“Never let a good crisis go to waste.”
Many people credit first use of this phrase to Winston Churchill. His vast body of speeches and writings have become a rich source for memorable quotes. Yet there’s no hard evidence to support the attribution in this particular case. No crackling sound recording. No hand written letter. No minutes from a late-night emergency meeting to document his use of the phrase. It does, however, sound very like the sort of thing he would say. Does it matter? Well, for most of us, the evidence of first use of the expression is of little importance. We are far more interested in the sentiment: that a time of crisis provides fertile conditions for significant change.
But evidence is of great importance in other contexts. The UK’s entire legal system is dependent on the burden of proof. A criminal conviction can only be secured by the existence of firm evidence. At times this can be infuriating. We feel great injustice when the perceived ‘guilty’ party walks free when the case against them collapses or when the rules have been dis-honourably applied. Evidence has to be robust, with judge and jury challenged to resolve the presence of conflicting information.
Doctors in the modern age are dedicated to the practice of evidence based medicine. This is a fairly straight-forward principle to apply when all the evidence is complimentary and pointing in one direction. However conflicting evidence creates the stress of ethical dilemma. Regardless of your specialty or field of interest, it is worth paying attention to a scenario being played out in the world of ophthalmology at present.
Pharmaceutical giants holding the NHS to ransom?
For previous generations, the onset of wet age-related macular degeneration (wet AMD) meant an inevitable loss of visual acuity. An otherwise healthy individual could expect this to have a significant detrimental impact on their quality of life. This typically meant losing the ability to drive in early stages, then ability to read or fulfill everyday tasks with the related loss of independence. The advent of anti-VGEF injections as an effective treatment or management option for many cases were therefore rightly recognised as a medical breakthrough. A few years down the line, however, and ophthamology is faced with a major headache:
- There are two drugs licensed for wet AMD treatment: Eylea produced by Bayer and Lucentis by Novartis.
- Over a decade ago another anti-VGEF drug, Avastin, was found to be as effective as Lucentis for treatment of AMD.
- Though it is widely used in the US and across the world as a treatment for wet AMD, the owners of Avastin have never applied for its license for use as an ocular treatment in the UK. Avastin is only licensed by the EMA for the treatment of cancer.
- The rites to Avastin are now owned by Roche. Novartis hold 33% of ownership shares in Roche.
- A single treatment of Lucentis costs the NHS £700. A single treatment of Avastin costs just £70.
- An NHS funded study of 2012 concluded equitable safety and efficacy of both drugs. Estimated annual savings at that point were estimated at £84m per year. The difference is likely to increase as the average age of the population increases
- 12 NHS Clinical Commissioning Groups have therefore decided to offer all relevant patients to option of using Avastin, the cheaper drug, explaining that this will free up significant funds for other purposes.
That decision will make sense to the vast majority of readers. However, Bayer and Novartis are now considering taking legal action against the CCGs in question. It “is not in line with the current UK and EU regulatory framework, the purpose of which is, among others, to protect patients and monitor the safe appropriate use of medicines. The framework provides that unlicensed medicines can only be used where there is an unmet medical need. That is not the case here as there are two licensed products available in the UK, both of which have been approved by NICE as clinically and cost effective.”
What is the relevance to other specialties?
There is no questioning the evidence here. Yet the collated evidence creates a conflict. Current regulations mean that the rules have to be breached in order to take the common sense approach. Pharmaceutical companies appear to be holding the NHS to ransom by evidencing regulations which were created with the best of intentions. As the financial pressures continue to take a grip of the NHS then the challenges to make the best use of the funds available are increasingly likely to lead to ethical dilemmas such as this. It leads to a few questions for consideration:
- How bad does a crisis have to get before it initiates true, fundamental change?
- Is there an equivalent scenario brewing in your own specialty?
- Could steps be taken to prevent it reaching this point?
- What can you learn from discussing the scenario with ophthalmologists and managers?
- Ophthalmologists: how could your experience benefit doctors from other specialties?
Never let a good crisis go to waste.
Stephen McGuire – Head of Development
UPDATE BMJ2018;360:k344 GMC have now stated “Where doctors work in partnership with patients, following clinical guidance , and making prescribing decisions in good faith on the basis of evidence and experience the use of Avastin would not cause us any concerns.” adding it will “not raise fitness to practise concerns” against doctor using Avastin for treatment of macular conditions.
