Wednesday, 12 September 2012

What price would you put on your bladder?


My mum is awesome. She is. For a million reasons. This is just one. Here's another. Decades of being a palliative care nurse and undertaking various forms of volunteer work is reason three, four, five, six, seven...

She was born in the war (as she will tell you many, many times, particularly if you ever mention wasting food or throwing anything away), and she hates bananas, and sugar in her tea. She also has bladder cancer.

Now this isn't a why do bad things happen to good people rant. It may still be a rant, but it's a specific rant about the treatment that my mum should be getting and now isn't.

In 2009, 10,540 people in the UK were diagnosed with bladder cancer. When the 2012 figures are released, my mum will make up one of the overall number.

Bladder cancer is the seventh most common cancer in the UK. Cancer Research UK has lots of information about it herehere and here.

My mum was diagnosed earlier this year with pretty advanced, pretty aggressive bladder cancer. She had the cancerous tissue removed, and undertook a six week induction course of intravesical therapy, which involves putting liquid drugs directly into the bladder through a catheter. Because she has a grade 3 tumour, she was given intravesical BCG (yep, the same BCG that resulted in a scar on your upper arm that would get punched at school, but in much higher doses).

Interestingly, no-one's that sure why BCG treatment is so effective for treating bladder cancer, but it is, and it was in the case of my mum. She completed the course, had a follow up investigation, and there was no sign of the cancer having reappeared.

She should now have moved on to what is called maintenance BCG therapy - having it every few weeks or months for the next three years. But she hasn't, because there is a worldwide shortage of it.

Professor Sir Mike Richards, National Cancer Director, notified the NHS about the shortage in a letter dated 6 July 2012. In it, he writes:

"I am writing to draw your attention to the current global shortage of products used to treat patients with bladder cancer"

"Two companies normally manufacture Intravesical BCG. Production of one of the two products (Immunocyst - manufactured by Sanofi Pasteur and distributed in the UK by Alliance Pharmaceuticals) has been stopped and is unlikely to resume before late 2013. The manufacturer of the second product (oncoTICE - MSD) is working hard to increase production, but this will take time"

"In any one year, 2000 patients will receive induction therapy with BCG and a further approximately 4000 will receive it as maintenance therapy"

"Initial estimates are that around 200 (patients) would normally start BCG each month and that 10-20% of these might now undergo surgery. This equates to around 20-40 additional patients undergoing cystectomy for every month that the shortage lasts"

Cystectomy is the partial or complete removal of the bladder. It's also what my mum most fears since being diagnosed.

The British Association of Urological Surgeons also provided information regarding the shortage on its website in July 2012, stating that the 'production difficulties' have not been clarified, but production is unlikely to recommence before the end of 2013.

Sooooo, now that I've set the scene, here's a list of my naive questions, given that hundreds of British citizens will most likely need to have their bladders removed prematurely/unnecessarily as a direct result of the BCG shortage:

1. How often do shortages like this occur?

2. How are existing stocks being rationed?

3. Why is the Secretary of State for Health (previously Andrew Lansley, now Jeremy Hunt) not addressing the patients affected directly and committing to do everything in his power to help resolve it as soon as possible?

4. Sanofi Pasteur is the largest company in the world devoted to vaccines. Why is it not addressing the patients affected directly and committing to do everything in its power to help resolve it as soon as possible? A sprinkler flood affected one of its factories, but why did it then choose to "temporarily suspend manufacturing of all BCG products in order to renovate the factory"? Was there no way in which ongoing production could have been better managed and maintained?

5. Heaven forbid that I encroach upon capitalism, market advantage and patents, but given that we are talking about people's lives, not about delays to the iPhone 555 caused by production problems, is there really no way in which in the year 2012 other companies could have helped manage and maintain production? And if either side needed a helping hand / push / carrot / stick, could Governments not have provided that?

There is clearly a market for the product. There is clearly a serious and urgent need for the product. And yet seemingly nothing is going to happen for more than 12 months.

Can that be right?


P.S. The image at the top of this post comes from this systematic review.

Tuesday, 27 March 2012

Endeth the time, cometh the risk register

"A risk register is not a forecast or a prediction. It's where civil servants contemplate the most extreme consequences of any major government project. They think the unthinkable to ensure that the unthinkable never happens"
- Simon Burns, 22 February 2012

"We do not comment on leaks. We have always been open about risk..."
- Department of Health, 27 March 2012

Yesterday, the Health and Social Care Bill transitional risk register was leaked to both Dr Phil Hammond and Roy Lilley. Or at least a version of it was. The excel document is dated October 2010, with a version number of 1.1, an "as at" date of 28 September, and a headline of "draft for discussion".

