EXPERIMENTOS PARA FLUJOS SOBRE UN OBST ´ ACULO

The process of approval of Herceptin for late stage breast cancer, therefore, displayed two characteristics: there was very little media surrounding the case, with scarce coverage about individual patients and not much about the drug itself, even though the debate about postcode lottery gained some traction after CancerBACUP’s intervention in 2003; secondly, once the technocratic process of appraisal started, it got enclosed in NICE’s committees, following its usual long course, led mainly by health professionals and health economists. Roche issued very little information about the drug during this time, with only one of the seven statements released by the company from 1998 to 2002 making reference to results and scientific data (Roche, 15th of March 2001), an unusual procedure. “When the drug is about to be launched, there will be another phase of producing papers and meetings which will continue after the drug is marketed, establishing its name and keeping people aware”67.

When the results of the HERA trials (phase 3) linked to early breast cancer were about to be released in 2005, however, the strategy was markedly different and more in line with the practice described above. The first to break the news was the National Cancer Institute, the medical facility conducting the randomised trials of the drug in the US. According to the report, “patients with early-stage breast cancer who received Herceptin in combination with chemotherapy had a significant decrease in risk for breast cancer recurrence compared with patients who received the same chemotherapy without trastuzumab”, an important achievement because HER-2 positive tumours grow faster and are more likely to return (24th of April 2005). The report states that patients receiving trastuzumab in combination with standard

combination chemotherapy had a 52 percent decrease in cancer recurrence compared to patients treated with chemotherapy alone, quoting scientists describing the drug as “truly lifesaving”.

Roche followed suit to announce the results through its own press office (26th of April 2005), a procedure also adopted in other key moments of the process: new favourable trial data was made public by Roche in May and June 2006 (3rd of June 2006; 29th of May 2006), straight after the new indication of the drug had been approved by the European Medicines Evaluation Agency (EMEA) but still needed a

NICE stamp. There was a clear clinical value story being used this time too: Herceptin was effective compared with placebo and other treatments, something that can be argued across different countries. The problem for Roche, therefore, was to create a convincing complement to the narrative about the cost-effectiveness of Herceptin for the particular British context in which “what they really want to know is how many life years do you gain and how much survival do you get for the money”? 68 Part of the answer is to deflect attention from the price or, rather, making sure “the drug is seen as having a good benefit so that it balances the price”69.

Media coverage worked most of the time in Roche’s favour, partially because of the particularities of the British debate surrounding medical care. Throughout the process, newspapers based their stories in two lines: one was about the life saving character of the drug, used by all kinds of media outlets but more common in broadsheet and financial newspapers; the other focused on rationing and postcode lottery, with refusals to fund the drug from the part of local authorities fuelling the use of individual stories, particularly in tabloids. While both story lines were compatible and frequently used together, emphasis on the former or the latter depended on the type of newspaper and timing of the process. The narrative about the new and miraculous nature of Herceptin started to circulate straightaway, with The Guardian (27th of April 2005) publishing an article with quotes about how “the NHS needs to make immediate provision” for Herceptin one day after the new results were

announced by Roche.

The Wall Street Journal Europe referred to ‘cure’ despite the follow up period of the drug reaching only 18 months of the usual 60 required. The article reproduced the opinion of Eric Winer, from Dana-Farber Cancer Institute in Boston:“HER2 positive may very well be the first subtype of breast cancer where we look back and say: we cured this type of breast cancer”(15th of July 2005). Tabloids were

unsurprisingly drawn to superlatives: after being dubbed the magic bullet or wonder drug by The Daily Mail (19th of September 2005), Herceptin coverage included only positive specialist opinion. George Sledge, a breast cancer specialist in Indiana, told The Daily Mail that Herceptin produced “the most stunning results in a clinical trial in my entire career”, while cancer consultant Andrew Wardley, from the Christie’s

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Hospital and Manchester University, stated that “it does not only shrink the cancerous tumour, it eradicates the cancer” ( 4th of October 2005).

Within the scientific community, the debate was more controversial, with professionals considering Herceptin as one of the biggest breakthroughs in the history of oncology and others showing more caution. The results of the US trials published in October 2005 in the New England Journal of Medicine were greeted by the British

Medical Journal as “stunning”. The American Medical Association, however, called

for some sort of “scepticism”, while The Lancet called the excitement “premature” and “profoundly misleading”, arguing that was insufficient evidence to make reliable judgements on the drug’s efficacy and safety and calling for cooler heads. Reported by the FT, NICE’s chairman, Sir Michael Rawlins, claimed that the evidence

published in medical journals was far from the necessary data taken into consideration before the licensing authority can give a verdict: “A couple of clinical trials published in a medical journal are woefully inadequate for really assessing the safety and

efficacy of a product”(FT, 11th of November 2005).