1 Centre for Reviews and Dissemination, University of York, UK
2 Centre for Reviews and Dissemination, University of York, UK
3 Department of Health Sciences, University of York, UK
Correspondence to: Paul M Wilson pmw7{at}york.ac.uk
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Design We used the NewsBank database to search eight national daily newspapers, and their Sunday equivalents, retrospectively from 19 February 2006 back to the earliest mention of trastuzumab or Herceptin (19 May 1998).
Setting UK national newspapers.
Main outcome measures To be eligible for inclusion, articles had to contain at least three sentences about trastuzumab. Articles that focused on the financial performance of companies associated with the drug were excluded from the analysis. For each included article, we extracted bibliographic details and data, and independently rated the reporting slant towards trastuzumab and, where relevant, the reporting slant towards access to treatment.
Results We identified 361 articles that met the study inclusion criteria. The proprietary name of Herceptin was always used, with only eight articles mentioning the generic alternative. 294/361 included articles (81.5%) were rated as being positive towards trastuzumab, the remainder rated as neutral. Access to trastuzumab treatment was the main narrative running across included articles and reports of individual patients seeking treatment featured prominently throughout. In 208/361 of included articles (57%) the reporting slant towards access to trastuzumab treatment was rated as negative. 178/361 of included articles (49.3%) mentioned licensing, but rarely mentioned that licensing processes can only occur when the manufacturer applies for a licence. Only a minority of articles mentioned that the drug had to be licensed before it could be subject to the NICE approval process.
Conclusions Newspaper coverage of trastuzumab has been characterized by uncritical reporting. Journalists (and consumers) should be more questioning when confronted with information about new drugs and of the motives of those who seek to set the news agenda.
| Introduction |
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There has been much discussion and debate about media reporting surrounding the introduction of the monoclonal antibody trastuzumab (Herceptin®, Roche, Basel, Switzerland) for early stage breast cancer.2–6 In particular, concerns have been raised about the role of media pressure in bringing about changes to the processes for assessing new and potentially life-saving medicines as undertaken by the National Institute for Health and Clinical Excellence.7
In the UK, daily national newspapers remain a major source of news for clinicians and consumers alike, with over 10 million newspapers sold every day. Although the role of media reporting has frequently been highlighted and questioned, no systematic and critical assessment of coverage surrounding trastuzumab has been undertaken. Given this, we set out to examine and critically describe the content and main narratives in UK national daily newspaper coverage of trastuzumab.
| Methods |
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The search aimed to identify relevant articles published in the major daily UK national newspapers and their Sunday equivalents. Based on figures from the Audit Bureau of Circulations (www.abc.org.uk), the combined average daily net circulation of these newspapers is in excess of 9.5 million. Two daily national newspapers, the Financial Times (daily net circulation of around 133,000) and the Daily Star (daily net circulation of around 650,000), were not available via the NewsBank database and so were excluded from the study.
To be eligible for inclusion, articles had to contain at least three sentences about trastuzumab. Articles that focused on the financial performance of companies associated with the drug were excluded from the analysis. Decisions about the inclusion of articles were made by one researcher and checked by another, with recourse to a third where necessary.
Using Microsoft Access, we recorded bibliographic details (headline, date of publication, newspaper, type of article), whether or not trastuzumab was the primary focus of the article and whether the article was primarily about effectiveness or access to treatment for each included article. We then recorded the following pre-defined details: any mention of early or advanced breast cancer; any attempt to describe how trastuzumab works; any mention of HER2 (a protein growth factor receptor that can affect the growth of cancer cells, and the over-expression of which trastuzumab suppresses); any descriptions of who is eligible for treatment; any mention of research findings (citation of the source research was not necessary – statements such as research has found or trials have shown were included); any mention of potential side effects; any attempt to describe the licensing status / regulatory process; any stated costs of treatment; details of all people or organizations referred to; any mention of NICE or the manufacturer Roche; any criticisms or cautions regarding trastuzumab.
For each included article the overall reporting slant towards trastuzumab was independently rated (positive, negative or neutral) by one researcher and checked by another, with recourse to a third where necessary. For an article to be rated positive, it would have to consistently use terms such as life-saving or wonder drug, and/or present supporting effectiveness data, and/or include enthusiastic testimonials without any balancing elements to set the drug in context. Negative articles would have to present the opposite. For an article to be rated neutral, it would have to avoid the use of emotive language, present any effectiveness data in context, and/or not promote a particular view.