First and foremost, I have read through the risk register and to my utmost surprise, I haven't gone blind and my brain hasn't turned to mush and leaked out of my ears. Who would have thought it? Viewing risk registers isn't so risky after all.

Secondly, I sincerely doubt that the fact the risk register has been leaked is going to change the way all risk registers are used forever more.

Now, on to the actual content.

45 risks are listed (numbered 1-46, but there is no number 8... too risky to even document?!?), with associated descriptions, actions and owners. Each risk is also given a priority (imminent or longer term), likelihood (from 1 = rare to 5 = almost certain), impact (from 1= very low to 5 = very high), and overall rating (its likelihood score multiplied by its impact score).

This is absolutely standard, text book, risk register stuff. Nothing scary, nothing extreme, nothing outlandish, and nothing unthinkable. Just an attempt to methodically detail, categorise and prioritise the relevant risks.

Leaving aside the fact that the colour coding of the overall risk ratings seems to have gone a bit awry, 7 of the 45 risks have a red overall risk rating (designated by a likelihood of 4/5 and an impact of 4/5) with a priority of imminent. Snippets from these risks are below:

"risk that Bill proceeds on basis of incomplete/flawed design"

"As the Bill proceeds through Parliamentary stages, amendments are made which have unforeseen consequences for the system, with possible impact on costs or performance of the system"

"Bill proceeds, without assurance that the whole system is affordable... system could be more costly if GP consortia make use of private sector"

"Aspects of implementation begin before adequate planning has been done"

"As transition progresses, management lose focus on BAU performance"

"Financial control is lost"

"Planning, preparation and governance is hindered and... policy design is limited leading to mistakes in design and legislative drafting"

A further 7 risk risks are red rated with a priority of longer term. Snippets from these risks are below:

"more failures, including financial, eg GP consortia go bust or have to cut services"

"lack of clarity during the transition in terms of acountability... leads to delays and increased costs and poor BAU performance"

"NHS commissioning board is not sufficiently developed to assess capability of consortia. GP leaders are not sufficiently developed to run Consortia"

"Staff morale"

"Public reputation"

Interestingly, 6 of the 45 risks have not been scored or rated. And one of these has not been marked as being covered by, or overlapping with, other risks. Snippets from that risk are below:

"Inability to reduce running costs because of consortia numbers"

"Loss of clinical time by GPs due to consortia management responsibilities"

"Failure to manage referral demand"

Now, reading through the above, do they sound like the unthinkable, the bizarre, the outlandish, the extreme? And how many of them do you think are no longer risks? And how many of them do you think have now actually become issues, rather than risks?

And although I agree that a risk register is not strictly an actual forecast, when you look at the highest risks (defined as high partly because they are likely) in this particular risk register, you are left thinking that it is pretty close to the mark and a pretty accurate prediction.

There's already some talk that the risk register has been deliberately leaked at this point, as it is too late to influence the passage of the Health and Social Care Bill, and it is a good distraction from 'Cam Dine With Me'. Whether deliberate or otherwise, having reviewed the risk register, I think it blows apart any and all arguments put forward for its suppression. It would have provided an excellent basis upon which to have an informed, intelligent debate about the proposed Health and Social Care Bill.

Just a shame that our elected and unelected representatives did not agree... or maybe they just didn't care?


Thursday, 22 March 2012

Would you shout from the rooftops about being well below average?

There's one thing I hate... ok, ok, there are many things that I hate. But one thing that I definitely do hate is people taking credit for other people's work. The Coalition Government seem incredibly happy to take credit for the increasing number of doctors in the NHS, despite only being in power for less than two years.

It takes seven years to train a doctor, so I will let you draw your own conclusions about how much credit they should take after less than two years in power. But leaving that aside, what do the figures actually show?

The Information Centre published the latest annual NHS workforce data on Wednesday 21 March. The annual figures are as at 30 September each year - the Coalition came into power in May 2010, therefore the latest annual figures mark a point about 17 months into their tenure.

The two graphs below show the total number of doctors in the NHS, and the year on year percentage change in the total number of doctors. To accompany the publication of the data, a briefing was produced by the Information Centre. The below graph compares the latest annual increase of some staff types included in the briefing against the average annual increase of that staff type over the last decade.

Now, looking at these three graphs, leaving aside how premature it may or may not be, if you were the Coalition Government, would you be so quick to herald your performance?


Saturday, 17 March 2012

Your house as the NHS (please indulge my whimsy)

It is generally agreed that the Health and Social Care (H&SC) Bill represents the biggest shake-up of the NHS since its inception.

The NHS budget for 2011/12 is around £106 billion. Estimates of the cost of implementing the H&SC Bill range from the Government's £1.3 billion to Labour's £3.5 billion. For simplicity, let's say the cost will be around £2 billion, equating to about 2% of the annual budget.

