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

http://www.bmj.com/content/349/bmj.g5105

RecForm_ReadyForSubmission

“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 

http://www.healthwatch-uk.org/concerns-over-age-extension-trial-of-mammography-screening/