• To view more of my views on the N.I.C.E decision in my external Blog Click Here

To see Andrew Dillon's response to my mail Click Here

My e-mail and response to NICE and my Local MP. I will be handing this in tomorrow, but have also e-mailed it to them as well

Andrew Dillon

Chief Executive

National Institute for health and Clinical Excellence

MidCity Place

71 High Holborn

London

WC1V 6NA


Dear Mr Dillon,


RE:Bevacizumab, sorafenib, sunitinib and temsirolimus for   renal cell carcinoma
 

As a Kidney Cancer patient I write to you in reference to your draft report on 7th August that
outlines your recommendation to not approve the drugs for Advanced Kidney Cancer i.e. Sutent,  
Nexavar, Avastin and Torisel.  

Over the past weeks I have heard a number of arguments that you’ve used to back your recommendation.

1. QALY, i.e. that these drugs do not extend a person’s life for long enough given the cost of the drugs 

My response:

• These drugs are used successfully across Europe and the US and have been proven to offer significant improvements to quality  
of life as well as extending the life of a terminally ill kidney cancer patient for up to 26 months 
(latest clinical trails data) or longer as witnessed by many Kidney Cancer patients around the world.

• It seems to me to be a carpet bomb approach to say no to all 4 on this basis, this says to me that the decision was purely cost
based and not on efficacy and clinical trial evidence, it was just NICE saying no to Kidney 
 Cancer Patients no matter what the drug.

• Although I realise that the QALY calculation is complex, (although we don’t know as NICE wont release their
methodology), I believe that your calculations have not taken into account the clinical trial evidence from other 
countries.  I believe you now have this and will be using it.


• There are no other effective treatments for Advanced Kidney Cancer patients.  As you know the 
current treatments have a very small percentage chance of working.  You have also now heard from 25 UK experts in this matter 
backing this fact.  To not give these drugs to patients is effectively condemning them to an early death.


2. The Pharmaceutical companies are to blame, their profits are too high and they charge too much for these drugs putting them 
out of reach for the NHS

My Response

• They do pump billions into research and as businesses are driven by their shareholders to make profits.  Admittedly there 
maybe an argument to say their profits are too high and should be looked at.  This however to me is a separate battle that the 
government/NICE should fight.  It is not fair to use patients as negotiation tools to try and bring the costs 
down, if the treatments work they should be given as part of the NHS.  NICE would earn more public respect and you 
will find much stronger public support for you battle with the pharmaceutical companies if you weren’t using patients   
in this way and I suspect you would win.
 
• The Pharmaceutical companies do offer schemes (e.g. Sutent) whereby they will pay for the first round of 
treatment.  Why is this overlooked? It seems common sense to me to allow this because if the drug doesn’t work for that 
patient then the treatment is stopped.

• The figures you quote do not seem to take into account central procurement deals you would be able to negotiate, bringing the
costs of drugs down.
 
• These drugs are offered at a lower cost to the UK than many other countries.
 
• Why do you ignore part funding/risk sharing schemes? 

 
3. Who else would have to suffer if these drugs were funded? Which critically ill patients should be condemned 
instead of Advanced Kidney Cancer patients?

My Response

• This to me is an unfair argument. Yes, costs have to be factored into the equation, but with all the waste going on in the 
NHS and in the country as a whole this is just sheer bad management at the most senior levels.  We seem as a country able 
spend billions bailing out our banking system (e.g. Northern Rock) and yet we can’t spare the cash to provide patients 
with much needed drugs.  Not that I condemn the decision to bail out the banks because of the human impact, however it does seem odd
that we’re able to do that and yet not provide for the NHS and patients who have no where else to turn.


4. The PCTs are adding to the confusion by not having a collective response to Exceptional Treatment policies and hence are 
fuelling the Post Code lottery.

My Response

• Patients are meant to be judged on their individual and specific exceptional needs. Wasn’t that their purpose to
provide local accountability and community based support?  If the PCTs and NICE are not communicating then what hope is 
there? It means 2 layers of management in-between the doctors and their patients.  I’m so heartened to see that finally
consultants and specialists are highlighting the clinical case for innovative cancer drugs and are fighting back.
 

5. Patients are using the media in an unfair way to put pressure on NICE.


My Response

• What did you expect? Central government does nothing, our local MPs do nothing, NICE denies the drug, the PCTs turn 
down the exceptional cases.  What course of action are patients left with?

• Try and put yourself in the feet of a patient, of course you would do anything you can to get drugs that you know
will help.  If you personally were told by a specialist that there is a drug that can help but it be wont approved 
for you even though it has been proven to work in other countries.  How would you feel?  It is nothing short of cruelty.
 
