Abstract
Summary
Background
In August 2006, the Australian government announced that Herceptin (Trastuzumab) would be added to the national Pharmaceutical Benefits Scheme (PBS) of government-subsidized drugs, for treatment with adjuvant chemotherapy of HER2 breast cancer. Following initial reticence, the health minister responded to a campaign by patients and patient advocacy groups by announcing PBS subsidization which lowered the cost of a weekly dose from A$1000 to A$30. The cost to the government would be A$470 million over three years for treatment of an estimated 2100 women annually.
Design
We analysed the news frames used in all direct and attributed statements (n=239) in television news coverage of the discourse preceding the Herceptin decision by the Australian government.
Setting
Five Sydney free-to-air channels between October 2005 and August 2006.
Main outcome measures
News frames or themes.
Results
Of five news frames identified, one (‘desperate, sick women in double jeopardy because of callous government/incompetent bureaucracy’) accounted for 54% of all reported statements. Government financial parsimony was framed as responsible for the women's plight, with drug industry pricing never mentioned. Claimed benefits of Herceptin often conflated cancer non-recurrence and survival and favoured quantification rhetoric which emphasized percentage increases in improvement rather than the more modest increases in absolute survival.
Conclusions
News frames invoking key tenets of the ‘rule of rescue’ dominated television discourse on Herceptin. Clinicians, patients, their families and patient advocacy groups invoking the rule of rescue can increase the likelihood of achieving their objective of gaining access to expensive healthcare such as pharmaceuticals. Rational, criteria-based public health policy will find it hard to resist the rule of rescue imperative.
Introduction
In August 2006, the Australian government announced that Herceptin (trastuzumab) would be added to the national Pharmaceutical Benefits Scheme (PBS) of government-subsidized drugs for treatment with adjuvant chemotherapy of HER2 breast cancer. 1 PBS decisions are based on recommendations by the Pharmaceutical Benefits Scheme Advisory Committee (PBAC), which assesses applications for subsidization based on a number of criteria, including cost-effectiveness. 2
Timeline
In 2006, confronted with a crescendo of media demands that Herceptin be subsidized for early stage cancer, the health minister, after initial public reticence, announced PBS subsidization, 5, 6, 7 lowering the cost of a weekly dose from A$1000 to A$30. 8 The cost to the government would be an estimated A$470 million over three years for treatment of an estimated 2100 women annually. 4
The HER2 protein is present in 15–25% of all breast cancers 9 , 10 and is associated with a more aggressive form of the disease. Women with HER2 are also at increased risk of recurrence and have poorer survival than those with non-HER2 variants. Since 2005, five trials of post-surgical treatment using Herceptin and adjuvant chemotherapy have reported a 42–50% reduction in relapse, and a reduction in risk of death of 33–44%. 11, 12, 13, 14, 15 In the most recently published multi-country trial, 89.7% of women not using trastuzumab were alive at three years, compared with 92.4% of women using the drug, an absolute survival benefit of 2.7%. 15
Publicity surrounding research in the New England Journal of Medicine (NEJM) 12 , 13 created a surge of demand for Herceptin in several countries, although the drug was unlicensed for treatment of early breast cancer and Roche had not submitted data for the drug's approval. 16 The European Commission approved Herceptin in May 2006; 17 France by-passed its own approvals process to release the drug; 16 a number of Canadian provinces fast-tracked it; 18 , 19 while in the UK the National Institute for Health and Clinical Excellence and the Department of Health ‘under considerable political and media pressure’ announced an acceleration of the assessment process for drugs deemed to be potentially life-saving, including Herceptin, in November 2005. 16 A more recent evaluation of Herceptin's progress in the UK cites the influence of the pharmaceutical industry, patients and their support groups, the media and politicians in the decision to fast-track the drug. 20
The key contested issue remains cost-effectiveness. A study published in 2005, before the Australian government's decision to subsidize the drug, claimed that Herceptin was not cost-effective but allowed that future improved survival rates and reduced drug costs may alter that conclusion. 21 More recent studies have concluded that one year of adjuvant Herceptin therapy is a cost-effective treatment for early breast cancer. 22 , 23 An assessment of the Australian context concluded that given as adjuvant therapy, Herceptin ‘may be cost-effective when given over either 52 or 9 weeks at current acquisition costs’, 24 also noted that the cost-effectiveness ‘with respect to mortality remains uncertain’. 24 Another concern is whether subsidization means that other treatments will be disadvantaged, given limited healthcare budgets. 10 , 25 , 26 Some contend that the price of Herceptin is acceptable given its reported effectiveness, and that failure to subsidize it limits its accessibility to wealthier individuals. 27
The role of media influence on health policy formulation is well established, 28, 29, 30, 31 including findings from a growing literature on media coverage of cancer, 32, 33, 34, 35 including breast cancer. 36 , 37 By presenting real people in distress, news reports often invoke Jonsen's ‘rule of rescue’ 38 – described as the ‘psychological imperative… to rescue identifiable individuals facing avoidable death without giving too much thought to the opportunity cost of doing so’. 39
This study considers how the campaign to have Herceptin subsidized was framed in Australian television news, and reflects on the broader issue of media influence on the public health policy process.