Now imagine your annual household budget is £50,000. One day, three men, two wearing blue ties and one wearing a yellow tie, knock on your front door. They tell you that they are here to do urgent, expensive work on your house. It's going to cost you £1,000 (2% of your annual budget).

You didn't invite or expect these men. In fact, you were under the impression that the workmen in your area had recently agreed not to do any cold calling. You ask the men to explain what's wrong with your house. They tell you that your kitchen is outdated and inefficient, and doesn't match european standards. You patiently explain to them that that was the case a decade ago, but since then you've systematically upgraded your kitchen, and it's now fine. You're feeling charitable, so you invite them to come and have a look at your kitchen for themselves, but they don't seem interested.

They then tell you that your household energy efficiency is only half as good as that of a house in France. Again, you patiently explain to them that that was the case quite a while ago, but since then you have been busy making your house greener, with loft insulation and energy saving light bulbs. And in fact, the latest information indicates that your house has become massively more energy efficient, and is improving at a much faster rate than the average french house. You're even considering adding solar panels to your roof, but that's a decision that you'll make for yourself in your own time.

They then tell you that the increasing annual cost of your household bills means that you absolutely have to let them do major work without delay, otherwise you won't be able to afford your house. You struggle to understand their point exactly, but you do concede that a few years ago your household bills were increasing quite rapidly. Since then, you've switched some providers around, set up direct debits, and consolidated your gas and electricity supplier, so that now your household bills aren't increasing at the same rate that they were, and actually aren't particularly alarming in the context of your annual household budget.

Visibly frustrated, the three men tell you that you're not listening and that they're sorry that you don't understand what they're telling you. They say that they're going to go for a walk around the block, and they'll be back soon.

When they return, you decide to take a different approach. It's clear to you that they can't explain why you need the work that they are recommending, so you decide to ask what exactly they are going to do and how it's going to improve your house. Somewhat bizarrely, one of them tells you that it's about empowering you as an individual home-owner. Another tells you that it's about making sure that your house is better than your neighbours' houses, and that by competing with your neighbours, he guarantees that your house will always be very good (at this point, you can't help think about all the times your neighbours have helped you out and vice versa... lending power tools, babysitting, the list goes on). And the third tells you that it's about doing the work now to avoid your house collapsing, so that he then doesn't have to worry about your house in the future.

Your house... collapsing?!? Yowsers. But hang on a minute, you think to yourself... you're very house proud, and you've devoted lots of time and energy making sure that it's a good house. You've had friends and family help you out over the years, doing the usual DIY bits and bobs. You've even had builder friends come round and tell you that your house is really impressive compared to lots of other houses, particularly when you take into account how much your house cost you and how much you've spent on it.

And you also think about how this unannounced, unrequested door steeping started. You had to keep correcting the three men about the current state of your house and what the main problems were - you're no fool, you know that there are always things that can be done to improve your house (and anyway, whose house is perfect?), but they weren't what the men claimed were the fundamental, urgent problems. You realise that the men have got a real credibility problem, and frankly you just don't trust them.

Your mind is starting to reel... £1,000... for what exactly? And why? They tell you that you can't afford not to do the exact work that they are peddling (although even this is confusing, as the three of them have done a fair bit of bickering on your doorstep, and have actually changed quite a few aspects of what they say they are going to do). In contrast, you're wondering whether you can afford to do the work, particularly right now, what exactly the work is, and what it will achieve.

Soooo, the question is - what do you do, hot shot? What do you do?


Wednesday, 14 March 2012

My love-hate relationship with Hansard (aka UUU spotting)

The Health and Social Care (H&SC) Bill was debated in the House of Commons again yesterday (Tuesday 13 March, 2012) - the full transcript is available here.

As usual, I wasn't impressed with the majority of contributions, but what I continue to find astounding and alarming is the number of times that... shall we call them unfortunate, unintended untruths (UUUs)... occur during these debates.

Not only do they occur, they go unchallenged and uncorrected (which arguably makes them UUUUUs).

A very quick scan of the transcript produced the following three (and trust me, there will be many more).

Unfortunate, unintended untruth number one - MRSA rates

Mrs Anne Main (St Albans) (Con): Does my right hon. Friend share my absolute astonishment at Labour Members’ collective amnesia when it comes to the 13 years of mixed-sex wards and rising levels of methicillin-resistant Staphylococcus aureus and C. difficile that they presided over, along with a failed patient record system that has cost billions?

MRSA figures are reported by the Health Protection Agency - results for the last 10 years are available here. And here's a graph plotting the MRSA rate over that time period. I'll give you two guesses as to whether or not you think that trend line is rising... go on, stick your neck out.