For each included article that mentioned access to treatment, the reporting slant was also independently rated as positive (i.e. gaining access to trastuzumab), negative (i.e. being denied access, losing out because of postcode prescribing, etc.) or neutral (i.e. not making a judgement either way). An article could be rated as being positive towards trastuzumab but negative in terms of access to treatment. For example, if a news article reported that women were being denied access to an effective or life-saving treatment, the reporting slant would be rated negative in relation to access to treatment but positive towards trastuzumab itself.
| Results |
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Stage of cancer
Before 2005, all newspaper coverage is focused primarily on trastuzumab for advanced breast cancer; the drug's availability for early breast cancer is only explicitly mentioned once (24 July 2001). From 2005 onwards the focus shifts to trastuzumab for early breast cancer. All except five of the 43 articles that only mentioned advanced breast cancer were published before 2005.
Research
Fewer than half of the articles made any mention of research (173/361, 47.9%). Of those that did, the majority appeared in 2005 (111/173, 64.2%). This was largely due to repeated newspaper reporting of an interim analysis from the HERA (HERceptin Adjuvant) trial and a joint interim analysis of the National Surgical Adjuvant Breast and Bowel Project (NASBP) and North Central Cancer Treatment Group (NCCTG) trials. These interim analyses were announced to the media in April by Roche, presented at the American Society of Clinical Oncology Annual Scientific Meeting in May and were published in the New England Journal of Medicine in October.11,12 Of the 111 articles published in 2005, 69 reported that trastuzumab halves the chances of recurrence if used for early stage breast cancer. Only one of all the included articles (Express on Sunday, 19 February 2006) reported the estimate of risk reduction in absolute terms.
Side effects
Of the 51 articles mentioning side effects, 22 mentioned that there was an increased risk of heart problems, eight mentioned that trastuzumab had fewer side effects than existing treatments, three stated that there were no side effects and one stated that women had died whilst taking the drug. The remainder stated either that the side effects were minimal or that the safety implications were still being assessed. The earliest mention of side effects occurred in 2000 .
Access to treatment
Estimates of the cost of one year of treatment on the NHS ranged from £5,000 to £40,000 (median £20,000). Half of all estimates were between £19,500 and £22,000. According to NICE,13 the average cost per person of the thrice-weekly regimen is £24,600 (excluding VAT) and the average cost of the once-weekly regimen is £28,000 (excluding VAT). The licensing status of trastuzumab was mentioned in around half of all included articles (178/361, 49.3%), and most stated that the drug had a licence for use in advanced but not early stage breast cancer. Thirty three of these 178 articles correctly stated that the drug had to be licensed before being subject to the NICE approval process. Only 19 of the 170 articles that mentioned licensing before Roche announced that it had applied for a licence on 17 February 200614 stated that the company had yet to apply for a licence for early stage breast cancer. Two articles stated that the company had not yet collected the safety data needed to apply for a licence for use in early-stage breast cancer, whilst one other stated that responsibility for the delay in licensing for early-stage lay largely with the manufacturer.
Named patients were mentioned in two thirds of all included articles; the earliest reference to a patient was made in January 2000 (see Box 2 for details of the main high-profile patients). Barbara Clark was the patient most frequently referred to (89 articles) followed by Anne Marie Rogers (58 articles) and Elaine Barber (31 articles). Dorothy Griffiths, a patient and founder of Women Fighting for Herceptin, was mentioned in 12 articles. Cancer charities were mentioned in 20% of all included articles (74/361), with CancerBacup being the charity most frequently referred to (33 articles). Roche, the manufacturer, were named in 70 articles. The Secretary of State for Health, Patricia Hewitt, was the most frequently mentioned politician (29 articles).
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| Discussion |
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Strengths and weaknesses of the study
Our study has focused exclusively on one sector of the media. Widespread coverage has also occurred in other media outlets, including local newspapers, television, radio and the internet. Given the breadth and depth of the national newspaper coverage, we feel it unlikely that any major reporting themes will have been missed by our study. In addition, our analysis has focused on a potentially life-saving treatment for breast cancer, a disease with dramatic advocacy and currency in the public consciousness. Because of this, we recognize that debates surrounding new technologies in other disease areas are unlikely to generate as much coverage as those for breast cancer do. However, recent UK newspaper coverage surrounding the availability of drugs for Alzheimers' disease, age related macular degeneration and colon and lung cancer all suggest that the nature of coverage presented in our analysis is not the exclusive preserve of more high profile diseases and conditions.
