Straight shooter

There is a cartoon which illustrates the difficulties of purely emotional arguments and the need for considering other people's positions. It shows two men sitting either side of a table, shouting loudly at one another. The caption says: 'The first one to pause for breath will be declared the listener'. We now appear to be in a similar position with regard to the availability of Herceptin and other new so-called 'wonder drugs'.

Allowing prescription of vital, potentially life-saving medicines on the basis of `who shouts loudest' is not a serious way to address the challenges posed by the development of new drugs. They need researching, developing, testing, proving, licensing, marketing and funding.

The way these processes happen is an important matter and deserves informed public debate. Unfortunately, much of the media, the populist papers in particular, are letting their readers down. In mitigation, however, I plead that they are being egged on by some of the UK's leading oncologists, cancer charities, the Prime Minister and the Secretary of State for Health.

The current hysteria is an inevitable consequence of the way health stories are reported, and the competing emotional and rational interests.

Contrary to Roy Lilley's comments in the December issue of Pharmaceutical Marketing, Herceptin does appear to be very effective in women with early-stage HER-2 positive breast cancer compared with what has been available so far.

Don't take my word for itÖ listen to Dr John Toy, medical director of Cancer Research UK. These are stunning results for women who have got this particular sort of breast cancer.' Professor Ian Smith, from the Royal Marsden, no less, hailed the results: One of the most important developments in breast cancer treatment.

Oncologists and folk who run reputable cancer charities are very sensitive to accusations of raising false hopes. They are not hysterical shoot-from-the-hip types, so when they make these kind of statements it's right that we should sit up and take notice.

It is, of course, correct that the 50 per cent figure being bandied around is the reduction in relative risk of the cancer returning, not the absolute reduction. Yes, a bigger absolute risk reduction would be great but, in its absence, we have to take what we're given and ask the experts to put it into context. When they use words like stunning and unprecedented what are we expected to think?

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However, for some newspapers those reports acted as the starting pistol for a race to see who could be the most emotional, one-sided and hysterical. When reports from medical and scientific journals appear in the lay press, a process of translation takes place. Herceptin provides us with a great example, but it always works like this:

• Fine details painted in subtle shades are replaced by broad brush strokes in primary colours

• Caveats are shedded, important details are lost completely

• Emotional case studies ('victim' sufferers or 'survivor' recipients of the miracle drug) are used to illustrate the story

• Cautionary words, like 'may' or 'could', appear in the body of the story, but not in the headline

• Selective quotes appear from study authors and independent experts

• Figures are rounded up or down to illustrate the biggest effect

• Emotional headlines top off the package.

The same process takes place whether the results are revealing a `miracle cure' or a `killer drug', the two classes of drugs favoured by journalists.

In the Herceptin case, the authors of the HERA study (the basis of Roche's submission to the EMEA and Genentech's submission to the FDA) acknowledged the limitations of their interim analysis.

They included the phrases: 'The interpretation of our results must take into account the very short follow-up periodÖ however, the significant reduction in riskÖ justified release of the results of the interim efficacy analysis.' They also admitted: `an incomplete picture of the risks associatedÖ the risk of cardiotoxicity is currently low in our trial, but this could change with longer follow-up'.

The initial reporting of the results mostly ignored the caveats, as headline-writers summarised the main efficacy findings: `HERCEPTIN CUTS RISK OF CANCER', and `BREAST CANCER DRUG HALVES RETURN RISK' were typical, from the Daily Mirror and Daily Mail.

It was the next stage when things started to get out of hand, with headlines like: `IT'S LIKE BEING ON DEATH ROW' or `YOUR GUIDE TO THE CANCER WONDER DRUG', and my own favourite from the Mail, `WE CAN'T CURE YOUR CANCER, BUT HERE'S A HEADSCARF'.

A blunt edge
Since then, in the populist papers at least, most of the coverage has been an attempt to portray something complex and rational, as simple and emotional.

