstad, Malcolm Coppleson, and Joe Jordan who were recognised world leaders in the field. The evidence about their work is, therefore, worth examining in some detail.
Professor Per Kolstad, was an expert from Norway, who in 1973, had visited NWH and reviewed six cases and attempted to persuade Green to treat them.
In his evidence Kolstad reviewed the complete notes of two of these six cases (Kolstad, 1987, p.20). Of the first case, (Case one 64/ 48), he said that in 1973 he had ‘advised Dr. Green and Dr. McIndoe that they should excise the complete lesion’ …’Dr Green did not agree with me and he wanted only to follow the patients without any treatment’. She had CIS ‘far down into the vagina’ for which Kolstad had recommended radiation. (p. 20). Despite this advice she was ‘followed’ for another 10 years, ‘the lesion was never treated and continued to shed malignant cells…’ and ‘this’ said Kolstad ‘is an example of mismanagement that should never have occurred’ (p. 21). Professor Kolstad told the inquiry that if ‘treatment had been given …in 1964, the patient would have been cured for extensive CIS lesion’ (p. 22).
A second patient (Case 2, 66w/74) who had been examined by Kolstad in 1973 had died in July 1976, after what Kolstad described as ‘severe mismanagement’ (1987, p. 23). The notes showed that she had been followed for 8 years without curative treatment with an abnormality on smear tests reported as’ suggestive’ or ‘conclusive’ of malignancy.
Kolstad examined other cases put to him by the Inquiry. Responding to the case of a woman who died after 18 years of inaction (Case 3, 69w/63) Professor Kolstad said, ‘I am horrified at the mismanagement of this patient’ (p. 24).
Of Case 4 (60w/64) a woman with CIS of the vagina which ‘was allowed to spread until it was impossible to achieve a permanent cure’ he expresses a sense of amazement that she was followed for 17 years: ‘The patient died …another example of mismanagement’ (p. 26). Had she been treated ‘at the time’ there was ‘a chance of complete cure’ (p. 26)
Commenting on our account and partial notes of Clare’s case where there had been no definitive treatment through 15 years of smears mostly ‘suggestive’ or ‘strongly suggestive of malignancy’ and repeated incomplete biopsies showing CIS or more seriously microinvasive cancer, Kolstad said ‘I am really horrified about the attitude of Dr. Green’ (p. 28) it is ‘another example of terrifying mismanagement of CIS in a relatively young patient’ (p. 29). He says of the decision by the medical disciplinary committee that it was her own fault for not asking for a smear after discharge from hospital ‘I have never experienced such a committee decision in my life….The fact that ‘Ruth’ was blamed for not asking for a smear, is unbelievable’ (p. 29).
In his evidence Kolstad was critical of the idea that Green’s regime was saving women from invasive interventions. Kolstad was concerned for those women who suffered from the terrible treatments made necessary by delayed intervention: ‘ it is not only a tragedy for those who have died from the disease, but also for those who have had to suffer from radical radiotherapy or radical surgery’(p. 32). Delayed treatment created the need for far more destructive interventions. In addition if pelvic lymph node metastases developed ‘it is’, he said, absolutely unbelievable how much they suffer….(p. 21). Most of this suffering could he believed have been avoided by early treatment.
It is hard to see how, when Bryder read this evidence about the case records, she could have continued to believe that Green was ‘monitoring’ or ‘following’ cases in order to treat them appropriately. Monitoring means taking action if there is no remission or if the condition continues or worsens. The case notes show conclusively that this was not occurring.
Unfamiliarity with the case histories examined in detail at the Inquiry leads to some of Bryder’s most serious errors. She, for example, claimed that when Professor Malcolm Coppleson from Sydney gave evidence critical of NWH (Coppleson, 1987) and later published his views (Gerber & Coppleson, 1989), he was protecting himself from criticism for similar treatment or had been influenced by what Bryder insinuates is bias by one of the Inquiry’s medical advisors, Dr. Charlotte Paul (Bryder, 2009, pp. 192-193). Coppleson’s purpose, Bryder argues, ‘appeared to be to absolve overseas specialists from any responsibility’ (p. 192). Having argued that Green’s practice conformed to international views Bryder can only explain that the experts gave contrary evidence to the Inquiry to distance themselves when it became clear the inquiry was going against Green.
