NICE one, Michael Rawlings

Dying for cash

Traduced, abused and misrepresented, Sir Michael Rawlings strikes back today. The accepted canard is that NICE are cruelly depriving the dying of weeks of life because of penny-pinching meanness.

Sir Michael is chairman of the National Institute for Clinical Excellence (NICE), which was recently hammered for failing to approve kidney cancer drugs.

He said, “Drugs are expensive because of "perverse incentives" in the pharmaceutical industry. Pharmaceutical companies have enjoyed double-digit growth year on year and they are out to sustain that, not least because their senior management's earnings are related to the share price.”

I had a meeting with Sir Michael at his invitation about five years ago on this issue. We agreed on everything. All I can fault him on in his claim today that ‘nobody’ has drawn attention to Big Pharma greed.

This blog on August the 7th said:-

“NICE cannot adopt a money no-object policy. That’s make-believe land not reality. But why are the drugs that cost pennies to manufacture priced at £30,000? The Big Pharmas blame the cost of research. At best that’s a half-truth. Even though the miraculous quality of the research is acknowledged.

All Big-Pharmas spend twice as much on marketing as they invest in research. Not marketing life saving drugs, but mass consumed medicines for trivial complaints. Their main investment is made to keep their profits buoyant. “

Sir Michael confirmed what I think is a deadly accusation, "Marketing costs generally are about twice the spend on research and development." Those are avoidable marketing costs. If the drugs work, they will sell themselves. Marketing is about multiplying profits.

Will this break through the permafrost of tabloid prejudice and ignorance that treats all new drugs as ‘miracle’ cures to be bought at any price? Big Pharma cynically exploit the suffering of the dying and their families to screw more money out the NHS budget.

Sir Michael said,” Kidney cancer drugs could be produced for about a tenth of their current cost, Rawlins said. While developing such medicines from scratch added to these costs, as did some 'unnecessary' bureaucracy around clinical trials, which should be scrapped, he said that was not the whole story. 'Part of the problem is that the pharmaceutical industry is looking at a very bad period in the future.

Share prices were driven by profits, he said. 'Pharmaceutical companies have enjoyed double-digit growth year on year and they are out to sustain that, not least because their senior management's earnings are related to the share price. It's not in their interests to take less profit, personally as well as from the point of view of the business. All these perverse incentives drive the price up.

The Big Guns of Big Pharma will now blast away at Sir Michael and NICE. It’s what they called ‘marketing’. Their PR riposte will be paid for eventually in the ballooning drugs budget of the NHS.

"Blessed be the price-cutters

for they will have  pollution eternal."

A prayer group in Washington DC is claiming the credit for the recent sharp drop in the US price of petrol. Rocky Twyman, 59, a veteran community campaigner, started Pray At The Pump meetings at petrol stations in April.

Since then, the average price of what the US calls gasoline has fallen from more than $4 a gallon to $3.80. More intensive praying needed there.

This week the group returned to the site of their first prayer meeting to celebrate. Singing "We shall overcome," they changed the words of the well-known hymn to "We'll have lower gas prices". How do they get that to work?

Now they have sorted out life's major problem, perhaps they'll now arrange to stop world poverty, war, disease and global warming.

Comments

[Andy Thomas]

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/index.php/Echo_%28KC%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

[PaulFlynn]

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.

[dotcommentator]

One only has to look at a GP's desk to get an idea of the volume of more crude promotional material that is sent out in the form of pens, notepads etc.

One of the Assembly Government's One Wales pledges was to rid the Welsh NHS of private sector involvement. What about the drugs?

[andy]

Good Old Marcia exposing the Pharma corruption.
The same Marcia Angell who co-wrote an editorial to the book 'Science Money and Politics' In this piece she asked why it was that the American Cancer Society only endorsed SmithKline Beecham's anti-smoking products.
The same Marcia Angell who when editor of the New England Journal of Medicine
responded to the EPA's RR (Relative Risk) of Second Hand Smoke causing lung cancer of 1.19 by saying:

"As a general rule of thumb, we are looking for a relative risk of 3 or more before accepting a paper for publication."

[Andy Thomas]

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

[David Gerard]

Of course they can't give away expensive cancer drugs, there's too much demand for free NHS Viagra. My take: http://notnews.today.com/2008/08/18/drug-firms-deny-pricing-for-profit/

[Andy Thomas]

Paul

You may want to listen to this BBC news link today

http://www.bbc.co.uk/iplayer/episode/b00d6801/b00d67ym/

Goto 5 mins 30 secs and listen from there

Thanks

Andy

[Jolly Roger]

Just a small but important point,
That may put a nose or two out of joint.
The National Institute for Clinical Excellence.
Is missing a word that adds to the sense.
The missing word is Health, it seems.
Which adds a whole new point to their schemes.
Clinical excellence is all very well.
Why do folks leave out Health. I really can't tell.

The acronym used here and elsewhere.
Is N.I.C.E. You should take more care,
To include the 'H' lest we forget it.
The acronym N.I.H.C.E should set it,
As an accurate acronym able to aid.
And bring Health to the fore in all that is said.
I sure that those patients who have been cruelly denied.
Think that their Health has been pushed to one side.

[paulflynn]

‘Health’ is the aim, Jolly Roger
But the ’H’ is an awkward lodger
in the tidy acronym of NICE
Which neatly rhymes with mice and spice

[paulflynn]

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.

[Andy Thomas]

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

[paulflynn]

As Sir Michael Rawlings has pointed out, NICE has not made its final decision on the kidney drugs. They will listen to the evidence, I'm sure. A reduction by the Pharmas to a reasonable price would clinch the deal.

[Johnny Boy]

RE. NICE one, Michael Rawlings.

Wow Socialism and stupidity really do ride hand-in-hand and have now perverted our health services so badly

Sir Michael Rawlings 'strikes back' at Big Pharma businesses with "Not marketing life saving drugs, but mass consumed medicines for trivial complaints. Their main investment is made to keep their profits buoyant. “

Where would Sir Rawlings like to throw investment at, a profitable sector or a low profit sector?

Sir Stupid may not have an economics, commercial or business background but like Socialism, private enterprise does not have the luxury of government of being able to extort ever large sums from the public pockets. Companies have to count costs, count the validity of investments and put their money where the returns are.

Similarly "life saving drugs" are an extremist minority health issue. Life killing disease is very rare (1 in 10,000 people) whereas the common cold or headaches effect more than 1 in 10 people. Sir Rawlings analysis ignores basic maths and exposes his stupidity on this issue.

It explains why a cold cure costs £2.99 for 12 tablets and a life saving drug costs £300 for 6 doses. R&D spread over mass production or micro low volume production is the capital costs something Socialism and stupidity cannot ignore (or like Russia go bankrupt and become technically inferior ignoring).

We cannot all behave like Socialists and the Labour Party with their out of control spending, throwing money at erroneous activities and expect the public to take kindly to being ripped off further by the legalised theft of a Chancellor to bail out his bankrupt books and credit card spending.

Sir Rawlings then says: "All these perverse incentives drive the price up."

Peoples pay being linked to performance on profits which drives value for shareholders is a capatalist lever to reward that perormance. Maybe if MP's and civil servants like Sir Rawlings pay and expenses were linked similarly to performance and value delivered £Billions could be wiped off the public bail out of failed and futile policy investments and wasteful, inefficient and inept public spending.

Sorry to insert some capatlist reality to rub up against the idealistic nonsense from Socialists.