Dynamic cyber-incident response

Permission to make digital or hard copies of this publication for internal use within NATO and for personal or educational use when for non-profi t or non-commercial purposes is granted providing that copies bear this notice and a full citation on the first page. Any other reproduction or transmission requires prior written permission by NATO CCD COE.Traditional cyber-incident response models have not changed significantly since the early days of the Computer Incident Response with even the most recent incident response life cycle model advocated by the US National Institute of Standards and Technology (Cichonski, Millar, Grance, & Scarfone, 2012) bearing a striking resemblance to the models proposed by early leaders in the field e.g. Carnegie-Mellon University (West-Brown, et al., 2003) and the SANS Institute (Northcutt, 2003). Whilst serving the purpose of producing coherent and effective response plans, these models appear to be created from the perspectives of Computer Security professionals with no referenced academic grounding. They attempt to defend against, halt and recover from a cyber-attack as quickly as possible. However, other actors inside an organisation may have priorities which conflict with these traditional approaches and may ultimately better serve the longer-term goals and objectives of an organisation

Faster access to new drugs doesn’t always mean better treatment

US President Donald Trump recently chose an adviser to a large pharmaceutical company to lead the country’s drug regulation agency. Scott Gottlieb – who reportedly sits on the boards of several small drug companies and is an adviser to GlaxoSmithKline – is expected to introduce greater flexibility to the evidence standards used by the Food and Drug Administration (FDA) to evaluate the benefit and risks of new medicines. This is consistent with Trump’s message to pharmaceutical executives in January, when he said: We’re going to be cutting regulations at a level nobody’s ever seen before […] You’re going to get your products – either approved or not approved – but it’s going to be a quick process. Trump’s views might seem extreme but his comments are not entirely out of step with the views of previous US governments. An example is the 21st Century Cures Act, which was passed late last year after heated debate. This aims to speed up innovation and the search for cures by setting lower thresholds for evaluating the safety and effectiveness of new medicines. The Act is an addition to a range of expedited programs the US already had in place for some time to permit drugs to enter the market based on less robust evidence than traditionally required. So Gottlieb already has the tools to make it easier to get drugs onto the market in the US. But what does this mean for Australia? A recent comment piece published in the journal Nature noted that weaker regulatory standards in the US can impact health everywhere. One reason is companies will have far less incentive to run the expensive high-quality trials needed to inform decision-making if the biggest market in the world does not demand it

Affordable access to innovative cancer medicines — don’t forget the prices

On 17 September 2015, the much anticipated Senate report on the and specialist cancer drugs in Australia Availability of new, innovative was released.1 The inquiry preceding the report, which was triggered by concerns about inadequate and inequitable access to cancer medicines, had attracted over 200 submissions from doctors, patients, patient advocacy groups and government decision makers. The report addressed the health burden of cancer on our society; the impact on patients of delayed access to cancer medicines; and the challenges of assessing cost-effectiveness, particularly for rare cancers. It also focused on ways of improving Australia’s processes of health technology assessment (HTA), by which we determine whether medicines are safe, effective and cost-effective.NHMRC project grant, App 108067

Propaganda or the cost of innovation? Challenging the high price of new drugs.

Concern is growing about the implications of rising drug prices for individuals and health systems around the world. With little transparency around the costs of drug development, Narcyz Ghinea and colleagues call for greater accountability from drug companies to ensure a fair price for new medicines Key messages The cost of drugs, particularly new biological agents, is overwhelming health budgets around the world Little is known about how much it really costs to develop new medicines and, therefore, what they are really worth This limits the ability of public and private payers to negotiate affordable prices and show that they are achieving “value for money” Basic information about drug development costs needs to be available to both payers and the public to ensure greater accountabilityNHMRC project grant 108067

Off-label promotion of prescription medicine: is it ever justifiable?

Off-label promotion has attracted intense scrutiny from regulators in recent decades resulting in many pharmaceutical companies paying hefty penalties for illegal marketing practices. At the same time, the pharmaceutical industry has accused governments of applying double standards by encouraging the use of cheaper off-label alternatives to registered treatments, and defended their ‘right’ to promote off-label drugs on freedom of speech grounds. However, the debate about off-label promotion and the prescribing that results has largely failed to address the issue that really matters – what impact does off-label promotion and prescribing have on patients and the health system? In this paper we explore the benefits and problems with off-label prescribing in order to determine whether off-label promotion is ever justified, and if so, under what conditions. KEYWORDS: off-label; promotion; misbranding; regulation; pharmaceutical industry; prescribin

Negotiating limits to the funding of high cost cancer medicines

The cost of pharmaceuticals is overwhelming health budgets around the world. A growing proportion of this burden stems from the ever-increasing demand for subsidisation of cancer medicines. Those making decisions about which cancer medicines should be subsidised are often criticised by patients, clinicians and the pharmaceutical industry for withholding life-saving treatments from patients in desperate need. While their arguments are emotionally compelling, these critics often fail to recognise the complexity of resource allocation decisions, and the challenges faced by those making such decisions. In this article we describe two of these challenges: 1) the need for decision-makers to balance their desire to rescue those in desperate need against their responsibility to consider population-level opportunity costs and to make decisions based on solid evidence of cost-effectiveness; and 2) their need to negotiate ‘fair’ prices for medicines when they lack negotiating power, and when prices seem to be more reflective of what the ‘market will bear’ than what the medicines are really ‘worth’. We conclude that, while there is no easy solution to these challenges, there is a need for greater transparency and procedural fairness, so that stakeholders are both more alert to the complexity of decisions about funding high cost cancer medicines, and more willing to accept the outcomes of these decisions.NHMRC project grant, App 108067

Propaganda or cost of innovation? The high price of new drugs

Ever wonder how much it costs to develop a new drug? The independent, non-profit research group, The Tufts Center for the Study of Drug Development, estimates US2.6 billion, almost double the centre’s previous estimate a decade ago. But how accurate is this figure? While the details of the study remain a secret, a press release, slideshow and background document on the Tufts website provide some insight into how this figure was calculated. Interestingly, only slightly more than half of this cost is directly related to research and development (R&D). US1.2 billion are “time costs” – returns that investors might have made if their money wasn’t tied up in developing a particular drug. As expected, these costings have attracted the attention of policymakers, consumer advocates and critics of big pharma. In the New England Journal of Medicine, Harvard University Professor of Medicine Jerry Avorn questions several assumptions underpinning the Tufts costing – particularly the unverifiable claim that up to 80% of compounds are abandoned at some point during development

The Right to Health: Implications for the funding of medicines in Australia

Australia’s health system is characterised by an ongoing tension between a commitment to utility and a commitment to individual rights. This tension is particularly problematic for the Australian Government when deciding which cancer medicines to add to the Pharmaceutical Benefits Scheme to make cheaper for patients. This paper investigates how the right to the highest attainable standard of health has influenced decisions about funding high cost cancer medicines in Australia. We then consider the value of the right to health for funders and conclude that resource allocation decisions should not be entirely informed by the right to health. We maintain that instead, regard should be had to the cost-effectiveness and affordability of cancer treatments before they are subsidised.NHMRC project grant, App 108067