Coppleson’s position had been the closest to that stated by Green. Like Green, in the 1960’s he was concerned that young women were being given hysterectomies on the evidence only of minor abnormal smears (Coppleson, 1987; Coppleson, Reid, & Pixley, 1967, p.6). In evidence to the Inquiry Coppleson said that he valued Green’s published work. He cited Green in support of his more conservative approach to treatment. He saw him as an ‘ally’ (1987, p.10) in ‘getting the message across’ (p.11) and in ’trying to stop the carnage’ (p. 6). He said Green’s study ‘valuable to my efforts to obtain a more conservative approach’ (p.10).
The Inquiry questioned Coppleson closely on his exact position. Four times he testified that he would not have been involved in research like Green’s because by the mid 1960’s he was convinced about the potential of CIS to progress to invasion (Coppleson 1987, p. 15, p. 19, p. 20, p. 21). Progression, he says was ‘No longer an issue in 1966’ (p. 14). An accurate account of Coppleson’s papers supports this assertion (Coppleson, 1977; Coppleson, K, & Dalrymple, 1981a, 1981b; Coppleson et al., 1967, pp. 152-173).
Coppleson said in evidence that the reason he had not criticised Green’s protocol at the time was because he had assumed it would ‘become obvious to the colposcopist if anything had started to go wrong…..and therefore common sense would prevail and another form of treatment would be instituted’ (Goddard, 1987, p.11). Coppleson was unaware, until shown the case notes at the Inquiry, that Green was not acting on the colposcopist’s advice but just observing lesions developing.
Careful reading of Coppleson’s published work in a temporal context shows that, like Kolstad, he did not change his fundamental position either at or after the Inquiry (Goddard, 1987; Paul, 2009a). Moreover, his practice had been very different to Green’s. He always aimed ‘to eliminate once and for all, the lesion by the most appropriate method’ (Coppleson, 1987, p. 23). The only time he advocated significant delay in definitive treatment was in cases of CIS diagnosed in pregnancy, and then only until after delivery (Coppleson, 1977, pp. 177-178; Coppleson et al., 1967, pp. 206-208).
Coppleson was at the forefront of developing ‘conservative management’ of CIS. By this he meant treatment without removing the uterus. Along with other means of examination and diagnosis, Coppleson was developing the ‘new colposcopy’ into a precise tool (1987: pp 2-4) which would allow the accurate grading, and most importantly, accurate prediction, of the likely course of a cervical lesion (pp 4-5). His argument was that while cytology or histopathology alone were not completely accurate, with the addition of colposcopy and close team work, diagnosis could be sufficiently precise to allow for treatment by measures which conserved the uterus, so long as follow-up was rigorous. ‘Colposcopy can help the gynaecologist select, with accuracy and safety, those women who should be treated conservatively with local excision’ (Coppleson et al., 1967, p. 196; see also Coppleson 1977, p. 178).
His views remained consistent throughout his career. When Coppleson advocated ‘follow up’ this was not a substitute for treatment, but after treatment to ensure it had been successful (Coppleson, 1987, p. 13; Paul, 2009b).
Bryder uses the subjectivity of histological diagnosis to suggest that grading was inherently so unreliable that Green’s ignoring some lesions was a legitimate issue of clinical judgement. Bryder supports this assertion by quoting from Coppleson, particularly his 1981 chapter in Gynaecologic Oncology (Coppleson, 1981). But the consistent argument in all Coppleson’s published work is that the addition of refined ‘new colposcopy’ to histology, combined with close systematic interdisciplinary co-operation, can increase accuracy sufficiently to overcome this problem.
Coppleson also gave evidence to the Inquiry that even in the 1960’s he ensured that the patient was fully informed, and was clear that ultimately the choice in both treatment and research lay with the women themselves (Coppleson, 1987, p. 27).
