The new analysis of the 1965-74 study, which was deemed to be unethical by a judicial inquiry in 1988, was performed by a multi-disciplinary team led by Dr Margaret McCredie of the University of Otago.
Dr McCredie says for the first time, researchers were able to look at the treatment of different women for the same pre-cancerous condition which was initiated both before (1955-1964) and after (1974-1975) the ten-year period when Dr Green’s clinical study took place.
Using this method, the differences in treatment and outcomes for women in Dr Green’s study group have been highlighted.
The study is published as an online ahead-of-print paper at the Australian and New Zealand Journal of Obstetrics and Gynaecology website.
The research team found that the ‘core group’ of 127 women in Dr Green’s study, who had treatment withheld or delayed after diagnosis of cervical carcinoma in situ (cervical intraepithelial neoplasia 3) had a ten times greater risk of developing invasive cervical or vaginal cancer than women diagnosed at the same time who received prompt treatment intended to cure them.
The ‘core group’ received only a small diagnostic biopsy, but no treatment in the six months after diagnosis. Eight women in the ‘core group’ died of cancer. The researchers found that almost all the deaths from cancer occurred in this group, though the numbers of deaths were too small to make a statistically valid comparison between the different treatment categories and differing study periods.
The women in the core group also had four times the risk of having positive smears that remained untreated and nearly five times as many cervical biopsies as women who received initial treatment with curative intent. Treatment with curative intent involved cone biopsy or hysterectomy.
Dr McCredie says inclusion in Herbert Green’s clinical study subjected women to many procedures designed to observe rather than to treat them, and increased their risk of developing cancer of the cervix and vaginal vault.
“Any suggestion that Herbert Green did no harm to these women is shown to be patently wrong,” she says.
The researchers conclude in their paper that the consequences of the clinical study were profound for the women who participated.
They write: “When initial treatment with curative intent was withheld, their lives were seriously disrupted by the need to attend hospital for numerous medical interventions that would not have been necessary had treatment of curative intent been provided at the outset.
“Moreover, they had a substantially increased incidence of invasive cancer, with all the emotional stress and physical symptoms that the diagnosis of genital malignancy entails. We have published these findings to document and to acknowledge the harm suffered by these women.”
Margaret McCredie, Charlotte Paul, Katrina Sharples, Judith Baranyai, Gabriele Medley, David Skegg and Ronald Jones
Title: Consequences in women for participating in a study of the natural history of cervical intraepithelial neoplasia 3
Australian and New Zealand Journal of Obstetrics and Gynaecology.
For more information, contact
Dr Margaret McCredie
Tel 0061 29 949 8583
(Before Saturday 5 June, Charlotte Paul will be available if Dr McCredie cannot be contacted.
Tel 03 479 7207 (work)