Now that you can see the weight of public opinion I implore you to change your recommendation and approve these drugs now, not next 
year.  Give patients and families their lives back.  Please back the clinical case and restore the faith of the public 
in our NHS doing the ethical thing and giving these vulnerable patients the treatment they desperately need.


Yours sincerely



Andy Thomas

Another response from Paul Flynn and my reply

Reply from Paul Flynn

Andy, I watched the link and anyone would have a heart of stone not to feel sympathy for the patients who may lose a drug that they trust.

I have no knowledge of this case, but I do know how Big Pharma works and it's not pretty.

It's a commercial calculation. A ridiculous price is set for drugs that were expensive to research but cost pennies to manufacture . Big Pharma enlists PR companies to expensively market the drug. That adds more to the high price. A patient who will attract public sympathy is promoted and (often trained) to present the most heart breaking account of their plight. These are a hard-headed business stunts that exploit all our emotions in order to serve the financial interests of Big Pharma. There can never be an infinite budget and hard choices are inevitable in the real world. That choice is best made by an independent body like Nice that any group that is open to pressure and bullying from Big Pharma- that includes politicians.

My Reponse

Hi Paul

There are so many of these stories sadly. I'm sure you saw the Panorama report last night on this subject.

With Kidney Cancer the fact is that these drugs work. Today, yet again I received notification from a patient who's tumours have reduced by 10cm on each side using Sutent. He's only been using it for a few months and the results are fantastic. Guess what, he had to find money privately to do it, totally unfair. I've received a number of comments both privately and on my blog today and yesterday from fellow cancer patients and carers in the US who are telling us that they work.

N.I.C.E cannot ignore the clinical evidence.

Yes the pharmas probably do charge too much, but that to me is a different battle. If a drug works then to me the NHS is obliged to give it i.e. "Treatment at the Point of Need", especially when the experts in the field prescribe it. Can you imagine what it feels like for a cancer patient to be told by their oncologist that there is a drug that works for their condition but the NHS wont provide it? It's cruelty.

If the government, NICE and the PCTs want to go into battle with the pharmas over cost, fantastic, I'm sure you will get support from all quarters. However please lets not kill patients in the mean time to make a point over those costs. That to me is using people's life's as a negotiation tool.

If you were to take the approach of fighting the pharmas whilst still treating the patients with latest available drugs then the ground swell of public support I'm sure would be in your favour and the battle would be won quicker.

At the moment the government, NICE and the PCTs are seen as (and are) the immediate problem. There were too many examples on last nights program of unfair and immoral decisions.

Andy

Paul Flynn's reply and my response to it -

written by Paul Flynn in response to Andy Thomas

At last, the real culprit is being nailed. NICE is a fine innovation which has been copied in other countries. They have the very difficult task of balancing out the advantages of where the money is spent. There are no 'miracle' drugs in spite of the tabloid hype. The drugs budget has been increasing at about 8% a year beyond inflation and taking money away from other NHS budgets that deliver good life-saving value treatments.

If politicians had to decide which patients should have which drugs, there would be chaos. The money would be spent on those who gained the greatest publicity. Big Pharma already cynically employ the media to enlist support for drugs that offer few benefits and have adverse side effects.

It's not true that these drugs are freely available in other countries. Often it's only at a price that is unaffordable to the poor are they available. Big Pharma have been stoking up the row in pursuit of their own bonuses. Rather than repeat past blogs, here are extract from a debate of a few years ago that illustrate the points:- Paul Flynn MP: My greatest shock in the last couple of years was when the BMJ published an article two years ago, giving examples of reports presented in the medical journals—reports that had got past the very suspicious editors—in which the conclusions did not match the data. The data said something and the conclusions said something else. There were examples of how this was done; the pharmaceutical companies write most of the reports and hawk them round for others to sign and approve. They get some figures and they provide some fat fees.

Dr. Blumsohn spent a year requesting to see the full data on which the work that was published under his name was based. He was one of two lead authors. Two years after raising his concern, he was suspended from his university post. In The Observer last Sunday, Proctor and Gamble is reported as saying that it is "standard industry practice" not to hand over all data to professionals. That seems extraordinary, and it is regrettable that the Government have failed to respond in any way to that crucial issue in their response to the report. That is the key issue turned up by the Health Committee. New Code of Practice

Paul Flynn MP : The new code of practice (ABPI) is entirely cosmetic and has been described by the British Medical Association as lacking teeth. The Drug and Therapeutics Bulletin describes it as fundamentally weak in all respects. It is purely window-dressing to hide the drugs industry's continuing close collaboration with the MHRA, which has been so detrimental to patients. Wonder Drugs