Perhaps the most tragically untreated women were those whose lesions were allowed to spread into the vagina. Once vaginal invasion had occurred treatment options were limited and terrible. Since treatment of advanced cases was unlikely to be successful, treatment might well only add to the misery of the disease.
Dr. Jordan reviewed two such cases before the Inquiry (patients 60/69; 60/64) who had developed vaginal abnormalities, Jordan referred to the treatment ‘dilemma’ faced by the doctor once this situation had been allowed to develop (Jordan, 1987a).
It is clear that Jordan made his comments about the clinical ‘dilemma’ in the context of condemning the inaction which had allowed the dilemma to occur in the first place. Bryder, however, misrepresents this reference and uses it on four occasions to imply that other clinicians sympathised with Green’s predicament (2009, pages 40, 51, 52, 55). She does not make clear that Jordan was making his remark in the context of condemning the development of that predicament in the first place as a result of inaction by Green.
In his evidence, Jordan describes how in the case of one of the two patients (patient 60/69) Green had overridden the pathologist and downgraded a histological diagnosis of invasion, justifying delays in curative treatment. In describing the ‘dilemma’ faced by Green in this case, Jordan explicitly condemns the 8 years of delay in definitive treatment (Jordan, 1987a, p.2).
For the complex case of the second patient, (patient 60/64), where Green was faced by a similar ‘dilemma’ Jordan also criticised repeated delays in curative treatment as the cancer spread from the early 1960’s until 1981 when she was finally confirmed as having ‘generalised cancersiation of the lower genital tract’ (p. 4). As Jordan recognised repeated procedures had unfortunately not prevented this. But this did NOT obviate his view ‘that some definitive treatment to the vaginal vault lesion should have been instituted in the early 1960’s, and at the latest in October 1965, when the vaginal vault biopsy confirmed the presence of severe dysplasia’ (Jordan, 1897a, p. 4).
Similar research studies overseas?
In arguing that the treatment at NWH was not unique but represented international best practice (2009, p. 55) , Bryder argues that international experts, including Professor Ralph Richart from New York (pp. 44-45) and specialist Joe Jordan from Birmingham University (p. 29) had undertaken or advocated similar studies.
After the Inquiry, Jordan did advocate a prospective study because he was concerned about effective use of screening resources, because more and more women were ‘being referred to colposcopy clinics for assessment of even the most minor cytology abnormality (Jordan, 1988). This was over-loading the capacity of the screening system and possibly to over treatment of young women with minor lesions. Jordan’s views, published in a study entitled, ‘Minor degrees of cervical neoplasia: time to establish a multicentre prospective study to resolve the question’, was of low grade lesions not CIS, as its title makes clear.
Bryder elides the important difference between minor lesions and CIS. She used Jordan’s 1988 proposal to suggest that internationally the controversy concerning the invasive potential of CIS continued up to and, even after the Inquiry (2009, p. 29, p. 31). The text of the proposal, however, shows that Jordan had accepted progression and supported population based screening. He was primarily concerned about the effective management of minor lesions in screening programmes.
Professor Ralph Richart, an expert witness from New York City had also undertaken prospective research; but once again it was into the development of low grade lesions not CIS (Bryder, 2009. pp. 44-45). In Richart’s study, if CIS developed then it triggered curative treatment to remove it. Unlike Green’s study, when invasion occurred the research was terminated as unsafe. Like Coppleson, Richart’s patients were also fully informed about potential risks.
Bryder ignores the differences between minor lesions and CIS on the grounds that the reading of histology slides and cytology smears can be equivocal. This occurs because the stages are not discrete steps but part of a continuum of cellular changes from minor abnormalities to CIS to invasion. However, this is not unusual in medicine, and does not mean that clinically meaningful differentiation between levels of abnormality is not possible, especially if multiple investigative methods are used. From the patient’s point of view these differences are critical. There is a huge difference in treatment and in its consequences. Treatment is far more difficult, damaging and traumatic in the later stages.
The propositions in Bryder’s argument
The argument in this paper shows that the first four steps of Bryder’s analysis fail.
