“ The Unfortunate Experiment” a  very  abbreviated tale   Rachel Walden
Cervical Cancer a few terms, courtesy of the NCI   Cervical cancer:  Cancer that forms in tissues of the cervix (organ con...
The Experiment Conducted at National Women’s Hospital, Auckland, New Zealand Headed by Dr. Herbert Green, OB/GYN at NWH, p...
The Methodology NWH patients recruited with cervical CIS who were under 35 yo, there were to be no signs of invasive carci...
The Results 1.5% of group A and 22% of group B developed invasive cancer Women with continuing abnormal cytology 24.8 time...
The Controversy In 1987, women’s health activists published an article, “An Unfortunate Experiment,” in the Metro magazine...
The Inquiry Findings Determined that the study was unethical: women not informed they were in a study; not informed of oth...
The Inquiry, continued Early attempts at questioning the by the cytologist and pathologist program went nowhere – Superint...
Women’s Statements “I can’t explain the shock that I felt when I found out by accident that I had a cone biopsy.” “…I was ...
Historical Context Declaration of Helsinki written in 1964; Nuremburg Code also in existence at time of study According to...
The Aftermath ~130 patients identified and contacted for follow-up. This was not perfect, as follow-up sometimes occurred ...
Summary Study based on personal beliefs rather than established facts Informed consent – completely absent  Lack of unders...
Resources Campbell AV. A report from New Zealand: an ‘unfortunate experiment.’ Bioethics. 1989 Jan;3(1):59-66. Committee o...
Resources - 2 Flagler EA, Winkler ER. ‘An unfortunate experiment’: the New Zealand study of cancer of the cervix. Ann R Co...
Resources - 3 Rosier P. The speculum bites back: feminists spark an inquiry into the treatment of carcinoma in situ at Auc...
Special Thanks to the EBL Document Delivery staff These amazing folks obtained a copy of  the  Cartwright Report, held by ...
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New Zealand Cervical Cancer Experiment

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Brief overview of Dr. Herbert Green's "unfortunate experiment" on New Zealand women with cervical abnormalities (please excuse the abundant text and lack of images)

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  • New Zealand Cervical Cancer Experiment