Methods
Frames in media reports on Herceptin
Results
Statements by category*
Desperate, sick women in double jeopardy because of callous government/incompetent bureaucracy
The most common frame, accounting for 54% of statements, featured women suffering from HER2 cancer, and their family members, unable to meet the cost of the drug or making enormous sacrifices to do so. Almost invariably, these items blamed this situation on government intransigence and mean-spiritedness. Many items featured women discussing their fears about their diagnosis and the associated costs of treatment. Some were described as being ‘forced to beg’ or ‘held to ransom’ 46 by the cost of treatment. Others were distressed that a price had seemingly been put on their lives. 45 Women were described as ‘pleading’ 47, 48, 49, 50 with government to subsidize Herceptin.
Underpinning this frame was the daunting cost of Herceptin. Women were portrayed as being in double jeopardy: they had a fatal illness and their survival would involve financial ruin – ‘staggering costs’; 51 and ‘hefty price tag of $70,000 makes the drug unreachable’. 52 Twenty separate references were made to selling the family home to underwrite treatment.
One series of reports featured a husband undertaking a 1000 km fund-raising walk. An oncologist described the walker's wife as having ‘a young family and a loving husband and we need to do the best by her.’ 53 Images of the clearly distressed woman were shown, including having her head shaved. Viewers (by constant implication, unlike the government) had ‘felt her pain’ and made sufficient donations to pay for her Herceptin treatment.
The subsidization roadblock was framed as reflecting government callousness, financial parsimony or incompetent bureaucracy, out of touch with decent, ordinary community values. Some expressed exasperation that current government policy made Herceptin available only to late stage cancer patients. It was ‘free for people with terminal breast cancer which begs the question why isn't it available to all of these women when they're the ones who at least have a fighting chance of living.’ One programme's introduction described ‘the extraordinary case of a woman suffering severe breast cancer who's being denied a life saving drug because she's not considered sick enough’. 54
A young mother with breast cancer was ‘also battling crazy bureaucracy which stops her getting a lifesaving drug’. There were also expert calls for fast-tracked subsidization. One demanded that government ‘listen to cancer specialists and to listen to the women who are in this difficult situation and to act with compassion and with speed to make sure this drug is available to women who need it.’ 55 On fast tracking, the Breast Cancer Network declared that the ‘buck stops with the federal government’, 46 while one oncologist complained that ‘to think that patients can't get optimal treatment in a country like Australia today I think is reprehensible’. 51
Other reports pointedly contrasted government neglect with the generosity of viewers who had made donations in response to broadcasts. 46 , 56 One praised the efforts of the drug's manufacturer: ‘Roche has now applied to the TGA [Therapeutic Goods Administration] for approval so Herceptin can be given free of charge to early breast cancer victims through the pharmaceutical benefits scheme’. 46
Release of Herceptin study findings
The release of the NEJM studies in October 2005 renewed media interest. Herceptin was the ‘biggest breakthrough in breast cancer treatment in 30 years’. 57 Declarations described ‘this breakthrough cancer treatment [as] now a proven lifesaver’, and that it was ‘highly effective and is widely regarded as a significant milestone on the path to an eventual cure’. 58
Herceptin was described by clinicians as cutting cancer recurrence rates by 50%. In
several instances, this figure was inflated to 90% in an apparent conflation of
cancer recurrence and survival outcomes by sufferers and their families, who may have
been citing figures provided by the media or health professionals:
‘without Herceptin the survival rate is usually about 30% with
Herceptin it would probably put me up to the 90%’
52
‘having the drug reduces the risk 90% of the cancer coming back, so it
is vital’
59
‘if I get this drug… there's a 90% chance that it will cure the cancer
and I won't get it back’
54
Expert opinion
Confirmation by clinicians that Herceptin would ‘undoubtedly save lives’ added authority to calls for fast tracking its PBS listing made by individuals and NGOs. News stories included assurances by the head of the Cancer Council Australia that solid evidence indicated that Herceptin halved the risk of recurrence of HER2 breast cancer. 46 , 48 , 49 , 51 , 57 , 60 , 61
There was no discussion, however, of the debate surrounding the trials that underlay the Herceptin campaign. A 2005 review maintained that randomized trials stopped prematurely for benefit, as was the case with the NEJM studies, can ‘show implausibly large treatment effects’ that should be viewed with scepticism. 62 A Lancet editorial noted that different dosing regimes made appraisal difficult, as did the fact that one of the papers combined results with two trials sponsored by US Herceptin manufacturer Genentech, 63 and suggested that the ‘best that can be said about Herceptin's efficacy and safety for the treatment of early breast cancer is that the available evidence is insufficient to make reliable judgments’. 16
