Another Attempt to Rewrite History
Challenging suggestions to honour Herbert Green
By Sue Claridge
It is not the intention of this article to debate the scientific merits (or absence of) of the research undertaken by Dr Herbert Green on women with cervical abnormalities and carcinoma in situ (CIS) at National Women’s Hospital in the 1960s and 70s.
The issue is the failure of some academics, health professionals and writers to accept that what he did was ethically wrong. For those people to persist in re-writing history in attempts to ‘beatify’ and honour the man is grossly offensive to the women upon whom he experimented – some of whom died – and their families, those of Green’s contemporaries who were horrified by his practices, the women who first shone a light on his ‘unfortunate experiment’, those who gave evidence at the Cartwright Inquiry into Allegations Concerning the Treatment of Cervical Cancer at National Women’s Hospital1, and those who have worked since to protect and uphold the rights of patients.
Over the years there have been a number of attempts to “rewrite” history, to denigrate and dismiss the Cartwright Inquiry and its outcomes and recommendations, to discredit Sandra Coney and Phillida Bunkle who wrote the article ‘An Unfortunate Experiment at National Women’s’ published in Metro magazine in June 1987, and to posthumously restore Herbert Green’s reputation.
On each occasion these attempts have been met with a combination of outrage, disbelief, protest and condemnation. The disputing and defence of the Cartwright Inquiry, and of Green’s research are well documented in the medical literature, and a number of responses to the revisionist writings can be found on this website.
2020 Papers in the Journal of Clinical Epidemiology
The most recent of these revisionist writings are two papers published in the June 1, 2020, edition of the Journal of Clinical Epidemiology (JCE).2, 3 While this AWHC article doesn’t set out to discuss the merits or otherwise of Herbert Green’s science, both JCE papers also discuss the ethics of his experiment. The papers present the argument that the ethical principles acceptable in the 1960s cannot be measured against ethics acceptable in the 21st century:
“Regarding 1960s research, university medical staff were expected to use their clinical practice to further medical science and the prevailing view was that doctors knew best. Research ethics committees were rare.”2
While that is strictly true, it is disingenuous to suggest that the environment was such that informed consent was a foreign concept. In 1966, when Green started his research at National Women’s the Nuremberg Code was 19 years old and the Declaration of Helsinki (see sidebar) two years into its influence on the ethics of medical research.
Raffle and Gray’s paper states that “The 1964 Declaration of Helsinki, which differs from the 1983 version, required patient consent ‘if at all possible, consistent with patient psychology,’ but consent did not need to be written.”2
For a man of Herbert Green’s supposed intellect and purported character, to suggest he was entirely unaware of the Nuremberg Code and Declaration of Helsinki seems somewhat incongruous. While it might not have required consent in writing as would be the case today, it is difficult to argue that the women that Green involved in his research were inadequately intellectually or psychologically equipped to provide informed consent, albeit verbally.
Raffle and Gray point out that “Evidence to the [Cartwright] Inquiry from patients and staff testified to the quality of Green’s care and to his kindness”; that “Dr Green was a person who cared intensely about his patients”.2
He has also been described as charming and charismatic, and some of his patients adored him,4 but charm and charisma do not absolve a medical researcher of the duty of care and obligation to inform patients of the fact that he was experimenting on them and obtain their consent to do so.
The second of the two papers in the Journal of Clinical Epidemiology, by Iain Chalmers,3 is written very much in the same vein as the Raffle and Gray paper. He engages in a semantic argument, that there was no ‘experiment’, however, there is no doubt that research was undertaken. It is well documented and directly quoted in Judge Silvia Cartwright’s Report from the Minutes of the Senior Medical Staff Meeting, using words such as “proposal” and stating that “his aim was to attempt to prove” his hypothesis.1 That he had a theory or hypothesis to “prove” about the progression of cervical abnormalities to invasive cancer identifies his treatment (or lack thereof) as observational research or a form of experiment.
Further proof of the experimental or research nature of Green’s work is his tests on healthy newborn baby girls (see sidebar). Chalmers doesn’t discuss this aspect of Green’s research, either because he isn’t aware of that part of Green’s history, or chooses to ignore it no doubt because it would not fit with his narrative of a brilliant clinician with only patients’ best interests at heart. Chalmers claims that Green’s work was not experimental, merely ‘conservative management’ of women with ‘cervical cytological abnormalities’.3 How then, would Chalmers justify the taking of vaginal swabs from newborn baby girls on the basis of it being acceptable medical management? How is that not research; how is it not experimental?