Paul Flynn MP: A few weeks ago, I received a letter that interested me greatly, as I had a constituent suffering from pancreatic cancer. The letter was about a new wonder drug called Tarceva, of which I had never heard. On investigation, however, it turns out that the cost of prescribing this drug will be £16,000 a year. Its effect was to increase the life expectancy of pancreatic cancer patients by 12 days, and it had adverse side effects including death in 10 per cent. of the patients involved. Increasingly, MPs are being approached to use our office here to put forward a case for the drug industry. That is a thorough abuse of our position. I sent a book to all the members of the Committee before it started its work. The book is called "Medicines Out of Control?", by Charles Medawar. It asks what would have happened if we had gone to see Sigmund Freud when he practised as a doctor. He gave all his patients and friends, and took himself, a medicine he knew that was believed to improve people's mental health and stability. That medicine was cocaine: it was the popular drug of the time. A later popular drug was bromide, which creates its own form of psychosis, called bromism, which was a scourge of society at the time of the first world war. For an awful period in the 1960s and 1970s, diazepam—or valium—and other similar drugs were prescribed like smarties. That caused great distress and did very little good. There was also the experimental period of the mental health industry in the 1950s, with the inducement of deep psychosis, lobotomies, leucotomies insulin coma therapy and electroconvulsive therapy. People were used as guinea pigs and suffered greatly.

More recently, we have had the tricyclics, which were regarded as wonder drugs, but they are now seen as old-fashioned and have been replaced by selective serotonin reuptake inhibitors—SSRIs—of which Seroxat is one. When the campaign against Seroxat was mounted by a few courageous people outside the drug industry, the drug companies mounted a ferocious campaign to ensure that the voices who were protesting about the dangers of Seroxat were muffled.

Tentacles of influence

This House is infested with organisations that, on the surface, are perfectly good. I had some influence in one of them—I shall not name it—and I see that it is now organising a relaunch with help from a lobbyist. Who is paying the lobbyist? It is one of the pharmaceutical companies. Their influence is everywhere and their tentacles stretch into the Government, the patient bodies and elsewhere.

The key, and most dramatic, moment in the Health Committee inquiry was the unbelievable evidence about the inducements given to clinicians and others to use particular drugs. One of the questioners asked whether the free trips, the holidays and the chance to take one's wife, husband or girlfriend to the Bahamas or the Alps had any effect. The witness replied that they did not, but that articles in the British Medical Journal and The Lancet did. The point, made with great force, was that the way to influence public and medical opinion was to get articles written by authoritative figures in those journals.

My Response:

Paul

Thanks for the reply. I’m not sure who you mean by the real culprit. To focus in on the 4 Kidney Cancer drugs (SUTENT, AVASTIN, NEXAVAR and TORISEL) which is the issue in the press at the moment, and the one I have a concern with I’ll try and come back on some of your points as they relate to Kidney Cancer. Hopefully N.I.C.E will see the light and realise that we are dealing with real individuals here and not a general issue. Reading from your reply it’s dealing more with the general problems rather than the specifics behind this problem.

Patients are left with no other choice other to employ the media, MPs , and in fact anyone who will help them get the drugs they need to keep them alive. I think if you talk to them you will find that Kidney Cancer patients realise that there is no “magic bullet”, I can’t think of a time when anyone has reported in this fashion in regards to this disease.

The current treatments have a less that 10% chance of working. The new drugs offer considerably better odds than this (as any of the UKs leading Kidney Cancer Oncologists will tell you). All Kidney Cancer patients realise that the best they can hope for on these drugs is a cessation of progression and shrinkage of their tumours. When you have a drug that can do this then it gives you back a quality of life AND a chance that new drugs will come on the market and offer a real cure.

In your example of Tarceva 12 extra days a hugely different from extra years. I hope N.I.C.E aren’t using that as an example. I think even a Cancer patient would realise that an extra 12 days is not offering that much extra.

The facts speak for themselves in this case, the article I pointed you to was of a man who was given 6 months to live and is now three years on to quote him “he’s never felt better largely thanks to a cancer drug called sutent”.

It is true to say that they are freely available in other countries, and in fact the drug companies offer these specific drugs to the UK at a cheaper rate than some others. Also in the case of Sutent the pharmaceutical companies offer the first months treatment free in the UK, this lowers the risk to the government costs, because if it shows no improvement in the patient then the treatment stops.

