Off-label use of Avastin in Wet-AMD – Are NHS Trusts really undermining the regulatory process?

Novartis (a major pharmaceutical company) is asking for a judicial review of the decision by some NHS trusts to pay for off-label use of Avastin to treat wet-AMD (age-related macular degeneration). They have expressed concern that regulatory process for safeguarding patients is being undermined and their safety put at risk.

 Instead, I would argue, it is the behaviour of pharmaceutical companies in this case which is undermining the regulatory process and obstructing healthcare providers from supplying safe and cost-effective treatments to patients. If Novartis and Roche are concerned with safeguarding patients, then Avastin should be submitted for licensing for use in wet-AMD. Unless large-scale randomised clinical trials show that there is an unacceptable level of adverse effects with use of split-doses of Avastin, then the NHS should be allowed to pay for its use.

 The reason that an unlicensed treatment is currently in use is largely because its manufacturer (Roche) is unwilling to submit it for licensing for wet-AMD. In a March 2012 Journal of Medical Ethics article (doi:10.1136/medethics-2011-100032), we argued that NICE should be able to appraise bevacizumab (Avastin) for use in the treatment of eye conditions, even in the absence of a request by its manufacturer for licensing.

 Roche has developed another drug – Lucentis – which is licensed for use for wet-AMD, but is much more expensive than using split doses of Avastin. Avastin – widely approved for use in treatment of various cancers – has been used off-label by ophthalmologists since 2005. A recent comparative trial in the US has shown the two drugs to have equivalent effectiveness in both monthly and ‘as needed’ treatment regimes (doi: 10.1056/NEJMoa1102673).

 Of course, it is legitimate for companies who have made significant investments in developing pharmaceuticals to charge a price that allows them to make some profit. Roche and Novartis have already had substantial income from sales of Avastin and Lucentis, and are likely to continue to do so (Roche’s 2011 Financial Report shows Avastin sales of 5,292 million Swiss francs (about £3600 million) and Lucentis sales of 1523 million Swiss francs (about £1037 million). The public makes significant investments in health care (and scientific research and development) through taxation and private payments for drugs. NHS Trusts, as representatives of the public should not be expected to pay over the odds for drugs.

It is worth questioning whether a regulatory process that would force the NHS to pay for the more expensive drug in this case is a process that truly safeguards patients, since resources are finite and choosing to fund a cheaper alternative with a similar clinical efficacy and safety profile would free up resources for other areas.

A commentary by Catherine Rhodes, Research Fellow in Science Ethics, Institute for Science, Ethics and Innovation.

Bloody Pell!! Q&A stoush with Dawkins fails to bridge the gap between faith and science

A commentary by Andrew McGee, Lecturer in Law, Queensland University of Technology, originally posted on The Conversation.

Watching the Q&A ‘Debate’ between Richard Dawkins and Cardinal Pell made me realise, for the first time, why Professor Dawkins has become so impatient and intolerant when expressing his atheism. His exasperation with narrow mindedness and wilful ignorance is as understandable as it is palpable.

If you are seriously going to go head to head with a leading scholar in his field – one who has written some of the best popular science books ever written – you really should know your facts. And aside from some of the more bigoted attitudes Cardinal Pell exhibited which have understandably been the focus in the press, the most embarrassing moment in the debate came when he suggested that we had descended from Neanderthals.

Natural, not random, selection

It is probably one of the most grievous intellectual errors anybody can make to reject a position without knowing anything about it, but that error is compounded if you then purport to accept the position as ‘probably’ true, but get the fundamental details wrong! This is not the kind of example we should set to our youngsters about how to pursue one of the greatest debates ever known in the history of humankind.

And as Dawkins rightly pointed out, the Cardinal repeated a prevalent misunderstanding about the doctrine of natural selection, namely, that we are here by chance. We are not. Natural selection is not a random process.

As Dawkins explains, one of the assumptions that inclined Paley – and many people who are not aware of the power of Darwin’s evolutionary theory to explain life – to believe there must have been a designer was the assumption that is impossible for something as complex and as beautiful as the eye to have come about “by chance” – the probability assumed by a belief to the contrary is just too great.

This assumption is one of the chief sources of bewilderment motivating the belief that there must have been some designer who is responsible for it. It is also one of the main reasons for the continuing rejection, by some, of Darwin’s alternative explanation of life.

But, as Dawkins points out, the belief that Darwin is committed to the view that complex natural things like the eye came about “by chance” is gravely mistaken. The eye itself is a result of a cumulative series of evolutionary steps, each of which consists of only a simple mutation. It is therefore only simple, not complex, things that come about “by chance”, and so the probabilities assumed by Darwin are not great at all.

But more than this, the simple thing that comes about by chance, and is passed on genetically through several generations, is not passed on by chance either. Rather, it is “selected” by nature as the change or mutation that better enables its bearer (the organism possessing the mutated gene) to survive.

This combination of random mutation and non-random selection is the mechanism by which evolution occurs and therefore offers an explanation that is not besaddled with any of the difficulties which motivated belief in the existence of a designer.

Religion for scientists

Where does that leave religion? I can only speak of Christianity, for that is the religion I know. It is important to note that there a number of different takes on the doctrine of Christianity, all of which inform some church practice or another. On the version that I myself am fond of, it rewrites the creation story in a fashion that is consistent with the creation of a new religion. The first verse in the Gospel of John, for example, speaks of ‘the word’ as the source of life. And that, of course, is the message that Jesus Christ said he came to bring: ‘I have come so that you might find life in all its fullness’.

It is not difficult to see that there may be some usurpation of a traditional belief system going on here.

Another interesting statement is this: “I and the Father are one”. This could mean many things, but one thing it could mean is: “forget about a metaphysical fairy in the sky. The way to divine happiness is to lead your life in the spirit that I lead mine, where you put others before your own interests, love rather than hate your enemies, turn the other cheek rather than exact revenge, etc. If you need to believe in God, I’ll be your God. The most important thing is to live your life like I do.”

 It’s a significant challenge, one that not many of us can live up to, but it certainly isn’t open to the kinds of objections that Dawkins makes, and there are churches that take this to be the essence of Christianity. It is in this sense that Christianity is compatible with science. Is it just possible that the real Christian message has been lost by our having taken it in the wrong way?

Revolutionary New Fertility Tech, or Just the Next Step?

http://www.independent.co.uk/life-style/health-and-families/health-news/scientists-rewrite-rules-of-human-reproduction-7624708.html?origin=internalSearch

This recent article in the Independent discusses the development of lab grown human eggs from stem cells and some of its implications. The most far reaching implication would seem to be the potential benefit to women and the ‘elimination’ of the menopause and the health issues related to it. It would also provide a potentially unlimited supply of human eggs which would reduce the need for harvesting eggs. This technological development is described as something that “will revolutionise fertility treatment”. I am not sure that this is accurate.

Undoubtedly the potential benefit tow the health of women, and the potential removal of ‘aging-effects’ will bring about a number of changes to current thinking. However the development of this technology is not exceptional, rather it is the logical progression of lab based fertility treatment. Technology relating to reproduction has consistently worked towards expanding the number of potential parents, the ways in which they can reproduce, and the ‘quality’ of the eggs to be brought to term. To me it seems that the development of lab grown eggs is worth noting but not to be unexpected as fertility technology has been pointing towards this for a long time due to the risks and difficulty of egg harvesting. In a similar manner that the development of lab grown organs are pursued to alleviate the organ shortage.

Perhaps I am understating the impact this development could have. Particularly if the benefit that could accrue to women are realised then this could be characterised as revolutionary. The development of this technology, however, is not revolutionary.