Women ‘duped’ into needless trial breast screenings

‘Misleading’ invitations left patients feeling manipulated

A CLINICAL trial funded by the Government and linked to the National Health Service’s biggest cancer scandal “duped” women into putting themselves at risk of needless surgery and chemotherapy, an investigation by The Sunday Telegraph has found.

The Age Extension Trial (AgeX), a study into the potential nationwide expansion of the UK’s breastscreening programme beyond ages 50 to 70 recruited millions of subjects without their express consent – some claim without their knowledge – including some with learning difficulties.

The Oxford University-led trial was engulfed this month by a scandal when Jeremy Hunt, the Health Secretary, announced that up to 450,000 women had been denied screenings and that up to 270 may have died following what Public Health England said was the analysis of “anomalies” in data for AgeX.

An independent review has been launched into what appears to have been a computer programming error.

Documents seen by The Telegraph show this month’s scandal was the latest in a string of controversies to hit a study into the impact of extending screening to those aged 47 to 49 at the lower end of the age spectrum and 71-73 at the upper end.

So-called “overdiagnosis” already occurs in the breastscreening programme, with women undergoing life-altering mastectomies, or treatments that can have serious side effects for cancer that would not have been fatal.

Critics of AgeX argue it is vital its participants are made fully aware of the consequences of overdiagnosis and asked to sign a consent form stating they accept this.

The Telegraph has spoken to several of the women invited for screenings as part of AgeX, which has already enlisted approximately 3.6million people.

One, Helen Drake, said: “Was I encouraged to have an early health intervention when there was no evidence it would be beneficial to my long-term well being?”

Some of the invitations did not explicitly inform the women that they were being recruited for a clinical trial. One was “horrified”, another felt they were “duped”, with the invitation branded “misleading”. All were critical of the fact that their prior written consent had not been sought the study.

Those who attend their appointment – around 1.2million women have to date – are assumed to be consenting to take part in the

‘There was no evidence it would be beneficial to my long-term wellbeing’

trial and to understand the implications of doing so. Most of the women who spoke to The Telegraph were enlisted between 2011 and 2014. Medical ethics chiefs have since forced those running AgeX to change its invitations, which now make the experiment clearer.

Sir Richard Peto, trial statistician, angrily denied the earlier invitation had been insufficient, pointing out that it informed the women they were taking part in a randomised age extension programme being scientifically evaluated by researchers at Oxford University.

He said he was “sorry” if anyone felt duped but added: “If you reproduce the leaflet and then said, ‘After reading this, somebody thinks she was duped into being randomised’, well, people would think, ‘God, what a prat’.

“Why don’t we put in the word ‘guinea pig’ as well? Come off it. This is really ridiculous. Really, it is. This is misinformation.

“I’m really not trying to be rude but why is somebody feeling outraged and betrayed by being told that? She’s been told exactly what is true.”