One of the Terms of Reference of Judge Cartwright’s inquiry into the treatment of cervical cancer at national Women’s Hospital was to answer the question, “Was there a research programme?”1
Judge Cartwright wrote in her report that witnesses in the proceedings varied in their views: “Some took the view that it was not a research proposal but a move to treat patients more conservatively. Others were clearly of the view that it was a research proposal, albeit a poorly designed one.”1
Nine pages of the Cartwright report are devoted to the question of whether Green’s work was research (Chapter 3, pages 61-69). Judge Cartwright concluded:
“It was an attempt to prove a theory that lacked scientific validity and little attention was given to ethical considerations. From 1966 and throughout the period of the 1966 trial, there were clear guidelines against which a doctor’s moral and professional right to include patients in research trials could be measured. I can think of no reason for gynaecologists who practised at National Women’s Hospital or in other parts of New Zealand, or administrators whose responsibility it was to be familiar with ethical principles, to overlook the basic ethical and scientific information that was then available.”1
In his paper, Chalmers goes further than Raffle and Gray with his ongoing criticism of Sandra Coney and Phillida Bunkle, the Cartwright Inquiry and many of the academics and epidemiologists and doctors who gave evidence (David Skegg, Charlotte Paul, Ron Jones, et al.) in that inquiry.
In his conclusion, Chalmers writes that “a public apology to Herbert Green is long overdue” over “unsubstantiated allegations that his practice in the 1960s was unethical.”3
He goes on to suggest that Herbert Green be honoured with the establishment of an international Herb Green Prize, “preferably jointly by epidemiologists in New Zealand and individuals who owe their very existence to conservative management of ‘‘cervical carcinoma in situ’’ at National Women’s Hospital.”3
This proposal must be especially galling to the surviving women and the families of those women who died as a result of inadequately treated cervical abnormalities.
The Response to the 2020 Journal of Clinical Epidemiology Papers
The responses to the Raffle and Gray, and Chalmers papers in JCE, subsequently published in that journal, are divided between those in full support of and those disputing the conclusions of those papers. To cover these responses in detail here would be longwinded and run the risk of descending into a “he said, she said” style of discussion.
However, it is worth noting a few comments from those defending the Cartwright Inquiry and its conclusions and outcomes:
Sandra Coney and Phillida Bunkle respond to criticisms by pointing out that they, and their legal counsel and medical adviser, had access to the women’s medical files and over 80 interviews of patients, and conducted many interviews with most of the personnel involved, including Green and his superior Professor Denis Bonham, which Raffle and Gray, and Chalmers did not.7
They point out that the legacy of the cervical cancer inquiry is not as Raffle and Gray claim “a climate of mistrust between patients and health professionals” but change that has “led to informed consent enshrined in law, ethical oversight of research, and a cervical screening programme that has reduced the incidence of cervical cancer by over 50 percent.” They say that “by and large health providers and their colleges embraced the need for change.”7
Ron Jones describes how he was “a young colleague of Herbert Green… I have first-hand experience, sadly, of the harms caused by Green withholding treatment. I was also a co-author of the paper that initially exposed the truth about Green’s experiment (this paper is completely misunderstood by Chalmers, as his thesis is based on conservative treatment and Green’s experiment was based on no treatment).”8
Ron Jones goes on to point out an uncomfortable truth: “The introduction of screening was delayed in New Zealand because of Green’s implacable opposition. If as had been suggested in 1959 by Dr George Weid, a national screening program had been introduced, rather than in 1991, about 3,200 New Zealand women would have been prevented developing cervical cancer.”8
Emeritus Professor Charlotte Paul writes that Raffle and Gray “rely uncritically on Professor Linda Bryder’s A History of the ‘Unfortunate Experiment’ at National Women’s Hospital, 2009.”9 She goes on to say that “scholarly integrity insists that Raffle and Gray should have evaluated the detailed critiques of Bryder’s work before deciding whether to rely on her,” specifically recommending The Cartwright Papers (ed. J Manning, 2009) and Doctors in Denial (2017) by Ron Jones.9
Prof Paul writes that she corresponded with Chalmers some ten years prior, writing “This is not just an academic dispute. I care about the harms that patients suffered. I care about medicine owning up to its mistakes. I reckon people need to be brave and speak out in this circumstance. If this continues to bring denigration on me, so be it. Matters more important than my reputation are at stake.”9
This is precisely what it is all about – the harms that patients suffer, accepting and owning up to mistakes, and speaking out where necessary to ensure that patients and their rights are protected and that lessons are learned. This a large part of what drives the Auckland Women’s Health Council and many other NGOs. Matters more important than reputations are at stake.
