Is the age extension trial unethical?

10 H0710 9 Ltr – Sub Amend 1 Unfav Op – 15 03 13 (2)

10 H0710 9 Ltr – Sub Amend 2 Unfav Opinion – 29 05 14

Just obtained 14/8/14

Essentially the Research Ethics Committee has declined to approve an amendment the age extension trial in February 2013, and again in May 2014. The basis seems to be in consent (or lack of it) ; that women don’t know they are in a trial; and that the harms aren’t spelled out – which is what I’d written about in the BMJ column below.

Susan Bewley et al have written in response to the BMJ to say the trial needs halted – could not agree more.



BMJ column here



“Currently there is limited evidence on the risks and benefits of extending the age range for breast screening; that is why

we are proposing this study. There may be a benefit to those study participants randomised for screening invitation of
having an extra screen. Similarly there may be risks and burdens although none of these are particular to the
randomisation that is central to our study. They apply to all routine breast screening carried out by the NHSBSP and will
be experienced by women in the extended age groups whether or not our study goes ahead since the age range of the
NHSBSP is being extended regardless of our study.”

More information including the study protocol is available here

One Response to “Is the age extension trial unethical?”

  1. Elizabeth (Aust) August 12, 2014 at 10:56 pm #

    We’re extending our screening program to include those aged 70 to 74, the same misinformation is being used to justify the change. We’ll see more women over-diagnosed that’s for sure…will some benefit? Who knows, but it seems the risks exceed any benefit for those aged 50 to 70. It would have been prudent, given the evidence, to take some time over this decision, but it seems to be a hasty political decision. Surely more screening for women is a good thing.
    More women are certainly backing away from the program, so extending the age range makes it easier to reach their target and justify the program and it’s huge expense. Vested interest will be content as well.
    It seems here as women get to the evidence, and it’s been well hidden, instead of addressing the issue, they simply try and find ways to persuade more women to screen. The scary stories have already started and the misinformation. So older women are in their sights now, some of these women have already had twenty years of screening, twenty years of radiation and compression. Let’s just say I’m sure they’ll find “things” and call the move successful.