Women ‘duped’ into need­less trial breast screen­ings

‘Mis­lead­ing’ in­vi­ta­tions left pa­tients feel­ing ma­nip­u­lated

The Sunday Telegraph - - News - 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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