Scientific debate always continues – medical science and understanding is not fixed and immutable, it is always changing. For the AWHC the main issue is one of informed consent and patient rights. The right to informed consent should remain a constant and unassailable truth. Sandra Coney and Phillida Bunkle’s article in Metro magazine led directly to the Cartwright Inquiry, and from Judge Silvia Cartwright’s recommendations the Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996 was enacted in New Zealand.
Regular readers of the AWHC Newsletter will know that those rights are not always adequately applied; breaches of those rights are regularly the subject of complaints to the Health and Disability Commissioner, and it seems that some health practitioners and organisations providing health services feel that rights of informed consent can be dispensed with. But no-one in the health sector can justifiably claim that they do not know that patients have these rights, or that the onus is on practitioners to obtain fully informed consent from patients. This is the legacy of the Cartwright Inquiry and possibly the only upside to the suffering of the women who were involved in Herbert Green’s research without their knowledge or consent.
- Cartwright SR, 1988: 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, 1988, Government Printing Office
- Raffle AE and Gray JAM, 2020: The 1960s cervical screening incident at National Women’s Hospital, Auckland, New Zealand: insights for screening research, policy making, and practice, Journal of Clinical Epidemiology, 2020 Jun;122:A8-A13, accessible at https://www.jclinepi.com/article/S0895-4356(20)30161-X/fulltext
- Chalmers I, 2020: The ‘‘unfortunate experiment’’ that was not, and the indebtedness of women and children to Herbert (‘‘Herb’’) Green (1916-2001), Journal of Clinical Epidemiology, 2020 Jun;122:A13-A19.
- Comm., J Warren August 2017.
- Jones RW. Doctors in Denial. The forgotten women in the ‘unfortunate experiment’. Dunedin: Otago University Press; 2017.
- Comm. Ron Jones August 2017.
- Coney S and Bunkle P, 2020: Letter to the editor: Women’s experience of ‘the unfortunate experiment’ at National Women’s Hospital, New Zealand, Journal of Clinical Epidemiology 127 (2020) 232e234.
- Jones R, 2020: Letter to the editor: A clinician’s perspective of the ‘unfortunate experiment’, Journal of Clinical Epidemiology 127 (2020) 229e230.
- Paul C, 2020: Letter to the editor, Journal of Clinical Epidemiology 127 (2020) 225e227.
- Annas GJ and Grodin MA, 2018: Reflections on the 70th Anniversary of the Nuremberg Doctors’ Trial, American Journal of Public Health, 2018 Jan;108(1):10-12.
- NIH: The Nuremberg Code, Office of NIH History and Stetten Museum, accessed at https://history.nih.gov/display/history/Nuremberg+Code
- Shuster E, Fifty Years Later: The Significance of the Nuremberg Code, New England Journal of Medicine, 1997 Nov 13;337(20):1436-40.
- WMA, 2013: World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, JAMA, 2013;310(20):2191-2194.
