Prof Sir John Burn's expert views on aspirin included in an
article in The Mail on Sunday dated August 19, 2012
Prof Burn's interview comes under the heading in the article:
"You're middle aged with a family bowel cancer history".
Read the full article at
The Mail on Sunday website.
posted on Wednesday, 15th August 2012
CaPP3: progress towards a launch in 2013
In 2009, we saw the first evidence that aspirin offered a
delayed protection against cancer in Lynch syndrome. We
immediately started dusting off our long held plans for a further
study to see if low dose aspirin would be as effective as the 2
tablets a day we had tested in CAPP2. All agreed we should develop
CaPP3 but first we agreed we needed to get CAPP2 published.
That took longer than expected. After initial rejection by
the New England Journal of Medicine, we took our work to the Lancet
where it eventually appeared online in October 2011 and in hard
copy in December 2011.
You can view the paper online at the Lancet website.
Meanwhile we had developed a detailed plan to test different
doses of aspirin. Statistical analysis indicated we would
need to find 3000 people to compare the effects of 2 tablets,
versus 1 tablet versus a quarter tablet ("low dose"). The
increase in international bureaucracy around clinical trials meant
we would need to set up each country separately so we designed a
study based on the UK population and prepared to submit an
application for funding in early 2011.
We approached Bayer, who had supported CAPP2 and received
encouragement. While they could not accept responsibility for
directly funding a trial of an off patent drug, their long term
involvement as the inventors of aspirin and their continued
involvement in the international aspirin market prompted them to
offer to supply the several million tablets in active and placebo
form needed to carry out the study.
An unexpected turn of events in Spring 2011 was the opportunity
to bid for support to traders in the international bond market as a
"humanitarian cause" which could benefit from their profits while
allowing them to take advantage of more generous trading
conditions. We were promised 5 million euros but sadly, the
turbulence in the bond markets throughout 2011 meant that this
promise was not fulfilled and we withdrew from that option in late
An application was written to the UK National Institute of
Health Research in Autumn 2011 under their "Efficacy and Mechanism
Evaluation" or EME programme. This was rejected.
Instead we designed an application to the Health Technology
Assessment programme for their deadline in January. This was
accepted as being of relevance to the NHS and put forward to the
committee in July. So far, we have not been allowed to
progress to a full application but feedback is awaited.
As a separate exercise, CaPP3 has been presented several times
to the Prevention sub- committee of the National Cancer Research
Institute who have been consistently supportive. With their
encouragement, an outline was submitted to the Clinical Trials
Awards and Advisory Committee (CTAAC) in April 2012. This was
given strong support by the Strategy group who recommended we be
invited to submit a full application. The committee accepted this
advice but required us to cut the budget request.
Our steering committee has achieved a cut by developing a
centralised dispensing and follow-up model. We will rely more
heavily on the genetic research nurse network funded by the
National Institute of Health Research. If and when we are
awarded the core funds by Cancer Research UK, the study will be
accepted on to the Genetics portfolio which makes it eligible for
local research support including research nurses to trace and
consent participants and pharmacy funding to cover the prescription
The closing date for our full submission is 24 August 2012
aiming for a start date in June 2013. We still have to
negotiate the aspirin packaging contract and the national Ethics
Committee permission followed by signing contracts with all 23
Foundation Trust Hospitals responsible for managing the national
network of regional genetics centres.
The full application and trial protocol with supporting
documents will be shared with colleagues in the CaPP consortium so
that they can explore the feasibility of local clinical funding to
allow them to join the effort. If they can secure their local
funds we can share the aspirin with them and offer randomisation
and analysis services through the secure CaPP3 website. This
will ensure we get our 3000 recruits in a timely fashion and keep
us on course for a final answer by 2020!
We recommend that all people with proven Lynch Syndrome or those
at high risk should start taking low dose aspirin as we think this
will offer some protection, based on all the other research coming
out at the moment and may turn out to be as effective as the higher
doses. We can include people in our study even if they have
started taking aspirin as long as they keep a note of the date they
John Burn Chief Investigator August 15th