- Medical literature and medical experts have agreed from the 1960’s onwards that CIS has a potential to lead to invasion and should be treated by removal of the abnormality. The most recent re-analysis of Green’s evidence shows that between one third and one half of CIS will lead to invasion if untreated (McCredie et al., 2008).
- Green’s management was not the same as that of Coppleson, Jordan or Kolstad all of whom advocated the elimination of CIS with follow up after treatment to ensure removal had been successful.
- Green’s motivation may have been to save women from un-necessarily invasive treatment, but in the event his regime led ultimately to some women enduring a multiplicity of destructive and even mutilating procedures.
- Objective analysis of Green’s records and clinical material shows that he subjected women to many procedures designed to ‘observe rather than treat’ their CIS (McCredie et al., 2010) and as I have shown sometimes even their invasive cancers.
National Archives privacy restrictions meant that Bryder had no access to cases and case notes. Nevertheless the appendix to the Cartwright Report contains the complete case notes of two patients who had been initially treated for CIS with small biopsies, and who had gone on to develop microinvasion which was not removed. They only had definitive treatment once invasion had developed, and then only after significant delays (Cartwright, 1988, Appendix 10, pp. 268-274; Appendix 11, pp. 275-286). The Judge commented that ‘the outcome’ for women like these ‘has been very poor indeed’ (Cartwright, 1988, p.114). These, and other case notes were also extensively discussed in the Report (pp.113-114; 89-90; 109-119).
These included those of Clare Matheson, who also bravely made them public in her book (Matheson, 1989). Bryder had access to the transcript of the cross examination of the experts about Matheson’s case. Bryder’s failure to make clear that years of delay in treatment meant that Clare’s CIS had developed into invasive cancer, and ignoring the acute and ongoing suffering entailed by the highly invasive resulting treatments minimises the experiences of all the women patients.
Bryder claims that the Inquiry exaggerated women’s ignorance of, and dissatisfaction with, their treatment (2009, pp. 58-59). She gives examples of patients who felt that Green was a good doctor who followed them assiduously. Many of these claims are, however, based on letters written by Green’s patients at the request of his lawyer before the Inquiry began and before they knew what had happened to them.
Some women did feel sufficiently informed (Goddard, 1987, Annexure 2 patient 21; patient 70, p.28; patient 30, p.11) and some preferred not to know, but Green actively resisted giving information to patients who asked for it. Many patients made vigorous attempts to obtain information about their case. One suspicious patient took her pathologist brother to a consultation but was still frustrated. Of the 72 patients whose evidence is recorded, eleven used the words ‘guinea pig’ when describing their experience (Goddard, 1987, Annexure 2)
One of most moving pieces of public testimony was from a Maori man who was the only husband who went with his wife to give evidence to the Inquiry.. His wife had ‘asked to see her file…. and was declined’ (Goddard, 1987, Annexure 3, Summary, p. 5). She told the Inquiry ‘I feel that a woman has a right to know what she wants to know from a doctor’ (Cartwright, 1988, p.119). He had gone with her to the hospital to find out about her condition and was deeply distressed at being confused and patronized.
A minority of patients who gave evidence were supportive of Green but remained ignorant of their diagnosis. One man initially believed that Green had been particularly caring; until he realized he had been actively misinformed about the circumstances of his wife’s death (Cartwright, 1988, pp.109-111).
Bryder quotes patient, Mrs. W, who was enthusiastically appreciative of Green’s care in her public testimony. Bryder points out that ‘She clearly enjoyed coming for check-ups’ and had ‘readily agreed’ to provide tissue samples and be a demonstration subject (2009, p. 49). Bryder contrasts her satisfaction with Rodney Harrison’s cross examination of Green about ‘why he did not adopt a more aggressive approach’ to her treatment, and Harrison’s suggestion that Green ‘did not perform a vaginectomy in order to keep her for research purposes’ (p.49). The implication was that the Inquiry ignored this woman’s evidence, and that Harrison’s questions demonstrated our bias.