Unfortunate, unintended untruth number two - A&E data

The Secretary of State for Health (Mr Andrew Lansley): We know that it is necessary for us to reform in order to deliver the improvements that the NHS needs, as well as the sustainability that it needs. We are not even speculating about this; we can demonstrate that it is happening. This is in contrast to what the right hon. Member for Leigh said. He said that he was not scaremongering, then he got up and did just that. He scaremongered all over again. He went to a completely different set of data on the four-hour A and E provision, for example. He went to the faulty monitoring data, which are completely different from the ones that we have always used in the past—namely, the hospital episodes statistics data, which demonstrate that we are continuing to meet the 95% target.

This is a bit technical, but basically the above is completely the wrong way round. It's actually the A&E HES data that is new. The Information Centre still describes it as experimental statistics. The Quarterly Monitoring of Accident and Emergency (QMAE) return is the long established data source, still described by the Information Centre as "the official source of A&E information".

Unfortunate, unintended untruth number three - cost savings associated with the H&SC Bill

Chris Skidmore (Kingswood) (Con): More hours have been given to debating this Bill than any other during this Session. Despite Labour’s message, which seems to be opposition for opposition’s sake, we are gradually learning what its policy will be for the next general election. According to the Opposition, this is the greatest reorganisation in history. Yet the Bill will save £4.5 billion straight away and then £1.5 billion recurrently, year on year, thereafter.
Er, what?!? The H&SC Bill will save £4.5 billion straight away... like what, the instant it's passed? Bizarre. And then it will save £1.5 billion every year after that. If either of those two claims were true, this would be the most economical piece of legislation in the history of the world. The NHS budget for 2011/12 is around £106 billion - according to Mr Skidmore, the H&SC Bill will mean that there will be no need for any NHS budget by the year 2080.

Oh, hang on just a minute, not spending any money on the NHS... hmmm, now there's an idea. Clever, Mr Skidmore. But of course our Government would never consider such a thing, and the H&SC Bill will in no way inch us towards it...

Highlights from the latest year (2010/11) of A&E data

The Accident and Emergency (A&E) data for the 2010/11 financial year was published by the Information Centre on January 26, 2012. The full data set is available here. It is definitely worth noting that it is still billed as 'experimental statistics', with there being caveats concerning data quality, completeness and coverage. It is however still well worth pulling out some highlights.

1. A&E attendances by age group

2. A&E attendances by month

3. A&E attendances by day of the week

4. A&E attendances by time of day

5. A&E attendances by type of outcome

6. Percentage of A&E attendances spending less than four hours in A&E by A&E unit

And having had to take my baby son to A&E last week, he'll be one of the 0-9 year old attendees on a Thursday in March at 17:00 in the 2011/12 figures.


Tuesday, 13 March 2012

A bitter pill that the NHS must swallow to avoid collapse? Can I get a second opinion, please?

"Caring for the ageing population and covering the annual £600m of new drug treatments mean NHS costs are rising at an unaffordable rate and underline why we need to rethink how the system works"
- Andrew Lansley, Secretary of State for Health, Tuesday 13 March 2012

Part of the case for change that has been repeatedly used to support the proposed Health and Social Care Bill is the escalating cost of medicines. Now, leaving aside whether or not the proposed Bill does anything to address this, let's take a look at whether the actual data supports such a claim. After all, it's important that the justifications given for the Health and Social Care Bill stand up to scrutiny, otherwise we'd be left wondering why exactly is it being brought in?

The two graphs below are based on data from the last ten years - by looking across the decade, the claim that has been made, and asserted as a fact, is that 'The cost of medicines is growing by over £600m per year'.

Well, first and foremost, it isn't. And secondly, using the full decade of data looks like a pretty dubious and spurious choice to me.

Here's the data supplied by the Department of Health. As you can see, the last time the cost of medicine grew by over £600m was back in 2004/05. For the five years since then, it has not once risen by £600m.

We can also look at the annual percentage increase as well as the annual actual increase in the cost of medicine, just to double check that there isn't any out of control escalation.

Yes, the percentage increase has crept up slightly over the last three years, but it is still well below the annual percentage increase that was witnessed in the first four years of the 21st century.

So why do I think the Government is using the full decade of data? It's because the oldest data makes their claim look the least dodgy (although even that doesn't make it dodge-free). Using the most recent five years of data, rather than the full ten years, the annual increase in the cost of medicine plummets from £580m to £390m.

Not such a bitter pill after all? And is the annual increase in cost of medicine really justification for the Health and Social Care Bill? To put it into context, the NHS budget for 2011/12 is around £106bn.