BSRBR 10th Anniversary brochure - The British Society for ...

Taking up the challenge
BSR was quick to grasp the importance of biologics and understood that a bold approach to
monitoring was needed in order to gain approval for the new treatments.
Professor Gabriel Panayi, BSR President from 2000 to 2002, recalls the
debates that surrounded BSR’s proposal to set up the Biologics Register.
4 | BSRBR 2001-2011
I was President of BSR just as biologics were
being introduced into rheumatology. Studies
showed that one drug, Infliximab, was having
a good impact in the treatment of
rheumatoid arthritis and we were keen to
have it approved for use in Britain.
The difficulty with disease-modifying drugs is
that the cost of monitoring them is often
more expensive than the drug itself. Clinical
trials use only a very small number of
patients, yet only when a new drug goes out
into the clinics do you see how effective and
safe they really are. To sell the fact we
needed this new drug to NICE, we came up
with the idea of a register of patients to spot
problems long term.
With a register we would be contributing to
patient safety, a key consideration for NICE,
and because treatments would be followed
for years we could study how long the drugs
maintained their efficacy, another important
point as far as NICE was concerned.
We had a model of what we wanted to do
and a good idea that our proposed register
would be based at what was then the arc
Epidemiology Unit in Manchester. Because
BSR could not afford to fund such a project,
we proposed the pharmaceutical companies
should fund it.
That decision came only after considerable
debate. We were well aware that we could
be saddling BSR with all sorts of problems.
Contracts to fund the register would have to
be negotiated with the drug companies.
There was also the very real possibility that
we could be laying ourselves open to legal
action, because of the role TNFs play in the
immune system. The introduction of these
new drugs might increase the risk of patients
developing cancerous tumours and
infectious diseases.
Andrew Bamji and his colleagues in the BSR
Clinical Affairs Committee played a crucial
role in the discussions surrounding these
issues. It was an act of bravery to establish
such a register, not least because everyone
was aware there were other complications,
too. Legal and insurance frameworks would
have to be in place if we received the
go-ahead. Not a lot of hard and fast
planning was done initially, because we
had no guarantees that either NICE or the
pharmaceutical companies would accept
our proposal.
NICE reviewed the clinical trial data on
anti-TNF drugs and made approval
conditional on the kind of long-term
monitoring that we proposed. It told the
drug companies they could set up registers
individually or they could go through the BSR.
Rheumatologists would own the data rather
than the drug companies, who were invited
to respond to any research about their
products in the usual manner of scientific
debate. It was a novel concept and
fortunately the pharmaceutical companies
came on board and supported it.
BSRBR was the first register of its kind in
rheumatology and it has changed the way
we approach the post-marketing surveillance
of drugs. In the past, surveillance depended
on drug companies and the NHS’s
yellow-card system. If a doctor saw a
reaction in a patient to a treatment, they
would fill in a card and post it to the
Department of Health.
That approach gives no indication of how
many patients are taking the drug at a given
time, making it hard to tell whether an
individual response is statistically important.
Also, doctors only report side-effects, not
the absence of side-effects.
By contrast, the Register is a never-ending
goldmine of information, a vast enterprise
that has made BSR known all over the world.