The patient and Bryder were unaware of something the Judge, counsel and parties knew. This patient had not, as she believed, been cured. Her CIS had been observed while it spread throughout her vagina. Her testimony emphasised her misinformation and how seriously misplaced her trust in the hospital was. Her visits to the hospital were part of her follow-up as a research subject. Mrs. W and Bryder were equally unaware that her vagina had been photographed and discussed in medical journals (Coney, 1988, p.115). Mrs. W., in fact, provided poignant evidence that patients were not informed and were put at continuing risk as part of research.
Mrs. W was not alone. Goddard’s summaries of the eleven interviews given in public were available to Bryder. They provide insight into why the Inquiry did not ‘balance’ the evidence in the way that Bryder claims it should. Of the eight patients, for example, who gave evidence on day 10, two, (Patients 70 and 71) (Bryder, 2009, p. 28), were very pleased with their treatment, including Mrs W. Goddard’s summaries (1987, Annexure 3), however, make clear that all eight patients were misinformed, although some had made attempts to find out about their situation The summaries show that the patient who complained that the hospital ‘doctors talked about her as if she was a bit of furniture’ (p.7) was not atypical.
Goddard’s ‘Summary of Patient Interviews’ given in private (Goddard, 1987, Annexure 2) were also available to Bryder. There are summaries of 72 interviews. Ten of these 72 believed they had sufficient information, but checks against their case notes show that only a maximum of five were correct. The rest, even when they were satisfied, were unaware they had been treated unconventionally or put in danger.
The Summary of Patient Interviews records that when patient 75 heard about the Inquiry and sought information about her case she was admonished by a GP for pursuing a ‘witch-hunt’ (Goddard, 1987 Annexure 2,, patient 75, p.30). Her regular GP also refused to provide her with information about herself. Even after the inquiry began the hospital did not voluntarily inform their patients about their true condition.
Many submissions from groups associated with the Women’s Health Movement argued for an urgent, independently evaluated recall of all women potentially at continuing risk. The Judge recommended that it take place and began sending details of women at risk to the Minister as the information became available (Coney, 1990, pp. 204-206). It took, however, very persistent lobbying before this independent recall occurred. Bryder’s claim that Coney exaggerated the outcome of this recall has been rebutted. The recall revealed that one patient had since died, one found to have invasive cancer and about a quarter needed further treatment (Coney, 2009, pp. 147-148).
Delayed could be dangerous. For example, Patient 81 had presented in 1970 with a diagnosis of invasive cancer (Goddard, 1987 Annexure 3, p. 32.). The patient wanted surgery, but Green refused for three years. When she ‘accidentally’ saw another doctor she was treated with surgery and radiotherapy which at that stage caused serious permanent bladder damage. Bryder says nothing about Green’s delays in treating even overt invasion; about which there was no international doubt.
Ignorance left women unable to protect themselves. If they left the region they might not see a doctor until they became symptomatic. Some only found out about their diagnosis when they reported their symptoms to doctors overseas. One woman moved to Wellington where a consultant recommended treatment, which Green resisted, writing to tell the doctor not to treat her, because of the importance of her case to his ‘series’.
Evidence of patient harm.
Bryder accepts as accurate Green’s statements that few of his patients developed invasion or died. Bryder is aware that Green achieved these results by reclassifying cases and removing most that developed invasion from his studies; but she appears to be so unaware of appropriate scientific practice that she defends this practice claiming that other researchers undertook similar reclassifications (Bryder, 2009, p. 77, pp. 78-80). It is true that in medicine diagnoses are sometimes reviewed retrospectively. When this occurs doctors do not, however, go back and expunge the original records. Researchers most definitively do not remove retrospectively reclassified cases from research cohorts after the event (Paul, 2009a, p.129).
Bryder takes Green’s words at face value accepting, for example, the evidence in his 1964 paper that only one woman in his sample progressed to invasion (Paul, 2009a, p.124) or the claim in Green’s 1974 paper that of ten cases of invasion only two represented real progression of pre-invasive lesions (Bryder, 2009, p. 47). But these figures were arrived at by what Paul calls ‘scientific misconduct’ which includes practices that in everyday language are called fraud. The Inquiry heard evidence that invasion cases were removed from these series by being retrospectively re-diagnosed as having invasive cancer at the outset; a conclusion that Bryder justifies and the implications of which she chooses to avoid.