- WMA, 1964: Declaration of Helsinki 1964, World Medical Association, accessed at https://www.wma.net/wp-content/uploads/2016/11/DoH-Jun1964.pdf
The Nuremberg Code
and the Helsinki Declaration
The Nuremberg Code originated from the Nuremberg Trials held after the end of World War Two and in response to the atrocities on human beings committed by the Nazis in name of “science”. The Doctors’ Trial (also known as the Medical Trial) involved US physicians working with US lawyers to “prosecute Nazi physicians for murder and torture done under the guise of human experimentation.”10
The Code’s first principle states:
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.11
The Codes second principle places the onus for obtaining consent squarely on the shoulders of the principle investigator or researcher:
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.11
Jay Katz, who was considered the world’s leading authority on the Nuremberg Code’s consent requirement, wrote that the consent principle of the Code was “stunning and uncompromising on respect for persons”.10
The Nuremberg Code is regarded as the “most important document in the history of the ethics of medical research.”12 While the Code was never officially adopted as law by any nation or as ethics by any major medical association, its “basic requirement of informed consent, for example, has been universally accepted” and the Declaration of Helsinki proclaimed by the World Medical Association in 1964, implicitly acknowledges the Code’s authority.12
The World Medical Association (WMA), of which New Zealand is a member, developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects.13 First adopted by the 18th WMA General Assembly, in Helsinki, Finland, in June 1964, the Declaration was amended nine times from 1975 to 2013.13
In 1964 (and at the time that Herbert Green was undertaking his research into the development of cervical cancer) the relevant clauses of the Declaration of Helsinki include:14
II. CLINICAL RESEARCH COMBINED WITH PROFESSIONAL CARE
1. … If at all possible, consistent with patient psychology, the doctor should obtain the patient’s freely given consent after the patient has been given a full explanation. In case of legal incapacity, consent should also be procured from the legal guardian; in case of physical incapacity the permission of the legal guardian replaces that of the patient.
III. NON-THERAPEUTIC CLINICAL RESEARCH
2. The nature, the purpose and the risk of clinical research must be explained to the subject by the doctor.
3a. Clinical research on a human being cannot be undertaken without his free consent after he has been informed; if he is legally incompetent, the consent of the legal guardian should be procured.
3b. The subject of clinical research should be in such a mental, physical and legal state as to be able to exercise fully his power of choice.
3c. Consent should, as a rule, be obtained in writing. However, the responsibility for clinical research always remains with the research worker; it never falls on the subject even after consent is obtained.
4a. The investigator must respect the right of each individual to safeguard his personal integrity, especially if the subject is in a dependent relationship to the investigator.
4b. At any time during the course of clinical research the subject or his guardian should be free to withdraw permission for research to be continued.
Beyond the dire outcomes from Green’s research on women with cervical abnormalities, the JCE and other authors ignore the experimentation that he carried out on newborn baby girls starting in 1963, a full three years before his proposal to undertake clinical research on women at National Women’s Hospital in 1966. Green had developed somewhat of an obsession with the idea that abnormal cervical cells were present as early as in utero and had examined tissue samples from female stillbirths and neonatal deaths. But this was not enough, and he began research on healthy newborn girls.5
Ron Jones writes:
“In another study… he organised nursing staff to collect vaginal cells. Taken with small swabs, from healthy newborn girls, to test for abnormal cells. These tests were performed without the knowledge of the mothers.”5
In his evidence to the Cartwright Inquiry, Green said “that he had lost interest in this trial after 200 babies had had smears taken.* Unfortunately his decision not to continue the trial was not communicated to the nursing staff and the trial continued until smears had been taken from 2244 new-born babies. There was no system in place that ensured that the trial stopped.”1
Dame Silvia Cartwright wrote:
“An effective system for monitoring research and ensuring that unnecessary procedures are not conducted, should have been in place. If this had been so, then more than 2000 babies would not have been subjected to a useless and possibly damaging procedure. Moreover, there was no provision made to comply with the fundamental requirement that children are not included in research without the consent of their guardians…. this was clearly a trial and not part of the day-to-day care of the babies concerned. It was non-therapeutic, clinical research.”1
This author acknowledges that this research started a year before the adoption of the Declaration of Helsinki, however, even basic morals were absent in this case. Newborn baby girls were vaginally swabbed and tested for cervical abnormalities without their mothers’ knowledge or consent, and no records were kept,6 nor did Green report his findings.5
That no records were kept of the babies that were tested6 is particularly concerning. Without knowing who the babies were that were tested we have no way of knowing if there were any adverse impacts resulting, perhaps years later, from the invasive procedure on hours old babies. How can we know if any of those 2244 girls, who would now (2020) be between 55 and 58 years old, went on to suffer any vaginal or cervical issues? If any women born at National Women’s Hospital during that time have experienced vaginal and/or cervical health issues, chances are they have no idea that this research even took place let alone whether or not they were one of the tested babies.
* Ron Jones writes that all of the tests on babies were negative for cervical cell abnormalities.5