Naughty and NICE

In the week that saw the wrecking of the Conservative party headquarters by student demonstrators the Coalition Government continued, more quietly, in its ongoing project of vandalism against the machinery of the British state.

This time it’s the National Institute of Health and Clinical Excellence (NICE) facing the axe. There have been many cruel and callous acts by this government during the six and a bit months it has been in office and it’s difficult to know where to begin when writing about them because cruelty and callousness often defy rational analysis.

Sheer stupidity, on the other hand, is easier to get a handle of and this move is profoundly and irredeemably stupid.

NICE was one of Labour’s more successful creations. It was designed to provide uniformity of access to innovative treatments and to control costs within the NHS by assessing every new treatment by a single standard. Treatments judged to be cost-effective would be offered to all NHS patients, whereas treatments judged too expensive would be rejected.

This idea was so simple and so effective that it soon began to attract international attention attention, as this New York Times article shows, with many other countries talking of introducing similar policies. Dr. Donald Berwick, the Administrator of the Centers for Medicare & Medicaid Services (CMS), in the US, described NICE as an “extremely effective, … conscientious, valuable and- importantly- knowledge building- system.”

The importance of NICE was that it tackled one of the major problems facing all advanced healthcare systems. The fundamental aims of healthcare – the treatment of ill health and the extension of lifespan – are goals without any natural limit. The ultimate logical aim, of immortality and perfect health, are forever out of reach and a country could very well expend all its resources in the effort.

This is particularly true given an intellectual property based model of healthcare innovation that means that drug developers can pretty much charge whatever they want and the end of the era of rapid advances in medical technology meaning that vast amounts of money could be spent on incremental improvements in outcome. NICE proved very effective at containing drugs costs by providing a clear non-negotiable cap on what the NHS would pay for treatments. It also helped to shield British patients from over-hyped and ineffective treatments.

Naturally, the pharmaceutical industry didn’t take this challenge to its control over drugs pricing lying down, whipping patients into a frenzy over “life-saving” treatments that were being denied, and creating fake patient advocacy groups. The tabloids relentlessly pushed this narrative, carrying multiple, emotive articles highlighting patients stories, and blaming NICE relatively poor cancer outcomes in the UK; a claim that makes no sense – the months of survival benefit these drugs have shown in clinical trials does not translate into years of advantage on a population level.

This campaign has often led to NICE being steadily undermined, a process that began with the Labour government intervening to ensure the approval of Herceptin for breast cancer in 2006, and continues with the coalition, first creating a separate fund to pay for refused cancer treatments, effectively neutering NICE in price negotiations, before removing its powers to approve or refuse new drugs altogether.

Health Secretary, Andrew Lansley, wants to replace this function with what he calls “value based pricing”. This will mean companies negotiating directly with the Department of Health over prices, and drugs being approved or refused directly by local GP consortia.

This plan is riddled with potential problems.

The DoH will be subject to extensive lobbying by industry and political pressure not to be seen to be denying drugs to needy patients – the ball will be entirely in the drug companies’ court and they know it.

GPs have neither the time, objectivity nor clout to handle these negotiations. Dr Ben Goldacre has written that it would take GPs 600 hours a month to read all the studies relevant to primary care alone, and that drugs companies are adept at massaging the data to favour their products, for example by failing to publish negative data and using positive data in multiple studies in different journals. These are tricks that are difficult to spot by all but the most careful reader, and certainly to busy GPs, themselves subject to corporate marketing and “hospitality.”

This plan effectively removes the ability of the NHS to force the pharmaceutical companies to lower prices, the GPs don’t have the clout to stand up to big multinational corporations and the government certainly doesn’t have the political will. It’s safe to say that the champagne corks will be popping in the boardrooms of those companies and their lobbyists (lobbyists such as the one wheeled out to defend the changes in the Guardian editorial linked to at the top of this paragraph) at the news.

Further to the reforms of the funding of the new medical treatments, we hear the news that many of the regulatory functions of the Food Standards Agency (FSA) with ”food networks” including representatives of the food companies to discuss “voluntary not regulatory approaches.”

We can see very clearly where Lansley’s political sympathies lie. He cannot plead ignorance, certainly on the issue of healthcare. He has spoken about the issue many times with Private Eye’s “MD” columnist (aka Phil Hammond), who has christened him “la-la Lansley,” assuring him that he has fully understood the need for rationing in the NHS.

These moves completely contradict the Conservative portion of the Coalition’s stated raison d’etre of fiscal responsibility- in an era of tightening health budgets, diverting precious resources to a small and vocal group of patients, to little end, and to pay to patch up an increasingly unhealthy public. This cuts away the myths of Conservative principles, exposing their core values of deference to business, deference to wealth and pathological hatred of the state.

