The New NICE Guidelines for Management of Breast Cancer—A Personal Commentary

Response from David Miles, Adrian Harnett and Fergus Macbeth, on behalf of the NICE Guidelines Development Group

Professor David Miles, Mount Vernon Cancer Centre, Northwood, Middlesex, Dr Adrian Harnett, Consultant Clinical Oncologist, Norfolk and Norwich University Hospital, Norwich, Fergus Macbeth, Director of the Centre for Clinical Practice, NICE.

Chris Poole’s article makes a good read but is full of misdirected and often ill informed criticism. His account of World War II food rationing is fascinating but not relevant. He implies that it was somehow good and necessary, compared with the malevolent rationing that NICE now imposes on the NHS. But the reality is that we live with limited healthcare resources which need to be used wisely and appropriately (call that ‘rationing’ if you want). A world in which oncologists have unfettered clinical freedom is called Utopia, not the NHS. NICE is there to help make appropriate choices on behalf of all NHS patients.

A few of Professor Poole’s misunderstandings include:

• Guidelines are for guidance. They are not mandatory and do not limit a clinician’s ability to make appropriate and justifiable clinical decisions for individual patients
• NICE has actually approved far more cancer drugs than it has turned down and, through the funding directive, has made millions of pounds available for cancer chemotherapy. When there have been delays, these have often not been because of NICE
• NICE’s processes are transparent. The health economics may be complicated, but that does not mean that the methods are opaque
• The very real problem of crossover in trials is well recognised and understood by NICE
• His criticism of the methods of assessing drug combinations makes no sense. The additional cost of providing the combination compared to the comparator regimen is what is used when constructing the ICER (incremental cost effectiveness ratio)
• The pronouncements of the Commons Health Select Committee are not ‘edicts’ and do not necessarily become policy

When NICE develops guidelines, its remit is to be clear, evidence-based and helpful. It strives to achieve this goal despite a background of widely divergent clinical opinion, which is often subjective, even anecdotal.

The current NICE guidelines for early-stage breast cancer¹ have caused some controversy, in two areas particularly, among those involved in the care of women with the disease, as reflected in the article. Firstly, there is unhappiness with the recommendations about the use of taxanes in early-stage disease:¹

• “Offer docetaxel to patients with lymph node-positive breast cancer as part of an adjuvant chemotherapy regimen"
• "Do not offer paclitaxel as an adjuvant treatment for lymph node-positive breast cancer”

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