Meaning of the study
New drugs by their very nature are incomplete products, as full information about their safety, effectiveness and impact on costs are not yet available. Additionally, the constraints of newspaper reporting are well documented,15,16 so it is naive to expect a comprehensive and detailed analysis of the effectiveness of a new technology. However, previous research has suggested that journalists tend to focus strongly on the positive aspects of a health technology during its early stages.17,18 This appears to be borne out in this instance, as the coverage is overwhelmingly positive and uncritical towards trastuzumab, with many articles opting to use phrases like wonder drug and magic bullet to describe the effects. There were articles by both tabloid and broadsheet newspapers that did attempt to provide a comprehensive and detailed analysis (using non-emotive language and discussing how the drug works, patient eligibility, the research evidence and potential adverse effects) but these were the exception rather than the rule. It is worth noting that enthusiastic support for what is new is not the sole preserve of newspapers and can often easily be seen in other media outlets and among the medical and scientific communities.
Our analysis also suggests that there appears to be a lack of media understanding of the licensing process for a new drug and the role of NICE. Criticism of the length of time taken by the NICE approval process for both advanced and then early disease was evident throughout the study time frame. Only a minority of articles correctly stated that the drug had to be licensed first before it could be subject to the NICE approval process. Licensing processes were put in place to protect the public and to ensure safety and efficacy; the Norplant case17 illustrates that when adverse events do arise the press tend to make it headline news and ask how such a thing was allowed to happen. The fact that Roche had not submitted a marketing authorization application to the European Medicines Agency (EMEA) for trastuzumab as adjuvant treatment for early-stage HER2-positive breast cancer was rarely mentioned in included articles and was mentioned in only one headline. Because of public pressure, the EMEA took the rare step of issuing a news release in September 2005 to state that it had not received any application,19 though this was not referred to in the press coverage at the time.
The use of the emotive human interest story to illustrate and individualize news issues has long been a cornerstone of journalism generally and health reporting in particular. What is striking about this media coverage is the number of individual cases that have been represented in the news and that have helped to sustain the newsworthiness of the issue over such a long period of time. How these individuals have come to be the focus of such extensive news coverage is not immediately apparent in all instances. The solicitors Irwin Mitchell have been responsible for the high profile of some patients, most notably Elaine Barber and Anne Marie Rogers. In fact, their promotional campaign Fighting for Herceptin was short listed for the 2006 Chartered Institute of Public Relations Excellence Awards. Other patients may have been approached as part of a promotional campaign organized by the PR company Ketchum, who provide Roche with public relations support for its portfolio of oncology products in the UK.20 The role played by the cancer charity CancerBacup in promoting access to trastuzumab and the fact that the charity receives sponsorship from the drug's manufacturer has been highlighted elsewhere.3,21 In this analysis, the charity actually features in less than 10% of included articles. As this is explicit coverage we have no way of knowing the extent of any influence behind the scenes in terms of promoting specific cases, or how much the charity was used as an information source.
It is crucial that journalists are critical of the motivations of those who bringing the stories to their attention. Direct-to-consumer advertising of prescription-only medicines is banned in most countries, appropriately so given that evidence suggests that it does have a negative impact on prescribing behaviour.22 Some journalists are very aware that health pages of newspapers can and are being used as a vehicle for product placement and that there is also some evidence of pharmaceutical companies targeting journalists as part of a marketing strategy to raise public awareness and stimulate demand.20,23 Pester power is a concept normally associated with advertising aimed at children. The question to be asked in this context is, are we witnessing patient pester power or quasi direct-to-consumer advertising, where awareness is raised about new products and patients, charities and indeed clinicians then demand that these products be made available? If this is the case, we need to know more about who is driving this type of marketing, its actual impact on clinician and consumer behaviours and whether it is permitted within the existing regulatory code of practice.
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| Footnotes |
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DECLARATIONS
Competing interests AB and PMW were part of the team that produced Hitting the Headlines (2000–2008), a news analysis service which aims to assess the reliability of both journalists' reporting of health stories and the research on which they are basedFunding None
Ethical approval Not required as the study was based purely on the analysis of material in the public domain
Guarantor ISW
Contributorship All authors contributed to the conception, design and analysis of the study. All authors were involved in the writing of the first and subsequentversions of the paper. The views expressed in this paper are those of the authors alone
| Acknowledgements |
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| References |
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R E Ferner and S. E McDowell A model for NICE in the US BMJ, June 3, 2009; 338(jun03_2): b2221 - b2221. [Full Text] |
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