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9 Responses to Naughty and NICE

  1. Is this not double facepalm worthy? Or are you saving it for something even dumber.

  2. John77 says:

    NICE is nice in theory but you unfortunately fail to grasp a single one of the complaints. The first major decision by NICE was over Glaxo’s flu vaccine – NICE decided it wasn’t worth the price; Glaxo thought it was worth it and offered every employee a free jab: the UK suffered one of its worst ‘flu epidemics that winter from which Glaxo employees were completely (well, all the ones I knew of heard about) exempt. The NHS now offers free ‘flu jabs to everyone over 60.
    Drug developers CANNOT charge whatever they want – the VPRS limits the profits earned from the NHS by UK pharmaceutical companies (including the UK research operations of US and other foreign companies) and compulsory licensing was invented by one J. Enoch Powell (what? did you think he was a right-winger?) to deal with Pfizer’s attempts to rip us off.
    NICE has NOT stopped ineffective treatments – cosmetic surgery and homeopathy were available on the NHS under New Labour.
    The postcode lottery continues (although the Coalition has stated that it will end it as soon as it can).
    IF YOU UNDERSTOOD PPRS/VPRS you would see that NICE is a waste of space: its only reason for existance was the economic illiteracy of Gordon Brown and his minions

    • hannahpaperbackrioter says:

      I’d like a citation for your story please, it doesn’t make a lot of sense given that NICE isn’t responsible for decisions on vaccines, only medicines and medical devices. Vaccine policy is the responsibility of the JCVI a completely separate body. The decision making process is different for vaccines ,because in many ways, you’re treating a population as well as an individual, and the risk of someone being exposed to or contracting a disease is a function of the vaccination status of everyone else they’re in contact with as well as whether or not they personally are vaccinated. Having said that, whilst googling to try to make head or tail of your comment, I discovered that the government is considering merging the two bodies- not a good idea for the above reasons and given that JCVI has all the expertise in this area.

      I’m not sure where Gordon Brown is supposed to come into this as NICE was set up in 1999, under the Blair government with Frank Dobson as health secretary. Also, Enoch Powell was right wing and the fact that he introduced a very modest, voluntary, form of regulation to ensure the safety (not cost effectiveness) of drugs, in the wake of the Thalidomide disaster, doesn’t change that.

      You are correct, however, that their were price ceilings in place before NICE, but again these were voluntary. In order to negotiate effectively with industry the NHS needs the big stick of contol of access to the UK drugs market. In any case NICE has the esteem of clinicians and health economists around the world, as I stated in my article, so your opinion of NICE as a waste of space does not seem to be shared by those in the know.

      Finally, cosmetic surgery could be considered effective under its own terms. My understanding is that it’s only available on the NHS it there was a high risk of psychological harm, which would mainly be in cases of serious disfigurement. Homeopathy, for all it’s faults is cheap and relatively safe (they’re only placebos, after all) and doesn’t compete with the newest patent medicines as a contributor to healthcare costs.

      • John77 says:

        @ Hannah
        You could read http://www.medinfo.co.uk/topics/relenza.html which specifically names NICE as rejecting the vaccine on cost grounds (and appears to be written by their press officer), also
        http://www.statistics.gov.uk/cci/nugget.asp?id=574
        which shows that it resulted in approaching 50,000 deaths.
        Secondly, the JCVI describes itself as “JCVI is a Standing Advisory Committee with statutory responsibilities to advise Ministers.” It is purely advisory and has no control over the NHS.
        Thirdly, Gordon Brown comes into this because NICE was a means to control costs in the NHS because he committed himself to stick to Ken Clarke’s spending plans and then decided to give Nurses a bigger pay rise than Ken Clarke had planned but did NOT increase the NHS budget to take account of the extra pay bill – that was economically illiterate
        Fourthly I said Enoch Powell introduced compulsory licensing of Pfizer’s drugs, NOT that he introduced VPRS – he didn’t.
        Fifthly, you just don’t get the point about PPRS/VPRS – these limited the maximum amount of profit that Glaxo, Zeneca etc could make from selling patented pharmaceuticals in the UK. If one price went up then, unless it was solely to compensate for a rise in costs of raw materials, another had to come down. What NICE does is attack the price of individual drugs without changing the total cost to the NHS – so in economic terms it is a waste of space and any health economist who doesn’t understand the NHS contract with the UK Pharmaceutical industry should not pontificate on it, but in fact Dr Berwick does not actually do so – he would like a body in the USA that could set price limits for Medicaid drugs and save him unlimited hassle, and what he likes is that NICE uses a system to evaluate cost-effectiveness of drugs. He does NOT discuss the cost-effectiveness of NICE itself or the accuracy of any of its judgements.
        The price control under VPRS was voluntary, the profit control was enforcible – and was, when necessary, enforced. That is a big enough stick – and is a lot more effective than maximum prices as costs per unit fall once economies of scale come in and companies continually seek to improve manufacturing techniques and product yields. Profit controls lead to falling prices as drugs mature.
        “My understanding is that it’s only available on the NHS it there was a high risk of psychological harm,” – that risk is always a matter of opinion
        Homeopathy is relatively safe except for the times when patients are lured into using it as a substitute for essential medical treatment (e.g. antibiotics)