I’ve just received a call from a young woman today (35) whose husband (40) has sadly just passed away 6 weeks ago. He was given an extra 5 years of life because of this drug, much much more than he would have had with any other treatment

I respect that there are more general and wider issues, however these are specific drugs with much better outcomes than are being reported by N.I.C.E. The debates you had a few years ago do not relate to these drugs, time has moved on, they are relatively new in this country despite being used widely elsewhere in the globe.

Kidney Cancer patients are not influenced by pharmaceutical companies, however because our MPs wont fight for us we are left fighting for ourselves. That’s not a good situation to be in when we know that our elected members wont stand behind their constituents.

I’m sorry that MPs are being used as a conduit for the pharmaceutical companies but I’d hope you’d be able to sort what is real and what is just PR. If you think you’re position is likely to be abused by the drug companies as an MP, can you imagine how abused a Kidney Cancer patient feels by N.I.C.E.

Andy

• My Response to Paul Flynn's Blog about N.I.C.E. Click Here

Hi Paul,

Thanks for raising awareness around this subject; it's good to see that someone is willing to debate the subject.

The issue I'd like to raise is that the Kidney Cancer drugs that NICE have chosen to deny are available in most other countries, so why not ours? Are we so much poorer?

I realise that cost always has to be taken into account, however NICE seem to shift their argument from cost to the drugs not offering enough benefit (which is not true), and now they are shifting the blame onto the PCTs for not being consistent and creating the whole postcode lottery.

I admit I'm confused. There appears to be no consistency around who does what and how. The PCTs claim they were setup to specifically work in the interest of their local communities which naturally creates a postcode lottery, and yet NICE say all the PCTs should be working together.

When I wrote to my local MP (Claire Ward) I was told that this was not a government issue and was the sole responsibility of NICE and the PCT. To say I was disappointed with that response would be an understatement, pointing a cancer patient at Cancer Research was little more than patronisation, I have no problem with Cancer Research but I think I could have worked that out for myself. If our elected members are unwilling to take responsibility then what hope is there?

To see her response feel free to open the links on my Blog

http://fit-vibes.co.uk/WordPress/?p=74

I tend to agree that the big pharmas are making huge profits, but then again that's business isn't it? If we didn't have them pumping huge amounts of money into research we wouldn't have the drugs in the first place, so to me it's a catch 22 situation.

Given we all tend to agree that the pharmas could maybe bring their costs down a little, then what cost should we put on a cancer patient's life? £2,000/Month? £2,500/Month? £1000/month? At what level will NICE agree to keep tax payers alive?

I think if NICE (or indeed the government) want to use cost as a reason for not delivering these much needed drugs to patients then I think we need to have more transparency around the whole process so we can all be made aware of how the money is used.

What will now happen to the people who have been granted these drugs already? Will they be denied now and condemned? Here's an example of a patient in such a situation:

http://www.kidneycancerresource.com...KC%29_15-Aug-08

Why would we want to put these people through so much stress? I hope I'm lucky and now free of cancer, however I can tell you from personal experience that the stress and turmoil this puts you through is unimaginable unless you've been there. To expect a patient to have to beg for a drug they know will help is unforgivable. Look at Jean Murphy who even got a human rights ruling against her local PCT and yet still they refused.

Anyway I could talk about this at length, however I hope you'll take the time to dig into more detail and help the Kidney Cancer patients that have been given less than 20 days to get their responses into NICE on the dreadful decision. Maybe you'd have access to the people who gave us such short notice to co-ordinate our responses?

Thanks

Andy

• To view more of my reactions to the N.I.C.E decision in my external Blog Click Here

• To view more of my reactions to the N.I.C.E decision in my external Blog Click Here

For those who'd prefer to see it on KCR:

N.I.C.E Say We’re Mean…………

It’s hard to feel sorry for them, let’s face it they’ll probably all have private health cover and will never be left in a position where they have to go down on bended knee to beg for drugs to keep them alive, do I feel sorry for them, do I feel we’re being “mean”….. no. Finally they’re getting shown up.

There’s been a huge amount of news coverage over the last week or so about the dreadful decision by N.I.C.E who have said no to SUTENT, NEXAVAR, AVASTIN and TORISEL being freely available on the NHS. It’s been hard for KCR to keep up with them all, which is great, finally some real traction.

This has been a devastating blow to mRCC patients across the UK. People who have already won their PCT appeals are now left wondering if their treatment will continue. For those who are waiting to go to appeal it means an almost definite no as the PCTs collectively stand behind the N.I.C.E decision. Before this announcement you could expect a chance of receiving the drug, in North West for example the PCTs were allowing the drug, now the answer is a resounding no. It’s a disgrace.