Headlines such as those above generate more heat than light on a complicated subject. It's not uncommon in some of the media, but the consequences here are far more serious than misreporting the hyped antics of Big Brother or X-Factor winners.

The readers in this case are also patients and their families. The readers also are, or have been, taxpayers whose contributions will fund Herceptin, other cancer treatments, Alzheimer's drugs, Tamiflu, statins, Viagra, MS treatments and all the other exciting developments promised by the pharmaceutical industry.

Like any shouting match, the quiet but calm voices urging caution go unheard. In the Herceptin case, an important point has been lost, and is almost unmentioned in much of the populist coverage: Herceptin is not licensed for early breast cancer.

Put another way, it's not about the money... it's about the licence. Once licensed, if recommended by the National Institute for Health and Clinical Excellence (NICE), the money will have to be found...but that is not yet the argument.

This is where the public is being short-changed. The differentiation between different types of breast cancer is seen as an irrelevant detail, and that between early- and late-stage HER-2 positive disease is almost never mentioned. The lack of a licence for early disease is dismissed as a mere technicality.

In this country we are used to the allegation of `Trial by media'. Usually this concerns politicians, celebrities and other high-profile people. Now, though, there is a dangerous development... `Clinical trial by media'.

'WE WANT IT NOW!' scream the headlines. Forget the randomised trials, the tight inclusion and exclusion criteria, the absolute versus relative risk reduction, the long-term follow-up, the potential cardiovascular effects, the considered opinion of ODAC (Oncologic Drugs Advisory Committee) and other licensing committees, the licensing procedure, the role of NICE... `WE WANT IT NOW!'

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No early use licence
The issue has been fuelled by emotional case studies and the campaign being waged by the patients, or the `Herceptin ladies' as they've become known. Pictures of them wearing campaign T-shirts outside 10 Downing Street guarantee coverage.

Is it right that they should be advised by communications specialists?

Of course it is. The researchers, lobbyists, journalists, doctors are all professionals, receiving high-quality advice. Sending a group of cancer sufferers into the bearpit that is the media spotlight without any help is really throwing people to the lions. Yet, their campaign, understandable though it is, hides an important element of the Herceptin story.

In recent times, there has been a growing clamour, led usually by patients, patient groups or medical charities, for a range of new drugs to be made available on the NHS. However, there is a crucial difference between Herceptin and almost all other cases. In most cases, the drug in question has received a licence and the argument has been with NICE, which has either turned the drug down, significantly restricted its use, or been attacked for taking so long over its deliberations.

The argument over Alzheimer's drugs is a case in point. Public and media pressure led to political pressure which led to a revisiting of last March's decision not to fund the drugs on the NHS because they were not cost-effective enough. Three of the four treatments will now be available to patients with moderate AD.

A drug is only licensed when it has been found to be safe and effective when used at the correct dose in the right way for the licensed indication. Such decisions are reached after exhaustive investigation of data, itself generated by long-term trials.Clinical trial by media takes no account of this procedure.

The Herceptin coverage demonstrates another key point about the media's relationship with the pharma industry: they like to have their cake and eat it. They want the right to call for unlicensed drugs to be used when they say it's OK, and licensed, safe drugs to be withdrawn when they say the treatments are dangerous - `miracle cures and killer drugs' again.

Yet, just as the mere fact of being observed in a clinical trial can change the way patients behave, so media reporting of an issue can affect its outcome.

The question to the media is: what would happen if drugs were rushed through the licensing procedure under media and political pressure, then found later to be ineffective or, worse, unsafe? What would the story be then? Would we see editors apologise to readers who'd been damaged? Would newspapers take up the case of drug developers and manufacturers against the women lining up to sue them? Dream on... it would be another top story, with screaming headlines, emotion and dire warnings about pharma being out of control.

The Author
John Clare is a former ITN and Daily Mail journalist.  He is a managing director of Lions Den Communications, a pharma specialist media and communications consultancy.  The views expressed here are his own, not necessarily his clients'.