Select Committee on Health Written Evidence

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 expertise to:

    —  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 their treatment.

  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 equivalent.

  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.[364] 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.[365] 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 medications.

  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.

September 2008

364   British National Formulary. March 2008. Pages 1,19, 100 &105. Back

365   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 2002. Back

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