The Sunday Telegraph

Women ‘duped’ into needless trial breast screenings

‘Misleading’ invitation­s left patients feeling manipulate­d

- By Ben Rumsby and Deborah Cohen

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.”

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