    1. 1. “ The Unfortunate Experiment” a very abbreviated tale Rachel Walden
    2. 2. Cervical Cancer a few terms, courtesy of the NCI Cervical cancer: Cancer that forms in tissues of the cervix (organ connecting the uterus and vagina). It is usually a slow-growing cancer that may not have symptoms, but can be found with regular Pap smears (procedure in which cells are scraped from the cervix and looked at under a microscope). Stage 0: The cancer is found only in the top layer of cells in the tissue that lines the cervix. Stage 0 is also called carcinoma in situ . Properly treated, tumor control of in situ cervical carcinoma should be nearly 100%. Punch biopsy : a sharp, hollow device is used to remove sample of cervical tissue. Cone biopsy: removes a cone-shaped sample of tissue.
    3. 3. The Experiment Conducted at National Women’s Hospital, Auckland, New Zealand Headed by Dr. Herbert Green, OB/GYN at NWH, professor 948 patients with carcinoma in situ (CIS) of the cervix Women followed from 1955 to 1976; study officially began in 1966 To prove that CIS never develops into invasive cervical cancer, is not a premalignant condition To reduce number of major/invasive procedures to treat CIS, such as hysterectomy
    4. 4. The Methodology NWH patients recruited with cervical CIS who were under 35 yo, there were to be no signs of invasive carcinoma Followed from 5 to 28 years Split into groups by normal (A) or abnormal (B) cytology at follow up Received cone biopsies and other diagnostic procedures – not complete cancer removal
    5. 5. The Results 1.5% of group A and 22% of group B developed invasive cancer Women with continuing abnormal cytology 24.8 times more likely to develop invasive carcinoma In group A (normal follow-up), 3.2 times more likely to develop cancer than women who never had CIS Some women later died Green reclassified some of those who developed invasive cancer as having been missed initially
    6. 6. The Controversy In 1987, women’s health activists published an article, “An Unfortunate Experiment,” in the Metro magazine outlining the study. This article focused on one patient, “Ruth,” who was followed from 1964 to 1979, and finally diagnosed with cervical cancer in 1985. Public outcry occurred, and judicial inquiry ordered by the Ministry of Health Cartwright inquiry – officially, “Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at National Women’s Hospital and into Other Related Matters,” headed by District Court Judge Silvia Cartwright 67 witnesses heard and >80 patients interviewed privately Report released August 5, 1988
    7. 7. The Inquiry Findings Determined that the study was unethical: women not informed they were in a study; not informed of other treatment options; inadequately addressed risks to patients; symptoms of invasive disease downplayed or overlooked; some women never even told they had CIS Dr. Green maintained it was not in the women’s interests to tell them what he was doing Other revelations: medical students were doing vaginal exams on anaesthetized women without their knowledge or consent; >2,000 newborn females received cervical smears; some women later enrolled in R Series trial of differing treatments of invasive cancer without their knowledge
    8. 8. The Inquiry, continued Early attempts at questioning the by the cytologist and pathologist program went nowhere – Superintendent-in-Chief of the Auckland Medical Board did not consider the matter “urgent” Other clinicians did not want to interfere with Dr. Green’s “clinical freedom” Cases of invasive cancer were identified in 1969, but trial continued Enrollment protocol not followed – women over 35 were included fairly regularly, invasive signs ignored Numerous recommendations for improvement: patient advocates, nationwide cervical cancer screening, improved informed consent, ethics
    9. 9. Women’s Statements “I can’t explain the shock that I felt when I found out by accident that I had a cone biopsy.” “…I was never actually told that I had carcinoma in situ.” “After I had the cone biopsy I was told that they had got it all. I have since learnt that this was not the case. I was told that the chance of getting any form of cancer again were the same as any other woman.” “For instance, if I had known that my biopsy in 1975 showed that I had microinvasion, I would never have ceased to go to follow-up clinics.”
    10. 10. Historical Context Declaration of Helsinki written in 1964; Nuremburg Code also in existence at time of study According to the Cartwright report: “By the early 1960s most experts in Europe, the United States of America and Australia considered that CIS was a precursor of invasive cervical cancer.” Indirect and direct evidence was in existence when study began that CIS could in fact lead to invasive cancer Less invasive management techniques were already gaining favor before 1966
    11. 11. The Aftermath ~130 patients identified and contacted for follow-up. This was not perfect, as follow-up sometimes occurred in the course of routine clinical care, without women being provided with full details of their past enrollment into Dr. Green’s study Bureaucracy and resistance slows action on Cartwright report recommendations. Some physicians call informed consent procedures too burdensome. Cartwright Inquiry challenged, attacked as a “feminist witch hunt,” but later vindicated Some physicians investigated and fined. Dr. Green not punished due to poor health. Several women sue and receive damages. In the 1990s a related inquiry occurs, after it is found that abnormal cervical smear results have been vastly underreported in one region of the national cervical cancer screening program. More women die of cervical cancer as a result.
    12. 12. Summary Study based on personal beliefs rather than established facts Informed consent – completely absent Lack of understanding and voluntariness Respect for persons – individuals not treated as autonomous agents Justice – subjects were chosen because they were available Beneficence – no efforts to minimize harm Questionable handling of adverse events Institutional safeguards broken/not followed Hypothesis disproved; trial continued
    13. 13. Resources Campbell AV. A report from New Zealand: an ‘unfortunate experiment.’ Bioethics. 1989 Jan;3(1):59-66. Committee on Inquiry into Allegations Concerning the Treatment of Cervical Cancer at National Women’s Hospital and into Other Related Matters. 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: The Committee, 1988. Davis P. A fortunate inquest: the report of the cervical cancer inquiry. Community Health Stud. 1988;12(3):246-50. Coney S, ed. Unfinished business: what happened to the Cartwright Report?: writings on the aftermath of 'the unfortunate experiment' at National Women's Hospital. Auckland: Women’s Health Action, 1993. Coney S. The Unfortunate Experiment. Auckland: Penguin Books, 1988.
    14. 14. Resources - 2 Flagler EA, Winkler ER. ‘An unfortunate experiment’: the New Zealand study of cancer of the cervix. Ann R Coll Physicians Surg Can. 1992 Apr;25(2):124-30. Heslop B. ‘All about research’ – looking back at the 1987 Cervical Cancer Inquiry. N Z Med J. 2004 Aug 6;117(1199):U1000. McIndoe WA, McLean MR, Jones RW, Mullins PR. The invasive potential of carcinoma in situ of the cervix. Obstet Gynecol. 1984 Oct;64(4):451-8. Munro K. The aftermath of the cervical caner inquiry in New Zealand: an antipodal aberration or universal struggle? Issues Reprod Genet Eng. 1991;4(1):31-9. Paul C. Internal and external morality of medicine: lessons from New Zealand. BMJ. 2000 Feb;320(7233):499-503.
    15. 15. Resources - 3 Rosier P. The speculum bites back: feminists spark an inquiry into the treatment of carcinoma in situ at Auckland’s National Women’s Hospital. Reprod Genet Eng. 1989;2(2):121-32. Williams L. Looking back at the 1987 Cervical Cancer Inquiry. N Z Med J. 2004 Sep 24;117(1202):U1084; author reply U1084. Women’s Health Action Trust. Women’s Health Action [web document]. Auckland: The Trust. [rev. 28 Dec 2005; cited 18 Apr 2006]. <http://www.womens-health.org.nz/>
    16. 16. Special Thanks to the EBL Document Delivery staff These amazing folks obtained a copy of the Cartwright Report, held by fewer than 20 libraries in the United States!

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