    • hannahpaperbackrioter says:

      Sorry for not replying sooner. Relenza is post exposure prophylactic medication not a vaccine, but that’s a forgivable error given that the whole media made exactly the same one with Tamiflu. It does still call into question whether your Glaxo story holds water as it’s delivered as an inhaler, not a jab, and only after exposure. Doctors hated it, as with these things you never quite know the side effects until it’s been rolled out to a large population, so with a low risk population its best to leave it. Also, it has everyone with a cough or cold traipsing into the surgery, which can overwhelm your resources in the case of a serious outbreak, preventing them being focussed on more serious cases.
      With cost controls, multiple methods can be useful. JCVI is still negotiated on a voluntary basis with the drugs companies which limits it’s ambition. NICE is recognised internationally as one of the most promising innovations in health economics and, as they say, imitation is the sincerest form of flattery, Dr Berwick described NICE as “scientifically based,” “valuable,” and “knowledge building.” You don’t get much more unequivocal than that.
      I agree with you on homeopathy but disagree that it is a significant issue in health care costs, unlike the cost of some newly developed drugs.

      • hannahpaperbackrioter says:

        Also, the article you linked to stated that the NHS was already offering actual vaccines to high risk populations in 1999. Outbreaks happen for all sorts of reasons, it’s impossible to attribute that one to the absence of Relenza.

      • John77 says:

        Thanks for the detailed explanation but (i) the main difference between vaccine and prophylactic is that journalists can spell “vaccine”. Relenza is effective in preventing an attack of influenza if taken prior to infection as well as relieving symptoms if taken after the patient is effected. In rare cases it promotes an immune reaction (which is why the inferior tamiflu outsold it in the USA – Glaxo Wellcome published warnings about bronchospasm while Hoffman-La Roche said virtually nothing about side-effects or resistance – so it is also an antigen. Hence Relenza satisfies the dictionary definition of a vaccine.
        (ii) Doctors did NOT hate it: they were quite willing to administer it (well, at least round here) as they prefer to give a preventative dose to a half-a-dozen well patients than have one come in with ‘flu that they cannot cure.
        (iii) it’s not my “story”, just my memory of what actually happened
        “With cost controls, multiple methods can be useful.” Generally true, but New Labour managed to increase NHS costs by having its spin doctors instead of medical doctors determine policy – that is a whole separate issue (actually three or four separate issues, and in one case it is difficult to express my opinions in the presence of a young lady) – and NICE produces no economic benefit and periodically results in a healthcare disbenefit.
        Oh, by the way, vaccines don’t have to be a jab – do you remember polio vaccine on a sugar cube? (I don’t, I’m too old)

  3. John77 says:

    “Outbreaks happen for all sorts of reasons, it’s impossible to attribute that one to the absence of Relenza.”
    It is quite possible because a lot of people did do so – and not just Glaxo staff (the production-line guys had a bit of an “I told you so” attitude). If you have a drug that can stop an outbreak in its tracks and NICE tells doctors that they cannot use it then a few cases can turn into an epidemic so they did. It’s not rocket science, it is the first (or at most second) week of an elementary course in stochastics. The first handful of cases were nothing to do with the NICE decision but NICE *was* responsible for it turning into an epidemic.
    The NHS have never pubically admitted it, as far as I know, but as soon as the newspapers had stopped talking about it they launched a campaign to get all, or most, over-65s vaccinated for the 2000-01 season and ever since then they’ve been gettiing at about two out of three over-65s vaccinated.
    Also, since Relenza relieves the symptoms if taken after the patient is infected a £24 dose probably saves two days off work for him/her, if a worker, as well as a fairly large number of the 50,000 lives lost among the retired population. A day’s wage is £40 or more. Cost-effectiveness, my sainted aunt!

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