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| Journal of the New Zealand Medical Association,
27-August-2010, Vol 123 No 1321
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Reassessing Cartwright—understanding the
factual record
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 30 July 2010 issue of the New Zealand Medical
Journal.
The nature and role of the ‘1984 paper’A number of assumptions and assertions concerning this paper
and its role demand elucidation.
A retrospective study—Professor Linda
Bryder stated in her book1 and at a seminar at
the University of London on 16 June 2010 that Sandra Coney has
‘admitted’ that the authors of the 1987 original Metro
article2(pp.47–64), Sandra Coney and I,
had not understood the retrospective nature of the 1984
analysis.1 (p.35)
This is a misrepresentation. Coney explained in her
book3 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.3(p.17)
The validity of the Cartwright Findings is
independent of the 1984 paper—It has been asserted by both
Professor Bryder1(p.35) and Helen
Overton4 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.
The important role of the patient case notesParties 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
Williams5–7 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:
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
care.1(p.49) 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.
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
so.8
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.
Definitions of ‘conventional treatment’Professor Sir Iain Chalmers criticises Professor Paul for
not providing the Inquiry with a definition of ‘conventional
treatment’.9 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’.10(p.106) Counsel 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...’.10(p.106)
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.....’.10(p.107)
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.10(p.104)
A series of propositions flows logically from this
definition:
Case
notes, the original research
proposal10(4–70) 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’.11
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
involved.10(232-233) 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’.12(p.28) The judge subsequently
found evidence of ‘cases where mircoinvasive carcinoma has not been
treated with even the least radical
procedure’.10(p.113)
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.
The support of Professor A CochraneProfessor Chalmers is concerned that there is inadequate
recognition of Professor Cochrane’s support for randomised trials to
settle the issues involved.9
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 research.10(p.82) In his own evidence to
the Inquiry, Dr Green also testified, in two places, that Professor Cochrane
supported the ethics of his
research.10(pp.77,79) 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 this.10(p.82)
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’.10(p.82) 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’.10(p.82)
The construction of Professor Bryder’s evidenceProfessor 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’.9(p.111)
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 women 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’. 12
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 position.
1 (pp. 40,50,51,55,149) 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 track.
13 (pp .2-5) 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. 10 (p. 233)
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 invasion
10 (pp. 232-233) and it was the difficulty in
treating these women that posed the dilemma to which Jordan referred.
13 (pp .2-5)
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 colon. 13
(p.4)
The sentence in Jordan’s statement which occurs
immediately before that quoted by Professor
Bryder,1(p. 40) 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.’13(p.4) 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. 12 This
is forthright professional criticism not sympathy, as Professor Bryder would
have us believe.
ConclusionIn 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
Pimlico, London, UK Research Fellow
Women’s and Gender Studies, Victoria University, Wellington, NZ (The author was co-author with Sandra Coney of An
unfortunate experiment at National Women’s Hospital, Metro magazine,
June 1987, pp. 47-65 and a Party to the Cartwright Inquiry.)
References:
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