Green not only removed cases from the study but tried to change the histology records themselves. Sandra and I were told by Michael Churchouse, Charge Technologist at NWH cytology laboratory, that their patient records were hidden under the floor boards to protect them from Green’s attempts to alter them. The Judge was told by Mclean about ‘several occasions’ on which Green ‘crossed out’ McLean’s diagnosis ‘on pathology reports and replaced it with his own’ (Cartwright, 1988, p.109). McLean described to us finding Green in the laboratory going through the histology slides attempting to alter the recorded diagnosis. From then on McLean tried to protect the integrity of his specimens by classifying them under a different system. As Bryder noted, Green complained of this at the Inquiry, implying that Mclean was unreasonable (Bryder, 2009, p.78). McLean was, at the time, the only fully qualified specialist gynaecological pathologist in New Zealand. That his concerns about Green’s unprofessional, unscientific practice were ignored demonstrates a serious failure in academic management at the hospital and university.
Our Closing Submission (Harrison, 1987, Appendix IV, pp.2-3) provided evidence that 26 deaths were associated with delayed and withheld treatment. Sandra showed how that figure had been compiled. By 1988, that figure had grown to 29 Coney, 1988). This claim has never been refuted.
The Report did not include a figure for deaths, although Appendix 12 lists 23 women who had died, including 8 who died of cervical cancer and 8 who died of vaginal cancer (Cartwright, 1988, Appendix 12, p. 287). More recently McCredie et al. (2010) have shown that eight of the ‘core group’ of women who began with CIS died, but this excludes those with vulval cancer, or who had delayed treatment for early invasion or those with recurrent or persistent disease after a cone biopsy and others with limited or delayed treatment.
Bryder argues, however, that claims that Green harmed women are exaggerated (2009, p.157). She quotes NWH gynaecologist, Dr. Tony Baird, saying there is no proof that recorded deaths were of patients in Green’s studies. Case records, however, make clear those for whom treatment was delayed or withheld and who died. The fact that some of these cases might have come from other doctors in the hospital is hardly a defence.
Sources of Bias in Bryder’s Account
I have identified a number of sources of error in Bryder’s use of the evidence available to her in case histories, medical publications and other sources of information. These include:
- Misusing the uncertainties of diagnosis, especially histological diagnosis, to justify clinical inaction;
- Ignoring the differences between minor abnormalities and CIS, and CIS and invasive cancer;
- Misrepresenting the subject of studies by Jordan and Richart;
- Misrepresenting the meaning and significance of Jordan’s statement on clinical dilemmas;
- Overstating the satisfaction of patients;
- Justifying Green’s scientific misconduct;
- Implying criticism of McLean for attempting to protect the integrity of his specimens.
There is a hole in the heart of Bryder’s analysis, resulting from her neglect of the patients’ perspectives. The proposition that lay at the heart of the Cartwright recommendations was that patient’s reality formed the standard by which medical conduct should be judged. Neglecting to accept or at least acknowledge this key proposition meant that Bryder ignored or misinterpreted most of the available evidence and failed to appreciate the significance of the Cartwright Inquiry and its associated reforms. The patient-centred perspective is the elephant in Bryder’s analytical room which she steadfastly neglected to discuss.
Sandra has offered a critique of Bryder’s anti-feminism (Coney, 2009a). The general tone of academic criticism, however, positions the critics as moderators bringing balance by acknowledging but not endorsing feminist input (Paul, 2009b; Skegg, 2009, pp.96-97) and suggesting that the key division this debate has exposed was one between doctors. It is important for historical accuracy, however, both to establish that there was significant feminist input into the Inquiry.