So what’s happened in the media then? 5 articles today spread across the national media all telling us how angry the drug chief is at the high prices the pharmaceutical companies put on these drugs which is making them too costly for the NHS. He even said that people were being “mean” to N.I.C.E. Is this the media trying to bring a balance to the argument or is it because government agencies have better access to the media than the general public. I fear it maybe the latter. This needs a proper balanced debate with both sides of the party given an equal chance.

The Oxford Kidney Cancer Support Group was supposed to be getting an article in the Sunday Times today. This article would have told everyone about the demonstration against N.I.C.E on the 27th August at 12 noon at High Holborn in London. Kidney Cancer patients across the country will be diverging on the N.I.C.E headquarters’ to personally hand in their responses on the N.I.C.E decision. Good luck to them, I’ll certainly be there to offer my support.

These drugs offer an increased quality of life for patients, perhaps when the people at N.I.C.E actually see some of these patients face to face they may have a change of heart.

I find it irksome that N.I.C.E are blaming the pharmaceutical companies. Forgive me if I’m wrong but the costs are the same in any country, and still doesn’t excuse why a so called developed nation such as ours that is supposedly proud of its NHS system effectively condemns patients to death. It’s a feable argument and makes me think that they are clutching at straws and know that their decision is flawed.

I hope they’re on the run and will soon do a much needed u-turn on this cruel and heartless decision

• To view more of my reactions to the N.I.C.E decision in my external Blog Click Here

• To view my reaction to the N.I.C.E decision in my external Blog Click Here

Well, although I’m sitting under a gazebo in the mid-day sun getting a severe Vitamin D boost ☺ I’ve managed to take a back up of the site, so all is safe. Can’t promise I’ll be able to take another but I’ll try.

Although I don’t want to gloat, it’s absolutely fantastic out here. Swum with a few turtles, even watched one lay its eggs on the beach outside our villa the other day, which is pretty rare.

Have to say that running 10K each day in this heat is tough going and makes me feel like I’m at high altitude, but it’s the only way I can stop my stomach from expanding any further than absolutely necessary ☺

btw - On a more serious note, I was disgusted to see the news on Jean Murphy, how these people can sleep at night is beyond me!

• To view another entry in my external Blog today Click Here

I can't believe how poorly Jean Murphy is being treated

• To view today's entry in my external Blog Click Here

Just as a caveat, I've published this as an article on the web to help raise the profile of KCR so I have to admit I'm not saying anything new tnhat hasn't already been reported, but the more we can help get the KCR name out there the better for everyone. Being a bit of a geek when I see words like nanoparticle I automatically get excited!!

Such is the life of a techie.

As a btw - My wife's been entering me (and her) into various 1/2 marathons and 10k's over the coming months and I was thinking of maybe getting a few t-shirts made up pushing KCR ..... thoughts? I ran a 5.6K yesterday (The JP Morgan Chase in Battersea Park) and the t-shirts they had made up for the company I work for were fantastic, bright and highly visible slogans. I don't know how much it costs to get these things printed but I'll let you all know when i find out.

• To view today's entry in my external Blog Click Here

• To view today's entry in my external Blog Click Here

• To view today's entry in my external Blog Click Here

• To view today's entry in my external Blog Click Here

• To view today's entry in my external Blog Click Here

• To view today's entry in my external Blog Click Here

• To view today's entry in my external Blog Click Here

• To view today's entry in my external Blog Click Here. It's a bit geeky today, so sorry about that!

• To view today's entry in my external Blog Click Here

• To view today's entry in my external Blog Click Here

• Not exactly Kidney Cancer related but I added a new entry in my external Blog Click Here - Just love her music!

To view today's entry in my external Blog Click Here

To view today's entry in my external Blog Click Here

To view today's entry in my external Blog Click Here

To view today's entry in my external Blog Click Here

To view today's entry in my external Blog Click Here

To view today's entry in my external Blog Click Here

To view today's entry in my external Blog Click Here

It's been a busy day today.

I've been preparing to upgrade the KCR site to the latest version of the mediawiki software which I hope to get done tomorrow.

Also I've added the new "my blog" functionality. Blogs on the site have become quite popular and I want to make sure it's as simple as possible for users. Going forward they can just click on the "my blog" menu item at the top of the page and then click "Add New Entry" and then they're off!! They no longer have to worry about the complexities of creating titles and breaking the pages down into smaller chunks because this new software does it for them automatically.

The added bonus is that we now have a menu item on the left hand side bar "Recent Blogs", enabling everyone to see who been adding entries. Much easier than trawling through the Recent Items section.

New Blog Entry about kidney cancer