Tag: end of life criteria

Dying your way – support the Assisted Dying (No2) Bill

An important moment is coming and everyone needs to think quite hard about it. In just over two weeks time the Assisted Dying (No2) Bill is to have its Second Reading in the House of Commons.

The Bill aims to make medically assisted suicide legal in the UK.

This Bill was originally introduced in the House of Lords by Lord Falconer but it lapsed when Parliament was dissolved for the General Election. It is being revived by Mr Rob Marris MP, who won the lottery for Private Members Bills in the new House of Commons.

The Bill has been very carefully framed and negotiated. Remember that Lord Falconer is a lawyer and former Lord Chancellor. In the Lords there was quite strongly felt debate. It lasted over 9 hours, there were over 100 speakers and two attempts to amend it to worthlessness were resisted, being out-voted by quite substantial margins. It was passed by a majority of two-thirds of those voting.

The Bill is a simple piece of legislation. It has very clear safeguards to prevent misuse of the new provisions. The fear that some elderly people may be exploited and bullied into assisted suicide has been addressed very carefully. Every written application has to be approved by the High Court. Doctors are not obliged to help a patient even to make an application and at every step the patient has the absolute right of withdrawal. Someone seeking to use this as a route to bump off a relative opens the way to life imprisonment.

The Bill’s first real test comes in the House of Commons on Friday 11th September. There will be a debate and a vote. There will, no doubt, be some opposed to the Bill.

There are many cancer patients who would like to see the Bill enacted and to have the option of dying at a time of their own choice. Dying from cancer rarely has much dignity. Even when at home and properly supported by medical and caring staff, extremes of medication are often necessary to control pain and other symptoms. The new NICE Guidance on end-of-life care is explicit about what symptoms might be experienced. It details treatment for agitation, anxiety, breathlessness, nausea and vomiting, “noisy respiratory secretions” and pain. It is not a menu, a list of options from which you make a choice. You might suffer all of them. You will not be in control.

If you would like to see this Bill take its next step through the House of Commons and, hopefully, make its way through Parliament to reach Royal Assent, write to your MP and ask him to join those who will support Rob Marris on September 11th by voting in favour of the Assisted Dying (No2) Bill.

Cancer Drugs Fund – inevitable signal for wider change

If I remember correctly the Cancer Drugs Fund was set up at the same time as the Government announced it was to establish a value-added base to NICE drug appraisal which could support and reward innovation. NICE was left to consult on it, which it diligently did. However it became apparent that without an agreed definition of ‘value’ and without agreed means and methods of measuring and quantifying ‘value’ this was a fruitless task. The current Secretary of State has made no comment on this issue and his dis-interest in value/pricing has left the Cancer Drugs Fund exposed in an unsustainable way that means that the Government just has to keep putting more money in.

The re-working of the Cancer Drugs Fund, now underway, is long overdue. Professor Peter Clark, the well respected oncologist who chairs it, has been left with the difficult task. One can argue that he has been left with the problem when the politicians who created the fund, and NHS England, which now owns it, don’t want that profile. Sadly for him, I don’t know of anyone better equipped for the task. He is, however, going to field a lot of criticism and it is going to echo into the l;eval system and the political arena.

The Fund was set up to ensure that people with a rarer cancer got an equal chance at new technology drugs as those with more common cancers. It was also aimed at treatment which had been refused NICE approval. Among rare cancers are drugs which have applicability to 50 or 60 patients a year and which are never going to be appraised by NICE because the cost of doing so is unreasonable. These should get funded. At the other end of the scale it is questionable whether a drug which NICE has rejected on the grounds of cost effectiveness should receive funding. However such drugs quite often already have an applicability outside the strict indication for which they were appraised by NICE. It is a factor of timing as much as anything else and these new indications can carry a badge of rarity because they are off the standard track of treatment.

The CDF budget has inevitably burgeoned and the focus on drugs is also threatening to distort the evolving balance of treatment opportunity as new technologies in radiotherapy and new therapy methods employing techniques such as sound and light, appear.

The review was inevitable, the squeaks of complaint from pharmaceutical companies are inevitable and the protest of patient groups is inevitable.

What is the answer?

There is no easy answer but if we look at the longer term history, which provides the context for the CDF, we can perhaps see a way through. The answer is in NICE which has consistently failed to recognise cancer as anything different from other disease/treatments areas. It uses a generic means of assessing the quality of benefit achieved by a treatment in isolation from the whole patient context in which that treatment takes place. Its former chairman, Professor Sir Michael Rawlins, instructed committee chairs to be ready to use their judgement. However the whole NICE appraisal process is quite rigorously focussed on the new drug and its immediate treatment purpose, not the value a drug can offer in the widest patient sense. The cost per QALY* benchmark has not altered in 18 years, not even to reflect inflation, and bandages put over the process such as “end of life” criteria are just that, bandages.

Peter Clark and his team are not trying to be another NICE but they are trying to identify criteria which allow them, openly, to refuse funding for a drug which offers little or no value. Let us hope they don’t try to evaluate drugs for rare cancers with the same sriteria as those for common cancers.

Rather than wingeing the pharmaceutical industry should be taking steps to illustrate indisputable value in their new agents. The current clinical trials model which industry (and to be fair regulators too) are wedded to does not do that. It’s a broken system. The patient community is not short of ideas on how to change things. The medical oncology community is also beginning to question the endless ‘me too’ drugs, treating yet another tumour pathway and offering another month of life with yet more side effects but only in common cancers of course**. Schemes like Cancer Research UK’s Stratified Medicine programme are welcome developments which will help change the shape of treatment and of drug regulation. Bring ‘em on.

 

*Quality Adjusted Life Year – a statistically derived measure of patient benefit built on factors which are so opaque you need a degree in Health Economics to argue them.

**Because that’s where you get the quickest payback.