Patient Centred Ethics and Feminism
In addressing the first term of reference of the Inquiry about ‘whether the CIS was adequately treated’, the judge included not merely the management of the disease, but the treatment of the patient. The judge included ‘acknowledgement of the dignity of the woman patient and her right to total privacy’ (Cartwright, 1988, p.119) and ‘knowledge and acceptance of her cultural needs’ as well as the provision of accurate information, including ‘about the consequences of treatment and the impact that her treatment or management may have on her personally, on her family, working life and her mental health’ (p.119). This holistic concept of ‘treatment’ is what distinguishes the Cartwright legacy and makes the Report truly innovative. I argue that this was derived from feminism not as a result of personal influences but as a cogent development from a human rights perspective, as our submissions show.
For Sandra and me this perspective was intrinsic to our feminism. It arose directly from our analysis of our experiences in the Women’s Health Movement. The validation of women’s perspective was a central tenet of our feminism and as the Women’s Health Movement grew a patient centred perspective naturally developed from it. We gave priority to women’s interests. As Sandra has written ‘The major motivation for Phillida and myself in pursuing the investigation and then as parties to the Cartwright Inquiry was to make sure the women who still needed treatment got it’ (Coney, 2009b, p.68). Our argument rested on an analysis of the personal and medical experiences of the women themselves.
This paper suggests that many of Bryder’s errors of interpretation are the consequence of moving women’s experience to the periphery of her understanding. Sandra has pointed out that Bryder’s indifference to the suffering of the subjects (Coney, 2009a, p.146) and apparent unconcern with their experience as patients. This indifference leads her to dismiss the development of patient-centred ethics as a significant step in the reform of medicine.
Bryder gives an accurate outline of the development of the New Zealand Women’s Health Movement in the 1970’s and early 1980’s in New Zealand (2009, pp.109-124). But she identifies the Women’s Health Movement as being characterised by a resistance to medical intervention (p.6). She argues that because Green was working to avoid hysterectomy he was more in line with feminist health principles than Coney, who Bryder believes (erroneously) was persistently advocating hysterectomy as a female cure all (Coney, 1987; Coney & Potter, 1990). Bryder thus implies that Coney and I betrayed our feminism because we were so eager to condemn Green as a representative male doctor. That is, we were motivated less by concern for women’s health and more by animosity against men, particularly as represented by male doctors.
While the Women’s Health Movement did resist unnecessary intervention particularly in well-women care it was equally concerned with the provision of safe and timely intervention in illness. The principles of the Women’s Health Movement were summed up by Celia Lampe of the Ministry of Women’s Affairs as ‘Voice, Choice and Safe Prospect’ (Lampe, personal communication with the author, 1987). Within the women’s rights language of feminism at the time, women’s empowerment expressed itself in health as a quest for patient-centred care. Protection of the patient’s autonomy and human dignity was at the heart of our agenda. We sought to give the women’s experiences credibility and place their interests as patients at the centre of the medical system. This was not brought about clandestinely but because of the applicability of our understanding of women’s rights.
Judge Cartwright, ‘made the experiences of the …. women who gave evidence the focus of the inquiry and she judged the profession’s performance relative to their reality’ (Bunkle, 1993, p.56). The medical hierarchy were initially bewildered by this challenge to their authority. One of my more vivid memories of the inquiry was Professor Bonham asking aghast ‘Do I have to answer that question? And the Judge replying ‘Unfortunately Professor Bonham you are here to be cross examined’. The Report’s recommendations suggested that a ‘shift to a patient focus…. must happen to the whole health service’ (p.56). This paper agues that this vision of patient-centred care came directly from a feminist vision of empowerment.
In the final analysis, whether or not Sandra and I exercised undue influence over Judge Cartwright it an esoteric academic point. The key question before us is how best to secure improvements in the health of New Zealand women. It is especially disappointing that no commentators, not even those holding publicly funded positions, have discussed how the vision of feminist, holistic patient-centred medicine can best be achieved within the narrowing confines of a national health system disintegrating and made mean by more than 20 years of neo-liberal managerialism. Whatever book is needed to provoke that debate, it isn’t Bryder’s exercise in gratuitous revisionism.
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