Researchers report on victims of unethical 1960s-era study

A final report on the unethical clinical study conducted by Dr. Herbert Green at National Women's Hospital in Auckland from the 1960s to the 1980s, known widely as the "Unfortunate Experiment", has just been published in the Australian and New Zealand Journal of Obstetrics and Gynaecology.

The publication: Outcomes for women without conventional treatment for stage 1A carcinoma of the cervix describes the medical experience of 82 women with microinvasive cancer.

It confirms that some women with microinvasive cancer were included in Dr. Green's natural history study of cervical pre-cancer. They underwent numerous procedures designed to observe, rather than treat, their condition and had a substantial risk of developing a higher stage of invasive cancer.

Previous reports have analysed the risk of invasive cancer in women with CIN3 (pre-cancer) and the consequences for women with CIN3 included in Dr. Green's study. But lead author, Emeritus Professor Charlotte Paul from the University of Otago's Department of Preventive and Social Medicine, says it is not widely known that his trial of withholding treatment also included women with microinvasive (Stage 1A) cervical cancer. The outcome for the women with microinvasive cancer has not previously been reported.

Among these 82 women diagnosed with microinvasive cervical cancer, 15 developed a more advanced stage of cancer of the cervix or vaginal vault and eight died from their disease. None of these women had received conventional treatment or appropriate follow-up, Emeritus Professor Paul says.

"We have reported these findings in order to document and acknowledge the harm suffered by these women and to complete the picture of the effects of Dr. Green's study."

The first independent publication on this study was in 1984. Since then there have been many papers recording outcomes for women of withholding treatment for cervical and vulval pre-cancer. This is the second paper to specifically address the medical experience and outcomes for the women.

All data abstracted from the National Women's Hospital files for these studies will be deposited in a special archive being established by the Auckland District Health Board.

Details of the whole human story can be found in the book by one of the study authors, gynaecologist Ron Jones: Doctors in Denial: The Forgotten Women in the 'Unfortunate Experiment', Otago University Press, 2017.