Government rationale for not listing on PBS
This category comprised statements made by the then Minister of Health in attempting to explain the government's original reticence to subsidize Herceptin. In response to ‘pressure from patient groups accusing him of delaying commonwealth subsidies’, 64 he cited fiscal responsibility, 51 , 61 arguing that the government wanted to ‘give the best possible treatment to people who are suffering breast cancer, but we also have to respect the taxpayers.’ 47 , 48
The August 2006 announcement that Herceptin would be subsidized was accompanied by positive spin from the minister, who now voiced the same arguments previously used by advocates. He noted that women would no longer have to ‘spend more than $50,000 [a year] to purchase the drug’ 65 , 66 The announcement was framed as ‘very good news for a very significant group of breast cancer sufferers’, 66 who would now have ‘what we think is about a 30 percent better survival chance with Herceptin than without it.’ 67
No side effects
A final category comprised ten statements made by women reporting no side effects. One reported that she had not experienced ‘any nausea and no hair loss and I don't think it has affected my health at all, only in positive ways.’ 68 There were two assurances that the drug's manufacturer and the government would have taken appropriate steps to ensure its safety. 68 , 69 In response to the health minister's announcement of imminent subsidization, a National Breast Cancer Centre spokeswoman noted that ‘it's fantastic news, particularly as we have known about benefits for some time but also because we know the government has carefully considered the possible harms and safety issues associated with the drug, so on balance it is a good drug’. 70
Discussion
News coverage of Herceptin subsidization in Australia underscores the profound influence the rule of rescue has on public discourse and possibly on policy makers' decisions. Emotive accounts and images of individuals facing the threat of imminent death ran over an 11-month period and were unambiguously aimed at forcing a shift in government policy. As one news host introduced a story: ‘now here's an issue we're been campaigning on for some months now’. 55
In Jonsen's original use of the term ‘rule of rescue’, he argued that when confronted with identifiable sufferers our ‘moral response to the imminence of death demands that we rescue the doomed’. 38 In the case of medical care, the deontological imperative prevails over cost issues ‘the most serious constraints are ethical: namely, our social commitment to an ethic of rescue and our social reluctance to count the costs of caring.’ 71
The rule is particularly applicable when identifiable individuals rather than statistical victims are presented, 72 and where intervention is said to be able to save these individuals from imminent death. 39 It demands the ‘non-abandonment of individuals with needs for highly specialized treatments, even in resource constrained settings’ and ‘supports the notion that society places a greater value on health gains made by individuals if there are a small number of cases, the condition is severe and no alternative treatments are available’. 73 The rule of rescue as imperative has been identified as the key factor in a previous treatment funding debate in Ontario in the early 1990s. 74
It has also become a formal criterion for resource allocation by organizations, including the PBS. 75 , 76 While the PBAC did not explicitly invoke the rule of rescue in its eventual decision to recommend that Herceptin be subsidized and would doubtless deny any media influence on its decision-making, we have provided evidence that news coverage provided an unavoidable backdrop to the way the issues involved were defined for the community in news coverage as a highly politicized, perhaps irresistible ‘psychological imperative’.
PBS specifications for listing under this requirement are that:
With an estimated 2100 women eligible to be prescribed subsidized Herceptin in Australia each year, it is a moot point as to whether this constitutes a ‘very small’ number. The health minister's initial defence of the government's cautious approach to subsidizing Herceptin illustrates the inherent difficulties faced by policy makers when confronted with the sort of news campaign we describe. With limited healthcare budgets, significant expenditure in one area holds implications for reduced expenditure in others. 10 , 72
In cases where public policy is influenced by emotive media accounts, legitimate questions arise of why ‘those who are lucky enough or manipulative enough to attract media attention [are] thought to have a special claim on resources’. 39 Here ‘luck’ refers to the ability of some diseases or victim-groups to attract greater and more compellingly sympathetic news attention than others. Pharmaceutical companies have often supported such groups, 78 doubtless calculating that unlike themselves, those suffering from disease are extremely unlikely to have their motives questioned when asking for hefty drug costs to be subsidized.
