Patient power can harm your health

The government’s decision to make the unlicensed breast cancer drug trastuzumab (Herceptin) available has been widely acclaimed as a victory for ‘patient power’. But patients could be the losers.

With the support of prominent breast cancer campaigns, Bridgwater nurse Barbara Clark threatened to take her local health authority to the European court if it refused to pay for her to have treatment with trastuzumab, at the cost of £20,000 a year. In response, health secretary Patricia Hewitt has announced that this drug will now be made available to any woman who can benefit from it (estimated at 5000 of the 35,000 breast cancer cases diagnosed each year). The National Institute for Clinical Excellence (Nice) and the drug regulatory authorities are now under intense pressure to approve the drug for use within the National Health Service (NHS).

Roche, the company that makes trastuzumab (which is currently licensed only for the treatment of advanced breast cancer) claims that, if given early in the course of the disease, it can save 1000 lives a year. If this turns out to be true then Barbara Clark’s initiative and Patricia Hewitt’s response will appear in retrospect to mark a significant breakthrough for women with breast cancer. But these claims are not at present confirmed by independent research. What if they do not, as is often the case for new cancer treatments, stand up to closer scrutiny?

The beneficiaries of the trastuzumab case are immediately apparent. Patricia Hewitt showed the characteristic cynicism of New Labour, making a populist gesture in response to consumer demand without regard for the wider consequences for the NHS or its patients. Roche will make a vast profit from the sales of trastuzumab, claiming that costs of ‘R&D’ justify its extraordinary price.

Roche will also no doubt continue to contribute to breast cancer charities that help to promote demand for its products. This case has also raised the profile of breast cancer campaigns as champions of patient power. These organisations provide valuable advice and support for women with breast cancer and their families. Yet their wider campaigning role in raising awareness of breast cancer appears to generate excessive anxiety – and demands for unnecessary screening and investigation.

For example, the British Boob Survey, commissioned by Breakthrough Breast Cancer, was featured in The Times (London) (1). This feature complained that ‘eight out of 10 women have not checked their breasts for signs of cancer in the past month’, that ‘more than half of women do not spare a thought for their breasts on a daily basis’ (!), and that ‘about half of women do not know how to check their breasts’. Yet breast cancer specialists agree that breast self-examination is not a useful technique: it simply provokes anxiety when women cannot tell the difference between benign and potentially significant findings (see What mammography misses, by Michael Baum).

The immediate danger of fast-tracking trastuzumab will be borne by patients with breast cancer who take it. In the current debate it seems to be taken for granted that this drug is both effective and safe. But the only evidence for this comes from trials sponsored by the manufacturer itself. It is true that an apparently well-conducted study reported at a conference in the USA over the summer showed positive results (2). However, because such preliminary studies are often not borne out by larger scale independent researches, it is good practice to await such confirmation before recommending a new drug for general use. Furthermore, this study confirmed earlier reports that trastuzumab may cause serious, potentially fatal, cardiac complications (as well as a range of less serious adverse effects). The authors themselves recommended further studies to investigate the scale of this problem.

Further research may confirm that the balance of benefits and risks in using trastuzumab justifies its widespread use. It may not. The dangers of taking short cuts are that patients’ hopes of a cure for their disease may have been raised only to be cruelly dashed – and that they may suffer the consequences of serious side-effects. Critics of the ponderous process of drug regulation should recall similar criticisms made 40 years ago of the US regulatory agency that refused to license a wonder drug that was already in widespread use in Europe and which was said to be entirely devoid of side-effects. The drug was thalidomide, and the USA was spared the large numbers of congenital abnormalities that resulted when pregnant women took this drug in Europe.

The case of trastuzumab raises a wider concern about patients with serious diseases for which existing treatments are largely ineffective. From the perspective of advocates of ‘patient power’, the way forward in the quest for a successful treatment is to study the latest research in the relevant field, to choose the latest wonder drug being promoted by the pharmaceutical companies and to campaign, lobby (and, if necessary, litigate) to gain access to it. At the very least, this process imposes a heavy burden on people who are ill and in a state of distress over an illness that may have a grim prognosis. The vast majority of patients are ill equipped to evaluate the scientific evidence for any particular treatment, and the struggle to do is likely to compound their distress. Even if they are expert in the relevant disciplines, the experience of illness is not conducive to the dispassionate enquiry necessary to make sound scientific and clinical judgements. Desperate people make poor choices – this is why the sick will always be vulnerable to charlatans.

It is interesting to note that one of the arguments marshalled by the breast cancer charities for fast-tracking trastuzumab through the NHS is that private medical insurers are already funding this treatment. The long record of over-treatment and poor quality treatment dictated by consumer demand in the private sector in the UK (an even bigger problem in the USA and elsewhere) is presented as a model for the NHS – a trend encouraged by the latest New Labour initiatives for extending private enterprise within the healthcare system in Britain.

In Britain today, the burden of having cancer is compounded by the burden of having to become both an expert patient and a heroic warrior in the wider battle against cancer. Both these images are assiduously cultivated by the numerous breast cancer campaigns, which appear to compete with one another in securing celebrity endorsements and promoting heroic images of marathon-running, plucky women, thinking positive thoughts and living virtuous lives. So soon after her death, the wise warnings of US critic Susan Sontag against treating ‘cancer as metaphor’ appear to have been forgotten (3). As one patient with breast cancer said to me, ‘I don’t want to fight anybody, I just want to enjoy whatever time I have left as much as I can’.

Dr Michael Fitzpatrick is author of The Tyranny of Health: Doctors and the Regulation of Lifestyle, Routledge, 2000 (buy this book from Amazon UK or Amazon USA), and MMR and Autism: What Parents Need to Know (buy this book from Amazon (UK) or Amazon (USA)).

(1) ‘Bad checks’, The Times, 6 October 2005

(2) HERA trial presentation, Martine J Piccart-Gebhart, American Society of Clinical Oncology, 2005

(3) Aids and Its Metaphors, Susan Sontag, Penguin, 1989