Memorandum by Bristol-Myers Squibb and
sanofi-aventis (PS 64)
1. Bristol-Myers Squibb and sanofi-aventis
welcome the opportunity to respond to the Health Committee's call
for evidence in relation to its inquiry into patient safety. We
are committed to ensuring the safety and integrity of our products,
working with the NHS and patients to ensure that the therapies
we make are properly and safely used to the benefit of patients.
2. With reference to this inquiry, we have
some particular comments to make with regard to minimising risk
to patients though appropriate medicines management and the role
of national policy in supporting this. We will be using the example
of cardiovascular disease (CVD), in which area the two companies
have considerable experience as the manufacturers of two medicines:
Plavix (clopidogrel), an anti-platelet agent and Aprovel (irbesartan),
an antihypertensive agent.
3. We firmly believe that clinicians are
best placed to advise their patients on the most appropriate intervention
for their condition and should be free to prescribe the therapy
which they feel is best for them.
4. The initiation of any medical intervention
by a healthcare professional is judged against the possibility
of the patient suffering greater harm or ill-health occurring
if no action is taken. Patients expect clinicians to use their
assess the various interventions
open to them;
judge the risks and benefits associated
with each; and
communicate these risks and benefits
clearly so that the patient can be involved in decisions about
5. We are therefore concerned by the proliferation
of metrics on the use of medicines, instigated as a result of
national policy direction, which may not only compromise clinical
judgement but could potentially put patients at risk of harm.
6. In particular we have reservations over
the safety and efficacy of the wholesale population-based switching
of patients between medications. The Department of Health has
recently developed a number of Better Care, Better Value (BCBV)
indicators, designed to introduce metric-based incentives for
switching patients' therapies. BCBV indicators can have serious
negative implications when applied to medicines that are not therapeutically
7. For example, we understand that the Department
has plans for a BCBV indicator in the area of antihypertensives,
encompassing different therapies including ACE inhibitors and
angiotensin II receptor blockers (ARBs). Different ARBs and ACE
inhibitors have very different licensed indications, levels of
proof of benefit and side effect profiles.
Switching the antihypertensive medication, even within the same
class, of a patient whose blood pressure had previously been controlled,
could potentially lead to a period of time where blood pressure
control is lost. Even small changes in blood pressure have been
seen to lead to significantly greater risk of poor health outcomes
such as stroke.
We suggest that switching the blood pressure medicine of a controlled
patient is an "avoidable risk".
8. While we support the Department of Health's
efforts to secure value for money to the NHS, we believe that
a national target in the form of a ratio in the area of antihypertensives
is inappropriate. Any ratio that would drive switching, not just
within a class of medicines but across classes, is a serious step
to take. Short term cost saving should not be given precedence
over individual clinical need and, importantly, patient safety.
9. We are also concerned by the development
of software technologies which may encourage GPs to switch patients'
medications, for example ScriptSwitch. These technologies work
by highlighting different medicines to the GP at the point of
prescribing and are sold to practices on the explicit basis that
they can help the practice make cost savings.
10. The software comes from the supplier
pre-loaded with recommendations that are based on cost-comparisons
of licensed doses. Though some primary care organisations take
the time to review these and ensure that dose responses of different
medications are compared and patients are switched to an equivalent
dose, others do not. This can result in controlled patients being
moved onto a cheaper but sub-therapeutic dose of an alternative
medicine. In addition, we are concerned that such programmes may
not have the sensitivity to make appropriate recommendations which
take into account individual patient variability in response to
11. Although these systems may have a role
to play in supporting clinicians and ensuring they are aware of
local PCO guidelines, they are no substitute for full assessment
of an individual's need made by their GP.
We would welcome the opportunity to discuss
the points outlined above in more detail and would be happy to
provide oral evidence if required.
364 British National Formulary. March 2008. Pages 1,19,
100 &105. Back
Lewington S, Clarke R et al. Age-specific relevant of usual blood
pressure to vascular mortality: a meta-analysis of individual
data for one million adults in 61 prospective studies. Lancet