A further concern, especially relevant to rule of rescue stories, is that news items about medications often present ‘inadequate or incomplete information about the benefits, risks, and costs of the drugs as well as the financial ties between study groups or experts and pharmaceutical manufacturers’. 28 Given these considerations, it is obvious that allowing the media to prioritize healthcare causes could ‘have an adverse effect upon the health of the community in the long run’. 39
Throughout the news coverage we reviewed, statements about Herceptin's benefits often conflated reductions in cancer recurrence with prolonged survival, with 30–90% unspecified ‘improvements’ being commonly stated. However, if the results of a two-year follow-up study of Herceptin treatment following adjuvant chemotherapy 79 are indicative, the drug might reduce ‘the absolute risk of death by 1.8% over 2 years’ meaning that ‘one extra woman will be alive for every 55 treated’. 80 One of the 2005 NEJM papers reported that the absolute difference in disease-free survival between women on trastuzumab and the control group was 12% at three years, 12 with the other paper reporting that overall survival rates between the two groups were not significantly different. 13 Such sobering perspectives were entirely absent in the advocacy for Herceptin, with quantification rhetoric 81 favouring the more optimistic sounding data on reduction in cancer recurrence. Plainly, with the drug having only been used in trials for a relatively small number of years, its impact on longer term survival cannot yet be assessed.
The rule of rescue is incompatible with the goals and principles of rational healthcare resource allocation. Applying the opportunity–cost principle 82 should maximize welfare for the whole population. Sacrificing the principle may be seen as an admirable human response to the plight of an identifiable individual who will die if she does not receive treatment, but the cumulative effect of repeatedly applying the rule of rescue will lower the average level of population benefit, 83 something Goodin describes as ‘unthinking, irresponsible behaviour at an institutional level’. 84
However rational the arguments may be that ‘[p]olitical pressure, patient advocacy, and media hyperbole should not determine who is treated and what they are treated with’, this Australian case exemplifies how the rule of rescue can bulldoze rapid changes in health policy. Hadorn argued that an aspect of the ‘human psyche that will inevitably trump the utilitarian rationality that is implicit in cost-effectiveness analysis: people cannot stand idly by when an identified person's life is visibly threatened if rescue measures are available’. 85 It has also been argued that, while incompatible with principles of cost-effectiveness, the rule of rescue imperative in fact does possess a utilitarian component in that observed rescues ‘increase well-being by reinforcing people's belief that they live in a community that places great value upon life’. 39
The Herceptin case suggests that media influence can have an important impact on the government funding of medicines. The PBAC monopsony inevitably leads to pressure from a range of competing interests, including a federal government increasingly concerned with PBS costs, 86 clinicians, patients, advocacy groups and multinational drug manufacturers who have ‘unequalled power within healthcare’. 87 The PBS process was further complicated by controversial restructuring of the PBAC by the federal government in 2001, 88 , 89 leading to accusations that it was pandering to pharmaceutical manufacturers increasingly displeased with the PBAC's rigorous listing criteria.
According to some observers, current rates of PBS expenditure, which has been rising by approximately 10% annually, is economically unfeasible. 90 Budget pressures will be exacerbated with the increasing arrival on the market of cancer drugs which, like Herceptin, are genetically targeted and extremely expensive. 91 Annual PBS figures to June 2006 show that while the volume of prescriptions decreased by 1.1% over the previous year, expenditures increased by 2.7%, reflecting the ‘continuing trend of doctors prescribing newer and more expensive drugs’. 92
Interestingly, at no point in any of the 239 news items analysed in this study did anyone question the price being demanded by Roche from the Australian government for Herceptin or allude to issues of profitability in the pharmaceutical industry. Herceptin's price was apparently seen as non-negotiable; the government was framed by advocates as being mean-spirited, while Roche was not seen to be playing any role in keeping Australian women of ordinary means from accessing Herceptin. This contrasted markedly to the vigorous global discourse questioning the price of anti-retroviral drugs in impoverished nations with high burdens of AIDS, where the theme of pharmaceutical industry venality has been centre-stage. The potential of the rule of rescue is of considerable interest to the pharmaceutical company Novartis Australia, 93 and presumably to its competitors. Drug industry financial and media training support is commonplace for victims of diseases, who are often compelling, articulate advocates for the application of the rule of rescue to support treatment options for their disease. 20 , 94 The lessons learned from Herceptin will be noted throughout the pharmaceutical industry and throw up major challenges to those in the health industry seeking to promote rational drug policy.
Footnotes
DECLARATIONS
Footnotes
Acknowledgements
None